I
103D CONGRESS
1ST SESSION
H. R. 872
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
FEBRUARY 4, 1993
Mr. WAXMAN 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 Food Safety Act of 1993’’.
(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. 4. Evaluation of existing pesticide chemical residue tolerances and exemp-
tions.
Sec. 5. Review of existing methods of analysis.
Sec. 6. Fees.
Sec. 7. 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—
‘‘(A) any substance that is a pesticide, as de-
fined in section 2(u) of the Federal Insecticide, Fun-
gicide, and Rodenticide Act (7 U.S.C. 136(u)); and
‘‘(B) each active ingredient and inert ingredi-
ent, as defined in subsections (a) and (m), respec-
tively, of section 2 of the Federal Insecticide, Fun-
gicide, and Rodenticide Act, of the pesticide.
‘‘(2) The term ‘pesticide chemical residue’ means a
residue in or on food of—
‘‘(A) any pesticide chemical; or
‘‘(B) any other substance that is present in the
commodity or food as a result of the metabolism or
other degradation of a pesticide chemical,
regardless of whether the residue may be detected.’’.
(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.
(b) CONFORMING AMENDMENTS.—
(1) Section 201 (21 U.S.C. 321) is amended by
adding at the end the following:
‘‘(gg) The term ‘processed food’ means any food that
has been subject to processing from a raw agricultural
commodity.
‘‘(hh) 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 is, or it bears or contains, a pesticide chem-
ical residue unsafe within the meaning of sec-
tion 408(a);’’; and
(C) in clause (C)—
(i) by striking ‘‘: Provided, That
where a pesticide chemical’’ and inserting
‘‘, except that if a pesticide chemical’’; and
(ii) by striking ‘‘sections 406 and
409’’ and inserting ‘‘section 406’’.
SEC. 3. TOLERANCES AND EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES.
(a) TOLERANCES AND EXEMPTIONS.—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 the quantity of such
residue is within the limits of such tolerance; or
‘‘(B) an exemption for such residue is in
effect under this section and such residue com-
plies 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).
‘‘(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 may provide for an expi-
ration date for the tolerance.
‘‘(C) SEPARATE
TOLERANCES.—The Ad-
ministrator may establish a separate tolerance
under subparagraph (A) for a pesticide chemi-
cal residue with respect to food at each of the
following times:
‘‘(i) At the time the food is harvested.
‘‘(ii) At the time the food is purchased
at retail.
‘‘(iii) After the food is processed.
‘‘(2) STANDARD.—
‘‘(A) GENERAL RULE.—Except as provided
in subparagraph (F)—
‘‘(i) a tolerance may be established for
a pesticide chemical residue only if the risk
to human health from dietary exposure to
the pesticide chemical residue is negligible;
and
‘‘(ii) the tolerance for a pesticide
chemical residue shall be revoked or modi-
fied unless the risk to human health from
dietary exposure to the pesticide chemical
residue is negligible.
‘‘(B) NEGLIGIBLE RISK.—
‘‘(i) GENERAL
RULE.—For purposes
of this paragraph, a risk to human health
from dietary exposure to a pesticide chemi-
cal residue is negligible only if dietary ex-
posure to the residue is reasonably certain
to cause no harm to human health and the
tolerance for such residue meets the re-
quirements of clause (ii) or (iii).
‘‘(ii) THRESHOLD PESTICIDES.—
‘‘(I) IN
GENERAL.—If the Ad-
ministrator is able to identify a level
at which a pesticide chemical residue
will not cause or contribute to any
known or anticipated harm to human
health, the Administrator may estab-
lish or leave in effect a level for a tol-
erance for such residue only if the Ad-
ministrator finds that such tolerance
will provide an ample margin of safe-
ty, for each population group set out
in subparagraph (E).
‘‘(II) 
CONSIDERATIONS.—The
level described in subclause (I) shall
be based on consideration of—
‘‘(aa) the nature of the toxic
effects caused by such residue
and data regarding the preva-
lence of the same effects caused
by other chemicals;
‘‘(bb) the validity, complete-
ness, and the reliability of the
data about the pesticide chemical
residue;
‘‘(cc) the variability of indi-
vidual sensitivities and the sen-
sitivities of population subgroups
to the adverse effects from such
residue; and
‘‘(dd) the possibility that
human susceptibility to such ad-
verse 
effects 
is 
significantly
greater than that of test animals.
‘‘(III) MARGIN OF SAFETY.—For
purposes of this clause, a margin of
safety for a level of a pesticide chemi-
cal residue is not ample unless human
exposure per unit of body measure-
ment, to the pesticide chemical resi-
due and other chemicals that cause
the same effect, is at least 100 times
less than the no observable effect level
in animals on which the pesticide
chemical residue was tested, and, if
human data are available, at least 10
times less than the no observable ef-
fect level in humans exposed to such
residue. The no observable effect level
is the level of exposure to a pesticide
chemical that reliable data, derived
from exposure of humans or animals
to the pesticide chemical, demonstrate
will cause no adverse effect.
