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EPA Announces It Is Extending Flexibilities to Minimize Supply-Chain Disruptions Facing the Pesticide Industry
On January 20, 2022, the U.S. Environmental Protection Agency (EPA) announced it is extending supply-chain flexibilities for registrants of certain conventional and biopesticide products to alleviate a supply-chain issue facing the pesticide industry.
This is an extension of EPA’s July 2, 2021, action when EPA implemented supply-chain flexibilities that allowed registrants to substitute a combination of pre-approved alternate inert ingredients for inert ingredients derived from propylene oxide (PO) feedstocks. This was intended to address the limited supply of PO feedstocks due to weather events that occurred in the U.S. Gulf Coast in February 2021. This action was originally set to expire on December 31, 2021, but EPA has extended these supply-chain flexibilities until December 31, 2022, due to continued disruptions to production.
EPA emphasized in its initial July 2021 action that this relates only to non-antimicrobial pesticide products and that EPA will handle “not in-kind” substitutions for antimicrobial pesticide products on a case-by-case basis.
The pre-approved alternates for propylene glycol, a derivative of PO feedstocks, include:
These substitutions can be added to a product formulation or a brand name mixture.
Registrants must self-certify that the substitute inert ingredients will:
EPA states that any registrants that wish to make the substitution permanent will have to go through the standard amendment process outlined in Pesticide Registration Notice (PRN) 98-10.
Supply-chain issues have become a national concern whether one is shopping for furniture or manufacturing pesticides. The Biden Administration across government agencies and programs has sought ways to ease difficulties as part of a national response to economic disruptions caused by the COVID-19 pandemic. Pesticide ingredients may not be subject to as much media coverage as consumer products, but in the end, could have impacts affecting availability of disinfectants and other pesticide products. In the broader economy, supply-chain issues have been identified as a factor affecting the availability of pesticides used to help meet the food and fiber production needs of the nation, along with concerns about freight capacity limiting the normal distribution of crop inputs and ultimately affecting the movement of finished crops.
On January 11, 2022, the U.S. Environmental Protection Agency (EPA) announced it is implementing a new policy regarding the evaluation and registration of new conventional pesticide active ingredients (AI) to comply further with the Endangered Species Act (ESA) (ESA Policy). EPA also issued a Question and Answer document regarding its ESA Policy. Effective immediately, EPA will evaluate the potential effects of new conventional AIs on federally threatened or listed endangered species (Listed Species) and their designated critical habitats, and initiate ESA consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) if necessary before EPA registers any new conventional AIs. The new ESA Policy will apply to all new conventional AI applications, including applications already submitted to EPA but not yet completed.
Under the ESA, EPA must ensure that its actions are not likely to result in jeopardy or adverse modification of designated critical habitat or Listed Species. To determine whether the action may affect Listed Species and their designated critical habitats, EPA makes one of three types of species-specific effects determinations: No Effect (NE), Not Likely to Adversely Affect (NLAA), or Likely to Adversely Affect (LAA). EPA states that historically it did not “consistently assess the potential effects of conventional pesticides on listed species when registering new AIs.” This, EPA states, “resulted in insufficient protections from new AIs for listed species, as well as resource-intensive litigation against EPA for registering new AIs prior to assessing potential effects on listed species.” EPA believes its new ESA Policy should assist in reducing these types of cases against EPA and improve the legal defensibility of new AIs.
EPA states that under the new ESA Policy, if EPA makes an LAA determination through its analyses of a new conventional pesticide AI, EPA will initiate formal consultation with the Services before granting a new AI registration. As part of its analysis and under its existing authorities, EPA will consider the likelihood that the registration action may jeopardize the continued existence of Listed Species or adversely modify their designated critical habitat and provide its findings to the Services. To determine or predict the potential effects of a pesticide on these species and habitats, EPA will use appropriate ecological assessment principles and apply what it has learned from past effects determinations and the Services’ biological opinions. EPA states it is determining whether any new information would be useful for assessing the potential impacts on Listed Species from a new AI, and it will specifically contact registrants that have a new Al application currently under consideration to discuss whether additional information is necessary for EPA’s ESA assessment for the new conventional AI.
