(g) "Certification" means a certification by the Director that a pesticide chemical is useful for the purpose for which a tolerance or exemption is sought under the act.

(h) "Petition" means a petition filed with the Administrator, Environmental Protection Agency pursuant to section 408(d)(1) of the act.

§ 163.3 Administration.

The Director is authorized to take such action as, in his discretion, may be necessary to carry out the provisions of sections 408(i) and 408(1) of the act and the regulations in this part.

§ 163.4 Filing of requests for certification.

All requests for a certification shall be made in writing to the Director. Action upon such a request will not be undertaken unless (a) the person making the request has, pursuant to the provisions of the Federal Insecticide, Fungicide, and Rodenticide Act, registered or submitted an application for the registration of an economic poison consisting of or containing the pesticide chemical for which the certification is sought and (b) the request is accompanied by a copy of the petition. The person requesting certification may at any time withdraw such request for certification.

§ 163.5 Material in support of the request for certification.

In addition to the data required by section 408(d)(1) of the Act to be inIcluded in the petition, the request for certification should be supported by the following material, to the extent it is relied upon by the petitioner:

(a) A complete report of the results of any experimental work by the petitioner on the effectiveness of the pesticide chemical for the purposes intended;

(b) Data relating to the usefulness of the pesticide chemical obtained by other qualified investigators;

(c) Any other material which the petitioner believes will justify a finding of usefulness.

If such material is fully shown in the petition, it need not be set forth separately in the request for certification.

8 163.6 Certification limited to economic

poison uses. If the product for which a certification is sought is intended for both economic poison and noneconomic poison uses, any certification relative to the usefulness of such product will refer only to economic poison uses. No action will be taken with respect to the noneconomic poison uses of such product.

8 163.7 Factors considered in determining

usefulness. In determining whether a pesticide chemical is useful for the purposes for which a tolerance or exemption is sought, consideration will be given, among other things, to:

(a) The results of any experimental work by the petitioner on the effectiveness of the pesticide chemical for the purposes intended.

(b) Data relating to the usefulness of the pesticide chemical obtained by other qualified investigators.

(c) Reports of other experimental work before the Director in publications, the official files of the Agency, or otherwise.

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

§ 163.9 Proposed certification; notice; re

quest 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. 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 Di. rector, (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 § 163.10. If no such request or withdrawal is filed with the Director within such time, the certification will be made as proposed.

§ 163.8 Basis for determination of useful

ness.

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.

$ 163.10 Withdrawal of request for certifi

cation pending clarification or comple

tion. 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.

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.

$ 163.11 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.

PART 164-RULES OF PRACTICE

GOVERNING HEARINGS, UNDER THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT, ARISING FROM REFUSALS TO REGISTER, CANCELLATIONS OF REGISTRATIONS, CHANGES OF CLASSIFICATIONS, SUSPENSIONS OF REGISTRATIONS AND OTHER HEARINGS CALLED PURSUANT TO SECTION 6 OF THE ACT

Subpart A-General

Sec. 164.1 Number of words. 164.2 Definitions. 164.3 Scope and applicability of this part. 164.4 Arrangements for examining Agency

records, transcripts, orders, and deci

sions. 164.5 Filing and service. 164.6 Time. 164.7 Ex parte discussion of proceeding. 164.8 Publication.

Subpart B-General Rules of Practice Concern

ing Proceedings (Other Than Expedited Hearings)

8 163.12 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 (1) 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 Agency, 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

COMMENCEMENT OF PROCEEDING 164.20 Commencement of proceeding. 164.21 Contents of a denial of registration,

notice of intent to cancel a registration, or notice of intent to change a classifica

tion. 164.22 Contents of document setting forth

objections. 164.23 Contents of the statement of issues

to accompany notice of intent to hold a

hearing. 164.24 Response to the Administrator's

notice of intention to hold a hearing. 164.25 Filing copies of notification of

intent to cancel registration or change classification or refusal to register, and statement of issues.

MOTIONS

164.60 Motions.

SUBPOENAS AND WITNESS FEES 164.70 Subpoenas. 164.71 Fees of witnesses.

THE HEARINGS 164.80 Order of proceeding and burden of

proof. 164.81 Evidence. 164.82 Transcripts.

INITIAL OR ACCELERATED DECISION 164.90 Initial decision. 164.91 Accelerated decision.

APPEALS 164.100 Appeals from or review of interloc

utory orders or rulings. 164.101 Appeals from or review of initial

decisions. 164.102 Appeals from accelerated decisions. 164.103 Final decision or order on appeal

or review. 164.110 Motion for reopening hearings; for

rehearing; for reargument of any pro

ceeding; or for reconsideration of order. 164.111 Procedure for disposition of mo

tions.

