FIFRA Enforcement Against Electrolux

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An October 6, 2020 Consent Agreement and Final Order (CAFO) between EPA and Electrolux Home Products, Inc. resulted in Electrolux agreeing to pay nearly $7 million.  EPA settled FIFRA violations in relation to the import and distribution of Electrolux dehumidifiers and air conditioners containing a filter manufactured with nanosilver.  Although the products made pesticidal claims, they were not registered with EPA – pesticide products imported into the United States for distribution or sale must be first registered with EPA, unless the product is exempt from FIFRA (e.g., under the treated articles exemption).  Marketing materials for the dehumidifiers and air conditioners included the following pesticidal claims “Antimicrobial Filter Cleans air by removing harmful bacteria” and “Our removable, washable filter reduces bacteria, room odors and other airborne particles for a healthier, more comfortable environment.”  The CAFO notes that “at no time relevant to the allegations herein was the nanosilver that was used to manufacture the filters that were contained in the [dehumidifiers and air conditioners] registered with the EPA”, in violation of Section 12(a)(1)(A) of FIFRA, 7 U.S.C. § 136j(a)(1)(A). 7 U.S.C. § 136l(a)(1).

Key Points of the Agreement are as follows:

  • Electrolux failed to file a Notice of Arrival of Pesticides and Devices for these imports on 141 occasions.
  • Electrolux imported unregistered pesticide products on 573 occasions.
  • EPA issued a Stop Sale, Use or Removal Order.
  • Electrolux offered to rework all dehumidifiers and air conditioners that contained a filter manufactured with nanosilver.
  • The Civil Penalty to settle the action is $6,991,400.
  • The Civil Penalty includes a 20% reduction in the amount for Electrolux’s good faith efforts to bring their products into compliance with FIFRA.

EPA Updated the Pesticide Label Review Manual

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EPA has substantively updated the General Labeling Requirements, Precautionary Statements, and Net Contents/Net Weight Chapters of the Pesticide Label Review Manual, and made minor editorial changes throughout the rest of the manual. This manual is designed to help industry understand the pesticide labeling process and how labels should be drafted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

The latest updates are as follows:

General Labeling Requirements — Chapter 3:

  • Web-distributed labeling section now includes container label language example;
  • Label submission requirements section now includes e-submission option;
  • Final printed labeling section now reflects current practices;
  • Updated mode of action symbol reference from PR Notice 2001-5 to PR Notice 2017-1; and
  • First aid statement location now reflects requirements of EPA’s guidance document “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement per 40 CFR 156.68.”

Precautionary Statements — Chapter 7:

  • Added dermal sensitization to acute toxicity categories table (Table 1);
  • Reinstated first aid statements per PR Notice 2001-1, and updated location of first aid statements per the Feb. 27, 2018, First Aid Guidance Document “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement per 40 CFR 156.68”;
  • Added Note to Physician statement for products containing zinc phosphide;
  • Updated National Pesticide Information Center NPIC information in first aid statements example in Table 9;
  •  Changed “Labeling Options” section to “Modified precautionary statements for diluted products (aqueous solutions only)”;
  • Removed redundant section on NPIC and referenced Chapter 15 for details; and
  • Removed “Optional Labeling/Deviations” section and moved directions under their respective sections.

Net Contents/Net Weight — Chapter 17:

  • Updated introduction section to include notes on declaring net contents information on application form 8570-1 and leaving net contents information blank on draft label for refillable containers; and
  • Updated labeling requirements for packages that use Bag on Valve technology to reflect 2018 NIST Handbook 130 regulations for net weight measurements.

EPA is Removing 72 Inert Ingredients Previously Approved for Use in Pesticide Products

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On October 22, 2014, EPA published for comment a proposal to remove from EPA’s list of inert ingredients approved for use in pesticide products 72 chemical substances that are no longer being used as inert ingredients in pesticide products. (79 FR 63120) In response to EPA’s request for comments, no specific information regarding those 72 chemical substances or any products that may include them was provided to EPA, indicating that these chemical substances are not being used in currently approved pesticide product formulations. Therefore, as of December 14, 2016, (81 FR 90356) EPA decided to remove all 72 from the inert ingredient list. A list of the 72 inert ingredients can be found here.