If EPA determines that jeopardy or adverse modification is likely for a designated critical habitat or Listed Species, it will only make a registration decision on the new conventional AI after requiring registrants to implement mitigation measures that EPA determines would likely prevent such jeopardy or adverse modification. If EPA finds that a new AI is likely to affect adversely a Listed Species or its critical habitat, but that a jeopardy or adverse modification is not likely, it may nonetheless require registrants to include mitigation measures as part of their registration and product labeling to minimize the potential effects of incidental take to Listed Species that could result from use of a pesticide. In both situations, formal consultation with the Services would still be necessary, as EPA states final jeopardy or adverse modification determinations must be made by the Services. Regarding timeframes, EPA states in the Q&A that it “strives to complete new AI applications within PRIA timelines,” but will work with affected registrations to “renegotiate” PRIA deadlines if EPA believes additional time will be needed under the ESA Policy.
EPA states that it has prioritized conventional pesticide AIs but that it is continuing to explore applying these new ESA approaches to new biopesticide AIs and new antimicrobial AIs. EPA also is developing a comprehensive strategy to address ESA for pesticides at all stages of the registration process. EPA is currently developing a detailed work plan to outline additional improvements to further its compliance with the ESA, including steps to implement protections for high-risk species more efficiently, provide growers with more flexible mitigation measures, and increase stakeholder engagement.
This announcement represents the next attempt by the Office of Pesticide Programs (OPP) to comply with ESA requirements in a way that, as the ESA Policy points out, will be more legally defensible while continuing its work to review and approve new pesticide AIs. In recent years, EPA has tried various arguments, mostly futile, to convince courts that past attempts to comply with ESA were sufficient.
This ESA Policy hints at important changes both in EPA’s past rhetoric regarding compliance and possible changes to the ways ESA assessments have been conducted in the past. On the record, EPA has maintained it complied with ESA when registering a new product. The courts have found this claim unsupported and almost always agreed with groups that challenged that claim. There have been a few exceptions where EPA, while not entirely resolving ESA concerns, had more “up front” consideration of ESA issues. Such earlier attention to resolving any ESA concerns, however, can add significantly to the time spent and data requirements to evaluate and address ESA issues.
Any relatively successful cases over past years complement the renewed and explicit commitment by the Biden Administration with the ESA Policy to attempt to resolve the long-standing problem of establishing a registration process that better addresses ESA issues with, among other things, improved coordination between EPA procedures and the review process (and conclusions) of the Services. Past Administrations have expressed similar rhetoric, but so far, many have tried, and all have failed.
In various forums, EPA has dryly described the efforts generally as -- “EPA is currently developing a detailed work plan to outline additional improvements to further the Agency’s compliance with the ESA.” More importantly, perhaps, and new to the mix is that EPA now has a senior political appointee (Jake Li as Deputy Assistant Administrator of OCSPP) especially tasked to lead efforts regarding the ESA-FIFRA integration process.
For applicants and registrants of new conventional AIs, these revised efforts may lead to some delays in the current expected timeframes to “work out” ESA concerns earlier in the process. And importantly, EPA’s ESA Policy describes how new approvals will include more “up front” mitigation measures designed to protect threatened and endangered species to a sufficient, or at least better, degree -- which appears to be a key change designed to reduce the litigation risks that have dogged new registration decisions in recent years.
On January 10, 2022, the U.S. Environmental Protection Agency (EPA) announced it is opening a 60-day comment period requesting public comments on the sixth proposed rule in an ongoing series of revisions to the pesticide crop grouping regulations.
EPA states it is proposing revisions to its pesticide tolerance crop grouping regulations, which allow the establishment of tolerances for multiple related crops based on data from a representative set of crops. EPA proposes to amend the following crop groups:
The proposed rule includes changes to the terminology in the names of Crop Groups 6, 7, and 16 and the addition of commodities and modifications that increase efficiencies in assessing the risks of pesticides used on crops grown in and outside of the United States. The crop groups will now include certain minor or specialty crops, many of which have become more popular since the crop groups were first established.
EPA sets the maximum amount of a pesticide allowed to remain in or on a food (tolerances) as part of the process of regulating pesticides that may leave residues in food. Crop groups are established when residue data for certain representative crops are used to establish pesticide tolerances for a group of crops that are botanically or taxonomically related. Representative crops of a crop group or subgroup are those crops whose residue data can be used to establish a tolerance for the entire group or subgroup.
According to EPA, these revisions will:
The March 1, 2022, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2021 reporting year is fast approaching. Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7(c)(1) (7 U.S.C. § 136e(c)(1)), “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, saves time by making the process faster, and saves money in mailing costs and/or courier delivery and related logistics. EPA is encouraging all reporters to submit electronically to ensure proper submission and a timely review of the report.
Links 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.
On December 30, 2021, the U.S. Environmental Protection Agency (EPA) issued a final rule rescinding the March 2, 2020, final rule (2020 inspection rule) regarding EPA’s procedures for conducting on-site civil inspections. This final rule applies to on-site inspections conducted by EPA civil inspectors, federal contractors, and Senior Environmental Employment employees conducting inspections on behalf of EPA.
This rule is effective immediately, as EPA states this rulemaking is procedural rather than substantive.
The 2020 inspection rule was promulgated to implement Executive Order (EO) 13892, “Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication” (84 Fed. Reg. 55239). The 2020 inspection rule, codified at 40 C.F.R. Part 31, set forth the elements of the process to conduct on-site civil inspections (e.g., timing of inspections, opening and closing conferences, document review) and guidance regarding each element.
EPA states it is rescinding the 2020 inspection rule in accordance with EO 13992, “Revocation of Certain Executive Orders Concerning Federal Regulation,” issued by President Biden on January 20, 2021 (86 Fed. Reg. 7049). Specifically, EO 13992 revokes EO 13892, stating that it is the policy of the Biden Administration “to use available tools to confront the urgent challenges facing the Nation, including the coronavirus disease 2019 (COVID-19) pandemic, economic recovery, racial justice, and climate change. To tackle these challenges effectively, executive departments and agencies (agencies) must be equipped with the flexibility to use robust regulatory action to address national priorities. This order revokes harmful policies and directives that threaten to frustrate the Federal Government's ability to confront these problems, and empowers agencies to use appropriate regulatory tools to achieve these goals.”
According to EPA, the 2020 inspection rule being rescinded converted a subset of what had been long-standing civil inspection practices, guided by applicable Agency policies, into “rules” of EPA procedure by which “all” civil inspections “shall be conducted.” 40 C.F.R. Part 31.1(a). EPA states:
EPA notes that it will continue to employ its policies and methods for public transparency of Agency procedures for conducting on-site civil inspections. For example, EPA notes procedures described in this rule already exist in inspection guidance documents and manuals, which are accessible to the public through EPA’s website. Additionally, EPA states it has met and will meet all statutory obligations pertaining to posting documents for public accessibility. To the extent that concerns arise regarding Agency guidance, a person may -- consistent with the Administrative Procedure Act -- petition EPA, including a request to issue, amend, or repeal EPA guidance, by contacting the EPA program office or regional office that is responsible for administering the area of stakeholder interest.
B&C, Acta, and BCCM Release Forecast for U.S. Federal and International Chemical Regulatory Policy 2022
Bergeson & Campbell, P.C. (B&C®) is pleased to provide our Forecast 2022 to FIFRA Blog readers, offering our best informed judgment as to the trends and key developments we expect to see in the new year. For the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP), 2021 was a full year of working from home while addressing ongoing priorities; continuing the march toward meeting the 2022 deadline for registration review of pesticides registered before 2006; attempting to comply with the requirements of the Endangered Species Act (ESA); and meeting Pesticide Registration Improvement Act (PRIA) deadlines for registration applications. OPP is expected to focus on long-standing challenges, especially a renewed effort to meet ESA consultation requirements and to meet core pesticide registration review obligations. More details on this, and expected regulatory changes of all varieties, are available in our Forecast for U.S. Federal and International Chemical Regulatory Policy 2022.
B&C will be presenting a complimentary webinar, “What to Expect in Chemicals in 2022,” focusing on themes outlined in the forecast. Join Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Director of Chemistry; and James V. Aidala, Senior Government Affairs Consultant, for this informative and forward-looking webinar.
