Antimicrobial Inert Ingredient QR Code/Website Link

EPA is now allowing companies to include a QR code or website link on their product labels to provide information on inert ingredients.  As of this publication date, this option is only available for antimicrobial pesticide products.  Providing this additional information is strictly voluntary for companies, with exception on a case-by-case basis for where it has been required.  Although voluntary, providing this information is encouraged for showing transparency.

EPA states that if a company chooses to disclose their inert ingredients, they should include all of them.  Any partial lists could mislead the consumer into believing it was a complete list.  The Agency also recommends listing ingredients in descending order of weight.

Pesticide producers should note that including a QR code or website link results in the information being subject to FIFRA and EPA review in order to ensure there is no violation of FIFRA’s provisions against misbranding (FIFRA sections 2(q) and 12(a)(1)(E)).  The companies including this information need to verify the its accuracy.  Companies must also submit an application to EPA for voluntary inert ingredient disclosure.  The application identifies the proposed changes on the product label detailing the QR code or website link, and includes a self-certification statement.  The self-certification statement includes acknowledgement that any false statements could lead to enforcement actions.   EPA’s announcement also mentions that once the Agency gains experience handling this type of labeling, they may allow inert ingredient disclosure applications to be included with other actions.

Chlorpyrifos Registration Status

Farmworker Justice is pressuring EPA to ban the use of the pesticide chlorpyrifos.  The organization is collecting signatures on a petition supporting the ban.  The petition notes that chlorpyrifos can cause dizziness, vomiting, convulsions, numbness in the limbs, loss of intellectual functioning, respiratory paralysis, and death.  Farmworker Justice plans to send the petition to EPA and key members of Congress.

According to EPA, chlorpyrifos has been in use since 1965 and is registered with various limitations, such as “restricting entry into treated fields for 24 hours up to five days.”  Use of the pesticide has been at issue for a number of years.  In 1996, EPA recognized the need to contain chlorpyrifos exposure after the Food Quality Protection Act created more stringent safety standards.  In 2000, EPA reached an agreement with registrants of chlorpyrifos to eliminate, phase out, and modify certain uses.  In 2002, EPA created buffer zones for using chlorpyrifos and increased the personal protective equipment requirement for application.  In 2011, EPA complete a comprehensive preliminary human health risk assessment for all chlorpyrifos uses and revised the assessment in 2014.  In 2012, EPA further restricted aerial application and created “no-spray” zones.  The U.S. Ninth Circuit Court of Appeals ordered EPA to ban chlorpyrifos within 60 days in August 2018, but the Department of Justice requested a rehearing, which was granted on February 6, 2019, effectively vacating the earlier ruling.

Until February 3, 2021, EPA is accepting public comment on a proposed interim decision on chlorpyrifos that was released in December 2020.  EPA’s proposed interim decision recognizes the need for precautions in the use of chlorpyrifos.  The proposed interim decision asserts that all pesticides registered by EPA follow FIFRA mandates that ensure that proper use, as directed by the product label, will not cause unreasonable risks to health.

Amicus Brief on EPA and Sulfoxaflor

On December 7, 2020, the attorneys general for 11 states filed an amicus brief with the Ninth Circuit Court of Appeals opposing EPA’s remand motion concerning the pesticide sulfoxaflor.  EPA’s motion asked the court to allow revision of its registration for sulfoxaflor without vacating it.  EPA initially registered sulfoxaflor for use in 2013 with limitations on its use due to its toxicity to bees and the potential risk to birds.  In 2019, EPA registered new uses for sulfoxaflor, including application to alfalfa, corn, cacao, grains, pineapple, strawberries.  At issue in the litigation are the following:

  • Approval of sulfoxaflor uses without consideration of its effects on endangered species after 2015 Ninth Circuit Court ruling to vacate the registration.
  • Need for consideration of sulfoxaflor’s effects on endangered species in its registration.
  • Need for consultation with expert agencies.
  • Whether the Endangered Species Act (ESA)-protected species are endangered in violation of EPA’s FIFRA mandate that its pesticide use approvals not result in “unreasonable adverse effects on the environment.”

