I
103D CONGRESS
2D SESSION
H. R. 4362
To amend the Federal Food, Drug, and Cosmetic Act to revise the authority
under that Act to regulate pesticide chemical residues in food.
IN THE HOUSE OF REPRESENTATIVES
MAY 5, 1994
Mr. WAXMAN (by request) introduced the following bill; which was referred
to the Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
revise the authority under that Act to regulate pesticide
chemical residues in food.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; REFERENCE; TABLE OF CON-
TENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Pesticide Reform Act of 1994’’.
(b) REFERENCE.—Whenever in this Act an amend-
ment 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 provi-
sion of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.).
(c) TABLE OF CONTENTS.—The table of contents of
this Act is as follows:
Sec. 1. Short title; reference; table of contents.
Sec. 2. Definitions.
Sec. 3. Tolerances and exemptions for pesticide chemical residues.
‘‘Sec. 408. Tolerances and exemptions for pesticide chemical residues.
‘‘(a) Requirement for tolerance or exemption.
‘‘(b) Tolerances.
‘‘(c) Exemptions.
‘‘(d) Petitions and action on the initiative of the Administrator.
‘‘(e) Temporary tolerance or exemption.
‘‘(f) Confidentiality of data.
‘‘(g) Existing pesticide chemical residues.
‘‘(h) Food and Drug Administration monitoring of pesticide chem-
ical residues.
‘‘(i) Fees.
‘‘(j) Judicial review.’’
Sec. 4. Embargo authority.
Sec. 5. Civil Money Penalties.
Sec. 6. Recall.
Sec. 7. Evaluation of existing pesticide chemical residue tolerances and exemp-
tions.
Sec. 8. Fees.
Sec. 9. General definitions.
SEC. 2. DEFINITIONS.
(a) PESTICIDE.—
(1) PESTICIDE CHEMICAL.—Section 201(q) (21
U.S.C. 321(q)) is amended to read as follows:
‘‘(q)(1) The term ‘pesticide chemical’ means any sub-
stance that is a pesticide, as defined in section 2(u) of
the Federal Insecticide, Fungicide, and Rodenticide Act
(7 U.S.C. 136(u)), including each active ingredient and
inert ingredient, as defined in paragraphs (a) and (m) of
section 2 of such Act, of the pesticide.
‘‘(2) The term ‘pesticide chemical residue’ means a
residue in or on food of—
‘‘(A) any pesticide chemical or a component of
such chemical; or
‘‘(B) any other substance that is present in or
on the commodity or food as a result of the metabo-
lism or other degradation of a pesticide chemical.’’
(2) 
PERSON.—Section 
201(s) 
(21 
U.S.C.
321(s)) is amended—
(A) by striking paragraphs (1) and (2) and
inserting the following:
‘‘(1) pesticide chemical residue; or’’; and
(B) by redesignating paragraphs (3), (4),
and (5) as paragraphs (2), (3), and (4), respec-
tively.
(3) RAW
AGRICULTURAL
COMMODITY.—Para-
graph (r) of section 201 (21 U.S.C. 321) is repealed.
(b) CONFORMING AMENDMENTS.—
(1) Section 201 (21 U.S.C. 321) is amended by
adding at the end the following:
‘‘(gg) The term ‘Administrator’ means the Adminis-
trator of the Environmental Protection Agency.’’.
(2) Section 402(a)(2) (21 U.S.C. 342(a)(2)) is
amended—
(A) in clause (A)(i), to read as follows: ‘‘(i)
a pesticide chemical residue’’;
(B) in clause (B), to read as follows: ‘‘(B)
if it bears or contains a pesticide chemical resi-
due that is unsafe within the meaning of sec-
tion 408(a);’’; and
(C) in clause (C), by striking ‘‘: Provided,
That where a pesticide chemical’’ through ‘‘sec-
tion 512’’.
(3) Section 403(l) (21 U.S.C. 343(l)) is amend-
ed by striking ‘‘raw agricultural commodity’’ and
‘‘commodity’’ each time it occurs and inserting
‘‘food’’.
SEC. 3. TOLERANCES AND EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES.
Section 408 (21 U.S.C. 346a) is amended to read as
follows:
‘‘SEC. 408. TOLERANCES AND EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES.
‘‘(a) REQUIREMENT FOR TOLERANCE OR EXEMP-
TION.—
‘‘(1) GENERAL RULE.—Any pesticide chemical
residue shall be deemed unsafe for the purpose of
section 402(a)(2)(B) unless—
‘‘(A) a tolerance for such residue is in ef-
fect under this section and such residue con-
forms with such tolerance; or
‘‘(B) an exemption for such residue is in
effect under this section and such residue con-
forms with such exemption.
‘‘(2) EFFECT
OF
A
TOLERANCE
OR
EXEMP-
TION.—While a tolerance or exemption from the re-
quirement for a tolerance is in effect under this sec-
tion for a pesticide chemical residue with respect to
any food, such food shall not by reason of bearing
or containing any amount of such residue be consid-
ered to be adulterated within the meaning of section
402(a)(1).
‘‘(3) DERIVED FOOD.—A tolerance or exemp-
tion for a pesticide chemical residue established for
a food shall apply to all foods derived from such
food unless a tolerance specifies otherwise.
‘‘(b) TOLERANCES.—
‘‘(1) AUTHORITY.—
‘‘(A) IN
GENERAL.—The Administrator
may promulgate regulations establishing, modi-
fying, or revoking a tolerance for a pesticide
chemical residue—
‘‘(i) in response to a petition filed
under subsection (d)(1); or
‘‘(ii) on the initiative of the Adminis-
trator under subsection (d)(4).
‘‘(B) EXPIRATION
DATE.—A regulation
under this paragraph shall contain an expira-
tion date for a tolerance for a pesticide chemi-
cal established by the regulation. Such date
shall be not later than—
‘‘(i) the expiration date (if any) for
such pesticide chemical established by the
Administrator under section 3 of the Fed-
eral 
Insecticide, 
Fungicide, 
and
Rodenticide Act, or
‘‘(ii) 18 years after the date such tol-
erance is established,
whichever occurs first.
‘‘(C) 
SEPARATE
TOLERANCES.—Under
subparagraph (A), the Administrator may es-
tablish a separate tolerance, which more closely
reflects actual exposure or which is necessary
for more efficient enforcement, and which is
based on reliable data and information relating
to the appropriate sampling, for a pesticide
chemical residue with respect to food at any
point in the chain of production or marketing,
including—
‘‘(i) at the time the food is harvested,
‘‘(ii) at the time the food is purchased
at retail, and
‘‘(iii) after the food is processed.
‘‘(2) STANDARD.—
‘‘(A) ASSURANCE OF SAFETY.—
‘‘(i) GENERAL RULE.—A tolerance for
a pesticide chemical residue in or on food
shall not be established or left in effect un-
less the residue permitted under the toler-
ance is safe.
‘‘(ii) CANCER.— For pesticides found
to induce cancer when ingested by humans
or animals or determined on the basis of
reliable scientific evidence to pose a poten-
tial dietary risk of cancer in humans, a tol-
erance shall not be established or left in ef-
fect unless the Administrator finds on the
basis of conservative methods of risk as-
sessment that the risk is negligible for all
anticipated consumer exposures to such
residue, including all other anticipated
consumer exposures for which there is reli-
‘‘(II) MARGIN
OF
SAFETY.—A
margin of safety is considered ample
if the Administrator determines there
is a reasonable certainty of no harm
to significant subpopulations from ex-
posure to the pesticide chemical resi-
due in the diet and from exposure to
the pesticide chemical by other path-
ways. In making this determination,
the Administrator shall give due con-
sideration to the exposure level which
is determined not to cause adverse ef-
fects in animal studies or in observa-
tions of exposed humans and to the
application of appropriate factors.
