[Title 40 CFR 179]
[Code of Federal Regulations (annual edition) - July 1, 1996 Edition]
[Title 40 - PROTECTION OF ENVIRONMENT]
[Chapter I - ENVIRONMENTAL PROTECTION AGENCY--(Continued)]
[Subchapter E - PESTICIDE PROGRAMS]
[Part 179 - FORMAL EVIDENTIARY PUBLIC HEARING]
[From the U.S. Government Publishing Office]




  40
  PROTECTION OF ENVIRONMENT
  11
  1996-07-01
  1996-07-01
  false
  FORMAL EVIDENTIARY PUBLIC HEARING
  179
  PART 179
  
    PROTECTION OF ENVIRONMENT
    ENVIRONMENTAL PROTECTION AGENCY--(Continued)
    PESTICIDE PROGRAMS
  


PART 179--FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents




                      Subpart A--General Provisions

Sec.
179.3  Definitions.
179.5  Other authority.

                    Subpart B--Initiation of Hearing

179.20  Notice of hearing.
179.24  Ex parte discussions; separation of functions.

            Subpart C--Participation and Appearance; Conduct

179.42  Notice of participation.

[[Page 266]]

179.45  Appearance.
179.50  Conduct at oral hearings or conferences.

                      Subpart D--Presiding Officer

179.60  Designation and qualifications of presiding officer.
179.70  Authority of presiding officer.
179.75  Disqualification of deciding officials.
179.78  Unavailability of presiding officer.

                      Subpart E--Hearing Procedures

179.80  Filing and service.
179.81  Availability of documents.
179.83  Disclosure of data and information.
179.85  Purpose of preliminary conference.
179.86  Time and place of preliminary conference.
179.87  Procedures for preliminary conference.
179.89  Motions.
179.90  Summary decisions.
179.91  Burden of going forward; burden of persuasion.
179.93  Testimony.
179.94  Transcripts.
179.95  Admission or exclusion of evidence; objections; offers of proof.
179.97  Conferences during hearing.
179.98  Briefs and arguments.

                    Subpart F--Decisions and Appeals

179.101  Interlocutory appeal from ruling of presiding officer.
179.105  Initial decision.
179.107  Appeal from or review of initial decision.
179.110  Determination by Administrator to review initial decision.
179.112  Decision by Administrator on appeal or review of initial 
          decision.
179.115  Motion to reconsider a final order.
179.117  Designation and powers of judicial officer.

                       Subpart G--Judicial Review

179.125  Judicial review.
179.130  Administrative record.

    Authority: 21 U.S.C. 346a, 348, 371(a); Reorg. Plan No. 3 of 1970.

    Source: 55 FR 50293, Dec. 5, 1990, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 179.3   Definitions.

    Administrator means the Administrator of the Agency, or any officer 
or employee of the Agency to whom the Administrator has delegated the 
authority to perform functions under this part.
    Agency means the United States Environmental Protection Agency.
    Assistant Administrator means the Agency's Assistant Administrator 
for Prevention, Pesticides and Toxic Substances, or any officer or 
employee of OPPTS to whom the Assistant Administrator has delegated the 
authority to perform functions under this part.
    FFDCA means the Federal Food, Drug, and Cosmetic Act, as amended, 21 
U.S.C. 301-392.
    FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act, 
7 U.S.C. 136-136y.
    Judicial Officer means a person who has been designated by the 
Administrator under Sec. 179.117 to serve as a judicial officer.
    Office of the Administrator means the Agency's Administrator and 
Deputy Administrator and their immediate staff, including the judicial 
officer.
    OPPTS means the Agency's Office of Prevention, Pesticides and Toxic 
Substances.

[55 FR 50293, Dec. 5, 1990, as amended at 57 FR 28087, June 24, 1992]



Sec. 179.5   Other authority.

    Questions regarding procedural matters arising under this part or 
part 178 of this chapter that are not addressed by this part or part 178 
of this chapter shall be resolved by the Administrator or presiding 
officer, as appropriate.



                    Subpart B--Initiation of Hearing



Sec. 179.20  Notice of hearing.

    (a) If the Administrator determines under Sec. 178.32 of this 
chapter that a hearing is justified on any issue, the Administrator will 
file with the hearing clerk and publish in the Federal Register a Notice 
of Hearing. The Notice of Hearing will set forth:
    (1) The docket number for the hearing.
    (2) Each order, regulation, or petition denial that is the subject 
of the hearing, and a statement specifying any part of any such 
regulation or order that has been stayed in the Administrator's 
discretion.
    (3) The identity of each person whose request for a hearing has been 
granted, and of any other person whose petition under Sec. 177.81 or 
Sec. 180.7 of this chapter

[[Page 267]]

occasioned the order that the hearing concerns.
    (4) A statement of the issues of fact on which a hearing has been 
found to be justified.
    (5) A statement of the objections whose resolution depends on the 
resolution of those issues of fact.
    (6) A statement that the presiding officer will be designated by the 
Chief Administrative Law Judge.
    (7) The time within which notices of participation should be filed 
under Sec. 179.42.
    (8) The date, time, and place of the preliminary conference, or a 
statement that the date, time, and place will be announced in a later 
notice, and the place of the hearing.
    (9) The time within which parties must submit written information 
and views under Sec. 179.83.
    (10) Designations with respect to separation of functions published 
under Sec. 179.24(b)(2).
    (b) The statement of the issues of fact on which a hearing has been 
justified determines the scope of the hearing and the matters on which 
evidence may be introduced. The issues may be revised by the presiding 
officer. A party may obtain interlocutory review by the Administrator of 
a decision by the presiding officer to revise the issues to include an 
issue on which the Administrator has not granted a request for a hearing 
or to eliminate an issue on which a request for a hearing has been 
granted.
    (c) A hearing is deemed to begin on the date of publication of the 
Notice of Hearing.



