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 pesticideâs registration, which assess if the continued registration of a pesticide causes an unreasonable adverse effect on human health or the environment.
Estimates of burden hours and costs are substantially larger than in the most recent ICR. This is primarily 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. The Agency has corrected this error and is now reporting annual total burden hours and costs throughout this ICR. Additionally, 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 these errors and this ICR represents an increase of 2,649,183 hours (3,274,852 â 625,669) in the total estimated annualized burden compared with what is currently approved by OMB. The burden increase is a result of several factors, including an increase in DCIs issued annually (Previous to Current Numbers), the addition of high-test costs for certain DCIs, and an increase in non-government wage rates. All these activities have contributed to the significant increase in burden.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
#13- DCIs for Percent Crop Treated Estimates