Fax-On-Demand
Telephone: (202)401-0527
Item: 6117                       

                                   8/24/98

                   PESTICIDE REGISTRATION (PR) NOTICE 98-8

               NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS
                    AND REGISTRANTS OF PESTICIDE PRODUCTS

ATTENTION:     Persons Responsible for Registration of Pesticide Products

SUBJECT:       Waiver of Fees Associated with Tolerance Objections

     This notice clarifies EPA's policy with respect to waivers of fees associated with filing
objections to tolerance actions under the Federal Food, Drug, and Cosmetic Act (FFDCA).  

I.   BACKGROUND
     
     Section 408(m) of the FFDCA gives EPA broad authority to require the payment of
fees in connection with the performance of the Agency's responsibilities with regard to
pesticide residues under section 408.  The statute specifically authorizes EPA to require that
fees be paid for the "acceptance for filing of objections" to final tolerance rulemaking actions 
[Section 408(m)(1)(C)].  Section 408 gives affected parties the right to file objections and
request an adjudicatory hearing in response to various final actions on tolerances or tolerance
petitions.  EPA is also authorized to waive any fee requirement "when in the judgment of the
Administrator such a waiver or refund is equitable and not contrary to the purposes of this
subsection."

     As authorized by the statute, EPA's regulations require that an objections be
accompanied by a filing fee of $3,275 [40 CFR  180.33(I)].  These regulations further
provide EPA with broad discretion to waive the requirement for fees, including the fees for
objections.  A person seeking a waiver or refund of any fee is required to submit such request
in writing to EPA.  Such request must be accompanied by a fee of $1,650 except that this fee
is not required of any person who has no financial interest in the action.  These fee regulations
were first promulgated by FDA and transferred to EPA when FDA's authority under section
408 was delegated to EPA. 

     In EPA's nearly 30-year history of administering the section 408 pesticide tolerance
authority, objections to tolerance actions have rarely been filed and thus objection fees rarely
submitted.  On those few occasions that fees have been submitted, they generally have been
waived or refunded by EPA under its discretionary authority.  These waivers or refunds have
been routinely granted where the objector does not have a financial interest in the matter.

     An objector to a recent tolerance action criticized EPA's tolerance fees regulations as
they pertain to objections, claiming that they imposed a barrier to public participation in the
tolerance rulemaking process for parties that did not have a financial interest in the tolerance
action.  The objector was especially concerned with "the current mandate to pay the [objection
fee] and then seek a refund."

II.  CLARIFICATION OF TOLERANCE FEES REGULATIONS

     EPA's tolerance fees regulations require that objections "shall be accompanied by a fee
of $3,275."  The regulations, however, also provide a procedure to request that EPA "waive or
refund part or all of any fee imposed by this section" [40 CFR  180.33(m)].  EPA does not
construe these provisions as requiring objectors who believe they are entitled to a waiver of
fees to file the specified fee with the objections and thereafter seek a refund.  Rather, such a
person may file a written request for a waiver of the objection fee with the objection.  A fee of
$1,600 must accompany the waiver request unless the objector has no financial interest in the
matter objected to.  If EPA later determines that a fee waiver is inappropriate, that
determination will not affect the timeliness of the filing of the objections; however, further
action on the objections will not proceed until the fee has been paid.  Failure to pay the fee
following denial of a waiver would be grounds for denial of the objections.  

     EPA believes this clarification of its tolerance fees regulations should alleviate any 
concern that EPA's regulations stand as a barrier to public participation in tolerance
rulemaking.    

III. FOR FURTHER INFORMATION

     For further information, contact Jim Tompkins at 703-305-5697 or at
tompkins.jim@epa.gov.

                              /signed by Marcia E. Mulkey/

                              Marcia E. Mulkey, Director
                              Office of Pesticide Programs