White House Office of Science and Technology Policy Requests Information on the Regulation of Biotechnology

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The White House Office of Science and Technology Policy (OSTP) recently released two Requests for Information (RFI) regarding the National Biotechnology and Biomanufacturing Initiative. The Initiative is intended to advance biotechnology and biomanufacturing for innovative solutions in a number of areas, including health, climate change, energy, food security, agriculture, and supply chain resilience. The goal of the program is to strengthen supply chains and lower prices, create sustainable products, create jobs, and spur new opportunities in agricultural communities.

The first RFI sought public input on how advances in biotechnology and biomanufacturing can help the country achieve societal goals related to health, climate change and energy, food and agricultural innovation, and resilient supply chains. Topics identified in the RFI include harnessing biotechnology and biomanufacturing R&D, identifying data gaps and collecting data on the bioeconomy, building a vibrant domestic biomanufacturing ecosystem, procuring biobased products, developing a biotechnology and biomanufacturing workforce, advancing biosafety and biosecurity, measuring the bioeconomy, and international engagement.

The second RFI focuses specifically on federal regulation of biotechnology. It requested public input on how to improve the clarity and efficiency of biotechnology product regulation. OSTP coordinated with the U.S. Environmental Protection Agency, the U.S. Food and Drug Administration, and the U.S. Department of Agriculture to develop the RFI.

 

 

EPA Issues Next Test Order Under National PFAS Testing Strategy — PFAS Used in Plastics at Issue

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EPA has issued its second round of Test Orders under its National PFAS Testing Strategy. The test orders require companies to conduct and submit testing on trifluoro (trifluoromethyl) oxirane (HFPO) (CASRN 428-59-1), a PFAS substance used in making plastics. According to EPA’s Chemical Data Reporting (CDR) database, more than 1,000,000 points of HFPO are manufactured each year. EPA has concluded, using existing hazard and exposure data, that HFPO may present an unreasonable risk of injury to health or the environment, finding that exposure may result in neurotoxicity, reproductive effects, and cancer. The Tier 1 testing will address human health from exposure via inhalation and hydrolysis. Tier 2 testing, if required, will look at reproductive toxicity, developmental neurotoxicity, and carcinogenicity.

The companies that are subject to the test order include The Chemours Company, DuPont De Nemours Inc., E.I. du Pont de Nemours and Company, and 3M Company. These companies are required to submit the results of testing data to EPA within 415 days of the effective date of the order. All data produced from this test order will subsequently be published on EPA’s website.

EPA Publishes Final IRIS Assessment of PFBA

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In December, EPA published the IRIS Toxicological Review of Perfluorobutanoic Acid and Related Salts. The Agency’s assessment addresses potential cancer and noncancer human health effects of exposure to perfluorobutanoic acid (PFBA) and its related salts. The most significant of the IRIS findings is that sufficient oral exposure to PFBA likely causes disruptions to normal thyroid hormone production, liver damage, and developmental effects. The Agency stated there was inadequate evidence to determine whether reproductive effects might represent a potential human health hazard following PFBA exposure.

PFBA and its related salts are members of the PFAS family.  It is a breakdown product of other PFAS that are used in a variety of products, including stain-resistant fabrics, carpets, and paper food packaging. PFBA can also be used in the manufacturing process of photo film and is used as a substitute for a type of PFAS, longer chain perfluoroalkyl carboxylic acids in consumer products. The substance can accumulate in agriculture crops, household dust, soils, food products, and surface, ground, and drinking water. Exposure to PFBA can occur through inhalation of indoor or outdoor air, ingesting contaminated drinking water and food, and dermal contact with PFBA-containing products.

As part of its PFAS Strategic Roadmap, EPA has been actively working on IRIS assessments for five PFAS: PFBA, PFHxA, PFHxS, PFNA, and PFDA. The PFBA IRIS is the first in this series to be released.

EPA Revokes Interim Approval of Glyphosate

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EPA recently withdrew its 2020 Interim Approval of glyphosate, often referred to by its trade name Roundup. Interim approvals are part of a conditional registration process used by the Agency to allow new active ingredients to enter the market for an unspecified period of time while the registrant generates missing data required by the Agency for the formal registration process.  Although the Interim Approval was revoked, EPA maintains that the chemical is not carcinogenic, and the product will remain on the market as the Agency completes its periodic review as required by law. In its registration review of glyphosate, the Agency will attempt to elaborate on its evaluation of the carcinogenic potential of glyphosate. EPA will also consider whether a better explanation is needed for its findings on other aspects of the human health analysis. EPA expects to complete the review of glyphosate in 2026.

