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By Lisa M. Campbell and James V. Aidala

On September 18, 2017, 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 to Manage Pesticide Funds More Efficiently.”  OIG states that it conducted the audit “to determine whether EPA manages the Pesticides Reregistration and Expedited Processing Fund (known as the [Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] Fund) and the Pesticide Registration Fund (known as the [Pesticide Registration Improvement Act (PRIA)] Fund) effectively to minimize reliance on appropriated funds.”

In the report, OIG states its finding that “EPA should manage the [Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] and [Pesticide Registration Improvement Act (PRIA)] Funds more effectively by reducing excess fund balances to within a target range. As of September 30, 2016, [OIG] identified excess funds of approximately $21.4 million for FIFRA and $8.5 million for PRIA, for a total of $29.9 million.  A reduction in fund balances would increase the availability of appropriated funds for other environmental purposes.”

In the report, OIG makes the following recommendations to EPA:

  1. For the Assistant Administrator for Chemical Safety and Pollution Prevention (OCSPP) to “establish a target range for its FIFRA and PRIA Fund balances and develop and implement a plan to reduce excess funds to within the target range”; and
  2. For the Chief Financial Officer to “reconcile the FIFRA and PRIA Funds’ balances to the corresponding liabilities.”

The report states that EPA concurred with establishing a target range and developing a plan to reduce excess funds for FIFRA Fund balances, but did not agree with establishing a target range and developing a plan to reduce excess funds for PRIA Fund balances, citing the lack of predictability of PRIA collections. OIG stated that it “still believe[s] PRIA has excess funds that should be addressed,” and “[t]he agency agreed to reconcile FIFRA and PRIA balances.”

This report follows two OIG reports issued on August 14, 2017, on audits of the financial statements of (1) the FIFRA Fund; and (2) the PRIA Fund for fiscal years (FY) 2015 and 2016.  OIG is required to perform an annual audit of the financial statements of the FIFRA Fund under the Food Quality Protection Act (FQPA), and of the PRIA Fund under PRIA.

OIG states in its reports on the audits for FYs 2015 and 2016, of both the FIFRA and the PRIA Funds, that it “noted a material weakness in that the EPA cannot adequately support its FY 2016 [PRIA/FIFRA] Fund costs.”  OIG further stated, however, that this issue has been noted in prior audit reports, and that EPA is taking corrective actions.”  For those reasons, OIG stated that it was making “no new recommendations for [these] material weakness[es].”  In FYs 2016 and 2015, EPA “lost the audit trail to properly support how much of the [PRIA/FIFRA] payroll expenses were paid for by appropriations.”  To address these losses, in October 2016, EPA instituted an enhancement to its timekeeping system’s cost allocation that will allow for “the creation of an audit trail to capture costs incurred by the [PRIA/FIFRA] Fund and other appropriations that support [PRIA/FIFRA]-related activities.”

More information on other EPA OIG reports is available on our blog under key terms OIG and EPA OIG.

Commentary

The reality of why the FIFRA funds are in surplus is a political response to the overall budgetary politics of Congress.  The Office of Pesticide Programs (OPP) has not been authorized to utilize these funds fully or freely hire staff due to the budget agreements of Congress, and, more recently, due to the attempt by the new Administration to keep the Presidential budget proposal more in balance.  The OIG knows this also, but “politics” is not the concern of a good audit, and this is not helped by the problem of EPA having “lost the audit trail” of how these monies were spent.  PRIA reauthorization is soon to be overdue, and now appears perhaps to be in some jeopardy, at least in the near term.  Fortunately for OPP, the surplus in these funds that OIG addresses will be able to buy the program some time to continue relatively “as is” while waiting for PRIA politics to subside to the point where reauthorization is approved and the program can focus more on the improvements suggested by the OIG report.


 

By Lisa M. Campbell, Sheryl L. Dolan, and Barbara A. Christianson

On September 6, 2017, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of and seeking public comment on draft guidance, Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendments.  EPA states it is issuing this notice to “align the notification program with the requirements of the Food Quality Protection Act (FQPA) and [the Pesticide Registration Improvement Act (PRIA)] and to clarify the processes for accepting minor, low risk registration amendments to be accomplished through notification, non-notification or as accelerated amendments.”  EPA is requesting comments, and specifically information on projected cost implications of this draft updated guidance.

