By Lisa M. Campbell and Margaret R. Graham

On June 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a notification that the EPA Administrator has forwarded to the Secretary of the United States Department of Agriculture (USDA) and the Secretary of the United States Department of Health and Human Services (HHS) a draft regulatory document concerning the draft final rule entitled ''Pesticides; Revisions to Minimum Risk Exemption.'' This notice states that the draft final rule will not be available to the public until after it has been signed and made available to EPA. Sections 25(a)(2)(B) and 21(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires the EPA Administrator to provide to the Secretary of USDA and the Secretary of HHS a copy of any draft final rule at least 30 days before signing it in final form for publication in the Federal Register; EPA must only provide any draft final rules pertaining to public health pesticides, however, to HHS.

The Spring 2015 Regulatory Agenda stated that EPA is developing the final rule related to revisions it proposed in December 2012: "Specifically, EPA proposed to more clearly describe the active and inert ingredients permitted in products eligible for the exemption from regulation for minimum risk pesticides. These lists would be reorganized by adding specific chemical identifiers that would make it clearer which ingredients are permitted in minimum risk pesticide products. No ingredients would be added or removed from the exemption. The label requirements in the exemption would also be modified to require the use of specific common chemical names in lists of ingredients on minimum risk pesticide product labels, and to require producer contact information on the label. These changes are intended to maintain the availability of minimum risk pesticide products while providing more consistent information for consumers, clearer regulations for producers, and easier identification by states, tribes and EPA as to whether a product is in compliance with the exemption."  Further information regarding the proposed rule is available in Bergeson & Campbell, P.C.'s (B&C^®) memorandum entitled EPA Proposes Revisions to Minimum Risk Exemption for Pesticides.

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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.  

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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. 

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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.

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By Lisa M. Campbell and Jane S. Vergnes, Ph.D.

On June 19, 2015, the U.S. Environmental Protection Agency (EPA) announced a plan for incorporating validated high throughput assays and a computational model into the Endocrine Disruptor Screening Program (EDSP) to screen chemicals for their ability to interact with the endocrine system.  These proposed new methods would serve as an alternative for three of the eleven current assays in the EDSP Tier 1 screening battery, specifically the estrogen receptor binding (ER), estrogen receptor transactivation (ERTA), and uterotrophic assays. 

These computational high-throughput (HTP) tools will have the potential to impact significantly the prioritization for testing and will have a significant impact on List 2 test orders.  EPA states that use of these alternative methods will accelerate the pace of screening, decrease costs, and reduce animal testing.  In addition, this approach advances the goal of providing sensitive, specific, quantitative, and efficient screening using alternative test methods to some assays in the Tier 1 battery to protect human health and the environment.  EPA has stated its commitment to the development of HTP and computational tools to improve regulatory science, as recommended in the 2007 National Research Council report, “Toxicity Testing in the 21st Century: A Vision and a Strategy,” and to meet its statutory obligations in the face of challenging budget constraints. 

Comments are due by August 18, 2015.  EPA specifically seeks comment on the following issues, which are related to its stated intention to use the scientific tools discussed as alternatives to some of the current EDSP Tier 1 screening assays:

1. The use of the ToxCast^TM “ER Model” for bioactivity as an alternative method for the current ER binding and ERTA Tier 1 screening assays.
2. The use of the ToxCast^TM “ER Model” for bioactivity as an alternative method for the current uterotrophic Tier 1 screening assay.
3. The use of results from the ToxCast^TM “ER Model” for bioactivity on over 1800 chemicals as partial screening for the estrogen receptor pathway.