Sec. 179.24  Ex parte discussions; separation of functions.

    (a) Any person may meet or correspond with any officer or employee 
of the Agency concerning a matter under parts 177, 178, or 180 of this 
chapter prior to publication of a Notice of Hearing under Sec. 179.20.
    (b) Upon publication of a Notice of Hearing, the following 
separation of function rules apply:
    (1) OPPTS, as a party to the hearing, is responsible for 
presentation of its position at the hearing and in any pleading or oral 
argument before the Administrator. The Pesticides and Toxic Substances 
Division of the Office of General Counsel shall advise and represent 
OPPTS with respect to the hearing and in any pleading or oral argument 
before the Administrator. An employee or other representatives of OPPTS 
may not participate in or advise the Administrator or any of his 
representatives on any decision under this part, other than as witness 
or counsel in public proceedings, except as provided by paragraph (b)(2) 
of this section. There is to be no other communication between 
representatives of OPPTS and the presiding officer or any representative 
of the Office of the Administrator concerning the merits of the hearing 
until after issuance of the decision of the Administrator.
    (2) The Administrator may designate persons who otherwise would be 
regarded as representatives of OPPTS, to serve as representatives of the 
Office of the Administrator on matters pertaining to the hearing, and 
may also designate persons who otherwise would be regarded as 
representatives of the Office of the Administrator to serve as 
representatives of OPPTS. Such designations will be included in the 
Notice of Hearing published underSec. 179.20.
    (3) The Office of the Administrator is responsible for the final 
decision of the matter, with the advice and participation of anyone in 
the Agency other than representatives of OPPTS.
    (c) Between the date of publication of the Notice of Hearing and the 
date of the Administrator's final decision on the matter, communication 
concerning the matter involved in the hearing will be restricted as 
follows:
    (1) No person outside the Agency may have an ex parte communication 
with the presiding officer or any representative of the Office of the 
Administrator concerning the merits of the hearing. Neither the 
presiding officer nor any representative of the Office of the 
Administrator may have any ex parte communication with a person outside 
the Agency concerning the merits of the hearing.
    (2) A written communication contrary to this section must be 
immediately served on all other participants and filed with the hearing 
clerk by the presiding officer at the hearing, or by the Administrator, 
depending on who

[[Page 268]]

received the communication. An oral communication contrary to this 
section must be immediately recorded in a written memorandum and 
similarly served on all other parties and filed with the hearing clerk. 
A person, including a representative of a party in the hearing, who is 
involved in an oral communication contrary to this section, must, to the 
extent necessary to determine the substance of the communication, be 
made available for cross-examination during the hearing with respect to 
the substance of that communication. Rebuttal testimony pertinent to a 
written or oral communication contrary to this section will be 
permitted.
    (d) The prohibitions specified in paragraph (c) of this section also 
apply to a person who, in advance of the publication of a Notice of 
Hearing, knows that the notice has been signed. The prohibitions become 
applicable to such a person as of the time the knowledge is acquired.
    (e) The making of a communication contrary to this section may, 
consistent with the interests of justice and the policies underlying the 
FFDCA, result in a decision adverse to the person knowingly making or 
causing the making of the communication.

[55 FR 50293, Dec. 5, 1990, as amended at 57 FR 28087, June 24, 1992]



            Subpart C--Participation and Appearance; Conduct



Sec. 179.42   Notice of participation.

    (a) OPPTS shall be a party to a hearing under this part. Any other 
person may participate as a party in such a hearing to the extent 
specified by this section.
    (b) A person desiring to participate in a hearing must file with the 
hearing clerk within 30 days after publication of the Notice of Hearing 
under Sec. 179.20, a Notice of Participation in the following form:

                         Notice of Participation

Docket No.______________________________________________________________
Under 40 CFR part l79, please enter the participation of:_______________
(Name)__________________________________________________________________
    (Street address)
_______________________________________________________________________
    (City and State)
_______________________________________________________________________
(Telephone number)______________________________________________________
    Service on the above will be accepted by:
_______________________________________________________________________
(Name)__________________________________________________________________
    (Street address)
_______________________________________________________________________
    (City and State)
_______________________________________________________________________
    (Telephone number)
Signed:_________________________________________________________________
Date:___________________________________________________________________

    (c) An amendment to a Notice of Participation must be filed with the 
hearing clerk and served on all parties.
    (d) No person may participate in a hearing who has not filed a 
written Notice of Participation or whose participation has been stricken 
under paragraph (f) of this section.
    (e) The presiding officer may permit the late filing of a Notice of 
Participation upon a showing of good cause. Arrangements and agreements 
previously made in the proceeding shall apply to any party admitted 
late.
    (f) The presiding officer may strike the participation of a person 
for failure to comply with any requirement of this subpart. Any person 
whose participation is striken may obtain interlocutory review thereof 
by the Administrator.