Removal of a chemical substance from the approved inert ingredient listing does not, in and of itself, restrict the use of the chemical substance in a pesticide product, instead it changes the way an application is processed. Once removed, the chemical substance would be considered a “new” inert ingredient. Any inert ingredient that is not on the approved list must be approved by EPA before registration for a formulation containing that chemical substance as an inert ingredient. EPA approval can be obtained by submitting a request, along with relevant data including, among other things, studies to evaluate potential carcinogenicity, adverse reproductive effects, developmental toxicity, genotoxicity, as well as environmental effects associated with any chemical substance that is persistent or bioaccumulative. Further, adding the chemical substance to the list of approved inert ingredients would also require payment of a fee in accordance with FIFRA Section 33, 7 U.S.C. 136w-8.

EPA releases interim guidance on data requirements for antimicrobial pesticides and food contact surfaces.

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Last week, EPA released interim guidance on the agency’s toxicology data requirements for antimicrobial pesticides on food contact surfaces. The interim guidance clarifies that the 200 parts per billion (ppb) threshold that triggers different data requirements is based on “total estimated daily dietary intake” for an individual and not the total amount of residue on a food item, which interpretation is in line with the policy of the U.S. Food and Drug Administration (FDA). Generally, if pesticide residues from food contact services are found in food at 200 ppb or less, EPA requires the submission of certain toxicology data, and additional data may be required if residues are greater than 200 ppb.

The interim guidance was issued as part of a March 2, 2015 settlement reached between the EPA and the American Chemistry Council (ACC) resolving the trade group’s challenge of EPA’s 2013 Final Rule on “Data Requirements for Antimicrobial Pesticides.” The settlement also requires that EPA propose, by July 2, 2015, a guidance document called the “Antimicrobial Pesticide Use Site Index,” which will be subject to public comment. In addition, by September 2, 2017, the agency must propose a “correction” to 40 C.F.R. § 158.2230(d) clarifying that the 200 ppb level relates to total estimated daily dietary intake, consistent with the FDA policy.

EPA and FDA announce data sharing agreement for CBI.

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Today, EPA and the Food and Drug Administration (FDA) announced a Memorandum of Understanding (MOU) to share data on pesticides and toxic substances. According to a notice published last month in the Federal Register, in response to the FDA’s spring 2014 request, EPA will grant FDA access to information collected under the Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), including information claimed by submitters as Confidential Business Information (CBI). This data-sharing initiative “is intended to maximize the utility of data collected under those statutes, and enhance the efficiency of the participants’ regulatory processes and facilitate better risk management activities.” The MOU applies specifically to EPA’s Office of Chemical Safety and Pollution Prevention and FDA’s Foods and Veterinary Medicine Program, Center for Food Safety and Applied Nutrition, and Center for Veterinary Medicine.

FDA and EPA “have complementary roles” regulating substances incorporated into food (including animal feed), animal drugs, and cosmetics. Antimicrobial food wash products, for example, must meet different standards for safety and non-adulteration of food (FDA), and no adverse environmental effects (EPA).

The MOU covers the sharing of non-public information exempt from public disclosure, including CBI and “confidential commercial information” (CCI). Information will be shared “on a reciprocal and as-needed basis” for substances that may be present in human food, animal food and feed, animal drugs, and cosmetics. The MOU provides that each agency will develop internal procedures and designate liaison officers for the information-sharing exchanges and to protect against unauthorized disclosure of CBI or CCI. Appendices to the MOU establish a framework process for information sharing, including specific language to be used in requesting information or responding to a request.

The MOU does not specify any limits as to programmatic uses for shared information. The disclosure of non-public information remains governed by applicable laws and regulations, and non-public information may not be disclosed further or shared with personnel at the other agency that have not been authorized to access non-public information. If EPA requests information from FDA identified as a trade secret, FDA will assess whether the information is in fact trade secret. TSCA/FIFRA-designated CBI requested by FDA will have to be returned to EPA or destroyed when no longer needed. Either agency may choose not to share requested information, or may choose to limit the scope of information provided in response to a request. The agencies may also protect information “in connection with research that has not been peer reviewed.”

EPA agrees to clarify data requirement rule for antimicrobial pesticides.

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EPA and the American Chemistry Council (ACC) have reached a settlement regarding the ACC’s petition concerning data requirements for antimicrobial pesticides. This settlement addresses a Final Rule published by EPA on May 8, 2013, “Data Requirements for Antimicrobial Pesticides,” for which the ACC, the chemical industry trade group, sought judicial review in the U.S. Court of Appeals for the D.C. Circuit.

