TITLE IV--AMENDMENTS TO THE
FEDERAL FOOD, DRUG, AND COSMETIC ACT
SEC 401. SHORT TITLE AND REFERENCE.
This title may be cited as the 'Food Quality Protection Act of 1996 '.
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 Food, Drug,
and Cosmetic Act.
SEC. 402. DEFINITIONS.
Section 201(q) (21 U.S.C. 321(q)) is amended to read as follows:
- (q)
- (1) The term 'pesticide chemical' means any substance that is a pesticide
within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act,
including all active and inert ingredients of such pesticide.
- (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 on or 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 or in 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.
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
Section 201 (21 U.S.C. 321) is amended by adding at the end the following:
- (gg) 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.
- (hh) 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 in the first sentence by
inserting before the period the following: '; or the violating of section
408(i)(2) or any regulation issued under that section.
SEC. 404. ADULTERATED FOOD.
Section 402(a) (21 U.S.C. 342(a)) is amended by striking '(2)(A) if it
bears' and all that follows through '(3) if it consists' and inserting the
following: '(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; or (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 (3) if it consists.
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- 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 quantity 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. 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.
- (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 pesticide chemical has been used in
or on the raw agricultural commodity in conformity with a tolerance under this
section, such residue in or on the raw agricultural commodity has been removed
to the extent possible in good manufacturing practice, and the concentration of
the pesticide chemical residue in the processed food is not greater than the
tolerance prescribed for the pesticide chemical residue in the raw agricultural
commodity; or
- (B) if an exemption for 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;
- (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 and does not state
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 TOLERANCE-
- (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 own initiative under subsection (e). As used
in this section, the term 'modify' shall not mean expanding the tolerance to
cover additional foods.
- (2) STANDARD-
- (A) GENERAL RULE-
- (i) STANDARD- The Administrator may establish or leave in effect a
tolerance for a pesticide chemical residue in or on a food only if the
Administrator determines that the tolerance is safe. The Administrator shall
modify or revoke a tolerance if the Administrator determines it is not safe.
- (ii) DETERMINATION OF SAFETY- As used in this section, the term 'safe',
with respect to a tolerance for a pesticide chemical residue, means that the
Administrator has determined that there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue, including
all anticipated dietary exposures and all other exposures for which there is
reliable information.
- (iii) RULE OF CONSTRUCTION- With respect to a tolerance, a pesticide
chemical residue meeting the standard under clause (i) is not an eligible
pesticide chemical residue for purposes of subparagraph (B).
- (B) TOLERANCES FOR ELIGIBLE PESTICIDE CHEMICAL RESIDUES-
- (i) DEFINITION- As used in this subparagraph, the term 'eligible pesticide
chemical residue' means a pesticide chemical residue as to which--
- (I) the Administrator is not able to identify a level of exposure to the
residue at which the residue will not cause or contribute to a known or
anticipated harm to human health (referred to in this section as a 'nonthreshold
effect');
- (II) the lifetime risk of experiencing the nonthreshold effect is
appropriately assessed by quantitative risk assessment; and
- (III) with regard to any known or anticipated harm to human health for
which the Administrator is able to identify a level at which the residue will
not cause such harm (referred to in this section as a 'threshold effect'), the
Administrator determines that the level of aggregate exposure is safe.
- (ii) DETERMINATION OF TOLERANCE- Notwithstanding subparagraph (A)(i), a
tolerance for an eligible pesticide chemical residue may be left in effect or
modified under this subparagraph if--
- (I) at least one of the conditions described in clause (iii) is met; and
- (II) both of the conditions described in clause (iv) are met.
- (iii) CONDITIONS REGARDING USE- For purposes of clause (ii), the conditions
described in this clause with respect to a tolerance for an eligible pesticide
chemical residue are the following:
- (I) Use of the pesticide chemical that produces the residue protects
consumers from adverse effects on health that would pose a greater risk than the
dietary risk from the residue.
- (II) Use of the pesticide chemical that produces the residue is necessary
to avoid a significant disruption in domestic production of an adequate,
wholesome, and economical food supply.
- (iv) CONDITIONS REGARDING RISK- For purposes of clause (ii), the conditions
described in this clause with respect to a tolerance for an eligible pesticide
chemical residue are the following:
- (I) The yearly risk associated with the nonthreshold effect from aggregate
exposure to the residue does not exceed 10 times the yearly risk that would be
allowed under subparagraph (A) for such effect.
