By Lisa M. Campbell and Timothy D. Backstrom
On March 8, 2016, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register stating that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) will hold a three-day meeting scheduled for April 19-21, 2016, from 9:00 a.m. to 5:00 p.m. (EDT) to consider and review Chlorpyrifos: Analysis of Biomonitoring Data. The meeting will be held at EPA’s Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington, Virginia 22202. The meeting will be webcast. More information will be posted online.
The notice states that written comments are encouraged through April 5, 2016, and that requests for oral comments are encouraged to be submitted by April 12, 2016, but that both may be submitted until the date of the meeting. Nominations of candidates to serve as ad hoc members of FIFRA SAP for the meeting are requested on or before March 23, 2016.
In this meeting, EPA states that it will solicit comment from FIFRA SAP on the evaluation of biomonitoring data using the physiologically-based pharmacokinetic (PBPK) model, proposed points of departure and extrapolation/uncertainty factors, and examples of a proposed approach to use the PBPK model to simulate internal doses of chlorpyrifos from current exposure patterns from drinking water, food, and worker exposure. The FIFRA SAP has been reviewing the human health effects of chlorpyrifos since 2008. The notice states that “at this point in time, the Agency’s analysis of biomonitoring data from the cord blood collected as part of the Columbia University epidemiology studies has progressed to a point where peer review would be useful” and that “[s]pecifically, the Agency has done additional characterization of the pharmacokinetic profile of simulated exposures from oral and dermal exposures using the PBPK model.”
The notice states that in 2008 and 2012, the FIFRA SAP “cautioned EPA against using the biomonitoring data from epidemiology studies … to directly derive points of departure due to uncertainties associated with a lack of knowledge about timing of indoor chlorpyrifos applications and a single measure of exposure (cord blood).” The 2012 FIFRA SAP recommended that EPA use the PBPK model to further characterize the dose estimates in the epidemiology studies.
The notice states that EPA would have preferred to complete its analysis of the available biomonitoring prior to commencing rulemaking, but that the timing for the proposal was directed by the U.S. Court of Appeals for the Ninth Circuit, which ordered EPA to respond to an administrative petition to revoke all chlorpyrifos tolerances by October 31, 2015.
More information on the Ninth Circuit case is available in our blog item Circuit Court Grants Writ of Mandamus Requiring EPA to Act on Petition to Ban Chlorpyrifos.
EPA’s decision to utilize biomonitoring data that was collected as part of the Columbia University epidemiology studies for chlorpyrifos to derive proposed points of departure for risk assessment purposes will be highly controversial. If EPA proceeds to use biomonitoring data from epidemiological studies to derive points of departure for risk assessment purposes, the implications for all pesticide product risk assessments could be significant. Whether EPA can defensibly do so from both a scientific and legal standpoint is a subject that will likely be debated strongly. All pesticide registrants should monitor these developments closely.
By Lisa M. Campbell and Timothy D. Backstrom
On February 29, 2016, the U.S. Environmental Protection Agency (EPA) released a prepublication copy of a notice of intent to cancel all Bayer CropScience, LP and Nichino America, Inc. (BCS/NAI) flubendiamide products. The affected products are:
- EPA Reg. No. 264-1025 -- BELT SC Insecticide;
- EPA Reg. No. 71711-26 -- FLUBENDIAMIDE Technical;
- EPA Reg. No. 71711-32 -- VETICA Insecticide; and
- EPA Reg. No. 71711-33 -- TOURISMO Insecticide.
The cancellation notice was issued by EPA, pursuant to Section 6(e) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and announces EPA’s intent to cancel the registration of these four products based on the registrants’ failure to comply with a required condition of their registrations. Under this condition, which EPA alleges was agreed to by the registrants, each flunbendiamide registrant is required to submit a voluntary cancellation request if EPA finds that the product causes unreasonable adverse effects on the environment.
