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Good Laboratory Practices: Questions and Answers - GLP Violations
FIFRA Topics
- Good Laboratory Practices
- FIFRA Grants
- Inspections
- Worker Protection Safety
- Pesticide Producing Establishments
- Pesticide Imports and Exports
EPA has prepared responses to several questions in order to help clarify the Good Laboratory Practices Standards (GLPS) rule. The Questions and Answers are grouped into eleven different categories listed below. The following Questions and Answers serve as official written policy.
Applicability
Definitions
Study Director
Quality Assurance Unit (QAU)
Facilities
Test Control and Reference Substance Characterization
Test Substance Storage Containers
Protocols
Reporting
Archives
GLP Violations
- Can EPA assess penalties for GLP violations?
- What are the possible violations under the statute?
- What are the maximum penalties that can be imposed?
- Will civil or criminal penalties be imposed for all GLPS violations?
- Can EPA reject studies not conducted in accordance with GLPS?
1. Can EPA assess penalties for GLP violations?
Yes. FIFRA section 14 states the EPA's authority to assess penalties for violations of the Act.
2. What are the possible violations under the statute?
Violations of GLPS may constitute unlawful acts under FIFRA. Under section 12(a)(2)(M) it is unlawful to knowingly falsify all or part of any application for registration, application for experimental use permit, any information submitted to the Administrator pursuant to section 7, any records required to be maintained pursuant to this Act, any report filed under this Act, or any information marked as confidential and submitted to the Administrator under any provision of this Act to be submitted to EPA or of records required to be maintained. Under section 12(a)(2)(Q) of FIFRA it is unlawful to falsify all or part of any information relating to the testing of any pesticide (or any ingredient, metabolite, or degradation product thereof), including the nature of any protocol, procedure, substance, organism, or equipment used, observation made, or conclusion or opinion formed, submitted to the Administrator, or that the person knows will be furnished to the Administrator, or will become a part of any records required to be maintained by this Act. Under section 12(a)(2)(R) of FIFRA it is unlawful to submit to the Administrator data known to be false in support of a registration. Finally, it is unlawful under FIFRA section 12(a)(2)(B)(I) of FIFRA to refuse to prepare, maintain or submit any records required by or under sections 5, 7, 8, 11, or 19.
3. What are the maximum penalties that can be imposed?
Penalties are set by statute and modified pursuant to the Debt Collection Improvement Act of 1996. EPA issued its most recent modification (PDF) (541K, 15 pages, About PDF) in 2004.
4. Will civil or criminal penalties be imposed for all GLPS violations?
No. Section 9(c)(3) of FIFRA allows a written notice of warning to be issued for a minor violation, if such warning is determined to be adequate to serve the public interest. Section 14(a)(4) of the Act further provides that in determining the size of a penalty EPA may issue a warning in the case that a violation occurred despite exercise of due caution or did not cause significant harm to health or the environment. Finally, section 14(a)(2) of FIFRA provides that persons other than registrants, commercial applicators, wholesalers, dealers, retailers or other distributors who violate any provision of the Act may be assessed a civil penalty only subsequent to receiving a written warning for a prior violation. Thus, persons who only perform testing and are not engaged in the distribution and sale of pesticides will not be assessed civil penalties for their first offense. This does not extend to criminal penalties as described at section 14(b)(2) of FIFRA.
5. Can EPA reject studies not conducted in accordance with GLPS?
Yes. The regulations specifically provide for this at 40 CFR 160.17(a), which states that "EPA may refuse to consider reliable ... any data from a study which [is] not conducted in accordance with [GLPS]." GLPS violations associated with a study submitted to EPA may also result in enforcement actions whether or not a study is rejected.