Note: This information is provided for reference purposes only.
Although the information provided here was accurate and current
when first created, it is now outdated.
Staff Background Paper # 1
LEGAL FRAMEWORK FOR OP TOLERANCE
The reassessment of organophosphate (OP) tolerances must take place within
the legal framework established by the Food Quality Protection Act of 1996
in the new section 408 of the FFDCA. Specifically, the new section 408 contains
the following provisions:
A tolerance is a regulation that establishes a legal limit for the amount
of residues of a pesticide chemical that may be in or on food. Food may not
be lawfully sold or distributed in commerce if it contains pesticide residues
in excess of an established tolerance.§§ 408(a)(1) and a(4).
As a general matter, tolerances are established, modified, or revoked through
a rulemaking process that provides notice and an opportunity for public comment
on the proposed action. §§ 408(d) and (e).
A regulation establishing, modifying, or revoking a tolerance becomes effective
upon publication unless the regulation specifies otherwise. Within 60 days
after a regulation is published, any person may challenge the regulation
by filing objections with EPA. These objections may include a request for
a hearing. As soon as practicable, EPA must rule on the objections and, if
appropriate, modify the regulation. § 408(g). The regulation thereafter
becomes reviewable in the U.S. Courts of Appeal if there are any further
challenges. § 408(h).
THE REQUIREMENT TO REASSESS TOLERANCES:
EPA must reassess, before August 3, 2006, all tolerances that were in effect
on August 2, 1996. This reassessment is to take place in 3 stages: EPA must
reassess 33 percent of the tolerances by August 3, 1999; another 33 percent
by August 3, 2002; and the remaining 34 percent by August 3, 2006. §
In determining which tolerances to review first, EPA is directed to give
priority to those tolerances that appear to pose the greatest risk to human
health. § 408(q)(2).
The purpose of tolerance reassessment is to determine whether existing tolerances
meet the new safety standard in section 408. § 408(q)(1).
By the reassessment deadline, EPA must issue regulations under section 408
to modify or revoke tolerances that do not meet the safety standard.
THE NEW SAFETY STANDARD:
Section 408 now provides that EPA may "establish or leave in effect a tolerance
... only if [EPA] determines that the tolerance is safe." §
EPA can find that a tolerance is safe only if it determines "there is a
reasonable certainty that no harm will result from aggregate exposure to
the pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information." §
FACTORS TO CONSIDER IN TOLERANCE REASSESSMENTS:
Section 408(b)(2)(D) identifies a number of factors that must be considered
in determining whether a tolerance is safe, including available information
concerning the cumulative effects of the pesticide under investigation "and
other substances that have a common mechanism of toxicity." §
Another factor to consider is available information concerning aggregate
exposure to the pesticide chemical and to other related substances, including
all dietary exposure to the chemical and exposure from other non-occupational
sources. § 408(b)(2)(D)(vi).
OTHER ISSUES TO CONSIDER:
KIDS' SAFETY - In determining whether a tolerance is safe, EPA needs to examine
information concerning any special susceptibility of infants and children
to the pesticide; the exposure of infants and children to the pesticide;
and the cumulative effects on infants and children of the pesticide and any
other substances sharing a common mechanism of toxicity. For chemicals with
threshold effects of concern (i.e., generally for most effects other
than cancer), EPA is directed to add an additional tenfold margin of safety
to take into account potential pre- and post-natal toxicity and completeness
of the data with respect to exposure and toxicity to infants and children
unless EPA determines, on the basis of reliable data, that a different margin
of safety will be safe for infants and children.§ 408(b)(2)(C).
ANTICIPATED/ACTUAL RESIDUE LEVELS - In determining whether a tolerance is
safe, EPA may consider available data on anticipated and/or actual residue
levels of a pesticide in or on food. If EPA does rely on such data, EPA must
require the submission of data five years later (and "thereafter as appropriate")
demonstrating that actual residue levels are not above the earlier levels
relied upon. § 408(b)(2)(E).
PERCENT CROP TREATED - In determining whether a tolerance is safe, EPA may
consider, when assessing chronic dietary risk, available data on the percent
of food actually treated if EPA finds that the data are reliable and provides
for the periodic reevaluation of EPA's estimate of percent crop treated.
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updated May 22, 1998