[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1627 Enrolled Bill (ENR)]
H.R.1627
One Hundred Fourth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Wednesday,
the third day of January, one thousand nine hundred and ninety-six
An Act
To amend the Federal Insecticide, Fungicide, and Rodenticide Act and the
Federal Food, Drug, and Cosmetic Act, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

2c06dfc598c16e7670174bdebc9d72f73fc6f6df6057e574463f77cd58c97bf8

This Act may be cited as the ``Food Quality Protection Act of
1996''.

a9f23a9fb539a51eeb219924ca1ed3cf97e5fddc3d97eda18e72cb3fc1c5e277

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

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TITLE I

-SUSPENSION-APPLICATORS

(a) Section 6(c)(1).--The second sentence of section 6(c)(1) (7
U.S.C. 136d(c)(1)) is amended to read: ``Except as provided in
paragraph (3), no order of suspension may be issued under this
subsection unless the Administrator has issued, or at the same time
issues, a 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 after 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 pesticide 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''.

18dd201bee7bcb7af76d1357bbdac8324a9df3800faa69a83098323afe44c1aa

Section 4(g)(2) (7 U.S.C. 136a-1(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 subparagraph (C) or
(D) with respect to pesticides containing a particular active
ingredient, the Administrator shall--
``(i) reassess each associated tolerance and exemption
from the requirement for a tolerance issued under section
408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
346a);
``(ii) determine whether such tolerance or exemption
meets the requirements of that Act;
``(iii) determine whether additional tolerances or
exemptions should be issued;
``(iv) publish in the Federal Register a notice setting
forth the determinations made under this subparagraph; and
``(v) commence promptly such proceedings under this Act
and section 408 of the Federal Food, Drug, and Cosmetic Act
as are warranted by such determinations.''.

c0c475aa2620518e5ee0479e44b5d0aa63244e843570140a14ed87b9e8d08ce8

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:
``(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 created under paragraph (1). Members
of the Board shall be compensated in the same manner as members of
the Panel.''.

1b71b92748e41b00813f158b08d4220db59214d19b7976278bee9c9369d87c90

(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:
``(hh) Nitrogen Stabilizer.--The term `nitrogen stabilizer' means
any substance or mixture of substances intended for preventing or
hindering the process of nitrification, denitrification, ammonia
volatilization, 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 volatilization 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 authority 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 combination,
the mixture or combination is mixed or combined in accordance with
such labeling, and the mixture or combination does not contain any
active ingredient other than the nitrogen stabilizer.''.

bdc64a53955cc306b42cff9a6f332f150113ff70c5fc6edf61dfefd28972d26d

(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 regulation
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 substantive 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 utilized for and be applicable to
any data required for registration review.''.
Subtitle B--Training for Maintenance Applicators and Service
Technicians

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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 structural pest control or
lawn pest control including janitors, general maintenance personnel,
sanitation personnel, and grounds maintenance 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, sanitizers or disinfectants; or who
otherwise apply ready to use consumer products pesticides.''.

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AND SERVICE TECHNICIANS.
The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136 et seq.) is amended--
(1) by redesignating sections 30 and 31 as sections 33 and 34,
respectively; and
(2) by adding after section 29 the following:
``SEC. 30. MINIMUM REQUIREMENTS FOR TRAINING OF MAINTENANCE APPLICATORS
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.''.
REGISTRATION REFORM, AND PUBLIC HEALTH PESTICIDES

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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--Minor Use Crop Protection

c1649141b73167f8470458e097b18fb468730332ad73bd83c4466b321a1b1ed3

TITLE II

-MINOR USE CROP PROTECTION, ANTIMICROBIAL PESTICIDE

4846becc8640232efd8bface6737d5e994c4d23261eb4f18fdb4ebbdaac94dc3

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 normally 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 substances
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 pesticide'
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
``(C) an aquatic herbicide product.
``(3) Included products.--The term `antimicrobial pesticide'
does include any other chemical sterilant product (other than
liquid chemical sterilant products exempt under subsection (u)),
any other disinfectant product, any other industrial microbiocide
product, and any other preservative product that is not excluded by
paragraph (2).''.