EPA made such a finding of unreasonable adverse effects in a decision memorandum issued on January 29, 2016, but BCS/NAI has rejected EPA’s request to submit a voluntary cancellation. More information on BCS/NAI’s refusal to submit a request for voluntary cancellation is available in our blog item Bayer Announces That It Will Not Submit Voluntary Cancellation Requests for Flubendiamide.
EPA’s finding of unreasonable adverse effects is based on the purported risk to aquatic invertebrates associated with flubendiamide. More information on EPA’s rationale, including the decision memorandum, is available on EPA’s website. After the cancellation notice is published, each registrant will have 30 days to request a hearing concerning the notice. FIFRA Section 6(e) provides that the only matters that may be considered in the resulting hearing are whether the registrants have complied with the condition in question and whether EPA’s determination on existing stocks is consistent with FIFRA. In contrast, the registrants have stated that EPA is required to provide an adjudicatory hearing concerning the substantive basis for EPA’s determination that the products in question cause unreasonable adverse effects on the environment.
The dispute between BCS/NAI and EPA concerning cancellation of the conditional registrations for flubendiamide products will be carefully watched by the pesticide industry. The critical issue is whether EPA can effectively circumvent the adjudicatory hearing that would otherwise be available on the substance of EPA’s determination concerning risks and benefits by imposing a condition that requires affected registrants to accept EPA’s determination. EPA will argue that the registrants accepted the condition in question when the registrations for flubendiamide were first issued. The registrants will argue that EPA may not use such a condition to constrain hearing rights because this contravenes the intent of FIFRA.
By Lisa M. Campbell and Timothy D. Backstrom
On February 10, 2016, the U.S. Environmental Protection Agency (EPA) announced it was initiating an external peer review of the updated draft protocol for testing the antimicrobial efficacy of copper-containing surface products. The products in question are hard surface copper-containing surface products such as door handles, light switch panels, and bed rails, which are utilized for their antimicrobial characteristics. EPA states that “the testing described in this draft protocol is designed to support registration of copper-containing surface products (such as door knobs or other items that are not intended for food contact) that bear sanitizer claims.” Numerous changes have been made to the draft, including changes to the test microbes, culture preparation, quality control process, and product characterization. Following completion of the review, EPA states that it will evaluate the findings and revise the draft as appropriate prior to posting the final protocol.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA evaluates the efficacy of antimicrobial products intended to control pathogens that can be detrimental to public health. EPA indicates that antimicrobial efficacy testing of copper-containing surface products poses challenges because of the prolonged product life span, the likelihood that cleaning and disinfecting agents would be used on the surfaces, and the wide variation in potential product forms and use patterns. EPA states the following regarding the protocols and how they will affect the test results:
- This protocol is designed to address these issues by including a product characterization component that challenges the product’s physical durability and chemical stability when used as proposed;
- The efficacy assessment component of the protocol involves evaluation of the performance of two product manufacturing lots against two pathogenic microorganisms -- Staphylococcus aureus and Pseudomonas aeruginosa; and
- The efficacy test results, in combination with the product durability/stability component, will be used to determine the sanitizing activity of the copper-containing surface.
More information is available on EPA’s Antimicrobial Pesticide Registration website. Information regarding other antimicrobial pesticide issues is available in our blog items EPA Posts Revised Antimicrobial Pesticides Use Site Index and EPA Releases Guidance Document: Antimicrobial Pesticides Use Site Index.
Products that are intended to have pesticidal efficacy over a protracted period require testing that differs materially from those pesticides that are only effective for a transient period and, thus, must be used repeatedly. Some believe copper-containing surfaces have great promise as antimicrobial sanitizers, particularly in health care environments where limiting patient exposure to potential pathogens has become a critical institutional concern. EPA’s enhanced test protocols are intended to address questions EPA and others have raised concerning the continued efficacy of a copper-containing surface over a prolonged life span, and the potential impact of cleaning and disinfecting agents.