EPA concludes that the ToxCast^TM “ER Model” meets the criteria for use as “other scientifically relevant information” to satisfy Tier 1 for the ER, ERTA, and uterotrophic assays.  EPA’s conclusion is based upon the findings of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) peer review held in December, 2014 that endorsed the ToxCast^TM “ER Model” as a replacement for the ER and ERTA assays, and additional data developed by EPA to address the SAP’s concerns regarding the uterotrophic assay.  Recipients of EDSP Tier 1 test orders would have three options for addressing the Tier 1 requirements with respect to the three EDSP Tier 1 endpoints that EPA considers validated:

1.  Cite existing ToxCast^TM “ER Model” data, if it is applicable.
2. Generate new data using the 18 ER HTP assays and the ToxCast^TM “ER Model.”
3. Generate Tier 1 data using the validated methods for the ER, ERTA, and uterotrophic endpoints in the traditional EDSP Tier 1.

EPA is careful to note that activity in the ToxCast^TM “ER Model” is not a determination that a chemical causes endocrine disruption, only that is has the potential to do so, and that further testing (Tier 2) would be needed to make a determination regarding the ability to cause “adverse effects in an intact organism or its progeny, or subpopulations,” as stated in the World Health Organization International Programme on Chemical Safety definition. 

More detailed information on the Endocrine Disruptor Screening Program and its use of computational tools is available at:  http://www.epa.gov/endo/ or http://www.epa.gov/endo/pubs/pivot.htm.

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By Lynn L. Bergeson and Carla N. Hutton

On May 19, 2015, the U.S. Environmental Protection Agency (EPA) announced that it issued a conditional registration for a nanosilver-containing antimicrobial pesticide product named “NSPW-L30SS,” or “Nanosilva.”  This is the second nanosilver registration issued by EPA and reflects the Agency’s growing expertise in addressing, processing, and approving nanopesticide registration applications.  According to EPA, the product will be used as a non-food-contact preservative to protect plastics and textiles from odor- and stain-causing bacteria, fungi, mold, and mildew.  Items to be treated include household items, electronics, sports gear, hospital equipment, bathroom fixtures, and accessories. EPA based its decision “on its evaluation of the hazard of nanosilver after reviewing exposure data and other information on nanosilver from the applicant, as well as data from the scientific literature.”  EPA states that these data show that treated plastics and textiles release “exceedingly small amounts of silver.”  Based on this evaluation, EPA “determined that NSPW-L30SS will not cause unreasonable adverse effects on people, including children, or the environment and that it would be beneficial because it will introduce less silver into the environment than competing products.”  EPA notes that it is requiring the company “to generate additional data to refine the Agency’s exposure estimates.”  According to EPA, it will post a response to comments received on its 2013 proposed registration decision document, as well as the current decision document, in the rulemaking docket.

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By Lisa M. Campbell and James V. Aidala

On April 2, 2015, the U.S. Environmental Protection Agency (EPA) sent a letter to all registrants of nitroguanidine neonicotinoid pesticide products stating that “until the data on pollinator health have been received and appropriate risk assessments completed,” EPA is “unlikely to be in a position to determine that such uses would avoid ‘unreasonable adverse effects on the environment’ as required under FFIRA to support further regulatory expansion of these pesticides in outdoor settings.” EPA asks that the affected registrants withdraw or modify pending new outdoor use/expansion and/or pending nitroguanidine neonicotinoid registrations with a new outdoor use by April 30, 2015.

The letter states that the letter recipients are companies that have submitted an application for a new outdoor use and/or hold registrations for products containing imidacloprid, dinotefuran, clothianidin or thiamethoxam that have directions for outdoor application.

Affected neonicotinoid actions include:

*  New Uses (including crop group expansion requests);

*  Addition of New Use Patterns, such as aerial application;

*  Experimental Use Permits; and

*  New Special Local Needs Registrations.

The letter does not, however, preclude the approval of “me-too” products -- “products that are identical or substantially similar to existing uses.” In addition, EPA states that if a significant new pest issue should arise that may be uniquely addressed by one of these chemicals, EPA may consider whether an emergency use under FIFRA Section 18 might be appropriate. In the event that an emergency use is requested, EPA plans to assess such requests by relying on available information and risk mitigation strategies.

