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

By Lynn L. BergesonJames 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).

Commentary

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 Lisa M. Campbell and Lisa R. Burchi

The U.S. Environmental Protection Agency (EPA) today released a pre-publication version of a Federal Register notice to be issued on August 16, 2016, extending the deadline to submit comments on draft Pesticide Registration Notice (PRN) 2016-X from August 15, 2016, to September 14, 2016.  A discussion of draft PRN 2016-X, which proposes to update Section 5 of PRN 97-2, and to clarify and update criteria by which EPA classifies crops as “minor use,” is discussed in our blog item EPA Solicits Comments on Updated Method for Establishing Economic Minor Use

 

In the notice extending the comment period, EPA noted that the current comment period is “one of the busiest times of year for pest control experts” and provides an extension that “will allow them extra time to complete their review and comment on the PR Notice.” 

There is one comment that already has been submitted by the U.S. Department of Agriculture (USDA), which EPA stated it consulted prior to releasing the draft PRN 2016-X.  In its comments, USDA states:

  • Regarding acreage cutoffs, USDA supports EPA’s use of acreage estimates from the USDA Agricultural Census, as it is the “most reliable and comprehensive public source for such information in the country.”
  • Regarding EPA’s proposal to apply a seven percent discount rate, USDA recommends that EPA be “open to using supplemental information in determining whether or not an alternative discount rate should be considered.” 
  • Regarding EPA’s proposal that all cases be evaluated using values for costs that range from 60 to 85 percent of gross revenue, USDA requests that EPA provide its rationale as to why this range was chosen.  USDA states: “Although USDA understands that EPA is attempting to reveal the ratio of gross revenue to cost associated with the minor use rather than across an entire company, one could assume that a rational company would not pursue registering a minor use if the ratio of costs to gross revenue was exceedingly higher than the average standard ratio for the company.  Qualitative information, as suggested by EPA, could then be used to further refine the estimate for this ratio.”
  • Regarding EPA’s proposal to use study cost estimates provided by independent laboratories, USDA notes there are instances where data can be significantly more expensive than what would be expected generally and, thus, recommends that EPA “be open to additional, verifiable data a registrant wishes to submit that may indicate that its cost of data generation differs from EPA's standard estimates.”  USDA also suggests that EPA “consider making the cost estimates it is using for individual tests available publically to aid registrants in determining whether or not they need to submit alternative incurred costs for studies they have conducted.”

 

By Lynn L. Bergeson and Margaret R. Graham

On July 18, 2016, the U.S. Environmental Protection Agency (EPA) announced that PuriCore Inc. (PuriCore), paid a $550,000 penalty for the unauthorized distribution of two of its pesticide products, ProduceFresh and FloraFresh, that were used in supermarkets nationwide.  Along with the penalty, EPA issued a stop-sale order to PuriCore prohibiting the sale of ProduceFresh.  PuriCore’s unauthorized distribution and sale of pesticide products violates the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

ProduceFresh is used as part of a crisping process in the produce section of stores, and FloraFresh is used in floral departments.  EPA states that PuriCore had submitted an application to EPA to register ProduceFresh as a pesticide, however, EPA has not completed its review of the risks associated with the product.  FloraFresh was registered as a pesticide as of February 12, 2016, but PuriCore had been distributing FloraFresh to supermarkets for at a least a year prior to it being registered.

The recent enforcement action offers a use reminder to FIFRA stakeholders not to market products before they are registered by EPA relevant state agencies.  More information on FIFRA requirements and pesticide registration issues can be found on our FIFRA FAQs webpage, as well as this blog -- keywords FIFRA and registration.


 

By Lisa M. CampbellLisa R. Burchi and Timothy D. Backstrom

On November 24, 2015, in the U.S. Court of Appeals for the Ninth Circuit, Case No. 14-73353, the U.S. Environmental Protection Agency (Respondent; EPA) filed a motion for voluntary vacatur and remand of EPA’s registration, as amended, of Dow AgroSciences LLC’s (Dow) Enlist Duo herbicide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  The motion for vacatur is unusual and noteworthy to all pesticide registrants.