EPA Announces Annual Pesticide Maintenance Fee Forms Available to Download from EPA Website -- Deadline for Paying Is January 18, 2022
The January 18, 2022, deadline for payment of the U.S. Environmental Protection Agency’s (EPA) annual maintenance fee for pesticide registrations is approaching. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A) requires everyone who holds an active or suspended pesticide registration granted under FIFRA Sections 3 and 24(c) (special local needs) to pay an annual maintenance fee to keep the registration in effect. The maintenance fee requirement does not apply to supplemental registrations of distributors, which are identified by a three-element registration number.
The fee for 2022 is $3,660 for each registration up to the maximum fees that can be assessed to a single registrant. Each registrant of a pesticide must pay the annual fee and e-mail the response to EPA by Tuesday, January 18, 2022. Registrations for which the fee is not paid will be canceled, by order and without a hearing. As in years past, payment must be made electronically online at www.pay.gov.
For certain qualified small businesses, the first product registration maintenance fee may be reduced by 25 percent, if the applicant meets the following criteria:
There also are maintenance fee waivers for products that meet the criteria in two specific categories: minor agricultural use products and public health pesticides. The procedure for requesting a fee waiver for individual products is described in the instructions provided by EPA.
More information on the annual maintenance fees is available on EPA’s website.
On November 18, 2021, the United Farm Workers and several other non-governmental organizations (NGO) filed a petition with the U.S. Environmental Protection Agency (EPA) to revoke all food tolerances and cancel registrations for organophosphate (OP) pesticides (Petition). The Petition was filed pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. Section 346a(d), the Administrative Procedure Act (APA), 5 U.S.C. Section 551, and the First Amendment Constitutional Right to Petition.
The Petition seeks final EPA actions to revoke tolerances and cancel registrations for 15 OPs by the registration review deadline of October 1, 2022.
The Petition also states that EPA must take the following actions:
The Petition focuses on 15 OPs that are currently going through registration review:
Now that EPA is in receipt of the Petition, it must determine that it has received a “complete” petition to revoke a tolerance based on criteria set forth in EPA’s regulations (40. C.F.R. § 180.7). If EPA determines the Petition is complete, it will publish in the Federal Register within 30 days a notice of filing for the Petition, which must include the informative summary of the Petition submitted by the petitioner. FFDCA Section 408(d)(3). A public comment period follows.
Generally, the Petition is an important signaling document that the petitioners use to outline how EPA should approach the 2022 registration review deadline for these OP products. It signals that unless EPA completes all elements of a registration review, including a complete ESA assessment and an endocrine disruptor review -- which may be impossible for EPA to complete -- then EPA should act now to revoke OP tolerances in light of arguments contained in the Petition. It stresses the environmental justice commitments announced by the Biden Administration, arguing that evidence is clear, in their view, of the need to take immediate action to end OP use across virtually all of the members of the class. It seems to anticipate that even if EPA rolls out registration reviews of the individual OP pesticides before the deadline, there will likely be comment and debate about the specific analyses and evaluation of each member of the category. This would additionally delay the completion of any revised cumulative risk assessment for the OPs.
From the view of the petitioners, not only will EPA miss the 2022 deadline, but they also argue the evidence is sufficient now for EPA to take action to revoke tolerances for these compounds based on evidence already before EPA. Other stakeholders and EPA’s eventual analyses will dispute such conclusions, but completing registration review (as defined in the Petition) will likely be impossible to complete before next October. As a result, the Petition here suggests the template these advocacy groups will use to challenge continued registration of OP products past the 2022 deadline.
EPA Announces Updated Registration Review Schedule and Announces Completion of Safety Assessments and Decisions for Hundreds of Pesticides
On December 2, 2021, the U.S. Environmental Protection Agency (EPA) announced it released the registration review schedule for the next four years through fiscal year (FY) 2025. While historically this schedule has been updated once each year, EPA states that going forward it will be updated on a quarterly basis.
The 2007 amendment of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires that EPA review each registered pesticide at least every 15 years. For the 726 pesticide cases that were registered before October 1, 2007, the amendment to FIFRA requires EPA to complete its review by October 1, 2022. This is significant, as it is intended to mark the end of the first 15-year registration review cycle.
