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Most Recent Highlights In Environmental

2021-11-15T06:00:00Z

86 FR 62917 Significant New Use Rules on Certain Chemical Substances (20-10.B)

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2020-0497; FRL-8215-01-OCSPP]

RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (20-10.B)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is issuing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances which were the subject of premanufacture notices (PMNs). This action requires persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use by this rule. This action further requires that persons not commence manufacture or processing for the significant new use until they have submitted a Significant New Use Notice (SNUN), EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken any risk management actions as are required as a result of that determination.

DATES: This rule is effective on January 14, 2022. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on November 29, 2021.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: William Wysong, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-4163; email address: wysong.william@epa.gov.

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

  • Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA, which would include the SNUR requirements. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import provisions. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR 721.20, any persons who export or intend to export a chemical substance that is the subject of this rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

B. How can I access the docket?

The docket includes information considered by the Agency in developing the proposed and final rules. The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0497, is available at https://www.regulations.gov and at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets.

Due to the public health emergency, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

II. Background

A. What action is the Agency taking?

EPA is finalizing SNURs under TSCA section 5(a)(2) for chemical substances which were the subject of PMNs P-18-289, P-18-330, P-18-334, P-18-335, and P-18-337. These SNURs require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.

Previously, in the Federal Register of October 20, 2020 (85 FR 66506) (FRL-10015-28), EPA proposed SNURs for these chemical substances. More information on the specific chemical substances subject to this final rule can be found in the Federal Register document proposing the SNURs. The docket includes information considered by the Agency in developing the proposed and final rules, including public comments and EPA's responses to the public comments received on the proposed rules, as described in Unit IV.

B. What is the Agency's authority for taking this action?

TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four TSCA section 5(a)(2) factors listed in Unit III.

C. Do the SNUR general provisions apply?

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before manufacture or processing for the significant new use can commence. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register , a statement of EPA's findings.

III. Significant New Use Determination

A. Determination Factors

TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

  • The projected volume of manufacturing and processing of a chemical substance.
  • The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
  • The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
  • The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, and potential human exposures and environmental releases that may be associated with the substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit. During its review of these chemicals, EPA identified certain conditions of use that are not intended by the submitters, but reasonably foreseen to occur. EPA is designating those reasonably foreseen conditions of use as well as certain other circumstances of use as significant new uses.

B. Procedures for Significant New Uses Claimed as Confidential Business Information (CBI)

By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1) and has referenced it to apply to other SNURs.

Under these procedures a manufacturer or processor may request EPA to determine whether a specific use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in 40 CFR 721.1725(b)(1) with that under 40 CFR 721.11 into a single step.

If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the annual production volume limit is not exceeded by the amount identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.

IV. Public Comments

EPA received a public comment from one identifying entity on the proposed rule. The Agency's response is described in a separate Response to Public Comments document that is available in the public docket for this rulemaking. In addition, EPA received three anonymous comments. They were either general in nature and did not pertain to the proposed rule or were broadly supportive of the rule and requested no changes to the rule itself; therefore, no response is required. EPA made no changes to the final rule based on these comments.

V. Substances Subject to This Rule

EPA is establishing significant new use and recordkeeping requirements for chemical substances in 40 CFR part 721, subpart E. In Unit IV. of the proposed SNUR, EPA provided the following information for each chemical substance:

  • PMN number.
  • Chemical name (generic name, if the specific name is claimed as CBI).
  • Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).
  • Basis for the SNUR.
  • Potentially useful information.
  • CFR citation assigned in the regulatory text section of this final rule.

The regulatory text section of these rules specifies the activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated in the rules, may be claimed as CBI.

VI. Rationale and Objectives of the Rule

A. Rationale

During review of the PMNs submitted for the chemical substances that are the subject of these SNURs and as further discussed in Unit IV. of the proposed rule, EPA identified certain other reasonably foreseen conditions of use in addition to those conditions of use intended by the submitter. EPA has determined that the chemical under the intended conditions of use is not likely to present an unreasonable risk. However, EPA has not assessed risks associated with the reasonably foreseen conditions of use. EPA is designating these conditions of use as well as certain other circumstances of use as significant new uses. As a result, those significant new uses cannot occur without going through a separate, subsequent EPA review and determination process associated with a SNUN.

B. Objectives

EPA is issuing these SNURs because the Agency wants:

  • To have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.
  • To be obligated to make a determination under TSCA section 5(a)(3) regarding the use described in the SNUN, under the conditions of use. The Agency will either determine under section 5(a)(3)(C) that the significant new use is not likely to present an unreasonable risk, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, or make a determination under TSCA section 5(a)(3)(A) or (B) and take the required regulatory action associated with the determination, before manufacture or processing for the significant new use of the chemical substance can occur.
  • To be able to complete its review and determination on each of the PMN substances, while deferring analysis on the significant new uses proposed in these rules unless and until the Agency receives a SNUN.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at https://www.epa.gov/tsca-inventory.

VII. Applicability of the Rules to Uses Occurring Before the Effective Date of the Final Rule

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule were undergoing premanufacture review at the time of signature of the proposed rule and were not on the TSCA inventory. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for the chemical substances subject to these SNURs, EPA concluded at the time of signature of the proposed rule that the designated significant new uses were not ongoing.

EPA designated October 7, 2020 (the date of web posting of the proposed rule) as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule.

Persons who began commercial manufacture or processing of the chemical substances for a significant new use identified on or after that date will have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and EPA would have to take action under TSCA section 5 allowing manufacture or processing to proceed.

VIII. Development and Submission of Information

EPA recognizes that TSCA section 5 does not require development of any particular new information (e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, Order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.

In the absence of a rule, Order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. of the proposed rule lists potentially useful information for all SNURs listed here. Descriptions are provided for informational purposes. The potentially useful information identified in Unit IV. of the proposed rule will be useful to EPA's evaluation in the event that someone submits a SNUN for the significant new use. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance, which may assist with EPA's analysis of the SNUN.

EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol election. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). For more information on alternative test methods and strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.

The potentially useful information described in Unit IV. of the proposed rule may not be the only means of providing information to evaluate the chemical substance associated with the significant new uses. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA sections 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

  • Human exposure and environmental release that may result from the significant new use of the chemical substances.

IX. SNUN Submissions

According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

X. Economic Analysis

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket for this rulemaking.

XI. Statutory and Executive Order Reviews

Additional information about these statutes and executive orders can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulations and Regulatory Review

This action establishes SNURs for new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

According to PRA, 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.

The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

The listing of the OMB control numbers of the collection instruments and their subsequent codification in the table in 40 CFR 9.1 satisfies the display requirements of the PRA and OMB's implementing regulations at 5 CFR part 1320. Since this ICR was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table in 40 CFR part 9, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table in 40 CFR 9.1 without further notice and comment.

C. Regulatory Flexibility Act (RFA)

Pursuant to RFA section 605(b), 5 U.S.C. 601 et seq., I hereby certify that promulgation of this SNUR would not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and 11 in FY2018. Only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq. ).

E. Executive Order 13132: Federalism

This action will not have federalism implications because it is not expected to have a substantial direct effect on States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

This action will not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes, significantly or uniquely affect the communities of Indian Tribal governments and does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use

This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

In addition, since this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.

J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994).

K. Congressional Review Act (CRA)

This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA will submit a rule report containing this rule and other required information to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.

Dated: October 26, 2021.

Tala Henry,

Deputy Director, Office of Pollution Prevention and Toxics.

Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:

PART 9—OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT

1. The authority citation for part 9 continues to read as follows:

Authority:

7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.

2. In §9.1, amend the table by adding entries for §§721.11561 through 721.11565 in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances” to read as follows:

§9.1

OMB approvals under the Paperwork Reduction Act.

* * * * *

40 CFR citationOMB control No.
* * * * *
Significant New Uses of Chemical Substances
* * * * *
721.115612070-0012
721.115622070-0012
721.115632070-0012
721.115642070-0012
721.115652070-0012
* * * * *

* * * * *

PART 721—SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

3. The authority citation for part 721 continues to read as follows:

Authority:

15 U.S.C. 2604, 2607, and 2625(c).

4. Add §§721.11561 through 721.11565 to subpart E to read as follows:

Subpart E—Significant New Uses for Specific Chemical Substances

Sec.

* * * * *

§721.11561 2-[2-(methylcarboxymonocyclic)amino)ethoxy]alcohol (generic).

§721.11562 Formaldehyde, polymer with alkyl aryl ketone (generic).

§721.11563 Propanedioic acid, 1,3-dihexyl ester.

§721.11564 Propanedioic acid, 1,3-dicyclohexyl ester.

§721.11565Propanedioic acid, 2,2-bis(hydroxymethyl)-, 1,3-dicyclohexyl ester.

* * * * *

§721.11561 2-[2-(methylcarboxymonocyclic)amino)ethoxy]alcohol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2-[2-(methylcarboxymonocyclic)amino)ethoxy]alcohol (generic).(PMN P-18-289) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(j) and (s). For purposes of §721.80(s), the annual manufacture and importation volume is 80,000 kilograms.

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of §721.1725(b)(1) apply to paragraph (a)(2)(i) of this section.

§721.11562 Formaldehyde, polymer with alkyl aryl ketone (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as formaldehyde, polymer with alkyl aryl ketone (PMN P-18-330) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o).

(ii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=770.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c), (i) and (k) are applicable to manufacturers and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

§721.11563 Propanedioic acid, 1,3-dihexyl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as propanedioic acid, 1,3-dihexyl ester (PMN P-18-334; CAS No. 1431-37-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(g).

(ii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=3.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c), (i) and (k) are applicable to manufacturers and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

§721.11564 Propanedioic acid, 1,3-dicyclohexyl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as propanedioic acid, 1,3-dicyclohexyl ester (PMN P-18-335; CAS No. 1152-57-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(g).

(ii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=6.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c), (i) and (k) are applicable to manufacturers and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

§721.11565Propanedioic acid, 2,2-bis(hydroxymethyl)-, 1,3-dicyclohexyl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as propanedioic acid, 2,2- bis(hydroxymethyl)-, 1,3-dicyclohexyl ester (PMN P-18-337; CAS No. 2222732-46-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=95.

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (k) are applicable to manufacturers and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.

[FR Doc. 2021-24789 Filed 11-12-21; 8:45 am]

BILLING CODE 6560-50-P

EHS Monthly Round Up - September 2024

EHS Monthly Round Up - September 2024

In this September 2024 video, we'll review the most impactful environmental, health, and safety news.

Hi everyone! Welcome to the monthly news roundup video, where we’ll review the most impactful environmental, health, and safety news. Please view the content links in the transcript for more information about the topics I’ll be covering today. Let’s get started!

OSHA published its proposed heat illness rule on August 30. It applies to both indoor and outdoor work in general industry, construction, agriculture, and maritime. Comments on the proposal will be accepted until December 30. OSHA encourages both employers and workers to submit comments.

Fall protection for construction remained number one on OSHA’s list of Top 10 violations for the 14th year in a row. There was little movement among the other Top 10 entries, with Hazard Communication at number 2 and ladders at number 3.

OSHA may exclude volunteer emergency response organizations from its proposed emergency response rule. During the rule’s public comment period, the agency received numerous comments that raised serious economic feasibility concerns.

During its silica enforcement inspections, OSHA also found violations of the hazard communication, respiratory protection, and noise standards. Over 200 companies were targeted as part of the agency’s respirable crystalline silica emphasis program.

Employers can view workplace injury and illness trends using OSHA’s Severe Injury Report dashboard. This new online tool allows users to search the agency’s severe injury report database. Severe injuries and illnesses are those that result in inpatient hospitalization, amputation, or loss of an eye.

And finally, turning to environmental news, an EPA final rule impacts facilities that reclassify from major to area source status under the National Emission Standards for Hazardous Air Pollutants program. These facilities must continue to meet the major source emission standards for seven hazardous air pollutants.

Thanks for tuning in to the monthly news roundup. We’ll see you next month!

2021-12-27T06:00:00Z

86 FR 73131 Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 5) for Public Water Systems and Announcement of Public Meetings

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 141

[EPA-HQ-OW-2020-0530; FRL-6791-03-OW]

RIN 2040-AF89

Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 5) for Public Water Systems and Announcement of Public Meetings

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule and notice of public meetings.

SUMMARY: The U.S. Environmental Protection Agency (EPA) is finalizing a Safe Drinking Water Act (SDWA) rule that requires certain public water systems (PWSs) to collect national occurrence data for 29 per- and polyfluoroalkyl substances (PFAS) and lithium. Subject to the availability of appropriations, EPA will include all systems serving 3,300 or more people and a representative sample of 800 systems serving 25 to 3,299 people. If EPA does not receive the appropriations needed for monitoring all of these systems in a given year, EPA will reduce the number of systems serving 25 to 10,000 people that will be asked to perform monitoring. This final rule is a key action to ensure science-based decision-making and prioritize protection of disadvantaged communities in accordance with EPA's PFAS Strategic Roadmap. EPA is also announcing plans for public webinars to discuss implementation of the fifth Unregulated Contaminant Monitoring Rule (UCMR 5).

DATES: This final rule is effective on January 26, 2022. The incorporation by reference of certain publications listed in this final rule is approved by the Director of the Federal Register as of January 26, 2022.

ADDRESSES: EPA has established a docket for this action under Docket ID No. EPA-HQ-OW-2020-0530. All documents in the docket are listed on the https://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available electronically through https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Brenda D. Bowden, Standards and Risk Management Division (SRMD), Office of Ground Water and Drinking Water (OGWDW) (MS 140), Environmental Protection Agency, 26 West Martin Luther King Drive, Cincinnati, Ohio 45268; telephone number: (513) 569-7961; email address: bowden.brenda@epa.gov; or Melissa Simic, SRMD, OGWDW (MS 140), Environmental Protection Agency, 26 West Martin Luther King Drive, Cincinnati, Ohio 45268; telephone number: (513) 569-7864; email address: simic.melissa@epa.gov. For general information, visit the Ground Water and Drinking Water web page at: https://www.epa.gov/ground-water-and-drinking-water.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Summary Information

A. Purpose of the Regulatory Action

1. What action is EPA taking?

2. Does this action apply to me?

3. What is EPA's authority for taking this action?

4. What is the applicability date?

B. Summary of the Regulatory Action

C. Economic Analysis

1. What is the estimated cost of this action?

2. What are the benefits of this action?

II. Public Participation

A. What meetings have been held in preparation for UCMR 5?

B. How do I participate in the upcoming meetings?

1. Meeting Participation

2. Meeting Materials

III. General Information

A. How are CCL, UCMR, Regulatory Determination process, and NCOD interrelated?

B. What are the Consumer Confidence Reporting and Public Notice Reporting requirements for public water systems that are subject to UCMR?

C. What is the UCMR 5 timeline?

D. What is the role of “States” in UCMR?

E. How did EPA consider Children's Environmental Health?

F. How did EPA address Environmental Justice?

G. How did EPA coordinate with Indian Tribal Governments?

H. How are laboratories approved for UCMR 5 analyses?

1. Request To Participate

2. Registration

3. Application Package

4. EPA's Review of Application Package

5. Proficiency Testing

6. Written EPA Approval

I. What documents are being incorporated by reference?

1. Methods From the U.S. Environmental Protection Agency

2. Alternative Methods From American Public Health Association—Standard Methods (SM)

3. Methods From ASTM International

IV. Description of Final Rule and Summary of Responses to Public Comments

A. What contaminants must be monitored under UCMR 5?

1. This Final Rule

2. Summary of Major Comments and EPA Responses

a. Aggregate PFAS Measure

b. Legionella Pneumophila

c. Haloacetonitriles

d. 1,2,3-Trichloropropane

B. What is the UCMR 5 sampling design?

1. This Final Rule

2. Summary of Major Comments and EPA Responses

C. What is the sampling frequency and timing?

1. This Final Rule

2. Summary of Major Comments and EPA Responses

D. Where are the sampling locations and what is representative monitoring?

1. This Final Rule

2. Summary of Major Comments and EPA Responses

E. How long do laboratories and PWSs have to report data?

1. This Final Rule

2. Summary of Major Comments and EPA Responses

F. What are the reporting requirements for UCMR 5?

1. This Final Rule

2. Summary of Major Comments and EPA Responses

a. Data Elements

b. Reporting State Data

G. What are the UCMR 5 Minimum Reporting Levels (MRLs) and how were they determined?

1. This Final Rule

2. Summary of Major Comments and EPA Responses

H. What are the requirements for laboratory analysis of field reagent blank samples?

1. This Final Rule

2. Summary of Major Comments and EPA Responses

I. How will EPA support risk communication for UCMR 5 results?

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

B. Paperwork Reduction Act (PRA)

C. Regulatory Flexibility Act (RFA)

D. Unfunded Mandates Reform Act (UMRA)

E. Executive Order 13132: Federalism

F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use

I. National Technology Transfer and Advancement Act (NTTAA)

J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

K. Congressional Review Act (CRA)

VI. References

Abbreviations and Acronyms

μg/L Microgram per Liter

11Cl-PF3OUdS 11-chloroeicosafluoro-3-oxaundecane-1-sulfonic Acid

4:2 FTS 1H, 1H, 2H, 2H-perfluorohexane Sulfonic Acid

6:2 FTS 1H, 1H, 2H, 2H-perfluorooctane Sulfonic Acid

8:2 FTS 1H, 1H, 2H, 2H-perfluorodecane Sulfonic Acid

9Cl-PF3ONS 9-chlorohexadecafluoro-3-oxanone-1-sulfonic Acid

ADONA 4,8-dioxa-3H-perfluorononanoic Acid

AES Atomic Emission Spectrometry

ASDWA Association of State Drinking Water Administrators

ASTM ASTM International

AWIA America's Water Infrastructure Act of 2018

CASRN Chemical Abstracts Service Registry Number

CBI Confidential Business Information

CCL Contaminant Candidate List

CCR Consumer Confidence Report

CFR Code of Federal Regulations

CRA Congressional Review Act

CWS Community Water System

DBP Disinfection Byproduct

DWSRF Drinking Water State Revolving Fund

EPA United States Environmental Protection Agency

EPTDS Entry Point to the Distribution System

FR Federal Register

FRB Field Reagent Blank

GW Ground Water

GWRMP Ground Water Representative Monitoring Plan

HFPO-DA Hexafluoropropylene Oxide Dimer Acid (GenX)

HRL Health Reference Level

ICP Inductively Coupled Plasma

ICR Information Collection Request

IDC Initial Demonstration of Capability

LCMRL Lowest Concentration Minimum Reporting Level

LC/MS/MS Liquid Chromatography/Tandem Mass Spectrometry

MDBP Microbial and Disinfection Byproduct

MRL Minimum Reporting Level

NAICS North American Industry Classification System

NCOD National Contaminant Occurrence Database

NDAA National Defense Authorization Act for Fiscal Year 2020

NEtFOSAA N-ethyl Perfluorooctanesulfonamidoacetic Acid

NFDHA Nonafluoro‐3,6‐dioxaheptanoic Acid

ng/L Nanogram per Liter

NMeFOSAA N-methyl Perfluorooctanesulfonamidoacetic Acid

NPDWR National Primary Drinking Water Regulation

NTNCWS Non-transient Non-community Water System

NTTAA National Technology Transfer and Advancement Act

NTWC National Tribal Water Council

OGWDW Office of Ground Water and Drinking Water

OMB Office of Management and Budget

PFAS Per- and Polyfluoroalkyl Substances

PFBA Perfluorobutanoic Acid

PFBS Perfluorobutanesulfonic Acid

PFDA Perfluorodecanoic Acid

PFDoA Perfluorododecanoic Acid

PFEESA Perfluoro (2‐ethoxyethane) Sulfonic Acid

PFHpA Perfluoroheptanoic Acid

PFHpS Perfluoroheptanesulfonic Acid

PFHxA Perfluorohexanoic Acid

PFHxS Perfluorohexanesulfonic Acid

PFMBA Perfluoro‐4‐methoxybutanoic Acid

PFMPA Perfluoro‐3‐methoxypropanoic Acid

PFNA Perfluorononanoic Acid

PFOA Perfluorooctanoic Acid

PFOS Perfluorooctanesulfonic Acid

PFPeA Perfluoropentanoic Acid

PFPeS Perfluoropentanesulfonic Acid

PFTA Perfluorotetradecanoic Acid

PFTrDA Perfluorotridecanoic Acid

PFUnA Perfluoroundecanoic Acid

PN Public Notice

PRA Paperwork Reduction Act

PT Proficiency Testing

PWS Public Water System

QC Quality Control

RFA Regulatory Flexibility Act

SBA Small Business Administration

SBREFA Small Business Regulatory Enforcement Fairness Act

SDWA Safe Drinking Water Act

SDWARS Safe Drinking Water Accession and Review System

SDWIS/Fed Safe Drinking Water Information System Federal Reporting Services

SM Standard Methods for the Examination of Water and Wastewater

SOP Standard Operating Procedure

SPE Solid Phase Extraction

SRMD Standards and Risk Management Division

SW Surface Water

SWTR Surface Water Treatment Rule

TNCWS Transient Non-community Water System

TOF Total Organic Fluorine

TOP Total Oxidizable Precursors

UCMR Unregulated Contaminant Monitoring Rule

UMRA Unfunded Mandates Reform Act of 1995

U.S. United States

USEPA United States Environmental Protection Agency

I. Summary Information

A. Purpose of the Regulatory Action

1. What action is EPA taking?

This final rule requires certain public water systems (PWSs), described in section I.A.2 of this preamble, to collect national occurrence data for 29 PFAS and lithium. PFAS and lithium are not currently subject to national primary drinking water regulations, and EPA is requiring collection of data under UCMR 5 to inform EPA regulatory determinations and risk-management decisions. Consistent with EPA's PFAS Strategic Roadmap, UCMR 5 will provide new data critically needed to improve EPA's understanding of the frequency that 29 PFAS (and lithium) are found in the nation's drinking water systems and at what levels. This data will ensure science-based decision-making and help prioritize protection of disadvantaged communities.

2. Does this action apply to me?

This final rule applies to PWSs described in this section. PWSs are systems that provide water for human consumption through pipes, or constructed conveyances, to at least 15 service connections or that regularly serve an average of at least 25 individuals daily at least 60 days out of the year. A community water system (CWS) is a PWS that has at least 15 service connections used by year-round residents or regularly serves at least 25 year-round residents. A non-transient non-community water system (NTNCWS) is a PWS that is not a CWS and that regularly serves at least 25 of the same people over 6 months per year. Under this final rule, all large CWSs and NTNCWSs serving more than 10,000 people are required to monitor. In addition, small CWSs and NTNCWSs serving between 3,300 and 10,000 people are required to monitor (subject to available EPA appropriations and EPA notification of such requirement) as are the PWSs included in a nationally representative sample of CWSs and NTNCWSs serving between 25 and 3,299 people (see “Selection of Nationally Representative Public Water Systems for the Unregulated Contaminant Monitoring Rule: 2021 Update” for a description of the statistical approach for EPA's selection of the nationally representative sample (USEPA, 2021a), available in the UCMR 5 public docket). EPA expects to clarify the monitoring responsibilities for affected small systems by approximately July 1 of each year preceding sample collection, based on the availability of appropriations each year.

As in previous UCMRs, transient non-community water systems (TNCWSs) ( i.e., non-community water systems that do not regularly serve at least 25 of the same people over 6 months per year) are not required to monitor under UCMR 5. EPA leads UCMR 5 monitoring as a direct-implementation program. States, Territories, and Tribes with primary enforcement responsibility (primacy) to administer the regulatory program for PWSs under SDWA (hereinafter collectively referred to in this document as “states”), can participate in the implementation of UCMR 5 through voluntary Partnership Agreements (see discussion of Partnership Agreements in Section III.D of this preamble). Under Partnership Agreements, states can choose to be involved in various aspects of UCMR 5 monitoring for PWSs they oversee; however, the PWS remains responsible for compliance with the final rule. Potentially regulated categories and entities are identified in the following table.

CategoryExamples of potentially regulated entitiesNAICS *
* NAICS = North American Industry Classification System.
State, local, & Tribal governmentsState, local, and Tribal governments that analyze water samples on behalf of PWSs required to conduct such analysis; State, local, and Tribal governments that directly operate CWSs and NTNCWSs required to monitor924110
IndustryPrivate operators of CWSs and NTNCWSs required to monitor221310
MunicipalitiesMunicipal operators of CWSs and NTNCWSs required to monitor924110

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. To determine whether your entity is regulated by this action, you should carefully examine the definition of PWS found in Title 40 in the Code of Federal Regulations (CFR) at 40 CFR 141.2 and 141.3, and the applicability criteria found in 40 CFR 141.40(a)(1) and (2). If you have questions regarding the applicability of this action to a particular entity, please consult the contacts listed in the preceding FOR FURTHER INFORMATION CONTACT section of this preamble.

3. What is EPA's authority for taking this action?

As part of EPA's responsibilities under SDWA, the agency implements section 1445(a)(2), Monitoring Program for Unregulated Contaminants. This section, as amended in 1996, requires that once every five years, beginning in August 1999, EPA issue a list of not more than 30 unregulated contaminants to be monitored by PWSs. SDWA requires that EPA enter the monitoring data into the agency's publicly available National Contaminant Occurrence Database (NCOD) at https://www.epa.gov/sdwa/national-contaminant-occurrence-database-ncod.

EPA must vary the frequency and schedule for monitoring based on the number of people served, the source of supply, and the contaminants likely to be found. EPA is using SDWA Section 1445(a)(2) authority as the basis for monitoring the unregulated contaminants under this final rule.

Section 2021 of America's Water Infrastructure Act of 2018 (AWIA) (Pub. L. 115-270) amended SDWA and specifies that, subject to the availability of EPA appropriations for such purpose and sufficient laboratory capacity, EPA's UCMR program must require all PWSs serving between 3,300 and 10,000 people to monitor for the contaminants in a particular UCMR cycle, and ensure that only a nationally representative sample of systems serving between 25 and 3,299 people are required to monitor for those contaminants. EPA has developed this final rule anticipating that necessary appropriations will become available; however, to date, Congress has not appropriated additional funding ( i.e., funding in addition to the $2.0 million that EPA has historically set aside each year from the Drinking Water State Revolving Fund, using SDWA authority, to support UCMR monitoring at small systems) to cover monitoring expenses for all PWSs serving between 3,300 and 10,000 people. Provisions in the final rule enable the agency to adjust the number of these systems that must monitor based upon available appropriations.

AWIA did not amend the original SDWA requirements for large PWSs. Therefore, PWSs serving a population larger than 10,000 people continue to be responsible for participating in UCMR.

Section 7311 of the National Defense Authorization Act for Fiscal Year 2020 (NDAA) (Pub. L. 116-92) amended SDWA and specifies that EPA shall include all PFAS in UCMR 5 for which a drinking water method has been validated by the Administrator and that are not subject to a national primary drinking water regulation.

4. What is the applicability date?

The applicability date represents an internal milestone used by EPA to determine if a PWS is included in the UCMR program and whether it will be treated as small ( i.e., serving 25 to 10,000 people) or large ( i.e., serving more than 10,000 people). It does not represent a date by which respondents need to take any action. The determination of whether a PWS is required to monitor under UCMR 5 is based on the type of system ( e.g., CWS, NTNCWS, etc.) and its retail population served, as indicated by the Safe Drinking Water Information System Federal Reporting Services (SDWIS/Fed) inventory on February 1, 2021. SDWIS/Fed can be accessed at https://www.epa.gov/ground-water-and-drinking-water/safe-drinking-water-information-system-sdwis-federal-reporting. Examining water system type and population served as of February 1, 2021 allowed EPA to develop a draft list of PWSs tentatively subject to UCMR 5 and share that list with the states during 2021 for their review. This advance planning and review then allowed EPA to load state-reviewed PWS information into EPA's reporting system so that those PWSs can be promptly notified upon publication of this final rule. If a PWS receives such notification and believes it has been erroneously included in UCMR 5 based on an incorrect retail population, the system should contact their state authority to verify its population served as of the applicability date. If an error impacting rule applicability is identified, the state or the PWS may contact EPA to address the error. The 5-year UCMR 5 cycle spans January 2022 through December 2026, with preparations in 2022, sample collection between January 1, 2023, and December 31, 2025, and completion of data reporting in 2026. By approximately July 1 of the year prior to each year's sample collection ( i.e., by July 1, 2022 for 2023 sampling; by July 1, 2023 for 2024 sampling; and by July 1, 2024 for 2025 sampling) EPA expects to determine whether it has received necessary appropriations to support its plan to monitor at all systems serving between 3,300 and 10,000 people and at a representative group of 800 smaller systems. As EPA finalizes its small-system plan for each sample collection year, the agency will notify the small PWSs accordingly.

B. Summary of the Regulatory Action

EPA is requiring certain PWSs to collect occurrence data for 29 PFAS and lithium. This document addresses key aspects of UCMR 5, including the following: Analytical methods to measure the contaminants; laboratory approval; monitoring timeframe; sampling locations; data elements ( i.e., information required to be collected along with the occurrence data); data reporting timeframes; monitoring cost; public participation; conforming and editorial changes, such as those necessary to remove requirements solely related to UCMR 4; and EPA responses to public comments on the proposed rule. This document also discusses the implication for UCMR 5 of the AWIA Section 2021(a) requirement that EPA collect monitoring data from all systems serving more than 3,300 people “subject to the availability of appropriations.”

Regardless of whether EPA is able to carry out the small-system monitoring as planned, or instead reduces the scope of that monitoring, the small-system data collection, coupled with data collection from all systems serving more than 10,000 people under this action, will provide scientifically valid data on the national occurrence of 29 PFAS and lithium in drinking water. The UCMR data are the primary source of national occurrence data that EPA uses to inform regulatory and other risk management decisions for drinking water contaminant candidates.

EPA is required under SDWA Section 1445(a)(2)(C)(ii) to pay the “reasonable cost of such testing and laboratory analysis” for all applicable PWSs serving 25 to 10,000 people. Consistent with AWIA, EPA will require monitoring at as many systems serving 3,300 to 10,000 people as appropriations support (see Section IV.B of this preamble for more information on the agency's sampling design).

The agency received several public comments expressing concern that significant laboratory capacity will be needed to support the full scope envisioned for UCMR 5 PFAS monitoring. EPA anticipates that sufficient laboratory capacity will exist to support the expanded UCMR 5 scope. EPA's experience over the first four cycles of UCMR implementation has been that laboratory capacity quickly grows to meet UCMR demand. EPA also notes that the number of laboratories successfully participating in the early stages of the UCMR 5 laboratory approval program is a good indicator that there will be a robust national network of laboratories experienced in PFAS drinking water analysis.

By early 2022, EPA will notify all small CWSs and NTNCWSs serving between 3,300 and 10,000 people of their anticipated requirement to monitor, which EPA expects to confirm and schedule by July 1 preceding each collection year based on the availability of appropriations. The nationally representative sample of smaller PWSs described in Section I.A of this preamble will be similarly notified and advised of their schedules.

This final rule addresses the requirements of the NDAA by including all 29 PFAS that are within the scope of EPA Methods 533 and 537.1. Both of these methods have been validated by EPA for drinking water analysis.

C. Economic Analysis

1. What is the estimated cost of this action?

EPA estimates the total average national cost of this action would be $21 million per year over the 5-year effective period of the final rule (2022-2026) assuming EPA collects information from all systems serving between 3,300 and 10,000 people. All of these costs are associated with paperwork burden under the Paperwork Reduction Act (PRA). EPA discusses the expected costs as well as documents the assumptions and data sources used in the preparation of this estimate in the “Information Collection Request for the Final Unregulated Contaminant Monitoring Rule (UCMR 5)” (USEPA, 2021b). Costs are incurred by large PWSs (for sampling and analysis); small PWSs (for sampling); state regulatory agencies ( i.e., those who volunteer to assist EPA with oversight and implementation support); and EPA (for regulatory support and oversight activities, and analytical and shipping costs for samples from small PWSs). These costs are also summarized in Exhibit 1 of this preamble. EPA's estimates are based on executing the full monitoring plan for small systems ( i.e., including all systems serving 3,300 to 10,000 people and a representative group of 800 smaller systems). As such, those estimates represent an upper bound. If EPA does not receive the necessary appropriations in one or more of the collections years—and thus collects data from fewer small systems—the actual costs would be lower than those estimated here.