8 164.2 Definitions.

For the purposes of this part, the following terms shall be defined, as listed below:

(a) The term “Act” means the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (86 Stat. 973) and other legislation supplementary thereto and amendatory thereof.

(b) The term “Administrative Law Judge" means an Administrative Law Judge appointed pursuant to 5 U.S.C. 3105 (see also 5 CFR Part 930, as amended), and such term is synonymous with the term “Hearing Examiner" as used in the Act or in the United States Code.

(c) The term “Administrator" means the Administrator of the Agency, or any officer or employee thereof to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his stead. When used in Subparts B and C of this part, the “Administrator" shall be interchangeable with the term “judicial officer."

(d) The term “Agency,” unless otherwise specified, means the United States Environmental Protection Agency.

(e) The term “Applicant” means any person who has made application to have a pesticide registered or classified pursuant to the provisions of the Act.

(f) The term “Committee" means a group of qualified scientists designated by the National Academy of Sciences according to agreement under the Act to submit an independent report to the Administrative Law Judge on questions of scientific fact

Subpart C-General Rules of Practice for

Expedited Hearings 164.120 Notification. 164.121 Expedited hearing. 164.122 Final order and order of suspen

sion. 164.123 Emergency order. Subpart D-Rules of Practice for Applications

Under Sections 3 and 18 To Modity Previous

Cancellation or Suspension Orders 164.130 General. 164.131 Review by Administrator. 164.132 Procedures governing hearing. 164.133 Emergency waiver of hearing.

referred from a hearing under subpart B of this part.

(g) The term "Expedited Hearing” means a hearing commenced as the result of the issuance of a notice of intention to suspend or the suspension of a registration of a pesticide by an emergency order, and is limited to a consideration as to whether a pesticide presents an imminent hazard which justifies such suspension.

(h) The term "Hearing” means a public hearing which is conducted pursuant to the provisions of Chapter 5, Subchapter II of Title 5 of the United States Code and the regulations of this part.

(i) The term “Hearing Clerk” means the Hearing Clerk, Environmental Protection Agency, Washington, D.C. 20460.

(j) The term "Initial Decision” means the decision of the Administrative Law Judge supported by findings of fact and conclusions regarding all material issues of law, fact, or discretion, as well as reasons therefor. Such decision shall become the final decision and order of the Administrator without further proceedings unless an appeal therefrom is taken or the Administrator orders review thereof as herein provided.

(k) The term “Judicial Officer" means an officer or employee of the Agency designated as a judicial officer, pursuant to these rules, who shall meet the qualifications and perform functions as herein provided.

(1) Office. There may be designated for the Agency one or more judicial officers, one of whom may be Chief Judicial Officer. As work requires, there may be a judicial officer designated to act for the purpose of a particular case. All prior designations of judicial officer shall stay in force until further notice.

(2) Qualification. A judicial officer shall be a permanent or temporary employee or officer of the Agency who may perform other duties for the Agency. Such judicial officer shall not be employed by the Office of Hazardous Materials Control or have any connection with the preparation or presentation of evidence for a hearing.

(3) Functions. The Administrator may delegate any or part of his authority to act in a given case under Subparts B and C of this part to a judicial officer. The Administrator can separately delegate his authority to rule on interlocutory orders and motions, and may also delegate his authority to make findings of fact and draw conclusions of law in a particular proceeding, providing that this delegation shall not preclude the Judicial Of. ficer from referring any motion or case to the Administrator when the Judicial Officer determines such referral to be appropriate. The Administrator, in deciding a case himself, may consult with and assign the preliminary drafting of conclusions of law and findings of fact to any judicial officer.

(1) The term "Party" means any person, group, organization, or Federal agency or department that participates in a hearing.

(m) The term “Person" includes any individual, partnership, association, corporation, and any organized group of persons, whether incorporated or not.

(n) The term “Petitioner" means any person adversely affected by a notice of the Administrator who requests a public hearing.

(0) The term “Presiding Officer" means any person designated by the Administrator to conduct an expedited hearing.

(p) The term “Recommended Decision" means the recommended findings and conclusions of the Presiding Officer in an expedited hearing.

(q) The term “Registrant” means any person who has registered a pesticide pursuant to the visions of the Act.

(r) The term the Assistant

of the Office of HS

Cort) of the A Terms plicit] with t

means

8 164.3

par The part sh