By Susan M. Kirsch
On January 26, 2016, the U.S. Environmental Protection Agency (EPA) published its draft National Pollutant Discharge Elimination System (NPDES) General Permit for Discharges from the Application of Pesticides in the Federal Register, which applies to discharges of pesticides to waters of the United States. EPA is requesting comments on the draft permit by March 11, 2016. This draft 2016 pesticide general permit (PGP) is largely an updated version of the 2011 PGP, which will expire on October 31, 2016. EPA’s permit would apply to Maine, New Hampshire, New Mexico, Idaho, and the District of Columbia; Puerto Rico and certain other territories; as well as Indian lands and federal facilities in other states that are covered by state-developed PGPs. Separately, 46 states must update their existing permits, and some states have already begun this process or have already reissued permits within the last year.
The draft 2016 PGP retains coverage of the previous pesticide use patterns (mosquito/flying insect; weed and algae; animal pest; and forest canopy), and leaves unchanged the reliance on technology-based effluent limitations (TBELs) to satisfy permit requirements, which require proper maintenance and calibration of equipment along with visual inspections to minimize discharges and meet water quality standards and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) label requirements. The draft 2016 PGP also retains the distinctions in compliance requirements of “For-hire Applicators” and “Decision Makers,” and includes the same requirements for recordkeeping and reporting of adverse incidents. The draft permit now mandates electronic reporting, which will make Notice of Intent (NOI) and Annual Report submissions public on EPA’s e-reporting website. The draft permit retains the “joint and several liability” provision that would extend potential legal risks to all parties involved in decision-making and application of pesticides. In spite of the lack of new or altered provisions, there are some aspects of the draft 2016 PGP that could signal an EPA policy change going forward, and could potentially appear in the final version of the permit. These areas include:
- Absence of a definition for “Waters of the U.S.,” which could create confusion as to the scope of jurisdiction;
- An ongoing Endangered Species Act (ESA) consultation, which could expand the list of requirements included in the final permit;
- Request for comments on whether water quality-based effluent limitations (WQBELs), such as water quality monitoring and fish tissue testing (i.e., laboratory studies), should be included in the final permit;
- Request for comments on whether additional information should be included in NOI submissions, including whether the treatment area includes a source water for public drinking water supplies; and
- An expanded discussion of required compliance with all other applicable state and federal laws, including FIFRA storage and handling requirements, which could be perceived to attach Clean Water Act liability to a PGP permittee’s violations of FIFRA and other laws.
EPA’s webpage for pesticide NPDES permitting includes links to the draft permit, fact sheet, and Federal Register docket.
By Lisa M. Campbell and James V. Aidala
On February 1, 2016, the U.S. Environmental Protection Agency (EPA) announced that Yu-Ting Guilaran has been selected as the new Director of the Pesticide Re-Evaluation Division (PRD) within the Office of Pesticide Programs (OPP), effective February 7, 2016. Yu-Ting has been the Biological and Economic Analysis Division (BEAD) Director since 2013, and with the agency for nearly 25 years. She has worked in EPA’s Office of Water, Office of International and Tribal Affairs, and Region 10’s Superfund program prior to joining OPP. Yu-Ting holds a BS and a MS Degree in Civil Engineering with emphasis in environmental engineering from the University of Washington in Seattle. Wynne Miller will serve as acting Director for BEAD until that position is filled.
By Lisa M. Campbell and Margaret R. Graham
On January 28, 2016, in docket EPA–HQ–OPP–2015–0302, the U.S. Environmental Protection Agency (EPA) posted its revised Antimicrobial Pesticides Use Site Index (USI). In the USI, EPA states that it “has developed [the USI] to provide guidance about the antimicrobial pesticide use sites associated with these antimicrobial pesticide use patterns,” and it “is a guidance document to assist applicants in identifying the data that are necessary to support registration of products and to determine if labeled uses necessitate establishment of a tolerance or exemption from the requirement of a tolerance.” EPA also posted a Response to Public Comments which stated that there have been a number of changes based on comments received, specifically from the American Chemistry Council’s Biocides Panel (ACC or Panel) and the Consumer Specialty Products Association (CSPA). These changes include:
- Clarifying that the USI is a guidance document and that the sites in the USI are not intended for use in labeling;
- Simplifying the USI by organizing example use sites into broader groups;
- Using a tabular format to provide examples of use sites organized by food use description (i.e., direct food use, indirect food use, and nonfood use) within each major use pattern category to make it easier to follow;
- Clarifying that “food” is defined under the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. Section 321(f), and that definition applies, as appropriate, to all food use descriptions;
- Revising the description of “nonfood use” to provide better clarity;
- Deleting from the USI some example use sites that were ambiguous, too vague, too specific, or incorrectly categorized regarding major use pattern category or food use description; and
- Incorporating many of ACC’s suggestions of specific use sites to include in the materials preservatives and wood preservatives general use pattern categories.
