Text: H.R.3292 — 101st Congress (1989-1990)All Information (Except Text)

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HR 3292 IH
101st CONGRESS
1st Session
 H. R. 3292
To amend the Federal Insecticide, Fungicide, and Rodenticide Act and the
Federal Food, Drug, and Cosmetic Act, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
September 19, 1989
Mr. DE LA GARZA (for himself, Mr. MADIGAN, Mr. BROWN of California,
Mr. ROBERTS, Mr. STENHOLM, Mr. COLEMAN of Missouri, Mr. HUCKABY, Mr. MARLENEE,
Mr. HOPKINS, Mr. HATCHER, Mr. STANGELAND, Mr. TALLON, Mr. EMERSON, Mr. OLIN,
Mr. MORRISON of Washington, Mr. PENNY, Mr. GUNDERSON, Mr. STALLINGS,
Mr. LEWIS of Florida, Mr. JOHNSON of South Dakota, Mr. ROBERT F. SMITH,
Mr. HARRIS, Mr. COMBEST, Mr. NAGLE, Mr. SCHUETTE, Mr. CAMPBELL of Colorado,
Mr. GRANDY, Mr. ESPY, Mr. HERGER, Mr. SARPALIUS, Mr. HOLLOWAY, Ms. LONG,
Mr. WALSH, Mr. DYSON, Mr. GRANT, Mr. LANCASTER, Mr. TAUKE, Mr. STAGGERS,
Mr. WHITTAKER, Mr. JONES of North Carolina, and Mr. VOLKMER) introduced the
following bill; which was referred jointly to the Committees on Agriculture
and Energy and Commerce
A BILL
To amend the Federal Insecticide, Fungicide, and Rodenticide Act and the
Federal Food, Drug, and Cosmetic Act, and for other purposes.
  Be it enacted by the Senate and House of Representatives of the United
  States of America in Congress assembled,
SECTION 1. SHORT TITLE.
  This Act may be cited as the `Food Safety Assurance Act of 1989'.
TITLE I--CANCELLATION AND SUSPENSION
SEC. 101. REFERENCE.
  Whenever in this title an amendment or repeal is expressed in terms of an
  amendment to, or repeal of, a section or other provision, the reference
  shall be considered to be made to a section or other provision of the
  Federal Insecticide, Fungicide, and Rodenticide Act.
SEC. 102. CANCELLATION.
  Section 6(b) (7 U.S.C. 136d(b)) is amended to read as follows:
  `(b) Cancellation and Change in Classification or Other Terms or Conditions
  of Registration-
  `(1) AUTHORITY- Notwithstanding any other provision of this Act, the
  Administrator may, by use of informal rulemaking under this subsection,
  prescribe requirements regarding the composition, packaging, and labeling
  of a pesticide (or a group of pesticides containing a common active or
  inert ingredient), or may classify any such pesticide, or may prohibit
  the registration or continued registration of any such pesticide for some
  or all purposes, to the extent necessary to assure that the pesticide,
  when used in accordance with widespread and commonly recognized practice,
  does not generally cause unreasonable adverse effects on the environment.
  `(2) BASIS FOR RULE-
  `(A) The Administrator may not initiate a rulemaking under this subsection
  unless the rulemaking is based on a validated test or other significant
  evidence raising prudent concerns of unreasonable adverse effects to man
  or to the environment.
  `(B)(i) The Administrator shall submit to a scientific peer review committee
  established by the Administrator the validated test or other significant
  evidence upon which the Administrator proposes to base a rulemaking under
  paragraph (1).
  `(ii) The scientific peer review committee shall provide written
  recommendations to the Administrator as to whether the test or evidence
  reviewed satisfies the criteria under paragraph (1) for initiating a
  rulemaking under paragraph (1).
  `(iii) The scientific peer review committee shall consist of employees of
  or consultants to the Environmental Protection Agency who have not been
  involved in any previous analysis of the validated test or significant
  evidence presented to the committee and who are expert in the physical or
  biological disciplines involved in the proposed rulemaking.
  `(3) Prenotice procedures-
  `(A) The Administrator may not initiate a rulemaking under paragraph (1)
  until the Administrator has furnished to the registrant of each affected
  pesticide a notice that includes a summary of the validated test or other
  significant evidence upon which the Administrator proposes to base the
  rulemaking and the basis for a determination that such test or evidence
  raises prudent concerns that the pesticide causes unreasonable adverse risks
  to man or to the environment. A registrant shall have 30 days after receipt
  of a notice provided under this subparagraph to respond to such notice.
  `(B) At the same time that the Administrator furnishes notice to registrants
  of the pesticide under subparagraph (A), the Administrator shall also
  furnish such notice to the Secretary of Agriculture and the Secretary of
  Health and Human Services. Upon receipt of such notification, the Secretary
  of Agriculture, when appropriate, shall prepare an analysis of the benefit
  and use data of the pesticide and provide the analysis to the Administrator.
  `(4) Advance notice to public-
  `(A) The Administrator after receiving the recommendation of the peer review
  committee established under paragraph (2)(B) together with any comments
  submitted by the Secretary of Agriculture, the Secretary of Health and
  Human Services, and any registrant shall either--
  `(i) issue an advance notice of proposed rulemaking, or
  `(ii) issue a notice of a proposed decision not to initiate a rulemaking
  under paragraph (1).
  `(B) The Administrator shall publish such notice in the Federal Register
  and provide a period of not less than 60 days for comment thereon. The
  notice shall contain a statement of its basis and purpose, which shall
  include a summary of--
  `(i) the factual data on which the notice is based,
  `(ii) the major scientific assumptions underlying the notice, and
  `(iii) a summary of the notice under paragraph (3) and any significant
  comments received from any registrant, the Secretary of Agriculture,
  and the Secretary of Health and Human Services.
  `(C) If the Administrator, after considering any comments received, decides
  not to issue a notice of proposed rulemaking, the Administrator shall publish
  in the Federal Register a notice setting forth the decision and its basis.
  `(5) DOCKET- For each rulemaking under paragraph (1), the Administrator shall
  establish a docket. The docket shall include a copy of the notice under
  paragraph (3), of any notice issued under paragraph (4), of the notice of
  proposed rulemaking under paragraph (6), of each timely comment filed with
  the Administrator, of the report of the Scientific Advisory Panel under
  paragraph (8), of a record of each hearing held by the Administrator in
  connection with the rulemaking, and of the final rule or decision to withdraw
  the rule. Information in the docket shall be made available to the public
  consistent with the requirements of section 10. No factual material that
  has not been entered into the docket in a timely manner may be relied upon
  by the Administrator in issuing a final rule or in withdrawing a proposed
  rule or by any person in a judicial review proceeding, except for--
  `(A) information of which the Administrator may properly take official
  notice,
  `(B) information of which a court may properly take judicial notice, or
  `(C) information that could not have been entered into the docket by
  the exercise of due diligence by the person proposing to rely upon the
  information.
  `(6) NOTICE OF PROPOSED RULEMAKING-
  `(A) Not less than 60 days after an advance notice of proposed rulemaking,
  except as provided in paragraph (14), the Administrator may issue a notice
  of proposed rulemaking. The notice of proposed rulemaking shall include
  a statement of its basis and purpose, a request for any additional data
  needed, and a bibliography of all significant scientific data and studies
  on which the proposed rule is based. The statement of basis and purpose
  shall include a summary of--
  `(i) the factual data on which the proposed rule is based,
  `(ii) the major scientific assumptions, legal interpretations, and policy
  considerations underlying the proposed rule,
  `(iii) a summary of available risk-benefit information, including benefits
  and use information as provided by the Secretary of Agriculture, and
  `(iv) the Administrator's analysis and tentative conclusions regarding
  the balancing of such risks and benefits.
  `(B) Registrants of the pesticide and any person who submits comments
  on the proposed rule shall make a report to the Administrator of all
  scientific data and studies in such person's possession concerning the
  risks and benefits of the pesticide that are the subject of the rulemaking
  and were not included in the bibliography included in the notice required
  in subparagraph (A). If such person receives additional scientific data
  or studies pertinent to the rulemaking that were not included in such
  bibliography, the person shall make a report of such scientific data and
  studies to the Administrator promptly after receipt. If the Administrator
  receives reports containing additional data concerning risks or benefits,
  the Administrator shall revise the bibliography to reflect such data and
  make the revised bibliography available to the public.
