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.

This week's All Things Chemical™ Podcast will be of interest to readers of the Pesticide Law & Policy Blog®. A brief description of the episode written by Lynn L. Bergeson is below.

This week, I sat down with Lisa Campbell, my Partner here at Bergeson & Campbell (B&C®) and its consulting affiliate, The Acta Group (Acta®), and a well-recognized expert on all things regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  With so much attention focused on registering new products to combat COVID-19, we thought it timely to check in again with the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) and see what it is up to.  OPP has been extraordinarily busy since March keeping up with new products to combat the coronavirus and forging new ways of leveraging its resources while maximizing the public health benefits of these new products.

We also discuss the government’s heightened interest in ensuring that marketers of products -- new and existing -- are precluded from placing products on the market that EPA believes are not effective against COVID-19, when they are promoted as effective against the virus.  EPA has been quite aggressive in ensuring that products that claim to be effective in fact are effective.

We then update our listeners on a few other OPP developments unrelated to the pandemic, as OPP’s jurisdiction extends far beyond approving new products to address COVID-19.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES.  THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES.  ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

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Tags: EPA, OPP, Podcast

 

By Lisa M. Campbell, Lara A. Hall, MS, RQAP-GLP, and Heather F. Collins, M.S.

On October 7, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is requesting comments on its draft guidance that would allow registrants, in certain circumstances, to forgo testing chemicals on animal skin to determine whether a pesticide would lead to adverse effects.  This new draft guidance is part of EPA’s continued efforts to reduce animal testing and achieve its goal of eliminating all EPA requests for studies and EPA funding of studies on mammals by 2035.

According to EPA, the draft dermal toxicity guidance would allow applicants to request waivers for acute dermal toxicity studies on single-active ingredients used to develop end-use products.  The new draft guidance also allows EPA to harmonize with the Pest Management Regulatory Agency (PMRA) of Canada, which published guidance on acute dermal toxicity waivers for both formulations and technical chemicals in 2017.  The draft guidance is in addition to the final guidance for waiving acute dermal toxicity tests published by EPA in November 2016 for pesticide formulations.

In developing the guidance, EPA states that it conducted a retrospective analysis of rat acute oral and acute dermal LD50 studies for 249 active ingredients across numerous chemical classes and toxicity categories.  Fumigants and rodenticides were excluded from this analysis, based on their physical state and/or anticipated exposures to them.  EPA concluded that for 67 percent of the 249 technical chemicals, the results of both oral and dermal acute toxicity studies fall within the same Toxicity Category.  For 32 percent of the chemicals, the oral study falls within a lower (i.e., more protective) Toxicity Category; thus, for 99 percent of the chemicals in the analysis, if the dermal study had not been available and labeling had been based only on the Toxicity Category for the oral acute toxicity study, the labeling requirements would have been equally or more protective.  For the two remaining chemicals (less than 1 percent), factors other than the dermal acute toxicity may influence labeling requirements.  EPA concluded that its requirements for such acute dermal toxicity studies provide little to no added value in regulatory decision making.  EPA states that this guidance, when finalized, is expected to reduce the number of test animals used annually by approximately 750, as well as save EPA, industry, and laboratory resources.

EPA states that it believes the retrospective analysis fully supports the conclusion that waivers may be granted for acute dermal toxicity studies for pesticide technical chemicals, except for fumigants and rodenticides.  Waivers may be accepted for fumigants and rodenticides on a case-by-case basis with appropriate scientific rationale.  Once the guidance is issued in final form, EPA states that applicants who wish to pursue waivers for these studies would submit formal waiver requests as part of the registration application through existing processes and cite the guidance as support for the requests.  EPA maintains the ability to request acute dermal toxicity data on a case-by-case basis, but states that it anticipates granting the waiver in most cases.

Comments on the draft guidance are due on or before November 9, 2020, and can be submitted at http://www.regulations.gov under Docket ID No. EPA-HQ-OPP-2016-0093.

