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Agency (EPA) published a notice in the Federal Register announcing the availability of and seeking public comment on draft guidance, Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendments.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:
- 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;
- 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.
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 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.”
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 Lynn L. Bergeson, James V. Aidala, and Margaret R. Graham
On February 14, 2017, in the House of Representatives, Rep. Rodney Davis (R-IL) introduced H.R. 1029, the “Pesticide Registration Enhancement Act of 2017,” which reauthorizes the Pesticide Registration Improvement Act (PRIA). H.R. 1029 was immediately referred to the Agriculture Committee and to the Energy and Commerce Committee; it was passed by the Agriculture Committee on February 16, 2017. Per Agriculture Committee Chair Michael Conaway’s opening statement at the Business Meeting markup of H.R. 1029, changes to PRIA include “reasonable increases in registration fees, funding for Good Laboratory Practices, and a seven year reauthorization as opposed to the five-year reauthorizations of the past.” H.R. 1029 would allow the U.S. Environmental Protection Agency (EPA) to collect up to 31 million in registration fees (up from 27.8 million) per year from fiscal years (FY) 2017-2023. It also includes the following registration increases for FY2017 through FY2023:
- The maximum annual fee for registrants holding 50 pesticide registrations or less would be $129,400 (up from $115,500);
- The maximum annual fee for registrants holding over 50 pesticide registrations would be $207,000 (up from $184,800);
- The maximum annual fee payable for a small business registrant holding 50 pesticide registrations or less would be $79,100 (up from $70,600); and
- The maximum annual fee payable for a small business registrant holding over 50 pesticide registrations would be $136,800 (up from $122,100).
PRIA represents a commitment by the pesticide registrants to help with the continued resource issues of the pesticide regulatory program. This has become an issue of increased concern with the arrival of the Trump Administration after campaign rhetoric about eliminating EPA and cutting budgets. Fees are seldom a popular topic, but an essential program component. Without staff and resources to approve pesticide registrations, registrants would be left with new products destined to pile in EPA in-boxes. PRIA is designed to help maintain some certainty and predictability to the review process.
Of some note is that in recent years Congress has appropriated funds at a level below the statutory minimum that originally was a line in the sand which, if breeched, would de-authorize EPA’s authority to charge application fees. The regulated community has reluctantly supported Congressional action to lower this “minimum” level of funding to hold onto the programmatic progress which has been made since the first PRIA authorization. This appears to be an uneasy acceptance of the budget realities surrounding federal spending on discretionary, non-defense expenditures.
By Sheryl L. Dolan, Lisa M. Campbell, and Henry M. Jacoby, M.S.
On September 22, 2105, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register listing its revised registration service fees applicable to specified pesticide applications and tolerance actions for fiscal year (FY) 2016 that are registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
The Pesticide Registration Improvement Act of 2003 (PRIA) established FIFRA Section 33, creating a registration fee-for-service system for certain types of pesticide applications, establishment of tolerances, and certain other regulatory decisions under FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA). Section 33 also created a schedule of decision review times for applications covered by the service fee system. EPA began administering the registration service fee system for covered applications received on or after March 23, 2004.
PRIA has been reauthorized twice, most recently by the Pesticide Registration Improvement Extension Act (PRIA 3) signed on September 28, 2012. PRIA 3 revised FIFRA section 33, reauthorized the service fee system through fiscal year 2017, and established fees and review times for applications received during fiscal years 2013 through 2017. The registration fees for covered pesticide registration applications received on or after October 1, 2015, increase by five percent from the fees published for fiscal year 2015 in the Federal Register notice issued September 26, 2013, Pesticides; Revised Fee Schedule for Registration Applications. The new fees became effective on October 1, 2015.
The notice retains the format of prior PRIA tables; it identifies the registration service fees and decision times and is organized according to the three Office of Pesticide Programs (OPP) registration divisions within EPA, with the additional sections for inert ingredients and other actions added as part of PRIA 3. Thereafter, the categories within main sections of the table are further organized according to the type of application being submitted, including new active ingredients, new uses, new products, and registration amendments There are 189 categories of activities spread across the three OPP divisions: Registration Division (63 categories), Antimicrobial Division (39 categories), and Biopesticides and Pollution Prevention Division (69 categories), plus ten inert ingredient and eight miscellaneous categories. Each has its own decision review time and service fee for FY 2016-2017. The scale of the fees differs between the three registration divisions. We note that not all submissions are subject to PRIA 3; generally speaking, any submission requiring data review will be subject to PRIA 3.