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Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as amended by section
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
protocols, timetables, and standards of review and reduce
burdens and redundancy caused to the registrant by multiple
requirements on the registrant.
``(II) The Administrator may enter into a cooperative
agreement with a State to carry out subclause (I).
``(III) 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.''.

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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 subparagraphs (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 information 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 distribution 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
Administrator may disapprove the modification by sending
the registrant notification in writing stating that the
proposed language is not acceptable and stating the reasons
why the Administrator finds the proposed modification
unacceptable.
``(iii) Restriction on sale.--A registrant may not sell
or distribute a product bearing a disapproved modification.
``(iv) Objection.--A registrant may file an objection
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 Administrator
following receipt and consideration of an objection 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 recommended diluted solution
of the pesticide than for use of a concentrate of the pesticide
if the Administrator determines 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
protection for exposure to the diluted solution of the
pesticide.''.

cfb97918e5265d6a42202420a27c4a8a722e0b88ce14053b47448c75df37e156

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 Pesticides.--
``(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 registration 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 registrations.
``(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 registered
active ingredient;
``(C) 120 days for any other new antimicrobial product;
``(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 paragraph.
``(3) Implementation.--
``(A) Proposed rulemaking.--
``(i) Issuance.--Not later than 270 days after the date
of enactment of this subsection, the Administrator shall
publish in the Federal Register proposed regulations to
accelerate and improve the review of antimicrobial
pesticide products designed to implement, 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 pesticides,
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 organisms, 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 undertaken
for antimicrobial pesticides;
``(III) conform the degree and type 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 product type;
``(IV) ensure that the registration process is
sufficient to maintain antimicrobial pesticide efficacy
and that antimicrobial pesticide products continue 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.
``(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 certification
process for regulatory actions involving risks that can
be responsibly managed, consistent with the degree of
risk, in the most cost-efficient manner;
``(II) consider the establishment of a
certification 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 regulations
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 ingredient
pesticide registration;
``(ii) 1 year for a new antimicrobial use of a
registered 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
registration, 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 the same
period as that established under this paragraph for an
antimicrobial pesticide product application, consistent 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 Administrator 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 considered an agency
action unlawfully withheld or unreasonably delayed for
purposes of judicial review under chapter 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 Agriculture, 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 pending
registration applications;
``(ii) progress toward achieving reforms under this
subsection; and
``(iii) recommendations to improve the activities of
the Agency pertaining to antimicrobial registrations.''.

ddcac53a5ed37e991647f65811736991b0825048de4daeaa383f128de2399dc2

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.''.
Subtitle C--Public Health Pesticides

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(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 pesticide'
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 prevention 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.''.

6c9b8f56043e2895f26eb26e0f0c947e007f1fd3a36c685fd39f9e207ce9616f

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 environment
to the pesticide'' and inserting ``potential beneficial or adverse
effects on man and the environment''.

f1a5f8711bc15b3bc7d3d4caf0bc8817692ddce679d829ff61e0ed5488a3e99e

Section 4 (7 U.S.C. 136a-1) 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 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.'';
(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.''.

1eca4b91a24f1167badef8f750a104e8fd438da8faaf9ed36dd7b850de325b2c

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 provide 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.''.

e0cea600435eeaced4ac24a6936d5f71a8c37e641cd0e8b8feb22924b9fba706

Section 21 (7 U.S.C. 136s) is amended by redesignating subsections
(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).''.

db7a3a87ca79a2a16eeb71dfb2a3604dd256f67df885de2a52cfab0f62282c5e

Section 25(a)(1) (7 U.S.C. 136w(a)(1)) is amended--
(1) by inserting after ``various classes of pesticides'' the
following: ``, including public health pesticides,''; and
(2) by striking ``and nonagricultural pesticides'' and
inserting ``, nonagricultural, and public health pesticides''.

af54d2dcd409eeb015d1c6e718208671071fc162c714dfbbe7b8e37864a1bb99

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 and control such
pests of public health importance.''.