EPA also announced the launch of its new webpage that provides metrics and strategies for reducing and replacing animal testing, including links and resources to all pertinent guidance and work plans tied to the larger Toxicology in the 21st Century Initiative across the federal government.  The directive, issued by EPA Administrator Andrew Wheeler in September 2019, calls for EPA to reduce animal testing and to reduce funding 30 percent by 2025 and eliminate it by 2035.  EPA states that its actions to date to support these efforts include:

  • In September 2019, EPA announced $4.25 million in funding for five universities to research and develop alternative test methods for evaluating chemical safety.
  • In December 2019, EPA convened a conference for achieving reduced animal testing in chemical safety research and updated its list of New Approach Methodologies (NAM) that could be used in EPA’s work under the amended Toxic Substances Control Act, including adding 21 new test guidelines related to health and ecological effects and six additional EPA policies that reduce the use of animal testing.
  • In June 2020, EPA released a NAMs work plan that details how EPA plans to develop, test, and apply chemical safety testing approaches without the use of animals.
  • In February 2020, EPA issued final guidance waiving the subacute dietary testing of pesticides on birds when the additional information is unnecessary to support a pesticide registration decision, which is expected to save 720 test animals annually.
  • In July 2020, EPA announced new guidance to reduce unnecessary testing on fish, which is expected to save 240 test animals annually.

EPA will host its Second Annual Conference on the State of the Science on Development and Use of NAMs for Chemical Safety Testing virtually on October 19 and 20, 2020.  Additional information on EPA’s efforts to reduce animal testing is available here.


 

By Timothy D. Backstrom, James V. Aidala, and Kelly N. Garson

On April 23, 2020, the Supreme Court ruled that pollution traveling indirectly to rivers and streams through groundwater can be covered by the Clean Water Act’s (CWA) permitting requirements.  The case, County of Maui, Hawaii v. Hawaii Wildlife Fund, et al, 590 U.S. (2020), concerned whether pollutants discharged from a point source into groundwater, a non-point source, and then conveyed into navigable waters fall within permitting requirements of the CWA.  In a 6-3 Opinion delivered by Justice Breyer, the Court held that the CWA “requires a permit when there is a direct discharge from a point source into navigable waters or when there is the functional equivalent of a direct discharge.” Slip op. at 15.

Under the CWA, a point source is a discernable conveyance such as a pipeline and other conduit, including wells (the Court notes that wells ordinarily result in discharge of pollutants through groundwater). Slip op. at 13.  The case at issue concerned the County of Maui’s (Maui) operation of a wastewater reclamation facility that collected and partially treated sewage before pumping the treated water into four underground injection wells.  From the wells, the treated water traveled half a mile through groundwater into the Pacific Ocean, a navigable water.  Maui had not obtained a permit for the discharge, and in 2012, several environmental groups brought a citizens’ CWA lawsuit against the county.

The legal question of whether the CWA’s permitting program covers pollution that travels from a point source, like a factory discharge pipe or a containment pond, through groundwater before reaching a downstream water has major implications for industries ranging from agriculture to oil and gas.  The Court’s “functional equivalent” standard for the reach of federal regulation is an interpretation that is narrower than the one sought by environmentalists and endorsed by the Ninth U.S. Circuit Court of Appeals, but the Court declined to defer to the U.S. Environmental Protection Agency’s (EPA) 2019 Interpretative Statement.  84 Fed. Reg. 16810, 16824 (April 2019).

EPA’s Interpretive Statement supported the argument of Maui and the U.S. Solicitor General that if any non-point source lies between the point source and the navigable water, a permit is not required for the release.  Groundwater and non-point pollution that is generated, for instance, by rainwater runoff is not covered by the CWA and is regulated by the states.  The Court rejected this interpretation, posing the question: “If that is the correct interpretation of the statute, then why could not the pipe’s owner, seeking to avoid the permit requirement, simply move the pipe back, perhaps only a few yards, so that the pollution must travel through at least some groundwater before reaching the sea?”  Slip op. at 10.  The Court held that “to follow EPA’s reading would open a loophole allowing easy evasion of the statutory provision’s basic purposes.  Such an interpretation is neither persuasive nor reasonable.” Slip op. at 12.

The Court did not adopt the “fairly traceable” standard supported by the environmental groups and the Ninth Circuit either, as its scope would be too broad, and would interfere too seriously with states’ traditional and intended regulatory authority over groundwater and non-source pollution. Slip op. at 7-8.

The “functional equivalent of a direct discharge” standard will require a permit for discharge from any point source directly into navigable waters, and from point sources when the discharge “reaches the same result through roughly similar means.”  The Court identified seven factors that may be relevant in determining whether the discharge comes “from” a point source:

(1) transit time, (2) distance traveled, (3) the nature of the material through which the pollutant travels, (4) the extent to which the pollutant is diluted or chemically changed as it travels, (5) the amount of pollutant entering the navigable waters relative to the amount of the pollutant that leaves the point source, (6) the manner by or area in which the pollutant enters the navigable waters, (7) the degree to which the pollution (at that point) has maintained its specific identity. Slip op. at 16.

The Court notes that time and distance will be important factors in many (though potentially not all) cases.  For example, a distance of a few feet is concretely within the scope of the permitting requirement; a distance of 50 miles that may take a year for the water and perhaps mixing with other materials before reaching the navigable water is indeterminate.

The Court stated that the “functional equivalent” standard will essentially maintain EPA’s longstanding interpretation of the 1972 water law’s requirements prior to the 2019 Interpretive Statement that sought to narrow its reach.  The Court further acknowledges that the new standard may expand the scope of the CWA as it applies to wells and septic systems, but does not expect an “unmanageable expansion” of the permitting program, and expects that EPA and the states will mitigate harms and initiate a best practices permitting policy, and that judges will exercise discretion mindful of the complexities of indirect discharges.  Slip op. at 18.

Commentary

The decision of the Supreme Court to construe National Pollutant Discharge Elimination System permitting requirements to extend to indirect discharges that originate at a point source but travel through groundwater before reaching navigable waters was not particularly surprising.  Reviewing courts have generally been mindful that completely excluding all discharges to groundwater from permitting might encourage dischargers to use discharges to groundwater to evade otherwise applicable control requirements.  Nonetheless, it was somewhat surprising when the Court created a new “functional equivalence” standard that was not specifically advocated by the litigants.

Although the Court clearly intended to adopt a construction that was less expansive than the “fairly traceable” standard adopted by the Ninth Circuit, EPA and the states will have to determine how the seven potentially relevant factors identified by the Court will be utilized in determining when a permit will be required for indirect discharges.  EPA and the states will also have discretion to determine whether there are other “potentially relevant factors applicable to factually different cases” as anticipated by the Court.  Slip op. at 16.  This case involved deliberate discharges of municipal wastewater to underground injection wells, but future policy disputes and litigation are likely to focus on indirect discharges that are more inadvertent in character.  Activities of particular interest include indirect discharges from agriculture, and indirect discharges from impoundments that have been used to collect coal ash, mining tailings, and other types of industrial waste.

In the absence of Congressional intervention to codify clearly what is required, the courts can only do so much.  The Supreme Court has concluded that Congress could not have intended to create a loophole in the water permitting scheme so large as to encourage deliberate evasion, but it falls now to EPA and the states to determine what sort of indirect discharges are “functionally equivalent” to a direct discharge.  Although the Court has afforded considerable latitude to permitting agencies in deciding how to effectuate the new standard, the decision will most likely lead to a new round of contentious litigation before a policy for permitting of indirect discharges can ultimately be adopted.


 

By Lynn L. Bergeson and Carla N. Hutton

As reported in our February 13, 2020 blog item, the U.S. Environmental Protection Agency (EPA) announced on February 12, 2020, that it is seeking public input on a proposal to incorporate a new nanosilver pesticide product into textiles to combat odors, discoloration, and other signs of wear.  The proposed registration decision is for NSPW Nanosilver, and the proposed pesticide product, Polyguard-NSPW Master Batch (Polyguard), will be incorporated into textiles to suppress bacteria, algae, fungus, mold, and mildew, which cause odors, discoloration, stains, and deterioration.  According to EPA, based on its human health and ecological risk assessment, it has preliminarily determined that the new active ingredient in Polyguard meets the regulatory standard under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use as a materials preservative in textiles.  According to a February 27, 2020, memorandum placed in Docket ID EPA-HQ-OPP-2020-0043, EPA received a request to extend the comment period 30 days to allow additional time to review the documentation contained in the docket.  The memorandum states that EPA “feels that 15 additional days should be sufficient to allow for adequate review of the Proposed Decision and supporting documentation.”  Comments are now due March 30, 2020.


