By Lynn L. Bergeson and Carla N. Hutton
After reading the article below by Jeffery Morris, former Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), we were inspired to post it. We appreciate having the opportunity to share his analysis with our audience.
TSCA as a Gap-Filling Statute: Potentially Exposed and Susceptible Subpopulations
By Jeffery Morris, PhD
In its response to public comments on the scope documents for its next twenty chemical risk evaluations conducted under the Toxic Substances Control Act (TSCA), the US Environmental Protection Agency (EPA) has asserted that TSCA is a “gap-filling statute” for the regulation of chemical substances in the United States (US EPA, Summary of Public Comments Received on the Draft Scopes of the Risk Evaluations for Twenty Chemical Substances Under the Toxic Substances Control Act (TSCA), August 2020, p. 13). This assertion relates to the regulatory nexus between TSCA and other federal statutes. At issue regarding regulatory nexus is whether TSCA’s role is to: (1) fill gaps where issues are not addressed by other laws that regulate chemicals1, (2) serve as the nation’s primary and preeminent statute for chemicals, or (3) operate somewhere between these two positions. Inherent in the TSCA-as-gap-filler position is the view that federal laws should work together to advance the public welfare, and that different environmental statutes have their own strengths in how they govern the impact of chemicals on people and the environment.
TSCA requires the consideration of potentially exposed or susceptible subpopulations in the EPA’s evaluation of chemicals. While TSCA is not the only environmental law with provisions for susceptible or vulnerable subpopulations, the direct, repeated emphasis across multiple sections of the law that the EPA consider potentially exposed or susceptible subpopulations may be unique in US environmental law. Therefore, how the EPA meets this requirement with respect to other laws’ treatment of such populations is an important consideration for regulatory nexus. Key questions regarding regulatory nexus and TSCA’s role are how to go about identifying whether other statutes leave gaps in this area for TSCA to fill and if they do, how those gaps should be filled in the EPA’s chemical evaluations.
The recently released final scope documents and the accompanying response-to-comments document do not fully answer these questions, including regarding comments that have been raised about how the EPA will apply exposure and susceptibility considerations to people living in communities located near high concentrations of chemicals-related activity. My hope is that exploring these questions now can help inform a path forward for further addressing comments the EPA has received on potentially exposed or susceptible subpopulations as the twenty draft risk evaluations are developed, as well as in scope documents for future chemicals brought into the TSCA prioritization process.
In its response to scope document comments, the EPA makes two important statements regarding the regulatory nexus issue as applied to potentially exposed or susceptible subpopulations. The first, on page 13, is that “EPA believes that coordinated action on exposure pathways and risks addressed by other EPA-administered statutes and regulatory programs is consistent with statutory text and legislative history, particularly as they pertain to TSCA’s function as a ‘gap-filling’ statute ….” In the second statement, also on page 13, the EPA adds that “[t]o the extent that specific exposure pathways are not under the jurisdiction of other EPA-administered statutes and associated regulatory programs, EPA plans to evaluate those exposures in the risk evaluations for the individual substances.”
The first statement’s focus on “coordinated action” between laws and regulations with respect to chemical evaluation and management is a crucial consideration for regulatory nexus. Coordination by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), which administers TSCA, with other EPA offices that manage statutes that address chemicals, as well as with other federal agencies that implement laws impacting chemicals, is good government practice. What is missing from the final scope documents, and therefore would be a valuable addition to the chemical-specific dockets, is a detailed description of the type of coordination cited in the response to comments. Ideally, this description would appear in the scope documents, but for these twenty chemicals an addition to the dockets would be helpful. For example, the EPA could strengthen its explanation of whether potential exposures or susceptibilities are based on geography (e.g., exposures are higher in a particular location), biology (e.g., a particular population has a genetic or otherwise biologically based predisposition to suffer adverse effects from exposure to a chemical), or cultural/societal factors (e.g., a cultural or community practice results in exposure potential greater than in the general population, or an attribute of the subpopulation’s location in society, such as having low income or poor access to health care, creates susceptibilities to adverse effects from chemical exposure).
