By Heather F. Collins, M.S. and Barbara A. Christianson
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:
- Crop Group 6: Legume Vegetables;
- Crop Group 7: Foliage of Legume Vegetables;
- Crop Group 15: Cereal Grains; and
- Crop Group 16: Forage, Fodder, and Straw of Cereal Grains.
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:
- Enhance EPA’s ability to conduct food safety evaluations for tolerance-setting purposes;
- Promote global harmonization of food safety standards;
- Reduce regulatory burden; and
- Ensure food safety for agricultural goods.
Comments on the proposed rule are due on or before March 11, 2022, in docket EPA-HQ-OPP-2006-0766 at www.regulations.gov.
By Heather F. Collins, M.S.
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.
By Lisa R. Burchi and Barbara A. Christianson
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:
Although not altering the rights of parties outside of EPA, the change from an Agency practice to a rule of procedure reduces the flexibility that is inherent in implementing agency policies in a case-by-case manner. The procedures for inspections must be adaptable to the site-specific conditions that the Agency faces in conducting its investigations. By rescinding the 2020 inspection rule, EPA is restoring the flexibility needed when carrying out civil inspections under a myriad of circumstances.
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.
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.
“What to Expect in Chemicals in 2022”
January 26, 2022, 12:00 p.m. EST
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.
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.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) product approval process is protracted, and often challenging, for any given product. Further complicating matters are the ensuing -- often expensive -- data, recordkeeping, and advocacy requirements associated with obtaining FIFRA product approvals. These courses are intended to provide on-demand knowledge to assist with the strategic planning that is critical to global product development. The subtleties of FIFRA are presented in a clear and business-focused context.
FIFRA Tutor online training courses include video lessons and detailed handout materials, including copies of all presentations and relevant course materials from the U.S. Environmental Protection Agency (EPA) and other sources. The newly-released modules cover:
- F101 -- An Overview of FIFRA
- F102 -- Import and Export of Pesticides
- F109 -- Defining Tolerances and Their Regulation
- F110 -- Adverse Effects Reporting Requirements
Additional modules in the FIFRA Tutor curriculum will be released throughout 2022.
FIFRA Tutor courses are developed and presented by members of B&C’s renowned FIFRA practice group, which includes former EPA officials, an extensive scientific staff, and a robust and highly experienced team of lawyers and non-lawyer professionals extremely well versed in all aspects of FIFRA law, regulation, policy, compliance, and litigation.
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.
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.
By Heather F. Collins, M.S. and Barbara A. Christianson
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:
- produce and store cultures of drug-resistant C. auris, and
- evaluate the effectiveness of antimicrobial products intended to treat surfaces contaminated with drug-resistant C. auris.
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.
By James V. Aidala
In early July 1996, I was returning on a flight from Amman, Jordan, wondering what kind of negotiation we in the Clinton Administration faced in completing the legislative text of what became the Food Quality Protection Act (FQPA). (I had been asked to go to Jordan to visit the Jordanian pesticide regulatory program by a friend who was a senior official at the State Department. The result of my visit may have played a very, very small role in the Middle East peace process -- but that is another story for another time).
Some weeks earlier, I had been approached by Congressional staff members whom I knew from my previous job at the Congressional Research Service (CRS) as the subject area expert on the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and pesticide regulation. I joined the Clinton Administration as a political deputy in the U.S. Environmental Protection Agency’s (EPA) Office of Prevention, Pesticides, and Toxic Substances (OPPTS, now renamed as the Office of Chemical Safety and Pollution Prevention (OCSPP)). Dr. Lynn Goldman was the Assistant Administrator who had recruited me to join the efforts to reform, that is, modernize, the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FFDCA). Over the years since it was enacted in 1958, risk assessment methods and our understanding of possible cancer risks had changed greatly.
