(d) Opinions of experts qualified in the fields involved.

§ 363.8 Basis for determination of usefulness.

Usefulness of a pesticide chemical for the purposes intended will be determined upon the basis of its practical pesticidal, or biological, effectiveness. Pesticidal effectiveness may be established in terms of percentage reduction or control of pests or, when appropriate, increase in yield or quality of crop following application of the specified pesticide under the conditions prescribed, compared with the results from adequate controls. Consideration may also be given to other economic gain or practical benefit, including: Economy or ease of production, harvest, or storage of crop; flexibility as regards the time of planting or harvest, even at the possible sacrifice of yield; and general benefit to livestock, plants, or human welfare. § 363.9 Proposed certification; notice; request for hearing.

(a) If, upon the basis of the data before him, it appears to the Director that the pesticide chemical is not useful for the purpose or purposes for which a tolerance or exemption is sought, or is useful for only some of the purposes for which a tolerance or exemption is sought, the Director shall notify the person requesting the certification of his proposal to so certify to the Department of Health, Education, and Welfare. Notice of such proposed certification will be given by registered mail.

(b) Within one week after receipt of such notice of proposed certification the person requesting the certification may, by filing a request with the Director, (1) request that the certification be made on the basis of the proposed certification; (2) request a hearing on the proposed certification or the parts objected to; (3) request both such certification and such hearing; or (4) withdraw the request for certification as provided for in § 363.10. If no such request or withdrawal is filed with the Director within such time, the certification will be made as proposed. § 363.10 Withdrawal of request for certification pending clarification or completion.

In some cases it may be necessary for the Director to notify the petitioner of his proposal to certify that the pesticide chemical does not appear to be useful for some or all of the purposes

for which a tolerance or exemption is sought only because the data submitted by the petitioner are not sufficiently clear or complete to justify a finding of usefulness. In such cases the petitioner may withdraw his request for certification pending its clarification or the obtaining of additional data, and no further action will be taken with respect to the making of the certification until the request for certification is resubmitted. Upon the resubmission of the request for certification, the time limitation within which final certification is required to be made will begin to run anew from the date of the resubmission.

§ 363.11

Registration under the Federal Insecticide, Fungicide, and Rodenticide Act.

(a) Since in most cases where a pesticide chemical may leave a residue in or on a raw agricultural commodity there can be no determination of the adequacy of the directions for use or the warning or caution statements appearing on the labeling of an economic poison until a tolerance or exemption has been established for the pesticide chemical which is, or is a part of, such economic poison, it will not ordinarily be possible to register the economic poison under the Federal Insecticide, Fungicide, and Rodenticide Act until such tolerance or exemption has been established.

(b) Factors other than pesticidal, or biological, effectiveness are considered in the granting of registration under the Federal Insecticide, Fungicide, and Rodenticide Act. Therefore, the criteria for registration are not all applied in considering the certification of usefulness, and the fact that such a certification has been made does not mean that the economic poison can be registered for the uses concerned.

§ 363.12 Opinion as to residue.

(a) In forming an opinion whether the tolerance or exemption proposed by the petitioner reasonably reflects the amount of residue likely to result when the pesticide chemical is used in the manner proposed, consideration will be given, among other things, to:

(1) Data furnished by the petitioner showing (i) the results of tests to ascertain the amount of residue remaining, including a description of the analytical methods used, and (ii) practicable methods for removing residue which exceeds any proposed tolerance;

(2) Reports of other experimental work before the Director in publications, the official files of the Department, or otherwise;

(3) Opinions of experts qualified in the fields involved.

(b) If a tolerance proposed by the petitioner is reasonably to reflect the amount of residue likely to result when a pesticide chemical is used, it must be large enough to include all residue which is likely to result when the pesticide chemical is used in the manner proposed by the petitioner, but not larger than needed for this purpose. The tolerance proposed by the petitioner may take into account reduction of residue by washing, brushing, or other applicable method.

(c) If there is insufficient information before the Director to support an opinion as to whether the tolerance proposed by the petitioner reasonably reflects the amount of residue likely to result, the opinion will so state.

ARS will maintain and make available at each office for public inspection and copying a current index providing identifying information for staff manuals and instructions, related forms, and other matters issued, adopted, or promulgated with respect to programs for which it has responsibility, and which are required to be made available pursuant to 5 U.S.C. 552(a)(2).

§ 370.5 Facilities for inspection and copies.

Facilities for public inspection and copying of the material described in the foregoing sections will be provided in a reading area by ARS. Addresses are listed below. Copies of such material may also be obtained in person or by mail. Applicable fees are prescribed by the Director, Office of Plant and Operations, USDA.

I. Farm Research-Material farm research programs:

concerning

Deputy Administrator for Farm Research, ARS, Room 324-A, Administration Building, 14th and Independence Avenue SW., Washington, D.C. 20250.

II. Nutrition, Consumer and Industrial Use Research-Material concerning research and development programs to provide new, wider, and more effective uses for agricultural products and byproducts:

Deputy Administrator, Nutrition Consumer and Industrial Use Research, ARS, Room 310-A, Administration Building, 14th and Independence Avenue SW., Washington, D.C. 20250.

III. Marketing Research-Material involving the research programs concerning the improvement and protection of quality and efficient handling of agricultural products as they pass through the marketing system: Deputy Administrator, Marketing Research, ARS, Room 359-A, Administration Building, 14th and Independence Avenue SW., Washington, D.C. 20250.