These factors may include factors to
account for differences in sensitivity
between and within species, adequacy
of the study or studies, and complete-
ness of the available data to assess
potential for adverse effects.
‘‘(III) RISK ASSESSMENT PROCE-
DURES.—The Administrator shall pe-
riodically review the risk assessment
procedures used to make safety deter-
minations under this paragraph, in-
cluding methodologies with respect to
estimating 
exposure 
to 
pesticide
chemicals and evaluating risks to sig-
nificant subpopulations. The Adminis-
trator periodically shall revise the risk
assessment procedures accordingly to
incorporate advances in science and
risk assessment. The Administrator
may determine that a method of risk
assessment different from the method
required by subclause (II) is appro-
priate if the Administrator finds that
the alternative risk assessment meth-
od will fully protect the public health.
‘‘(B) FACTORS.—In determining whether
to establish, modify, or revoke a tolerance under
subparagraph (A) for a pesticide chemical resi-
due on a food, the Administrator—
‘‘(i) except as provided in clause (ii),
shall in estimating the anticipated dietary
exposure to such residue assume that all
food for which the pesticide chemical resi-
due has or will have a tolerance bears or
contains residues of the pesticide chemical
equal to the levels established by their re-
spective tolerances and where separate tol-
erances for a pesticide chemical residue in
the same food are established for different
points in the chain of production or mar-
keting pursuant to subsection (b)(1)(C),
the Administrator shall assume that the
food bears or contains residues of the pes-
ticide chemical equal to the level estab-
lished by the tolerance set at the point
closest to the time the food is purchased at
retail;
‘‘(ii) may use data regarding the per-
cent of a crop treated by a pesticide chemi-
cal to estimate dietary exposure to such
residue only if the Administrator—
‘‘(I) finds that the data are reli-
able 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 esti-
mate does not understate exposure for
any significant subpopulation group;
‘‘(III) if data are available on
pesticide use and consumption of food
in a particular area, finds that 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 antici-
pated dietary exposure;
‘‘(iii) shall fully account for available
information on the probable consumption
of foods for which there is or will be a tol-
erance for residues of the pesticide chemi-
cal, including, to the extent possible, con-
sumption by significant subpopulations
with differing food consumption patterns,
including infants, children, and other sub-
populations with disproportionately high
consumption of particular foods;
‘‘(iv) shall fully account for available
information on the cumulative effect of
such residue and any chemically or phar-
macologically related substances in the
human diet, and other ways in which the
consumer may be exposed to such residue
and substances, including, to the extent
representative data permit, through drink-
ing water;
‘‘(v) shall fully account for valid sci-
entific information regarding any estro-
genic or other hormonal effects associated
with the residue; and
‘‘(vi) shall apply safety factors which
after consultation with experts qualified by
scientific training and experience to evalu-
ate the safety of pesticide chemical resi-
dues determine are appropriate for use in
connection with animal experimentation or
other relevant data.
‘‘(C) EXPOSURE OF INFANTS AND CHIL-
DREN.—In determining whether to establish,
modify, or revoke a tolerance for a pesticide
chemical residue, the Administrator, in addition
to the requirements of subparagraph (B)—
‘‘(i) shall assess the risk of the pes-
ticide chemical residue based on the follow-
ing:
‘‘(I) Available information about
consumption patterns among infants
and children that are likely to result
in disproportionately high consump-
tion of foods containing or bearing
such residue among infants and chil-
dren in comparison to the general
population.
‘‘(II) Available information con-
cerning the special susceptibility of in-
fants and children to the pesticide
chemical residues, including neuro-
logical differences between infants and
children and adults, and effects of in
utero exposure to pesticide chemicals.
‘‘(III) Available information con-
cerning the cumulative effects on in-
fants and children of such residues
and other substances that have a com-
mon mechanism of toxicity;
‘‘(ii) shall—
‘‘(I) ensure that there is an
ample margin of safety for infants
and children and impose other re-
quirements necessary to ensure that
exposure to the pesticide chemical res-
idue will be safe; and
‘‘(II) publish a specific deter-
mination 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 consulta-
tion with the Administrator, shall conduct sur-
veys to document dietary exposure to pesticides
among infants and children. For the purpose of
subclause (I), an additional 10-fold margin of
safety for the pesticide chemical residue and
other sources of exposure shall be applied for
children and infants to take into account poten-
tial pre- and post-natal toxicity and complete-
ness of the data with respect to exposure to in-
fants and children. Notwithstanding this re-
quirement for an additional factor, the Admin-
istrator may determine that a margin of safety
for a pesticide chemical residue is considered
ample for children and infants if, on the basis
of reliable data, such margin will fully protect
the public health.
‘‘(D) UNAVOIDABLE
PERSISTENCE.—If a
tolerance or an exemption from the requirement
for a tolerance for a pesticide chemical residue
is revoked and the Administrator finds the pes-
ticide chemical residue will unavoidably persist
in the environment and be found in food, the
Administrator shall establish a new tolerance
under subsection (d)(4) for the pesticide chemi-
cal residue. The level permitted by the tolerance
shall not be greater than and may be less than
the lowest level that permits only such unavoid-
able levels to remain in food. The Administrator
shall evaluate any such tolerance at least every
5 years to determine whether modification of
such tolerance is necessary so that the tolerance
provides only for no greater than the level of
the pesticide chemical residue that is unavoid-
able.
‘‘(E) PRACTICAL
METHODS
OF
ANALY-
SIS.—
‘‘(i) GENERAL RULE.—Except as pro-
vided in clause (ii), a tolerance for a pes-
ticide chemical residue shall not be estab-
lished or left in effect unless the Adminis-
trator determines, after consultation with
the Secretary, that—
‘‘(I) there is a multi-residue
method for detecting and measuring
the levels of such pesticide chemical
residue in or on a food that will meas-
ure the residue at the level established
by the tolerance; and
‘‘(II) such method can be per-
formed by the Secretary on a routine
basis as part of surveillance and com-
pliance sampling of foods for pesticide
chemical residues with the personnel,
equipment, and other resources avail-
able to the Secretary.
‘‘(ii) EXCEPTION.—If the Adminis-
trator is not able to make the determina-
tion described in clause (i), the Adminis-
trator shall identify, after consultation
with the Secretary, the method for detect-
ing and measuring levels of such pesticide
chemical residue in or on a food that will
measure the residue at the level established
by the tolerance. The Administrator shall,
every 2 years after the date of the deter-
mination under this clause, reevaluate the
determination.
‘‘(iii) PESTICIDE REFERENCE STAND-
ARD.—
‘‘(I) PROVISION TO THE ADMIN-
ISTRATOR.—A registrant of a pes-
ticide chemical for which a tolerance
has been established shall provide the
Administrator, upon request, with an
appropriate pesticide reference stand-
ard for such pesticide chemical, in-
cluding standards for all residues of
toxicological significance. Each pes-
ticide reference standard provided to
the Administrator shall be certified by
a competent laboratory for both iden-
tity and purity.
‘‘(II) 
ADMINISTRATOR
AC-
TIONS.—The 
Administrator 
shall
maintain a repository of pesticide ref-
erence standards, audit the certifi-
cation of such standards, and make
such standards available to any pri-
vate, public, domestic, or foreign lab-
oratory requesting the standard. The
Administrator may also request pes-
ticide reference standards for pesticide
chemical manufactured or used in for-
eign countries. To the extent that the
Administrator obtains standards for
pesticide chemicals manufactured or
used in foreign countries, the Admin-
istrator shall certify such standards
for identity and purity and make
them available to any private, public,
domestic, or foreign laboratory re-
questing such standard.
‘‘(III) DEFINITION.—For pur-
poses of this clause, the term ‘pes-
ticide reference standard’ means a
pesticide chemical of known identity,
purity, and composition that is re-
quired for comparison purposes in lab-
oratory 
analysis 
to 
measure 
the
amount and confirm the identity of a
pesticide chemical residue in food.
‘‘(3) CONSISTENT APPLICATION.—The Adminis-
trator shall issue guidelines providing for the con-
sistent application of the requirements of paragraphs
(1) and (2). The lack of guidelines does not affect
the authority of the Administrator to implement
such paragraphs.
‘‘(4) REEVALUATION PERIOD.—Each tolerance
for a pesticide chemical residue established under
this subsection shall prescribe the period (at least
every 5 years) for reevaluating the estimate of the
amount of dietary exposure to such residue made
under paragraph (2)(B)(ii).
‘‘(5) TOLERANCES IN EFFECT ON DATE OF EN-
ACTMENT.—For pesticide chemical residue toler-
ances in effect on the date of enactment of the Pes-
ticide Reform Act of 1994 this subsection shall
apply as prescribed by section 7 of such Act.
‘‘(c) EXEMPTIONS.—
‘‘(1) AUTHORITY.—
‘‘(A) IN
GENERAL.—The Administrator
may promulgate regulations establishing or re-
voking an exemption from the requirement for
a tolerance for a pesticide chemical residue—
‘‘(i) in response to a petition filed
under subsection (d)(1); or
‘‘(ii) on the initiative of the Adminis-
trator under subsection (d)(4).
‘‘(B) EXPIRATION DATE.—Such a regula-
tion may provide for an expiration date for the
exemption.
‘‘(2) STANDARD.—
‘‘(A) AUTHORITY AND RISK STANDARD.—
‘‘(i) ESTABLISHMENT.—An exemption
may be established for a pesticide chemical
residue if such residue is not a human or
animal carcinogen and presents no risk to
human health at any level that is reason-
ably likely to occur under extreme condi-
tions of use, including the health of the
subpopulations identified in subsection
(b)(2)(B)(iii), from dietary exposure to
such residue.
‘‘(ii) 
REVOCATION.—An 
exemption
shall be revoked unless the residue is not
a human or an animal carcinogen and oth-
erwise presents no risk to human health at
any level that is reasonably likely to occur
under extreme conditions of use, including
the health of subpopulations identified in
subsection (b)(2)(B)(iii), from dietary ex-
posure to such residue.
‘‘(B) EXPOSURE.—For purposes of sub-
paragraph (A), in determining dietary exposure
to a pesticide chemical residue, the Adminis-
trator shall—
‘‘(i) use only reliable information re-
garding the dietary exposure resulting
from the consumption of the food for
which the exemption for such residue is
proposed or is in effect;
‘‘(ii) fully account for all other exemp-
tions in effect for such residue;
‘‘(iii) fully account for all other
sources of dietary exposure to the pesticide
chemical and to chemically or pharma-
cologically related chemicals if there is ade-
quate information about such sources of
exposure; and
‘‘(iv) consider the exposure to be the
level of exposure that would occur if
human exposure to the pesticide chemical
residue at the level that is reasonably likely
to occur under extreme conditions of use
occurs for a period equal to a lifetime.
‘‘(3) CONSISTENT APPLICATION.—The Adminis-
trator shall issue guidelines providing for the con-
sistent application of the requirements of paragraphs
(1) and (2). The lack of guidelines does not affect
the authority of the Administrator to implement
such paragraphs.
‘‘(4) EXEMPTIONS IN EFFECT ON DATE OF EN-
ACTMENT.—For pesticide chemical residue exemp-
tions in effect on the date of enactment of the Pes-
ticide Reform Act of 1994 this subsection shall
apply as prescribed by section 7 of such Act.
‘‘(d) PETITIONS AND ACTION ON THE INITIATIVE OF
THE ADMINISTRATOR.—
‘‘(1) GENERAL
RULE.—Any person may file
with the Administrator a petition proposing the issu-
ance of a regulation establishing, modifying, or re-
voking a tolerance or exemption for a pesticide
chemical residue. Sections 553 and 554 of title 5,
United States Code, shall not apply with respect to
procedures concerning such petitions.
‘‘(2) REQUIREMENTS FOR PETITIONS.—A peti-
tion under paragraph (1) to establish a tolerance or
exemption for a pesticide chemical residue shall con-
tain—
‘‘(A) an informative summary of the peti-
tion and of the data, information, and argu-
ments submitted or cited in support of the peti-
tion, including—
‘‘(i) a summary of the reports re-
quired under subparagraph (D); and
‘‘(ii) a characterization of—
‘‘(I) the exposure to the pesticide
chemical residue due to any tolerance
or exemption already granted for such
residue; and
‘‘(II) the additional exposure to
such residue that would result if the
requested tolerance or exemption were
granted;
‘‘(B) a proposed tolerance for such residue,
if a tolerance is proposed;
‘‘(C) the name, chemical identity, and com-
position of the pesticide chemical that produces
such residue;
‘‘(D) reports of tests and investigations
made with respect to the safety of such pes-
ticide chemical residue, including complete in-
formation as to the methods and controls used
in conducting such tests and investigations;
‘‘(E) data showing the amount, frequency,
method, and time of application of such pes-
ticide chemical;
‘‘(F) 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 food when ready for sale to
consumers, including a description of the ana-
lytical methods used;
‘‘(G) a description of methods for detecting
and measuring the levels of such pesticide
chemical residue in or on the food, which meth-
ods meet the requirements of subsection
(b)(2)(E);
‘‘(H) reports of investigations conducted
on the effects of processing methods used to
produce food on the level and identity of such
pesticide chemical residue;
‘‘(I) if the petition is for a pesticide chemi-
cal residue that is described in subsection
(b)(2)(A)(ii), all relevant data bearing on the
physical or other technical effect the pesticide
chemical involved is intended to have and the
quantity of the pesticide chemical residue re-
quired to accomplish such effect;
‘‘(J) the pesticide reference standard (as
defined in subsection (b)(2)(E)(iii)) for the pes-
ticide chemical residue;
‘‘(K) such other data and information as
the Administrator may require to support the
petition; and
‘‘(L) the data referred to in subsection
(b)(2)(B)(ii)(III) if available.
‘‘(3) ACTIONS ON PETITIONS.—
‘‘(A) FILING DETERMINATION.—
‘‘(i) IN GENERAL.—Within 45 days of
the filing of a petition under paragraph (1)
for the establishment, modification, or rev-
ocation of a tolerance or an exemption, the
Administrator shall determine if the peti-
tion complies with the requirements of
paragraph (2) or applicable requirements
for petitions to modify or revoke tolerances
or exemptions from tolerances. If the Ad-
ministrator determines that the petition
complies with such requirements, the Ad-
ministrator shall publish a notice of the fil-
ing of the petition. If the Administrator
determines that the petition does not com-
ply with such requirements, the Adminis-
trator shall notify the petitioner of such
determination.
‘‘(ii) CONTENTS OF NOTICE OF FIL-
ING.—A notice under clause (i) shall—
‘‘(I) if it is a notice of the filing
of a petition to establish a tolerance
or exemption, announce the availabil-
ity of a complete description of the
analytical methods available to the
Administrator for the detection and
measurement of the pesticide chemical
residue with respect to which the peti-
tion is filed and include the summary
required by paragraph (2)(A); and
‘‘(II) if it is a notice of the filing
of a petition to modify or revoke a tol-
erance or exemption, contain the full
petition or a summary of the petition.
‘‘(B) ACTION.—The Administrator shall,
within one year of the publication of a notice
under subparagraph (A) with respect to a peti-
tion, and after giving due consideration to the
petition, any comments on the petition, and any
other information available to the Adminis-
trator—
‘‘(i) issue a final regulation in accord-
ance with the petition establishing, modify-
ing, or revoking a tolerance or exemption
for the pesticide chemical residue;
‘‘(ii) issue a proposed regulation es-
tablishing, modifying, or revoking a toler-
ance or exemption for the pesticide chemi-
cal residue, which tolerance or exemption
is different from the tolerance or exemp-
tion requested in the petition; or
‘‘(iii) issue an order denying the peti-
tion.
‘‘(C) COMMENTS.—If the Administrator is-
sues a notice of the filing of a petition under
subparagraph (A)(i) or a proposed regulation
under subparagraph (B)(ii), the Administrator
shall allow at least 30 days for comments on
such notice or proposed regulation.
‘‘(D) FINAL REGULATION.—If the Admin-
istrator issues a proposed regulation under sub-
paragraph (B)(ii), the Administrator shall issue
a final regulation within 180 days of the date
of the publication of the proposed regulations.
‘‘(E) 
PRIORITIES.—The 
Administrator
shall give priority to petitions for the establish-
ment or modification of a tolerance for a pes-
ticide chemical residue that appears to pose a
significantly lower risk to human health from
dietary exposure than pesticide chemical resi-
dues that have tolerances in effect for the same
or similar uses.
‘‘(4) ACTION ON THE ADMINISTRATOR’S INITIA-
TIVE.—
‘‘(A) GENERAL RULE.—The Administrator
may, on the initiative of the Administrator,
issue a final regulation establishing, modifying,
or revoking a tolerance or exemption for a pes-
ticide chemical residue.
‘‘(B) NOTICE.—Before issuing a final reg-
ulation under subparagraph (A), the Adminis-
trator shall issue a notice of proposed rule-
making and provide a period of not less than 30
days for public comment on the proposed regu-
lation unless the Administrator finds that such
notice and comment would be contrary to the
public interest and states the reasons for the
finding in the notice of the final regulation. If
the Administrator makes such a finding and is-
sues such a regulation, the Administrator shall
provide at least 30 days for comment on the
regulation after it is issued.
‘‘(5) EFFECTIVE DATE.—
‘‘(A) GENERAL RULE.—Except as provided
in subparagraph (B), a final regulation issued
under paragraph (3) or (4) shall take effect
upon publication.
‘‘(B) DELAY.—
‘‘(i) GENERAL RULE.—If a regulation
issued under paragraph (3) or (4) revokes
or modifies a tolerance for a pesticide
chemical residue or revokes an exemption
for a pesticide chemical residue, the Ad-
ministrator may, in accordance with clause
(ii), delay the effective date of the regula-
tion to permit the tolerance or exemption
to remain in effect at a level not to exceed
the level in effect immediately before such
regulation is issued only—
‘‘(I) for foods that contain such
pesticide 
chemical 
residue 
in 
an
amount that is not more than the
amount that would remain if the pes-
ticide chemical had been legally ap-
plied on the date the Administrator
acted under paragraph (3) or (4); and
‘‘(II) if dietary exposure to the
pesticide chemical residue in or on the
foods described in subclause (I) is safe
during the period of delay of the effec-
tive date.
‘‘(ii) PERIOD OF DELAY.—If the Ad-
ministrator finds that delay of the effective
date of such a revocation or modification is
consistent with the public health, the Ad-
ministrator may delay such date under
clause (i), for each type of food that con-
tains such pesticide chemical residue, for
the period that is required for such food to
be sold to consumers in the course of the
usual practice for persons engaged in the
production, 
processing, 
transportation,
storage, and distribution of the food.
‘‘(6) REQUIRED SUBMISSION OF DATA.—
‘‘(A) GENERAL
RULE.—If the Adminis-
trator finds that additional data are required to
determine whether an existing tolerance or ex-
emption from a tolerance meets the safety
standard in subsection (b)(2) or (c)(2), the Ad-
ministrator shall publish an order—
‘‘(i) requiring one or more interested
persons to notify the Administrator that
such person will submit the required data;
‘‘(ii) describing the type of data re-
quired to be submitted;
‘‘(iii) describing the reports required
to be made during and after the collection
of the data; and
‘‘(iv) establishing deadlines for the ac-
tions described in clauses (i), (ii), and (iii).
‘‘(B) DEADLINES.—If an order is issued
under subparagraph (A) with respect to a toler-
ance or an exemption and the Administrator
finds that a deadline or other condition in the
order is not met, the Administrator may revoke,
pursuant to the procedures in paragraph (4),
the tolerance or exemption for failure to comply
with such order.
‘‘(C) EXTENSIONS.—
‘‘(i) EXTENSION REQUEST.—Any per-
son may request the Administrator to issue
an order to extend the schedule established
under subparagraph (A) before the expira-
tion of a deadline in the schedule.
‘‘(ii) GRANT OF REQUEST.—The Ad-
ministrator may grant a request under
clause (i) only if the Administrator finds
that extraordinary circumstances beyond
the control of such person prevented such
person from submitting the required data.
‘‘(iii) EXTENSION.—If the Adminis-
trator issues an order extending a sched-
ule, the Administrator may extend the
deadline for a period no longer than such
times as is necessary for such person to
submit the data.
‘‘(7) TOLERANCE
FOR
USE
OF
PESTICIDES
UNDER AN EMERGENCY EXEMPTION.—If the Admin-
istrator grants an exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act
(7 U.S.C. 136p) for a pesticide chemical, the Admin-
istrator shall establish a tolerance or exemption from
a tolerance for the residue of the pesticide chemical.
Such a tolerance or exemption from a tolerance shall
have an expiration date. The Administrator may es-
tablish such a tolerance or exemption without pro-
viding notice or a period for comment on the toler-
ance or exemption. The Administrator shall promul-
gate regulations within 365 days after the date of
the enactment of this paragraph governing the es-
tablishment of tolerances and exemptions under this
paragraph. Such regulations shall be consistent with
the safety standard under subsection (b)(2) and with
section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act.
‘‘(e) EXPERIMENTAL PERMITS.—To the extent con-
sistent with the public health, the Administrator shall pro-
mulgate regulations for exempting from the operation of
this section new pesticide chemicals intended solely for in-
vestigational use by experts qualified by scientific training
and experience to investigate the safety of pesticide chemi-
cals. Such regulations may, in the discretion of the Admin-
istrator, among other conditions relating to the protection
of the public health, provide for—
‘‘(1) conditioning such exemption upon the es-
tablishment and maintenance of such records, and
‘‘(2) the making of such reports to the Sec-
retary, by the manufacturer or the sponsor of the in-
vestigation of such article, of data (including analyt-
ical reports by investigators) obtained as a result of
such investigational use of such article,
as will enable the Administrator to evaluate the safety of
such article in the event of the filing of an application
pursuant to this section. Such regulations, among other
things, shall set forth the conditions (if any) upon which
food treated with such pesticide chemicals may be mar-
keted for food use.
‘‘(f) CONFIDENTIALITY OF DATA.—
‘‘(1) ACCESS TO DATA AND INFORMATION.—
‘‘(A) GENERAL RULE.—Except as provided
in paragraphs (2) and (3), the Administrator
shall not make public data or information sub-
mitted to the Administrator or cited to the Ad-
ministrator in a petition under subsection
(d)(1) and data and information otherwise con-
sidered by the Administrator in issuing a pro-
posed or final regulation or order under this
section which contains or relates to trade se-
crets or commercial or financial information ob-
tained from a person and is privileged or con-
fidential. The person submitting information
which they believe are privileged or confidential
information shall notify the Administrator of
such information. If a notice is not made to the
Administrator, the Administrator may make
such information public.
‘‘(B) NOTICE.—Except as to data or infor-
mation disclosed under paragraph (2), 30 days
before disclosing data or information claimed as
privileged or confidential under subparagraph
(A), the Administrator shall notify the person
who submitted or cited the data or information
of the intent to disclose the data or information
to the public.
‘‘(2) AUTHORIZED DISCLOSURE FOR GOVERN-
MENTAL PURPOSES.—Data and information that are
entitled to confidential treatment under paragraph
(1)—
‘‘(A) shall be disclosed to either House of
Congress, to the extent of matter within its ju-
risdiction, to any committee or subcommittee of
the Congress, and to any joint committee of the
Congress or subcommittee of such a joint com-
mittee and to the Comptroller General of the
United States;
‘‘(B) shall be disclosed to any officer or
employee of the United States or of any
State—
‘‘(i) in connection with the official du-
ties of such officer or employee under any
law for the protection of health or the envi-
ronment, or
‘‘(ii) for specific law enforcement pur-
poses;
‘‘(C) shall be disclosed, under such security
requirements as the Administrator may provide,
to contractors with the United States and em-
ployees of such contractors, if such disclosure is
necessary for the satisfactory performance by
the contractor of a contract with the United
States or for work in connection with this sec-
tion or other statutes administered by the Ad-
ministrator;
‘‘(D) shall be disclosed to the extent the
Administrator determines disclosure is nec-
essary to protect the public health; and
‘‘(E) may be disclosed when relevant in
any proceeding under this section, except that
disclosure in such a proceeding shall be made in
such manner as to preserve confidentiality to
the extent practicable.
‘‘(3) DISCLOSURE OF HEALTH EFFECTS DATA
AND RESIDUE DATA.—
‘‘(A) GENERAL RULE.—All data and infor-
mation concerning any test of a pesticide chem-
ical residue or a pesticide chemical to determine
the potential effects of such residue or chemical
on human health or concerning the levels of
such residue in or on food shall be available for
disclosure to the public except to the extent
such data or information include—
‘‘(i) manufacturing or quality control
processes,
‘‘(ii) methods for detecting the quan-
tity of any deliberately added inert ingredi-
ent of a pesticide chemical other than
methods for detecting residues of the inert
ingredient in or on food, or
‘‘(iii) the identity or quantity of any
deliberately added inert ingredient of a
pesticide chemical other than an inert in-
gredient which is the subject of a petition
under subsection (d)(1) or an action of the
Administrator under subsection (d)(4).
‘‘(B) DATA AND INFORMATION ALSO SUB-
MITTED UNDER FIFRA.—Data and information
described in subparagraph (A) which were also
submitted to the Administrator under the Fed-
eral Insecticide, Fungicide, and Rodenticide Act
shall be available for disclosure to the public in
accordance with section 10(g) of such Act (7
U.S.C. 136h(g)).
‘‘(g) EXISTING PESTICIDE CHEMICAL RESIDUES.—
‘‘(1) PESTICIDE
CHEMICAL
RESIDUES
UNDER
REGULATIONS UNDER SECTION 406.—Regulations af-
fecting pesticide chemical residues promulgated, in
accordance with sections 701(e) and 406, upon the
basis of public hearings instituted before January 1,
1953, shall be deemed to be tolerances issued under
this section and shall be subject to modification or
revocation under subsection (d).
‘‘(2) PESTICIDE
CHEMICAL
RESIDUES
UNDER
REGULATIONS.—Regulations establishing, modifying,
or revoking tolerances for pesticide chemical residues
under this section and section 409 or exemptions for
pesticide chemical residues under this section on or
before the date of the enactment of this section shall
be deemed to be tolerances or exemptions issued
under this section and shall be subject to modifica-
tion or revocation under subsection (d).
‘‘(3) GENERALLY RECOGNIZED AS SAFE PES-
TICIDE CHEMICAL RESIDUES.—
‘‘(A) GENERAL RULE.—Pesticide chemical
residues that, on the day before the date of the
enactment of the Pesticide Reform Act of 1994,
do not have tolerances or exemptions from tol-
erances under this section because the residues
are generally recognized as safe under this sec-
tion or section 201(s) shall, until the expiration
of the period prescribed by subparagraph (C),
not 
be 
considered 
unsafe 
under 
section
402(a)(2)(B) solely because the residues do not
have such a tolerance or exemption.
‘‘(B) LIST.—The Administrator shall—
‘‘(i) not later than 180 days after the
date of the enactment of such Act, publish
a list of all pesticide chemical residues that
the Administrator has determined are gen-
erally recognized, on the day before the
date of the enactment of such Act, as safe
under this section or section 201(s); and
‘‘(ii) require that any person who, be-
fore the date of the enactment of such Act,
distributed in commerce as a pesticide
chemical, a pesticide chemical that pro-
duces a pesticide chemical residue that is
not on the list described in clause (i), and
that such person determined such pesticide
chemical is generally recognized as safe
under this section or section 201(s), shall
within 6 months of the date of the publica-
tion of the list under clause (i), report to
the Administrator the data that supports
the claim that the pesticide chemical resi-
due is generally recognized as safe.
‘‘(C) DETERMINATION
OF
THE
ADMINIS-
TRATOR.—Not later than 21⁄2 years after the
date of the enactment of the Pesticide Reform
Act of 1994, the Administrator shall determine
if each pesticide chemical reported to the Ad-
ministrator in accordance with subparagraph
(B)(ii) is generally recognized as safe. If the
Administrator determines, by order, that such
pesticide chemical residue is generally recog-
nized as safe, the residue of such pesticide
chemical shall be considered a pesticide chemi-
cal residue subject to an exemption under this
section, which exemption shall be subject to
modification or revocation under subsection (d).
‘‘(h) MONITORING OF PESTICIDE CHEMICAL RESI-
DUES.—
‘‘(1) SAMPLING.—The Secretary shall conduct a
comprehensive surveillance and compliance enforce-
ment monitoring program for domestic and imported
food for pesticide chemical residues to determine if
the pesticide chemical residues are in compliance
with this section. In carrying out this paragraph, the
Secretary shall give priority to—
‘‘(A) sampling foods for pesticide chemical
residues included in a notice under paragraph
(2);
‘‘(B) sampling foods that are high con-
sumption items for infants and children;
‘‘(C) analyzing pesticides most likely to re-
sult in violation of this section;
‘‘(D) conducting incidence and level mon-
itoring; and
‘‘(E) collecting data on dietary intake of
pesticide residues on food as it is consumed.
‘‘(2) NOTIFICATION.—The Administrator shall
notify the Secretary of the pesticide chemical resi-
dues that the Administrator determines, in the ad-
ministration of this section—
‘‘(A) are above the standard prescribed by
subsection (b)(2); or
‘‘(B) are not above such standard but that
may under certain circumstances reach or ex-
ceed such standard.
‘‘(i) 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 ade-
quate service for the performance of the functions of the
Administrator under this section. Under such regulations,
the performance of the services or other functions of the
Administrator under this section may be conditioned upon
the payment of such fees. Such regulations may further
provide that the continuation in effect of a tolerance or
exemption shall be conditioned upon the payment of an
annual fee and for waiver or refund of fees in whole or
in part when, in the judgment of the Administrator, such
waiver or refund is equitable and not contrary to the pur-
poses of this subsection. Such fees shall be deposited in
the Treasury and shall be credited to the appropriation
account of the Administrator for salaries and expenses
and shall be available for costs incurred in carrying out
this section in accordance with appropriation Acts until
expended without fiscal year limitation.
‘‘(j) JUDICIAL REVIEW.—A petition for review of any
final order of the Administrator issued under subsection
(d) or any regulation that is the subject of an order may
be filed by any adversely affected person only in the
United States Court of Appeals for the District of Colum-
bia circuit. Any such petition for review must be filed with-
in 60 days of the issuance of such order or regulation.
Judicial review shall be in accordance with sections 701
through 706 of title 5, United States Code, and the chal-
lenged order or regulation shall be sustained unless it is
found to be arbitrary, capricious, and an abuse of discre-
tion or not in accordance with law. Orders and regulations
of the Administrator with respect to which review could
have been obtained under this subsection shall not be sub-
ject to judicial review in civil or criminal proceedings for
enforcement or other judicial proceedings.’’.
SEC. 4. EMBARGO AUTHORITY.
(a) ADMINISTRATIVE EMBARGO AUTHORITY.—Sec-
tion 304(g) (21 U.S.C 334(g)) is amended by redesignat-
ing paragraph (2) as paragraph (3) and adding after para-
graph (1) the following new paragraph:
‘‘(2) If an officer or employee of the Department has
reason to believe that any article of food is adulterated
within the meaning of section 402(a)(2)(B), the officer or
employee may order the food detained (in accordance with
regulations prescribed by the Secretary) for a reasonable
period which may not exceed 20 days (or 10 days, in the
case of a perishable food) unless the Secretary determines
that a longer period of detention is required to institute
an action under subsection (a) or section 302, in which
case the Secretary may authorize a detention period of not
more than 30 days (or not more than 15 days, in the case
of a perishable food). Regulations of the Secretary shall
require that before a food may be detained, the Secretary
or an officer or employee designated by the Secretary shall
approve the detention order. Such an order may require
the labeling or marking of a food during the period of its
detention for the purpose of identifying the food as de-
tained.’’.
(b) PROHIBITION ON REMOVAL.—Paragraph (3) of
section 304(g) (21 U.S.C. 334(g)), as redesignated by sub-
section (a), is amended—
(1) in subparagraph (A), by striking ‘‘a device
subject to a detention order issued under paragraph
(1)’’ and inserting ‘‘an article subject to a detention
order under paragraph (1) or (2)’’,
(2) in the matter preceding clause (i) of sub-
paragraph (B), by striking ‘‘a device subject to a de-
tention order under paragraph (1)’’ and inserting
‘‘an article subject to a detention order under para-
graph (1) or (2)’’, and
(3) in subparagraph (B)(ii), by striking ‘‘if’’
and inserting ‘‘in the case of a device’’.
(c) PROHIBITED ACT.—Section 301(r) (21 U.S.C.
331(r)) is amended by inserting ‘‘or a food’’ after ‘‘device’’
each time it appears.
SEC. 5. CIVIL MONEY PENALTIES.
Section 303(f) (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 follow-
ing:
‘‘(2) Any person who introduces into interstate com-
merce or delivers for introduction into interstate com-
merce an article of food that is adulterated within the
meaning of section 402(a)(2)(B) shall be subject, in addi-
tion to any other penalties that may be prescribed by law,
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.’’,
(3) in paragraph (3), as so redesignated, by
striking ‘‘paragraph (1)’’ each place it occurs and
inserting ‘‘paragraph (1) or (2)’’, and
(4) in paragraph (5), as so redesignated, by
striking ‘‘(3)’’ each place it occurs and inserting
‘‘(4)’’.
SEC. 6. RECALL.
(a) AUTHORITY.—Chapter III is amended—
(1) by redesignating sections 309 and 310 as
section 310 and 311, respectively, and
(2) by adding after section 308 the following:
‘‘RECALL
‘‘SEC. 309. (a) GENERAL RULE.—If the Secretary
has reason to believe that an article of food is adulterated
within the meaning of section 402(a)(2)(B), the Secretary
may require the manufacturer, processor, or distributor
of such article to take immediately all action necessary to
recall such article from all wholesale and retail establish-
ments. A recall order of the Secretary under this sub-
section shall be a final agency action subject to review by
the United States district court for the judicial district
in which the manufacturer, processor, or distributor re-
sides or transacts business or in which is located the arti-
cle of food that is the subject of such order.
‘‘(b) REPORT.—Manufacturers, processors, and dis-
tributors shall report promptly to the Secretary any recall
of a food undertaken by the manufacturer, processor, or
distributor, including any recall required under subsection
(a) or section 302 and any recall conducted at the initia-
tive of the manufacturer, processor, or distributor on the
grounds that the food may be adulterated within the
meaning of section 402(a)(2)(B).
‘‘(c) SCOPE OF ORDER.—For purposes of this sec-
tion, an order under subsection (a) with respect to an arti-
cle of food shall include an order to retrieve or replace
such article.’’.
(b) PROHIBITED ACT.—Section 301 (21 U.S.C. 331)
is amended by adding at the end the following:
‘‘(w) The failure to comply with a recall order under
section 309(a) or a requirement to report a recall under
section 309(b).’’.
SEC. 7. EVALUATION OF EXISTING PESTICIDE CHEMICAL
RESIDUE TOLERANCES AND EXEMPTIONS.
(a) CLASSIFICATION.—
(1) IDENTIFICATION.—Within 180 days of the
date of enactment of this Act, the Administrator of
the Environmental Protection Agency shall, for each
pesticide chemical residue that has a tolerance or ex-
emption in effect on such date, identify each toler-
ance or exemption which does not appear to meet
the requirements of section 408(b)(2) or 408(c)(2)
of the Federal Food, Drug, and Cosmetic Act and
publish a notice summarizing the data and analysis
upon which such determination is made. The notice
published pursuant to this paragraph shall include
all tolerances for a pesticide chemical, if the cumu-
lative risk from exposure for any pesticide chemical
residue, calculated by the methodology in paragraph
(2), appears not to meet the requirements of section
408(b)(2) of the Federal Food, Drug, and Cosmetic
Act.
(2) FACTORS.—In making the determination
under paragraph (1) with respect to tolerances for
a pesticide chemical residue, the Administrator
shall—
(A) use the toxicological conclusions, in-
cluding appropriate factors where applicable,
used in the most current risk assessment for
the pesticide chemical residue performed by the
Administrator on or before the date of enact-
ment; and
(B) assume that all food for which the pes-
ticide chemical residue has a tolerance bears or
contains residues of the pesticide chemical equal
to the levels established by their respective tol-
erances.
(3) OBJECTIONS.—Any person adversely af-
fected by the Administrator’s action under para-
graph (1) may file objections to the action with the
Administrator. Such objections must be filed within
30 days of publication of the notice required in para-
graph (1). The Administrator shall act on such ob-
jections within 60 days of the receipt of the objec-
tions.
(4) SUBSEQUENT
IDENTIFICATIONS.—On a
yearly basis in the 4 year period after the date of
enactment of this Act, if the Administrator con-
cludes that any additional tolerances or exemptions
do not appear to meet the requirements of section
408(b)(2) and 408(c)(2) of the Federal Food, Drug,
and Cosmetic Act, the Administrator shall identify
such tolerances and exemptions and publish a notice
summarizing the data and analysis upon which such
identification is made. Prior to identifying any addi-
tional tolerances or exemptions under this para-
graph, the Administrator shall publish the identifica-
tion as a proposal and seek public comment.
(b) DATA SUBMISSION.—
(1) DEADLINE FOR SUBMISSION OF DATA ON
APPARENTLY UNACCEPTABLE PESTICIDE CHEMICAL
RESIDUES.—For any pesticide chemical residue for
which the Administrator makes the identification de-
scribed in subsection (a)(1) or (a)(4), any person
wanting to maintain the tolerance or exemption for
such pesticide chemical shall have 2 years from the
publication of the notices in subsection (a) to submit
data or information on such chemical relative to the
safety standard in section 408(b)(2) or 408(c)(2) of
the Federal Food, Drug, and Cosmetic Act.
(2) DEADLINE FOR SUBMISSION OF DATA ON
ALL OTHER PESTICIDE CHEMICAL RESIDUES.—For
any other pesticide chemical residue that had a tol-
erance or exemption from a tolerance on the date of
enactment of this Act, any person wanting to main-
tain the tolerance or exemption for such pesticide
chemical residue shall have not more than 5 years
from such date of enactment, subject to any sched-
ule imposed under paragraph (3), to submit data or
information relative to the safety standards in such
section 408(b)(2) or 408(c)(2) of the Federal Food,
Drug, and Cosmetic Act.
(3) SCHEDULE.—For any pesticide chemical
residue for which the Administrator does not make
the identification described in subsection (a), the
Administrator may establish a schedule for the sub-
mission of data for the tolerance or exemption for
such pesticide chemical residue which data shall be
the basis for a determination by the Administrator
as to whether the tolerance or exemption meets the
requirements of such section 408(b)(2) or 408(c)(2)
of the Federal Food, Drug, and Cosmetic Act.
(4) EXTENSIONS.—
(A) REQUEST.—Any person may request
the Administrator to issue an order to extend a
deadline established under paragraph (1), (2),
or (3) before expiration of the deadline.
(B) GRANT OF REQUEST.—The Adminis-
trator may grant such a request only if the Ad-
ministrator 
finds 
that 
extraordinary 
cir-
cumstances beyond the control of such person
prevented such person from submitting the re-
quired data.
(C) EXTENSION.—If the Administrator is-
sues an order extending a deadline—
(i) the Administrator may extend the
deadline for a period no longer than such
time as is necessary for such person to
submit the data; and
(ii) the Administrator may extend the
deadline in paragraph (1) for no more than
1 year and any deadline established under
paragraph (2) or (3) so long as such exten-
sion does not extend the deadline beyond 6
years from the date of enactment of the
Act.
(c) DEADLINES FOR ACTION.—
(1) 3-YEAR DEADLINE.—Within 3 years of the
date of enactment of this Act, the Administrator
shall issue a final decision for 75 percent of the tol-
erances and exemptions of the pesticide chemical
residues identified in subsection (a)(1) by classifying
such tolerances and exemptions as meeting or not
meeting the requirements of section 408(b)(2) or
408(c)(2) of the Federal Food, Drug, and Cosmetic
Act. Such decisions shall be based only on data re-
ceived by the Administrator before the deadline in
subsection (b)(1) or before the expiration of an ex-
tension granted under subsection (b)(4), whichever
is later.
(2) 4-YEAR DEADLINE.—Within 4 years of the
date of enactment of the Act, the Administrator
shall issue a final decision for 100 percent of the tol-
erances and exemptions of the pesticide chemical
residues identified in subsection (a)(1) by classifying
such tolerances and exemptions as meeting or not
meeting the requirements of section 408(b)(2) or
408(c)(2) of the Federal Food, Drug, and Cosmetic
Act. Such decision shall be based only on data re-
ceived by the Administrator before the deadline in
subsection (b)(1) or before the expiration of an ex-
tension granted under subsection (b)(4), whichever
is later.
(3) DEADLINE
FOR
SUBSEQUENTLY
IDENTI-
FIED
TOLERANCES
AND
EXEMPTIONS.—Within 4
years of the date of identification of a tolerance or
exemption under subsection (a)(4) or 7 years from
the date of enactment, whichever is sooner, the Ad-
ministrator shall issue a final decision classifying
such tolerance or exemption as meeting or not meet-
ing the requirements of section 408(b)(2) or
408(c)(2) of the Federal Food, Drug, and Cosmetic
Act. Such decision shall be based only on data re-
ceived by the Administrator before the deadline in
subsection (b)(1) or before the expiration of an ex-
tension granted under subsection (b)(4), whichever
is later.
(4) 7-YEAR DEADLINE.—Within 7 years of the
date of the enactment of this Act, the Administrator
shall determine if each tolerance or exemption in ex-
istence on the date of enactment of this Act and not
identified in subsection (a) meets the requirements
of section 408(b)(2) or 408(c)(2) of the Federal
Food, Drug, and Cosmetic Act. Such determination
shall be based only on data received by the Adminis-
trator before the deadline in subsection (b)(2) or the
deadline in a schedule established by the Adminis-
trator for the pesticide chemical residue under sub-
section (b)(3) or the expiration of an extension
granted under subsection (b)(4), whichever is later.
(5) REVOCATION PROCEEDINGS.—If the Admin-
istrator determines under this subsection that any
tolerance or exemption does not meet the require-
ments of section 408(b)(2) or 408(c)(2) of the Fed-
eral Food, Drug, and Cosmetic Act, the Adminis-
trator shall promptly initiate revocation proceedings
for such tolerance or exemption under section
408(d) of such Act.
(d) EXPIRATION
OF
A TOLERANCE
OR EXEMP-
TION.—
(1) GENERAL RULE.—No later than 6 and 1⁄2
years but not before 6 years after the date of the en-
actment of this Act, the Administrator shall publish
a list of tolerances and exemptions for pesticide
chemical residues which shall expire 7 years after
such date of enactment, unless the Administrator—
(A) has issued a decision finding that such
pesticide chemical residue meets the require-
ments of section 408(b)(2) or 408(c)(2) of the
Federal Food, Drug, and Cosmetic Act, or
(B) has granted an extension under para-
graph (2).
(2) EXTENSION.—Upon petition of any person,
the Administrator may grant an extension beyond
the 7-year period in section (d)(1), of not more than
1 year for the term of a tolerance or exemption for
a pesticide chemical residue if the Administrator
finds that a person seeking to support such toler-
ance or exemption has met all applicable require-
ments for the submission of information or data re-
quired by subsection (b), the Administrator has not
completed review of the data submitted pursuant to
subsection (b), and the extension would not ad-
versely affect public health. Any tolerance granted
an extension under this paragraph shall expire when
the extension expires, unless prior to expiration of
the extension the Administrator makes the finding
in subparagraph (A).
(3) LIST.—The Administrator shall include on
the list established under paragraph (1) each toler-
ance and exemption which was identified under sub-
section (a)(1) or (a)(4) for which the Administrator
has not issued a decision classifying it as meeting or
not meeting the requirements of section 408(b)(2) or
408(c)(2) of the Federal Food, Drug, and Cosmetic
Act and which the Administrator now determines do
not appear to meet such requirements. The Adminis-
trator shall develop such list using the methodology
specified in subsection (a)(2)(B) and is only required
to consider data submitted on or before the expira-
tion of the deadlines for data submission in sub-
section (b).
(4) OBJECTIONS.—Any person adversely af-
fected by the Administrator’s action under para-
graph (1) may file objections to the action with the
Administrator. The person filing the objection must
file it within 30 days of the publication of the list
under paragraph (1) and must demonstrate, using
the methodology specified in subsection (a)(2)(B)
and considering only data submitted on or before the
expiration of the deadlines for data submission in
subsection (b), that the tolerance or exemption
which was identified under subsection (a)(1) or
(a)(4) should not be included on the list under para-
graph (1). The Administrator shall act on such ob-
jections within 60 days of the receipt of the
objections.
(e) TRANSITIONAL REVOCATION RULE.—
(1) GENERAL RULE.—If the Administrator de-
termines under section 408 of the Federal Food,
Drug, and Cosmetic Act that a tolerance for a pes-
ticide chemical residue should be revoked or if a tol-
erance will expire within 1 year based on operation
of subsection (d), the Administrator may, upon a pe-
tition from any person, extend the tolerance for a
period not longer than 5 years after such determina-
tion if the Administrator finds—
(A) the risk to health presented by expo-
sure to such residue is equal to or less than 10
times the risk allowed under section 408(b)(2)
of such Act, and
(B)(i) that the health benefits to the per-
son exposed to such residue are greater than
the dietary risks to health presented to such
person by such exposure, or
(ii) that such extension is necessary to
avoid a significant disruption in domestic food
production.
The Administrator may not extend a tolerance under
this paragraph for a period which extends beyond 10
years after the date of enactment of this Act.
(2) MODIFICATION.—The Administrator may
modify or revoke a tolerance or exemption extended
under paragraph (1), if the Administrator deter-
mines that circumstances no longer justify the con-
tinuation of such tolerance or exemption as ex-
tended.
(3) DEFINITIONS.—For purposes of this sub-
section, the term ‘‘health benefits’’ means the bene-
fits which occur when the application of a pesticide
chemical residue to a food directly reduces the inci-
dence of illness or disease but such term does not in-
clude benefits from an adequate, wholesome, or eco-
nomical food supply.
(f) DEADLINE SUITS, JUDICIAL REVIEW.—
(1) DEADLINE SUITS.—Any person may com-
mence a civil action on such person’s own behalf
against the Administrator in the United States Dis-
trict Court for the District of Columbia where there
is alleged a failure of the Administrator to perform
any of the nondiscretionary acts required by sub-
sections (c)(2), (c)(3), or (c)(4). The court shall
have jurisdiction in actions brought under this para-
graph to order the Administrator to perform such
act. For suits involving subsections (c)(2) or (c)(3),
if the court finds that the Administrator has failed
to perform a nondiscretionary act, the court shall
have jurisdiction to order the Administrator to per-
form such act within a specified period of time, but
that period may not exceed 8 years after the date of
enactment of this Act. Suits involving subsections
(c)(2) or (c)(3) must be brought within 6 years of
the date of the enactment of this Act. No action may
be commenced prior to 60 days after the plaintiff
has given notice of such action to the Administrator.
(2) JUDICIAL REVIEW.—A petition for review of
a final action of the Administrator under subsection
(a)(3), (a)(4), (d)(2), (d)(3), or (e)(1) may be filed
by any adversely affected person only in the United
States Court of Appeals for the District of Columbia
Circuit. Any such petition for review must be filed
within 60 days of the issuance of the final action.
Judicial review shall be in accordance with sections
701 through 706 of title 5 of the United States
Code, and the challenged action shall be sustained
unless it is found to be arbitrary, capricious, an
abuse of discretion, or not in accordance with law.
Any determinations made by the Administrator
under subsections (b) or (c), shall be subject to judi-
cial review only in a petition for review of a final ac-
tion of the Administrator under section 408(d) of
the Federal Food, Drug, and Cosmetic Act pursuant
to section 408(j) of such Act. In reviewing a final
action of the Administrator under subsection (a)(3),
the court may not extend the deadline for data sub-
mission in subsection (b)(1). Actions of the Adminis-
trator with respect to which review could have been
obtained under this subsection shall not be subject
to judicial review in civil or criminal proceedings for
enforcement or other judicial proceedings.
(g) REPORT TO CONGRESS.—The Administrator shall
annually submit a report to Congress that lists the toler-
ances which have been revoked pursuant to Tolerance Re-
view. The report shall also provide an analysis of the im-
pacts of tolerance revocation.
(h) CONSTRUCTION.—Any reference under this sec-
tion to any provision of section 408 of the Federal Food,
Drug, and Cosmetic Act is a reference to such provision
as amended by this Act.
SEC. 8. FEES.
(a) GENERAL RULE.—The Administrator of the En-
vironmental Protection Agency shall by regulation require
the payment of such fees as will in the aggregate, in the
judgment of the Administrator, be sufficient over a rea-
sonable term to provide, equip, and maintain an adequate
service for the performance of the functions of the Admin-
istrator under this Act. The fee requirement of this sub-
section shall not apply to any agency of the Federal Gov-
ernment.
(b) DEPOSIT, ETC.—Such fees shall be deposited in
the Treasury and shall be credited to the appropriation
account of the Administrator for salaries and expenses
and shall be available for costs incurred in carrying out
this section in accordance with appropriation Acts until
expended without fiscal year limitation.
SEC. 9. GENERAL DEFINITIONS.
As used in sections 4 and 5 of this Act:
(1) IN GENERAL.—The terms that are also used
in section 408 of the Federal Food, Drug, and Cos-
metic Act shall have the meanings given the terms
by sections 201 and 408 of such Act.
(2) DIETARY
EXPOSURE.—The term ‘‘dietary
exposure’’ means dietary exposure as determined
under section 408(b)(2)(C) of the Federal Food,
Drug, and Cosmetic Act.
(3) 
EXEMPTION.—The 
term 
‘‘exemption’’
means an exemption from the requirement for a tol-
erance under section 408 of the Federal Food, Drug,
and Cosmetic Act.
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