- (II) The tolerance is limited so as to ensure that the risk over a lifetime
associated with the nonthreshold effect from aggregate exposure to the residue
is not greater than twice the lifetime risk that would be allowed under
subparagraph (A) for such effect.
- (v) REVIEW- Five years after the date on which the Administrator makes a
determination to leave in effect or modify a tolerance under this subparagraph,
and thereafter as the Administrator deems appropriate, the Administrator shall
determine, after notice and opportunity for comment, whether it has been
demonstrated to the Administrator that a condition described in clause (iii)(I)
or clause (iii)(II) continues to exist with respect to the tolerance and that
the yearly and lifetime risks from aggregate exposure to such residue continue
to comply with the limits specified in clause (iv). If the Administrator
determines by such date that such demonstration has not been made, the
Administrator shall, not later than 180 days after the date of such
determination, issue a regulation under subsection (e)(1) to modify or revoke
the tolerance.
- (vi) INFANTS AND CHILDREN- Any tolerance under this subparagraph shall meet
the requirements of subparagraph (C).
- (C) EXPOSURE OF INFANTS AND CHILDREN- In establishing, modifying, leaving
in effect, or revoking a tolerance or exemption for a pesticide chemical
residue, the Administrator--
- (i) shall assess the risk of the pesticide chemical residue based on--
- (I) available information about consumption patterns among infants and
children that are likely to result in disproportionately high consumption of
foods containing or bearing such residue among infants and children in
comparison to the general population;
- (II) available information concerning the special susceptibility of infants
and children to the pesticide chemical residues, including neurological
differences between infants and children and adults, and effects of in utero
exposure to pesticide chemicals; and
- (III) available information concerning the cumulative effects on infants
and children of such residues and other substances that have a common mechanism
of toxicity; and
- (ii) shall--
- (I) ensure that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical residue;
and
- (II) publish a specific determination regarding the safety of the pesticide
chemical residue for infants and children.
The
Secretary of Health and Human Services and the Secretary of Agriculture, in
consultation with the Administrator, shall conduct surveys to document dietary
exposure to pesticides among infants and children. In the case of threshold
effects, for purposes of clause (ii)(I) an additional tenfold margin of safety
for the pesticide chemical residue and other sources of exposure shall be
applied for infants and children to take into account potential pre- and
post-natal toxicity and completeness of the data with respect to exposure and
toxicity to infants and children. Notwithstanding such requirement for an
additional margin of safety, the Administrator may use a different margin of
safety for the pesticide chemical residue only if, on the basis of reliable
data, such margin will be safe for infants and children.
- (D) FACTORS- In establishing, modifying, leaving in effect, or revoking a
tolerance or exemption for a pesticide chemical residue, the Administrator shall
consider, among other relevant factors--
- (i) the validity, completeness, and reliability of the available data from
studies of the pesticide chemical and pesticide chemical residue;
- (ii) the nature of any toxic effect shown to be caused by the pesticide
chemical or pesticide chemical residue in such studies;
- (iii) available information concerning the relationship of the results of
such studies to human risk;
- (iv) available information concerning the dietary consumption patterns of
consumers (and major identifiable subgroups of consumers);
- (v) available information concerning the cumulative effects of such
residues and other substances that have a common mechanism of toxicity;
- (vi) available information concerning the aggregate exposure levels of
consumers (and major identifiable subgroups of consumers) to the pesticide
chemical residue and to other related substances, including dietary exposure
under the tolerance and all other tolerances in effect for the pesticide
chemical residue, and exposure from other non-occupational sources;
- (vii) available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers;
- (viii) such information as the Administrator may require on whether the
pesticide chemical may have an effect in humans that is similar to an effect
produced by a naturally occurring estrogen or other endocrine effects; and
- (ix) safety factors which in the opinion of experts qualified by scientific
training and experience to evaluate the safety of food additives are generally
recognized as appropriate for the use of animal experimentation data.
- (E) DATA AND INFORMATION REGARDING ANTICIPATED AND ACTUAL RESIDUE LEVELS-
- (i) AUTHORITY- In establishing, modifying, leaving in effect, or revoking a
tolerance for a pesticide chemical residue, the Administrator may consider
available data and information on the anticipated residue levels of the
pesticide chemical in or on food and the actual residue levels of the pesticide
chemical that have been measured in food, including residue data collected by
the Food and Drug Administration.