‘‘(iii) NONTHRESHOLD PESTICIDES.—
If the Administrator is not able to identify
a level at which a pesticide chemical resi-
due will not cause or contribute to any
known or anticipated harm to human
health or if the Administrator finds that a
pesticide chemical residue causes cancer in
animals or humans, the Administrator may
establish a level for a tolerance for such
residue or leave a level in effect for such
residue only if the Administrator finds that
such level—
‘‘(I) will not cause or contribute
to, in individuals exposed to such pes-
ticide chemical residue, a lifetime risk
of an adverse human health effect
that occurs at a rate of one in a mil-
lion or a risk of an adverse human
health effect that occurs at a rate of
one in a million, divided by 70, for
any single year of exposure during the
first 5 years of the life of an exposed
person, using conservative risk assess-
ment models;
‘‘(II) is the lowest level reason-
ably required to allow the accomplish-
ment of the physical or other technical
effect for which the use of the pes-
ticide chemical involved is intended;
and
‘‘(III) in the case of processed
food, is the lowest level that occurs if
such pesticide chemical residue is re-
moved to the extent possible in ac-
cordance with good manufacturing
practice.
‘‘(C) EXPOSURE.—Except as provided in
subparagraph (D), in determining dietary expo-
sure to a pesticide chemical residue for pur-
poses of this paragraph, the Administrator
shall—
‘‘(i)(I) use only reliable, statistically
significant data regarding the dietary expo-
sure to persons who have consumed the
food for which the tolerance for the residue
is proposed or is in effect;
‘‘(II) take into account all other toler-
ances in effect for the same pesticide
chemical residue; and
‘‘(III) take into account all other
sources (including drinking water if data
demonstrating widespread or significant
regional contamination in drinking water
are available) of dietary exposure to the
same pesticide chemical residue; and
‘‘(ii) consider the exposure to be the
level of exposure that would occur if—
‘‘(I) all the food, for which the
tolerance for the pesticide chemical
residue is proposed or in effect, has
amounts of the pesticide chemical res-
idue equal to the tolerance proposed
or in effect;
‘‘(II) all other sources of dietary
exposure to such residue described in
clause (i)(III) occur; and
‘‘(III) human exposure to the
pesticide chemical residue at the toler-
ance level occurs for a period equal to
a lifetime.
‘‘(D) SPECIAL EXPOSURE RULE.—
‘‘(i) DATE.—The Administrator may
calculate dietary exposure to a food based
on reliable data that provide the Adminis-
trator with a valid statistical basis to iden-
tify the percentage of the food in which the
pesticide chemical residue actually occurs.
‘‘(ii) PERCENTAGE.—Such percentage
shall be not less than the percentage of the
food consumed in an appropriate locality,
identified by the Administrator, which per-
centage represents the highest level of ex-
posure to such residue in the United
States.
‘‘(iii) REEVALUATION.—The Adminis-
trator shall reevaluate the determination
under this subparagraph every 2 years
after the date of the determination. If,
under such a reevaluation, the Adminis-
trator finds that the determination is not
justified, the Administrator shall promptly
issue a regulation requiring that the toler-
ance involved be set on the basis of the
new determination.
‘‘(E) POPULATION
COVERED.—In deter-
mining if the dietary exposure to a pesticide
chemical residue is negligible, the Administrator
shall evaluate the risk to—
‘‘(i) infants of the age 0 to 1;
‘‘(ii) children of the age 1 to 2;
‘‘(iii) children of the age 2 to 3;
‘‘(iv) children of the age 3 to 4;
‘‘(v) children of the age 4 to 5;
‘‘(vi) children of the age 6 to 10;
‘‘(vii) adolescents of the age 11 to 18;
‘‘(viii) other population groups that
have been identified by the Administrator
to have special food consumption patterns
or for which data are sufficient to dem-
onstrate special food consumption patterns;
and
‘‘(ix) the entire population,
who consume food with such pesticide chemical
residue.
‘‘(F) 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 contaminate 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 the lowest level that
permits only such unavoidable levels to remain
in food. The Administrator shall evaluate any
such tolerance at least once a year to determine
whether modification of such tolerance is nec-
essary so that the tolerance provides only for
the level of the pesticide chemical residue that
is unavoidable.
‘‘(G) PRACTICAL
METHODS
OF
ANALY-
SIS.—
‘‘(i) GENERAL RULE.—A tolerance for
a pesticide chemical residue shall not be
established or allowed to remain in effect
unless the Administrator determines, after
consultation with the Secretary, that—
‘‘(I) there is a method for detect-
ing and measuring the levels of such
pesticide chemical residue in or on a
food that will detect the residue at the
level established by the tolerance; and
‘‘(II) except as provided in clause
(ii), such method is the best available,
practical method.
