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FIFRA Stakeholders: Update to How to Respond to an Enforcement Action or Inquiry

Contrary to popular opinion, the U.S. Environmental Protection Agency’s (EPA) enforcement activity under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) has been trending upward over the last couple of years. As noted in our earlier advisory memorandum on enforcement activity under the Toxic Substances Control Act (TSCA), although most parties subject to TSCA inspections receive a “boilerplate” letter, FIFRA enforcement actions tend to be more heterogeneous. Potential FIFRA enforcement communications include a notice or letter announcing that EPA has commenced an investigation or will conduct an inspection, a Notice of Warning (NOW), a refused Notice of Arrival (NOA) or a Notice of Detention (NOD), or a Stop Sale, Use, or Removal Order (SSURO). EPA also sends Information Request Letters (IRL), although less frequently than it does in TSCA contexts. This memorandum provides guidance to FIFRA stakeholders on how to respond to a typical EPA FIFRA inspection letter.

What We Observe

The type of FIFRA enforcement action that EPA utilizes depends on the circumstances. Recent areas of special interest under FIFRA include imports of pesticide products and devices, product composition issues (e.g., a new active ingredient supplier, foreign or contract manufacturing), Internet sales and pesticidal claims, and “gray areas” such as cleaners with antimicrobial claims or fertilizers with biostimulant claims. In the discussion below, we review the various types of FIFRA enforcement actions that pesticide registrants and producers are most likely to encounter, and provide some general guidance concerning what to do in response to each type of action. Many of the documents discussed below can be publicly available, particularly enforcement actions posted by EPA in its administrative enforcement dockets. These documents generally are very fact-specific, but examples on EPA’s website provide guidance as to the level of detail and discussion found in such documents.

Inspection Notices and Letters

A pesticide registrant, manufacturer, formulator, or establishment (FIFRA stakeholder) may receive a notice or letter from the pertinent EPA regional office requesting specific information or documentation, or announcing that EPA plans to conduct an inspection. A FIFRA stakeholder that receives such a communication should promptly consult with in-house or outside counsel so that the communication from EPA can be reviewed to identify specific areas of EPA interest and evaluate potential enforcement liability. Companies on notice of an inspection should review EPA’s rule on how it conducts on-site administrative inspections to understand the process and what to expect during an inspection (i.e., (1) Timing of Inspections and Facility Notification; (2) Inspector Qualifications; (3) Obtaining Consent to Enter; (4) Opening Conference; (5) Physical Inspection; (6) Managing Confidential Business Information (CBI); (7) Interview Facility Personnel; (8) Records Review; (9) Sampling; (10) Closing Conference; and (11) Inspection Reports).

A recipient should not be reluctant to request an extension if additional time is needed to provide a full response, which is often the case. The recipient should provide all requested information and records promptly, and should allow EPA inspectors to copy pertinent records and to collect samples of any pesticide or other product that has been released for shipment. Nonetheless, the recipient of such a communication should avoid gratuitously providing any information that EPA has not requested or answering any questions that EPA has not asked.

After receipt of an enforcement communication, it is important not to dispose of any potentially responsive records or product samples. FIFRA stakeholders should establish and then rigorously adhere to a document retention policy. Counsel should be consulted before adopting any document retention policy. FIFRA does not specify any separate statute of limitations for imposition of administrative civil penalties, so the general five-year statute of limitations in 28 U.S.C. Section 2462 applies based on the applicable judicial precedent. EPA will typically contend that this statute of limitations is reset for violations of a “continuing” nature, but it is prudent for registrants to retain records needed to document compliance with FIFRA for at least five years unless EPA has specifically required a longer retention period for the type of record at issue. In any case, once a FIFRA stakeholder receives an enforcement communication, no pertinent records should be destroyed.

FIFRA stakeholders should consider conducting periodic compliance audits to discover and correct any inadvertent non-compliance. If a company chooses to self-report, it generally is eligible for more lenient treatment, especially with respect to the imposition of penalties. Although it is often desirable to review past compliance while preparing for an enforcement inspection or investigation, EPA’s policy is to deny more favorable treatment for any violation that is self-reported but was discovered after receipt of an enforcement communication.

Information Request Letters

In addition to conducting inspections, EPA may issue IRLs to obtain necessary information to assess compliance with FIFRA. Though EPA may use IRLs only occasionally, recipients should provide all records promptly as if EPA were conducting a formal inspection. As FIFRA IRLs may be case-specific and vary depending on the type of information sought by EPA, recipients may consider the following steps when they receive an IRL.

FIFRA stakeholders that receive an IRL should ensure that EPA provides the request in writing, and review closely for instructions or deadlines for providing a response. It is important to be aware that EPA may review responses to requests for evidence of violations. As with inspection notices, recipients should not hesitate to ask EPA for a written extension if needed. Responsive documents to IRLs should be precise and tailored to EPA’s request and assert confidentiality where needed. The recipient should also review its responses carefully to identify any compliance concerns, and if any are discovered, take swift corrective action and consult with counsel as needed to ensure compliance. If uncertain about whether the issue constitutes a violation, it is important to resolve any questions and consult with counsel as needed before providing a response, or presenting any questions regarding compliance, to EPA. As noted above, periodic compliance audits assist FIFRA stakeholders in ensuring continued compliance. Choosing to conduct an audit following receipt of an IRL may be prudent to review other activities for compliance in the event that EPA follows up with additional IRLs, or decides to initiate an inspection.