EPA received several comments on the cost of monitoring. EPA has accounted for the cost/burden associated with all of the PWS activities as part of the comprehensive cost/burden estimates. In order to provide the most accurate and updated cost estimate, EPA re-examined labor burden estimates for states, EPA, and PWS activities and updated costs of laboratory services for sample analysis, based on consultations with national drinking water laboratories, when developing this final rule.

The costs for a particular UCMR cycle are heavily influenced by the selection of contaminants and associated analytical methods. EPA identified three EPA-developed analytical methods (and, in the case of lithium, multiple optional alternative methods) to analyze samples for UCMR 5 contaminants. EPA's estimate of the UCMR 5 analytical cost is $740 per sample set ( i.e., $740 to analyze a set of samples from one sample point and one sample event for the 30 UCMR 5 contaminants).

Exhibit 1 of this preamble details the EPA-estimated annual average national costs (accounting for labor and non-labor expenses). Laboratory analysis and sample shipping account for approximately 65 percent of the estimated total national cost for the implementation of UCMR 5. EPA estimated laboratory costs based on consultations with multiple commercial drinking water testing laboratories. EPA's cost estimates for the laboratory methods include shipping and analysis.

EPA expects that states will incur modest labor costs associated with voluntary assistance with the implementation of UCMR 5. EPA estimated state costs using the relevant assumptions from the State Resource Model developed by the Association of State Drinking Water Administrators (ASDWA) (ASDWA, 2013) to help states forecast resource needs. Model estimates were adjusted to account for actual levels of state participation under UCMR 4. State assistance with EPA's implementation of UCMR 5 is voluntary; thus, the level of effort is expected to vary among states and will depend on their individual agreements with EPA.

EPA assumes that one-third of the systems will collect samples during each of the three sample-collection years from January 2023 through December 2025.

Exhibit 1—Estimated Average Annual Costs of UCMR 5 1
EntityAverage annual cost (million) (2022-2026) 2
1 Based on the scope of small-system monitoring described in AWIA.
2 Totals may not equal the sum of components due to rounding.
3 Labor costs pertain to PWSs, states, and EPA. Costs include activities such as reading the final rule, notifying systems selected to participate, sample collection, data review, reporting, and record keeping.
4 Non-labor costs will be incurred primarily by EPA and by large and very large PWSs. They include the cost of shipping samples to laboratories for testing and the cost of the laboratory analyses.
5 For a typical UCMR program that involves the expanded scope prescribed by AWIA, EPA estimates an average annual cost to the agency of $17M/year (over a 5-year cycle) ($2M/year for the representative sample of 800 PWSs serving between 25 and 3,299 people and $15M/year for all PWSs serving between 3,300 and 10,000 people). The projected cost to EPA for UCMR 5 implementation is lower than for a typical UCMR program because of lower sample analysis expenses. Those lower expenses are a result of analytical method efficiencies ( i.e., being able to monitor for 30 chemicals with only three analytical methods).
Small PWSs (25-10,000), including labor 3 only (non-labor costs 4 paid for by EPA)$0.3
Large PWSs (10,001-100,000), including labor and non-labor costs7.0
Very Large PWSs (100,001 and greater), including labor and non-labor costs2.2
States, including labor costs related to implementation coordination0.8
EPA, including labor for implementation and non-labor for small system testing5 10.5
Average Annual National Total20.8

Additional details regarding EPA's cost assumptions and estimates can be found in the Information Collection Request (ICR) (USEPA, 2021b), ICR Number 2040-0304, which presents estimated cost and labor hours for the 5-year UCMR 5 period of 2022-2026. Copies of the ICR may be obtained from the EPA public docket for this final rule under Docket ID No. EPA-HQ-OW-2020-0530.

2. What are the benefits of this action?

The public benefits from the information about whether or not unregulated contaminants are present in their drinking water. If contaminants are not found, consumer confidence in their drinking water should improve. If contaminants are found, related health effects may be avoided when subsequent actions, such as regulations, are implemented, reducing or eliminating those contaminants.

II. Public Participation

A. What meetings have been held in preparation for UCMR 5?

EPA held three public meetings on UCMR 5 over the period of 2018 through 2021. EPA held a meeting focused on drinking water methods for unregulated contaminants on June 6, 2018, in Cincinnati, Ohio. Representatives from state agencies, laboratories, PWSs, environmental organizations, and drinking water associations joined the meeting via webinar and in person. Meeting topics included an overview of regulatory process elements (including the Contaminant Candidate List (CCL), UCMR, and Regulatory Determination), and drinking water methods under development (see USEPA, 2018 for presentation materials). EPA held a second meeting on July 16, 2019, in Cincinnati, Ohio. Representatives from State agencies, Tribes, laboratories, PWSs, environmental organizations, and drinking water associations participated in the meeting via webinar and in person. Meeting topics included the impacts of AWIA, analytical methods and contaminants being considered by EPA, potential sampling design, and other possible aspects of the UCMR 5 approach (see USEPA, 2019a for meeting materials). EPA held two identical virtual meetings on April 6 and 7, 2021, during the public comment period for the proposed rule (see USEPA, 2021c for presentation materials). Topics included the proposed UCMR 5 monitoring requirements, analyte selection and rationale, analytical methods, the laboratory approval process, and ground water representative monitoring plans (GWRMPs). Representatives of state agencies, laboratories, PWSs, environmental organizations, and drinking water associations participated in the meeting via webinar. In Section II.B of this preamble, the agency is announcing additional meetings to be held in 2022, which will assist with implementation.

B. How do I participate in the upcoming meetings?

EPA will hold multiple virtual meetings during 2022 to discuss UCMR 5 implementation planning, data reporting using Safe Drinking Water Accession and Review System (SDWARS), and best practices for sample collection. Dates and times of the upcoming meetings will be posted on EPA's website at https://www.epa.gov/dwucmr/unregulated-contaminant-monitoring-rule-ucmr-meetings-and-materials. EPA anticipates hosting the meetings focused on implementation planning in spring 2022, and the SDWARS and sample-collection meetings in fall 2022. Stakeholders who have participated in past UCMR meetings and/or those who register to use SDWARS will receive notification of these events. Other interested stakeholders are also welcome to participate.

1. Meeting Participation

Those who wish to participate in the public meetings, via webinar, can find information on how to register at https://www.epa.gov/dwucmr/unregulated-contaminant-monitoring-rule-ucmr-meetings-and-materials. The number of webinar connections available for the meetings are limited and will be available on a first-come, first-served basis. If stakeholder interest results in exceeding the maximum number of available connections for participants in upcoming webinar offerings, EPA may schedule additional webinars, with dates and times posted on EPA's Unregulated Contaminant Monitoring Program Meetings and Materials web page at https://www.epa.gov/dwucmr/unregulated-contaminant-monitoring-rule-ucmr-meetings-and-materials.

2. Meeting Materials

EPA expects to send meeting materials by email to all registered participants prior to the meeting. The materials will be posted on EPA's website at https://www.epa.gov/dwucmr/unregulated-contaminant- monitoring-rule-ucmr-meetings-and-materials for people who do not participate in the webinar.

III. General Information

A. How are CCL, UCMR, Regulatory Determination process, and NCOD interrelated?

Under the 1996 amendments to SDWA, Congress established a multi-step, risk-based approach for determining which contaminants would become subject to drinking water standards. Under the first step, EPA is required to publish a CCL every five years that identifies contaminants that are not subject to any proposed or promulgated drinking water regulations, are known or anticipated to occur in PWSs, and may require future regulation under SDWA. EPA published the draft CCL 5 in the Federal Register on July 19, 2021 (86 FR 37948, July 19, 2021 (USEPA, 2021d)). Under the second step, EPA must require, every five years, monitoring of unregulated contaminants as described in this action. The third step requires EPA to determine, every five years, whether or not to regulate at least five contaminants from the CCL. Under Section 1412(b)(1)(A) of SDWA, EPA regulates a contaminant in drinking water if the Administrator determines that:

(1) The contaminant may have an adverse effect on the health of persons;

(2) The contaminant is known to occur or there is substantial likelihood that the contaminant will occur in PWSs with a frequency and at levels of public health concern; and

(3) In the sole judgment of the Administrator, regulation of such contaminant presents a meaningful opportunity for health risk reduction for persons served by PWSs.

For the contaminants that meet all three criteria, SDWA requires EPA to publish national primary drinking water regulations (NPDWRs). Information on the CCL and the regulatory determination process can be found at: https://www.epa.gov/ccl.

The data collected through the UCMR program are made available to the public through the National Contaminant Occurrence Database (NCOD) for drinking water. EPA developed the NCOD to satisfy requirements in SDWA Section 1445(g), to assemble and maintain a drinking water contaminant occurrence database for both regulated and unregulated contaminants in drinking water systems. NCOD houses data on unregulated contaminant occurrence; data from EPA's “Six-Year Review” of national drinking water regulations; and ambient and/or source water data. Section 1445(g)(3) of SDWA requires that EPA maintain UCMR data in the NCOD and use the data when evaluating the frequency and level of occurrence of contaminants in drinking water at a level of public health concern. UCMR results can be viewed by the public via NCOD ( https://www.epa.gov/sdwa/national-contaminant-occurrence-database-ncod ) or via the UCMR web page at: https://www.epa.gov/dwucmr.

B. What are the Consumer Confidence Reporting and Public Notice Reporting requirements for public water systems that are subject to UCMR?

In addition to reporting UCMR monitoring data to EPA, PWSs are responsible for presenting and addressing UCMR results in their annual Consumer Confidence Reports (CCRs) (40 CFR 141.153) and must address Public Notice (PN) requirements associated with UCMR (40 CFR 141.207). More details about the CCR and PN requirements can be viewed by the public at: https://www.epa.gov/ccr and https://www.epa.gov/dwreginfo/public-notification-rule, respectively.

C. What is the UCMR 5 timeline?

This final rule identifies a UCMR 5 sampling period of 2023 to 2025. Prior to 2023 EPA will coordinate laboratory approval, tentatively select representative small systems (USEPA, 2021a), organize Partnership Agreements, develop State Monitoring Plans (see Section III.D of this preamble), establish monitoring schedules and inventory, and conduct outreach and training. Exhibit 2 of this preamble illustrates the major activities that EPA expects will take place in preparation for and during the implementation of UCMR 5.

BILLING CODE 6560-50-P



BILLING CODE 6560-50-C

D. What is the role of “States” in UCMR?

UCMR is a direct implementation rule ( i.e., EPA has primary responsibility for its implementation) and state participation is voluntary. Under the previous UCMR cycles, specific activities that individual states agreed to carry out or assist with were identified and established exclusively through Partnership Agreements. Through Partnership Agreements, states can help EPA implement UCMR and help ensure that the UCMR data are of the highest quality possible to best support the agency decision making. Under UCMR 5, EPA will continue to use the Partnership Agreement process to determine and document the following: The process for review and revision of the State Monitoring Plans; replacing and updating PWS information, including inventory ( i.e., PWS identification codes (PWSID), facility identification code along with associated facility types and water source type, etc.); review of proposed GWRMPs; notification and instructions for systems; and compliance assistance. EPA recognizes that states often have the best information about their PWSs and encourages them to partner in the UCMR 5 program.

E. How did EPA consider Children's Environmental Health?

By monitoring for unregulated contaminants that may pose health risks via drinking water, UCMR furthers the protection of public health for all citizens, including children. Children consume more water per unit of body weight compared to adults. Moreover, formula-fed infants drink a large amount of water compared to their body weight; thus, children's exposure to contaminants in drinking water may present a disproportionate health risk (USEPA, 2011). The objective of UCMR 5 is to collect nationally representative drinking water occurrence data on unregulated contaminants for future regulatory consideration. Information on the prioritization process, as well as contaminant-specific information ( e.g., source, use, production, release, persistence, mobility, health effects, and occurrence), that EPA used to select the analyte list, is contained in “Information Compendium for Contaminants for the Final Unregulated Contaminant Monitoring Rule (UCMR 5)” (USEPA, 2021e), available in the UCMR 5 public docket.

Since this is a final rule to monitor for contaminants and not to reduce their presence in drinking water to an acceptable level, the rule does not concern environmental health or safety risks presenting a disproportionate risk to children that would be addressed by this action (See Section V.G Executive Order 13045 of this preamble). Therefore, Executive Order 13045 does not apply to UCMR. However, EPA's Policy on Evaluating Health Risks to Children, which ensures that the health of infants and children is explicitly considered in the agency's decision making, is applicable, see: https://www.epa.gov/children/epas-policy-evaluating-risk-children.

EPA considered children's health risks during the development of UCMR 5. This included considering public comments about candidate contaminant priorities. Many commenters supported the agency's inclusion of PFAS and lithium in UCMR 5. Some commenters requested that EPA consider children and infant health risks in its risk communication for UCMR 5.

Using quantitation data from multiple laboratories, EPA establishes statistically-based UCMR reporting levels the agency considers feasible for the national network of approved drinking water laboratories. EPA generally sets the reporting levels as low as is technologically practical for measurement by that national network of laboratories, even if that level is well below concentrations that are currently associated with known or suspected health effects. In doing so, EPA positions itself to better address contaminant risk information in the future, including that associated with unique risks to children.

F. How did EPA address Environmental Justice (EJ)?

EPA has concluded that this action is not subject to Executive Order 12898 because it does not establish an environmental health or safety standard (see Section V.J Executive Order 12898 of this preamble). EPA Administrator Regan issued a directive to all EPA staff to incorporate environmental justice (EJ) into the agency's work, including regulatory activities, such as integrating EJ considerations into the regulatory development processes and considering regulatory options to maximize benefits to communities that “continue to suffer from disproportionately high pollution levels and the resulting adverse health and environmental impacts.” In keeping with this directive, and consistent with AWIA, EPA will, subject to the availability of sufficient appropriations, expand UCMR 5 to include all PWSs serving between 3,300 and 10,000 people as described in Sections I.A.4 and IV.B of this preamble. If there are sufficient appropriations, the expansion in the number of participating PWSs will provide a more comprehensive assessment of contaminant occurrence data from small and rural communities, including disadvantaged communities.

By developing a national characterization of unregulated contaminants that may pose health risks via drinking water from PWSs, UCMR furthers the protection of public health for all citizens. If EPA receives the needed appropriations, the expansion in monitoring scope reflected in UCMR 5 ( i.e., including all PWSs serving 3,300 to 10,000 people) will better support state and regional analyses and determination of potential EJ-related issues that need to be addressed. EPA structured the UCMR 5 rulemaking process to allow for meaningful involvement and transparency. EPA organized public meetings and webinars to share information regarding the development and implementation of UCMR 5; consulted with Tribal governments; and convened a workgroup that included representatives from several states. EPA will support stakeholder interest in UCMR 5 results by making them publicly available, as described in Section III.A of this preamble, and by developing additional risk-communication materials to help individuals and communities understand the significance of contaminant occurrence.

EPA received multiple comments on environmental justice considerations. Commenters expressed support for the continued collection of U.S. Postal Service Zip Codes for each PWS's service area and requested that EPA provide multilingual UCMR materials. EPA will continue to collect Zip Codes for UCMR 5, as collected under UCMR 3 and UCMR 4, to support potential assessments of whether or not certain communities are disproportionately impacted by particular drinking water contaminants. EPA also intends to develop the sampling instructions, fact sheets, and data summaries in both English and Spanish.

G. How did EPA coordinate with Indian Tribal Governments?

EPA has concluded that this action has Tribal implications. However, it will neither impose substantial direct compliance costs on federally recognized Tribal governments, nor preempt Tribal law. (See section V.F Executive Order 13175 of this preamble).

EPA consulted with Tribal officials under the EPA Policy on Consultation and Coordination with Indian Tribes early in the process of developing this action to ensure meaningful and timely input into its development. EPA initiated the Tribal consultation and coordination process before proposing the rule by mailing a “Notification of Consultation and Coordination” letter on June 26, 2019, to the Tribal leadership of the then 573 federally recognized Tribes. The letter invited Tribal leaders and representatives of Tribal governments to participate in an August 6, 2019, UCMR 5 Tribal consultation and coordination informational meeting. Presentation topics included an overview of the UCMR program, potential approaches to monitoring and implementation for UCMR 5, and the UCMR 5 contaminants and analytical methods under consideration. After the presentation, EPA provided an opportunity for input and questions on the action. Eight representatives from five Tribes attended the August meeting. Tribal representatives asked clarifying questions regarding program costs to PWSs and changes in PWS participation per AWIA. EPA addressed the questions during the meeting. Following the meeting, EPA received and addressed one additional clarifying question from a Tribal representative during the Tribal consultation process. No other Tribal representatives submitted written comments during the UCMR 5 consultation comment period that ended September 1, 2019.

Prior to the August 2019 meeting, EPA provided additional opportunities for Tribal officials to provide meaningful and timely input into the development of the proposed rule. On July 10, 2019, EPA participated in a monthly conference call with the National Tribal Water Council (NTWC). EPA shared a brief summary of UCMR statutory requirements with the Council and highlighted the upcoming official Tribal meeting. EPA also invited Tribal leaders and representatives to participate in a public meeting, held on July 16, 2019, to discuss the development of the proposed rule. Representatives from six Tribes participated in the public meeting. Following the publication of the proposal, EPA advised the Indian Health Services of the 60-day public comment period to assist with facilitating additional Tribal comments on the proposed rule. EPA received no public comments from Tribal officials.

A complete summary of the consultation, titled, “Summary of the Tribal Coordination and Consultation Process for the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” is provided in the UCMR 5 public docket listed in the ADDRESSES section of this preamble.

H. How are laboratories approved for UCMR 5 analyses?

Consistent with prior UCMRs, this action maintains the requirement that PWSs use laboratories approved by EPA to analyze UCMR 5 samples. Interested laboratories are encouraged to apply for EPA approval as early as possible. The UCMR 5 laboratory approval process, which began with the publication of the UCMR 5 proposal, is designed to assess whether laboratories possess the required equipment and can meet laboratory-performance and data-reporting criteria described in this action.

EPA expects demand for laboratory support to increase significantly based on the greater number of PWSs expected to participate in UCMR 5. EPA anticipates that the number of participating small water systems will increase from the typical 800 to approximately 6,000 (see Exhibit 5 in Section IV.B of this preamble). In preparation for this increase, EPA will solicit proposals and award contracts to laboratories to support small system monitoring prior to the end of the proficiency testing (PT) program. As in previous UCMR programs, EPA expects that laboratories awarded contracts by EPA will be required to first be approved to perform all methods. The requirements for the laboratory approval process are described in steps 1 through 6 of the following paragraphs.

EPA will require laboratories seeking approval to: (1) Provide EPA with data documenting an initial demonstration of capability (IDC) as outlined in each method; (2) verify successful performance at or below the minimum reporting levels (MRLs) as specified in this action; (3) provide information about laboratory standard operating procedures (SOPs); and (4) participate in two EPA PT studies for the analytes of interest. Audits of laboratories may be conducted by EPA prior to and/or following approval, and maintaining approval is contingent on timely and accurate reporting. The “UCMR 5 Laboratory Approval Manual” (USEPA, 2021f), available in the UCMR 5 public docket, provides more specific guidance on EPA laboratory approval program and the specific method acceptance criteria. EPA has included sample-collection procedures that are specific to the methods in the “UCMR 5 Laboratory Manual,” and will address these procedures in our outreach to the PWSs that will be collecting samples.

The UCMR 5 laboratory approval program will provide an assessment of the ability of laboratories to perform analyses using the methods listed in 40 CFR 141.40(a)(3), Table 1 of this preamble. Laboratory participation in the program is voluntary. However, as in the previous UCMRs, EPA will require PWSs to exclusively use laboratories that have been approved under the program. EPA will post a list of approved UCMR 5 laboratories to https://www.epa.gov/dwucmr and will bring this to the attention of the PWSs in our outreach.

1. Request To Participate

Laboratories interested in the UCMR 5 laboratory approval program first email EPA at: UCMR_Lab_Approval@epa.gov to request registration materials. EPA began accepting requests beginning with the publication of the proposal in the Federal Register .

2. Registration

Laboratory applicants provide registration information that includes laboratory name, mailing address, shipping address, contact name, phone number, email address, and a list of the UCMR 5 methods for which the laboratory is seeking approval. This registration step provides EPA with the necessary contact information and ensures that each laboratory receives a customized application package.

3. Application Package

Laboratory applicants will complete and return a customized application package that includes the following: IDC data, including precision, accuracy, and results of MRL studies; information regarding analytical equipment and other materials; proof of current drinking water laboratory certification (for select compliance monitoring methods); method-specific SOPs; and example chromatograms for each method under review.

As a condition of receiving and maintaining approval, the laboratory must promptly post UCMR 5 monitoring results and quality control data that meet method criteria (on behalf of its PWS clients) to EPA's UCMR electronic data reporting system, SDWARS.

Based on the January 1, 2023 start for UCMR 5 sample collection, the deadline for a laboratory to submit the necessary registration and application information is August 1, 2022.

4. EPA's Review of Application Package

EPA will review the application packages and, if necessary, request follow-up information. Laboratories that successfully complete the application process become eligible to participate in the UCMR 5 PT program.

5. Proficiency Testing

A PT sample is a synthetic sample containing a concentration of an analyte or mixture of analytes that is known to EPA, but unknown to the laboratory. To be approved, a laboratory must meet specific acceptance criteria for the analysis of a UCMR 5 PT sample(s) for each analyte in each method, for which the laboratory is seeking approval. EPA offered three PT studies between publication of the proposed rule and final rule, and anticipates offering at least two additional studies. Interested laboratories must participate in and report data for at least two PT studies. This allows EPA to collect a robust dataset for PT results, and provides laboratories with extra analytical experience using UCMR 5 methods. Laboratories must pass a PT for every analyte in the method to be approved for that method and may participate in multiple PT studies in order to produce passing results for each analyte. EPA has taken this approach in UCMR 5, recognizing that EPA Method 533 contains 25 analytes. EPA does not expect to conduct additional PT studies after the start of PWS monitoring; however, EPA expects to conduct laboratory audits (remote and/or on-site) throughout the implementation of UCMR 5 on an as needed and/or random basis. Initial laboratory approval is contingent on successful completion of PT studies, which includes properly uploading the PT results to SDWARS. Continued laboratory approval is contingent on successful completion of the audit process and satisfactorily meeting all the other stated conditions.

6. Written EPA Approval

For laboratories that have already successfully completed steps 1 through 5, EPA sent the laboratory a notification letter listing the methods for which approval was “pending” ( i.e., pending promulgation of this final rule). Because no changes have been made to the final rule that impact the laboratory approval program, laboratories that received pending-approval letters will be notified of full approval without further action on their part. Approval actions for additional laboratories that successfully complete steps 1 through 5 will also be documented by EPA in writing.

I. What documents are being incorporated by reference?

The following methods are being incorporated by reference into this section for UCMR 5 monitoring. All method material is available for inspection electronically at https://www.regulations.gov (Docket ID No. EPA-HQ-OW-2020-0530), or from the sources listed for each method. The methods that may be used to support monitoring under this final rule are as follows:

1. Methods From the U.S. Environmental Protection Agency

The following methods are available at EPA's Docket No. EPA-HQ-OW-2020-0530.

(i) EPA Method 200.7 “Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry,” Revision 4.4, 1994. Available at https://www.epa.gov/esam/method-2007-determination-metals-and-trace-elements-water-and-wastes-inductively-coupled-plasma. This is an EPA method for the analysis of metals and trace elements in water by ICP-AES and may be used to measure lithium during UCMR 5. See also the discussion of non-EPA alternative methods for lithium in this section.

(ii) EPA Method 533 “Determination of Per- and Polyfluoroalkyl Substances in Drinking Water by Isotope Dilution Anion Exchange Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry,” November 2019, EPA 815-B-19-020. Available at https://www.epa.gov/dwanalyticalmethods/analytical-methods-developed-epa-analysis-unregulated-contaminants. This is an EPA method for the analysis PFAS in drinking water using SPE and LC/MS/MS and is to be used to measure 25 PFAS during UCMR 5 (11Cl-PF3OUdS, 8:2 FTS, 4:2 FTS, 6:2 FTS, ADONA, 9Cl-PF3ONS, HFPO-DA (GenX), NFDHA, PFEESA, PFMPA, PFMBA, PFBS, PFBA, PFDA, PFDoA, PFHpS, PFHpA, PFHxS, PFHxA, PFNA, PFOS, PFOA, PFPeS, PFPeA, and PFUnA).

(iii) EPA Method 537.1 “Determination of Selected Per- and Polyfluorinated Alkyl Substances in Drinking Water by Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS),” Version 2.0, March 2020, EPA/600/R-20/006. Available at https://www.epa.gov/dwanalyticalmethods/analytical-methods-developed-epa-analysis-unregulated-contaminants. This is an EPA method for the analysis of PFAS in drinking water using SPE and LC/MS/MS and is to be used to measure four PFAS during UCMR 5 (NEtFOSAA, NMeFOSAA, PFTA, and PFTrDA).

2. Alternative Methods From American Public Health Association—Standard Methods (SM)

The following methods are from American Public Health—Standard Methods (SM), 800 I Street NW, Washington, DC 20001-3710.

(i) “Standard Methods for the Examination of Water & Wastewater,” 23rd edition (2017).

(a) SM 3120 B, “Metals by Plasma Emission Spectroscopy (2017): Inductively Coupled Plasma (ICP) Method.” This is a Standard Method for the analysis of metals in water and wastewater by emission spectroscopy using ICP and may be used for the analysis of lithium.

(ii) “Standard Methods Online,” approved 1999. Available for purchase at https://www.standardmethods.org.

(a) SM 3120 B, “Metals by Plasma Emission Spectroscopy: Inductively Coupled Plasma (ICP) Method, Standard Methods Online,” revised December 14, 2020. This is a Standard Method for the analysis of metals in water and wastewater by emission spectroscopy using ICP and may be used for the analysis of lithium.

3. Methods From ASTM International

The following methods are from ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959.

(i) ASTM D1976-20, “Standard Test Method for Elements in Water by Inductively-Coupled Plasma Atomic Emission Spectroscopy,” approved May 1, 2020. Available for purchase at https://www.astm.org/Standards/D1976.htm. This is an ASTM method for the analysis of elements in water by ICP-AES and may be used to measure lithium.

IV. Description of Final Rule and Summary of Responses to Public Comments

EPA published “Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 5) for Public Water Systems and Announcement of Public Meeting;” Proposed Rule, on March 11, 2021 (86 FR 13846, (USEPA, 2021g)). The UCMR 5 proposal identified three EPA analytical methods, and multiple alternative methods, to support water system monitoring for 30 UCMR 5 contaminants (29 PFAS and lithium) and detailed other potential changes relative to UCMR 4. Among the other changes reflected in the UCMR 5 proposal were the following: Requirement for water systems serving 3,300 to 10,000 people to monitor per AWIA requirements “subject to the availability of appropriations”; provisions for sampling frequency, timing, and locations; submission timeframe for GWRMPs; data reporting timeframes; and reporting requirements.

EPA received 75 sets of comments from 72 public commenters, including other federal agencies, state and local governments, utilities and utility stakeholder organizations, laboratories, academia, non-governmental organizations, and other interested stakeholders. After considering the comments, EPA developed the final UCMR 5 as described in Exhibit 3 of this preamble. Except as noted, the UCMR 5 final rule approach is consistent with the proposed rule. A track-changes version of the rule language, comparing UCMR 4 to UCMR 5, (“Revisions to 40 CFR 141.35 and 141.40” (USEPA, 2021h)), is included in the electronic docket listed in the ADDRESSES section of this preamble.

This section summarizes key aspects of this final rule and the associated comments received in response to the proposed rule. EPA has compiled all public comments and EPA's responses in the “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble.

Exhibit 3—Key Elements of Final UCMR 5
NumberTitle
CFR rule sectionDescription of sectionCorresponding preamble section
NumberTitle
40 CFR 141.40(a)(3)Contaminants in UCMR 5Maintains proposed list of 29 PFAS and lithium for monitoringIV.A
40 CFR 141.35(d), 40 CFR 141.40(a)(2)(ii), and 40 CFR 141.40(a)(4)(ii)Scope of UCMR 5 applicabilityRevises the scope of UCMR 5 to reflect that small CWSs and NTNCWSs serving 25 to 10,000 people will monitor (consistent with AWIA), if they are notified by the agencyIV.B
40 CFR 141.40(a)(i)(B)Sampling frequency and timingMaintains proposed sample frequency (four sample events for SW, two sample events for GW)IV.C
40 CFR 141.35(c)(3)Sampling locations and Ground Water Representative Monitoring Plans (GWRMPs)Maintains proposed flexibility for PWSs to submit a GWRMP proposal to EPAIV.D
40 CFR 141.35(c)(6)(ii) and 40 CFR 141.40(a)(5)(vi)Reporting timeframeMaintains proposed timeframe (“within 90 days from the sample collection date”) for laboratories to post and approve analytical results in EPA's electronic data reporting system (for review by the PWS). Maintains proposed timeframe (“30 days from when the laboratory posts the data to EPA's electronic data reporting system”) for PWSs to review, approve, and submit data to the state and EPAIV.E
40 CFR 141.35(e)Reporting requirementsRemoves one proposed data element, maintains 27 proposed data elements, and clarifies the use of state dataIV.F
40 CFR 141.40(a)(3)Minimum reporting levels (MRL)Maintains proposed MRLs for contaminantsIV.G

A. What contaminants must be monitored under UCMR 5?

1. This Final Rule

EPA is maintaining the proposed list of UCMR 5 contaminants and the methods associated with analyzing those contaminants (see Exhibit 4 of this preamble). Further information on the prioritization process, as well as contaminant-specific information ( e.g., source, use, production, release, persistence, mobility, health effects, and occurrence), that EPA used to select the analyte list, is contained in “Information Compendium for Contaminants for the Final Unregulated Contaminant Monitoring Rule (UCMR 5)” (USEPA, 2021e). This Information Compendium can be found in the electronic docket listed in the ADDRESSES section of this preamble.

