By Lynn L. Bergeson, Charles M. Auer, Richard E. Engler, Ph.D., and Carla N. Hutton
On April 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule regarding its plan to review certain confidential business information (CBI) claims to protect the specific chemical identities of substances on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory. 84 Fed. Reg. 16826. The CBI claims that would be reviewed under this plan are those that were asserted on Notice of Activity (NOA) Form A’s filed in accordance with the requirements in the Active-Inactive rule. Comments are due June 24, 2019. See the full memorandum for more information on the proposed rule.
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham, M.S.
On February 20, 2019, during a cold, snow-filled winter day, the rugged staff of Bergeson & Campbell, P.C. (B&C®) as well as several hearty senior U.S. Environmental Protection Agency (EPA) officials got together over some steaming cups of coffee and discussed the upcoming fate of the Toxic Substances Control Act (TSCA) during a Bloomberg-hosted, B&C-developed webinar: Chemical Policy Summit Series Part V: Chemical Regulation After the Mid-Terms: What We Can Expect to See in 2019.
In attendance were: The Honorable Alexandra Dapolito Dunn, the newly appointed Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP); Jeffery T. Morris, Ph.D., Director, Office of Pollution Prevention and Toxics (OPPT); Rick P. Keigwin, Jr., Director of the Office of Pesticide Programs (OPP); Beau Greenwood, Executive Vice President, Government Affairs, CropLife America; Lynn L. Bergeson, Managing Partner of B&C; and James V. Aidala, Senior Government Affairs Consultant, B&C. Ms. Dunn, Dr. Morris, and Mr. Keigwin described their priorities in the webinar. Ms. Dunn stated 2019 “is going to be one of those buckle-your-seat-belt kind of years” in relation to getting everything done as required under TSCA. Some of the takeaways from that webinar are listed below.
TSCA Milestones: 2019 and Beyond
- EPA must complete the first ten risk evaluations by December 2019, with a possible extension up to June 2020; EPA may need to take advantage of the extension;
- By April 2019, EPA will need to release the “20 high- and 20 low-” priority candidate chemicals;
- EPA released its first draft chemical risk evaluation -- Colour Index (C.I.) Pigment Violet 29 -- on which many comments were submitted. EPA realized that this selection was challenging given certain data ownership issues and restrictions on those data occasioned by European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation issues; therefore, this initial evaluation was not the best representation of how the other evaluations will be conducted (more information on the risk evaluation is available in our memo EPA Publishes First Draft TSCA Chemical Risk Evaluation);
- EPA is using a new risk assessment program process called “Systematic Review” that has been used in non-risk assessment fields; EPA is the first agency to use this process. EPA welcomes input on the process and stated that the National Academy of Sciences (NAS) will be reviewing this process as well;
- In March 2019, EPA will release a proposed rule outlining how it will review and substantiate all Confidential Business Information (CBI) claims seeking to protect the specific chemical identities of substances on the confidential portion of the TSCA Inventory; and
- EPA will be proposing its rule to regulate five persistent, bioaccumulative, and toxic chemicals by June 2019; EPA will be using a different approach than what is typically used for risk assessments.
Approving New Chemicals:
- EPA intends to explore its process for new chemical review to be more predictable and to make reviews final within 90 days;
- EPA will post “frequently asked questions” documents to help chemical manufacturers submit clearer applications online;
- EPA is urging pre-submission meetings between premanufacture notice (PMN) submitters and EPA staff prior to submitting a PMN for a new product to reduce agency time spent clarifying omissions; and
- EPA has pledged to make all PMNs, all health and safety studies, attachments, amendments and other associated information available in public dockets.
B&C’s other upcoming seminars and webinars are available here. Some other resources of interest are B&C’s newly minted TSCA Tutor™ Modular Training Program which provides live in-person training at a company’s site, live online training, and pre-recorded webinar training modules -- all designed to offer expert, efficient, and essential TSCA training; as well as B&C’s All Things Chemical™ Podcasts, which provide intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals.
By Lynn L. Bergeson, Carla N. Hutton, and Margaret R. Graham
On February 19, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was releasing an update to the Toxic Substances Control Act (TSCA) Inventory listing the chemicals that are actively being manufactured, processed and imported in the United States, which is required under amended TSCA. Some of the highlights from EPA’s announcement are:
- A key result of the update is that less than half of the total number of chemicals on the current TSCA Inventory (47 percent or 40,655 of the 86,228 chemicals) are currently in commerce; EPA states that this information will help it focus risk evaluation efforts on chemicals that are still on the market.