- (ii) REQUIREMENT- If the Administrator relies on anticipated or actual
residue levels in establishing, modifying, or leaving in effect a tolerance, the
Administrator shall pursuant to subsection (f)(1) require that data be provided
five years after the date on which the tolerance is established, modified, or
left in effect, and thereafter as the Administrator deems appropriate,
demonstrating that such residue levels are not above the levels so relied on. If
such data are not so provided, or if the data do not demonstrate that the
residue levels are not above the levels so relied on, the Administrator shall,
not later than 180 days after the date on which the data were required to be
provided, issue a regulation under subsection (e)(1), or an order under
subsection (f)(2), as appropriate, to modify or revoke the tolerance.
- (F) PERCENT OF FOOD ACTUALLY TREATED- In establishing, modifying, leaving
in effect, or revoking a tolerance for a pesticide chemical residue, the
Administrator may, when assessing chronic dietary risk, consider available data
and information on the percent of food actually treated with the pesticide
chemical (including aggregate pesticide use data collected by the Department of
Agriculture) only if the Administrator--
- (i) finds that the data are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide chemical residue;
- (ii) finds that the exposure estimate does not understate exposure for any
significant subpopulation group;
- (iii) finds that, if data are available on pesticide use and consumption of
food in a particular area, the population in such area is not dietarily exposed
to residues above those estimated by the Administrator; and
- (iv) provides for the periodic reevaluation of the estimate of anticipated
dietary exposure.
- (3) DETECTION METHODS-
- (A) GENERAL RULE- A tolerance for a pesticide chemical residue in or on a
food shall not be established or modified 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.
- (B) DETECTION LIMIT- A tolerance for a pesticide chemical residue in or on
a food shall not be established at or modified to 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 (A).
- (4) INTERNATIONAL STANDARDS- In establishing a tolerance for a pesticide
chemical residue in or on a food, the Administrator shall determine whether a
maximum residue level for the pesticide chemical has been established by the
Codex Alimentarius Commission. If a Codex maximum residue level has been
established for the pesticide chemical and the Administrator does not propose to
adopt the Codex level, the Administrator shall publish for public comment a
notice explaining the reasons for departing from the Codex level.
- (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 food--
- (A) in response to a petition filed under subsection (d); or
- (B) on the Administrator's initiative under subsection (e).
- (2) STANDARD-
- (A) GENERAL RULE-
- (i) STANDARD- The Administrator may establish or leave in effect an
exemption from the requirement for a tolerance for a pesticide chemical residue
in or on food only if the Administrator determines that the exemption is safe.
The Administrator shall modify or revoke an exemption if the Administrator
determines it is not safe.
- (ii) DETERMINATION OF SAFETY- The term 'safe', with respect to an exemption
for a pesticide chemical residue, means that the Administrator has determined
that there is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable information.
- (B) FACTORS- In making a determination under this paragraph, the
Administrator shall take into account, among other relevant considerations, the
considerations set forth in subparagraphs (C) and (D) of subsection (b)(2).
- (3) LIMITATION- An exemption from the requirement for a tolerance for a
pesticide chemical residue in or on food shall not be established or modified 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 food; or
- (B) that there is no need for such a method, and states the reasons for
such determination in issuing the regulation establishing or modifying the
exemption.
(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, modifying, 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 Administrator,
including--
- (i)
- (I) an informative summary of the petition and of the data, information,
and arguments submitted or cited in support of the petition; and
- (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 for exemptions, a statement why
such a method is not needed;
- (vii) a proposed tolerance for the pesticide chemical residue, if a
tolerance is proposed;
- (viii) 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;
- (ix) such information as the Administrator may require to make the
determination under subsection (b)(2)(C);
- (x) such information as the Administrator may require on whether the
pesticide chemical may have an effect in humans that is similar to an effect
produced by a naturally occurring estrogen or other endocrine effects;
- (xi) information regarding exposure to the pesticide chemical residue due
to any tolerance or exemption already granted for such residue;
- (xii) practical methods for removing any amount of the residue that would
exceed any proposed tolerance; and
- (xiii) 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 modify or 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)(I).
