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. Bergeson and Margaret R. Graham, M.S.

On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was seeking comments on the experts who are candidates to serve as ad hoc panelists for the review of EPA’s Draft Product Performance Test Guidelines OCSPP 810.3300:  Treatments Topically Applied to Pets to Control Certain Invertebrate Ectoparasitic Pests.  The candidate list is available on EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) website.  Comments on the candidates are due by May 18, 2019, to the Designated Federal Official (DFO) Dr. Suhair Shallal (.(JavaScript must be enabled to view this email address)).  EPA is requesting these comments prior to the FIFRA SAP public in-person meeting scheduled for June 11-14, 2019, from 9:00 a.m. to 5:00 p.m. (EDT), which will review EPA’s proposed guidelines referenced above and the supplemental document Sample Size for Pet Product Studies84 Fed. Reg. 15214.  The charge questions to the panel are available here (Charge Questions). 

EPA’s Federal Register notice announcing the meeting states that the meeting will be augmented with additional experts to provide independent scientific advice on the proposed guidelines.  Preceding the in-person meeting, there will be a public half-day preparatory virtual meeting to consider the scope and clarity of the draft charge questions for this peer review.  The in-person meeting on June 11-14, 2019, will be held at the EPA Conference Center, Lobby Level, One Potomac Yard (South Building), 2777 South Crystal Drive in Arlington, Virginia.  The meeting will also be available via webcast.

EPA’s original Product Performance Test Guidelines, OPPTS 810.3300, Treatments to Control Pests of Humans and Pets were published in March 1998.  EPA’s Charge Questions state that “[t]o increase clarity and consistency in efficacy testing and to include current scientific standards, the agency is revising this product performance guideline.”  Further, the proposed guidelines apply to products “in any topically applied formulation, such as a spray, spot-on, collar, shampoo, or dust, if intended to be directly applied to pets for a pesticidal purpose such as to kill, repel, or control ticks, fleas, mosquitoes, and biting flies”; do not apply “to those products exempt from FIFRA Registration under 40 CFR 152.25, products applied to humans or livestock, or product performance testing described in other agency guidelines”; and, in addition to guidance for testing efficacy against fleas, ticks, mosquitoes, and biting flies, the proposed guideline “also includes testing methods for evaluating efficacy under simulated environmental conditions.”

EPA believes the current Draft Guidelines represent the state of the science with regard to efficacy testing for these products; but is still seeking advice and recommendations from the FIFRA SAP on scientific issues related to the Draft Guidelines.  EPA states that it is committed to reducing the use of animals in testing but, at this time, no reliable non-animal alternatives are available to avoid the use of animals for efficacy testing of fleas, ticks, mosquitoes, and biting flies.  EPA is soliciting comment from the FIFRA SAP on approaches that may, in the future, support the replacement or reduction of animal use in efficacy testing of ectoparasitic pests on pets.

Information on attending the meeting in person and via webcast can be found on the FIFRA SAP website.  EPA is requesting that written comments on the documents undergoing peer review be submitted to Docket No. EPA-HQ-OPP-2019-0161 by May 17, 2019, to provide the FIFRA SAP the time necessary to consider and review the written comments.


 

This week, Lynn L. Bergeson sat down with Sheryl Lindros Dolan, a senior regulatory consultant here at Bergeson & Campbell (B&C®), to discuss all things pesticides:  past, present, and future.

In the discussion, Ms. Dolan provides the historical and legal/regulatory background necessary to understand the current state of pesticide regulation, which the U.S. Environmental Protection Agency (EPA) manages under the Federal Insecticide, Fungicide, and Rodenticide Act, or FIFRA, as we like to call it.  Listen to the full episode and subscribe here.

