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 Susan Hunter Youngren, Ph.D.
The U.S. Environmental Protection Agency (EPA) issued an updated schedule for the Pesticide Registration Review program that sets forth a timetable for opening dockets for the next three years, through end of fiscal year 2017 (September 2017).
Through the Pesticide Registration Review program, EPA reviews all registered pesticides at least every 15 years, as mandated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Following the newly issued schedule, all pesticides registered as of October 1, 2007, will have entered the registration review process with the exception of certain biopesticides. All pesticides registered by October 1, 2007, are scheduled to be assessed by October 1, 2022.
The rodenticide and triazole groups of chemicals have had their schedules adjusted so that all chemicals in the groups will be assessed during the same time frame. The rodenticides have dockets opening in first and second quarter 2016, while the triazoles have dockets opening from fourth quarter 2015 through third quarter 2016. In addition, EPA states that it has moved some chemicals that it believes may have significant data needs earlier in the schedule, but does not specify which were moved. Those with significant moves forward in the schedule (all moved from fourth quarter 2015 to first quarter 2015) include yellow mustard seed, sulfonic acids, fluazifop butyl, isomers, and flonicamid.
More information about the Pesticide Registration Review schedule is available here.
By Lisa R. Burchi
The European Commission (EC) Standing Committee on Plants, Animals, Food and Feed has issued a guidance document entitled Draft Guidance Document on the Interpretation of the Transitional Measures for the Data Requirements for Chemical Active Substances and Plant Protection Products according to Regulation (EU) No. 283/2013 and Regulation (EU) No. 284/2013. Following the adoption in 2009 of Regulation (EC) No. 1107/2009 concerning the placing of plant protection products (PPP), additional regulations were adopted to establish the necessary data requirements for active substances and PPPs. In 2013, Regulation (EU) No. 283/2013 (amended by Regulation (EU) No. 1136/2014) updated the data requirements for active substances, while Regulation (EU) No. 284/2013 updated data requirements for products. These Regulations include transitional measures to explain when certain applications can rely upon former data requirements and when the updated data requirements must be satisfied.
The Guidance provides two charts describing the transitional measures for: (1) applications for approval, renewal, or approval or amendment of approval of Active Substances; and (2) applications for authorization, renewal of authorization, or amendment of authorization of Plant Protection Products. Each chart describes the type of application at issue and the resulting data requirements. For authorization applications, the Guidance divides the types of applications and resulting data requirements into four active substances categories: (1) AIR-2 active substances; (2) AIR-3 active substances/substances not yet renewed; (3) new active substances; and (4) mixtures.
The Guidance was developed to assist EU Member States in consistently applying and interpreting these transitional measures. Many of the data requirement decisions depend on the type of active substances and whether an application is submitted before or after December 31, 2015, so companies considering or planning to submit applications should review the Guidance carefully to determine what data requirements may be applicable.
By Timothy D. Backstrom
On January 20, 2015, the National Marine Fisheries Service (NMFS) issued its latest Biological Opinion (BiOp) in a series of BiOps evaluating potential effects of pesticide use on salmon in the Pacific Northwest. When the U.S. Environmental Protection Agency (EPA) decides to permit continued registration of a pesticide (during reregistration or registration review), Endangered Species Act (ESA) Section 7(a)(2) requires EPA to determine, in consultation with the NMFS and/or the Fish and Wildlife Service (FWS), that continued registration is not likely to jeopardize the continued existence of any endangered or threatened species. Under current procedures, EPA scientists make an initial threshold determination whether or not continued registration “might” have such an effect, followed by referral to the FWS or the NMFS for formal consultation in those instances where that threshold is met.
The January 20, 2015, NMFS BiOp concerns the pesticides diflubenzuron, fenbutatin oxide, and propargite, and is one in a series of NMFS BiOps for Pacific salmon. As part of litigation that began in 2001, the Ninth Circuit Court of Appeals ordered EPA to determine whether it should have consulted with NMFS concerning reregistration of 55 specific pesticides. EPA subsequently initiated a formal consultation with NMFS for 37 of these 55 pesticides.
Like most of the prior BiOps, the latest NMFS BiOp recommends that EPA require the affected pesticide registrants to adopt buffer zones and other mitigation measures. The scientific methodology underlying the NMFS BiOps has been sharply criticized by industry and questioned by EPA. EPA has not yet adopted the measures recommended by NMFS in any of the previous BiOps. The BiOp for the pesticides chlorpyrifos, diazinon, and malathion was vacated and remanded to NMFS by the Fourth Circuit Court of Appeals on February 21, 2013. That decision was based in part on use of implausible assumptions in the NMFS model and on the decision of NMFS to recommend uniform buffer zones without regard to site-specific factors. Industry has criticized the latest BiOp on similar grounds. Some may also ask why NMFS did not utilize methodology like that recommended in 2013 by a panel of the National Academy of Sciences, but NMFS states that consultations with other agencies concerning a process to implement the NAS recommendations are still pending.