‘‘(ii) SPECIAL RULE.—If the Adminis-
trator determines that a practical method
of analysis for a pesticide chemical residue
is not available, the Administrator shall
identify the best available method that is
designed to identify the lowest detectable
amount of the pesticide chemical residue.
The Administrator shall, every 2 years
after the date of the determination under
this clause, reevaluate the determination.
‘‘(iii) PRACTICAL METHOD.—A meth-
od shall be considered practical for pur-
poses of this subparagraph only if it is a
multiresidue method that can be performed
by the Secretary on a routine basis as part
of surveillance and compliance sampling of
foods for pesticide chemical residues with
the personnel, equipment, and other re-
sources available to the Secretary, or, if no
multiresidue method is available, only if it
can be so performed by the Secretary.
‘‘(3) CONSISTENT APPLICATION.—The Adminis-
trator shall issue guidelines providing for the con-
sistent application of the requirements of paragraphs
(1) and (2).
‘‘(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 otherwise presents
no risk to human health, including the
health of individuals in the population
groups set out in subsection (b)(2)(E),
from dietary exposure to such residue.
‘‘(ii) 
REVOCATION.—An 
exemption
shall be revoked unless the residue is not
a human or animal carcinogen and the res-
idue does not present any risk to human
health, including the health of individuals
in the population groups set out in sub-
section (b)(2)(E), from dietary exposure to
such residue.
‘‘(iii) 
TOLERANCE.—No 
exemption
may be established or allowed to remain in
effect for a pesticide chemical residue for
which there is in effect a tolerance.
‘‘(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, statistically sig-
nificant data regarding the dietary expo-
sure resulting from the consumption of the
food for which the exemption for such resi-
due is proposed or is in effect;
‘‘(ii) take into account all other ex-
emptions in effect for such residue and all
other sources (including drinking water if
data demonstrating widespread or signifi-
cant regional contamination in drinking
water are available) of dietary exposure to
such residue; and
‘‘(iii) consider the exposure to be the
level of exposure that would occur if—
‘‘(I) all the food, for which the
tolerance for such residue is proposed
or in effect, has amounts of such resi-
due equal to the tolerance proposed or
in effect, respectively;
‘‘(II) all other sources of dietary
exposure to such residue described in
clause (ii) occur; and
‘‘(III) human exposure to the
pesticide chemical residue at the toler-
ance level occurs for a period equal to
a lifetime.
‘‘(C) PRACTICAL
METHODS
OF
ANALY-
SIS.—An exemption for a pesticide chemical
residue shall not be established or allowed to re-
main in effect unless the Administrator deter-
mines, after consultation with the Secretary,
that there is a method for detecting and meas-
uring the levels of such pesticide chemical resi-
due on a food and that such method is the best
available, practical method, as defined in sub-
section (b)(2)(G).
‘‘(3) CONSISTENT APPLICATION.—The Adminis-
trator shall issue guidelines providing for the con-
sistent application of the requirements of paragraphs
(1) and (2).
‘‘(d) PETITIONS AND ACTION ON THE INITIATIVE OF
THE ADMINISTRATOR.—
‘‘(1) GENERAL
RULE
FOR
PETITIONS.—Any
person may file with the Administrator a petition
proposing the issuance of a regulation establishing,
modifying, or revoking a tolerance or exemption for
a pesticide chemical residue.
‘‘(2) REQUIREMENTS
FOR
PETITIONS
TO
ES-
TABLISH A TOLERANCE OR EXEMPTION.—
‘‘(A) CONTENTS.—A petition under para-
graph (1) to establish a tolerance or exemption
for a pesticide chemical residue shall contain—
‘‘(i) an informative summary of the
petition and of the data, information, and
arguments submitted or cited in support of
the petition, including—
‘‘(I) a summary of the reports re-
quired under clause (iv) respecting the
safety of the pesticide chemical resi-
due; and
‘‘(II) a characterization of—
‘‘(aa) the exposure to the
pesticide chemical residue due to
any tolerance or exemption al-
ready granted for such residue;
and
‘‘(bb) the additional expo-
sure to such residue that would
result if the requested tolerance
or exemption were granted;
‘‘(ii) a proposed tolerance for such
residue, if a tolerance is proposed;
‘‘(iii) the name, chemical identity, and
composition of the pesticide chemical that
produces such residue;
‘‘(iv) reports of tests and investiga-
tions made with respect to the safety of
such pesticide chemical, including complete
information as to the methods and controls
used in conducting such tests and inves-
tigations;
‘‘(v) data showing the amount, fre-
quency, method, and time of application of
such pesticide chemical;
‘‘(vi) reports of tests and investiga-
tions 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 analytical methods used;
‘‘(vii) a description of methods for de-
tecting and measuring the levels of such
pesticide chemical residue in or on the
food, which methods meet the require-
ments of subsection (b)(2)(G) or (c)(2)(C);
‘‘(viii) reports of investigations con-
ducted on the effects of processing meth-
ods used to produce food on the level and
identity of such pesticide chemical residue;
‘‘(ix) if the petition is for a pesticide
chemical residue that is described in sub-
section (b)(2)(B)(iii), all relevant data
bearing on the physical or other technical
effect the pesticide chemical involved is in-
tended to have and the quantity of the pes-
ticide chemical residue required to accom-
plish such effect; and
‘‘(x) such other data and information
(including a sample of the pesticide chemi-
cal from which the pesticide chemical resi-
due is derived) as the Administrator may
require to support the petition.