Tags: FIFRA, Podcast

 

By Lisa M. Campbell and Lisa R. Burchi

On February 6, 2019, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order granting the U.S. Environmental Protection Agency’s (EPA) and Acting EPA Administrator Andrew Wheeler’s (collectively EPA or Respondents) September 24, 2018, petition for an en banc rehearing concerning the Ninth Circuit’s August 9, 2018, decision that vacated an EPA order maintaining chlorpyrifos registrations and remanded the case to EPA with directions to revoke all tolerances and cancel all registrations for chlorpyrifos within 60 days. 

The Ninth Circuit’s order granting the Respondent’s petition that the case be re-heard en banc does not provide an explanation for its decision.  The Ninth Circuit evidently found the arguments offered by Respondents and other interested parties that filed amicus curiae briefs more persuasive than Petitioners’ brief (including the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC)), who argued against submission of certain amicus curiae briefs and also that, with limited exception, Respondent’s petition for rehearing lacked merit and should be denied. 

The en banc oral argument will be held March 26, 2019, at 2:30 p.m. (PST).

Arguments for Rehearing

Prior to the February 6, 2019, order, on October 15, 2018, three amicus curiae briefs were filed in support of EPA’s petition by CropLife America (CLA), Agribusiness Council of Indiana (Agribusiness), and Dow Agrosciences LLC (DAS).  Despite Petitioners’ objection to the motions of Agribusiness and CLA for leave to file amicus curiae briefs in support of Respondent’s petition for rehearing, on November 13, 2018, the Ninth Circuit granted the motions for leave to file amicus curiae briefs.

EPA’s petition for rehearing made multiple arguments as to why an en banc and panel rehearing should be granted, including the Panel’s lack of jurisdiction, the Panel’s order conflicting with applicable Supreme Court precedent, and specific modifications to be addressed to the order to comply with Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requirements.  More information regarding EPA’s petition is available in our blog item “EPA Petitions for En Banc and Panel Rehearing in Ninth Circuit Chlorpyrifos Case.”

The amicus curiae briefs supported EPA’s arguments and also made arguments supporting rehearing in addition to those previously set forth by EPA.  CLA’s brief focused on the fact that the Panel’s decision disregarded FIFRA’s cancellation process, stating: “if EPA ultimately were to determine that any chlorpyrifos registration would need to be cancelled, such an action could not be accomplished in the way the panel majority prescribed:  by circumventing the procedures Congress required to ensure that pesticide cancellation decisions are not made unless and until these harms and the best science available are properly vetted.”  DAS’ brief addressed in detail the Panel’s violation of administrative law in dictating how EPA must act (i.e., cancel the chlorpyrifos registrations) and the potential violation of FIFRA by EPA if forced to comply with the Panel’s order regarding the timing for cancelling such registrations.  The amicus curiae briefs also sought to provide information on the practical consequences that chlorpyrifos registrants and users would face if the panel opinion is not revised.  For example, DAS discussed its proprietary interest in protecting its registrations and defending its product, while Agribusiness in its brief provided some background on the use and benefits of chlorpyrifos, the lack of viable alternatives, and the ramifications of the order on insect pest resistance and the ability to combat new invasive pests. 

Petitioners’ response to the petition for rehearing and rehearing en banc argued that there was no basis for rehearing.  Petitioners noted that en banc review is “disfavored” and appropriate in limited “extraordinary circumstances” and in the face of “an irreconcilable conflict between the holdings of controlling prior decisions of this court.”  Petitioners argued that the Panel decision was in accord with precedent and that a request for rehearing “would only result in further delay.”  Petitioners did concede on two points:  (1) modifying the order to direct EPA to cancel the registrations under the FIFRA cancellation process, which necessitates more time than the 60 days set forth in the order; and (2) clarifying that the order is limited to cancelling registrations that can result in residues on food. 

EPA, chlorpyrifos registrants and users, and industry generally should be encouraged by the decision to grant an en banc rehearing in this case, but the outcome is far from certain.  Given the issues at stake, registrants should monitor this hearing closely.


 

By Heather F. Collins, M.S. and Margaret R. Graham, M.S.

The March 1, 2019, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2018 reporting year is fast approaching.  Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7 (7 U.S.C. § 136e), “any producer operating an establishment registered [under Section 7] shall inform the Administrator within 30 days after it is registered of the types and amounts of pesticides and, if applicable, active ingredients used in producing pesticides” and this information “shall be kept current and submitted to the Administrator annually as required.”  

Reports must be submitted on or before March 1 annually for the prior year’s production.  The report, filed through the submittal of EPA Form 3540-16:  Pesticide Report for Pesticide-Producing and Device-Producing Establishments, must include the name and address of the producing establishment; and pesticide production information such as product registration number, product name, and amounts produced and distributed.  The annual report is always required, even when no products are produced or distributed. 

EPA has created the electronic reporting system to submit pesticide producing establishment reports using the Section Seven Tracking System (SSTS).  Users will be able to use SSTS within EPA’s Central Data Exchange (CDX) to submit annual pesticide production reports.  Electronic reporting is efficient, it saves time by making the process faster, and saves money in mailing costs and/or courier delivery and related logistics.

Link to EPA Form 3540-16, as well as instructions on how to report, and how to add and use EPA’s SSTS electronic filing system are available below. 

Further information is available on EPA’s website.


 

By James V. Aidala and Lisa M. Campbell

On December 19, 2018, the Senate passed a short-term Continuing Resolution (CR) to prevent a government shutdown and continue funding for the government through February 8, 2019.  Currently, however, given the uncertainty over border wall funding, it appears likely that there may well be a government shutdown for some period of time.  Until the immigration issue is ultimately resolved in an eventual agreement, however, the majority and Democratic staff of the U.S. House of Representatives Agriculture Committee expect that the Pesticide Registration Improvement Act (PRIA) extension will be included in the CR.  Both the majority and minority in both the House and Senate have reportedly agreed to support PRIA in the new year.

The recent House Conference Report for H.R. 2, the Agriculture Improvement Act of 2018, or the Farm Bill, deleted previously inserted provisions regarding the Pesticide Registration Improvement Enhancement Act of 2017.  The House version of the Farm Bill included the enactment of the Pesticide Registration Improvement Enhancement Act of 2017 (H.R. 1029, Section 9119), but the Senate version contained no comparable provisions.  More information on the Farm Bill Conference Report is available in our memorandum “Congress Passes Farm Bill Conference Report.”

Commentary

The positive news is that many members of both the House and Senate appear to remain committed to legislative reauthorization of PRIA.  At the same time, with the change in party control in the House of Representatives, reauthorization may continue to be delayed as the new Congress with new Committee leadership devotes time and energy to competing priorities. 

In addition, as PRIA amends the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), it could provide an opportunity for amendments to FIFRA outside of the funding context to be offered by members interested in other pesticide-relevant issues.  Debate on additional pesticide issues would only likely lead to further delay and uncertainty about long-term reauthorization of PRIA.


 

By Timothy D. Backstrom

On December 12, 2018, the U.S. Environmental Protection Agency (EPA) announced a proposed joint stipulation and proposed stipulated notice of dismissal for Ellis v. Keigwin, No. 3:13-CV-1266 (N.D. Cal).  83 Fed. Reg. 63865.  The Federal Register notice states that the parties are “proposing to reach a settlement in the form of a joint stipulation" that would, among other provisions “set a June 30, 2022, deadline for EPA to complete ESA [Endangered Species Act] effects determination for EPA’s registration reviews of clothianidin and thiamethoxam and, as appropriate, request initiation of any ESA consultations with the FWS [U.S. Fish and Wildlife Service] that EPA may determine to be necessary as a result of those effects determinations.”  EPA would “also agree to initiate informal consultation" with the FWS prior to completing its effects determinations.  In addition, defendant-intervenors Syngenta, Bayer, and Valent (the registrants of products containing clothianidin and thiamethoxam) have agreed to request that EPA voluntarily cancel the registrations under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(b)(1) for 12 specific products that contain either clothianidin or thiamethoxam.  EPA is requesting comments on both the proposed joint stipulation and the stipulated notice of dismissal.  Comments are due by January 11, 2019.