  `(C) The Administrator shall provide a comment period of not less than 90
  days after the publication of the notice of proposed rulemaking. During such
  period any person may submit comments, data, or documentary information on
  the proposed rule. Promptly upon receipt by the Administrator, all written
  comments and documentary information on the proposed rule received from
  any person for inclusion in the docket during the comment period, shall
  be placed in the docket.
  `(D) At the same time that the Administrator publishes notice under
  subparagraph (A), the Administrator shall provide the Secretary of
  Agriculture and the Secretary of Health and Human Services with a copy
  of the proposed rule. Not later than 90 days after the publication of
  the notice of proposed rulemaking, the Secretary of Agriculture and the
  Secretary of Health and Human Services may provide comments on such proposed
  rule. Where appropriate, the Secretary of Agriculture shall provide to
  the Administrator an analysis of the impact of the proposed action on the
  production and prices of agricultural commodities and retail food prices
  and any associated societal impacts.
  `(7) INFORMAL HEARING-
  `(A) Any person who has submitted a comment may, not later than 15 days
  after the close of the comment period, request of the Administrator an
  informal hearing on questions of fact pertaining to the proposed rule or
  comments thereon. Upon such request, the Administrator shall schedule an
  informal hearing not to exceed 20 days duration, and to conduct not later
  than 60 days after the close of the comment period. The Administrator
  shall announce the time, place, and purpose of the hearing in the Federal
  Register. The informal hearing shall be limited to addressing questions
  of fact raised by materials in the docket. A transcript shall be made of
  any oral presentation, discussion, or debate and included in the docket.
  `(B) The Administrator shall appoint a presiding officer who shall have the
  authority to administer oaths, regulate the course of the hearing, conduct
  prehearing conferences, schedule presentations, and exclude irrelevant,
  immaterial, or unduly repetitious evidence.
  `(C) The presiding officer shall conduct the informal hearing in a manner
  that encourages discussion and debate on questions of fact regarding
  the docket. The Administrator shall designate one or more employees of
  the Environmental Protection Agency to participate in the hearing. Any
  person who submitted a comment on the proposed rule may participate in the
  hearing and shall be entitled to present evidence and argument to support
  the participant's position or rebut a contrary position and may choose to
  present materials in oral or written form.
  `(8) REVIEW BY SCIENTIFIC ADVISORY PANEL- At the time the Administrator
  issues a notice of proposed rulemaking under paragraph (6), the Administrator
  shall provide a copy of such notice to the Scientific Advisory Panel
  established under section 25(d). If any person submits comments under
  paragraph (6) in opposition to the proposed rule, the Administrator shall
  request the comments, evaluations, and recommendations of the Panel as
  to the impact on health and the environment of the proposed rule and
  on any disputed issues of fact or scientific policy that appear to be
  of significance in the rulemaking. The Panel may hold a public hearing
  to discuss the proposed rule. The Panel shall provide a report to the
  Administrator not later than 30 days after the close of comment period
  (or, if a hearing has been requested under paragraph (7), not later than
  30 days after the end of such hearing). A copy of the Panel's report shall
  be included in the rulemaking docket.
  (9) FINAL ACTION- After considering all material in the docket, the
  Administrator shall publish in the Federal Register either a final rule or
  a withdrawal of the proposed rule. The Administrator may not prohibit a use
  of a pesticide if alternative requirements will assure that the pesticide,
  when used in accordance with widespread and commonly recognized practice,
  will not generally cause unreasonable adverse effects on the environment. In
  taking any final action, the Administrator shall take into account the
  impact of the action on production and prices of agricultural commodities,
  retail food prices, and otherwise on agricultural economy. The final rule
  or withdrawal of the proposal shall be accompanied by a statement that--
  `(A) explains the reasons for the action;
  `(B) responds to any comments made by the Secretary of Agriculture or the
  Secretary of Health and Human Services, and responds to any report of the
  Scientific Advisory Panel;
  `(C) responds to each significant comment contained in the docket; and
  `(D) in the case of a final rule--
  `(i) explains the reasons for any major differences between the final rule
  and the proposed rule;
  `(ii) describes the impact of the final rule on production and prices
  of agricultural commodities, retail food prices, and otherwise on the
  agricultural economy; and
  `(iii) explains any significant disagreements the Administrator may have with
  the comments, evaluations, or recommendations contained in the report under
  paragraph (8) or the benefits and use information described in paragraph
  (6)(A)(iii) as it bears on the final rule.
A final rule issued under this subsection shall be effective upon the date
of its publication in the Federal Register.
  `(10) MODIFICATION OR CANCELLATION-
  `(A) A final rule shall state any requirements, classifications, or
  prohibitions imposed by the rule, and shall state that each affected
  registrant shall have a 30-day period from the date of publication of the
  rule in the Federal Register to apply for an amendment to the registration
  to comply with the rule or to request voluntary cancellation of the
  registration. However, if the rule unconditionally prohibits all uses of
  a pesticide, the rule may provide that cancellation of the registration of
  the pesticide is effective upon publication of the rule. The final rule may
  prohibit or limit distribution or sale by the registrant of the affected
  pesticide to any other person in any State during such 30-day period.
  `(B) Notwithstanding any other provision of this Act, if an application
  for an amendment to the registration to make it comply with a rule issued
  under subparagraph (A) is not submitted within such 30-day period, the
  Administrator may issue and publish in the Federal Register an order
  canceling the registration, effective upon the date of publication of the
  order in the Federal Register.
  `(11) DENIAL OF APPLICATIONS- Notwithstanding any other provision of this
  Act, no application for initial or amended registration of any pesticide
  under section 3 or 24(c) may be approved if the registration would be
  inconsistent with a rule in effect under this subsection.
  `(12) AMENDMENT OF RULE- A registrant, or other interested person with the
  concurrence of the registrant, may petition for the amendment or revocation
  of a rule that has been issued under this subsection. The petition shall
  state the factual material and argument that form the basis for the
  petition. The Administrator shall publish a notice of the petition in the
  Federal Register and allow a 60-day comment period thereon. Not later than
  180 days after publication of the notice, the Administrator shall determine
  whether to deny the petition or to propose to amend or revoke the rule,
  and publish the determination and its basis in the Federal Register. In
  making such a determination, the Administrator shall give due regard to
  the desirability of finality, to the opportunity that the petitioner had to
  present the factual material and argument in question in the prior rulemaking
  proceeding, and to any new evidence submitted by the petitioner. If the
  Administrator proposes to amend or revoke the rule, then the procedures
  established by paragraph (1) and paragraphs (6) through (9) apply. A denial
  of a petition shall be judicially reviewable as provided in paragraph (13).
  `(13) JUDICIAL REVIEW- A decision not to initiate a rulemaking published
  under paragraph (4), a final rule or a withdrawal of a proposed rule
  published under paragraph (9) or a denial of a petition under paragraph (12)
  shall be judicially reviewable in the manner specified by section 16(b)(2).
  `(14) EXCEPTION TO REQUIREMENTS- If the Administrator finds it necessary
  to issue a suspension order under subsection (c), the Administrator may
  waive the requirements of paragraphs (3) and (4) of this subsection.'.
SEC. 103. PESTICIDES IN REVIEW.
  If the Administrator, on or before January 1, 1990, has published a document
  instituting a special review proceeding or public interim administrative
  review proceeding with respect to a particular pesticide or active ingredient
  thereof, the Administrator may, in lieu of proceeding under section 6(b)
  of the Federal Insecticide, Fungicide, and Rodenticide Act as amended by the
  Food Safety Assurance Act of 1989, elect to continue such review proceeding
  and, upon its completion, take action as warranted in accordance with
  sections 3(c) (6), 6(b), and 6(d) as those sections were in effect on the
  day before the date of enactment of the Food Safety Assurance Act of 1989.
SEC. 104. SUSPENSION.
  (a) SECTION 6(c)(1)- The second sentence of section 6(c)(1) (7
  U.S.C. 136d(c)(1)) is revised to read: `Except as provided in paragraph
  (3), no order of suspension may be issued under this subsection unless
  the Administrator has issued, or at the same time issues, a proposed rule
  under subsection (b).'.
