March 23, 2017

[Name Withheld]
154 Pleasant Street
Ronkonkoma, New York 11779

Dear [Name Withheld]:

Thank you for your letter to the Occupational Safety and Health Administration (OSHA). Your letter was referred to OSHA’s Directorate of Enforcement Programs for a response to your questions. In your letter, you asked about standards regarding employee exposure to formaldehyde and had several questions on the safe use, storage and disposal of formaldehyde, formalin, and formalin-fixed specimens in laboratories; e.g., storage of 55- gallon drums, ventilation requirements, and air monitoring for laboratory workers. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence. Your specific questions and our responses are below.

Background: One of my staff members e-mailed your office links to several resources, including the OSHA Formaldehyde Standard (29 CFR 1910.1048), and the OSHA Occupational Exposure to Hazardous Chemicals in Laboratories Standard (29 CFR 1910.1450).

Question 1: What OSHA standards are in place for people who work with formaldehyde in laboratories?

Response: Federal OSHA has safety and health standards that apply to laboratory employers for the protection of workers who use formaldehyde and formalin. Among these standards is the Formaldehyde Standard (29 CFR 1910.1048). This standard applies to all occupational exposures to formaldehyde, i.e. from formaldehyde gas, its solutions, and materials that release formaldehyde. The Formaldehyde Standard is available on OSHA’s website at: www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10075. Information on the Formaldehyde standard is also provided in an OSHA fact sheet at: www.osha.gov/OshDoc/data_General_Facts/formaldehyde-factsheet.pdf, and at the OSHA Safety and Health Topics page on Formaldehyde:https://www.osha.gov/SLTC/formaldehyde/

Additionally, OSHA’s Occupational Exposure to Hazardous Chemicals in Laboratories Standard (29 CFR 1910.1450), which is also referred to as the Laboratory Standard, applies to all employers engaged in the laboratory use of hazardous chemicals. The standard applies to non-production laboratories that use small quantities of hazardous chemicals, including formaldehyde or formalin (e.g., research labs), but it does not apply to production labs (e.g., histology, pathology, and human or animal anatomy labs) that use formaldehyde/formalin.

The Formaldehyde Standard applies to all types of production labs if formaldehyde or formalin is used in the labs. However, in labs where the Laboratory Standard applies, i.e., in non-production labs, only certain requirements of the Formaldehyde Standard apply. Pursuant to 29 CFR 1910.1450(a)(2), in such labs, the Laboratory Standard supersedes all other requirements of the Formaldehyde Standard, except for compliance with:

1. The permissible exposure limit (PEL) (0.75 parts per million (ppm)), action level (0.5 ppm), and short-term exposure limit (STEL) (2 ppm for 15 minutes) for formaldehyde (see 29 CFR 1910.1048(b), 1910.1048(c), and 29 CFR 1910.1048(d)(2)).
2. Use of chemical protective clothing made of materials impervious to formaldehyde and the use of other personal protective equipment, such as goggles and face shields, as appropriate to the operation to prevent all contact of the eyes and skin with liquids containing 1 percent or more formaldehyde (see 29 CFR 1910.1048(h)(1)(i)-(iv)).

Additionally, in non-production labs where the action level for formaldehyde is exceeded, the exposure monitoring and medical surveillance requirements of the Formaldehyde Standard apply (see 29 CFR 1910.1450(d) and (g)(1)(ii)). You can access further information on OSHA’s Laboratory Standard in fact sheets at: www.osha.gov/Publications/laboratory/OSHAfactsheet-laboratory-safety-osha-lab-standard.pdf, and www.osha.gov/OshDoc/data_General_Facts/hazardouschemicalsinlabs-factsheet.pdf, including a publication on laboratory safety at: www.osha.gov/Publications/laboratory/OSHA3404laboratory-safety-guidance.pdf. The OSHA Safety and Health Topics page on Laboratories at: https://www.osha.gov/SLTC/laboratories/, can also provide you with additional information. Since your letter appears to deal with a production lab, the rest of this response will not address the requirements of the Laboratory Standard.

