2017-24112. New Chemicals Review Program Implementation and Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations Under the Amended Toxic Substances Control Act (TSCA); Notice of Public Meetings ...

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is holding two meetings to discuss implementation activities under the Toxic Substances Control Act as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (TSCA). The first meeting is to update and engage with the public on the Agency's progress in implementing changes to the New Chemicals Review Program as a result of the 2016 amendments to TSCA, including discussion of EPA's draft New Chemicals Decision-Making Framework. EPA will describe its review process for new chemical substances under the amended statute and interested parties will have the opportunity to provide input and to ask questions. The Agency plans to utilize the feedback it receives from the public meeting and comments received to improve policy and processes relating to the review of new chemicals under TSCA. The second meeting will focus on possible approaches for identifying potential candidate chemical substances for EPA's prioritization process under TSCA. As amended, TSCA required that EPA establish processes for prioritizing and evaluating risks from existing chemical substances. EPA will describe and take comment on a number of possible approaches that could guide the Agency in the identification of potential candidate chemical substances for prioritization.

DATES:

The New Chemicals Review Program Implementation meeting will be held on December 6, 2017 from 9:00 a.m. to 5:00 p.m. The meeting regarding approaches for identifying potential candidates for prioritization will be held on December 11, 2017 from 9:00 a.m. to 5:00 p.m. EPA will accept questions from the public in advance of the meetings, and the Agency will respond to these questions at each meeting as time allows, if such questions are received by November 20, 2017 (see Unit III under SUPPLEMENTARY INFORMATION).

Members of the public who register to speak at either meeting may make comments and may ask additional questions. Online requests to participate in either meeting must be received on or before December 5, 2017. On-site registration will be permitted, but seating and speaking priority will be given to those who pre-register by the deadline.

To request accommodation of a disability, please contact the meetings logistics person listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request.

EPA will hear oral comments at these meetings. EPA will accept written comments and materials submitted to the docket for the New Chemicals Review Program Implementation meeting on or before January 20, 2018. EPA will accept written comments and materials submitted to the docket for the meeting regarding approaches for identifying potential candidates for prioritization on or before January 25, 2018. The dockets will remain open to receive comments and materials until these dates. When submitting comments to the dockets, please be as specific as possible, and please include any supporting data or other information.

ADDRESSES:

The meetings will both be held at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue NW., Washington, DC 20004. The meetings will also be available by remote access for registered participants. For further information, see Unit III under SUPPLEMENTARY INFORMATION.

To participate in the New Chemicals Review Program Implementation meeting on December 6 (identified by docket identification (ID) number EPA-HQ-OPPT-2017-0585) you may register online (preferred) or in person at the meeting. To register online, go to https://epa-ncrp.eventbrite.com.

To participate in the meeting regarding approaches for identifying potential candidates for prioritization on December 11 (identified by docket ID number EPA-HQ-OPPT-2017-0586) you may register online (preferred) or in person at the meeting. To register online, go to https://epa-prioritization.eventbrite.com. See Unit III under SUPPLEMENTARY INFORMATION for information about submitting questions in advance of the meetings.

Written comments, identified by the docket ID number EPA-HQ-OPPT-2017-0585 (for the New Chemicals Review Program meeting) or EPA-HQ-OPPT-2017-0586 (for the meeting regarding approaches for identifying potential candidates for prioritization), can be submitted by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
• Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/​dockets/​contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets in general is available at http://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

 

For technical information about the New Chemicals Review Program Implementation meeting contact: Greg Schweer, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: [phone]; email address: [e-mail].

For technical information about the meeting regarding approaches for identifying potential candidates for prioritization contact: Ryan Schmit, Office of Pollution Prevention and Toxics (7101M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: [phone]; email address: [e-mail].

For meeting logistics or registration contact: Klara Zimmerman, Abt Associates; telephone number: [phone]; email address: [e-mail].

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

This action is directed to the public in general, and may be of interest to a wide range of stakeholders including chemical manufacturers, processors and users, consumer product companies, non-profit organizations in the environmental and public health sectors, state and local government agencies, and members of the public interested in the environmental and human health assessment and regulation of chemical substances. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

B. How can I get copies of this document and other related information?

The docket for the New Chemical Program Implementation meeting (identified by docket ID number EPA-HQ-OPPT-2017-0585) and the docket for the meeting regarding approaches for identifying potential candidates for prioritization (identified by docket ID number EPA-HQ-OPPT-2017-0586) are available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is [phone], and the telephone number for the OPPT Docket is [phone]. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/​dockets.

II. Background

The Frank R. Lautenberg Chemical Safety for the 21st Century Act, amending the Toxic Substances Control Act of 1976, was signed into law on June 22, 2016. The amendments have enhanced EPA's authority to evaluate chemical substances.

