Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Margaret R. Graham

On October 26, 2017, the U.S. Environmental Protection Agency (EPA) announced it would be hosting a public meeting on November 2, 2017, from 9:00 a.m. to 5:00 p.m. (EST) to obtain input from interested parties and the public on its development of a Strategic Plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing.  EPA is required under Section 4(h) of the Toxic Substances Control Act (TSCA), as amended, to develop this Strategic Plan by June 22, 2018.  EPA states that it “will consider input from the meeting and from written comments to develop a draft Strategic Plan that will be shared with the public for comment.”

EPA has posted materials for the meeting to inform the Strategic Plan and that can be used for discussion and comment on its website, including:

EPA is requesting input about the draft Strategic Plan to be shared during the meeting and in the form of written comments that may be submitted to Docket No. EPA-HQ-OPPT-2017-0559 on www.regulations.gov; comments must be received no later than 60 days following the meeting.  Registration for the meeting and further information is available on EPA’s Alternative Test Methods webpage.


 

By Lynn L. Bergeson and Margaret R. Graham

On October 26, 2017, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a proposed rule on reporting requirements for the Toxic Substances Control Act (TSCA) mercury inventory.  82 Fed. Reg. 49564.  Under TSCA Section 8(b)(10)(B), the mercury inventory, which includes mercury “supply, use, and trade” in the United States, is required to be published every three years.  Information on the 2017 mercury inventory report is available in our blog item "EPA Releases Inventory Report of Mercury Supply, Use, and Trade in the U.S."

Through this proposed rule, EPA is on its way to delivering timely on its mandate under TSCA Section 8(b)(10)(D) to promulgate a rule within two years of the enactment of new TSCA (by June 22, 2018) that will require “any person who manufactures [including import] mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process” to make periodic reports to EPA to assist in the preparation of the mercury inventory. 

TSCA Section 8(b)(10)(C) further directs to “identify any manufacturing processes or products that intentionally add mercury; and … recommend actions, including proposed revisions of Federal law or regulations, to achieve further reductions in mercury use.”  The proposed rule, however, states that “[a]t this time, EPA is not making such identifications or recommendations.” 

The proposed rule requests comments on several changes, including:

  • On the proposed limited data collection requirements, such as the identification of countries that manufacture, import, or export mercury-added products (i.e., countries of origin and destination), as well as the identification of purchasing or receiving industry sectors via North American Industrial Classification System (NAICS) codes, to inform activities under the Minamata Convention on Mercury;
  • On whether to require one-time reporting for exports of the mercury compounds prohibited from export under TSCA Section 12(c)(7);
  • On its proposal to apply the proposed reporting requirements to any person who manufactures (including imports) mercury, mercury-added products or otherwise intentionally uses mercury in a manufacturing process regardless of the amount of mercury at issue;
  • On its proposal that because of the similarities in the intentional addition of mercury to manufacture a product and otherwise intentional use of mercury in a manufacturing process, all quantities of mercury used in both activities should be reported without a reporting threshold;
  • On what kinds of information would be particularly important to address for small entities if EPA were to develop compliance guides tailored to small entities that will be required to comply with the reporting requirements;
  • On whether the proposed reporting requirements should apply to persons who do not manufacture or import mercury or mercury-added products, or otherwise intentionally use mercury in a manufacturing process, but engage in the supply, use, and trade of mercury in the United States; and
  • On its proposal to require mandatory electronic reporting.

EPA also requests comments on the proposed timelines and reporting deadlines; and on the proposed interpretations of activities to be considered as part of supply, use, and trade of mercury in the United States -- as described below.

For those who will need to report, EPA proposes the following reporting periods and deadlines:

  • The 2020 reporting year will be from January 1 to December 31, 2018; subsequent recurring reporting years will be from January 1 to December 31 at three-year intervals beginning in 2021;
  • All information reported for an applicable reporting year must be submitted on or before the first day of July following the reporting year.  The 2020 submission deadline is July 1, 2019; subsequent recurring submission deadlines are from July 1, in three-year intervals, beginning in 2022.