Exhibit 4—UCMR 5 Analytes
1 EPA Method 533 (Solid phase extraction (SPE) liquid chromatography/tandem mass spectrometry (LC/MS/MS)) (USEPA, 2019b).
2 EPA Method 537.1 Version 2.0 (Solid phase extraction (SPE) liquid chromatography/tandem mass spectrometry (LC/MS/MS)) (USEPA, 2020).
3 EPA Method 200.7 (Inductively coupled plasma-atomic emission spectrometry (ICP-AES)) (USEPA, 1994).
4 Standard Methods (SM) 3120 B (SM, 2017) or SM 3120 B-99 (SM Online, 1999).
5 ASTM International (ASTM) D1976-20 (ASTM, 2020).
Twenty-five Per- and Polyfluoroalkyl Substances (PFAS) using EPA Method 533 (SPE LC/MS/MS):
11-chloroeicosafluoro-3-oxaundecane-1-sulfonic acid (11Cl-PF3OUdS)perfluorodecanoic acid (PFDA).
1H, 1H, 2H, 2H-perfluorodecane sulfonic acid (8:2 FTS)perfluorododecanoic acid (PFDoA).
1H, 1H, 2H, 2H-perfluorohexane sulfonic acid (4:2 FTS)perfluoroheptanesulfonic acid (PFHpS).
1H, 1H, 2H, 2H-perfluorooctane sulfonic acid (6:2 FTS)perfluoroheptanoic acid (PFHpA).
4,8-dioxa-3H-perfluorononanoic acid (ADONA)perfluorohexanesulfonic acid (PFHxS).
9-chlorohexadecafluoro-3-oxanone-1-sulfonic acid (9Cl-PF3ONS)perfluorohexanoic acid (PFHxA).
hexafluoropropylene oxide dimer acid (HFPO-DA) (GenX)perfluorononanoic acid (PFNA).
nonafluoro‐3,6‐dioxaheptanoic acid (NFDHA)perfluorooctanesulfonic acid (PFOS).
perfluoro (2‐ethoxyethane) sulfonic acid (PFEESA)perfluorooctanoic acid (PFOA).
perfluoro‐3‐methoxypropanoic acid (PFMPA)perfluoropentanesulfonic acid (PFPeS).
perfluoro‐4‐methoxybutanoic acid (PFMBA)perfluoropentanoic acid (PFPeA).
perfluorobutanesulfonic acid (PFBS)perfluoroundecanoic acid (PFUnA).
perfluorobutanoic acid (PFBA)
Four Per- and Polyfluoroalkyl Substances (PFAS) using EPA Method 537.1 (SPE LC/MS/MS):
n-ethyl perfluorooctanesulfonamidoacetic acid (NEtFOSAA)perfluorotetradecanoic acid (PFTA).
n-methyl perfluorooctanesulfonamidoacetic acid (NMeFOSAA)perfluorotridecanoic acid (PFTrDA).
One Metal/Pharmaceutical using EPA Method 200.7 (ICP-AES) or alternate SM or ASTM:
lithium

2. Summary of Major Comments and EPA Responses

Those who expressed an opinion about the proposed UCMR 5 analytes were supportive of EPA's inclusion of the 29 PFAS and lithium. Commenters expressed mixed opinions on the consideration of additional contaminants, particularly “aggregate PFAS,” Legionella pneumophilia, haloacetonitriles, and 1,2,3-trichloropropane. The major comments and EPA responses regarding these contaminants are summarized in the discussion that follows.

a. Aggregate PFAS Measure

EPA received multiple comments encouraging the agency to validate and include a total organic fluorine (TOF) and/or total oxidizable precursors (TOP) technique in UCMR 5 as a screening tool to determine “total PFAS.” EPA also received comments expressing concern for the limitations of the analytical methodologies, including a lack of sensitivity and specificity for PFAS using TOF.

EPA has not identified a complete, validated, peer-reviewed aggregate PFAS method with the appropriate specificity and sensitivity to support UCMR 5 monitoring. EPA's Office of Water and Office of Research and Development are currently developing and evaluating methodologies for broader PFAS analysis in drinking water, however, the measurement approaches are subject to significant technical challenges. The sensitivity of TOF is currently in the low μg/L range, as opposed to the low ng/L range of interest required for PFAS analysis in drinking water. TOF is also not specific to PFAS. TOP, while focusing on PFAS, is limited to measuring compounds that can be detected by LC/MS/MS and the technique requires two LC/MS/MS analyses; one before oxidation and one after oxidation. EPA is evaluating the TOP approach to understand the degree to which certain precursors are oxidized, and subsequently measurable by LC/MS/MS, as well as the degree to which PFAS that were measured in the pre-oxidation sample are still measured post-oxidation.

EPA is also monitoring progress by commercial laboratories and academia. In 2020 and 2021, EPA contacted commercial laboratories that advertised TOF capability, and these laboratories indicated that they had not yet commercialized the TOF method (see Appendix 4 in “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble). TOP has been more widely commercialized but is often used as an exploratory tool to estimate precursors.

In summary, there are still analytical challenges leading to uncertainties in the results using the TOF and TOP techniques. More research and method refinement are needed before a peer-reviewed validated method that meets UCMR quality control needs is available to address PFAS more broadly.

b. Legionella Pneumophila

Some comments supported EPA's proposal to not include Legionella pneumophila in UCMR 5, while others encouraged EPA to add it. EPA has decided not to include Legionella pneumophila in the final UCMR 5.

Under EPA's Surface Water Treatment Rule (SWTR), EPA established NPDWRs for Giardia, viruses, Legionella, turbidity and heterotrophic bacteria and set maximum contaminant level goals of zero for Giardia lamblia, viruses and Legionella pneumophila (54 FR 27486, June 29, 1989 (USEPA, 1989)). EPA is currently examining opportunities to enhance protection against Legionella pneumophila through revisions to the suite of Microbial and Disinfection Byproduct (MDBP) rules. In addition to the SWTR, the MDBP suite includes the Stage 1 and Stage 2 Disinfectants and Disinfection Byproduct Rules; the Interim Enhanced Surface Water Treatment Rule; and the Long Term 1 Enhanced Surface Water Treatment Rule.

As stated in the conclusions from EPA's third “Six-Year Review of Drinking Water Standards” (82 FR 3518, January 11, 2017 (USEPA, 2017)), “EPA identified the following NPDWRs under the SWTR as candidates for revision, because of the opportunity to further reduce residual risk from pathogens (including opportunistic pathogens such as Legionella ) beyond the risk addressed by the current SWTR.” In accordance with the dates in the Settlement Agreement between EPA and Waterkeeper Alliance ( Waterkeeper Alliance, Inc. v. U.S. EPA, No. 1:19-cv-00899-LJL (S.D.N.Y. Jun. 1, 2020)), the agency anticipates signing a proposal for revisions to the MDBP rules and a final action on the proposal by July 31, 2024 and September 30, 2027, respectively. EPA has concluded that UCMR 5 data collection for Legionella pneumophila would not be completed in time to meaningfully inform MDBP revision and that UCMR 5 data for Legionella pneumophila would soon lack significance because it would not reflect conditions in water systems after any regulatory revisions become effective (because water quality would be expected to change as a result of PWSs complying with such regulatory revisions).

EPA estimates that Legionella pneumophila monitoring under UCMR 5 would have added $10.5 million in new expenses for large PWSs, $20 million in new expenses for the agency for small system monitoring, and $0.5 million in new expenses for small PWSs and states over the 5-year UCMR period. Because the data would not be available in time to inform MDBP regulatory revisions and because MDBP revisions could change the presence of Legionella pneumophila in drinking water distribution systems ( Legionella occurrence may change, for example, if the required minimum disinfectant residual concentration is higher following MDBP revisions), EPA concluded that the expense of this monitoring is not warranted given the limited utility of the data.

c. Haloacetonitriles

Some commenters agreed with EPA's rationale for not including the four unregulated haloacetonitrile disinfection byproducts (DBPs) in UCMR 5, while others encouraged EPA to include them. EPA has decided not to include haloacetonitrile DBPs in the final UCMR 5.

As was the case with Legionella pneumophila, EPA has concluded that UCMR 5 data collection for haloacetonitriles would not be completed in time to meaningfully inform MDBP revision and that UCMR 5 data would not reflect conditions in water systems after any regulatory revisions become effective (haloacetonitrile occurrence may change, for example, if the required minimum disinfectant residual concentration is higher following MDBP revisions).

As with Legionella pneumophila, inclusion of haloacetonitriles in UCMR 5 would introduce significant monitoring and reporting complexity and cost compared to the sampling design for PFAS and lithium. If haloacetonitriles were to be added to UCMR 5, most of the additional expenses would be borne by large PWSs (for analysis of their samples) and EPA (for analysis of samples from small PWSs). EPA estimates this would result in $13 million in new expenses for large PWSs, $19 million in new expenses for the agency, and $0.5 million in new expenses for small PWSs and states over the 5-year UCMR period.

Because the data would not be available in time to inform MDBP regulatory revisions and because MDBP revisions could change the presence of haloacetonitriles in drinking water distribution systems, EPA concluded that the expense of this monitoring is not warranted given the limited utility of the data.

d. 1,2,3-Trichloropropane

EPA received some comments that support the agency's proposed decision to not include 1,2,3-trichloropropane (1,2,3-TCP) monitoring in UCMR 5, and others recommending that 1,2,3-TCP be included. EPA concluded that appropriate analytical methods are not currently available to support additional UCMR data collection ( i.e., above and beyond the data collection under UCMR 3 (USEPA, 2019c)).

Several commenters suggested that EPA consider analytical methods to monitor for 1,2,3-trichloropropane at lower levels. They suggested, for example, that the agency use California method SRL-524M (California DHS, 2002), which is prescribed by the state for compliance monitoring at 0.005 μg/L (5 ng/L). EPA has reviewed SRL 524M and determined that the associated quality control (QC) and IDC criteria do not meet the EPA's needs for drinking water analysis. See also EPA's “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble.

Occurrence data collected during UCMR 3 (77 FR 26072, May 2, 2012 (USEPA, 2012)) for 1,2,3-trichloropropane may be found at https://www.epa.gov/dwucmr/occurrence-data-unregulated-contaminant-monitoring-rule#3.

B. What is the UCMR 5 sampling design?

1. This Final Rule

EPA has utilized up to three different tiers of contaminant monitoring, associated with three different “lists” of contaminants, in past UCMRs. EPA designed the monitoring tiers to reflect the availability and complexity of analytical methods, laboratory capacity, sampling frequency, and cost. The Assessment Monitoring tier is the largest in scope and is used to collect data to determine the national occurrence of “List 1” contaminants for the purpose of estimating national population exposure. Assessment Monitoring has been used in the four previous UCMRs to collect occurrence data from all systems serving more than 10,000 people and a representative sample of 800 smaller systems. Consistent with AWIA, the Assessment Monitoring approach was redesigned for UCMR 5 and reflects the plan, subject to additional appropriations being made available for this purpose, that would require all systems serving 3,300 or more people and a representative sample of systems serving 25 to 3,299 people to perform monitoring (USEPA, 2021a). The population-weighted sampling design for the nationally representative sample of small systems (used in previous UCMR cycles to select 800 systems serving 25 to 10,000 people and used in UCMR 5 to select 800 systems serving 25 to 3,299 people) calls for the sample to be stratified by water source type (ground water or surface water), service size category, and state (where each state is allocated a minimum of two systems in its State Monitoring Plan). The allowable margin of error at the 99 percent confidence level is ±1 percent for an expected contaminant occurrence of 1 percent at the national level. Assessment Monitoring is the primary tier used for contaminants and generally relies on analytical methods that use more common techniques that are expected to be widely available. EPA has used an Assessment Monitoring tier for 72 contaminants and contaminant groups over the course of UCMR 1 through UCMR 4. The agency is exclusively requiring Assessment Monitoring in UCMR 5. This monitoring approach yields the most complete set of occurrence data to support EPA's decision making.

2. Summary of Major Comments and EPA Responses

Many commenters expressed support for the increase in small system Assessment Monitoring, with no opposition to the inclusion of all PWSs serving 3,300 to 10,000 people in UCMR 5. The U.S. Small Business Administration asked that EPA clarify small-system responsibilities in the event of inadequate EPA funding to fully support the envisioned monitoring.

Recognizing the uncertainty in funding from year-to-year, the agency will implement a “monitor if notified” approach for PWSs serving 25 to 10,000 people. In 2022, EPA will notify the approximately 6,000 small PWSs tentatively selected for the expanded UCMR 5 (all PWSs serving 3,300 to 10,000 people and a statistically-based, nationally representative set of 800 PWSs serving 25 to 3,299 people) of their anticipated UCMR 5 monitoring requirements; that initial notification will specify that monitoring is conditioned on EPA having sufficient funds and will be confirmed in a second notification. Upon receiving appropriations for a particular year, EPA will determine the number of small PWSs whose monitoring is covered by the appropriations, and notify the included small PWSs of their upcoming requirements at least six months prior to their scheduled monitoring. EPA has made minor edits to 40 CFR 141.35 and 40 CFR 141.40 for consistency with this approach.

Additionally, to ensure that EPA has access to a nationally representative set of small-system data, even in the absence of sufficient appropriations to support the planned monitoring by small systems, a statistically-based nationally representative set of 800 PWSs will also be selected from among the PWSs serving 25 to 10,000 people. An updated description of the statistical approach for the nationally representative samples for UCMR 5 is available in the docket as “Selection of Nationally Representative Public Water Systems for the Unregulated Contaminant Monitoring Rule: 2021 Update” (USEPA 2021a).

To minimize the impact of the final rule on small systems (those serving 25 to 10,000 people), EPA pays for their sample kit preparation, sample shipping fees, and sample analysis. Large systems (those serving more than 10,000 people) pay for all costs associated with their monitoring. Exhibit 5 of this preamble shows a summary of the estimated number of PWSs subject to monitoring.

Exhibit 5—Systems Expected To Participate in UCMR 5 Monitoring
List 1 chemicals
1 EPA pays for all analytical costs associated with monitoring at small systems.
2 Counts for small PWSs serving 3,300-10,000 people are approximate.
3 Large system counts are approximate.
4 In the absence of appropriations to support monitoring at all PWSs serving 3,300 to 10,000 people, EPA could instead include as few as 400 PWSs serving 25 to 3,299 people and 400 PWSs serving 3,300 to 10,000 people (for a representative sample of 800 PWSs serving 25 to 10,000 people).
System size (number of people served)National sample: Assessment monitoring designTotal number of systems per size category
List 1 chemicals
Small Systems1 (25-3,299)800 randomly selected systems (CWSs and NTNCWSs)4 800
Small Systems12 (3,300-10,000)All systems (CWSs and NTNCWSs) subject to the availability of appropriations4 5,147
Large Systems3 (10,001 and over)All systems (CWSs and NTNCWSs)4,364
Total10,311

C. What is the sampling frequency and timing?

1. This Final Rule

This final rule maintains the proposed sampling frequency and timeframe for Assessment Monitoring. On a per-system basis, the anticipated number of samples collected by each system is consistent with sample collection during prior UCMR cycles (although, as described elsewhere in this document, the number of water systems expected to participate in UCMR 5 is significantly greater under this final rule per AWIA). Water systems will be required to collect samples based on the typical UCMR sampling frequency and timeframe as follows: For surface water, ground water under the direct influence of surface water, and mixed locations, sampling will take place for four consecutive quarters over the course of 12 months (total of 4 sampling events). Sampling events will occur three months apart. For example, if the first sample is taken in January, the second will then occur anytime in April, the third will occur anytime in July, and the fourth will occur anytime in October. For ground water locations, sampling will take place twice over the course of 12 months (total of 2 sampling events). Sampling events will occur five to seven months apart. For example, if the first sample is taken in April, the second sample will then occur anytime in September, October, or November.

EPA, in conjunction with the states, will initially determine schedules (year and months of monitoring) for large water systems. Thereafter, large PWSs will have an opportunity to modify this initial schedule for planning purposes or other reasons ( e.g., to spread costs over multiple years, if a sampling location will be closed during the scheduled month of monitoring, etc.). EPA will schedule and coordinate small system monitoring (for PWSs serving 3,300 to 10,000 people and for the nationally representative sample of smaller PWSs) by working closely with partnering states. State Monitoring Plans provide an opportunity for states to review and revise the initial sampling schedules developed by EPA (see discussion of State Monitoring Plans in Section III.D of this preamble).

2. Summary of Major Comments and EPA Responses

EPA received two comments recommending that the agency reduce the sampling frequency for both ground water (GW) and surface water (SW) systems, including a suggestion that UCMR 5 require only one sample per system. EPA concluded that less frequent data collection would affect the integrity of the data and result in insufficient data to fulfill the needs envisioned by the 1996 SDWA Amendments, particularly with regard to supporting the Administrator's regulatory determinations and drinking water regulation development. Maintaining the proposed sampling frequency allows the resulting contaminant data to be analyzed for temporal variability, in addition to between-system variability. These analyses are not possible with a single-sample structure. When making regulatory determinations, EPA evaluates the number of systems (and populations) with means or single measured values above health levels of concern, as both values provide important information.

EPA acknowledges that based on UCMR 3 (77 FR 26072, May 2, 2012 (USEPA, 2012)) data, the correlation between results from multiple sample events can be high; however, the approach suggested by commenters would yield less accurate data for several reasons. EPA's assessment of sampling frequency using UCMR 3 and UCMR 4 data (see Appendix 2 in “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble) shows that for both SW and GW systems, there are numerous cases where occurrence is notably different between sample events. Focusing first on UCMR 3 results for PWS with SW sources, the number of sample points at which PFOS was measured at or above the MRL was 108 percent greater when considering multiple sample events, versus only considering the first sample event. There were multiple occasions where the results from the first sample event were below the health-based reference concentration while subsequent results were above it. Looking at UCMR 3 results for PWSs with GW sources, PFOS was measured at or above the MRL at 26 percent more sample points in the second sample event relative to the first. Similar to the UCMR 3 results for SW systems, there were multiple occasions where the second result from a GW system exceeded the reference concentration while the first result did not.

Some commenters suggested that between-system variability is much greater for PFAS than within-system variability. While it may be less than between-system variability, within-system variability can still be important. Shifting to a single sample prevents reasonable assessments of within-system variability and limits the ability to observe between-system variability estimates. This would then drastically reduce the ability to characterize uncertainty.

Additionally, although the provisions of AWIA could include the addition of approximately 5,200 more PWSs to UCMR 5 relative to earlier cycles and thus capture more spatial variation in the resulting dataset, it is important to note that spatial variation is different than temporal or seasonal variation. Capturing more of one does not diminish the influence of the others on national occurrence data and reducing the frequency of sampling eliminates the possibility of analyzing the resulting data for temporal variation. In addition, statistical means based on two measurements have considerably less error than a single measurement per system, and provide a more robust dataset for future regulatory decisions. Having more than one sample event also greatly reduces the chance of underestimating the true proportion of occurrence of the contaminant in drinking water ( i.e., exposure).

Regarding monitoring frequency and burden, EPA notes that the agency allows large GW systems the opportunity to reduce monitoring burden by using approved representative entry points (40 CFR 141.35(c)(3)) as described in Section IV.D of this preamble. Representative monitoring plans will result in fewer samples and thus time and cost savings to the PWS. Consecutive systems with multiple connections from a particular wholesaler are also permitted to choose one entry point as representative, thus reducing burden.

D. Where are the sampling locations and what is representative monitoring?

1. This Final Rule

Consistent with past UCMR cycles, sample collection for UCMR 5 contaminants will take place at the entry point to the distribution system (EPTDS). As during past UCMRs and as described in 40 CFR 141.35(c)(3) of this preamble, this final rule will allow large ground water systems (or large surface water systems with ground water sources) that have multiple ground water EPTDSs to request approval to sample at representative monitoring locations rather than at each ground water EPTDS. GWRMPs approved under prior UCMRs may be used for UCMR 5, presuming no significant changes in the configuration of the ground water EPTDSs since the prior approval. Water systems that intend to use a previously approved plan must send EPA a copy of the approval documents received under prior UCMRs from their state (if reviewed by the state) or EPA.

Relative to the rules for prior UCMR cycles, this final rule provides greater flexibility to PWSs in submitting GWRMPs to EPA. Plans must be submitted to EPA six months prior to the PWS's scheduled sample collection, instead of by a specified date; those PWSs scheduled to collect samples in 2024 or 2025 will have significant additional time to develop and propose representative plans. PWSs, particularly those scheduled for sample collection in 2023, are encouraged to submit proposals for a new GWRMP by December 31, 2022, to allow time for review by EPA and, as appropriate, the state. EPA will work closely with the states to coordinate the review of GWRMPs in those cases where such review is part of the state's Partnership Agreement. Changes to inventory data in SDWARS that impact a PWS's representative plan before or during the UCMR sampling period must be reported within 30 days of the change. EPA will collaborate with small systems (particularly those with many ground water locations) to develop a GWRMP when warranted, recognizing that EPA pays for the analysis of samples from small systems.

2. Summary of Major Comments and EPA Responses

EPA received multiple comments regarding GWRMPs and representative sampling for wholesale systems and consecutive connections. Generally, commenters supported the continued use of GWRMPS and the use of previously approved monitoring plans. An additional supporting document, titled, “Instructions for Preparing a Ground Water Representative Monitoring Plan for the Unregulated Contaminant Monitoring Rule,” (USEPA, 2021j) has been placed in the electronic docket listed in the ADDRESSES section of this preamble.

Several commenters recommended that EPA not require monitoring by consecutive systems that purchase 100 percent of their water from wholesale systems that are already subject to UCMR 5 monitoring. They requested that EPA instead require wholesalers to identify the PWSIDs of consecutive systems receiving water from the wholesaler, and that EPA rely on wholesaler monitoring in lieu of monitoring by the consecutive systems. EPA has decided to require monitoring by consecutive systems to conduct monitoring in accordance with UCMR 5. Previous UCMR data demonstrate that wholesalers and purchasers can have different analytical results (see Appendix 3 in “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble). For example, pairing the results from wholesaler to consecutive connections for 190 manganese results from UCMR 4 (81 FR 92666, December 20, 2016 (USEPA, 2016)), one-third of the results are higher at the wholesaler and one-third of the results are higher at the consecutive connection, with one-third of all results being comparable [±0.4 μg/L]. The agency therefore elected to maintain the proposed approach in which all eligible consecutive systems must monitor, irrespective of monitoring being conducted by the wholesale system from which they purchase drinking water.

E. How long do laboratories and PWSs have to report data?

1. This Final Rule

EPA is maintaining the revised reporting timeframes for laboratories and PWSs as proposed. For UCMR 5, laboratories have 90 days (versus 120 days in prior UCMR cycles) from the sample collection date to post and approve analytical results in SDWARS for PWS review. Large PWSs have 30 days (versus 60 days in prior UCMR cycles) to review and approve the analytical results posted to SDWARS. As with the UCMR 4 requirements, data will be considered approved and available for state and EPA review if the PWS takes no action within their allotted review period.

In the proposed rule for UCMR 5, EPA noted that multiple states have expressed an interest in earlier access to UCMR data (see Docket ID No. EPA-HQ-OW-2020-0530). EPA believes that the shorter timeframes for posting and approving data are feasible and reasonable based on our experience with UCMR reporting to date.

2. Summary of Major Comments and EPA Responses

Commenters generally agreed with the revised timeframes for laboratories to post and approve analytical results in SDWARS. The 90-day laboratory timeframe makes UCMR results more readily available to interested stakeholders and states. Some commenters supported the timely reporting of data by laboratories to ensure that PWSs have adequate time to reconcile QC issues, especially those that may require a PWS to resample. Some expressed concerns that the revised timeframe could be challenging for laboratories. Some suggested that the shorter timeframe be conditioned on consistent functionality and availability of SDWARS.

Commenters generally agreed with the changes in the timeframes for large PWSs to review and approve analytical results posted to SDWARS, though several requested that EPA maintain the 60-day review period.

EPA has observed that many laboratories are routinely posting data to SDWARS within 90 days of sample collection and that many large PWSs are approving and submitting data within 30 days of their laboratory posting the data. Judging by reporting for 2020 monitoring under UCMR 4 (81 FR 92666, December 20, 2016 (USEPA, 2016)), more than 75 percent of laboratories posted and approved data within 90 days, and more than 85 percent of large PWSs who chose to act on their data, did so within 30 days of the laboratory posting it. During UCMR 3 and UCMR 4, less than half of large PWSs chose to actively review and approve their data, as opposed to letting the results default to “approved” status after the review period. The many large PWSs that have routinely chosen to not review and approve their data will not be impacted by the revised timeframe for PWS data review for UCMR 5. See also Appendix 5 in “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble.

EPA does not anticipate functionality or availability issues with SDWARS during UCMR 5 but is prepared to make case-by-case exceptions for reporting timeframes should significant issues occur with the reporting system.

F. What are the reporting requirements for UCMR 5?

1. This Final Rule

Today's final rule removes 1 of the proposed data elements (“Direct Potable Reuse Water Information”) and maintains the 27 others described in the proposed rule. EPA has updated some of the data-element definitions for clarity and consistency in the reporting requirements. Please see Table 1 of 40 CFR 141.35(e) of this preamble for the complete list of data elements, definitions and drop-down options that will be provided in the data reporting system.

2. Summary of Major Comments and EPA Responses

a. Data Elements

EPA received multiple comments on the proposed contaminant-specific data elements, with some commenters questioning the quality, reliability, and utility of some of the data that would be provided to the agency per the proposed data element requirements. Several commenters requested that EPA include rationale explaining the intended use of such data. EPA has updated the data elements for clarity ( e.g., clarifying treatment types, and abbreviations for them; adding the treatment option “NMT = not modified after testing”) and has provided additional rationale (including describing how the information could impact regulatory decision making and risk-management strategies) in the “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), available in the UCMR 5 public docket (see the ADDRESSES section of this preamble). EPA acknowledges the data collected will have some limitations but believes that the collection of the information is still valuable. In addition, EPA notes the modest burden associated with the collection.

b. Reporting State Data

EPA received several comments suggesting that PWSs be permitted to submit occurrence data collected under state-based monitoring, in lieu of conducting UCMR 5 monitoring, to reduce the monitoring burden. In those cases where the monitoring required by a state is aligned with the requirements of UCMR 5, PWSs may be able to conduct PFAS monitoring that meets the needs of their state and UCMR 5, with the understanding that UCMR 5 requirements must be met. This includes the requirement that PFAS samples be analyzed by a UCMR 5-approved laboratory using EPA Method 533 and Method 537.1. EPA offers flexibility for PWSs to reschedule their UCMR 5 monitoring, and PWSs may do so to coordinate it with their state-required monitoring. PWSs wishing to conduct “dual purpose” monitoring ( i.e., concurrently meeting the state and UCMR 5 needs) may contact their state or EPA, as appropriate, if there are questions about whether the state and UCMR 5 requirements are being met.

G. What are the UCMR 5 Minimum Reporting Levels (MRLs) and how were they determined?

1. This Final Rule

EPA is maintaining the proposed minimum reporting levels for the UCMR 5 contaminants. EPA establishes MRLs to ensure consistency in the quality of the information reported to the agency. As defined in 40 CFR 141.40(a)(5)(iii) of this preamble, the MRL is the minimum quantitation level that, with 95 percent confidence, can be achieved by capable analysts at 75 percent or more of the laboratories using a specified analytical method. More detailed explanation of the MRL calculation is in the “Technical Basis for the Lowest Concentration Minimum Reporting Level (LCMRL) Calculator” (USEPA, 2010), available at ( https://www.epa.gov/dwanalyticalmethods/lowest-concentration-minimum-reporting-level-lcmrl-calculator ).

EPA requires each laboratory interested in supporting UCMR analyses to demonstrate that they can reliably make quality measurements at or below the established MRL to ensure that high quality results are being reported by participating laboratories. EPA established the proposed MRLs in 40 CFR 141.40(a)(3), Table 1 of this preamble, for each analyte/method by obtaining data from at least three laboratories that performed “lowest concentration minimum reporting level” (LCMRL) studies. The results from these laboratory LCMRL studies can be found in the “UCMR 5 Laboratory Approval Manual” (USEPA, 2021f), available in the electronic docket (see the ADDRESSES section of this preamble).

The multiple laboratory LCMRLs were then processed through a statistical routine to derive an MRL that, with 95 percent confidence, is predicted to be attainable by 75 percent of laboratories using the prescribed method. EPA considers these to be the lowest reporting levels that can practically and consistently be achieved on a national basis (recognizing that individual laboratories may be able to measure at lower levels).

2. Summary of Major Comments and EPA Responses

Some commenters recommended that EPA establish lower MRLs for the 29 PFAS in UCMR 5. MRLs used for the UCMR program are based on calculations that account for the ability of laboratories to report accurate and precise measurements with a specific statistical confidence. Based on the results from multiple laboratories that participated in MRL-setting studies, EPA concluded that the proposed MRLs represent the lowest feasible levels for a national MRL measure. Sensitivity ( i.e., quantitation limit) may improve with time, experience, and instrumentation advances.

H. What are the requirements for laboratory analysis of field reagent blank samples?

1. This Final Rule

EPA initially proposed that laboratories analyze all field reagent blank (FRB) samples, along with the corresponding field samples, to reduce the possibility of invalidating a positive field sample result ( i.e., a field sample result at or above the MRL) because of FRB hold times being exceeded.

2. Summary of Major Comments and EPA Responses

EPA did not receive any comments expressing concerns with the laboratory approval process; however, the agency did receive a comment on the FRB sample analysis criteria, suggesting that the agency not require analysis of every FRB sample. EPA Method 537.1 and Method 533, used for PFAS analysis, require collection of a corresponding FRB sample from each unique sampling location for each sampling event. The methods require that the FRB be analyzed if there is a positive result for a PFAS analyte in a corresponding field sample. Based on further consideration, EPA is now providing laboratories with discretion as to whether they analyze every FRB sample proactively or only those associated with positive field sample results. This is with the understanding that laboratories must analyze field samples promptly enough such that the corresponding FRB analyses, if needed, may be completed within the prescribed hold time. Compliance with the method hold-time requirements, and other provisions of the methods, is a condition of maintaining laboratory approval. EPA is studying the possibility of extending the FRB hold times for EPA Method 537.1 and Method 533, and will communicate the results of the studies with the approved laboratories.

I. How will EPA support risk communication for UCMR 5 results?

EPA received comments requesting that the agency develop and provide risk communication materials to support interpretation and characterization of UCMR 5 results. EPA intends to publish a “reference concentration” summary document with available EPA health values; provide a template for PWSs to consider using in communicating with their customers about the detection of PFAS in drinking water; and provide other supporting material as risk-related information becomes available.

V. Statutory and Executive Order Reviews

Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket. A full analysis of potential costs associated with this action, the “Information Collection Request for the Final Unregulated Contaminant Monitoring Rule (UCMR 5),” (USEPA, 2021b) ICR Number 2040-0304, is also available in the docket (Docket ID No. EPA-HQ-OW-2020-0530). A summary of the ICR can be found in Section I.C of this preamble.

B. Paperwork Reduction Act (PRA)

The information collection activities in this final rule have been submitted for approval to the Office of Management and Budget (OMB) under the PRA. The Information Collection Request (ICR) document (USEPA, 2021b) that EPA prepared has been assigned EPA ICR number ICR 2683.02. You can find a copy of the ICR in the docket for this final rule, and it is briefly summarized here. The information collection requirements are not enforceable until OMB approves them.

The information that EPA will collect under this final rule fulfills the statutory requirements of Section1445(a)(2) of SDWA, as amended in 1996, 2018, and 2019. The data will describe the source of the water, location, and test results for samples taken from public water systems (PWSs) as described in 40 CFR 141.35(e). The information collected will support EPA's decisions as to whether or not to regulate particular contaminants under SDWA. Reporting is mandatory. The data are not subject to confidentiality protection.

The 5-year UCMR 5 period spans 2022-2026. UCMR 5 sample collection begins in 2023 and continues through 2025. Since ICRs cannot be approved by OMB for a period longer than three years pursuant to 5 CFR 1320.10, the primary analysis in the ICR only covers the first three years of the UCMR 5 period ( i.e., 2022-2024). Prior to expiration of the initial UCMR 5 ICR, EPA will seek to extend the ICR and thus receive approval to collect information under the PRA in the remaining two years of the UCMR 5 period (2025-2026).

EPA received several comments regarding cost and burden of the proposed rule. Those comments recommended that EPA provide more accurate cost estimates. EPA's response is detailed more fully in the “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble.

EPA has reviewed and, as appropriate, revised the cost and burden figures for UCMR 5; this includes using updated unit cost estimates for sample analysis. The annual burden and cost estimates described in this section are based on the implementation assumptions described in Section III of this preamble, among them the inclusion of all systems serving 3,300 to 10,000 people and a representative sample of smaller systems. As such, those estimates represent an upper bound. If EPA does not receive the necessary appropriations in one or more of the collections years—and thus collects data from fewer small systems—the actual costs would be lower than those estimated here. In general, burden hours were calculated by:

1. Determining the activities that PWSs and states would complete to comply with UCMR activity;

2. Estimating the number of hours per activity;

3. Estimating the number of respondents per activity; and

4. Multiplying the hours per activity by the number of respondents for that activity.

Respondents/affected entities: The respondents/affected entities are small PWSs (those serving 25 to 10,000 people); large PWSs (those serving 10,001 to 100,000 people); very large PWSs (those serving more than 100,000 people); and states.

