Food Quality Protection Act of 1996
PL 104-170 (H.R.1627), enacted 08/03/1996

PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1489 
Public Law 104-170 
104th Congress 
An Act 
To amend the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal 
Aug. 3, 1996 
Food, Drug, and Cosmetic Act, and for other purposes. 
[H.R. 1627] 
Be it enacted by the Senate and House of Representatives of 
the United States of America in Congress assembled, 
Food Quality 
Protection Act of 
SECTION 1. SHORT TITLE. 
1996. 
7 u s e 136 note. 
This Act may be cited as the "Food Quality Protection Act 
of 1996". 
TITLE I—SUSPENSION-APPLICATORS 
SEC. 101. REFERENCE. 
Whenever in this title an amendment or repeal is expressed 
in terms of an amendment to, or repeal of, a section or other 
provision, the reference shall be considered to be made to a section 
or other provision of the Federal Insecticide, Fungicide, and 
Rodenticide Act. 
Subtitle A—Suspension 
SEC. 102. SUSPENSION. 
(a) SECTION 6(c)(1).—^The second sentence of section 6(c)(1) (7 
U.S.C. 136d(c)(l)) is amended to read: "Except as provided in para-
graph (3), no order of suspension may be issued under this sub-
section unless the Administrator has issued, or at the same time 
issues, a notice of intention to cancel the registration or change 
the classification of the pesticide under subsection (b).". 
(b) SECTION 6(C)(3).—Section 6(c)(3) (7 U.S.C. 136d(c)(3)) is 
amended— 
(1) by inserting Eifter the first sentence the following new 
sentence: "The Administrator may issue an emergency order 
under this paragraph before issuing a notice of intention to 
cancel the registration or change the classification of the pes-
ticide under subsection (b) and the Administrator shall proceed 
to issue the notice under subsection (b) within 90 days of 
issuing an emergency order. If the Administrator does not 
issue a notice under subsection (b) within 90 days of issuing 
an emergency order, the emergency order shall expire."; and 
(2) by striking "In that case" and inserting "In the case 
of an emergency order". 
110 STAT. 1490 
PUBLIC LAW 104-170—AUG. 3, 1996 
SEC. 
1
0
3
. 
TOLERANCE 
REEVALUATION 
AS 
PART 
OF 
REREGISTRATION. 
Section 4(g)(2) (7 U.S.C. 136a-l(g)(2)) is amended by adding 
at the end the following: 
"(E) As soon as the Administrator has 
sufficient 
information with respect to the dietary risk of a particular 
active ingredient, but in any event no later than the time 
the Administrator makes a determination under subpara-
graph (C) or (D) with respect to pesticides containing a 
particular active ingredient, the Administrator shall— 
"(i) reassess each associated tolerance and exemp-
tion from the requirement for a tolerance issued under 
section 408 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 346a); 
"(ii) determine whether such tolerance or exemp-
tion meets the requirements of that Act; 
"(iii) determine whether additional tolerances or 
exemptions should be issued; 
Federal Register, 
"(iv) publish in the Federal Register a notice set-
publication, 
ting forth the determinations made under this subpara-
graph; and 
"(v) commence promptly such proceedings under 
this Act and section 408 of the Federal Food, Drug, 
and Cosmetic Act as are warranted by such determina-
tions.". 
SEC. 104. SCIENTIFIC ADVISORY PANEL. 
Section 25(d) (7 U.S.C. 136w(d)) is amended— 
(1) in the first sentence, by striking "The Administrator 
shall" and inserting: 
"(1) IN GENERAL.—^The Administrator shall"; and 
(2) by adding at the end the following: 
Establishment. 
"(2) SCIENCE REVIEW BOARD.—^There is established 
a 
Science Review Board to consist of 60 scientists who shall 
be available to the Scientific Advisory Panel to assist in reviews 
conducted by the Panel. Members of the Board shall be selected 
in the same manner as members of temporary subpanels cre-
ated under paragraph (1). Members of the Board shall be com-
pensated in the same manner as members of the Panel.". 
SEC. 105. NITROGEN STABILIZER. 
(a) SECTION 2.—Section 2 (7 U.S.C. 136) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1) by striking "or" after "defoliant," 
and inserting ", or nitrogen stabilizer" after "desiccant"; 
(B) at the end of paragraph (3) by striking "and"; 
(C) at the end of paragraph (4) by striking the period 
and inserting "; and"; and 
(D) at the end by adding the following: 
"(5) in the case of a nitrogen stabilizer, an ingredient 
which will prevent or hinder the process of nitrification, 
denitrification, ammonia volatilization, or urease production 
through action affecting soil bacteria."; 
(2) in subsection (u), by striking "and" before "(2)" and 
by inserting "and (3) any nitrogen stabilizer," after "desiccant,"; 
and 
(3) at the end by adding the following: 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1491 
"(hh) NITROGEN STABILIZER.—^The term 'nitrogen stabilizer' 
means any substance or mixture of substances intended for prevent-
ing or hindering the process of nitrification, denitrification, ammo-
nia volatiUzation, or urease production through action upon soil 
bacteria. Such term shall not include— 
"(1) dicyandiamide; 
"(2) ammonium thiosulfate; or 
"(3) any substance or mixture of substances.— 
"(A) that was not registered pursuant to section 3 
prior to January 1, 1992; and 
"(B) that was in commercial agronomic use prior to 
January 1, 1992, with respect to which after January 1, 
1992, the distributor or seller of the substance or mixture 
has made no specific claim of prevention or hindering of 
the process of nitrification, denitrification, ammonia vola-
tilization urease production regardless of the actual use 
or purpose for, or future use or purpose for, the substance 
or mixture. 
Statements made in materials required to be submitted to any 
State legislative or regulatory authority, or required by such author-
ity to be included in the labeling or other literature accompanying 
any such substance or mixture shall not be deemed a specific 
claim within the meaning of this subsection.". 
(b) SECTION 3(f).—Section 3(f) (7 U.S.C. 136a(f)) is amended 
by adding at the end the following: 
"(4) MIXTURES OF NITROGEN STABILIZERS AND FERTILIZER 
PRODUCTS.—^Any mixture or other combination of— 
"(A) 1 or more nitrogen stabilizers registered under 
this Act; and 
"(B) 1 or more fertilizer products, 
shall not be subject to the provisions of this section or sections 
4, 5, 7, 15, and 17(a)(2) if the mixture or other combination 
is accompanied by the labeling required under this Act for 
the nitrogen stabilizer contained in the mixture or other com-
bination, the mixture or combination is mixed or combined 
in accordance with such labeling, and the mixture or combina-
tion does not contain any active ingredient other than the 
nitrogen stabilizer.". 
SEC. 106. PERIODIC REGISTRATION REVIEW. 
(a) SECTION 6.—Section 6 (7 U.S.C. 136d) is amended— 
(1) in subsection (a), by striking the heading and inserting 
the following: 
"(a) EXISTING STOCKS AND INFORMATION.—"; and 
(2) by amending paragraph (1) of subsection (a) to read 
as follows: 
"(1) EXISTING STOCKS.—^The Administrator may permit the 
continued sale and use of existing stocks of a pesticide whose 
registration is suspended or canceled under this section, or 
section 3 or 4, to such extent, under such conditions, and 
for such uses as the Administrator determines that such sale 
or use is not inconsistent with the purposes of this Act.". 
(b) SECTION 3.—Section 3 (7 U.S.C. 136a) is amended by adding 
at the end the following: 
"(g) REGISTRATION REVIEW.— 
"(1)(A) GENERAL RULE.—The registrations of pesticides are 
to be periodically reviewed. The Administrator shall by regula- Regvdations. 
110 STAT. 1492 
PUBLIC LAW 104-170—AUG. 3, 1996 
tion establish a procedure for accomplishing the periodic review 
of registrations. The goal of these regulations shall be a review 
of a pesticide's registration every 15 years. No registration 
shall be canceled as a result of the registration review process 
unless the Administrator follows the procedures and sub-
stantive requirements of section 6. 
"(B) LIMITATION.—Nothing in this subsection shall prohibit 
the Administrator from undertaking any other review of a 
pesticide pursuant to this Act. 
"(2)(A) DATA.—^The Administrator shall use the authority 
in subsection (c)(2)(B) to require the submission of data when 
such data are necessary for a registration review. 
"(B) DATA SUBMISSION, COMPENSATION, AND EXEMPTION.— 
For purposes of this subsection, the provisions of subsections 
(c)(1), (c)(2)(B), and (c)(2)(D) shall be utiUzed for and be 
applicable to any data required for registration review.". 
Subtitle B—^Training for Maintenance 
Applicators and Service Technicians 
SEC. 120. MAINTENANCE APPLICATORS AND SERVICE TECHNICIANS 
DEFINITIONS. 
Section 2 (7 U.S.C. 136), as amended by section 106, is amended 
by adding at the end the following: 
"(jj) 
MAINTENANCE 
APPLICATOR.—The 
term 
'maintenance 
applicator' means any individual who, in the principal course of 
such individual's employment, uses, or supervises the use of, a 
pesticide not classified for restricted use (other than a ready to 
use consumer products pesticide); for the purpose of providing struc-
tural pest control or lawn pest control including janitors, general 
maintenance personnel, sanitation personnel, and grounds mainte-
nance personnel. The term 'maintenance applicator' does not include 
private applicators as defined in section 2(e)(2); individuals who 
use antimicrobial pesticides, sanitizers or disinfectants; individuals 
employed by Federal, State, and local governments or any political 
subdivisions thereof, or individuals who use pesticides not classified 
for restricted use in or around their homes, boats, sod farms, 
nurseries, greenhouses, or other noncommercial property. 
"(kk) 
SERVICE TECHNICIAN.—^The term 'service technician' 
means any individual who uses or supervises the use of pesticides 
(other than a ready to use consumer products pesticide) for the 
purpose of providing structural pest control or lawn pest control 
on the property of another for a fee. The term 'service technician' 
does not include individuals who use antimicrobial pesticides, sani-
tizers or disinfectants; or who otherwise apply ready to use 
consumer products pesticides.". 
SEC. 121. MINIMUM REQUIREMENTS FOR TRAINING OF MAINTENANCE 
APPUCATORS AND SERVICE TECHNICIANS. 
The Federal Insecticide, Fungicide, and Rodenticide Act (7 
U.S.C. 136 et seq.) is amended— 
7USC136X, 
(1) by redesignating sections 30 and 31 as sections 33 
I36y. 
and 34, respectively; and 
(2) by adding after section 29 the following: 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1493 
"SEC. 30. MINIMUM REQUIREMENTS FOR TRAINING OF MAINTENANCE 
7 USC 136w-5. 
APPUCATORS AND SERVICE TECHNICIANS. 
"Each State may establish minimum requirements for training 
of maintenance applicators and service technicians. Such training 
may include instruction in the safe and effective handling and 
use of pesticides in accordance with the Environmental Protection 
Agency approved labeling, and instruction in integrated pest 
management techniques. The authority of the Administrator with 
respect to minimum requirements for training of maintenance 
applicators and service technicians shall be limited to ensuring 
that each State understands the provisions of this section.". 
TITLE II—MINOR USE CROP PROTEC-
TION, 
ANTIMICROBIAL 
PESTICIDE 
REGISTRATION REFORM, AND PUBLIC 
HEALTH PESTICIDES 
SEC. 201. REFERENCE. 
Whenever in this title an amendment or repeal is expressed 
in terms of an amendment to, or repeal of, a section or other 
provision, the reference shall be considered to be made to a section 
or other provision of the Federsd Insecticide, Fungicide, and 
Rodenticide Act. 
Subtitle A—^Minor Use Crop Protection 
SEC. 210. MINOR CROP PROTECTION. 
(a) DEFINITION.—Section 2 (7 U.S.C. 136), as amended by sec-
tion 120, is further amended by adding at the end the following: 
"(11) MINOR USE.—^The term 'minor use' means the use of a 
pesticide on an animal, on a commercial agricultural crop or site, 
or for the protection of public health where— 
"(1) the total United States acreage for the crop is less 
than 300,000 acres, as determined by the Secretary of Agri-
culture; or 
"(2) the Administrator, in consultation with the Secretary 
of Agriculture, determines that, based on information provided 
by an applicsint for registration or a registrant, the use does 
not provide sufficient economic incentive to support the initial 
registration or continuing registration of a pesticide for such 
use and— 
"(A) there are insufficient efficacious alternative reg-
istered pesticides available for the use; 
"(B) the alternatives to the pesticide use pose greater 
risks to the environment or human health; 
"(C) the minor use pesticide plays or will play a signifi-
cant part in managing pest resistance; or 
"(D) the minor use pesticide plays or will play a signifi-
cant part in an integrated pest management program. 
The status as a minor use under this subsection shall continue 
as long as the Administrator has not determined that, based on 
existing data, such use may cause an unreasonable adverse effect 
on the environment and the use otherwise qualifies for such status.". 
110 STAT. 1494 
PUBLIC LAW 104-170—AUG. 3, 1996 
(b) 
EXCLUSIVE 
USE OF MINOR 
USE 
PESTICIDES.—Section 
3(c)(1)(F) (7 U.S.C. 136a(c)(l)(F)) is amended— 
(1) by redesignating clauses (ii) and (iii) as clauses (iii) 
and (iv), respectively; and 
(2) by inserting after clause (i) the following: 
"(ii) The period of exclusive data use provided 
under clause (i) shall be extended 1 additional year 
for each 3 minor uses registered after the date of 
enactment of this clause and within 7 years of the 
commencement of the exclusive use period, up to a 
total of 3 additional years for all minor uses registered 
by the Administrator if the Administrator, in consulta-
tion with the Secretary of Agriculture, determines that, 
based on information provided by an applicant for reg-
istration or a registrant, that— 
"(I) there are insufficient efficacious alter-
native registered pesticides available for the use; 
"(II) the alternatives to the minor use pesticide 
pose greater risks to the environment or human 
health; 
"(III) the minor use pesticide plays or will 
play a significant part in managing pest resistance; 
or 
"(IV) the minor use pesticide plays or will 
play a significant part in an integrated pest 
management program. 
The registration of a pesticide for a minor use on 
a crop grouping establisned by the Administrator shall 
be considered for purposes of this clause 1 minor use 
for each representative crop for which data are pro-
vided in the crop grouping. Any additional exclusive 
use period under this clause shall be modified as appro-
priate or terminated if the registrant voluntarily can-
cels the product or deletes from the registration the 
minor uses which formed the basis for the extension 
of the additional exclusive use period or if the Adminis-
trator determines that the registrant is not actually 
marketing the product for such minor uses."; 
(3) in clause (iv), as amended by paragraph (1), by striking 
"and (ii)" and inserting ", (ii), and (iii)"; and 
(4) at the end of the section, as amended by paragraph 
(1), by adding the following: 
Effective date. 
"(v) The period of exclusive use provided under 
clause (ii) shall not take effect until 1 year after enact-
ment of this clause, except where an applicant or reg-
istrant is applying for the registration of a pesticide 
containing an active ingredient not previously reg-
istered. 
"(vi) With respect to data submitted after the date 
of enactment of this clause by an applicant or reg-
istrant to support an amendment adding a new use 
to an existing registration that does not retain any 
period of exclusive use, if such data relates solely to 
a minor use of a pesticide, such data shall not, without 
the written permission of the original data submitter, 
be considered by the Administrator to support an 
application for a minor use by another person during 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1495 
the period of 10 years following the date of submission 
of such data. The applicant or registrant at the time 
Notification. 
the new minor use is requested shall notify the 
Administrator that to the best of their knowledge the 
exclusive use period for the pesticide has expired and 
that the data pertaining solely to the minor use of 
a pesticide is eligible for the provisions of this para-
graph. If the minor use registration which is supported 
by data submitted pursuant to this subsection is volun-
tarily canceled or if such data are subsequently used 
to support a nonminor use, the data shall no longer 
be subject to the exclusive use provisions of this clause 
but shall instead be considered by the Administrator 
in accordance with the provisions of clause (i), as appro-
priate.". 
(c) TIME EXTENSIONS FOR DEVELOPMENT OF MINOR USE DATA.— 
(1) 
DATA 
CALL-IN.—Section 
3(c)(2)(B) 
(7 
U.S.C. 
