By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) will host a webinar on May 19, 2020, from 1:00 to 3:00 p.m. (EDT) to provide an overview of the 2020 Chemical Data Reporting (CDR) requirements. The 2020 CDR submission period is from June 1, 2020, to November 30, 2020. The webinar will include information about the revised reporting requirements, including:
- New requirements for making confidential business information (CBI) claims;
- Reporting refinements related to byproducts, including exemptions;
- Phasing in certain processing and use data codes; and
- Process improvements for reporting co-manufacturing.
The webinar will also introduce the updated e-CDRweb reporting tool. EPA notes that the presentation will be similar to the webinars EPA hosted on March 31 and April 9, 2020.
EPA states that although registration is not required, it is preferred. Details on how to access the webinar and slides will be sent to participants after registering via Eventbrite.com. Participants should follow along with the webinar slides and use the following call-in number to access the audio: (866) 609-6049; Conference ID: 2499985. EPA will provide webinar materials, including transcripts and recordings, on its CDR website following the webinar.
By Lynn L. Bergeson and Carla N. Hutton
On May 12, 2020, the U.S. Environmental Protection Agency (EPA) released the signed final rule updating the definition of small manufacturers, including a new definition of what is considered a small government, used to determine reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA). According to EPA, the updated definitions will reduce reporting burdens on chemical manufacturers and small governments while maintaining the agency’s ability to receive the information it needs to understand exposure to chemical substances manufactured in the United States. The final rule makes a technical correction to the small manufacturer reference at 40 C.F.R. Section 704.104 for hexafluoropropylene oxide, which only includes a rule-specific small processor definition and not a small manufacturer definition. When reviewing the small manufacturer size standards, EPA found this to be an “inadvertent error.” The final rule also updates the current small manufacturer definition in the Preliminary Assessment Information Rule (PAIR) at 40 C.F.R. Section 712.25 to align it with the updated small manufacturer definition at 40 C.F.R. Section 704.3.
EPA notes that the updated definitions will apply to the Chemical Data Reporting (CDR) rule reporting period beginning June 1, 2020, and will impact certain reporting and recordkeeping requirements for TSCA Section 8(a) rules. EPA states that the final rule is based on 2018 dollars to ensure that the definition is as up to date as possible at the time of promulgation. The final rule will be effective 30 days after publication in the Federal Register. EPA has posted the pre-publication version of the final rule on its website.
More information on CDR reporting is available in our May 13, 2020, blog item, “New Reporting Procedure for Co-Manufacturers under TSCA CDR Rule May Catch Certain Manufacturers Off Guard,” and our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”
By Lynn L. Bergeson and Christopher R. Blunck
One of several changes to the Toxic Substance Control Act (TSCA) Chemical Data Reporting (CDR) Rule, issued in final on April 9, 2020, is that in the 2020 cycle, the U.S. Environmental Protection Agency (EPA) has changed the way that toll manufacturing must be reported. In this cycle, EPA will not accept reporting from only the contracting manufacturer in situations where a company contracts with another company (i.e., a toll manufacturer) for the production of chemicals. As in years’ past, EPA states in its final rule that if no report is filed, both the contracting and producing companies will be held liable if no reporting occurs. Under past CDR cycles, EPA would accept reporting from either the contracting manufacturer or the producing (formerly referred to as “toll”) manufacturer. In 2020, EPA has stated in multiple fora that for the 2020 reporting period, EPA will only accept manufacturing details from the actual producers, even if manufacturing was contracted by another company. This change may come as a surprise, especially to producing companies that heretofore may not have reported under the CDR Rule and instead relied on the contracting company to do so.
EPA stated in the preamble to the final CDR rule that it chose to include two different reporting methodologies for a co-manufacturing situation, indicating that the methodologies are based on a desire to reduce reporting burden and maintain flexibility for both the contracting and producing company. EPA noted that the companies must work together to select between the methodologies for preparing their CDR methodologies. The two methodologies for reporting, codified at 40 C.F.R. Section 711.22(c), are:
(1) The contracting company initiates the required report for that site [defined by EPA at 40 C.F.R. §711.3 as the location where the chemical substance is physically manufactured for chemical substances co-manufactured] as the primary submitter. The contracting company must indicate on the report that this is a co-manufacturing situation, notify the producing company, and record the production volume domestically co-manufactured as set forth in §711.15(b)(3) and processing and use information set forth in §711.15(b)(4). Upon notification by the contracting company, the producing company must also record the production volume domestically co-manufactured and complete the rest of the report as prompted by e-CDRweb.
