Coverage of laboratories under OSHA's Laboratory Standard

February 8, 1991

MEMORANDUM FOR: JOHN B. MILES, JR
Regional Administrator

FROM: PATRICIA K. CLARK, DIRECTOR
DIRECTORATE OF COMPLIANCE PROGRAMS

SUBJECT: Requests for Interpretation of the Laboratory Standard

This is in response to your memorandum of October 31, 1990, with attachments from two area offices requesting interpretations of the Laboratory Standard, 29 CFR 1910.1450. Your questions with our answers are as follows:
a. The standard does not apply to QC/QA laboratories in manufacturing establishments. What is a manufacturing establishment? Are we referring only to establishments in SIC codes 20 - 39, or are we talking about all production facilities. For example, electrical power generation facilities produce a product, but they are not in the traditional manufacturing SIC codes (in this case power generation facilities have water treatment laboratories).
The standard talks about production processes, not manufacturing establishments. SIC codes are not used as criteria for scope of coverage. Because they are producing a product - electricity, electrical power generation facilities's water treatment laboratories conducting quality assurance monitoring used for process control information are not within the scope of the standard. However, the Laboratory Standard does apply to laboratories performing wastewater analyses simply for determining compliance with EPA discharge criteria.
b. Are laboratories which monitor environmental emissions (air emissions, waste water quality, etc.) from the manufacturing process considered to be QA/QC laboratories? Often these do repetitive sampling and analytical procedures which are directly related to the manufacturing process.
No. As mentioned in the above, most if not all of these laboratories are not conducting operations that constitute quality control of production processes but are monitoring emissions for environmental control purposes; therefore, they are not exempted from the Laboratory Standard. Such operations would only be considered quality control of production if the result of the monitoring is used as a source of information for process control adjustment. The repetitive nature of the laboratory operations is not part of the definition of "laboratory use" or "laboratory scale" as defined in 29 CFR 1910.1450 and is merely discussed in the preamble to the regulation as one of the characteristics sometimes found in laboratories.
The memorandum from Ronald E. Morin of the Springfield Office asked whether the following operations are covered by the Laboratory Standard:
(1) I.H. Lab doing asbestos analysis all day long.
This lab would be covered by the standard, assuming the other criteria of coverage are met, since asbestos analysis is not considered a production process.
(2) Small medical labs just drawing blood.
If the labs are just drawing blood and are not performing other activities, they are not covered by the Laboratory Standard, as biological hazards are not within the scope of 29 CFR 1910.1450. However, to the extent that they use chemicals to analyze the blood, they may be covered. The labs should note, in addition, that OSHA has issued enforcement policies regarding bloodborne pathogens and infectious diseases. Please refer to [OSHA Instruction CPL 2-2.69, Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens].
(3) Bench scale operations that look at substitutes for processes.
In most cases these operations are considered research and not quality control related to production; therefore, they are within the scope of coverage of the Laboratory Standard, if the other criteria for coverage are met.
(4) Soil and water analysis of unknowns.
If these operations are not assuring reliability of a product, they are not considered to be related to quality control of production. In such a case, they are within the scope of the Laboratory Standard, if the other criteria for coverage are met.
(5) Labs that use toxic materials just for calibration.
If the calibration is performed for the purpose of quality control of production processes, then the labs are not within the scope of coverage. If the calibration is for other purposes, assuming employees are exposed to toxic materials, then the Laboratory Standard would apply.
(6) Fish tissue bioassays done routinely.
If definitions of "laboratory scale" and "laboratory use" are met, then these bioassays are covered. The routine nature of operations is not a criterion for determination of coverage under the definitions.
In response to the questions sent in by the Hartford Office, asking which of the labs, whose functions are described below, are exempt from the Laboratory Standard:
a. QC/QA of manufactured products and raw materials.
b. Development of potential new production processes.
The Agency has determined that operations that meet the definition of "laboratory scale" and "laboratory use" are covered by the standard. Most quality control laboratories and pilot plants would not qualify for coverage because they simulate or are related to the production process. However, there are cases where the operations remain part of the research activity or where the quality control work is neither part of nor related to production processes. In these instances, the Laboratory Standard would apply.
Facilities that are not involved in production but perform quality analyses on the chemicals they store or utilize may be covered by the Laboratory Standard. QC/QA of raw materials for use in the production process would not be within the scope of the standard; whereas, QC/QA of raw materials for research purposes or, as in example (b) given above, development of potential new production processes, would be covered by the standard.
The test to be applied when evaluating these labs under the Laboratory Standard is whether or not these labs meet the definitions of "laboratory use" and "laboratory scale," as defined in 29 CFR 1910.1450. If the definitions are met, then the standard is applicable. The words "quality control" or "routine, standardized tests" do not necessarily mean exemption from the standard. One must determine whether or not these operations simulate or are part of a production process. If not, then these operations are within the scope of the Laboratory Standard, provided that other criteria of the "laboratory use" and "laboratory scale" are met.
We hope we have adequately addressed your concerns. If we can be of further assistance, please do not hesitate to contact us again.
[Corrected 10/29/02]

[The regional request and attached inquiries are reproduced on the source page; omitted here.]