‘‘(B) INFORMATION AVAILABLE TO ADMIN-
ISTRATOR.—If information or data required by
this paragraph are available to the Adminis-
trator, the person submitting the petition may,
in lieu of submitting the information or data,
cite the availability of the information or data.
‘‘(3) ACTIONS ON PETITIONS.—
‘‘(A) NOTICE.—
‘‘(i) IN GENERAL.—Within 45 days of
the filing of a petition under paragraph (1)
for the establishment of a tolerance or an
exemption, the Administrator shall deter-
mine if the petition complies with the re-
quirements of paragraph (2). 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.—A notice published
under this subparagraph shall—
‘‘(I) announce the availability of
a complete description of the analyt-
ical methods available to the Adminis-
trator for the detection and measure-
ment of the pesticide chemical residue
with respect to which the petition is
filed;
‘‘(II) include the summary re-
quired by paragraph (2)(A)(i); and
‘‘(III) provide at least 30 days
for comments on the petition.
‘‘(B) ACTION.—The Administrator shall,
within 270 days 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 a toler-
ance or exemption for the pesticide chemi-
cal residue;
‘‘(ii) issue a proposed regulation es-
tablishing a tolerance or exemption for the
pesticide chemical residue, which tolerance
or exemption is different from the toler-
ance or exemption requested in the peti-
tion; or
‘‘(iii) issue an order denying the peti-
tion.
‘‘(C) MODIFICATION OR REVOCATION.—
‘‘(i) NOTICE.—Within 45 days of the
filing of a petition under paragraph (1) for
the modification or revocation of a toler-
ance or exemption, the Administrator shall
publish a notice of the filing of the peti-
tion. Such notice shall contain the full peti-
tion or a summary of the petition and shall
provide at least 30 days for comments on
the petition.
‘‘(ii) 
ACTION.—The 
Administrator
shall, within 270 days of the publication of
the notice under subparagraph (A) and
after giving due consideration to the peti-
tion, any comments on the petition, and
any other information available to the Ad-
ministrator—
‘‘(I) issue a final regulation in
accordance with the petition modify-
ing or revoking a tolerance or exemp-
tion for the pesticide chemical residue;
‘‘(II) issue a proposed regulation
modifying or revoking a tolerance or
exemption for the pesticide chemical
residue, which tolerance or exemption
is different from the modification or
revocation requested in the petition;
or
‘‘(III) issue an order denying the
petition.
‘‘(D) COMMENTS
AND
FINAL
REGULA-
TIONS.—If the Administrator issues a proposed
regulation 
under 
subparagraph 
(B)(ii) 
or
(C)(ii)(II), the Administrator shall allow at
least 30 days for comments on such proposed
regulations. The Administrator shall issue a
final decision 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 of a tolerance for a pesticide chemical res-
idue that appears to pose a significantly lower
risk to human health from dietary exposure
than pesticide chemical residues that have toler-
ances in effect for the same or similar uses.
‘‘(4) ACTION ON THE INITIATIVE BY THE AD-
MINISTRATOR.—
‘‘(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 it
would be contrary to the public interest to issue
the notice and provide the period and states the
reasons for the finding in the notice of the final
regulation.
‘‘(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 the level in effect im-
mediately before such regulation is issued
only—
‘‘(I) for foods that, on the date of
the publication of the regulation, con-
tain such pesticide chemical residue in
an amount that is not more than the
amount that could legally be applied
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) meets
the negligible risk standard prescribed
by subsection (b)(2) during the period
of delay of the effective 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 type of
food.