EPA’s proposed interpretations of activities to be considered as part of the supply, use, and trade of mercury in the United States are as follows:

  • Import of mercury or a mercury added product with the purpose of obtaining an immediate or eventual commercial advantage for the importer, except where such mercury is generated as a byproduct not used for commercial purposes or an impurity.
  • Manufacture (other than import) of mercury or a mercury-added product with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer, except where such mercury is generated as a byproduct not used for commercial purposes or an impurity. In this context, EPA considers manufacture to be the intentional production of mercury, a mercury compound, or a mercury-added product.
  • Otherwise intentional use of mercury in a manufacturing process, other than the manufacture of a mercury compound or a mercury-added product, with the purpose of obtaining an immediate or eventual commercial advantage for the user, except where such mercury is generated as a byproduct not used for commercial purposes.
  • Distribution in commerce, including domestic sale or transfer, of mercury or a mercury-added product.
  • Storage of mercury after manufacture (including import).
  • Export of mercury or a mercury-added product, including the determining and controlling the sending of mercury (unless specifically prohibited) or a mercury-added product to a destination out of the customs territory of the United States.

Comments on the proposed rule are due by December 26, 2017.


 

By Lynn L. Bergeson and Kathleen M. Roberts

On October 12, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register announcing the cancellation of the fourth meeting of the Negotiated Rulemaking Committee for Chemical Data Reporting (CDR) requirements for inorganic byproducts (Reg Neg Committee) scheduled for October 25-26, 2017.  82 Fed. Reg. 47423. 

During their September 13-14, 2017, meeting, the members of the Reg Neg Committee concluded that further dialogue within the Committee context would be unproductive, and that the fourth meeting was not necessary.  EPA is, however, still providing the public an opportunity to weigh in on the legislative directive to reduce the CDR reporting burden for inorganic substances that are recycled, while maintaining EPA’s access to exposure information needed for risk assessment purposes.  The notice states that the Reg Neg Committee docket will remain open until December 11, 2017, to allow for public comment.

The Reg Neg Committee was established to respond to the legislative mandate under Section 8(a)(6)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which states:

The [EPA] Administrator shall enter into a negotiated rulemaking … to develop and publish … a proposed rule providing for limiting the reporting requirements, under this subsection, for manufacturers of any inorganic byproducts, when such byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.

During the first set of Reg Neg Committee meetings, EPA stressed its desire to implement the outcome of the Reg Neg Committee work during the next CDR reporting cycle in 2020.  To achieve this timeline, the Committee would need to reach a consensus on an approach or approaches by the October 2017 meetings.   While several different stakeholder organizations offered proposals for consideration, it became clear to Committee members during the September 14-15, 2017, meeting that those proposals would not have consensus support because they either required considerable further refinement and discussion beyond the October 2017 timeframe; did not provide EPA with appropriate exposure information needed for risk assessment; or did not adequately achieve the mandated goal of limiting reporting requirements. 

It is unclear if EPA will be able to complete the myriad of tasks needed to take a proposal received during the public comment period to final implementation before the 2020 CDR reporting cycle, as this would require EPA to complete a thorough analysis of additional proposals, consider potential impacts to the EPA offices, develop a proposed rulemaking, obtain public review and comment on the proposal, issue a final rulemaking, and provide clear and detailed guidance on the new approaches for reporting on recycled inorganic products prior to the 2020 CDR reporting cycle. 

More information on the negotiated rulemaking process as related to inorganic byproducts is available on our blog under key phrases negotiated rulemaking and inorganic byproducts.


 

By Lynn L. Bergeson and Margaret R. Graham

On September 14, 2017, the U.S. Environmental Protection Agency (EPA) filed a motion in the two Ninth Circuit Court of Appeals cases regarding review of the EPA Toxic Substances Control Act (TSCA) framework rule Procedures for Chemical Risk Evaluation under TSCA:  Safer Chemicals Healthy Families v. EPA, Case No. 17-72260 (filed August 10, 2017); and Environmental Defense Fund v. EPA, Case No. 17-72501 (filed September 6, 2017), requesting that the cases be transferred to the Fourth Circuit and to hold the cases in abeyance.  In the motion, EPA states three reasons why these cases should be transferred:

  1. "It is in the interest of judicial economy for the same court to hear the challenges to both EPA Rules,” and “[a]lthough the two Rules are distinct and have separate administrative records, the parties anticipate that there will be some overlap of issues.”
  2. “It would be more convenient for the parties and conserve travel resources for these cases to be heard in the Fourth Circuit, because all counsel of record are located in Washington, DC, or New York.”
  3. “The Fourth Circuit may be able to resolve the petitions for review more quickly than this Court given the respective complexity of the courts’ dockets.”

