Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala

On October 27, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report on an evaluation conducted by OIG entitled “EPA Needs Policies and Procedures to Manage Public Pesticide Petitions in a Transparent and Efficient Manner” (OIG Report).  OIG evaluated how EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) tracks the receipt, disposition and resolution of public petitions, focusing on OCSPP’s Office of Pesticide Programs (OPP) and its policies and procedures used to ensure consistency and transparency when responding to pesticide-related public petitions.  Although pesticide petitions can be submitted to EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Federal Food, Drug, and Cosmetic Act (FFDCA), the Administrative Procedure Act (APA), or any combination of these authorities, OIG’s “At a Glance,” a document summarizing the OIG Report, states that OPP “does not have policies or procedures to ensure transparency when managing public pesticide petitions.” 

OIG’s Report outlines three main areas for improvement in communication, stating that OPP has not effectively communicated with petitioners in the following manner:  (1) acknowledging petition receipt; (2) providing updates about the agency’s work to resolve petitions; and (3) providing petition decisions.  For example, OIG noted that since FIFRA does not set forth requirements for EPA to respond to a petition within a specific timeframe, petitioners in many circumstances filed lawsuits claiming EPA had not responded within a reasonable amount of time as required under the APA.

In addition, OIG states that OPP lacks policies and procedures to manage petitions in a generally efficient or effective manner, specifically noting:  (1) petition documentation is not readily accessible, which was inconsistent with each of the EPA’s Records Management Policies in place during the timeframe of OIG’s review; (2) some petition data are inaccurate, which results in the duplication of work to confirm data; (3) according to OPP, petitions may take weeks to arrive at the correct office for action, because there is no guidance on how to submit petitions directly to OPP; and (4) OPP does not provide guidance to the public on how to submit complete petitions, which results in some petitioners providing supplemental information, therefore increasing the time and resources to reach petition decisions.

The report makes four recommendations of actions that should be taken by the Assistant Administrator for OCSPP that OIG believes will address the issues.  In a memorandum attached to the OIG report, OCSPP agreed with these recommendations, provided corrective actions, and estimated completion dates.  OIG’s recommendations and OCSPP’s Corrective Actions in response to them are as follows:

Recommendation 1:  Develop policies and standard operating procedures to manage public petitions received by OPP in a transparent and efficient manner, which includes direct communication with petitioners by:

  • Providing a letter to the petitioner acknowledging receipt of the petition;
  • Communicating petition decisions to the petitioner in writing; and
  • Providing updates to petitioners about the status and progress of pending petitions.

Corrective Action 1:  OCSPP’s OPP will develop appropriate policies and standard operating procedures (SOP) to manage public petitions received by OPP in a transparent and efficient manner.  The procedures will include the direct communication protocols listed in the OIG’s recommendation.  Estimated date of completion:  October 2016.

Recommendation 2:  Train staff managing public pesticide petitions to adhere to the EPA’s Records Management Policy.

Corrective Action 2:  The SOPs described in Corrective Action 1 will address maintaining appropriate records for covered petitions.  When the SOP is final, OPP will issue a memorandum informing appropriate staff and management of their responsibilities for maintaining these records, and directing the use of the SOPs to meet their responsibilities under the Agency’s Records Management Policy.  Estimated date of completion:  November 2016.

Recommendation 3:  Develop and implement an effective petition tracking system for public pesticide petitions.

Corrective Action 3:  The SOPs described in Corrective Action 1 will include procedures for tracking petitions not covered by certain regulations, including petitions seeking FIFRA and APA rulemaking or cancellation of registrations.  Estimated date of completion:  October 2016.

Recommendation 4: Provide criteria and guidelines for submission of public pesticide petitions that provide sufficient information for EPA review.

Corrective Action 4:  OCSPP commits to develop and post to the Agency Pesticides website criteria and guidelines for public submission of pesticide petitions not covered by 40 CFR § 180.7.  Estimated date of completion:  October 2017.