136a(c)(2)(B)) is amended by adding at the end the following: 
"(vi) Upon the request of a registrant the Administrator 
shall, in the case of a minor use, extend the deadline 
for the production of residue chemistry data under this 
subparagraph for data required solely to support that minor 
use until the final deadline for submission of data under 
section 4 for the other uses of the pesticide established 
as of the date of enactment of the Food Quality Protection 
Act of 1996, if— 
"(I) the data to support other uses of the pesticide 
on a food are being provided; 
"(II) the registrant, in submitting a request for 
such an extension, provides a schedule, including 
interim dates to measure progress, to assure that the 
data production will be completed before the expiration 
of the extension period; 
"(III) the Administrator has determined that such 
extension will not significantly delay the Administra-
tor's schedule for issuing a reregistration eligibility 
determination required under section 4; and 
"(IV) the Administrator has determined that based 
on existing data, such extension would not significantly 
increase the risk of any unreasonable adverse effect 
on the environment. If the Administrator grants an 
extension under this clause, the Administrator shall 
monitor the development of the data and shall ensure 
that the registrant is meeting the schedule for the 
production of the data. If the Administrator determines 
that the registrant is not meeting or has not met 
the schedule for the production of such data, the 
Administrator may proceed in accordance with clause 
(iv) regarding the continued registration of the affected 
products with the minor use and shall inform the public 
of such action. Notwithstanding the provisions of this 
clause, the Administrator may take action to modify 
or revoke the extension under this clause if the 
Administrator determines that the extension for the 
minor use may cause an unreasonable adverse effect 
on the environment. In such circumstance, the Notice. 
Administrator shall provide, in writing to the reg-
110 STAT. 1496 
PUBLIC LAW 104-170—AUG. 3, 1996 
istrant, a notice revoking the extension of time for 
submission of data. Such data shall instead be due 
in accordance with the date established by the 
Administrator for the submission of the data.". 
(2) REREGISTRATION.—Sections 4(d)(4)(B), 4(e)(2)(B), and 
4(f)(2)(B) (7 U.S.C. 136a-l(d)(4)(B), (e)(2)(B), and (f)(2)(B)) are 
each amended by adding at the end the following: "Upon 
application of a registrant, the Administrator shall, in the 
case of a minor use, extend the deadline for the production 
of residue chemistry data under this subparagraph for data 
required solely to support that minor use until the final dead-
line for submission of data under this section for the other 
uses of the pesticide established as of the date of enactment 
of the Food Quality Protection Act of 1996 if— 
"(i) the data to support other uses of the pesticide 
on a food are being provided; 
"(ii) the registrant, in submitting a request for 
such an extension provides a schedule, including 
interim dates to measure progress, to assure that the 
data production will be completed before the expiration 
of the extension period; 
"(iii) the Administrator has determined that such 
extension will not significantly delay the Administra-
tor's schedule for issuing a reregistration eligibility 
determination required under this section; and 
"(iv) the Administrator has determined that based 
on existing data, such extension would not significantly 
increase the risk of any unreasonable adverse effect 
on the environment. If the Administrator grants an 
extension under this subparagraph, the Administrator 
shall monitor the development of the data and shall 
ensure that the registrant is meeting the schedule 
for the production of the data. If the Administrator 
determines that the registrant is not meeting or has 
not met the schedule for the production of such data, 
the Administrator may proceed in accordance with 
clause (iv) of section 3(c)(2)(B) or other provisions of 
this section, as appropriate, regarding the continued 
registration of the affected products with the minor 
use and shall inform the public of such action. Notwith-
standing the provisions of this subparagraph, the 
Administrator may take action to modify or revoke 
the extension under this subparagraph if the Adminis-
trator determines that the extension for the minor 
use may cause an unreasonable adverse effect on the 
environment. In such circumstance, the Administrator 
shall provide written notice to the registrant revoking 
the extension of time for submission of data. Such 
data shall instead be due in accordance with the date 
then established by the Administrator for submission 
of the data.", 
(d) MINOR USE WAiVER.^ection 3(c)(2) (7 U.S.C. 136a(c)(2)) 
is amended— 
(1) by inserting "IN GENERAL.—" after "(A)"; 
(2) by inserting "ADDITIONAL DATA.—" afler "(B)"; 
(3) by inserting "SIMPLIFIED PROCEDURES.—" after "(C)"; 
and 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1497 
(4) by adding at the end the following: 
"(E) MINOR USE WAIVER.—In handling the registration 
of a pesticide for a minor use, the Administrator may 
waive otherwise applicable data requirements if the 
Administrator determines that the absence of such data 
will not prevent the Administrator from determining— 
"(i) the incremental risk presented by the minor 
use of the pesticide; and 
"(ii) that such risk, if any, would not be an 
unreasonable adverse effect on the environment.". 
(e) EXPEDITING MINOR USE REGISTRATIONS.—Section 3(c)(3) (7 
U.S.C. 136a(c)(3)) is amended— 
(1) 
by 
inserting 
after 
"(A)" the 
following: "IN 
GENERAL.—"; 
(2) by inserting after "(B)" the following: "IDENTICAL OR 
SUBSTANTIALLY SIMILAR.—"; a n d 
(3) by adding at the end the following: 
"(C) MINOR USE REGISTRATION.— 
"(i) The Administrator shall, as expeditiously as Review, 
possible, review and act on any complete application— 
"(I) that proposes the initial registration of 
a new pesticide active ingredient if the active 
ingredient is proposed to be registered solely for 
minor uses, or proposes a registration amendment 
solely for minor uses to an existing registration; 
or 
"(II) for a registration or a registration amend-' 
ment that proposes significant minor uses, 
"(ii) For the purposes of clause (i)— 
"(I) the term 'as expeditiously as possible' 
means that the Administrator shall, to the greatest 
extent practicable, complete a review and evalua-
tion of all data, submitted with a complete applica-
tion, within 12 months after the submission of 
the complete application, and the failure of the 
Administrator to complete such a review and 
evaluation under clause (i) shall not be subject 
to judicial review; and 
"(II) the term 'significant minor uses' means 
3 or more minor uses proposed for every nonminor 
use, a minor use that would, in the judgment 
of the Administrator, serve as a replacement for 
any use which has been canceled in the 5 years 
preceding the receipt of the application, or a minor 
use that in the opinion of the Administrator would 
avoid the reissuance of an emergency exemption 
under section 18 for that minor use. 
"(D) ADEQUATE TIME FOR SUBMISSION OF MINOR USE 
DATA.—If a registrant makes a request for a minor use 
waiver, regarding data required by the Administrator, 
pursuant to paragraph (2)(E), and if the Administrator 
denies in whole or in part such data waiver request, the 
registrant shall have a full-time period for providing such 
data. For purposes of this subparagraph, the term 'full-
time period' means the time period originally established 
by the Administrator for submission of such data, beginning 
29-194 O - 96 - 23 : QL 3 Part 2 
110 STAT. 1498 
PUBLIC LAW 104-170—AUG. 3, 1996 
Federal Register, 
publication. 
Notice. 
with the date of receipt by the registrant of the Administra-
tor's notice of denial.". 
(f) TEMPORARY EXTENSION OF REGISTRATION FOR UNSUPPORTED 
MINOR USES.— 
(1 ^ REREGISTRATION 
(A) Sections 4(d)(6) and 4(f)(3) (7 U.S.C. 136a-l(d)(6) 
and (f)(3)) are each amended by adding at the end the 
following: "If the registrant does not commit to support 
a specific minor use of the pesticide, but is supporting 
and providing data in a timely and adequate fashion to 
support uses of the pesticide on a food, or if all uses 
of the pesticide are nonfood uses and the registrant does 
not commit to support a specific minor use of the pesticide 
but is supporting and providing data in a timely and ade-
quate fashion to support other nonfood uses of the pesticide, 
the Administrator, at the written request of the registrant, 
shall not take any action pursuant to this paragraph in 
regard to such unsupported minor use until the final dead-
line established as of the date of enactment of the Food 
Quality Protection Act of 1996, for the submission of data 
under this section for the supported uses identified pursu-
ant to this paragraph unless the Administrator determines 
that the absence of the data is significant enough to cause 
human health or environmental concerns. On such a deter-
mination the Administrator may refuse the request for 
extension by the registrant. Upon receipt of the request 
from the registrant, the Administrator shall publish in 
the Federal Register a notice of the receipt of the request 
and the effective date upon which the uses not being sup-
ported will be voluntarily deleted from the registration 
pursuant to section 6(f)(1). If the Administrator grants 
an extension under this paragraph, the Administrator shall 
monitor the development of the data for the uses being 
supported and shall ensure that the registrant is meeting 
the schedule for the production of such data. If the Adminis-
trator determines that the registrant is not meeting or 
has not met the schedule for the production of such data, 
the Administrator may proceed in accordance with section 
3(cX2)(B)(iv) regarding the continued registration of the 
affected products with the minor and other uses and shall 
inform the public of such action in accordance with section 
6(f)(2). Notwithstanding this subparagraph, the Adminis-
trator may deny, modify, or revoke the temporary extension 
under this paragraph if the Administrator determines that 
the continuation of the minor use may cause an unreason-
able adverse effect on the environment. In the event of 
modification or revocation, the Administrator shall provide, 
in writing, to the registrant a notice revoking the temporary 
extension and establish a new effective date by which the 
minor use shall be deleted from the registration.". 
(B) Section 4(e)(3)(A) (7 U.S.C. 136a-l(e)(3)(A)) is 
amended by adding at the end the following: "If the reg-
istrant does not commit to support a specific minor use 
of the pesticide, but is supporting and providing data in 
a timely and adequate fashion to support uses of the pes-
ticide on a food, or if all uses of the pesticide are nonfood 
uses and the registrant does not commit to support a 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1499 
specific minor use of the pesticide but is supporting and 
providing data in a timely and adequate fashion to support 
other nonfood uses of the pesticide, the Administrator, 
at the written request of the registrant, shall not take 
any action pursuant to this subparagraph in regard to 
such unsupported minor use until the final deadline estab-
lished as of the date of enactment of the Food Quality 
Protection Act of 1996, for the submission of data under 
this section for the supported uses identified pursuant to 
this subparagraph unless the Administrator determines 
that the absence of the data is significant enough to cause 
human health or environmental concerns. On the basis 
of such determination, the Administrator may refuse the 
request for extension by the registrant. Upon receipt of Federal Register, 
the request from the registrant, the Administrator shall publication, 
publish in the Federal Register a notice of the receipt 
of the request and the effective date upon which the uses 
not being supported will be voluntarily deleted from the 
registration pursuant to section 6(f)(1). If the Administrator 
grants an extension under this subparagraph, the Adminis-
trator shall monitor the development of the data for the 
uses being supported and shall ensure that the registrant 
is meeting the schedule for the production of such data. 
If the Administrator determines that the registrant is not 
meeting or has not met the schedule for the production 
of such data, the Administrator may proceed in accordance 
with section 3(c)(2)(B)(iv) regarding the continued registra-
tion of the Eiffected products with the minor and other 
uses and shall inform the public of such action in accord-
ance with section 6(f)(2). Notwithstanding this subpara-
graph, the Administrator may deny, modify, or revoke the 
temporary extension under this subparagraph if the 
Administrator determines that the continuation of the 
minor use may cause an unreasonable adverse effect on 
the environment. In the event of modification or revocation, Notice. 
the Administrator shall provide, in writing, to the reg-
istrant a notice revoking the temporary extension and 
establish a new effective date by which the minor use 
shall be deleted from the registration.". 
(2) DATA.—Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as 
amended by subsection (c)(1), is further amended by adding 
at the end the following: 
"(vii) If the registrant does not commit to support 
a specific minor use of the pesticide, but is supporting 
and providing data in a timely and adequate fashion to 
support uses of the pesticide on a food, or if all uses 
of the pesticide are nonfood uses and the registrant does 
not commit to support a specific minor use of the pesticide 
but is supporting and providing data in a timely and ade-
quate fashion to support other nonfood uses of the pesticide, 
the Administrator, at the written request of the registrant, 
shall not take any action pursuant to this clause in regard 
to such unsupported minor use until the final deadline 
established as of the date of enactment of the Food Quality 
Protection Act of 1996, for the submission of data under 
section 4 for the supported uses identified pursuant to 
this clause unless the Administrator determines that the 
110 STAT. 1500 
PUBLIC LAW 104-170—AUG. 3, 1996 
Federal Register, 
publication. 
Notice. 
absence of the data is significant enough to cause human 
health or environmental concerns. On the basis of such 
determination, the Administrator may refuse the request 
for extension by the registrant. Upon receipt of the request 
from the registrant, the Administrator shall publish in 
the Federal Register a notice of the receipt of the request 
and the effective date upon which the uses not being sup-
ported will be voluntarily deleted from the registration 
pursuant to section 6(f)(1)- If the Administrator grants 
an extension under this clause, the Administrator shall 
monitor the development of the data for the uses being 
supported and shall ensure that the registrant is meeting 
the schedule for the production of such data. If the Adminis-
trator determines that the registrant is not meeting or 
has not met the schedule for the production of such data, 
the Administrator may proceed in accordance with clause 
(iv) of this subparagraph regarding the continued registra-
tion of the affected products with the minor and other 
uses and shall inform the public of such action in accord-
ance with section 6(f)(2). Notwithstanding the provisions 
of this clause, the Administrator may deny, modify, or 
revoke the temporary extension under this subparagraph 
if the Administrator determines that the continuation of 
the minor use may cause an unreasonable adverse effect 
on the environment. In the event of modification or revoca-
tion, the Administrator shall provide, in writing, to the 
registrant a notice revoking the temporary extension and 
establish a new effective date by which the minor use 
shall be deleted from the registration.", 
(g) Section 6(f) (7 U.S.C. 136d(f)) is amended— 
(1) in paragraph (l)(C)(ii) by striking "90-day" each place 
it appears and inserting "180-day"; and 
(2) in paragraph (3)(A) by striking "90-day" and inserting 
"180-day". 
(h) UTILIZATION OF DATA FOR VOLUNTARILY CANCELED CHEMI-
CALS.—Section 6(f) (7 U.S.C. 136d(f)) is amended by adding at 
the end the following: 
"(4) UTILIZATION OF DATA FOR VOLUNTARILY CANCELED PES-
TICIDE.—When an application is filed with the Administrator 
for the registration of a pesticide for a minor use and another 
registrant subsequently voluntarily cancels its registration for 
an identical or substantially similar pesticide for an identical 
or substantially similar use, the Administrator shall process, 
review, and evaluate the pending application as if the voluntary 
cancellation had not yet taken place except that the Adminis-
trator shall not take such action if the Administrator deter-
mines that such minor use may cause an unreasonable adverse 
effect on the environment. In order to rely on this subsection, 
the applicant must certify that it agrees to satisfy any outstand-
ing data requirements necessary to support the reregistration 
of the pesticide in accordance with the data submission schedule 
established by the Administrator.". 
(i) 
ENVIRONMENTAL PROTECTION AGENCY MINOR USE 
PRO-
GRAM.—^The Federal Insecticide, Fungicide, and Rodenticide Act 
(7 U.S.C. 136 et seq.), as amended by section 121, is amended 
by adding after section 30 the following: 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1501 
Public 
infonnation. 
Reports. 
"SEC. 31. ENVIRONMENTAL PROTECTION AGENCY MINOR USE PRO- 7 USC 136w-6. 
GRAM. 
"(a) The Administrator shall assure coordination of minor use 
issues through the establishment of a minor use program within 
the Office of Pesticide Programs. Such office shall be responsible 
for coordinating the development of minor use programs and policies 
and consulting with growers regarding minor use issues and reg-
istrations and amendments which are submitted to the Environ-
mental Protection Agency. 
"(b) The Office of Pesticide Programs shall prepare a public 
report concerning the progress made on the registration of minor 
uses, including implementation of the exclusive use as an incentive 
for registering new minor uses, within 3 years of the passage 
of the Food Quality Protection Act of 1996.". 
(j) DEPARTMENT OF AGRICULTURE MINOR USE PROGRAM.—^The 
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 
et seq.), as amended by subsection (i), is amended by adding after 
section 31 the following: 
"SEC. 32. DEPARTMENT OF AGRICULTURE MINOR USE PROGRAM. 
7 USC 136w-7. 
"(a) IN GENERAL.—^The Secretary of Agriculture (hereinafter 
in this section referred to as the 'Secretary') shall assure the -
coordination of the responsibilities of the Department of Agriculture 
related to minor uses of pesticides, including— 
"(1) carrying out the Inter-Regional Project Number 4 (IR-
4) as described in section 2 of PubUc Law 89-106 (7 U.S.C. 
450i(e)) and the national pesticide resistance monitoring pro-
gram established under section 1651 of the Food, Agriculture, 
Conservation, and Trade Act of 1990 (7 U.S.C. 5882); 
"(2) supporting integrated pest management research; 
"(3) consulting With growers to develop data for minor 
uses; and 
"(4) providing assistance for minor use registrations, toler-
ances, and re 
registrations with the Environmental Protection 
Agency. 