‘‘(e) SPECIAL DATA REQUIREMENTS.—
‘‘(1) DETERMINATION OF INADEQUATE DATA.—
The Administrator shall take the action described in
paragraph (2) if a tolerance or exemption is in effect
for a pesticide chemical residue and the Adminis-
trator determines that data contained in the peti-
tion, which had been submitted, under subsection
(d)(1) for establishment of the tolerance or exemp-
tion, or under this section, before the date of the en-
actment of the Pesticide Food Safety Act of 1993,
are not adequate to support the continuation of such
tolerance or exemption because—
‘‘(A) based on the data contained in the
petition and other data available to the Admin-
istrator, the Administrator determines that die-
tary exposure to such pesticide chemical residue
may present a risk to human health that is
greater than the standard prescribed by sub-
section (b)(2) or (c)(2); or
‘‘(B) the data contained in the petition are
insufficient to determine if the tolerance or ex-
emption meets the requirements of subsection
(b)(2) or (c)(2) or the requirements of sub-
section (d)(2).
‘‘(2) ACTION BY ADMINISTRATOR.—When the
Administrator makes the determination described in
paragraph (1) with respect to a tolerance or exemp-
tion for a pesticide chemical residue, the Adminis-
trator shall—
‘‘(A) within 30 days of a determination
under paragraph (1)(A), initiate an action
under subsection (d)(4) to modify or revoke the
tolerance or exemption so that the tolerance or
exemption meets the standard prescribed by
subsection (b)(2) or (c)(2), and within 1 year of
such determination issue a final regulation to
complete such action; and
‘‘(B) within 30 days of the date of a deter-
mination under paragraph (1)(B), require the
submission of data to support—
‘‘(i) the existing tolerance or exemp-
tion; or
‘‘(ii) a new tolerance or exemption for
such residue,
that meets the standard prescribed by sub-
section (b)(2) or (c)(2).
‘‘(3) SUBMISSION OF REQUIRED DATA.—When
the Administrator requires the submission of data
under paragraph (2)(B), the Administrator shall
publish an order—
‘‘(A) requiring one or more interested per-
sons to notify the Administrator that such per-
son will submit the required data;
‘‘(B) describing the type of data required
to be submitted;
‘‘(C) describing the reports required to be
made during and after the collection of the
data; and
‘‘(D) establishing deadlines for the actions
described in subparagraphs (A) and (C).
‘‘(4) DEADLINES.—
‘‘(A) GENERAL RULE.—Except as provided
in subparagraphs (B) and (C), if an order is is-
sued under paragraph (3) with respect to a tol-
erance or exemption and a deadline in the order
is not met, the tolerance or exemption is re-
voked, effective 45 days after the date the dead-
line is not met. Immediately after such deadline
is not met, the Administrator shall publish a
notice of the revocation.
‘‘(B) EXTENSION REQUEST.—
‘‘(i) REQUEST.—Any person may re-
quest the Administrator to issue an order
to extend the deadline established under
paragraph (3)(D) before expiration of the
deadline.
‘‘(ii) GRANT OF REQUEST.—The Ad-
ministrator may grant such a request only
if—
‘‘(I) the person submitting the
request notified the Administrator
pursuant to paragraph (3)(A) in com-
pliance with the deadline established
under paragraph (3)(C); and
‘‘(II) the Administrator finds
that extraordinary circumstances be-
yond the control of such person pre-
vented such person from submitting
the required data.
‘‘(iii) EXTENSION.—If the Adminis-
trator issues an order extending a dead-
line—
‘‘(I) the Administrator may ex-
tend the deadline for a period no
longer than such time as is necessary
for such person to submit the data;
and
‘‘(II) the Administrator shall es-
tablish a new deadline in accordance
with paragraph (3)(D).
‘‘(C) DELAY.—If a tolerance or exemption
is revoked under subparagraph (A), the Admin-
istrator may delay the effective date of the rev-
ocation in accordance with subsection (d)(5)(B).
‘‘(5) EVALUATION OF DATA.—Within 90 days
of the date of the receipt of data under paragraph
(3), the Administrator shall evaluate such data and
determine whether action is required under sub-
section (d)(4) with respect to the tolerance or ex-
emption for the pesticide chemical residue for which
the data were submitted so that such tolerance
meets the negligible risk standard prescribed under
subsection (b)(2) or (c)(2). If the Administrator de-
termines that action under subsection (d)(4) is re-
quired, the Administrator shall complete such action
within 1 year of the date of such determination.
‘‘(f) CONFIDENTIALITY OF DATA.—
‘‘(1) GENERAL RULE.—Data submitted to the
Administrator in support of a petition under sub-
section (d)(1), which data have not previously been
made available to the public without restriction,
shall, upon request of the petitioner, be considered
as entitled to confidential treatment by the Adminis-
trator until publication of a regulation or order
under subsection (d)(3) in response to the petition
unless disclosure of such data is required by sub-
section (d)(3)(A)(ii)(II) or (g) or is allowed by para-
graph (2).
