assessment criteria and concepts that had never pre-
viously been used by the Administrator and that re-
quire the development of major modifications to ex-
isting Agency practices. New regulatory concepts in-
troduced by such Act include, but are not limited to,
those associated with new statutory terms such as
‘‘exposures for which there is reliable information’’,
‘‘aggregate exposure’’, ‘‘reasonable certainty that no
harm will result’’, ‘‘common mechanism of toxicity’’,
‘‘cumulative effects’’, ‘‘potential pre- and post-natal
toxicity’’, ‘‘completeness of the data with respect to
exposure and toxicity’’, ‘‘significant subpopulation
group’’, ‘‘additional data or information [that] are
reasonably required to support the continuation of a
tolerance’’, and ‘‘pose the greatest risk to human
health’’. How these terms are defined and used by
the Administrator, singly and in combination, will
greatly affect the outcome of the assessments and
reassessments required to be conducted under the
Act as amended.
(4) The Act as amended requires the Environ-
mental Protection Agency to revoke tolerances now
in effect if the Administrator finds that the sum of
the exposure from all the tolerances exceeds safe lev-
els. However, the Act as amended does not provide
any criteria for determining which of the tolerances
should be revoked in such situations in order to re-
duce the exposure sufficiently. Nor does the Act as
amended establish procedures for providing pesticide
producers, agricultural producers, food processors
and distributors, and non-food pesticide users the
opportunity to participate in such decision making
before proposed rules are issued by the Adminis-
trator.
(5) Under the revised criteria of the Act as
amended, entirely new categories of data regarding
toxicity, metabolism, cumulative effects, and dietary,
drinking water, and other nonoccupational exposure
levels are required to allow the Administrator to
reach sound, accurate, valid, and understandable de-
cisions on tolerance assessments and reassessments.
In some areas, massive data collection efforts are
underway but will not yield results for another year
or more. In other areas, the need for new data de-
pends on decisions not yet made by the Adminis-
trator about what kinds of tests should be conducted
and which compounds should be the subjects of
these new test requirements.
(6) The Administrator has instituted public
proceedings to discuss how the new criteria of the
Act as amended should be interpreted and amended,
what new kinds of data are needed and how the new
data would be used once available, how criteria can
be made more transparent, equitable, and under-
standable, how the Administrator should use avail-
able authority to be flexible, how to decide which tol-
erances should be revoked when some action is de-
cided to be necessary, and how to provide needed
transition periods in case some existing products or
product uses should be removed from the market.
These proceedings are not yet finished and in some
cases planned public proceedings have been sched-
uled but have not yet begun.
(7) Unless the Administrator implements sec-
tion 408 of the Act as amended carefully and wisely,
decisions made under it could cause great harm to
American agriculture, to food production, food stor-
age and transportation, and related industries, and
to other business. Such decisions could reduce avail-
ability of fruits and vegetables, and other foods
known to aid human health, and could also have
highly disruptive and problematic effects on a vari-
ety of other important public and private areas such
as public health protection against insects and other
disease vectors and residential and business pest
control. A major concern is that some products will
be removed from the market that are essential in
integrated pest management programs or pesticide
resistance management programs, and that pest spe-
cies will more easily develop resistance to the fewer
remaining products that remain available.
(8) The regulatory requirements under the
Food Quality Protection Act of 1996 could have
both short and long term deleterious effects on U.S.
agricultural products as these producers move to a
free market system as envisioned by the Freedom to
Farm Act.
(9) These disruptive and harmful effects could
occur without necessarily bringing about any signifi-
cant health benefits or risk reductions. The Adminis-
trator is now engaged in making decisions on toler-
ance assessments and reassessments at the same
time that the Administrator is conducting a massive
program of policy development and reevaluation, and
while the Administrator is determining what data
would be needed under the new criteria and policies
to answer some of the new questions. If these deci-
sions on individual pesticides are issued and put into
effect before the new policies are in place or before
the needed data are available, they may be based on
outdated and overly stringent policies, worst-case as-
sumptions, or both. These actions may be accom-
panied by adverse publicity that could lead to un-
warranted concern and could effectively destroy the
marketability of products that in fact are safe.
(10) The Act as amended has caused a major
slowing of the process for approval of new pesticide
chemicals, new uses of pesticides already registered
for other uses, and applications for emergency ex-
emptions from the need for registration. This is
traceable to—
(A) the Agency’s need to develop new cri-
teria and procedures;
(B) the diversion of resources to developing
such criteria and procedures and to the reas-
sessment of existing tolerances and registra-
tions;
(C) the requirement that no new tolerance
can be issued until the Administrator deter-
mines that all existing tolerances for the pes-
ticide have been reassessed and found safe; and
(D) the priority choices and resource allo-
cation decisions that are either dictated by the
Act as amended or chosen by the Administrator
as a matter of discretion.