By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) will hold a public meeting on December 10, 2019, to engage with interested stakeholders on the implementation of EPA’s Toxic Substances Control Act (TSCA) New Chemicals program. At the meeting, EPA will:
- Provide an overview of EPA’s updated “Working Approach” document that builds upon EPA’s November 2017 “New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA”;
- Demonstrate how EPA has used concepts in the “Working Approach” document to reach conclusions and make determinations under TSCA Section 5(a)(3) using specific case examples;
- Provide an update on confidential business information (CBI) process improvements and clarifications; and
- Discuss its progress on transparency in the TSCA New Chemicals program.
By the end of 2019, EPA intends to announce the availability of the updated “Working Approach” document and provide an opportunity for written public comment. EPA states that feedback from the public meeting and comments received will help inform its ongoing efforts to improve the way EPA reviews new chemicals under TSCA. Details regarding the meeting are available in the prepublication version of the Federal Register notice announcing the meeting.
EPA states in the prepublication version of the Federal Register notice that after considering comments received on the 2017 version of the “Working Approach” document and based on additional implementation experience, EPA is updating the “Working Approach” document. Later in December 2019, EPA will announce the availability of the updated document after the public meeting and will hold a public comment period. According to the notice, EPA expects the updated document to provide further clarity and detail on EPA’s approach and practices, including: (1) EPA’s general guiding principles and concepts for making determinations on new chemical notices submitted to EPA under TSCA Section 5; (2) the decision-making logic and the key questions that EPA must address; and (3) a discussion of how EPA might apply the working approach to reach one of the five new chemical determinations allowable under the statute.
By Lynn L. Bergeson and Carla N. Hutton
On November 8, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a supplemental notice of proposed rulemaking regarding revisions to the confidential business information (CBI) substantiation requirements under the Toxic Substances Control Act (TSCA). 84 Fed. Reg. 60363. EPA states that in response to a recent federal circuit court decision, it is proposing revisions to existing and proposed substantiation requirements for certain CBI claims. Specifically, EPA is proposing two additional questions that manufacturers and processors would be required to answer to substantiate certain CBI claims for specific chemical identities and is proposing procedures for manufacturers and processors to use in amending certain previously submitted substantiations to include responses to the additional questions. Comments on the supplemental notice are due December 9, 2019.
EPA notes that these proposed revisions supplement the proposed rule issued in the April 23, 2019, Federal Register and would amend the TSCA Inventory Notification (Active-Inactive) Requirements rule promulgated on August 11, 2017. More information on the proposed rule is available in our April 11, 2019, memorandum, “EPA Announces Proposed Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory,” and more information on the final rule is available in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules.”
By Lynn L. Bergeson and Carla N. Hutton
On October 30, 2019, the U.S. Environmental Protection Agency (EPA) announced that in response to an April 2019 court decision on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements Final Rule, EPA will publish a supplemental notice of proposed rulemaking that includes two additional questions about “reverse engineering” that manufacturers and processors would be required to answer when making confidential business information (CBI) claims. According to EPA, these questions would help provide additional information on CBI claims for specific chemical identities and would ensure that chemical companies are fully supporting their CBI claims. EPA is also proposing a process for manufacturers and processors to use to amend and update certain previously submitted claims to include responses to these additional questions, as required to be addressed by federal circuit court decision.
EPA notes that the supplemental notice is limited in scope and that “[i]t impacts only the universe of CBI claims made for specific chemical identities for chemicals reported as ‘active’ in response to the Active-Inactive Rule.” Publication of the supplemental notice in the Federal Register will begin a 30-day comment period.
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on September 19, 2019, that it posted the first public Toxic Substances Control Act (TSCA) Inventory to include unique identifier (UID) information. EPA states that the UID is a numerical identifier assigned to a chemical substance when EPA approves a confidential business information (CBI) claim for specific chemical identity. When EPA approves such a claim, it assigns a UID to that chemical identity; applies the UID to other information or submissions concerning the same substance; and ensures that any non-confidential information received by EPA identifies the chemical substance using the UID while the specific chemical identity of the chemical substance is protected from disclosure.
EPA notes that this is the first time that the public version of the TSCA Inventory includes both a field containing a UID for those chemical substances with approved confidentiality claims for specific chemical identity and a field containing the ten-year expiration date from the assertion of such approved claims. EPA states that the UIDs provide the public with a way to connect the specific chemical identity previously listed on the confidential portion of the TSCA Inventory with other relevant information in EPA’s holdings.