  (b) SECTION 6(c)(3)- Section 6(c)(3) (7 U.S.C. 136d(c)(1)) is amended by
  inserting after the first sentence thereof the following new sentence:
  `The Administrator may issue an emergency order under this paragraph
  before issuing a proposed rule under subsection (b), provided that the
  Administrator shall proceed expeditiously to issue a proposed rule.'.
SEC. 105. TOLERANCE REEVALUATION AS PART OF REREGISTRATION.
  Section 4(g) (7 U.S.C. 136b(g)) is amended in paragraph (2) by adding at
  the end the following:
  `(E) As soon as the Administrator has sufficient information with respect to
  the dietary risk of a particular active ingredient, but in any event no later
  than the time the Administrator makes a determination under subparagraph (C)
  or (D) with respect to pesticides containing a particular active ingredient,
  the Administrator shall--
  `(i) reassess each associated tolerance and exemption from the requirement
  for a tolerance issued under section 408 of the Federal Food, Drug, and
  Cosmetic Act (21 U.S.C. 346a),
  `(ii) determine whether such tolerance or exemption meets the requirements
  of that Act,
  `(iii) determine whether additional tolerances or exemptions should
  be issued,
  `(iv) publish in the Federal Register a notice setting forth the
  determinations made under this subparagraph, and
  `(v) commence promptly such proceedings under this Act and section 408
  of the Federal Food, Drug, and Cosmetic Act as are warranted by such
  determinations.'.
SEC. 106. SCIENTIFIC ADVISORY PANEL.
  The first sentence of section 25(d) (7 U.S.C. 136w(d)) is amended by
  striking out `The Administrator shall' and inserting in lieu thereof--
  `(1) IN GENERAL- The Administrator shall' and such section is amended by
  adding at the end the following:
  `(2) SCIENCE REVIEW BOARD- There is established a Science Review Board to
  consist of 60 scientists who shall be available to the Scientific Advisory
  Panel to assist in reviews conducted by the Panel. The Scientific Advisory
  Panel shall select the scientists from 60 nominations submitted each by the
  National Science Foundation and the National Institutes of Health. Members of
  the Board shall be compensated in the same manner as members of the Panel.'.
SEC. 107. CONFORMING AMENDMENTS.
  (a) SECTION 3(c)(6)- Section 3(c)(6) (7 U.S.C. 136a(c)(6)) is amended to
  read as follows:
  `(6) DENIAL OF APPLICATION FOR REGISTRATION-
  `(A) Except as provided in subparagraph (B), if the Administrator proposes
  to deny an application for registration because it does not satisfy
  the requirements of paragraph (5), the Administrator shall notify the
  applicant of the proposal and the reasons (including the factual basis
  thereof). Unless the applicant makes the necessary corrections to the
  application and notifies the Administrator thereof during the 30-day
  period beginning with the day after the date the applicant receives the
  notice, or during that time the applicant submits a request for a hearing,
  the Administrator may issue an order denying the application. If during
  that time the Administrator does not receive such corrections to the
  application or such a request for hearing, the Administrator may issue
  an order denying the application. Such an order shall be published in the
  Federal Register and shall not subject to judicial review. If during that
  time the Administrator receives a request for a hearing, a hearing shall
  be conducted under section 6(d) of the Act. If such a hearing is held,
  a decision after completion of such hearing shall be final and shall be
  subject to judicial review under section 16(b)(1) of this Act.
  `(B) The Administrator may deny an application for registration because
  it does not comply with the requirements of a rule issued under section
  6(b) of this Act. The Administration shall notify the applicant of such
  denial. Such notice shall explain why the application does not comply with
  such requirements and shall state that the applicant may petition to amend
  or revoke such rule under section 6(b)(12) of this Act.'.
  (b) SECTION 3(c)(8)- Section 3(c)(8) (7 U.S.C. 136a(c)(8)) is repealed.
  (c) SECTION 3(d)- Section 3(d) (7 U.S.C. 136a(dd)) is amended--
  (1) in paragraph (1)(A) thereof by deleting the words `on the initial
  classification and registered pesticides' and substituting therefor the
  words `under section 6(b) of this Act. Registered pesticides'.
  (2) in paragraph (2) thereof by deleting all that follows the words `on
  the environment,' and substituting therefor the words `the Administrator
  may initiate a proceeding under section 6(b) of the Act.'.
  (d) SECTION 4(e)- Section 4(e) (7 U.S.C. 136b(e)) is amended in paragraph
  (3)(B)(iii)(III) thereof--
  (1) by deleting the words `section 6(d), except that the' and substituting
  therefor the words `section 6(d). The'.
  (2) by inserting after the word `guidelines.' the words `If a hearing is
  held, a decision after completion of such hearing shall be final.'.
  (e) SECTION 6(c)- Section 6(c) (7 U.S.C. 136d(c)) is amended in paragraph
  (4) thereof by deleting the words `section 16' and substituting therefor
  the words `section 16(b)(1)'.
  (f) SECTION 6(d)- Section 6(d) (7 U.S.C. 136(d)) is amended--
  (1) by revising the first sentence thereof to read as follows: `If
  a hearing is requested pursuant to section 3(c)(2)(B)(iv), 3(c)(6),
  4(e)(3)(B)(iii)(III), 6(c)(2), or 6(e)(2), such hearing shall be held
  for the purpose of receiving evidence relevant and material to the issues
  raised by the request for hearing.';
  (2) by striking all that follows the 8th sentence and inserting the
  following: `A hearing under this subsection shall be held in accordance
  with the provisions of sections 554, 556, and 557 of title 5, United States
  Code. As soon as practicable after the completion of the hearing, the
  Administration shall issue a final order setting forth the Administrator's
  decision. Such order and decision shall be based only on substantial
  evidence of record of such hearing, shall set forth detailed findings
  of fact upon which the order is based, and shall be subject to judicial
  review under section 16(b)(1).'.
  (g) SECTION 16(a)- Section 16(a) (7 U.S.C. 136n(a)) is amended by inserting
  `or a proceeding under section 6(b)' after `a hearing'.
  (h) SECTION 16(b)- Section 16(b) (17 U.S.C. 136n(b)) is amended--
  (1) by striking out `(b) REVIEW BY COURT OF APPEALS- In the case of'
  and inserting in lieu thereof the following:
  `(b) REVIEW BY COURT OF APPEALS-
  `(1) REVIEW OF CERTAIN ORDERS- In the case of';
  (2) by striking `under this section' in the sixth sentence of paragraph (1)
  (as so designated) and inserting `under this paragraph'; and
  (3) by adding at the end thereof the following new paragraph:
  `(2) REVIEW OF CERTAIN RULES- In the case of actual controversy as to the
  validity of any rule issued by the Administrator under section 6(b)(9),
  any decision by the Administrator under section 6(b)(4) or 6(b)(9) not
  to issue a proposed rule or to withdraw a proposed rule, or any denial
  of a petition to revoke or amend a final rule under section 6(b)(12), any
  person who will be adversely affected by such rule or decision and who has
  filed comments in the proceeding leading to the rule or decision may obtain
  judicial review by filing a petition in the United States court of appeals
  for the circuit wherein such person resides or has a place of business,
  within 60 days after the entry of such order. A copy of the petition shall
  be forthwith transmitted to the Administrator or any officer designated by
  him for that purpose, and thereupon the Administrator shall file in court
  the record of the proceedings on which the Administrator based such rule or
  decision, as provided in section 2112 of title 28, United States Code. Upon
  the filing of such petition the court shall have exclusive jurisdiction to
  affirm or set aside such rule or decision in whole or in part. The standard
  review shall be that set forth in section 706 of title 5, United States
  Code. The judgment of the court under this paragraph shall be final, subject
  to review by the Supreme Court upon certiorari or certification as provided
  in section 1254 of title 28 of the United State Code. The commencement of
  proceedings under this section shall not, unless specifically ordered by
  the court to the contrary, operate as a stay of an order.'.
  (i) SECTION 25(a)- Section 25(a) (7 U.S.C. 136w(a)) is amended by adding
  a new paragraph (5) at the end thereof, to read as follows:
  `(5) EXCEPTION- The requirements of this subsection shall not apply to
  any rule or rulemaking proceeding under section 6(b).'.
