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containing the pesticide chemical under the (Date)
Federal Insecticide, Fungicide, and Rodenti. Pesticides Tolerance Division,
cide Act. Environmental Protection Agency,
(c) Except as noted in paragraph (d) Washington, D.C. 20460
of this section, a petition shall not be Dear Sirs:
accepted for filing if any of the data The undersigned,
prescribed by section 408(d) are lacking mits this petition pursuant to section 408
or are not set forth so as to be readily (d) (1) of the Federal Food, Drug, and Cos
understood. Data in a petition entitled metic Act with respect to the pesticide chem
to protection as a trade secret will be ical
Attached hereto, in duplicate and consti- held confidential and not revealed unless tuting a part of this petition, are the follow- it is necessary to do so in administrative ing:
or judicial proceedings under section 408. A. The name, chemical identity, and com- (d) The Pesticides Tolerance Division position of the pesticide chemical. (If the
shall notify the petitioner within 15 days pesticide chemical is an ingredient of an
after its receipt of acceptance or noneconomis poison, the complete quantitative
acceptance of a petition, and if not acformal of the resulting economic poison should be submitted. The submission of this cepted the reasons therefor. Copy of the Information does not restrict the application notice shall be sent to the Pesticides Reg. of any tolerance or exemption granted to the ulation Division, Environmental Protecspecific formula(s) submitted.)
tion Agency. If accepted, the date of B. The amount, frequency, and time of ap- notification becomes the date of filing plication of the pesticide chemical,
for the purposes of section 408(d) (1). C. Full reports of investigations made with
If petitioner desires, he may supplement respect to the safety of the pesticide chemical. (These reports should include, where
a deficient petition after notification as
to deficiencies. Each supplement shall be necessary, detailed data derived from appropriate animal or other biological experi- accompanied by a deposit of fees as spements in which the methods used and the cified in § 180.33(e). If the supplementary results obtained are clearly set forth.)
material or explanation of petition is D. The results of tests on the amount of
deemed acceptable, petitioner shall be residue remaining, including a description of
notified, and date of such notification the analytical method used. (See $ 180.34
becomes the date of filing. If the petifor further information about residue tests.)
tioner does not wish to supplement or E. Practicable methods for removing residue that exceeds any proposed tolerance.
explain the petition and requests in writF. Proposed tolerances for the pesticide ing that it be filed as submitted, the petichemical if tolerances are proposed.
tion shall be filed and the petitioner so G. Reasonable grounds in support of the notified. The date of such notification petition.
becomes the date of filing. The AdminEnclosed 18 (money order, bank draft, or istrator shall publish in the FEDERAL certified check) for $------, payable to the
REGISTER within 30 days a notice of filing, Environmental Protection Agency to cover clerical operations, initial administrative re
name of petitioner, and a brief outline view, and the cost incurred in considering of the ition, including description of the petition after it has been fled.
analytical method or reference to a pubVery truly yours,
lication in which it appears, if such pub
lication is generally available. (Petitioner)
(e) The Pesticides Tolerance Division Per
may request a sample of the pesticide (Indicate authority)
chemical at any time while a petition is Mall address
under consideration. The Pesticides TolThis petition must be signed by the peti- erance Division shall specify in its request tloner or by bis attorney or agent, or (U & for a sample of the pesticide chemical, a corporation) by an authorized official.
quantity which it deems adequate to The data specified under the several let
permit tests of analytical methods used tered headings should be on separate sheets
to determine residues of the pesticide or sets of sheets, suitably identiaed. If such
chemical and of methods proposed by data have already been submitted with an earlier application, the present petition may
the petitioner for removing any residues incorporate it by reference to the earlier
of the chemical that exceed the tolerone.
ance proposed. The date used for comThe petition shall be submitted in dupli- puting the 90-day limit for the purposes cate. The petitioner shall show that he has of section 408(d) (2) shall be moved forregistered or has submitted an application ward 1 day for each day in excess of for the registration of an economic polson 15 from the mailing date of the request
taken by the petitioner to submit the
ADVISORY COMMITTEES sample. If the sample is not submitted
§ 180.10 Referral of petition to advisory within 180 days after mailing date of the
committee. request, the petition will be considered withdrawn without prejudice.