More information regarding the draft USI is available in our blog post EPA Releases Guidance Document: Antimicrobial Pesticides Use Site Index.
By Lisa M. Campbell, Lisa R. Burchi, and Timothy D. Backstrom
On January 25, 2016, in a significant development in the case involving the continued registration of DowAgrosciences LLC’s (DowAgro) Enlist Duo product, the U.S. Court of Appeals for the Ninth Circuit in Case Nos. 14-73353, et al. (consolidated), denied the U.S. Environmental Protection Agency’s (EPA) motion for voluntary vacatur of the Enlist Duo registration, but granted EPA’s motion to remand its decision granting that registration. DowAgro’s December 7, 2015, response to the EPA motions stated that DowAgro had “absolutely no problem with the requested remand to allow the agency to review that information, and hereby consents to such relief.” DowAgro did oppose EPA’s request that the court vacate the registration, arguing that EPA was attempting to circumvent the normal cancellation process by having the court vacate the registration. The case will now be remanded to EPA, and the Enlist Duo registration remains nominally in place. The court’s order allows EPA to consider further action to vacate the registration, but this appears unlikely since DowAgro has previously indicated that it is willing to “stop sales of Enlist Duo, and to work out an appropriate agreement to that effect with the agency.” After reviewing the new information concerning synergistic effects recently submitted by DowAgro, EPA will then make a new decision concerning the registration of Enlist Duo.
The court also denied DowAgro’s motion to strike the Natural Resources Defense Council’s (NRDC) December 17, 2015, reply in support of EPA’s motion for vacatur and remand. DowAgro moved to strike NRDC’s reply because NRDC’s pleading was more of a “reply brief” than a response, and a “litigant has no right to file a ‘reply’ brief in support of a motion filed by another party.” DowAgro’s motion to strike included a request to the court to grant it leave to respond to NRDC’s filing as well as a proposed response brief. This procedural question is now moot because the court has acted on the EPA motions and the registration has been remanded to EPA.
More information on the recent case proceedings is available in our blog entry EPA Replies in Support of its Motion for Voluntary Vacatur and Remand.
By Lisa M. Campbell and Timothy D. Backstrom
On January 6, 2016, a complaint was filed against the U.S. Environmental Protection Agency (EPA) in the United States District Court for the Northern District of California by a coalition of U.S. beekeepers, farmers, and affiliated non-government organizations (Petitioners). The Petitioners allege that EPA has allowed “the ongoing sale and use of unregistered pesticide products” because, they claim, EPA has incorrectly construed seeds coated with neonicotinoid insecticides to be “treated articles” exempt from registration under 40 C.F.R. § 152.25(a). Petitioners argue that a 2013 guidance document prepared by EPA for enforcement personnel investigating bee incidents improperly expanded the scope of the “treated article” exemption and was in effect an unlawful rule issued without prior notice and comment.
According to Petitioners, seeds coated with neonicotinoid pesticides should not be considered eligible for the “treated article” exemption because the neonicotinoid pesticide in the coating acts systemically to protect the growing plants after the seeds germinate, rather than to protect the seeds themselves. Based on this analysis, Petitioners argue that each coated seed product is in fact a separate unregistered pesticide that has not been properly evaluated under FIFRA. Petitioners also argue that pesticide loss from these coated seeds has a variety of collateral environmental effects, including effects on pollinators that EPA has not appropriately considered.