Commentary

Petitions under FIFRA have been a relatively obscure tool in the past because of some of the issues this report seeks to address.  With no deadline for a response, some petition responses have languished for many years (reportedly up to seven years in some cases).  This partly becomes a “chicken and egg problem;” since it was not clear if and when a response would be forthcoming, it was a relatively unused tool.  Indeed, as OIG’s report points out, only 40 pesticide petitions were submitted between FY2005 and 2014, with almost half (17) still pending.

In recent years, the Obama Administration has made it a point to respond more timely to FIFRA petitions, and as a result, petition filings may have become more attractive to various stakeholders.  One practice that has been a vulnerability for OPP in the past is that not responding whatsoever would more likely lead to a successful “unreasonable delay” suit.  OSCPP’s agreement with the OIG Report recommendations to more clearly state rules of engagement and how to frame expectations about a petition response process appears to be a continuation of the emphasis of EPA leadership on responding to petitions in a timely and more predictable manner.


 

By Lara A. Hall, MS, RQAP-GLP, Jane S. Vergnes, Ph.D., DABT®, and Lisa M. Campbell
 
On Tuesday, August 25, 2015, in a Federal Register notice, the U.S. Environmental Protection Agency (EPA) announced the addition of three Office of Chemical Safety and Pollution Prevention (OCSPP) final test guidelines to its 890 Series, entitled “Endocrine Disruptor Screening Program Test Guidelines,” as follows:

These test guidelines are part of a series of test guidelines established by OCSPP for use in developing data on potentially adverse effects of pesticides and chemical substances on the endocrine system for submission to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408 (21 U.S.C. 346a), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.).  These final guidelines have been revised based on public comments received following the release of draft test guidelines in January 2015, existing EPA test guidelines, and concurrent Organisation for Economic Co-operation and Development (OECD) test guidelines
 
EPA worked with OECD to harmonize test guidelines for MEOGRT and LAGDA.  The specific OECD Guidelines for the Testing of Chemicals, Section 2, that apply to MEOGRT and LAGDA, are available here.  Substantive changes reflected in the final OCSPP MEOGRT and LAGDA test guidelines include:
 
1.         The test will end following hatching of the second generation (F2) offspring.  The option for extending the MEOGRT through reproduction by the F2 generation has been removed from the final test guideline pending additional data. This is consistent with the decision made in the draft OECD test guideline for MEOGRT. This test guideline may be updated as new information and data are considered. For example, guidance on extending the F2 generation through reproduction may be potentially useful under certain circumstances (e.g., chemicals with high bioconcentration potential or indications of trans-generational effects in other taxa).
 
2.         The mean water temperature over the duration of the MEOGRT has been changed to 25 ± 2 °C to be consistent with the analogous OECD test guideline.
 
3.         The LAGDA developmental stage terminology has been clarified to avoid confusion with what is meant by complete metamorphosis.
 
4.         An effort was made to clarify and provide more explicit guidance as to what specific histopathology is appropriate based on the results of the study, e.g., the conduct of liver and kidney histopathology in the MEOGRT and LAGDA test guidelines with respect to overt toxicity.
 
5.         The rationale for use of solvent control only, dilution water control only, or pooled controls in the statistical analyses for the MEOGRT and LAGDA was clarified.
 
6.         The guidelines have been modified to address commenters' concerns that they be more flexible and less prescriptive. Examples have been provided as appropriate to add clarity. 
 
The JQTT draft test guideline (OCSPP 890.2100) was revised to address comments provided by the public, the draft OECD test guideline for the avian two-generation toxicity test in the Japanese quail, as well as the existing EPA test guidelines and OECD test guidelines for avian one-generation toxicity tests.
 
