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HCS listing of occupational exposure limits (OELs) in section 8 on a safety data sheet (SDS), and applicability of different exposures to pharmaceutical drugs
|Standard Number:||1910.1200(b)(6)(vii); 1910.1200(g)(2)(viii)|
March 30, 2021
Mr. Nick Stone
Mr. Kirk Nelson
MSDSonline - a VelocityEHS Solution
222 Merchandise Mart Plaza, Suite 1750
Chicago, IL 60654
Dear Messrs. Stone and Nelson:
Thank you for your letter to the Occupational Safety and Health Administration (OSHA), Directorate of Enforcement Programs. You requested guidance related to OSHA's Hazard Communication standard (HCS), 29 CFR §1910.1200, for the listing of occupational exposure limits (OELs) in section 8 of a safety data sheet (SDS), and the HCS's applicability of different worker exposure scenarios to pharmaceutical drugs. This letter constitutes OSHA's interpretation only of the requirements herein, and may not be applicable to any questions not delineated within your original correspondence. Your questions are paraphrased below, followed by our response.
Questions Regarding Crystalline Silica
Question 1 and 2: If a hazardous chemical (e.g., crystalline silica) has an action level (AL), is the responsible party required to list the AL in section 8 of the SDS?
Response: No. There is no requirement to list an AL for any hazardous chemical in section 8 of the SDS: however, the responsible party may choose to include it as supplemental information. The HCS only requires section 8 of the SDS to include the OSHA permissible exposure limit (PEL), American Conference of Governmental Industries Hygienists (ACGIH) Threshold Limit Value (TLV), and any other exposure limit used or recommended by the chemical manufacturer, importer, or employer preparing the SDS, where available. See Appendix D to 29 CFR §1910.1200, Table D.1, Minimum Information for an SDS. Please note, however, that the ACGIH TLV for respirable crystalline silica is 25 ug/m 3, which is the same as the AL under OSHA's Respirable Crystalline Silica standard.
Question 3: Does OSHA expect the mineral dust exposure limit for respirable crystalline silica on Table Z-3 of 29 CFR §1910.1000 (Air contaminants standard) to be present in section 8 of the SDS for any silica-containing material in addition to the required OELs indicated above? Alternatively, is it only required to include the Table Z-3 exposure limit for any operations or sectors where the silica exposure limit in the Respirable Crystalline Silica (General Industry/Maritime) standard, 29 CFR §1910.1053, is stayed or is otherwise not in effect.
Response: OSHA expects the mineral dust exposure limit for respirable crystalline silica on Table Z-3 of 29 CFR §1910.1000 be listed in section 8 of the SDS for materials where the exposure limit in §1910.1053 is not in effect. An example of such a material is sorptive clay, which is excluded per 29 CFR §1910.1053(a)(2). This requirement is regardless of the type of operation or sector in which the chemical is used. See also response to question1 for other required exposure limits, as appropriate.
The HCS exempts certain pharmaceutical drugs from coverage. See 29 CFR §1910.1200(b)(6)(vii). The following questions and responses relate to the packaging, reconstituting, administration, and dispensing of pharmaceutical drugs in regarding to the exemption. The exemption under section 1910.1200(b)(6)(vii) is limited to:
Any drug, as that term is defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C 301 et seq.), when it is in solid, final form for direct administration to the patient (e.g., tables or pills); drugs which are packaged by the chemical manufacturer for sale to consumers in a retail establishment (e.g., over-the-counter drugs); and drugs intended for personal consumption by employees while in the workplace (e.g., first aid supplies).
Questions Regarding Pharmaceutical Drugs
Question 1: Are small plastic packages of a powder drug (for administration to patients who have trouble swallowing pills) exempt from the HCS under 29 CFR §1910.1200(b)(6)(vii)? The packages are potentially distributed to clinics, hospitals, and pharmacies for direct administration to patients, and will not be repackaged or opened prior to administration to the patient.
Response: A sealed prepackaged powder drug that is not intended to be repackaged or administered to a patient by a worker (e.g., nurse), but in intended to be opened only by the patient and self-administered, would be exempt under 29 CFR §1910.1200(b)(6)(vii). In the situation described, the sealed prepackaged powder drug would be considered to be in "final form". The intended downstream use and handling are important considerations for coverage. If workers would need to open the sealed prepackaged powder drug during normal conditions of use of foreseeable emergency, then it would be covered by the HCS.
Question 2: If a powder drug is intended to be reconsituted (i.e., mixed with water or another liquid) prior to administration to a patient by a nurse or pharmacist, is it exempt from the HCS under 29 CFR §1910.1200(b)(6)(vii)? Would this be the same for lyophilized (freeze dried) powders for injection?
Response: Powder drugs, including lyophilized powders for injection, that need to be reconstituted by a worker (e.g., nurse or pharmacist) are not in final form and do not fall under the 29 CFR §1910.1200(b)(6)(vii) exemption, and thus, are covered by the HCS.
Question 3: Does the 29 CFR §1910.1200(b)(6)(vii) exemption cover drug products that are sublingual films or adhesive patches used to administer a drug through prolonged dermal absorption?
Response: Sublingual film and dermal absorption drugs, if only intended to be handled by patients and self-administered, are exempt under 29 CFR §1910.1200(b)(6)(vii). However, if the film or patch contains hazardous ingredient(s) and intended to be handled by a worker during normal conditions of use or a foreseeable emergency, then the film and/or patch is covered by the HCS.
Question 4: Do pills, tablets, or capsules sent to the pharmacy directly from a manufacturer that require the pharmacist/pharmacy technician to handle/count the pills, tablets, or capsules to fill a prescription, fall under the 29 CFR §1910.1200(b)(6)(vii) exemption?
Response: No. In the situation you described, the pharmacist/pharmacy technician who counts pills, tablets, or capsules in preparation for packaging are handling the drugs in a matter that would potentially result in exposure to hazardous dust from crumbled pills, tablets, or capsules. Where there is potential for exposure, employees are covered by the HCS and have the right to know the hazards of the chemicals to which they are exposed. Therefore, in this situation, pills, tablets, or capsules that are handled or counted by a pharmacist/pharmacy technician (e.g., in a pharmacy setting) do not fall under the 29 CFR §1910.1200(b)(6)(vii) exemption.
Question 5: If pills, tablets, or capsules are received from the manufacturer by a downstream company where an employee may be counting and (re)packaging, would this cause the drug product to fall under HCS?
Response: Yes. Repackaging of pills, capsules, or tablets is a process that is considered manufacturing, and therefore covered under the HCS.
Thank you for your interest in occupational safety and health. I hope you find this information helpful. OSHA's requirements are set by statute, standards, and regulations. Letters of interpretation do not create new or additional requirements but rather explain these requirements and how they apply to particular circumstances. This letter constitutes OSHA's interpretation of the requirements discussed. From time to time, letters are affected when the agency updates a standard, a legal decision impacts a standard, or changes in technology affect the interpretation. To ensure that you are using the correct information and guidance, please consult OSHA's website at https://www.osha.gov. If you have any questions feel free to contact the Office of Health Enforcement at (202) 693-2190.
Patrick J. Kapust, Acting
Director Directorate of Enforcement Programs
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