Respondent's obligation to respond: Mandatory (40 CFR 141.35).

Estimated number of respondents: Respondents to UCMR 5 include 5,947 small PWSs, 4,364 large PWSs, and the 56 primacy agencies (50 States, one Tribal nation, and five Territories) for a total of 10,367 respondents.

Frequency of response: The frequency of response varies across respondents and years. Across the initial 3-year ICR period for UCMR 5, small PWSs will sample an average of 2.8 times per PWS ( i.e., number of responses per PWS); large PWSs will sample and report an average of 3.2 times per PWS; and very large PWSs will sample and report an average of 3.7 times per PWS.

Total estimated burden: 48,469 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $9,404,007 annualized capital or operation & maintenance costs.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves this ICR, the agency will announce that approval in the Federal Register and publish a technical amendment to 40 CFR part 9 to display the OMB control number for the approved information collection activities contained in this final rule.

C. Regulatory Flexibility Act (RFA)

For purposes of assessing the impacts of this final rule on small entities, EPA considered small entities to be PWSs serving 25 to 10,000 people. As required by the RFA, EPA proposed using this alternative definition in the Federal Register (63 FR 7606, February 13, 1998 (USEPA, 1998a)), sought public comment, consulted with the Small Business Administration (SBA) Office of Advocacy, and finalized the alternative definition in the Consumer Confidence Reports rulemaking (63 FR 44512, August 19, 1998 (USEPA, 1998b)). As stated in that document, the alternative definition applies to this regulation.

Exhibit 6—Number of Publicly- and Privately-Owned Small Systems Subject to UCMR 5 1
1 In the absence of appropriations to support monitoring at all PWSs serving 3,300 to 10,000 people, EPA could instead include as few as 400 PWSs serving 25 to 3,299 people and 400 PWSs serving 3,300 to 10,000 people (for a representative sample of 800 PWSs serving 25 to 10,000 people).
2 PWS counts were adjusted to display as whole numbers in each size category.
System size (number of people served)Publicly-ownedPrivately-ownedTotal 2
Ground Water
500 and under42126168
501 to 3,300320121441
3,301 to 10,0002,3345412,875
Subtotal Ground Water2,6967883,484
Surface Water (and Ground Water Under the Direct Influence of Surface Water)
500 and under91120
501 to 3,30012645171
3,301 to 10,0001,7625102,272
Subtotal Surface Water1,8975662,463
Total of Small Water Systems4,5931,3545,947

The basis for the UCMR 5 RFA certification is as follows: For the 5,947 small water systems that EPA anticipates will be affected, per the planned monitoring, the average annual cost for complying with this final rule represents an average of 0.02 percent of system revenues. The average yearly cost to small systems to comply with UCMR 5 over the 5-year period of 2022-2026, is approximately $0.3 million. EPA anticipates that approximately one third of the 5,947 small PWSs will collect samples in each of three years (2023, 2024, and 2025).

PWS costs are attributed to the labor required for reading about UCMR 5 requirements, monitoring, reporting, and record keeping. The estimated average annual burden across the 5-year UCMR 5 implementation period of 2022-2026 is 1.3 hours at $52 per small system. By assuming all costs for laboratory analyses, shipping and quality control for small entities, EPA incurs the entirety of the non-labor costs associated with UCMR 5 small system monitoring, or 96 percent of total small system testing costs. Exhibit 7 and Exhibit 8 of this preamble present the estimated economic impacts in the form of a revenue test for publicly- and privately-owned systems.

Exhibit 7—UCMR 5 Relative Cost Analysis for Small Publicly-Owned Systems [2022-2026] 1
System size (number of people served)Annual number of systems impacted 2Average annual hours per systemAverage annual cost per systemSBREFA criteria- revenue test 3 (%)
1 In the absence of appropriations to support monitoring at all PWSs serving 3,300 to 10,000 people, EPA could instead include as few as 400 PWSs serving 25 to 3,299 people and 400 PWSs serving 3,300 to 10,000 people (for a representative sample of 800 PWSs serving 25 to 10,000 people).
2 PWS counts were adjusted to display as whole numbers in each size category. Includes the publicly-owned portion of small systems subject to UCMR 5.
3 Costs are presented as a percentage of median annual revenue for each size category.
Ground Water Systems
500 and under81.0$40.650.09
501 to 3,300641.143.370.02
3,301 to 10,0004671.349.920.01
Surface Water (and Ground Water Under the Direct Influence of Surface Water) Systems
500 and under21.454.390.07
501 to 3,300251.456.190.02
3,301 to 10,0003531.557.390.004
Exhibit 8—UCMR 5 Relative Cost Analysis for Small Privately-Owned Systems [2022-2026] 1
System size (number of people served)Annual number of systems impacted 2Average annual hours per systemAverage annual cost per systemSBREFA criteria- revenue test 3 (%)
1 In the absence of appropriations to support monitoring at all PWSs serving 3,300 to 10,000 people, EPA could instead include as few as 400 PWSs serving 25 to 3,299 people and 400 PWSs serving 3,300 to 10,000 people (for a representative sample of 800 PWSs serving 25 to 10,000 people).
2 PWS counts were adjusted to display as whole numbers in each size category. Includes the privately-owned portion of small systems subject to UCMR 5.
3 Costs are presented as a percentage of median annual revenue for each size category.
Ground Water Systems
500 and under251.0$40.650.48
501 to 3,300241.1$43.370.03
3,301 to 10,0001081.3$49.920.004
Surface Water (and Ground Water Under the Direct Influence of Surface Water) Systems
500 and under21.4$54.390.11
501 to 3,30091.4$56.190.02
3,301 to 10,0001021.5$57.390.004

Up to 9.4 percent of all small systems ( i.e., up to 5,947 small PWSs serving 25 to 10,000 people) will participate in UCMR 5 if EPA receives the necessary appropriations to support its plan. EPA has determined that participating small systems will experience an average impact of 0.02 percent of revenues. This accounts for small PWSs familiarizing themselves with the regulatory requirements; reading sampling instructions; traveling to the sampling location; collecting and shipping the samples; and maintaining their records. The 5,947 small PWSs are comprised of all 5,147 systems serving between 3,300 and 10,000 people, and the representative group of 800 systems serving between 25 and 3,299 people; the remainder of small systems will not participate in UCMR 5 monitoring and will not be impacted.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action along with a description of the very minor impacts are previously addressed in this section. Although this final rule will not have a significant economic impact on a substantial number of small entities, EPA has attempted to reduce impacts by assuming all costs for analyses of the samples, and for shipping the samples from small systems to laboratories contracted by EPA to analyze the UCMR 5 samples (the cost of shipping is included in the cost of each analytical method). EPA has historically set aside $2.0 million each year from the Drinking Water State Revolving Fund (DWSRF) with its authority to use DWSRF monies for the purposes of implementing this provision of SDWA. EPA anticipates drawing on these and additional funds, if available, to implement the plan and carry out the expanded UCMR monitoring approach outlined in AWIA. We have therefore concluded that this action will have no significant impact on any directly regulated small entities.

D. Unfunded Mandates Reform Act (UMRA)

This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action implements mandate(s) specifically and explicitly set forth in SDWA Section 1445(a)(2), Monitoring Program for Unregulated Contaminants.

E. Executive Order 13132: Federalism

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

This action has Tribal implications. However, it will neither impose substantial direct compliance costs on federally recognized Tribal governments, nor preempt Tribal law. As described previously in this document, this final rule requires monitoring by all large PWSs. Information in the SDWIS/Fed water system inventory indicates there are approximately 27 large Tribal PWSs (serving 10,001 to 40,000 people). EPA estimates the average annual cost to each of these large PWSs, over the 5-year rule period, to be $1,783. This cost is based on a labor component (associated with the collection of samples), and a non-labor component (associated with shipping and laboratory fees). As planned, UCMR 5 is expected to also require monitoring by all small PWSs serving 3,300 to 10,000 people and a nationally representative sample of small PWSs serving 25 to 3,299 people. Information in the SDWIS/Fed water system inventory indicates there are approximately 75 small Tribal PWSs (serving 3,300 to 10,000 people). EPA estimates that less than 2 percent of small Tribal systems serving 25 to 3,299 people will be selected as part of the nationally representative sample. EPA estimates the average annual cost to small Tribal systems over the 5-year rule period to be $52. Such cost is based on the labor associated with collecting a sample and preparing it for shipping. All other small-PWS expenses (associated with shipping and laboratory fees) are paid by EPA.

EPA consulted with Tribal officials under the EPA Policy on Consultation and Coordination with Indian Tribes early in the process of developing this regulation to permit them to have meaningful and timely input into its development. A summary of that consultation, titled, “Summary of the Tribal Coordination and Consultation Process for the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” is provided in the electronic docket listed in the ADDRESSES section of this preamble.

As required by section 7(a), the EPA's Tribal Consultation Official has certified that the requirements of the executive order have been met in a meaningful and timely manner. A copy of the certification is included in the docket for this action.

G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern such an environmental health risk or safety risk.

H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use

This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution or use of energy and has not otherwise been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. This is a national drinking water occurrence study that was submitted to OMB for review.

I. National Technology Transfer and Advancement Act (NTTAA)

This action involves technical standards. EPA has identified options that involve using analytical methods developed by the agency and three major voluntary consensus method organizations to support UCMR 5 monitoring. The voluntary consensus method organizations are Standard Methods for the Examination of Water and Wastewater, and ASTM International. EPA identified acceptable consensus method organization standards for the analysis of lithium. A summary of each method along with how the method specifically applies to UCMR 5 can be found in Section III.I of this preamble.

All of these standards are reasonably available for public use. EPA methods are free for download on the agency's website. The methods in the Standard Methods for the Examination of Water and Wastewater 23rd edition are consensus standards, available for purchase from the publisher, and are commonly used by the drinking water laboratory community. The methods in the Standard Methods Online are consensus standards, available for purchase from the publisher's website, and are commonly used by the drinking water laboratory community. The methods from ASTM International are consensus standards, are available for purchase from the publisher's website, and are commonly used by the drinking water laboratory community.

J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. Background information regarding EPA's consideration of Executive Order 12898 in the development of this final rule is provided in Section III.F of this preamble, and an additional supporting document, titled, “Summary of Environmental Justice Considerations for the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” has been placed in the electronic docket listed in the ADDRESSES section of this preamble.

K. Congressional Review Act (CRA)

This action is subject to the CRA, and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

VI. References

(i) ASDWA. 2013. Insufficient Resources for State Drinking Water Programs Threaten Public Health: An Analysis of State Drinking Water Programs' Resources and Needs. December 2013. Available at https://www.asdwa.org/asdwa-reports/.

(ii) ASTM. 2020. ASTM D1976-20— Standard Test Method for Elements in Water by Inductively-Coupled Plasma Atomic Emission Spectroscopy. ASTM, 100 Barr Harbor Drive, West Conshohocken, PA, 19428. Approved May 1, 2020. Available for purchase at https://www.astm.org/Standards/D1976.htm.

(iii) California DHS. 2002. California Department of Health Services. Determination of 1,2,3-Trichloropropane in Drinking Water by Purge and Trap Gas Chromatography/Mass Spectrometry. Division of Drinking Water and Environmental Management, Sanitation and Radiation Laboratories Branch, Berkeley, CA. Available at https://www.waterboards.ca.gov/drinking_water/certlic/drinkingwater/documents/123-tcp/tcp_by_pt_gcms.pdf.

(iv) Settlement Agreement, Waterkeeper Alliance, Inc. v. U.S. EPA, No. 1:19-cv-00899-LJL (S.D.N.Y. Jun. 1, 2020).

(v) SM. 2017. 3120B—Metals by Plasma Emission Spectroscopy (2017): Inductively Coupled Plasma (ICP) Method. Standard Methods for the Examination of Water and Wastewater, 23rd edition. American Public Health Association, 800 I Street NW, Washington, DC 20001-3710.

(vi) SM Online. 1999. 3120B-99—Metals by Plasma Emission Spectroscopy: Inductively Coupled Plasma (ICP) Method (Editorial Revisions, 2020). Standard Methods Online. Available for purchase at http://www.standardmethods.org.

(vii) USEPA. 1989. National Primary Drinking Water Regulations; Filtration, Disinfection; Turbidity, Giardia lamblia, Viruses, Legionella, and Heterotrophic Bacteria; Final Rule. Federal Register . Vol. 54, No. 124, p. 27486, June 29, 1989.

(viii) USEPA. 1994. EPA Method 200.7—Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry, Revision 4.4. Office of Research and Development, Cincinnati, OH. Available at https://www.epa.gov/esam/method-2007-determination-metals-and-trace-elements-water-and-wastes-inductively-coupled-plasma.

(ix) USEPA. 1998a. National Primary Drinking Water Regulations: Consumer Confidence Reports; Proposed Rule. Federal Register . Vol. 63, No. 30, p. 7606, February 13, 1998.

(x) USEPA. 1998b. National Primary Drinking Water Regulation: Consumer Confidence Reports; Final Rule. Federal Register . Vol. 63, No. 160, p. 44512, August 19, 1998.

(xi) USEPA. 2010. Technical Basis for the Lowest Concentration Minimum Reporting Level (LCMRL) Calculator. EPA 815-R-11-001. Office of Water. December 2010. Available at https://www.epa.gov/dwanalyticalmethods.

(xii) USEPA. 2011. Exposure Factors Handbook 2011 Edition (Final Report). U.S. EPA, Washington, DC, EPA/600/R-09/052F. Office of Research and Development, Washington, DC. September 2011. Available at https://www.epa.gov/expobox/about-exposure-factors-handbook.

(xiii) USEPA. 2012. Revisions to the Unregulated Contaminant Monitoring Regulation (UCMR 3) for Public Water Systems; Final Rule. Federal Register . Vol. 77, No. 85, p. 26072, May 2, 2012.

(xiv) USEPA. 2016. Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) for Public Water Systems and Announcement of Public Meeting. Federal Register . Vol. 81, No. 244, p. 92666, December 20, 2016.

(xv) USEPA. 2017. National Primary Drinking Water Regulations; Announcement of the Results of EPA's Review of Existing Drinking Water Standards and Request for Public Comment and/or Information on Related Issues. Federal Register . Vol. 82, No. 7, p. 3518, January 11, 2017.

(xvi) USEPA. 2018. Method Development for Unregulated Contaminants in Drinking Water: Public Meeting and Webinar. EPA 815-A-18-001. Office of Water. June 2018. Available at https://www.epa.gov/dwanalyticalmethods.

(xvii) USEPA. 2019a. Development of the Proposed Unregulated Contaminant Monitoring Rule for the Fifth Monitoring Cycle (UCMR 5). Presentation Slides. EPA 815-A-19-001. Office of Water. Available at https://www.epa.gov/dwucmr/unregulated-contaminant-monitoring-rule-ucmr-meetings-and-materials.

(xviii) USEPA. 2019b. EPA Method 533—Determination of Per- and Polyfluoroalkyl Substances in Drinking Water by Isotope Dilution Anion Exchange Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry. EPA 815-B-19-020. Office of Water, Cincinnati, OH. November 2019. Available at https://www.epa.gov/dwanalyticalmethods.

(xix) USEPA. 2019c. Appendix C: 1,2,3-Trichloropropane in Regulatory Determination 4 Support Document for Selected Contaminants from the Fourth Drinking Water Contaminant Candidate List (CCL 4). EPA 815-R-19-006. Docket ID EPA-HQ-OW-2019-0583. Available at https://www.regulations.gov.

(xx) USEPA. 2020. EPA Method 537.1—Determination of Selected Per- and Polyfluorinated Alkyl Substances in Drinking Water by Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS). Version 2.0. EPA/600/R-20/006. Office of Research and Development, Cincinnati, OH. March 2020. Available at https://www.epa.gov/dwanalyticalmethods.

(xxii) USEPA. 2021a. Selection of Nationally Representative Public Water Systems for the Unregulated Contaminant Monitoring Rule: 2021 Update. EPA 815-B-21-012. Office of Water. December 2021.

(xxiii) USEPA. 2021b. Information Collection Request for the Final Unregulated Contaminant Monitoring Rule (UCMR 5). EPA 815-B-21-008. Office of Water. December 2021.

(xxiv) USEPA. 2021c. Revisions to the Unregulated Contaminant Monitoring Rule for the Fifth Monitoring Cycle (UCMR 5): Public Meeting and Webinar. Presentation Slides. EPA 815-A-21-001. Office of Water. April 2021. Available at https://www.epa.gov/dwucmr/unregulated-contaminant-monitoring-rule-ucmr-meetings-and-materials.

(xxv) USEPA. 2021d. Drinking Water Contaminant Candidate List 5—Draft. Federal Register . Vol. 86, No. 135 p. 37948, July 19, 2021.

(xxvi) USEPA. 2021e. Information Compendium for Contaminants for the Final Unregulated Contaminant Monitoring Rule (UCMR 5). EPA 815-B-21-009. Office of Water. December 2021.

(xxvii) USEPA. 2021f. UCMR 5 Laboratory Approval Manual. EPA 815-B-21-010. Office of Water. December 2021.

(xxviii) USEPA. 2021g. Revisions to the Unregulated Contaminant Monitoring Rule for Public Water Systems and Announcement of Public Meeting; Proposed Rule and Notice of Public Meeting. Federal Register . Vol. 86, No. 46, p. 13846, March 11, 2021.

(xxix) USEPA. 2021h. Revisions to 40 CFR 141.35 and 141.40. EPA 815-B-21-011. Office of Water. December 2021. Available in EPA's public docket (under Docket ID No. EPA-HQ-OW-2020-0530) at https://www.regulations.gov.

(xxx) USEPA. 2021i. Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal. EPA 815-R-21-008. Office of Water. December 2021.

(xxi) USEPA. 2021j. Instructions for Preparing a Ground Water Representative Monitoring Plan for the Unregulated Contaminant Monitoring Rule. EPA 815-B-21-013. Office of Water. December 2021.

List of Subjects in 40 CFR Part 141

Environmental protection, Chemicals, Incorporation by reference, Indian—lands, Intergovernmental relations, Reporting and recordkeeping requirements, Water supply.

Michael S. Regan,

Administrator.

For the reasons set forth in the preamble, EPA amends 40 CFR part 141 as follows:

PART 141—NATIONAL PRIMARY DRINKING WATER REGULATIONS

1. The authority citation for part 141 continues to read as follows:

Authority:

42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-4, 300j-9, and 300j-11.

Subpart D—Reporting and Recordkeeping

2. Amend §141.35 as follows:

a. In paragraph (a), revise the fourth sentence;

b. In paragraph (c)(1), remove the text “December 31, 2017” and add, in its place the text “December 31, 2022”;

c. Revise paragraphs (c)(2), (c)(3)(i) through (iii), (c)(4), (c)(5)(i), and (c)(6)(ii);

d. In paragraph (d)(2), revise the first, second, and third sentences; and

f. Revise paragraph (e).

The revisions read as follows:

§141.35 Reporting for unregulated contaminant monitoring results.

(a) * * * For the purposes of this section, PWS “population served” is the retail population served directly by the PWS as reported to the Federal Safe Drinking Water Information System (SDWIS/Fed). * * *

* * * * *

(c) * * *

(2) Sampling location inventory information. You must provide your inventory information by December 31, 2022, using EPA's electronic data reporting system, as specified in paragraph (b)(1) of this section. You must submit, verify, or update data elements 1-9 (as defined in Table 1 of paragraph (e) of this section) for each sampling location, or for each approved representative sampling location (as specified in paragraph (c)(3) of this section) regarding representative sampling locations. If this information changes, you must report updates, including new sources, and sampling locations that are put in use before or during the UCMR sampling period, to EPA's electronic data reporting system within 30 days of the change.

(3) * * *

(i) Qualifications. Large PWSs that have EPA- or State-approved representative EPTDS sampling locations from a previous UCMR cycle, or as provided for under 40 CFR 141.23(a)(1), 40 CFR 141.24(f)(1), or 40 CFR 141.24(h)(1), may submit a copy of documentation from your State or EPA that approves your representative sampling plan. PWSs that do not have an approved representative EPTDS sampling plan may submit a proposal to sample at representative EPTDS(s) rather than at each individual EPTDS if: You use ground water as a source; all of your well sources have either the same treatment or no treatment; and you have multiple EPTDSs from the same source ( i.e., same aquifer). You must submit a copy of the existing or proposed representative EPTDS sampling plan, as appropriate, at least six months prior to your scheduled sample collection, as specified in paragraph (b)(1) of this section. If changes to your inventory that impact your representative plan occur before or during the UCMR sampling period, you must report updates within 30 days of the change.

(ii) Demonstration. If you are submitting a proposal to sample at representative EPTDS(s) rather than at each individual EPTDS, you must demonstrate that any EPTDS that you propose as representative of multiple wells is associated with a well that draws from the same aquifer as the wells it will represent. The proposed well must be representative of the highest annual volume and most consistently active wells in the representative array. If that representative well is not in use at the scheduled sampling time, you must select and sample an alternative representative well. You must submit the information defined in Table 1, paragraph (e) of this section for each proposed representative sampling location. You must also include documentation to support your proposal that the specified wells are representative of other wells. This documentation can include system-maintained well logs or construction drawings indicating that the representative well(s) is/are at a representative depth, and details of well casings and grouting; data demonstrating relative homogeneity of water quality constituents ( e.g., pH, dissolved oxygen, conductivity, iron, manganese) in samples drawn from each well; and data showing that your wells are located in a limited geographic area ( e.g., all wells within a 0.5 mile radius) and/or, if available, the hydrogeologic data indicating the ground water travel time between the representative well and each of the individual wells it represents ( e.g., all wells within a five-year time of travel delineation). Your proposal must be sent in writing to EPA, as specified in paragraph (b)(1) of this section.

(iii) Approval. EPA or the State (as specified in the Partnership Agreement reached between the State and EPA) will review your proposal and coordinate any necessary changes with you. Your plan will not be final until you receive written approval from EPA, identifying the final list of EPTDSs where you will be required to monitor.

(4) Contacting EPA if your PWS has not been notified of requirements. If you believe you are subject to UCMR requirements, as defined in 40 CFR 141.40(a)(1) and (a)(2)(i), and you have not been contacted by either EPA or your State by April 26, 2022, you must send a letter to EPA, as specified in paragraph (b)(1) of this section. The letter must be from your PWS Official and must include an explanation as to why the UCMR requirements are applicable to your system along with the appropriate contact information. A copy of the letter must also be submitted to the State as directed by the State. EPA will make an applicability determination based on your letter, and in consultation with the State when necessary and will notify you regarding your applicability status and required sampling schedule. However, if your PWS meets the applicability criteria specified in 40 CFR 141.40(a)(2)(i), you are subject to the UCMR monitoring and reporting requirements, regardless of whether you have been contacted by the State or EPA.

(5) * * *

(i) General rescheduling notification requirements. Large systems may independently change their monitoring schedules up to December 31, 2022, using EPA's electronic data reporting system, as specified in paragraph (b)(1) of this section. After this date has passed, if your PWS cannot sample according to your assigned sampling schedule ( e.g., because of budget constraints, or if a sampling location will be closed during the scheduled month of monitoring), you must mail or email a letter to EPA, as specified in paragraph (b)(1) of this section, prior to the scheduled sampling date. You must include an explanation of why the samples cannot be taken according to the assigned schedule, and you must provide the alternative schedule you are requesting. You must not reschedule monitoring specifically to avoid sample collection during a suspected vulnerable period. You are subject to your assigned UCMR sampling schedule or the schedule that you revised on or before December 31, 2022, unless and until you receive a letter from EPA specifying a new schedule.

* * * * *

(6) * * *

(ii) Reporting schedule. You must require your laboratory, on your behalf, to post and approve the data in EPA's electronic data reporting system, accessible at https://www.epa.gov/dwucmr, for your review within 90 days from the sample collection date (sample collection must occur as specified in 40 CFR 141.40(a)(4)). You then have 30 days from when the laboratory posts and approves your data to review, approve, and submit the data to the State and EPA via the agency's electronic data reporting system. If you do not electronically approve and submit the laboratory data to EPA within 30 days of the laboratory posting approved data, the data will be considered approved by you and available for State and EPA review.

* * * * *

(d) * * *

(2) Sampling location inventory information. You must provide your inventory information by December 31, 2022, using EPA's electronic data reporting system, as specified in paragraph (b)(1) of this section. If this information changes, you must report updates, including new sources, and sampling locations that are put in use before or during the UCMR sampling period, to EPA's electronic data reporting system within 30 days of the change, as specified in paragraph (b)(1) of this section. * * *

(e) Data elements. Table 1 defines the data elements that must be provided for UCMR monitoring.

Table 1 to Paragraph (e)—Unregulated Contaminant Monitoring Reporting Requirements
Data elementDefinition
1. Public Water System Identification (PWSID) CodeThe code used to identify each PWS. The code begins with the standard 2-character postal State abbreviation or Region code; the remaining 7 numbers are unique to each PWS in the State. The same identification code must be used to represent the PWS identification for all current and future UCMR monitoring.
2. Public Water System NameUnique name, assigned once by the PWS.
3. Public Water System Facility Identification CodeAn identification code established by the State or, at the State's discretion, by the PWS, following the format of a 5-digit number unique within each PWS for each applicable facility (i.e., for each source of water, treatment plant, distribution system, or any other facility associated with water treatment or delivery). The same identification code must be used to represent the facility for all current and future UCMR monitoring.
4. Public Water System Facility NameUnique name, assigned once by the PWS, for every facility ID ( e.g., Treatment Plant).
5. Public Water System Facility TypeThat code that identifies that type of facility as either: CC = Consecutive connection. SS = Sampling station. TP = Treatment plant. OT = Other.
6. Water Source TypeThe type of source water that supplies a water system facility. Systems must report one of the following codes for each sampling location:
SW = Surface water (to be reported for water facilities that are served entirely by a surface water source during the 12-month period).
GU = Ground water under the direct influence of surface water (to be reported for water facilities that are served all or in part by ground water under the direct influence of surface water at any time during the 12-month sampling period), and are not served at all by surface water during this period.
MX = Mixed water (to be reported for water facilities that are served by a mix of surface water, ground water, and/or ground water under the direct influence of surface water during the 12-month period).
GW = Ground water (to be reported for water facilities that are served entirely by a ground water source during the 12-month period).
7. Sampling Point Identification CodeAn identification code established by the State, or at the State's discretion, by the PWS, that uniquely identifies each sampling point. Each sampling code must be unique within each applicable facility, for each applicable sampling location (i.e ., entry point to the distribution system). The same identification code must be used to represent the sampling location for all current and future UCMR monitoring.
8. Sampling Point NameUnique sample point name, assigned once by the PWS, for every sample point ID ( e.g., Entry Point).
9. Sampling Point Type CodeA code that identifies the location of the sampling point as: EP = Entry point to the distribution system.
10. Disinfectant TypeAll of the disinfectants/oxidants that have been added prior to and at the entry point to the distribution system. Please select all that apply:
PEMB = Permanganate.
HPXB = Hydrogen peroxide.
CLGA = Gaseous chlorine.
CLOF = Offsite generated hypochlorite (stored as a liquid form).
CLON = Onsite generated hypochlorite.
CAGC = Chloramine (formed with gaseous chlorine).
CAOF = Chloramine (formed with offsite hypochlorite).
CAON = Chloramine (formed with onsite hypochlorite).
CLDB = Chlorine dioxide.
OZON = Ozone.
ULVL = Ultraviolet light.
OTHD = All other types of disinfectant/oxidant.
NODU = No disinfectant/oxidant used.
11. Treatment InformationTreatment information associated with the sample point. Please select all that apply.
CON = Conventional (non-softening, consisting of at least coagulation/sedimentation basins and filtration).
SFN = Softening.
RBF = River bank filtration.
PSD = Pre-sedimentation.
INF = In-line filtration.
DFL = Direct filtration.
SSF = Slow sand filtration.
BIO = Biological filtration (operated with an intention of maintaining biological activity within filter).
UTR = Unfiltered treatment for surface water source.
GWD = Groundwater system with disinfection only.
PAC = Application of powder activated carbon.
GAC = Granular activated carbon adsorption (not part of filters in CON, SFN, INF, DFL, or SSF).
AIR = Air stripping (packed towers, diffused gas contactors).
POB = Pre-oxidation with chlorine (applied before coagulation for CON or SFN plants or before filtration for other filtration plants).
MFL = Membrane filtration.
IEX = Ionic exchange.
DAF = Dissolved air floatation.
CWL = Clear well/finished water storage without aeration.
CWA = Clear well/finished water storage with aeration.
ADS = Aeration in distribution system (localized treatment).
OTH = All other types of treatment.
NTU = No treatment used.
DKN = Do not know.
12. Sample Collection DateThe date the sample is collected, reported as 4-digit year, 2-digit month, and 2-digit day (YYYYMMDD).
13. Sample Identification CodeAn alphanumeric value up to 30 characters assigned by the laboratory to uniquely identify containers, or groups of containers, containing water samples collected at the same sampling location for the same sampling date.
14. ContaminantThe unregulated contaminant for which the sample is being analyzed.
15. Analytical Method CodeThe identification code of the analytical method used.
16. Extraction Batch Identification CodeLaboratory assigned extraction batch ID. Must be unique for each extraction batch within the laboratory for each method. For CCC samples report the Analysis Batch Identification Code as the value for this field. For methods without an extraction batch, leave this field null.
17. Extraction DateDate for the start of the extraction batch (YYYYMMDD). For methods without an extraction batch, leave this field null.
18. Analysis Batch Identification CodeLaboratory assigned analysis batch ID. Must be unique for each analysis batch within the laboratory for each method.
19. Analysis DateDate for the start of the analysis batch (YYYYMMDD).
20. Sample Analysis TypeThe type of sample collected and/or prepared, as well as the fortification level. Permitted values include: CCCL = MRL level continuing calibration check; a calibration standard containing the contaminant, the internal standard, and surrogate analyzed to verify the existing calibration for those contaminants.
CCCM = Medium level continuing calibration check; a calibration standard containing the contaminant, the internal standard, and surrogate analyzed to verify the existing calibration for those contaminants.
CCCH = High level continuing calibration check; a calibration standard containing the contaminant, the internal standard, and surrogate analyzed to verify the existing calibration for those contaminants.
FS = Field sample; sample collected and submitted for analysis under this final rule.
LFB = Laboratory fortified blank; an aliquot of reagent water fortified with known quantities of the contaminants and all preservation compounds.
LRB = Laboratory reagent blank; an aliquot of reagent water treated exactly as a field sample, including the addition of preservatives, internal standards, and surrogates to determine if interferences are present in the laboratory, reagents, or other equipment.
LFSM = Laboratory fortified sample matrix; a UCMR field sample with a known amount of the contaminant of interest and all preservation compounds added.
LFSMD = Laboratory fortified sample matrix duplicate; duplicate of the laboratory fortified sample matrix.
QCS = Quality control sample; a sample prepared with a source external to the one used for initial calibration and CCC. The QCS is used to check calibration standard integrity.
FRB = Field reagent blank; an aliquot of reagent water treated as a sample including exposure to sampling conditions to determine if interferences or contamination are present from sample collection through analysis.
21. Analytical Result—SignA value indicating whether the sample analysis result was: (<) “less than” means the contaminant was not detected, or was detected at a level below the Minimum Reporting Level. (=) “equal to” means the contaminant was detected at the level reported in “Analytical Result— Measured Value.”
22. Analytical Result—Measured ValueThe actual numeric value of the analytical results for: Field samples; laboratory fortified matrix samples; laboratory fortified sample matrix duplicates; and concentration fortified.
23. Additional ValueRepresents the true value or the fortified concentration for spiked samples for QC Sample Analysis Types (CCCL, CCCM, CCCH, QCS, LFB, LFSM, and LFSMD).
24. Laboratory Identification CodeThe code, assigned by EPA, used to identify each laboratory. The code begins with the standard two-character State postal abbreviation; the remaining five numbers are unique to each laboratory in the State.
25. Sample Event CodeA code assigned by the PWS for each sample event. This will associate samples with the PWS monitoring plan to allow EPA to track compliance and completeness. Systems must assign the following codes:
SE1, SE2, SE3, and SE4—Represent samples collected to meet UCMR Assessment Monitoring requirements; where “SE1” and “SE2” represent the first and second sampling period for all water types; and “SE3” and “SE4” represent the third and fourth sampling period for SW, GU, and MX sources only.
26. Historical Information for Contaminant Detections and TreatmentA yes or no answer provided by the PWS for each entry point to the distribution system. Question: Have you tested for the contaminant in your drinking water in the past? YES = If yes, did you modify your treatment and if so, what types of treatment did you implement? Select all that apply.
PAC = Application of powder activated carbon.
GAC = Granular activated carbon adsorption (not part of filters in CON, SFN, INF, DFL, or SSF).
IEX = Ionic exchange.
NRO = Nanofiltration and reverse osmosis.
OZN = Ozone.
BAC = Biologically active carbon.
MFL = Membrane filtration.
UVL = Ultraviolet light.
OTH = Other.
NMT = Not modified after testing.
NO = Have never tested for the contaminant.
DK = Do not know.
27. Potential PFAS SourcesA yes or no answer provided by the PWS for each entry point to the distribution system. Question: Are you aware of any potential current and/or historical sources of PFAS that may have impacted the drinking water sources at your water system?
YES = If yes, select all that apply:
MB = Military base.
FT = Firefighting training school.
AO = Airport operations.
CW = Car wash or industrial launderers.
PS = Public safety activities ( e.g., fire and rescue services).
WM = Waste management.
HW = Hazardous waste collection, treatment, and disposal.
UW = Underground injection well.
SC = Solid waste collection, combustors, incinerators.
MF = Manufacturing.
FP = Food packaging.
TA = Textile and apparel ( e.g., stain- and water-resistant, fiber/thread, carpet, house furnishings, leather).
PP = Paper.
CC = Chemical.
PR = Plastics and rubber products.
MM = Machinery.
CE = Computer and electronic products.
FM = Fabricated metal products (e.g., nonstick cookware).
PC = Petroleum and coal products.
FF = Furniture.
OG = Oil and gas production.
UT = Utilities (e.g ., sewage treatment facilities).
CT = Construction (e.g ., wood floor finishing, electrostatic painting).
OT = Other.
NO = Not aware of any potential current and/or historical sources.
DK = Do not know.

Subpart E—Special Regulations, Including Monitoring Regulations and Prohibition on Lead Use

3. Amend §141.40 as follows:

a. In paragraph (a) introductory text, remove the text “December 31, 2015” and add in its place the text “February 1, 2021 or subsequent corrections from the State”;

b. Revise paragraphs (a)(2)(ii) introductory text, (a)(2)(ii)(A), and (a)(3);

c. In paragraph (a)(4)(i) introductory text, remove the text “December 31, 2017” and add in its place the text “December 31, 2022”;

d. Revise paragraphs (a)(4)(i)(A) through (C), (a)(4)(ii) introductory text, and the first sentence in paragraph (a)(4)(ii)(A);

e. Remove paragraph (a)(4)(iii);

f. In paragraph (a)(5)(ii), revise the fifth and sixth sentences;

g. Revise paragraph (a)(5)(iii) introductory text;

h. Remove and reserve paragraph (a)(5)(iv); and

i. Revise paragraphs (a)(5)(v) and (vi) and paragraph (c).

The revisions read as follows:

§141.40 Monitoring requirements for unregulated contaminants.

(a) * * *

(2) * * *

(ii) Small systems. EPA will provide sample containers, provide pre-paid air bills for shipping the sampling materials, conduct the laboratory analysis, and report and review monitoring results for all small systems selected to conduct monitoring under paragraphs (a)(2)(ii)(A) through (C) of this section. If you own or operate a PWS (other than a transient non-community water system) that serves a retail population of 10,000 or fewer people and you are notified of monitoring requirements by the State or EPA, you must monitor as follows:

(A) Assessment Monitoring. You must monitor for the contaminants on List 1 per table 1 to paragraph (a)(3) if you are notified by your State or EPA that you are part of the State Monitoring Plan for Assessment Monitoring.

* * * * *

(3) Analytes to be monitored. Lists 1, 2, and 3 contaminants are provided in table 1 to paragraph (a)(3):

Table 1 to Paragraph(a)(3)—UCMR Contaminant List
1—Contaminant2—CASRN3—Analytical methods a4—Minimum reporting level b5—Sampling location c6—Period during which sample collection to be completed
Column headings are:
1—Contaminant: The name of the contaminant to be analyzed.
2—CASRN (Chemical Abstracts Service Registry Number) or Identification Number: A unique number identifying the chemical contaminants.
3—Analytical Methods: Method numbers identifying the methods that must be used to test the contaminants.
4—Minimum Reporting Level (MRL): The value and unit of measure at or above which the concentration of the contaminant must be measured using the approved analytical methods. If EPA determines, after the first six months of monitoring that the specified MRLs result in excessive resampling, EPA will establish alternate MRLs and will notify affected PWSs and laboratories of the new MRLs. N/A is defined as non-applicable.
5—Sampling Location: The locations within a PWS at which samples must be collected.
6—Period During Which Sample Collection to be Completed: The time period during which the sampling and testing will occur for the indicated contaminant.
a The analytical procedures shall be performed in accordance with the documents associated with each method, see paragraph (c) of this section.
b The MRL is the minimum concentration of each analyte that must be reported to EPA.
c Sampling must occur at your PWS's entry points to the distribution system (EPTDSs), after treatment is applied, that represent each non-emergency water source in routine use over the 12-month period of monitoring. Systems that purchase water with multiple connections from the same wholesaler may select one representative connection from that wholesaler. The representative EPTDS must be a location within the purchaser's water system. This EPTDS sampling location must be representative of the highest annual volume connections. If the connection selected as the representative EPTDS is not available for sampling, an alternate highest volume representative connection must be sampled. See 40 CFR 141.35(c)(3) for an explanation of the requirements related to the use of representative GW EPTDSs.
List 1: Assessment Monitoring
Per- and Polyfluoroalkyl Substances (PFAS)
11-chloroeicosafluoro-3-oxaundecane-1-sulfonic acid (11Cl-PF3OUdS)763051-92-9EPA 5330.005 µg/LEPTDS1/1/2023-12/31/2025
1H, 1H, 2H, 2H-perfluorodecane sulfonic acid (8:2 FTS)39108-34-4EPA 5330.005 µg/LEPTDS1/1/2023-12/31/2025
1H, 1H, 2H, 2H-perfluorohexane sulfonic acid (4:2 FTS)757124-72-4EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
1H, 1H, 2H, 2H-perfluorooctane sulfonic acid (6:2 FTS)27619-97-2EPA 5330.005 µg/LEPTDS1/1/2023-12/31/2025
4,8-dioxa-3H-perfluorononanoic acid (ADONA)919005-14-4EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
9-chlorohexadecafluoro-3-oxanone-1-sulfonic acid (9Cl-PF3ONS)756426-58-1EPA 5330.002 µg/LEPTDS1/1/2023-12/31/2025
hexafluoropropylene oxide dimer acid (HFPO-DA) (GenX)13252-13-6EPA 5330.005 µg/LEPTDS1/1/2023-12/31/2025
nonafluoro‐3,6‐dioxaheptanoic acid (NFDHA)151772-58-6EPA 5330.02 µg/LEPTDS1/1/2023-12/31/2025
perfluoro (2‐ethoxyethane) sulfonic acid (PFEESA)113507-82-7EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluoro‐3‐methoxypropanoic acid (PFMPA)377-73-1EPA 5330.004 µg/LEPTDS1/1/2023-12/31/2025
perfluoro‐4‐methoxybutanoic acid (PFMBA)863090-89-5EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluorobutanesulfonic acid (PFBS)375-73-5EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluorobutanoic acid (PFBA)375-22-4EPA 5330.005 µg/LEPTDS1/1/2023-12/31/2025
perfluorodecanoic acid (PFDA)335-76-2EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluorododecanoic acid (PFDoA)307-55-1EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluoroheptanesulfonic acid (PFHpS)375-92-8EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluoroheptanoic acid (PFHpA)375-85-9EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluorohexanesulfonic acid (PFHxS)355-46-4EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluorohexanoic acid (PFHxA)307-24-4EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluorononanoic acid (PFNA)375-95-1EPA 5330.004 µg/LEPTDS1/1/2023-12/31/2025
perfluorooctanesulfonic acid (PFOS)1763-23-1EPA 5330.004 µg/LEPTDS1/1/2023-12/31/2025
perfluorooctanoic acid (PFOA)335-67-1EPA 5330.004 µg/LEPTDS1/1/2023-12/31/2025
perfluoropentanesulfonic acid (PFPeS)2706-91-4EPA 5330.004 µg/LEPTDS1/1/2023-12/31/2025
perfluoropentanoic acid (PFPeA)2706-90-3EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluoroundecanoic acid (PFUnA)2058-94-8EPA 5330.002 µg/LEPTDS1/1/2023-12/31/2025
n-ethyl perfluorooctanesulfonamidoacetic acid (NEtFOSAA)2991-50-6EPA 537.10.005 µg/LEPTDS1/1/2023-12/31/2025
n-methyl perfluorooctanesulfonamidoacetic acid (NMeFOSAA)2355-31-9EPA 537.10.006 µg/LEPTDS1/1/2023-12/31/2025
perfluorotetradecanoic acid (PFTA)376-06-7EPA 537.10.008 µg/LEPTDS1/1/2023-12/31/2025
perfluorotridecanoic acid (PFTrDA)72629-94-8EPA 537.10.007 µg/LEPTDS1/1/2023-12/31/2025
Metal/Pharmaceutical
Lithium7439-93-2EPA 200.7, SM 3120 B, ASTM D1976-209 µg/LEPTDS1/1/2023-12/31/2025
List 2: Screening Survey
ReservedReservedReservedReservedReservedReserved
List 3: Pre-Screen Testing
ReservedReservedReservedReservedReservedReserved

(4) * * *

(i) * * *

(A) Sample collection period. You must collect the samples in one continuous 12-month period for List 1 Assessment Monitoring, and, if applicable, for List 2 Screening Survey, or List 3 Pre-Screen Testing, during the timeframe indicated in column 6 of table 1 to paragraph (a)(3) of this section. EPA or your State will specify the month(s) and year(s) in which your monitoring must occur. As specified in 40 CFR 141.35(c)(5), you must contact EPA if you believe you cannot collect samples according to your schedule.

(B) Frequency. You must collect the samples within the timeframe and according to the frequency specified by contaminant type and water source type for each sampling location, as specified in table 2 to this paragraph (a)(4)(i)(B). For the second or subsequent round of sampling, if a sample location is non-operational for more than one month before and one month after the scheduled sampling month ( i.e., it is not possible for you to sample within the window specified in table 2), you must notify EPA as specified in 40 CFR 141.35(c)(5) to reschedule your sampling.

Table 2 to Paragraph ( )(4)( )(B)—Monitoring Frequency by Contaminant and Water Source Types
Contaminant typeWater source typeTimeframeFrequency 1
1 Systems must assign a sample event code for each contaminant listed in Table 1. Sample event codes must be assigned by the PWS for each sample event. For more information on sample event codes see 40 CFR 141.35(e) Table 1.
List 1 ContaminantsSurface water, Mixed, or GWUDI12 monthsYou must monitor for four consecutive quarters. Sample events must occur three months apart. (Example: If first monitoring is in January, the second monitoring must occur any time in April, the third any time in July, and the fourth any time in October).
Ground water12 monthsYou must monitor twice in a consecutive 12-month period. Sample events must occur 5-7 months apart. (Example: If the first monitoring event is in April, the second monitoring event must occur any time in September, October, or November.)

(C) Location. You must collect samples for each List 1 Assessment Monitoring contaminant, and, if applicable, for each List 2 Screening Survey, or List 3 Pre-Screen Testing contaminant, as specified in table 1 to paragraph (a)(3) of this section. Samples must be collected at each sample point that is specified in column 5 and footnote c of table 1 to paragraph (a)(3) of this section. If you are a GW system with multiple EPTDSs, and you request and receive approval from EPA or the State for sampling at representative EPTDS(s), as specified in 40 CFR 141.35(c)(3), you must collect your samples from the approved representative sampling location(s).

* * * * *

(ii) Small systems. If you serve a population of 10,000 or fewer people and are notified that you are part of the State Monitoring Plan, you must comply with the requirements specified in paragraphs (a)(4)(ii)(A) through (H) of this section. If EPA or the State informs you that they will be collecting your UCMR samples, you must assist them in identifying the appropriate sampling locations and in collecting the samples.

(A) Sample collection and frequency. You must collect samples at the times specified for you by the State or EPA. Your schedule must follow both the timing of monitoring specified in table 1 to paragraph (a)(3) of this section, List 1, and, if applicable, List 2, or List 3, and the frequency of monitoring in table 2 to paragraph (a)(4)(i)(B) of this section.

* * * * *

(5) * * *

(ii) * * * To participate in the UCMR Laboratory Approval Program, the laboratory must register and complete the necessary application materials by August 1, 2022. Correspondence must be addressed to: UCMR Laboratory Approval Coordinator, USEPA, Technical Support Center, 26 West Martin Luther King Drive, (MS 140), Cincinnati, Ohio 45268; or emailed to EPA at: UCMR_Lab_Approval@epa.gov.

(iii) Minimum Reporting Level. The MRL is defined by EPA as the quantitation limit achievable, with 95 percent confidence, by 75 percent of laboratories nationwide, assuming the use of good instrumentation and experienced analysts.

* * * * *

(v) Method defined quality control. You must ensure that your laboratory analyzes Laboratory Fortified Blanks and conducts Laboratory Performance Checks, as appropriate to the method's requirements, for those methods listed in column 3 in table 1 to paragraph (a)(3) of this section. Each method specifies acceptance criteria for these QC checks.

(vi) Reporting. You must require your laboratory, on your behalf, to post and approve these data in EPA's electronic data reporting system, accessible at https://www.epa.gov/dwucmr, for your review within 90 days from the sample collection date. You then have 30 days from when the laboratory posts and approves your data to review, approve, and submit the data to the State and EPA, via the agency's electronic data reporting system. If you do not electronically approve and submit the laboratory data to EPA within 30 days of the laboratory posting approved data, the data will be considered approved by you and available for State and EPA review.

* * * * *

(c) Incorporation by reference. The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at U.S. Environmental Protection Agency, Water Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC 20004, (202) 566-1744, email Docket-customerservice@epa.gov, or go to https://www.epa.gov/dockets/epa-docket-center-reading-room, and is available from the sources indicated elsewhere in this paragraph. The material is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fr.inspection@nara.gov, or go to www.archives.gov/federal-register/cfr/ibr-locations.html.

(1) U.S. Environmental Protection Agency, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC 20004; telephone: (202) 566-1744.

(i) Method 200.7, “Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry,” Revision 4.4, EMMC Version, 1994. Available at https://www.epa.gov/esam/method-2007-determination-metals-and-trace-elements-water-and-wastes-inductively-coupled-plasma.

(ii) Method 537.1, “Determination of Selected Per- and Polyfluorinated Alkyl Substances in Drinking Water by Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry,” Version 2.0, 2020. Available at https://www.epa.gov/water-research/epa-drinking-water-research-methods.

(iii) Method 533, “Determination of Per- and Polyfluoroalkyl Substances in Drinking Water by Isotope Dilution Anion Exchange Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry,” November 2019, EPA 815-B-19-020. Available at https://www.epa.gov/dwanalyticalmethods.

(2) American Public Health Association, 800 I Street NW, Washington, DC 20001-3710; telephone: (202) 777-2742; email: comments@apha.org; www.apha.org.

(i) “Standard Methods for the Examination of Water & Wastewater,” 23rd edition (2017).

(A) SM 3120 B, “Metals by Plasma Emission Spectroscopy (2017): Inductively Coupled Plasma (ICP) Method.”

(B) [Reserved]

(ii) “Standard Methods Online,” approved 1999; https://www.standardmethods.org.

(A) SM 3120 B, “Metals by Plasma Emission Spectroscopy: Inductively Coupled Plasma (ICP) Method,” revised December 14, 2020.

(B) [Reserved]

(3) ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959; telephone: (610) 832-9500; email: service@astm.org; www.astm.org.

(i) ASTM D1976-20, “Standard Test Method for Elements in Water by Inductively-Coupled Plasma Atomic Emission Spectroscopy,” approved May 1, 2020.

(ii) [Reserved]

[FR Doc. 2021-27858 Filed 12-23-21; 8:45 am]

BILLING CODE 6560-50-P

Vehicle emissions defeat devices: Steer clear!
2024-10-07T05:00:00Z

Vehicle emissions defeat devices: Steer clear!

The Environmental Protection Agency (EPA) regulates emissions from motor vehicles, engines, and the fuels used to operate them. The agency requires vehicle manufacturers to install control devices that limit the amount of air pollutants a vehicle may emit. However, defeat devices attempt to detour around these controls and allow emissions beyond federal limits.

Excess vehicle emissions can threaten the health of others, impair state and local efforts to maintain national air quality standards, and — as one company and its owner learned — subject you and your business to steep monetary penalties.

Steer clear of defeat devices to ensure a smooth regulatory road.

Company learns multimillion-dollar lesson

EPA and the U.S. Department of Justice reached a settlement agreement with a North Carolina automotive parts company and its owner for violating the Clean Air Act (CAA) requirements for mobile sources by:

  • Manufacturing, selling, and installing more than 250,000 defeat devices on diesel pickup trucks; and
  • Installing aftermarket defeat devices on hundreds of diesel pickup trucks.

The company and its owner face civil and criminal consequences and will pay a total of $10 million in fees and penalties.

Civil enforcement

A July 2024 consent decree (pending court approval) requires both parties to pay a combined $7 million penalty. It also bans the company and owner from:

  • Manufacturing, selling, offering to sell, and installing defeat devices;
  • Transferring intellectual property to help others make or sell defeat devices; and
  • Investing in or profiting from other businesses’ defeat devices.

Criminal enforcement

Both the company and owner pleaded guilty to conspiring to violate the CAA. The federal court ordered the company to pay a $2.4 million fine and complete three years of organizational probation. It also ordered the owner to pay a $600,000 fine and serve three years of probation.

What are defeat devices?

A defeat device is any component that “bypasses, impairs, defeats, or disables the control of emissions of any regulated pollutant” (40 CFR 1068.101(b)(2)). Put simply, it’s an illegal device that removes or disables a vehicle’s emissions controls.

There are generally two types of defeat devices: hardware (such as modified automotive parts) and software (like delete tuners). In fact, many of the devices consist of both types that work in tandem. Federal law (and EPA regulations at 1068.101(b)) bans defeat devices used to swerve around vehicle emissions controls. Section 203(a)(3) of the CAA prohibits anyone from:

  • Tampering with an EPA-certified vehicle’s emissions control devices to remove them or make them inoperative before selling the vehicle,
  • Knowingly tampering with an EPA-certified vehicle’s emissions control devices to remove them or make them inoperative after the vehicle is sold and delivered to the purchaser, and
  • Knowingly manufacturing, selling, offering to sell, or installing defeat devices that bypass, defeat, or render inoperative any emission control device.

Common emission control devices include:

  • Onboard diagnostic systems,
  • Catalytic converters,
  • Electronic control units,
  • Fuel systems, and
  • Diesel particulate filters.

Who do the regulations affect?

The prohibition on defeat devices applies to everyone, from the original equipment manufacturer that installs the vehicle emissions controls to the vehicle owner and operators.

The 1990 CAA Amendments expanded the tampering provision in Section 203(a)(3) to include “any person.” Further, EPA’s regulations at 1068.101(b) “apply to everyone,” such as:

  • Vehicle manufacturers;
  • Vehicle dealers;
  • Automobile repair shops;
  • Commercial mechanics;
  • Fleet operators;
  • Aftermarket automotive part manufacturers, sellers, and installers;
  • Owners; and
  • Operators.

Compliance tips

Consider these helpful suggestions for maintaining compliance:

  • Check and comply with your state and local regulations, as they may be more stringent than federal requirements and impose additional rules. For example, states may require certified technicians to conduct automotive maintenance services on emission controls. States may also prohibit operating, selling, and/or registering tampered vehicles.
  • Purchase aftermarket automotive parts only from reputable sources. Obtain proof that the aftermarket parts won’t increase emissions.
  • Self-disclose any potential violations you find to EPA and/or the state environmental agency. EPA and many states will lower or waive civil penalties for self-reporting violations.

The case against this automotive parts company and owner serves as a multimillion-dollar reminder about making, selling, installing, or using defeat devices — steer clear!

Key to remember: Steer clear of defeat devices that try to detour around EPA’s vehicle emissions controls to ensure a smooth regulatory road.

Our Nation’s air — A recap of 2023
2024-09-30T05:00:00Z

Our Nation’s air — A recap of 2023

Implementation of the Clean Air Act in 1970 has fueled impressive long-term emissions reductions, improving the air we breathe. Still, approximately 140 million Americans live in counties where air quality concentrations are above set levels. While long-term trends continue to improve, the Environmental Protection Agency (EPA) states that there’s still work to be done.

Continued emissions reduction

The Clean Air Act requires EPA to set National Ambient Air Quality Standards (NAAQS) for six principal pollutants called criteria air pollutants, which can be harmful to public health and the environment.

Between 1970 and 2023, the combined emissions of these criteria pollutants have dropped by 78 percent. This is of particular significance due to the continued growth of the U.S. economy by 320 percent over that same period of time. Since 1990, air pollutant concentrations of these six key pollutants have declined as follows:

  • Carbon monoxide (CO) 8-hour is down 79 percent.
  • Lead (Pb) 3-month average is down 87 percent (since 2010).
  • Nitrogen dioxide (NO2) annual is down 62 percent.
  • Nitrogen dioxide (NO2) 1-hour is down 55 percent.
  • Ozone (O3) 8-hour is down 18 percent.
  • Particulate matter 10 microns (PM10) 24-hour is down 29 percent.
  • Particulate matter 2.5 microns (PM2.5) annual is down 37 percent (since 2000).
  • Particulate matter 2.5 microns (PM2.5) 24-hour is down 29 percent (since 2000).
  • Sulfur dioxide (SO2) 1-hour is down 92 percent.

Effects on health and the environment

The link between air pollution and these criteria air pollutants contributes to a variety of health problems and impacts on the environment. Breathing elevated levels of CO can decrease the amount of oxygen reaching a person's organs and tissues. Lead exposure can harm the development of children, leading to lower IQs, learning deficits, and behavioral problems. Short-term exposure to NO2 can aggravate asthma and other respiratory diseases. The environmental effects of ozone include damage to vegetation by injuring leaves, which reduces photosynthesis, therefore impairing growth and decreasing crop yields. Particulate matter in the air is the main cause of reduced visibility in parts of the U.S. It can settle on soils and surface waters, which can change the pH, deplete nutrients, and negatively affect ecosystems.

Actions being taken

EPA and states continue to track emissions data from industry, state, tribal, and local agencies from sources in their jurisdictions, including:

  • Highway vehicles;
  • Industrial and other processes (e.g., smelters, refineries, and dry cleaners);
  • Non-road mobile sources (e.g., recreational and construction equipment, marine vessels, aircraft, and locomotives); and
  • Stationary fuel combustion sources (e.g., electric utilities and industrial boilers).

The government continues to invest in climate pollution action efforts to improve the economic and public health of those living in the country, including:

  • Creating rules to reduce methane emissions from oil and natural gas operations,
  • Updating pollution standards for the transportation industry,
  • Establishing greenhouse gas standards for heavy-duty vehicles,
  • Implementing standards for existing coal-fired and natural gas-fired power plants,
  • Investing in infrastructure, and
  • Working to embed environmental justice in all of EPA’s work.

Key to remember: While long-term trends continue to show an improvement in the air we breathe, EPA states that there’s still work to be done.

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EPA extends 2024 Chemical Data Reporting deadline
2024-09-25T05:00:00Z

EPA extends 2024 Chemical Data Reporting deadline

The Environmental Protection Agency (EPA) has extended the submission period for the Chemical Data Reporting (CDR) report. The submission period opened on June 1, and EPA has pushed the submission deadline from September 30 to November 22, 2024.

Who’s impacted?

Under the Toxic Substances Control Act (TSCA), EPA’s CDR rule requires manufacturers (including importers) of chemicals on TSCA’s Chemical Substance Inventory to report information on the production and use of the chemicals in commerce if they meet certain production volume thresholds at any one site.

Why the delay?

The deadline extension is due to technical errors with e-CDRweb, the electronic reporting tool on EPA’s Central Data Exchange system that reporters use to submit the CDR report (Form U). The specific issue only impacts submissions with multiple confidential business information (CBI) claims for chemical identity.

The tool’s copy function fails to properly capture the substantiations submitted by facilities making multiple CBI claims, leaving out some of the questions and answers. Additionally, it doesn’t let submitters who used the copy function add the missing information.

EPA expects to fix the reporting tool by the end of September.

About the 2024 CDR report

The CDR report is submitted to EPA every four years. The 2024 CDR report covers activities that occurred between the calendar years 2020 and 2023. Note that this extension applies only to the 2024 CDR submission period.

Key to remember: Due to technical difficulties with the electronic reporting tool, EPA has extended the 2024 Chemical Data Reporting submission deadline to November 22, 2024.

3 compliance agencies dubbed hardest nuts to crack, per healthcare poll
2024-09-24T05:00:00Z

3 compliance agencies dubbed hardest nuts to crack, per healthcare poll

It’s no secret that the healthcare industry is swamped by government requirements from a host of federal, state, and local agencies. New survey results put three agencies in a near tie for the “greatest compliance challenge” category for leaders, managers, and others in healthcare.

Two of the agencies may be no surprise — the Centers for Medicare & Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC). However, some might be taken aback to learn that the Occupational Safety and Health Administration (OSHA) ranked just as challenging to comply with for the healthcare industry.

The lion’s share of the attention in healthcare has long been on patient care and safety. Therefore, to discover that OSHA — a worker safety and health agency — weighed in as a huge pain point with the other two agencies should raise eyebrows.

Survey data

An August 2024 survey report from the J. J. Keller Center for Market Insights recently tapped 220 professionals from healthcare. This included respondents from clinics/offices; hospitals; ambulatory, nursing, and home care services; outpatient facilities; behavioral health services; medical/dental labs; and other healthcare service types.

As stated, the CMS, CDC, and OSHA each took over 20 percent of the findings in answer to the question, “What government entity’s standards pose the greatest compliance challenge(s) to your organization?” Together, these three stand out from any others for that survey question. In total, they racked up 75 percent of the results!

Other agencies and organizations made up another 10 percent in aggregate, while “none of the above” garnered 14 percent.

Healthcare is dogged by OSHA

OSHA’s mission is “to assure America’s workers have safe and healthful working conditions.” While patient safety is not part of that mission, worker safety and health efforts can spill over into that space. For example, ensuring that workers have proper means of egress and fire protections relates to patient safety. In fact, patient safety efforts may not succeed without safe healthcare workers.

OSHA requires private-sector healthcare employers to provide workers with a safe and healthful work setting free of known serious hazards. The agency has over 1,600 pages of regulations covering general industry, and that includes healthcare. These regulations are complex, but healthcare employers must comply with all applicable requirements.

Healthcare organizations have well over 100 applicable OSHA regulations. The top-cited OSHA regulations for hospitals in fiscal year 2023 include:

  1. 29 CFR 1910.134, Respiratory Protection;
  2. 29 CFR 1910.1030, Bloodborne Pathogens; and
  3. 29 CFR 1910.147, Lockout/tagout.

OSHA’s Healthcare topic page also showcases regulations for personal protective equipment, formaldehyde, ethylene oxide, ionizing radiation, chemical hazard communication, and laboratories.

Yet, the agency’s reach can go beyond regulations. Hazards related to ergonomics, workplace violence, and infectious diseases may be cited. The citations point to section 5(a)(1) of the Occupational Safety and Health Act, which calls for worker protections from serious, recognized hazards. Also, OSHA officers follow the agency’s “Inspection Guidance for Inpatient Healthcare Settings,” which targets lifting-related musculoskeletal disorders, workplace violence, tuberculosis, and other hazards.

OSHA and state-plan state inspections are unannounced — they can happen at any time! In addition, an OSHA penalty can reach over $161,000 per violation.

Industry hit by worker injuries/illnesses

Statistics show that healthcare settings are hazardous places to work! The injury/illness incidence rates for hospitals and nursing and residential care facilities are higher than in the construction industry!

Note that the Bureau of Labor Statistics reveals that the leading injury/illness events with days away from work in hospitals in 2021 and 2022 were:

Because of the severity of some injuries/illnesses and the potential for a worker to suffer one, it’s critical to meet OSHA regulations and beyond. Worker injuries/illnesses come at a high cost that most healthcare facilities likely cannot afford.

The good news is OSHA compliance can lead to a marked decline in worker injuries/illnesses. Even accreditation organizations like The Joint Commission expect to see compliance with applicable OSHA regulations. That’s because meeting OSHA worker safety and health regulations has been discovered to have a positive effect on patient safety. A stable workforce with few worker injuries/illnesses creates a setting conducive to patient confidence and satisfaction.

Where to start

OSHA has resources such as a small business handbook, quick start page, and Hospitals eTool. However, given the importance of OSHA compliance and the challenges it poses to healthcare, it may be wise to have a third party do a comprehensive OSHA compliance audit of each healthcare facility. This is particularly true if leadership is new to workplace safety or does not have the in-house expertise. This baseline may help the facility spot the major hazards and flag OSHA requirements for the site.

The agency recommends that employers conduct compliance inspections at least quarterly. This would be more often if conditions change frequently.

Key to remember

OSHA, along with the CMS and CDC, top the list of compliance challenges for healthcare. A third-party audit or inspection may help these facilities get a handle on the requirements.

How to conduct 3 types of solid waste assessments
2024-09-24T05:00:00Z

How to conduct 3 types of solid waste assessments

No organization wants to throw away the chance to improve operational efficiency. Yet, many businesses unknowingly discard such opportunities by overlooking a process that happens every day: nonhazardous (solid) waste management. That’s where a waste assessment comes in; it’s a tool that can help your facility avoid wasted opportunities.

Why conduct a solid waste assessment?

The ultimate goal of a solid waste assessment is to achieve operational efficiency by cutting the amount of waste a facility generates and improving management practices for waste that can’t be eliminated. As a result, facilities send less waste to landfills (minimizing environmental impact) and require fewer resources for waste management (cutting costs).

Through a waste assessment, your facility can:

  • Evaluate waste streams (i.e., the flow of waste from creation to disposal),
  • Analyze current waste management processes (including sorting, storing, and disposing methods), and
  • Identify ways to improve waste management (such as modifying products or recycling).

Types of solid waste assessments

The Environmental Protection Agency (EPA) identifies three leading methods for conducting waste assessments: records examinations, walkthroughs, and sorts.

Records examinations

A records examination answers two questions: How does your facility remove solid waste (landfill vs. recycling), and how much does it cost your facility to remove it?

First, calculate the total amount of waste removed (typically in pounds) and total costs for:

  • Collection (conducted via a contractor or internally),
  • Container and dumpster rentals,
  • Removal (e.g., flat, per-weight/volume, or per-pull fees), and
  • Disposal, including landfill tipping fees (if applicable).

Next, using the same measurement units, sum up the number of recyclables collected and recycling costs for:

  • Collection (conducted via a contractor or internally),
  • Container and dumpster rentals,
  • Removal (e.g., flat, per-weight/volume, or per-pull fees), and
  • Revenues for each product or material (if applicable).