- As recently as 2018, the TSCA Inventory showed over 86,000 chemicals available for commercial production and use in the U.S. Until this update, EPA states that it was not known which of these chemicals on the TSCA Inventory were actually in commerce.
- More than 80 percent (32,898) of the chemicals in commerce have identities that are not Confidential Business Information (CBI), increasing public access to additional information about them.
- For the less than 20 percent of the chemicals in commerce that have confidential identities, EPA states that it is developing a rule outlining how it will review and substantiate all CBI claims seeking to protect the specific chemical identities of substances on the confidential portion of the TSCA Inventory.
- From August 11, 2017, through October 5, 2018, chemical manufacturers and processors provided information on which chemicals were manufactured, imported or processed in the U.S. over the past ten years, the period ending June 21, 2016. EPA received more than 90,000 responses, a significant reporting effort by manufacturers, importers and processors.
Look for our memorandum on this important development tomorrow; it will be posted to our Regulatory Developments webpage.
On March 13, 2019, EPA will host a webinar to assist manufacturers (including importers) and processors with future reporting requirements. Under the final TSCA Inventory notification (active-inactive) rule, a substance is not designated as an “inactive substance” until 90 days after EPA publishes the initial version of the Inventory with all listings identified as active or inactive. EPA states that manufacturers and processors should be aware that if there is a substance that is listed as “inactive” that is currently being manufactured or processed, they have 90 days to file a Notice of Activity (NOA) Form B so that they can continue their current activity. Manufacturers and processors that intend to manufacture or process an “inactive” substance in the future must submit an NOA Form B before they start their activity.
The webinar is scheduled for 1:00 p.m. - 4:00 p.m. (EDT) on Wednesday, March 13, 2019. The webinar will include an overview of filing a NOA Form B, a demonstration of the electronic reporting application, and time for questions and answers. Registration for the webinar is not required.
More information about the TSCA Inventory update and the webinar is available on EPA’s TSCA Chemical Substance Inventory webpage.
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.
By Lynn L. Bergeson and Margaret R. Graham
On November 29, 2019, the U.S. Environmental Protection Agency (EPA) announced that it has scheduled the first public meetings of the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). The first meeting, a preparatory virtual meeting, and will be held on January 8, 2019, from 2:00 p.m. to 4:00 p.m. (EST). The second meeting, a four-day in-person meeting, will be held on January 29, 2019, from 1:00 p.m. (EST) to 5:30 p.m. and on January 30, 31, and February 1, 2019, from 9 a.m. to 5:30 p.m. (EST). The official announcement is scheduled to be published in the Federal Register on November 30, 2018. Further information, including the location of the in-person meeting and how to register, will be posted on EPA’s TSCA Scientific Peer Review Committees website.
The topic for this first series of meetings is the peer review of the draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 and associated documents developed under EPA’s existing chemical substance process under TSCA. EPA states that the two-hour preparatory virtual meeting on January 8, 2019, will consider the scope and clarity of the draft charge questions for this peer review -- included with EPA’s Transmission of Background Materials and Charge to the Panel for the TSCA SACC Reviewing the Draft Risk Evaluation for C.I. Pigment Violet 29 (Attachment 23). The 4-day, in-person, public meeting will be comprised of the peer review panel deliberations and a general TSCA orientation for the TSCA SACC. A portion of the in-person meeting will be closed to the public, however, for the discussion of information claimed as confidential business information (CBI).
During these upcoming meetings, EPA states that the public is invited to provide oral comments for the peer review on the draft risk evaluation for C.I. Pigment Violet 29 and related documents; comments submitted by January 14, 2019, on the draft risk evaluation will be provided to the peer review panel members before the in-person meeting. Comments on the draft charge questions will be accepted prior to and during the 2-hour preparatory virtual meeting (but preferably by January 7, 2019); the TSCA SACC peer review panel will consider these comments during their discussions.
More information on the draft risk evaluation for C.I. Pigment Violet 29 is available in our memorandum EPA Publishes First Draft TSCA Chemical Risk Evaluation.
By Lynn L. Bergeson and Margaret R. Graham
On October 17, 2018, the Trump Administration published its Unified Agenda of Regulatory and Deregulatory Actions (Regulatory Agenda). There are many interesting entries, some of which are flagged here.