EPA revised the terminology, procedures, endpoints measured, figures, tables, and appendices in the JQTT test guideline to clarify specific points raised by public commenters, and to address commenters' concerns that they be more flexible and less prescriptive, as follows:

1.         The revised test guideline includes fewer endpoints.  For example, the revisions eliminated behavioral endpoints to reduce the overall numbers of birds required for the study; eliminated endpoints that are difficult to obtain (i.e., hormone levels measured in embryo blood samples); and eliminated redundant endpoints and statistical analyses.
 
2.         For clarity, the test terminates with measurement of the 14-day survival of the F2 generation chicks.  This is the minimum length of the study necessary to evaluate and measure a chemical's effect on the first generation’s (F1) reproductive performance.  If delayed reproduction is observed in F1 birds, a decision to extend the F2 generation may be made.  If extended, the test should be terminated when F2 birds are approximately 6 weeks old, when 90 percent of control animals have reached sexual maturity.  The decision to limit the length of the JQTT is consistent with EPA's efforts to move to extended one-generation reproduction test protocols for Tier 2 testing rather than require multigenerational studies.  Extended one-generation reproduction tests are scientifically justified in many cases, reduce the use of animals in testing, and reduce costs.

Electronic access to OCSPP test methods and guidelines is available here.
 
The release of these final testing guidelines marks another significant step in the overall Endocrine Disruptor Screening Program (EDSP), making way for the anticipated Tier 2 testing phase with the List 1 chemicals.  EPA recently released Tier 1 weight-of-evidence assessments for List 1 substances in the EDSP and registrants are now receiving the associated data evaluation records (DER) for the Tier 1 screening studies.  The purpose of the Tier 1 screening was to identify potential interactions with three hormonal pathways (estrogen, androgen and thyroid) in the endocrine system.  As a result of the  potential interactions with one or more of these pathways observed, EPA has recommended Tier 2, multigenerational studies across various species for 18 of the 52 List 1 chemicals, including the MEOGRTS (13 chemicals) and LAGDA (5 chemicals).  Test Orders for Tier 2 studies will be issued following completion of the Information Collection Request (ICR) process within the Office of Management and Budget (OMB).  The public review and comment period for this ICR concludes on September 2, 2015, with a response from OMB to follow in early October 2015.  In the interim, registrants are closely reviewing their respective assessments and DERs, and industry groups are assessing the approach employed by EPA in these Tier 1 assessments, including but not limited to, the statistical reanalysis of study data and conclusions drawn by EPA.


 

By Lisa R. Burchi and Lisa M. Campbell

 

On June 16, 2015, the California Superior Court for the County of Almeda denied the petition of the Pesticide Action Network North America, et al. (PANNA) for a writ of mandate to direct the California Department of Pesticide Regulation (DPR) to set aside and vacate its final decisions approving amended registrations of Dinotefuran 20SG manufactured by Mitsui Chemicals Agro and Venom manufactured by Valent USA. 

 

The active ingredient in both products at issue, dinotefuran, is a neonicotinoid pesticide that has been subject to additional reviews and labeling requirements with regard to its impact on pollinating bees on the federal and state level.  PANNA argued, in part, that under the California Environmental Quality Act (CEQA), DPR should not have approved the amended labels because it had not developed an Environmental Impact Report (EIR) describing the potential environmental impacts, analyzing direct, indirect, and cumulative impacts, and analyzing alternatives. 

 

The court held as a matter of law that “to give effect to CEQA’s current policy goals as developed since 1979 in the Public Resources Code, in the CEQA Guidelines and in case law, that the court must read the DPR’s regulations as requiring that the DPR apply current CEQA analysis in deciding whether to register pesticides.”  That does not, however, require DPR to comply with all of CEQA’s documentation requirements; instead, DPR’s environmental documentation is required to “address only those significant adverse environmental effects that can reasonably be expected to occur, directly or indirectly, from implementing the proposal.”

