Office of Pesticides
and Toxic Substances JANUARY 1990
Washington DC 20460
Office of Pesticide Programs
vvEPA Environmental
Fact Sheet
THE DBIANEY PARADOX AND NEGLIGIBLE RISK
INTRODUCTION
The U.S. Environmental Protection Agency (EPA) regulates
pesticides under two statutes, the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and the Federal Food,
Drug, and Cosmetic Act (FFDCA). Under FIFRA, EPA may license or
"register" pesticide products for sale and use in the United
States if the benefits of these uses outweigh the risks. Under
the FFDCA, EPA sets legally enforceable limits, or "tolerances",
for pesticide residues that are expected to remain in or on foods
treated with pesticides. Tolerances are set for pesticide
residues remaining in raw agricultural commodities under the
provisions of section 408 of the FFDCA, while "food additive
tolerances" are set for residues remaining in certain processed
foods under section 409 of the FFDCA.
For many years, EPA's program to regulate pesticides used on
food has been complicated by the differing statutory standards of
FIFRA and the FFDCA. Section 409 of the FFDCA contains the
"Delaney Clause", which has been especially problematic. While
EPA may make other pesticide registration and tolerance-setting
decisions taking into account both risks and benefits of
pesticides, the Delaney Clause bars EPA from establishing a food
additive tolerance for pesticide residues in certain processed
food if there is evidence that the pesticide may cause cancer in
man or animals, no matter how small the risk or how large the
benefits. The conflicting "zero risk" standard embodied in the
Delaney Clause has hindered the overall progress of EPA's
pesticide reregistration and food safety programs, as explained
further below.
Based on recommendations of the National Academy of
Sciences, EPA has adopted a new approach to setting food additive
tolerances which partly overcomes the inconsistency between the
scientifically obsolete Delaney Clause and both FIFRA and the
rest of the FFDCA. As described in a policy statement issued by
EPA in October 1988, whenever possible, the Agency will use a
"negligible risk" standard rather than the zero risk standard set
forth in the Delaney Clause. EPA plans to apply this approach as
it proceeds with its reregistration and tolerance reassessment
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programs, and is developing legislative initiatives to make
clear, consistent standards explicit in our pesticide and food
safety lavs.
BACKGROUND
The inconsistent standards in our current laws—what the
National Academy of Sciences has called the "Delaney paradox"--
have been a source of difficulty and confusion for pesticide
regulators and the general public alike for many years. The
paradox occurs because the regulatory standard which EPA is
required to apply in establishing pesticide tolerances under
section 409 of the FFDCA is different from the standards that
apply under FIFRA and section 408 of the FFDCA. FIFRA
specifically directs the Agency to balance pesticide risks and
benefits in making registration and other regulatory decisions.
Similarly, under section 408 of the FFDCA, EPA gives appropriate
consideration to the necessity for the production of an adequate,
wholesome and economical food supply in setting tolerances for
raw agricultural commodities. Thus, both FIFRA and section 408
of the FFDCA require consideration of the benefits of pesticide
use as well as the risks.
By contrast, the Delaney Clause set forth in section 409 of
the FFDCA, which applies when setting tolerances for pesticide
residues that concentrate in processed food products (often
called "food additive tolerances'1) says that, "no additive shall
be deemed safe [and therefore no food additive tolerance may be
set] if it is found to induce cancer when ingested by man or
animal, or if it is found, after tests which are appropriate for
the evaluation of the safety of food additives, to induce cancer
in man or animal..." Literally interpreted, the Delaney Clause
sets a "zero risk" standard for pesticides that induce cancer
responses in test animals, even if the risk to humans is
inconsequential because the oncogenic potential of the pesticide
is weak and/or human exposure is very low.
The Delaney Clause became increasingly problematic for EPA
in cases where pesticides were found to meet the risk/benefit
test of FIFRA, but not the Delaney standard. In reviewing
existing pesticides, questions about applying the Delaney Clause
arose in two types of instances. First, in some cases, new risk
data have indicated that a pesticide with previously approved
registrations and food additive tolerances induces tumors in test
animals. Second, in other instances, newer, more sophisticated
testing techniques have allowed EPA to detect low levels of
pesticide residues that previous analytical methods could not
detect. These new residue data have indicated a need for food
additive tolerances for certain uses of pesticides that are known
to induce some degree of tumor response in laboratory animals.