(a) If within the prescribed period a (f) The date of receipt from the Ad- person filing a petition requests that the ministration of certification as to useful- petition be referred an advisory comness shall be the date used for comput
mittee, he shall make such request in ing the 90-day limit for the purposes of writing to the Administrator and forward section 408(d) (2).
with such request an advance deposit for (g) Unless the petition is referred to fees prescribed by 180.33(i) (3). an advisory Committee, the Adminis- (b) It further advance deposits are trator shall publish in the FEDERAL REG- not made upon request of the AdminisISTER within 90 days after receipt of the
trator, as provided for in § 180.33(i) (3), certification of usefulness, a regulation
the request for referral of the petition establishing & tolerance for residues of to an advisory committee shall be conthe pesticide chemical or exempting
sidered withdrawn, and a tolerance shall such residues from the necessity of a
be established within 90 days of the date tolerance, as provided in section 408(d) on which the Administrator requested (2) of the act.
the further advance deposit.
(c) In case the Administrator on his (Sec. 701, 52 Stat. 1065, as amended; 21 U.S.C.
own initiative deems it necessary to refer 371)
& petition to an advisory committee, he § 180.8 Withdrawal of petitions with- shall, in writing, so inform the person out prejudice.
filing the petition. In some cases the Pesticides Tolerance § 180.11 Appointment of advisory comDivision or an advisory committee to mittee. which the petition has been referred will
(a) Whenever the referral of a petinotify the petitioner that the petition,
tion or proposal to an advisory commitwhile technically complete, is inadequate
tee is requested or the Administrator othto justify the establishment of a toler
erwise deems such referral necessary, the ance or the tolerance requested by peti
Administrator will request the National tioner. This may be due to the fact that
Academy of Sciences, National Research the data are not sufficiently clear or com
Council, to select qualified experts, inplete. In such cases, the petitioner may
cluding at least one representative from withdraw the petition pending its clarifi
land-grant colleges, willing to serve on cation or the obtaining of additional
the advisory committee. All such experts data. This withdrawal may be without
shall have had sufficient training and exprejudice to a future filing. Upon refil
perience in biology, medicine, physiology, ing, the time limitation will begin to run
toxicology, pharmacology, veterinary anew from the date of refiling or the date
medicine, or other appropriate science to of receipt of certification from the
evaluate the safety of pesticide chemi. Administrator, whichever is later, A de
cals. The Administrator will request the posit for fees as specified in § 180.33(f) shall accompany the resubmission of the
National Academy of Sciences, when it petition.
furnishes the names of such experts, to (Sec. 701, 62 Stat. 1055, as amended; 21 U.S.C.
supply a biographical sketch showing the 371)
background of their experience and their | 180.9 Substantive amendments to pe
connection, if any, with academic and titions.
(b) Each advisory Committee shall After a petition has been filed or re
consist of not less than three experts. ferred to an advisory committee, the pe
at least one of whom is a representative titioner may submit additional Information or data in support thereof, but in
from a land-grant college. The Adminsuch cases the petition will be given a istrator may specify a larger number new filing date or a new initial date of to serve. He shall appoint one member consideration by the advisory committee, of the committee as chairman, and the and the time limitation will begin to run chairman shall be the spokesman of the anew. The additional data shall be ac- committee for receiving and forwarding companied by a deposit of fees as speci- reports and other functions of the comfied in § 180.33(g).
(c) The Administrator shall appoint of the committee, including any minorthe experts so selected and fix their ity report, and shall return the peti. compensation at not to exceed the max- tion for tolerances and the certification. imum permitted by other authority per The report will include copies of all releday for each day or part thereof spent vant material considered by the commitin committee meetings and in traveling tee, except that in the case of scientific to and from committee meetings held literature readily available in scientific outside the city of their residence, plus libraries proper reference may be made necessary traveling and subsistence ex- to it instead of furnishing actual copies. penses while the experts are serving away The report of the advisory committee from their places of residence. Subsist- shall be available for inspection by any ence expenses shall not exceed the max- interested person after a tolerance or imum per diem permitted by other exemption resulting from the petition is authority.
published. $ 180.12 Procedure for advisory com
(d) If at any time within 60 days, the mittee.
chairman believes that the advisory
committee needs more time, he shall so (a) The Administrator shall submit to inform the Administrator in writing, in the chairman of the committee the peti- which case he shall make the certification for tolerances, together with certifi- tion contemplated by section 408(d) (3) cation by the Administrator and such of the act within the additional 30 days. other relevant, reliable information as (e) The date of receipt of the commay be available. When the Adminis
mittee report will be the date for comtrator submits a proposal to an ad- puting time for the Administrator to act visory committee, he shall inform the
for the purposes of both sections 408 (d) petitioner and furnish him with copies (3) and (e). of material other than the petition and (f) The chairman of the committee, certification that is furnished the com- after consultation with the committee mittee. The chairman of the committee members, will inform the National shall acknowledge receipt of the infor- Academy of Sciences of the committee's mation and readiness of the committee
opinion as to the member who may best to act. The date of receipt of such in- represent the committe at a hearing, 1 formation shall be considered the begin
one occurs. ning of the period allowed for considera- (g) More than one petition or proposal tion by the committee. Copy of this may be handled by a committee conacknowledgment shall be forwarded to currently. the petitioner by the chairman of the
(h) Persons authorized under section committee.