[55 FR 50293, Dec. 5, 1990, as amended at 57 FR 28087, June 24, 1992]




Sec. 179.45  Appearance.

    (a) A party to a hearing may appear in person or by counsel or other 
representative in the hearing.
    (b) The presiding officer may strike a person's right to appear in 
the hearing for violation of the rules of conduct in Sec. l79.50.




Sec. 179.50  Conduct at oral hearings or conferences.

    The parties and their representatives must conduct themselves with 
dignity and observe the same standards of practice and ethics that would 
be required of parties in a judicial proceeding. Disrespectful, 
disorderly, or contumacious language or conduct, refusal to comply with 
directions, use of dilatory tactics, or refusal to adhere to reasonable 
standards of orderly and ethical conduct during any hearing

[[Page 269]]

constitute grounds for immediate exclusion from the proceeding by the 
presiding officer.



                      Subpart D--Presiding Officer



Sec. 179.60   Designation and qualifications of presiding officer.

    The presiding officer in a hearing will be an administrative law 
judge qualified under 5 U.S.C. 3l05 and designated by the Agency's chief 
administrative law judge.




Sec. 179.70   Authority of presiding officer.

    The presiding officer shall conduct the hearing in a fair and 
impartial manner subject to the precepts of the Administrative Procedure 
Act. The presiding officer has all powers necessary to conduct a fair, 
expeditious, and orderly hearing, including the power to:
    (a) Specify and change the date, time, and place for conferences, 
and issue and modify a schedule for the hearing.
    (b) Establish an orderly manner for developing evidentiary facts at 
preliminary conferences under Sec. 179.87, for making rulings on oral 
testimony and cross-examination under Sec. 179.93, and for making other 
similar evidentiary rulings in accord with these regulations.
    (c) Prepare statements of the areas of factual disagreement among 
the participants.
    (d) Hold conferences to settle, simplify, or determine the issues in 
a hearing or to consider other matters that may expedite the hearing.
    (e) Administer oaths and affirmations.
    (f) Control the course of the hearing and the conduct of the 
participants.
    (g) Examine witnesses and strike their testimony if they fail to 
respond fully to proper questions.
    (h) Rule on, admit, exclude, or limit evidence.
    (i) Set the time for filing pleadings.
    (j) Rule on motions and other procedural matters.
    (k) Rule on motions for summary decision under Sec. l79.90.
    (l) Conduct the hearing in stages if the number of parties is large 
or the issues are numerous and complex.
    (m) Strike the participation of any person under Sec. l79.42(f), or 
exclude any person from the hearing under Sec. l79.50, or take other 
reasonable disciplinary action.
    (n) Take any other action for the fair, expeditious, and orderly 
conduct of the hearing that is not in conflict with law or these rules.




Sec. 179.75   Disqualification of deciding officials.

    (a) A deciding official in a hearing under this part (including, 
e.g., the Administrator, judicial officer, or presiding officer) shall 
not decide any matter in connection with which he or she has a financial 
interest in any of the parties, or a relationship that would make it 
otherwise inappropriate for him or her to act.
    (b) A party may request that a deciding official disqualify himself/
herself and withdraw from the proceeding. The party may obtain 
interlocutory review by the Administrator of a denial of such a request 
made to any deciding official other than the Administrator.
    (c) A deciding official who is aware of grounds for disqualification 
shall withdraw from the proceeding.




Sec. 179.78   Unavailability of presiding officer.

    If the presiding officer is unable to act for any reason, his or her 
powers with respect to the hearing will be assigned by the Chief 
Administrative Law Judge to another presiding officer. The substitution 
will not affect the hearing, i.e., the testimony of the witnesses will 
not be taken anew except as the new presiding officer may order upon the 
request of a party where the credibility of a witness is of particular 
importance.



                      Subpart E--Hearing Procedures



Sec. 179.80   Filing and service.

    (a) All documents required or authorized to be filed by a party to a 
hearing under this part regarding any matter to be decided by the 
presiding officer, the judicial officer, or the Administrator shall be 
filed in triplicate with the hearing clerk, in the manner specified by 
Sec. 178.25(b) of this chapter. Each

[[Page 270]]

filing shall prominently note the docket number. To determine compliance 
with deadlines in a hearing, a document is considered filed on the date 
it is actually received by the hearing clerk. When this part allows a 
response by a party to a submission and prescribes a period of time for 
the filing of the response, an additional 3 days are allowed for the 
filing of the response if the submission is served by mail.
    (b) Each notice, order, decision, or other document issued under 
this part by the presiding officer, the judicial officer, or the 
Administrator shall be filed with the hearing clerk. The hearing clerk 
shall immediately serve all parties with a copy of such order, decision, 
or other document.
    (c) At the same time that a party files any document with the 
hearing clerk, the party shall serve a copy thereof on each other party, 
unless the presiding officer specifies otherwise. Each filing shall be 
accompanied by a certificate of service, or a statement that service is 
not required. Service on a party is accomplished by mailing a submission 
to the address shown in the Notice of Participation or by personal 
delivery.
    (d) The presiding officer may grant an extension of time for the 
filing of any pleading, document, or motion (1) Upon timely motion by a 
party, for good cause shown, and after consideration of prejudice to 
other parties, or (2) upon the presiding officer's own motion.
    (e) A motion by a party for an extension may only be made after 
serving a copy of the motion on all other parties, unless the movant can 
show good cause why doing so is impracticable. The motion shall be filed 
in advance of the date on which the pleading, document, or motion is due 
to be filed, unless the failure of the party to make a timely motion for 
an extension was the result of excusable neglect.