Under the settlement, EPA will within the next four months release for public comment a proposed guidance document, “Antimicrobial Pesticide Use Site Index.” This guidance will include “a compilation of existing antimicrobial pesticide use sites and identify how each use site fits within the 12 use patterns established in the regulation.” The Use Site Index will include the following descriptions, as set forth in the settlement:

  • Direct Food Use: a use is generally considered to be a direct food use if an antimicrobial pesticide is intended to be directly applied to food (defined for purposes of the Federal Food, Drug, and Cosmetic Act at 21 U.S.C. § 321(f)) or applied to a material or article for the purpose of treating food.
  • Indirect Food Use: a use is generally considered to be an indirect food use if the use involves application of the antimicrobial pesticide in or on a material or article that comes into contact with food and may result in residues in or on food, but the use is not intended for pesticidal treatment of food.
  • Nonfood Use: a use is generally considered to be a nonfood use when there is a reasonable certainty of no residues in or on food, for example because the antimicrobial pesticide is not expected to come into contact (directly or indirectly) with food as a result of its intended use.

In addition to the Site Index proposed guidance, the settlement agreement provides that EPA shall propose an interim guidance document and then a “correction to the Final Rule” regarding the 200 ppb level for antimicrobial residues in or on a food item, as established at 40 C.F.R. § 158.2230(d). Under the Final Rule, additional toxicology tests are required for indirect food uses with antimicrobial residue levels greater than 200 ppb. Within 60 days, EPA must issue an interim guidance document “explaining EPA’s interpretation of the 200 ppb level established in the Final Rule.” Within two and a half years, EPA must propose a “correction” to make “clear that the 200 ppb level established in the Final Rule is based on total estimated daily dietary intake, and is not based on the amount of residue present on only a single commodity.”

EPA sued over lack of nanosilver regulations.

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On December 16, a group of NGOs sued [PDF] the U.S. EPA over the agency’s failure to regulate nanosilver in consumer products. The plaintiffs, which include the Center for Food Safety, Center for Environmental Health, and Beyond Pesticides, seek to compel EPA to take action in response to their 2008 petition for rulemaking. The groups’ petition requested that EPA regulate nanosilver products as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), thus requiring product manufacturers to obtain pesticide registrations. The petition also asked EPA to analyze “the potential human health and environmental risks” of nanosilver under FIFRA and other environmental statutes, including the Endangered Species Act (ESA) and National Environmental Policy Act (NEPA).

Since the 2008 petition, EPA has accepted comments on the petition, enforced against companies making antimicrobial claims about nanosilver-containing products, convened a scientific advisory panel, and proposed a policy statement on the subject, but the NGOs maintain that EPA’s actions constitute an “ongoing failure to meaningfully regulate nanotechnology.” The plaintiffs contend that EPA has violated the Administrative Procedure Act by failing to provide a timely response to the 2008 petition.

The case is Center for Food Safety et al v. McCarthy, Case No. 14-cv-2131, in the U.S. District Court for the District of Columbia.

EPA agrees to update enforcement guidance for FIFRA and TSCA.

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The Environmental Protection Agency (EPA) has agreed to update its enforcement guidance for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Toxic Substances Control Act (TSCA) following a report [PDF] from the agency’s Office of Inspector General (OIG) released on September 27, 2013. The report contained findings and recommendations related to FIFRA and TSCA good faith reductions and “ability to pay” penalties, based on the OIG’s review of 23 FIFRA cases and 20 TSCA cases (13 lead disclosure and 7 PCB cases).

The OIG found that EPA regions differed in how they assessed FIFRA and TSCA enforcement penalty reductions; some appeared to justify reductions automatically, without considering the good faith compliance efforts of the violators. Because of the lack of adequate guidance and supporting documentation for determining and justifying good faith penalty reductions, there is a risk that EPA might treat violators inequitably and might be losing opportunities to fully collect all penalties due. Based on the OIG’s findings and recommendations, EPA has agreed to reissue the enforcement policy document GM-88, “Documenting Penalty Calculations and Justifications in EPA Enforcement Actions.”

The OIG also found that EPA’s enforcement response and penalty policy for lead-based paint disclosure rule to address violators who are unable to pay penalties is inadequate. Specifically, no guidance exists for applying non-monetary penalty alternatives (such as public service or delayed payment plans) when violators do not have the cash to pay the penalty. EPA has agreed to evaluate whether additional guidance is needed to clarify whether non-monetary alternatives must meet the agency’s existing Supplemental Environmental Projects policy.