- (4) ACTIONS BY THE ADMINISTRATOR-
- (A) IN GENERAL- The Administrator shall, after giving due consideration to
a petition filed under paragraph (1) and any other information available to the
Administrator--
- (i) 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 (which final regulation shall be issued without
further notice and without further period for public comment);
- (ii) issue a proposed regulation under subsection (e), and thereafter issue
a final regulation under such subsection; or
- (iii) issue an order denying the petition.
- (B) PRIORITIES- The Administrator shall give priority to petitions for the
establishment or modification of a tolerance or exemption for a pesticide
chemical residue that appears to pose a significantly lower risk to human health
from dietary exposure than pesticide chemical residues that have tolerances in
effect for the same or similar uses
- (C) EXPEDITED REVIEW OF CERTAIN PETITIONS-
- (i) DATE CERTAIN FOR REVIEW- If a person files a complete petition with the
Administrator proposing the issuance of a regulation establishing a tolerance or
exemption for a pesticide chemical residue that presents a lower risk to human
health than a pesticide chemical residue for which a tolerance has been left in
effect or modified under subsection (b)(2)(B), the Administrator shall complete
action on such petition under this paragraph within 1 year.
- (ii) REQUIRED DETERMINATIONS- If the Administrator issues a final
regulation establishing a tolerance or exemption for a safer pesticide chemical
residue under clause (i), the Administrator shall, not later than 180 days after
the date on which the regulation is issued, determine whether a condition
described in subclause (I) or (II) of subsection (b)(2)(B)(iii) continues to
exist with respect to a tolerance that has been left in effect or modified under
subsection (b)(2)(B). If such condition does not continue to exist, the
Administrator shall, not later than 180 days after the date on which the
determination under the preceding sentence is made, issue a regulation under
subsection (e)(1) to modify or revoke the tolerance.
- (e) Action on Administrator's Own Initiative-
- (1) GENERAL RULE- The Administrator may issue a regulation--
- (A) establishing, modifying, suspending under subsection (l)(3), or
revoking a tolerance for a pesticide chemical or a pesticide chemical residue;
- (B) establishing, modifying, suspending under subsection (l)(3), 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.
- (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 in 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 person 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;
- (B) issue a rule requiring that testing be conducted on a substance or
mixture under section 4 of the Toxic Substances Control Act; or
- (C) publish in the Federal Register, after first providing notice and an
opportunity for comment of not less than 60 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 or section 4 of the Toxic Substances Control Act;
- (iii) describing the reports of 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 under subparagraph (C) revise any
such order to correct an error. The Administrator may under this paragraph
require data or information pertaining to whether the pesticide chemical may
have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen or other endocrine effects.
- (2) NONCOMPLIANCE- If a submission required by a notice issued in
accordance with paragraph (1)(A), a rule issued under paragraph (1)(B), or an
order issued under paragraph (1)(C) is not made by the time specified in such
notice, rule, or order, the Administrator may by order published in the Federal
Register modify or revoke the tolerance or exemption in question. In any review
of such an order under subsection (g)(2), the only material issue shall be
whether a submission required under paragraph (1) was not made by the time
specified.
- (g) EFFECTIVE DATE, OBJECTIONS, HEARINGS, AND ADMINISTRATIVE
REVIEW-
- (1) EFFECTIVE DATE- A regulation or order issued under subsection (d)(4),
(e)(1), or (f)(2) shall take effect upon publication unless the regulation or
order specifies otherwise. The Administrator may stay the effectiveness of the
regulation or order if, after issuance of such regulation or order, objections
are filed with respect to such regulation or order pursuant to paragraph (2).
- (2) FURTHER PROCEEDINGS-
- (A) OBJECTIONS- Within 60 days after a regulation or order is issued under
subsection (d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or (n)(5)(C), 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 subsection (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) HEARING- 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) FINAL DECISION- 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.
- (h) JUDICIAL REVIEW-
- (1) PETITION- In a case of actual controversy as to the validity of any
regulation issued under subsection (e)(1)(C), or any order issued under
subsection (f)(1)(C) or (g)(2)(C), 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 or regulation, a petition praying
that the order or regulation be set aside in whole or in part.
- (2) RECORD AND JURISDICTION- A copy of the petition under paragraph (1)
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. As to orders issued following a public
evidentiary hearing, 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.
- (3) ADDITIONAL EVIDENCE- 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.
