March 12, 2012

Aldo Franco, Ph.D.
6680 Thornhill Court
Boca Raton, FL 33433

Dear Dr. Franco:

Thank you for your May 13, 2011, letter to the Occupational Safety and Health Administration (OSHA). Your letter was referred to the Directorate of Enforcement Programs (DEP) for a response. You requested an interpretation of OSHA's Occupational Exposure to Hazardous Chemicals in Laboratories (Laboratory) standard, 29 CFR 1910.1450, regarding the labeling of containers. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to issues not delineated within your original correspondence. We apologize for the delay in our reply. Your paraphrased question and our response are below.

Question: What are the labeling requirements for an analytical research and development laboratory of a pharmaceutical company, with respect to incoming reagents and secondary containers?

Response: For a facility to be covered under OSHA's Laboratory standard, 29 CFR 1910.1450, it must satisfy the standard's definition of a laboratory: a facility where the "laboratory use of hazardous chemicals" occurs. This means the handling or use of hazardous chemicals where all of the following conditions are met:

(i) Chemical manipulations are carried out on a laboratory scale ¹ ;

(ii) Multiple chemical procedures or chemicals are used;

(iii) The procedures involved are not part of a production process, nor in any way simulate a production process; and

(iv) Protective laboratory practices and equipment ² are available and in common use to minimize the potential for employee exposure to hazardous chemicals.

When these conditions are met, the labeling requirements in the Laboratory standard supersede the labeling requirements in OSHA's Hazard Communication standard (HCS), paragraph 29 CFR 1910.1200(f). Specifically, the labeling requirements of the Laboratory standard are provided in paragraph 1910.1450(h), which include:

• 1910.1450(h)(1)(i) Employers shall ensure that labels on incoming containers of hazardous chemicals are not removed or defaced.
• 1910.1450(h)(1)(ii) Employers shall maintain any material safety data sheets that are received with incoming shipments of hazardous chemicals, and ensure that they are readily accessible to laboratory employees.

Unlike the Hazard Communication standard, OSHA's Laboratory standard does not specifically address the labeling of secondary containers in the laboratory. The Laboratory standard allows laboratories flexibility in tailoring their written Chemical Hygiene Plan (CHP) and standard operating procedures to be protective of employees in laboratories (29 CFR 1910.1450(b)). In addition, paragraph 1910.1450(f)(4), Training, requires the employer to train employees regarding the physical and health hazards of chemicals in the work area, the measures employees can take to protect themselves from these hazards, and the employer's CHP.

Additionally, OSHA encourages employers to consult non-mandatory Appendix A of the standard, National Research Council Recommendations Concerning Chemical Hygiene in Laboratories. Specifically, Appendix A, Section D.8(b), Signs and Labels, provides that "Prominent signs and labels of the following types should be posted: Identity labels, showing contents of containers (including waste receptacles) and associated hazards." Employers may also wish to consult the most recent edition of the National Resource Council's Prudent Practices in the Laboratory Handling and Management of Chemical Hazards ³ for further recommendations on safe laboratory practices.

For further information, we have enclosed an OSHA letter of interpretation, January 11, 2001, which provides additional discussion of the requirements for labeling reagent bottles within workplaces covered by either the HCS or the Laboratory standard.

Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can continue to consult OSHA's Web site 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

Enclosure: OSHA letter to Ms. Danette Pravidica, January 11, 2001

1 "Laboratory scale" means work with substances in which the containers used for reactions, transfers, and other handling of substances are designed to be easily and safety manipulated by one person, excluding workplaces whose function is to produce commercial quantities of materials. 29 CFR 1910.1450(b).

2 "Protective laboratory practices and equipment" means those laboratory procedures, practices and equipment accepted by laboratory health and safety experts as effective, or that the employer can show to be effective, in minimizing the potential for employee exposure to hazardous chemicals. 29 CFR 1910.1450(b).

3 National Research Council. "Prudent Practices in the Laboratory Handling and Management of Chemical Hazards" (Updated Version). Washington DC: National Academy Press.