(2) Upon written agreement between the contracting company and the producing company, the producing company completes the full report for the co-manufactured chemical. The contracting company supplies the information not otherwise known to or reasonably ascertainable by the producing company.
In both cases, the producing company (toll manufacturer) must provide the manufacturing details. There is no mechanism for the contracting company to submit the entire Form U.
More information on the final CDR rule is available in our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”
The Acta Group (Acta®) announced today the launch of CDR Cross-Check™, an ingenious yet simple tool developed and offered by Acta to assist companies in preparing for the 2020 Chemical Data Reporting (CDR) required by the U.S. Environmental Protection Agency (EPA). CDR Cross-Check utilizes the most recent CDR listing information publicly available provided by EPA (currently, 2016 lists) to identify whether all or some of a company’s inventory of chemical substances are subject to CDR under the Toxic Substances Control Act (TSCA) and, if so, at what reporting threshold. CDR Cross-Check will make CDR reporting easier.
CDR Cross-Check will identify whether chemicals are listed on the TSCA Inventory and, if so,
- whether they are listed as active or inactive;
- whether they were subject to specific TSCA regulatory actions in 2016;
- whether they are exempt; and
- what the 2020 reporting thresholds would be based on the 2016 data.
Sample CDR Cross-Check™ Report:
(Click image to enlarge.)
A CDR Cross-Check report prepared at this time will be extremely useful as a preliminary check in preparation for the 2020 CDR reporting. It will confirm regulatory statuses from the 2016 reporting cycle, so for those chemicals, users will know what the reporting threshold will be for 2020 and can determine now whether reporting is needed. It will also give users time to address potential issues well before the 2020 reports are due.
To access CDR Cross-Check, a customer will upload the list of chemicals to be evaluated by the CDR Cross-Check tool and pay the appropriate fee based on the number of chemicals to be evaluated. Fees are $3.00 (USD) per chemical for the first 750 chemicals plus $2.00 (USD) per chemical for additional chemicals over 750. The minimum fee is $400 (USD).
Acta anticipates that additional chemicals will be added to the regulatory lists in June 2020 that may result in lower reporting thresholds. The CDR Cross-Check will be updated at that time to include the new lists. Customers that have already used the CDR Cross-Check prior to the 2020 updates will receive a 50% discount for an updated list.
Visit the CDR Cross-Check website, https://cdr-cross-check.actagroup.com/, for more information and to order a CDR Cross-Check report.
More information on recent CDR developments is available in Acta’s March 19, 2020, memorandum “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”
The Acta Group is a global scientific and regulatory consulting firm that assists companies with strategic commercialization planning and complex product registration and compliance matters in North America, South America, Europe, the Middle East, and Asia. Acta is the consulting affiliate of Washington, D.C., law firm Bergeson & Campbell, P.C.
Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), sat down with Dr. Richard Engler, Director of Chemistry at B&C, to bring everyone up to date on the U.S. Environmental Protection Agency’s (EPA) implementation of the Toxic Substances Control Act (TSCA) fee rule and how it applies to entities obligated to pay a portion of the $1,350,000 per chemical fee for preparing an EPA-initiated risk evaluation, the legal and regulatory significance of the supplemental rulemaking on long-chain perfluoroalkyl carboxylate (LCPFAC) chemicals and the precedent it sets for eliminating the article exemption for imported articles containing these substances, and the significance of the recently updated TSCA Chemical Inventory with regard to the fast-approaching Chemical Data Reporting (CDR) cycle. As always, Rich is a font of information on these topics, and he does a great job of contextualizing this information for busy business people working in the chemical space.
ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.