- (4) FINAL JUDGMENT; SUPREME COURT REVIEW- The judgment of the court
affirming or setting aside, in whole or in part, any regulation or any order 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
subsection shall not, unless specifically ordered by the court to the contrary,
operate as a stay of a regulation or order.
- (5) APPLICATION- Any issue as to which review is or was obtainable under
this subsection shall not be the subject of judicial review under any other
provision of law.
- (i) CONFIDENTIALITY AND USE OF DATA-
- (1) GENERAL RULE- Data and information that are or have been submitted to
the Administrator under this section or section 409 in support of a tolerance or
an exemption from a tolerance shall be entitled to confidential treatment for
reasons of business confidentiality and to exclusive use and data compensation
to the same extent provided by sections 3 and 10 of the Federal Insecticide,
Fungicide, and Rodenticide Act.
- (2) EXCEPTIONS-
- (A) IN GENERAL- Data and information that are entitled to confidential
treatment under paragraph (1) may be disclosed, under such security requirements
as the Administrator may provide by regulation, to--
- (i) employees of the United States authorized by the Administrator to
examine such data and information in the carrying out of their official duties
under this Act or other Federal statutes intended to protect the public health;
or
- (ii) contractors with the United States authorized by the Administrator to
examine such data and information in the carrying out of contracts under this
Act or such statutes.
- (B) CONGRESS- This subsection does not authorize the withholding of data or
information from either House of Congress or from, to the extent of matter
within its jurisdiction, any committee or subcommittee of such committee or any
joint committee of Congress or any subcommittee of such joint committee.
- (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.
- (j) 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), and shall be subject to review under subsection
(q).
- (2) REGULATIONS UNDER SECTION 409- Regulations that established tolerances
for substances that are pesticide chemical residues in or on 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), and shall be subject to review under subsection (q).
- (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), and shall be subject to review under subsection
(q).
- (k) 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 subsection
(a) or section 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. Any exemption under this subsection may be modified or revoked
as if it had been issued under subsection (c).
- (l) HARMONIZATION WITH ACTION UNDER OTHER LAWS-
- (1) COORDINATION WITH FIFRA- To the extent practicable and consistent with
the review deadlines in subsection (q), in issuing a final rule under this
subsection that suspends or revokes a tolerance or exemption for a pesticide
chemical residue in or on food, the Administrator shall coordinate such action
with any related necessary action under the Federal Insecticide, Fungicide, and
Rodenticide Act.
- (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. Subsection (e) shall apply to actions taken 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. Subsection (e) shall apply to actions taken 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 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 suspended or canceled prior to the date of the enactment of this paragraph
under the Federal Insecticide, Fungicide, and Rodenticide Act, 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. In establishing such a tolerance, the Administrator shall take
into account both the factors set forth in subsection (b)(2) and the
unavoidability of the residue. Subsection (e) shall apply to the establishment
of such tolerance. The Administrator shall review any such tolerance
periodically and modify it as necessary so that it allows no greater level of
the pesticide chemical residue than 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 satisfaction 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.
- (6) TOLERANCE FOR USE OF PESTICIDES UNDER AN EMERGENCY EXEMPTION- If the
Administrator grants an exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136p) for a pesticide chemical, the
Administrator shall establish a tolerance or exemption from the requirement for
a tolerance for the pesticide chemical residue. Such a tolerance or exemption
from a tolerance shall have an expiration date. The Administrator may establish
such a tolerance or exemption without providing notice or a period for comment
on the tolerance or exemption. The Administrator shall promulgate regulations
within 365 days after the date of the enactment of this paragraph governing the
establishment of tolerances and exemptions under this paragraph. Such
regulations shall be consistent with the safety standard under subsections
(b)(2) and (c)(2) and with section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act.
- (m) FEES-
- (1) AMOUNT- 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--
- (A) the acceptance for filing of a petition submitted under subsection (d);
- (B) establishing, modifying, leaving in effect, or revoking a tolerance or
establishing, modifying, leaving in effect, or revoking an exemption from the
requirement for a tolerance under this section;
- (C) the acceptance for filing of objections under subsection (g); or
- (D) the certification and filing in court of a transcript of the
proceedings and the record under subsection (h); 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.