 

With regard to the standard of review, the court found that DPR’s decision is in the nature of an EIR, which required the court to review the adequacy of the decision for substantial evidence, and not, as PANNA had argued, the functional equivalent of a negative declaration that would have triggered a “fair argument” review standard.  The court then found there was substantial evidence in the administrative record supporting DPR’s decision that the proposed mitigation measures will eliminate any significant environmental impact.  The court held that the record supported DPR’s assertion that the product labels provide necessary environmental protections, noting, for example, that EPA’s conclusion that the federal labeling is adequate to protect bees is substantial evidence to support DPR’s “identical conclusion.”  The court further held that DPR was not required to consider the feasibility of alternatives. 

 

Since the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) preempts a state from imposing label requirements that are different from the U.S. Environmental Protection Agency (EPA)-approved label, the court noted that DPR’s decision was either to register the products consistent with EPA’s approved labels or not register the products for use in California.  Although DPR’s failure to conduct a risk-benefit analysis was not argued before the court, the decision, by way of dicta, noted that the “record suggests that the DPR conducted a de facto risk-benefit analysis and did not actually conclude that the labeling on the Insecticides would mitigate all adverse affect on bees.”  Instead, the court suggests DPR’s risk-benefit analysis was based on the fact that under FIFRA, the only alternative would be to deny the registrations and that would be infeasible considering economic, social, or other considerations. 

 

The decision is a significant judgment regarding DPR’s ability to make decisions regarding label amendments and the court’s ability to review such decisions.  It appears likely an appeal will be filed.  It is also important to note that DPR’s reevaluation of neonicotinoids is still pending -- DPR is required under AB 1789 (codified at Food and Agricultural Code Section 12838(a)) to issue a determination before July 1, 2018, regarding the neonicotinoid registrations and to adopt any control measures determined to be necessary to protect pollinator health.  


 

By Lisa R. Burchi

 

On June 19, 2015, the United States District Court for the District of Columbia granted a motion for default judgment by the Non-Dietary Exposure Task Force (Task Force) and confirmed an arbitration award against an Indian pesticide manufacturer, Tagros Chemicals India, Ltd. (Tagros) (Non-Dietary Exposure Task Force v. Tagros Chems. India Ltd., 2015 BL 195490, D.D.C., 1:15-cv-00132, 6/19/15).  The Task Force sued Tagros after Tagros refused to sign a $500,000 settlement agreement negotiated by the parties in the midst of a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) arbitration proceeding, and continued its refusal to pay after the Task Force successfully moved the arbitrator to issue an award enforcing the settlement agreement.  The Court determined it has jurisdiction because FIFRA “confers jurisdiction on the judiciary to enforce [such] arbitration awards” in federal court and Tagros’ participation in the arbitration allowed the court to exercise jurisdiction over Tagros.  The Court found that the arbitration award must be confirmed in full absent evidence of fraud, misrepresentation, or other misconduct by one of the parties, and no such allegations were put forth.  The Court also granted the Task Force’s motion seeking permission to register this judgment in other district courts based on information that Tagros’ assets were not in the District of Columbia and evidence of assets in other jurisdictions. 

 

This decision adds to a growing number of recent cases where companies have sought judicial enforcement of a FIFRA arbitration award.  Judicial judgments enforcing arbitration awards, in addition to judicial authority to register such judgments in districts where assets are available, are tools data owners are increasingly using to obtain the compensation owed. 


 

By Lisa M. Campbell and Lisa R. Burchi

On June 10, 2015, and June 15, 2015, the U.S. Environmental Protection Agency (EPA) held a webinar entitled “eDisclosure:  EPA's Plan to Modernize the Implementation of the Audit Policy and the Small Business Compliance Policy.”  During the webinar, EPA set forth its plans to release in fall 2015 a centralized online portal called eDisclosure to allow companies to submit self-disclosures electronically under EPA’s Incentives for Self-Policing:  Discovery, Disclosure, Correction and Prevention of Violations (Audit Policy) and Small Business Compliance Policy.  EPA stated that it is developing eDisclosure in an effort to continue to promote the benefits of self-disclosures, while also saving time and resources by modernizing and streamlining the disclosure procedure.