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EPA has questioned the appropriateness of a strict
application of the Delaney Clause for a number of reasons. For
example, pesticide uses that result in residues requiring food
additive tolerances (for example, in tomato paste) do not
necessarily pose risks that are greater than pesticide uses that
result in residues requiring only regular section 408 tolerances
(for example, on fresh tomatoes). Also, when a pesticide has
shown only a marginal carcinogenic effect in a.high dose animal
study, or when study results conflict, EPA has questioned whether
a strict, retroactive application of the Delaney Clause would in
fact serve to promote the overall safety of the food supply.
In reviewing new pesticides and new uses of "old"
pesticides, EPA has in the past consistently applied a rigorous
interpretation of the Delaney Clause. However, in instances such
as those described above, where new test data required by EPA on
older pesticides have raised questions about the retroactive
application of the Delaney Clause, the Agency has deferred making
chemical-specific decisions, to date. The effect overall is to
seriously hamper the Agency's ability to make sound decisions in
conducting the pesticide reregistration and tolerance
reassessment programs.
HAS REPORT AND RECOMMENDATIONS
In 1985, EPA commissioned the National Academy of Sciences
(HAS), an expert, non-governmental body, to examine the
scientific and regulatory implications of the varying food safety
standards contained in FIFRA and the Delaney Clause of the FFDCA.
The HAS report, Regulating Pesticides in Food; The Delanev
Paradox, issued on May 20, 1987, was the result of this study.
The NAS study report reached four principal conclusions:
1. All pesticides should be regulated on the basis of a
consistent standard, so that there is no "double standard"
for raw vs. processed foods or for old vs. new pesticides.
2° A uniform "negligible risk" rather than a "zero risk"
standard for carcinogens in food, consistently applied,
would best enable EPA to improve the overall safety of the
food supply, and would result in only modest reductions in
the benefits of pesticide use to farmers.
3. EPA should set its regulatory priorities by focusing
first on the most worrisome pesticides used on the most-
consumed crops.
4. The Agency should adopt a comprehensive analytical
framework for forecasting the broad-scale impact of its
pesticide-specific regulatory actions on the overall safety
of the food supply.
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4
EPA POLICY STATEMIMT
In response to the HAS report, EPA published in the Federal
Register on October 19, 1988, the policy statement, "Regulation
of Pesticides in Food: Addressing the Delaney Paradox." A
point-by-point summary follows.
EPA Response to NAS Conclusions 1 and 2
Ideally, in the absence of Delaney Clause constraints, EPA
would evaluate and reevaluate all pesticides, old and new,
according to a uniform risk/benefit standard. Pesticide residues
in food would be considered in terms of the risks they present—
based on their toxicity and anticipated dietary exposures—rather
than according to the form of the food bearing them.
However, due to the specific language of the Delaney Clause,
EPA cannot take the ideal approach in regulating pesticide uses
that come under the purview of FFDCA section 409. Only a
legislative change would allow EPA to implement fully its favored
approach and the recommendations of the NAS.
As a matter of policy, however, EPA no longer considers the
Delaney Clause an absolute bar to issuance of food additive
tolerances under section 409 of the FFDCA. The Agency is now
interpreting the Delaney Clause according to the de minimis
principle of law, which holds that an administrative agency
ordinarily has the inherent authority to avoid applying the terms
of a statute literally when to do so would yield pointless or
absurd results. EPA's position is that the Delaney Clause is
subject to a de minimis interpretation when the human dietary
risk from residues of a pesticide is at most negligible.
NAS recommends such use of a uniform negligible risk
standard rather than a zero risk standard for carcinogens in
food, but does not define "negligible risk". However, the NAS
report does refer to past practice of both the Food and Drug
Administration (FDA) and EPA. In cases where a quantitative risk
estimate has been made, both agencies have generally used an
upper-bound incremental lifetime risk on the order to 10
(0.000001 or 1 in a million), calculated using conservative risk
assessment techniques as a benchmark. EPA's October 1988 notice
therefore stated that its negligible risk policy would generally
aPPly ^° risks of 10"6 or less, allowing for some variability in
risk levels depending on the quality and strength of the data
underlying the risk assessment.
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EPA's use of negligible risk standard will affect different
categories of pesticides, as follows. (See also Table I
attached.)