"(b)(1) MINOR USE PESTICIDE DATA.— 
"(A) GRANT AUTHORITY.—^The Secretary, in consultation 
with the Administrator, shall establish a program to make 
grants for the development of data to support minor use pes-
ticide registrations and reregistrations. The amount of any 
such grant shall not exceed V
b of the cost of the project for 
which the grant is made. 
"(B) APPLICANTS.—^Any person who wants to develop data 
to support minor use pesticide registrations and reregistrations 
may apply for a grant under subparagraph (A). Priority shall 
be given to an applicant for such a grant who does not directly 
receive funds from the sale of pesticides registered for minor 
uses. 
"(C) DATA OWNERSHIP.—^Any data that is developed under 
a grant under subparagraph (A) shall be jointly owned by 
the Department of Agriculture and the person who received 
the grant. Such a person shall enter into an agreement with 
the Secretary under which such person shall share any fee 
paid to such person under section 3(c)(1)(F). 
"(2) MINOR USE PESTICIDE DATA REVOLVING FUND.— 
"(A) ESTABLISHMENT.—There is established in the Treasury Nomendature. 
of the United States a revolving fund to be known as the 
110 STAT. 1502 
PUBLIC LAW 104-170—AUG. 3, 1996 
Minor Use Pesticide Data Revolving Fund. The Fund shall 
be available without fiscal year limitation to carry out the 
authorized purposes of this subsection. 
"(B) CONTENTS OF THE FUND.—There shall be deposited 
in the Fund— 
"(i) such amounts as may be appropriated to support 
the purposes of this subsection; and 
"(ii) fees collected by the Secretary for any data devel-
oped under a grant under paragraph (1)(A). 
"(C) 
AUTHORIZATIONS OF APPROPRIATIONS.—There 
are 
authorized to be appropriated for each fiscal year to carry 
out the purposes of this subsection $10,000,000 to remain avail-
able until expended.". 
Subtitle B—^Antimicrobial Pesticide 
Registration Reform 
SEC. 221. DEFINITIONS. 
Section 2 (7 U.S.C. 136), as amended by section 210(a) is 
further amended— 
(1) in subsection (u), by adding at the end the following: 
"The term 'pesticide' does not include liquid chemical sterilant 
products (including any sterilant or subordinate disinfectant 
claims on such products) for use on a critical or semi-critical 
device, as defined in section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321). For purposes of the preceding 
sentence, the term 'critical device' includes any device which 
is introduced directly into the human body, either into or in 
contact with the bloodstream or normally sterile areas of the 
body and the term 'semi-critical device' includes any device 
which contacts intact mucous membranes but which does not 
ordinarily penetrate the blood barrier or otherwise enter nor-
mally sterile areas of the body."; and 
(2) by adding at the end the following: 
"(mm) ANTIMICROBIAL PESTICIDE.— 
"(1) IN GENERAL.—^The term 'antimicrobial pesticide' means 
a pesticide that— 
"(A) is intended to— 
"(i) disinfect, sanitize, reduce, or mitigate growth 
or development of microbiological organisms; or 
"(ii) protect inanimate objects, industrial processes 
or systems, surfaces, water, or other chemical sub-
stances from contamination, fouling, or deterioration 
caused by bacteria, viruses, fungi, protozoa, algae, or 
slime; and 
"(B) in the intended use is exempt from, or otherwise 
not subject to, a tolerance under section 408 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 346a and 348) 
or a food additive regulation under section 409 of such 
Act. 
"(2) EXCLUDED PRODUCTS.—^The term 'antimicrobial pes-
ticide' does not include — 
"(A) a wood preservative or antifouling paint product 
for which a claim of pesticidal activity other than or in 
addition to an activity described in paragraph (1) is made; 
"(B) an agricultural fungicide product; or 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1503 
"(C) an aquatic herbicide product. 
"(3) INCLUDED PRODUCTS.—The term 'antimicrobial pes-
ticide' does include any other chemical sterilant product (other 
than liquid chemical sterilant products exempt under sub-
section (u)), any other disinfectant product, any other industrial 
microbiocide product, and any other preservative product that 
is not excluded by paragraph (2).". 
SEC. 222. FEDERAL AND STATE DATA COORDINATION. 
Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as amended by sec-
tion 210(f)(2), is amended by adding at the end the following: 
"(viii)(I) If data required to support registration of a 
pesticide under subparagraph (A) is requested by a Federal 
or State regulatory authority, the Administrator shall, to 
the extent practicable, coordinate data requirements, test 
P
rotocols, timetables, and standards of review and reduce 
urdens and redundancy caused to the registrant by mul-
tiple requirements on the registrant. 
"(II) The Administrator may enter into a cooperative 
agreement with a State to carry out subclause (I). 
"(Ill) Not later than 1 year after the date of enactment 
of this clause, the Administrator shall develop a process 
to identify and assist in alleviating future disparities 
between Federal and State data requirements.". 
SEC. 223. LABEL AND LABELING. 
Section 3(c) (7 U.S.C. 136a(c)) is amended by adding at the 
end the following: 
"(9) LABELING.— 
"(A) 
ADDITIONAL STATEMENTS.—Subject to subpara-
graphs (B) and (C), it shall not be a violation of this 
Act for a registrant to modify the labeling of an 
antimicrobial pesticide product to include relevant informa-
tion on product efficacy, product composition, container 
composition or design, or other characteristics that do not 
relate to any pesticidal claim or pesticidal activity. 
"(B) REQUIREMENTS.—^Proposed labeling information 
under subparagraph (A) shall not be false or misleading, 
shall not conflict with or detract from any statement 
required by law or the Administrator as a condition of 
registration, and shall be substantiated on the request 
of the Administrator. 
"(C) NOTIFICATION AND DISAPPROVAL.— 
"(i) NOTIFICATION.—^A registration may be modified 
under subparagraph (A) if — 
"(I) the registrant notifies the Administrator 
in writing not later than 60 days prior to distribu-
tion or sale of a product bearing the modified 
labeling; and 
"(II) the Administrator does not disapprove 
of the modification under clause (ii). 
"(ii) DISAPPROVAL.—^Not later than 30 days after 
receipt of a notification under clause (i), the Adminis-
trator may disapprove the modification by sending the 
registrant notification in writing stating that the pro-
posed language is not acceptable and stating the rea-
sons why the Administrator finds the proposed modi-
fication unacceptable. 
110 STAT. 1504 
PUBLIC LAW 104-170—AUG. 3, 1996 
"(iii) RESTRICTION ON SALE.—^A registrant may not 
sell or distribute a product bearing a disapproved modi-
fication. 
"(iv) OBJECTION.—^A registrant may file an objec-
tion in writing to a disapproval under clause (ii) not 
later than 30 days after receipt of notification of the 
disapproval. 
"(v) FINAL ACTION.—^A decision by the Adminis-
trator following receipt and consideration of an objec-
tion filed under clause (iv) shall be considered a final 
agency action. 
"(D) USE DILUTION.—The label or labeling required 
under this Act for an antimicrobial pesticide that is or 
may be diluted for use may have a different statement 
of caution or protective measures for use of the rec-
ommended diluted solution of the pesticide than for use 
of a concentrate of the pesticide if the Administrator deter-
mines that — 
"(i) adequate data have been submitted to support 
the statement proposed for the diluted solution uses; 
and 
"(ii) the label or labeling provides adequate protec-
tion for exposure to the diluted solution of the pes-
ticide.". 
SEC. 224. REGISTRATION REQUIREMENTS FOR ANTIMICROBIAL PES-
TICIDES. 
Section 3 (7 U.S.C. 136a), as amended by section 106(b), is 
further amended by adding at the end the following: 
"(h) REGISTRATION REQUIREMENTS FOR ANTIMICROBIAL PES-
TICIDES.— 
"(1) EVALUATION OF PROCESS.—To the maximum extent 
practicable consistent with the degrees of risk presented by 
an antimicrobial pesticide and the type of review appropriate 
to evaluate the risks, the Administrator shall identify and 
evaluate reforms to the antimicrobial registration process that 
would reduce review periods existing as of the date of enactment 
of this subsection for antimicrobial pesticide product registra-
tion applications and applications for amended registration of 
antimicrobial pesticide products, including— 
"(A) new antimicrobial active ingredients; 
"(B) new antimicrobial end-use products; 
"(C) substantially similar or identical antimicrobial 
pesticides; and 
"(D) amendments to antimicrobial pesticide registra-
tions. 
"(2) REVIEW TIME PERIOD REDUCTION GOAL.—Each reform 
identified under paragraph (1) shall be designed to achieve 
the goal of reducing the review period following submission 
of a complete application, consistent with the degree of risk, 
to a period of not more than— 
"(A) 540 days for a new antimicrobial active ingredient 
pesticide registration; 
"(B) 270 days for a new antimicrobial use of a reg-
istered active ingredient; 
"(C) 120 days for any other new antimicrobial product; 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1505 
"(D) 90 days for a substantially similar or identical 
antimicrobial product; 
"(E) 90 days for an amendment to an antimicrobial 
registration that does not require scientific review of data; 
and 
"(F) 90 to 180 days for an amendment to an 
antimicrobial registration that requires scientific review 
of data and that is not otherwise described in this para-
graph. 
"(3) IMPLEMENTATION.— 
"(A) PROPOSED RULEMAKING.— 
"(i) ISSUANCE.—^Not later than 270 days after the Federal Register, 
date of enactment of this subsection, the Administrator publication, 
shall publish in the Federal Register proposed regula-
tions to accelerate 
and 
improve the review of 
antimicrobial pesticide products designed to imple-
ment, to the extent practicable, the goals set forth 
in paragraph (2). 
"(ii) REQUIREMENTS.—Proposed regulations issued 
under clause (i) shall— 
"(I) define the various classes of antimicrobial 
use patterns, including household, industrial, and 
institutional 
disinfectants 
and 
sanitizing pes-
ticides, preservatives, water treatment, and pulp 
and paper mill additives, and other such products 
intended to disinfect, sanitize, reduce, or mitigate 
growth or development of microbiological orga-
nisms, or protect inanimate objects, industrial 
processes or systems, surfaces, water, or other 
chemical substances from contamination, fouling, 
or deterioration caused by bacteria, viruses, fungi, 
protozoa, algae, or slime; 
"(II) differentiate the types of review under-
taken for antimicrobial pesticides; 
"(III) conform the degree and tjrpe of review 
to 
the 
risks 
and 
benefits 
presented 
by 
antimicrobial pesticides and the function of review 
under this Act, considering the use patterns of 
the product, toxicity, expected exposure, and prod-
uct type; 
"(IV) ensure that the registration process is 
sufficient to maintain antimicrobial pesticide effi-
cacy and that antimicrobial pesticide products con-
tinue to meet product performance standards and 
effectiveness levels for each type of label claim 
made; and 
"(V) implement effective and reliable deadlines 
for process management. 
"(iii) COMMENTS.—In developing the proposed 
regulations, the Administrator shall solicit the views 
from registrants and other affected parties to maximize 
the effectiveness of the rule development process. 
"(B) FINAL REGULATIONS.— 
"(i) ISSUANCE.—^The Administrator shall issue final 
regulations not later than 240 days after the close 
of the comment period for the proposed regulations. 
110 STAT. 1506 
PUBLIC LAW 104-170—AUG. 3, 1996 
Review. 
"(ii) FAILURE TO MEET GOAL.—If a goal described 
in paragraph (2) is not met by the final regulations, 
the Administrator shall identify the goal, explain why 
the goal was not attained, describe the element of 
the regulations included instead, and identify future 
steps to attain the goal. 
"(iii) REQUIREMENTS.—In issuing final regulations, 
the Administrator shall— 
"(I) consider the establishment of a certifi-
cation process for regulatory actions involving risks 
that can be responsibly managed, consistent with 
the degree of risk, in the most cost-efiicient man-
ner; 
"(II) consider the establishment of a certifi-
cation process by approved laboratories as an 
adjunct to the review process; 
"(III) use all appropriate and cost-effective 
review mechanisms, including— 
"(aa) expanded use of notification and non-
notification procedures; 
"(bb) revised procedures for application 
review; and 
"(cc) allocation of appropriate resources to 
ensure 
streamlined 
management 
of 
antimicrobial pesticide registrations; and 
"(IV) clarify criteria for determination of the 
completeness of an application. 
"(C) EXPEDITED REVIEW.—This subsection does not 
affect the requirements or extend the deadlines or review 
periods contained in subsection (c)(3). 
"(D) ALTERNATIVE REVIEW PERIODS.—If the final regu-
lations to carry out this paragraph are not effective 630 
days after the date of enactment of this subsection, until 
the final regulations become effective, the review period, 
beginning on the date of receipt by the Agency of a complete 
application, shall be— 
"(i) 2 years for a new antimicrobial active ingredi-
ent pesticide registration; 
"(ii) 1 year for a new antimicrobial use of a reg-
istered active ingredient; 
"(iii) 180 days for any other new antimicrobial 
product; 
"(iv) 90 days for a substantially similar or identical 
antimicrobial product; 
"(v) 90 days for an amendment to an antimicrobial 
registration that does not require scientific review of 
data; and 
"(vi) 
240 
days 
for 
an 
amendment 
to 
an 
antimicrobial 
registration 
that 
requires 
scientific 
review of data and that is not otherwise described 
in this subparagraph. 
"(E) WOOD PRESERVATIVES.—^An application for the reg-
istration, or for an amendment to the registration, of a 
wood preservative product for which a claim of pesticidal 
activity listed in section 2(mm) is made (regardless of any 
other pesticidal claim that is made with respect to the 
product) shall be reviewed by the Administrator within 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1507 
the same period as that estabHshed under this paragraph 
for an antimicrobial pesticide product appHcation, consist-
ent with the degree of risk posed by the use of the wood 
preservative product, if the application requires the 
applicant to satisfy the same data requirements as are 
required to support an application for a wood preservative 
product that is an antimicrobial pesticide. 
"(F) NOTIFICATION.— 
"(i) IN GENERAL.—Subject to clause (iii), the 
Administrator shall notify an applicant whether an 
application has been granted or denied not later than 
the final day of the appropriate review period under 
this paragraph, unless the applicant and the Adminis-
trator agree to a later date. 
"(ii) FINAL DECISION.—If the Administrator fails 
to notify an applicant within the period of time 
required under clause (i), the failure shall be consid-
ered an agency action unlawfully withheld or unreason-
ably delayed for purposes of 
judicial review under chap-
ter 7 of title 5, United States Code. 
"(iii) EXEMPTION.—This subparagraph does not 
apply to an application for an antimicrobial pesticide 
that is filed under subsection (c)(3)(B) prior to 90 days 
after the date of enactment of this subsection. 
"(4) ANNUAL REPORT.— 
"(A) SUBMISSION.—Beginning on the date of enactment 
of this subsection and ending on the date that the goals 
under paragraph (2) are achieved, the Administrator shall, 
not later than March 1 of each year, prepare and submit 
an annual report to the Committee on Agriculture of the 
House of Representatives and the Committee on Agri-
culture, Nutrition, and Forestry of the Senate. 
"(B) 
REQUIREMENTS.—^A 
report 
submitted 
under 
subparagraph (A) shall include a description of— 
"(i) measures taken to reduce the backlog of pend-
ing registration applications; 
"(ii) progress toward achieving reforms under this 
subsection; and 
"(iii) recommendations to improve the activities 
of the Agency pertaining to antimicrobial registra-
tions.". 
SEC. 225. DISPOSAL OF HOUSEHOLD, INDUSTRLVL, OR INSTITUTIONAL 
ANTIMICROBIAL PRODUCTS. 
Section 19(h) (7 U.S.C. 136q(h)) is amended— 
(1) by striking "Nothing in" and inserting the following: 
"(1) IN GENERAL.—Nothing in"; and 
(2) by adding at the end the following: 
"(2) ANTIMICROBIAL PRODUCTS.—^A household, industrial, 
or institutional antimicrobial product that is not subject to 
regulation under the Solid Waste Disposal Act (42 U.S.C. 6901 
et seq.) shall not be subject to the provisions of subsections 
(a), (e), and (f), unless the Administrator determines that such 
product must be subject to such provisions to prevent an 
unreasonable adverse effect on the environment.". 
110 STAT. 1508 
PUBLIC LAW 104-170—AUG. 3, 1996 
Subtitle C—Public Health Pesticides 
SEC. 230. DEFINITIONS. 
(a) ADVERSE EFFECTS.—Section 2(bb) (7 U.S.C. 136(bb)) is 
amended by adding at the end the following: "The Administrator 
shall consider the risks and benefits of public health pesticides 
separate from the risks and benefits of other pesticides. In weighing 
any regulatory action concerning a public health pesticide under 
this Act, the Administrator shall weigh any risks of the pesticide 
against the health risks such as the diseases transmitted by the 
vector to be controlled by the pesticide.". 
