82 FR 33765 - Guidance To Assist Interested Persons in Developing and Submitting Draft Risk Evaluations Under the Toxic Substances Control Act; Notice of Availability

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 138 (July 20, 2017)

As required by the Toxic Substances Control Act (TSCA), which was amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act in June 2016, EPA is announcing the availability of a guidance document, entitled ``Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations Under the Toxic Substances Control Act''. This guidance document is intended to assist interested persons, or external parties, in developing and submitting draft risk evaluations to be considered by EPA under TSCA. The guidance document addresses the science standards, the data quality considerations, and the steps of the risk evaluation process that external parties should follow when developing draft risk evaluations for consideration by EPA.

[Federal Register Volume 82, Number 138 (Thursday, July 20, 2017)]
[Notices]
[Pages 33765-33766]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-14323]



Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / 
Notices

[[Page 33765]]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0341; FRL-9964-25]


Guidance To Assist Interested Persons in Developing and 
Submitting Draft Risk Evaluations Under the Toxic Substances Control 
Act; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: As required by the Toxic Substances Control Act (TSCA), which 
was amended by the Frank R. Lautenberg Chemical Safety for the 21st 
Century Act in June 2016, EPA is announcing the availability of a 
guidance document, entitled ``Guidance to Assist Interested Persons in 
Developing and Submitting Draft Risk Evaluations Under the Toxic 
Substances Control Act''. This guidance document is intended to assist 
interested persons, or external parties, in developing and submitting 
draft risk evaluations to be considered by EPA under TSCA. The guidance 
document addresses the science standards, the data quality 
considerations, and the steps of the risk evaluation process that 
external parties should follow when developing draft risk evaluations 
for consideration by EPA.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Iris Camacho, Risk Assessment Division, Office of Pollution Prevention 
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001; telephone number: (202) 564-1229; email 
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are 
interested in developing and submitting a draft chemical specific risk 
evaluation to the Agency for consideration under TSCA. Since there are 
a number of entities that may be interested, the Agency has not 
attempted to describe all the specific entities and corresponding NAICS 
codes for entities that may be interested in or affected by this 
action.

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

    The docket for this action, identified by docket identification 
(ID) number EPA-HQ-OPPT-2017-0341, is available online at http://www.regulations.gov or in person 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 (202) 
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information 
about the docket that is available at http://www.epa.gov/dockets.

C. What is the Agency's authority for taking this action?

    This action implements TSCA section 26(l)(5), 15 U.S.C. 2601 et 
seq.

II. Background

    On June 22, 2016, the ``Frank R. Lautenberg Chemical Safety for the 
21st Century Act'' was signed into law, thereby amending the 1976 
Toxics Substances Control Act. One of the key features of the amended 
law is the requirement that EPA prioritize and assess existing 
chemicals, and manage identified unreasonable risks. Through a 
combination of new authorities, a risk-based assessment mandate, 
deadlines for action, and minimum throughput requirements, TSCA 
effectively creates a process by which EPA will conduct risk evaluation 
and management of existing chemicals. The law also requires EPA to 
develop guidance to assist external parties in submitting draft risk 
evaluations for EPA consideration under TSCA. To facilitate that 
consideration, the guidance is required, at a minimum, to address the 
quality of the information submitted and the process to be followed in 
developing the draft risk evaluations.
    The guidance avoids being prescriptive as to EPA's approaches--and 
consequently the guidance that EPA would provide to external parties--
will likely evolve over time, and new relevant guidance documents will 
be developed as necessary. EPA's goal is to ensure that external 
parties have flexibility to use the best available science by adapting 
and keeping current with changing science. The guidance may be refined, 
updated, or superseded in the future to capture the latest changes to 
the risk evaluation process resulting from Agency experience, advances 
in science, and future guidance which may be developed or updated.
    EPA expects external party draft risk evaluations to be of the same 
high quality as those developed by EPA. To that end, the guidance 
discusses the science standards, data quality considerations, and the 
steps of the risk evaluation process that external parties should 
follow when developing draft TSCA risk evaluations. Having these key 
factors in the risk evaluation process laid out in the guidance will 
foster predictability by transparently communicating EPA's 
expectations.

III. What action is the Agency taking?

    EPA is announcing the availability of a guidance document, entitled 
``Guidance to Assist Interested Persons in Developing and Submitting 
Draft Risk Evaluations Under the Toxic Substances Control Act''. This 
guidance document is intended to assist interested persons, or external 
parties, in developing and submitting draft risk evaluations to be 
considered by the EPA Administrator under TSCA.
    EPA maintains a list of Significant Guidance Documents at http://www.epa.gov/regulations/guidance/ as called for by the Office of 
Management and Budget's (OMB) Final Bulletin for Agency Good Guidance 
Practices (https://www.thefederalregister.org/fdsys/pkg/FR-2007-01-25/pdf/E7-1066.pdf). Please be aware that the EPA list of Significant Guidance 
Documents does not include every guidance document issued by EPA and 
only encompasses those documents that are ``significant'' as defined by 
OMB's Bulletin.
    This final document has been determined to be an EPA Significant 
Guidance Document per the OMB Bulletin definition and is included on 
the EPA list of significant guidance documents. OMB's Bulletin directs 
agencies to allow for the public to submit comments on any Significant 
Guidance Document that appears on the agency's list of significant 
guidance documents. EPA allows for public comments to be submitted 
through the Agency's electronic docket and commenting system at http://www.regulations.gov. Please note that although you may receive an 
acknowledgement that EPA has received your comment, you may not receive 
a detailed response to your comment. Your feedback is nevertheless 
important to EPA and will be forwarded to the appropriate program for 
consideration.

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


[[Page 33766]]


    Dated: June 22, 2017.
E. Scott Pruitt,
Administrator.
[FR Doc. 2017-14323 Filed 7-19-17; 8:45 am]
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