The notice also provides information on how to pay fees, how to submit applications, and the addresses for applications.
More information on the registration fees is available on EPA’s webpage FY 2016/17 Fee Schedule for Registration Applications.
By Timothy D. Backstrom
On June 12, 2015, Federal District Judge Maxine Chesney issued a decision in Ellis v. Housenger (N.D. Cal.) allowing the plaintiffs to utilize expert declarations and exhibits that were not included in the certified administrative record to support their contentions that the U.S. Environmental Protection Agency (EPA) improperly failed to consult the Fish and Wildlife Service (FWS) under Section 7 of the Endangered Species Act (ESA). The plaintiffs in the Ellis case are individual beekeepers and non-governmental organizations, and two out of the six claims in their complaint allege a failure by EPA to consult under the ESA before registering or adding new registered uses for products containing two neonicotinoid pesticides, clothianidin and thiamethoxam. Judge Chesney’s order was issued in response to separate motions by EPA and by industry intervenors Bayer Crop Science, Syngenta Crop Protection, and Croplife America to preclude the plaintiffs from utilizing extra record material to support their ESA claims.
Although EPA and the intervenors argued that the Court’s review of the ESA claims should be confined to the administrative record based on the Administrative Procedure Act (APA), Judge Chesney determined that extra record material may be used to support an allegation that an administrative agency failed to consult with the FWS as required by ESA Section 7. The Judge based this holding on two cases decided in the Ninth Circuit, Washington Toxics Coalition v. EPA and Western Watersheds Project v. Kraayenbrink, which each held that extra record material may be properly considered in determining whether an agency improperly failed to consult under ESA Section 7. The Judge rejected the contention by EPA and the intervenors that these two decisions were supplanted by Karup Tribe v. U.S. Forest Service, concluding that the “arbitrary and capricious” standard of review established by the APA is utilized to review the ESA claims, but the scope of review for these claims is not constrained by the APA.
The effect of this decision will be to allow the plaintiffs to present expert opinion and evidence concerning the claimed adverse effects of the two neonicotinoid pesticides on endangered and threatened species, including but not limited to pollinator species, that was not expressly considered by EPA when it decided to register these pesticides. The plaintiffs will argue that such extra record material establishes that there was a sufficient basis to conclude that these pesticides “may affect” endangered or threatened species for EPA’s failure to consult FWS under the ESA to be arbitrary and capricious. This preliminary ruling could materially affect review of the ESA counts because there is a substantial division of expert scientific opinion concerning the alleged adverse effects of neonicotinoid pesticides, and the Court may conclude that EPA did not afford adequate weight to some of this opinion.
By Lisa M. Campbell and Lisa R. Burchi
On Thursday, April 30, 2015, the U.S. Environmental Protection Agency (EPA) issued interim guidance that it intends to clarify its toxicology data requirements for antimicrobial pesticides used on food contact surfaces. In addition, EPA issued a letter to antimicrobial registrants that EPA states is intended “to summarize how the Agency has been implementing 158W with respect to existing registered antimicrobial pesticides, as well as new and pending antimicrobial pesticide applications.”
The interim guidance is intended to satisfy a condition of the March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC), which followed ACC’s July 2013 initiation of a legal challenge to the antimicrobial data requirements (subpart 158W of Title 40 of the Code of Federal Regulations) in the U.S. Court of Appeals in the District of Columbia. The settlement agreement is discussed here.
In the settlement, EPA agreed to issue, within 60 days of the Agreement becoming final, an interim guidance document explaining EPA’s interpretation of the 200 parts per billion (ppb) residue level above which additional toxicology testing would be required for indirect food uses.