(b) NEW DEFINITIONS.—Section 2 (7 U.S.C. 136), as amended 
by section 221, is amended by adding at the end the following: 
"(nn) PUBLIC HEALTH PESTICIDE.—The term 'public health pes-
ticide' means any minor use pesticide product registered for use 
and used predominantly in public health programs for vector control 
or for other recognized health protection uses, including the preven-
tion or mitigation of viruses, bacteria, or other microorganisms 
(other than viruses, bacteria, or other microorganisms on or in 
living man or other living animal) that pose a threat to public 
health. 
"(oo) VECTOR.—The term Vector' means any organism capable 
of transmitting the causative agent of human disease or capable 
of producing human discomfort or injury, including mosquitoes, 
flies, fleas, cockroaches, or other insects and ticks, mites, or rats.". 
SEC. 231. REGISTRATION. 
Section 3(c)(2)(A) (7 U.S.C. 136a(c)(2)(A)) is amended— 
(1) by inserting after "pattern of use," the following: "the 
public health and agricultural need for such minor use,"; and 
(2) by striking "potential exposure of man and the environ-
ment to the pesticide" and inserting "potential beneficial or 
adverse effects on man and the environment". 
SEC. 232. REREGISTRATION. 
Section 4 (7 U.S.C. 136a-l) is amended— 
(1) in subsection (i)(4), by redesignating subparagraphs 
(B) and (C) as subparagraphs (C) and (D), respectively, and 
by adding after subparagraph (A) the following: 
"(B) The Administrator shall exempt any public health 
pesticide from the payment of the fee prescribed under 
paragraph (3) if, in consultation with the Secretary of 
Health and Human Services, the Administrator determines, 
based on information supplied by the registrant, that the 
economic return to the registrant from sales of the pesticide 
does not support the registration or reregistration of the 
pesticide."; 
(2) in subsection (i)(5), by redesignating subparagraphs 
(F) and (G) as subparagraphs (G) and (H), respectively, and 
by adding after subparagraph (E) the following: 
"(F) The Administrator shall exempt any public health 
pesticide from the payment of the fee prescribed under 
paragraph (3) if, in consultation with the Secretary of 
Health and Humans Services, the Administrator deter-
mines, based on information supplied by the registrant, 
that the economic return to the registrant from sales of 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1509 
the pesticide does not support the registration or reregistra-
tion of the pesticide."; 
(3) in subsection (i)(7)(B), by striking "or to determine" 
and inserting ", to determine" and by inserting before the 
period the following: ", or to determine the volume usage for 
public health pesticides"; and 
(4) in subsection (k)(3)(A), by striking "or" at the end of 
clause (i), by striking the period at the end of clause (ii) and 
inserting thereof "; or", and by adding after clause (ii) the 
following: 
"(iii) proposes the initial or amended registration 
of an end use pesticide that, if registered as proposed, 
would be used for a public health pesticide.". 
SEC. 233. CANCELLATION. 
Section 6(b) (7 U.S.C. 136d(b)) is amended by adding after 
the eighth sentence the following: "When a public health use is 
affected, the Secretary of Health and Human Services should pro-
vide available benefits and use information, or an analysis thereof, 
in accordance with the procedures followed and subject to the same 
conditions as the Secretary of Agriculture in the case of agricultural 
pesticides.". 
SEC. 
234. 
VIEWS 
OF 
THE 
SECRETARY 
OF 
HEALTH 
AND 
HUMAN 
SERV-
ICES. 
Section 21 (7 U.S.C. 136s) is amended by redesignating sub-
sections (b) and (c) as subsections (c) and (d), respectively, and 
by adding after subsection (a) the following: 
"(b) 
SECRETARY OF HEALTH 
AND HUMAN 
SERVICES.—The 
Administrator, before publishing regulations under this Act for 
any public health pesticide, shall solicit the views of the Secretary 
of Health and Human Services in the same manner as the views 
of the Secretary of Agriculture are solicited under section 25(a)(2).". 
SEC. 235. AUTHORITY OF ADMINISTRATOR. 
Section 25(a)(1) (7 U.S.C. 136w(a)(l)) is amended— 
(1) by inserting after "various classes of pesticides" the 
following: ", including public health pesticides,"; and 
(2) by striking "and nonagricultural pesticides" and insert-
ing ", nonagricultural, and public health pesticides". 
SEC. 236. IDENTIFICATION OF PESTS. 
Section 28 (7 U.S.C. 136w-3) is amended by adding at the 
end the following: 
"(d) PUBLIC HEALTH PESTS.—The Administrator, in coordination 
with the Secretary of Agriculture and the Secretary of Health 
and Human Services, shall identify pests of significant public health 
importance and, in coordination with the Public Health Service, 
develop and implement programs to improve and facilitate the 
safe and necessary use of chemical, biological, and other methods 
to combat gmd control such pests of public health importance.". 
SEC. 237. PUBLIC HEALTH DATA. 
Section 4 (7 U.S.C. 136a-l) is amended by adding at the end 
the following: 
"(m) AUTHORIZATION OF FUNDS TO DEVELOP PUBLIC HEALTH 
DATA.— 
110 STAT. 1510 
PUBLIC LAW 104-170—AUG. 3, 1996 
Regulations. 
Notification. 
Notification. 
"(1) DEFINITION.—For the purposes of this section, 'Sec-
retary' means the Secretary of Health and Human Services, 
acting through the Pubhc Health Service. 
"(2) CONSULTATION.—In the case of a pesticide registered 
for use in public health programs for vector control or for 
other uses the Administrator determines to be human health 
protection uses, the Administrator shall, upon timely request 
by the registrant or any other interested person, or on the 
Administrator's own initiative may, consult with the Secretary 
prior to taking final action to suspend registration under section 
3(c)(2)(B)(iv), or cancel a registration under section 4, 6(e), 
or 6(f). In consultation with the Secretary, the Administrator 
shall prescribe the form and content of requests under this 
section. 
"(3) BENEFITS TO SUPPORT FAMILY.—The Administrator, 
after consulting with the Secretary, shall make a determination 
whether the potential benefits of continued use of the pesticide 
for public health or health protection purposes are of such 
significance as to warrant a commitment by the Secretary 
to conduct or to arrange for the conduct of the studies required 
by the Administrator to support continued registration under 
section 3 or reregistration under section 4. 
"(4) ADDITIONAL TIME.—If the Administrator determines 
that such a commitment is warranted and in the public interest, 
the Administrator shall notify the Secretary and shall, to the 
extent necessary, amend a notice issued under section 3(c)(2)(B) 
to specify additional reasonable time periods for submission 
of the data. 
"(5) ARRANGEMENTS.—^The Secretary shall make such 
arrangements for the conduct of required studies as the Sec-
retary finds necessary and appropriate to permit submission 
of data in accordance with the time periods prescribed by 
the Administrator. Such arrangements may include Public 
Health Service intramural research activities, grants, contracts, 
or cooperative agreements with academic, public health, or 
other organizations qualified by experience and training to 
conduct such studies. 
"(6) SUPPORT.—^The Secretary may provide for support of 
the required studies using funds authorized to be appropriated 
under this section, the Public Health Service Act, or other 
appropriate authorities. After a determination is made under 
subsection (d), the Secretary shall notify the Committees on 
Appropriations of the House of Representatives and the Senate 
of the sums required to conduct the necessary studies. 
"(7) AUTHORIZATION OF APPROPRIATIONS.—There is author-
ized to be appropriated to carry out the purposes of this section 
$12,000,000 for fiscal year 1997, and such sums as may be 
necessary for succeeding fiscal years.". 
Subtitle D—Expedited Registration of 
Reduced Risk Pesticides 
SEC. 250. EXPEDITED REGISTRATION OF PESTICIDES . 
Section 3(c) (7 U.S.C. 136a(c)), as amended by section 223, 
is amended— 
(1) by adding at the end of paragraph (1) the following: 
PUBLIC l A W 104-170—AUG. 3, 1996 
110 STAT. 1511 
"(G) If the applicant is requesting that the registration 
or amendment to the registration of a pesticide be expe-
dited, an explanation of the basis for the request must 
be submitted, in accordance with paragraph (10) of this 
subsection."; and 
(2) by adding at the end the following: 
"(10) EXPEDITED REGISTRATION OF PESTICIDES.— 
"(A) Not later than 1 year after the date of enactment Gvddelines. 
of this paragraph, the Administrator shall, utilizing public 
comment, develop procedures and guidelines, and expedite 
the review of an application for registration of a pesticide 
or an amendment to a registration that satisfies such guide-
lines. 
"(B) Any application for registration or an amendment, 
including biological and conventional pesticides, will be 
considered for expedited review under this paragraph. An 
application for registration or an amendment shall qualify 
for expedited review if use of the pesticide proposed by 
the application may reasonably be expected to accomplish 
1 or more of the following: 
"(i) Reduce the risks of pesticides to human health, 
"(ii) Reduce the risks of pesticides to nontarget 
organisms. 
"(iii) Reduce the potential for contamination of 
groundwater, surface water, or other valued environ-
mental resources. 
"(iv) Broaden the adoption of integrated pest 
management strategies, or make such strategies more 
available or more effective. 
"(C) The Administrator, not later than 30 days after 
Notification. 
receipt of an application for expedited review, shall notify 
the applicant whether the application is complete. If it 
is found to be incomplete, the Administrator may either 
reject the request for expedited review or ask the applicant 
for additional information to satisfy the guidelines devel-
oped under subparagraph (A).". 
TITLE III—DATA COLLECTION ACTIVI-
TIES TO ASSURE THE HEALTH OF IN-
FANTS AND CHILDREN AND OTHER 
MEASURES 
SEC. 301. DATA COLLECTION ACTIVITIES TO ASSURE THE HEALTH 
OF INFANTS AND CHILDREN. 
(a) IN GENERAL.—^The Secretary of Agriculture, in consultation 
with the Administrator of the Environmental Protection Agency 
and the Secretary of Health and Human Services, shall coordinate 
the development and implementation of survey procedures to ensure 
that adequate data on food consumption patterns of infants and 
children are collected. 
(b) PROCEDURES.—^To the extent practicable, the procedures 
referred to in subsection (a) shall include the collection of data 
on food consumption patterns of a statistically valid sample of 
infants and children. 
21 use 346a 
note. 
110 STAT. 1512 
PUBLIC LAW 104-170—AUG. 3, 1996 
7 u s e 136i-2. 
7 u s e 136r-l. 
7 u s e 136i-2 
note. 
Reports. 
(c) RESIDUE DATA COLLECTION.—^The Secretary of Agriculture 
shall ensure that the residue data collection activities conducted 
by the Department of Agriculture in cooperation with the Environ-
mental Protection Agency and the Department of Health and 
Human Services, provide for the improved data collection of pes-
ticide residues, including guidelines for the use of comparable 
analytical and standardized reporting methods, and the increased 
sampling of foods most likely consumed by infants and children. 
SEC. 302. COLLECTION OF PESTICIDE USE INFORMATION. 
(a) IN GENERAL.—The Secretary of Agriculture shall collect 
data of statewide or regional significance on the use of pesticides 
to control pests and diseases of major crops and crops of dietary 
significance, including fruits and vegetables. 
(b) COLLECTION.—^The data shall be collected by surveys of 
farmers or from other sources offering statistically reliable data. 
(c) COORDINATION.—The Secretary of Agriculture shall, as 
appropriate, coordinate with the Administrator of the Environ-
mental Protection Agency in the design of the surveys and make 
available to the Administrator the aggregate results of the surveys 
to assist the Administrator. 
SEC. 303. INTEGRATED PEST MANAGEMENT. 
The Secretary of Agriculture, in cooperation with the Adminis-
trator, shall implement research, demonstration, and education pro-
grams to support adoption of Integrated Pest 
Management. 
Integrated Pest Management is a sustainable approach to managing 
pests by combining biological, cultural, physical, and chemical tools 
in a way that minimizes economic, health, and environmental risks. 
The Secretary of Agriculture and the Administrator shall make 
information on Integrated Pest Management widely available to 
pesticide users, including Federal agencies. Federal agencies shall 
use Integrated Pest Management techniques in carrying out pest 
management activities and shall promote Integrated Pest Manage-
ment through procurement and regulatory policies, and other activi-
ties. 
SEC. 304. COORDINATION OF CANCELLATION. 
Section 2(bb) (7 U.S.C. 136(bb)) is amended— 
(1) by inserting "(1)" after "means"; and 
(2) by striking the period at the end of the first sentence 
and inserting ", or (2) a human dietary risk from residues 
that result from a use of a pesticide in or on any food inconsist-
ent with the standard under section 408 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 346a).". 
SEC. 305. PESTICIDE USE INFORMATION STUDY. 
(a) The Secretary of Agriculture shall, in consultation with 
the Administrator of the Environmental Protection Agency, prepare 
a report to Congress evaluating the current status and potential 
improvements in Federal pesticide use information gathering activi-
ties. This report shall at least include— 
(1) an analysis of the quality and reliability of the informa-
tion collected by the Department of Agriculture, the Environ-
mental Protection Agency, and other Federal agencies regarding 
the agricultural use of pesticides; and 
(2) an analysis of options to increase the effectiveness of 
national pesticide use information collection, including an 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1513 
analysis of costs, burdens placed on agricultural producers and 
other pesticide users, and effectiveness in tracking risk reduc-
tion by those options. 
(b) The Secretary shall submit this report to Congress not 
later than 1 year following the date of enactment of this section. 
TITLE rV—AMENDMENTS TO THE FED- F
o
o
d
Q
u
a
u
t
y 
ERAL FOOD, DRUG, AND COSMETIC i
g
^
r
^
"
^
^
*
^
^ 
ACT 
SEC 401. SHORT TITLE AND REFERENCE. 
(a) SHORT TITLE.—This title may be cited as the "Food Quality 
2i use 30i note. 
Protection Act of 1996 ". 
(b) REFERENCE.—Whenever in this title an amendment or 
repeal is expressed in terms of an amendment to, or repeal of, 
a section or other provision, the reference shall be considered to 
be made to a section or other provision of the Federal Food, Drug, 
and Cosmetic Act. 
SEC. 402. DEFINITIONS. 
(a) SECTION 20l(q),—Section 201(q) (21 U.S.C. 321(q)) is 
amended to read as follows: 
"(q)(l) The term 'pesticide chemical' means any substance that 
is a pesticide within the meaning of the Federal Insecticide, Fun-
gicide, and Rodenticide Act, including all active and inert ingredi-
ents of such pesticide. 
"(2) The term 'pesticide chemical residue' means a residue 
in or on raw agricultural commodity or processed food of— 
"(A) a pesticide chemical; or 
"(B) any other added substance that is present on or in 
the commodity or food primarily as a result of the metabolism 
or other degradation of a pesticide chemical. 
"(3) Notwithstanding paragraphs (1) and (2), the Administrator 
may by regulation except a substance from the definition of 'pes-
ticide chemical' or 'pesticide chemical residue' if— 
"(A) its occurrence as a residue on or in a raw agricultural 
commodity or processed food is attributable primarily to natural 
causes or to human activities not involving the use of any 
substances for a pesticidal purpose in the production, storage, 
processing, or transportation of any raw agricultural commodity 
or processed food; and 
"(B) the Administrator, after consultation with the Sec-
retary, determines that the substance more appropriately 
should be regulated under one or more provisions of this Act 
other than sections 402(a)(2)(B) and 408.". 
(b) SECTION 20 1(S).—Paragraphs (1) and (2) of section 201(s) 
(21 U.S.C. 321(s)) are amended to read as follows: 
"(1) a pesticide chemical residue in or on a raw agricultural 
commodity or processed food; or 
"(2) a pesticide chemical; or". 
(c) SECTION 201.—Section 201 (21 U.S.C. 321) is amended by 
adding at the end the following: 
"(gg) The term 'processed food' means any food other than 
a raw agricultural commodity and includes any raw agricultural 
110 STAT. 1514 
PUBLIC LAW 104-170—AUG. 3, 1996 
commodity that has been subject to processing, such as canning, 
cooking, freezing, dehydration, or milHng. 
"(hh) The term 'Administrator' means the Administrator of 
the United States Environmental Protection Agency.". 
SEC. 403. PROfflBITED ACTS. 
Section 301(j) (21 U.S.C. 331(j)) is amended in the first sentence 
by inserting before the period the following: "; or the violating 
of section 408(i)(2) or any regulation issued under that section.". 
SEC. 404. ADULTERATED FOOD. 