Because some comments on community exposures refer specifically to 1,3-butadiene, it is a useful example to illustrate the challenges and opportunities presented by the coordination the EPA is conducting within the regulatory nexus construct; it also can illustrate what I mean by a detailed description of cross-office coordination on potentially exposed or susceptible subpopulations. This example looks at just one of 1,3-butadiene’s uses: in the production of tires. Under its Clean Air Act (CAA) authority, the EPA’s Office of Air and Radiation (OAR) conducted a Residual Risk Assessment for the Rubber Tire Manufacturing Source Category in Support of the 2020 Risk and Technology Review Final Rule (EPA-HQ-OAR-2019-0392-0047, February 2020) that includes 1,3-butadiene within this source category, among numerous other chemical substances designated as hazardous air pollutants (HAP). This assessment supports a July 24, 2020, final rule, National Emission Standards for Hazardous Air Pollutants: Rubber Tire Manufacturing Residual Risk and Technology Review (EPA-HQ-OAR-2019-0392; FRL 10008-48-OAR, 85 FR 44752, July 24, 2020).
The coordination challenge, therefore, is to crosswalk the CAA review, which covers numerous HAPs within one sector, with a TSCA risk evaluation covering the conditions of use of a single HAP chemical across multiple sectors. On page 49 of the 1,3-butadiene TSCA scope document, the EPA states that air emission pathways are covered under the CAA (Final Scope of the Risk Evaluation for 1,3-Butadiene, EPA Document # EPA-740-R-20-011, August 2020). It would be useful for the 1,3-butadiene record to include a table and/or narrative that describes how, for its TSCA coordination on the consideration of potentially exposed or susceptible subpopulations, OCSPP evaluated the 1,3-butadiene conditions of use against the respective source category-based and any other analyses conducted by OAR that included 1,3-butadiene. Such a crosswalk could serve as a best practice for application of regulatory nexus analysis in the implementation of TSCA. It would also aid in transparency to the public around a very complex but important concept: that although different environmental statutes may use different approaches (e.g., sector or source category versus individual chemical analysis), it is possible to coordinate their respective contributions to chemical evaluation and management so that, if gaps exist, TSCA can play its appropriate role in health and environmental protection.
For instance, OAR’s 2020 final rule states that “the percentage of the population potentially impacted by Rubber Tire Manufacturing emissions is greater than its corresponding nationwide percentage for: African Americans (25 percent for the source category compared to 12 percent nationwide) and below the poverty level (21 percent for the source category compared to 14 percent nationwide)” (page 44759). Strong coordination between TSCA and the CAA would suggest that such information obtained through CAA activities would be helpful to OCSPP in determining how to address the “potentially exposed or susceptible subpopulations” considerations required under TSCA section 6, including as they may apply to TSCA’s gap-filler role in addressing comments to the 1,3-butadiene scope document concerning disproportionate exposure to communities located near high concentrations of chemicals-related activity.
This consideration leads to the EPA’s statement in its response-to-comments document that where there is not overlap with another regulatory jurisdiction, the EPA will evaluate the exposures. Using the above TSCA-CAA coordination example for 1,3-butadiene, a question for OCSPP could be whether the TSCA requirement that the EPA consider potentially exposed or susceptible subpopulations in its risk evaluations is covered by the work done by OAR on 1,3-butadiene, specifically with respect to commenters’ input on community-based impacts. One would assume “covered” to mean that this particular aspect of TSCA’s potentially exposed or susceptible subpopulations requirement has been evaluated and addressed in OAR’s CAA activities, and therefore can be excluded from the 1,3-butadiene risk evaluation. However, if the CAA has not addressed this particular TSCA requirement in a manner or to an extent intended by the best read of TSCA’s language regarding the consideration of those potentially exposed or susceptible subpopulations in a particular chemical risk evaluation, then there exists a gap that TSCA, as a gap-filling statute, should address.
The manner in which a TSCA risk evaluation fills any identified gaps is also important. This again will require careful and transparent coordination and analysis between statutes. In its chemical risk evaluations, EPA would presumably want to fill gaps in ways that meet the specific requirements of TSCA for potentially exposed or susceptible subpopulations, without doing so in a manner that is at odds with other statutes’ treatment of a chemical substance under TSCA evaluation. Not only would this careful gap filling be in general sound government practice, but it also would help avoid difficulties if the risk evaluation identifies unreasonable risks that the EPA determines, under TSCA section 9, should be addressed under a law other than TSCA.