PR Notices are issued by the Office of Pesticide Programs (OPP).  EPA states that PR Notice 2017-XX will update and clarify “the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products, and supersedes both PR Notices 95-2 and 98-10 in their entirety.”  The PR Notice lists the changes from PRN 98-10 in a table.  Those changes include:

In addition to the changes listed on the table, modifications to PR Notice 98-10 consist of the following:

Notifications

  • F. Product Composition:  (1) Pesticide Category -- Under PR Notice 98-10, the pesticide categories "disinfectant" and "sanitizer" were two pesticide categories that were allowed to be added to a label by notification.  Under the proposed PR Notice, "disinfectant" and "sanitizer" were removed.
     
  • F. Product Composition: (2) Odor -- Under PR Notice 98-10, the terms "fragrance free" and "unscented" were allowed to be added to a label by a notification provided that the product is odorless or nearly odorless and contains odor-masking ingredient such as a perfume.  Under the proposed PR Notice, these terms were removed. 

Minor Formulation Amendments

  • A. Minor Formulation Amendments:  (1) Addition, deletion or substitution of one or more colorants in a formulation -- Under PR Notice 98-10, if a product was intended for a use as a seed treatment or rodenticide, it would not be eligible for an accelerated review; that restriction was deleted from the proposed PR Notice.
     
  • A. Minor Formulation Amendments:  (2) Addition, deletion or substitution of one or more inert ingredients (other than colorants and fragrances) in a formulation -- Under the proposed PR Notice, if a product is a dog/cat pet spot-on product or if an inert is a bittering agent or a safener, the product would not be eligible for an accelerated review. 
     
  • A. Minor Formulation Amendments:  (3) Addition, deletion or substitution of one or more fragrances in a formulation -- Under the proposed PR Notice, fragrances will be eligible for an accelerated review if all fragrance component ingredients are included on the Fragrance Ingredient List; individual fragrance component ingredients that exceed 0.1 percent (by weight) of the total pesticide product composition have existing approval for non-food use as an inert ingredient; and new/modified fragrances for antimicrobial products making public health claims are within the certified limits established for fragrances already approved for the product. 
     
  • Under the proposed PR Notice, products that are not eligible for accelerated review under minor formulation amendments are:
    • Pet spot-on products;
    • Rodenticides;
    • Change to an active ingredient source; 
    • Change to nominal concentration of the active ingredient; or
    • Addition of new or additional Confidential Statements of Formula (CSF).

 

EPA Procedures to Review Notifications

Under the proposed PR Notice, EPA outlines changes to the policy for processing notifications by the Registration Division (RD) and the Biopesticides and Pollution Prevention Division (BPPD), but procedures to process notifications by the Antimicrobials Division remain the same. 

One item to note under the proposed notification process for RD and BPPD is that a registrant may distribute or sell a product modified by notification once EPA receives the notification but, if EPA determines that a product has been modified through notification inappropriately, EPA may initiate regulatory and/or enforcement action without first providing the registrant with an opportunity to submit an application to amend the registration.

Registrants Submitting Minor Formulation Amendments

Under the proposed PR Notice, EPA requires that registrants submit with their application for registration a cover letter listing names and dates of all EPA accepted CSFs.  EPA will consider any CSFs not listed in the cover letter as superseded/no longer valid.

Comments on this PR notice are due October 6, 2017, and can be submitted online under Docket ID EPA-HQ-OPP-2016-0671.

Commentary

Registrants should review the draft PR Notice carefully, as it includes important changes.  For example, the consequence for submitting a minor formulation amendment and neglecting to include a list of all current CSFs is severe.  As another example, EPA signals in its proposal that proceeding to market with a product revised through the notification process may be risky if the submitter has erred in its judgment regarding what is eligible for a notification.  Should the PR Notice be issued without change to this provision, submitters may wish to give close consideration to waiting until it has EPA’s written confirmation that a notification has been accepted before introducing the revised product to market.  Comments on issues of concern should be considered.