Another OSHA standard that applies to laboratories is the Hazard Communication Standard (29 CFR 1910.1200). Paragraph 1910.1200(b)(3) of the Hazard Communication standard outlines the requirements that apply to laboratories. As part of these requirements, employers must maintain safety data sheets (SDSs) that are received with incoming shipments of hazardous chemicals, and ensure that the SDSs are readily accessible during each work shift to laboratory employees when they are in their work areas. An SDS provides information on the hazards associated with the chemicals and other relevant information on the substance (e.g., physical/chemical properties, composition/ingredients, handling and storage, and disposal considerations for the chemicals). The Hazard Communication Standard is available at: www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10099, and the OSHA Safety and Health Topics page on Hazard Communication is at: https://www.osha.gov/dsg/hazcom/index.html

Question 2: How often do laboratory workers exposed to formaldehyde need to be monitored? Are they selected randomly for monitoring?

Response: According to paragraph 1910.1048(d)(2) of the Formaldehyde Standard, the employer must conduct initial monitoring to identify all workers who may be exposed at or above the action level or the short-term exposure limit (STEL). The action level for formaldehyde is 0.5 ppm, averaged over an 8-hour time period, and the STEL (measured over 15 minutes) is 2 ppm. The initial monitoring process must be repeated each time there is a change in production, equipment, process, personnel, or control measures that may result in new or additional exposure to formaldehyde, or if a worker reports signs or symptoms of respiratory or dermal conditions associated with formaldehyde exposure.

If initial monitoring shows that workers are exposed at or above the action level or at or above the STEL for formaldehyde, per paragraph 1910.1048(d)(3)(i) of the Formaldehyde Standard, the employer must periodically measure and determine exposure to formaldehyde for those workers. If the last monitoring results reveal worker exposures at or above the action level, the employer must repeat monitoring of the workers for at least every 6 months; if worker exposures are at or above the STEL, the employer must repeat monitoring of the workers at least once a year under worst conditions. Periodic monitoring may be discontinued when results from two consecutive sampling periods at least 7 days apart are below the action level or STEL. 1910.1048(d)(3)(ii).

For employee monitoring, paragraph 1910.1048(d)(2)(i) of the Formaldehyde Standard states that unless the employer chooses to measure the exposure of each worker potentially exposed to formaldehyde, the employer must develop a representative sampling strategy and measure sufficient exposures within each job classification for each work shift to correctly characterize the exposure of any worker within each exposure group. Appendix A to the Formaldehyde Standard further clarifies that the employer need not measure every exposure if a “high exposure” worker (within each job classification for each work shift) can be identified. A “high exposure” worker usually spends the greatest amount of time nearest to the process equipment. Appendix A to the Formaldehyde standard is available at: www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10076.

Question 3: Should workers be provided a separate space for performing non-formaldehyde related work, e.g., clerical work?

Response: The Formaldehyde Standard requires employers to limit access to regulated areas. 1910.1048(e). Regulated areas are areas where the concentration of airborne formaldehyde either exceeds its PEL of 0.75 ppm as an 8-hour time-weighted average or the STEL of 2 ppm. Only authorized persons who have been trained to recognize the hazards of formaldehyde may enter a regulated area. Additionally, all entrances and access ways to regulated areas must be posted with signs bearing the following information:

DANGER
FORMALDEHYDE
MAY CAUSE CANCER
CAUSES SKIN, EYE, AND RESPIRATORY IRRITATION
AUTHORIZED PERSONNEL ONLY

The employer must communicate the locations of and access restrictions for these regulated areas to employees, pursuant to 29 CFR 1910.1200(h)(2) (employees must be informed of operations in their work areas where hazardous chemicals are present) and 1910.1200(h)(3)(iii) (employees must be trained about measures to protect themselves from hazardous chemicals). At a multi-employer worksite an employer who establishes a regulated area must communicate the access restrictions and location of the regulated area to other employers with work operations at that worksite. See 1910.1048(e)(3).