The Petitioners have requested that the District Court provide declaratory relief stating that seeds coated with neonicotinoid insecticides are not eligible for the treated article exemption. Petitioners also request that the District Court enjoin EPA from: (1) allowing any new unregistered neonicotinoid-coated seeds of any crops; and (2) allowing any new unregistered seeds of any crops if they are coated with other systemic insecticides that cause pesticidal effects extending beyond the coated seed and plant itself.
The potential consequences of a reviewing court finding that EPA has improperly construed or expanded the “treated article” exemption by including seeds coated with neonicotinoid insecticides are of significant concern. Such a construction could require that EPA separately register each type of coated seed under FIFRA, regardless of whether EPA adequately evaluated the risks associated with seed treatment when each insecticide was first registered for this use. EPA could seek dismissal of some or all of the Petitioner’s claims on jurisdictional grounds, arguing that the risks and benefits of seed treatment were considered at the time each neonicotinoid insecticide was registered for such use, and that the Petitioners should have sought prior review of those registration decisions in the Court of Appeals within the applicable 60-day window. EPA may also object to the apparent failure of the Petitioners to exhaust their administrative remedies before challenging the policy embodied in the purported “rule,” and also to the Petitioners’ extensive reliance on extra-record evidence.
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
On January 6, 2016, the U.S. Environmental Protection Agency (EPA), in collaboration with California’s Department of Pesticide Regulation (DPR) announced the release of a preliminary pollinator risk assessment for the neonicotinoid insecticide, imidacloprid (Preliminary Risk Assessment or Assessment). In its assessment, EPA states that imidacloprid potentially poses a risk to hives when the pesticide comes in contact with certain crops that attract pollinators.
EPA coordinated efforts with Canada’s Pest Management Regulatory Agency (PRMA). PMRA simultaneously released the overview and science evaluation of its imidacloprid pollinator-only assessment, which reaches the same preliminary conclusions as set forth in EPA’s Assessment. PMRA plans to release the complete assessment with appendices as a revised version on January 18, 2016, and to accept written comments until March 18, 2016.
EPA’s Preliminary Risk Assessment will be subject to a 60-day comment period commencing on the announcement of the Assessment in the Federal Register. EPA did not indicate how long it will be before the Federal Register notice is issued.
This Assessment is the first of four such assessments that will be prepared in 2016 under President Obama’s National Pollinator Strategy. The other three assessments, for neonicotinoid insecticides clothianidin, thiamethoxam, and dinotefuran, are scheduled to be released for public comment in December 2016. EPA also states that following the receipt of public comments on this Assessment by December 2016, it plans to issue a revised Preliminary Ecological Risk Assessment that will: “(i) consider any comments or information submitted in response to this bee-only preliminary risk assessment; (ii) incorporate additional data EPA anticipates to receive that is relevant to bees; and, (iii) assess the potential risks of all registered uses of imidacloprid to all taxa.”
EPA’s Preliminary Risk Assessment describes how EPA conducted a screening level assessment (Tier I) for the various uses of imidacloprid, with a stepwise, tiered risk assessment approach evaluating risks to individual bees first and, if needed, risks to the colony. EPA has divided its risk findings for honey bees for the registered use patterns of imidacloprid into three categories: (1) Crop Groups/Use Patterns that Present Low On-Field Risk; (2) Crop Groups/Use Patterns with Uncertainty in Colony (Tier II) Assessment; and (3) Crop Groups/Use Patterns with Colony (Tier II) Risk Indicated, with this last category including “Citrus Fruits (Oranges)” and “Oilseed (Cotton).” EPA further states: “Based on a tri-agency analysis of the statistical and biological considerations of the data, a NOAEC and LOAEC of 25 and 50 μg a.i./L in nectar were determined based on reductions of the number of adult workers, numbers of pupae, pollen stores and honey stores which persisted across much of the study duration. The level of imidacloprid in nectar at or below which no effects would be expected to the colony is determined to be 25 μg a.i./L.”