 

By Heather F. Collins

On August 28, 2017, the U.S. Environmental Protection Agency (EPA) announced the first of three feature and functionality updates to the Pesticide Submission Portal (PSP) expected this year.  The portal is a web-based application allowing registrants to submit pesticide application packages to EPA electronically.  The PSP application is accessed through EPA’s Central Data Exchange (CDX) Network which requires user registration. 

This new PSP, version 1.4, release expands the feature to allow users to submit voluntary data related to specific registration review cases.  Users can submit study citations, data matrices (Form 8570-35), cover letters and studies (protocols, study profiles, supplemental study data) using the new "Voluntary Submission" link on the PSP home page.  This new release also allows users to resubmit previously submitted 90-day responses. Once a 90-day response or data submission has been successfully transmitted to the Office of Pesticide Programs (OPP), users may now modify responses to data requirements, cite additional studies, upload additional documents, and change how the product registration is supported.  EPA states:  “This action is another step in a phased approach that will ultimately lead to EPA’s ability to accept all pesticide applications electronically, a move that will help modernize the pesticide registration process, increase operational efficiencies and reduce paper waste.”  EPA indicates that in addition to these changes, this update introduces enhancements and bug fixes.

EPA also released the OPP Pesticide Submission Portal (PSP) User Guide Version 1.4 which provides detailed instructions on how to use the PSP application and guidance on how to prepare a package for electronic submission.

Applicants using PSP need not submit multiple electronic copies of any pieces of their applications; EPA states that the requirement to submit multiple copies of data in Pesticide Registration Notice 2011-3 is applicable only to paper submissions.  Pesticide registrants who previously submitted information via paper, CD, or DVD may instead use the portal and forego the courier costs of sending to EPA.

More information about the Electronic Submissions of Pesticide Applications is available on EPA’s website.


 

By Lisa M. Campbell, James V. Aidala, and Margaret R. Graham

On July 18, 2017, four Senators (Tom Udall (D-NM); Benjamin Cardin (D-MD); Richard Blumenthal (D-CT); and Cory Booker (D-NJ)) submitted a letter to Senators Pat Roberts (R-KS) and Debbie Stabenow (D-MI), the Chairman and the Ranking Member of the Senate Committee on Agriculture, Nutrition, and Forestry, regarding reauthorizing the Pesticide Registration Improvement Act (PRIA), worker protections, and the U.S. Environmental Protection Agency’s (EPA) “legal duty to protect the public from unreasonable harm from pesticides.”  H.R. 1029, the Pesticide Registration Improvement Extension Act of 2017, which reauthorizes PRIA, was passed by the Agriculture Committee on February 16, 2017.  The letter states that it should include a “limited number of improvements” before being approved by the full Senate, including “adequately reflect[ing] important worker safety priorities” via “ensuring that the worker protection rules are implemented in a timely manner” and “finalizing the EPA staff recommended ban on chlorpyrifos.” The letter states the EPA’s decision to deny the petition to ban chlropyrifos should be “reversed immediately.”

More information on H.R. 1029 is available in our blog item House Agriculture Committee Passes Pesticide Registration Enhancement Act of 2017.

On July 25, 2017, Udall, Blumenthal, Booker, Cardin, and several other Senators introduced S. 1624, the Protect Children, Farmers, and Farmworkers from Nerve Agent Pesticides Act of 2017, which prohibits the use of chlorpyrifos on food and directs EPA to enter into a contract with the National Research Council to “conduct a cumulative and aggregate risk assessment that addresses all populations, and the most vulnerable subpopulations, including infants, children, and fetuses, of exposure to organophosphate pesticides.”  S. 1624 proposes to amend Section 402 of the Federal Food, Drug, and Cosmetic Act (FFDCA) to add to the list of adulterated food any food that “bears or contains chlorpyrifos, including any residue of chlorpyrifos, or any other added substance that is present on or in the food primarily as a result of the metabolism or other degradation of chlorpyrifos.”

Commentary

The Senate letter regarding issues with H.R. 1029 can possibly forestall the reauthorization of PRIA, which would cause many problems for EPA’s Office of Pesticide Programs (OPP), as the PRIA funds are necessary for OPP to operate the pesticide regulatory program.