Not surprisingly, the U.S. Environmental Protection Agency (EPA) listed implementing Toxic Substances Control Act (TSCA) amendments to enhance public health and chemical safety as one of its top priorities. According to EPA, the amendments to TSCA that were enacted in June 2016 require EPA “to evaluate existing chemicals on the basis of the health risks they pose -- including risks to vulnerable groups and to workers who may use chemicals daily as part of their jobs.” If unreasonable risks are found, EPA must then take steps to eliminate these risks but, “during the risk management phase, EPA must balance the risk management decision with potential disruption based on compliance to the national economy, national security, or critical infrastructure.” The following TSCA items were included.
The rules in the proposed rule stage are:
- Microorganisms: General Exemptions From Reporting Requirements; Revisions of Recipient Organisms Eligible for Tier I and Tier II Exemptions, 2070-AJ65. The Regulatory Agenda states that EPA is still developing a revised proposal that will address concerns raised by commenters in response to its preliminary determination that certain strains of Trichoderma reesei and Bacillus amyloliquefaciens will not present an unreasonable risk of injury to health or the environment when used as a recipient microorganism, provided that certain criteria for the introduced genetic material and the physical containment conditions are met. EPA is also considering expanding the earlier proposal to prohibit the inclusion of antibiotic resistance genes in the introduced genetic material in microorganisms qualifying for the TSCA Section 5(h)(4) exemption. EPA was scheduled to issue a proposed rule by October 2018.
- Long-Chain Perfluoroalkyl Carboxylate (LCPFAC) and Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use Rule (SNUR), 2070-AJ99. The Regulatory Agenda states that EPA is developing a supplemental proposal for part of a SNUR under TSCA Section 5(a)(2) for LCPFAC chemical substances to make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of certain articles. This rule was scheduled to be proposed by October 2018 and issued in final by November 2019. EPA’s initial proposed rule was issued on January 21, 2015.
- Procedural Rule: Review of Confidential Business Information (CBI) Claims for the Identity of Chemicals on the TSCA Inventory -- Amended TSCA Section 8(b)(4)(C), 2070-AK21. The Regulatory Agenda states that EPA is developing a proposed rule that establishes a plan to review all claims to protect the specific chemical identities of chemical substances on the confidential portion of the active TSCA Inventory. EPA is scheduled to issue the proposed rule by January 2019 and the final rule by December 2019, as TSCA directs a final rule to be issued by December 16, 2019.
- TSCA Chemical Data Reporting Revisions and Small Manufacturer Definition Update for Reporting and Recordkeeping Requirements Under TSCA Section 8(a), 2070-AK33. The Regulatory Agenda states that before the next Chemical Data Reporting (CDR) period of 2020, EPA intends to revise the reporting requirements to better align with new statutory requirements resulting from TSCA, as amended, to address submitters' feedback following the 2016 submission period, and may consider reporting requirements for inorganic byproducts. EPA is also proposing amendments to the size standards for small manufacturers, which impacts certain reporting and recordkeeping requirements for TSCA Section 8(a) rules, including CDR. EPA is scheduled to issue the proposed rule by December 2018 and the final rule by October 2019.
- Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h), 2070-AK34. The Regulatory Agenda states that EPA is developing a proposed rule to implement TSCA Section 6(h), as amended, which directs EPA to issue regulations for certain persistent, bioaccumulative, and toxic (PBT) chemical substances that were identified in the 2014 update of the TSCA Work Plan. TSCA directs these regulations to be proposed by June 22, 2019, and issued in final form no later than 18 months after proposal. According to the Regulatory Agenda, EPA will issue a proposed rule by June 2019.
- Technical Issues; Formaldehyde Emission Standards for Composite Wood Products, 2070-AK47. EPA is proposing to amend the regulations promulgated in a final rule published on December 12, 2016, concerning formaldehyde emission standards for composite wood products, specifically to address certain technical issues and further align the final rule requirements with the California Air Resources Board (CARB) Airborne Toxic Control Measures (ATCM) Phase II program. EPA issued the proposed rule on November 1, 2018, in the Federal Register; comments are due by December 3, 2018. EPA expects to issue a final rule by March 2019.