The proposed joint stipulation and dismissal have been agreed to by all parties, including the plaintiffs, EPA, and defendant-intervenors Bayer, Syngenta, Valent, and CropLife America.   This stipulation was negotiated by the parties after the District Court in the Ellis case issued an order ruling on cross motions for summary judgment on May 8, 2017.  In that order, the court dismissed plaintiffs’ claims that EPA improperly denied a petition requesting that EPA immediately suspend products containing clothianidin, and also dismissed other claims that EPA violated FIFRA requirements for products containing clothianidin and thiamethoxam.  At the same time, the court granted summary judgment for the plaintiffs on claims arising under ESA Section 7(a)(2), because EPA had failed to consult with FWS before taking particular actions concerning 59 pesticide products containing clothianidin or thiamethoxam.  As part of the order, the court directed the parties to schedule a settlement conference to discuss an appropriate remedy, and the proposed stipulation is the result of those settlement discussions.

Commentary

The Ellis case was brought by beekeepers and honey producers who wanted EPA to take immediate action to ban or restrict clothianidin and thiamethoxam products based on their belief that these neonicotinoid active ingredients pose an unacceptable risk to pollinator species.  The court found that the plaintiffs did not demonstrate that these registered pesticidal active ingredients present an "imminent hazard" that would warrant suspension or emergency suspension under FIFRA Section 6(c), and the court also rejected the plaintiffs' other FIFRA claims concerning these products.  In contrast, the court granted relief under the ESA because EPA did not make the required effects determinations concerning endangered and threatened species before taking various registration actions for pesticides containing these active ingredients, and the plaintiffs asserted a specific interest in those endangered or threatened species that might be adversely affected by these products.  At this juncture, it is unknown whether the ESA review required by the agreed joint stipulation will lead to any further restrictions on these active ingredients that would have a collateral benefit for domesticated pollinators.

The proposed joint stipulation and the proposed stipulated notice of dismissal are available in EPA Docket No. EPA-HQ-OGC-2018-0745.    


 

By Lynn L. Bergeson and Carla N. Hutton

On October 19, 2018, the U.S. Environmental Protection Agency (EPA) posted the Final Work Plan (FWP) for the nanosilver registration review process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  The FWP explains what the Office of Pesticide Programs (OPP) “knows about nanosilver generally, highlighting anticipated data and assessment needs for each unique nanosilver chemistry, identifying the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing review of the nanosilver case.”  According to the FWP, EPA has identified the following use patterns to date:  swimming pool/spa treatments; and material preservative products for coatings, textiles, and plastics.  The FWP states that people may be exposed to nanosilver through inhalation and dermal exposures while applying the products to swimming pools and from incidental oral exposures during swimming.  Further exposures may come from material preservative uses either while applying or from nanosilver that leaches out when textiles and plastics are washed.  Nontarget organisms can be exposed when swimming pool water is released or when nanosilver used as a material preservative leaches.  

According to the FWP, EPA “anticipates the need to require generation and submission of human health hazard and exposure data and to conduct a human health risk assessment for nanosilver during registration review.”  The FWP states that EPA plans to conduct an environmental risk assessment for the nanosilver uses, “particularly focusing on materials preservative uses, such as plastics and textiles if the particular nanosilver chemistries are shown to leach, and swimming pool uses.”  Any of the other use patterns may also be subject to ecological assessment if the fate and product chemistry profiles indicate the potential for environmental exposures.  According to the FWP, the risk assessment integrates the environmental fate and effects data to determine if any uses pose risks to nontarget organisms.  Potential risks to fish, aquatic invertebrates, aquatic plants, and birds and mammals will be assessed after the data gaps specified in the FWP are satisfied and the relevant data are available.

EPA invites any label amendments that could be considered to eliminate the anticipated need to require certain data, reduce the possibility that EPA’s planned risk assessments overestimate risk due to reliance on conservative assumptions, and/or improve label clarity.  EPA anticipates issuing in 2018 a DCI requiring the data set out in Table 7 of the FWP, “Studies Anticipated as Needed for Nanosilver Registration Review.”