Granting EPA’s motion would allow sulfoxaflor use for at least seven years.

The amicus brief states EPA’s motion for remand without vacatur is unwarranted because EPA has demonstrated ongoing and systematic failure to consult under the ESA.  The attorneys general noted that Congress ordered EPA to report on its ESA consultation progress in 2014 and 2018.  The brief stressed that the backlog of pesticide chemicals for review is already quite long, and that EPA has admitted that the evaluation of sulfoxaflor on remand would not begin until June 2025, at the earliest.  Concern that without proper foundational review by EPA, the burden of ensuring pesticide safety passes down to the states was emphasized by the brief.  Finally, the brief argues that “proceeding to the merits would most efficiently resolve the issues in this case.”

Proposed TSCA Fee Rule Changes

On December 18, 2020, EPA signed a proposed rule revision for TSCA fees to defray costs for activities under TSCA sections 4, 5, and 6.  This revision proposes updates to the 2018 fees rule and requires EPA to review the fees every three years with ability to adjust the fees.  This adds three new fee categories of a Bona Fide Intent to Manufacture or Import Notice, a Notice of Commencement of Manufacture or Import, and an additional fee associated with test orders.

The Bona Fide Intent to Manufacture or Import Notice covers EPA costs of reviewing bona fide notices.  The 2018 Fee Rule did not have any fees associated with reviewing the notices.  The cost is proposed as 500 dollars, and 90 dollars for small businesses.

The Notice of Commencement (NOC) of Manufacture or Import requires those who submit premanufacture notices to provide notice to the EPA within 30 days of when the chemical substance is first manufactured or imported.  Unlike the new Bona Fide Fee proposal, the NOC fees already existed under the 2018 Fee Rule, but fell under other categories, such as premanufacture notices.  The new proposal will have NOC fees as their own category and are proposed as 500 dollars, and 90 dollars for small businesses.

The new proposed fee associated with test orders applies to recipients who fail to follow terms or conditions of an original order.  Under the 2018 Fee Rule, the recipient had the option to redo the testing and submit new data without paying additional costs from the original test order.  The proposed fee with require payment for the original test order and any resubmitted data.  The new fee for resubmitted data is proposed to be equal to the cost of reviewing the initial data.

EPA is also proposing exemptions to some fee triggering activities:

  • an exemption for research and development activities on fees for EPA-initiated risk evaluations,
  • an exemption for entities manufacturing less than 2,500 lbs. of a chemical subject to an EPA-initiated risk evaluation fee;
  • an exemption for manufacturers of chemical substances produced as a non-isolated intermediate on fees for EPA-initiated risk evaluations;
  • and exemptions for manufacturers of a chemical substance subject to an EPA-initiated risk evaluation if the chemical substance is imported in an article, produced as a byproduct, or produced or imported as an impurity

Two other notable proposed changes are:

  • EPA proposes a volume-based fee allocation for EPA-initiated risk evaluation fees in any situation that does not involve a consortium.
  • EPA proposes export-only manufacturers to pay fees for EPA-initiated risk evaluations.

FIFRA Enforcement Against Electrolux

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 Petition on Chemours PFAS

On October 14, 2020, EPA received a petition to require health and environmental testing under Section 21 of the Toxic Substances Control Act (TSCA) on certain PFAS manufactured by Chemours in Fayetteville, North Carolina.  The petitioners consist of the Center for Environmental Health, the Cape Fear River Watch, Clean Cape Fear, Democracy Green, Toxic Free NC, and the NC Black Alliance.  The petition requests testing on 54 PFAS which Chemours produces.  The petition states that the 54 PFAS meet the criteria for testing in section 4(a) of TSCA.  It states that,

Based on the known hazards of these analogues, untested PFAS with potential for exposure would meet the criteria for testing in section 4(a)(1)(A) of TSCA because they “may present an unreasonable risk of injury” and have “insufficient information and experience” to determine their effects on health or the environment.

