Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Pesticides Data Call-In (DCI) Program

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The Environmental Protection Agency has submitted an information collection request (ICR), Pesticides Data Call-In (DCI) Program (EPA ICR Number 2288.04, OMB Control Number 2070-0174) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through November 30, 2021. Public comments were previously requested via the Federal Register on March 31, 2021 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.

DATES:

Additional comments may be submitted on or before December 27, 2021.

ADDRESSES:

Submit your comments to EPA, referencing docket ID No. EPA-HQ-OPP-2020-0693, online using www.regulations.gov (our preferred method) or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all comments received will be included in the 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.

Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:

Carolyn Siu, Mission Support Division (7101M), Office of Program Support, Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (703) 347-0159; email address: siu.carolyn@epa.gov.

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, WJC 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.

Abstract: This ICR covers the information collection activities associated with the issuance of DCIs under section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA regulates the use of pesticides under the authority of two federal statutes: FIFRA (7.U.S.C. 136 et seq. ) and the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 346). In general, before manufacturers can sell pesticides in the United States, EPA must evaluate the pesticides thoroughly to ensure that they meet federal safety standards to protect human health and the environment. EPA grants a “registration” or license that permits a pesticide's distribution, sale, and use only after the company meets the scientific and regulatory requirements.

In evaluating a pesticide registration application, EPA assesses a wide variety of potential human health and environmental effects associated with the use of the product. Applicants, or potential registrants, must generate or provide the scientific data necessary to address concerns pertaining to the identity, composition, potential adverse effects, and environmental fate of each pesticide. The data allow EPA to evaluate if a pesticide has the potential to cause harmful effects on certain non-target organisms and endangered species, and on surface or ground water.

Through a scientific and public process, EPA specifies the kinds of data and information necessary to make regulatory judgments about the risks and benefits of pesticide products under FIFRA sections 3, 4 and 5, as well as the data and information needed to determine the safety of pesticide chemical residues under FFDCA section 408. The regulations in 40 CFR part 158 describe the minimum data and information EPA typically requires in an application for pesticide registration or amendment; reregistration of a pesticide product; maintenance of a pesticide registration by means of the DCI process ( e.g., as used in the registration review program); or to establish or maintain a tolerance or exemption from the requirements of a tolerance for a pesticide chemical residue. EPA uses the DCIs issued under this ICR to acquire the data necessary for its statutorily mandated review of a pesticide's registration, which assess if the continued registration of a pesticide causes an unreasonable adverse effect on human health or the environment.

Form Numbers: EPA Form No. 8570-4, 8574-27, 8570-28, 8570-32, 8579-34, 8570-35, 8570-36, 8570-37, 6300-3, and 6300-4.

Respondents/affected entities: Pesticide registrants.

Respondent's obligation to respond: Mandatory under FIFRA section 3(c)(2)(B).

Estimated number of respondents: 122 (total).

Frequency of response: On occasion.

Total estimated burden: 3,227,892 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $254,539,344 (per year), includes $0 annualized capital or operation & maintenance costs.

Changes in the Estimates: Due to an error in past ICRs where annual totals were misreported as 3-year totals underestimating the total approved burden hours and costs by a factor of 3. Also, due to a clerical error, a burden of 58,206 hours was approved rather than the submitted 625,669 burden hours from the currently approved ICR by OMB. The Agency has corrected this error and there is an increase of 2,649,183 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This increase is due to an increase of DCIs issued over the next three years from 663 to 802, that will require data generation thus raising the average of DCIs issued annually from 221 to 267. Other factors are the addition of high-test costs for certain DCIs, and an increase in non-government wage rates. This is a program adjustment and correction.