Finally:

  • Subtract the total weight of recyclables collected from the total weight of all waste removed to determine the total weight of waste sent to landfills, and
  • Subtract the total recyclables costs from the total waste costs to determine the various costs for landfill wastes (e.g., total waste collection costs – total recyclables collection cost = total landfill collection costs).

Facility walkthroughs

A facility walkthrough requires physical observation of the processes that generate waste and the types of waste they create.

Each facility can tailor the walkthrough process to its unique objectives. However, effective walkthroughs generally incorporate these elements:

  • Alert the department leaders of upcoming walkthroughs.
  • Interview workers in each walkthrough area. Employees can ask questions about waste management processes, and you can ask for valuable input from those directly involved.
  • Ask whether variations occur in the waste generated (e.g., increased waste during delivery days) and if any new equipment or procedures will affect the waste created.
  • Identify current waste-reduction efforts.
  • Look for processes that generate unnecessary waste.
  • Include waste generated by maintenance operations.

Waste sorts

Sometimes, the most effective assessment requires a hands-on approach, and that’s what a waste sort delivers. It enables you to estimate how much each type of waste contributes to the total amount of generated waste.

  1. Gather a representative sample of waste, such as daily waste generated.
  2. Sort the waste into major categories, like paper, plastics, etc.
  3. If applicable, sort the major categories into subcategories, such as glass by color.
  4. Weigh each container of waste.

Remember to weigh the containers when they’re empty. Subtract the weight of the empty containers from the weight of waste to obtain each subcategory’s net component weight. Add these measurements to obtain the total weight of waste generated.

Which waste assessment method is best for your facility?

The “right” waste assessment is unique to each facility. You can use one method or a combination. When selecting the waste assessment(s) to use, consider these factors:

  • What type of data do you need? Should the assessment provide quantitative data (e.g., the weight of waste produced), qualitative data (e.g., how the waste is produced), or both?
  • What types of waste do you want to assess? Do you want to look at just one or multiple kinds?
  • What’s the scope of your assessment? Do you want to target a specific process, one or more departments, or the entire facility?
  • What resources are available? How much time and manpower can you allocate toward conducting an assessment?

Key to remember: Waste assessments help facilities improve operational efficiency by identifying ways to reduce waste and enhance waste management practices.

Reclassification of major sources to area sources rule paves the way for cleaner air and streamlined compliance
2024-09-23T05:00:00Z

Reclassification of major sources to area sources rule paves the way for cleaner air and streamlined compliance

The "Review of Final Rule Reclassification of Major Sources as Area Sources Under Section 112 of the Clean Air Act” rule allows certain major sources to reclassify as area sources under specific conditions. The reclassification process typically involves a review of the source's emissions profile, its location within a specific air quality nonattainment area, and other relevant factors. If it’s determined that a major source isn’t making a substantial contribution to air quality problems, it may be eligible for reclassification as an area source. Under this rule (finalized on August 30, 2024), the Environmental Protection Agency (EPA) allows a major source of hazardous air pollutants (HAPs) to reclassify as an area source after acting to limit emissions under the National Emission Standards for Hazardous Air Pollutants (NESHAP) program. However, sources of persistent and bioaccumulative HAPs listed in Clean Air Act (CAA) Section 112(c)(6) must continue to comply with certain major source emission standards under Sections 112(d)(2) or 112(d)(4) even if these sources reclassify as area sources.

The seven persistent and bioaccumulative HAPs include:

  • Alkylated lead compounds,
  • Polycyclic organic matter (POM),
  • Mercury,
  • Hexachlorobenzene,
  • Polychlorinated biphenyls (PCBs),
  • 2,3,7,8-tetrachlorodibenzofurans (TCDF), and
  • 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD).

The following subparts are included in the list of NESHAPs (see 40 CFR 63.1(c)(6)(iii)) that cannot be avoided through reclassification:

  • Subpart FFFF (miscellaneous organic chemical manufacturing),
  • Subpart JJJJ (paper and other web coating),
  • Subpart MMMM (surface coating of miscellaneous metal parts and products),
  • Subpart PPPP (surface coating of plastic parts and products),
  • Subpart ZZZZ (stationary reciprocating internal combustion engines),
  • Subpart CCCCC (coke oven pushing, quenching, and battery stacks),
  • Subpart DDDDD (boilers and process heaters),
  • Subpart FFFFF (iron and steel manufacturing facilities),
  • Subpart IIIII (mercury cell chlor-alkali plants),
  • Subpart LLLLL (asphalt processing and roofing manufacturing),
  • Subpart YYYYY (area source electric arc furnace steelmaking facilities),
  • Subpart JJJJJJ (area source boilers), and
  • Subpart EEEEEEE (area source gold mine ore processing and production ).

Implications for reclassified facilities

• Continued compliance: Facilities that have already reclassified from major to area source status and fall under one of the listed subparts will need to continue to comply with the associated maximum achievable control technology (MACT) requirements, including monitoring, recordkeeping, testing, and reporting. MACT standards are performance criteria that apply to major sources.

• Potential challenges: Reclassification may have been a strategy to reduce regulatory burden. However, the new limitations could increase the compliance costs and operational challenges for affected facilities.

Exemptions and uncertainties

• Stationary combustion turbines: The NESHAP for stationary combustion turbines isn’t included in the list of affected subparts, providing some relief for facilities using this technology.

• Retroactive applicability: The final rule doesn’t specifically address whether the effective date of reclassification is the revised permit, notification to EPA or date of change in potential emissions. This uncertainty could impact facilities that have recently reclassified.

Overall, the new reclassification limitations will have significant implications for facilities operating under the affected NESHAP subparts. It’s essential for affected facilities to carefully review the specific requirements and consider the potential impacts on their operations.

Key to remember: EPA finalized requirements for sources that reclassify from major source status to area source status under the National Emission Standards for Hazardous Air Pollutants (NESHAP) program. Sources subject to certain major source NESHAPs for seven specific pollutants must remain subject to those NESHAPs even if the sources reclassify to area source status.

Reclassifying facilities must keep stricter emission standards for 7 HAPs
2024-09-16T05:00:00Z

Reclassifying facilities must keep stricter emission standards for 7 HAPs

A final rule issued by the Environmental Protection Agency (EPA) in September 2024 requires facilities that reclassify from major to area source status under the National Emission Standards for Hazardous Air Pollutants (NESHAP) program to continue to meet the major source emission standards for seven persistent and bioaccumulative hazardous air pollutants (HAPs).

Who does this impact?

The final rule applies to facilities subject to any of the seven major source NESHAPs that reclassify from major to area source status. The major and area source categories differ based on the emissions and/or potential to emit (PTE) certain hazardous air pollutants. Major sources emit or have the PTE:

  • 10+ tons per year of one HAP, or
  • 25+ tons per year of a combination of HAPs.

Area sources are facilities with actual and/or potential emissions below these thresholds.

Which HAPs are affected?

The final rule targets seven HAPs:

  • Alkylated lead compounds,
  • Hexachlorobenzene,
  • Mercury,
  • Polychlorinated biphenyls (or PCBs),
  • Polycyclic organic matter (or POM),
  • 2,3,7,8-tetrachlorodibenzofurans (or TCDR), and
  • 2,3,7,8-tetrachlorodibenzo-p-dioxin (or TCDD).

What are the notification changes?

The final rule also made minor adjustments to the reclassification notification requirements. Specifically, the agency clarifies that facilities must:

  • Submit reclassification applications electronically through the Compliance and Emissions Data Reporting Interface on EPA’s Central Data Exchange, and
  • Include the required information listed at 40 CFR 63.9(j)(1)–(4).

EPA also added electronic submission procedures for confidential business information.

Key to remember: Facilities that reclassify from major to area source status under EPA’s NESHAP program must continue complying with the major source emission standards for seven hazardous air pollutants.

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Guide to underground storage tank financial requirements
2024-09-13T05:00:00Z

Guide to underground storage tank financial requirements

With great hazards comes great financial responsibility. This certainly applies to owners and operators of underground storage tanks (USTs). The Environmental Protection Agency (EPA) requires most UST owners or operators to show that they have the financial resources to take corrective actions should an accidental leak happen.

When a UST leaks, the substance can leach into the soil and contaminate groundwater, which supplies drinking water for nearly half of Americans. Leaks also pose risks of fire and explosions. With funds prepared in advance, owners and operators can start cleanups sooner and, therefore, reduce the risk of harm to human health and the environment.

Who’s covered, and what’s covered?

The financial responsibility regulations (40 CFR Part 280 Subpart H) apply to owners or operators of USTs that store petroleum. Owners or operators must show that they have the financial ability to pay for:

  • Cleanup costs,
  • Corrective actions to address environmental damage, and
  • Third-party injuries and property damage.

If the owner and operator are different individuals, it’s up to the organization to decide whether the owner or operator demonstrates financial responsibility. However, it’s important to note that both parties are liable for noncompliance.

What’s the amount of coverage required?

The amount of financial coverage required depends on your type of business, the throughput (i.e., the volume of petroleum loaded into or dispensed from the tank), and the number of USTs.

Type of business

EPA categorizes the types of businesses into two groups:

  • Petroleum producers, refiners, and marketers (i.e., those who sell gasoline to the public, like service stations); and
  • Nonmarketers (i.e., those who use petroleum only for internal operations, such as fleet operators).

Owners or operators must have both per-occurrence coverage (the total cost of one leak) and annual aggregate coverage (the total cost of all leaks that might occur in a year).

Throughput

A UST’s throughput determines the per-occurrence coverage:

  • Regardless of throughput, petroleum producers, refiners, and marketers must have $1 million of per-occurrence coverage.
  • Nonmarketers must have $500,000 of per-occurrence coverage if monthly throughput is 10,000 gallons or less. If monthly throughput exceeds 10,000 gallons, nonmarketers must have $1 million of per-occurrence coverage.

Number of USTs

The same thresholds for aggregate coverage apply to both types of businesses:

  • Owners or operators must have $1 million in aggregate coverage if they have no more than 100 USTs.
  • Owners or operators must have $2 million in aggregate coverage if they have more than 100 USTs.

What are the methods for demonstrating financial responsibility?

Owners or operators may show their financial responsibility through one or a combination of the methods detailed at 280.95–280.103. The method(s) you choose must cover all costs (cleanup, corrective actions, and third-party liability) and meet the required coverage amount.

The table lists the top advantages and disadvantages to consider for each method.

UST financial responsibility methods
MethodProCon
Financial testsLeverage existing assets without incurring extra costsRequires tangible net worth of at least $10 million
GuaranteesLeverage existing business relationship with another firmProvider must pass a financial test
Insurance and risk retention group coverage Expand existing insurance policyRequires additional costs (premiums, deductibles, etc.)
Surety bondsTypically, more cost-effective (requires minimum premium payment)May have to pay back the full bond amount as well as interest and fees
Letters of creditCustomizable terms and conditionsRequires additional costs (namely, service fees)
State fund or other state assurancesFinancial help for cleanup and third-party liability costsMay pay only part of the costs or require a deductible
Trust fundsCustomizable terms and conditionsGenerally, must pay the full aggregate amount upfront and additional costs (fees, taxes, etc.)
Standby trust fundsTypically, don’t have to pay upfront to establish the fundRequires additional costs to run the trust
*State-required methods*You may use any state-required methods approved by the regional administrator.

What happens if a financial assurer cancels my coverage?

Financial assurance providers may cancel or not renew your assurance. EPA requires assurers to notify the UST owner or operator before terminating coverage:

  • Insurance or risk retention coverage (except for nonpayment or misrepresentation) and state-funded assurance may not stop until at least 60 days after notification.
  • Guarantees, surety bonds, and letters of credit may not stop until at least 120 days after notification.

Generally, you must establish alternate coverage within 60 days of learning that your financial assurer will stop coverage.

Check your state’s regulations!

The regulations for tanks in a state with EPA approval to implement a state UST program may differ from federal rules. USTs in a state without EPA state program approval are subject to federal and state requirements.

Key to remember: EPA regulations require underground storage tank owners or operators to prove they can cover the financial costs of an accidental leak.

EHS Monthly Round-Up - August 2024

EHS Monthly Round-Up - August 2024

In this August 2024 roundup, we'll review the most impactful environmental, health, and safety news.

Hi everyone! Welcome to the monthly news roundup video, where we’ll review the most impactful environmental, health, and safety news. Please view the content links in the transcript for more information about the topics I’ll be covering today. Let’s get started!

Two State Plan agencies allegedly provided advance notice of workplace inspections to employers, a practice that’s prohibited under the Occupational Safety and Health Act. Now, lawmakers have requested that the Department of Labor’s acting secretary address the allegations and explain what challenges OSHA faces when monitoring and enforcing State Plan compliance.

A recent study shows jobs in agriculture, forestry, fishing, and hunting are among California’s most dangerous, accounting for the highest number of fatalities among full-time workers. Transportation and utilities jobs ranked second and construction was third.

Remote isolation of process equipment can quickly stop the release of hazardous materials, which can help prevent fatalities and injuries, limit facility damage, and better protect communities and the environment. A U.S. Chemical Safety Board study explores their use and makes recommendations for their utilization in chemical facilities.

A National Safety Council report explores the role of diversity, equity, and inclusion on work-related musculoskeletal disorders, or MSDs. MSDs are the most common workplace injury and often lead to worker disability, early retirement, and employment limitations.

And finally, turning to environmental news, EPA published a final rule that revises its hazardous waste export manifest regulations. All hazardous waste shipments and manifest-related reports will be managed electronically through the agency’s e-Manifest program.

Thanks for tuning in to the monthly news roundup. We’ll see you next month!

Expert Insights: What's an environmental incident?
2024-09-06T05:00:00Z

Expert Insights: What's an environmental incident?

Yes, this includes traditional spills and releases. But have you considered looking beyond that? It can be beneficial to evaluate all types of environmental situations in your compliance programs that warrant tracking, corrective action, and, sometimes, reporting.

First, identify how your organization defines environmental incidents. You may decide it includes a wide range of environmental events or is very narrow in focus. For example, determine if it makes sense to include only releases that trigger regulatory reporting or if there’s a lower reporting threshold that’s more appropriate. If you track and investigate small spills, determine to what level they’re addressed.

If your organization has multiple locations, does it make sense to establish one set of rules for environmental incidents? Or does it create a stronger program to set different criteria and thresholds for each site or group of locations? I recently worked with a customer who operates three beverage manufacturing facilities and a dozen distribution centers. Because the risks and materials were different enough, it made sense for the customer to create distinct internal reporting criteria for each type of facility.

Also, consider the potential value of tracking and recording spills or leaks that occur inside buildings. These typically aren’t reportable, so you may be wondering why you should bother. There are many benefits to recording inside spills and leaks. I’ve worked with some environmental incident programs that effectively used this tracking as a leading indicator. Plus, you can see trends in equipment maintenance, operation, and housekeeping that, if adjusted, can help prevent similar incidents from occurring outside that would be reportable and could have a negative environmental impact. Identifying and investigating indoor spills can be an important component of employee safety as well.

Administrative program pieces are less commonly associated with an “incident,” but they should be considered. These incidents can fall under the radar, but most environmental enforcement actions are related to administrative incidents. Missed recordkeeping, missed reporting deadlines, and incomplete reports are all areas that trigger violations.

Clearly defining when something is and isn’t officially considered an incident helps you maintain a strong and compliant environmental program.

Characteristic hazardous wastes: When actions speak louder than lists
2024-08-20T05:00:00Z

Characteristic hazardous wastes: When actions speak louder than lists

“Actions speak louder than words.” You can apply this expression to hazardous waste with a minor revision: “Actions speak louder than lists.” Even if a solid waste isn’t on any of the Environmental Protection Agency’s (EPA’s) hazardous waste lists, it may still be considered hazardous based on how it acts.

The Resource Conservation and Recovery Act (RCRA) requires all businesses to determine whether the waste generated is hazardous. If it’s a hazardous waste, it’s subject to the RCRA Subtitle C hazardous waste management regulations.

A waste is hazardous if:

  • It appears on any of the four lists at 40 CFR Part 261 Subpart D (called a listed waste),
  • It exhibits one or more of four hazardous characteristics (called a characteristic waste), or
  • Both.

Whether or not it’s a listed waste, you must determine if each waste you produce is a characteristic waste.

Characteristic hazardous wastes

Let’s take a closer look at each of the four hazardous waste characteristics.

1. Ignitability

Ignitable wastes are easily combustible or flammable. They include:

  • Liquids with flash points below 60 degrees Celsius;
  • Non-liquids that can cause fire under standard temperature and pressure through friction, absorption of moisture, or spontaneous chemical changes;
  • Ignitable compressed gases; and
  • Oxidizers.

Common ignitable wastes are paints and degreasers.

2. Corrosivity

Corrosive wastes dissolve metals and other materials. Such wastes include:

  • Aqueous wastes with a pH of:
    • Less than or equal to 2, or
    • Equal to or greater than 12.5.
  • Liquid wastes that corrode steel under certain conditions.

Examples are rust removers, certain cleaning fluids, and battery acid.

3. Reactivity

Reactive wastes are unstable wastes that can react rapidly and/or violently when mixed with other materials. These include:

  • Wastes that are normally unstable and can easily undergo violent changes without detonating;
  • Wastes that react violently with water;
  • Wastes that form potentially explosive mixtures with water;
  • Wastes that give off dangerous amounts of toxic gases, vapors, or fumes when:
    • They’re mixed with water, or
    • They contain cyanide or sulfide and are exposed to pH conditions between 2 and 12.5.
  • Wastes that can detonate or have an explosive decomposition or reaction at standard temperature and pressure;
  • Wastes that can detonate or have an explosive reaction when subject to a strong initiating source or heated under confinement; and
  • Wastes considered forbidden explosives or Division 1.1, 1.2, or 1.3 explosives (per Part 173).

Bleach, peroxide, and lithium-sulfur batteries are considered reactive.

4. Toxicity

Toxic wastes have contaminants that are harmful or fatal through ingestion or skin contact. Improper disposal of toxic wastes can pollute groundwater.

Wastes with any of the contaminants in concentrations at or above the regulatory level specified in the regulations (261.24) are designated as toxic.

Cadmium, lead, and mercury are examples.

Is it a characteristic waste?

The RCRA hazardous waste identification process requires you to determine whether a waste is listed and if it has any hazardous characteristics. That means that regardless of whether the waste is listed, you must determine if the waste has one or more hazardous characteristics.

You may determine if a waste has any hazardous characteristics by:

  • Applying acceptable knowledge defined at 262.11(d)(1), and/or
  • Testing the waste via approved methods (required when you can’t make a determination based on the available information).

Characteristic hazardous wastes comparison table

Use the RCRA Characteristic Hazardous Wastes table as a helpful reference when determining whether a waste has hazardous characteristics.

RCRA Characteristic Hazardous Wastes
Ignitable wasteCorrosive wasteReactive wasteToxic waste
DescriptionEasily catches fire and sustains combustionReadily dissolves metal and other materialsQuickly reacts violently or explodesExcessively leaches dangerous contaminants
EPA Hazardous Waste Number(s)D001D002D003D004–D043*
Approved SW-846 Test Methods
  • 1010B
  • 1020C
  • 1030
  • 9040C
  • 1110A
  • None
  • 1311
Regulation (40 CFR Part 261)261.21261.22261.23261.24
* “Table 1 — Maximum Concentration of Contaminants for the Toxicity Characteristic” at 261.24 lists the EPA Hazardous Waste Number for each contaminant.

Consider these RCRA reminders when designating waste:

  • Designate solid waste (defined at 261.2) at the point it’s generated before diluting, mixing, or otherwise altering it.
  • Use all relevant EPA Hazardous Waste Numbers for compliance with applicable RCRA notification, recordkeeping, and reporting requirements.
  • Evaluate every waste for hazardous characteristics, even for listed wastes.

All nonexempt characteristic hazardous waste that your facility generates is subject to RCRA’s Subtitle C hazardous waste management requirements.

Key to remember: Wastes that exhibit any of the four hazardous characteristics (ignitability, corrosivity, reactivity, and toxicity) are subject to RCRA Subtitle C regulations.

Industrial wastewater discharges: NPDES permits get to the point (source)
2024-08-05T05:00:00Z

Industrial wastewater discharges: NPDES permits get to the point (source)

The Environmental Protection Agency (EPA) limits the pollutants in industrial wastewater that facilities can release through the National Pollutant Discharge Elimination System (NPDES) Program. Any facility that discharges pollutants directly into the waters of the United States must obtain an NPDES permit.

Each permit lists the quantity, discharge rate, and concentration discharge limits for each pollutant (known as effluent limitations). The permit also covers monitoring and reporting requirements, applicable special conditions (like compliance schedules), and standard conditions that apply to all permits. States typically issue NPDES permits. EPA issues the federal permit, called the Multi-Sector General Permit (or MSGP), for just a handful of states and territories.

Does my facility require an NPDES permit?

The federal regulation at 40 CFR 122.1(b)(1) states that the NPDES program requires permits for the discharge of “pollutants” from any “point source” into “waters of the United States."

To determine whether your facility requires a permit, answer the following three questions.

Does the facility discharge covered pollutants?

The NPDES permit covers any kind of industrial, municipal, and agricultural waste that’s discharged into waters of the United States. It encompasses:

  • Conventional pollutants, such as oil and grease;
  • Nonconventional pollutants, like phosphorus; and
  • Toxic pollutants, including solvents and metals.

EPA’s regulatory definition of “pollutants” (122.2) includes solid waste, sewage, chemical wastes, heat, rock, and more. However, it excludes sewage from vessels as well as certain materials injected into wells for oil or gas production and water derived from oil or gas production that’s disposed of in a well.

If your facility releases pollutants through its wastewater, the next factor to consider is how it discharges the pollutants.

Is the facility a point source?

A “point source” is defined at 122.2 as “any discernible, confined, and discrete conveyance … from which pollutants are or may be discharged.” It doesn’t include return flows from irrigated agriculture or agricultural stormwater runoff.

In clearer terms, a point source is a specific, identifiable source that discharges pollutants directly into a waterbody, like an industrial facility. Examples of points of discharge are pipes, ditches, tunnels, wells, and containers.

What if your facility discharges wastewater pollutants to a publicly owned treatment works facility? In this case, your facility is considered a non-point source (or indirect discharger) and must meet the requirements of the NPDES National Pretreatment Program.

Does the facility discharge into waters of the United States?

EPA’s current regulations define “waters of the United States” at 120.2. However, ongoing litigation has muddied the implementation of the current definition.

Here’s a general timeline of the definition’s changes:

  • January 2023 — EPA and the Department of the Army updated the definition (Revised Definition of “Waters of the United States” rule).
  • May 2023 — The U.S. Supreme Court’s decision in Sackett v. EPA (Case No. 21—454) made parts of the Revised Definition of “Waters of the United States” rule invalid.
  • August 2023 — The agencies amended the Revised Definition of “Waters of the United States” rule to conform it to the Supreme Court’s decision. The final rule (Revised Definition of “Waters of the United States, Conforming” rule) took effect in September 2023.

Currently, EPA implements the definition according to the Revised Definition of “Waters of the United States, Conforming” rule in 23 states, the District of Columbia, and the U.S. territories. In the remaining 27 states, EPA implements the pre-2015 definition and interprets it consistently with the Sackett v. EPA decision.

Make sure to confirm with your state’s wastewater permitting agency which definition of waters of the United States applies to your facility.

If you answer “yes” to all three questions, your facility must obtain an NPDES permit.

What’s next?

Now that you’ve determined your facility needs an NPDES permit, it’s time to apply for one:

  • Connect with the state water permitting agency (or EPA if the state isn’t authorized to issue permits) to confirm that your facility requires a permit and determine what type of NPDES permit the state requires you to have (general or individual).
  • Apply for the relevant NPDES permit through the permitting agency.
    • Facilities under general permits typically submit a Notice of Intent to the permitting authority.
    • Facilities not covered by general permits must apply for NPDES individual permits. Because these are developed for specific sites, the permitting process takes longer (possibly more than six months).

Key to remember: Facilities must obtain a general or individual NPDES permit before directly discharging industrial wastewater into waters of the United States.

See More

Most Recent Highlights In Human Resources

Hazardous waste export manifests join e-Manifest system
2024-08-02T05:00:00Z

Hazardous waste export manifests join e-Manifest system

The Environmental Protection Agency (EPA) published the final Third Rule on July 26, 2024, revising hazard waste export manifest regulations under the Resource Conservation and Recovery Act (RCRA). All hazardous waste shipments (regardless of destination) and manifest-related reports will be managed electronically through the e-Manifest program, EPA’s national system that tracks hazardous waste shipments.

What are the changes?

Hazardous waste export manifests

Export manifests track hazardous waste that’s shipped out of the country for treatment, storage, and disposal. The final rule integrates hazardous waste export manifests into the e-Manifest system and designates the exporter as the entity responsible for submitting the manifest and paying the requisite user fee.

EPA’s Third Rule also:

  • Expands the international shipment data elements on the manifest form,
  • Updates the requirements for the document that tracks hazardous waste movement to better connect the manifest information with the movement document information (assisting with the integration of EPA’s Waste Import Export Tracking System with RCRAInfo), and
  • Requires the last transporter (which transports hazardous waste export shipments out of the U.S.) to send a signed copy of the manifest and continuation sheet to the exporter instead of the generator.

Manifest-related reports

The final rule integrates other reports into the e-Manifest system, including:

  • Discrepancy Reports for mismatches in the amount of waste,
  • Exception Reports for shipment problems, and
  • Unmanifested Waste Reports for waste found without proper tracking documents.

Further, small and large quantity generators must register for e-Manifest access to obtain their final signed manifest copies from the system.

Other changes

The final rule aligns the manifest requirements for polychlorinated biphenyls (or PCBs) under the Toxic Substances Control Act with the RCRA manifest regulations. It also removes outdated requirements, fixes typographical errors, provides clear definitions, and ensures better alignment with the e-Manifest program.

What are the compliance deadlines?

The final Third Rule takes effect on January 22, 2025. However, these requirements don’t take effect until December 1, 2025:

  • Exporters must submit hazardous waste export manifests to the e-Manifest system and pay the user fee.
  • Entities must submit Discrepancy, Exception, and Unmanifested Waste Reports to the e-Manifest system.
  • The last transporters must provide the export manifests and continuation sheets to the exporters.

Meanwhile, organizations must comply with existing hazardous waste manifest requirements through November 30, 2025.

Key to remember: EPA’s final Third Rule combines hazardous waste export manifests and related reports into the e-Manifest system. All hazardous waste shipments (regardless of destination) and manifest-related reports will be managed electronically.

wholesale distributionmanufacturing (31/food/textiles)waste managementpersonal servicesentertainmentconstructionminingwarehousingmanufacturing (32/non-durable)manufacturing (33/durable)real estatepublic administrationretailtransportationprofessional servicesutilitiesrepair serviceshealthcareoily ragshhcehsstagscontinuous releasespackagesvery small quantity generatorstsdfscorrosivityemergency coordinatorsnational response centercerclahazardous waste generatorsncpe-manifestsdouble walled tanksdischargeswaste storageconditionally excluded wasteleakagesvsqgswaste codeshazardous secondary materialsbulk packagingsgarbagerecyclingtrashintegrated contingency planslarge quantity generatorsform 8700-12extinguisherone planemergency releasesbiennial reportingreceiving facilitiescontainment systemsfiresindustrial furnaceswaste burningsumpsmunicipal solid wasteelectronic manifestsblasting agentstoxic chemicalsreportable quantitiesepa id numbersaerosol canssection 304 reportingresiduesground watersolvent wasteplacardsground-waterhighly hazardous chemicallandfillingemergency equipmentexception reportingliabilitysolvent contaminated wipesportable fire extinguisherschemicalscesqgsspill reportingcharacteristic wasteshop ragswaste burnerslqgshmtlisted wastewaste disposalrcraprecious metalswaste transportationhazardous materialsaccumulationnon-acute wasteeriwaste treatmenthmrp codescercla hazardous substanceschemical spillsreactivitywaste shippersextremely hazardous substancestoxicityhazardous chemicalshazwastechemical releasesacute wasteignitabilitychemical accidentsfinancial coverageconditionally exemptnon-bulk packagingsu codeslabelsused batteriesspill kitstscaicpspharmaceutical wastetreatment storage and disposaloverfillsfinancial assurancepost-closuresmall quantity generatorsemergency response informationsection 103 reportingnational contingency plannational response systemcrtstoxic substancesinterim statusrqsmunitionsepcrawaste shippingboilerscathode ray tubeschemical listsepisodic generationsqgsresource conservation and recoverysms essentialsms advancedsms trial enterprisesms premiumsms trialr40cfr265r40cfr261r40cfr262r40cfr761r40cfr271r40cfr264r40cfr267r40cfr260r40cfr263r40cfr27040 cfr 26540 cfr 26140 cfr 26240 cfr 76140 cfr 27140 cfr 26440 cfr 26740 cfr 26040 cfr 26340 cfr 27040 cfr 265 interim status standards for owners and operators of hazardous waste treatment, storage, and disposal facilities40 cfr 261 identification and listing of hazardous waste40 cfr 262 standards applicable to generators of hazardous waste40 cfr 761 polychlorinated biphenyls (pcbs) manufacturing, processing, distribution in commerce, and use prohibitions40 cfr 271 requirements for authorization of state hazardous waste programs40 cfr 264 standards for owners and operators of hazardous waste treatment, storage, and disposal facilities40 cfr 267 standards for owners and operators of hazardous waste facilities operating under a standardized permit40 cfr 260 hazardous waste management system: general40 cfr 263 standards applicable to transporters of hazardous waste40 cfr 270 epa administered permit programs: the hazardous waste permit program
2021-12-27T06:00:00Z

86 FR 73207 National Perchloroethylene Air Emission Standards for Dry Cleaning Facilities Technology Review

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2005-0155; FRL-8391-02-OAR]

RIN 2060-AV44

National Perchloroethylene Air Emission Standards for Dry Cleaning Facilities Technology Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: The U.S. Environmental Protection Agency (EPA) is proposing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for dry cleaning facilities using perchloroethylene (PCE) as the cleaning solvent (PCE Dry Cleaning NESHAP). The proposed amendments address the results of the technology review for the PCE Dry Cleaning NESHAP, in accordance with section 112 of the Clean Air Act (CAA). Based on the findings of the technology review, the EPA proposes to add provisions to the rule which will require all dry-to-dry machines at existing major and area sources to have both refrigerated condensers and carbon adsorbers as secondary controls.

DATES: Comments must be received on or before February 10, 2022.

Public hearing: If anyone contacts us requesting a public hearing on or before January 11, 2022, we will hold a virtual public hearing. See SUPPLEMENTARY INFORMATION for information on requesting and registering for a public hearing.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-OAR-2005-0155, by any of the following methods:

  • Federal eRulemaking Portal: https://www.regulations.gov/ (our preferred method). Follow the online instructions for submitting comments.
  • Email: a-and-r-docket@epa.gov. Include Docket ID No. EPA-HQ-OAR-2005-0155 in the subject line of the message.
  • Fax: (202) 566-9744. Attention Docket ID No. EPA-HQ-OAR-2005-0155.
  • Mail: U.S. Environmental Protection Agency, EPA Docket Center, Docket ID No. EPA-HQ-OAR-2005-0155, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
  • Hand/Courier Delivery: EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. The Docket Center's hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday (except Federal holidays).

Instructions: All submissions received must include the Docket ID No. for this rulemaking. Comments received may be posted without change to https://www.regulations.gov/, including any personal information provided. For detailed instructions on sending comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document. Out of an abundance of caution for members of the public and our staff, the EPA Docket Center and Reading Room are open to the public by appointment only to reduce the risk of transmitting COVID-19. Our Docket Center staff also continues to provide remote customer service via email, phone, and webform. Hand deliveries and couriers may be received by scheduled appointment only. For further information on EPA Docket Center services and the current status, please visit us online at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

For questions about this proposed action, contact Brian Storey, Sector Policies and Programs Division (Mail Code D243-04), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-1103; fax number: (919) 541-4991; and email address: brian.storey@epa.gov.

