United States
Environmental Protection
Agency
Office of Enforcement
& Compliance Assurance
Washington, DC 20460
EPA 305-F-00-006
October 2000
www.epa.gov
A T**°Tr*HT~^
Ag Center
Helping Agriculture Comply with
Environmental Requirements
FOCUS ON
Review of Pesticides and
Pesticide Registrations
The Food Quality Protection Act (FQPA) of 1996 amended the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA).
These amendments fundamentally changed the way EPA regulates pesticides. FQPA:
• mandates a single, health-based standard for all pesticides in all foods
' provides special protections for infants and children
* expedites approval of safer pesticides
* creates incentives for the development and maintenance of effective crop protection tools
for American farmers
* requires periodic re.'evaluation of pesticide registrations and tolerances to ensure that the
scientific data supporting pesticide registrations wiU remain up to date in the future.
This fact sheet will help you understand the law regarding reviews of pesticides and pesticide
registrations.
Issue: Periodic Review of
Pesticide Registrations
Previous law and practice
Under amendments to FIFRA enacted
in 1988, EPA is reviewing all pesticides
first registered before
November 1984 and their associated
tolerances (maximum limits for pesticide
residues in foods). This review would
bring the science base supporting
registrations and tolerances up to
current standards, on a one-time-only
basis.
-------
EPA must complete
reassessment of 33
percent of tolerances
by August 1999, 66
percent by August
2002, and the
remaining tolerances by
August 2006.
FQPA
FQPA requires EPA to reassess all
tolerances and tolerance exemptions
that were in effect when the law was
passed in August 1996.
In addition to requiring tolerance
reassessments, the law requires EPA to
establish a system for periodic review of
all pesticide registrations, aimed at
updating them on a 15-year cycle. If new
data are needed for these reviews, or for
any other review, EPA may require
them at any time under FIFRA's "data
call-in" authority in Section 3 (c) (2) (B).
What does this mean?
The goal of this requirement is to ensure
that all pesticides continue to meet
up-to-date standards for safety testing,
public health, and environmental
protection.
Within 10 years, EPA must reassess all
existing tolerances, considering
pesticides that appear to pose the
greatest risks first, to ensure that they
meet FQPA's new safety standard. EPA
retains authority to require data and
take action if needed in the interim, but
at a minimum, registrations should be
updated on a 15-year cycle.
In completing each review of a
registered pesticide's human health and
environmental effects, the Agency
makes changes to the pesticide's
registration where necessary to reduce
risks. EPA's evaluation and regulatory
changes are summarized in a Re-
registration Eligibility Decision (RED).
Of the 612 pesticide cases (or groups of
related active ingredients) subject to re-
registration, EPA had issued a total of
198 REDs as of September 30, 1999. An
additional 231 cases have been
voluntarily cancelled, leaving 192 REDs
to be completed. (To obtain REDs and
fact sheets, see www.epa.gov/REDs)
Accomplishments since FQPA
EPA is using the re-registration program
to accomplish tolerance reassessment,
the cornerstone of the FQPA. Through
re-registration, the Agency is making
decisions on the future of both existing
tolerances and pesticide registrations.
As required by FQPA, EPA reassessed
3,290 tolerances by July 30, 1999,
surpassing the 33 percent goal for
August 1999.
Since FQPA was enacted, EPA has
completed 48 post-FQPA REDs, 33 for
pesticides with food uses. Seven of
these were voluntary cancellations, and
all include measures to reduce risks and
improve the safety of the uses that were
Ag Center Fact Sheet Series
Agrichemicals/Food Quality Protection Act - Review
Page 2
-------
Agrichemicals
EPA is involving
stakeholders in an
ongoing dialogue about
the best ways to protect
human health and the
environment while
streamlining
registration procedures.
allowed to continue. Tolerances for the
chemicals that are eligible for re-
registration have been found to meet
the FQPA safety standard either with
modifications or as they stood.
Issue: Review of Antimicrobial
Pesticides
Previous law and practice
There were no special provisions for
antimicrobial pesticides under previous
law. EPA and FDA shared
responsibilities for some products, and
EPA reviewed applications consistent
with Agency priorities, resources, and
the timing of submissions.
FQPA
The law reforms the antimicrobial
registration process, with the goal of
achieving significantly shorter EPA
review times. It also amends the
definition of pesticide under FIFRA to
exclude liquid chemical sterilants, which
are to be regulated exclusively by FDA.
What does this mean?
EPA has made significant changes in the
way it manages antimicrobial
registration activities. EPA has greatly
reduced the backlog of applications for
registration activity, and is processing
registration submissions more quickly
than in the past.
EPA has also taken major steps to
address the proliferation of unregistered
"treated articles," such as cutting boards
and kitchenware, that make unlawful
pesticidal claims and could lead to
increased public health risks.
Issue: Expediting Review of Safer
Pesticides
Previous law and practice
While there were no comparable
provisions in previous law, EPA has
established policies that give priority to
applications for pesticides that meet
reduced risk criteria.
FQPA
The law requires EPA to develop
criteria for reduced-risk pesticides, and
expedite review of applications that
reasonably appear to meet the criteria.
What does this mean?
FQPA formalized the expedited review
for reduced-risk pesticides. EPA
published the review process as Pesticide
Registration Notice 97-3 on September
4, 1997.
The reduced-risk program, together with
a streamlined registration process for
biopesticides, has resulted in dozens of
new "safer" products being introduced
into the marketplace, providing greater
protections to human health and the
environment, and clear benefits to
growers and homeowners.
For more information
You can find more information about
antimicrobials at
http://www.epa.gov/oppfeadl/fqpa, and
http://www.epa.gov/oppadOO 1,
or on food safety at
http://www.epa.gov/agriculture/tfsy.html
Ag Center Fact Sheet Series
Page 3
-------
Agrichemicals
The Ag Center
welcomes
comments on this
document and its
other services.
For more facts about compliance, call
the Ag Center's toll-free number,
I -888-663-2155. Materials can be sent to
you by fax or by mail, or you can talk to
an Ag Center representative. For a list
of all publications available from the Ag
Center, request document number
10001, "Ag Center Publications."
National Agriculture Compliance
Assistance Center
901 N. 5th Street
Kansas City, KS 66 1 0 1
Toll-free:
Internet:
Fax:
1-888-663-2155
www.epa.gov/agriculture
913-551-7270
United States Environmental
Protection Agency
Washington, DC 20460
Ag Center Fact Sheet Series
Page 4
------- |