 

Companies with potential Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) violations that can satisfy all nine conditions of self-disclosure under the Audit Policy (i.e., systematic discovery; voluntary discovery; prompt disclosure; independent discovery and disclosure; correction and remediation; prevent recurrence; repeat violations are ineligible; certain types of violations are ineligible; and cooperation) are eligible for 100 percent penalty mitigation, while companies that satisfy conditions 2-9 (i.e., all except systematic discovery) are eligible for 75 percent penalty mitigation.  A related policy for small businesses (those with 100 or fewer employees) modifies the conditions as further incentives (e.g., 100 percent penalty mitigation even if the discovery is not systematic, with longer compliance timeframes).

 

FIFRA self-disclosures will fall into Tier 2, under which the eDisclosure system will automatically issue an electronic Acknowledgement Letter (AL) confirming EPA’s receipt of the disclosure, and promising that EPA will make a determination as to eligibility for penalty mitigation if and when it considers taking an enforcement action for environmental violations.  There are timeframes set for the submission, and/or potential extension, of compliance reports certifying violations have been corrected. 

 

If an extension is sought for more than 60 days (or within 90 days of submitting an online Small Business Compliance Policy disclosure) past the date of discovery of such violation(s), EPA states that eDisclosure will automatically grant the request, but that EPA could later determine, if and when it considers taking an enforcement action, that the correction was not made promptly and thus this Audit Policy condition is not satisfied. 

 

Commentary

 

Companies with potential FIFRA violations can benefit from EPA’s development of eDisclosure, as this is a positive step indicating EPA’s support for and interest in encouraging continued use of its Audit Policy  There are several issues that companies will need to review carefully, including Central Data Exchange (CDX) registration, protection of confidential business information, special issues for “new” owners disclosing violations of recently acquired companies, and changing EPA policies regarding its potential disclosure of settled and unsettled Audit Policy cases. 

 

EPA will issue in fall 2015 a Federal Register notice simultaneously with its launch of e-Disclosure to describe the new portal and how EPA plans to implement the Audit Policy and Small Business Compliance Policy.  Although there is no formal comment period, stakeholders should consider providing input now while EPA is in the midst of developing eDisclosure.


 

By Lisa M. Campbell, James V. Aidala, and Susan Hunter Youngren, Ph.D.


On April 15, 2015, the U.S. Environmental Protection Agency (EPA), the U.S. Fish and Wildlife Service (FWS), the National Oceanic and Atmospheric Administration National Marine Fisheries Service (NMFS), and the U.S. Department of Agriculture (USDA) held a one-day workshop regarding assessing risks to endangered and threatened species from pesticides. This workshop was intended to provide a forum for stakeholders to offer scientific and technical feedback on the ongoing agency efforts to develop draft Biological Evaluations (BE) for three pilot chemicals (chlorpyrifos, diazinon, and malathion) in response to the National Academy of Sciences’ (NAS) report “Assessing Risks to Endangered and Threatened Species from Pesticides.” The workshop was the fourth interagency workshop on this issue, and follows previously-held public meetings in November and December 2013, April 2014, and October 2014, and was held as part of the enhancement of the stakeholder engagement process finalized in March 2013. A copy of the Fourth ESA Stakeholder Workshop agenda is available online. The Interagency presentations are also available online.

This workshop presentations and discussion appeared to demonstrate progress among the agencies in coordinating their work to address the issues that have been the subject of this and prior workshops. The presentation content exhibited a better understanding of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) evaluation process by the Services, and the presentations themselves allowed for more interaction between the presenters and participants; some of the question and answer sessions (conducted after each segment) included detailed exchanges of information among the participants.