The rules in the final rule stage are:
- Review of Dust-Lead Hazard Standards and the Definition of Lead-Based Paint, 2070-AJ82. EPA issued a proposed rule on July 2, 2018, that would lower the current dust-lead hazard standards (DLHS) from 40 mg/ft2 and 250 mg/ft2 to 10 mg/ft2 and 100 mg/ft2 on floors and window sills, respectively, per a final decision of the U.S. Court of Appeals for the Ninth Circuit. The Regulatory Agenda states that while EPA has proposed standards of 10 mg/ft2 and 100 mg/ft2 for floors and window sills respectively, EPA encouraged public comment on the full range of candidate standards analyzed as alternatives to the proposal, including the option not to change the current standard or to reduce the floor dust standard but leave the sill dust standard unchanged, since reducing floor dust lead has the greatest impact on children's health. EPA is scheduled to issue the final rule by June 2019. More information on the proposed rule is available in our memorandum “Recent Federal Developments -- July 2018.”
- SNUR for Toluene Diisocyanates (TDI) and Related Compounds, 2070-AJ91. The Regulatory Agenda states that EPA is preparing the final version of a proposed SNUR issued on January 15, 2015, under TSCA Section 5(a)(2) for 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, toluene diisocyanate unspecified isomers, and related compounds; and that there are no changes in the chemicals subject to the SNUR between the proposed and final rule. EPA is scheduled to issue the final rule in November 2018.
- Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices, 2070-AJ94. On July 28, 2016, EPA issued a rule proposing changes to the applicable significant new uses of chemical substances regulations at 40 C.F.R. Part 721 to align EPA's regulations, where possible, with the final revisions to the U.S. Occupational Safety and Health Administration (OSHA) Hazard Communications Standard. The Regulatory Agenda states that EPA is reviewing the comments received and is planning to issue a final rule in February 2019.
- Certain Nonylphenols and Nonylphenol Ethoxylates; SNUR, 2070-AJ96. The Regulatory Agenda states that EPA is reviewing the comments received on the proposed SNUR issued on October 1, 2014, for certain chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE) and is planning to issue a final rule in September 2019. More information on the proposed SNUR is available in our memorandum “EPA Proposes SNUR for Nonylphenols and Nonylphenol Ethoxylates.”
- Methylene Chloride; Rulemaking Under TSCA Section 6(a), 2070-AK07. The Regulatory Agenda states that EPA is scheduled to issue the final rule prohibiting the consumer and commercial paint stripping uses for methylene chloride by December 2018. In a press release issued on May 10, 2018, EPA stated that it will not re-evaluate the paint stripping uses of methylene chloride and will rely on its previous risk assessments. See our memorandum “EPA Will Send Final Methylene Chloride Rule to OMB ‘Shortly’” for more information on the proposed rule.
- Asbestos; SNUR, 2070-AK45. The Regulatory Agenda states that EPA’s proposed SNUR under TSCA Section 5(a)(2) for certain uses of asbestos that are no longer in use in the United States is scheduled to be issued in final by January 2019. The proposed SNUR was issued on June 11, 2018, and the comment period ended on August 10, 2018. More information on the proposed rule is available in our memorandum “Monthly Update for June 2018.”
The following Long-Term Action was also listed:
- N-Methylpyrrolidone (NMP); Regulation of Certain Uses Under TSCA Section 6(a), RIN 2070-AK46. The Regulatory Agenda states that EPA’s two co-proposals for NMP that were proposed on January 19, 2017 (as part of RIN 2070-AK07), will be issued in final with a future date “To Be Determined.” The first co-proposal would prohibit the manufacture, processing, and distribution in commerce of NMP for all consumer and most commercial paint and coating removal and the use of NMP for most commercial paint and coating removal. The second co-proposal would require commercial users of NMP for paint and coating removal to establish a worker protection program and not use paint and coating removal products that contain greater than 35 percent NMP by weight, with certain exceptions; and require processors of products containing NMP for paint and coating removal to reformulate products such that they do not exceed 35 percent NMP by weight, to identify gloves that provide effective protection for the formulation, and to provide warnings and instructions on any paint and coating removal products containing NMP. For more information on the proposed rule, please see our memorandum "Monthly Update for February 2017."
For information on the TSCA items included in the Spring 2018 Regulatory Agenda, please see our blog item “EPA’s Spring 2018 Unified Agenda and Regulatory Plan Includes TSCA Rulemakings.”
B&C is launching a podcast November 1, 2018. It’s called All Things Chemical™ and it will engage listeners in intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals. B&C’s talented team of lawyers, scientists, and consultants will keep listeners abreast of the changing world of both domestic and international chemical regulation and provide analysis of the many intriguing and complicated issues surrounding this space.