Working toward that goal, EPA states that it has completed the following over the past 15 years:
EPA states its updated registration review schedule provides a “roadmap” for the next four years of EPA’s registration review program. EPA’s schedule includes 297 entries describing the registration review “action” (e.g., Draft Risk Assessment, Proposed Interim Decision, Interim Decision, Preliminary Work Plan, Final Work Plan) to be addressed by EPA’s different divisions (e.g., Pesticide Reevaluation Division; Antimicrobials Division, Biopesticides and Pollution Prevention Division). Throughout its review, EPA makes the information, assessments, and supporting material for each case available to the public at regulations.gov.
Significantly, but not surprisingly, EPA acknowledges that for some pesticides registered before October 1, 2007, it “anticipates that its review will extend beyond” the October 1, 2022, deadline “due to a number of challenges including delays in receiving data from registrants; the demands of responding to COVID-19; and a significant increase in recent years of resources devoted to litigation.” EPA also warns that the schedule is “subject to change based on shifting priorities and is intended to be an estimated timeline.” EPA notes further that data that are not submitted on time may affect EPA’s registration review timeline and that “several cases are not found on the schedule due to uncertainty of when necessary data will be received.”
Complying with the Endangered Species Act (ESA) is also part of the registration review process. Since 2007, EPA states that it has completed ESA assessments for certain high-priority pesticides and, in the coming years, plans to assess the effects of many more pesticides on endangered species in registration review. According to EPA, it will release its first ESA pesticides work plan in the coming months, which will outline steps EPA will take to come into compliance with the ESA in ways that are fair and transparent to the agriculture sector.
Information on EPA’s registration review process is available here.
On November 19, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is extending COVID-19 activation of the emerging viral pathogens (EVP) guidance for antimicrobial pesticides indefinitely. EPA states that its EVP guidance for antimicrobial pesticides is a part of the federal government’s pandemic preparedness, allowing manufacturers to provide EPA with data, even in advance of an outbreak, demonstrating that their products are effective against hard-to-kill viruses.
EPA activated its EVP guidance for antimicrobial pesticides for the first time in January 2020 in response to the emergence of SARS-CoV-2. EPA has allowed for expedited review and approval of surface disinfectant products for use against SARS-CoV-2 for more than 12 months, including accelerated review for products seeking to add EVP claims to product labels. To date, EPA has added 591 products with emerging viral pathogens claims to its list of Disinfectants for Coronavirus (List N).
EPA states that registrants must remove EVP claims from consumer messaging no later than 24 months after the original notification of the outbreak, unless directed otherwise by EPA. With this extension, EPA will now provide a notification at least six months before inactivating the EVP guidance for SARS-CoV-2 to allow registrants time to adjust product marketing materials as required.
Additional information on the EVP guidance is available here.
Bergeson & Campbell, P.C. (B&C®) is pleased to announce that FIFRA Tutor™ regulatory training courses are now available at www.FIFRAtutor.com. Professionals can preview and enroll in on-demand classes to complete at their own pace and timing. FIFRA Tutor joins B&C’s existing TSCA Tutor® training courses in offering efficient and essential training for chemical regulatory professionals, and a third training program, HazCom GHS Tutor, is planned for 2022.
Additional modules in the FIFRA Tutor curriculum will be released throughout 2022.
Courses can be completed at the learner’s own pace, and enrollment is valid for one full year. Interested professionals should visit www.FIFRAtutor.com to view sample course segments and purchase modules.
Watch a preview of TSCA Tutor and FIFRA Tutor courses: T101 – TSCA Inventory Overview, T202 – TSCA Section 5 (Part 1) TSCA Chemical Inventory, Exemptions, and F109 – Defining Tolerances and Their Regulation.
Bergeson & Campbell, P.C. is a Washington, D.C., law firm focusing on conventional, biobased, and nanoscale industrial, agricultural, and specialty chemical product approval and regulation, and associated business issues. B&C represents clients in many businesses, including basic, specialty, and agricultural and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; paints and coatings; plastic products; and chemical manufacturing, formulation, distribution, and consumer product sectors. Visit www.lawbc.com for more information.