  (j) SECTION 25(d)- Section 25(d) (7 U.S.C. 136w(d)) is amended--
  (1) in the first sentence by deleting the words `in notices of intent
  issued under subsection 6(b) and'; and
  (2) in the second sentence by deleting the words `notices of intent and'
  and by deleting the words `section 6(b) or'.
  (k) SECTION 25(e)- Section 25(e) (7 U.S.C. 136w(e)) is amended by deleting
  the period at the end of the second sentence thereof and substituting thereof
  the words `, except for any action that may be taken under section 6(b).'.
TITLE II--DATA COLLECTION
SEC. 201. PESTICIDE USE DATA.
  The Secretary of Agriculture shall collect by surveys on a biennial basis
  pesticide use data of State-level significance for all the major crops
  and crops of dietary significance. There is authorized to be appropriated
  $8,000,000 for each fiscal year to carry out this section.
SEC. 202. TARGETED INTEGRATED PEST MANAGEMENT INITIATIVE.
  (a) IN GENERAL- The National Agricultural Research, Extension, and Teaching
  Policy Act of 1977 is amended as follows:
  (1) Section 1402(8) is amended by striking out `and' at the end of
  subparagraph (O), by adding `and' at the end of subparagraph (P), and by
  adding the following:
  `(Q) the development of integrated pest management techniques, and other
  pest control methods that are less dependent upon those pesticides posing
  greater than negligible risks to human health or the environment, with
  a special focus on crops critical to a balanced, healthy diet which are
  considered as minor crops in terms of acreage produced;'.
  (2) Section 1405 is amended by striking out `and' at the end of paragraph
  (11), by striking out the period at the end of paragraph (12) and inserting
  in lieu thereof `; and', and by adding the following:
  `(13) establish with the Administrator of the Environmental Protection
  Agency a committee to oversee coordination between the Department of
  Agriculture's conservation, commodity, research, and education programs and
  the Environmental Protection Agency's pesticide regulatory activities. The
  committee shall include scientists and program officials from the United
  States Department of Agriculture and the Environmental Protection Agency;
  one representative from each of the following: the President's Office of
  Science and Technology Policy, the President's Council on Environmental
  Quality, and the National Science Foundation; and representatives of
  State agencies with responsibility for administering agricultural, natural
  resources use, and public health protection programs. The committee shall
  design and oversee an integrated pest management initiative, directed toward
  minor use crops important in the human diet and in control of pests in such
  crops that require pesticides which may pose greater than negligible risk.'.
  (3) Add a new substitute at the end as follows:
`Subtitle N--Targeted Integrated Pest Management Initiative
`IPM RESEARCH AND EDUCATION
  `SEC. 1485. (a) The interagency coordinating committee authorized under
  section 1405(14) shall develop and oversee integrated pest management
  research and education initiatives targeted toward principal pests of
  crops, with a special emphasis on crops which constitute significant
  human dietary exposure to pesticide residues and for which few pesticide
  alternatives exist.
  `(b) The interagency coordinating committee shall advise the Administrator
  regarding ways to take into account in registration, reregistration, and
  cancellation actions the potential implications of the emergence or severity
  of genetic resistance in pest populations to pesticides, or the viability
  and profitability of integrated pest management systems. These factors
  shall also be considered by the Secretary in administering agricultural
  research and teaching programs under this title.
  `(c) To implement the program of research and education under this subtitle,
  there are authorized to be appropriated $4,000,000 for each of the fiscal
  years 1990 through 1995.'.
  (b) RESEARCH- Section 2(b) of the Act of August 4, 1965 (7 U.S.C. 450(b)),
  is amended by striking out `and' at the end of paragraph (7), by striking
  out the period at the end of paragraph (8) and inserting in lieu `; and',
  and by adding the following:
  `(9) research to develop and refine integrated pest management techniques
  and other nonchemical or reduced chemical control technologies targeted
  toward pests of crops, particularly those pests and crops which require
  applications of pesticides that may pose greater than a negligible risk
  to man or the environment.'.
TITLE III--AUTHORIZATIONS
SEC. 301. AUTHORIZATIONS.
  Paragraphs (2) and (3) of section 31 of the Federal Insecticide, Fungicide,
  and Rodenticide Act (7 U.S.C. 136y) are amended--
  (1) by striking out `$95,000,000' and inserting in lieu thereof
  `$96,000,000', and
  (2) by inserting after `this Act' the following: `and of which $1,000,000
  shall be available for the implementation of regulations relating to insert
  ingredients in pesticide products'.
TITLE IV--AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
SEC. 401. REFERENCE.
  Whenever in this title an amendment is expressed in terms of an amendment
  to a section or other provision, or refers to a section or other provision,
  the reference shall be considered to be made to a section or other provision
  of the Federal Food, Drug, and Cosmetic Act.
SEC. 402. DEFINITIONS.
  (a) Section 201(q) (21 U.S.C. 321(q)) is amended to read as follows:
  `(q)(1) The term `pesticide chemical' means--
  `(A) any substance that is a pesticide within the meaning of the Federal
  Insecticide, Fungicide, and Rodenticide Act, or
  `(B) any active or inert ingredient of a pesticide within the meaning of
  the Federal Insecticide, Fungicide, and Rodenticide Act.
  `(2) The term `pesticide chemical residue' means a residue in or on raw
  agricultural commodity or processed food of--
  `(A) a pesticide chemical, or
  `(B) any other added substance that is present in the commodity or food
  primarily as a result of the metabolism or other degradation of a pesticide
  chemical.
  `(3) Notwithstanding paragraphs (1) and (2), the Administrator may by
  regulation except a substance from the definition of `pesticide chemical'
  or `pesticide chemical residue' if--
  `(A) its occurrence as a residue on a raw agricultural commodity or processed
  food is attributable primarily to natural causes or to human activities
  not involving the use of any substances for a pesticidal purpose in the
  production, storage, processing, or transportation of any raw agricultural
  commodity or processed food, and
  `(B) the Administrator, after consultation with the Secretary, determines
  that the substance more appropriately should be regulated under one or
  more provisions of this Act other than sections 402(a)(2)(B) and 408.'.
  (b) Paragraphs (1) and (2) of section 201(s) (21 U.S.C. 321(s)) are amended
  to read as follows:
  `(1) a pesticide chemical residue in or on a raw agricultural commodity
  or processed food; or
  `(2) a pesticide chemical; or'.
  (c) Section 201 (21 U.S.C. 321) is amended by adding at the end the
  following:
  `(bb) The term `processed food' means any food other than a raw agricultural
  commodity and includes any raw agricultural commodity that has been subject
  to processing, such as canning, cooking, freezing, dehydration, or milling.
  `(cc) The term `Administrator' means the Administrator of the United States
  Environmental Protection Agency.'.
SEC. 403. PROHIBITED ACTS.
  Section 301(j) (21 U.S.C. 331(j)) is amended--
  (1) by striking the period at the end thereof; and
  (2) by adding at the end thereof `, or the violation of section 408(g)(2)
  or any regulation issued under that section.'.
SEC. 404. ADULTERATED FOOD.
  Section 402(a)(2) (21 U.S.C. 342(a)(2)) is amended to read as follows:
  `(2)(A) if it bears or contains any added poisonous or added deleterious
  substance (other than a substance that is a pesticide chemical residue
  in or on a raw agricultural commodity or processed food, a food additive,
  a color additive, or a new animal drug) that is unsafe within the meaning
  of section 406;
  `(B) if it bears or contains a pesticide chemical residue that is unsafe
  within the meaning of section 408(a); or
  `(C) if it is or if it bears or contains--
  `(i) any food additive that is unsafe within the meaning of section 409, or
  `(ii) a new animal drug (or conversion product thereof) that is unsafe
  within the meaning of section 512; or'.
SEC. 405. TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES.