‘‘(2) DISCLOSURE.—Data that are entitled to
confidential treatment under paragraph (1) until
publication of a regulation or order under subsection
(d)(3) may be revealed to—
‘‘(A) either House of Congress or any com-
mittee or subcommittee of such House to the
extent of matter within the jurisdiction of the
committee or subcommittee;
‘‘(B) any officer or employee of the United
States in connection with the official duties of
such officer or employee under any law for the
protection of health or the environment or for
specific law enforcement purposes;
‘‘(C) any officer or employee of a State in
connection with the official duties of such offi-
cer or employee under any law of the State for
the protection of health or the environment or
for specific law enforcement purposes; or
‘‘(D) contractors with the United States
authorized by the Administrator to examine
such data in the carrying out of contracts under
such statutes under such security requirements
as the Administrator may provide.
‘‘(g) ACCESS TO DATA IN SUPPORT OF PETITION.—
‘‘(1) GENERAL RULE.—
‘‘(A) PUBLIC ACCESS.—If data in support
of a petition are submitted to the Adminis-
trator, the Administrator, before acting on such
petition, shall provide, in accordance with this
subsection, public access to health and safety
data that are submitted or cited in support of
such petition.
‘‘(B) REQUEST.—To obtain access to such
data, a person shall, not later than 30 days
after the publication under subsection (d)(3)(A)
of a notice of the filing of a petition, send by
certified mail to the Administrator and to the
petitioner a request for such access and the af-
firmation required by paragraph (2).
‘‘(C) GRANT OF REQUEST.—The Adminis-
trator shall grant such request unless, within
15 days after the receipt by the Administrator
of such request and affirmation, the petitioner
submits to the Administrator an objection to
the request asserting that the affirmation is in-
accurate and other reasons for the objection.
‘‘(D) OBJECTION.—If an objection to a re-
quest is submitted to the Administrator within
such 15-day period, the Administrator shall de-
termine whether to grant the request within 5
days after the receipt of the objection. If the
Administrator determines to grant the request,
access shall not be permitted until 5 days after
the petitioner making the objection has been
notified that access has been granted.
‘‘(E) DENIAL OF REQUEST.—If access to
data is denied, comments on the petition for
which such data were submitted or cited shall
be filed within 30 days after the decision of the
Administrator denying access.
‘‘(2) RESTRICTION.—
‘‘(A) AFFIRMATION.—Data referred to in
paragraph (1) may be made available only to a
person who provides an affirmation (and such
supporting evidence as the Administrator may
require) that—
‘‘(i) states that the person is not en-
gaged in, and is neither employed by, nor
acting (directly or indirectly) on behalf of,
any other person, or affiliate of a person,
engaged in, the production, sale, or dis-
tribution of a pesticide chemical;
‘‘(ii) identifies any business, employer,
or other person, if any, on whose behalf
the person is requesting access to the data;
and
‘‘(iii) states that the person will not
intentionally or recklessly violate this sub-
section.
‘‘(B) AFFILIATE.—For purposes of this
paragraph, an affiliate of a person is a person
who directly or indirectly, through one or more
intermediates, controls or is controlled by or is
under common control with the other person.
‘‘(C) FRAUD.—Section 1001 of title 18,
United States Code, shall apply to an affirma-
tion made under this paragraph.
‘‘(3) COMMENTS.—
‘‘(A) GENERAL RULE.—Data supporting a
petition may be made available under para-
graph (1) to a person only for the purpose of
‘‘(C) BASIS FOR COMMENTS.—Once access
to data supporting a petition is granted, the
data may be examined and notes may be taken
for use in developing comments on the petition.
Such comments on the petition shall be filed
within 60 days after the decision of the Admin-
istrator granting access, unless the comment
period is extended by the Administrator for an
additional 30 days for good cause.
‘‘(h) ACCESS TO DATA AFTER DECISION.—When the
Administrator takes final action on a petition submitted
under subsection (d)(1) or on the initiative of the Adminis-
trator under subsection (d)(4), the Administrator shall
make available to the public the administrative record of
the decision, including the data relied upon for the deci-
sion.
‘‘(i) 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) or (e).
‘‘(2) PESTICIDE
CHEMICAL
RESIDUES
UNDER
REGULATIONS.—Regulations establishing 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 modification or revocation
under subsection (d) or (e).
‘‘(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 Food Safety Act of
1993, do not have tolerances or exemptions
from tolerances under this section because the
residues are generally recognized as safe under
this section or section 409 shall, until the expi-
ration of the period prescribed by subparagraph
(C), not be considered unsafe under section
402(a)(2)(B) solely because the chemicals do
not have such a tolerance or exemption.
‘‘(B) LIST.—Not later than 90 days after
the date of the enactment of such Act, the Ad-
ministrator shall—
‘‘(i) publish a list of all pesticide
chemical residues that the Administrator
has determined are generally recognized,
on the day before the date of the enact-
ment of such Act, as safe under this sec-
tion or section 409; and
‘‘(ii) require, by regulation, that any
person who, before the date of the enact-
ment of such Act, distributed in commerce
as a pesticide chemical, a pesticide chemi-
cal that is not on the list described in
clause (i), and that such person deter-
mined is generally recognized as safe under
this section or section 409, shall—
‘‘(I) report to the Administrator
the identity of such pesticide chemical;
and
‘‘(II) report to the Administrator
the data that supports the claim that
the pesticide chemical is so safe.