- (2) DEPOSIT- All fees collected under paragraph (1) shall be deposited in
the Reregistration and Expedited Processing Fund created by section 4(k) of the
Federal Insecticide, Fungicide, and Rodenticide Act. Such fees shall be
available to the Administrator, without fiscal year limitation, for the
performance of the Administrator's services or functions as specified in
paragraph (1).
- (n) 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, and 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 this
subsection.
- (2) QUALIFYING FEDERAL DETERMINATION- For purposes of this subsection, the
term 'qualifying Federal determination' means a tolerance or exemption from the
requirement for a tolerance for a qualifying pesticide chemical residue that--
- (A) is issued under this section after the date of the enactment of this
subsection and determined by the Administrator to meet the standard under
subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in the case of an
exemption); or
- (B)
- (i) pursuant to subsection (j) is remaining in effect or is deemed to have
been issued under this section, or is regarded under subsection (k) as exempt
from the requirement for a tolerance; and
- (ii) is determined by the Administrator to meet the standard under
subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in the case of an
exemption).
- (3) LIMITATION- The Administrator may make the determination described in
paragraph (2)(B)(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 (g) and
(h).
- (4) STATE AUTHORITY- Except as provided in paragraphs (5), (6), and (8) no
State or political subdivision 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. A State or political subdivision shall be
deemed to establish or enforce a regulatory limit on a pesticide chemical
residue in or on a food if it purports to prohibit or penalize the production,
processing, shipping, or other handling of a food because it contains a
pesticide residue (in excess of a prescribed limit).
- (5) PETITION PROCEDURE-
- (A) IN GENERAL- 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) PETITION REQUIREMENTS- 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, and data on exposure of humans within such State to
the pesticide chemical residue.
- (C) AUTHORIZATION- The Administrator may, by order, grant the authorization
described in subparagraph (A) if the Administrator determines that the proposed
State regulatory limit--
- (i) is justified by compelling local conditions; and
- (ii) would not cause any food to be a violation of Federal law.
- (D) TREATMENT- 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 modify or revoke a tolerance or 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) REVIEW- 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 (g) and (h).
- (6) URGENT PETITION PROCEDURE- Any State petition to the Administrator
pursuant to paragraph (5) that demonstrates that consumption of a food
containing such pesticide residue level during the period of the food's likely
availability in the State will pose a significant public health threat from
acute exposure shall be considered an urgent petition. If an order by the
Administrator to grant or deny the requested authorization in an urgent petition
is not made within 30 days of receipt of the petition, the petitioning State may
establish and enforce a temporary regulatory limit on a qualifying pesticide
chemical residue in or on the food. The temporary regulatory limit shall be
validated or terminated by the Administrator's final order on the petition.
- (7) RESIDUES FROM LAWFUL APPLICATION- No State or political subdivision 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 section 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.
- (8) SAVINGS- Nothing in this Act preempts the authority of any State or
political subdivision to require that a food containing a pesticide chemical
residue bear or be the subject of a warning or other statement relating to the
presence of the pesticide chemical residue in or on such food.
- (o) CONSUMER RIGHT TO KNOW-
Not later than 2 years after the date of the enactment of the Food Quality
Protection Act of 1996, and annually thereafter, the Administrator shall, in
consultation with the Secretary of Agriculture and the Secretary of Health and
Human Services, publish in a format understandable to a lay person, and
distribute to large retail grocers for public display (in a manner determined by
the grocer), the following information, at a minimum:
- (1) A discussion of the risks and benefits of pesticide chemical
residues in or on food purchased by consumers.
- '(2) A listing of actions taken under subparagraph (B) of subsection (b)(2)
that may result in pesticide chemical residues in or on food that present a
yearly or lifetime risk above the risk allowed under subparagraph (A) of such
subsection, and the food on which the pesticide chemicals producing the residues
are used.
- (3) Recommendations to consumers for reducing dietary exposure to pesticide
chemical residues in a manner consistent with maintaining a healthy diet,
including a list of food that may reasonably substitute for food listed under
paragraph (2). Nothing in this subsection shall prevent retail grocers from
providing additional information.
- (p) ESTROGENIC SUBSTANCES SCREENING PROGRAM-
- (1) DEVELOPMENT- Not later than 2 years after the date of enactment of this
section, the Administrator shall in consultation with the Secretary of Health
and Human Services develop a screening program, using appropriate validated test
systems and other scientifically relevant information, to determine whether
certain substances may have an effect in humans that is similar to an effect
produced by a naturally occurring estrogen, or such other endocrine effect as
the Administrator may designate.