Section 402(a) (21 U.S.C. 342(a)) is amended by striking "(2)(A) 
if it bears" and all that follows through "(3) if it consists" and 
inserting the following: "(2)(A) if it bears or contains any added 
poisonous or added deleterious substance (other than a substance 
that is a pesticide chemical residue in or on a raw agricultural 
commodity or processed food, a food additive, a color additive, 
or a new animal drug) that is unsafe within the meaning of section 
406; or (B) if it bears or contains a pesticide chemical residue 
that is unsafe within the meaning of section 408(a); or (C) if it 
is or if it bears or contains (i) any food additive that is unsafe 
within the meaning of section 409; or (ii) a new animal drug 
(or conversion product thereof) that is unsafe within the meaning 
of section 512; or (3) if it consists". 
SEC. 405. TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL 
RESIDUES. 
Section 408 (21 U.S.C. 346a) is amended to read as follows: 
"TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
" S E C 408. (a) REQUIREMENT FOR TOLERANCE OR EXEMPTION.— 
"(1) GENERAL RULE.—Except as provided in paragraph (2) 
or (3), any pesticide chemical residue in or on a food shall 
be deemed unsafe for the purpose of section 402(a)(2)(B) 
unless— 
"(A) a tolerance for such pesticide chemical residue 
in or on such food is in effect under this section and 
the quantity of the residue is within the limits of the 
tolerance; or 
"(B) an exemption from the requirement of a tolerance 
is in effect under this section for the pesticide chemicsd 
residue. 
For the purposes of this section, the term 'food', when used 
as a noun without modification, shall mean a raw agricultural 
commodity or processed food. 
"(2) PROCESSED FOOD.—Notwithstanding paragraph (1)— 
"(A) if a tolerance is in effect under this section for 
a pesticide chemical residue in or on a raw agricultural 
commodity, a pesticide chemical residue that is present 
in or on a processed food because the food is made from 
that raw agricultural commodity shall not be considered 
unsafe within the meaning of section 402(a)(2)(B) despite 
the lack of a tolerance for the pesticide chemical residue 
in or on the processed food if the pesticide chemical has 
been used in or on the raw agricultural commodity in 
conformity with a tolerance under this section, such residue 
in or on the raw agricultural commodity has been removed 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1515 
to the extent possible in good manufacturing practice, and 
the concentration of the pesticide chemical residue in the 
processed food is not greater than the tolerance prescribed 
for the pesticide chemical residue in the raw agricultural 
commodity; or 
"(B) if an exemption for the requirement for a tolerance 
is in effect under this section for a pesticide chemical 
residue in or on a raw agricultural commodity, a pesticide 
chemical residue that is present in or on a processed food 
because the food is made from that raw agricultural 
commodity shall not be considered unsafe within the mean-
ing of section 402(a)(2)(B). 
"(3) RESIDUES OF DEGRADATION PRODUCTS.—If a pesticide 
chemical residue is present in or on a food because it is a 
metabolite or other degradation product of a precursor sub-
stance that itself is a pesticide chemical or pesticide chemical 
residue, such a residue shall not be considered to be unsafe 
within the meaning of section 402(a)(2)(B) despite the lack 
of a tolerance or exemption from the need for a tolerance 
for such residue in or on such food if— 
"(A) the Administrator has not determined that the 
degradation product is likely to pose any potential health 
risk from dietary exposure that is of a different type than, 
or of a greater significance than, any risk posed by dietary 
exposure to the precursor substance; 
"(B) either— 
"(i) a tolerance is in effect under this section for 
residues of the precursor substance in or on the food, 
and the combined level of residues of the degradation 
product and the precursor substance in or on the food 
is at or below the stoichiometrically equivalent level 
that would be permitted by the tolerance if the residue 
consisted only of the precursor substance rather than 
the degradation product; or 
"(ii) an exemption from the need for a tolerance 
is in effect under this section for residues of the precur-
sor substance in or on the food; and 
"(C) the tolerance or exemption for residues of the 
precursor substance does not state that it applies only 
to particular named substances and does not state that 
it does not apply to residues of the degradation product. 
"(4) EFFECT OF TOLERANCE OR EXEMPTION.—^While a toler-
ance or exemption from the requirement for a tolerance is 
in effect under this section for a pesticide chemical residue 
with respect to any food, the food shall not by reason of bearing 
or containing any amount of such a residue be considered 
to be adulterated within the meaning of section 402(a)(1). 
"(b) AUTHORITY AND STANDARD FOR TOLERANCE.— 
"(1) AUTHORITY.—^The Administrator may issue regulations 
establishing, modifying, or revoking a tolerance for a pesticide 
chemical residue in or on a food— 
"(A) in response to a petition filed under subsection 
(d); or 
"(B) on the Administrator's own initiative under sub-
section (e). 
As used in this section, the term 'modify' shall not mean 
expanding the tolerance to cover additional foods. 
110 STAT. 1516 
PUBLIC LAW 104-170—AUG. 3, 1996 
"(2) STANDARD.— 
"(A) GENERAL RULE.— 
"(i) STANDARD.—^The Administrator may establish 
or leave in effect a tolerance for a pesticide chemical 
residue in or on a food only if the Administrator deter-
mines that the tolerance is safe. The Administrator 
shall modify or revoke a tolersmce if the Administrator 
determines it is not safe. 
"(ii) DETERMINATION OF SAFETY.—AS used in this 
section, the term 'safe', with respect to a tolerance 
for a pesticide chemical residue, means that the 
Administrator has determined that there is a reason-
able certainty that no harm will result from aggregate 
exposure to the pesticide chemical residue, including 
all anticipated dietary exposures and all other expo-
sures for which there is reliable information. 
"(iii) RULE OF CONSTRUCTION.—With respect to a 
tolerance, a pesticide chemical residue meeting the 
standard under clause (i) is not an eligible pesticide 
chemical residue for purposes of subparagraph (B). 
"(B) TOLERANCES FOR ELIGIBLE PESTICIDE CHEMICAL 
RESIDUES.— 
"(i) DEFINITION.—^As used in this subparagraph, 
the term 'eligible pesticide chemical residue' means 
a pesticide chemical residue as to which— 
"(I) the Administrator is not able to identify 
a level of exposure to the residue at which the 
residue will not cause or contribute to a known 
or anticipated harm to human health (referred 
to in this section as a 'nonthreshold effect'); 
"(II) the lifetime risk of experiencing the non-
threshold effect is appropriately assessed by quan-
titative risk assessment; and 
"(III) with regard to any known or anticipated 
harm to human health for which the Administrator 
is able to identify a level at which the residue 
will not cause such harm (referred to in this section 
as a 'threshold effect'), the Administrator deter-
mines that the level of aggregate exposure is safe. 
"(ii) 
DETERMINATION OF TOLERANCE.—Notwith-
standing subparagraph (A)(i), a tolerance for an eligible 
pesticide chemical residue may be left in effect or modi-
fied under this subparagraph if— 
"(I) at least one of the conditions described 
in clause (iii) is met; and 
"(II) both of the conditions described in clause 
(iv) are met. 
"(iii) CONDITIONS REGARDING USE.—For purposes 
of clause (ii), the conditions described in this clause 
with respect to a tolerance for an eligible pesticide 
chemical residue are the following: 
"(I) Use of the pesticide chemical that produces 
the residue protects consumers from 
adverse 
effects on health that would pose a greater risk 
than the dietary risk from the residue. 
"(II) Use of the pesticide chemical that pro-
duces the residue is necessary to avoid a significant 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1517 
disruption in domestic production of an adequate, 
wholesome, and economical food supply. 
"(iv) CONDITIONS REGARDING RISK.—For purposes 
of clause (ii), the conditions described in this clause 
with respect to a tolerance for an eligible pesticide 
chemical residue are the following: 
"(I) The yearly risk associated with the non-
threshold effect from aggregate exposure to the 
residue does not exceed 10 times the yearly risk 
that would be allowed under subparagraph (A) 
for such effect. 
"(II) The tolerance is limited so as to ensure 
that the risk over a lifetime associated with the 
nonthreshold effect from aggregate exposure to the 
residue is not greater than twice the lifetime risk 
that would be allowed under subparagraph (A) 
for such effect. 
"(v) REVIEW.—Five years after the date on which 
the Administrator makes a determination to leave in 
effect or modify a tolerance under this subparagraph, 
and thereafter as the Administrator deems appro-
priate, the Administrator shall determine, after notice 
and opportunity for comment, whether it has been 
demonstrated to the Administrator that a condition 
described in clause (iii)(I) or clause (iii)(II) continues 
to exist with respect to the tolerance and that the 
yearly and lifetime risks from aggregate exposure to 
such residue continue to comply with the limits speci-
fied in clause (iv). If the Administrator determines Regulations, 
by such date that such demonstration has not been 
made, the Administrator shall, not later than 180 days 
after the date of such determination, issue a regulation 
under subsection (e)(1) to modify or revoke the toler-
ance. 
"(vi) INFANTS AND CHILDREN.—^Any tolerance under 
this subparagraph shall meet the requirements of 
subparagraph (C). 
"(C) 
EXPOSURE 
OF 
INFANTS 
AND 
CHILDREN.—In 
establishing, modifying, leaving in effect, or revoking a 
tolerance or exemption for a pesticide chemical residue, 
the Administrator— 
"(i) shall assess the risk of the pesticide chemical 
residue based on— 
"(I) available information about consumption 
patterns among infants and children that are likely 
to result in disproportionately high consumption 
of foods containing or bearing such residue among 
infants and children in comparison to the general 
population; 
"(II) available information concerning the spe-
cial susceptibility of infants and children to the 
pesticide chemical residues, including neurological 
differences between infants and children and 
adults, and effects of in utero exposure to pesticide 
chemicals; and 
"(III) available information concerning the 
cumulative effects on infants and children of such 
110 STAT. 1518 
PUBLIC LAW 104-170—AUG. 3, 1996 
Publication. 
Surveys. 
residues and other substances that have a common 
mechanism of toxicity; and 
"(ii) shall— 
"(I) ensure that there is a reasonable certainty 
that no harm will result to infants and children 
from aggregate exposure to the pesticide chemical 
residue; and 
"(II) publish a specific determination regarding 
the safety of the pesticide chemical residue for 
infants and children. 
The Secretary of Health and Human Services and the 
Secretary of Agriculture, in consultation with the Adminis-
trator, shall conduct surveys to document dietary exposure 
to pesticides among infants and children. In the case of 
threshold effects, for purposes of clause (ii)(I) an additional 
tenfold margin of safety for the pesticide chemical residue 
and other sources of exposure shall be applied for infants 
and children to take into account potential pre- and post-
natal toxicity and completeness of the data with respect 
to exposure and toxicity to infants and children. Notwith-
standing such requirement for an additional margin of 
safety, the Administrator may use a different margin of 
safety for the pesticide chemical residue only if, on the 
basis of reliable data, such margin will be safe for infants 
and children. 
"(D) FACTORS.—In establishing, modifying, leaving in 
effect, or revoking a tolerance or exemption for a pesticide 
chemical residue, the Administrator shall consider, among 
other relevant factors— 
"(i) the validity, completeness, and reliability of 
the available data from studies of the pesticide chemi-
cal and pesticide chemical residue; 
"(ii) the nature of any toxic effect shown to be 
caused by the pesticide chemical or pesticide chemical 
residue in such studies; 
"(iii) available information concerning the relation-
ship of the results of such studies to human risk; 
"(iv) available information concerning the dietary 
consumption patterns of consumers (and major identifi-
able subgroups of consumers); 
"(v) available information concerning the cumu-
lative effects of such residues and other substances 
that have a common mechanism of toxicity; 
"(vi) available information concerning the aggre-
gate exposure levels of consumers (and major identifi-
able subgroups of consumers) to the pesticide chemical 
residue and to other related substances, including 
dietary exposure under the tolerance and all other 
tolerances in effect for the pesticide chemical residue, 
and exposure from other non-occupational sources; 
"(vii) available information concerning the varia-
bility of the sensitivities of major identifiable sub-
groups of consumers; 
"(viii) such information as the Administrator may 
require on whether the pesticide chemical may have 
an effect in humans that is similar to an effect pro-
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1519 
duced by a naturally occurring estrogen or other endo-
crine effects; and 
"(ix) safety factors which in the opinion of experts 
qualified by scientific training and experience to evalu-
ate the safety of food additives are generally recognized 
as appropriate for the use of animal experimentation 
data. 
"(E) DATA AND INFORMATION REGARDING ANTICIPATED 
AND ACTUAL RESIDUE LEVELS.— 
"(i) AUTHORITY.—In establishing, modifying, leaving in 
effect, or revoking a tolerance for a pesticide chemical 
residue, the Administrator may consider available data 
and information on the anticipated residue levels of the 
pesticide chemical in or on food and the actual residue 
levels of the pesticide chemical that have been measured 
in food, including residue data collected by the Food and 
Drug Administration. 
"(ii) REQUIREMENT.—If the Administrator relies on 
anticipated or actual residue levels in establishing, modify-
ing, or leaving in effect a tolerance, the Administrator 
shall pursuant to subsection (f)(1) require that data be 
provided five years after the date on which the tolerance 
is established, modified, or left in effect, and thereafter 
as the Administrator deems appropriate, demonstrating 
that such residue levels are not above the levels so relied 
on. If such data are not so provided, or if the data do Regulations, 
not demonstrate that the residue levels are not above the 
levels so relied on, the Administrator shall, not later than 
180 days after the date on which the data were required 
to be provided, issue a regulation under subsection (e)(1), 
or an order under subsection (f)(2), as appropriate, to mod-
ify or revoke the tolerance. 
"(F) 
PERCENT 
OF 
FOOD 
ACTUALLY 
TREATED.—In 
establishing, modifying, leaving in effect, or revoking a 
tolerance for a pesticide chemical residue, the Adminis-
trator may, when assessing chronic dietary risk, consider 
available data and information on the percent of food actu-
ally treated with the pesticide chemical (including aggre-
gate pesticide use data collected by the Department of 
Agriculture) only if the Administrator— 
"(i) finds that the data are reliable and provide 
a valid basis to show what percentage of the food 
derived from such crop is likely to contain such pes-
ticide chemical residue; 
"(ii) finds that the exposure estimate does not 
understate exposure for any significant subpopulation 
group; 
"(iii) finds that, if data are available on pesticide 
use and consumption of food in a particular area, the 
population in such area is not dietarily exposed to 
residues above those estimated by the Administrator; 
and 
"(iv) provides for the periodic reevaluation of the 
estimate of anticipated dietary exposure. 
"(3) DETECTION METHODS.— 
"(A) GENERAL RULE.—^A tolerance for a pesticide chemi-
cal residue in or on a food shall not be established or 
110 STAT. 1520 
PUBLIC LAW 104-170—AUG. 3, 1996 
modified by the Administrator unless the Administrator 
determines, after consultation with the Secretary, that 
there is a practical method for detecting and measuring 
the levels of the pesticide chemical residue in or on the 
food. 
"(B) DETECTION LIMIT.—^A tolerance for a pesticide 
chemical residue in or on a food shall not be established 
at or modified to a level lower than the limit of detection 
of the method for detecting and measuring the pesticide 
chemical residue specified by the Administrator under 
subparagraph (A). 
"(4) INTERNATIONAL STANDARDS.—In establishing a toler-
ance for a pesticide chemical residue in or on a food, the 
Administrator shall determine whether a maximum residue 
level for the pesticide chemical has been established by the 
Publication. 
Codex Alimentarius Commission. If a Codex maximum residue 
level has been established for the pesticide chemical and the 
Administrator does not propose to adopt the Codex level, the 
Administrator shall publish for public comment a notice 
explaining the reasons for departing from the Codex level. 
"(c) AUTHORITY AND STANDARD FOR EXEMPTIONS.— 
"(1) AUTHORITY.—^The Administrator may issue a regula-
tion establishing, modifying, or revoking an exemption from 
the requirement for a tolerance for a pesticide chemical residue 
in or on food— 
"(A) in response to a petition filed under subsection 
(d); or 
"(B) on the Administrator's initiative under subsection 
(e). 
"(2) STANDARD.— 
"(A) GENERAL RULE.— 
"(i) STANDARD.—^The Administrator may establish 
or leave in effect an exemption from the requirement 
for a tolerance for a pesticide chemical residue in or 
on food only if the Administrator determines that the 
exemption is safe. The Administrator shall modify or 
revoke an exemption if the Administrator determines 
it is not safe. 
"(ii) DETERMINATION OF SAFETY.—^The term 'safe', 
with respect to an exemption for a pesticide chemical 
residue, means that the Administrator has determined 
that there is a reasonable certainty that no harm will 
result from aggregate exposure to the pesticide chemi-
cal residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable 
information. 
"(B) FACTORS.—In making a determination under this 
paragraph, the Administrator shall take into account, 
among other relevant considerations, the considerations 
set forth in subparagraphs (C) and (D) of subsection (b)(2). 
"(3) LIMITATION.—^An exemption from the requirement for 
a tolerance for a pesticide chemical residue in or on food shall 
not be established or modified by the Administrator unless 
the Administrator determines, after consultation with the Sec-
retary— 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1521 
"(A) that there is a practical method for detecting 
and measuring the levels of such pesticide chemical residue 
in or on food; or 
"(B) that there is no need for such a method, and 
states the reasons for such determination in issuing the 
regulation establishing or modifying the exemption. 
"(d) PETITION FOR TOLERANCE OR EXEMPTION.— 
"(1) PETITIONS AND PETITIONERS.—^Any person may file with 
the Administrator a petition proposing the issuance of a regula-
tion— 
"(A) establishing, modifying, or revoking a tolerance 
for a pesticide chemical residue in or on a food; or 
"(B) establishing, modifying, or revoking an exemption 
from the requirement of a tolerance for such a residue. 
"(2) PETITION CONTENTS.— 
"(A) ESTABLISHMENT.—^A petition under paragraph (1) Regulations. 
to establish a tolerance or exemption for a pesticide chemi-
cal residue shall be supported by such data and information 
as are specified in regulations issued by the Administrator, 
including— 
"(i)(I) an informative summary of the petition and 
of the data, information, and arguments submitted 
or cited in support of the petition; and 
"(II) a statement that the petitioner agrees that 
such summary or any information it contains may 
be published as a part of the notice of filing of the 
petition to be published under this subsection and as 
part of a proposed or final regulation issued under 
this section; 
"(ii) the name, chemical identity, and composition 
of the pesticide chemical residue and of the pesticide 
chemical that produces the residue; 
"(iii) data showing the recommended amount, fre-
quency, method, and time of application of that pes-
ticide chemical; 
"(iv) full reports of tests and investigations made 
with respect to the safety of the pesticide chemical, 
including full information as to the methods and con-
trols used in conducting those tests and investigations; 
"(v) full reports of tests and investigations made 
with respect to the nature and amount of the pesticide 
chemical residue that is likely to remain in or on 
the food, including a description of the anal3rtical meth-
ods used; 
"(vi) a practical method for detecting and measur-
ing the levels of the pesticide chemical residue in or 
on the food, or for exemptions, a statement why such 
a method is not needed; 
"(vii) a proposed tolerance for the pesticide chemi-
cal residue, if a tolerance is proposed; 
"(viii) if the petition relates to a tolerance for a 
processed food, reports of investigations conducted 
using the processing method(s) used to produce that 
food; 
"(ix) such information as the Administrator may 
require to make the determination under subsection 
(b)(2)(C); 
110 STAT. 1522 
PUBLIC LAW 104-170~AUG. 3, 1996 
Publication. 
Regulations. 
"(x) such information as the Administrator may 
require on whether the pesticide chemical may have 
an effect in humans that is similar to an effect pro-
duced by a naturally occurring estrogen or other endo-
crine effects; 
"(xi) information regarding exposure to the pes-
ticide chemical residue due to any tolerance or exemp-
tion already granted for such residue; 
"(xii) practical methods for removing any amount 
of the residue that would exceed any proposed toler-
ance; and 
"(xiii) such other data and information as the 
Administrator requires by regulation to support the 
petition. 
If information or data required by this subparagraph is 
available to the Administrator, the person submitting the 
petition may cite the availability of the information or 
data in lieu of submitting it. The Administrator may 
require a petition to be accompanied by samples of the 
pesticide chemical with respect to which the petition is 
filed. 
"(B) 
MODIFICATION OR REVOCATION.—^The Adminis-
trator may by regulation establish the requirements for 
information and data to support a petition to modify or 
revoke a tolerance or to modify or revoke an exemption 
from the requirement for a tolerance. 
"(3) NOTICE.—^A notice of the filing of a petition that the 
Administrator determines has met the requirements of para-
graph (2) shall be published by the Administrator within 30 
days after such determination. The notice shall announce the 
availability of a description of the anal3^ical methods available 
to the Administrator for the detection and measurement of 
the pesticide chemical residue with respect to which the petition 
is filed or shall set forth the petitioner's statement of why 
such a method is not needed. The notice shall include the 
summary required by paragraph (2)(A)(i)(I). 
"(4) ACTIONS BY THE ADMINISTRATOR.— 
"(A) IN GENERAL.—^The Administrator shall, after giv-
ing due consideration to a petition filed under paragraph 
(1) and any other information available to the Adminis-
trator— 
"(i) issue a final regulation (which may vary from 
that sought by the petition) establishing, modifying, 
or revoking a tolerance for the pesticide chemical resi-
due or an exemption of the pesticide chemical residue 
from the requirement of a tolerance (which final regula-
tion shall be issued without further notice and without 
further period for public comment); 
"(ii) issue a proposed regulation under subsection 
(e), and thereafter issue a final regulation under such 
subsection; or 
"(iii) issue an order denying the petition. 
"(B) PRIORITIES.—The Administrator shall give priority 
to petitions for the establishment or modification of a toler-
ance or exemption for a pesticide chemical residue that 
appears to pose a significantly lower risk to human health 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1523 
from dietary exposure than pesticide chemical residues that 
have tolerances in effect for the same or similar uses. 
"(C) EXPEDITED REVIEW OF CERTAIN PETITIONS.— 
"(i) DATE CERTAIN FOR REVIEW.—If a person files 
a complete petition with the Administrator proposing 
the issuance of a regulation establishing a tolerance 
or exemption for a pesticide chemical residue that pre-
sents a lower risk to human health than a pesticide 
chemical residue for which a tolerance has been left 
in effect or modified under subsection (b)(2)(B), the 
Administrator shall complete action on such petition 
under this paragraph within 1 year. 
"(ii) REQUIRED DETERMINATIONS.—If the Adminis-
trator issues a final regulation establishing a tolerance 
or exemption for a safer pesticide chemical residue 
under clause (i), the Administrator shall, not later 
than 180 days after the date on which the regulation 
is issued, determine whether a condition described in 
subclause (I) or (II) of subsection (b)(2)(B)(iii) continues 
to exist with respect to a tolerance that has been 
left in effect or modified under subsection (b)(2)(B). 
If such condition does not continue to exist, the Regulations. 
Administrator shall, not later than 180 days after the 
date on which the determination under the preceding 
sentence is made, issue a regulation under subsection 
(e)( 1) to modify or revoke the tolerance. 
"(e) ACTION ON ADMINISTRATOR'S OWN INITIATIVE.— 
"(1) GENERAL RULE.—^The Administrator may issue a regu-
lation— 
"(A) establishing, modifying, suspending under sub-
section (1)(3), or revoking a tolerance for a pesticide chemi-
cal or a pesticide chemical residue; 
"(B) establishing, modifying, suspending under sub-
section (1)(3), or revoking an exemption of a pesticide chemi-
cal residue from the requirement of a tolerance; or 
"(C) establishing general procedures and requirements 
to implement this section. 
"(2) NOTICE.—Before issuing a final regulation under para-
graph (1), the Administrator shall issue a notice of proposed 
rulemaking and provide a period of not less than 60 days 
for public comment on the proposed regulation, except that 
a shorter period for comment may be provided if the Adminis-
trator for good cause finds that it would be in the public 
interest to do so and states the reasons for the finding in 
the notice of proposed rulemaking. 
"(f) SPECIAL DATA REQUIREMENTS.— 
"(1) REQUIRING SUBMISSION OF ADDITIONAL DATA.—If 
the 
Administrator determines that additional data or information 
are reasonably required to support the continuation of a toler-
ance or exemption that is in effect under this section for a 
pesticide chemical residue on a food, the Administrator shall— 
"(A) issue a notice requiring the person holding the Notice. 
pesticide registrations associated with such tolerance or 
exemption to submit the data or information under section 
3(c)(2)(B) of the Federal Insecticide, Fungicide, 
and 
Rodenticide Act; 
110 STAT. 1524 
PUBLIC LAW 104-170—AUG. 3, 1996 
Rules. 
Federal Register, 
publication. 
"(B) issue a rule requiring that testing be conducted 
on a substance or mixture under section 4 of the Toxic 
Substances Control Act; or 
"(C) publish in the Federal Register, after first provid-
ing notice and an opportunity for comment of not less 
than 60 days' duration, an order— 
"(i) requiring the submission to the Administrator 
by one or more interested persons of a notice identify-
ing the person or persons who will submit the required 
data and information; 
"(ii) describing the type of data and information 
required to be submitted to the Administrator and 
stating why the data and information could not be 
obtained under the authority of section 3(c)(2)(B) of 
the Federal Insecticide, Fungicide, and Rodenticide Act 
or section 4 of the Toxic Substances Control Act; 
"(iii) describing the reports of the Administrator 
required to be prepared during and after the collection 
of the data and information; 
"(iv) requiring the submission to the Administrator 
of the data, information, and reports referred to in 
clauses (ii) and (iii); and 
"(v) establishing dates by which the submissions 
described in clauses (i) and (iv) must be made. 
The Administrator may under subparagraph (C) revise any 
such order to correct an error. The Administrator may 
under this paragraph require data or information pertain-
ing to whether the pesticide chemical may have an effect 
in humans that is similar to an effect produced by a natu-
rally occurring estrogen or other endocrine effects. 
"(2) NONCOMPLIANCE.—If a submission required by a notice 
issued in accordance with paragraph (1)(A), a rule issued under 
paragraph (1)(B), or an order issued under paragraph (1)(C) 
is not made by the time specified in such notice, rule, or 
order, the Administrator may by order published in the Federal 
Register modify or revoke the tolerance or exemption in ques-
tion. In any review of such an order under subsection (g)(2), 
the only material issue shall be whether a submission required 
under paragraph (1) was not made by the time specified. 
"(g) EFFECTIVE DATE, OBJECTIONS, HEARINGS, AND ADMINISTRA-
TIVE REVIEW.— 
"(1) EFFECTIVE DATE.—^A regulation or order issued under 
subsection (d)(4), (e)(1), or (f)(2) shall take effect upon publica-
tion unless the regulation or order specifies otherwise. The 
Administrator may stay the effectiveness of the regulation or 
order if, after issuance of such regulation or order, objections 
are filed with respect to such regulation or order pursuant 
to paragraph (2). 
"(2) FURTHER PROCEEDINGS.— 
"(A) OBJECTIONS.—^Within 60 days after a regulation 
or order is issued under subsection (d)(4), (e)(1)(A), (e)(1)(B), 
(f)(2), (n)(3), or (n)(5)(C), any person may file objections 
thereto with the Administrator, specifying with particular-
ity the provisions of the regulation or order deemed 
objectionable and stating reasonable grounds therefor. If 
the regulation or order was issued in response to a petition 
under subsection (d)(1), a copy of each objection filed by 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1525 
a person other than the petitioner shall be served by the 
Administrator on the petitioner. 
"(B) HEARING.—An objection may include a request 
for a public evidentiary hearing upon the objection. The 
Administrator shall, upon the initiative of the Adminis-
trator or upon the request of an interested person and 
after due notice, hold a public evidentiary hearing if and 
to the extent the Administrator determines that such a 
public hearing is necessary to receive factual evidence rel-
evant to material issues of fact raised by the objections. 
The presiding officer in such a hearing may authorize 
a party to obtain discovery from other persons and may 
upon a showing of good cause made by a party issue 
a subpoena to compel testimony or production of documents 
from any person. The presiding officer shall be governed 
by the Federal Rules of Civil Procedure in making any 
order for the protection of the witness or the content of 
documents produced and shall order the payment of reason-
able fees and expenses as a condition to requiring testimony 
of the witness. On contest, such a subpoena may be 
enforced by a Federal district court. 
"(C) FINAL DECISION.—^As soon as practicable after 
Orders, 
receiving the arguments of the parties, the Administrator 
shall issue an order stating the action taken upon each 
such objection and setting forth any revision to the regula-
tion or prior order that the Administrator has found to 
be warranted. If a hearing was held under subparagraph 
(B), such order and any revision to the regulation or prior 
order shall, with respect to questions of fact at issue in 
the hearing, be based only on substantial evidence of record 
at such hearing, and shall set forth in detail the findings 
of facts and the conclusions of law or policy upon which 
the order or regulation is based. 
"(h) JUDICIAL REVIEW.— 
"(1) PETITION.—In a case of actual controversy as to the 
validity of any regulation issued under subsection (e)(1)(C), 
or any order issued under subsection (f)(1)(C) or (g)(2)(C), or 
any regulation that is the subject of such an order, any person 
who will be adversely affected by such order or regulation 
may obtain judicial review by filing in the United States Court 
of Appeals for the circuit wherein that person resides or has 
its principal place of business, or in the United States Court 
of Appeals for the District of Columbia Circuit, within 60 days 
after publication of such order or regulation, a petition praying 
that the order or regulation be set aside in whole or in part. 
"(2) RECORD AND JURISDICTION.—^A copy of the petition 
under paragraph (1) shall be forthwith transmitted by the 
clerk of the court to the Administrator, or any officer designated 
by the Administrator for that purpose, and thereupon the 
Administrator shall file in the court the record of the proceed-
ings on which the Administrator based the order or regulation, 
as provided in section 2112 of title 28, United States Code. 
Upon the filing of such a petition, the court shall have exclusive 
jurisdiction to affirm or set aside the order or regulation com-
plained of in whole or in part. As to orders issued following 
a public evidentiary hearing, the findings of the Administrator 
with respect to questions of fact shall be sustained only if 
110 STAT. 1526 
PUBLIC LAW 104-170—AUG. 3, 1996 
supported by substantial evidence when considered on the 
record as a whole. 
"(3) ADDITIONAL EVIDENCE.—If a party applies to the court 
for leave to adduce additional evidence and shows to the satis-
faction of the court that the additional evidence is material 
and that there were reasonable grounds for the failure to 
adduce the evidence in the proceeding before the Administrator, 
the court may order that the additional evidence (and evidence 
in rebuttal thereof) shall be taken before the Administrator 
in the manner and upon the terms and conditions the court 
deems proper. The Administrator may modify prior findings 
as to the facts by reason of the additional evidence so taken 
and may modify the order or regulation accordingly. The 
Administrator shall file with the court any such modified find-
ing, order, or regulation. 
"(4) FINAL JUDGMENT; SUPREME COURT REVIEW.—^The judg-
ment of the court affirming or setting aside, in whole or in 
part, any regulation or any order and any regulation which 
is the subject of such an order shall be final, subject to review 
by the Supreme Court of the United States as provided in 
section 1254 of title 28 of the United States Code. The 
commencement of proceedings under this subsection shall not, 
unless specifically ordered by the court to the contrary, operate 
as a stay of a regulation or order. 
"(5) APPLICATION.—^Any issue as to which review is or 
was obtainable under this subsection shall not be the subject 
of judicial review under any other provision of law. 
"(i) CONFIDENTIALITY AND USE OF DATA.— 
"(1) GENERAL RULE.—Data and information that are or 
have been submitted to the Administrator under this section 
or section 409 in support of a tolerance or an exemption from 
a tolerance shall be entitled to confidential treatment for rea-
sons of business confidentiality and to exclusive use and data 
compensation to the same extent provided by sections 3 and 
10 of the Federal Insecticide, Fungicide, and Rodenticide Act. 
"(2) EXCEPTIONS.— 
"(A) IN GENERAL.—Data and information that are enti-
tled to confidential treatment under paragraph (1) may 
be disclosed, under such security requirements as the 
Administrator may provide by regulation, to— 
"(i) employees of the United States authorized by 
the Administrator to examine such data and informa-
tion in the carrying out of their official duties under 
this Act or other Federal statutes intended to protect 
the public health; or 
"(ii) contractors with the United States authorized 
n 
by the Administrator to examine such data and 
information in the carrying out of contracts under this 
Act or such statutes. 
"(B) CONGRESS.—This subsection does not authorize 
the withholding of data or information from either House 
of Congress or from, to the extent of matter within its 
jurisdiction, any committee or subcommittee of such 
committee or any joint committee of Congress or any sub-
committee of such joint committee. 
"(3) SUMMARIES.—Notwithstanding any provision of this 
subsection or other law, the Administrator may publish the 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1527 
informative summary required by subsection (d)(2)(A)(i) and 
may, in issuing a proposed or final regulation or order under 
this section, publish an informative summary of the data relat-
ing to the regulation or order. 
