In accordance with 5 CFR 1320, the information collection is approved for three years. Prior to the next renewal, OMB requests that EPA evaluate and begin efforts to implement the received public feedback (e.g., allow all forms to be prepared and submitted electronically, allow electronic signature on all forms, reconsider the use of Forms 8570-36 and 8570-37). Refreshing the initial Terms of Clearance, under this approval, DCIs must be approved by high-level management (Deputy Division Director or above). Before EPA may issue a specific DCI under this approval, EPA must submit the DCI to OMB, and OMB must approve the DCI. The information sent to OMB must include basic information on the pesticide, the total number of respondents, the planned schedule for issuance and data submission, a list of required studies, the practical utility of the data, and an estimate of the paperwork burden and testing costs. OMB may request that EPA provide additional information as necessary to explain the basis for the DCI. OMB may also request that EPA issue a FR notice seeking public comment on the DCI. OMB does not commit to expedited review of a requested DCI, and OMB does not authorize EPA to proceed with a DCI automatically after a fixed number of days. Based on its review, OMB may determine that a requested DCI does not comply with the requirements in 5 CFR 1320 and may either return the request to EPA for reconsideration or disapprove the request. EPA may not issue the returned DCI until addressing the issues raised, resubmitting the request, and receiving OMB approval.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
12/31/2025
36 Months From Approved
12/31/2022
283
0
472
3,274,852
0
58,206
0
0
0
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.
Form 6300-3, 6300-4 Data Call-in Response, Requirements Status and Registrant's Response
2288ss04.docx
Attachment A.pdf
DCI for Streptomycin Sulfate