Document ID: EPA-HQ-OPPT-2012-0979-0002
Agency: epa
Document Type: Notice
Title: Draft Chemical Risk Assessments; Availability, etc.
Posted Date: 2013-01-09T05:00Z

[Federal Register Volume 78, Number 6 (Wednesday, January 9, 2013)]
[Notices]
[Pages 1856-1858]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00268]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2012-0979; FRL-9375-1]

Availability of Draft Chemical Risk Assessments; Public Comment 
Opportunity

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: With this document, EPA is announcing the availability of and 
opening the 60-day public comment period for several draft chemical 
risk assessments. These draft risk assessments address five of the 
initial seven chemicals from the Agency's TSCA Work Plan identified on 
March 1, 2012, for assessment during 2012. The chemicals are antimony 
trioxide, methylene chloride, n-methylpyrrolidone, trichloroethylene, 
and 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta[g]-2-
benzopyran. Methylene chloride and n-methylpyrrolidone are included in 
a single docket because both assessments will be addressed by the same 
peer review panel. EPA is also asking the public for nominations of 
expert peer reviewers and to submit names with contact information 
(full name, address, affiliation, telephone, and email) within 30 days 
of the opening of this public comment period. The nominations of expert 
peer reviewers from the public will be relayed to the independent peer 
review contractor setting up the individual peer review panels. Public 
comments submitted on these draft risk assessments will be included in 
materials submitted to peer review panels for their reviews of the 
assessments after this public comment period closes.

DATES: Comments for nominations of peer reviewers must be received on 
or before February 8, 2013 and comments on the draft assessments and 
the charge questions for the external peer reviews must be received on 
or before March 11, 2013.

ADDRESSES: Submit your comments, identified by the docket 
identification (ID) number for the corresponding chemical risk 
assessment as identified in this document, 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: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
ATTN: Docket ID Number [Please include the applicable docket ID number 
as identified in this document]. The DCO is open from 8 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The telephone number 
for the DCO is (202) 564-8930. Such deliveries are only accepted during 
the DCO's normal hours of operation, and special arrangements should be 
made for deliveries of boxed information. To make special arrangements 
for hand delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Stanley Barone, Risk Assessment 
Division (7403M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (202) 564-1169; fax 
number: (202) 564-7450; email address: barone.stan@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. 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 those interested in 
environmental and human health; the chemical industry; chemical users; 
consumer product companies and members of the public interested in the 
assessment of chemical risks. Since others also may be interested, the 
Agency has not attempted to describe all the specific entities that may 
be affected by this action.

II. What authorities apply to this action?

    In the Agency's February 2012 TSCA Work Plan Chemicals Methods 
Document (http://www.epa.gov/oppt/existingchemicals/pubs/wpmethods.pdf), released to the public on March 1, 2012, EPA described 
the two-step process the Agency used to identify potential candidate 
chemicals for near-term review and assessment under the Toxic 
Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.). The Agency 
announced its intent to use the TSCA Work Plan to help focus and direct 
the activities of the Existing Chemicals Program in the Office of 
Pollution Prevention and Toxics (OPPT). EPA also identified an initial 
group of seven of the Work Plan Chemicals to begin assessment in 2012. 
EPA invited public comment throughout this process through a non-
regulatory docket created for this activity, EPA-HQ-OPPT-2011-0516,

[[Page 1857]]

which can be accessed online at http://www.regulations.gov.
    As described in the Methods Document, EPA notes that identification 
of a chemical as a TSCA Work Plan Chemical does not itself constitute a 
finding by the Agency that the chemical presents a risk to human health 
or the environment. Rather, identification of a chemical as a TSCA Work 
Plan Chemical indicates only that the Agency intends to consider it for 
further review.

III. What action is the agency taking?

    EPA is announcing the availability of and opening the public 
comment period for the following draft chemical risk assessments. EPA 
also invites comments on whether there are other uses that may result 
in high potential consumer exposures EPA should consider as future 
assessment and/or collection priorities for these chemicals. This unit 
identifies the individual draft chemical risk assessments by title, 
docket ID number, and chemical or chemicals covered. Use the specific 
docket ID number provided in this unit to locate a copy of the 
chemical-specific document, as well as to submit comments via http://www.regulations.gov.

A. Docket ID Number EPA-HQ-OPPT-2012-0722

    Title: Availability of Draft Chemical Risk Assessments; Public 
Comment Opportunity: 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-
hexamethylcyclopenta[g]-2-benzopyran (HHCB) (CASRN 1222-05-5).
    Chemical Covered: 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-
hexamethylcyclopenta[g]-2-benzopyran (HHCB; CASRN 1222-05-5).
    Summary: HHCB is a synthetic polycyclic musk used as an ingredient 
in a wide range of consumer products including perfumes, cosmetics, 
shampoos, lotions, detergents, fabric softeners, and cleaning agents. 
The draft assessment focuses on environmental risk due to release of 
HHCB to the aquatic and terrestrial environment from all combined uses. 
Human health risks have been evaluated previously and are summarized in 
this draft assessment.
    For HHCB, EPA is asking for nominations of peer reviewers who are 
experts in the following areas: Aquatic ecotoxicology, terrestrial 
ecotoxicology, fate and biodegradation, fate and bioaccumulation, 
environmental risk assessment (aquatic and terrestrial), and analytical 
chemistry of organic waste water contaminants.