The 1,3-butadiene example shows how greater explanation, preferably in scoping documents, on how the EPA coordinates among its offices and other agencies to make regulatory nexus decisions for TSCA risk evaluations can not only provide greater transparency to the public on individual chemical evaluations, but also can inform broader discussions on regulatory nexus by showing how such coordination can identify gaps that TSCA is best situated to fill. For some chemicals, it may be the case that other statutes have already adequately assessed the risks to potentially exposed or susceptible subpopulations, obviating the need for additional analysis in a TSCA risk evaluation. However, the mere existence of another statute with jurisdiction over a particular environmental pathway or human exposure scenario for a chemical substance subject to TSCA review should not lead to an a priori assumption that there is not an evaluation gap for TSCA to fill. Any assumptions about other statutes’ coverage of TSCA’s chemical evaluation requirements should be explored, tested, and fully described in TSCA chemical scope documents or elsewhere in the risk evaluation record. This is particularly important with potentially exposed or susceptible subpopulations, given TSCA’s unique approach to requiring their consideration in chemical prioritization, evaluation, and management. I would argue that a good starting point for articulating TSCA’s gap-filling role is in the application of these requirements to people living near high concentrations of chemicals-related activity.
1 By “chemicals” I refer in this article to chemicals regulated under TSCA, and not to chemicals that are regulated under other federal statutes, such as pesticides, drugs, and food additives.
By Lynn L. Bergeson , Lisa M. Campbell, and Carla N. Hutton
Representatives Frank Pallone, Jr. (D-NJ), Chair of the House Committee on Energy and Commerce, and Jan Schakowsky (D-IL), Chair of the House Energy and Commerce Subcommittee on Consumer Protection and Commerce, wrote to Amazon Chief Executive Officer (CEO) and Chair Jeff Bezos on October 7, 2020, requesting that he launch an investigation into the safety of Amazon’s product line, AmazonBasics, and answer a series of questions pertaining to the company’s product safety and recall practices. The Committee’s October 7, 2020, press release notes that the request comes after a CNN investigation found that many of AmazonBasics’ electronic products “have exploded, caught fire, sparked, melted, or otherwise created hazardous situations at rates well above comparable products.” According to the press release, many of these products were never recalled and continue to be sold.
In addition to their request that Bezos initiate an investigation into the safety of AmazonBasics products, Pallone and Schakowsky also seek answers to a series of questions, including:
- What Amazon-owned products are no longer for sale due at least in part to safety concerns?
- What products -- both Amazon-owned and third party -- have been officially recalled?
- What notification does Amazon provide to customers who have purchased products that are later recalled or found to be unsafe?
- In addition to direct notification, what other kinds of consumer or public outreach does Amazon conduct to ensure consumers properly dispose of, repair, or replace an unsafe product?
- How can consumers find information regarding recalled products? If information is not readily available, why not, and what plans exist to make it available?
- How can consumers report product safety issues to Amazon?
- How many staff does Amazon have devoted to ensuring that products sold on its platform follow all applicable laws and regulations, and that Amazon is in compliance with obligations to notify the U.S. Consumer Product Safety Commission (CPSC) when a product is suspected of being unsafe?
The letter requests a response no later than October 21, 2020.
The letter and request for answers to the questions noted above are another indication of the pressure certain Members in Congress are putting on Amazon to ensure the safety of the products the platform hosts. Amazon is under increasing scrutiny by the U.S. Environmental Protection Agency (EPA) in this regard, as reported in our February 16, 2018, and June 17, 2020, blog items, and this Congressional inquiry seems more of the same. These efforts will almost certainly cause more pressure on product manufacturers to ensure the products they offer for sale on Amazon are compliant.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) granted on October 6, 2020, a manufacturer request for a risk evaluation of octamethylcyclotetra-siloxane (D4), a chemical used to make other silicone chemicals and as an ingredient in some personal care products. Through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center, Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation requested a risk evaluation of D4 pursuant to Section 6 of the Toxic Substances Control Act (TSCA). For manufacturer-requested risk evaluations under TSCA Section 6, the manufacturers requesting the risk evaluation are responsible for payment of the associated fees. The fee for a manufacturer-requested risk evaluation of a chemical included in the 2014 update to the TSCA Work Plan is 50 percent of total actual costs, with a $1,250,000 initial payment. D4 is included in the 2014 update to the TSCA Work Plan. EPA notes that if the request is not withdrawn within 30 days, D4 will enter the TSCA risk evaluation process.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) is accepting public comments for all candidates under consideration for membership on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). Biographies for all candidates are available in Docket ID EPA-HQ-OPPT-2020-0135. When providing comments, EPA states that stakeholders should not submit electronically any information considered to be confidential business information (CBI) or other information whose disclosure is restricted by statute. Comments are due October 30, 2020. EPA will use public comments to assist in selecting multiple members of the SACC over the next year.
