AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: As required under section 6(b)(4) of the Toxic Substances
Control Act (TSCA), EPA is issuing a rule that establishes a process
for conducting risk evaluations to determine whether a chemical
substance presents an unreasonable risk of injury to health or the
environment, without consideration of costs or other non-risk factors,
including an unreasonable risk to a potentially exposed or susceptible
subpopulation, under the conditions of use. This process incorporates
the science requirements of the amended statute, including best
available science and weight of the scientific evidence. Risk
evaluation is the second step, after Prioritization, in a new process
of existing chemical substance review and management established under
recent amendments to TSCA. This rule identifies the steps of a risk
evaluation process including: scope, hazard assessment, exposure
assessment, risk characterization, and finally a risk determination.
This process will be used for the first ten chemical substances
undergoing evaluation from the 2014 update of the TSCA Work Plan for
Chemical Assessments (to the maximum extent practicable). Chemical
substances designated as High-Priority Substances during the
prioritization process and those chemical substances for which EPA has
initiated a risk evaluation in response to a manufacturer request, will
always be subject to this process. The final rule also includes the
required "form and criteria" applicable to such manufacturer
DATES: This final rule is effective September 18, 2017.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2016-0654, is 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 (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 available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Susanna W. Blair, Immediate
Office, Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (202) 564-4321; email address:
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.