[Federal Register Volume 78, Number 115 (Friday, June 14, 2013)]
[Notices]
[Pages 35903-35904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-14233]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2013-0275; FRL-9529-9]


Information Collection Request Submitted to OMB for Review and 
Approval; Comment Request; ICR Addendum for the Second List of 
Chemicals; Tier 1 Screening of Certain Chemicals Under the Endocrine 
Disruptor Screening Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has submitted the following Information Collection Request 
(ICR) to the Office of Management and Budget (OMB) for review and 
approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 
et seq.): ``ICR Addendum for the Second List of Chemicals; Tier 1 
Screening of Certain Chemicals Under the Endocrine Disruptor Screening 
Program (EDSP)'' (EPA ICR No. 2488.01, OMB Control No. 2070--[new]). 
This is a new ICR that will amend an ICR that is currently approved 
under OMB Control No. 2070-0176 (EPA ICR No. 2249) and that covers the 
first list of chemicals. The ICR, which is abstracted below, describes 
the nature of the information collection activity and its expected 
burden and costs.

DATES: Submit comments on or before July 15, 2013.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OPPT-2013-0275, to (1) EPA online using http://www.regulations.gov (our 
preferred method) or by mail to: Pollution Prevention and Toxics 
Docket, Environmental Protection Agency Docket Center (28221T), 1200 
Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to 
[email protected] (address your comments to the OMB Desk 
Officer for EPA).
    EPA's policy is that all comments received will be included in the 
public docket without change including any personal information 
provided, unless the comment includes profanity, threats, information 
claimed to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Pat West, (7203M), Office of Science 
Coordination and Policy (OSCP), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-1656; fax number: (202) 564-8482; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail 
the information that the EPA will be collecting are available in the 
public docket for this ICR. The docket can be viewed online at 
www.regulations.gov or in person at the EPA Docket Center, EPA West, 
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone 
number for the Docket Center is 202-566-1744. For additional 
information about EPA's public docket, visit http://www.epa.gov/dockets.
    EPA received several comments in response to its solicitation of 
comments pursuant to 5 CFR 1320.8(d) in the Federal Register issue of 
November 17, 2010 (75 FR 70569). The ICR submitted to OMB includes 
EPA's responses, and reflects revisions made in response to those 
comments. Please note that when comments were sought in 2010, the draft 
ICR was identified under EPA ICR No. 2249.02 and OMB Control No. 2070-
0176, and comments were directed to Docket ID No. EPA-HQ-OPPT-2007-
1081, which had been established for the initial ICR related to List 1 
chemicals. Given the resulting confusion in finding documents in that 
docket, EPA has established a new docket, which is linked to the old 
docket.
    ICR Status: This is an addendum to an existing ICR that is 
currently approved under OMB Control No. 2070-0176 (EPA ICR No. 2249), 
covering the first list of chemicals screened under the EDSP. Under OMB 
regulations, the Agency may continue to conduct or sponsor an approved 
collection of information while this submission is pending at OMB. In 
this case, this applies to the activities associated with the chemicals 
on List 1, but not those associated with the chemicals on List 2. Under 
the PRA, an agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.
    Abstract: This ICR covers the information collection activities 
associated with Tier 1 screening of the List 2 Chemicals under EPA's 
EDSP. List 2 consists of 109 identified chemicals, 41 of which are 
pesticide active ingredients (PAIs) and 68 are chemicals identified 
under the Safe Drinking Water Act (SDWA). The EDSP is established under 
section 408(p) of the Federal Food, Drug and Cosmetic Act (FFDCA) (21 
U.S.C. 346a(p)), which requires EPA to develop a chemical screening 
program using appropriate validated test systems and other 
scientifically relevant information to determine whether certain 
substances

[[Page 35904]]

may have hormonal effects. The EDSP consists of a two-tiered approach 
to screen chemicals for potential endocrine disrupting effects. The 
purpose of Tier 1 screening is to identify substances that have the 
potential to interact with the estrogen, androgen, or thyroid hormone 
systems using a battery of assays. Substances that have the potential 
to interact with estrogen, androgen or thyroid systems may proceed to 
Tier 2, which is designed to identify any adverse endocrine-related 
effects caused by the substance, and establish a quantitative 
relationship between the dose and that endocrine effect. Additional 
information about the EDSP is available at http://www.epa.gov/endo.
    This ICR addendum covers the information collection activities and 
burden associated with issuing orders, generating and collecting data 
for List 2 Chemicals. The information collection activities otherwise 
remain the same as those described in the existing ICR that covers EDSP 
Tier 1 screening of List 1 Chemicals, with a few modifications that are 
necessary to address procedural differences that apply to SDWA 
chemicals. The Agency is also establishing an electronic mechanism for 
these activities to reduce burden and increase efficiencies.
    Form Numbers: EPA form numbers 6300-05; 6300-05-C; 6300-06; and 
6300-06-C.
    Respondents/Affected Entities: Entities potentially affected by 
this ICR are those who receive an EDSP test order issued by the Agency 
because they are a registrant or manufacturer/importer of a chemical 
substance identified on List 2. Under FFDCA section 408(p)(5)(A), EPA 
``shall issue'' EDSP test orders ``to a registrant of a substance for 
which testing is required . . . or to a person who manufactures or 
imports a substance for which testing is required.''
    Respondent's Obligation to Respond: Mandatory under FFDCA section 
408(p).
    Estimated Number of Respondents: 1,000.
    Frequency of Response: On occasion.
    Estimated Burden: The per response burden is estimated to range 
between 204 and 4,729 hours, depending on the respondent category and 
activities. The total annualized burden is estimated to be 296,820 
hours. Burden is defined at 5 CFR 1320.03(b).
    Estimated Cost: The per response cost is estimated to range between 
$18,842 and $297,171, depending on the respondent category and 
activities. The total annualized cost is estimated to be $21,054,546. 
This includes $400 for non-labor costs related to mailing the 
submissions. Delivery of paper submissions will be eliminated with the 
full implementation of the electronic system.
    Changes in Burden Estimates: This represents an increase of 296,820 
hours in the total estimated annualized burden compared with that 
currently approved by OMB. This is a program change that reflects the 
planned issuance of Tier 1 orders for List 2 chemicals to be screened 
under Tier 1 of the EDSP.

    Dated: June 4, 2013.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2013-14233 Filed 6-13-13; 8:45 am]
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