The 2020 Interim Approval was challenged in the U.S. Court of Appeals for the Ninth Circuit. Petitioners made two main allegations, first that EPA’s analysis of human health, particularly related to cancer analysis, was faulty. Second, the Agency violated the Endangered Species Act (ESA) which requires the weighing of such risks against the benefits of glyphosate and the interim risk mitigation measures.

In June 2022, the Court vacated the human health portion of the glyphosate interim review decision and held that EPA’s registration review decision under FIFRA triggered ESA obligations. It also granted EPA’s request for voluntary remand, without vacatur, of the ecological portion of the interim registration review decision but imposed a deadline for EPA to issue a new ecological potion.

While the EPA has made this withdrawal decision, it is unable to finalize the new ecological portion in a registration review decision as mandated by the Court decision. The Agency states the delay is necessary to appropriately address the issues EPA sought to remedy in the ecological potion and satisfy the ESA requirements. EPA is currently working on a consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Services. Any proposed decisions will require a 60-day comment period and an assessment of comments received. You can read EPA’s full release on its withdrawal decision here.

EPA Updates New Chemical Review Program Webpage to Increase Transparency

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In December 2022, EPA announced updates to its New Chemicals Review Program website to include additional information and metrics on the Agency’s review of new chemicals and significant new uses.  In the announcement, the Agency stressed its commitment to increasing efficiency, effectiveness, and transparency through the chemical review process. To progress in this goal, the website will now include:

  • A more detailed breakdown of new chemical submissions, including a month-by-month count of new chemical submissions, completed risk assessments, and completed risk management actions for all notices and exemptions.
  • Greater details and explanations on each step of the review process. This includes “the extent to which the submitter has provided additional information during the review period – subsequent to the original submission – and the level of effort needed to potentially rework some or all of the risk assessment as a result” and applicability of new approaches developed by the Agency to standardize reviews for certain new chemicals.
  • A status tracker for new chemical exemptions (e.g., Low Volume Exemptions (LVEs) and Test Market Exemptions (TMEs)).

According to EPA, the new website will be updated monthly.

Danone Waters Sued Over Label’s “Carbon Neutral” Statements

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A class action suit was recently brought against Danone Waters of America Inc. The company sells bottled water worldwide under various brand names, including Aqua, Bonafont, and Evian. The lawsuit is specific to its Evian-branded water, which petitioners allege is deceptively and factually inaccurately marketed as “carbon neutral,” a practice referred to as “greenwashing.” The Petitioners’ suit claims violations of California’s Consumer Legal Remedies Act, New York’s Business Law sections on consumer protection and false advertising, as well as breach of express warranty, breach of implied warranty, unjust enrichment, and fraud.

The Complaint states technical definition of carbon neutral is a product “having or resulting in no net addition of carbon dioxide into the atmosphere.” (Citing Carbon-neutral, MERRIAM-WEBSTER (2022); see also A Beginner’s Guide to Climate Neutrality, UNITED NATIONS CLIMATE CHANGE, (Feb. 26, 2021), https://unfccc.int/blog/abeginner-s-guide-to-climate-neutrality). Evian labels and packaging do not include a definition of carbon neutral or direct consumers to its website for further information. Petitioners believe that reasonable consumers reading an Evian label would interpret the carbon neutral claim to mean that the manufacturing process does not create carbon emissions, which is factually inaccurate. Beyond the manufacturing process, it has also been found that the companies Danone utilizes to transport its Evian products are not carbon neutral.

Danone will likely argue that many interpret carbon neutrality to include carbon credits which a company can purchase to offset its carbon emissions. Rather than reducing or eliminating emissions, Danone founded and contributed funds to Livelihood Carbon Funds, which invests in agroforestry projects. Instead of a monetary return on investment, Danone will receive credits that, at least theoretically, offset carbon emissions. Petitioners claim that because the offsets created by these agroforestry programs won’t be realized for decades, Danone cannot make a successful carbon offsetting counterargument.