‘‘(C) DETERMINATION
OF
THE
ADMINIS-
TRATOR.—Not later than 270 days after such
date, the Administrator shall determine if each
pesticide chemical reported to the Adminis-
trator in accordance with subparagraph (B)(ii)
is generally recognized as safe. If the Adminis-
trator determines, by order, that such pesticide
chemical is generally recognized as safe, the
residue of such pesticide chemical shall be con-
sidered a pesticide chemical residue subject to
an exemption under this section, which exemp-
tion shall be subject to modification or revoca-
tion under subsection (d) or (e).
‘‘(j) FOOD AND DRUG ADMINISTRATION MONITOR-
ING OF PESTICIDE CHEMICAL RESIDUES.—
‘‘(1) SAMPLING.—The Secretary shall conduct
surveillance and compliance sampling of food for
pesticide chemical residues to determine if the pes-
ticide chemical residues are in compliance with this
section. In carrying out this paragraph, the Sec-
retary shall give priority to foods that contain pes-
ticide chemical residues included in a notice under
paragraph (2).
‘‘(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.
‘‘(k) FEES.—The Administrator shall by regulation
require the payment of such fees as will in the aggregate,
in the judgment of the Administrator, be sufficient over
a reasonable term to provide, equip, and maintain an 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.
‘‘(l) JUDICIAL REVIEW.—
‘‘(1) REVIEW.—Any person (including a person
without an economic interest) who may be adversely
affected by a final regulation or order issued under
subsection (d)(3), (d)(4), (e)(4), or (i)(3) may obtain
judicial review of such regulation or order by filing
a petition requesting that the regulation or order be
set aside in whole or in part in the United States
Court of Appeals for the circuit in which such per-
son resides or has its principal place of business, or
in the United States Court of Appeals for the Dis-
trict of Columbia Circuit, within 60 days after publi-
cation of the regulation or order under such sub-
section.
‘‘(2) REVIEW OF DATA.—
‘‘(A) IN GENERAL.—Any person (including
a person without an economic interest) may ob-
tain judicial review, of the adequacy of the data
made available by the Administrator under sub-
section (h) to support the issuance of a toler-
ance or exemption for a pesticide chemical resi-
due, by filing a petition for the review of the
data in the United States Court of Appeals for
the circuit in which such person resides or has
its principal place of business, or in the United
States Court of Appeals for the District of Co-
lumbia Circuit.
‘‘(B) SCOPE OF REVIEW.—Review in a pro-
ceeding initiated under this paragraph shall be
limited to whether the data under review are
adequate to demonstrate that the tolerance or
exemption supported by such data meets the
standards required by subsection (b)(2) or
(c)(2) and interpreted by the guidelines issued
under subsection (b)(3) or (c)(3). Unless the
court determines that such data are adequate,
the court shall revoke the tolerance or exemp-
tion supported by such data.
‘‘(C) BURDEN
OF
PROOF.—In any such
proceeding the Administrator shall have the
burden of proof on all issues.
‘‘(3) COURT
RESPONSIBILITY.—In any action
seeking judicial review of actions under this section,
the court shall have the principal responsibility for
deciding issues of law.
‘‘(4) ATTORNEY
FEES.—Any petitioner who
prevails in a proceeding brought under this section
shall be entitled to recover reasonable attorney fees
and expenses (including expert witness fees).
‘‘(m) DEFINITIONS.—For purposes of this section,
the terms ‘modify’ and ‘modification’ mean the lowering
of a tolerance for a pesticide chemical residue.’’.
(b) CONFORMING AMENDMENT.—Section 303 (21
U.S.C. 333) is amended by adding at the end the follow-
ing:
‘‘(g) A person who violates a tolerance established
under section 408(b)(2) for a food at the time the food
is purchased at retail shall not be subject to any penalty
under this section.’’.
SEC. 4. EVALUATION OF EXISTING PESTICIDE CHEMICAL
RESIDUE TOLERANCES AND EXEMPTIONS.
(a) EVALUATION.—Within 1 year of the date of the
enactment of this Act, the Administrator of the Environ-
mental Protection Agency shall, for each pesticide chemi-
cal residue that has a tolerance or exemption in effect
under the Federal Food, Drug, and Cosmetic Act, evaluate
all available data with respect to the safety of such pes-
ticide chemical residue and the nature and amount of such
residue remaining in or on foods and determine if—
(1) the tolerance or exemption meets the re-
quirements of subsection (b)(2) or (c)(2) of section
408 of such Act;
(2) the tolerance or exemption does not meet
such requirements; or
(3) the data are insufficient to determine if the
tolerance or exemption meets such requirements.