The PFAS produced by Chemours includes both commercial products and byproducts from their manufacturing process.  Some of the testing differs based on whether the compound is Tier 1 (detection in human sera, food or drinking water) or Tier 2 (significant potential for human exposure based on detection in environmental media and other evidence).  The petition also states that Gen X chemicals have been detected in drinking water and private wells in the vicinity of the Chemours plant.  A major point of concern for the petitioners involves the North Carolina consent order, which is the result of a lawsuit against Chemours from the North Carolina Department of Environmental Quality addressing PFAS contamination in the Cape Fear River basin from the Chemours’ facility.  The petition states current testing of Gen X chemicals by Chemours has been inadequate to fully evaluate the risks and additional carcinogenicity studies are needed.

The petition proposes testing with animal studies:

  • 28-day repeated dose rodent toxicology studies to determine impact on health,
  • Multigeneration or extended one-generation and 2-year rodent carcinogenicity studies for Tier 1 substances,
  • Testing on both mice and rats using oral routes of administration,
  • Inhalation testing used for volatile chemicals, and
  • Toxicokinetic studies to characterize relationship between serum concentrations and dermal to evaluate biological half-life and potential for bioaccumulation.

The petition also proposes the following human studies:

  • A human health study for the Cape Fear watershed to determine the relationship between exposure in the Cape Fear watershed and health outcomes.
  • Testing to determine human half-lives of the listed chemicals through longitudinal biomonitoring and exposure estimation in workers.

PFAS in California’s Water Supply

Testing of California’s public water supply wells reveals that 60 percent of them contain the “forever” chemicals, perfluoroalkyl and polyfluoroalkyl substances (PFASs). The concentrations of these substances were higher at airports than landfills and public supply wells.  One million parts per trillion were detected at airports, while landfills had 10,000 parts per trillion and public wells had 100 parts per trillion. EPA has established a health advisory level at 70 parts per trillion for the combined amounts of PFOA and PFOS.

The health advisories from EPA offer guidance for states and the federal government to meet standards that will avoid adverse health effects.  Studies of individuals exposed to PFASs show increases in hormonal issues, organ damage, and cancer. Nationally, the Safe Drinking Water Act (SDWA) regulates maximum contaminant levels (MCLs) allowed in drinking water for over 90 chemicals.  However, PFASs currently remain on EPA’s unregulated and non-enforceable list for SDWA MCLs.  EPA’s PFAS Action Plan shows that the Agency is still in the information gathering phase to determine the prevalence and full effects of the PFASs with regulation in the future.

Individual states have been putting their own regulation forward for PFASs.  For example, in September 2020 California Governor Gavin Newsom signed Senate Bill No. 1044, which governs the tracking and recall of firefighting foam containing PFASs.

EPA Proposed Regulations for Scientific Integrity in Contracting

On September 26, EPA published a proposal addressing scientific integrity in the context of agency contractors who perform scientific research or analyses. It would create a new standard contract clause designed to ensure that all scientific work performed for the Agency is done consistently with the agency’s scientific integrity policy, which dates from 2009. The proposal also includes regulations for addressing loss of scientific integrity, including steps for mitigation or termination in appropriate cases.

Contractors who become aware of “an actual or potential” loss of integrity would be required to report it to the contracting officer, who would ultimately decide on the remedy, if any. Contractors would bear the primary responsibility for prevention and detection of research misconduct and for the inquiry, investigation, and adjudication of research misconduct alleged to have occurred in association with its own institution. However, EPA would retain the ultimate oversight authority for EPA-supported research.

This could be a useful tool in addressing any noncompliance with EPA’s integrity policies that may come to light in research sponsored by EPA. However, there are a couple of apparent holes in the proposal. It does not clearly state that the contractor or contracting officer must investigate a loss (or potential loss) of integrity brought to their attention by a third party, such as a potentially regulated stakeholder. In addition, it focuses on EPA’s 2009 integrity policy but does not mention compliance with the regulations for strengthening integrity in regulatory science that EPA proposed earlier this year. Comments on this proposal are due by November 26.

