United States
Environmental Protection
Agency
Office of Enforcement
& Compliance Assurance
Washington, DC 20460
EPA 305-F-00-005
October 2000
www.epa.gov
Helping Agriculture Comply wilh
Environmental Requirements
FOCUS
O N
Children
The Food Quality Protection Act (FQPA) of 1996 amended the Federal Insecticide, Fungicide,
and Rodentidde 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
a provides special protections for infants and children
• expedites approval of safer pesticides
8 creates incentives for the development and maintenance of effective crop protection tools
for American farmers
8 requires periodic re-evaluation of pesticide registrations and tolerances to ensure that the
scientific data supporting pesticide registrations will remain up to date in the future.
This fact sheet will help you understand the law regarding special provisions for infants and
children, and consumer right'to-know provisions.
Issue: Special Provisions for
Infants and Chiidren
Previous law and practice
EPA is currently addressing some of the
high, priority issues identified in the
1993 National Academy of Sciences
report on "Pesticides in the Diets of
Infants and Children." The Agency
routinely assesses risks by age group,
ethnicity, and region when setting
tolerances. There was no explicit
mandate to do so under previous law,
and the data available to EPA have been
criticized as outdated and inadequate.
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EPA uses
reliable data when
considering the need
to retain, modify, or
remove the [Q'fold
additional safety
factor.
FQPA
FQPA explicitly requires EPA to address
risks to infants and children before a
tolerance can be established. The law
also provides for an additional safety
factor to ensure that tolerances are safe
for infants and children.
What does this mean?
In keeping with FQPA, each tolerance
decision issued after August 3, 1996,
contains a specific finding that the
tolerance levels are appropriately
protective of children. FQPA requires
EPA to apply an additional safety factor
of 10 during its risk assessment to
account for the potential for pre- and
post-natal toxicity, as well as for the
completeness of the toxicology and
exposure database, unless the Agency
determines that another factor is
adequately protective.
Recognizing the importance of the 10-
fold safety factor, EPA began developing
policy and implementation procedures
soon after passage of FQPA to ensure
consistent and defensible decisions.
Within 3 months, EPA sought advice
regarding the Agency's approach to this
issue. In January 1997, EPA issued
guidance that describes generally the
types of information needed to
determine whether infants and children
are especially sensitive to a chemical and
whether an additional safety factor is
needed for their protection.
More recently, an EPA task force has
considered policy issues related to the
FQPA safety factor, and EPA submitted
a revised draft policy and operational
practices for making decisions on the
safety factor for scientific peer review in
May 1999. These documents were
released in July 1999 for public review
and comment.
EPA has also updated pesticide toxicity
testing guidelines to enable the Agency
to better assess risks to infants and
children. In July 1998, EPA published
updated guidelines for animal studies on
prenatal development and reproduction,
and new guidelines on effects to the
immune system for use by registrants in
conducting such studies. These new
guidelines incorporate recommendations
from external scientific peer review.
EPA has initiated a "National Agenda
to Protect Children's Health from
Environmental Threats." EPA is
implementing several pesticide-related
recommendations published by the
Children's Health Protection Advisory
Committee:
" Reevaluate the atrazine pesticide
tolerances
•Reevaluate pesticide tolerances for
methyl parathion, dimethoate, and
chlorpyrifos
•Reevaluate the Worker Protection
Standard.
Ag Center Fact Sheet Series
Agrlchemicals/Food Quality Protection Act - Children and Consumers
Page 2
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While EPA had
general information
materials that describe
how to reduce
pesticide exposure,
developing materials
to reach consumers at
the supermarket level
was a new departure.
The Ag Center
welcomes comments
on this document and
its other services.
issue; Consumer "Right to ICnow"
Provisions
Previous law and practice
There is no comparable law or practice
at the Federal level.
The law required EPA to publish a short
pamphlet containing consumer-friendly
information on the risks and benefits of
pesticides. It includes any tolerances
that EPA has established based on
benefits considerations, and
recommendations for reducing exposure
to pesticide residues and maintaining a
healthy diet.
In addition, petitions for tolerances
must include informative summaries
that can be published and made publicly
available. The law also recognizes a
State's right to require warnings or
labeling of food that has been treated
with pesticides.
What does this mean?
EPA coordinated with the U.S.
Departments of Agriculture (USDA)
and Health and Human Services (HHS)
to accomplish this.
With advice from the Pesticide Program
Dialogue Committee and consumers,
and consultation with USD A and FDA,
EPA developed a brochure, Pesticides
and Food, to inform consumers about
pesticide use on food, government
programs that protect them from
pesticide risks, and ways they can reduce
their exposure to pesticides. The
brochure also explains how the Food
Quality Protection Act (FQPA)
increases protection of infants and
children from exposure to pesticides.
The pamphlet is available at
www.epa.gov/ pesticides/food/. This
information has been distributed as
required by FQPA to large retail grocers
for public display.
EPA has distributed more than 4 million
copies -- to 30,000 grocery stores, and to
public health officials, libraries, and the
medical community. EPA also designed
a companion Pesticides and Food web
site, which is referenced in the printed
brochure and gives consumers more
detailed information.
(www.epa.gov/pesticides/food)
For more information,
You can get online information about
FQPA at
http://www.epa.gov/oppfeadl/fqpa
and about food safety at
http://www.epa.gov/oeca/ag/tfsy.html.
For more facts about compliance, call
the Ag Center's toll-free number,
! -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. 5* Street
Kansas City, KS 66101
Toll-free: 1-888-663-2155
Internet: www.epa.gov/agriculture
Fax: . 913-551-7270
United States Environmental
Protection Agency
Washington, DC 20460
Ag Center Fact Sheet Series
Agrichemicals/Food Quality Protection Act - Children and Consumers
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