In December 2022, two separate lawsuits were filed against Inhance Technologies USA regarding its alleged production of certain PFAS substances in violation of the Toxic Substances Control Act (“TSCA”). These lawsuits are important as they raise novel questions of TSCA interpretation and enforcement.
The first lawsuit was filed by the U.S. Department of Justice, Environment and Natural Resources Division on behalf of the U.S. Environmental Protection Agency (“EPA”). The second case is a citizen suit filed by the non-profit organizations Center for Environmental Health (“CEH”) and Public Employees for Environmental Responsibility (“PEER”). U.S. v. Inhance Technologies LLC, U.S. Eastern District of Pennsylvania, Case No. 2:22-cv-05055; Center for Environmental Health v. Inhance Technologies USA, U.S. District Court for the District of Columbia, Case No. 1:22-cv-03819. It is rare that EPA pursues TSCA enforcement actions in federal court. Similarly, the citizen suit provision of TSCA is exercised infrequently.
Defendant Inhance Technologies USA (“Inhance”) is a Texas-based corporation that treats plastic containers, including high-density polyethylene (HDPE), using a fluorination process. Inhance is the principal supplier of post-mold fluorination services in the United States.
According to the Complaints, Inhance has been in violation of the Long-Chain Perfluoroalkyl Carboxylate (“LCPFAC”) Significant New Use Rule (“SNUR”) that requires manufacturers to file a Significant New Use Notice (“SNUN”) for any manufacturing (including importing) or processing of an LCPFAC for which there were no ongoing uses as of January 21, 2015. See 40 CFR 721.10536. This includes substances that are typically exempt byproducts under TSCA and LCPFACs that are imported as part of articles. Inhance allegedly violated two SNUR requirements. The complaints assert that Inhance failed to submit a SNUN for LCPFAC substances formed during the fluorination of plastic containers at least 90 days prior to the manufacture of these substances. The second violation charged is the company’s manufacture of these substances before completion of the requisite 90-day SNUN review period.
Inhance received warning of its violation of the LCPFAC Rule by the Plaintiffs of each lawsuit months prior to litigation. The lawsuits follow a March 2022 letter EPA sent to the HDPE industry. EPA issued the letter, first “to remind industry of this issue to help prevent unintended PFAS formation and contamination,” and second, to “emphasize the requirement under TSCA as it related to PFAS and fluorinated polyolefins.” In its letter, EPA reminded the industry of the SNUR, highlighting that while LCPFAC chemical substances are byproducts of the fluorination process from the chemical and commercial standpoint, these substances are not eligible for the byproducts exemption in 40 CFR § 721.45(e). The Agency letter further encouraged the industry to pursue alternative fluorination processes which are less likely to foster unintentional PFAS creation. EPA’s lawsuit is its first enforcement matter against the HDPE industry following the Agency’s warnings.
In March 2022, EPA issued a Notice of Violation (NOV), requesting that Inhance provide the Agency with additional information on changes the company may have made to the HDPE fluorination process that would eliminate PFAS production. The NOV stated that if no changes to the manufacturing process had been made, Inhance would need to immediately cease manufacturing PFAS and submit a SNUN to the Agency for review. Agency review of the information submitted by the company confirmed that the company was producing substances that are subject to the LCPFAC Rule.
In September 2022, Inhance notified EPA that it intended to submit a SNUN for its fluorination processes, but that it was unwilling to cease its fluorination processes before or during the EPA SNUN review period. Inhance has consistently maintained that it believes its operations are in full regulatory compliance.
EPA’s lawsuit was filed on December 19, 2022, with the non-profit lawsuit following about a week behind. The Complaints allege a variety of TSCA violations, namely the following:
- Section 5(a)(1) of TSCA, which states no person may manufacture or process a chemical substance for a significant new use unless (1) that person submits a Significant New Use Notice (“New Use Notice”) to the EPA; (2) the EPA reviews that notice; and (3) the EPA makes a determination on that use under Section 5(a)(3) of TSCA, 15 U.S.C. § 2604(a)(3). 15 U.S.C. § 2604(a)(1).
- Title 40 C.F.R. § 721.25 prescribes similar requirements for any person seeking to engage in a significant new use of a chemical substance.