"(j) STATUS OF PREVIOUSLY ISSUED REGULATIONS.— 
"(1) REGULATIONS UNDER SECTION 406.—Regulations affect-
ing pesticide chemical residues in or on raw agricultural 
commodities promulgated, in accordance with section 701(e), 
under the authority of section 406(a) upon the basis of public 
hearings instituted before January 1, 1953, shall be deemed 
to be regulations issued under this section and shall be subject 
to modification or revocation under subsections (d) and (e), 
and shall be subject to review under subsection (q). 
"(2) REGULATIONS UNDER SECTION 409.—Regulations that 
established tolerances for substances that are pesticide chemi-
cal residues in or on processed food, or that otherwise stated 
the conditions under which such pesticide chemicals could be 
safely used, and that were issued under section 409 on or 
before the date of the enactment of this paragraph, shall be 
deemed to be regulations issued under this section and shall 
be subject to modification or revocation under subsection (d) 
or (e), and shall be subject to review under subsection (q). 
"(3) REGULATIONS UNDER SECTION 408.—Regulations that 
established tolerances or exemptions under this section that 
were issued on or before the date of the enactment of this 
paragraph shall remain in effect unless modified or revoked 
under subsection (d) or (e), and shall be subject to review 
under subsection (q). 
"(k) TRANSITIONAL PROVISION.—If, on the day before the date 
of the enactment of this subsection, a substance that is a pesticide 
chemical was, with respect to a particular pesticidal use of the 
substance and any resulting pesticide chemical residue in or on 
a particular food— 
"(1) regarded by the Administrator or the Secretary as 
generally recognized as safe for use within the meaning of 
the provisions of subsection (a) or section 201(s) as then in 
effect; or 
"(2) regarded by the Secretary as a substance described 
by section 201(s)(4); 
such a pesticide chemical residue shall be regarded as exempt 
from the requirement for a tolerance, as of the date of enactment 
of this subsection. The Administrator shall by regulation indicate Regulations. 
which substances are described by this subsection. Any exemption 
under this subsection may be modified or revoked as if it had 
been issued under subsection (c). 
"(1) HARMONIZATION WITH ACTION UNDER OTHER LAWS.— 
"(1) COORDINATION WITH FIFRA.—To the extent practicable 
and consistent with the review deadlines in subsection (q), 
in issuing a final rule under this subsection that suspends 
or revokes a tolerance or exemption for a pesticide chemical 
residue in or on food, the Administrator shall coordinate such 
action with any related necessary action under the Federal 
Insecticide, Fungicide, and Rodenticide Act. 
"(2) REVOCATION OF TOLERANCE OR EXEMPTION FOLLOWING 
CANCELLATION OF ASSOCIATED REGISTRATIONS.—If the Adminis-
trator, acting under the Federal Insecticide, Fungicide, and 
Rodenticide Act, cancels the registration of each pesticide that 
110 STAT. 1528 
PUBLIC LAW 104-170—AUG. 3, 1996 
Effective date. 
Applicability. 
Effective date. 
Applicability. 
Review. 
contains a particular pesticide chemical and that is labeled 
for use on a particular food, or requires that the registration 
of each such pesticide be modified to prohibit its use in connec-
tion with the production, storage, or transportation of such 
food, due in whole or in part to dietary risks to humans posed 
by residues of that pesticide chemical on that food, the Adminis-
trator shall revoke any tolerance or exemption that allows 
the presence of the pesticide chemical, or any pesticide chemical 
residue that results from its use, in or on that food. Subsection 
(e) shall apply to actions taken under this paragraph. A revoca-
tion under this paragraph shall become effective not later than 
180 days after— 
"(A) the date by which each such cancellation of a 
registration has become effective; or 
"(B) the date on which the use of the canceled pesticide 
becomes unlawful under the terms of the cancellation, 
whichever is later. 
"(3) SUSPENSION OF TOLERANCE OR EXEMPTION FOLLOWING 
SUSPENSION OF ASSOCIATED REGISTRATIONS.— 
"(A) SUSPENSION.—If the Administrator, acting under 
the Federal Insecticide, Fungicide, and Rodenticide Act, 
suspends the use of each registered pesticide that contains 
a particular pesticide chemical and that is labeled for use 
on a particular food, due in whole or in part to dietary 
risks to humans posed by residues of that pesticide chemi-
cal on that food, the Administrator shall suspend any toler-
ance or exemption that allows the presence of the pesticide 
chemical, or any pesticide chemical residue that results 
from its use, in or on that food. Subsection (e) shall apply 
to actions taken under this paragraph. A suspension under 
this paragraph shall become effective not later than 60 
days after the date by which each such suspension of 
use has become effective. 
"(B) EFFECT OF SUSPENSION.—^The suspension of a 
tolerance or exemption under subparagraph (A) shall be 
effective as long as the use of each associated registration 
of a pesticide is suspended under the Federal Insecticide, 
Fungicide, and Rodenticide Act. While a suspension of a 
tolerance or exemption is effective the tolerance or exemp-
tion shall not be considered to be in effect. If the suspension 
of use of the pesticide under that Act is terminated, leaving 
the registration of the pesticide for such use in effect under 
that Act, the Administrator shall rescind any associated 
suspension of tolerance or exemption. 
"(4) TOLERANCES FOR UNAVOIDABLE RESIDUES.—In connec-
tion with action taken under paragraph (2) or (3), or with 
respect to pesticides whose registrations were suspended or 
canceled prior to the date of the enactment of this paragraph 
under the Federal Insecticide, Fungicide, and Rodenticide Act, 
if the Administrator determines that a residue of the canceled 
or suspended pesticide chemical will unavoidably persist in 
the environment and thereby be present in or on a food, the 
Administrator may establish a tolerance for the pesticide chemi-
cal residue. In establishing such a tolerance, the Administrator 
shall take into account both the factors set forth in subsection 
(b)(2) and the unavoidability of the residue. Subsection (e) 
shall apply to the establishment of such tolerance. The Adminis-
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1529 
trator shall review any such tolerance periodically and modify 
it as necessary so that it allows no greater level of the pesticide 
chemical residue than is unavoidable. 
"(5) PESTICIDE RESIDUES RESULTING FROM LAWFUL APPLICA-
TION OF PESTICIDE.—Notwithstanding any other provision of 
this Act, if a tolerance or exemption for a pesticide chemical 
residue in or on a food has been revoked, suspended, or modified 
under this section, an article of that food shall not be deemed 
unsafe solely because of the presence of such pesticide chemical 
residue in or on such food if it is shown to the satisfaction 
of the Secretary that— 
"(A) the residue is present as the result of an applica-
tion or use of a pesticide at a time and in a manner 
that was lawful under the Federal Insecticide, Fungicide, 
and Rodenticide Act; and 
"(B) the residue does not exceed a level that was 
authorized at the time of that application or use to be 
present on the food under a tolerance, exemption, food 
additive regulation, or other sanction then in effect under 
this Act; 
unless, in the case of any tolerance or exemption revoked, 
suspended, or modified under this subsection or subsection 
(d) or (e), the Administrator has issued a determination that 
consumption of the legally treated food during the period of 
its likely availability in commerce will pose an unreasonable 
dietary risk. 
"(6) TOLERANCE FOR USE OF PESTICIDES UNDER AN EMER-
GENCY EXEMPTION.—If the Administrator grants an exemption 
under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (7 U.S.C. 136p) for a pesticide chemical, the 
Administrator shall establish a tolerance or exemption from 
the requirement for a tolerance for the pesticide chemical resi-
due. Such a tolerance or exemption from a tolerance shall 
have an expiration date. The Administrator may establish such 
a tolerance or exemption without providing notice or a period 
for comment on the tolerance or exemption. The Administrator 
shall promulgate regulations within 365 days after the date 
of the enactment of this paragraph governing the establishment 
of tolerances and exemptions under this paragraph. Such regu-
lations shall be consistent with the safety standard under sub-
sections (b)(2) and (c)(2) and with section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act. 
"(m) FEES.— 
"(1) AMOUNT.—The Administrator shall by regulation 
require the payment of such fees as will in the aggregate, 
in the judgment of the Administrator, be sufficient over a 
reasonable term to provide, equip, and maintain an adequate 
service for the performance of the Administrator's functions 
under this section. Under the regulations, the performance 
of the Administrator's services or other functions under this 
section, including— 
"(A) the acceptance for filing of a petition submitted 
under subsection (d); 
"(B) establishing, modifying, leaving in effect, or revok-
ing a tolerance or establishing, modifying, leaving in effect, 
or revoking an exemption from the requirement for a toler-
ance under this section; 
Regulations. 
Regulations. 
29-194 O - 96 - 24 : QL 3 Part 2 
110 STAT. 1530 
PUBLIC LAW 104-170—AUG. 3, 1996 
"(C) the acceptance for filing of objections under sub-
section (g); or 
"(D) the certification and fiHng in court of a transcript 
of the proceedings and the record under subsection (h); 
may be conditioned upon the payment of such fees. The regula-
tions may further provide for waiver or refund of fees in whole 
or in part when in the judgment of the Administrator such 
a waiver or refund is equitable and not contrary to the purposes 
of this subsection. 
"(2) DEPOSIT.—^All fees collected under paragraph (1) shall 
be deposited in the Reregistration and Expedited Processing 
Fund created by section 4(k) of the Federal Insecticide, Fun-
gicide, and Rodenticide Act. Such fees shall be available to 
the Administrator, without fiscal year limitation, for the 
performance of the Administrator's services or functions as 
specified in paragraph (1). 
"(n) NATIONAL UNIFORMITY OF TOLERANCES.— 
"(1) QUALIFYING PESTICIDE CHEMICAL RESIDUE.—For pur-
poses of this subsection, the term 'qualifying pesticide chemical 
residue' means a pesticide chemical residue resulting from the 
use, in production, processing, or storage of a food, of a pesticide 
chemical that is an active ingredient and that— 
"(A) was first approved for such use in a registration 
of a pesticide issued under section 3(c)(5) of the Federal 
Insecticide, Fungicide, and Rodenticide Act on or after April 
25, 1985, on the basis of data determined by the Adminis-
trator to meet all applicable requirements for data pre-
scribed by regulations in effect under that Act on April 
25, 1985;or 
"(B) was approved for such use in a reregistration 
eligibility determination issued under section 4(g) of that 
Act on or after the date of enactment of this subsection. 
"(2) QUALIFYING FEDERAL DETERMINATION.—For purposes 
of this subsection, the term 'qualifying Federal determination' 
means a tolerance or exemption from the requirement for a 
tolerance for a qualifying pesticide chemical residue that— 
"(A) is issued under this section after the date of the 
enactment of this subsection and determined by the 
Administrator to meet the standard under subsection 
(b)(2)(A) (in the case of a tolerance) or (c)(2) (in the case 
of an exemption); or 
"(B)(i) pursuant to subsection (j) is remaining in effect 
or is deemed to have been issued under this section, or 
is regarded under subsection (k) as exempt from the 
requirement for a tolerance; and 
"(ii) is determined by the Administrator to meet the 
standard under subsection (b)(2)(A) (in the case of a toler-
ance) or (c)(2) (in the case of an exemption). 
"(3) LIMITATION.—The Administrator may make the deter-
mination described in paragraph (2)(B)(ii) only by issuing a 
rule in accordance with the procedure set forth in subsection 
(d) or (e) and only if the Administrator issues a proposed 
rule and allows a period of not less than 30 days for comment 
on the proposed rule. Any such rule shall be reviewable in 
accordance with subsections (g) and (h). 
"(4) STATE AUTHORITY.—^Except as provided in paragraphs 
(5), (6), and (8) no State or political subdivision may establish 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1531 
or enforce any regulatory limit on a qualifying pesticide chemi-
cal residue in or on any food if a qualifying Federal determina-
tion applies to the presence of such pesticide chemical residue 
in or on such food, unless such State regulatory limit is identical 
to such qualifying Federal determination. A State or political 
subdivision shall be deemed to establish or enforce a regulatory 
limit on a pesticide chemical residue in or on a food if it 
purports to prohibit or penalize the production, processing, 
shipping, or other handling of a food because it contains a 
pesticide residue (in excess of a prescribed limit). 
"(5) PETITION PROCEDURE.— 
"(A) IN GENERAL.—^Any State may petition the Adminis-
trator for authorization to establish in such State a regu-
latory limit on a qualifying pesticide chemical residue in 
or on any food that is not identical to the qualifying Federal 
determination 
applicable to such qualifying 
pesticide 
chemical residue. 
"(B) PETITION REQUIREMENTS.—^Any petition under 
subparagraph (A) shall— 
"(i) satisfy any requirements prescribed, by rule, 
by the Administrator; and 
"(ii) be supported by scientific data about the pes-
ticide chemical residue that is the subject of the peti-
tion or about chemically related pesticide chemical resi-
dues, data on the consumption within such State of 
food bearing the pesticide chemical residue, and data 
on exposure of humans within such State to the pes-
ticide chemical residue. 
"(C) AUTHORIZATION.—The Administrator 
may, by 
order, grant the authorization described in subparagraph 
(A) if the Administrator determines that the proposed State 
regulatory limit— 
"(i) is justified by compelling local conditions; and 
"(ii) would not cause any food to be a violation 
of Federal law. 
"(D) TREATMENT.—In lieu of any action authorized 
under subparagraph (C), the Administrator may treat a 
petition under this paragraph as a petition under sub-
section (d) to modify or revoke a tolerance or an exemption. 
If the Administrator determines to treat a petition under 
this paragraph as a petition under subsection (d), the 
Administrator shall thereafter act on the petition pursuant 
to subsection (d). 
"(E) REVIEW.—^Any order of the Administrator granting 
or denying the authorization described in subparagraph 
(A) shall be subject to review in the manner described 
in subsections (g) and (h). 
"(6) URGENT PETITION PROCEDURE.—^Any State petition to 
the Administrator pursuant to paragraph (5) that demonstrates 
that consumption of a food containing such pesticide residue 
level during the period of the food's likely availability in the 
State will pose a significant public health threat from acute 
exposure shall be considered an urgent petition. If an order 
by the Administrator to grant or deny the requested authoriza-
tion in an urgent petition is not made within 30 days of receipt 
of the petition, the petitioning State may establish and enforce 
a temporary regulatory limit on a qualifying pesticide chemical 
110 STAT. 1532 
PUBLIC LAW 104-170—AUG. 3, 1996 
residue in or on the food. The temporary regulatory limit shall 
be validated or terminated by the Administrator's final order 
on the petition. 
"(7) RESIDUES FROM LAWFUL APPLICATION.—^No State or 
political subdivision may enforce any regulatory limit on the 
level of a pesticide chemical residue that may appear in or 
on any food if, at the time of the application of the pesticide 
that resulted in such residue, the sale of such food with such 
residue level was lawful under this section and under the 
law of such State, unless the State demonstrates that consump-
tion of the food containing such pesticide residue level during 
the period of the food's likely availability in the State will 
pose an unreasonable dietary risk to the health of persons 
within such State. 
"(8) SAVINGS.—^Nothing in this Act preempts the authority 
of any State or political subdivision to require that a food 
containing a pesticide chemical residue bear or be the subject 
of a warning or other statement relating to the presence of 
the pesticide chemical residue in or on such food. 
PubUcation. 
"(o) CONSUMER RiGHT To KNOW.—Not later than 2 years after 
Public 
the date of the enactment of the Food Quality Protection Act of 
information. 
1996, and annually thereafter, the Administrator shall, in consulta-
tion with the Secretary of Agriculture and the Secretary of Health 
and Human Services, publish in a format understandable to a 
lay person, and distribute to large retail grocers for public display 
(in a manner determined by the grocer), the following information, 
at a minimum: 
"(1) A discussion of the risks and benefits of pesticide 
chemical residues in or on food purchased by consumers. 
"(2) A listing of actions taken under subparagraph (B) 
of subsection (b)(2) that may result in pesticide chemical resi-
dues in or on food that present a yearly or lifetime risk above 
the risk allowed under subparagraph (A) of such subsection, 
and the food on which the pesticide chemicals producing the 
residues are used. 
"(3) Recommendations to consumers for reducing dietary 
exposure to pesticide chemical residues in a manner consistent 
with maintaining a healthy diet, including a list of food that 
may reasonably substitute for food listed under paragraph (2). 
Nothing in this subsection shall prevent retail grocers from 
providing additional information. 
"(p) ESTROGENIC SUBSTANCES SCREENING PROGRAM.— 
"(1) DEVELOPMENT.—Not later than 2 years after the date 
of enactment of this section, the Administrator shall in con-
sultation with the Secretary of Health and Human Services 
develop a screening program, using appropriate validated test 
systems and other scientifically relevant information, to deter-
mine whether certain substances may have an effect in humans 
that is similar to an effect produced by a naturally occurring 
estrogen, or such other endocrine effect as the Administrator 
may designate. 