In this motion, EPA also requests for these cases to be held in abeyance as it “will conserve party resources to wait until resolution of EPA’s motion to transfer before completing any scheduled filings, particularly because the two have different schedules” and “the deadline for interested persons to file petitions for review of the Prioritization and Risk Evaluation Rules has not yet expired…. additional petitions for review … could be filed as late as October 2, 2017.” 

In Case No. 17-72260, Petitioners’ briefs are due October 30, 2017, and Respondent EPA’s briefs are due November 28, 2017.  A briefing schedule has not been scheduled yet in Case No. 17-72501.  On September 11, 2017, in Alliance of Nurses for Healthy Environments, et al. v. EPA, Case No. 17-1926, the Fourth Circuit case regarding review of EPA’s TSCA framework rule Procedures for Chemical Risk Evaluation under TSCA, the Fourth Circuit rescinded the briefing schedule.  A new briefing schedule has not been set. 

More information on these petitions for review is available on our blog under key phrases framework rules and petition for review.  


 

By Lynn L. Bergeson and Margaret R. Graham

On September 6, 2017, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register extending the period for public comments on the candidates for consideration for the Science Advisory Committee on Chemicals from September 5, 2017, to September 17, 2017.  Comments can be submitted online in Docket Identification Number EPA-HQ-OPPT-2016-0713.

EPA is considering candidates for SACC membership listed in the August 26, 2016, Federal Register notice pool of requested nominees; the 29 candidates for membership identified in the December 9, 2016, Federal Register notice; and the additional candidates provided in the August 3, 2017, Federal Register notice.  More information on the background, qualification of members, and the process of obtaining nominees is available in our memorandum EPA Seeks Comment on Nominations to “Augmented” Science Advisory Committee on Chemicals.


 

By Lynn L. Bergeson and Margaret R. Graham

On September 1, 2017, the Environmental Defense Fund (EDF) filed a petition for review in the U.S Court of Appeals for the D.C. Circuit (No. 17-1201) of the U.S. Environmental Protection Agency’s (EPA) final Toxic Substances Control Act (TSCA) framework rule TSCA Inventory Notification (Active-Inactive) Requirements, published on August 11, 2017 (82 Fed. Reg. 37520). 

This is the third and final challenge by EDF to the framework rules implementing amended TSCA (there are only three framework rules), but the seventh total challenge, as other parties have also petitioned for review.  On August 11, 2017, EDF petitioned for review of the TSCA framework rules Procedures for Chemical Risk Evaluation under TSCA and the final rule Procedures for Prioritization of Chemicals for Risk Evaluation, filed on August 11 (Second Cir. Case Nos. 17-2464 and 17-2403, respectively).  Per the Consolidation Orders of the United States Judicial Panel on Multidistrict Litigation, both of EDF’s August 11 petitions have now been consolidated with other petitions for review of the same orders.  Case No. 17-2464 was moved to the Fourth Circuit, and Case No. 2403 was moved to the Ninth Circuit. 

In the Fourth Circuit, the opening brief, record from agency, and the appendix are due September 20, 2017, and the response brief is due October 20, 2017.  In the Ninth Circuit, the Petitioners’ briefs are due October 30, 2017, and Respondent EPA’s briefs are due November 28, 2017.                                       


 

By Lynn L. Bergeson and Carla N. Hutton

On August 17, 2017, the U.S. Environmental Protection Agency (EPA) submitted a proposed rule regarding reporting requirements for a mercury inventory to the Office of Management and Budget (OMB).  The proposed rule would establish reporting deadline(s) and information requirements for the purpose of assisting EPA’s periodic update and publication of the inventory of mercury supply, use, and trade in the U.S.  As required under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA must “carry out and publish in the Federal Register an inventory of mercury supply, use, and trade” in the U.S.  The Lautenberg Act defines mercury as “elemental mercury” or “a mercury compound.”  The inventory was to be published no later than April 1, 2017, and every three years thereafter, as supported by a rule authorized in the Lautenberg Act.  As reported in our March 29, 2017, blog item, EPA published an initial inventory report on March 29, 2017.  For subsequent inventories, EPA is authorized to promulgate a rule to “assist in the preparation of the inventory” so that “any person who manufactures mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process shall make periodic reports to the Administrator, at such time and including such information as the Administrator shall determine.”  EPA expects future triennial inventories of mercury supply, use, and trade to include data collected directly from such persons.  In future inventories, EPA also will “identify any manufacturing processes or products that intentionally add mercury; and . . . recommend actions, including proposed revisions of Federal law or regulations, to achieve further reductions in mercury use.”  EPA must promulgate a final rule by June 22, 2018.