Sec. 179.81   Availability of documents.

    (a) All orders, decisions, pleadings, transcripts, exhibits, and 
other docket entries shall become part of the official docket and shall 
be retained by the hearing clerk. Except as otherwise provided by 
paragraph (b) of this section or part 2 of this chapter, all documents 
that are a part of the official docket shall be made available to the 
public for reasonable inspection during Agency business hours. Copies of 
such documents may be obtained by members of the public as provided in 
part 2 of this chapter.
    (b) Whenever any information or data are required to be produced or 
examined in a hearing and any party makes a business confidentiality 
claim regarding such information under part 2 of this chapter, the 
availability of such information to the other parties or to the public 
shall be determined by EPA in accordance with part 2 of this chapter, 
including specifically the procedures and principles set forth in 
Sec. 2.30l(g)(3) and (g)(4) of this chapter. The presiding officer shall 
make the determinations with respect to the matters referred to in 
Sec. 2.301(g)(3) and (g)(4) to the extent provided, and shall take such 
steps as are necessary for the protection of information entitled to 
confidential treatment or otherwise exempt from public disclosure, 
including issuance of protective orders to parties or taking testimony 
in a closed hearing.



Sec. 179.83   Disclosure of data and information.

    (a) Within 60 days of the publication of the Notice of Hearing under 
Sec. l79.20, or, if no party will be prejudiced, within another period 
set by the presiding officer, the Assistant Administrator shall file 
with the hearing clerk, in accordance with Sec. 179.80, the following 
documents numbered and organized in the manner prescribed by the 
presiding officer:
    (1) The portions of the administrative record of the proceeding 
developed under part 178 of this chapter, and under parts 177 or 180 of 
this chapter, that are relevant to the issues in the hearing.
    (2) All documents in the files of OPPTS containing factual 
information or expert opinion, whether favorable or unfavorable to the 
position of OPPTS, which relate to the issues involved in the hearing. 
For purposes of this paragraph, ``files'' means the principal files in 
OPPTS in which documents relating to each of the issues in the hearing 
are ordinarily kept. Documents that are

[[Page 271]]

internal memoranda reflecting the deliberative process, or are attorney 
work product, or were prepared specifically for use in connection with 
the hearing, are not required to be submitted.
    (3) All other documentary data and information upon which OPPTS 
plans to rely upon in the hearing.
    (4) A narrative position statement on the factual issues in the 
Notice of Hearing and the nature of the supporting evidence that OPPTS 
intends to introduce.
    (5) A signed statement that, to the best knowledge and belief of the 
Assistant Administrator, the submission complies with this section.
    (b) Within 70 days of the publication of the Notice of Hearing or, 
if no party will be prejudiced, within another period of time set by the 
presiding officer, each party other than OPPTS shall submit to the 
hearing clerk in accordance with Sec. 179.80 the following documents, 
numbered and organized in the manner prescribed by the presiding 
officer:
    (1) Any objections that the administrative record filed under 
paragraph (a)(l) of this section is incomplete.
    (2) All documents (other than those filed under paragraph (a) of 
this section) in the party's files containing factual information or 
expert opinion, whether favorable or unfavorable to the party's 
position, that relates to the issues involved in the hearing. For 
purposes of this paragraph, ``files'' means the party's principal files 
in which documents relating to each of the issues in the hearing are 
ordinarily kept. Documents that are attorney work product, or were 
prepared specifically for use in connection with the hearing, are not 
required to be submitted.
    (3) All other documentary data and information the party plans to 
rely upon in the hearing.
    (4) A narrative position statement on the factual issues in the 
Notice of Hearing and the nature of the supporting evidence the party 
intends to introduce.
    (5) A signed statement that, to the best knowledge and belief of the 
party, the submission complies with this section.
    (c) Submissions required by paragraphs (a) and (b) of this section 
may be supplemented later in the proceeding, with the approval of the 
presiding officer, upon a showing that the material contained in the 
supplement was not reasonably known by or available to the party when 
the submission was made or that the relevance of the material contained 
in the supplement could not reasonably have been foreseen.
    (d) If a party fails to comply substantially and in good faith with 
this section, the presiding officer may infer that such failure was for 
the purpose of withholding information that is unfavorable to the 
party's position, and may make such further adverse inferences and 
findings with respect to such failure as are warranted.
    (e) Parties may reference each other's submissions. To reduce 
duplicative submissions, parties are encouraged to exchange and 
consolidate lists of documentary evidence. If a particular document is 
bulky or in limited supply and cannot reasonably be reproduced, and it 
constitutes relevant evidence, the presiding officer may authorize 
submission of a reduced number of copies.
    (f) The presiding officer will rule on questions relating to this 
section.