The case is ongoing in the U.S. District Court, Southern District of New York. The full docket can be found here.

EPA Allegedly Refuses to Address Toxic Pesticide Ingredients

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The Center for Food Safety and other non-profit organizations dedicated to environmental advocacy brought suit against the EPA, claiming that the Agency fails to assess the full environmental and health impacts of pesticides in its approval process. Current EPA regulations require pesticide producers to submit toxicity data on active ingredients as part of the registration process.  However, such data is not required for inert ingredients. Active ingredients are those designed to harm the targeted pests, while inert ingredients, which can also be toxic, are used for other purposes, such as acting as a solvent to help the active ingredient penetrate a plant’s leaf surface, preventing foaming or caking, and extending a product’s shelf life. EPA is required to determine the safety of all active and inert pesticide ingredients. Petitioners argue this isn’t achievable without toxicity data for inert ingredients. This is not the Center for Food Safety’s first plea to the Agency to address this issue; in 2017, it filed a petition with EPA requesting a rulemaking change for pesticide regulations, but the Agency never responded.

Vinyl Institute Seeks Judicial Review of EPA Test Order

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Congress granted EPA new test order authority through the 2016 Lautenberg Amendments to the Toxic Substances Control Act (TSCA).  In May 2022, EPA received its first legal challenge to this new authority from the Vinyl Institute.  The Vinyl Institute is a coalition of seven companies which manufacture a solvent, 1,1,2-trichloroethane, that EPA listed as a priority chemical in December 2019 and that is currently undergoing risk evaluation.  The Vinyl Institute is seeking judicial review of a test order for 1,1,2-trichloroethane, for an avian reproduction test.  Specifically, the petition to the DC Circuit Court argues that EPA has not adequately explained the need for the data.  1,1,2-trichloroethane is used as a solvent and an intermediate in the production of 1,1-dichloroethane.  During the risk prioritization process, the Agency determined that it had insufficient data on the substance to understand if it has the potential to harm wildlife and issued the test order.

The Vinyl Institute stated in their petition that the Test Rule is arbitrary, capricious, and an abuse of discretion.  It alleges that EPA failed to:

  • Adequately explain why the avian reproduction test is necessary,
  • Consider all available information and data for the substance,
  • Cite reliable and representative information and data in support of the Test Order,
  • Adequately justify the need for the test without first requiring screening level testing, and
  • Consider the relative costs of the Test protocols, along with availability of facilities and personnel to perform the testing.

As of this date, the parties have filed motions regarding whether additional submission may be made to the record.

EPA Releases Initial Regulatory Flexibility Analysis for the Proposed PFAS Reporting Rule

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On November 25, 2022, EPA released an Initial Regulatory Flexibility Analysis (IRFA) for public comment as part of its development of a rule to collect information about PFAS. The IRFA follows the Agency’s June 2021 proposed rule, which would require all manufacturers and importers of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal. In the proposed rule, EPA certified that the rule would not have a significant impact on a substantial number of small entities under the Regulatory Flexibility Act (RFA). In response to public comments from the June 2021 proposed rule and additional data sources on PFAS-containing imports, EPA convened a Small Business Advocacy Review Panel and prepared the IRFA to investigate further the burdens the proposed rule would place on small businesses.

EPA significantly increased its cost estimates for the proposed rule, stating social costs would be approximately $875 million, from the original $10.8 million estimate, and Agency costs would be approximately $1.5M,  from the originally estimated $948,078.  The IRFA anticipates that in order to report years of production and importation data, small businesses would be expected to pay the lion’s share of these costs, $863.5 million, not the originally anticipated $1.8 million. Additionally, the IRFA details the percentage of small firms that will be impacted by the rule, finding that approximately 93% of manufacturers and 97.3% of article importers affected by the proposed rule are small businesses. The total number of small businesses expected to be impacted is 127,794.