Additional information regarding EPA’s actions regarding neonicotinoid insecticides and the National Pollinator Strategy can be found on our blog. EPA stated its intent to hold a webinar regarding the imidacloprid Preliminary Risk Assessment in early February 2016. More information can be found on EPA’s website.
EPA’s statements about the assessment have indicated that imidacloprid uses on citrus and cotton are of greatest concern. Not included in this assessment is what, if any, specific regulatory actions might be needed to reduce any risks to an acceptable level. Regardless, the registrants, along with other stakeholders, will almost certainly comment on the assessment (likely to say that the risks are both overestimated, according to the registrants, and underestimated, according to environmental groups).
What may be of less notice is what EPA appears to conclude about the other uses of the pesticide. Not long ago, many claimed that significant honeybee decline was due to planting crops, especially corn, with neonicotinoid seed treatments such as imidacloprid. This assessment appears to contradict that assertion (along with other improvements that have been made in reducing fugitive dust exposures during application). And, even if EPA is correct in its assessment that the citrus and cotton uses are of concern, there are many other uses of imidacloprid currently suspended from the market in the European Union (EU) -- where cotton and citrus are not widely produced. This EPA assessment might become part of the debate about the rationale behind the current EU policies.
The documents released today are long (the assessment is 305 pages with an appendix of 212 pages). That EPA plans to complete its assessment within this calendar year indicates that current EPA leaders want any decision to be issued (or at least be framed) before the arrival of any new Administration. That alone will cause some to question the degree to which any actions are based more on “science and data” or on the “politics” of pollinator protection.
By Lisa M. Campbell and Lisa R. Burchi
The final rule revising the U.S. Environmental Protection Agency (EPA) regulations governing the minimum risk pesticide exemption from pesticide registration requirements was published in the Federal Register on December 28, 2015. The revisions include codifying the inert ingredients list and adding specific chemical identifiers, where available, for all active and inert ingredients permitted in products eligible for the minimum risk pesticide exemption. Labeling requirements for minimum risk pesticides are also revised to require manufacturers to list ingredients on product labels with a designated label display name and to provide the producer’s contact information on the products’ labels. EPA states that the revisions are intended to “clarify the terms of the original exemption and to provide additional clarity and transparency concerning the ingredients that are currently used in exempted products.” Information regarding the proposed rule that was issued on December 31, 2012, is available in our memorandum entitled EPA Proposes Revisions to Minimum Risk Exemption for Pesticides.
The final rule will become effective on February 26, 2016. The compliance date for the new label requirements is February 26, 2019.
Under the revised regulations, the minimum risk exemption requirements are as follows:
- Condition 1: The product's active ingredients must be only those that are listed in 40 C.F.R. Section 152.25(f)(1). Previously, the regulations included only the names of the active ingredients. Under the newly revised reguations, the new Table 1 includes the “Label Display Name,” the “Chemical Name,” any “Specifications,” and the Chemical Abstracts Services Registry Number (CAS No.).
- In response to comments, EPA restored two active ingredients inadvertently omitted from the proposed rule (sodium chloride and ground sesame plant) and clarified how “mint and mint oils” are listed. EPA also has changed the name of one active ingredient from cedar oil to cedarwood oil and clarified its chemical names and CAS Nos.
- EPA removed United States Pharmacopeia (USP) specifications for 19 active ingredients because such specifications would have removed technical grade active ingredients that are currently eligible but do not meet USP specifications, and EPA states that it did not intend with this rule to add or remove substances from the ingredients list. The USP specification for castor oil remains since that was part of the original active ingredient list.
- Condition 2: Prior to these revisions, EPA’s regulations stated that a product's inert ingredients may be only those that have been classified by EPA as: (1) List 4A “Inert Ingredients of Minimal Concern”; (2) commonly consumed food commodities, animal feed items, and edible fats and oils as described in 40 C.F.R. Sections 180.950(a), (b), and (c); and (3) certain chemical substances listed under 40 C.F.R. Section 180.950(e). The final rule codifies, at 40 C.F.R. Section 152.25(f)(2)(iv), a list of inert ingredients permitted in minimum risk pesticide products. The codified list at Table 2 includes the “Label Display Name,” the “Chemical Name,” and the Chemical Abstract Services Registry Number (CAS No.).