1. Pesticides Posing No Cancer Risk - EPA will continue to
issue registrations under FIFRA and set tolerances under
sections 408 and 409 of the FFDCA, provided that these
pesticides meet all other FIFRA criteria; EPA generally
will not scrutinize the benefits of these pesticides,
consistent with current practice; benefits will be assumed
from the applicant's willingness to bear the cost of
supporting the registration.
2c Pesticides Posing Negligible Cancer Risk - EPA will
treat negligible risk as essentially no risk, proceeding as
in 1 above to issue registrations under FIFRA and to set
both section 408 and section 409- tolerances under the FFDCA.
This represents a change in policy in that EPA will now use
a negligible risk standard rather than a literal zero risk
standard to set food additive tolerances under section 409
of the FFDCA.
3. Pesticides Posing Greater than Negligible Risk - EPA
will continue to register such pesticides and issue relevant
section 408 raw agricultural commodity tolerances if the
benefits of these uses exceed their risks. However, under
current law, EPA cannot and will not issue section 409 food
additive tolerances for these pesticides, regardless of the
benefits they afford.
EPA Response to NAS Conclusion 3
NAS' recommendation that EPA focus its energies on reducing
risk from the most worrisome pesticides used on the most-consumed
crops is reflected in the Agency's priority system for reviewing
old pesticides. Priorities for reregistration review have been
set according to a scheme which groups pesticides that are used
©n similar crops. This scheme is designed to address first those
high volume uses which present the greatest potential risks.
Therefore, reregistration reviews for most of the major food use
pesticides in the U.S. are already underway.
EPA Response to NAS Conclusion 4
EPA is also taking steps to develop new analytical tools
that will help us implement the fourth NAS recommendation—that
EPA should develop improved tools and methods to estimate more
systematically the overall impact of prospective regulatory
actions on the safety of the food supply.
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For example -, EPA has laid the groundwork for tolerance
reassessment by requiring pesticide registrants to submit up-to-
date test data where studies are missing or inadequate. In
addition, the Agency has developed a computerized Dietary Residue
Exposure System (DUES), which enables EPA to assess the dietary
risks of pesticides with much more sophistication than has
previously been possible. As resources permit, EPA hopes to
obtain more and better data on actual pesticide residues in food
and on food consumption patterns. Using these data, EPA will be
able to improve its pesticide risk assessments.
LEGISLATIVE INITIATIVES
Working with the Department of Health and Human
Services/Food and Drug Administration and the Department of
Agriculture, EPA is developing concrete legislative proposals to
implement the President's Food Safety Plan, a set of needed, far-
reaching pesticide regulatory reforms announced by President Bush
in October 1989. A key element of this plan is harmonization of
the legal standards that EPA uses in evaluating the safety of
pesticide residues in food. The plan calls for use of a
consistent negligible risk standard in evaluating the safety of
pesticide residues in both raw and processed foods. Appropriate
changes in the FFDCA and FIFRA currently are being drafted to
implement these and other provisions of the President's plan,
including enhanced EPA suspension and enforcement authorities and
streamlined cancellation procedures.
Additional information is available from EPA on the
provisions of the Bush Food Safety Plan and on the current status
of relevant legislation.
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TABLE I - REGULATORY OUTCOMES
OUTCOMES UNDER OLD AND NEW POLICIES
CANCER RISK
LEVEL
NEED 409
CLEARANCE?
ACTION
UNDER FFDCA
(NEW POLICY)
ACTION
UNDER FIFRA
(NEW POLICY)
COMPARISON
TO PRIOR
POLICY
No risk
No
Issue 408
tolerance
Register
Same
Yes
Issue 408,
409 tolerances
Register
Same
Negligible No
cancer risk
Issue 408
tolerance
Register
Same
Yes
Issue 408,
409 tolerances
Register
Changed:
Under old
policy, EPA
would have
refused to
issue 408,
issue 409,
or
register
Greater than
negligible
cancer risk
No
Issue 408
tolerance if
benefit out-
weighs risk
Register
if. benefit
outweighs
risk
Same ,
Yes
Refuse to
issue 409
because of
Delaney;
refuse to
issue 408
because 409
barred
Refuse to Same
register
because of
lack of
needed
FFDCA clearances
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