|
Pesticide legislation:Food Quality Protection Act
of 1996
(P.L. 104-170) IV 96-759
ENR
96-759 ENR
CONTENTS FOR THIS SECTION
Appendix B. Section-by-Section summary of P.L. 104-170
Appendix B. Section-by-Section
Summary of P.L. 104-170
Provision
|
P.L.
104-170
|
| Short
Title |
§1
- The Act is the "Food Quality Protection Act of
1996" |
Title
I-- Suspension - Applicators
|
| Reference |
§101
- Title I amends FIFRA |
Subtitle
A - Suspension
|
| Suspension |
§102
- Amends FIFRA §6(c); authorizes an emergency suspension
order before EPA issues a notice of its intention to
cancel the registration or to change the classification
of the pesticide. Such emergency order expires after 90
days if EPA has not issued a notice under Section 6(b). |
Reregistration
of
Foed-Use
Pesticides |
§103
- Amends FIFRA §4(g)(2) to require reassessment of
residue tolerances and exemptions issued under the FFDGA
as soon as EPA has sufficient information about the
dietary risk of an active ingredient and at the time EPA
makes a reregistration decision |
Science
Review
Board
Established |
§104
- Amends FIFRA §25(b) to establish a Science Review
Board of
60 scientists to assist in Scientific Advisory Panel
(SAP) reviews; SAP
selects Board members |
| Nitrogen
Stabilizers |
§
105 - Distinguishes "nitrogen stabilizers" from
other pesticides |
| State
and Local Authority |
§106
- Amends FIFRA to eliminate Section 6 requirement to
cancel registration after 5 years; adds new subsection
(g) to Section 3 requiring periodic registration review,
with a goal of every 15 years |
Subtitle
B - Training for Maintenance Applicators and Service
Technicians
|
| Definitions |
§
120 - Defines "maintenance applicators" and
"service technician" |
| Training of Maintenance workers |
§121
- Authorizes States to establish requirements for
training maintenance applicators and service technicians
in handling and use of pesticides; limits EPA authority |
Title
II - Minor Use Crop Protection,
Antlinicrobial Pesticide Registration
Reform, and Public Health Pesticides
|
| Reference |
§201 -
Title II amends FIFRA |
|
Subtitle
A - Minor Use Crop Protection
|
| Definitions |
§210(a)
- Defines "minor use" |
Time
to Submit
Data Supporting
Minor Use
Registration |
§210(b)
- Extends exclusive data use period 1 year for each 3
minor uses registered; protects for 10 years data
supporting a new minor use of a registered pesticide with
no remaining period of data protection |
| Deadline
for Residue Data |
§210(c)
- Extends deadline for residue chemistry data for a minor
use registration until final submission date for other
pesticide uses |
Provision
|
P.L.
104-170
|
Authority
to
Waive Data
Requirements |
§210(d)
- Authorizes data waiver for minor use registration if
risk still could be assessed and would be reasonable |
| Expedited
Registration |
§210(e)
- Requires EPA to act expeditiously on a complete
application for minor use registration |
Unsupported
Minor Use
Registrations |
§210(f)
- Requires EPA to temporarily extend registration for a
minor use that is not supported for reregistration until
after the final data submission deadline for all
supported uses |
Cancellation
of a
Minor Use
Registration |
§210(g)
- Lengthens from 90 days to 180 days the EPA waiting
period prior to granting a request for voluntary
cancellation of a pesticide registered for a minor use |
| Registration
Transfers |
§210(h)
- Requires EPA to consider an application to register a
minor use in light of a substantially similar pesticide
use that was registered if such registration was
voluntarily canceled while the new application was
pending |
| EPA
Minor Use Coordination |
§210(j)
- Establishes a minor use program in EPA; requires EPA
report on progress in registering minor uses |
USDA
Minor Use
Coordination and
Grant Program |
§210j)
- Requires USDA to coordinate its minor use activities;
establishes a minor use matching grant program to develop
data supporting minor use pesticide registrations and
reregistrations; establishes a Minor Use Pesticide Data
Revolving Fund; authorizes appropriations of $10 million
annually |
Subtitle B - Antimicrobial
Pesticide Registration Reform
|
| Definition |
§221
- Defines "antimicrobial pesticide" |
| Coordination
of Requirements and Deadlines |
§222
- Amends FIFRA to require coordination of FIFRA data
requirements for pesticide registration |
| Changes
to Labels |
§223