Setting the Context
In 1989, the National Academy of Sciences issued a report on “The Delaney Paradox,” examining how the Delaney Clause ironically prevented safer new pesticides from entering the market. After an important court decision (Les v. Riley), EPA was told that even if it was undesirable public policy, the law can only be changed by Congress. As EPA went along with its work, many feared that numerous pesticides might be forced off the market even if, using modern evaluation policies, they presented little risk or were in fact safer than the alternatives.
During this time, advocacy groups were concerned that the then-current law was not protective enough of the possible risks to children’s diets. A simple way to say this is, for purposes of risk assessment: “Children are not little adults,” and supporters emphasized that dietary risk assessments by EPA should pay special attention to possible children’s risk given differences in metabolism, growth stages, and other important physiological characteristics.
This led to another National Academy of Sciences report in 1994 on “Pesticides in the Diets of Infants and Children,” which recommended that pesticide regulation include particular attention and possibly greater regulation of estimated dietary risks from pesticides. Given that the new Assistant Administrator of OPPTS was Dr. Lynn Goldman, a pediatrician, this concern was a priority for the Clinton Administration.
“The Gingrich Revolution”
A less noticed irony, but also important to the history of FQPA, is the change in party control of the House of Representatives, led by Representative Newt Gingrich (R-GA) and the “Contract with America” during the 1994 elections. Unexpectedly, the Republicans had the majority in the House for the first time in 40 years, and they elected Representative Gingrich Speaker of the House.
Much longer stories have been and will be written, but shortly after taking power in the House in January 1995, the Republicans were viewed as letting lobbyists run amok -- even suggesting amendments to environmental laws while lobbyists were sitting on the dais of Committee meetings. By the end of 1995 and going into an election year in 1996, “word was” the leadership, at least on the House Energy and Commerce Committee -- chaired by Representative Thomas Bliley (R-VA) -- was looking for a “green vote” to offset the image of an anti-environment House majority. Led by staff from the office of Chair Bliley and Representative John Dingell (D-MI), who was the senior Democrat on the Committee, a draft of a compromise bill was floated and made its way to my office at EPA.
Meantime, during the previous Congress (103rd Congress, 1993 - 1994), a team of EPA staff, led by Jim Jones (a later even more famous name in EPA pesticide regulation) of the Assistant Administrator’s office, along with staff from the Office of Pesticide Programs (OPP) and the Office of General Counsel (OGC), and staff from the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) (it takes a village), had developed a Clinton Administration bill that did not gather much support during 1994. The legislation did have the core concepts of “fixing Delaney” and including the “reasonable certainty of no harm” standard, and it incorporated strong protections about possible risks from residues in the diets of infants and children.
In the new Congress (the 104th), there was some action during 1995 in the House Agriculture Committee on FIFRA issues related to antimicrobial products, minor uses of pesticides, and ways to prod the registration process to become more predictable and timely (this was before the Pesticide Registration Improvement Act (PRIA)). The FIFRA amendments were not viewed as controversial and were successfully discussed between both sides of the aisle (the Agriculture Committees were much more bipartisan in those days). By itself, that package was not likely to make it through the legislative gauntlet, given the shift in political power on the Hill.
Also in 1995, Carol Browner (the EPA Administrator) cautioned us that successful bipartisan legislation was unlikely, so not much effort should be invested, given other priorities.
The key event came in the late spring of 1996, when we first saw a draft of the legislation floated by the staff of Representatives Bliley and Dingell. It was far from perfect, but it included the core elements of what the Administration had proposed in the previous Congress. Since that earlier bill had been drafted with the coordination of EPA, FDA, and USDA, if it had the essential ingredients, we thought it might be a viable vehicle for further discussion. We also sought comment from some of the influential environmental groups that had been disappointed in the Administration’s legislation in the previous Congress. Suffice it to say, inclusion of the core elements of a tough standard (reasonable certainty of no harm) and special protections regarding children’s diets made the proposals a “possible” vehicle for further discussion.