B. Docket ID Number EPA-HQ-OPPT-2012-0723

    Title: Availability of Draft Chemical Risk Assessments; Public 
Comment Opportunity: Trichloroethylene (CASRN 79-01-6).
    Chemicals Covered: Trichloroethylene (TCE; CASRN 79-01-6).
    Summary: The draft assessment focuses on uses of TCE as a degreaser 
and in consumer products used by individuals in the arts/crafts field. 
Given the range of endpoints (cancer; non-cancer, including potential 
effects on the developing fetus), the susceptible populations addressed 
are children and adults of all ages (including pregnant women). Thus, 
the draft assessment focuses on all human lifestages.
    For TCE, EPA is asking for nominations of peer reviewers who are 
experts in the following areas: Toxicology of TCE (developmental 
cardiotoxicity, immunotoxicology, reproductive toxicology, and cancer 
biology), expertise in physiologically based pharmaco-kinetics modeling 
for TCE, exposure of volatile organics, experts on use of volatiles as 
solvent degreasers and in the arts/crafts field, chemical/environmental 
risk assessment experts, experts familiar with environmental release 
data (i.e., TRI, NEI) and associated modeling/interpretation.

C. Docket ID Number EPA-HQ-OPPT-2012-0724

    Title: Availability of Draft Chemical Risk Assessments; Public 
Comment Opportunity: Antimony Trioxide (CASRN 1309-64-4).
    Chemical Covered: Antimony trioxide (ATO; CASRN 1309-64-4).
    Summary: This draft assessment focuses on the ecological hazards 
that may be associated with ATO use in flame retardants. Human health 
risks for the flame retardant use have been evaluated previously and 
are summarized in this draft assessment. Because ATO use in plastics 
was previously evaluated for human health and the environment, that use 
scenario is not evaluated here.
    For ATO, EPA is asking for nominations of peer reviewers who are 
experts in the following areas: Exposure modeling, aquatic 
ecotoxicology, terrestrial ecotoxicology, inorganic chemistry 
addressing water and sediment issues, and ground water.

D. Docket ID Number EPA-HQ-OPPT-2012-0725

    Title: Availability of Draft Chemical Risk Assessments; Public 
Comment Opportunity: Methylene Chloride (dichloromethane, DCM; CASRN 
75-09-2) and N-Methylpyrrolidone (NMP; CASRN 872-50-4).
    Chemicals Covered: Methylene Chloride (dichloromethane, DCM; CASRN 
75-09-2) and N-Methylpyrrolidone (NMP; CASRN 872-50-4).
    Summary: These related draft assessments focus on the use of DCM 
and NMP in paint stripping and will be addressed by the same peer 
review panel. With regard to DCM, the draft assessment focuses on 
inhalation exposure to consumers and workers, and addresses human 
health concerns for both cancer and non-cancer effects. The low concern 
for environmental effects of DCM is discussed in the draft assessment. 
With regard to NMP, the draft assessment focuses on inhalation and 
dermal exposure to consumers and workers. The low concern for 
environmental effects of NMP is discussed in the draft assessment.
    For DCM and NMP, EPA is asking for nominations of peer reviewers 
who are experts in the following areas: Inhalation toxicology, 
toxicokinetics/PBPK modeling, dermal toxicology, neurotoxicology, 
immunotoxicology, developmental and reproductive toxicology, cancer 
biology, expertise in U.S. consumer modeling (inhalation and dermal), 
expertise in occupational exposure assessment (inhalation and dermal) 
especially as related to volatile organic chemicals.
    The draft risk assessments on the two remaining chemicals from the 
initial group of seven Work Plan chemicals scheduled to begin 
assessment in 2012--the long- and medium-chain chlorinated paraffins--
are on a different schedule for completion and will be made available 
for public comment through another Federal Register notice issued on a 
later date.

V. What is the next step?

    The list of candidate peer reviewers, those nominated by the public 
as well as those identified by a contractor, will be made available in 
the Federal Register for public comment. After a 30-day comment period, 
informed by any comments, the contractor will select the peer 
reviewers. The detailed Peer Review Plans for the draft assessments are 
accessible through the Agency's Peer Review Agenda Web site at http://cfpub.epa.gov/si/si_public_pr_agenda.cfm. EPA will consider comments 
received from the public and the subsequent peer review when finalizing 
the individual chemical risk assessments and will describe in a written 
report how EPA addressed public and reviewer comments in the

[[Page 1858]]

final assessments. EPA will issue another Federal Register notice to 
announce the availability of the final risk assessments. If you have 
any questions about any of these risk assessments or the Agency's 
programs in general, please contact the person listed under FOR FURTHER 
INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: January 3, 2013.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2013-00268 Filed 1-8-13; 8:45 am]
BILLING CODE 6560-50-P