EPA anticipates appointing approximately 15 members to the SACC by March 2021. EPA notes that current SACC members are eligible for reappointment during this period. Therefore, the appointments completed by March 2021 may include a mix of newly appointed and reappointed members.
By Christopher R. Blunck and Lynn L. Bergeson
In a letter dated July 28, 2020, the U.S. Environmental Protection Agency (EPA) acknowledged the receipt of a Toxic Substances Control Act (TSCA) Section 21 petition requesting EPA to “initiate a proceeding for the issuance of a risk management procedural rule under TSCA section 6” submitted on behalf of the National Association of Manufacturers, the American Coatings Association, the National Association of Home Builders, the Toy Association, and the U.S. Chamber of Commerce. In the acknowledgement letter, EPA states that the request is not a valid petition under TSCA Section 21. EPA goes on to state “[u]nder TSCA section 21, as it relates to TSCA section 6, any person may petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule under TSCA section 6 imposing chemical-specific regulatory controls for setting forth facts showing such action is ‘necessary’” and that “Section 21 does not provide a means for petitioning EPA to initiate a procedural rule.” The acknowledgement letter further states that “EPA will, however, consider your request as a petition under the Administrative Procedure Act (APA) for the issuance of a procedural rule” and that the “petition is under review by the Office of Pollution Prevention and Toxics (OPPT), which is responsible for programs under TSCA.”
As mentioned in our memorandum addressing the TSCA Section 21 petition, there are requirements under the APA that agencies respond to APA petitions for rulemakings within a reasonable time, that Petitioners are given prompt notice of a denial, and that a brief statement of the grounds for denial be included. A denial of a petition under the APA may be judicially reviewed and set aside if determined to be “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) published on September 30, 2020, its audit of EPA’s Toxic Substances Control Act (TSCA) Service Fee Fund financial statements for the period from Inception (June 22, 2016) through September 30, 2018. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) requires EPA to prepare and OIG to audit the TSCA Service Fee Fund financial statements each year. OIG states that its primary objectives were to determine whether the financial statements were fairly stated in all material respects; EPA’s internal controls over financial reporting were in place; and EPA management complied with laws and regulations. OIG notes that the TSCA Service Fee Fund has been designed to defray up to 25 percent of the costs associated with implementing key TSCA provisions. According to OIG, EPA overstated expenses from other appropriations by $8.4 million. OIG states it found that EPA made errors in multiple iterations of its calculation for expenses from other appropriations. No significant matters involving compliance with applicable laws and regulations, contracts, and grant agreements came to OIG’s attention during the course of the audit.
OIG recommends that the chief financial officer: (1) improve the management review process for calculating expenses from other appropriations to be consistent with EPA component financial statement audits and to ensure that costs support the TSCA Service Fee Fund activities; and (2) establish written policies and procedures so that expenses from other appropriations in component audits reflect actual costs. According to OIG, EPA concurred with its recommendations and provided “acceptable corrective actions and estimated completion dates.” OIG states that it considers the recommendations resolved with corrective actions pending.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on September 24, 2020, the 2020 Safer Choice Partner of the Year award winners. EPA recognized 18 Safer Choice Partner of the Year award winners across ten states and the District of Columbia for achievement in the design, manufacture, selection, and use of products with safer chemicals that furthers outstanding or innovative source reduction. EPA states that the Safer Choice program helps consumers and purchasers for facilities, such as schools and office buildings, find products that perform and are safer for human health and the environment. According to EPA, the 2020 Partner of the Year award winners represent businesses, including woman-owned and small- and medium-sized; federal and local government; and associations. The following organizations from eight EPA regions are being awarded this year:
- Apple -- Cupertino, California;
- BASF Home Care and I&I Cleaning Solutions -- Florham Park, New Jersey;
- Berkley Green -- Uniontown, Pennsylvania;
- The Clorox Company -- Oakland, California;
- Defunkify -- Eugene, Oregon;
- DuPont Nutrition & Biosciences -- Palo Alto, California;
- ECOS -- Cypress, California;
- Grove Collaborative -- San Francisco, California;
- Hazardous Waste Management Program -- King County, Washington;
- Household & Commercial Products Association -- Washington, D.C.;
- Jelmar, LLC -- Skokie, Illinois;
- Lemi Shine -- Austin, Texas;
- Naval Supply Systems Command Weapons System Support -- Mechanicsburg, Pennsylvania;
- PROSOCO -- Lawrence, Kansas;
- PurposeBuilt Brands -- Gurnee, Illinois;
- Sea Mar Community Health Centers -- Seattle, Washington;
- Seventh Generation -- Burlington, Vermont; and
- Wegmans Food Markets -- Rochester, New York.