We also started to have discussions with the staff of Representative Waxman (D-CA) in the House and Senator Kennedy (D-MA). Representative Waxman was the ranking Democrat on the Energy and Commerce Subcommittee, and Senator Kennedy was the ranking Democrat on the Labor Committee, which had jurisdiction over the FFDCA.
Back to July 1996
To shorten the story, we had intense, long meetings with the various interested parties -- pesticide registrants; environmental groups; trade associations; agency staff at EPA, FDA, and USDA; Congressional staff from the authorizing Committees; and Administration leaders within the agencies and the White House. In an amazingly short time, we came to agreement over the text, which is now FQPA. Representatives Waxman and Roberts (R-KS -- Chair of the House Agriculture Committee) held a press event about the historic compromise -- even more historic since the two Representatives rarely agreed on significant legislation. Their joint endorsement and statement of support signaled to members of both parties on both sides of Capitol Hill that this was an unusual, and important, compromise. The Congressional staff then recognized the next hurdle: the August recess was approaching fast, and if not enacted into law by then, the delay could be fatal, or at least make matters more complicated, as the multitude of interest groups would likely pick apart and want further changes to the agreement that had been reached. So the rush was on to get the “green vote” to the floor of the House and Senate.
Some last-moment hiccups took a little more time. Senator Lugar (R-IN), the Senate Agriculture Committee Chair, wanted a hearing to at least review the legislation. This was not a huge hurdle, but finding time on the floor was a race against the clock before the August recess. The House was the first to vote on July 23, 1996. The bill was approved with a surprising unanimous roll call vote in the majority Republican House (the vote was 417-0 with 16 not voting). Unanimous bipartisan support! -- imagine that in today’s world.
Then, with a sprinkling of clarifying (that is, reassuring) pieces of correspondence, the Senate agreed to the House legislation under unanimous consent. (In fact, for any trivia nuts out there, if you watch the C-SPAN video of how long the Senate deliberation lasted at the end of the day on July 24, 1996 -- the request for unanimous consent and agreement clocks in under 30 seconds.)
So with unanimous support in both the House and the Senate, FQPA was approved.
One Last Step
One very important last step was needed before FQPA became law -- the President needed to sign the legislation. That happened at the White House when H.R. 1627 was signed by President Clinton on August 3, 1996.
By Kelly N. Garson and Barbara A. Christianson
On August 25, 2021, the U.S. Environmental Protection Agency (EPA) announced that it issued a penalty against Seychelle Environmental Technologies, Inc. (Seychelle), based in Aliso Viejo, California, for violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The violations, which EPA states that Seychelle has since corrected, involved the sale of unregistered antimicrobial products and the manufacture of products in an unregistered establishment.
According to EPA, in 2017 and 2018, Seychelle sold a collection of related water filtration products known as the “Seychelle Standard Filter” and the “Seychelle Advanced Filter.” EPA states that these Seychelle filter products made “numerous” antimicrobial claims, and thus under FIFRA, EPA considered these products to be pesticides that must be registered with EPA. Additionally, under FIFRA, pesticide manufacturers must register their facilities with EPA as establishments and annually report their pesticide production. Since Seychelle’s water filter products were not produced in an EPA-registered establishment, EPA determined there was another FIFRA violation. Based on the sale or distribution of an unregistered pesticide and the unregistered establishment, EPA assessed a penalty to Seychelle in the amount of $150,000 (USD).
By James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson
On August 18, 2021, the U.S. Environmental Protection Agency (EPA) announced that it will stop the use of the pesticide chlorpyrifos on all food. In the pre-publication of the Federal Register notice released on August 19, 2021, EPA revoked all “tolerances” for chlorpyrifos, which establish an amount of a pesticide that is allowed on food. In addition, EPA states that it will issue a Notice of Intent to Cancel under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to cancel registered food uses of chlorpyrifos associated with the revoked tolerances. EPA has stated the cancellation order will follow in approximately six months after the tolerance revocations.