EPA’s goal is to publish an up-to-date version of the TSCA Inventory about every six months. With the version published on September 19, 2019, EPA has taken another positive step in implementing its obligations under TSCA. The Inventory now includes two new fields: UI (for the unique identifier or UID) and EX (indicating the expiration date of the CBI claim). EPA continues to work through CBI identities, so only a few of the CBI substances have a UID. We expect that EPA will begin to assign UIDs to CBI substances that are newly added to the Inventory (e.g., through a Notice of Commencement submitted going forward). We also expect that EPA will assign UIDs to substances that were claimed as CBI on a Form A as EPA works through reviewing the almost 8,000 substances listed as active on the confidential portion of the Inventory. A more detailed commentary is available in our September 20, 2019, memorandum, “EPA Includes Unique Identifier Information on Updated TSCA Inventory.”
By Lynn L. Bergeson and Lisa R. Burchi
In a significant victory for industry, on August 27, 2019, the State of New York Supreme Court invalidated the New York Department of Environmental Conservation (NYDEC) Household Cleansing Product Information Disclosure Program (Disclosure Program). Information related to NYDEC’s prior delay of its enforcement of its Disclosure Program is available here, and general information regarding the Program and its extensive requirements for manufacturers of certain consumer cleaning products to disclose information regarding the ingredients in those products is available here.
Two trade associations, the Household and Commercial Cleaning Products Association (HCPA) and the American Cleaning Institute (ACI) (Petitioners), filed the lawsuit last October. Petitioners sought declaratory relief and a judgment invalidating the Disclosure Program on the basis that the Program was a “rule” for which NYDEC did not comply with its State Administrative Procedure Act (SAPA) rulemaking procedures. Petitioners also argued that the Program was established in violation of Article IV Section 8 of the New York State Constitution, was issued in excess of NYDEC’s statutory authority, and was arbitrary and irrational.
The court found that the Disclosure Program was established in violation of SAPA and the New York State Constitution. In making this finding, the court held that the Program was a “rule” as argued by Petitioners and not “guidance” for which adherence to SAPA was not required, as argued by NYDEC. The court also found that “since there is no opt out provision whereby petitioners may choose to deviate from the program, the Disclosure Program is not mere guidance.” The Disclosure Program is thus “null and void and the matter is remitted back to DEC with the directive to comply with SAPA.” Since the decision was reached based on violations of SAPA, the court did not address the other bases upon which Petitioners sought to invalidate the Program. A more detailed analysis and commentary are available in our August 30, 2019, memorandum, “NY Department of Environmental Conservation Household Cleansing Product Information Disclosure Program Ruled ‘Null and Void.’”
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Kathleen M. Roberts
The cost of generating health and safety studies is considerable and data owners have every right to expect some protection from disclosure to preserve the value of their intellectual property. This is no longer guaranteed as Lynn L. Bergeson, Richard E. Engler, Ph.D., and Kathleen M. Roberts wrote in a two-part article in Bloomberg Environment Insights. The authors propose that the U.S. Environmental Protection Agency’s (EPA) practice of disclosing entire health and safety studies voluntarily submitted under Toxic Substances Control Act (TSCA) Section 6 is based upon a misinterpretation of TSCA Section 14(b)(2)(A)(i) and should be reconsidered in light of a recent judicial decision and the pressing need to acknowledge the global relevance of health and safety studies.
Many of the studies that will be relevant to EPA’s risk evaluations under TSCA Section 6 have significant monetary and competitive value, and data owners have every right to expect some protection from the disclosure of the study reports to preserve their value. If EPA as a matter of practice routinely posts entire study reports publicly, the reports would be rendered valueless for data compensation purposes. Some organizations have considered approaches that include the selective claiming of certain information elements in the study report as confidential to protect the value of the research while providing relevant information on the general findings and health and safety effects observed in the study. It is unclear, however, if this practice provides other stakeholders with sufficient information or if this practice is entirely effective in preserving the monetary and competitive value of the study report. EPA’s insistence that those who send in study reports accept the fact that the entire submission will be posted publicly also ignores the reality that many of these reports are jointly owned. Multiple entities often have title to the study as joint owners and its disclosure is generally subject to data sharing agreements that expressly prohibit its publication unless required by law.
Despite these concerns with the interpretation of TSCA Section 14(b)(2)(A)(i), submitters need to up their game, as it were, in identifying confidential business information (CBI) and certifying that release of such information would pose “substantial commercial harm.” For more information on the greater burden being placed on submitters, and for possible options to protect CBI, read the full article “Protecting the Value of Health, Safety Studies—Emerging TSCA Issues” online.