 

By Lisa M. Campbell, Lisa R. Burchi and Barbara A. Christianson

On February 28, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a new web portal that is available to the public to search for EPA guidance documents.  The EPA Guidance Portal (Portal) was created under Executive Order 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents,” where agencies are to develop a central web portal for the public to review active guidance documents and the ability to request for modification or withdrawal of the guidance documents. 

Information available about each guidance document listed on the Portal includes:

  • A concise name for the guidance document;
  • The date on which the guidance document was issued;
  • The date on which the guidance document was posted to the web portal
  • An agency unique identifier;
  • A hyperlink to the guidance document;
  • The general topic addressed by the guidance document; and
  • A summary of the guidance documents’ content.

EPA states that the “guidance documents lack the force and effect of law, unless expressly authorized by statute or incorporated into a contract” and EPA “may not cite, use, or rely on any guidance that is not posted on this web area, except to establish historical facts.”

The portal is broken down by office, including regional offices:

  • Office of Air and Radiation (OAR)
  • Office of Chemical Safety and Pollution Prevention (OCSPP)
  • Office of Enforcement and Compliance Assurance (OECA)
  • Office of General Counsel (OGC)
  • Office of International and Tribal Affairs (OITA)
  • Office of Land and Emergency Management (OLEM)
  • Office of Mission Support (OMS)
  • Office of Research and Development (ORD)
  • Office of Water (OW)
  • All EPA Regional offices

Currently, there are a total of 1,735 guidance documents listed under OCSPP.  Within the 1,735 documents, 117 appear to be specific to FIFRA. Examples of guidance documents included in the portal are:

  • Inert Ingredients Overview and Guidance;
  • Exporting Unregistered Pesticides: Foreign Purchaser Acknowledgement Statements;
  • EPA's Regulation of Biotechnology for Use in Pest Management;
  • CPARD USER GUIDE: For State Lead Agency (SLA) and Tribal Representatives with Certification Plans (CPs);
  • Frequent Questions for the 2018 Series 810 – Product Performance Test Guidelines: Antimicrobial Efficacy Test Guidelines;
  • Pesticide Registration Manual;
  • Guidance on FIFRA 24(c) Registrations;
  • Design for the Environment Logo for Antimicrobial Pesticide Products;
  • Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants;
  • Structured Product Labeling (SPL) Draft Implementation Guide with Validation Procedures and User Guide;
  • Reregistration and Other Review Programs Predating Pesticide Registration Review;
  • FIFRA Pesticides Export Policy: Questions & Answers Issue: Research and Development Pesticides; Active Ingredient Concentrations;
  • State FIFRA Issues, Research, and Evaluation Group Final Guidance for State Lead Agencies for the Development and Implementation of Managed Pollinator Protection Plans; and
  • E-FAST, Down the Drain Assessment Model.

Under OECA, there are six documents specific to FIFRA.  The guidance documents included in this portal are:

  • Compliance Advisory: High Number of Complaints Related to Alleged Misuse of Dicamba Raises Concerns;
  • Good Laboratory Practices - Questions and Answers;
  • EPA and Association of American Pesticide Control Officials (AAPCO) Advisory Notice on Pesticide-related E-Commerce;
  • Fact Sheet on Pesticides Sales in E-Commerce;
  • Documents with Questions and Answers on FIFRA Pesticides Export Policy; and
  • FIFRA Pesticide Export Policy: Interpretive Guidance: Multilingual Labeling.