©2020 Bergeson & Campbell, P.C. All Rights Reserved
By Lynn L. Bergeson and Carla N. Hutton
On March 17, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a final rule amending the Chemical Data Reporting (CDR) rule. According to EPA, the amendments are intended to reduce the burden for certain CDR reporters, improve the quality of CDR data collected, and align reporting requirements with the Frank R. Lautenberg Chemical Safety for the 21st Century Act’s (Lautenberg Act) amendments to the Toxic Substances Control Act (TSCA). EPA states that some of the key revisions include:
- Simplifying reporting, including allowing manufacturers to use certain processing and use data codes already in use by many chemical manufacturers as part of international codes developed through the Organization for Economic Cooperation and Development (OECD);
- Updating requirements for making confidentiality claims to align with the requirements in amended TSCA; and
- Adding reporting exemptions for specific types of byproducts manufactured in certain equipment.
Additionally, EPA is extending the reporting period for CDR data submitters from September 30, 2020, to November 30, 2020, to provide additional time for the regulated community to familiarize themselves with the amendments and to allow time for reporters to familiarize themselves with an updated public version of the reporting tool. The reporting period will still begin on June 1, 2020. EPA will host a webinar on Tuesday, March 31, 2020, to discuss the revised reporting requirements, provide an overview of the 2020 CDR submission period, and to give an introduction to the updated e-CDRweb reporting tool. EPA has posted pre-publication versions of the final rules amending the CDR rule and extending the reporting period. More information will be available in a forthcoming memorandum that will be posted on our website.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on October 23, 2019, that it settled with Miles Chemical Company Inc. for failing to report timely chemical substances it imported. Under the settlement, the company will pay a $45,000 penalty. According to EPA, between 2012 and 2015, Miles Chemical Company failed to submit timely forms to EPA documenting the import of large quantities of two chemicals. EPA notes that under the Toxic Substances Control Act (TSCA), chemical importers and manufacturers are required to submit Chemical Data Reporting (CDR) information to EPA every four years. This reporting allows EPA to track the chemicals being imported, assess potential human health and environmental effects of these chemicals, and make the non-confidential business information it receives available to the public. EPA notes that chemical substances listed on the TSCA Inventory that are manufactured or imported at volumes of 25,000 pounds or greater must be reported to EPA, as required by TSCA’s CDR rule.
By Lynn L. Bergeson, Kathleen M. Roberts, and Carla N. Hutton
On April 25, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule that would amend the Toxic Substances Control Act (TSCA) Section 8(a) Chemical Data Reporting (CDR) requirements and the TSCA Section 8(a) size standards for small manufacturers. 84 Fed. Reg. 17692. The current CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Chemical Substance Inventory (TSCA Inventory) to report data on chemical manufacturing, processing, and use every four years. EPA is proposing several changes to the CDR rule to make regulatory updates to align with new statutory requirements of TSCA, improve the CDR data collected as necessary to support the implementation of TSCA, and potentially reduce the burden for certain CDR reporters. Proposed updates to the definition for small manufacturers, including a new definition for small governments, are being made in accordance with TSCA Section 8(a)(3)(C) and impact certain reporting and recordkeeping requirements for TSCA Section 8(a) rules, including CDR. EPA states that the definitions may reduce the burden on chemical manufacturers by increasing the number of manufacturers considered small. Overall, according to EPA, the regulatory modifications may better address EPA and public information needs by providing additional information that is currently not collected; improve the usability and reliability of the reported data; and ensure that data are available in a timely manner. Comments are due by June 24, 2019. More information on the proposed rule is available in our full memorandum.
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham
On January 31, 2019, the U.S. Environmental Protection Agency (EPA) was petitioned by the Attorneys General of 14 states (Massachusetts, Pennsylvania, California, Connecticut, Hawaii, Maine, Maryland, Minnesota, New Jersey, New York, Oregon, Rhode Island, Vermont, and Washington) and the District of Columbia under Toxic Substances Control Act (TSCA) Section 21(a) to issue an asbestos reporting rule to require reporting under TSCA Section 8(a) of information necessary for EPA to administer TSCA as to the manufacture (including importation), processing, distribution in commerce, use, and disposal of asbestos. Specifically, the petition states that the Attorneys General are petitioning EPA’s Administrator to:
- [I]nitiate a rulemaking and issue a new asbestos reporting rule to: (i) eliminate any applicability of the “naturally occurring substance” (NOCS) exemption in the [Chemical Data Reporting (CDR)] for asbestos reporting; (ii) apply the CDR reporting requirements to processors of asbestos, as well as manufacturers, including importers, of the chemical substance; (iii) ensure that the impurities exemption in the CDR does not apply to asbestos; and (iv) require reporting with respect to imported articles that contain asbestos.