More information is available on EPA’s website.
By Lynn L. Bergeson and Carla N. Hutton
On September 24, 2020, the U.S. Environmental Protection Agency (EPA) published the final risk evaluation for cyclic aliphatic bromide cluster (HBCD). EPA found unreasonable risks to the environment from six out of 12 conditions of use and unreasonable risks to workers and occupational non-users (ONU) from the use and disposal of HBCD in building and construction materials. EPA found no unreasonable risks to the general population and no unreasonable risks to consumers. EPA’s next step in the process required by the Toxic Substances Control Act (TSCA) is to develop a plan to reduce or eliminate the unreasonable risks found in the final risk evaluation. EPA states that it “is moving immediately to risk management for this chemical and will work as quickly as possible to propose and finalize actions to protect workers, occupational non-users, and the environment.” EPA states that the action it could take to address these risks includes regulating how HBCD is used or limiting or prohibiting the manufacture, processing, distribution in the marketplace, use, or disposal of HBCD, as applicable. As with any chemical product, EPA “strongly recommends that users of products containing HBCD continue to carefully follow all instructions on the product’s label and safety data sheet.” EPA notes that this is the third final risk evaluation that it has issued and that it plans to issue the seven remaining final risk evaluations by the end of 2020. More information will be available in a forthcoming memorandum that will be posted on our website.
By Lynn L. Bergeson and Carla N. Hutton
On September 30, 2020, the U.S. Environmental Protection Agency (EPA) will hold a webinar on “Identification of NAMs for Placement on the TSCA Section 4(h)(2)(C) List: A Proposed NAM Nomination Form.” The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amended Section 4(h)(2)(c) of the Toxic Substances Control Act (TSCA) to require EPA to develop a list of alternative test methods or strategies that are “scientifically reliable, relevant, and capable of providing information of equivalent or better scientific reliability and quality to that which would be obtained from vertebrate animal testing.” The current TSCA Section 4(h)(2)(C) List is available on the EPA website. EPA’s 2018 Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program provides initial criteria for considering scientific reliability and relevance of new approach methodologies (NAM) to be eligible for placement on the List. EPA states that it “envisions that any party interested in proposing a NAM for placement on the List would use a nomination form.” The webinar will walk through the proposed nomination form.
The webinar is co-organized by the People for the Ethical Treatment of Animals (PETA) International Science Consortium, EPA, and the Physicians for Responsible Medicine (PCRM). EPA notes that it does not necessarily endorse the views of the speakers.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on September 16, 2020, that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to two Small Business Advocacy Review (SBAR) Panels. There will be one Panel for methylene chloride and one Panel for 1-bromopropane (1-BP). According to EPA, each Panel will focus on EPA’s development of proposed rules to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA) risk evaluations for these chemicals. As reported in our June 25, 2020, memorandum, and August 11, 2020, memorandum, EPA’s final risk evaluations showed unreasonable risks to workers and consumers under certain conditions of use. EPA is now moving to the risk management step in the TSCA process by working to draft regulations to protect public health from the unreasonable risks identified in the final risk evaluations.
According to EPA, the Regulatory Flexibility Act requires agencies to establish an SBAR Panel for rules that may have a significant economic impact on a substantial number of small entities. The SBAR Panels will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA. The SBAR Panels will select SERs to provide comments on behalf of their company, community, or organization and advise the Panel on the potential impacts of the proposed rule on small entities. EPA states that it is seeking self-nominations directly from the small entities that may be subject to the rule requirements. EPA notes that other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs. Self-nominations may be submitted online for the methylene chloride and 1-BP SBAR Panels and must be received by September 30, 2020.
EPA states that in addition to engaging with small businesses, it “is executing a robust outreach effort on risk management that includes one-on-one meetings with stakeholders and formal consultations with state and local governments, tribes, and environmental justice communities.” EPA notes that there will also be an open public comment period on any draft risk management regulations.