- Section 15 of TSCA, which states that it is a prohibited act to fail or refuse to comply with any requirement of TSCA or any rule promulgated under TSCA. 15 U.S.C. § 2614.
- Under 40 C.F.R. § 721.35, it is a violation of Section 15 of TSCA to fail to comply with any provision of Title 40, Part 721 of the regulations implementing TSCA.
Plaintiffs in both cases are seeking declaratory and injunctive relief under Section 15(a) of TSCA (15 U.S.C. § 2616(a)) and the Declaratory Judgment Act (28 U.S.C. § 2201) for Inhance to cease production of all products using the PFAS forming fluorination process. To resume production, Inhance must demonstrate to EPA that it has altered its production process to eliminate PFAS production.
Case Update
In April 2023, the U.S. District Court of the District of Columbia dismissed the lawsuit brought by CEH and PEER. Shortly after CEH and PEER filed their lawsuit, Inhance filed a motion to dismiss the case arguing that the lawsuit was inappropriate under TSCA’s diligent prosecution bar. DOJ filed an amicus brief supporting Inhance’s motion to dismiss. For the CEH and PEER lawsuit to proceed, the organizations would have needed to demonstrate that DOJ was not diligently prosecuting the case. The court granted Inhance’s motion stating that “[n]othing in the eight days between when DOJ filed its lawsuit and when the Plaintiffs filed theirs suggests that [DOJ] was not diligently prosecuting the case.”
On June 13, the court presiding over the DOJ lawsuit scheduled oral arguments for August 23, 2023.
Delta Airlines Sued for Greenwashing Making Carbon Neutral Claims
/in Green Marketing, Sustainable Products /by aneumannDelta Airlines is the latest company to face a greenwashing class action lawsuit. The complaint alleges that the company has misled its customers by making carbon neutral claims. According to the complaint, Delta advertises that it has been carbon-neutral since March 2020; however, because Delta is using carbon offsets to achieve this, the complaint alleges that the company is making representations that are “manifestly and provably false.”
While on paper the purchase of carbon offsets should account for Delta’s global emissions, the complaint claims that issues exist with the accuracy and reliability of offsets issued by a voluntary carbon offset market. The complaint alleges that the voluntary offset market is comprised of “a loose arrangement of companies and NGOs that facilitate investment in green projects such as renewable energy and prevention of deforestation,” but that these carbon neutral projects have foundational issues such as inaccurate and speculative accounting of true carbon offsets, and the fact that many of these projects were scheduled and would have occurred regardless of participating carbon offset programs. Therefore, Delta’s claims “hinge[] on an underlying set of representations” that Plaintiff asserts are “manifestly and provably false.”
The complaint purports that “both scientists and government regulators have specifically identified [Delta] as one of many companies who have grossly misstated the actual carbon reduction produced by their carbon offset portfolio.” If these allegations are true, this would mean that, in reality, Delta is not fully carbon neutral, as the offsets it purchases are not accurately measured.
The Plaintiff alleges the carbon neutral claims are false and misleading and that consumers would not have purchased tickets on Delta flights at all or would have paid substantially less for them had they been aware the claims were false. This assertion is consistent with the increasing trend of consumers paying market premiums for greener products and services, i.e., products and services that have a smaller carbon footprint than competitors or no carbon footprint.
This complaint was brought pursuant to California’s Consumers Legal Remedies Act and California’s False Advertising, Business and Professions Code, which prohibits improper representations regarding the sale and source, sponsorship, approval, or certification of the services sold.
TSCA Enforcement Action Taken Over Failure to Comply with PFAS SNUR
/in Enforcement, News & Events, PFAS, TSCA /by aneumannIn December 2022, two separate lawsuits were filed against Inhance Technologies USA regarding its alleged production of certain PFAS substances in violation of the Toxic Substances Control Act (“TSCA”). These lawsuits are important as they raise novel questions of TSCA interpretation and enforcement.