- (2) IMPLEMENTATION- Not later than 3 years after the date of enactment of
this section, after obtaining public comment and review of the screening program
described in paragraph (1) by the scientific advisory panel established under
section 25(d) of the Federal Insecticide, Fungicide, and Rodenticide Act or the
science advisory board established by section 8 of the Environmental Research,
Development, and Demonstration Act of 1978 (42 U.S.C. 4365), the Administrator
shall implement the program.
- (3) SUBSTANCES- In carrying out the screening program described in
paragraph (1), the Administrator--
- (A) shall provide for the testing of all pesticide chemicals; and
- (B) may provide for the testing of any other substance that may have an
effect that is cumulative to an effect of a pesticide chemical if the
Administrator determines that a substantial population may be exposed to such
substance.
- (4) EXEMPTION- Notwithstanding paragraph (3), the Administrator may, by
order, exempt from the requirements of this section a biologic substance or
other substance if the Administrator determines that the substance is
anticipated not to produce any effect in humans similar to an effect produced by
a naturally occurring estrogen.
- (5) COLLECTION OF INFORMATION-
- (A) IN GENERAL- The Administrator shall issue an order to a registrant of a
substance for which testing is required under this subsection, or to a person
who manufactures or imports a substance for which testing is required under this
subsection, to conduct testing in accordance with the screening program
described in paragraph (1), and submit information obtained from the testing to
the Administrator, within a reasonable time period that the Administrator
determines is sufficient for the generation of the information.
- (B) PROCEDURES- To the extent practicable the Administrator shall minimize
duplicative testing of the same substance for the same endocrine effect,
develop, as appropriate, procedures for fair and equitable sharing of test
costs, and develop, as necessary, procedures for handling of confidential
business information.
- (C) FAILURE OF REGISTRANTS TO SUBMIT INFORMATION-
- (i) SUSPENSION- If a registrant of a substance referred to in paragraph
(3)(A) fails to comply with an order under subparagraph (A) of this paragraph,
the Administrator shall issue a notice of intent to suspend the sale or
distribution of the substance by the registrant. Any suspension proposed under
this paragraph shall become final at the end of the 30-day period beginning on
the date that the registrant receives the notice of intent to suspend, unless
during that period a person adversely affected by the notice requests a hearing
or the Administrator determines that the registrant has complied fully with this
paragraph.
- (ii) HEARING- If a person requests a hearing under clause (i), the hearing
shall be conducted in accordance with section 554 of title 5, United States
Code. The only matter for resolution at the hearing shall be whether the
registrant has failed to comply with an order under subparagraph (A) of this
paragraph. A decision by the Administrator after completion of a hearing shall
be considered to be a final agency action.
- (iii) TERMINATION OF SUSPENSIONS- The Administrator shall terminate a
suspension under this subparagraph issued with respect to a registrant if the
Administrator determines that the registrant has complied fully with this
paragraph.
- (D) NONCOMPLIANCE BY OTHER PERSONS- Any person (other than a registrant)
who fails to comply with an order under subparagraph (A) shall be liable for the
same penalties and sanctions as are provided under section 16 of the Toxic
Substances Control Act (15 U.S.C. 2601 and following) in the case of a violation
referred to in that section. Such penalties and sanctions shall be assessed and
imposed in the same manner as provided in such section 16.
- (6) AGENCY ACTION- In the case of any substance that is found, as a result
of testing and evaluation under this section, to have an endocrine effect on
humans, the Administrator shall, as appropriate, take action under such
statutory authority as is available to the Administrator, including
consideration under other sections of this Act, as is necessary to ensure the
protection of public health.
- (7) REPORT TO CONGRESS- Not later than 4 years after the date of enactment
of this section, the Administrator shall prepare and submit to Congress a report
containing--
- (A) the findings of the Administrator resulting from the screening program
described in paragraph (1);
- (B) recommendations for further testing needed to evaluate the impact on
human health of the substances tested under the screening program; and
- (C) recommendations for any further actions (including any action described
in paragraph (6)) that the Administrator determines are appropriate based on the
findings.