[55 FR 50293, Dec. 5, 1990, as amended at 57 FR 28087, June 24, 1992]



Sec. 179.85   Purpose of preliminary conference.

    The presiding officer will conduct one or more preliminary 
conferences for the following purposes:
    (a) To determine the areas of factual disagreement to be considered 
at the hearing.
    (b) To establish any necessary procedural rules to control the 
course of the hearing and the schedule for the hearing.
    (c) To group parties with substantially similar interests, for 
purposes of presenting evidence, making objections, cross-examination, 
and presenting oral argument.
    (d) To obtain stipulations and admissions of facts.
    (e) To take other action that may expedite the hearing.

[[Page 272]]



Sec. 179.86   Time and place of preliminary conference.

    A preliminary conference will commence at the date, time, and place 
announced in the Notice of Hearing, or as otherwise specified by the 
Administrator or presiding officer in a subsequent notice. The 
preliminary conference may not commence until after expiration of the 
time for filing notices of participation under Sec. 179.42. The 
presiding officer may specify that two or more such conferences shall be 
held.



Sec. 179.87   Procedures for preliminary conference.

    Parties in a hearing must appear at the preliminary conference(s) 
prepared to present a position on the matters specified in Sec. 179.85. 
A preliminary conference may be held by telephone, or other electronic 
means, if appropriate.
    (a) To expedite the hearing, parties are encouraged to prepare in 
advance for the conference. Parties should cooperate with each other and 
should request information and begin preparation of testimony at the 
earliest possible time. Failure of a party to appear at the preliminary 
conference or to raise matters that could reasonably be anticipated and 
resolved at that time will not delay the progress of the hearing, and 
constitutes a waiver of the rights of the party regarding such matters 
as objections to the agreements reached, actions taken, or rulings 
issued. Such failure to appear may also be grounds for striking the 
party's participation under Sec. 179.42(f).
    (b) Each party shall bring to the preliminary conference the 
following specific information, which will be filed with the hearing 
clerk under Sec. 179.80:
    (1) Any additional information to supplement the submission which 
may have been filed under Sec. 179.83, and/or which may be filed if 
approved under Sec. 179.83(c).
    (2) A list setting forth each person who has been identified as a 
witness whose oral or written testimony will be offered by the party at 
the hearing, with a full curriculum vitae for each and a summary of the 
expected testimony (including a list of the principal exhibits on which 
the witness will rely) or a statement as to when such a summary will be 
furnished. A party may amend its witness and document list to add, 
delete, or substitute witnesses or documents.
    (c) The presiding officer may hold preliminary conferences off the 
record in an effort to reach agreement on disputed factual or procedural 
questions.
    (d) The presiding officer shall issue and file under Sec. 179.80 a 
written order reciting the actions taken at each preliminary conference 
and setting forth the schedule for the hearing. The order will control 
the subsequent course of the hearing unless modified by the presiding 
officer for good cause.




Sec. 179.89   Motions.

    A motion, unless made in the course of a preliminary conference or a 
transcribed oral hearing before the presiding officer, must be filed in 
the manner prescribed by Sec. 179.80 and include a draft order. A 
response may be filed within 10 days of service of a motion. The moving 
party has no right to reply, except as permitted by the presiding 
officer. The presiding officer shall rule upon the motion.




Sec. 179.90   Summary decisions.

    (a) After the hearing commences, a party may file a written motion, 
with or without supporting affidavits or brief, for a summary decision 
on any issue in the hearing. Any other party may, within 10 days after 
service of the motion, which time may be extended for an additional 10 
days for good cause shown, serve opposing affidavits or brief or 
countermove for summary decision. The presiding officer may set the 
matter for argument and call for the submission of briefs if not 
submitted by the parties.
    (b) The presiding officer will grant the motion if the objections, 
requests for hearing, other pleadings, affidavits, and other material 
filed in connection with the hearing, or matters officially noticed, 
show that there is no genuine disagreement as to any material fact 
bearing on the issue and that a party is entitled to summary decision.
    (c) Affidavits should set forth facts that would be admissible in 
evidence and show affirmatively that the affiant is competent to testify 
to the matters

[[Page 273]]

stated. When a properly supported motion for summary decision is made, a 
party opposing the motion may not rest upon mere allegations or denials 
or general descriptions of positions and contentions; affidavits or 
other responses must demonstrate specifically that there is a genuine 
issue of material fact for the hearing.
    (d) Should it appear from the affidavits of a party opposing the 
motion that for sound reasons stated, facts essential to justify the 
opposition cannot be presented by affidavit, the presiding officer may 
deny the motion for summary decision, order a continuance to permit 
affidavits or additional evidence to be obtained, or issue other just 
order.
    (e) If a summary decision is not rendered upon all issues or for all 
the relief asked, and evidentiary facts need to be developed, the 
presiding officer will issue an order specifying the facts that appear 
without substantial controversy and directing further evidentiary 
proceedings. The facts so specified will be deemed established.
    (f) A party may obtain interlocutory review by the Administrator of 
a summary decision of the presiding officer.