408(h) to discuss proposals or petitions (b) A secretariat to advisory commit
with the committee shall notify the tees will be established by the Admin
chairman and if practicable make apistrator. The secretariat shall furnish
pointments through him. The report of members of the committee with copies
the committee shall show the names of of the proposal or petition, certification
persons other than committee memfrom the Administrator, and any data bers discussing proposals or petitions received by the chairman. If the chair
with the committee. Except for discusman of the committee believes that a
sions with authorized persons the commeeting of the committee is necessary mittee shall not disclose data originatbefore making a recommendation, he
ing with a petitioner prior to publication shall so advise the Administrator. Such
of a regulation. meetings shall be held in Washington, D.C., or such other place as the Admin
PROCEDURE FOR FILING OBJECTIONS AND istrator may designate. The Administra
HOLDING A PUBLIC HEARING tor shall furnish a suitable meeting place $ 180.13 Objections to regulations and for the committee. If a meeting is held,
requests for hearings. the secretariat shall keep the minutes and provide clerical assistance.
(a) Objections under section 408(d) (c) As soon as practicable, but not
(5) shall be submitted in quintuplicate later than 60 days after receipt of pro
to the hearing clerk of the Agency posal or petition (unless the time has and shall be accompanied by a filing fee been extended as provided in paragraph as specified in § 180.33(h). Each objec(d) of this section), the chairman shall tion to a provision of the regulation shall certify to the Administrator the report be separately numbered.
(b) A statement of objections shall not nated by the Administrator for conductbe accepted for filing if:
ing the hearing. Any such designation (1) It fails to establish that the ob may be made or revoked by the Adminjector is adversely affected by the regu. istrator at any time. Hearings shall lation; or
be conducted in an informal but orderly (2) It does not specify with particu- manner in accordance with these regularity the provisions of the regulation to lations and the requirements of the Adwhich objection is taken; or
ministrative Procedure Act. The pre(3) It does not state reasonable siding officer shall have the power to grounds for each objection raised. administer oaths and affirmations; to Grounds which it is reasonable to con- request the member of an advisory comclude are capable of being established mittee designated as provided by section by reliable evidence at the hearing and 408(d) (5) to testify with respect to the which if proved would call for changing report and recommendations of the comthe provisions specified in the objections mittee; to rule upon offers of proof and will be deemed reasonable grounds. admissibility of evidence; to receive rel
(c) If the statement of objections evant evidence; to examine witnesses; may not be filed, the Administrator shall to regulate the course of the hearing; to inform the objector of the reasons.
hold conferences for the simplification (d) If objections to a regulation issued of the issues, and to dispose of procedural pursuant to a petition are filled by a per- requests; but he shall not have power son other than the petitioner, the Agency to decide any motion that involves final shall send a copy of the objections by determination of the merits of the procertified mail, return receipt requested, ceeding. to the petitioner at the address given in the petition. Petitioner shall have 2 weeks
8 180.16 Parties; burden of proof; apfrom the date of receipt of the objections pearances. to make written reply.
At the hearing, the person whose ob$ 180.14 Public hearing; notice.