Federal Agencies Reaffirm Commitment to Protecting Endangered Species, Providing Effective Pest Control Tools, and Regulating Pesticide Use in a Fair, Transparent, and Predictable Manner
On November 3, 2021, the U.S. Environmental Protection Agency (EPA), the White House Council on Environmental Quality (CEQ), the U.S. Department of Agriculture (USDA), the U.S. Department of Commerce, and the U.S. Department of the Interior “reaffirm[ed] their commitment to working together and with stakeholders to protect endangered species, provide effective pest control tools, and regulate pesticide use in a fair, transparent, and predictable manner.” According to EPA’s November 3, 2021, press release, on October 15, 2021, all five agencies met as part of the Interagency Working Group (IWG) created under the 2018 Farm Bill to discuss improvements to the consultation process for pesticide registration and registration review under Section 7 of the Endangered Species Act (ESA). EPA states that the group’s first meeting resulted in specific commitments to improve the pesticide consultation process for endangered species and engaging stakeholders, including by capitalizing on the strong interest among stakeholders for a workable process.
According to the press release, the IWG is optimistic about its ability to collaborate on improvements that the Biden Administration can implement. The IWG’s actions focused on improving processes that will contribute to tangible benefits for species conservation and for stakeholders. EPA states that the IWG “is intent to adopt improvements expeditiously and that endure across administrations.” To guide its future work, the IWG has identified the following initial priorities and approaches:
EPA states that “[e]ffective endangered species protection cannot be accomplished solely by federal agencies,” but also requires “open and continuous engagement with stakeholders on practical solutions to harmonizing species conservation with pesticide use.” To that end, the IWG plans to hold its first stakeholder listening session in early 2022 and will provide details on the proposed session before the end of 2021.
EPA Announces Revisions to Guidance to Ensure Effectiveness of Antimicrobial Pesticides against Candida auris
On October 15, 2021, the U.S. Environmental Protection Agency (EPA) announced that it has revised its guidance for evaluating the efficacy of antimicrobial pesticides against Candida auris (C. auris). EPA states that pesticide manufacturers seeking to register their products with a C. auris claim should use this updated guidance to test the effectiveness of the products against a drug-resistant strain of C. auris.
EPA states that C. auris is an emerging, multidrug-resistant yeast (a type of fungus). It can cause serious infections and spreads easily among hospitalized patients and nursing home residents. C. auris can spread in healthcare settings through contact with contaminated environmental surfaces or equipment, or from person to person. According to the Centers for Disease Control and Prevention (CDC), more than one in three patients with an invasive (e.g., affecting the blood, heart, or brain) C. auris infection die.
In 2017, in consultation with the CDC, EPA issued interim guidance for testing the effectiveness of hospital disinfectants against C. auris. Subsequently, based on input from the CDC on its tracking of clinical cases of multi-drug resistant C. auris isolates in the United States, the laboratory data were generated to ensure antimicrobial efficacy against a more relevant strain of the pathogen.
Working closely with experts from the CDC, EPA conducted a comparative evaluation of isolates and found that the drug-resistant isolates were more tolerant to some disinfectant treatments. Since a drug-resistant isolate (AR Bank #0385) is highly relevant to current outbreaks in the United States, it is considered a suitable test microbe for regulatory purposes.
The guidance provides recommendations for laboratory methodology on how to:
Under the updated guidance, all new products seeking registration with claims against C. auris should test for efficacy using the more relevant strain (AR Bank #0385). Efficacy testing using AR Bank #0381 is acceptable in some cases where the study initiation date is between October 15, 2020, and October 15, 2021. For study initiation dates between October 15, 2020, and October 15, 2021, EPA will accept studies conducted with isolate AR Bank #0381 for products whose active ingredients are either sodium hypochlorite or hydrogen peroxide plus acetic acid. For products with other active ingredients, it will be necessary to retest using isolate AR Bank #0385.
Existing antimicrobial products with C. auris claims based on the previous strain (AR Bank #0381) will be allowed to retain their claim of effectiveness against C. auris. To claim effectiveness against drug-resistant C. auris, EPA requires retesting with the more relevant strain (AR Bank #0385) identified in the updated guidance and according to the revised test method.