Politically, the hiccup on PRIA reauthorization indicates a further acceleration of the partisan sniping already sapping the ability of the Senate to reach agreement on any subject.  PRIA contributes to EPA’s budget, with specific funds directed to support farmworker protection.  As such, it has not proven to be controversial in past reauthorization efforts.  PRIA represents an industry contribution to support EPA’s regulatory reviews and farmworker protection programs, and without it, EPA’s budget will face further cuts.  Normally, democratic members of Congress would be expected to be against further cuts to EPA and applaud the more robust regulatory regime supported by the regulated community’s own fees.

The chlorpyrifos legislation also portends a new, more hostile operating environment for the current leadership of EPA.  It has been years since action on specific pesticide products has seen a serious legislative proposal; generally Congress is reluctant to engage on a specific regulatory conclusion which has complex scientific disputes at its core.

Opposition to current EPA leadership and Administration agendas appears to be so intense that partisan bickering will surround almost any EPA-related initiative brought to the Senate floor.


 

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

On July 20, 2017, the Trump Administration released its 2017 Unified Regulatory Agenda.  The U.S. Environmental Protection Agency’s (EPA) Agency Rule List included several pesticide rulemakings in the proposed rule stage, as well as the Certification of Pesticide Applicators rulemaking that is in the final rule stage.  The five items in the proposed rule stage are:

  1. RIN 2015-AA00:  Revision of Procedural Rules for Hearings on Cancellations, Suspensions, Changes in Classifications, and Denials of Pesticide Registrations.  The agenda states that this proposed rulemaking is a “revision of the Rules of Practice governing the conduct of licensing adjudications under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).”   The issuance of the proposed rule is scheduled for January 2018.
  2. RIN 2070-AK00:  Pesticides; Technical Amendments to Data Requirements.  The agenda states that to satisfy one of the commitments in a settlement agreement reached with the American Chemistry Council (Docket ID Number EPA-HQ-OPP-2008-0110-0139), EPA is proposing a correction pertaining to the 200 parts per billion (ppb) level described in 40 C.F.R. Section 158.2230(d) that was originally used by the U.S. Food and Drug Administration with respect to the “concentration of residues in or on food for tiering of data requirements for indirect food use biocides.”  Through this rulemaking, the agenda states that EPA intends to “clarify that the 200 ppb level is based on total estimated daily dietary intake for an individual and not on the amount of residue present on a single food.”   The issuance of the proposed rule is scheduled for July 2017.
  3. RIN 2070-AK06:  Pesticides; Procedural Rule Amendment; Requirement for Certain Pesticide Actions to Publish Notices in the Federal Register.  In the agenda, EPA states that as the as the Federal Register is “no longer the most cost effective or efficient way for providing notice or sharing information with the public,” it is considering changing the way that it provides notice on or shares information with the public -- specifically, by no longer publishing certain information in the Federal Register, but instead providing the same information on a consolidated website which the agenda states “will be more accessible to the public and other interested parties, as well as a more cost effective and efficient mechanism for providing timely updates.”  The agenda lists the following kinds of notification it is considering making this change regarding: (1) reregistration of a pesticide product with a new active ingredient or new use; (2) announcing approvals of specific, quarantine and public health exemptions; and (3) Summaries of certain state registrations.  For Registration Review, the agenda state that EPA “intends to announce availability of the documents that are currently announced in the Federal Register on the EPA's Registration Review Website.”  For notices of availability announced in the Federal Register, the agenda states that “EPA intends to direct the public to a case-specific docket on Regulations.gov to view pertinent registration review documents and provide comment.”  The issuance of the proposed rule is scheduled for April 2018.
  4. RIN 2070-AK40:  Extension of Compliance Date(s); Agricultural Worker Protection Standard.  As reported in our memoranda summarizing the Worker Protection Standard (WPS) final rule, EPA Publishes Worker Protection Standard Final Rule, the WPS final rule was issued on November 2, 2015, but has not yet been made effective.  More information on the delay of its effective date is available in our blog item EPA to Delay Agricultural WPS Indefinitely; Cites Issues with Guidance and Training.  This proposed rulemaking will adjust the compliance date.  The issuance of the proposed rule is scheduled for July 2017 and the issuance of the final rule is scheduled for November 2017.
  5. RIN 2080-AA13:  Updates to 40 C.F.R. § 26 Subpart K to reflect recent changes to 40 C.F.R. Subpart A (The Common Rule).  As reported in our blog item Federal Agencies Announce Revision to Modernize Federal Policy for the Protection of Human Subjects, on January 19, 2017, EPA, together with a host of other federal agencies, released a final rule to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991, and is now codified in 40 C.F.R. § 26, Subpart A.  These revisions, scheduled to become effective on January 19, 2018, will create a conflict within some of the EPA-specific subparts, in particular, Subpart K of 40 C.F.R. 26 (Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intention Exposure of Non-Pregnant, Non-Nursing Adults) which regulates third party pesticide research.  The agenda states that this proposed rulemaking is “intended to resolve proposed rulemaking discrepancies created by the recent revision to Subpart A, and will not alter the fundamental protections for human subjects, including vulnerable populations.”  The issuance of the proposed rule is scheduled for January 2018.