Sec. 179.91   Burden of going forward; burden of persuasion.

    (a) The party whose request for an evidentiary hearing was granted 
has the burden of going forward in the hearing with evidence as to the 
issues relevant to that request for a hearing.
    (b) The party or parties who contend that a regulation satisfies the 
criteria of section 408 or 409 of the FFDCA has the burden of persuasion 
in the hearing on that issue, whether the proceeding concerns the 
establishment, modification, or revocation of a tolerance or food 
additive regulation.




Sec. 179.93   Testimony.

    (a) The presiding officer will conduct such proceedings as are 
necessary for the taking of oral direct testimony and for the conduct of 
oral examination of witnesses by the parties. The presiding officer 
shall limit oral examination to prevent irrelevant, immaterial or unduly 
repetitious examination.
    (b) Direct testimony shall be submitted in writing, except that the 
presiding officer may order direct testimony to be presented orally in 
those unusual cases where the memory or demeanor of the witness is of 
importance. Written direct testimony shall be in the form of a verified 
statement of fact or opinion prepared by the witness, in narrative form 
or in question-and-answer form. Written direct testimony may incorporate 
exhibits. Such a verified statement or exhibit may not be admitted into 
evidence sooner than 14 days (or such other reasonable period as the 
presiding officer may order) after the witness has delivered to the 
presiding officer and each party a copy of the statement or exhibit. The 
admissibility of the evidence contained in such a statement is subject 
to the same rules as if such testimony had been given orally.
    (c) Oral cross-examination of witnesses will be permitted. Each 
exhibit that a party intends to rely upon in cross-examining a witness 
shall be furnished to the other parties not later than 3 days (or such 
other reasonable period as the presiding officer may order) before such 
exhibit is used in the cross-examination.
    (d) Witnesses shall give testimony under oath or affirmation.




Sec. 179.94   Transcripts.

    (a) The hearing clerk shall make arrangements to have all oral 
testimony stenographically reported or recorded and transcribed, with 
evidence that is admitted in the form of written testimony or exhibits 
attached or incorporated as appropriate.
    (b) Unless the presiding officer orders otherwise, parties shall 
have 15 days from the date that the transcript of particular oral 
testimony first becomes available to propose corrections in the 
transcript of that testimony. Corrections are permitted only for 
transcription errors. The presiding officer shall promptly order 
justified corrections.
    (c) As soon as practicable after the taking of the last evidence, 
the presiding officer shall certify:
    (1) That the original transcript is a true transcript of the oral 
testimony offered or received at the hearing, except in such particulars 
as the presiding officer specifies.

[[Page 274]]

    (2) That the written testimony and exhibits accompanying the 
transcript are all the written testimony and exhibits introduced at the 
hearing, with such exceptions as the presiding officer specifies.
    (3) The transcript with attached or incorporated material, as so 
certified by the presiding officer, shall be submitted to and filed by 
the hearing clerk under Sec. 179.80.
    (d) Copies of the transcript shall be available to the public in 
accordance with Sec. 179.81; parties may make special arrangements 
through the hearing clerk to obtain copies on an ongoing, expedited 
basis.




Sec. 179.95  Admission or exclusion of evidence; objections; offers of proof.

    (a) Written material identified as direct testimony or as an 
evidentiary exhibit and offered by a party in a hearing, and oral 
testimony, whether on direct or on cross-examination, is admissible as 
evidence unless the presiding officer excludes it (on objection of a 
party or on the presiding officer's own initiative) because it is 
irrelevant, immaterial, or unduly repetitive, or because its exclusion 
is necessary to enforce a specific requirement of this part relating to 
the admissibility of evidence.
    (b) If a party objects to the admission or rejection of any evidence 
or to the limitation of the scope of any examination or cross-
examination, the party shall state briefly the grounds for such 
objection. The transcript shall include any argument or debate thereon, 
unless the presiding officer, with the consent of all the parties, 
orders that such argument not be transcribed. The ruling and the reasons 
given therefor by the presiding officer on any objection shall be a part 
of the transcript. An automatic exception to that ruling will follow.
    (c) Whenever evidence is deemed inadmissible, the party offering 
such evidence may make an offer of proof, which shall be included in the 
transcript. The offer of proof for excluded oral testimony shall consist 
of a brief statement describing the nature of the evidence excluded. If 
the evidence consists of a document or exhibit, it shall be inserted in 
the record in total. If the Administrator in reviewing the record under 
Sec. 179.112 decides that the presiding officer's ruling in excluding 
the evidence was erroneous and prejudicial, the hearing may be reopened 
to permit the taking of such evidence, or, where appropriate, the 
Administrator may evaluate the evidence and proceed to a final decision.
    (d) Official notice may be taken of Agency proceedings, any matter 
that might be judicially noticed by the courts of the United States, or 
any other fact within the knowledge and experience of the Agency as an 
expert agency. Any party shall be given adequate opportunity to show 
that such facts are erroneously noticed by presenting evidence to the 
contrary.




Sec. 179.97  Conferences during hearing.