This case commenced in October 2014 when the Natural Resources Defense Council (NRDC) and other environmental groups including the Center for Food Safety (CFS, et al.) (together, Petitioners) filed petitions for review challenging EPA’s decision to register Enlist Duo, a new product designed for use with crops genetically modified to be resistant to glyphosate and 2,4,-D.  Petitioners argued, in part, that EPA failed to consider the impacts of increased glyphosate use on monarch butterflies, and did not fully assess the potential human health effects from 2,4-D.

EPA’s motion reverses EPA previous position that Dow’s application for Enlist Duo satisfied the requirements for issuance of an unconditional registration under FIFRA Section 3(c)(5).  EPA states that it is seeking a voluntary remand to reconsider the Enlist Duo registration in light of new information regarding potential synergistic effects referred to as “synergistic herbicidal weed control” between the two active ingredients 2,4-D and glyphosate contained in Enlist Duo on non-target plants.  Specifically, EPA is in the process of evaluating information submitted to it by DAS on November 9, 2015, in response to EPA’s request for all available information related to synergistic effects. EPA asserts that none of this information was submitted to EPA prior to EPA’s issuance of the Enlist Duo registration.

EPA states that the claimed synergism could affect EPA’s “assessment of drift reduction measures for avoiding impacts to non-target organisms, including those listed as endangered.”  EPA also states that it “cannot be sure, without a full analysis of the new information, that the current registration does not cause unreasonable effects to the environment, which is a requirement of the registration standard under FIFRA” and that its initial review “indicates that the 30-foot buffer included in the registration may not be adequate.”

DAS has until December 7, 2015, to file its response before the court will consider EPA’s motion to remand the registration.  Although it has not completed its assessment, EPA states that if the court vacates the Enlist Duo registration, EPA will issue a cancellation order to regulate the sale, distribution, and use of existing stocks of Enlist Duo pursuant to FIFRA.  This case is being considered for the March 2016 oral argument calendar but the exact date of oral argument has not been determined at this time.  More information regarding this case is available in our blog items Environmental Groups File Opening Briefs Challenging EPA’s Decision to Register Enlist Duo and Ninth Circuit Denies Requests to Stay Use of Enlist Duo Herbicide During Judicial Review.

Commentary

EPA’s request for remand with vacatur rather than a remand without vacatur is a severe action.  EPA could have chosen to seek remand without requesting that the registration be vacated, and then demanded prompt revision of the buffer zone that EPA now believes may be inadequate to protect non-target plants from synergistic effects.  EPA may have decided to send a message that there will be serious consequences when an applicant fails to submit all of the data in its possession that may be pertinent to EPA’s assessment of the statutory criteria for registration.  In any case, Dow reportedly has stated that it does “not expect these issues to result in the long-term cancellation of the Enlist Duo product registration” and that Dow will “continue to prepare for commercial sales of Enlist Duo for the 2016 growing season with enthusiastic grower adoption."


 

By Lisa M. Campbell and Timothy D. Backstrom

On November 12, 2015, the U.S. Environmental Protection Agency (EPA) issued a final cancellation order for all previously registered pesticide products containing the active ingredient sulfoxaflor, pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(1).  The registrations for the sulfoxaflor products in question were cancelled effective on November 12, 2015, by an order issued by the U.S. Court of Appeals for the Ninth Circuit that vacated the original EPA decision to grant unconditional registrations for sulfoxaflor.  More information on the court’s order is available in our blog item Ninth Circuit Vacates EPA's Unconditional Registration for the Neonicotinoid Pesticide Sulfoxaflor Based on Hazard to Bees.  The stated purposes of the “cancellation order” issued by EPA are:  (1) to allow distribution or sale of existing stocks of cancelled products for the purpose of return to the manufacturer, proper disposal, or lawful export; and (2) to allow existing stocks of cancelled products in the possession of end-users to be used provided such use is consistent in all respects with the previously-approved labeling for the product.