The two items in the final rule stage are:

  1. RIN 2070-AJ20:  Pesticides; Certification of Pesticide Applicators.  As reported in our memoranda summarizing the Certification of Pesticide Applicators’ final rule, Final EPA Rule Requires Stronger Standards for Applying Riskiest Pesticides, the final rule was issued on January 4, 2017.  More information on the delay of its effective date is available in our blog item EPA Delays Effective Date of Certification of Pesticide Applicators Final Rule.  On June 2, 2017, a Federal Register publication was issued that delayed the effective date until May 22, 2018.
  2. RIN 2070-AK13:  Procedural Rule to Remove Obsolete Information.  The agenda states that this final rule will remove information from EPA’s existing pesticide regulations that is now out of date or obsolete and will “provide clearer and more reliable information to those seeking to register a pesticide product.”  The agenda further states that as rulemaking is intended to be a non-substantive, procedural rulemaking “since the EPA does not intend to make any substantive changes to the existing requirements,” EPA is considering issuing this as a final rule and not going through the notice and comment period.  The issuance of the final rule is scheduled for January 2018.

Commentary

Much of the work noted emphasizes potential procedural efficiencies and clarifications.  The potential move to more announcements on the websites and away from the Federal Register is, at least in part, likely intended as a cost-saving measure.  It is also a change that will be closely watched.  For example, in recent years, EPA has seen registrations challenged based on assertions of an alleged lack of appropriate notice concerning the receipt or processing of registration applications, and these past challenges will likely influence any new procedures that EPA may adopt. 

Of more interest is the new Administration’s call for suggestions of what rules or policies should be changed as part of a broader push for economic growth and less regulatory costs, which may result in more substantive regulatory changes and some likely controversial decisions about what rules or programs will be modified or eliminated -- but that exercise is not part of this announcement.  The delay in the compliance date for the WPS regulation is more substantive, but changes that may be proposed have not yet been announced.


 

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

On July 18, 2017, a panel of three judges at the U.S. Court of Appeals for the Ninth Circuit issued an order denying petitioners’ Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (Petitioners) Motion for Further Mandamus in the chlorpyrifos proceedings.  In that motion, Petitioners asked the court to grant further mandamus relief, asserting that the U.S. Environmental Protection Agency’s (EPA) denial of Petitioners’ petition to revoke all food tolerances and cancel all chlorpyrifos registrations was inadequate because it contained “no new safety findings” and no “final determination as to whether chlorpyifos food tolerances must be revoked.”  More information on the motion is available in our blog item Petitioners File Motion for Further Mandamus Relief in Response to EPA’s Order Denying Petition to Ban Chlorpyrifos.

In its order, the panel held that since the prior mandamus proceedings “addressed the timing, not the substance, of EPA’s response,” EPA had “complied with the panel’s previous orders by issuing a ‘final response to the petition.’”  The mandamus motion thus was “premature, and its substantive objections to the EPA’s denial must first be made through the administrative process mandated by statute.”

The demand imposed by the court earlier was to make a decision, and EPA met that deadline with its denial.  This is a significant win for industry, but is far from the end of this debate, which will continue in a number of different forums.  More information on the proceedings is available on our blog under key word chlorpyrifos.