jections raised the issues to be deter
mined shall be, within the meaning of I the objections and statements filed section 7(c) of the Administrative Proby any person, when they are considered
cedure Act, the proponent of the order with the record in the proceeding (in- sought, and accordingly shall have the cluding any reply to the objections that burden of proof. Any interested person the petitioner may have filed) show that shall be given an opportunity to apthe person filing the objections is ad- pear at the hearing, either in person or versely affected and that the grounds by his authorized representative, and to stated in support of the objections are be heard with respect to matters relereasonable, the Administrator shall vant to the issues raised by the objeccause to be published in the FEDERAL
tions. Any interested person who desires REGISTER a notice reciting the objections to be heard at the hearing in person or and announcing a public hearing to re- through a representative shall, within ceive evidence on them. The notice the time specified in the notice of hearshall designate the place where the hear- ing, file with the presiding officer a writing will be held, specify the time within ten notice of appearance setting forth which appearances must be filed, and his name, address, and employment. It specify the time (not earlier than 30 days such person desires to be heard through after the date of the notice) when the a representative, such person or such hearing will start. The hearing shall representative shall file with the presidconvene at the place and time announced ing officer a written appearance setting in the notice but thereafter it may be forth the name, address, and employment moved to a different place and may be of such person. Any person or representcontinued from day to day or recessed ative shall state with particularity in the to a later day without other notice than appearance his interest in the proceedannouncement thereof by the presiding ings and shall set forth the specific proofficer at the hearing.
visions of the regulations concerning $ 180.15 Presiding officer.
which objections have been made on
which such person desires to be heard. The hearing shall be conducted by a
The appearance shall also set forth with presiding officer, who shall be a hearing particularity the position to be taken examiner appointed as provided in the concerning the objections on which he Administrative Procedure Act and desig- wishes to be heard. No person shall be
heard i he failed to file his appearance order the time within which objection to within the time prescribed in the ab- the authenticity of such document must sence of a clear showing of good cause be made to comply with paragraph (d) why the appearance was not filed. All of this section. present at the hearing shall conform to (c) Documentary evidence not suball reasonable standards of orderly and mitted in advance in accordance with ethical conduct.
the requirements of paragraphs (a) and
(b) of this section shall not be received § 180.17 Prehearing and other
in evidence in the absence of a clear ferences.
showing that the offering party had good (a) The presiding officer, on his own cause for his failure to produce the evimotion, or on the motion of any party or dence sooner. his representative, may direct all parties (d) The authenticity of all documents or their representatives to appear at a submitted in advance shall be deemed specified time and place for a conference admitted unless written objection to consider:
thereto is filed with the presiding officer (1) The simplification of the issues. upon notice to the other parties within
(2) The possibility of obtaining stipu- the time specified by the presiding officer lations, admissions of facts and docu
in accordance with paragraph (b) of ments.
this section, except that a party will be (3) The limitation of the number of permitted to challenge such authenticity expert witnesses.
at a later time upon a clear showing of (4) The scheduling of witnesses to be
good cause for fallure to have fled such called.
written objection. (5) The advance submission of all doc- $ 180.19 Excerpts from documentary umentary evidence.
evidence. (6) Such other matters as may aid in
When portions only of a document are the disposition of the proceeding. to be relied upon, the offering party shall The presiding oficer shall make an order prepare the pertinent excerpts, adewhich recites the action taken at the quately identified, and shall supply copies conference, the agreements made by the of such excerpts, together with a stateparties or their representatives, and the ment indicating the purpose for which schedule of witnesses, and which limits such materials will be offered, to the prethe issues for hearing to those not dis- siding officer and to the other parties. posed of by admissions or agreements. Only the excerpts, so prepared and subSuch order shall control the subsequent mitted, shall be received in the record. course of the proceeding unless modified However, the whole of the original docufor good cause by subsequent order.
ment should be made available for ex(b) The presiding oficer may also
amination and for use by opposing coundirect all parties and their representa
sel for purposes of cross-examination. tives to appear at conferences at any
& 180.20 Submission and receipt of evitime during the hearing with a view to
dence. simplification, clarification, or shortening of the hearing.
(a) Each witness shall, before pro
ceeding to testify, be sworn or make al. $ 180.18 Submission of documentary firmation. evidence in advance.
(b) When necessary to prevent undue (a) All documentary evidence to be prolongation of the hearing, the presid. offered at the hearing shall be submitted ing officer may limit the number of times to the presiding oficer and to the parties any witness may testify, the repetitious suficiently in advance of the offer of
examination and cross-examination of such documentary evidence for introduc- witnesses, or the amount of corroborative tion into the record to permit study and or cumulative evidence. preparation of cross-examination and (c) The presiding oficer shall admit rebuttal evidence.
only evidence which is relevant, mate(b) The presiding officer, after con- rial, and not unduly repetitious. sultation with the parties at & confer- (d) Opinion evidence shall be ad. ence called in accordance with $ 180.17, mitted when the presiding oficer is satisshall make an order specifying the time fied that the witness is properly qualified. at which documentary evidence shall be (e) The presiding officer shall file as submitted. He shall also specify in his exhibits the FEDERAL REGISTER promul.