The first lawsuit was filed by the U.S. Department of Justice, Environment and Natural Resources Division on behalf of the U.S. Environmental Protection Agency (“EPA”). The second case is a citizen suit filed by the non-profit organizations Center for Environmental Health (“CEH”) and Public Employees for Environmental Responsibility (“PEER”). U.S. v. Inhance Technologies LLC, U.S. Eastern District of Pennsylvania, Case No. 2:22-cv-05055; Center for Environmental Health v. Inhance Technologies USA, U.S. District Court for the District of Columbia, Case No. 1:22-cv-03819. It is rare that EPA pursues TSCA enforcement actions in federal court. Similarly, the citizen suit provision of TSCA is exercised infrequently.
Defendant Inhance Technologies USA (“Inhance”) is a Texas-based corporation that treats plastic containers, including high-density polyethylene (HDPE), using a fluorination process. Inhance is the principal supplier of post-mold fluorination services in the United States.
According to the Complaints, Inhance has been in violation of the Long-Chain Perfluoroalkyl Carboxylate (“LCPFAC”) Significant New Use Rule (“SNUR”) that requires manufacturers to file a Significant New Use Notice (“SNUN”) for any manufacturing (including importing) or processing of an LCPFAC for which there were no ongoing uses as of January 21, 2015. See 40 CFR 721.10536. This includes substances that are typically exempt byproducts under TSCA and LCPFACs that are imported as part of articles. Inhance allegedly violated two SNUR requirements. The complaints assert that Inhance failed to submit a SNUN for LCPFAC substances formed during the fluorination of plastic containers at least 90 days prior to the manufacture of these substances. The second violation charged is the company’s manufacture of these substances before completion of the requisite 90-day SNUN review period.
Inhance received warning of its violation of the LCPFAC Rule by the Plaintiffs of each lawsuit months prior to litigation. The lawsuits follow a March 2022 letter EPA sent to the HDPE industry. EPA issued the letter, first “to remind industry of this issue to help prevent unintended PFAS formation and contamination,” and second, to “emphasize the requirement under TSCA as it related to PFAS and fluorinated polyolefins.” In its letter, EPA reminded the industry of the SNUR, highlighting that while LCPFAC chemical substances are byproducts of the fluorination process from the chemical and commercial standpoint, these substances are not eligible for the byproducts exemption in 40 CFR § 721.45(e). The Agency letter further encouraged the industry to pursue alternative fluorination processes which are less likely to foster unintentional PFAS creation. EPA’s lawsuit is its first enforcement matter against the HDPE industry following the Agency’s warnings.
In March 2022, EPA issued a Notice of Violation (NOV), requesting that Inhance provide the Agency with additional information on changes the company may have made to the HDPE fluorination process that would eliminate PFAS production. The NOV stated that if no changes to the manufacturing process had been made, Inhance would need to immediately cease manufacturing PFAS and submit a SNUN to the Agency for review. Agency review of the information submitted by the company confirmed that the company was producing substances that are subject to the LCPFAC Rule.
In September 2022, Inhance notified EPA that it intended to submit a SNUN for its fluorination processes, but that it was unwilling to cease its fluorination processes before or during the EPA SNUN review period. Inhance has consistently maintained that it believes its operations are in full regulatory compliance.
EPA’s lawsuit was filed on December 19, 2022, with the non-profit lawsuit following about a week behind. The Complaints allege a variety of TSCA violations, namely the following:
Plaintiffs in both cases are seeking declaratory and injunctive relief under Section 15(a) of TSCA (15 U.S.C. § 2616(a)) and the Declaratory Judgment Act (28 U.S.C. § 2201) for Inhance to cease production of all products using the PFAS forming fluorination process. To resume production, Inhance must demonstrate to EPA that it has altered its production process to eliminate PFAS production.
Case Update
In April 2023, the U.S. District Court of the District of Columbia dismissed the lawsuit brought by CEH and PEER. Shortly after CEH and PEER filed their lawsuit, Inhance filed a motion to dismiss the case arguing that the lawsuit was inappropriate under TSCA’s diligent prosecution bar. DOJ filed an amicus brief supporting Inhance’s motion to dismiss. For the CEH and PEER lawsuit to proceed, the organizations would have needed to demonstrate that DOJ was not diligently prosecuting the case. The court granted Inhance’s motion stating that “[n]othing in the eight days between when DOJ filed its lawsuit and when the Plaintiffs filed theirs suggests that [DOJ] was not diligently prosecuting the case.”