Of note, the portal sets forth an option for petitioning EPA to modify or withdraw a guidance document from the Portal by completing an online form.  The required information to submit using the online form is name, email address, unique identifier of the guidance document, the office and/or region, and comments related to the withdrawal or modification of the guidance document.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on February 12, 2020, that it is seeking public input on a proposal to incorporate a new nanosilver pesticide product into textiles to combat odors, discoloration, and other signs of wear.  The proposed registration decision is for NSPW Nanosilver, and the proposed pesticide product, Polyguard-NSPW Master Batch (Polyguard), will be incorporated into textiles to suppress bacteria, algae, fungus, mold, and mildew, which cause odors, discoloration, stains, and deterioration.  According to EPA, based on its human health and ecological risk assessment, it has preliminarily determined that the new active ingredient in Polyguard meets the regulatory standard under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use as a materials preservative in textiles.  EPA invites public comment on its proposal and preliminary findings.  Comments are due March 13, 2020.  More information is available in Docket ID EPA-HQ-OPP-2020-0043

EPA notes that NSPW Nanosilver was the active ingredient in a previous conditional registration that it granted in 2015, for use as a materials preservative in textiles and plastics.  As reported in our May 31, 2017, memorandum, that decision was challenged, and the U.S. Court of Appeals for the Ninth Circuit “vacated it on grounds that EPA’s public interest finding for granting the registration was without support in the record.”  EPA states that the currently proposed product “is solely for use in specified textiles; therefore, Polyguard will have a more limited use authorization than the previously vacated conditional registration.”  EPA notes that Polyguard will be formulated as a master batch, meaning that NSPW Nanosilver would be embedded within plastic beads or pellets, in contrast to the previous product registration, which was in the form of a liquid suspension.


 

By Timothy D. Backstrom

On February 3, 2020, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of an interim registration review decision for glyphosate.  EPA previously issued a proposed interim registration review decision (PID) for glyphosate for comment in April 2019.  At the time EPA issued the glyphosate PID for comment, EPA also issued a draft human health risk assessment and a preliminary ecological risk assessment for glyphosate.  After reviewing the comments received concerning these assessments, EPA has not made any revisions to either assessment.  EPA has determined that there are no dietary, residential, bystander, or occupational human health risks of concern associated with glyphosate use.   EPA has also determined that there are some potential risks to plants, birds, mammals, and invertebrates from glyphosate use, but that these can be appropriately mitigated by label changes requiring enforceable spray drift management measures and adding a warning concerning the potential hazards to non-target organisms.  EPA also has proposed some new measures to manage the development and spread of herbicide-resistant weeds.  EPA has generally retained the proposed labeling changes identified in the PID, except for some modest adjustments to the proposed language concerning droplet size restrictions and swath displacement restrictions for aerial applications, and removal of spray drift advisory language for airblast application.

Despite considerable publicity recently concerning purported carcinogenic risks for glyphosate, including allegations that human exposure to glyphosate can be linked to non-Hodgkin's lymphoma, EPA has determined that glyphosate is not likely to be a human carcinogen and has steadfastly adhered to this basic conclusion.  EPA made this determination for glyphosate after convening a meeting of the FIFRA Scientific Advisory Panel (SAP) to evaluate the carcinogenic potential of glyphosate in 2016.

The general purposes of the PID process are to allow EPA to move forward with aspects of the registration review process that are essentially complete, and to adopt interim risk mitigation measures, even though some of the actions required prior to a final registration review decision are not yet complete.  As in the case of most recent PIDs, EPA states that it has not yet made a complete determination concerning potential effects or any required consultation for glyphosate under the Endangered Species Act (ESA), nor has it made a determination for glyphosate under the Endocrine Disruptor Screening Program (EDSP).  In addition, EPA is considering a pending petition to prohibit preharvest use of glyphosate on oats, and to reduce the tolerance for glyphosate in oats, that was filed in 2018 by the Environmental Working Group and others.  This petition is predicated on the potential carcinogenicity of glyphosate.  Finally, EPA is still evaluating the question of whether additional data will be needed to evaluate properly the potential effects of glyphosate use on pollinators.  

More information on glyphosate and EPA’s interim registration review decision is available here.

Commentary

EPA's interim registration review decision for glyphosate is predicated on EPA's prior determination that the best available scientific data do not substantiate the claims that glyphosate may be a human carcinogen.  As discussed above, the potential carcinogenicity of glyphosate was thoroughly evaluated by the FIFRA SAP in 2016.  EPA's determination after that review that glyphosate is not a carcinogen has also been supported by other pesticide regulatory authorities.  Nonetheless, EPA's view conflicts with a cancer classification decision for glyphosate by the World Health Organization (WHO), and with some recent tort case decisions that were based on the premise that there is a credible linkage between glyphosate exposure and human cancer.  EPA recently announced that it would not permit or approve any cancer warning statements for inclusion in glyphosate labeling (including any statements that may be required pursuant to California's Prop 65) because EPA believes that such statements are false or misleading and would therefore cause the pesticides to be "misbranded."