- Allows specified changes to labels for antimicrobial
pesticides
60 days after the registrant notifies EPA, if EPA does
not disapprove
within 30 days of receiving notice |
Antimicrobial
Pesticide
Registration
Reform |
§224
- Adds a new subsection (g) to FIFRA §3; directs EPA to
reduce registration requirements for antimicrobial
pesticides; establishes goals and limits for review and
notification requirements; requires annual report on
reform progress |
Transportation,
Storage, and
Disposal of
Disinfectants and
Sanitizers |
§225
- Removes EPA authority to specify requirements for
pesticide registration and labeling with respect to
storage, disposal, transportation, and recall of
household, industrial, and institutional antimicrobial
products that are not subject to the Solid Waste Disposal
Act (42 USC 6901 et seq.), unless regulation is necessary
to prevent an unreasonable adverse effect |
Subtitle C - Public Health Pesticides
|
| Definition §230 - Amends the definition
of "unreasonable adverse effects on the
environment;" requires EPA to weigh pesticide risks
against health risks posed by the pesticide target, e.g.,
diseases carrier insects; defines "public health
pesticide" and "vector" |
Provision
|
P.L.
104-170
|
| Data Requirements |
§231
- Requires EPA to consider the public health and
agricultural need for a minor use pesticide and
beneficial or adverse effects on the environment when
establishing data requirements |
Reregistration of
Public Health
Pesticides |
§232
- Exempts public health pesticides from reregistration
fees if economic return does not support registration;
requires EPA to use existing expedited processing funds
to assure expedited review of public health pesticide
applications |
Changes in
Public Health
Pesticide
Registrations |
§233
- Requires DHHS to provide benefits and use information
and
analysis when a public health use is affected by a
proposed change in
a pesticide registration |
DHHS
Comments |
§234
- Requires EPA to solicit DHHS views prior to publishing
a regulation for a public health pesticide |
Consideration
of
Public Health
Pesticides |
§235
- Requires EPA to take into account the risk and relevant
data for public health pesticides |
Control
of
Significant Public
Health Pests |
§236
- Requires EPA to identify pests of "significant
public health importance" and to promote methods to
control them |
| Authorization of Appropriations |
§237
- Authorizes arrangements to conduct studies to develop
data needed to register or reregister public health
pesticides; authorizes appropriations for FIFRA Section 4
of up to $12 million for FY1997, and thereafter, such
sums as may be necessary |
Subtitle D - Expedited Registration of
Reduced Risk Pesticides
|
Reduced Risk
Pesticides |
§250
- Amends FIFRA §3(c); directs EPA to develop
procedures to expedite reviews of pesticide uses that
may: reduce pesticide risks to
human health, reduce pesticide risks to nontarget
organisms, reduce contamination of valued environmental
resources, or broaden adoption of integrated pest
management (IPM) strategies |
Title III- Data Collection Activities to
Assure the Health of Infants and Children
and Other Measures
|
| Data
Collection to Assure the Health of Infants and Children |
§301
- Requires USDA, EPA, and DHHS to coordinate in
developing and implementing survey procedures to ensure
collection of adequate data on feed consumption of
infants and children (Also see §405 amendment to FFDCA
§408(b)(2)(C)) |
| Pesticide
Use Data |
§302
- Requires USDA to collect data of statewide or regional
importance on pesticide use on major crops and crops of
dietary significance |
| Integrated
Pest Management |
§303
- Requires USDA to cooperate with EPA to conduct
research, demonstration, and education programs
supporting IPM; directs federal agencies to use and
promote 1PM |
FIFRA-FFDCA
Coordination |
§304
- Amends FIFRA definition of "unreasonable adverse
effects on
the environment" to include dietary risk from
pesticide residues
inconsistent with the EPA-established food tolerance
under FFDCA
§408 |
Provision
|
P.L. 104-170
|
| Pesticide
Use Data Report |
§305
- Requires USDA, in consultation with EPA, to report on
pesticide use data collection by federal agencies |
Title IV - Amendments
to the Federal Food, Drug, and Cosmetic Act
|
| Short
Title and Reference |
§401
- Title IV may be cited as the Food Quality Protection
Act of 1996; it amends FFDCA |
| Definitions |
§402