 

By Lynn L. Bergeson and Margaret R. Graham

On August 18, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register stating that it will be holding the third and fourth committee meetings of the Negotiated Rulemaking Committee (NRC) on September 13, 2017, from 9:00 a.m to 5:00 p.m. (EDT) to September 14, 2017, from 9:00 a.m to 3:00 p.m. (EDT); and on October 25, 2017, from 9:00 a.m. to 5:00 p.m. (EDT) to October 26, 2017, from 9:00 a.m. to 3:00 p.m. (EDT).  The third meeting will take place at the Ronald Reagan Building and International Trade Center, Oceanic Suite, 1300 Pennsylvania Avenue N.W., Washington, D.C. 20004, while the fourth meeting will be held at the William Jefferson Clinton East Building, Room 1153, 1201 Constitution Avenue N.W., Washington, D.C. 20004.  Both meetings are open to the public.

The NRC’s objective is to “negotiate a proposed rule that would limit chemical data reporting requirements under Section 8(a) of the Toxic Substances Control Act (TSCA), [as amended], for manufacturers of any inorganic byproduct chemical substances when such byproduct chemical substances are subsequently recycled, reused, or reprocessed.”  Kathleen M. Roberts, Vice President of B&C® Consortia Management, L.L.C. (BCCM), an affiliate of Bergeson & Campbell, P.C. (B&C®), is on the NRC on behalf of a BCCM client.  EPA states that written comments can be submitted at any time during the negotiated rulemaking process, but is asking for written comments to be e-mailed to .(JavaScript must be enabled to view this email address) no later than one week prior to the meeting dates (September 6, 2017; and October 19, 2017).  Information about attending these meetings and their agendas will be posted to the NRC website.   More information regarding the NRC is available on our blog under key phrase Negotiated Rulemaking


 

By Lynn L. Bergeson and Carla N. Hutton

On August 14, 2017, as the final Toxic Substances Control Act (TSCA) Section 8(a) information gathering rule on nanomaterials took effect, the U.S. Environmental Protection Agency (EPA) published “working guidance” intended to assist stakeholders in complying with the rule.  The working guidance notes that it “will not provide answers to all of the potential questions that will arise as manufacturers and processors seek to comply with the rule.  Commenters to the draft guidance asked several questions that would require more details or information before EPA could respond to their question.”  If the guidance does not answer questions about the rule, companies are directed to contact Jim Alwood, Chemical Control Division, Office of Pollution Prevention and Toxics, .(JavaScript must be enabled to view this email address).  EPA states that it will answer questions on a case-by-case basis.  EPA intends to add further questions/answers and revisions to the guidance based on questions identified by persons who may be subject to the rule. 

As reported in our January 11, 2017, blog item, the January 12, 2017, final rule establishes reporting and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale.  Under the rule, manufacturers and processers, or persons who intend to manufacture or process these chemical substances must report certain information to EPA.  The information to be reported includes, insofar as known to or reasonably ascertainable by the person making the report, the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects.  Persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to August 14, 2017, the effective date of the final rule, must report to EPA one year after the effective date of the final rule.  There is also a standing one-time reporting requirement for persons who intend to manufacture or process a discrete form of a reportable chemical substance on or after the effective date of the rule.  These persons must report to EPA at least 135 days before manufacture or processing of that discrete form.  More information regarding the final rule is available in our January 12, 2017, memorandum EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.


 

By Lynn L. Bergeson and Margaret R. Graham

On August 11, 2017, the U.S. Environmental Protection Agency (EPA) published the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements.  This final rule is effective as of August 11, 2017 (the date of publication).

As further detailed in the final rulemaking, chemical manufacturers and importers are required to submit notifications for chemicals that were manufactured or imported over the ten year look-back period of June 21, 2006, to June 21, 2016.  Pursuant to the rulemaking, the retrospective reporting period for manufacturers begins on August 11, 2017, and ends on February 7, 2018.  The submission period for processors also begins on August 11, 2017, but processors have until October 5, 2018, to submit retrospective activity notifications.

More information on the final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.


 
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