Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tolerance Petitions for Pesticides on Food/Feed Crops and New Inert Ingredients

This Notice document was issued by the Environmental Protection Agency (EPA)

For related information, Open Docket Folder

[EPA-HQ-OPP-2012-0744; FRL-9531-7]

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


Environmental Protection Agency (EPA).




The Environmental Protection Agency has submitted an Information Collection Request (ICR), Tolerance Petitions for Pesticides on Food/Feed Crops and New Inert Ingredients (EPA ICR No. 0597.11, OMB No. 2070-0024), 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.). This is a proposed extension of the ICR, which is currently approved through July 31, 2013. Public comments were previously requested via theFederal Register(77 FR 69821) on November 21, 2012 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. 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.


Additional comments may be submitted on or before July 22, 2013.


Submit your comments, referencing Docket ID Number EPA-HQ-OPP-2012-0744, to (1) 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 (2) 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 whose disclosure is restricted by statute.

For Further Information Contact

Scott Drewes, Field and External Affairs Division, 7506P, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (703) 347-0107; fax number: (703) 308-5884; email address:

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 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

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.

Under the law, 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, and are subject to seizure by FDA, and may result in civil penalties.

Trade secret or CBI is frequently submitted to EPA in support of a tolerance petition because submissions usually include the manufacturing process, product formulation, and supporting data. When such information is provided to the Agency, the information is protected from disclosure under FIFRA section 10. CBI data submitted to the EPA is handled strictly in accordance with the provisions of the FIFRA Confidential Business Information Security Manual.

Form Numbers: None.

Respondents/affected entities: Entities potentially affected by this ICR include anyone who files a petition asking EPA to take a specific tolerance action. While any entity can file a petition with EPA, petitions typically come from those businesses engaged in the manufacturing of pesticides and the Interregional Research Project No. 4 (IR-4). The NAICS codes for the most frequent type of respondent are 325320 (pesticide and other agricultural chemical manufacturing) and 541600 (management, scientific, and technical consulting services).

Respondent's obligation to respond: Mandatory.

Estimated number of respondents: 137.

Frequency of response: On occasion.

Total estimated burden: 236,800 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost:$21,280,921 (per year). This is the estimated burden cost; there is no cost for capital investment or maintenance and operational costs in this information collection.

Changes in the Estimates: There is an increase of 58,515 hours in the total estimated respondent burden hours compared with the ICR currently approved by OMB. This increase reflects EPA's updating of the burden estimate to account for an increase in the estimated average number of tolerance petitions submitted annually from 103 to 137, which resulted in a change to the annual burden hours for respondents from 178,285 in the previous renewal to 236,800 in the current renewal. This change is an adjustment.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2013-14749 Filed 6-19-13; 8:45 am]
Comment Period Closed
Jul 22 2013, at 11:59 PM ET
ID: EPA-HQ-OPP-2012-0744-0018
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Date Posted: Jun 20, 2013
Federal Register Number: 2013-14749
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