- Amends and adds definitions for "pesticide
chemical," "pesticide chemical residue,"
"food additive," "processed food,"
and "Administrator" |
| Confidential
Data |
§403
- Amends FFDCA §301(j) to prohibit disclosure of
confidential data |
| Adulterated
Processed Food |
§404
- Amends FFDCA §402(a)(2) so that pesticide residues on
raw or processed food that are "unsafe" within
the meaning of §408 cause a food to be deemed
adulterated |
| Pesticide
Residues in Food |
§405
- Amends FFDCA §408 regulating pesticide residues in
food |
Safety
of
Pesticide
Residues |
New
§408(a)(1) - Defines raw and processed food products as
"food" and a pesticide residue on food as
"unsafe," unless a tolerance is in effect and
the residue level is below the tolerance, or an exemption
from the requirement exists |
Safety of
Residues in
Processed Food |
New
§408(a)(2) - Defines a pesticide chemical residue on
processed food as not unsafe if the residue results from
pesticide use that conforms to a tolerance for the raw
commodity, the residue has been removed to the extent
possible in "good manufacturing practice," and
the concentration of processed food residue is not
greater than the raw food tolerance, or an exemption is
in effect for the raw food |
Pesticide
Degradation
Products |
New
§408(a)(3) - Defines a food residue of a degradation
product of a pesticide as safe if: (A) EPA has determined
that the dietary health risk posed by the breakdown
product is not likely to be different than that posed by
the parent pesticide; (B)(j) a tolerance exists for the
parent pesticide and the combined residue of the parent
pesticide and breakdown product is less than the
tolerance; or (ii) a tolerance exemption exists for the
parent pesticide; and (C) the tolerance or exemption for
the parent pesticide does not state that it applies only
to the parent pesticide or that it does not apply to the
breakdown product |
Effect
of a
Tolerance or
Exemption |
New
§408(a)(4) - Food with pesticide residue shall not be
"adulterated" within the meaning of §402(a)(
1) while a tolerance or exemption is in effect for that
pesticide residue on that food |
| Authority
for Tolerance Setting |
New
§408(b)(1) - Authorizes EPA to establish, modify, or
revoke tolerances for pesticide residues on food in
response to a citizen petition or on its own initiative |
Provision
|
P.L.
104-170
|
| Standard
for Tolerances |
New
§408(b)(2)(A) - (j) Prohibits setting or retaining a
tolerance unless EPA determines that the level is
"safe;' directs EPA to modify or revoke any
tolerance that is not "safe;" (ii) defines
"safe' to mean that there is "a reasonable
certainty that no harm will result from aggregate
exposure to the pesticide chemical residue,"
considering all sources of exposure for which there is
reliable information; (iii) a pesticide chemical residue
for which a "safe" tolerance exists is not an
eligible_pesticide chemical residue (see below) |
Eligible
Pesticide
Chemical
Residues |
New
§408(b)(2)(B) - (j) Defines "eligible pesticide
chemical residue" as a residue for which a harmless
exposure level cannot be identified (that is, it exerts a
nonthreshold health effect), the lifetime risk of such
effect has been estimated using quantitative risk
assessment, and aggregate exposure to the residue is safe
with respect to other effects for which EPA is able to
identify a harmless level (that is, threshold effects)
(ii) - Allows EPA to maintain a tolerance for an eligible
residue if (iii) the pesticide use protects consumers
from greater health risks than are posed by the residue,
or the pesticide use is needed to avoid a
"significant disruption in domestic production of an
adequate, wholesome, and economical food supply;"
and (iv) aggregate exposure to the pesticide chemical
(including dietary exposure at the tolerance level) poses
a yearly risk not more than 10 times and a lifetime risk
not more than twice that of aggregate pesticide exposure
when the tolerance is at a "safe" level
(v) - Requires review of tolerances for eligible residues
at least every five years
(vi) - Requires tolerances for eligible residues to
protect the health of infants and children (see below) |
Exposure
of
Infants and
Children to
Eligible Residues |
New
§408(b)(2)(C) - Directs EPA when evaluating an existing
tolerance or exemption, (j) to assess the risk to infants
and children considering consumption patterns, special