To the dismay of some registrants and observers, however, as the various evaluation models were described, and an avian case study presented, the direction of the joint analyses seemed to be moving towards the marriage of very conservative EPA assessment models and assumptions with the Services’ desire to avoid any potential impacts on individual members of a protected species and any habitat. Should this direction not change, the Endangered Species Act pilot assessments could be very conservative and indicate what many may believe is an unwarranted need for significant changes in some current pesticide labels. Simply put, from a registrant perspective, the good news is that the agencies are cooperating and working better together; the bad news is that both EPA and the Services appear to be planning to use very conservative models and assumptions, which could result in proposals for severe restrictions on some current use patterns.

 


 

By Lynn L. Bergeson and Carla N. Hutton

Almost seven years ago, the International Center for Technology Assessment (ICTA) filed a petition for rulemaking requesting that the U.S. Environmental Protection Agency (EPA) regulate products containing nanosilver as pesticides and for related other forms of relief. On March 19, 2015, EPA responded to the petition. In general, the response does not alter EPA’s legal position with regard to nanosilver and its regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), or otherwise contribute any new interpretations of existing EPA pesticide registration or enforcement policy.

Briefly, the key decisions articulated in EPA’s response to the petition are:

* EPA will treat products containing nanosilver as pesticides under FIFRA if intended for pesticidal purposes, even in the absence of explicit pesticidal claims.

* EPA rejected ICTA’s claim that all products containing nanosilver are categorically pesticides and should be regulated as such.

* EPA will continue to apply its statutory and regulatory criteria as to what is a pesticide on a case-by-case basis. The determination “would be fact specific, typically based upon information on the use patterns intended, the claims or other advertising used to distribute or sell the ingredient or product, and any other information or knowledge made known to or known by the distributor or seller.”

* Importantly, EPA disagrees with ICTA’s claim that the treated article exemption should not apply to any nanosilver pesticide product because nanosilver specifically is not the registered pesticide active ingredient. According to EPA, application of the treated article exemption is available if a registered pesticide product is used, consistent with any terms and conditions of use of the registered product.

* EPA granted ICTA’s request to review the health and safety impacts from use of a nanosilver ingredient in a pesticide product based on nanosilver data for the portion released as nanosilver and based on macro-scaled silver for the portion released as silver ions, and agrees that FIFRA Section 3(c)(7)(C) is the appropriate authority for review of applications for registration of products containing nanosilver ingredients.

* EPA rejected ICTA’s claim that EPA must comply with the National Environmental Policy Act (NEPA) to assess the environmental impacts of EPA’s decision regarding nanopesticides, citing EPA’s well-settled view that it is exempt from NEPA requirements under FIFRA under Merrell v. Thomas, 807 F.2d 776 (9th Cir. 1986).

* EPA denied ICTA’s request to use a particular enforcement strategy to address unregistered pesticides sold or distributed in the U.S., believing that EPA lacks a factual basis to conclude that all nanosilver products are pesticides and thus does not have the legal basis upon which to conclude that all products are illegally sold or distributed.
 


 

REMINDER

Border Security: EPA's Increased FIFRA Import Enforcement Initiative
March 12, 2015
2:00 p.m. - 3:00 p.m. (EDT)
Register online


Bergeson & Campbell, P.C. (B&C®) is pleased to host a complimentary webinar on recent compliance and enforcement issues regarding the importation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The U.S. Environmental Protection Agency's (EPA) 2014 revisions to its Notice of Arrival (NOA) form (EPA Form 3540-1), coupled with EPA's increasing scrutiny of pesticide imports, indicate that this is an issue of growing interest to EPA and could result in a rise of enforcement cases or, at a minimum, business disruption for shipments that are refused entry.
This webinar will highlight recent developments and suggest steps importers should take to ensure compliance and avoid potential enforcement. There will be 45 minutes of presentation, followed by a 15 minute Q&A period.
Topics will include:
*  Requirements for importation of registered and unregistered pesticides
* Revised NOA "recommendations" and "optional" sections -- what they really mean
* EPA's recent enforcement priority on pesticide importations and examples of EPA and U.S. Customs detentions of imported pesticides
* Industry perspective and steps to avoid non-compliance

