EPA 730-N-98-008
                  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                WASHINGTON, D.C. 20460
                              ,    -     . .         -               -.          OFFICE OF
 Fax-On-Demand                                                        PREVENTION, PESTICIDES AND
 Telephone: (202)401-0527                                                    TOXIC SUBSTANCES
 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)(l)(C)j. 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 objection be
 accompanied by a filing fee of $3,275 [40 CFR § 180.33(1)].  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.                                                  -.   -':.
           Recycled/Recyclable . Printed with Vegetable Oil Based Inks on 100% Recycled Paper (40% Postconsumer)

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       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.
                                          larcia E. MulKey, Director
                                        Office of Pesticide Programs

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