The interim guidance states with regard to the 200 ppb standard:
No later than September 2, 2017, the Agency will propose a correction to 40 CFR Part 158W to make the rule’s language as it pertains to the 200 ppb level established in 40 C.F.R. § 158.2230(d) consistent with the U.S. Food and Drug Administration’s use of that same level. The proposal will be to clarify that the 200 ppb level established in the rule is based on total estimated daily dietary intake, and is not based on the amount of residue present on only a single commodity. The Agency is providing this interim guidance to registrants that the referenced 200 ppb level is based on total estimated daily dietary intake rather than on the amount of residue present on only a single commodity.
EPA states that this interpretation is consistent with the U.S. Food and Drug Administration’s (FDA) policy. In general, if pesticide residues in food resulting from use on food contact surfaces are 200 ppb or less, EPA requires certain toxicology data. If residues are greater than 200 ppb, additional data may be required, depending on other conditions such as test results.
Also in the settlement, EPA agreed to propose, within four months of the Agreement becoming final, a guidance document entitled Antimicrobial Pesticide Use Site Index (USI), and provide a 30-day comment period. The USI guidance will provide descriptions of direct food uses, indirect foods uses, and nonfood uses. The letter states the following regarding its development of the USI guidance:
The Agency is developing a guidance document called the Antimicrobial Pesticide Use Site Index (USI) that will serve as a compilation of existing use sites and will identify how each use site fits within the twelve use patterns established in 158W. The guidance document will serve to assist prospective registrants with the application requirements by making it easier for them to identify which data are necessary to register their product(s).
EPA’s letter also discusses the following regarding existing and pending antimicrobial pesticide applications:
- EPA may find it necessary, “in the context of, but not limited to, the requirements in 158W,” to call in data as each active ingredient is evaluated under the Registration Review program. EPA does not intend to conduct this generic evaluation for new products or applications to amend existing products that are covered in Pesticide Registration Improvement Extension Act (PRIA3) fee category Table 9 -- Antimicrobial Division -- New Products and Amendments.
- During early implementation of the 158W requirements, EPA recognizes that not all new applications will have all the newly-required data. EPA may thus find it appropriate to issue Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(7) conditional registrations and set a deadline for the submission of the required data.
- Any application submitted after July 8, 2013 (the effective date of the 158W requirements) must contain the required data or an adequate justification for any data requirements not submitted. On the issue of timing, applicants should explain why any data are not yet submitted and when the data can be submitted. Failure to submit required data or provide an adequate justification will result in EPA rejecting the application as incomplete under the 45/90 day preliminary technical screen under the Pesticide Registration Improvement Act (PRIA).
The settlement agreement and additional documents are available at http://www2.epa.gov/pesticide-registration/epa-data-requirements-registration-antimicrobial-pesticides-part-158w#interim and www.regulations.gov in docket EPA-HQ-OPP-2008-0110. More information on antimicrobial policies and guidance is available here.
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
o Pesticide Worker Protection
o Partnership Grants
o Progress in Meeting Decision Times
* Fees Collected and Expended
o Expedited Processing FIFRA Section 3(c)(3)(B)
o Pesticide Reevaluation Programs
Process Improvements in the Pesticide Program
* 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.
By Sheryl Lindros Dolan
On December 16, 2014, the U.S. Environmental Protection Agency (EPA) will host a half-day workshop on the application process for the use of inert ingredients in pesticide products. The workshop will take place in Arlington, Virginia. The goal of the workshop is to clarify the necessary elements of an application for approval to use an inert ingredient in a pesticide product. Complete application packages save applicants time and money, and reduce the number of application rejections. The workshop will cover: selection of a Pesticide Registration Improvement Act (PRIA) category, elements of an application, EPA’s evaluation process, and a retrospective review of inerts under PRIA. EPA will answer stakeholder questions throughout the workshop.
By Sheryl Lindros Dolan
On September 30, 2014, the U.S. Environmental Protection Agency (EPA) redesigned the Pesticide Registration Improvement Extension Act of 2012 (PRIA 3) website. The new website is available at www2.epa.gov/pria-fees. The purpose of the redesign is to make PRIA 3 information more easily accessible to stakeholders and the public, regardless of the type of device being used. EPA made no technical or regulatory changes to PRIA 3.