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or complete to justify a finding of use- (3) Opinions of experts qualified in fulness. In such cases the petitioner the fields involved. may withdraw his request for certifica- (b) If a tolerance proposed by the tion pending its clarification or the petitioner is reasonably to reflect the obtaining of additional data, and no fur- amount of residue likely to result when ther action will be taken with respect to a pesticide chemical is used, it must be the making of the certification until the large enough to include all residue which request for certification is resubmitted. is likely to result when the pesticide Upon the resubmission of the request for chemical is used in the manner proposed certification, the time limitation within by the petitioner, but not larger than which final certification is required to be needed for this purpose. The tolerance made will begin to run anew from the proposed by the petitioner may take into date of the resubmission.
account reduction of residue by washing, $ 163.11 Registration under the Fed.
brushing, or other applicable method. eral Insecticide, Fungicide, and Ro
(c) If there is insuficient information denticide Act.
before the Director to support an opinion
as to whether the tolerance proposed (a) Since in most cases where &
by the petitioner reasonably reflects the pesticide che cal may leave a residue
amount of residue likely to result, the in or on a raw agricultural commodity
opinion will so state. there can be no determination of the adequacy of the directions for use or the warning or caution statements appearing
PART 164-RULES GOVERNING THE on the labeling of an economic poison APPOINTMENT, COMPENSATION, until a tolerance or exemption has been AND PROCEEDINGS OF AN AD. established for the pesticide chemical VISORY COMMITTEE; AND RULES which is, or is a part of, such economic
OF PRACTICE GOVERNING HEARpoison, it will not ordinarily be possible to register the economic poison under the
INGS UNDER THE FEDERAL INSECFederal Insecticide, Fungicide, and Ro- TICIDE, FUNGICIDE, AND RODENdenticide Act until such tolerance or TICIDE ACT exemption has been established. (b) Factors other than pesticidal, or
Sec. biological, effectiveness are considered
164.1 Meaning of words. in the granting of registration under the
164.2 Definitions. Federal Insecticide, Fungicide, and Ro- 164.3 Scope and applicability of this part denticide Act. Therefore, the criteria 164.4 Submission of a determination refor registration are not all applied in
specting an economic poison to an considering the certification of useful
adivsory committee, and instituness, and the fact that such a certifica
tion of a hearing regarding the tion has been made does not mean that
application for registration or can.
cellation or suspension of an ecothe economic poison can be registered
nomic poison under the Act. for the uses concerned. § 163.12 Opinion as to residue.
Subpart B Rules Governing the Appointment,
Compensation, and Proceedings of an Advisory (a) In forming an opinion whether the Committee tolerance or exemption proposed by the 164.10 Appointment of advisory committee. petitioner reasonably reflects the amount 164.11 Procedure for advisory committee. of residue likely to result when the pes
Subpart C—Rules of Practice Governing Hearings ticide chemical is used in the manner
Sec. proposed, consideration will be given,
164.20 Docketing of request for hearing. among other things, to:
164.21 Contents of document setting forth (1) Data furnished by the petitioner
objections. showing (1) the results of tests to ascer- 164.22 Filing copies of notification respecttain the amount of residue remaining,
ing registration. including a description of the analytical 164.23 Answer to objections. methods used, and (11) practicable meth
164.24 Motions and requests.
164.25 Intervention. ods for removing residue which exceeds
164.26 Depositions. any proposed tolerance;
164.27 Fees of witnesses. (2) Reports of other experimental
164.28 Consolidation. work before the Director in publications,
164.29 Prehearing conference. the official files of the Agency, or other- 164.30 Qualifications and duties of wise;
Sec. 164.31 Procedure for a public hearing. 164.32 Order of proceeding and burden of
proof. 164.33 Evidence. 164.34 Transcripts. 164.35 Proposed findings of fact, conclu
sions, and order. 164.36 Examiner's report. 164.37 Exceptions, objections, request for
oral argument. 164.38 Argument before the Administrator. 164.39 Final order. 164.40 Ex parte discussion of proceeding. 164.41 Application for reopening hearings;
for rehearing; or reargument of proceeding; or for reconsideration
of order. 164.42 Procedure for disposition of petitions. 164.43 Filing and service. 164.44 Computation and extensions of time.
AUTHORITY: The provisions of this part 164 Issued under secs. 4, 6, 61 Stat. 167–168, as amended; 7 U.S.C. 135b, 135d.