On June 13, the court presiding over the DOJ lawsuit scheduled oral arguments for August 23, 2023.
Cosmetic Industry Increasing Supply Chain Ingredient Transparency
/in FDA /by aneumannThe United States Congress has introduced a bill (H.R. 3622, The Cosmetic Supply Chain Transparency Act of 2023) to amend the Federal Food, Drug, and Cosmetic Act to increase transparency regarding the ingredients used in cosmetic and personal care products. Currently, cosmetic brand owners are not entitled to reliable and accurate information from their suppliers, formulating laboratories, or the companies that package their products. Access to composition information and cooperation in gaining such information from these parties varies. However, despite limited access to supply chain data, brand owners are ultimately liable for the safety of the final products. Subsequently, brand owners are open to FDA enforcement actions, civil lawsuits, and marketplace reputational damage if safety issues with their products arise.
If passed, the bill will require upstream providers — from fragrance houses and formulating laboratories to contract manufacturers and suppliers of raw materials and finished products — to provide cosmetic companies with the following information upon request:
The abovementioned parties must furnish this information to the requesting cosmetic company within 90 days of a data request, or they will be subject to penalties of up to $10,000 per day until the request is completed.
EPA Proposes Ban on Perchloroethylene
/in EPA, TSCA /by aneumannUsing its authority under the Toxic Substances Control Act (TSCA), EPA has released a proposed rule to ban the use of perchloroethylene (“PCE”) for most commercial and industrial uses. (PCE is also referred to as perc and tetrachloroethylene.) PCE is used in a number of applications and industries, including petroleum manufacturing, aerosol degreasing, and dry cleaning.
The proposed rule follows the Agency’s assessment of the risk to human health presented by the substance. EPA conducted a risk evaluation of the substance under TSCA section 6(b). That assessment determined that PCE, as a whole chemical substance, presents an unreasonable risk of injury to human health as PCE exposure causes a variety of adverse health effects. PCE is a known carcinogen; it also causes neurotoxicity, including impaired visual and cognitive function. Various other health effects were noted by the risk evaluation, including central nervous system depression, kidney and liver effects, immune system toxicity, and developmental toxicity.
Under TSCA section 6(a), EPA is required to address, by rule, any unreasonable risk of injury to health or the environment found during a TSCA risk evaluation. Section 6(a) also requires the Agency to identify actions necessary to ensure the chemical does not continue presenting an unreasonable risk by either a) implementing “a requirement [either] prohibiting or otherwise restricting the manufacturing, processing, or distribution in commerce of such substance or mixture,” or b) “limiting the amount of such substance or mixture which may be manufactured, processed, or distributed in commerce.” To meet these requirements, EPA is proposing to prohibit the manufacture, import, processing, and distribution of PCE for a number of commercial and consumer uses, such as in dry cleaning, spot-cleaning operations and degreasing. The prohibition allows a 10-year phaseout period.
The Agency will still permit limited use of PCE for some uses, particularly those which help its efforts in addressing climate-damaging hydrofluorocarbons (an initiative happening under the American Innovation and Manufacturing Act of 2020). PCE will also be used in uses that are important for national security applications or to meet other critical national needs. In these cases, EPA would require the implementation of a PCE workplace chemical protection program. The chemical protection program would include requirements to meet an inhalation exposure concentration limit and prevent direct dermal contact. The Agency has also put forward prescriptive requirements for laboratory use, recordkeeping, and downstream notification.
EPA will permit certain time-limited exemptions from the ban for certain critical or essential emergency uses of PCE when no alternative is technically or economically feasible safer alternative is available.
European Chemicals Agency Releases Proposal Banning PFAS
/in EU, PFAS /by aneumannOn February 7, The European Chemical Agency (ECHA) proposed a ban on per- and poly-fluoroalkyl substances (PFAS) as part of the European Union’s Registration, Evaluation, Authorization, and Restriction of Chemicals (“REACH”) regulation. The ban, which would include about 10,000 PFAS substances, could greatly impact US companies that export virtually any product to the European Union (“EU”). These companies will need to examine whether their products contain PFAS before exporting products to the EU.