 


 

By Lynn L. Bergeson and Margaret R. Graham

In June 2017, the U.S. Environmental Protection Agency (EPA) issued a draft Office of Chemical Safety and Pollution Prevention (OCSPP) National Program Manager Guidance for Fiscal Year (FY) 2018-2019, which sets forth the strategies and actions that EPA and its state and tribal partners will undertake to protect human health and the environment via six key programmatic activities.  EPA uses an Annual Commitment System (ACS) to track annual regional performance information and results.  Below is a listing of the six programmatic activities and their ACS measures, if applicable:

  1. Strengthening state and tribal partnerships through continued effective management of pesticide cooperative agreements.  The guidance states that the “National Pesticide Program depends on cooperative agreements with states and tribes to implement many of the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and to help ensure [EPA’s] regulatory decisions and programs achieve intended protections.  For the ACS measure, the commitment target is 100 percent of pesticide program required activities included in grantee work plans completed under pesticide program portion of the FIFRA Grant Guidance.  More information on the activities is listed in the guidance.
  2. Assisting in national, regional, and local pollinator protection efforts.  EPA states that “through risk assessment, mitigation, education, and outreach, EPA’s Office of Pesticides Programs’ goal for pollinator protection is to ensure all pollinators, including managed pollinators such as honey bees, and native pollinator including Monarch Butterflies, are protected from adverse effects of pesticide exposure.”  More information on the activities is listed in the guidance.  EPA is not proposing any ACS measures to be associated with this area of focus for FY2018-2019.
  3. Effectively implementing the revised pesticides worker protection standard rule.  More information on this rule is available on our blog under key phrase Worker Protection Standard.  EPA states that no ACS measure is proposed to be associated with this area of focus for FY2018-2019 to “allow regional offices the flexibility to direct their efforts where they are most needed, and to select the activities and level of effort appropriate for the needs of their region.”
  4. Effectively implementing the revised certification of pesticide applicators rule.  Same as above, EPA states that no ACS measure is proposed to be associated with this area of focus for FY2018-2019 to “allow regional offices the flexibility to direct their efforts where they are most needed, and to select the activities and level of effort appropriate for the needs of their region.”  More information on this rule is available on our blog under key phrase pesticide applicators.
  5. Focusing region-specific pesticide priorities on those areas of greatest need nationally.  EPA states that region-specific pesticide priority areas “support the agency’s national pesticide program efforts. In addition, these projects support one or more of the agency’s Strategic Plan goals and strategies, and directly benefit states and/or tribes.  The region-specific pesticide priority areas to choose from are: (1) promotion of state and tribal pesticide program coordination and communication; (2) bed bug outreach and assistance; (3) promotion, development or support of integrated pest management efforts; (4) support of water quality risk assessment and mitigation; (5) spray drift outreach and incident data collection; and (6) support of emerging public health pesticide issues.  The ACS measure commitment target is one project or initiative contributing to the implementation and enhancement of the region-specific pesticide program priority areas.
  6. Toxics Release Inventory (TRI).  For the TRI program, EPA includes three ACS measures on the number of TRI data quality checks:
  • The TRI-1 measure allows EPA to track performance of the TRI program, and aid in improving the accuracy and reliability of environmental data.  This measure will provide valuable information as more than 21,000 facilities report to the TRI program annually.
  • For FY2018, TRI-1 is a non-commitment measure of data quality calls and emails to 600 facilities in total across all regional offices.
  • For FY2019, TRI-1 will be a commitment measure of data quality calls and email to 600 facilities in total across all regional offices.

 

By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

A noteworthy development in the U.S. Environmental Protection Agency’s (EPA) ongoing and controversial consideration of the potential use of epidemiological data in its pesticide risk assessments occurred on May 25, 2017, when EPA placed in the public dockets for certain organophosphate (OP) pesticides an “update” of the September 15, 2015, Literature Review and Food Quality Protection Act (FQPA) determination, along with a response to comments on the original document.  These documents were signed by EPA scientists on December 29, 2016, prior to the new Administration, but were placed in the docket only last month, under the new Administration.  The documents attempt to rebut the various criticisms of EPA’s assessment of the epidemiology studies for chlorpyrifos and the original FQPA safety factor determination for OP pesticides, and they reaffirm the policy embodied in the original Literature Review.  Because these new documents were signed in the last days of the Obama Administration, they may be viewed by some industry stakeholders as an effort by some at EPA to “lock in” the prior policy concerning OP pesticides.