In addition, the OIG report found that EPA’s “INDIPAY” economic model may be limited in its ability to help teams evaluate individuals’ claims of inability to afford penalties or clean-up costs. According to the OIG, the INDIPAY model does not assess an individual’s assets and should be updated to improve its accuracy. Furthermore, the report found that EPA does not provide adequate guidance or case development training to help regional teams evaluate ability to pay cases. In order to improve the agency’s consistency in handling the growing number of ability to pay cases, EPA has agreed to provide regional staff with updated training for case development of ability to pay claims. EPA also agreed to update its 1986 document “Guidance on Determining a Violator’s Ability to Pay a Civil Penalty” [PDF] to further improve guidance on evaluating ability to pay cases and address the inadequacies of the INDIPAY model.

EPA Announces FIFRA/TSCA Settlements with Finland-Based Kemira Group

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TSCA/FIFRA Enforcement:

EPA continues to steadily increase its enforcement of U.S. chemical control laws.  Last Thursday, the EPA announced settlements with two subsidiaries of the Finland-based Kemira Group to resolve alleged violations of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Toxic Substance Control Act (TSCA). Kemira Chemicals agreed to pay a civil penalty of over $300,000 to settle claims that the company sold and distributed unregistered and misbranded pesticides, and violated pesticide production reporting requirements. Kemira Chemicals also agreed to correct the alleged violations.

In addition, Kemira Water Solutions agreed to pay a civil penalty of over $500,000 regarding violations of TSCA’s Inventory Update Reporting (IUR) rule during the 2006 reporting period. Under the IUR rule, manufacturers and importers of substances included on the TSCA Chemical Substances Inventory must report the production volume and location of each facility processing such chemicals; this information is used to develop risk-screening and assessment. EPA discovered Kemira Water Solutions’ reporting violations following a January 2012 inspection and the company has since submitted the required information.

EPA Announces Proposed Revisions to FIFRA Minimum Risk Exemption

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FIFRA:

In a December 31, 2012 Federal Register notice, (77 Fed. Reg. 76,979) EPA announced a new proposed rule that would revise the labeling requirements for minimum risk pesticide products. The proposed rule affects section 25(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) by changing how minimum risk pesticides are identified on product labels as well as the way ingredient lists are organized in the implementing regulations. In addition, producer contact information will be required on product labels.

Under FIFRA’s § 25(b) minimum risk exemption, pesticides with active and inert ingredients which are demonstrably safe do not need to be registered with EPA. These permitted ingredients are listed in 40 CFR 152.25(f), but because of ambiguities across the various ingredient lists, confusion remains as to which ingredients are covered and how they should be labeled, leading to increased regulatory burden and inefficiencies for state regulators. Many chemicals may be known by producers, regulators, and consumers by different names; for example, soybean oil may be described on a product label as “Glycine Soja Oil.”

EPA’s new proposed rule is intended to make clear which active ingredients are permitted in exempted pesticide products, and does not add or remove any ingredients from the list. Instead, EPA will identify permitted active ingredients by re-organizing them in tables including the chemical’s “Label Display Name” (e.g., “Citric Acid”), “Chemical Name” as determined by the Chemical Abstract Services (“CAS”) (e.g., “2-Hydroxypropane-1,2,3-tricarboxylic acid”) and “CAS Registry Number,” a unique identifier which is easy to use for consumers and widely accepted by industry and regulators alike. In addition, the table will include a “Specifications” column which will be empty for most ingredients, but will indicate the United States Pharmacopeia (“USP”) standard for “approximately 20 of the active ingredients.”

Inactive ingredients will also be re-organized into a table similar to the one proposed for active ingredients. This table will codify “List 4A,” the list of chemicals currently maintained on EPA’s website. In addition, EPA proposes to incorporate references to other CFR sections which describe which chemicals may be used as inert ingredients for the purpose of the minimum risk exemption. In the case of pesticides that may come in contact with foods, for which there are no federal tolerance levels or tolerance exemptions, EPA proposes to amend the text of the exemption to direct users to an EPA website for more information on which of the listed chemicals may be used in food-use pesticide products.

Finally, EPA proposes that exempted product labels must use the “label display name” in the product’s ingredient listing. The proposed rule also requires that producers of minimum risk pesticide products must include their company’s contact information (address and telephone number) on the product label. In the case of a product label which includes the name of a company that is not the producer, EPA proposes that the label text should clarify that the product was “packed for,” “distributed by,” or “sold by” the non-producer company.

EPA is requesting comments on various topics related to this proposal, including: the format and information to be included in the new tables; whether reference to an online resource with more information on food-use pesticide tolerance requirements would provide clarity for stakeholders; impacts on state and local agencies; and whether products would need to be reformulated as a result of the changes. The comment period for this proposed rule ends on April 1, 2013.