Bergeson & Campbell, P.C. (B&C®) is pleased to present the complimentary webinar “New TSCA at 3: Key Implementation Issues.” The webinar will drill down on key implementation challenges facing industry and the U.S. Environmental Protection Agency (EPA) three years into navigating the legal, regulatory, and science policy issues arising under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention (OCSPP); Lynn L. Bergeson, Managing Partner, B&C; and Richard E. Engler, Ph.D., Director of Chemistry, B&C, will present. Register online now.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) has published statistics concerning its review of confidential business information (CBI) cases received between June 22 2016, and June 25, 2019. The Frank R. Lautenberg Chemical Safety for the 21st Century Act, enacted in 2016, amended the CBI provisions of the Toxic Substances Control Act (TSCA). Since then, EPA “has established numerous new processes, systems, and procedures to enable submitters to provide the information required when making confidentiality claims and to facilitate EPA's review, and where applicable, determinations on these claims.” According to EPA, the statistics show EPA's progress toward meeting the requirements of TSCA Section 14(g). EPA uses “case” to describe a submission made under a specific section of TSCA and all subsequent submissions and amendments by the same submitter that relate back to the first submission.
|CBI Review Statistics (cases received between June 22, 2016 and June 25, 2019)
|Cases in which the specific chemical identity is subject to CBI review
|Cases in which information other than the specific chemical identity is subject to CBI review
|Cases in which both the specific chemical identity and information other than the specific chemical identity is subject to CBI review
|Total cases subject to CBI review
|Cases resulting in final CBI determinations
|Cases with all CBI claims subject to review, approved
|Cases with all CBI claims subject to review, denied
|Cases with CBI claims subject to review, approved-in-part/denied-in-part
|Cases with all CBI claims subject to review, denial - appeal period pending*
|Total cases resulting in final CBI determinations
* “Denial - appeal period pending” cases are those for which a CBI determination denying one or more CBI claims in a case has been issued to the submitter of the information, but for which the required 30-day notification period following receipt of the determination under TSCA Section 14(g)(2)(B) has not yet passed.
|Cases reviewed with no final CBI determination necessary
|Cases with all CBI claims screened and found to be exempt from review
|Cases with all CBI claims withdrawn by submitter
|Cases identified for CBI review, for which no determination required (e.g., in some instances, older EPA information systems do not specifically identify which information is claimed as CBI and upon review, it is determined that no claims require review)
|Total cases reviewed/screened with no final CBI determination necessary
|Cases currently undergoing CBI review
|Cases currently undergoing CBI review
EPA states that later this year, it plans to publish a comprehensive list of cases subject to CBI review to be updated quarterly. The table will include information showing the results of individual cases with completed reviews.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on July 15, 2019, that it will cease sending notices of deficiency to businesses that submit procedurally flawed confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA). This is a significant change from the interpretation EPA announced in January 2017, and a company’s failure to appreciate its consequences could prove damaging. Effective August 15, 2019, EPA will provide written notice to affected business submitters that because they submitted procedurally flawed CBI claims, including unsubstantiated CBI claims, those CBI claims are invalid, and the underlying information is not protected from disclosure under TSCA Section 14. EPA states in the Federal Register notice issued on July 16, 2019, that under its 2017 interpretation, it undertook a “non-statutorily required practice of sending a notice of deficiency to an affected business that submitted a non-exempt CBI claim without a substantiation, providing an opportunity to correct the deficiency.” 84 Fed. Reg. 33939. Under the new policy, EPA will provide written notice to affected business submitters that because they submitted procedurally flawed CBI claims, including unsubstantiated CBI claims, those CBI claims are invalid, and the underlying information is not protected from disclosure under TSCA Section 14. EPA notes that unlike the notice of deficiency, this written notice will not provide affected businesses 30 calendar days to remedy their deficient CBI claims. Instead, the written notice will inform affected businesses that their “procedurally flawed” CBI claims may be disclosed to the public without further notice. More information is available in our July 16, 2019, memorandum, “EPA Announces Important New Policy on TSCA CBI Claims of Deficiency.”
By Lynn L. Bergeson and Carla N. Hutton
On June 20, 2019, Senators Tom Udall (D-NM), Cory Booker (D-NJ), Ed Markey (D-MA), Jeff Merkley (D-OR), and Sheldon Whitehouse (D-RI) sent a letter to U.S. Environmental Protection Agency (EPA) Administrator Andrew Wheeler requesting information on EPA’s implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). The letter notes that the Lautenberg Act was intended to enact reforms addressing “longstanding structural problems” with the Toxic Substances Control Act (TSCA). According to the letter, EPA’s implementation of the Lautenberg Act “has deviated dramatically from Congress’ intent and the new law’s requirements.” The Senators’ letter requests EPA’s responses to a number of questions regarding the following areas of concern:
- Section 4: EPA’s failure to use its enhanced information authorities under TSCA. Under the Lautenberg Act, EPA can now acquire information where needed to review new chemicals or to prioritize or review the risks of a chemical already on the market. The law also makes clear that EPA can require the development of real-world exposure information. According to the Senators, in the nearly three years since enactment of the Lautenberg Act, “EPA has not once used these new authorities, and seems to be avoiding using them at all costs -- even where there are critical information gaps.”
