Availability of Draft Chemical Risk Assessments; Public Comment Opportunity

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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, 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 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.