 

By James V. Aidala and Margaret R. Graham

On September 28, 2018, the U.S. Environmental Protection Agency (EPA) announced it was accepting public nominations of scientific experts to be considered for ad hoc participation on the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) through membership on the Food Quality Protection Act (FQPA) Science Review Board (SRB).  83 Fed. Reg. 49091.  EPA states that “all nominees will be considered for ad hoc participation providing independent scientific advice to the EPA on health and safety issues related to pesticides”  and requests that any individuals nominated have expertise in one or more of the following areas:  biochemistry; chemistry; epidemiology; human health risk assessment; pathology; physiologically based pharmacokinetic (PBPK) modeling; aquatic modeling; pharmacology; ecological risk assessment; environmental exposure and fate; environmental toxicology; occupational, consumer, and general exposure assessment; toxicology; dose response modeling; environmental engineering; statistics; water quality monitoring; hydrologist; Geographic Information Systems (GIS) specialist; computational toxicology; entomology; veterinary entomology; medical entomology, insect ecology, allergenicity, research veterinarian; inhalation toxicology; volatile organics; endocrinology, alternative testing methods, high throughput testing approaches, adverse outcome pathways, cross species extrapolation, and systematic review.  The Designated Federal Officer’s to whom nominations should be provided is listed in the Federal Register notice.  Nominations are due by November 13, 2018

Commentary

FPQA added this SRB to the previous authorization for the SAP to recognize the expanding universe of scientific questions which often underlie issues surrounding pesticide registration.  The FQPA amendment simply adds that “60 scientists who shall be available to the SAP” without specifying any particular disciplines or skills which might be useful to assist with the deliberations and review by the SAP.  This was intended to continually allow EPA to adapt to changing or evolving scientific questions without constantly tinkering with the membership of the SAP itself.  At the same time, it allows these ad hoc members to be recognized for their contributions and to be compensated in the same manner as SAP members.  


 

By Lisa R. Burchi and Lisa M. Campbell

On September 25, 2018, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report Measures and Management Controls Needed to Improve EPA’s Pesticide Emergency Exemption Process that details the results from the its audit done to determine whether EPA has a comprehensive pesticide emergency exemption approval process that maintains environmental and human health safeguards.  Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) allows EPA to “grant federal and state lead agencies the authority to approve -- in certain emergency situations -- the limited application of a pesticide not registered for that particular use.  These short-term pesticide use approvals are called emergency exemptions.”  OIG states that the scope of the audit “focused on the emergency exemption management process and the internal controls necessary to consistently implement and administer it.”  OIG did not “evaluate the science used to review emergency exemptions or the subsequent emergency exemption application decisions.”

OIG’s main criticisms of EPA’s emergency exemption program listed in the report are:

  1. EPA’s Office of Pesticide Programs (OPP) collects human health and environmental data through its emergency exemption application process, including the total acres affected, the proposed and actual quantities of the exempted pesticide applied, and the estimated economic losses but it does not use these data to support outcome-based performance measures that capture the scope of each exemption, to measure the potential benefits or risks of each exemption, or to determine how well the emergency exemption process maintains human health and environmental safeguards.
  2. OPP does not consistently communicate emergency exemption information with its stakeholders.  OPP previously sent a “year in review” letter to states that summarized the emergency exemption activity for that year and provided additional information regarding the emergency exemption process.  OPP has not sent this letter since 2015, however.
  3. There were significant deficiencies in the OPP’s online database management, in its draft Section 18 emergency exemption standard operating procedure and application checklist, and in its reports to Congress and the Office of Management and Budget.

The eight OIG recommendations in the report for the Assistant Administrator (AA) for the Office of Chemical Safety and Pollution Prevention’s (OCSPP) consideration, and OCSPP’s response to those recommendations, are as follows:   

Recommendation 1:  Develop and implement applicable outcome-based performance measures to demonstrate the human health and environmental effects of the EPA’s emergency exemption decisions.

  • OCSPP Response and OIG Resolution:  OCSPP did not agree with this recommendation, stating that development of an outcome-based performance measure for the Section 18 emergency exemption process was neither appropriate nor feasible.  No proposed corrective actions were proposed and this issue remains unresolved. 

Recommendation 2:  Determine which application review performance target for emergency exemption applications the OPP plans to meet, and make that target consistent between its Annual Performance Goal and its internal controls governing the emergency exemption process.

  • OCSPP Response and OIG Resolution:  OCSPP did not agree or disagree with Recommendation 2, but it nevertheless provided a corrective action “to avoid future confusion” and a completion date (July 31, 2019) that was considered acceptable to OIG.

Recommendation 3:  Update and prepare the draft standard operating procedure in final that OPP uses to guide the emergency exemption process.

  • OCSPP Response and OIG Resolution:  OCSPP agreed with this recommendation and provided planned corrective actions and a completion date (July 31, 2019) that was considered acceptable to OIG.

Recommendation 4:  Develop formal emergency exemption application review procedures that detail specific data collection, management and reporting control steps, and procedures that require specific management controls for accurately and consistently updating the OPP’s Section 18 database.

  • OCSPP Response and OIG Resolution:  OCSPP agreed with this recommendation and provided acceptable planned corrective actions and a completion date (July 31, 2019) that was considered acceptable to OIG.

Recommendation 5:  Develop concise emergency exemption application guidance that specifies the minimum requirements of an application submission and is available on the OPP’s Section 18 website.

  • OCSPP Response and OIG Resolution:  OCSPP did not agree or disagree with Recommendation 2, but it nevertheless proposed to:  (1) evaluate how its web resources can be enhanced to respond to this recommendation; and (2) if it determines that enhancements to the Section 18 website are necessary, implement any needed web updates by December 2019.  OIG does not believe the proposed corrective action for this recommendation is sufficient to meet the intent of the recommendation and states this recommendation remains unresolved.

Recommendation 6:  Provide clear guidance to state lead agencies on how and when they can use efficacy data from other state lead agencies to satisfy the emergency exemption application criteria.

  • OCSPP Response and OIG Resolution:  OCSPP did not agree with this recommendation, stating that the only example provided by OIG to support this recommendation represents an extremely rare situation.  No corrective actions were proposed and this issue remains unresolved. 

Recommendation 7:  Expand the data presented in the OPP’s Section 18 database by considering additional data points, such as application acreage requested, actual acreage applied, and registration status of each exempted pesticide.

  • OCSPP Response and OIG Resolution:  OCSPP agreed with this recommendation and stated it would “consider additional data points, such as application acreage requested, decision documents, and registration status of each exempted pesticide, as OCSPP explores ways to improve the website database and its overall content.”  OCSPP proposed that by December 2019 recommendations would be made to the OPP Director for enhancing the Section 18 database and a memorandum would be provided to the OCSPP AA with a plan for updating the Section 18 database addressing these recommendations.  OIG states that OCSPP did not commit to expanding the data presented in the Section 18 database and, thus, this issue remains unresolved.

Recommendation 8:  Provide an annual update and information summary to state lead agencies to better inform them about any changes to the emergency exemption application-and-review process.

  • OCSPP Response and OIG Resolution:  OCSPP agreed with this recommendation and stated it would “explore how to provide periodic and useful program updates to applicants.”  OCSPP proposed by that December 2019 it would “work with State Lead Agencies to identify the types of information they may find helpful for periodic updates” and “develop a strategy which details the activities that might be conducted to provide periodic and useful program updates to applicants.”  OIG states that OCSPP found the term “periodic” unclear and stated the issue remains unresolved.

Although several of these recommendations and EPA’s proposals remain unresolved, registrants should monitor for actions to be taken by EPA in response to the OIG Report. 