  Section 408 (21 U.S.C. 346a) is amended to read as follows:
`TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
  `SEC. 408. (a) REQUIREMENT FOR TOLERANCE OR EXEMPTION-
  `(1) GENERAL RULE- For the purposes of this section, the term `food,'
  when used as a noun without modification, shall mean a raw agricultural
  commodity or processed food. Except as provided in paragraph (2) or (3),
  any pesticide chemical residue in or on a food shall be deemed unsafe for
  the purpose of section 402(a)(2)(B) unless--
  `(A) a tolerance for such pesticide chemical residue in or on such food
  is in effect under this section and the concentration of the residue is
  within the limits of the tolerance, or
  `(B) an exemption from the requirement of a tolerance is in effect under
  this section for the pesticide chemical residue.
  `(2) PROCESSED FOOD- Notwithstanding paragraph (1)--
  `(A) if a tolerance is in effect under this section for a pesticide chemical
  residue in or on a raw agricultural commodity, a pesticide chemical residue
  that is present in or on a processed food because the food is made from
  that raw agricultural commodity shall not be considered unsafe within the
  meaning of section 402(a)(2)(B) despite the lack of a tolerance for the
  pesticide chemical residue in or on the processed food if the concentration
  of the pesticide chemical residue in the processed food when ready for
  consumption or use is not greater than the tolerance prescribed for the
  pesticide chemical residue in the raw agricultural commodity.
  `(B) If an exemption from the requirement for a tolerance is in effect under
  this section for a pesticide chemical residue in or on a raw agricultural
  commodity, a pesticide chemical residue that is present in or on a processed
  food because the food is made from that raw agricultural commodity shall
  not be considered unsafe within the meaning of section 402(a)(2)(B).
  `(3) RESIDUES OF DEGRADATION PRODUCTS- If a pesticide chemical residue is
  present in or on a food because it is a metabolite or other degradation
  product of a precursor substance that itself is a pesticide chemical or
  pesticide chemical residue, such a residue shall not be considered to be
  unsafe within the meaning of section 402(a)(2)(B) despite the lack of a
  tolerance or exemption from the need for a tolerance for such residue in
  or on such food if--
  `(A) the Administrator has not determined that the degradation product is
  likely to pose any potential health risk from dietary exposure that is of
  a different type than, or of a greater significance than, any risk posed
  by dietary exposure to the precursor substance, and
  `(B) either--
  `(i) a tolerance is in effect under this section for residues of the
  precursor substance in or on the food, and the combined level of residues
  of the degradation product and the precursor substance in or on the food is
  at or below the stoichiometrically equivalent level that would be permitted
  by the tolerance if the residue consisted only of the precursor substance
  rather than the degradation product, or
  `(ii) an exemption from the need for a tolerance is in effect under this
  section for residues of the precursor substance in or on the food, and
  `(C) the tolerance or exemption for residues of the precursor substance
  does not state that it applies only to particular named substances or
  states that it does not apply to residues of the degradation product.
  `(4) EFFECT OF TOLERANCE OR EXEMPTION- While a tolerance or exemption
  from the requirement for a tolerance is in effect under this section for a
  pesticide chemical residue with respect to any food, the food shall not by
  reason of bearing or containing any amount of such a residue be considered
  to be adulterated within the meaning of section 402(a)(1).
  `(b) AUTHORITY AND STANDARD FOR TOLERANCES-
  `(1) AUTHORITY- The Administrator may issue regulations establishing,
  modifying, or revoking a tolerance for a pesticide chemical residue in or
  on a food--
  `(A) in response to a petition filed under subsection (d), or
  `(B) on the Administrator's initiative under subsection (e).
  `(2) STANDARD- (A) A tolerance may not be established for a pesticide
  chemical residue in or on a food at a level that is higher than a level
  that the Administrator determines is adequate to protect the public health.
  `(B) The Administrator shall modify or revoke a tolerance if it is at a
  level higher than the level that the Administrator determines is adequate
  to protect the public health.
  `(C) In making a determination under this paragraph the Administrator shall
  take into account, among other relevant factors, the validity, completeness,
  and reliability of the available data from studies of the pesticide chemical
  residue, the nature of any toxic effects shown to be caused by the pesticide
  chemical in such studies, available information and reasonable assumptions
  concerning the relationship of the results of such studies to human risk,
  available information and reasonable assumptions concerning the dietary
  exposure levels of food consumers (and major identifiable subgroups of food
  consumers) to the pesticide chemical residue, and available information
  and reasonable assumptions concerning the variability of sensitivities of
  individual food consumers (and of major identifiable subgroups of food
  consumers) to such exposure levels and shall consider other factors to
  the extent required by subparagraph (E).
  `(D) For purposes of subparagraph (A), a tolerance level for a pesticide
  chemical residue in or on a food shall be deemed to be adequate to protect
  the public health if the dietary risk posed to food consumers by such level
  of the pesticide chemical residue is negligible. The Administrator shall
  by regulation set forth the factors and methods for determining whether
  such a risk is negligible.
  `(E) For purposes of subparagraph (A), a level of a pesticide chemical
  residue in or on a food that poses a greater than negligible dietary
  risk to consumers of the food shall be deemed to be adequate to protect
  the public health if the Administrator determines that such risk is not
  unreasonable because--
  `(i) use of the pesticide that produces the residue protects humans or the
  environment from adverse health effects that would, directly or indirectly,
  result in greater harm to humans or the environment than the dietary risk
  from the pesticide chemical residue;
  `(ii) use of the pesticide avoids risks to workers, the public, or the
  environment that would be expected to result from the use of another
  pesticide on the same food and that are greater than the risks that result
  from dietary exposure to the pesticide chemical residue; or
  `(iii) the unavailability of the pesticide would reduce the availability
  to consumers of an adequate, wholesome, and economical domestic supply of
  the food, and the adverse effects from such reduction would outweigh the
  risk posed by the residue.
  `(3) LIMITATIONS- (A) A tolerance may be issued under the authority of
  paragraph (2)(E) only if the Administrator has assessed the extent to
  which efforts are being made to develop either an alternative method of
  pest control or an alternative pesticide chemical for use on such commodity
  or food that would meet the requirements of paragraph (2)(D).
  `(B) A tolerance for a pesticide chemical residue in or on a food shall not
  be established by the Administrator unless the Administrator determines,
  after consultation with the Secretary, that there is a practical method
  for detecting and measuring the levels of the pesticide chemical residue
  in or on the food.
  `(C) A tolerance for a pesticide chemical residue in or on a food shall not
  be established at a level lower than the limit of detection of the method
  for detecting and measuring the pesticide chemical residue specified by
  the Administrator under subparagraph (B).
  `(c) AUTHORITY AND STANDARD FOR EXEMPTIONS-
  `(1) AUTHORITY- The Administrator may issue a regulation establishing,
  modifying, or revoking an exemption from the requirement for a tolerance
  for a pesticide chemical residue in or on a food--
  `(A) in response to a petition filed under subsection (d), or
  `(B) on the Administrator's initiative under subsection (e).
  `(2) STANDARD- (A) An exemption from the requirement for a tolerance for
  a pesticide chemical residue in or on a food may be established only if
  the Administrator determines that a tolerance is not needed to protect the
  public health, in view of the levels of dietary exposure to the pesticide
  chemical residue that could reasonably be expected to occur.
  `(B) An exemption from the requirement for a tolerance for a pesticide
  chemical residue in or on a food shall be revoked if the Administrator,
  in response to a petition for the revocation of the exemption or at the
  Administrator's own initiative determines that the exemption does not
  safisfy the criterion of subparagraph (A).
  `(C) In making a determination under this subparagraph, the Administrator
  shall take into account, among other relevant factors, the factors set
  forth in subsection (b)(2)(C).
  `(3) LIMITATION- An exemption from the requirement for a tolerance for
  a pesticide chemical residue in or on a food shall not be established by
  the Administrator unless the Administrator determines, after consultation
  with the Secretary--
  `(A) that there is a practical method for detecting and measuring the
  levels of such pesticide chemical residue in or on such food; or
  `(B) that there is no need for such a method, and states the reasons for
  such determination in the order issuing the regulation establishing or
  modifying the regulation.
  `(d) PETITION FOR TOLERANCE OR EXEMPTION-
  `(1) PETITIONS AND PETITIONERS- Any person may file with the Administrator
  a petition proposing the issuance of a regulation--
  `(A) establishing, modifying, or revoking a tolerance for a pesticide
  chemical residue in or on a food, or
  `(B) establishing or revoking an exemption from the requirement of a
  tolerance for such a residue.