Cancellation of all sulfoxaflor registrations was an automatic consequence of the order vacating the registrations under FIFRA issued by the court on September 10, 2015, which took effect on November 12, 2015, with the formal issuance of the court’s mandate.  In response to the court’s decision, EPA stated: “While the Agency had determined that the benefits of sulfoxaflor outweighed that uncertain risk when mitigation measures were applied, EPA will not second-guess the Court's conclusion that the registrations at issue in the case were not supported by substantial evidence.”  According to EPA, this unusual mechanism for cancellation created an anomalous situation, where all distribution or sale to remove existing stocks of sulfoxaflor from channels of trade would be unlawful, but all existing stocks of the now unregistered products in the hands of users could be used without even observing the original label directions.  The “cancellation order” issued by EPA is intended to address these anomalies.  Rather than attempting to issue an order that would preclude all use, EPA stated: “While EPA agrees that there is uncertainty about sulfoxaflor's risks to bees, EPA does not believe use of existing stocks of sulfoxaflor would significantly impact bees.”

Commentary

In recent years, EPA has begun to characterize existing stocks orders issued under authority of FIFRA Section 6(a)(1) as “cancellation orders.”  This allows EPA to enforce the terms of its existing stocks’ determinations under FIFRA Section 12(a)(2)(K).  The order governing existing stocks of sulfoxaflor illustrates the potential utility of this approach.

The petitioners who obtained an order vacating EPA’s unconditional registration of sulfoxaflor are likely to be unhappy about the decision of EPA to allow some stocks of sulfoxaflor already in the hands of end-users to be used in accordance with label directions they deem inadequate to protect pollinators.  On the other hand, EPA has pointed out that the use of unregistered pesticides is not normally regulated at all under FIFRA, so the order issued by EPA allowing some use of existing stocks of sulfoxaflor assures that users are required to follow the existing product labeling until the stocks have been exhausted.  EPA also states that disposal of existing stocks already in the hands of end-users would be difficult and costly, and that EPA disfavors imposing “restrictions on existing stocks unless the holders of stocks are notified of the restrictions and are likely to comply with them.”   

 


 

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

On October 23, 2015, in the U.S. Court of Appeals for the Ninth Circuit, the Natural Resources Defense Council (NRDC) and other environmental groups including the Center for Food Safety (CFS, et al.) (together, Petitioners) filed separate opening briefs in Case Nos. 14-73353 and 14-73359 (consolidated) arguing that the U.S. Environmental Protection Agency’s (EPA) decision to register Dow AgroScience’s Enlist Duo herbicide (a combination of glyphosate and 2,4,-D) for use on Enlist corn and soybeans should be overturned because it violates the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Endangered Species Act (ESA).   EPA approved Enlist Duo for use in six states on October 15, 2014, and granted an amendment on March 31, 2015, to authorize use in an additional nine states.  On August 11, 2015, the Court of Appeals denied motions for a stay pending review that were filed by these same environmental Petitioners on December 18, 2014, and February 6, 2015.   SeeNinth Circuit Denies Requests to Stay Use of Enlist Duo Herbicide During Judicial Review.”

In its brief, NRDC notes that when EPA proposed to register Enlist Duo, it stated that no new assessment is needed for glyphosate because use of glyphosate on herbicide-resistant crops is not a new use.  NRDC argues that there are many new studies concerning glyphosate’s human health effects and impacts on monarch butterflies since EPA reregistered glyphosate and last prepared comprehensive environmental and human health assessments in 1993. NRDC argues that “By failing to consider up-to-date science on glyphosate’s cancer risk, EPA again violated its statutory duty to ensure that registration of Enlist Duo would not cause ‘unreasonable adverse effects on the environment,’ which includes an unreasonable risk to human health.”