A teaser introduction to the podcast is available now. Full episodes will be available November 1, 2018, on iTunes, Spotify, and Stitcher.
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
On July 20, 2018, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report on its audit of EPA’s implementation of the OIG recommendations for the Presidential Green Chemistry Challenge Awards (PGCCA) Program. The PGCCA Program is sponsored by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) to promote the environmental and economic benefits of developing and using green chemistry by recognizing industry innovations. In 2015, OIG reported that award results submitted to the EPA’s Pollution Prevention (P2) Program from PGCCA recipients were not adequately supported or transparent. In its audit, OIG found that EPA discontinued the use of unverified PGCCA results in EPA performance metrics, but “a lack of documented controls presents risk that these data may be used in the future.”
Please see the full memorandum for more information including a short history on performance metrics of the Green Chemistry Program.
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Molly R. Blessing
Bergeson & Campbell, P.C. (B&C®) will present a webinar regarding confidential business information (CBI) as related to chemical regulation on September 18, 2018. Register for “TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules” online. This webinar is part of the 2018 Chemical Policy Summit Series presented by B&C and Bloomberg Next.
On June 21, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance intended to “assist companies in creating structurally descriptive chemical names for chemical substances whose specific chemical identities are claimed confidential, for purposes of protecting the specific chemical identities from disclosure while describing the chemical substances as specifically as practicable, and for listing substances on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory.” EPA states that the guidance, Guidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting under the Toxic Substances Control Act, was developed in response to the requirement under new TSCA Section 14(c)(4) that EPA “develop guidance regarding – (A) the determination of structurally descriptive generic names, in the case of claims for protection from disclosure of specific chemical identity…” and the requirement under new TSCA Section 14(c)(1)(C) that submitters who assert a confidentiality claim for a specific chemical identity must include a structurally descriptive generic name developed consistent with EPA guidance. The guidance updates and replaces the 1985 guidance published in the TSCA Inventory, 1985 Edition (Appendix B: “Generic names for Confidential Chemical Substance Identities”). EPA states that, also consistent with Sections 14(c)(4) and 14(c)(1)(C), EPA will be reviewing generic names upon receipt in TSCA filings where chemical identity is claimed as confidential for consistency with the guidance. EPA encourages companies to consult the Agency’s Office of Pollution, Prevention, and Toxics (OPPT) if they feel that it will be necessary to mask more than one structural element of a specific chemical name to mask a confidential chemical identity. More information on this guidance is available in our full memorandum.
By Lynn L. Bergeson, Charles M. Auer, and Margaret R. Graham
On March 13, 2018, the U.S. Environmental Protection Agency (EPA) released three draft guidance documents for public comment clarifying the circumstances under which EPA may disclose Toxic Substances Control Act (TSCA) confidential business information (CBI) with an expanded set of people. Amended TSCA Section 14(d) expanded the categories of people to whom EPA may disclose TSCA CBI by specifically authorizing EPA to disclose TSCA CBI to state, tribal, and local governments; environmental, health, and medical professionals; and emergency responders, under certain conditions, including consistency with guidance that EPA is required to develop. The draft guidance documents are:
EPA’s prepublication version of the notice of availability of the draft guidance states the conditions for access vary under each of the new provisions, but generally include the following: requesters must show that they have a need for the information related to their employment, professional, or legal duties; recipients of TSCA CBI are prohibited from disclosing or permitting further disclosure of the information to individuals not authorized to receive it (physicians/nurses may disclose the information to their patient); and, except in emergency situations, EPA must notify the entity that made the CBI claim at least 15 days prior to disclosing the CBI. In addition, under these new provisions, requesters (except in some emergency situations) are required to sign an agreement and may be required to submit a statement of need to EPA. In accordance with the requirements of TSCA section 14(c)(4)(B), each guidance document covers the content and form of the agreements and statements required under each provision and include information on where and how to submit requests to EPA. A 30-day comment period for the draft guidance documents will open upon the notice’s publication in the Federal Register; comments can be submitted to docket EPA-HQ-OPPT-2017-0652 via www.regulations.gov.
On March 12, 2018, EPA also announced that it collecting comments on burden and other information required by the Paperwork Reduction Act related to these documents in the form of an Information Collection Request (ICR), as detailed in a separate notice. 83 Fed. Reg. 10719. Comments on the ICR are due May 11, 2018. EPA states that it anticipates using comments received in response to the guidance document notice and the ICR notice to inform the development of final guidance documents, which it anticipates to be released in June 2018.