In support of their requests in the petition, the Attorneys General state the following:
- NOCS Exemption: “The identified uses of imported raw asbestos represent pathways of exposure that present risks to health and the environment that EPA must consider in conducting its risk evaluation and regulating asbestos, and accordingly EPA should promulgate an asbestos reporting rule to require reporting of such information. Moreover, the required asbestos reporting must capture information with respect to the quantities imported, and these potential exposure pathways so this information can be made available to inform the states’ and the public’s knowledge regarding asbestos exposure risks.”
- Reporting from Processors: “[T]o enable EPA to carry out its responsibility to impose requirements on processors to eliminate unreasonable risks of injury to health or the environment arising from exposures to asbestos, EPA must promulgate new regulations to apply the reporting requirements of the CDR to processors of asbestos notwithstanding that the current CDR does not expressly require such reporting. Should EPA fail to do so, EPA would be violating TSCA, acting arbitrarily and capriciously, and abusing its discretion in implementing TSCA.”
- Exemptions for “Impurities” and “Articles”: “[W]hile the CDR exempts reporting with respect to ‘impurities’ and for chemical substances imported as ‘part of an article,’ neither of these exceptions should be applied to reporting with respect to the presence of asbestos if EPA is to satisfy TSCA’s mandate to prevent unreasonable risks associated with exposures to this highly toxic chemical.”
- Reporting for Asbestos: “EPA must account for the many tons of asbestos that are imported into the U.S., whether as a raw material or processed, to evaluate adequately the current and likely future risks of exposure to asbestos, and must also account for asbestos in consumer products, whether or not the asbestos is intentionally included in those products. These data … are needed for EPA to be able to make informed technically complex decisions regarding the regulation of asbestos. Without these data to rely on, the agency will be unable to meet its obligations under TSCA to make its decisions based on the weight of the scientific evidence and using the best available science …. Accordingly, EPA must issue an asbestos reporting rule to ensure that the NOCS, the impurities, and the articles exemptions do not apply to asbestos, and that processors of asbestos are required to report.”
The petition cites EPA’s denial of a petition submitted by a group of non-governmental organizations (NGO) seeking similar action that the Attorneys General are requesting, but does not address the many reasons that EPA denied the first petition. Why the Attorneys General would follow up EPA’s well-reasoned denial with a petition of their own with very similar requests and only marginal additional facts, is unclear. More information on the NGO petition is available in our blog item "EPA Denies Section 21 Petition Seeking Increased Asbestos Reporting."
By Lynn L. Bergeson, Carla N. Hutton, and Margaret R. Graham
On December 21, 2018, the U.S. Environmental Protection Agency’s (EPA) Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP) Nancy B. Beck, Ph.D., signed a Federal Register document denying a Toxic Substances Control Act (TSCA) Section 21 petition requesting that EPA amend the Chemical Data Reporting (CDR) rule to increase asbestos reporting, exclude asbestos from certain exemptions, and lift Confidential Business Information (CBI) claims on asbestos information reported under the CDR rule. Due to the government shutdown, the notice has not yet been published in the Federal Register, but EPA has posted a prepublication version. EPA’s carefully reasoned response to the request is set forth in the notice.
The petition was filed on September 27, 2018, by the Asbestos Disease Awareness Organization, American Public Health Association, Center for Environmental Health, Environmental Working Group, Environmental Health Strategy Center, and Safer Chemicals, Healthy Families (Petitioners). According to EPA, Petitioners requested the following specific amendments to the existing CDR rule to collect information for the ongoing asbestos risk evaluation being conducted under TSCA Section 6(b) (required to be completed by December 22, 2019), and, if necessary, any subsequent risk management decisions under TSCA Section 6(a):
- Amend the CDR rule to require immediate submission, “from January 1, 2019, to April , 2019,” of reports on asbestos for the 2016 reporting cycle.