It appears probable there will be continued litigation based on the purported carcinogenicity of glyphosate, along with various proposals to ban or restrict glyphosate use.  The pending petition to restrict use of glyphosate on oats that was filed by EWG, et al., is expressly predicated on the potential carcinogenicity of glyphosate, so it appears probable that this petition will ultimately be denied by EPA.  Nonetheless, unless WHO decides to reverse or modify its classification determination, or the courts determine that the recent tort awards for glyphosate users cannot be scientifically substantiated, the battles over the claimed carcinogenicity of glyphosate may persist for years.

More information on glyphosate issues is available on our blog under keyword glyphosate.


 

By Heather F. Collins, M.S.

The March 1, 2020, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2019 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 Timothy D. Backstrom

On January 9, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced the launch of a new website created in coordination with the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) that provides information about actions the federal government is taking to oversee the development of agricultural biotechnology products.  This “one-stop-shop” website was created under the direction of Executive Order (EO) “Modernizing the Regulatory Framework for Agricultural Biotechnology Products.”

EPA regulates biotechnology-based pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and residues from such pesticides under the Federal Food, Drug and Cosmetic Act (FFDCA).  EPA also regulates under the Toxic Substances Control Act (TSCA) certain new microorganisms that are not subject to regulation under other statutes.  USDA regulates certain new biotechnology products under the Plant Protection Act (PPA), including agricultural crops that have been modified to be resistant to conventional pesticides.  FDA regulates the safety of human and animal foods produced using biotechnology, including genetically modified agricultural crops and animals, and the safety of drugs and human biologics produced with biotechnology, under the FFDCA.

The website, The Unified Website for Biotechnology Regulation, describes the federal review process for biotechnology products, outline’s each agency’s role in regulating biotechnology products, and allows users to submit questions to the three agencies.  EPA Administrator Andrew Wheeler states that the new website “will help provide regulatory certainty and clarity to our nation’s farmers and producers by bringing together information on the full suite of actions the Trump Administration is taking to safely reduce unnecessary regulations and break down barriers for these biotechnology products in the marketplace.”

Commentary

In recent years, a number of Non-Governmental Organizations (NGO) have raised concerns regarding the risks from products that have been genetically modified using biotechnology, including agricultural crops that have been genetically modified to improve pesticide or disease resistance, and agricultural animals that have been genetically modified to enhance food production.  In some instances, farmers have also expressed concern that crops with novel traits may exchange genetic information with other plant strains or species.  Implicit in all of this criticism is a presumption that the agencies with regulatory jurisdiction over these novel organisms have not adequately prevented or mitigated the risks associated with biotechnology.

In contrast, proponents of biotechnology have complained that regulatory requirements imposed by the responsible agencies have stifled useful innovation and have requested relief from regulatory requirements that they contend have impeded or slowed introduction of new products of agricultural biotechnology.  The Executive Order that underlies the new website seeks to streamline the administrative process for introducing novel agricultural products without increasing potential risks of biotechnology.

Additional information on how EPA regulates biotechnology products is available here.


 

By Heather F. Collins, M.S.

The January 15, 2020, deadline for payment of the U.S. Environmental Protection Agency’s (EPA) annual maintenance fee for pesticide registrations is fast approaching.  The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 4(i)(5) requires that 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 2020 is $4,000 for each registration up to the maximum fees which can be assessed to a single registrant.  Each registrant of a pesticide must pay the annual fee and mail the response to EPA by Wednesday, January 15, 2020.  Registrations for which the fee is not paid will be canceled, by order and without a hearing.

For certain qualified small businesses, the first product registration maintenance fee may be reduced by 25 percent, if the applicant meets the following criteria:

  1. The applicant has 500 or fewer employees globally;
  2. During the 3-year period prior to the most recent maintenance fee billing cycle the applicant has average annual gross revenue from all sources that do not exceed $10,000,000; and
  3. The applicant holds a total of 5 or fewer registrations subject to the maintenance fee.

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.


 
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