Subpart A-General SOURCE: 36 FR 22535, Nov. 25, 1971, unless otherwise noted. & 164.1 Meaning of words.
As used in this part, words in the singular form shall be deemed to import the plural, and vice-versa, as the case may require. § 164.2 Definitions.
For the purposes of this part, the following terms shall be construed, respectively, to mean:
(a) The term "Act” means the Federal Insecticide, Fungicide, and Rodenticide Act (61 Stat. 163, et seq. as amended, 7 U.S.C. 135-135k).
(b) The term “person" includes any Individual, partnership, associa tion, corporation, or any organized group of persons, whether incorporated or not.
(c) The term "Administrator” means the Administrator of the Environmental Protection Agency of the United States, or any officer or employee of the Environmental Protection Agency to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his stead, including the Judicial Officer of the Environmental Protection Agency.
(d) The term "Hearing Clerk” means the Hearing Clerk, Environmental Protection Agency, Washington, D.C. 20250.
(e) The term "Examiner" means an examiner in the Office of the Hearing Examiners, Environmental Protection Agency.
(f) The term "Examiner's Report" means the report made by the Examiner to the Administrator with respect to proposed:
(1) Findings of fact and conclusions regarding all material issues of fact, law or discretion, as well as the reasons or basis therefor, and
(h) The term "Director" means the Director, Pesticides Regulation Division, Environmental Protection Agency, or any official or employee of the Environmental Protection Agency to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his stead.
(i) The term "Division" means the Pesticides Regulation Division, Environmental Protection Agency.
(j) The term “applicant” means any person who has made application to have an economic poison registered pursuant to the provisions of the Act.
(k) The term “registrant” means any person who has registered an economic poison pursuant to the provisions of the Act.
(1) The term “petitioner” means any person who has been notified that his application for registration of an economic poison' has been refused or any person who has received a notice of cancellation or suspension of the registration of an economic poison under the Act, and who has filed a petition requesting that the matter be referred to an advisory committee.
(m) The term "advisory Committee" means a group of qualified experts designated to submit an independent report to the Administrator regarding the registration of an economic poison.'
(n) The term "hearing" means any action arising under the Act, in which it is required by law that relevant and material evidence be received at a public hearing.
(0) The term "final order" includes the Administrator's findings, conclusions, order and rulings on motions, exceptions, statements of objections and proposed findings, conclusions and orders submitted by parties and not theretofore ruled upon.
* See definition of "economic poison" ang related terms contained in section 2 of the Act (7 0.8.c. 135b) and $ 162.2 of tho regulations for the enforcement of the Act (7 CFR 162.2).
§ 164.3 Scope and applicability of this (1) Makes the necessary corrections; part.
(2) Files a petition with the Hearing The provisions of Subpart B of this
Clerk requesting that the matter be part shall be applicable to the appoint
referred to an advisory committee; or ment, compensation, and proceedings of
(3) Files objections with the Hearing an advisory Committee; and the pro
Clerk and requests a public hearing. visions of Subpart of this part shall
(c) Suspension of the registration of govern hearings conducted pursuant to
an economic poison under the Act. the provisions of the Act.
Whenever the Director finds that such
action is necessary to prevent an im§ 164.4 Submission of a determination minent hazard to the public, he may, by
respecting an economic poison to an order, suspend the registration of the advisory Committee, and institution
economic poison immediately. In such of a hearing regarding the applica- event, the Director will give the registion for registration or cancellation
trant notice of the action and the regis. or suspension of an economic poison
trant shall have the opportunity to have under the Act.
