Label Review Training: Module 1: Label Basics, Page 11
Section 3: How are label requirements regulated?
Compliance and Enforcement Process
Everyone who participates in the compliance and enforcement process shares the common goal of protecting human health and the environment.
Step 1: Label reviewer conducts label review.
When a registrant submits a product for registration, a label reviewer at EPA conducts a label review to:
- Ensure that the user can understand and follow the label.
- Ensure that the label is clear, accurate, consistent with EPA policy, and enforceable by the states or EPA Regions.
Once the review is complete, EPA stamps the label “accepted.” If an accepted label is not clear, accurate, consistent with EPA policy, and enforceable, it can have far-reaching effects, as illustrated in the learning activity later in this section.
Step 2: Inspector conducts investigation.
An inspector conducts an investigation to:
- Detect violations.
- Collect evidence necessary to successfully prosecute violators.
Inspectors include representatives from state lead agencies (SLAs), federally recognized tribes, and EPA Regional offices. They may conduct inspections that are routine or “for cause,” which means they are the result of a complaint or tip. Inspectors may investigate retail establishments or pesticide dealers to see if products for sale are legal. They may also investigate use sites, such as farms, to see if misuse has occurred or if standards and labeling requirements for worker protection have been violated.
The inspector must fulfill certain statutory requirements under FIFRA when conducting their investigations. If the inspector does not, enforcement is jeopardized.
Step 3: Laboratory analyst examines physical samples.
If the investigation involves physical samples, the inspector collects those samples and submits them to a laboratory for analysis. A laboratory analyst:
- Verifies formulation of samples.
- Sometimes performs antimicrobial efficacy testing on samples.
The laboratory analyst must have a Quality Assurance Project Plan in place to ensure that sample chain of custody is maintained, that samples are analyzed using approved methods, and that instrumentation is correctly calibrated.
The laboratory analyst must follow standard operating procedures to ensure not only the integrity of the samples collected but also the integrity of the entire case.
Step 4: Case developer builds a case.
Finally, to determine whether a violation has taken place, a case developer (or attorney) develops a case following the FIFRA Enforcement Response Policy, as well as the administrative procedures set forth in 40 CFR Part 22. The case developer:
- Reviews the inspector's report.
- Reviews the evidence.
- Performs a word-for-word comparison of the accepted label and the label collected during the inspection.
- May send an Enforcement Case Review (ECR) to the Office of Enforcement and Compliance Assurance (OECA) and OPP to help build a case. ECRs often include label interpretation questions.
If the label reviewer(s), investigator(s), and laboratory analyst(s) involved in the case have all performed their jobs in accordance with standard operating procedures, then the case developer has a good chance of winning the case.