On December 19, 2014, EPA opened the public comment period for 19 registration reviews. 79 Fed. Reg. 75801. The registrations are for: 3-methyl-cyclohexen-1-one (Case 6074); alkyl trimethylenediamines (ATMD) (Case 3014); boscalid (Case 7039); dikegulac sodium (Case 3061); ethoxyquin (Case 0003); fenpyroximate (Case 7432); flonicamid (Case 7436); fluazifop butyl, isomers (Case 2285); flufenpyr-ethyl (Case 7262); HHT (Grotan) (Case 3074); metolachlor & s-metolachlor (Case 0001); napthaleneacetic acid (Case 0379); oxadiazon (Case 2485); oxyfluorfen (Case 2490); pentachlorophenol (Case 2505); sodium fluoride (Case 3132); sulfonic acid salts (Case 7619); triclopyr (Case 2710); and yellow mustard seed (Case 7618). EPA will accept comments and information until February 17, 2015.
By: Lisa M. Campbell and Susan Hunter Youngren, Ph. D.
Spray drift and volatilization issues increasingly are significant issues in pesticide product risk assessments. Earlier this year, the U.S. Environmental Protection Agency (EPA) issued drafts of key guidance documents, which focused on issues that were key in the chlorpyrifos petition response, and more recently, at least one registration review decision that reflects current and still evolving EPA policy on spray drift and volatilization issues.
How potential for spray drift and for volatilization are identified and then managed are likely to be key elements of ongoing and future risk assessments underlying forthcoming EPA registration and reregistration, with significant potential impact on these decisions. Registrants should monitor closely the policies, EPA decisions implementing them, and their potential impact on their products, particularly given the public interest in these issues.
The EPA documents issued in the past eight or so months are significant, particularly given the years of controversy and difficulty in past attempts to propose a clear and “simple” definition of “drift.” The perception by some advocacy groups is that EPA is not adequately addressing alleged harms posed by drift, and resulting appeals for court intervention will undoubtedly complicate the matrix of considerations influencing EPA’s policy. These reasons alone make monitoring the development of these policies critical for registrants.
By Timothy D. Backstrom
In a wide-ranging decision issued on August 13, 2014, in Center for Biological Diversity v. EPA (N.D. Cal.) (often referred to as the “Mega ESA” case), Magistrate Judge Spero has dismissed most of the claims by the Plaintiffs that the U.S. Environmental Protection Agency (EPA) failed to consult or to reinitiate consultation under Endangered Species Act (ESA) Section 7(a)(2) in connection with EPA’s registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) of a variety of pesticides. This decision is significant not only for its findings concerning judicial review of consultations under the ESA, but also for the potential effect on challenges to generic reregistration decisions, and on individual product actions based on those EPA decisions. Registrants should carefully consider the impact of this decision on potential challenges to EPA actions involving their products. A copy of the decision is available online.
The ESA claims that were dismissed fall in three principal categories: (1) claims concerning Reregistration Eligibility Decisions (RED) for which the general six-year statute of limitations has expired; (2) claims concerning REDs that are reviewable only in the Court of Appeals under FIFRA Section 16(b) and that were not brought in that court within the applicable 60-day period; and (3) claims based solely on Plaintiffs’ allegations that EPA retains ongoing discretionary control over pesticide registration. Claims by the Plaintiffs that currently survive this decision, at least pending further submissions by the Parties, include claims concerning EPA’s reregistration of specific pesticide products, and claims concerning EPA’s failure to reinitiate consultation for any pesticidal active ingredients that were subject to prior Biological Opinions issued by the Fish and Wildlife Service (FWS) for which the process of reregistration is not yet complete.
By Lisa M. Campbell
On July 7, 2014, the Natural Resources Defense Council (NRDC) filed with the U.S. Environmental Protection Agency (EPA) a petition requesting that EPA commence a Special Review for the neonicotinoid pesticides, including six specific active ingredients (dinotefuran, acetamiprid, clothianidin, thiacloprid, imidacloprid, and thiamethoxam), based on the risk that NRDC believes this class of compounds poses to honey bees and native bees. In the petition, NRDC alleges that neonicotinoids “may suppress bee immunity, disrupt brood cycles, impair foraging behavior by interfering with memory and learning, and cause disorientation, preventing bees from finding their way back to the hive.” By submitting this petition, NRDC effectively asks that EPA expedite the evaluation of the effect of this class of active ingredients on pollinators that EPA already intends to undertake as part of the Registration Review process required by Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(g), 7 U.S.C. § 136a(g). A copy of the petition is available online.