susceptibility, and cumulative effects, and (ii) to
ensure with a reasonable certainty that no harm will
result to infants and children; EPA may apply a tenfold
margin of safety for potential pre- and post-natal
toxicity and inadequate exposure and toxicity data |
Mandated
Considerations in
Tolerance
Decisions |
New
§408(b)(2)(D) - Requires EPA to consider certain factors
when it establishes or reconsiders a tolerance or
exemption |
| Residue
Data |
New
§408(b)(2)(E) - Authorizes EPA to consider
data on anticipated residue levels and actual residue
level; 5 years after a tolerance is set, requires data
submissions demonstrating residues are below those used
to set tolerances; requires tolerance to be modified or
revoked if data are not provided or fail to demonstrate
that residues are below those used to set the tolerance |
Percent
of Food
Treated with
Pesticide |
New
§408(b)(2)(F) - Authorizes EPA when setting tolerances
to consider data on the percent of food actually treated
with the pesticide, but only if EPA finds that the data
meet certain criteria and provides for periodic
reevaluation of the estimate derived from the data |
Provision
|
P.L.
104-170
|
| Tolerances
Near the Level of Detection |
New
§408(b)(3) - (A) Prohibits tolerance setting unless a
practical method is identified for detecting and
measuring pesticide levels; (B) Prohibits setting a
tolerance below the limit of detection of the specified
method |
| International
Residue Levels |
New
§408(b)(4) - Directs EPA to explain its reasons if it
proposes a tolerance inconsistent with the international
Codex Maximum Residue Level |
Authority
for
Issuing
Exemptions |
New
§408(c) - Authorizes EPA to establish, modify, or revoke
a tolerance exemption in response to a petition or on its
own initiative; permits EPA to allow an exemption only if
it is "safe," meaning that there is a
"reasonable certainty that no harm will result from
aggregate exposure" to the pesticide residue from
all sources for which information is reliable; requires
consideration of certain factors; prohibits exemptions if
there is no practical method for detecting and measuring
the levels of residue, unless there is no need for such a
method and a reason is provided |
| Petitions |
New
§408(d) - Authorizes any person to file a petition for
issuance, modification, or revocation of a tolerance or
exemption; requires specified petition contents and
authorizes EPA regulations requiring information and data
to support a petition; directs EPA to publish a notice of
each complete petition and to respond by issuing a
regulation revising the tolerance or exemption or an
order denying the petition; establishes priorities and an
expedited procedure for reviews of petitions relating to
residue tolerances that appear safer than existing
residue tolerances for other pesticides with similar
uses; requires EPA action within 180 days respecting a
tolerance for an "eligible pesticide residue"
if a tolerance or exemption is established for a safer
pesticide residue for a similar use |
| Administrative
Procedures |
New
§408(e) - Authorizes EPA to issue regulations to set,
suspend, or revoke tolerance or an exemption or to
establish general implementation procedures; requires
60-day comment period |
Data
to Support
Existing
Tolerances and
Exemptions |
New
§408(f) - Requires EPA to collect additional data when
they are reasonably required to support an existing
tolerance or exemption; directs EPA to issue a notice
under FIFRA §3(c)(2)(B), a rule under the Toxic
Substances Control Act 4, or an order to request testing
and data submissions; authorizes modification or
revocation of a tolerance or exemption if data are not
submitted on time |
| Objections
and Hearings |
New
§408(g) - Provides any person 60 days to file an objection to a rule or
order and to request a hearing; authorizes EPA to decide
whether a hearing is necessary |
| Judicial
Review |
New
§408(h) - Authorizes persons adversely affected to
petition for judicial review of a regulation establishing
general implementation procedures under new §408(e) or
an order requesting data submissions under new §408(f)
or stating EPA's response to objections filed under new
§408(g); 60 days are provided for filing petitions after
the regulation or order is published |
Confidential
Business
Information |
New
§408(j) - Requires confidential treatment of data
supporting a tolerance |
Provision
|
P.L.