In their brief, CFS, et al. argue that EPA violated FIFRA by ignoring its own modelling indicating that risks to wildlife from Enlist Duo exceed EPA’s risk thresholds.  CFS, et al. also focus on purported violations of the ESA, arguing that EPA improperly failed to consult with the U.S. Fish and Wildlife Service on the potential impacts of Enlist Duo on protected species and their critical habitat, and that EPA applied an “unlawful approach” to determine whether registration of Enlist Duo “may affect” listed species or critical habitats.

NRDC also filed a motion to supplement the record with three documents that it states were submitted to EPA, but it contends were not considered by EPA before it issued its registration decision for Enlist Duo.  The documents include an article published by the World Health Organization’s (WHO) International Agency for Research on Cancer stating that glyphosate is “probably carcinogenic to humans”; a statement published by WHO in conjunction with its cancer finding, and a letter from NRDC and other concerned parties calling on EPA to reconsider its initial decision to register Enlist Duo in light of the WHO’s cancer finding.

Discussion

Petitioners’ arguments in these opening briefs are not unexpected, as pesticide products containing glyphosate have been challenged and controversial for many years.  In briefs opposing the prior stay motions by the Petitioners, EPA and the registrant Dow AgroSciences argued that registration of Enlist Duo will not lead to any increase in the use of glyphosate, and that EPA also considered all of the human health effects of 2,4-D before granting the registration.  The Petitioners acknowledge that EPA did not state when it last conducted environmental and human health assessments for glyphosate, and EPA is likely to object to Petitioners' inference that EPA has not reviewed the environmental and health effects of glyphosate since 1993.  In the fact sheet concerning its decision to register Enlist Duo, EPA states that it conducted a “rigorous analysis” of all the scientific studies, considered all public comments, and used worst-case estimates when assessing the safety of Enlist Duo.  In addition, the Petitioners do not discuss the determination by the the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS), that three varieties of herbicide resistant corn and soybeans on which Enlist Duo will be applied are no longer considered regulated articles under regulations governing the introduction of certain genetically engineered organisms, because they are unlikely to pose a plant pest risk.

EPA and Dow AgroSciences’ answering briefs are due December 18, 2015, and reply briefs are due January 15, 2016.  Oral argument has not yet been scheduled.

 

 


 

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

In an opinion issued on September 10, 2015, the U.S. Court of Appeals for the Ninth Circuit vacated the U.S. Environmental Protection Agency’s (EPA) unconditional registration for the pesticide sulfoxaflor and remanded the matter to EPA to obtain further studies and data regarding the effects of sulfoxaflor on bees and bee colonies.  Sulfoxaflor is a new insecticide in the class of insecticides referred to as neonicotinoids, but its mechanism of action is distinct from other neonicotinoids.  The Petitioners in this case were various trade organizations representing commercial beekeepers, as well as some individual beekeepers.  The registrant Dow AgroSciences LLC (Dow) intervened in the action.

EPA granted an unconditional registration for sulfoxaflor on May 6, 2013, subject to a variety of risk mitigation measures, including a lower application rate, longer intervals between applications, and certain crop-specific label restrictions.  EPA had previously proposed to issue a conditional registration for sulfoxaflor in January 2013, citing pollinator data gaps that could be addressed by requiring Dow to conduct and submit further studies.  Under that proposal, use of sulfoxaflor would have been allowed at a reduced application rate during the time needed to complete data development.  The court found that the subsequent decision by EPA to register unconditionally sulfoxaflor was not supported by substantial evidence, as required by Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 16(b), both because EPA failed to adhere to its own scientific methodology and because the rationale that EPA provided for granting an unconditional registration could not be reconciled with the analysis upon which EPA based its prior proposal to register conditionally sulfoxaflor.