  `(2) PETITION CONTENTS-
  `(A) ESTABLISHMENT- A petition under paragraph (1) to establish a tolerance
  or exemption for a pesticide chemical residue shall be supported by
  such data and information as are specified in regulations issued by the
  Administator, including--
  `(i)(I) an informative summary of the petition and of the data, information,
  and arguments submitted or cited in support of the petition,
  `(II) a statement that the petitioner agrees that such summary or any
  information it contains may be published as a part of the notice of filing
  of the petition to be published under this subsection and as part of a
  proposed or final regulation issued under this section,
  `(ii) the name, chemical identity, and composition of the pesticide chemical
  residue and of the pesticide chemical that produces the residue,
  `(iii) data showing the recommended amount, frequency, method, and time
  of application of that pesticide chemical,
  `(iv) full reports of tests and investigations made with respect to the
  safety of the pesticide chemical, including full information as to the
  methods and controls used in conducting those tests and investigations,
  `(v) full reports of tests and investigations made with respect to the nature
  and amount of the pesticide chemical residue that is likely to remain in
  or on the food, including a description of the analytical methods used,
  `(vi) a practical method for detecting and measuring the levels of the
  pesticide chemical residue in or on the food, or a statement why such a
  method is not needed,
  `(vii) practical methods for removing any amount of the residue that would
  exceed any proposed tolerance,
  `(viii) a proposed tolerance for the pesticide chemical residue, if a
  tolerance is proposed,
  `(ix) all relevant data bearing on the physical or other technical effect
  that the pesticide chemical is intended to have and the quantity of the
  pesticide chemical that is required to produce the effect,
  `(x) if the petition relates to a tolerance for a processed food, reports
  of investigations conducted using the processing method(s) used to produce
  that food,
  `(xi) such information as the Administrator may require to make the
  determination under subsection (b)(2)(E), and
  `(xii) such other data and information as the Administrator requires by
  regulation to support the petition.
If information or data required by this subparagraph is available to the
Administrator, the person submitting the petition may cite the availability
of the information or data in lieu of submitting it. The Administrator may
require a petition to be accompanied by samples of the pesticide chemical
with respect to which the petition is filed.
  `(B) MODIFICATION OR REVOCATION- The Administrator may by regulation
  establish the requirements for information and data to support a petition to
  modify or revoke a tolerance or to revoke an exemption from the requirement
  for a tolerance.
  `(3) NOTICE- A notice of the filing of a petition that the Administrator
  determines has met the requirements of paragraph (2) shall be published
  by the Administrator within 30 days after such determination. The notice
  shall announce the availability of a description of the analytical methods
  available to the Administrator for the detection and measurement of the
  pesticide chemical residue with respect to which the petition is filed
  or shall set forth the petitioner's statement of why such a method is not
  needed. The notice shall include the summary required by paragraph (2)(A)(i).
  `(4) ACTIONS BY THE ADMINISTRATOR- The Administrator shall, after giving
  due consideration to a petition filed under paragraph (1) and any other
  information available to the Administrator--
  `(A) issue a final regulation (which may vary from that sought by the
  petition) establishing, modifying, or revoking a tolerance for the pesticide
  chemical residue or an exemption of the pesticide chemical residue from
  the requirement of a tolerance;
  `(B) issue a proposed regulation under subsection (e), and thereafter
  either issue a final regulation under subsection (e) or an order denying
  the petition; or
  `(C) issue an order denying the petition.
  `(5) EFFECTIVE DATE- A regulation issued under paragraph (4) shall take
  effect upon publication.
  `(6) FURTHER PROCEEDINGS-
  `(A) Within 60 days after a regulation or order is issued under paragraph
  (4), subsection (e)(1), or subsection (f)(1), any person may file objections
  thereto with the Administrator, specifying with particularity the provisions
  of the regulation or order deemed objectionable and stating reasonable
  grounds therefor. If the regulation or order was issued in response to
  a petition under paragraph (d)(1), a copy of each objection filed by a
  person other than the petitioner shall be served by the Administrator on
  the petitioner.
  `(B) An objection may include a request for a public evidentiary hearing
  upon the objection. The Administrator shall, upon the initiative of
  the Administrator or upon the request of an interested person and after
  due notice, hold a public evidentiary hearing if and to the extent the
  Administrator determines that such a public hearing is necessary to
  receive factual evidence relevant to material issues of fact raised by
  the objections. The presiding officer in such a hearing may authorize
  a party to obtain discovery from other persons and may upon a showing
  of good cause made by a party issue a subpoena to compel testimony or
  production of documents from any person. The presiding officer shall be
  governed by the Federal Rules of Civil Procedure in making any order for
  the protection of the witness or the content of documents produced and
  shall order the payment of reasonable fees and expenses as a condition
  to requiring testimony of the witness. On contest, such a subpoena may be
  enforced by a Federal district court.
  `(C) As soon as practicable after receiving the arguments of the parties,
  the Administrator shall issue an order stating the action taken upon each
  such objection and setting forth any revision to the regulation or prior
  order that the Administrator has found to be warranted. If a hearing was
  held under subparagraph (B), such order and any revision to the regulation
  or prior order shall, with respect to questions of fact at issue in the
  hearing, be based only on substantial evidence of record at such hearing,
  and shall set forth in detail the findings of facts and the conclusions
  of law or policy upon which the order or regulation is based.
  `(D) An order issued under this paragraph ruling on an objection shall
  not take effect before the 90th day after its publication unless the
  Administrator finds that emergency conditions exist necessitating an
  earlier effective date, in which event the Administrator shall specify in
  the order his findings as to such conditions.
  `(7) JUDICIAL REVIEW- (A) In a case of actual controversy as to the
  validity of any order issued under paragraph (6) or any regulation that is
  the subject of such an order, any person who will be adversely affected by
  such order or regulation may obtain judicial review by filing in the United
  States Court of Appeals for the circuit wherein that person resides or has
  its principal place of business, or in the United States Court of Appeals
  for the District of Columbia Circuit, within 60 days after publication of
  such order, a petition praying that the order or regulation be set aside
  in whole or in part
  `(B) A copy of the petition shall be forthwith transmitted by the
  clerk of the court to the Administrator, or any officer designated by
  the Administrator for that purpose, and thereupon the Administrator shall
  file in the court the record of the proceedings on which the Administrator
  based the order or regulation, as provided in section 2112 of title 28,
  United States Code. Upon the filing of such a petition, the court shall
  have exclusive jurisdiction to affirm or set aside the order or regulation
  complained of in whole or in part. The findings of the Administrator
  with respect to questions of fact shall be sustained only if supported by
  substantial evidence when considered on the record as a whole.
  `(C) If a party applies to the court for leave to adduce additional evidence,
  and shows to the satisfaction of the court that the additional evidence
  is material and that there were reasonable grounds for the failure to
  adduce the evidence in the proceeding before the Administrator, the court
  may order that the additional evidence (and evidence in rebuttal thereof)
  shall be taken before the Administrator in the manner and upon the terms
  and conditions the court deems proper. The Administrator may modify prior
  findings as to the facts by reason of the additional evidence so taken and
  may modify the order or regulation accordingly. The Administrator shall
  file with the court any such modified finding, order, or regulation.
  `(D) The judgment of the court affirming or setting aside, in whole or
  in part, any order under paragraph (6) and any regulation which is the
  subject of such an order shall be final, subject to review by the Supreme
  Court of the United States as provided in section 1254 of title 28 of the
  United States Code. The commencement of proceedings under this paragraph
  shall not, unless specifically ordered by the court to the contrary,
  operate as a stay of a regulation or order.
  `(E) Any issue as to which review is or was obtainable under paragraph
  (6) and this paragraph shall not be the subject of judicial review under
  any other provision of law.
  `(e) ACTION ON ADMINISTRATOR'S OWN INITIATIVE-
  `(1) GENERAL RULE- The Administrator may issue a regulation--
  `(A) establishing, modifying, or revoking a tolerance for a pesticide
  chemical or a pesticide chemical residue,
  `(B) establishing or revoking an exemption of a pesticide chemical residue
  from the requirement of a tolerance, or
  `(C) establishing general procedures and requirements to implement this
  section.