The public release of the “updated” Literature Review and response to comments must be considered in the context of the ongoing chlorpyrifos battles that have received significant public attention.  During the five months between the date that these “update” documents were signed and the date that EPA placed them in the public docket, EPA Administrator Pruitt issued a decision on March 29, 2017, to deny the petition filed by the Pesticide Action Network North America (PANNA) and the National Resources Defense Council (NRDC) requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos products.  See EPA Denies Petition to Ban Chlorpyrifos.  In his denial decision, Administrator Pruitt concluded it would be appropriate for EPA to defer determining whether chlorpyrifos is likely to cause neurodevelopmental effects at exposure levels below the levels that cause acetylcholinesterase (AChE) inhibition until the completion of the registration review process for chlorpyrifos.  Administrator Pruitt based his decision on the premise that “the science addressing neurodevelopmental effects remains unresolved” and that “significant uncertainty … exists regarding the potential for chlorpyrifos to cause adverse neurodevelopmental effects.”

Some industry stakeholders may argue that the decision by the EPA scientists who prepared the “updated” Literature Review which concluded that EPA should retain the 10X FQPA uncertainty factor for OP pesticides can be reconciled with Administrator Pruitt’s subsequent denial decision, because the “updated” FQPA safety factor determination does not preclude further scientific discussion concerning the potential for neurodevelopmental effects from OP pesticide exposures.  On the other hand, other industry stakeholders may be concerned about the immediate adverse impact of this “updated” FQPA determination on the risk assessments prepared by EPA for OP pesticides and the measures that will be demanded by EPA to mitigate purported risks.

On April 5, 2017, PANNA and NRDC responded to Administrator Pruitt’s March 29, 2017, decision to deny their petition to revoke the tolerances and cancel the registrations for chlorpyrifos by submitting to the Ninth Circuit Court of Appeals a Motion for Further Mandamus Relief.  That motion was substantially based on the premise that EPA does not “suggest that it has reconsidered its finding that chlorpyrifos is unsafe.”  The briefing on the new mandamus motion was completed on May 5, 2017, several weeks before EPA disclosed the documents concerning the “updated” FQPA determination.  Nevertheless, petitioners could try to argue that these documents constitute further evidence supporting their key premise that EPA has not actually revisited its prior determination that chlorpyrifos exposures are unsafe.

The legal and policy issues posed by EPA’s evaluation of the epidemiological data for chlorpyrifos and by EPA’s determination that these data create sufficient uncertainty to warrant retention of the FQPA 10X safety factor for all OP pesticides will be a continued source of controversy, and will be watched with interest by all stakeholders.

More information and updates on chlorpyrifos, the epidemiological data, and their surrounding legal issues is available on our blog item under keyword chlorpyrifos.


 

By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

On June 22, 2017, a complaint was filed against the U.S. Environmental Protection Agency (EPA) by American Oversight, a nonprofit organization (Plaintiff), in the United States District Court for the District of Columbia.  The complaint asks the court to compel EPA to provide information in response to a Freedom of Information Act (FOIA) request submitted by the Plaintiff on April 11, 2017, “seeking communications between certain individuals at each agency and certain outside entities related to chlorpyrifos or other pesticides.”  The records requested included:   (1) a copy of any decision memoranda and attachments associated with the decision to deny the petition to ban chlorpyrifos; and (2) all communications between certain individuals involved with EPA’s Administration as well as certain transition team members, and the following listed entities:

  • Any agricultural or other trade group with an interest in pesticides, including but not limited to CropLife, the American Farm Bureau, the National Corn Growers, or the Oklahoma Farm Bureau;
  • Any pesticide manufacturer or anyone acting on behalf of a pesticide manufacturer, including but not limited to Dow Chemical or Dow AgroSciences;
  • Any member of Congress or anyone acting on behalf of a member of Congress (including both personal and committee staff) regarding agricultural issues or pesticides; and
  • Any think tanks, including but not limited to the Heritage Foundation, regarding agricultural issues or pesticides.