EPA evaluated the potential risk to bees and bee colonies from sulfoxaflor use utilizing the Pollinator Risk Assessment Framework, a scientific risk assessment methodology developed after consultations between EPA, Canada’s Pest Management Regulatory Agency, and the State of California, and presented by EPA to the FIFRA Scientific Advisory Panel in 2012.  The court found that the rationale provided for EPA’s unconditional registration decision could not be reconciled with findings that EPA itself made using this methodology or with the rationale EPA provided for its prior proposal to issue a conditional registration.  EPA had decided it was necessary to proceed to Tier 2 of the pollinator risk assessment after reviewing risk quotients and residue data in Tier 1 of the assessment.  EPA found the available data for Tier 2 to be insufficient to allow indefinite use of sulfoxaflor, even at a reduced application rate.  The court could not reconcile this finding with the subsequent decision to grant an unconditional registration, even with the specified mitigation measures.  The court found that “given the precariousness of bee populations, leaving the EPA’s registration of sulfoxaflor in place risks more potential environmental harm than vacating it.”  The court stated that “EPA has no real idea whether sulfoxaflor will cause unreasonable adverse effects on bees, as prohibited by FIFRA.”

EPA argued that with a reduced application rate, the risk quotients and residue analysis in Tier 1  was “close enough” to sufficient to avoid the specified quantitative trigger for a Tier 2 analysis, thereby rendering any deficiencies in the available Tier 2 data irrelevant.  The court effectively stated in response that close enough is not good enough, citing another recent Ninth Circuit decision in which a risk concern that is triggered by a margin of exposure less than or equal to 1000 was held to be triggered when the margin was exactly 1000.  Thus, this court once again placed EPA on notice that it must follow its own methodology with precision, and that EPA cannot justify deviations from its own methodology by simply stating that it is exercising expert judgment.

Commentary

This is an unusual case because the registration of a new pesticidal active ingredient has been vacated on substantive as opposed to procedural grounds.  The court’s rationale reflects a lack of judicial deference to what EPA typically refers to as the scientific “weight of the evidence.”  While the term itself does not appear in the opinion, the court is insisting that EPA must follow its standard methodology without allowing for any deviations based on professional judgment.  Although in this instance the court has supported the position of opponents of pesticide use, judicial reluctance to accept scientific “weight of the evidence” conclusions could also make it harder for EPA to impose additional restrictions when new but inconclusive evidence appears.

This case could cause EPA to be more explicit in adding procedures to its standard analytic methodologies that allow deviations from the methodology based on professional judgment.  The case could also cause EPA to reconsider its recent reluctance to avoid issuing conditional registrations and its preference for unconditional registrations for new active ingredients.  In any case, decisions that afford EPA less discretion to use “weight of the evidence” reasoning when basing scientific conclusions on less than conclusive data or studies could have an impact on a number of EPA practices and policies involving interpretation of scientific data.


 

By Lisa M. Campbell

On July 01, 2015, the U.S. Environmental Protection Agency (EPA) issued a notice announcing the availability of and requesting public comment on a proposed guidance document called the Antimicrobial Pesticide Use Site Index (USI)

In 2014, EPA issued a final rule amending the regulations setting forth the data requirements that support an application to register a pesticide product.  The final rule contains the data requirements specifically applicable to antimicrobial pesticides, which were codified in 40 C.F.R. Part 158, subpart W.  The final rule lists 12 antimicrobial use patterns in 40 C.F.R. § 158.2201.  The data requirements applicable to a pesticide product depend in part on the product’s use pattern.  The general use patterns are broad designations and are used as columns in the antimicrobial data requirements tables to identify which data requirements might be pertinent to the particular pesticide use site.

EPA has developed the USI to assist antimicrobial pesticide applicants and registrants and EPA staff to identify the use pattern that applies to a pesticide product, and thus the data requirements that must be met to register the product.  EPA states that the USI serves as a compilation of the specific use sites that are commonly listed on antimicrobial labels and links these commonly listed use sites with the twelve general use patterns.  

The posting of this proposed guidance document for public comment is intended to satisfy a condition of the March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC) that followed ACC’s July 2013 initiation of a legal challenge to the data requirements regulation in the U.S. Court of Appeals for the District of Columbia Circuit.  Comments are due by July 31, 2015.

 


 

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.


 

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.


 
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