FDA Announces Withdrawal of Temporary Guidance Documents Concerning Alcohol-Based Hand Sanitizer Products
The Food and Drug Administration (FDA) published a Federal Register notice on October 13, 2021, announcing the withdrawal of three guidance documents: “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)”; “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency”; and “Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).” 86 Fed. Reg. 56960. According to the notice, FDA is withdrawing the guidance documents “because current data indicate that consumers and healthcare personnel are no longer experiencing difficulties accessing alcohol-based hand sanitizer products, and these temporary policies are no longer needed to help meet demand for alcohol-based hand sanitizer products or for alcohol for use in alcohol-based hand sanitizer.” The withdrawal date for the guidance documents is December 31, 2021. The notice states that firms manufacturing alcohol under the temporary policies for use in alcohol-based hand sanitizers and firms preparing alcohol-based hand sanitizers under the temporary policies must cease production of these products by December 31, 2021. Firms must cease, by March 31, 2022, distribution of any remaining hand sanitizer products that were prepared under the temporary policies before or on December 31, 2021. After March 31, 2022, FDA states that it intends to cease its temporary policy of not taking action with regard to distribution of hand sanitizers, or alcohol for use in alcohol-based hand sanitizers, prepared consistent with the circumstances described in the guidance documents.
The withdrawal of these documents is not unexpected. FDA issued the documents in March 2020 to provide regulatory flexibility to certain firms to help meet the demand for alcohol-based hand sanitizer during the COVID-19 public health emergency (PHE). FDA states that it has determined that the demand for alcohol-based hand sanitizer has decreased and the supply of hand sanitizer from traditional manufacturers (i.e., firms other than those that entered into the over-the-counter drug industry for the first time to supply hand sanitizers during the PHE) has increased. FDA notes that although the temporary policies are being withdrawn, firms may continue to manufacture alcohol-based hand sanitizer products without an approved application, provided they comply with the applicable tentative final monograph and other applicable requirements, including current good manufacturing practice requirements under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. FDA reminds distributors, re-packagers, and importers that they are also responsible for the safety and quality of the drugs they introduce into interstate commerce. Firms that registered and submitted drug product listing(s) for hand sanitizer(s) only but no longer manufacture such product, or plan to cease manufacturing such product, can deregister and delist their hand sanitizer product listing(s) by following the Electronic Drug Registration and Listing Instructions.
On October 7, 2021, U.S. Environmental Protection Agency (EPA) Administrator Michael S. Regan announced the appointment of Rod Snyder to become EPA’s Agriculture Advisor. Snyder will lead outreach and engagement efforts with the agricultural community for EPA.
Snyder is nationally recognized for his leadership at the intersection of agricultural and environmental policy, and joins EPA after serving as president of Field to Market: The Alliance for Sustainable Agriculture, the largest multi-stakeholder initiative working to advance the sustainability of commodity crop farming in the United States. In that role, he forged science-based consensus among stakeholders across the food and agriculture value chain on issues such as climate change, water quality, biodiversity, and pest management.
Prior to his time at Field to Market, Snyder worked for the National Corn Growers Association and CropLife America. He previously organized farmer delegations to participate in UN Climate Summits in Paris and Copenhagen. In 2015, Snyder co-founded the Sustainable Agriculture Summit, which has grown to be the largest and most prominent annual sustainable agriculture conference in North America. Snyder holds a B.A. in Political Science from Eastern University in St. Davids, Pennsylvania.
This position is important in the Office of the EPA Administrator. It allows stakeholders interested in issues that affect agriculture or agricultural policies a central contact point within the Administrator’s office. EPA in all program areas has a large number of interested stakeholders, but agricultural groups may be less likely to focus on EPA activities across all of the EPA media programs. This position facilitates outreach to agricultural stakeholders who might otherwise not realize they may have an interest in certain EPA policies (example, hazardous waste), in addition to those issues with a more obvious impact on agriculture (renewable fuel policies, pesticides, non-point pollution). Given the Biden Administration emphasis on addressing climate change, agricultural interests are expected to play a role in advocating “climate positive” agriculture policies, and could be affected by EPA’s climate initiatives.
The Agriculture Advisor position has potential to provide EPA leadership with input from stakeholders who otherwise may not typically focus on EPA activities. The impact of such input on EPA subsequent actions varies widely across different Administrations. Some Administrations leave the position vacant altogether. Outside groups will be interested in how influential this office will be for the current Administration.