SUPPLEMENTARY INFORMATION:

Participation in virtual public hearing. Please note that because of current Centers for Disease Control and Prevention (CDC) recommendations, as well as state and local orders for social distancing to limit the spread of COVID-19, the EPA cannot hold in-person public meetings at this time.

To request a virtual public hearing, contact the public hearing team at (888) 372-8699 or by email at SPPDpublichearing@epa.gov. If requested, the virtual hearing will be held on January 11, 2022. The hearing will convene at 9:00 a.m. Eastern Time (ET) and will conclude at 3:00 p.m. ET. The EPA may close a session 15 minutes after the last pre-registered speaker has testified if there are no additional speakers. The EPA will announce further details at https://www.epa.gov/stationary-sources-air-pollution/dry-cleaning-facilities-national-perchloroethylene-air-emission.

If a public hearing is requested, the EPA will begin pre-registering speakers for the hearing upon publication of this document in the Federal Register . To register to speak at the virtual hearing, please use the online registration form available at https://www.epa.gov/stationary-sources-air-pollution/dry-cleaning-facilities-national-perchloroethylene-air-emission or contact the public hearing team at (888) 372-8699 or by email at SPPDpublichearing@epa.gov. The last day to pre-register to speak at the hearing will be January 10, 2022. Prior to the hearing, the EPA will post a general agenda that will list pre-registered speakers in approximate order at: https://www.epa.gov/stationary-sources-air-pollution/dry-cleaning-facilities-national-perchloroethylene-air-emission.

The EPA will make every effort to follow the schedule as closely as possible on the day of the hearing; however, please plan for the hearings to run either ahead of schedule or behind schedule.

Each commenter will have 5 minutes to provide oral testimony. The EPA encourages commenters to provide the EPA with a copy of their oral testimony electronically (via email) by emailing it to brian.storey@epa.gov. The EPA also recommends submitting the text of your oral testimony as written comments to the rulemaking docket.

The EPA may ask clarifying questions during the oral presentations but will not respond to the presentations at that time. Written statements and supporting information submitted during the comment period will be considered with the same weight as oral testimony and supporting information presented at the public hearing.

Please note that any updates made to any aspect of the hearing will be posted online at https://www.epa.gov/stationary-sources-air-pollution/dry-cleaning-facilities-national-perchloroethylene-air-emission. While the EPA expects the hearing to go forward as set forth above, please monitor our website or contact the public hearing team at (888) 372-8699 or by email at SPPDpublichearing@epa.gov to determine if there are any updates. The EPA does not intend to publish a document in the Federal Register announcing updates.

If you require the services of a translator or special accommodation such as audio description, please pre-register for the hearing with the public hearing team and describe your needs by January 3, 2022. The EPA may not be able to arrange accommodations without advanced notice.

Docket. The EPA has established a docket for this rulemaking under Docket ID No. EPA-HQ-OAR-2005-0155. All documents in the docket are listed in https://www.regulations.gov/. Although listed, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy. With the exception of such material, publicly available docket materials are available electronically in Regulations.gov .

Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-2005-0155. The EPA's policy is that all comments received will be included in the public docket without change and may be made available online at https://www.regulations.gov/, including any personal information provided, unless the comment includes information claimed to be CBI or other information whose disclosure is restricted by statute. Do not submit electronically any information that you consider to be CBI or other information whose disclosure is restricted by statute. This type of information should be submitted by mail as discussed below.

The EPA may publish any comment received to its public docket. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e., on the Web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

The https://www.regulations.gov/ website allows you to submit your comment anonymously, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through https://www.regulations.gov/, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any digital storage media you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should not include special characters or any form of encryption and be free of any defects or viruses. For additional information about the EPA's public docket, visit the EPA Docket Center homepage at https://www.epa.gov/dockets.

Due to public health concerns related to COVID-19, the Docket Center and Reading Room are open to the public by appointment only. Our Docket Center staff also continues to provide remote customer service via email, phone, and webform. Hand deliveries or couriers will be received by scheduled appointment only. For further information and updates on EPA Docket Center services, please visit us online at https://www.epa.gov/dockets.

The EPA continues to carefully and continuously monitor information from the CDC, local area health departments, and our federal partners so that we can respond rapidly as conditions change regarding COVID-19.

Submitting CBI. Do not submit information containing CBI to the EPA through https://www.regulations.gov/ or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information on any digital storage media that you mail to the EPA, mark the outside of the digital storage media as CBI and then identify electronically within the digital storage media the specific information that is claimed as CBI. In addition to one complete version of the comments that includes information claimed as CBI, you must submit a copy of the comments that does not contain the information claimed as CBI directly to the public docket through the procedures outlined in Instructions above. If you submit any digital storage media that does not contain CBI, mark the outside of the digital storage media clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and the EPA's electronic public docket without prior notice. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 Code of Federal Regulations (CFR) part 2. Send or deliver information identified as CBI only to the following address: OAQPS Document Control Officer (C404-02), OAQPS, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, Attention Docket ID No. EPA-HQ-OAR-2005-0155. Note that written comments containing CBI and submitted by mail may be delayed and no hand deliveries will be accepted.

Preamble acronyms and abbreviations. Throughout this document wherever “we,” “us,” or “our” is used, it is intended to refer to the EPA. We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of this preamble and for reference purposes, the EPA defines the following terms and acronyms here:

CAA Clean Air Act

CBI Confidential Business Information

CDC Center for Disease Control

CFR Code of Federal Regulations

ECHO Enforcement and Compliance History Online

EPA Environmental Protection Agency

EJ environmental justice

FR Federal Register

GACT generally available control technology

HAP hazardous air pollutant(s)

LDAR leak detection and repair

MACT maximum achievable control technology

NAICS North American Industry Classification System

NESHAP national emission standards for hazardous air pollutants

NTTAA National Technology Transfer and Advancement Act

OAQPS Office of Air Quality Planning and Standards

OECA Office of Enforcement and Compliance Assurance

OMB Office of Management and Budget

ORCR Office of Resource Conservation and Recovery

PCE perchloroethylene

ppm parts per million

PRA Paperwork Reduction Act

RBLC RACT/BACT/LAER Clearinghouse

RCRA Resource Conservation and Recovery Act

RFA Regulatory Flexibility Act

SBA Small Business Administration

SBEAP Small Business Environmental Assistance Program

tpy tons per year

TTN Technology Transfer Network

UMRA Unfunded Mandate Reform Act

Organization of this document. The information in this preamble is organized as follows:

I. General Information

A. Does this action apply to me?

B. Where can I get a copy of this document and other related information?

II. Background

A. What is the statutory authority for this action?

B. What are these source categories and how does the current NESHAP regulate their HAP emissions?

C. What data collection activities were conducted to support this action?

D. What other relevant background information and data are available?

E. How does the EPA perform the technology review?

III. Proposed Rule Summary and Rationale

A. What are the results and proposed decisions based on our technology review, and what is the rationale for those decisions?

B. What compliance dates are we proposing, and what is the rationale for the proposed compliance dates?

IV. Summary of Cost, Environmental, and Economic Impacts

A. What are the affected sources?

B. What are the air quality impacts?

C. What are the cost impacts?

D. What are the economic impacts?

E What are the benefits?

F. What analysis of environmental justice did we conduct?

V. Request for Comments

VI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

B. Paperwork Reduction Act (PRA)

C. Regulatory Flexibility Act (RFA)

D. Unfunded Mandates Reform Act (UMRA)

E. Executive Order 13132: Federalism

F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use

I. National Technology Transfer and Advancement Act (NTTAA)

J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

I. General Information

A. Does this action apply to me?

The standards in 40 CFR part 63, subpart M, apply to industrial and commercial dry cleaning facilities that use PCE. The North American Industry Classification System (NAICS) codes applicable to 40 CFR part 63, subpart M, are 812310 (coin-operated laundries and dry cleaners), 812320 (dry cleaning and laundry services other than coin-operated services), and 812332 (industrial launderers). This list of categories and NAICS codes is not intended to be exhaustive, but rather provides a guide for readers regarding the entities that this proposed action are likely to affect.

As defined in the Initial List of Categories of Sources Under Section 112(c)(1) of the Clean Air Act Amendments of 1990 (see 57 FR 31576, July 16, 1992) and Documentation for Developing the Initial Source Category List, Final Report ( see EPA-450/3-91-030, July 1992), the PCE dry cleaning source categories include any facility engaged in cleaning soiled apparel, leather, and other fine goods. These are usually small independently operated neighborhood shops, franchise shops, and small specialty shops. The source categories only include facilities that use PCE as a cleaning agent.

Federal, state, local, and tribal government entities would not be affected by this proposed action.

B. Where can I get a copy of this document and other related information?

In addition to being available in the docket, an electronic copy of this action is available on the internet. Following signature by the EPA Administrator, the EPA will post a copy of this proposed action at https://www.epa.gov/dry-cleaning-facilities-national-perchloroethylene-air-emission. Following publication in the Federal Register , the EPA will post the Federal Register version of the proposal and key technical documents at this same website.

A redline version of the regulatory language that incorporates the proposed changes is available in the docket for this action (Docket ID No. EPA-HQ-OAR-2005-0155).

II. Background

A. What is the statutory authority for this action?

The statutory authority for this action is provided by sections 112 and 301 of the Clean Air Act (CAA), as amended (42 U.S.C. 7401 et seq. ). Section 112 of the CAA establishes a two-stage regulatory process to develop standards for emissions of hazardous air pollutants (HAP) from stationary sources. Generally, the first stage involves establishing technology-based standards and the second stage involves evaluating those standards that are based on maximum achievable control technology (MACT) to determine whether additional standards are needed to address any remaining risk associated with HAP emissions. This second stage is commonly referred to as the “residual risk review.” In addition to the residual risk review, the CAA also requires the EPA to review MACT and generally available control technology (GACT) standards set under CAA section 112 every 8 years and revise the standards as necessary taking into account developments in practices, processes, or control technologies. This review is commonly referred to as the “technology review,” and is the subject of this proposal. The discussion that follows identifies the most relevant statutory sections and briefly explains the contours of the methodology used to implement these statutory requirements. A more comprehensive discussion appears in the document titled CAA Section 112 Risk and Technology Reviews: Statutory Authority and Methodology, in the docket for this rulemaking.

In the first stage of the CAA section 112 standard setting process, the EPA promulgates technology-based standards under CAA section 112(d) for categories of sources identified as emitting one or more of the HAP listed in CAA section 112(b). Sources of HAP emissions are either major sources or area sources, and CAA section 112 establishes different requirements for major source standards and area source standards. “Major sources” are those that emit or have the potential to emit 10 tons per year (tpy) or more of a single HAP or 25 tpy or more of any combination of HAP. All other sources are “area sources.” For major sources, CAA section 112(d)(2) provides that the technology-based NESHAP must reflect the maximum degree of emission reductions of HAP achievable (after considering cost, energy requirements, and non-air quality health and environmental impacts). These standards are commonly referred to as MACT standards. CAA section 112(d)(3) also establishes a minimum control level for MACT standards, known as the MACT “floor.” In certain instances, as provided in CAA section 112(h), the EPA may set work practice standards in lieu of numerical emission standards. The EPA must also consider control options that are more stringent than the floor. Standards more stringent than the floor are commonly referred to as “beyond-the-floor” standards. For area sources, CAA section 112(d)(5) allows the EPA to set standards based on GACT standards in lieu of MACT standards. For categories of major sources and any area source categories subject to MACT standards, the second stage in standard-setting focuses on identifying and addressing any remaining ( i.e., “residual”) risk pursuant to CAA section 112(f) and concurrently conducting a technology review pursuant to CAA section 112(d)(6). For categories of area sources subject to GACT standards, there is no requirement to address residual risk, but, similar to the major source categories, the technology review is required.

CAA section 112(d)(6) requires the EPA to review standards promulgated under CAA section 112 and revise them “as necessary (taking into account developments in practices, processes, and control technologies)” no less often than every 8 years. In conducting this review, which we call the “technology review,” the EPA is not required to recalculate the MACT floors that were established in earlier rulemakings. Natural Resources Defense Council (NRDC) v. EPA, 529 F.3d 1077, 1084 (D.C. Cir. 2008). Association of Battery Recyclers, Inc. v. EPA, 716 F.3d 667 (D.C. Cir. 2013). The EPA may consider cost in deciding whether to revise the standards pursuant to CAA section 112(d)(6). The EPA is required to address regulatory gaps, such as missing standards for listed air toxics known to be emitted from the source category, and any new MACT standards must be established under CAA sections 112(d)(2) and (3), or, in specific circumstances, CAA sections 112(d)(4) or (h). Louisiana Environmental Action Network (LEAN) v. EPA, 955 F.3d 1088 (D.C. Cir. 2020).

B. What are these source categories and how does the current NESHAP regulate their HAP emissions?

The PCE Dry Cleaning NESHAP was originally promulgated September 22, 1993 (58 FR 49376) as 40 CFR part 63, subpart M. Significant amendments were promulgated on June 3, 1996 (61 FR 27788), December 14, 1999 (64 FR 69643), July 27, 2006 (71 FR 42743), and July 11, 2008 (73 FR 39871). The PCE Dry Cleaning NESHAP includes MACT standards which apply to major sources, and GACT standards which apply to area sources of dry cleaning that use the chemical PCE. The PCE Dry Cleaning NESHAP regulates PCE emitted from the dry cleaning process.

Dry cleaning is any cleaning process for clothing and other garments using a solvent other than water. PCE, also known as perc, tetrachloroethene, or tetrachloroethylene has been, historically, the most widely used liquid solvent in dry cleaning. Dry cleaning facilities may provide dry cleaning and laundering services at the location, or the facility may be a drop-off only location that transports the garments to a separate location where the cleaning is performed. Establishments may also offer specialty cleaning services for garments and textiles such as fur, leather, suede, wedding gowns, draperies, and pillows.

PCE dry cleaning machines are classified into two types: Transfer and dry-to-dry. Similar to residential washing machines and dryers, transfer machines include a unit for washing and another unit for drying. Following the wash cycle, PCE-containing articles are manually transferred from the washer to the dryer. The transfer of wet fabrics is the predominant source of PCE emissions in these systems. Transfer machines are prohibited at all existing and new major and area sources due to the NESHAP's requirement that dry cleaning systems eliminate any emissions of PCE while transferring articles between the washer and the dryer or reclaimer. Therefore, transfer machines are no longer sold, and none are known to still be in operation as these machines have reached the end of their useful lives and should have been replaced by dry-to-dry machines. Dry-to-dry machines wash, extract, and dry the articles in a single machine. The articles enter and exit the machine dry. Because the transfer step is eliminated, dry-to-dry machines have much lower emissions than transfer machines.

“Fourth generation” dry-to-dry machines were introduced in the early 1990s. A fourth generation dry-to-dry machine is a closed-loop system that uses a refrigerated condenser(s) to recycle PCE from the wash cycle, and a carbon adsorption unit(s) to filter PCE from the drum at the end of the dry cycle. The refrigerated condenser is a vapor recovery system into which an air-PCE gas-vapor stream is routed and the PCE is condensed by cooling the gas-vapor stream. The air remaining in the machine at the end of the dry cleaning cycle then passes through a carbon adsorber prior to opening the machine door. The carbon adsorber is a bed of activated carbon into which the air-PCE gas-vapor stream is routed and PCE is adsorbed on the carbon. The use of the carbon adsorber in combination with the refrigerated condenser offers greater emissions reductions over a dry-to-dry machine equipped with only a refrigerated condenser because it reduces the PCE concentration in the air remaining in the machine once the dry cleaning cycle is complete instead of allowing those vapors to be vented or released at the end of the dry cleaning cycle.

The latest generation machines, or “fifth generation” machines were introduced in the late 1990s. They have the same control technology as fourth generation machines, but they are also equipped with an inductive fan, internal solvent vapor monitoring devices (sensor), and interlock (lockout) devices that will not allow access to the machine until solvent vapor concentrations are below 300 ppm. The lockout feature ensures that the PCE set-point has been attained before the machine door can be opened, but it does not remove additional PCE.

Per 40 CFR 63.320, a dry cleaning facility is a major source if the facility emits or has the potential to emit more than 10 tons per year of PCE to the atmosphere. A dry cleaning facility is considered an area source if it does not meet the criteria for major sources, as specified in 40 CFR 63.320. However, in lieu of measuring or determining a facility's potential to emit PCE emissions, a dry cleaning facility is a major source if: (1) It includes only dry-to-dry machine(s) and has a total yearly PCE consumption greater than 2,100 gallons as determined according to 40 CFR 63.323(d); or (2) it includes only transfer machine system(s) or both dry-to-dry machine(s) and transfer machine system(s) and has a total yearly PCE consumption greater than 1,800 gallons as determined according to 40 CFR 63.323(d).

As defined by the initial list of source categories publish on July 16, 1992 (57 FR 31576), the PCE Dry Cleaning NESHAP applies to the following major and area sources of HAP emissions:

Major Source Categories

  • Commercial Dry Cleaning [Perchloroethylene]—Transfer Machines
  • Industrial Dry Cleaning [Perchloroethylene]—Transfer Machines
  • Industrial Dry Cleaning [Perchloroethylene]—Dry-to-Dry Machines

Area Source Categories

  • Commercial Dry Cleaning [Perchloroethylene]—Transfer Machines
  • Commercial Dry Cleaning [Perchloroethylene]—Dry-to-Dry Machines

In general, the PCE Dry Cleaning NESHAP affects three types of dry cleaners that use PCE: Commercial, industrial, and co-residential. Commercial facilities clean household items such as suits, dresses, coats, pants, comforters, curtains, leather clothing, and formal wear. Industrial dry cleaners clean heavily stained articles such as work gloves, uniforms, mechanics' overalls, mops, and shop rags. Co-residential facilities are usually a subset of commercial operations and include dry cleaning operations located in buildings in which people reside. Co-residential facilities are generally found in urban areas where commercial and residential occupancy occur in a single building.

The PCE Dry Cleaning NESHAP identifies all major sources as “large” industrial and commercial dry cleaners. These dry cleaners are subject to MACT standards under this NESHAP. It is estimated that there are five or fewer of these major source dry cleaners remaining in the United States. 1 The PCE Dry Cleaning NESHAP requires new major source PCE dry cleaners operating dry-to-dry machines to:

1  Estimated quantity of major source PCE dry cleaners is based on details provided to EPA by state regulators, state small business environmental assistance providers' programs (SBEAP) personnel, and industry trade association representatives. Refer to the docket for this proposed rule (Docket ID No. EPA-HQ-OAR-2005-0155).

  • Operate with a refrigerated condenser and carbon adsorber process controls.
  • Use an enhanced leak detection and repair (LDAR) program to detect PCE leaks from the machines ( i.e., PCE gas analyzer operated according to EPA Method 21), repair the leaks, and maintain records.

The PCE Dry Cleaning NESHAP requires existing major source PCE dry cleaners operating dry-to-dry machines to:

  • Operate with a refrigerated condenser or a carbon adsorber as process control.
  • Use an enhanced LDAR program to detect PCE leaks from the machines ( i.e., PCE gas analyzer operated according to EPA Method 21), repair the leaks, and maintain records.

Dry cleaners that are commonly found in community settings ( e.g., shopping centers and strip malls) are typically “area sources,” meaning they emit less than 10 tons of PCE each year, and are smaller in size in comparison to major source industrial and commercial PCE dry cleaners. The PCE Dry Cleaning NESHAP standards for these area sources are GACT standards. The PCE Dry Cleaning NESHAP requires existing area source PCE dry cleaners operating dry-to-dry machines to:

  • Use a halogenated hydrocarbon detector or PCE gas analyzer monthly to detect PCE leaks, repair the leaks, and maintain records.

New area source PCE dry cleaners operating dry-to-dry machines must:

  • Operate with a refrigerated condenser and carbon adsorber process controls.
  • Use a halogenated hydrocarbon detector or PCE gas analyzer to detect PCE leaks, repair the leaks, and maintain records.

The 2006 amendments to the PCE Dry Cleaning NESHAP eliminated the use of PCE by dry cleaners in co-residential buildings ( e.g., a dry cleaner found on the ground floor of an apartment building). EPA recognized that because co-residential dry cleaners are located very close to residences, residents' exposures and their cancer risks could be much higher than for typical area source dry cleaners. As such, the PCE Dry Cleaning NESHAP includes requirements to eliminate risks associated with PCE emissions from co-residential dry cleaners. Under 40 CFR 63.322(o)(5)(i), owners/operators were required to eliminate any PCE emissions from systems located in residential buildings by December 21, 2020. These dry cleaner owner/operators were allowed to replace PCE machines with newer available non-PCE technology. This sunset date allowed owners of existing co-residential sources to operate their machines for their maximum estimated useful life, 15 years, assuming they were first installed no later than December 21, 2005. Additionally, under 40 CFR 63.320(b)(2)(ii) and 63.322(o)(5)(ii), any PCE dry cleaning machines in co-residential buildings that began operating between December 21, 2005 and July 13, 2006, were required to install equipment to aggressively control PCE emissions ( i.e., refrigerated condensers, carbon adsorbers, and vapor barriers), and to conduct weekly inspections to detect PCE leaks, repair the leaks, and maintain records, before eliminating PCE emissions by July 27, 2009.

Petitions for judicial review of the 2006 amendments to the NESHAP were filed by the Sierra Club, Halogenated Solvents Industry, Neighborhood Cleaners Association, International Fabricare Institute, and Textile Care Allied Trades Association. Sierra Club et al. v. USEPA, No. 06-1330 (and consolidated cases) (D.C. Cir.). Petitioners questioned: Whether the EPA reasonably interpreted CAA section 112(d)(6) to allow consideration of risk and costs as factors in determining the extent to which it was necessary to revise standards regulating PCE; whether EPA reasonably determined under section 112(d)(6) that it was necessary to revise standards regulating PCE, and to require elimination of PCE emissions at co-residential systems but not at other systems; whether the EPA had complied with the Regulatory Flexibility Act (RFA); and whether EPA had reasonably denied a petition for reconsideration of the rule submitted by the Sierra Club. Although the case was fully briefed, in 2009 before it could be argued at the D.C. Circuit, the parties agreed to EPA taking a voluntary remand of the rule in order for the then-new administration to consider whether further administrative action was warranted regarding the challenged issues, while leaving the rule in force. As discussed in section III.A of this preamble, we are proposing our response to the voluntary remand as part of this proposal.

C. What data collection activities were conducted to support this action?

For this technology review, the EPA investigated developments in practices, processes, and control technologies through communications and direct discussions with state agencies (including regional, state, and local regulators), Small Business Environmental Assistance Program (SBEAP) personnel, industry stakeholders, and trade association representatives. Details of these conversations are included in the memorandum titled Technology Review for the PCE Dry Cleaning NESHAP, December 2021, available in the docket for this action (Docket ID No. EPA-HQ-OAR-2005-0155).

We performed a search of the EPA's Technology Transfer Network (TTN) Clean Air Technology Center—RACT/BACT/LAER Clearinghouse (RBLC) database. The RBLC provides several options for searching the permit database on-line to locate applicable control technologies. We searched the RBLC database for specific dry cleaning process types (“49.002—Dry Cleaning, PERC/Chlorinated Solvents” and “49.003—Dry Cleaning, Petroleum Solvents”). In querying results dating back to January 1, 2000, no results were returned when searching for Process Type 49.002 and three results were returned for Process Type 49.003, however none of the information returned was more recent than 2005 or included any new or improved control technologies. In addition to searches conducted using the process type codes above, the RBLC was queried for any sources with “cleaning”, “cleaners”, or “dry cleaning” in their name. The NAICS and SIC codes for dry cleaners, 812320 and 7216, respectively, were also used to search the RBLC. None of these searches returned relevant information on new or improved control technologies used in dry cleaning facilities. Full details of the RBLC database search in support of this technology review are included in the memorandum titled Technology Review for the PCE Dry Cleaning NESHAP, December 2021, available in the docket for this action (Docket ID No. EPA-HQ-OAR-2005-0155).

The EPA also reviewed information and details for facilities that are subject to the PCE Dry Cleaning NESHAP using the Agency's Enforcement and Compliance History Online (ECHO) database. The ECHO database provides integrated compliance and enforcement information for approximately 800,000 regulated facilities nationwide. Using the features in the ECHO database, we searched for dry cleaning facilities by NAICS. The database identified approximately 7,900 facilities. However, these data are not likely to be comprehensive for the dry cleaning source category because not all states submit data on smaller sources to ECHO. Details of the ECHO database search in support of this technology review are included in the memorandum titled Technology Review for the PCE Dry Cleaning NESHAP, December 2021, available in the docket for this action (Docket ID No. EPA-HQ-OAR-2005-0155).

D. What other relevant background information and data are available?

To supplement the information collected from the ECHO search, the EPA collected information from the EPA's Office of Resource Conservation and Recovery (ORCR) hazardous waste generator databases. ORCR is responsible for implementation and oversight of the hazardous waste program required by subtitle C of the Resource Conservation and Recovery Act (RCRA). As part of the hazardous waste program, hazardous waste generators must report hazardous waste quantities about a specified threshold, as required by RCRA, subtitle C. Active PCE dry cleaning facilities were identified in the ORCR hazardous waste generator databases, based on a search of reported PCE waste generation, and the NAICS for dry cleaning. Approximately 9,000 active hazardous waste generators were identified in the database. This list does not represent the full list of dry cleaning facilities or indicate the number of facilities subject to the PCE Dry Cleaning NESHAP. For many area sources in this source category the amount of PCE waste generated is below the threshold to notify or report under the RCRA regulations, therefore, there are potentially area source dry cleaning facilities that do not generate enough PCE waste to be included in the hazardous waste generator database. In this technology review, the EPA assumes that the total number of dry cleaning facilities is higher than the approximate 9,000 facilities we were able to identify by the RCRA hazardous waste generator database. A copy of the facility list developed for this technology review can be found in the docket (Docket ID No. EPA-HQ-OAR-2005-0155).

E. How does the EPA perform the technology review?

Our technology review primarily focuses on the identification and evaluation of developments in practices, processes, and control technologies that have occurred since the MACT and GACT standards were promulgated. Where we identify such developments, we analyze their technical feasibility, estimated costs, energy implications, and non-air environmental impacts. We also consider the emission reductions associated with applying each development. This analysis informs our decision of whether it is “necessary” to revise the emissions standards. In addition, we consider the appropriateness of applying controls to new sources versus retrofitting existing sources. For this exercise, we consider any of the following to be a “development”:

  • Any add-on control technology or other equipment that was not identified and considered during development of the original MACT and GACT standards;
  • Any improvements in add-on control technology or other equipment (that were identified and considered during development of the original MACT and GACT standards) that could result in additional emissions reduction;
  • Any work practice or operational procedure that was not identified or considered during development of the original MACT and GACT standards;
  • Any process change or pollution prevention alternative that could be broadly applied to the industry and that was not identified or considered during development of the original MACT and GACT standards; and
  • Any significant changes in the cost (including cost effectiveness) of applying controls (including controls the EPA considered during the development of the original MACT and GACT standards).

In addition to reviewing the practices, processes, and control technologies that were considered at the time we originally developed (or last updated) the NESHAP, we review a variety of data sources in our investigation of potential practices, processes, or controls to consider. We also review the NESHAP and the available data to determine if there are any unregulated emissions of HAP within the source category, and evaluate this data for use in developing new emission standards. See sections II.C and II.D of this preamble for information on the specific data sources that were reviewed as part of the technology review.

III. Proposed Rule Summary and Rationale

A. What are the results and proposed decisions based on our technology review, and what is the rationale for those decisions?

This section provides a brief discussion of our review of the various information sources listed sections II.C and II.D of this preamble, and our proposed decision pursuant to the CAA section 112(d)(6) technology review to require that all PCE dry-to-dry machines at existing major and area sources have both refrigerated condensers and carbon adsorbers as secondary controls. None of the searches of the RBLC database returned relevant information on new or improved control technologies related to reducing HAP emissions from dry cleaning machines used by facilities in the PCE Dry Cleaning source category. To further identify any developments in practices, processes, and emission control technologies and strategies, the EPA held several meetings with state agencies (including state agency representatives and SBEAP personnel), industry stakeholders and trade association representatives. The EPA asked several questions pertaining to developments since the last technology review on July 26, 2006 (71 FR 42724). The responses to this inquiry did not identify any developments in new or improved control technologies that had not previously been identified and considered that would warrant revision to the existing emission standards for the PCE dry cleaning source category.

Additionally, web search queries for technical literature pertaining to dry cleaning emissions controls, process controls, and work practices did not identify any new or improved practices, processes, or control technologies that were not previously addressed since the technology review performed in 2006.

However, there have been developments in practices, processes, and control technologies that had been identified and considered at the time of adoption of the original NESHAP and/or of the last technology review in 2006. These developments reflect a widespread transition away from some practices that had been allowed to continue for existing sources but were not permitted for new or reconstructed sources. In this technology review, for example, the EPA confirmed with industry representatives that the useful life of a dry-to-dry machine is 15 years. In accordance with the PCE Dry Cleaning NESHAP, PCE dry cleaning machines installed after 1993 for major sources and 2005 for area sources would be equipped with refrigerated condensers and carbon adsorbers. Therefore, the EPA is proposing to require all sources subject to the PCE Dry Cleaning NESHAP, whether new or existing, to be equipped with refrigerated condensers and carbon adsorbers in order to reflect this development.

Refrigerated condensers and carbon adsorbers have been standard secondary controls on all new machines for the last 15 years. The information gathered during the technology review, including details obtained from PCE dry cleaning industry and trade association representatives, revealed that dry-to-dry non-vented dry cleaning machines with refrigerated condensers and carbon adsorbers are the machines that are overwhelmingly used in PCE dry cleaning operations. These fourth generation and newer machines reuse PCE within the machine, which reduces the PCE emissions from the dry cleaning process. These machines are much more effective at recovering solvent vapors than machines equipped with a carbon adsorber or refrigerated condenser alone. 2

2  Further details on the evolution of dry cleaning machines and detailed descriptions of the generations of these machines can be found in the refer to the Technology Review for the Perchloroethylene Dry Cleaning Source Category memorandum in the docket as well as at the following websites: https://www.cdc.gov/niosh/docs/hazardcontrol/hc18.html ; https://www.enviroforensics.com/blog/the-history-of-dry-cleaning-solvents-and-the-evolution-of-the-dry-cleaning-machine/ .

It has been over 25 years since the initial NESHAP was promulgated in 1993 (58 FR 66287) and 15 years since the last major revisions (71 FR 42724), which required certain machines to be equipped with refrigerated condensers and carbon adsorbers. Even though we expect that almost all currently operating dry cleaning machines have both of these controls, the EPA has determined that we should preclude any possible future use of any machines that do not have both controls. This revision to the standards is necessary to ensure that current improved PCE emissions control achieved by the widespread use of fourth generation (or better) machines is maintained and not compromised by permissible continued operation of earlier generation machines that have exceeded their useful lives. As such, the EPA is proposing to require that all PCE dry-to-dry machines at existing major and area sources have both refrigerated condensers and carbon adsorbers as secondary controls. This revision to the standards will ensure that all dry cleaning systems, both new and existing, will be similarly controlled.

Additionally, the EPA re-examined the use of alternative solvents in use by the dry cleaning industry. This includes the use of non-PCE containing products such as silica-based solvents and high flash point hydrocarbon solvents. As part of this assessment, the EPA reviewed the list of alternative solvents identified in the 2006 PCE Dry Cleaning NESHAP risk and technology review (RTR) (71 FR 42743), and found that, for the purposes of the PCE Dry Cleaning NESHAP MACT or GACT standards, the list of alternative solvents available to the dry cleaning industry remains essentially the same. Since our 2006 assessment, there have been some products that are no longer marketed, and a few products added to the list. In the 2006 PCE Dry Cleaning NESHAP RTR, we looked at the use of alternative solvents as it relates to a potential ban of PCE use. In the 2006 RTR, we identified limitations with the alternative solvents available, when compared to PCE use. These limitations included a comparison of costs, cleaning ability, ease of use, applicability to certain fabrics, safety, and others. After reviewing our assessment made for the 2006 final rule, and the limitations of the alternative solvents available in 2021, we find no new information that would change our 2006 assessment for purposes of the MACT or GACT standards for this industry.