EPA's New Chemicals Review Program has and will continue to support innovation while managing potential risks to human health and the environment from chemical substances new to the marketplace. Under section 5 of TSCA, anyone who plans to manufacture (including import) a new chemical substance for a non-exempt commercial purpose is required to provide EPA with notice before initiating the activity.

Additionally, EPA must also be notified before chemical substances are manufactured or processed for a use that the Agency has designated, by rule, as a significant new use. Under the amended law, EPA is now required to make one of several determinations regarding whether the new use or new chemical presents an unreasonable risk of injury to health or the environment, whether there is insufficient information to allow for a reasoned evaluation of the health and environmental effects of the chemical substance, or whether the substance is produced in substantial quantities and may either enter into the environment in substantial quantities or have significant or substantial human exposure.

The amended statute has resulted in significant changes for both the EPA's New Chemicals Review Program and those manufacturers submitting notices prior to commercialization. EPA has worked to keep stakeholders informed of its efforts to implement the statutory changes and will continue this dialogue during the meeting on December 6, 2017. Information obtained during this meeting and collected in the docket will be considered as the Agency works to increase efficiency in its review process under TSCA. An agenda for the meeting and supporting materials will be made available in the docket and on the Agency's Web site in advance of the meeting.

TSCA, as amended, also required that EPA establish procedures for prioritizing and evaluating risks from existing chemical substances. EPA announced its final procedures on June 22, 2017 (see https://www.epa.gov/​assessing-and-managing-chemicals-under-tsca/​federal-register-notice-procedures-prioritization), and the final procedural rule addressing the prioritization process published in the Federal Register on July 20 2017 (82 FR 33753) (FRL-9964-24). The prioritization process involves a 9-month to 12-month public process, including multiple opportunities for public comment, to designate a chemical substance as either High-Priority for further risk evaluation, or Low-Priority for which risk evaluation is not warranted at the time. In the proposed Prioritization rule, EPA included several provisions intended to convey activities the Agency would expect to undertake prior to initiating prioritization (e.g., potential candidate identification, information gathering/review, etc.). Based on public comments received, EPA determined not to finalize those particular provisions at the time and to engage in further discussions with interested stakeholders.

The purpose of the second meeting is to describe and take comment on a number of possible approaches that could guide the Agency in the identification of potential candidate chemical substances for prioritization. More information on these possible approaches will be made available in the docket and on EPA's Web site prior to the meeting. EPA is fully committed to further dialogue on best practices for these activities, and to carrying out these activities in a transparent, science-based manner, to ensure successful implementation of the prioritization and risk evaluation processes required by section 6 of TSCA.

Additional information on the TSCA amendments can be found at https://www.epa.gov/​assessing-and-managing-chemicals-under-tsca/​frank-r-lautenberg-chemical-safety-21st-century-act.

III. Meetings

A. Remote Access

The meetings will both be accessible remotely for registered participants. Registered participants will receive information on how to connect to the meetings prior to their start.

B. Public Participation at the Meetings

Members of the public may register to attend either or both the New Chemicals Review Program Implementation meeting and or the meeting regarding approaches for identifying potential candidates for prioritization as observers and may also register to provide oral comments and ask questions on the day of the respective meetings, using one of the registration methods described under ADDRESSES. A registered speaker is encouraged to focus on issues directly relevant to the meeting's subject matter. Each speaker is allowed no more than five minutes at each meeting to provide oral comments and ask questions. A speaker must be registered in order to provide oral comments or ask questions during the meetings. To accommodate as many registered speakers as possible, speakers may present oral comments and questions only, without visual aids or written material. Persons registered to speak (as well as others) may submit written materials to the dockets as described under ADDRESSES. Agendas for the meetings and supporting materials will be made available in the dockets and on EPA's Web site in advance of the respective meetings. Additionally, EPA will accept questions from the public in advance of the meetings, and will respond to these questions at the meetings as time allows, if such questions are received by November 20, 2017. Additional information regarding methods of submission of advance questions will be available on EPA's Web site and in the dockets along with the supporting materials.

IV. How can I request to participate in these meetings?

A. Registration

To attend the meetings in person or to receive remote access, you must register online no later than December 5, 2017, using one of the methods described under ADDRESSES. While on-site registration will be available, seating will be on a first-come, first-served basis, with priority given to early registrants, until room capacity is reached. For registrants not able to attend in person, the meetings will also provide remote access capabilities; registered participants will be provided information on how to connect to the meetings prior to its start.

B. Required Registration Information

Members of the public may register to attend as observers or to speak if planning to offer oral comments during the scheduled public comment periods. To register for the meetings online, you must provide your full name, organization or affiliation, and contact information.

Authority: 15 U.S.C. 2601 et seq.

Dated: October 27, 2017.

Nancy Beck,

Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention.