80 FR 23545 - Notice of Availability of Work Plan Chemical Problem Formulation and Initial Assessment for 1,4-Dioxane; Request for Public Comment

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 81 (April 28, 2015)

With this notice, EPA is announcing that it will be publishing a problem formulation and initial assessment or data needs assessment document for each TSCA Work Plan Chemical prior to conducting further risk analysis. This notice is also announcing the availability of a problem formulation and initial assessment document for the Work Plan Chemical 1,4-Dioxane and opening the 60-day public comment period for the document. Based on experience in conducting TSCA Work Plan Chemical assessments to date and stakeholder feedback, starting in 2015 EPA will publish a problem formulation and initial assessment or data needs assessment for each TSCA Work Plan Chemical as a stand-alone document to facilitate public and stakeholder input prior to conducting further risk analysis. EPA believes publishing problem formulations and initial assessments for TSCA Work Plan Chemicals will increase transparency about EPA's thinking and analysis process, provide opportunity for the public and stakeholders to comment on EPA's approach and provide the opportunity to receive additional information/data to supplement or refine the assessment approach prior to EPA conducting detailed risk analysis and risk characterization.

[Federal Register Volume 80, Number 81 (Tuesday, April 28, 2015)]
[Notices]
[Pages 23545-23546]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09888]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2015-0078; FRL-9923-84]


Notice of Availability of Work Plan Chemical Problem Formulation 
and Initial Assessment for 1,4-Dioxane; Request for Public Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: With this notice, EPA is announcing that it will be publishing 
a problem formulation and initial assessment or data needs assessment 
document for each TSCA Work Plan Chemical prior to conducting further 
risk analysis. This notice is also announcing the availability of a 
problem formulation and initial assessment document for the Work Plan 
Chemical 1,4-Dioxane and opening the 60-day public comment period for 
the document. Based on experience in conducting TSCA Work Plan Chemical 
assessments to date and stakeholder feedback, starting in 2015 EPA will 
publish a problem formulation and initial assessment or data needs 
assessment for each TSCA Work Plan Chemical as a stand-alone document 
to facilitate public and stakeholder input prior to conducting further 
risk analysis. EPA believes publishing problem formulations and initial 
assessments for TSCA Work Plan Chemicals will increase transparency 
about EPA's thinking and analysis process, provide opportunity for the 
public and stakeholders to comment on EPA's approach and provide the 
opportunity to receive additional information/data to supplement or 
refine the assessment approach prior to EPA conducting detailed risk 
analysis and risk characterization.

DATES: Comments must be received on or before June 29, 2015.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2015-0078, 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 generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical 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; 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?

    This action is directed to the public in general, and may be of 
interest to a

[[Page 23546]]

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.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. What action is the Agency taking?

    EPA is announcing that it will be publishing a problem formulation 
and initial assessment or data needs assessment document for each TSCA 
Work Plan Chemical prior to conducting further risk analysis. Based on 
experience in conducting TSCA Work Plan Chemical assessments to date 
and stakeholder feedback, starting in 2015 EPA will publish a problem 
formulation and initial assessment or data needs assessment document 
for each TSCA Work Plan Chemical as a stand-alone document. A problem 
formulation and initial assessment document will serve to inform the 
public and other interested stakeholders about EPA's initial scoping of 
findings and plan for any further risk assessment. Problem formulation 
and initial assessment is the analytical phase of the assessment in 
which the purpose for the assessment is articulated, the problem 
defined and a plan for analyzing and characterizing risk is determined.
    Outcomes of a problem formulation and initial assessment are: (a) 
Conceptual Model--including a visual representation and written 
description of actual or predicted relationships between chemicals and 
human or wildlife; (b) Analysis Plan--describing the intentions 
regarding the technical aspects of the risk assessment. In some 
instances, as a result of problem formulation and initial assessment, 
EPA identifies data gaps (uses, exposure pathways, toxicity data) so 
significant as to prevent conducting a meaningful risk assessment. In 
these cases, EPA will publish a Data Needs Assessment document and 
provide opportunity for the public and stakeholders to comment, 
identify or provide data or information that may fill identified data 
gaps prior to EPA pursing data collection via TSCA authorities.
    To facilitate public and stakeholder input prior to conducting 
further risk analysis, EPA will open a public docket for receiving 
comments, data or information from interested stakeholders when it 
publishes each problem formulation and initial assessment or data needs 
assessment document. EPA believes publishing problem formulation and 
initial assessment documents for TSCA Work Plan Chemicals will increase 
transparency of EPA's thinking and analysis process, provide 
opportunity for the public and stakeholders to comment on EPA's 
approach and provide additional information or data to supplement or 
refine assessment approaches prior to EPA conducting detailed risk 
analysis and risk characterization. Following receipt of comments on 
the problem formulation and initial assessment document and 
consideration of any additional data or information received, EPA will 
initiate a risk assessment which is the process to estimate the nature 
and probability of adverse health and environmental effects in humans 
and ecological receptors from chemical contaminants that may be present 
in the environment.
    EPA is also announcing the availability of the TSCA Work Plan 
Chemical Problem Formulation and Initial Assessment for 1,4-Dioxane for 
public comment. 1,4-Dioxane is the first chemical for which EPA is 
releasing a problem formulation and initial assessment document under 
the TSCA Work Plan Chemical Assessment Program. 1,4-Dioxane is a 
chemical that is used primarily as a solvent in the manufacture of 
other chemicals. 1,4-Dioxane is also found as an impurity in anti-
freeze and aircraft deicing fluids and in some consumer products 
[deodorants, shampoos, and cosmetics] (ATSDR 2012; EPA 2006; Mohr 
2001). During problem formulation and initial assessment, EPA reviewed 
previous assessments by EPA and other organizations and additional 
published studies on the exposure and hazard of 1,4-Dioxane. EPA 
examined likely exposure and hazard scenarios based on current 
production, use, and fate information to identify scenarios amenable to 
a risk analysis. The data available and scenarios evaluated for 
conducting a risk assessment are provided in EPA's TSCA Work Plan 
Chemical Problem Formulation and Initial Assessment for 1,4-Dioxane. 
The conclusions of the problem formulation and initial assessment are: 
(a) EPA will further assess potential risks to workers exposed during 
product formulation and use as a cleaning agent; (b) EPA will further 
assess potential risks to workers and consumers exposed during the use 
of TSCA-use products that contain 1,4-Dioxane as a contaminant, such as 
paints, varnishes, adhesives, cleaners and detergents; (c) Risk to the 
general population through inhalation exposure to ambient air emissions 
is estimated to be low; (d) An assessment of risk from exposure through 
drinking water is not needed at this time because 1,4-Dioxane is 
currently being monitored and EPA will determine whether or not 
regulatory action is needed as part of its Regulatory Determination 
Process; (e) Based on the low hazard profile for 1,4-Dioxane to aquatic 
organisms, risks to these organisms are expected to be low. EPA does 
not have the hazard data needed to determine if there are risks to 
sediment and soil organisms. Therefore, further analysis of 
environmental risk is not planned. EPA plans to review and evaluate the 
results of previous exposure assessments and health benchmarks for this 
chemical. As a result, EPA/OPPT will develop margins of exposure and 
cancer risk estimates to evaluate the potential risks from worker and 
consumer exposure to 1,4-Dioxane. Use the docket ID number: EPA-HQ-
OPPT-2015-0078 to locate a copy of the 1,4-Dioxane problem formulation 
and initial assessment document, as well as to submit comments via 
http://www.regulations.gov.

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

    Dated: April 21, 2015.
Wendy C. Hemnett,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2015-09888 Filed 4-27-15; 8:45 am]
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