fef563a9d722ad027bf962a78abcfb06404925a45aa606bb8c545be657358abc

Section 4 (7 U.S.C. 136a-1) is amended by adding at the end the
following:
``(m) Authorization of Funds To Develop Public Health Data.--
``(1) Definition.--For the purposes of this section,
`Secretary' means the Secretary of Health and Human Services,
acting through the Public 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 Secretary 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 authorized 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

d609b0136fa9ea28cf8f8d5987788d5fae5318992f8d2adf9de24667aa3f63bd

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:
``(G) If the applicant is requesting that the registration
or amendment to the registration of a pesticide be expedited,
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 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 guidelines.
``(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 environmental
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
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 developed
under subparagraph (A).''.
AND CHILDREN AND OTHER MEASURES

623c90c227537ea76b62f269c2cf8c88fa068cd021a178b0eda0705a80373c65

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.
(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 Environmental
Protection Agency and the Department of Health and Human Services,
provide for the improved data collection of pesticide 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.

7b4adce608e1bcaa49340597b1af132763fdbbbb16ccb85f43453f917ac1ca06

TITLE III

-DATA COLLECTION ACTIVITIES TO ASSURE THE HEALTH OF INFANTS

(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 Environmental
Protection Agency in the design of the surveys and make available to
the Administrator the aggregate results of the surveys to assist the
Administrator.

2313912317b2b2e07f82dbf30a16753d48fdfd9079b2e071a83668a5cd42c1a3

The Secretary of Agriculture, in cooperation with the
Administrator, shall implement research, demonstration, and education
programs 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 Management through procurement and
regulatory policies, and other activities.

c5fef0d0f58e9bbe7880272e953de86e5ba13bd0dccbfed4aa608fdcb0cab260

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 inconsistent with the
standard under section 408 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 346a).''.

cf6dafca6b25eb13fffbd92b29d3c37acad413b3a9fee15a73030c5d56e37698

(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 activities. This report
shall at least include--
(1) an analysis of the quality and reliability of the
information collected by the Department of Agriculture, the
Environmental 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
analysis of costs, burdens placed on agricultural producers and
other pesticide users, and effectiveness in tracking risk reduction
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.
SEC 401. SHORT TITLE AND REFERENCE.
(a) Short Title.--This title may be cited as the ``Food Quality
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.

f8ccfe71a086c99a1b565d7cf1cd6c3dfb5bf6d9200ea616803a890e67519b44

(a) Section 201(q).--Section 201(q) (21 U.S.C. 321(q)) is amended
to read as follows:
``(q)(1) The term `pesticide chemical' means any substance that is
a pesticide within the meaning of the Federal Insecticide, Fungicide,
and Rodenticide Act, including all active and inert ingredients of such
pesticide.
``(2) The term `pesticide chemical residue' means a residue in or
on raw agricultural commodity or processed food of--
``(A) a pesticide chemical; or
``(B) any other added substance that is present on or in the
commodity or food primarily as a result of the metabolism or other
degradation of a pesticide chemical.
``(3) Notwithstanding paragraphs (1) and (2), the Administrator may
by regulation except a substance from the definition of `pesticide
chemical' or `pesticide chemical residue' if--
``(A) its occurrence as a residue on or in a raw agricultural
commodity or processed food is attributable primarily to natural
causes or to human activities not involving the use of any
substances for a pesticidal purpose in the production, storage,
processing, or transportation of any raw agricultural commodity or
processed food; and
``(B) the Administrator, after consultation with the Secretary,
determines that the substance more appropriately should be
regulated under one or more provisions of this Act other than
sections 402(a)(2)(B) and 408.''.
(b) Section 201(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 commodity that
has been subject to processing, such as canning, cooking, freezing,
dehydration, or milling.
``(hh) The term `Administrator' means the Administrator of the
United States Environmental Protection Agency.''.

a690d81cab48c42343431df4482a36bbc08ff310f5d4ec3b39e9b1a518653d49

TITLE IV

-AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

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.''.