The proposed ban is the EU’s largest-ever chemicals prohibition. It is intended to achieve the EU’s goal of a non-toxic environment by 2050. ECHA proposes banning chemicals, mixtures, and articles with 25 parts per billion (ppb) or more of a particular PFAS or 250 ppb of a combination of PFAS. ECHA defined PFAS as “Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it).” According to ECHA, this definition encompasses more than 10,000 PFAS. The proposal explains that this definition is aligned with the definition of PFAS published in 2021 by the OECD. Excluded from the scope of the proposed ban are PFAS substances that are fully degradable as they do not fulfill the underlying concern of high persistence. The ban would begin 18 months following the finalization of the restriction, which is anticipated for some time in 2025.
The initial regulation will include a variety of exemptions with phase-out periods of five or 12 years. Pesticides (referred to as biocides in the EU), along with human and veterinary medicines, would also be exempted from the restriction. PFAS used in specialized fire-fighting suppressants, called aqueous film-forming foam (AFFF), are also exempt as they are being phased out through a separate restriction.
The proposed regulation would supersede existing regulations that allow PFAS in products such as food packaging, pesticides (referred to as biocides in the EU), and human and veterinary medicines. PFAS used in firefighting suppressants (aqueous film-forming foam) used largely by airports, fire departments, and military bases, are being phased out through a separate restriction.
Affected businesses may need to evaluate thousands of products for the presence of PFAS, ranging from camping gear to mobile phones. The ban is likely to have a significant impact on any US company selling products in the EU.
ECHA will accept public comments on the proposal until September 2023. EU companies, working through their trade associations, are already commenting on the proposed ban suggesting a longer phase-out period of 32 months instead of the proposed 18 months and additional exemptions where alternatives are not yet available. The final restriction is expected in 2025.
EPA’s First PFAS Clean Water Act Enforcement
/in EPA, News & Events /by Russell MarksOn April 26, 2023, EPA announced that the Agency has taken the first federal Clean Water Act enforcement action for PFAS discharges. The Agency ordered Chemours Company to follow corrective measures relating to exceedances of the limits set for per and polyfluoroalkyl substances (PFAS) in stormwater and wastewater discharges from the Washington Works facility in Parkersburg, WV. The PFAS limits were set by in the company’s National Pollution Discharge Elimination System (NPDES) permits.
EPA issued an administrative order on consent (AOC) for the facility for exceeding permit limits on PFOA and HFPO Dimer Acid on more than 20 dates from September 2018 to March 2023. The exceedances were documented in the discharge monitoring reports submitted by the company to the West Virginia Department of Environmental Protection – a permit requirement. EPA also stated that Chemours was in violation of requirements for properly operating and maintaining all facilities and systems for permit compliance. The AOC requires that Chemours take the following actions:
1) Implement a sampling plan to analyze PFAS and conduct analysis on the presence of PFAS in the stormwater and wastewater discharges. The plan must be submitted to EPA for approval.
2) Submit and implement a PFAS treatment plan or minimizing plan to EPA for compliance with the permit limits.
3) Submit its existing Standard Operating Procedures for their management of wastewater for various systems and their revised Storm Water Pollution Prevention Plan.
In its press release, EPA noted that “Administrator Regan has directed EPA staff to use every enforcement tool at our disposal to compel manufacturers of PFAS to characterize, control, and clean up ongoing and past PFAS contamination,”
The AOC can be accessed here.
EPA Releases Chemical Data Reporting National Review
/in CDR, EPA, TSCA /by aneumannEPA has released its first-ever Chemical Data Reporting (CDR) National Review (“Review”), which provides a comprehensive analysis of data submitted to the Agency during the 2020 CDR reporting cycle. The report presents information about chemicals that were manufactured and imported into the US from 2016 through 2019. In its press release on the Review, the Agency stated that the document will assist stakeholders in evaluating and understanding information about the types, quantities, and uses of chemicals produced domestically or imported into the U.S.