IV. Regulatory and Control-Material concerning regulatory and control programs covering animal and plant pests and diseases: Deputy Administrator, Regulatory and Control, ARS, Room 302-E, Administration Building, 14th and Independence Avenue SW., Washington, D.C. 20250.

V. Administrative Management-Material concerning administrative management activities:

Deputy Administrator, Administrative Management, ARS, Room 304-A, Administration Building, 14th and Independence Avenue SW., Washington, D.C. 20250.

VI. Foreign Research and Technical Activities-Materials concerning foreign research contract and grant activities for the Department carried out by foreign governments and scientific organizations under Public Law 480 and related legislation:

Director, Foreign Research and Technical Programs Division, ARS, Room 344-A, Administration Building, 14th and Independence Avenue SW., Washington, D.C. 20250. VII. Information Division-Published material concerning research and regulatory activities, including press releases, special articles, periodicals:

Director, Information Division, ARS, Room 5133, South Agriculture Building, 14th and Independence Avenue SW., Washington, D.C. 20250.

Subpart B-Disclosure of Identifiable Records

§ 370.10 Requests.

Requests for ARS records, pursuant to 5 U.S.C. 552(a) (3), shall (a) be made in writing to the appropriate Deputy Administrator or Division Director responsible for the program (30 F.R. 5799, April 24, 1965, as amended) and (b) identify each record sought with reasonable specificity. Requests may be submitted in person or by mail.

The above does not preclude persons from requesting such material in person, or in writing, directly from a field office,

if it has been customary to obtain the information in this matter and the request is made during the local working hours of the office involved.

§ 370.11 Delegation of authority.

Subject to section 370.15, the Deputy Administrators or the Directors of the Information or Foreign Research and Technical Programs Division are authorized to act, on behalf of ARS, on all such requests in accordance with 5 U.S.C. 552, as implemented by this subpart. § 370.12 Available records.

ARS will promptly make available all ARS records requested in accordance with section 370.10 except exempt records as described in section 370.13.

§ 370.13 Exempt records.

Exempt records of ARS include the following:

(a) Matters specifically required by executive order to be kept secret.

(b) Matters related solely to the internal personnel rules and practices of the agency.

specifically

(c) Matters exempted from disclosure by statute. This would include but would not be limited to:

(1) Section 3c(4) of the Federal Insecticide, Fungicide, and Rodenticide Act, prohibiting the disclosure of information relative to formulas of products acquired by authority of section 4 of the Act.

(d) Matters that are trade secrets and commercial or financial information obtained from a person and privileged or confidential. This would include but would not be limited to:

(1) Scientific and technical data on products or processing methods submitted by contractor, grantee, cooperator and manufacturer or processor.

(2) Data in research studies including information on commercial facilities and procedures where disclosure would adversely affect the respondent.

(3) Records concerning research project descriptions, progress reports or information concerning incomplete research prior to formal publication when such release would adversely affect the public interest.

(4) Data on products, sales, manufacturing or processing methods (includes data on plants, animals or animal byproducts, being moved by permit or license, etc.) from manufacturers or processors, licensee, registrant, permittee and laboratory or field tests.

(5) Data relating to disease outbreak identifying suspect or related animal, owner, source of outbreak, etc.

(e) Interagency or intraagency memorandums or letters which would not be available by law to a party other than an agency in litigation with the agency. This would include but would not be limited to:

(1) Records involving any pending or expected claim actions against the Government resulting from property damage or personal injury.

(2) Records involving pesticide accidents resulting from plant pest control programs.

(3) Documents covering agency plans which may be subject to revision before presentation.

(4) Reports of internal deliberations where premature release could harm the authorized and appropriate purpose for which they are being used.

(5) Preparatory budget material.

(f) Personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. This would include but would not be limited to:

(1) Records regarding revocation of accreditation of veterinarians to conduct tests on animals and poultry diseases.

(g) Investigatory files compiled for law enforcement purposes except to the

The denial of any request for an ARS record or records may be appealed by the person who made the request to the Administrator of ARS. The appeal shall be made in writing within 30 days. The Administrator will give written notice of ARS' final determination.

§ 370.16 Inspection and copies.

A person who has requested available records shall be promptly notified that upon payment of applicable fees, he may inspect and copy such records (or copies) and purchase copies or extracts thereof, in the office, listed under section 370.5, on business days from 9:30 a.m. to 5 p.m. Copies of such records may also be purchased by mail. The applicable fees are prescribed by the Director, Office of Plant and Operations, USDA.

and in counties within limits prescribed by and in accordance with the provisions of the Federal Crop Insurance Act, as amended. The crops and counties shall be designated by the Manager of the Corporation from those approved by the Board of Directors of the Corporation. Before insurance is offered in any county, there shall be published by appendix to this section the name of the county and the crops on which insurance will be offered.

§ 401.102 Premium rates, production guarantees or amounts of insurance, and prices at which indemnities shall be computed and insurable crops. (a) The Manager shall establish (1) premium rates, (2) production guarantees or amounts of insurance, and (3) when applicable, prices at which indemnities shall be computed for each crop which is insurable in a county, and for combined crop insurance. Such premium rates, production guarantees or amounts of insurance, prices at which indemnities shall be computed, and insurable crops