the matter submitted to an advisory com(a) Applications for registration of an mittee and shall have the opportunity economic poison under the Act. When- for an expedited hearing regarding the ever the Director shall determine, in con- matter. nection with an application for registra- (d) Procedure available if there is an tion of an economic poison under the Act, adverse order after referral to an adthat it does not appear that the article is visory committee. If a matter regarding such as to warrant the proposed claims the registration of an economic poison for it or if the article and its labeling has been referred to an advisory comand other material required to be sub- mittee and thereafter the Administrator mitted do not comply with the provisions makes a determination and issues an of the Act, the Director shall notify the order that is adverse to the applicant or applicant of the manner in which the registrant, the applicant or the registrant article, labeling, or other material re- may, within 60 days from the date of the quired to be submitted fail to comply with order of the Administrator, file objecthe Act and the applicant shall have an tions thereto with the Hearing Clerk opportunity to make the necessary cor- and request a public hearing regarding rections. If the applicant does not make the matter. the corrections, the Director will refuse (e) Referral to an advisory committee to register the article: Provided, however, at the request of the Administrator. The That an applicant may, within 30 days Administrator may, on his own initative after service of notice of refusal to regis- and when in his opinion it is desirable to ter and the reasons therefor:
have an independent evaluation respect(1) File a petition with the Hearing ing the merits of the registration of any Clerk requesting that the matter be economic poison, refer the matter to an referred to an advisory committee, or advisory committee. In such event, the
(2) File objections with the Hearing Administrator shall give the applicant or Clerk to the determination of the Di- the registrant notice of the submission of rector and request a public hearing the matter to the advisory committee. respecting the matter.
Subpart B-Rules Governing the Ap(b) Cancellation of the registration of an economic poison under the Act. The
pointment, Compensation, and ProDirector may cancel the registration of ceedings of an Advisory Committee an economic poison whenever it does not
SOURCE: 36 FR 22535, Nov. 25, 1971, unless appear that the article or its labeling or otherwise noted. other material required to be submitted complies with the provisions of the Act.
§ 164.10 Appointment of advisory com
mittee. Whenever the Director determines that a registration of an economic poison (a) Qualifications of experts. Whenshould be canceled, he will notify the ever a petition for an advisory committee registrant of his action and state the rea- is filed or the Administrator otherwise sons therefor. A cancellation of registra- deems such referral desirable, the Adtion shall be effective 30 days after service ministrator shall request the National of the cancellation notice on the regis- Academy of Sciences, National Research trant, unless within such time the Council, to select qualified experts, inregistrant:
cluding at least one representative from
a land-grant college, willing to serve on be established by the Administrator. The the advisory committee. All such experts secretariat shall furnish members of the shall have had sufficient training and committee with copies of the petition and experience in toxicology, pharmacology, any data received by the chairman. If bacteriolozy, chemistry, entomology, the chairman of the committee believes plant pathology and physiology, human that a meeting of the committee is necespathology and physiology, or other ap- sary before making a recommendation, propriate science to evaluate the safety he shall so advise the Administrator and or efficacy of economic poisons. The the petitioner. Such_meeting shall be Administrator will request the National held in Washington, D.C., or such other Academy of Sciences, when it furnishes place as the Admir.istrator may desigthe names of such experts, to supply a nate. The Administrator shall furnish a biographical sketch showing the back- suitable meeting place for the committee. ground of their experience and their con- If a meeting is held, the secretariat shall nection, if any, with academic and com- keep the minutes and provide clerical mercial institutions.
assistance. (b) Number of experts. The Admin- (c) Report of the advisory committee. istrator shall designate the number and As soon as practicable, but not later names of experts to serve on the advisory than 60 days after the date on which committee, and each such committee the information referred to in paragraph shall have at least one expert who is a (a) of this section has been submitted representative from a land-grant college. to the committee (unless the time has The Administrator shall appoint one been extended as provided in paragraph member of the committee as chairman, (d) of this section), the chairman shall and the chairman shall be the spokes- certify to the Administrator the report man of the committee for receiving and of the committee, including any minority forwarding reports and other functions report. The report shall include a recof the committee.
ommendation as to the registration of (c) Compensation for experts. The the article and a statement of the reasons Administrator shall appoint the experts or basis for the recommendation, toso selected and fix their compensation gether with copies of all relevant data at not to exceed the maximum permitted or material considered by the committee, by other authority per day for each day except that in the case of scientific literor part thereof spent in committee meet- ature readily available in scientific liings, plus necessary traveling and sub- braries, proper reference may be made sistence expenses while the experts are to it instead of furnishing actual copies. serving away from their places of resi- The report of the advisory Committee dence. Subsistence expenses shall not shall be available for inspection by any exceed the maximum per diem permitted interested person after the Administra. by this Department.
tor's order with respect to registration $164.11 Procedure for advisory com
of the product is issued.
