Tolerance Reassessment Advisory Committee

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 Although the information provided here was accurate and current when first created, it is now outdated.

TRAC 5/27/98

Staff Background Paper # 1

LEGAL FRAMEWORK FOR OP TOLERANCE REASSESSMENT

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:

TOLERANCES GENERALLY:

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. § 408(q)(1).
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. § 408(q)(1).

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." § 408(b)(2)(A)(I).
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." § 408(b)(2)(A)(ii).

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." § 408(b)(2)(D)(v).
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. § 408(b)(2)(F).