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Agency Information Collection Activities; Submitted to OMB for Review and Approval; Comment Request; Tolerance Petitions for Pesticides on Food or Feed Crops and New Food Use Inert Ingredients

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Information about this document as published in the Federal Register.

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Environmental Protection Agency (EPA).




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: “Tolerance Petitions for Pesticides on Food or Feed Crops and New Food Use Inert Ingredients” (EPA ICR No. 0597.12, OMB Control No. 2070-0024). This is a request to renew the approval of an existing ICR, which is currently approved through August 31, 2016. EPA did not receive any comments in response to the previously provided public review opportunity issued in the Federal Register of December 24, 2015 (80 FR 80357). With this submission, EPA is providing an additional 30 days for public review.


Comments must be received on or before September 28, 2016.


Submit your comments, identified by Docket ID Number EPA-HQ-OPP-2015-0715, to both EPA and OMB as follows:

To EPA online using (our preferred method) or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460, and

To OMB via email to Address comments to 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 for which disclosure is restricted by statute.

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Amaris Johnson, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (703) 305-9542; email address:

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Docket: Supporting documents, including the ICR that explains in detail the information collection activities and the related burden and cost estimates that are summarized in this document, are available in the docket for this ICR. The docket can be viewed online at or in person at the EPA Docket Center, West William Jefferson Clinton Bldg., Rm. 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​dockets.

ICR status: This ICR is currently scheduled to expire on August 31, 2016. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB.

Under PRA, 44 U.S.C. 3501 et seq., 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 numbers are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.

Abstract: The use of pesticides to increase crop production often results in pesticide residues in or on the crop. To protect the public health from unsafe pesticide residues, EPA sets limits on the nature and level of residues permitted pursuant to section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA). A pesticide may not be used on food or feed crops unless the Agency has established a tolerance (maximum residue limit) for the pesticide residues on that crop or established an exemption from the requirement to have a tolerance.

EPA is responsible for ensuring that the maximum residue levels likely to be found in or on food/feed are safe for human consumption through a careful review and evaluation of residue chemistry and toxicology data. In addition, EPA must ensure that adequate enforcement of the tolerance can be achieved through the testing of submitted analytical methods. If the data are adequate for EPA to determine that there is a reasonable certainty that no harm will result from aggregate exposure, the Agency will establish the tolerance or grant an exemption from the requirement of a tolerance.

This ICR only applies to the information collection activities associated with the submission of a petition for a tolerance action. While EPA is authorized to set pesticide tolerances, the Food and Drug Administration (FDA) is responsible for their enforcement. Food or feed commodities found to contain pesticide residues in excess of established tolerances are considered adulterated, are subject to seizure by FDA, and may result in civil penalties.

Form Numbers: None.

Respondents/affected entities: Pesticide manufacturers, IR-4, and similar entities.

Respondent's obligation to respond: Mandatory under FIFRA section 408.

Estimated number of respondents: 165 (total).

Frequency of response: On occasion.

Total estimated burden: 285,128 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $27,475,223.58 (per year), there is no cost for capital or operation & maintenance costs.

Changes in the estimates: There is an increase of 48,328 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This increase is a result of a change in the estimated average number of tolerance petitions submitted annually (from 137 to 165), which changes the annual burden hours for respondents. There is no change in the per tolerance petition burden. This change is an adjustment.

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Authority: 44 U.S.C. 3501 et seq.

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Courtney Kerwin,

Director, Regulatory Support Division.

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[FR Doc. 2016-20598 Filed 8-26-16; 8:45 am]