(d) Extension of time for advisory mittce.
committee report. If at any time within (a) Submission of information to ad- the 60-day period referred to in paravisory committee. The Administrator graph (c) of this section the chairman shall submit to the chairman of the com- believes that the advisory committee mittee the petition and such other rele- needs more time, he shall so inform the vant information as he may have avail- Administrator in writing, in which case able with respect to registration of the the Administrator may extend said time product. When the Administrator sub
not to exceed 60 additional days. Notifi. mits a matter to an advisory committee cation of any such extension of time will he shall inform the applicant or the reg
be sent to the applicant or registrant istrant and shall furnish him with copies
by the Administrator.
(e) Assessment of costs of submission edge receipt of the information and read
to an advisory Committee. (1) In the iness of the committee to act. A copy of
event that an applicant or a registrant this acknowledgment shall be forwarded
requests that a matter concerning the to the applicant or registrant by the
registration of an economic poison be chairman of the committee.
referred to an advisory committee, the (b) Advisory committee meetings. A costs of such referral shall be borne by secretariat to advisory committees will the applicant or the registrant unless the
committee shall recommend in favor of (h) Order of the Administrator. The the applicant or the registrant.
date of receipt of the advisory committee (2) Costs of the advisory committee report and recommendations shall be the shall include compensation for experts date for computing the time for the Ad. as provided in § 164.10(c) and the ex- ministrator to act with respect to regispenses of the secretariat, including the tration of the economic poison. Within 90 costs of duplicating petitions and other days of such date, the Administrator related material referred to the com- shall make his determination and issue mittee.
an order, with findings of fact, with re(3) An advance deposit shall be made spect to the registration of the economic in the amount of $2,500 to cover the costs. poison. The Administrator shall serve & Further advance deposits of $2,500 each copy of his order on the applicant or the shall be made upon request of the Ad- registrant. ministrator when necessary to prevent (i) National Academy of Sciences to arrears in the payment of such costs. designate committee member to testify. Any deposits in excess of actual expenses The National Academy of Sciences shall will be refunded to the depositor.
designate one of the committee members (4) All deposits and fees required who will be available to appear and by the regulations in this part shall be testify at the request of the Administra. paid by money order, bank draft, or cer- tor, the applicant or registrant, or the tified check drawn to the order of the Examiner, at a public hearing, if one Environmental Protection Agency, occurs, with respect to the report and Washington, D.C. 20250, whereupon after recommendations of the committee, and making appropriate record thereof they the Academy shall notify the Adminwill be transmitted to the Treasurer of istrator of the name of such member: the United States, for deposit to the Provided, however, That this shall not proper account.
preclude any other member of the com(5) The Administratoi may waive or mittee from being requested to appear refund such fees in whole or in part and testify at such hearing. when in his judgment such action will
Subpart C-Rules of Practice be warranted and equitable under the particular circumstances and promote
Governing Hearings the public interest.
SOURCE: 37 FR 9478, May 11, 1972, unless (6) Any person who believes that pay- otherwise noted. ment of these fees will work a hardship § 164.20 Docketing of
request for on him may petition the Administrator hearing. to waive or refund the fees.
Whenever a document setting forth (f) Consultation with advisory com
objections and requesting a public hearmittee. The applicant or registrant and
ing is filed with the hearing clerk, the representatives of the Environmental
matter shall be docketed and assigned Protection Agency shall have the right to
and "I.F.&R.” docket number: Provided, consult with the advisory Committee.
That if the matter has previously been Such persons shall notify the chairman
assigned an “I.F.&R.” number pursuant of a desire to consult with the commit
to § 164.10, it shall be assigned that same tee and, if practicable, make appoint
number. Notice of the filing of such obments through him. The report of the
jection shall be given to the public by advisory committee shall show the names
appropriate announcement in the FEDof all persons, other than committee
ERAL REGISTER. members, discussing the petition or referral with the committee or a commit
§ 164.21 Contents of document setting tee member.
forth objections. (g) Confidentiality of data. All data (a) Concise statement required. Any submitted to an advisory committee shall document containing objections to an be considered confidential by such com- order of the Administrator refusing to mittee: Provided, That this provision register an economic poison or detershall not be construed as prohibiting the mining to cancel or suspend the regisuse of such data by the Committee in tration of such a product, shall clearly connection with its consultation with the and concisely set forth such objections applicant or registrant or representatives and the basis for each objection, includof the Environmental Protection Agency, ing relevant allegations of fact concernand in connection with its report and ing the economic poison under considerrecommendations to the Administrator. ation. The document shall indicate the