- (q) SCHEDULE FOR REVIEW-
- (1) IN GENERAL- The Administrator shall review tolerances and exemptions
for pesticide chemical residues in effect on the day before the date of the
enactment of the Food Quality Protection Act of 1996, as expeditiously as
practicable, assuring that--
- (A) 33 percent of such tolerances and exemptions are reviewed within 3
years of the date of enactment of such Act;
- (B) 66 percent of such tolerances and exemptions are reviewed within 6
years of the date of enactment of such Act; and
- (C) 100 percent of such tolerances and exemptions are reviewed within 10
years of the date of enactment of such Act.
In conducting a review
of a tolerance or exemption, the Administrator shall determine whether the
tolerance or exemption meets the requirements of subsections (b)(2) or (c)(2)
and shall, by the deadline for the review of the tolerance or exemption, issue a
regulation under subsection (d)(4) or (e)(1) to modify or revoke the tolerance
or exemption if the tolerance or exemption does not meet such requirements.
- (2) PRIORITIES- In determining priorities for reviewing tolerances and
exemptions under paragraph (1), the Administrator shall give priority to the
review of the tolerances or exemptions that appear to pose the greatest risk to
public health.
- (3) PUBLICATION OF SCHEDULE- Not later than 12 months after the date of the
enactment of the Food Quality Protection Act of 1996, the Administrator shall
publish a schedule for review of tolerances and exemptions established prior to
the date of the enactment of the Food Quality Protection Act of 1996. The
determination of priorities for the review of tolerances and exemptions pursuant
to this subsection is not a rulemaking and shall not be subject to judicial
review, except that failure to take final action pursuant to the schedule
established by this paragraph shall be subject to judicial review.
- (r) TEMPORARY TOLERANCE OR EXEMPTION-
The Administrator may, upon the request of any person who has obtained an
experimental permit for a pesticide chemical under the Federal Insecticide,
Fungicide, and Rodenticide Act or upon the Administrator's own initiative,
establish a temporary tolerance or exemption for the pesticide chemical residue
for the uses covered by the permit. Subsections (b)(2), (c)(2), (d), and (e)
shall apply to actions taken under this subsection.
Nothing in this section shall be construed to amend or modify the provisions
of the Toxic Substances Control Act or the Federal Insecticide, Fungicide, and
Rodenticide Act.
SEC. 406. AUTHORIZATION FOR INCREASED MONITORING.
For the fiscal years 1997 through 1999, there is authorized to be
appropriated in the aggregate an additional $12,000,000 for increased monitoring
by the Secretary of Health and Human Services of pesticide residues in imported
and domestic food.
SEC. 407. ALTERNATIVE ENFORCEMENT.
Section 303(g) (21 U.S.C. 333(f)) is amended--
- (1) by redesignating paragraphs (2), (3), and (4) as paragraphs (3),
(4), and (5), respectively;
- (2) by inserting after paragraph (1) the following:
- (2)(A) Any person who introduces into interstate commerce or delivers for
introduction into interstate commerce an article of food that is adulterated
within the meaning of section 402(a)(2)(B) shall be subject to a civil money
penalty of not more than $50,000 in the case of an individual and $250,000 in
the case of any other person for such introduction or delivery, not to exceed
$500,000 for all such violations adjudicated in a single proceeding.
- (B) This paragraph shall not apply to any person who grew the article of
food that is adulterated. If the Secretary assesses a civil penalty against any
person under this paragraph, the Secretary may not use the criminal authorities
under this section to sanction such person for the introduction or delivery for
introduction into interstate commerce of the article of food that is
adulterated. If the Secretary assesses a civil penalty against any person under
this paragraph, the Secretary may not use the seizure authorities of section 304
or the injunction authorities of section 302 with respect to the article of food
that is adulterated.
- (C) In a hearing to assess a civil penalty under this paragraph, the
presiding officer shall have the same authority with regard to compelling
testimony or production of documents as a presiding officer has under section
408(g)(2)(B). The third sentence of paragraph (3)(A) shall not apply to any
investigation under this paragraph.
- (3) in paragraph (3), as so redesignated, by striking 'paragraph (1)' each
place it occurs and inserting 'paragraph (1) or (2)';
- (4) in paragraph (4), as so redesignated, by striking '(2)(A)' and
inserting '(3)(A)'; and
- (5) in paragraph (5), as so redesignated, by striking '(3)' each place it
occurs and inserting '(4)'.
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