A regulation issued under this paragraph shall become effective upon its
publication and shall upon publication be subject to subsection (d)(6).
  `(2) NOTICE- Before issuing a final regulation under paragraph (1), the
  Administrator shall issue a notice of proposed rulemaking and provide
  a period of not less than 60 days for public comment on the proposed
  regulation, except that a shorter period for comment may be provided if
  the Administrator for good cause finds that it would be contrary to the
  public interest to do so and states the reasons for the finding in the
  notice of proposed rulemaking.
  `(f) SPECIAL DATA REQUIREMENTS-
  `(1) REQUIRING SUBMISSION OF ADDITIONAL DATA- If the Administrator determines
  that additional data or information are reasonably required to support
  the continuation of a tolerance or exemption that is in effect under this
  section for a pesticide chemical residue on a food, the Administrator shall--
  `(A) issue a notice requiring the persons holding the pesticide
  registrations associated with such tolerance or exemption to submit the
  data or information under section 3(c)(2)(B) of the Federal Insecticide,
  Fungicide, and Rodenticide Act, or
  `(B) publish in the Federal Register, after first providing notice and an
  opportunity for comment of not less than 90 days' duration, an order--
  `(i) requiring the submission to the Administrator by one or more interested
  persons of a notice identifying the person or persons who will submit the
  required data and information,
  `(ii) describing the type of data and information required to be submitted
  to the Administrator and stating why the data and information could not
  be obtained under the authority of section 3(c)(2)(B) of the Federal
  Insecticide, Fungicide, and Rodenticide Act,
  `(iii) describing the reports to the Administrator required to be prepared
  during and after the collection of the data and information,
  `(iv) requiring the submission to the Administrator of the data, information,
  and reports referred to in clauses (ii) and (iii), and
  `(v) establishing dates by which the submissions described in clauses (i)
  and (iv) must be made.
The Administrator may revise any such order to correct an error.
  `(2) NONCOMPLIANCE- If a submission required by a notice issued in accordance
  with paragraph (1)(A) or an order issued under paragraph (1)(B) is not
  made by the time specified in such notice or order, the Administrator may
  by order published in the Federal Register modify or revoke the tolerance
  or exemption in question.
  `(3) REVIEW- An order issued under this subsection shall be effective upon
  publication and shall be subject to review in accordance with paragraphs
  (6) and (7) of subsection (d).
  `(g) CONFIDENTIALITY OF DATA-
  `(1) GENERAL RULE- Data and information that are submitted to
  the Administrator under this section and are also submitted to the
  Administrator to support an application for a registration under the
  Federal Insecticide, Fungicide, and Rodenticide Act or to maintain such
  a registration in effect shall be entitled to confidential treatment for
  reasons of business confidentiality to the same extent provided by section
  10 of that Act. Disclosure of data and information submitted under this
  section otherwise shall be governed by the provisions of section 552 of
  title 5, United States Code.
  `(2) EXCEPTIONS- Data that are entitled to confidential treatment under
  paragraph (1) may nonetheless be disclosed to the Congress of the United
  States, and may be disclosed, under such security requirements as the
  Administrator may provide by regulation, to--
  `(A) employees of the United States authorized by the Administrator to
  examine such data in the carrying out of their official duties under this
  Act or other Federal statutes intended to protect the public health, or
  `(B) contractors with the United States authorized by the Administrator
  to examine such data in the carrying out of contracts under such statutes.
  `(3) SUMMARIES- Notwithstanding any provision of this subsection or other
  law, the Administrator may publish the informative summary required by
  subsection (d)(2)(A)(i) and may, in issuing a proposed or final regulation
  or order under this section, publish an informative summary of the data
  relating to the regulation or order.
  `(h) STATUS OF PREVIOUSLY ISSUED REGULATIONS-
  `(1) REGULATIONS UNDER SECTION 406- Regulations affecting pesticide
  chemical residues in or on raw agricultural commodities promulgated, in
  accordance with section 701(e), under the authority of section 406(a)
  upon the basis of public hearings instituted before January 1, 1953,
  shall be deemed to be regulations issued under this section and shall be
  subject to modification or revocation under subsections (d) and (e).
  `(2) REGULATIONS UNDER SECTION 409- Regulations that established tolerances
  for substances that are pesticide chemical residues on or in processed
  food, or that otherwise stated the conditions under which such pesticide
  chemicals could be safely used, and that were issued under section 409 on or
  before the date of the enactment of this paragraph, shall be deemed to be
  regulations issued under this section and shall be subject to modification
  or revocation under subsection (d) or (e).
  `(3) REGULATIONS UNDER SECTION 408- Regulations that established tolerances
  or exemptions under this section that were issued on or before the date
  of the enactment of this paragraph shall remain in effect unless modified
  or revoked under subsection (d) or (e).
  `(i) TRANSITIONAL PROVISION- If, on the day before the date of the enactment
  of this subsection, a substance that is a pesticide chemical was, with
  respect to a particular pesticidal use of the substance and any resulting
  pesticide chemical residue in or on a particular food--
  `(1) regarded by the Administrator or the Secretary as generally recognized
  as safe for use within the meaning of the provisions of section 408(a)
  or 201(s) as then in effect, or
  `(2) regarded by the Secretary as a substance described by section 201(s)(4),
such a pesticide chemical residue shall be regarded as exempt from
the requirement for a tolerance, as of the date of enactment of this
subsection. The Administrator shall by regulation indicate which substances
are described by this subsection. An exemption under this subsection may be
revoked or modified as if it had been issued under subsection (c).
  `(j) HARMONIZATION WITH ACTION UNDER OTHER LAWS-
    `(1) LIMITATION- Notwithstanding any other provision of this Act, a final
    rule under this section that revokes, modifies, or suspends a tolerance or
    exemption for a pesticide chemical residue in or on a food may be issued
    only if the Administrator has first taken any necessary action under the
    Federal Insecticide, Fungicide, and Rodenticide Act with respect to the
    registration of the pesticide(s) whose use results in such residue to
    ensure that any authorized use of the pesticide in producing, storing,
    processing, or transporting food that occurs after the issuance of such
    final rule under this section will not result in pesticide chemical
    residues on such food that are unsafe within the meaning of subsection (a).
  `(2) REVOCATION OF TOLERANCE OR EXEMPTION FOLLOWING CANCELLATION OF
  ASSOCIATED REGISTRATIONS- If the Administrator, acting under the Federal
  Insecticide, Fungicide, and Rodenticide Act, cancels the registration of
  each pesticide that contains a particular pesticide chemical and that is
  labeled for use on a particular food, or requires that the registration of
  each such pesticide be modified to prohibit its use in connection with the
  production, storage, or transportation of such food, due in whole or in part
  to dietary risks to humans posed by residues of that pesticide chemical on
  that food, the Administrator shall revoke any tolerance or exemption that
  allows the presence of the pesticide chemical, or any pesticide chemical
  residue that results from its use, in or on that food. The Administrator
  shall use the procedures set forth in subsection (e) in taking action under
  this paragraph. A revocation under this paragraph shall become effective
  not later than 180 days after--
  `(A) the date by which each such cancellation of a registration has become
  effective, or
  `(B) the date on which the use of the canceled pesticide becomes unlawful
  under the terms of the cancellation, whichever is later.
  `(3) SUSPENSION OF TOLERANCE OR EXEMPTION FOLLOWING SUSPENSION OF ASSOCIATED
  REGISTRATIONS-
  `(A) SUSPENSION- If the Administrator, acting under the Federal Insecticide,
  Fungicide, and Rodenticide Act, suspends the use of each registered pesticide
  that contains a particular pesticide chemical and that is labeled for use
  on a particular food, due in whole or in part to dietary risks to humans
  posed by residues of that pesticide chemical on that food, the Administrator
  shall suspend any tolerance or exemption that allows the presence of the
  pesticide chemical, or any pesticide chemical residue that results from
  its use, in or on that food. The Administrator shall use the procedures set
  forth in subsection (e) in taking action under this paragraph. A suspension
  under this paragraph shall become effective not later than 60 days after
  the date by which each such suspension of use has become effective.