In the IRFA, EPA proposed and requested comment on a variety of regulatory flexibility alternatives, including:

  • Exemptions for businesses with less than $12 million in sales.
  • Exemptions for businesses with less than $6 million in sales.
  • Exemptions for article importers with less than $6 million in sales.
  • Exemptions for article importers with less than $2 million in sales.
  • Limiting the scope of PFAS subject to the rule to a finite list of PFAS, removing the structural definition. (Although EPA expressed concern over the Agency’s inability to list substance identities based on CBI claims.)
  • Exemption for reporting thresholds of either 2,500 lbs. per year or 25,000 lbs. per year.
  • Allow for small businesses, providing a six-month deferral of data submission.
  • Simplified reporting forms for R&D substances manufactured in volumes less than 10 kg. per year — including limiting reporting to company information, generic chemical name, and production volume.
  • Simplified reporting forms for article importers– excluding requiring information on existing environmental and health effects data, environmental release and disposal data, or occupational exposure data.
  • Exemptions for R&D substances, byproducts, impurities, recyclers, and intermediates. (However, EPA stated that these exemptions would limit the Agency’s ability to achieve its goal of better understanding the entire scope of existing information on PFAS.)

The Agency also requested information and comment on items pertaining to CBI, including treatment of chemical identity claims, notice prior to publication on the public TSCA Inventory, and the generic naming of PFAS. These issues were not included in the IRFA and the Updated Economic Analysis. Regarding the treatment of CBI claims, EPA sought to clarify language related to an entity’s knowledge of a specific chemical identity stating:

[A]n entity that does not have knowledge of a specific chemical identity must initiate a joint submission with its supplier or other manufacturer. In these cases, the secondary submitter would be responsible for providing the specific chemical identity and for asserting and substantiating any CBI claims concerning the specific chemical identity. See, e.g.,40 CFR 711.15(b)(3); 711.30(c).

Regarding notice prior to publication on the public TSCA Inventory, EPA sought to clarify that if a submitter reports a PFAS substance by a specific chemical identity and does not assert CBI, that chemical identity will be published on the public Inventory without notice to the submitter. Importantly, EPA requested comment on aligning this provision with the language in the proposed CBI Procedures rule indicating that persons who previously made a CBI claim for the same specific chemical identity will not receive prior notice before the specific chemical identity is moved to the public Inventory. Lastly, EPA clarified that generic names must sufficiently identify the chemical as a PFAS; for example, under TSCA Section 14(c)(1)(C), a generic name for a PFAS that does not contain “fluor” would be rejected as insufficient.

Federal Trade Commission Seeks Comment on Green Guides

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The Federal Trade Commission (FTC) released a request for public comment on updating its  Guides for the Use of Environmental Marketing Claims (“Green Guides”), which provides guidelines for businesses that want to use environmental marketing claims in their advertising and labeling. The Green Guides aim to help businesses avoid making deceptive or misleading environmental. This includes assisting businesses in determining how consumers are likely to interpret specific claims and how to substantiate environmental claims.  In addition, the Green Guides present options for qualifying claims to avoid deception.

The Commission reviews the Green Guides every ten years, with the last review occurring in. Accordingly, FTC is now seeking comments on the Green Guides to ensure they continue providing helpful guidance for businesses and consumers.

In its request for public comment, the Commission has requested feedback by providing approximately 40 questions as prompts. The questions focus on what FTC Chair Lina M. Khan describes as “relatively emerging environmental topics” and businesses’ views on the Green Guides’ value. Topics include:

  • The use of environmental marketing claims in the context of emerging technologies and market trends, such as ozone friendly/safe, carbon offsets, recyclability, and energy efficiency, and whether the Green Guides should be updated in addressing these areas.
  • The impact of the Green Guides on small businesses, including any challenges or benefits that small businesses have experienced as a result of following the guidelines.
  • The extent to which the Green Guides are consistent with international guidelines and standards for environmental marketing claims.
  • Any additional guidance or clarification that the FTC could provide to help businesses make accurate and non-deceptive environmental marketing claims.

FTC also asks for comment on whether the Guides overlap or conflict with other federal, state, or local laws or regulations, and if so, how?

Additionally, the Commission requests comments on the Guides’ interaction with other environmental marketing regulations and whether the Commission should consider rulemaking to establish independently enforceable requirements related to unfair and deceptive environmental claims.

The Federal Register notice also discusses the types of information that the Commission would find helpful regarding specific environmental marketing claims, including carbon offsets and climate change, degradable, and recyclable.

The Agency is accepting comments until February 21, 2023. You can submit your comments online here.