SUPPLEMENTARY INFORMATION:

I. What Should I Consider when I Prepare My Comments for EPA?

A. Considerations Under the PRA

Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits comments and information to enable it to:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility.

2. Evaluate the accuracy of the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.

3. Enhance the quality, utility, and clarity of the information to be collected.

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

B. Tips for Preparing Your Comments

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible and provide specific examples.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Offer alternative ways to improve the collection activity.

7. Make sure to submit your comments by the deadline identified under DATES .

8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

C. Submitting CBI

Do not submit CBI to EPA through regulations.gov or e-mail. 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.

II. What Information Collection Activity or ICR Does this Action Apply to?

Affected entities: Entities potentially affected by this action are those individuals and companies that receive an EDSP test order issued by the Agency. Under the Federal Food, Drug, and Cosmetic Act (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.” Using the North American Industrial Classification System (NAICS) codes, the Agency has ( printed page 70841) determined that potential respondents to this ICR may include, but is not limited to: Chemical manufacturers and processors (NAICS code 325); Pesticide, fertilizer, and other agricultural chemical manufacturing (NAICS code 3253); Producers and formulators of pesticide products (NAICS code 32532); Producers of antifouling paints (NAICS code 32551); Producers of antimicrobial pesticides (NAICS code 32561); Producers of nitrogen stabilizers (NAICS code 32531); and Producers of wood preservatives (NAICS code 32519).

Title: Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP).

ICR numbers: EPA ICR No. 2249.01, OMB Control No. 2070-new.

ICR status: This ICR is for a new information collection activity. 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. The OMB control number for this ICR will be displayed by publication in the Federal Register and by inclusion of a Paperwork Reduction notice on the related collection instrument, i.e., test order and/or form.

Abstract: This new ICR covers the information collection activities associated with Tier 1 screening of the first group of chemicals under the EDSP. The EDSP is established under section 408(p) of the FFDCA, which requires endocrine screening of all pesticide chemicals and was established in response to growing scientific evidence that humans, domestic animals, and fish and wildlife species have exhibited adverse health consequences from exposure to environmental chemicals that interact with their endocrine systems.

The EDSP, which was established in 1998, consists of a two-tiered approach to screen all pesticide chemicals for potential endocrine disrupting effects. The purpose of Tier 1 screening (referred to as “screening”) is to identify substances that have the potential to interact with the estrogen, androgen, or thyroid hormone systems using a battery of assays. The purpose of Tier 2 testing (referred to as “testing”), therefore, is to identify and establish a dose-response relationship for any adverse effects that might result from the interactions identified through the Tier 1 assays. Additional information about the EDSP is available through the Agency's web site at https://www.epa.gov/​scipoly/​oscpendo/​index.htm.

EPA is currently implementing the EDSP in three major parts that are being developed in parallel and with substantial work on each well underway: 1) Assay validation; 2) Priority setting; and 3) Procedures. This ICR is related to the third component of the EDSP, i.e., the procedures for Tier 1 screening. This ICR is not intended to cover all of the activities currently underway for the EDSP. Instead, the focus of this ICR is on the information collection activities associated with the Tier 1 screening of the 73 chemicals identified for initial screening under the EDSP. A separate ICR will be developed to address the information collection activities associated with Tier 2 testing. In addition, subsequent Tier 1 screening of additional chemicals not selected for the initial round will be addressed in a future ICR, either when this ICR is amended in three years or in a separate ICR. In either case, EPA will follow the notice and comment process prescribed by the PRA to first seek public comment on the ICR before submitting it to OMB for review and approval under the PRA.

Burden statement: The annualized public reporting and recordkeeping burden for this collection of information is estimated to average 2,649 hours per response, although individual respondent burden varies based on their individual activities. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal Agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements which have subsequently changed; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

The ICR, a copy of which is available in the docket, provides a detailed explanation of this estimate, which is only briefly summarized here:

Estimated total number of potential respondents: 445.

Frequency of response: On occasion.

Estimated total average number of responses for each respondent: Two responses per chemical: An initial response and the final data submission. All respondents will provide an initial response, while only those that generate the data will complete the final data submission.

Estimated total annual burden hours: 93,655 hours.

Estimated total annual costs: $6,887,418. This includes an estimated annualized cost of $267 for non-burden hour or delivery costs.

III. What is the Next Step in the Process for this ICR?

EPA will consider the comments received and amend the ICR as appropriate. Although included as attachments to the ICR, EPA has issued a separate Federal Register document to solicit public review and comments on the related draft policy describing the procedures for responding to the 408(p) order, and the draft template for the 408(p) order itself. In addition to considering comments submitted on the ICR, EPA will also consider comments received on those documents in response to that separate solicitation. Changes to those documents may result in changes to the ICR as well. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the person listed under FOR FURTHER INFORMATION CONTACT .

72 FR 70839