452cc7c5658522490f8155770d90be6b66eff26aa9473d9f28840d201b2cecd6

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''.

ab8d9a1e047164fa0a82c6ec03629e13a431a5291f8be829ccb593cfc38262cd

db898495e5b9661928f2a24b43b1343d298aadf11046cffdf238a8fb6d5ad8b9

For the fiscal years 1997 through 1999, there is authorized to be
appropriated in the aggregate an additional $12,000,000 for increased
monitoring by the Secretary of Health and Human Services of pesticide
residues in imported and domestic food.

f8a15a9788df3908210432edae40b8a63cef15f2ba686abd667a6015454e3e9e

Section 303(g) (21 U.S.C. 333(f)) is amended--
(1) by redesignating paragraphs (2), (3), and (4) as paragraphs
(3), (4), and (5), respectively;
(2) by inserting after paragraph (1) the following:
``(2)(A) Any person who introduces into interstate commerce or
delivers for introduction into interstate commerce an article of food
that is adulterated within the meaning of section 402(a)(2)(B) shall be
subject to a civil money penalty of not more than $50,000 in the case
of an individual and $250,000 in the case of any other person for such
introduction or delivery, not to exceed $500,000 for all such
violations adjudicated in a single proceeding.
``(B) This paragraph shall not apply to any person who grew the
article of food that is adulterated. If the Secretary assesses a civil
penalty against any person under this paragraph, the Secretary may not
use the criminal authorities under this section to sanction such person
for the introduction or delivery for introduction into interstate
commerce of the article of food that is adulterated. If the Secretary
assesses a civil penalty against any person under this paragraph, the
Secretary may not use the seizure authorities of section 304 or the
injunction authorities of section 302 with respect to the article of
food that is adulterated.
``(C) In a hearing to assess a civil penalty under this paragraph,
the presiding officer shall have the same authority with regard to
compelling testimony or production of documents as a presiding officer
has under section 408(g)(2)(B). The third sentence of paragraph (3)(A)
shall not apply to any investigation under this paragraph.'';
(3) in paragraph (3), as so redesignated, by striking
``paragraph (1)'' each place it occurs and inserting ``paragraph
(1) or (2)'';
(4) in paragraph (4), as so redesignated, by striking
``(2)(A)'' and inserting ``(3)(A)''; and
(5) in paragraph (5), as so redesignated, by striking ``(3)''
each place it occurs and inserting ``(4)''.

6476bc7b676cbe31d8878b79e304ce130b84e97bfa3bcfebafe0fd61675f8113

(a) Section 4(i).--Section 4(i) (7 U.S.C. 136a-1(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 additional
$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)(1).--Section 4(k)(1) (7 U.S.C. 136a-1(k)(1)) 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-1(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, without
fiscal year limitation, specifically to offset the costs of
reregistration and expedited processing of the applications
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 appropriated for use by
the Administrator and expended in such year for such costs of
reregistration and expedited processing of such applications.
The Administrator shall, prior to expending any such moneys
derived from fees--
``(i) effective October 1, 1997, adopt specific and
cost accounting rules and procedures as approved by the
General Accounting Office and the Inspector General 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;
``(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
applications specified in paragraph (3); and
``(iii) ensure that personnel and facility costs
associated with the functions to be carried out under this
paragraph do not exceed agency averages for comparable
personnel and facility costs.
``(B) The Administrator shall also--
``(i) complete the review of unreviewed reregistration
studies required to support the reregistration eligibility
decisions scheduled for completion in accordance with
subsection (l)(2); and
``(ii) contract for such outside assistance as may 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-1(k)(3)) is
amended--
(1) in subparagraph (A), by striking out ``for each of the
fiscal years 1992, 1993, and 1994, \1/7\th 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 \1/7\ 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 subparagraph (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 a fiscal year, the limitations imposed by the first sentence
of this subparagraph shall apply until all overdue applications
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-1(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 (l). The Reregistration 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 of performance measures and goals
established under subsection (l). 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 applications specified in paragraph (3), and the basis for and
accuracy 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 Administrator 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 (l) and (m) of section 4 (7 U.S.C. 136a-1),
as amended by section 237, are redesignated as subsections (m) and (n)
respectively and the following is inserted after subsection (k):
``(l) Performance Measures and Goal.--The Administrator 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 product
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 subsection
(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.''.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.

Food Quality Protection Act of 1996

Other Sections

TITLE I

TITLE II

TITLE III

TITLE IV

TITLE V

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