In response to the voluntary remand of the 2006 rule, we are not proposing any amendments addressing the objections raised by the litigants in Sierra Club et al. v. USEPA, No. 06-1330 and consolidated cases (D.C. Cir.). Since the voluntary remand, EPA has conducted numerous subsequent RTRs for other NESHAPs and source categories and has consistently implemented section 112(d)(6) to take into consideration costs of revising standards and the environmental value of requiring additional HAP reductions when determining whether it is necessary to revise standards taking into consideration developments in practices, processes, and control technologies. We also maintain that we have the discretion to qualitatively consider as a relevant factor the benefits of requiring additional HAP emission reductions and their consequential effect on public health risk under 112(d)(6), as we considered them in the 2006 RTR. Although we are not further considering such reductions and their impacts in this current proposed action because we have not received additional information indicating such are necessary for CAA purposes related to dry cleaning sources beyond the review that we conducted in 2006, we stand by the analyses we conducted and conclusions we reached in the 2006 RTR. Moreover, subsequent reviewing courts have affirmed EPA's now well-established approach of considering costs and cost effectiveness in CAA section 112(d)(6) reviews and making judgments about whether to it is necessary to require additional HAP emissions reductions under CAA section 112(d)(6). See, e.g., National Association for Surface Finishing v. EPA, 795 F.3d 11-12 (D.C. Cir. 2015) (finding that EPA permissibly considered costs in revising standards under section 112(d)(6)); see also, Association of Battery Recyclers, et al. v. EPA, 716 F.3d 667, 673-74 (D.C. Cir. 2013) (approving EPA's consideration of cost as a factor in its section 112(d)(6) decision-making and EPA's reliance on cost effectiveness as a factor in its standard-setting). In addressing industry petitioners' challenge to EPA's CAA section 112(d)(6) determinations, the National Association for Surface Finishing court explained that “[r]eductions in emissions are, of course, relevant to the cost effectiveness of emissions-control technologies in controlling emissions.” See 795 F.3d at 12. The court then affirmed that EPA's conclusions “that more stringent technology-based standards were cost effective and otherwise appropriate” was not arbitrary and capricious. Id (emphasis added). The EPA thus maintains that our approach in the 2006 RTR to base our decisions to revise the standards as necessary for dry cleaners located in residential settings, based in part on the unique public health impacts that the additionally mandated HAP reductions would mitigate in that particular context, was warranted under CAA section 112(d)(6).

Consequently, what may have appeared novel in 2006 to the litigants in the earliest stages of the EPA's development of the RTR program (the EPA's consideration of costs and HAP reduction along with the enumerated factors in CAA section 112(d)(6)) has become settled and judicially endorsed practice, and it is not necessary for the EPA to fundamentally re-evaluate that well-established process in this follow-up technology review or in response to the voluntary remand. Moreover, since the 2006 RTR, the EPA has not received any information calling into question the risk-based information that supported our action requiring elimination of PCE emissions from systems located in buildings with a residence. Nor has the EPA received additional information addressing the specific risks presented by PCE emissions to ambient air from co-commercial PCE dry cleaning systems ( e.g., those located in strip malls with adjacently located other commercial entities) that suggest that our decision in 2006 to limit the required elimination of PCE emissions to co-residential settings was unwarranted. The EPA requests public comments on our response to the remand, particularly on our proposed determination that no specific revisions to the standards are necessary in light of the remand.

B. What compliance dates are we proposing, and what is the rationale for the proposed compliance dates?

The EPA is proposing that existing affected sources would comply with the proposed amendments in this rulemaking no later than 180 days after the effective date of the final rule. The affected existing facilities would have to continue to meet the current requirements of 40 CFR part 63, subpart M, until the applicable compliance date of the amended rule. As discussed in section III.B of this preamble, the EPA is proposing to require all dry-to-dry machines at both major and area sources to have both refrigerated condensers and carbon adsorbers as secondary controls. The final action is not expected to be a “major rule” as defined by 5 U.S.C. 804(2). Therefore, the effective date of the final rule would be the promulgation date as specified in CAA section 112(d)(10). From our assessment of the timeframe needed for compliance with the entirety of the revised requirements, the EPA considers a period of 180 days to be the most expeditious compliance period practicable. We base this proposed compliance period on several factors. First, from our discussions with state and local agencies, trade association representatives, and other stakeholders, the EPA found that fourth and fifth generation dry-to-dry machines are standard throughout the industry. Additionally, the EPA confirmed that the useful life of a dry-to-dry machine is 15 years, and that new dry cleaning machines sold in the last 20 years are only fourth and fifth generation machines. Based on these findings, we believe that almost all of the industry is already in compliance with the proposed amendments. The 180 days is provided as a courtesy to allow familiarity with the proposed changes. We solicit comment on this proposed compliance period, and we specifically request submission of information from the sources in the major and area source categories regarding specific actions that would need to be undertaken to comply with the proposed amended requirements and the time needed to make the adjustments for compliance with any of the revised requirements. We note that information provided may result in changes to the proposed compliance date.

IV. Summary of Cost, Environmental, and Economic Impacts

A. What are the affected sources?

The PCE Dry Cleaning NESHAP prescribes a combination of equipment, work practices, and operational requirements. The NESHAP allows regulated sources to determine their major or area source status based on the annual PCE purchases for all machines at a facility. The consumption criterion (which affects the amount of PCE purchased) varies depending on multiple variables, including number of machines, size of business, etc. The affected source is each individual dry cleaning system that uses PCE. Consequently, a single dry cleaning facility could comprise multiple affected sources, if it has multiple dry cleaning systems onsite. As a result, some of a facility's systems could be subject to “new” source requirements under the NESHAP, and some could be “existing” sources, depending upon when they were placed into service.

The July 27, 2006, final rule amendments (71 FR 42743) indicate that at that time, there were approximately 34,000 dry cleaning facilities in the United States, approximately 28,000 of which used PCE. Those estimated counts of the number of overall dry cleaners and PCE dry cleaners are prior to business impacts from the 2008 financial crisis, the coronavirus (COVID-19) pandemic of 2020-2021, recent shifts in consumer demands, changes in garment technologies, fashion trends, dry cleaning machine conversions to alternative solvents, and other factors that have resulted in reductions in the number of PCE dry cleaning operations. Based on information provided by dry cleaning industry stakeholders, including trade organizations, the EPA estimates that the number of PCE dry cleaners decreased by 20 to 30 percent due to the 2008 financial crisis, the aforementioned demand trends in the industry, and increasing replacements of PCE operations with alternative solvent technologies. Additionally, the EPA estimates that another 10 to 15 percent of PCE dry cleaners have ceased operation due to financial impacts from the COVID-19 pandemic. As such, the EPA estimates that there are approximately 10,000 to 15,000 PCE dry cleaning facilities in the U.S.

B. What are the air quality impacts?

The EPA is proposing that all PCE dry-to-dry machines operate with both refrigerated condensers and carbon adsorbers as secondary controls ( i.e., be fourth or fifth generation machines). The PCE dry cleaning facilities that are in operation have most likely realized the reduction in emissions associated with operating both refrigerated condensers and carbon adsorbers. Additionally, any new machines have been required to have both refrigerated condensers and carbon adsorbers since the original promulgation of part 63, subpart M, in 1993 (for major sources) and the 2006 RTR (for area sources); any existing third generation or older machines at the time of those rules are now beyond their 15-year expected lifespan. For those facilities who may still be operating older machines, the proposed amendments of this rulemaking would reduce emissions by mandating the use of newer machines with the required controls.

Indirect or secondary air emissions impacts are impacts that would result from the increased electricity usage associated with the operation of control devices ( i.e., increased secondary emissions of criteria pollutants from power plants). Energy impacts consist of the electricity and steam needed to operate control devices and other equipment that would be required under this proposed rule. The EPA expects minimal secondary air emissions impacts or energy impacts from this rulemaking.

C. What are the cost impacts?

Any new PCE dry-to-dry machines purchased in the last 20 years for this source category are closed-loop dry-to-dry machines with a refrigerated condenser and a carbon adsorber  3 and thus would not be impacted by these proposed amendments. The PCE dry cleaning operations that would be impacted by the proposed amendments would most likely already have incurred the costs of installing and operating these fourth-generation machines. Specifically, any older machines ( i.e., third generation or prior transfer machines or dry-to-dry machines without refrigerated condenser and a carbon adsorber) would now be beyond their projected useful life, and we expect that operators would have already replaced these machines with fourth- and fifth-generation machines, as part of continued PCE dry cleaning operations. However, we also recognize that there may be some facilities that are still operating older PCE machines. We expect that if there are any facilities operating older machines, they would be area sources. For reasons previously discussed in section II.C and II.D of this preamble, the number of older machines in use is unknown. The EPA is soliciting comment on the number of sources operating older machines and will reassess the cost and economic impacts if we receive additional data.

3  U.S. EPA, Office of Air Quality Planning and Standards. Phone Conference Communication with Dry Cleaning & Laundry Institute (DLI) and National Cleaners Association (NCA) representatives. March 2021.

Based on available information, the EPA concludes that most or all existing PCE dry cleaning facilities that are subject to the NESHAP would be able to comply with the proposed requirements without incurring additional capital or operational costs because they have purchased newer machines as part of normal business operations. There may be small number of facilities operating older machines, but we do not have information on these facilities to determine the full cost impacts to these entities. We have assessed the costs associated with reading and understanding the proposed amendments as a total one-time cost of $108 per facility, using a labor rate for 4 hours of review time, as described in section IV. D of this preamble. Based on an estimate of 10,000 to 15,000 facilities that are subject to the PCE Dry Cleaning NESHAP, the total cost is estimated to be in a range of $1,080,000 to $1,620,000 nationwide.

D. What are the economic impacts?

Economic impact analyses focus on changes in market prices and output levels. If changes in market prices and output, such as clothes to be cleaned in the primary markets served by dry cleaners, are significant enough, impacts on other markets may also be examined. Both the magnitude of costs needed to comply with a proposed rule and the distribution of these costs among affected facilities can have a role in determining how the market would change in response to a proposed rule. To estimate the economic impacts of this proposal, the EPA reviewed the mean hourly wage of $12.29 per hour indicated by the Bureau of Labor Statistics for laundry and dry cleaning workers in 2021. We then applied a benefits and overhead factor of 1.1 to calculate a total compensation rate of $26.86 per hour. Additionally, we estimated 4 hours for a dry cleaning worker to familiarize themselves with the proposed amendments to the rule, and calculated a cost of $108 per facility ($23.86/hr × 4 hr/facility = $107.44, or $108/facility). This is a conservative estimate. We anticipate that some facilities may not require 4 hours to review the proposed amendments to the rule. These costs are not expected to result in a significant impact to primary markets served by dry cleaners.

We do not anticipate any significant economic impacts from these proposed amendments to require all dry-to-dry machines to have both refrigerated condensers and carbon adsorbers as secondary controls. This is consistent with our assumptions made in the original rule development that the useful life of a machine is 15 years. Machines installed after 1993 for major sources and 2005 for area sources are to be equipped with refrigerated condensers and carbon adsorbers, in accordance with the NESHAP. Thus, given the useful life of a typical dry-cleaning machine, the EPA expects that most or all sources in the regulated source categories would have discontinued use of third generation or older machines by 2021.

E. What are the benefits?

Although the EPA does not anticipate reductions in HAP emissions as a result of the proposed amendments, the Agency believes that the action, if finalized as proposed, would result in improved clarity to the rule. Specifically, the proposed amendments would revise the standards such that it is clear that only fourth (or newer) generation machines can be used in PCE solvent dry cleaning operations. This requirement is implied in the useful life determination at the inception of the original NESHAP; however, this proposed amendment would make this assumption clear and would work to eliminate any older machines (third generation and prior) that could still be operating. This action would further protect public health and the environment and would ultimately result in less potential confusion or misinterpretation by the regulated community.

F. What analysis of environmental justice did we conduct?

Executive Order 12898 directs the EPA, to the greatest extent practicable and permitted by law, to make environmental justice part of its mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of its programs, policies and activities on minority populations and low-income populations in the United States. (59 FR 7629, February 16, 1994.) Additionally, Executive Order 13985 was signed to advance racial equity and support underserved communities through Federal Government actions (86 FR 7009, January 20, 2021). The EPA defines environmental justice (EJ) as the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies. The EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies” ( https://www.epa.gov/environmentaljustice ). In recognizing that minority and low-income populations often bear an unequal burden of environmental harms and risks, the EPA continues to consider ways of protecting them from adverse public health and environmental effects of air pollution. To examine the potential for any EJ issues that might be associated with the source categories, we performed a demographic analysis, which is an assessment of individual demographic groups of the populations living within 5 kilometers (km) and within 50 km of the facilities. The EPA then compared the data from this analysis to the national average for the demographic indicators.

In the analysis, we evaluated the percentage of minority and low-income groups within the populations that live near identified PCE dry cleaning facilities. The PCE Dry Cleaning NESHAP applies to sources often operating as small facilities, and limited location data for these small subject facilities were available, adding considerable uncertainty to the analysis. As described in the technology review memorandum, available in the docket for this action, and section II.C of this preamble, we did conduct searches for available information. The demographic results do not account for emission or risk impacts from sources and may not be fully representative of the full distribution of facilities across all locations and populations. This analysis provides an indication of the potential for disparities in human health or environmental effects.

Our analysis includes the general population of dry cleaners across the country and does not differentiate which facilities are PCE major and area source dry cleaners. As stated above, our analysis indicates that sources are likely to operate compliant technologies to meet the proposed standard. Based upon the number of facilities in this analysis (9,080 facilities), we find that approximately 48 percent of the U.S. population lives within 5 km of a facility, and approximately 87 percent live within 50 km of a facility. We find that dry cleaner facilities are generally located in areas where within the 5 km distance the category of minority demographics are higher than the national average, but demographics generally match the national average within 50 km. We also note that demographics analyses for individual urban facilities often show that the percentages of various minority and disadvantaged populations tend to exceed the national averages due to the urban locations. The results of the demographic analysis for populations within 5 km of the facilities within the source category indicate that the percentage of the minority population (the total population minus the white population) is higher when compared to the national percentage of people who are minority (an average of 48 percent versus 40 percent). These comparisons also hold true for other demographic groups (African American, Other and Multiracial Groups, and Hispanics), whose populations near dry cleaning facilities are approximately an average of 3 percent greater the national average. The demographic group composed of people living in linguistic isolation was an average of approximately 1 percent greater than the national average. The percentages of people in all the remaining demographic groups were below the national average for their respective demographic. The methodology and the results of the demographic analysis are presented in a technical report, Technology Review— Analysis of Demographic Factors for Populations Living Near the Dry-cleaners for Major and Area Sources, available in this docket for this action (Docket ID EPA-HQ-OAR-2005-0155).

Table 1—Proximity Demographic Assessment Results
Notes:
• The population numbers and demographic percentages are based on the Census' 2015-2019 American Community Survey five-year averages and include Puerto Rico. Demographic percentages based on different averages may differ.
• Minority population is the total population minus the white population.
• To avoid double counting, the “Hispanic or Latino” category is treated as a distinct demographic category for these analyses. A person is identified as one of five racial/ethnic categories above: White, African American, Native American, Other and Multiracial, or Hispanic/Latino. A person who identifies as Hispanic or Latino is counted as Hispanic/Latino for this analysis, regardless of what race this person may have also identified as in the Census.
NationwideSource category
Population within 50 km of 9,080 facilities Population within 5 km of 9,080 facilities
Total Population328,016,242285,838,206156,313,800
White and Minority by Percent
White606052
Minority404048
Minority by Percent
African American121315
Native American0.70.50.4
Hispanic or Latino (includes white and nonwhite)191822
Other and Multiracial8811
Income by Percent
Below Poverty Level131314
Above Poverty Level878786
Education by Percent
Over 25 and without a High School Diploma121212
Over 25 and with a High School Diploma888888
Linguistically Isolated by Percent
Linguistically Isolated557

This action is not likely to change levels of emissions near facilities. Based on our technology review, we did not identify, and are not requiring, any new add-on control technologies, process equipment, work practices or procedures that were not already in place when the NESHAP was promulgated in 1993 or considered when the NESHAP was last reviewed in 2006; and we did not identify other developments in practices, processes, or control technologies that would result in additional emission reductions for purposes of these MACT and GACT standards, beyond the transition to greater use of fourth and fifth generation machines. Given the useful life of a dry cleaning machine, and the fact that industry should already be operating the newer machines with both refrigerated condensers and carbon adsorbers as secondary controls, we do not anticipate reductions in HAP emissions as a result of the proposed amendments.

V. Request for Comments

We solicit comments on this proposed action. In addition to general comments on this proposed action, we are also interested in additional data that may improve the analyses. We are specifically interested in receiving any information regarding the number of third generation and earlier model dry cleaning machines that potentially could still be operating, and on other developments in practices, processes, and control technologies that reduce HAP emissions beyond the widespread shift to fourth generation (or better) machines.

VI. Statutory and Executive Order Reviews

Additional information about these statutes and Executive orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

This action is not a significant regulatory action and was, therefore, not submitted to OMB for review.

B. Paperwork Reduction Act (PRA)

This action does not impose an information collection burden under the PRA. The action does not contain any information collection activities.

C. Regulatory Flexibility Act (RFA)

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action are industrial and commercial dry cleaning facilities that use PCE. The North American Industry Classification System (NAICS) codes applicable to 40 CFR part 63, subpart M, are 812310 (coin-operated laundries and dry cleaners), 812320 (dry cleaning and laundry services other than coin-operated services), and 812332 (industrial launderers). The small business size definitions for those industries are $8.0 million, $6.0 million, and $41.5 million respectively. The costs associated with reading and understanding the proposed amendments are a one-time cost of $108 per facility and are not significant. In addition, the useful life of a PCE dry-to-dry machine is assumed to be 15 years, and the industry has already purchased fourth or fifth generation dry-to-dry machines that are in compliance with these amendments as part of normal operational costs. We have therefore concluded that this action will not have a significant economic impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act (UMRA)

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, or tribal governments or the private sector. This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. While this action creates an enforceable duty on the private sector, the cost does not exceed $100 million or more.

E. Executive Order 13132: Federalism

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the National Government and the states, or on the distribution of power and responsibilities among the various levels of government. The action affects private industry and does not impose economic costs on state or local governments.

F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

This action has tribal implications. However, it will neither impose substantial direct compliance costs on federally recognized tribal governments, nor preempt tribal law. The EPA consulted with tribal officials under the EPA Policy on Consultation and Coordination with Indian tribes early in the process of developing this regulation to permit them to have meaningful and timely input into its development. A summary of that consultation is provided in the docket for this action (Docket ID No. EPA-HQ-OAR-2005-0155).

G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children.

H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).

The documentation for this decision is contained in section IV.B of this preamble and the technical report, Risk and Technology Review Analysis of Demographic Factors for Populations Living Perchloroethylene Dry Cleaning Facility Source Category Operations.

List of Subjects in 40 CFR Part 63

Environmental protection, Air pollution control, Hazardous substances, Reporting and recordkeeping requirements.

Michael S. Regan,

Administrator.

For the reasons stated in the preamble, EPA proposes to amend 40 CFR part 63 as set forth below:

PART 63—NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES

1. The authority citation for part 63 continues to read as follows:

Authority:

42 U.S.C. 7401 et seq.

Subpart M—National Perchloroethylene Air Emission Standards for Dry Cleaning Facilities

2. Section 63.322 is amended by:

a. Revising paragraph (a) introductory text;

b. Adding paragraph (a)(4); and

c. Revising paragraph (o)(2).

The revisions and addition read as follows:

§63.322 Standards.

(a) Before [date 180 days after date of publication of the final rule in the Federal Register ], the owner or operator of each existing dry cleaning system and of each new transfer machine system and its ancillary equipment installed between December 9, 1991, and September 22, 1993, shall comply with either paragraph (a)(1) or (2) of this section and shall comply with paragraph (a)(3) of this section if applicable. On and after [date 180 days after date of publication of the final rule in the Federal Register ], the owner or operator of any existing dry cleaning system shall comply with paragraph (a)(4) of this section.

* * * * *

(4) The owner or operator of each existing dry cleaning system shall route the air-perchloroethylene (PCE) gas-vapor stream contained within each dry cleaning machine through a refrigerated condenser and pass the air-PCE gas-vapor stream from inside the dry cleaning machine drum through a non-vented carbon adsorber or equivalent control device immediately before the door of the dry cleaning machine is opened. The carbon adsorber must be desorbed in accordance with manufacturer's instructions.

* * * * *

(o) * * *

(2) The owner or operator of each dry cleaning system at an area source shall route the air-PCE gas-vapor stream contained within each dry cleaning machine through a refrigerated condenser and pass the air-PCE gas-vapor stream from inside the dry cleaning machine drum through a non-vented carbon adsorber or equivalent control device immediately before the door of the dry cleaning machine is opened. The carbon adsorber must be desorbed in accordance with manufacturer's instructions.

* * * * *

3. Section 63.324 is amended by revising paragraphs (d)(5) and (6) to read as follows:

§63.324 Reporting and recordkeeping requirements.

* * * * *

(d) * * *

(5) The date and monitoring results (temperature sensor or pressure gauge), as specified in §63.323, when a refrigerated condenser is used to comply with §63.322(a), (b), or (o); and

(6) The date and monitoring results, as specified in §63.323, when a carbon adsorber is used to comply with §63.322(a)(2) or (b)(3).

* * * * *

4. Section 63.325 is amended by revising paragraph (a)(7) to read as follows:

§63.325 Determination of equivalent emission control technology.

(a) * * *

(7) Information on the cross-media impacts (to water and solid waste) of the candidate emission control technology and demonstration that the cross-media impacts are less than or equal to the cross-media impacts of a refrigerated condenser and carbon adsorber.

* * * * *

[FR Doc. 2021-26469 Filed 12-23-21; 8:45 am]

BILLING CODE 6560-50-P

What’s new in hazardous waste management?
2024-07-31T05:00:00Z

What’s new in hazardous waste management?

Does your facility need a hazardous waste manifest? If so, you’ll want to learn more about the recent rule from the Environmental Protection Agency (EPA). On June 28, 2024, the agency introduced a final rule to combine export and other manifest-related reports into the e-Manifest system, EPA’s national system that tracks hazardous waste shipments electronically. This rule changes parts of the regulations under the Resource Conservation and Recovery Act (RCRA) for the paperwork that goes with hazardous waste shipments.

EPA's latest updates focus on the following three areas:

Exporting hazardous waste

Previously, there was a separate process for tracking hazardous waste shipped out of the country for treatment, storage, and disposal. The new rule integrates this process into the e-Manifest system and designates the exporter as the entity responsible for submitting the manifest and paying the requisite user fee. This means that all hazardous waste shipments, whether they're going across town or across the ocean , will be tracked in the same way. The rule also expands the required international shipment data elements on the manifest form. Further, it updates the requirements for the document that tracks the movement of hazardous waste, aiming to better connect the information on the manifest with the information on the movement document. This will help track the manifest and integrate EPA’s Waste Import Export Tracking System with RCRAInfo.

Other important reports

EPA has also streamlined the process for submitting other reports related to hazardous waste. Discrepancy Reports for a mismatch in the amount of waste, Exception Reports for a problem with the shipment, and Unmanifested Waste Reports for waste found without a proper tracking document will now be handled electronically through the e-Manifest system. The rule also requires small and large quantity generators to register for access to e-Manifest to obtain their final signed manifest copies from the system.

Technical improvements

The agency has made some behind-the-scenes changes to improve the e-Manifest system's overall performance and user-friendliness. Some of the changes relate to aligning the polychlorinated biphenyl manifest regulations under the Toxic Substances Control Act (TSCA) with the RCRA manifest regulations. Other technical corrections remove outdated requirements, fix typographical errors, provide clear definitions, and ensure better alignment with the e-Manifest program.

Why these changes matter

The changes save time and money for organizations that handle hazardous waste. All hazardous waste shipments, regardless of destination, will be managed on a single platform, simplifying the process for generators and transporters. This integration will provide better visibility and tracking of hazardous waste throughout its journey, including international shipments.

Using a unified system improves data consistency, making it easier for regulators to monitor and analyze waste management practices and to prepare for future potential integration with biennial reporting requirements.

What does this mean for you?

If you handle hazardous waste and need a hazardous waste manifest, familiarize yourself with the new rules and make any necessary adjustments to your processes. For example, organizations may need to update their software or systems to comply with the new e-Manifest requirements. Also, employees involved in hazardous waste management may require training on the new procedures and system functionalities.

Compliance dates

This rule is effective on January 22, 2025.

However, the following requirements don’t go into effect until December 1, 2025:

  • Collection of hazardous waste export manifests in the e-Manifest system,
  • Use of electronic manifests for hazardous waste export shipments, and
  • Use of electronic Exception, Discrepancy, and Unmanifested Waste Reports.

Key to remember: EPA introduced a final rule to combine export and other manifest-related reports into the e-Manifest system and make technical corrections to improve efficiency.

EPA reconsidering application exclusion zone with key amendments
2024-07-26T05:00:00Z

EPA reconsidering application exclusion zone with key amendments

The recently announced Spring 2024 regulatory agenda showcases an EPA proposed final rule that would reinstate certain requirements of the Agricultural Worker Protection Standard (WPS), particularly the reconsideration of the 2015 application exclusion zone (AEZ) amendments. If finalized, affected entities need to be aware of the proposed changes.

Proposed change #1: The area where the AEZ applies

Pesticide handlers must suspend applications if any worker or person, other than appropriately trained and equipped handlers involved in the application enters an AEZ, regardless of whether they are on or off the establishment.

Proposed change #2: The exception to application suspension requirements for property easements

Pesticide handlers must suspend applications if any worker or person, other than appropriately trained and equipped handlers involved in the application enters an AEZ, regardless of whether they are in an area subject to an easement.

Proposed change #3: The distances from the application equipment in which entry restrictions associated with ongoing pesticide applications apply

During pesticide application, the AEZ distance would be 100 feet for ground-based fine spray applications and a 25-foot AEZ for ground-based applications using medium or larger droplet sizes sprayed above 12 inches.

Potentially affected entities

If you work in or employ persons working in crop production agriculture where pesticides are applied, you may be potentially affected by this action. While not an exhaustive list, the applicability of this action may include the following North American Industrial Classification System (NAICS) codes:

  • 111000 – Agricultural establishments
  • 111421 – Nursery and tree production
  • 113110 – Timber tract operations
  • 113210 – Forest nurseries and gathering of forest products
  • 11511, 115112, and 115114 – Farmworkers
  • 115112 – Pesticide handling on farms
  • 115115 – Farm labor contractors and crew leaders
  • 115310 – Pesticide handling in forestry
  • 325320 – Pesticide manufacturers
  • 813311, 813312, and 813319 – Farmworker support organizations
  • 813930 – Farmworker labor organizations
  • 115112, 541690, and 541712 – Crop advisors

Regulatory history in brief

The original WPS regulation was enacted in 1992 under EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to protect farm workers from pesticide exposures in production agriculture.

In 2015, EPA finalized various significant revisions to the 1992 WPS. Among those revisions was a new provision requiring agricultural employers to keep workers and all other individuals out of the AEZ during outdoor pesticide applications.

Five years later, in October 2020, EPA finalized improvements to the enforceability and workability of the AEZ requirements, which were to decrease regulatory burdens for farmers while maintaining critical worker protections. Two months later, petitions were filed challenging the rule, and a preliminary injunction was filed, which stayed the effective date of the 2020 rule.

Fast-forward to March 2023, when the EPA published a notice of proposed rulemaking that would reconsider the 2020 requirements. If finalized, it would reinstate some 2015 WPS AEZ requirements and retain certain 2020 AEZ rule provisions.

Key to remember: The EPA proposed rule will, if amended, reinstate previous AEZ requirements that are protective of public health and limit exposure to those who may be near ongoing pesticide applications.

Nonattainment NSR permits: Preventing bad air days
2024-07-18T05:00:00Z

Nonattainment NSR permits: Preventing bad air days

The Environmental Protection Agency (EPA) has several regulations in place to protect and improve the nation’s air quality. The nonattainment New Source Review (NSR) permit program ensures that the construction of new facilities and major modifications to existing facilities don’t cause more “bad air days."

You must obtain a preconstruction permit to build a new facility or make a major modification to one that will significantly increase emissions of criteria air pollutants (known as a major source). The type of permit required is based on whether the proposed construction will occur in an area that meets EPA’s national air quality standards.

If you plan to build or modify a facility in an area that doesn’t meet national standards for any criteria air pollutant, a nonattainment NSR permit is required.

What are attainment and nonattainment areas?

Under the Clean Air Act (CAA), EPA regulates the emissions of six criteria air pollutants through the National Ambient Air Quality Standards (NAAQS). The agency determines whether each geographic area in the U.S. meets the national emission standard for each criteria pollutant. The agency designates areas that meet or outperform the NAAQS as attainment areas. Conversely, it designates areas that don’t meet the NAAQS as nonattainment areas.

The CAA requires states to develop and adopt general State Implementation Plans (SIPs) for achieving and maintaining the NAAQS. States must also develop specific plans for each nonattainment area to reduce emissions of criteria pollutants and maintain the NAAQS. One of the required components of an SIP is an outline of NSR permitting requirements.

What’s the NSR program?

Typically issued at the state level, NSR permits require major sources to install and maintain pollution control equipment. They also establish:

  • What construction is allowed,
  • Emissions limits, and
  • Applicable operating requirements.

Don’t forget to check state regulations! States may have more stringent emissions limits, monitoring requirements, and application processes than federal standards.

The three types of NSR permitting requirements include:

  • Prevention of Significant Deterioration permits (issued in attainment areas),
  • Nonattainment NSR permits, and
  • Minor source permits.

Let’s zoom in on the nonattainment NSR permit.

What does the nonattainment NSR permit require?

To construct a new major source or modify an existing one in a nonattainment area, you must obtain a nonattainment NSR permit. Facilities with nonattainment NSR permits are subject to more restrictive requirements.

Lowest achievable emission rate

Facilities must install the most stringent level of emissions control technology, known as the lowest achievable emission rate (LAER). You must apply LAER to any criteria air pollutant that will meet or exceed its emission limit.

LAER is based on whichever rate is most stringent, either:

  • The most stringent emission limitation in the SIP for your facility’s class or source category, or
  • The most stringent emission limitation achieved by facilities in the same class or source category.

To meet the LAER, your facility may need to implement various measures, such as modifying existing processes and implementing add-on controls.

Emission offsets

For each criteria pollutant a facility proposes to emit, it must obtain offsets to compensate for the increased emissions and provide a net air quality benefit. Emission offsets are primarily acquired from existing sources within the same nonattainment area.

Public involvement

Facilities must provide public input opportunities throughout the permitting process. Examples include publishing a notice of a draft nonattainment NSR permit for public review and comment as well as holding requested public hearings on the proposed permit.

Where do I start?

If you’re considering building or modifying a major source, the first thing to do is establish whether the construction will occur in an attainment or nonattainment area.

  • Check the EPA Green Book, which provides nonattainment statuses across the U.S. by criteria pollutant. Make sure to check the statuses for all criteria pollutants!
  • Confirm any nonattainment areas with the state or local environmental agency for each criteria pollutant.
  • Evaluate the nonattainment NSR permitting requirements in the SIP.

A nonattainment NSR permit allows you to build or modify your facility while ensuring it doesn’t contribute to bad air days.

Key to remember: A nonattainment NSR permit is required to build or modify a facility in an area that doesn’t meet National Ambient Air Quality Standards.

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