EPA’s announcement responds to the Ninth Circuit’s order, issued on April 29, 2021, that vacated EPA orders issued in 2017 and 2019 denying a 2007 petition filed by Pesticide Action Network North America and Natural Resources Defense Council. That petition requested that EPA revoke all chlorpyrifos tolerances, or the maximum allowed residue levels in food, because those tolerances were not safe, in part due to the potential for neurodevelopmental effects in children. The 2017 and 2019 orders denying the 2007 petition were challenged in the Ninth Circuit by a coalition of farmworker, health, environmental, and other groups.
In its order, the Ninth Circuit found that “...EPA had abdicated its statutory duty under the Federal Food, Drug and Cosmetic Act (FFDCA) ...” to “conclude, to the statutorily required standard of reasonable certainty, that the present tolerances caused no harm.” After vacating the 2017 and 2019 orders, the court remanded the matter to EPA with instructions to: “(1) grant the 2007 Petition; (2) issue a final regulation within 60 days following issuance of the mandate that either (a) revokes all chlorpyrifos tolerances or (b) modifies chlorpyrifos tolerances and simultaneously certifies that, with the tolerances so modified, the EPA ‘has determined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information,’ including for ‘infants and children’; and (3) modify or cancel related FIFRA registrations for food use in a timely fashion consistent with the requirements of 21 U.S.C. § 346a(a)(1).”
In its announcement, EPA states that it has determined that the current aggregate exposures from the use of chlorpyrifos do not meet the legally required safety standard that there is a reasonable certainty that no harm will result from such exposures. Chlorpyrifos is an organophosphate insecticide used for a large variety of agricultural uses and has been continually reviewed with regard to potential adverse effects, including possible neurological effects in children, which has been the subject of considerable controversy for many years. EPA’s announcement notes that a number of other countries, including the European Union and Canada, and some states, including California, Hawaii, New York, Maryland, and Oregon, have taken similar action to restrict the use of this pesticide on food.
EPA states its action also will be incorporated into the ongoing registration review for chlorpyrifos. EPA is continuing to review the comments submitted on the chlorpyrifos proposed interim decision, draft revised human health risk assessment, and draft ecological risk assessment. These documents are available in the chlorpyrifos registration review docket EPA-HQ-OPP-2008-0850 at www.regulations.gov and a discussion of these issues is available on our blog here.
After considering public comments, EPA will proceed with its registration review of the remaining non-food uses of chlorpyrifos by issuing the interim decision, which may consider additional measures to reduce human health and ecological risks.
Separate from any issues of science, evidence, or interpretation, the FFDCA’s channels of trade provision is designed to address what happens if EPA cancels a pesticide product for not meeting Food Quality Protection Act (FQPA) standards and then revokes the tolerance. EPA’s initial description of its decision was unclear on this important point regarding the status of food already in the channels of trade that may contain chlorpyrifos residues.
EPA statements at an August 18, 2021, phone briefing with agricultural stakeholders appeared to present a position that the tolerance revocations would be in effect immediately upon publication in the Federal Register. This implied that there may be an immediate revocation of the tolerances before any parallel action to cancel the associated pesticide registrations. The pre-publication version of the notice clarified that the revocation of chlorpyrifos tolerances would not become effective until six months after the publication of the notice in the Federal Register. As of August 24, 2021, the notice has not been published in the Federal Register.
This revocation delay of six months aligns with the statement also made by EPA to cancel the registration of chlorpyrifos food use products six months after the revocation notice. EPA may face questions from some of the groups that have been advocating for this type of EPA action concerning why, if these tolerances need to be revoked, the use of the pesticide will continue in effect for the remainder of this growing season. Ed Messina, Office Director of the Office of Pesticide Programs, made a glancing reference to this at the phone conference when he stated EPA and the U.S. Food and Drug Administration (FDA) are “having discussions.”
According to EPA, use of chlorpyrifos has been in decline due to restrictions at the state level and reduced production. EPA also notes that some alternatives have been registered in recent years for most crops, other chemistries and insect growth regulators are available for certain target pests, and that EPA is committed to reviewing replacements for and alternatives to chlorpyrifos. Some growers, however, are using registered chlorpyrifos products on food crops and hoped to be able to continue certain uses.