Speakers:
* Eileen B. Salathé Gernhard, Lead Counsel, Regulatory and EH&S at Dow AgroSciences, LLC
* Lisa M. Campbell, Partner, B&C
* Lisa R. Burchi, Of Counsel, B&C
* Jon Jacobs, a 25-year veteran of EPA's Office of Enforcement and Compliance Assurance, now in private practice with Jacobs Stotsky PLLC


For questions regarding this webinar, please contact .(JavaScript must be enabled to view this email address).
 


 

March 12, 2015
2:00 p.m. - 3:00 p.m. (EST)

Bergeson & Campbell, P.C. (B&C®) is pleased to host a complimentary webinar on recent compliance and enforcement issues regarding the importation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The U.S. Environmental Protection Agency's (EPA) 2014 revisions to its Notice of Arrival (NOA) form (EPA Form 3540-1), coupled with EPA's increasing scrutiny of pesticide imports, indicate that this is an issue of growing interest to EPA and could result in a rise of enforcement cases or, at a minimum, business disruption for shipments that are refused entry.

Speakers who will be highlighting recent developments and steps for importers to take to ensure compliance and avoid potential enforcement include: Eileen B. Salathé Gernhard, Lead Counsel -- Regulatory and EH&S at Dow AgroSciences, LLC, B&C's Lisa M. Campbell and Lisa R. Burchi, and attorney Jon Jacobs, a 25-year veteran of EPA's Office of Enforcement and Compliance Assurance, now in private practice at Jacobs Stotsky PLLC. There will be 45 minutes of presentation followed by a 15 minute Q&A period.

Please save the date -- registration details will follow.


 

By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala

The U.S. Environmental Protection Agency (EPA) has announced its new more “user-friendly” website for minimum risk pesticides. Under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b)(2) and EPA’s implementing regulations at 40 C.F.R. § 152.25(f), pesticides meeting certain criteria (e.g., containing only specified, listed active and inert ingredients, not bearing public health claims) are determined by EPA to pose little to no risk to human health or the environment and exempt from FIFRA registration requirements. EPA states the website “highlights the most-requested information and has been redesigned based on historic website traffic, with a focus on stakeholders who are interested in manufacturing, selling or distributing minimum risk pesticides.” Specifically, the website is now focused on four main areas:

          *   About Minimum Risk Pesticides;
          *  Conditions to Qualify as a Minimum Risk Pesticide Product;
          *  Clarifications about Minimum Risk Active and Inert Ingredients; and
          *  Regulation and Enforcement of Minimum Risk Pesticides.

Although the scope of application of minimum risk pesticides has been the focus of proposed regulatory changes in recent years, EPA states that this website is not intended to include any regulatory changes or new requirements. There is, however, a December 2010 rule proposing changes to the minimum risk pesticide requirements that has yet to be issued in final. It is noteworthy that EPA has highlighted and clarified its Section 25(b) policies, but has not yet issued a final rule. A memorandum regarding EPA’s proposed rule is available at http://www.lawbc.com/regulatory-developments/entry/epa-proposes-revisions-to-minimum-risk-exemption-for-pesticides/.

Instead, EPA states it has included more information to be clearer about the conditions that a product must meet to be considered minimum risk. Any clarifications of the applicable requirements could be helpful for manufacturers that are responsible for ensuring compliance at the federal level for minimum risk pesticides since EPA does not review or approve such registrations. It is important to note that minimum risk pesticides exempt from EPA registration are still frequently subject to registration requirements at the state level, and state regulators perennially identify non-compliance by products asserting eligibility for minimum risk status. Any outreach that makes the eligibility and compliance requirements clearer should assist companies in navigating both federal and state requirements.

The address for the new website is www2.epa.gov/minimum-risk-pesticides.


 


 
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