    The presiding officer may schedule and hold conferences as needed to 
monitor the progress of the hearing, narrow and simplify the issues, and 
consider and rule on motions, requests, or other matters concerning the 
development of the evidence.




Sec. 179.98  Briefs and arguments.

    (a) Promptly after the taking of evidence is completed, the 
presiding officer will announce a schedule for the filing of briefs. 
Briefs must include a statement of position on each issue, with specific 
and complete citations to the evidence and points of law relied on. 
Briefs must contain proposed findings of fact and conclusions of law.
    (b) The presiding officer may, as a matter of discretion, permit 
oral argument after the briefs are filed.



                    Subpart F--Decisions and Appeals



Sec. 179.101  Interlocutory appeal from ruling of presiding officer.

    (a) Except as provided in paragraph (b) of this section and in 
Secs. 179.20(b), 179.42(f), 179.75(b), and 179.90(f), rulings of the 
presiding officer may not be appealed to the Administrator before the 
Administrator's consideration of the entire record of the hearing.
    (b) A ruling of the presiding officer is subject to interlocutory 
appeal to the Administrator if the presiding officer certifies on the 
record or by document

[[Page 275]]

submitted under Sec. 179.80 that immediate review is necessary to 
prevent exceptional delay, expense, or prejudice to any party or 
substantial harm to the public interest. When an order or ruling is not 
certified by the presiding officer, it shall be reviewed by the 
Administrator only upon appeal from the initial decision except when the 
Administrator determines upon the request of a party and in exceptional 
circumstances, that delaying review would be deleterious to vital public 
or private interests. Except in extraordinary circumstances, proceedings 
will not be stayed pending an interlocutory appeal. Where a stay is 
granted, a stay of more than 30 days must be approved by the 
Administrator.
    (c) Ordinarily, the interlocutory appeal will be decided on the 
basis of the submission made to the presiding officer, but the 
Administrator may allow further briefs and oral arguments. Any oral 
argument will be transcribed and the transcript will be prepared and 
certified in the same manner as provided in Sec. 179.94.




Sec. 179.105  Initial decision.

    (a) After the filing of briefs and any oral argument, the presiding 
officer shall prepare and file an initial decision on the issues of fact 
in the hearing and the objections relating to those issues.
    (b) The initial decision must be based on a fair evaluation of the 
entire record, and must contain:
    (1)(i) A conclusion that no change is warranted in the order or 
regulation to which objection was taken; or
    (ii) A conclusion that changes in the order or regulation are 
warranted, the language of the order or regulation as changed, and an 
effective date for the order or regulation as changed, which date must 
not be earlier than the 90th day after it is published unless the order 
contains findings as to the existence of emergency conditions that 
necessitate an earlier effective date.
    (2) Findings of fact supported by reliable, probative and 
substantial evidence that has been found admissible by the presiding 
officer, and adequate citations to the record supporting those findings.
    (3) Conclusions on legal and policy issues, if such conclusions are 
necessary to resolve the objections.
    (4) A discussion of the reasons for the findings and conclusions, 
including a discussion of the significant contentions made by any party.
    (c) Except as otherwise provided by order of the Administrator filed 
in accordance with Sec. 179.80, after the initial decision is filed, the 
presiding officer has no further jurisdiction over the matter and any 
motions or requests filed with the hearing clerk will be decided by the 
Administrator.
    (d) The initial decision becomes the final decision of the 
Administrator by operation of law unless a party files exceptions with 
the hearing clerk under Sec. 179.107 or the Administrator files a notice 
of review under Sec. 179.110.



Sec. 179.107  Appeal from or review of initial decision.

    (a) A party may appeal an initial decision to the Administrator by 
filing exceptions with the hearing clerk, and serving them on the other 
parties, within the period specified in the initial decision. The period 
may not exceed 30 days, unless extended by the Administrator under 
paragraph (d) of this section.
    (b) Exceptions must specifically identify alleged errors in the 
findings of fact or conclusions of law or policy in the initial decision 
and, if errors in the findings of fact are alleged, must provide 
supporting citations to evidence of record. Oral argument before the 
Administrator may be requested in the exceptions.
    (c) Any reply to the exceptions is to be filed and served within the 
timeperiod specified in the initial decision. The timeperiod may not 
exceed 30 days after the end of the period (including any extensions) 
for filing exceptions, unless extended by the Administrator under 
paragraph (d) of this section.
    (d) The Administrator may extend the time for filing exceptions or 
replies to exceptions for good cause shown.
    (e) If the Administrator decides to hear oral argument, the parties 
will be informed of the date, time, and place; the amount of time 
allotted to each party, and the issues to be addressed.

[[Page 276]]



Sec. 179.110  Determination by Administrator to review initial decision.

    Within 10 days following the expiration of the time for filing 
exceptions (including any extensions), the Administrator may file with 
the hearing clerk, and serve on the parties, a notice of the 
Administrator's determination to review the initial decision. The 
Administrator may invite the parties to file briefs or present oral 
argument on the matter. The time for filing briefs or presenting oral 
argument will be specified in that or a later notice.



Sec. 179.112  Decision by Administrator on appeal or review of initial decision.