- Amend the naturally occurring chemical substance exemption at 40 C.F.R. § 711.6(a)(3) to make the exemption inapplicable to asbestos;
- Amend the articles exemption at 40 C.F.R. § 711.10(b) to require reporting pursuant to the CDR rule for all imported articles in which asbestos is present at detectable levels;
- Amend the CDR rule to exclude asbestos from the exemption at 40 C.F.R. § 711.10(c) to require the reporting of asbestos as a byproduct or impurity;
- Amend the reporting threshold for CDR at 40 C.F.R. § 711.8(b) to set a reporting threshold of ten pounds for asbestos; and
- Amend 40 C.F.R. § 711.8 to add processors of asbestos and asbestos-containing articles as persons required to report under the CDR rule.
In addition to the above requests, Petitioners also requested that EPA use its authority under TSCA Sections 14(d)(3) and 14(d)(7) to lift CBI claims on asbestos information reported under the CDR rule. EPA responds in detail as to why it is denying each of these requests. A short summary is below.
- 2016 Reporting Cycle: EPA states that based on the extensive research and data gathering already conducted during the asbestos risk evaluation process, EPA believes that “the requested amendments to the CDR rule would not lead to the reporting of new information that would contribute to EPA’s ongoing asbestos risk evaluation or, if needed, subsequent risk management decision(s)” and Petitioners have “failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to require immediate past reporting of the manufacturing and use of asbestos under the CDR rule for the 2016 reporting cycle.”
- Naturally Occurring Substances Exemption: EPA states that removing the exemption for reporting on naturally occurring substances for asbestos would not provide any additional data to EPA “given that the purpose of domestic manufacturing or importing of raw asbestos is to make asbestos diaphragms, for which EPA already has use and exposure information” and Petitioners have “failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to lift the naturally occurring chemical substances exemption for asbestos under the CDR rule.”
- Articles Exemption: EPA states that it believes that lifting the articles exemption for the reporting of asbestos under the CDR rule “would not provide any new use information that would inform the ongoing risk evaluation or any subsequent risk management decisions, if needed” and that Petitioners “have failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to lift the articles exemption for asbestos under the CDR rule.”
- Reporting as a Byproduct or Impurity: EPA states that it does not believe that making the requested amendment to the CDR rule would result in “reporting of asbestos as an impurity or a byproduct, for uses that are known or reasonably ascertainable,” that Petitioners “have not provided evidence that there are such known uses that are ongoing but remain outside the scope of the asbestos risk evaluation,” and “have failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to lift the byproducts and impurities exemptions for asbestos under the CDR rule.”
- Reporting Threshold of Ten Pounds: EPA states that Petitioners “fail to show that lowering the reporting threshold would provide any new information to EPA” and, therefore, finds that the Petitioners “have failed to set sufficient facts to establish that it is necessary to issue the requested amendment to lower the CDR reporting threshold for asbestos.”
- Adding Processors to CDR: EPA states that it does not believe that “requiring processors of asbestos under the CDR rule will provide useful information not already in its possession,” Petitioners “have failed to indicate what additional information EPA would collect by requiring asbestos processors to report under the CDR rule” and, therefore, EPA finds that the Petitioners “have failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to require processors of asbestos to report under the CDR rule.”
- Lifting CBI Claims: EPA states that Petitioners’ request to lift CBI claims on asbestos information reported under the CDR rule is "not appropriate for a TSCA Section 21 petition, as a TSCA Section 21 only pertains to the “issuance, amendment, or repeal of a rule under TSCA sections 4, 6, or 8, or an order under TSCA sections 4 or 5(e) or (f),” therefore, a TSCA Section 21 petition “is not a vehicle to petition EPA to initiate an action under TSCA section 14.” Further, EPA states that it believes that “disclosure of CBI would have no practical relevance to the risk evaluation or risk determination as the CBI claims are limited and EPA retains the ability to characterize the information without revealing the actual protected data.”
Please look for the full analysis in our upcoming memorandum that will be posted on our Regulatory Developments page.