EPA states in the pre-publication notice that some uses in certain areas appear to be able to meet the FQPA standard as evaluated in its 2016 and 2020 risk assessment documents, even if including the full 10x FQPA “extra” safety factor (these assessments are the reference documents EPA cites in its revocation notice). EPA further states that the Ninth Circuit’s order did not provide EPA with time to consider further changes to the use patterns or label restrictions to align with such changes hinted at in the revocation notice, and so EPA is issuing the revocation decision now. This begs the question of whether EPA might consider some continued uses in the future, although even considering any “new” tolerance would be very controversial.
In addition, none of the current actions affect (for now) the tolerances for stored grains using the sister chemical (chlorpyrifos-methyl) with a similar toxicological profile. There also are non-food use applications of chlorpyrifos, for example, mosquito control application of chlorpyrifos sprayed over a large area, that are not affected by the tolerance revocation.
This mix of messages may not be easy to explain to users and the consuming public.
Issues regarding the timing of the revocations and continued uses are also likely to present challenges for FDA. For example, there are various blended commodities (e.g., animal feed grain, possibly co-mingling harvests from different times) where FDA may be unable to determine what part of any enforcement sample came from a particular date of use.
The orderly transition for treated commodities was designed to avoid public and grower confusion that characterized the episodes of StarLink corn chaos in 2000 or the Cheerios contamination incident in 1994 involving a reported over 100 million boxes of cereal that were eventually destroyed. EPA cites international trade obligations as another reason for the coordinated actions effective in six months to notify foreign trading partners with a “reasonable interval” for adjusting to a changed regulatory situation.
Additional information on chlorpyrifos is available on our blog.
By Heather F. Collins, M.S. and Barbara A. Christianson
On August 17, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is now accepting official Foreign Purchaser Acknowledgement Statements (FPAS) and FPAS annual summaries through the Central Data Exchange Pesticide Submission Portal (CDX PSP). EPA states this improved process allows for pesticide exporters to submit an FPAS electronically rather than physically mailing them, providing a key flexibility during the COVID-19 public health emergency. According to the Federal Register notice, an FPAS may be submitted using CDX PSP as of August 18, 2021. 86 Fed. Reg. 46246.
Pesticides intended solely for export from the U.S. to a foreign country are not required to be registered in the U.S., but exporters must submit an FPAS to EPA to comply with requirements under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 17(a)(2). An FPAS includes critical information about the pesticide intended for export, which EPA uses to notify the Designated National Authority of the importing country.
Exporters have two options for complying with FIFRA Section 17(a) and 40 C.F.R. Section 168.75 through submission of an FPAS to EPA: per-shipment reporting and annual reporting.
Per-Shipment Reporting: To comply with requirements for per-shipment reporting, the exporter must provide EPA with the signed purchaser acknowledgement statement and the accompanying certification for each export within seven working days of the exporter’s receipt of the signed statement or by the date of export (whichever occurs first). The exporter must continue to submit this documentation prior to each shipment.
Annual Reporting: The exporter must submit a signed per-shipment purchaser acknowledgement statement for the first shipment each calendar year of an unregistered pesticide product to a particular purchaser and an annual summary of shipments to that purchaser. This FPAS should indicate that the exporter is choosing to provide an annual summary and certifying that the shipment in the FPAS was the first of the calendar year. When using the annual reporting option, the exporter is required to submit an annual report for each unregistered pesticide exported within the preceding calendar year. The exporter must submit the annual summary no later than March 1 of the following calendar year.
The annual summary report must be in writing, signed by the exporter, and include the following information:
- The dates of each shipment of the pesticide exported to the foreign purchaser during that calendar year; and
- If known, or reasonably ascertainable, the country or countries of final destination of the export shipments.
Information on the required contents of FPAS about submitting statements electronically is available here.