- Section 5, Part 1: EPA’s failure to protect workers when reviewing new chemicals under TSCA. The Lautenberg Act strengthened EPA’s authority to regulate chemicals that may present risks to workers “by explicitly naming workers as a ‘potentially exposed or susceptible subpopulation’ and requiring that EPA consider and address potential risks to workers when assessing new or existing chemicals.” According to the Senators, EPA is failing to use TSCA’s health standard, which is more stringent than the Occupational Safety and Health Administration’s (OSHA) workplace standards, to determine whether any of the new chemicals “may present an unreasonable risk” to workers. Where EPA finds a new chemical does or may present serious risks to workers, it is allowing that chemical onto the market without imposing any conditions to protect the workers. EPA’s “only justification for this is that it simply ‘expects’ that workers will protect themselves from harmful workplace exposures by wearing personal protective equipment (PPE) that the company is not required to provide or train workers to use properly.” This deference to OSHA regulations “allow[s] workers to be exposed to chemical risks that are a thousand or more times higher than are acceptable under TSCA.
- Section 5, Part 2: EPA’s failure to adequately identify and review “reasonably foreseen” conditions of use when reviewing new chemicals under TSCA. When reviewing a new chemical, the Lautenberg Act directs EPA to examine the chemical under its “conditions of use” -- “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.” According to the Senators, “EPA has attempted to skirt this requirement for an integrated assessment of both intended and reasonably foreseen conditions of use in several ways that are contrary” to TSCA’s requirements:
- For most new chemicals that EPA has reviewed in recent months, it simply asserts there are no such reasonably foreseen uses;
- For those new chemicals where EPA identifies a reasonably foreseen use, it merely states, without providing any analysis, that it expects that use to present no greater risk than the intended use. By doing this, EPA not only fails to demonstrate that the reasonably foreseen use is not likely to present an unreasonable risk, it also fails to consider that the combination of use could present such a risk; and
- For the remaining new chemicals where EPA does identify a reasonably foreseen use and identifies some potential concern with that use, EPA has separately promulgated a significant new use rule (SNUR) that requires a company to notify EPA prior to engaging in that reasonably foreseen use. In these SNURs, EPA has not made clear that it would assess the potential exposure and risks from that use in combination with the already approved intended uses as part of its review of any such notice, however.
The Senators note that none of these recent policy changes to EPA’s examination of new chemicals’ conditions of use has been made public or subject to a public comment opportunity.
- Section 6: EPA’s failure to assess even known conditions of use and pathways of exposure in conducting risk evaluations of existing chemicals under TSCA. The Lautenberg Act requires EPA to evaluate potential risks arising from activities across the entire lifecycle of a chemical, considering all “known” and “reasonably foreseen” circumstances, not just those “intended” by a company making or using a chemical. The letter states that EPA “has sought in numerous ways to limit the scope of its risk evaluations and risk determinations.” In its final Risk Evaluation Rule, EPA “asserted sweeping authority to pick and choose what activities and what exposures it includes in its risk evaluation of a chemical.” According to EPA, it can ignore any exposure to a chemical that also falls under the authority of another agency, such as OSHA, regardless of whether that agency has actually taken any action to mitigate the risks of the chemical. EPA also stated that it will exclude “legacy” activities associated with a chemical. EPA has begun to conduct risk evaluations that exclude most or all pathways of exposure to a chemical that falls under the jurisdiction of another statute administered by EPA.
- Section 14: EPA’s failure to provide timely public access to non-confidential information and access by eligible parties to confidential business information under TSCA. The Lautenberg Act amended Section 14, enhancing requirements for companies’ assertion and substantiation, and EPA’s review of confidential business information (CBI) claims; for providing public access to chemical information; and for providing expanded access to CBI. Although these provisions were immediately effective, nearly three years after enactment, “there is little evidence that EPA is effectively implementing these provisions or requiring compliance with them.”
The letter is well written if not quite one-sided. Complicated issues require thoughtful analysis, and this letter demands a clear and compelling response from industry advocates that may well respectfully disagree with the Senators’ position on many of the points made in the letter. We suspect this letter may well be a point of discussion at Monday’s TSCA at Three conference.