 

By Heather F. Collins, M.S., and Sheryl Lindros Dolan

On June 21, 2018, during the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) webinar, EPA discussed the new draft risk-based strategy for ensuring the performance of public health antimicrobial products and announced the intended replacement of the former Antimicrobial Testing Program (ATP) with the new Antimicrobial Product Evaluation Program (APEP).  Comments on the draft risk-based strategy may be submitted to EPA until July 16, 2018.

Public health antimicrobial products are those products that bear a claim to control microorganisms that pose a threat to human health, and whose presence cannot readily be observed by the user, including microorganisms infectious to people in any area of the inanimate environment.  The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires product performance (i.e., efficacy) data to support registration of antimicrobial products bearing a public health claim. 

EPA began the webinar with an overview of the Office of Inspector General (OIG) Report entitled “EPA Needs a Risk-Based Strategy to Assure Continued Effectiveness of Hospital-Level Disinfectants.”  Report #16-P-0316 (Sept. 19, 2016).  OIG conducted a review of EPA’s ATP to “determine whether the program ensures the efficacy of EPA-registered hospital sterilants, disinfectants, and tuberculocides (“hospital-level disinfectants”); and to evaluate options for improving the ATP.”  See Bergeson & Campbell, P.C.’s article dated September 21, 2016, “Results of EPA OIG’s Review of EPA’s Antimicrobial Testing Program” for a full summary of the OIG report.  In the 2016 report, OIG recommends OPP suspend administering the current ATP and develop a risk-based strategy to assure the effectiveness of public health pesticides used in hospital settings once products are in the marketplace.  EPA agreed with OIG’s recommendations.

EPA provided that “[t]he intent of the [APEP] is to ensure continued effectiveness of antimicrobial products with public health claims (hospital disinfectants, tuberculocides, and other health care claims) in the marketplace.  The maintenance and development of technically-sound test methods, quality improvement tools (e.g., peer review of new protocols), and outreach and stewardship activities will further support the program.” 

The risk-based testing strategy will ensure the effectiveness of public health pesticides used in hospital settings by:

  • Establishing a framework for periodic testing after registration;
  • Defining a program that is responsive to current public health risks;
  • Identifying risk factors for selecting products to test;
  • Establishing a process to be used for obtaining samples for testing; and
  • Setting a date to begin risk-based post-registration testing.

Risk-based factors under consideration by EPA include:

  • Use of healthcare-associated infection data reports;
  • Claims against microorganisms of greatest concern to healthcare-associated infections (e.g., Clostridium difficile, MRSA,VRE);
  • Emerging pathogens and homeland security considerations;
  • Trends in previous ATP compliance history (e.g., claims against Mycobacterium bovis BCG);
  • Atypical label claims (e.g., very short contact times, use sites and surfaces, new product delivery and application procedures); 
  • Claims not evaluated under the previous ATP;
  • New and unusual active ingredients;
  • Formulation chemistry-related issues (e.g., shelf-life/stability once prepared, lack of expiration dates);
  • Use of new or procedurally-revised test methods;
  • Tips and complaints;
  • Issues identified during reregistration (e.g., frequency of repeat testing, acceptance criteria not met); and
  • Link to other federal initiatives.

OIG recommends a functional program begin after registration review is completed in 2022.  According to OIG, the development of a solid, acceptable testing strategy is key -- the strategy must be finalized and communicated to regulated and public health communities.  OIG specified other EPA outreach activities for the testing program that must be considered, e.g., setting and clearly communicating goals and establishing the baseline reporting mechanisms.

EPA expects to release this final strategy in November 2018 and seeks public input prior to implementation.  Please submit your comments on this topic by July 16, 2018, to the Office of Pesticide Programs Docket, EPA-HQ-OPP-2018-0265 at https://www.regulations.gov.

For additional information, please visit https://www.epa.gov/pesticide-registration/antimicrobial-testing-program or https://www.epa.gov/pesticide-registration/webinar-risk-based-strategy-ensure-continued-effectiveness-hospital.


 
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