Notice of Warning

FIFRA Section 9(c)(3) affords EPA discretion to send a “suitable written notice of warning” in lieu of imposing a penalty for “minor violations” when EPA “believes that the public interest will be adequately served.” In general, EPA's current FIFRA Enforcement Response Policy states that EPA will consider a violation to be “minor” for FIFRA stakeholders if the total “gravity adjustment value” determined by EPA is three or less or for “certain first-time recordkeeping violations.”

FIFRA stakeholders that receive an NOW should immediately take precautionary action to ensure that the claimed violation is not repeated. If the recipient questions the factual or legal basis for the claimed violation, the recipient can consider initiating a dialogue with regional enforcement personnel, but it is usually prudent to conform prospectively to EPA's interpretation of the applicable FIFRA requirements pending resolution of any contested issues. A recipient of an NOW may also dispute the EPA interpretation but conclude that it is commercially expedient simply to accept EPA's position.

Refused Notice of Arrival and Notice of Detention

When a FIFRA stakeholder is importing any pesticide or pesticidal device into the United States, an NOA is required. EPA may deny entry for imported pesticides or devices that it deems to be in violation of FIFRA, either by refusing to accept the submitted NOA, or by issuing a separate NOD. In instances where EPA has issued an NOD, EPA will, pursuant to FIFRA Section 17(c) Custom’s regulations (19 C.F.R. § 12.117(b)), provide companies with an opportunity, in writing or during a hearing, to explain why the shipment should not be destroyed or refused entry. When an import shipment to a FIFRA stakeholder that contains pesticides or pesticidal devices is denied entry, the most frequent response is that the FIFRA stakeholder will export the shipment.

When an importer contests the validity of a refusal by EPA to permit entry, the importer can ask EPA to release the shipment pending a formal determination of the admissibility of the contested shipment. Under U.S. Customs regulations for FIFRA (see 19 C.F.R. §§ 12.110 - 12.117), such a release requires that the importer post a bond, and the products in the released shipment cannot be used or disposed of pending resolution of the admissibility of the shipment. If EPA ultimately refuses entry after a hearing, and the shipment is not subsequently exported, the posted bond will be forfeited.

In our experience, if a FIFRA stakeholder cannot promptly convince the EPA regional office that entry for a shipment has been erroneously refused, it is seldom worthwhile to demand a hearing or to ask that the shipment be released pending such a hearing. When the objective is to secure prompt receipt of the pesticides or devices contained in a refused shipment, the most expedient choice often is to export the refused shipment, and then to import it again following relabeling, repackaging, or other action intended to resolve the disputed issue. This is particularly true when the pesticide or device at issue is not located at a FIFRA registered establishment where production (including labeling and packaging) must take place.

Stop Sale, Use, or Removal Orders

FIFRA Section 13 authorizes EPA to issue a SSURO prohibiting sale, use, or removal of a pesticide product or pesticidal device if it violates FIFRA, or it has been or is intended to be distributed or sold in violation of FIFRA, or if the registration for a pesticide product has been finally cancelled or suspended by EPA. EPA can issue a SSURO without any prior hearing. Moreover, although a SSURO is subject to judicial review upon issuance, the cost of obtaining such review and the generally deferential standard for such review may limit the practical utility of this remedy.

Receiving a SSURO is a serious matter, and a FIFRA stakeholder who receives a SSURO should immediately seek the advice of in-house or outside legal counsel. Because a SSURO is a draconian remedy and can inflict severe commercial harm without affording the injured party any prior process, EPA has adopted enforcement criteria in the current FIFRA Enforcement Response Policy that generally require that EPA determine that there is a significant potential hazard to human health or the environment before a SSURO may be issued. Unfortunately, these criteria are not consistently followed by the EPA regional offices, and a FIFRA stakeholder may be subject to a SSURO based on little more than an EPA determination that FIFRA has been violated. As in the instance of a refusal by EPA to accept an NOA, the most commercially expedient approach to a SSURO may be to determine why each affected product has been deemed to violate FIFRA, and then to offer to modify the composition, labeling, or other claims made for the product to eliminate the purported FIFRA violation. Based on such an offer, the recipient of a SSURO can then request that EPA modify the SSURO to allow sale or use of the contested product to resume.

The principal problem with asking EPA to modify or lift a SSURO is that EPA may then presume that the inclusion of a product in the SSURO had a legitimate factual and legal basis. Because such a presumption may result in a proposed imposition of administrative penalties, such a proposal can be contested separately in a formal enforcement adjudication.

©2022 Bergeson & Campbell, P.C.National Law Review, Volume XII, Number 60

About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...