- In response to comments, EPA removed from the “Label Display Name” certain bracketed language intended to provide clarifying language, for example, “safety limitations on certain inert ingredients such as vinegar (maximum 8% acetic acid in solutions) to chemical formulas for inert ingredients such as calcite (Ca(CO3)).” This bracketed language remains in the Chemical Name column to assist manufacturers in correctly identifying inert ingredients eligible for the exemption.
- As it did with respect to active ingredients, EPA states that this rule is not intended to add or remove any inert ingredients. EPA states that it is considering developing guidance to describe the petition process and types of information EPA would need to add or delete an inert ingredient from this list.
- Condition 3: Previously, EPA required that all of the ingredients (both active and inert) be listed on the label, with active ingredient(s) listed by name and percentage by weight and each inert ingredient listed by name only. Under the provisions of the newly promulgated rule, the label must include the following: (1) the “Label Display Name” for each active ingredient with its percentage by weight; (2) the “Label Display Name” for each inert ingredient; (3) “prominent” display of the name of the producer or the company for whom the product was produced; and (4) “prominent” display of contact information (i.e., street address including zip code and telephone number) for the producer/company listed.
- Condition 4: The label cannot include any false or misleading statements. The final rule does not propose any explicit changes to this condition, but some new changes may affect the requirements necessary to meet this condition. For example, under the newly promulgated revisions, while all active and inert ingredients may be used in non-food use products, “food and animal feed in commerce can bear pesticide residues only for those ingredients that have tolerances or tolerance exemptions in part 180 of this chapter.” Regarding requirement, EPA states:
- EPA is not attempting to enforce adherence to the labels of minimum risk pesticides, which as noted cannot be done for pesticides subject to 40 CFR 152.25(f). Rather, the Agency is assisting minimum risk pesticide producers in ensuring that the use directions on the product do not cause the label to be false or misleading. An exemption from FIFRA requirements under section 25(b) of the statute, including the minimum risk exemption at 40 CFR 152.25(f), cannot exempt pesticides from the requirements of a tolerance or tolerance exemption under FFDCA. Under FFDCA, any pesticide chemical residue to be used in or on foods in commerce in the United States must have either an established tolerance or tolerance exemption. When a minimum risk product explicitly states on its label that it can be used in or on food or food-use sites in commerce, but one or more of the ingredients does not have an established tolerance or tolerance exemption, the label is indicating that the product may be used in a way that would violate Federal law. Such a label is therefore false or misleading.
- Condition 5: The product must not bear claims either to control or mitigate organisms that pose a threat to human health, or to control insects or rodents carrying specific diseases. The final rule does not change this condition.
EPA states that it intends the newly promulgated revisions to assist manufacturers, the public, and federal, state, and tribal inspectors in determining whether a chemical substance can be used in a minimum risk product (i.e., is eligible for the exemption) as well as to provide improved clarity and transparency for consumers who want more information about the ingredients used in a product. EPA also hopes that requiring company contact information on labels will provide further transparency and accountability should an adverse event occur during the use of a minimum risk pesticide product.
EPA has determined that the total cost for industry to comply with the labeling requirements of this rulemaking is approximately $800,000, under a three-year implementation period. The three-year implementation period was extended from the two-year proposed implementation plan in response to comments that “[s]ince most companies update their labels every three years…a rule implementation period of three years will allow most companies to meet the labeling requirements of the rule as part of their normal labeling practices and will therefore keep industry costs to a minimum.”
EPA’s recently updated minimum risk pesticides webpage includes guidance on pesticide tolerances for minimum risk ingredients and provides alternative formats of the active and inert ingredient lists that may be more suitable for some users. EPA states that it intends to include additional guidance, as needed, such as labeling guidance for minimum risk pesticides and how to request additional ingredients to be added or removed from the minimum risk exemption shortly after the final rule becomes effective.