"(2) IMPLEMENTATION.—^Not later than 3 years after the 
date of enactment of this section, after obtaining public com-
ment and review of the screening program described in para-
graph (1) by the scientific advisory panel established under 
section 25(d) of the Federal Insecticide, Fungicide, and 
Rodenticide Act or the science advisory board established by 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1533 
section 8 of the Environmental Research, Development, and 
Demonstration Act of 1978 (42 U.S.C. 4365), the Administrator 
shall implement the program. 
"(3) SUBSTANCES.—In carrying out the screening program 
described in paragraph (1), the Administrator— 
"(A) shall provide for the testing of all pesticide chemi-
cals; and 
"(B) may provide for the testing of any other substance 
that may have an effect that is cumulative to an effect 
of a pesticide chemical if the Administrator determines 
that a substantial population may be exposed to such sub-
stance. 
"(4) EXEMPTION.—Notwithstanding paragraph 
(3), the 
Administrator may, by order, exempt from the requirements 
of this section a biologic substance or other substance if the 
Administrator determines that the substance is anticipated not 
to produce any effect in humans similar to an effect produced 
by a naturally occurring estrogen. 
"(5) COLLECTION OF INFORMATION.— 
"(A) IN GENERAL.—The Administrator shall issue an 
order to a registrant of a substance for which testing is 
required under this subsection, or to a person who manufac-
tures or imports a substance for which testing is required 
under this subsection, to conduct testing in accordance 
with the screening program described in paragraph (1), 
and submit information obtained from the testing to the 
Administrator, within a reasonable time period that the 
Administrator determines is sufficient for the generation 
of the information. 
"(B) PROCEDURES.—^To the extent practicable the 
Administrator shall minimize duplicative testing of the 
same substance for the same endocrine effect, develop, 
as appropriate, procedures for fair and equitable sharing 
of test costs, and develop, as necessary, procedures for 
handling of confidential business information. 
"(C) 
FAILURE OF REGISTRANTS TO SUBMIT INFORMA-
TION.— 
"(i) SUSPENSION.—If a registrant of a substance 
referred to in paragraph (3)(A) fails to comply with 
an order under subparagraph (A) of this paragraph, 
the Administrator shall issue a notice of intent to 
suspend the sale or distribution of the substance by 
the registrant. Any suspension proposed under this 
paragraph shall become final at the end of the 30-
day period beginning on the date that the registrant 
receives the notice of intent to suspend, unless during 
that period a person adversely affected by the notice 
requests a hearing or the Administrator determines 
that the registrant has complied fully with this para-
graph. 
"(ii) HEARING.—If a person requests a hearing 
under clause (i), the hearing shall be conducted in 
accordance with section 554 of title 5, United States 
Code. The only matter for resolution at the hearing 
shall be whether the registrant has failed to comply 
with an order under subparagraph (A) of this para-
graph. A decision by the Administrator after comple-
Orders. 
Notice. 
110 STAT. 1534 
PUBLIC LAW 104-170—AUG. 3, 1996 
Regulations. 
tion of a hearing shall be considered to be a final 
agency action. 
"(iii) 
TERMINATION 
OF 
SUSPENSIONS.—^The 
Administrator shall terminate a suspension under this 
subparagraph issued with respect to a registrant if 
the Administrator determines that the registrant has 
^ complied fully with this paragraph. 
"(D) NONCOMPLIANCE BY OTHER PERSONS.^Any person 
(other than a registrant) who fails to comply with an order 
under subparagraph (A) shall be liable for the same pen-
alties and sanctions as are provided under section 16 of 
the Toxic Substances Control Act (15 U.S.C. 2601 and 
following) in the case of a violation referred to in that 
section. Such penalties and sanctions shall be assessed 
and imposed in the same manner as provided in such 
section 16. 
"(6) AGENCY ACTION.—In the case of any substance that 
is found, as a result of testing and evaluation under this section, 
to have an endocrine effect on humans, the Administrator shall, 
as appropriate, take action under such statutory authority as 
is available to the Administrator, including consideration under 
other sections of this Act, as is necessary to ensure the protec-
tion of public health. 
"(7) REPORT TO CONGRESS.—Not later than 4 years after 
the date of enactment of this section, the Administrator shall 
prepare and submit to Congress a report containing— 
"(A) the findings of the Administrator resulting from 
the screening program described in paragraph (1); 
"(B) recommendations for further testing needed to 
evaluate the impact on human health of the substances 
tested under the screening program; and 
"(C) recommendations for any further actions (includ-
ing any action described in paragraph (6)) that the 
Administrator determines are appropriate based on the 
findings, 
"(q) SCHEDULE FOR REVIEW.— 
"(1) IN GENERAL.—The Administrator shall review toler-
ances and exemptions for pesticide chemical residues in effect 
on the day before the date of the enactment of the Food Quality 
Protection Act of 1996, as expeditiously as practicable, assuring 
that— 
"(A) 33 percent of such tolerances and exemptions are 
reviewed within 3 years of the date of enactment of such 
Act; 
"(B) 66 percent of such tolerances and exemptions are 
reviewed within 6 years of the date of enactment of such 
Act; and 
"(C) 100 percent of such tolerances and exemptions 
are reviewed within 10 years of the date of enactment 
of such Act. 
In conducting a review of a tolerance or exemption, the 
Administrator shall determine whether the tolerance or exemp-
tion meets the requirements of subsections (b)(2) or (c)(2) and 
shall, by the deadline for the review of the tolerance or exemp-
tion, issue a regulation under subsection (d)(4) or (e)(1) to 
modify or revoke the tolerance or exemption if the tolerance 
or exemption does not meet such requirements. 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1535 
"(2) PRIORITIES.—In determining priorities for reviewing 
tolerances and exemptions under paragraph (1), the Adminis-
trator shall give priority to the review of the tolerances or 
exemptions that appear to pose the greatest risk to public 
health. 
"(3) PUBLICATION OF SCHEDULE.—Not later than 12 months 
after the date of the enactment of the Food Quality Protection 
Act of 1996, the Administrator shall publish a schedule for 
review of tolerances and exemptions established prior to the 
date of the enactment of the Food Quality Protection Act of 
1996. The determination of priorities for the review of toler-
ances and exemptions pursuant to this subsection is not a 
rulemaking and shall not be subject to judicial review, except 
that failure to take final action pursuant to the schedule estab-
lished by this paragraph shall be subject to judicial review. 
"(r) TEMPORARY TOLERANCE OR EXEMPTION.—The Adminis-
trator may, upon the request of any person who has obtained 
an experimental permit for a pesticide chemical under the Federal 
Insecticide, Fungicide, and Rodenticide Act or upon the Administra-
tor's own initiative, establish a temporary tolerance or exemption 
for the pesticide chemical residue for the uses covered by the 
permit. Subsections (b)(2), (c)(2), (d), and (e) shall apply to actions 
taken under this subsection. 
"(s) SAVINGS CLAUSE.—Nothing in this section shall be con-
strued to amend or modify the provisions of the Toxic Substances 
Control Act or the Federal Insecticide, Fungicide, and Rodenticide 
Act.". 
SEC. 406. AUTHORIZATION FOR INCREASED MONITORING. 
For the fiscal years 1997 through 1999, there is authorized 
to be appropriated in the aggregate an additional $12,000,000 for 
increased monitoring by the Secretary of Health and Human Serv-
ices of pesticide residues in imported and domestic food. 
SEC. 407. ALTERNATIVE ENFORCEMENT. 
Section 303(g) (21 U.S.C. 333(f)) is amended— 
(1) by redesignating paragraphs (2), (3), and (4) as para-
graphs (3), (4), and (5), respectively; 
(2) by inserting after paragraph (1) the following: 
"(2)(A) Any person who introduces into interstate commerce 
or delivers for introduction into interstate commerce an article 
of food that is adulterated within the meaning of section 402(a)(2)(B) 
shall be subject to a civil money penalty of not more than $50,000 
in the case of an individual and $250,000 in the case of any 
other person for such introduction or delivery, not to exceed 
$500,000 for all such violations adjudicated in a single proceeding. 
"(B) This paragraph shall not apply to any person who grew 
the article of food that is adulterated. If the Secretary assesses 
a civil penalty against any person under this paragraph, the Sec-
retary may not use the criminal authorities under this section 
to sanction such person for the introduction or delivery for introduc-
tion into interstate commerce of the article of food that is adulter-
ated. If the Secretary assesses a civil penalty against any person 
under this paragraph, the Secretary may not use the seizure 
authorities of section 304 or the injunction authorities of section 
302 with respect to the article of food that is adulterated. 
"(C) In a hearing to assess a civil penalty under this paragraph, 
the presiding officer shall have the same authority with regard 
110 STAT. 1536 
PUBLIC LAW 104-170—AUG. 3, 1996 
to compelling testimony or production of documents as a presiding 
officer has under section 408(g)(2)(B). The third sentence of para-
graph (3)(A) shall not apply to any investigation under this para-
graph."; 
(3) in paragraph (3), as so redesignated, by striking "para-
graph (1)" each place it occurs and inserting "paragraph (1) 
or (2)"; 
(4) in paragraph (4), as so redesignated, by striking "(2)(A)" 
and inserting "(3)(A)"; and 
(5) in paragraph (5), as so redesignated, by striking "(3)" 
each place it occurs and inserting "(4)". 
TITLE V—FEES 
SEC. 501. REREGISTRATION FEES. 
(a) SECTION 4(i).—Section 4(i) (7 U.S.C. 136a-l(i)), as amended 
by section 232(2), is amended— 
(1) in paragraphs (5)(H) and (6), by striking "1997" and 
inserting "2001"; and 
(2) in paragraph (5)(C), by inserting "(i)" after "(C)" and 
by adding at the end the following: 
"(ii) in each of the fiscal years 1998, 1999, and 2000, 
the Administrator is authorized to collect up to an addi-
tional $2,000,000 in a manner consistent with subsection 
(k)(5) and the recommendations of the Inspector General 
of the Environmental Protection Agency. The total fees 
that may be collected under this clause shall not exceed 
$6,000,000.". 
(b) SECTION 4(k)(l).—Section 4(k)(l) (7 U.S.C. 136a-l(k)(l)) 
is amended by inserting before the period the following: "which 
shall be known as the Reregistration and Expedited Processing 
Fund". 
(c) SECTION 4(k)(2).—Section 4(k)(2) (7 U.S.C. 136a-l(k)(2)) is 
amended to read as follows: 
"(2) SOURCE AND USE.— 
"(A) All moneys derived from fees collected by the 
Administrator under subsection (i) shall be deposited in 
the fund and shall be available to the Administrator, with-
out fiscal year limitation, specifically to offset the costs 
of reregistration and expedited processing of the applica-
tions specified in paragraph (3). Such moneys derived from 
fees may not be expended in any fiscal year to the extent 
such moneys derived from fees would exceed money appro-
priated for use by the Administrator and expended in such 
year for such costs of reregistration and expedited process-
ing of such applications. The Administrator shall, prior 
to expending any such moneys derived from fees— 
Effective date. 
"(i) effective October 1, 1997, adopt specific and 
Rules and 
cost accounting rules and procedures as approved by 
procedures. 
^^le General Accounting Office and the Inspector Gen-
eral of the Environmental Protection Agency to ensure 
that moneys derived from fees are allocated solely to 
the costs of reregistration and expedited processing 
of the applications specified in paragraph (3) in the 
same portion as appropriated funds; 
PUBLIC LAW 104-170—AUG. 3, 1996 
110 STAT. 1537 
"(ii) prohibit the use of such moneys derived from 
fees to pay for any costs other than those necessary 
to achieve reregistration and expedited processing of 
the appHcations specified in paragraph (3); and 
"(iii) ensure that personnel and facility costs asso-
ciated with the functions to be carried out under this 
paragraph do not exceed agency averages for com-
parable personnel and facility costs. 
"(B) The Administrator shall also— 
"(i) complete the review of unreviewed reregistra- Review, 
tion studies required to support the reregistration eligi-
bility decisions scheduled for completion in accordance 
with subsection (1)(2); and 
"(ii) contract for such outside assistance as may Contracts. 
be necessary for review of required studies, using a 
generally accepted competitive process for the selection 
of vendors of such assistance.". 
(d) SECTION 4(k)(3).—Section 4(k)(3) (7 U.S.C. 136a-l(k)(3)) 
is amended— 
(1) in subparagraph (A), by striking out "for each of the 
fiscal years 1992, 1993, and 1994, Wth of the maintenance 
fees collected, up to 2 million each year" and inserting in 
lieu thereof "for each of the fiscal years 1997 through 2001, 
not more than V? of the maintenance fees collected in such 
fiscal year"; and 
(2) by adding a new subparagraph (C) to read as follows: 
"(C) So long as the Administrator has not met the 
time frames specified in clause (ii) of section 3(c)(3)(B) 
with respect to any application subject to section 3(c)(3)(B) 
that was received prior to the date of enactment of the 
Food Quality Protection Act of 1996, the Administrator 
shall use the full amount of the fees specified in subpara-
graph (A) for the purposes specified therein. Once all 
applications subject to section 3(c)(3)(B) that were received 
prior to such date of enactment have been acted upon, 
no limitation shall be imposed by the preceding sentence 
of this subparagraph so long as the Administrator meets 
the time frames specified in clause (ii) of section 3(c)(3)(B) 
on 90 percent of affected applications in a fiscal year. 
Should the Administrator not meet such time frames in Applicability. 
a fiscal year, the limitations imposed by the first sentence 
of this subparagraph shall apply until all overdue applica-
tions subject to section 3(c)(3)(B) have been acted upon.". 
(e) SECTION 4(k)(5).—Section 4(k)(5) (7 U.S.C. 136a-l(k)(5)) 
is amended to read as follows: 
"(5) ACCOUNTING AND PERFORMANCE.—^The Administrator 
shall take all steps necessary to ensure that expenditures from 
fees authorized by subsection (i)(5)(C)(ii) are used only to carry 
out the goals established under subsection (1). The Reregistra-
tion and Expedited Processing Fund shall be designated as 
an Environmental Protection Agency component for purposes 
of section 3515(c) of title 31, United States Code. The annual 
audit required under section 3521 of such title of the financial 
statements of activities under this Act under section 3515(b) 
of such title shall include an audit of the fees collected under 
subsection (i)(5)(C) and disbursed, of the amount appropriated 
to match such fees, and of the Administrator's attainment 
110 STAT. 1538 
PUBLIC LAW 104-170—AUG. 3, 1996 
of performance measures and goals established under sub-
section (1). Such an audit shall also include a review of the 
reasonableness of the overhead allocation and adequacy of 
disclosures of direct and indirect costs associated with carrying 
out the reregistration and expedited processing of the applica-
tions specified in paragraph (3), and the basis for and accuracy 
Reports. 
of all costs paid with moneys derived from such fees. The 
Inspector General shall conduct the annual audit and report 
the findings and recommendations of such audit to the Adminis-
trator and to the Committees on Agriculture of the House 
of Representatives and the Senate. The cost of such audit 
shall be paid for out of the fees collected under subsection 
(i)(5)(C).". 
(f) GOALS.—Subsections (1) and (m) of section 4 (7 U.S.C. 
136a-l), as amended by section 237, are redesignated as subsections 
(m) and (n) respectively and the following is inserted after sub-
section (k): 
Federal Register, 
"(D PERFORMANCE MEASURES AND GOAL.—The A d m i n i s t r a t o r 
publication. 
shall establish and publish annually in the Federal Register 
performance measures and goals. Such measures and goals shall 
include— 
"(1) the number of products reregistered, canceled, or 
amended, the status of reregistration, the number and type 
of data requests under section 3(c)(2)(B) issued to support prod-
uct reregistration by active ingredient, the progress in reducing 
the number of unreviewed, required reregistration studies, the 
aggregate status of tolerances reassessed, and the number of 
applications for registration submitted under subsection (k)(3) 
that were approved or disapproved; 
"(2) the future schedule for reregistrations, including the 
projection for such schedules that will be issued under sub-
section (g)(2)(A) and (B) in the current fiscal year and the 
succeeding fiscal year; and 
"(3) the projected year of completion of the reregistrations 
under this section.". 
Approved August 3, 1996. 
LEGISLATIVE HISTORY—H.R. 1627: 
HOUSE REPORTS: No. 104-669, Pt. 1 (Comm. on Agriculture) and Pt. 2 (Comm. 
on Commerce). 
CONGRESSIONAL RECORD, Vol. 142 (1996): 
July 23, considered and passed House. 
July 24, considered and passed Senate. 
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 32 (1996): 
Aug. 3, Presidential remarks and statement.