EPA Administrator Pruitt Establishes Policy Regarding “Regulation Through Litigation”

On October 16, 2017 EPA Administrator Scott Pruitt said in a directive and accompanying memorandum that he is ending a “sue-and-settle” practice that has resulted in closed-door agreements committing the agency to “regulation through litigation.”

Under the policy, the EPA will:

  1. Publish any notices of intent to sue the Agency within 15 days of receiving the notice;
  2. Publish any complaints or petitions for review in regard to an environmental law, regulation, or rule in which the Agency is a defendant or respondent in federal court within 15 days of receipt;
  3. Reach out to and including any states and/or regulated entities affected by potential settlements or consent decrees;
  4. Publish a list of consent decrees and settlement agreements that govern Agency actions within 30 days, along with any attorney fees paid, and update it within 15 days of any new consent decree or settlement agreement;
  5. Expressly forbid the practice of entering into any consent decrees that exceed the authority of the courts;
  6. Exclude attorney’s fees and litigation costs when settling with those suing the Agency;
  7. Provide sufficient time to issue or modify proposed and final rules, take and consider public comment; and
  8. Publish any proposed or modified consent decrees and settlements for 30-day public comment, and providing a public hearing on a proposed consent decree or settlement when requested.

This policy may lead to increased and longer litigation, with the courts exercising direct control of the outcome. For example, the court might set the schedule for publication of an overdue rule instead of the litigants. It may also lead to more influence for third party intervenors who generally are shut out of the consent order negotiations by the Department of Justice (DOJ).

One thing to keep in mind moving forward, however, is that while the DOJ does consult with the EPA on litigation strategy, technically the DOJ has the authority to settle cases. So, if DOJ wants to settle a case, it is unclear if and how Administrator Pruitt’s policy will deter DOJ’s decision-making process.

Separately, Attorney General Jeff Sessions has barred DOJ attorneys from negotiating settlements that result in payments from industry to third-party organizations, such as Supplemental Environmental Projects paid to environmental organizations.

EPA seeks input on ecolabels for paints, flooring, and furniture.

As part of its pilot project to test its “Draft Guidelines for Product Environmental Performance Standards and Ecolabels for Voluntary Use in Federal Procurement,” the Environmental Protection Agency (EPA) is seeking input on private sector environmental performance standards and ecolabels applicable to paints/coatings, flooring, and furniture. According to the Information Collection Request (ICR) submitted to the Office of Management and Budget (OMB), the Agency is expecting responses from standards development organizations, ecolabel programs, and certification entities with environmental performance standards for products. EPA is also asking these entities to participate in self-assessments, using checklists specific to each product category and based on the draft Guidelines, as well as in follow-up interviews with an independent assessor. The ICR was announced in a Federal Register notice published on Monday; public comments on the ICR must be received by May 25, 2016.

EPA developed the draft Guidelines in 2013 to help federal purchasers select appropriate private sector ecolabels and standards for environmentally preferable purchasing. In the ICR, EPA states: “While Federal purchasing policy is clear for the several standards and ecolabels that are listed in statute, regulation, or Executive Order, the lack of independently assessed information about and federal guidance on using other product environmental performance standards and ecolabels often results in an inconsistent approach by Federal purchasers and confusion and uncertainty for vendors and manufacturers.” With this ICR, EPA seeks to address this problem by testing an approach to determine which standards and ecolabels to support “in a fair, transparent, and consistent manner.” Ecolabels and standards will be assessed based on the criteria used in developing and managing the standards and ecolabels as well as “the effectiveness of the standards in ecolabels in protecting environmental and human health.”

EPA is contracting with two companies, Resolve and Industrial Economics, to conduct the pilot project to further refine the draft Guidelines and test how to assess standards and ecolabels. Resolve will “convene a coordinating Governance Committee, product category-specific multi-stakeholder panels,” while Industrial Economics will “develop and pilot test an approach” to assess standards and ecolabels in paints/coatings, flooring, and furniture.

Along with the ICR itself, the pilot project’s survey and assessment criteria are also available in the ICR’s docket (EPA-HQ-OPPT-2014-0838) on Regulations.gov.