  `(B) EFFECT OF SUSPENSION- The suspension of a tolerance or exemption under
  subparagraph (A) shall be effective as long as the use of each associated
  registration of a pesticide is suspended under the Federal Insecticide,
  Fungicide, and Rodenticide Act. While a suspension of a tolerance or
  exemption is effective the tolerance or exemption shall not be considered
  to be in effect. If the suspension of use of the pesticide under that
  Act is terminated, leaving the registration of the pesticide for such use
  in effect under that Act, the Administrator shall rescind any associated
  suspension of a tolerance or exemption.
  `(4) TOLERANCES FOR UNAVOIDABLE RESIDUES- In connection with action
  taken under paragraph (2) or (3), or with respect to pesticides whose
  registrations were canceled prior to the effective date of this paragraph,
  if the Administrator determines that a residue of the canceled or suspended
  pesticide chemical will unavoidably persist in the environment and thereby
  be present in or on a food, the Administrator may establish a tolerance for
  the pesticide chemical residue at a level that permits such unavoidable
  residue to remain in such food. In establishing such a tolerance, the
  Administrator shall take into account the factors set forth in subsection
  (b)(2)(A)(iii) and shall use the precedures set forth in subsection
  (e). The Administrator shall review any such tolerance periodically and
  modify it as necessary so that it allows only that level of the pesticide
  chemical residue that is unavoidable.
  `(5) PESTICIDE RESIDUES RESULTING FROM LAWFUL APPLICATION OF PESTICIDE-
  Notwithstanding any other provision of this Act, if a tolerance or exemption
  for a pesticide chemical residue in or on a food has been revoked, suspended,
  or modified under this section, an article of that food shall not be deemed
  unsafe solely because of the presence of such pesticide chemical residue in
  or on such food if it is shown to the satisfication of the Secretary that--
  `(A) the residue is present as the result of an application or use of
  a pesticide at a time and in a manner that was lawful under the Federal
  Insecticide, Fungicide, and Rodenticide Act; and
  `(B) the residue does not exceed a level that was authorized at the time
  of that application or use to be present on the food under a tolerance,
  exemption, food additive regulation, or other sanction then in effect
  under this Act;
unless, in the case of any tolerance or exemption revoked, suspended, or
modified under this subsection or subsection (d) or (e), the Administrator has
issued a determination that consumption of the legally treated food during
the period of its likely availability in commerce will pose an unreasonable
dietary risk.
  `(k) FEES- The Administrator shall by regulation require the payment of
  such fees as will in the aggregate, in the judgment of the Administrator,
  be sufficient over a reasonable term to provide, equip, and maintain an
  adequate service for the performance of the Administrator's functions under
  this section. Under the regulations, the performance of the Administrator's
  services or other functions under this section, including--
  `(1) the acceptance for filing of a petition submitted under subsection (d),
  `(2) the promulgation of a regulation establishing, modifying, or revoking
  a tolerance or establishing or revoking an exemption from the requirement
  of a tolerance under this section,
  `(3) the acceptance for filing of objections under subsection (d)(6), or
  `(4) the certification and filing in court of a transcript of the proceedings
  and the record under subsection (d)(7),
may be conditioned upon the payment of such fees. The regulations may further
provide for waiver or refund of fees in whole or in part when in the judgment
of the Administrator such a waiver or refund is equitable and not contrary
to the purposes of this subsection.
  `(l) NATIONAL UNIFORMITY OF TOLERANCES-
  `(1) QUALIFYING PESTICIDE CHEMICAL RESIDUE- For purposes of this subsection,
  the term `qualifying pesticide chemical residue' means a pesticide chemical
  residue resulting from the use, in production, processing, or storage of
  a food, of a pesticide chemical that is an active ingredient and that--
  `(A) was first approved for such use in a registration of a pesticide issued
  under section 3(c)(5) of the Federal Insecticide, Fungicide, Rodenticide
  Act on or after April 25, 1985, on the basis of data determined by the
  Administrator to meet all applicable requirements for data prescribed by
  regulations in effect under that Act on April 25, 1985; or
  `(B) was approved for such use in a reregistration eligibility determination
  issued under section 4(g) of that Act on or after the date of enactment
  of the Food Safety Assurance Act of 1989.
  `(2) QUALIFYING FEDERAL DETERMINATION- For purposes of this subsection,
  the term `qualifying Federal determination' means--
  `(A) a tolerance or exemption from the requirement for a tolerance for a
  qualifying pesticide chemical residue that was--
  `(i) issued under this section after the date of enactment of the Food
  Safety Assurance Act of 1989;
  `(ii) issued (or, pursuant to subsection (h) or (i), deemed to have been
  issued) under this section, and determined by the Administrator to meet
  the standard under subsection (b)(2) (in the case of a tolerance) or (c)(2)
  (in the case of an exemption); and
  `(B) any statement, issued by the Secretary, of the residue level below
  which enforcement action will not be taken under this Act with respect
  to any qualifying pesticide chemical residue, if the Secretary finds that
  such pesticide chemical residue level permitted by such statement during
  the period to which such statement applies protects human health.
  `(3) LIMITATION- The Administrator may make the determination described in
  paragraph (2)(A)(ii) only by issuing a rule in accordance with the procedure
  set forth in subsection (d) or (e) and only if the Administrator issues a
  proposed rule and allows a period of not less than 30 days for comment on
  the proposed rule. Any such rule shall be reviewable in accordance with
  subsections (d)(6) and (d)(7).
  `(4) STATE AUTHORITY- Except as provided in paragraph (5), no State or
  political subdivision thereof may establish or enforce any regulatory
  limit on a qualifying pesticide chemical residue in or on any food if a
  qualifying Federal determination applies to the presence of such pesticide
  chemical residue in or on such food, unless such State regulatory limit
  is identical to such qualifying Federal determination.
  `(5) PETITION PROCEDURE-
  `(A) Any State may petition the Administrator for authorization to establish
  in such State a regulatory limit on a qualifying pesticide chemical
  residue in or on any food that is not identical to the qualifying Federal
  determination applicable to such qualifying pesticide chemical residue.
  `(B) Any petition under subparagraph (A) shall--
  `(i) satisfy any requirements prescribed, by rule, by the Administrator; and
  `(ii) be supported by scientific data about the pesticide chemical
  residue that is the subject of the petition, or about chemically related
  pesticide chemical residues; data on the consumption within such State of
  food bearing the pesticide chemical residue; data on exposure of humans
  within such State to the pesticide chemical residue; and information about
  the effect on human health within such State of dietary exposure to the
  pesticide chemical residue if such data or information has been developed
  since the qualifying Federal determination was issued, was unavailable at
  the time such determination was issued, or has not been considered by the
  Administrator in making such determination.
  `(C) Subject to paragraph (6), the Administrator may, by order, grant the
  authorization described in subparagraph (A) if the Administrator finds
  that such qualifying Federal determination is not adequate to protect the
  public health (within the meaning of subsection (b)(2)) of persons within
  the petitioning State or a particular group of food consumers within such
  State, from dietary exposure to the pesticide chemical residue which is
  the subject of the petition.
  `(D) In lieu of any action authorized under subparagraph (C), the
  Administrator may treat a petition under this paragraph as a petition under
  subsection (d) to revoke or modify a tolerance or to revoke an exemption. If
  the Administrator determines to treat a petition under this paragraph as
  a petition under subsection (d), the Administrator shall thereafter act
  on the petition pursuant to subsection (d).
  `(E) Any order of the Administrator granting or denying the authorization
  described in subparagraph (A) shall be subject to review in the manner
  described in subsections (d)(6) and (d)(7).
  `(6) RESIDUES FROM LAWFUL APPLICATION- No State or political subdivision
  thereof may enforce any regulatory limit on the level of a pesticide
  chemical residue that may appear in or on any food if, at the time of
  the application of the pesticide that resulted in such residue, the sale
  of such food with such residue level was lawful under this Act and under
  the law of such State, unless the State demonstrates that consumption of
  the food containing such pesticide residue level during the period of the
  food's likely availability in the State will pose an unreasonable dietary
  risk to the health of persons within such State.'.
SEC. 406. AUTHORIZATION FOR INCREASE MONITORING.
  There is authorized to be appropriated an additional $12,000,000 for
  increased monitoring by the Secretary of Health and Human Services of
  pesticide residues in imported and domestic food.