(b) SUFFICIENT DATA.—
(1) ACCEPTABLE RISK DATA.—If, with respect
to any pesticide chemical residue that is evaluated
under subsection (a), the Administrator finds that
data for the pesticide chemical residue are sufficient
to determine that the tolerance or exemption for the
pesticide chemical residue meets the standard under
section 408(b)(2) or 408(c)(2) of such Act, the Ad-
ministrator shall publish such finding.
(2) UNACCEPTABLE RISK DATA.—If, with re-
spect to any pesticide chemical residue that is evalu-
ated under subsection (a), the Administrator finds
that data for the pesticide chemical residue are suffi-
cient to determine that the tolerance or exemption
for the pesticide chemical residue does not meet the
standard under section 408(b)(2) or 408(c)(2) of
such Act, the Administrator shall, within 1 year of
the date of such finding, modify or revoke the toler-
ance.
(3) INSUFFICIENT DATA.—
(A) GENERAL RULE.—
(i) SUBMISSION
OF
DATA.—If, with
respect to any pesticide chemical residue
that is evaluated under subsection (a), the
Administrator determines that the data are
insufficient to determine whether the toler-
ance or exemption meets the requirements
of section 408(b)(2) or 408(c)(2) of such
Act, the Administrator shall establish a
schedule for the submission of data in ac-
cordance with the requirements of sections
408(e)(2)(B) and 408(e)(3) of such Act,
which data shall be the basis for a deter-
mination by the Administrator as to
whether the tolerance or exemption meets
the 
standard 
prescribed 
by 
section
408(b)(2) or 408(c)(2) of such Act.
(ii) DETERMINATIONS.—The Adminis-
trator shall—
(I) within 2 years of the date of
the enactment of this Act, make such
a determination respecting a tolerance
or exemption meeting a standard
under section 408 of such Act for at
least 30 percent of the tolerances or
exemptions in effect for pesticide
chemical residues in existence on such
date;
(II) within 4 years of the date of
the enactment of this Act, make such
a determination for at least 60 per-
cent of the tolerances or exemptions
in effect for pesticide chemical resi-
dues in existence on such date;
(III) within 6 years of the date of
the enactment of this Act, make such
a determination for at least 90 per-
cent of the tolerances or exemptions
in effect for pesticide chemical resi-
dues in existence on such date; and
(IV) within 7 years of the date of
the enactment of this Act, make such
a determination for 100 percent of the
tolerances or exemptions in effect for
pesticide chemical residues in exist-
ence on such date.
(iii) DEADLINES.—Section 408(e)(4)
of such Act shall apply to the deadlines es-
tablished by such schedule.
(B) PRIORITIES.—In establishing such
schedule, the Administrator shall give priority
to the consideration of any pesticide chemical
residue for which there is reason to believe that
the tolerance or exemption in effect for such
residue may present a risk greater than the
negligible risk standard prescribed by section
408(b)(2) or 408(c)(2) of such Act.
(C) ACTION BY THE ADMINISTRATOR.—If
the Administrator determines under subpara-
graph (A) that a tolerance or exemption does
not meet the standard under section 408(b)(2)
or 408(c)(2) of such Act after the submission of
data in accordance with the schedule prescribed
by such subparagraph, the Administrator shall
take 
the 
action 
described 
in 
section
408(e)(2)(A) of such Act with respect to such
tolerance or exemption.
SEC. 5. REVIEW OF EXISTING METHODS OF ANALYSIS.
(a) DETERMINATION.—Within 180 days of the date
of the enactment of this Act, the Administrator of the En-
vironmental Protection Agency shall determine, for each
method of detecting and measuring levels of pesticide
chemical residues, whether the requirements of section
408(b)(2)(G) of the Federal Food, Drug, and Cosmetic
Act have been met.
(b) NOTICE.—The Administrator shall issue a notice
identifying each pesticide chemical for which there is such
a method that does not meet such requirements. Any such
method that does not meet such requirements shall be re-
vised so that the method meets such requirements within
3 years of the date of the issuance of the notice.
(c) REVOCATION.—If upon the expiration of such 3-
year period, a method does not meet such requirements,
then any tolerance or exemption in effect for the pesticide
chemical residue subject to such method shall be consid-
ered revoked.
SEC. 6. FEES.
The Administrator of the Environmental Protection
Agency shall by regulation require the payment of such
fees as will in the aggregate, in the judgment of the Ad-
ministrator, be sufficient over a reasonable term to pro-
vide, equip, and maintain an adequate service for the per-
formance of the functions of the Administrator under this
section and sections 4 and 5 of this Act.
SEC. 7. 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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