Manufacturers and importers of chemical substances listed on the Toxic Substances Control Act (“TSCA”) Inventory are required to report data to the EPA every four years if they manufacture or import substances at or above specific thresholds unless the chemical has been exempted from the reporting requirement. Typically reporting is required when an entity manufactures or imports 25,000 pounds or more of a chemical during any year in the reporting period at any single site. Companies must report how chemicals are processed or used (industrial processing and use data), and whether they are used in commercial or consumer products (commercial and/or consumer use data) in addition to manufacturing and import volumes.
According to EPA, the CDR database is the most comprehensive source of basic screening-level, exposure-related information on chemicals that is available to the Agency. EPA uses the database to screen and prioritize chemicals for further review.
The Review summarizes data from the most recent CDR reporting cycle data (2020), covering activities from 2016 to 2019, and provides trend data for reporting over the past decade. During this reporting period, more than 7.2 trillion pounds of chemicals were manufactured or imported at 5,238 sites.
The Review provides interactive trend analysis, including an interactive map of CDR sites and characteristics of the communities in which these sites are located. It also includes maps displaying CDR reporting sites by state, and figures with production volumes. In addition, the Review contains informational charts and figures to increase understanding of a variety of CDR data elements, such as analyses of chemical use information. Environmental justice tools from EPA’s EJScreen, the Agency’s environmental justice mapping tool, are also contained in the document.
The Review’s key findings include:
Supreme Court to Debate Overturning Chevron Doctrine
/in Uncategorized /by aneumannThe U.S. Supreme Court has agreed to consider overturning the Chevron doctrine in the Court’s October 2023 term. Chevron is the legal doctrine that has given federal regulators broad power to define their authority. The appeal in Loper Bright Enterprises v. Raimondo, by four New Jersey fishing companies, asks the court to overturn the watershed 1984 Chevron v. Natural Resources Defense Council ruling. In the Chevron decision, the Supreme Court held that courts should defer to administrative agencies when they offer a reasonable interpretation of an unclear statute.
The case involves a federal requirement that some fishing vessels that are fishing herring off the Atlantic coast hire monitors for conservation and management purposes. The requirement specifically mandates that the fishing companies themselves are expected to pay for the monitors. The fishing companies challenged the requirement, claiming that Congress did not authorize the National Marine Fisheries Service (Service) to require them to pay for the monitors. The fishing companies allege that they could spend as much as 20 percent of their revenues on the monitors. In August 2022, the United States Court of Appeals, District of Columbia Circuit upheld the district court’s “grant of summary judgment [upholding the monitoring requirement] to the Service based on its reasonable interpretation of its authority and its adoption of the Amendment and the Rule through a process that afforded the requisite notice and opportunity to comment” requirement relying upon the Chevron doctrine.
The fishing companies argue that the Court can simply say Chevron does not apply because the law in question (the Magnuson-Stevens Act, which governs the management of marine fisheries in federal waters) does not say anything at all about requiring the industry to fund the cost of monitors. Therefore, there is no ambiguity to be interpreted in favor of the Agency. On May 1, the Court granted certiorari to hear Question 2 from the fishing companies’ petition, which asked: “Whether the Court should overrule Chevron or at least clarify that statutory silence concerning controversial powers expressly but narrowly granted elsewhere in the statute does not constitute an ambiguity requiring deference to the agency.”
Overturning Chevron would put more responsibility on Congress to directly address policy issues and give judges more authority to define the limit of agency powers.
EPA Releases Draft National Strategy to Prevent Plastic Pollution
/in EPA, Recycling /by aneumannIn April, EPA released the Draft National Strategy to Prevent Plastic Pollution. This strategy document, part of EPA’s Series on Building a Circular Economy for All, outlines voluntary actions aimed at eliminating plastic waste released into the environment from land-based sources by 2040. Under this plan, EPA seeks to reduce, reuse, recycle, collect, and capture plastic waste. The draft strategy comprises three primary objectives, each focusing on different aspects of plastic pollution prevention:
Objective A: Reduce pollution during plastic production
This objective emphasizes minimizing pollution throughout the life cycle of plastic products. It encourages manufacturers and consumers to implement upstream actions such as designing products for reuse and recycling, using less impactful materials, and controlling plastic production facilities. Proposed actions include reducing the production and consumption of single-use, unrecyclable, or frequently littered plastic products, as well as minimizing pollution across the entire life cycle of plastic products.