104-170
|
| Technical
Corrections |
New
§408(j) - Makes technical corrections to FFDCA |
Substances
Generally
Recognized as
Safe |
New
§408(k) - Requires EPA to publish a list of substances
that are generally recognized as safe (GRAS) and that are
exempt from tolerance regulations |
FFDCA-FIFRA
Coordination |
New
§408(1) - (1) Directs EPA when possible to coordinate
suspension or revocation of a tolerance or exemption with
related necessary action under FIFRA; (2) Requires
revocation of tolerances and exemptions permitting a
pesticide residue on a food within 180 days after EPA has
canceled the registration of that pesticide for that food
use due to dietary risks posed by residues; (3) Requires
suspension of a tolerance or exemption within 60 days of
the date a pesticide registration is suspended under
FIFRA; (4) Authorizes EPA to set tolerances for
unavoidable residues of canceled or suspended pesticides;
(5) Declares food is not unsafe solely because it
contains a residue for which the tolerance has been
revoked, suspended, or modified, if the residue results
from a legal application of pesticide and was within the
tolerance set at that time and EPA has not determined
that consumption would pose an unreasonable dietary risk;
(6) Requires EPA to issue a tolerance or exemption,
consistent with the safety standard of §408(b)(2) and
(c)(2) and for a limited time, for pesticide residues
resulting from pesticide use during an emergency
exemption from registration requirements under FIFRA §18 |
| Fees |
New
§408(m) - Retains current requirements for collecting
fees to cover costs of the tolerance program; directs EPA
to deposit fees in the FIFRA Reregistration and Expedited
Processing Fund |
| State
and Local Preemption |
New
§408(n) - Preempts state and local regulation of food
with residues below the tolerance or which are exempt;
allows state petitions for exceptions; allows state and
local warning requirements for such foods |
| Consumer
Right to Know |
New
§408(0) - Requires EPA to publish and distribute to
large retail grocers for public display easily understood
information about the risks and benefits of pesticide
residues on food, including information identifying
reasonable nutritional substitutes for foods with
"eligible pesticide residues" for which special
tolerances or exemptions have been established |
| Endocrieie
Effects |
New
§408(p) - Directs EPA to develop a screening program to
determine whether pesticides or other substances have
effects in humans that are similar to effects produced by
naturally occurring estrogens or other endocrine effects;
requires EPA to order testing and submission of reports
and to suspend registration for a registrant's failure to
comply with testing requirements; authorizes penalties
for others who fail to comply with test orders; requires
EPA action when necessary using existing statutory
authority if a substance is found to have an endocrine
effect on humans |
Provision
|
P.L.
104-170
|
Review
of
Tolerances and
Exemptions |
New
§408(q) - Requires EPA to review all tolerances and
exemptions for pesticide residues within 10 years of
enactment; tolerances and exemptions not meeting the
standard of §408 as amended must be revised or revoked;
directs EPA to prioritize reviews based on relative risk
to public health |
Temporary
Tolerances or
Exemptions |
New
§408(r) - Authorizes EPA to establish a temporary
tolerance or exemption for a residue that results from
pesticides uses covered by an experimental permit |
| Savings |
New
§408(5) - Notes that §408 does not amend or modify TSCA
or FIFRA |
Monitoring
Pesticide
Residues on Food |
§406
- Authorizes additional appropriations for FY1997 through
FY1999 of $12 million (total) for increased monitoring by
FDA of pesticide residues in imported and domestic food |
| Alternative
Enforcement |
§407
- Authorizes civil money penalties in lieu of penalties
assessed under FFDCA criminal authorities, seizure
authorities, or injunction authorities for persons who
introduce adulterated food into interstate commerce, but
not for growers; penalties may not exceed $50,000 for
individuals and $250,000 for other persons and may not
exceed $500,000 for all such violations adjudicated in a
single proceeding |
Title V - Fees
|
| Fees |
§501
- Extends EPA authorization to collect FIFRA registration
maintenance fees of $14 million annually through FY2001;
authorizes collection of an additional $2 million per
year for FY1998, FY1999, and FY2000; requires annual
full-scale audit of the reregistration fees collected and
expended |
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