The complaint asserts that although EPA responded to the FOIA request by stating that it was “proceeding with the search,” EPA “has not taken any additional actions,” and as of June 14, 2017, had not provided any of the requested records.  Plaintiff claims that EPA has failed to comply with the applicable time-limit provisions of FOIA and the complaint contains two Counts:  Count I:  Failure to Conduct Adequate Search for Responsive Records; and Count II:  Wrongful Witholding of Non-Exempt Records.  Based on these alleged violations, Plaintiff asks the court to order EPA to conduct a search reasonably calculated to uncover all records responsive to the FOIA request; order EPA to produce any and all non-exempt records responsive to the FOIA request and indexes justifying the withholding of any responsive records withheld under claim of exemption; and enjoin EPA from continuing to withhold any and all non-exempt records responsive to the FOIA request.

This Plaintiff appears to be seeking the responsive records to demonstrate that some kind of untoward or inappropriate communication occurred between the incoming Administration and outside groups leading to the chlorpyrifos petition response that allowed continued use of chlorpyrifos products, pending the completion of the registration review process.  Given the record that the Obama Administration constructed to propose the revocation of the chlorpyrifos tolerances, environmental advocates were disappointed that the new EPA leadership decided to postpone a decision.  EPA in its petition response articulated its rationale for its decision, but the Plaintiff may believe that these documents would likely show the “politics” behind the decision.  This is somewhat ironic since many stakeholders in the agricultural user community are convinced that the initial proposal to revoke chlorpyrifos tolerances issued during the prior Administration was itself an example of “politics over science.”

In this instance, it does not appear that EPA has made any determination yet whether any of the requested records are exempt from disclosure.  Moreover, the Plaintiff appears to be seeking decision memoranda and communications between EPA employees and other parties outside of EPA; this fact could affect EPA’s consideration of the applicability of the “deliberative process” privilege set forth in FOIA Exemption 5 to try to withhold any of the requested records, an issue that could be controversial. 

The Plaintiffs contend that EPA has not met the mandatory time limits applicable to a FOIA request.  This is a common problem, particularly when multiple individuals must participate in the search for responsive records, the records requested are voluminous, or exempt material like confidential commercial information must be redacted from otherwise responsive records.  Unless EPA ultimately determines that some records can and should be withheld, and Plaintiff disagrees, this suit may become moot in the event that EPA produces the requested documents before the case can be adjudicated.  Regardless of the outcome, Plaintiff has succeeded in keeping EPA’s controversial chlorpyrifos decision in the spotlight. 


 

By Lisa M. Campbell and Margaret R. Graham

On June 14, 2017, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of a final test guideline, Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; OCSPP Test Guideline 810.3900, part of a series of test guidelines established by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances.  82 Fed. Reg. 27254.  EPA states that this test guideline provides “guidance for conducting a study to determine pesticide product performance against bed bugs, and is used by EPA, the public, and companies that submit data to EPA,” and “recommendations for the design and execution of laboratory studies to evaluate the performance of pesticide products intended to repel, attract, and/or kill the  common bed bug (Cimex lectularius) in connection with registration of pesticide products under the [Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].”  EPA states that this guidance applies to products “in any formulation such as a liquid, aerosol, fog, or impregnated fabric, if intended to be applied to have a pesticidal purpose such as to attract, repel, or kill bed bugs.”  This guideline provides appropriate laboratory study designs and methods for evaluating the product performance of pesticides against bed bugs and includes statistical analysis and reporting.

EPA issued the draft guideline on February 14, 2012.  This original document was the subject of FIFRA Scientific Advisory Panel (SAP) review conducted on March 6-7, 2012.  EPA indicates that the final version of the guideline reflects revisions to the original draft based on comments from the SAP and the public.  EPA states that the revisions include the following:

  • Decreasing the number of individuals and replicates tested;
  • Rescinding the recommendation to test each field strain for its resistance ratio; and including a resistance management statement;
  • Clarifying the agency's Good Laboratory Practices (GLP) requirements;
  • Reducing the recommended length of time individuals are exposed to insecticides;
  • Recommending individuals to be observed up to 96 hours after treatment; and
  • Revising the statistical analyses recommendations.

EPA has also placed two other relevant documents in the docket:


 
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