Objective B: Improve post-use materials management
While the National Recycling Strategy identified actions to enhance recycling, this objective expands the focus to other pathways of circularity, including reuse, refill, and composting. Proposed actions involve conducting a study of existing policies and incentives to evaluate their effectiveness, developing or expanding capacity for maximizing material reuse, facilitating effective composting, increasing solid waste collection, enhancing public understanding of plastic mismanagement, and exploring ratification of the Basel Convention for environmentally sound management of scrap and recyclables.
Objective C: Prevent trash and micro/nanoplastics from entering waterways and remove escaped trash from the environment
Proposed actions include implementing policies, programs, and compliance assurance measures to prevent trash and microplastics from entering waterways, improving water management to capture trash in waterways and stormwater/wastewater systems, increasing awareness of the impacts of plastic products in waterways, and coordinating research on micro/nanoplastics.
The agency aims to gauge the importance of different actions, identify key steps and milestones for successful implementation, determine the roles and actions federal agencies should lead, and evaluate potential unintended consequences on overburdened communities. EPA also seeks input on relevant metrics and indicators to measure progress and invites recommendations for additional actions to include in the strategy.
Congress Enacts Modernization of Cosmetics Regulation
/in FDA /by aneumannLast month FDA published a webinar titled Modernization of Cosmetics Regulation Act of 2022 – Key Terms and Provisions. The purpose of the program was to provide an overview of the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”). The Act imposes new reporting and registration requirements on cosmetic manufacturers. In addition, under MOCRA, cosmetic manufacturing facilities will be required to implement Good Manufacturing Practices (GMPs).
Under MOCRA, mandatory reporting will be required for serious adverse health events caused by cosmetic products. Responsible persons (i.e., manufacturers, packers, and distributors) will be required to report such events to FDA within 15 business days of learning about them. MOCRA defines serious adverse health events to include infections, incapacitation, significant disfigurement (e.g., serious rashes, second or third-degree burns, significant hair loss, or alternation of appearance), or any condition of severity that requires professional medical attention. Reports of adverse events must be accompanied by a copy of the label of the product at issue. Records related to adverse events must be maintained for six years. Responsible persons shall make these records to “authorized persons’ during inspections. FDA claims the new requirement aims to help FDA identify potential safety concerns with cosmetic products more quickly and take appropriate action to protect the public.
Cosmetic manufacturing facilities will now be required to register with FDA; existing facilities must register within one year of enactment of the Act, and new facilities must register within 60 days of first beginning cosmetics manufacture. Facilities must renew their registration biennially. Registration requirements include providing all brand names under which cosmetic products manufactured or processed in the facility are sold, a list of all cosmetic products manufactured at the facility, and for each product listed, product ingredients, including ingredients in fragrances and flavors. Manufacturers must also keep records documenting ‘adequate substantiation of safety’ providing competent and reliable evidence that products are safe for use. Further, the Act tasks FDA with establishing Good Manufacturing Practices within 2 years of MOCRA’s passage.
MOCRA also mandates the labeling of fragrance allergens for all cosmetics and ingredient labeling for professional use-only products used by salon workers. Additionally, FDA is to establish a standardized testing method for detecting asbestos in talc-containing products within 1 year of MOCRA’s enactment. MOCRA also requires the FDA to assess the use and safety of PFAS in cosmetics and to publish a report of the assessment to be by December 2025.
In addition, MOCRA allows FDA to request records related to a product’s safety substantiation and ingredients and request a mandatory recall of products that are misbranded and/or adulterated.
MOCRA includes a small business exemption for businesses reporting average gross annual sales for the previous three-year period is less than $1 million. The exemption is limited to small businesses that do not make cosmetics that come in contact with eye mucus membranes, are injected, intended for internal use, or alter the appearance for more than 24 hours. Qualifying businesses are exempt from the core provisions of MOCRA, including facility registration (Section 607) and good manufacturing practice or GMP (Section 606).
MOCRA preempts states from passing more stringent laws related to registration, product listing, good manufacturing practice, records, recalls, adverse event reporting, or safety substantiation. This means that cosmetic manufacturers will be subject to a uniform set of regulations across the country.