This new missive from EPA provides yet another example of a recent trend that many registrants believe is of concern, whereby EPA makes a broadly applicable set of regulatory decisions without an associated administrative process. With this approach, EPA summarily issues a letter to a class of registrants with immediate direct affect on their registrations with little or no room for consideration of individual facts, and with little explanation of important risk issues. In this letter, for example, EPA precludes the expansion of new uses, but yet allows the continued processing of “me-too” applications with no explanation from a risk profile of the risk difference that allows one type of product to be processed, but not the other. There are many possible scenarios where a new or expanded use of a product would not present any more risk to pollinators than the me-too product that EPA indicates will be considered.

This one-size-fits-all approach also appears to exclude consideration of any risk reduction potential of the pending applications (for example, when a pending neonic application represents a reduction in worker risk or endangered species when compared to an existing use pattern). Some applications may replace current exposure levels to organophosphate insecticides that EPA has generally sought to reduce. The potential processing of Section 18 exemptions may provide an avenue for such considerations, but the presumption that the pollinator issue a priori makes all other risk elements secondary is a tacit admission of where EPA currently evaluates the potential risk to honeybees in comparison to other possible impacts from pesticide use, including human health risks.

More information on EPA’s efforts to protect pollinators: http://www2.epa.gov/pollinator-protection.
 

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By Lisa M. Campbell and Lisa R. Burchi

On March 1, 2015, the U.S. Environmental Protection Agency (EPA) released the 11th Annual Report on EPA’s implementation of the Pesticide Registration Improvement Extension Act (PRIA 3) that is required under Section 33(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

This annual report details changes in processes, practices, and policies for Fiscal Year (FY) 2014 that ran from October 1, 2013, through September 30, 2014. The report is divided into different sections related to: (1) pesticide registration service fees; (2) maintenance fees; and (3) process improvements in the pesticide program; all of which can be accessed on EPA’s website at the below links. Specifically, the report covers the following topics:

Pesticide Registration Service Fees
* Fees Collected, Waived, Exempted and Expended
* Accomplishments
        o Pesticide Worker Protection
        o Partnership Grants
        o Progress in Meeting Decision Times

Maintenance Fees
* Fees Collected and Expended
* Accomplishments
        o Inerts
        o Expedited Processing FIFRA Section 3(c)(3)(B)
        o Pesticide Reevaluation Programs

Process Improvements in the Pesticide Program
* Registration
* Pesticide Reevaluation Programs
* Information Technology and Labeling
* Science Review/Assessment Improvements

EPA’s report addressing process improvements in the pesticide program discusses several areas where EPA believes its registration programs have improved, either through increased efficiency, consistency, and/or transparency. The areas discussed are:

* EPA’s use of the “Lean” business model to improve business processes;

* Delegation of authority to EPA’s Biopesticides and Pollution Prevention Division (BPPD) to expedite fast track and notification actions to reduce approval times and the number of actions in backlog status;

* Biopesticide Industry Alliance Registration Workshops to improve quality of application submissions;

* Release of testing guidelines to clarify scenarios under which efficacy testing at the lower certified limit is needed;

* Reduction of registered products for which EPA is taking action under the Antimicrobial Testing Program;

* Continued crop grouping regulations to save resources and reduce the number of required residue studies;

* Establishment of a Pre-decisional Determination Due Date to provide adequate time to reach agreement with the registrant on required label changes prior to EPA approving the label; and

* International work sharing to assist in individual country registration decisions while striving to harmonize regulatory decisions with global partners.

With regard to EPA’s review of electronic labels, EPA states the following:

1. Of approximately 6,300 labels submitted to EPA in FY 2014, almost half included an electronic label. Comparing the statistics from FY 2011 to FY 2014 reveals a steady increase of approximately 10 percent each year in the percentage of labels submitted in electronic format.

2. The use of electronic label review software varies significantly across the three regulatory divisions with the Registration Division reporting the highest use, the Antimicrobials Division reporting moderate use, and BPPD the lowest use.

PRIA 3 is effective from October 1, 2013, through September 30, 2017.
 

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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.

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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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