    (a) On appeal from or review of the initial decision, the 
Administrator shall have the same powers as did the presiding officer in 
making the initial decision. On the Administrator's own initiative or on 
motion, the Administrator may remand the matter to the presiding officer 
for any further action necessary for a proper decision.
    (b) The scope of the issues on appeal to, or on review by the 
Administrator is the same as the scope of the issues before the 
presiding officer, unless the Administrator specifies otherwise.
    (c) After the filing of briefs and any oral argument, the 
Administrator will issue a final decision on the issues of fact in the 
hearing and the objections related to those issues. A final decision 
must contain the elements required for an initial decision by 
Sec. 179.105(b).
    (d) The Administrator may adopt the initial decision as the final 
decision.
    (e) The Administrator's decision, or a summary of the decision and a 
notice of its availability, will be published in the Federal Register.



Sec. 179.115  Motion to reconsider a final order.

    A party may file a motion requesting the Administrator to reconsider 
a final decision under this part. Any such motion must be filed within 
10 days after service of the final decision, and must set forth the 
matters claimed to have been erroneously decided and the nature of the 
alleged errors. Such a motion shall not stay the effective date of the 
final decision unless specifically so ordered by the Administrator.



Sec. 179.117  Designation and powers of judicial officer.

    (a) One or more judicial officers may be designated by the 
Administrator. A judicial officer shall be an attorney who is a 
permanent or temporary employee of the Agency or of another Federal 
agency. A judicial officer may perform other duties. A judicial officer 
who performs any duty under this part may not be employed by OPPTS, by 
the Pesticides and Toxic Substances Division of the Office of General 
Counsel, or by any other person who is a representative of OPPTS in the 
hearing. A person may not be designated as a judicial officer in a 
hearing if he or she performed any prosecutorial or investigative 
functions in connection with that hearing or any other factually related 
hearing.
    (b) The Administrator may delegate to the judicial officer all or 
part of the Administrator's authority to act in a given proceeding under 
this part. Such a delegation does not prevent the judicial officer from 
referring any motion or case to the Administrator when appropriate.

[55 FR 50293, Dec. 5, 1990, as amended at 57 FR 28087, June 24, 1992]



                       Subpart G--Judicial Review



Sec. 179.125  Judicial review.

    (a) The Administrator's final decision is final agency action 
reviewable in the courts as provided by FFDCA section 408(i) or 
409(g)(1), as of the date of entry of the order, which shall be 
determined in accordance with Secs. 23.10 and 23.11 of this chapter. The 
failure of a person to file a petition for judicial review within the 
period ending on the 60th day after the date of the entry of the order 
constitutes a waiver under FFDCA sections 408(i) or 409(g)(1) of the 
right to judicial review of the order and of any regulation promulgated 
by the order.
    (b) The record for judicial review of a final decision under this 
part consists of the record described in Sec. 179.130.



Sec. 179.130  Administrative record.

    (a) For purposes of judicial review, the record of a hearing that 
culminates in a final decision of the Administrator

[[Page 277]]

under Sec. 179.105(d) or Sec. 179.112(c) ruling on an objection shall 
consist of:
    (1) The objection ruled on (and any request for hearing that was 
included with the objection).
    (2) Any order issued under Sec. 177.125 of this chapter to which the 
objection related, and:
    (i) The regulation or petition denial that was the subject of that 
order.
    (ii) The petition to which such order responded.
    (iii) Any amendment or supplement of the petition.
    (iv) The data and information submitted in support of the petition.
    (v) The notice of filing of the petition.
    (3) Any order issued under Sec. 177.130 of this chapter to which the 
objection related, the regulation that was the subject of that order, 
and each related Notice of Proposed Rulemaking.
    (4) Any order issued under Sec. 180.7(g) of this chapter to which 
the objection related, and:
    (i) The regulation or petition denial that was the subject of that 
order.
    (ii) The petition to which such order responded.
    (iii) Any amendment or supplement of the petition.
    (iv) The data and information submitted in support of the petition.
    (v) The notice of filing of the petition.
    (5) Any order issued under Sec. 180.29(f) of this chapter to which 
the objection related, the regulation that was the subject of that 
order, and each related Notice of Proposed Rulemaking.
    (6) The comments submitted by members of the public in response to 
the Notice of Filing or Notice of Proposed Rulemaking, and the 
information submitted as part of the comments, the Administrator's 
response to comments and the documents or information relied on by the 
Administrator in issuing the regulation or order.
    (7) All other documents or information submitted to the docket for 
the rulemaking in question under parts 177 or part 180 of this chapter.
    (8) The Notice of Hearing published under Sec. 179.20.
    (9) All notices of participation filed under Sec. 179.42.
    (10) Any Federal Register notice issued under this part that 
pertains to the proceeding.
    (11) All submissions filed under Sec. 179.80.
    (12) Any document of which official notice was taken under 
Sec. 179.95.
    (b) The record of the administrative proceeding is closed:
    (1) With respect to the taking of evidence, when specified by the 
presiding officer.
    (2) With respect to pleadings, at the time specified in 
Sec. 179.98(a) for the filing of briefs.
    (c) The presiding officer may reopen the record to receive further 
evidence at any time before the filing of the initial decision.