For questions 4, 5, and 6 below, which focus on ventilation, storage, and disposal of formalin and formalin-fixed specimens, it is important to note that the concentration of formaldehyde in the formalin solution and the presence of other chemical components in the solution ,e.g., a methanol stabilizer) can alter the hazard posed by the solution. For example, 37-50 percent solutions of formaldehyde present a much greater hazard to the skin and eyes from spills or splashes than solutions containing less than 1 percent formaldehyde. Similarly, the flash point and flammability potential of the formalin solution depends on the concentration of formaldehyde and the presence or absence of other flammables in the solution. Safety data sheets for the formalin solution being used in the workplace should be consulted to identify the chemicals and their respective concentrations in the solution. This information will assist in making a more accurate determination of the storage, ventilation, and disposal considerations for the formulation or in supporting the requirements outlined in our responses to questions 4-6. Our responses are based on the assumption that the formalin used in the workplace is uninhibited formalin solution, i.e., without a methanol stabilizer, which is composed of 37 percent formaldehyde and 63 percent water.

Question 4: Do cupboards that store formalin-fixed specimens need special ventilation?

Response: Uninhibited formalin (composed of 37 percent formaldehyde and 63 percent water, with no methanol stabilizer) is identified as a Category 4 flammable in Appendix A to the Formaldehyde Standard. However, the Formaldehyde Standard and the OSHA standard for flammable liquids (29 CFR 1910.106) do not require special ventilation for the storage of formalin-fixed specimens. Paragraph 1910.106(a)(31) of the Flammable Liquids Standard, which requires ventilation for the prevention of fire and explosion, provides that ventilation is considered adequate if it is sufficient to prevent accumulation of significant quantities of vapor-air mixtures in concentration over one-fourth of the lower flammable limit of the chemical.

Question 5: Can 55-gallon drums of formalin be stored in regular rooms or do they need special chemical rooms for storage?

Response: Some requirements of OSHA’s Flammable Liquids Standard for inside storage rooms would apply if 55-gallon drums of a flammable such as formalin are stored in rooms within a building that houses a worksite. Paragraph 1910.106(d)(4) of OSHA’s Flammable Liquids standard addresses the design and construction of inside storage rooms, fire resistance rating and capacity, wiring, ventilation, and other requirements for safe storage of flammables in inside storage rooms. To access specific information in paragraph 1910.106(d)(4) and its sub-paragraphs, visit the OSHA Flammable Liquids Standard at: www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9752#1910.106(a)(22).

Question 6: When disposing of formalin-fixed specimens, can the whole specimen, along with the formalin, be disposed of in a biohazard bag or does the formalin need to be disposed of separately in a container?

Response: The whole specimen along with the formalin may be disposed of in a biohazard bag. In addition, the Formaldehyde Standard at 1910.1048(j)(4) provides: “Formaldehyde-contaminated waste and debris resulting from leaks or spills shall be placed for disposal in sealed containers bearing a label warning of formaldehyde's presence and of the hazards associated with formaldehyde. The employer shall ensure that the labels are in accordance with paragraph (m) of this section.”

For additional help with all your safety and health questions, you should know about OSHA's On-site Consultation Program. This program offers free and confidential safety and occupational health advice to small and medium-sized businesses in all states across the country, with priority given to high-hazard worksites. On-site consultation services are separate from OSHA enforcement activities and do not result in penalties or citations. Consultants from state agencies or universities work with employers to identify workplace hazards, provide advice on compliance with OSHA standards, and assist in establishing injury and illness prevention programs. For more information, see: www.osha.gov/dcsp/smallbusiness/consult.html.

You should also know that workers who work for state and local governments are not covered by Federal OSHA, but have protections at least as protective as Occupational Safety and Health (OSH) Act protections if they work in a state that has an OSHA-approved state plan. New York currently has an OSHA-approved state program that covers only state and local government workplaces. Here is a link to OSHA’s webpage that explains New York’s State Plan: www.osha.gov/dcsp/osp/stateprogs/new_york.html.

Finally, if you wish to file a complaint for unsafe working conditions, you should contact the local OSHA area office, which can be found at www.osha.gov/html/RAmap.html. Information about worker rights can be found at the following:

• Worker rights and complaint information: www.osha.gov/workers/index.html
• Whistleblower Program information: www.whistleblowers.gov/index.html; www.whistleblowers.gov/complaint_page.html

Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA’s requirements are set by statute, standards, and regulations. Our 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 assure that you are using the correct information and guidance, please consult OSHA’s website at www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.

Sincerely,


Thomas Galassi, Director
Directorate of Enforcement Programs