[Federal Register Volume 59, Number 35 (Tuesday, February 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-3758]
[[Page Unknown]]
[Federal Register: February 22, 1994]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-300224A; FRL-4751-3]
Abandoned and Incomplete Pesticide Petitions; Policy Statement
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: EPA is announcing that it will subject to a final review all
pesticide petitions for tolerances, exemptions from the requirement of
a tolerance, and food or feed additive regulations currently pending
with the Agency where the petitioner has failed to respond to a notice
of deficiency within 75 days of receipt of the notice. At the time of a
final review, pesticide petitions that do not provide sufficient
evidence for the Agency to find that the tolerance or exemption is
protective of the public health will be denied. The policies reflected
in this Statement will be applied by the Agency on a case-by-case
basis.
DATES: The policies announced in this Statement are currently in
effect.
FOR FURTHER INFORMATION CONTACT: By mail: James A. Tompkins or Melissa
L. Chun, Registration Division (7505W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location and telephone numbers: 6th Fl., Westfield Building,
2800 Crystal Drive, Arlington, VA 22202, (703)-308-8358 (Tompkins) or
(703)-308-8318 (Chun).
SUPPLEMENTARY INFORMATION:
I. Introduction
In the Federal Register of September 4, 1991 (56 FR 43759), EPA
issued a Policy Statement concerning its procedures for reviewing
petitions for tolerances, exemptions from the requirement of a
tolerance, and food or feed additive regulations under section 408 or
409 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (as amended).
In the Statement, EPA said it would subject certain pesticide petitions
to a final review unless, within a specified period, the petitioner
submits the necessary data or a reasonable timetable for supplying data
to correct deficiencies. Additionally, EPA announced that it would
subject all other pending and future petitions to such a final review
annually. If, at the time of any final review, there is insufficient
scientific data before the Administrator to establish a tolerance,
exemption from a tolerance, or a food or feed additive regulation
capable of protecting the public health, the petition will be denied.
EPA received comments from the Mobay Corp. (Mobay) in response to
the Policy Statement. This notice clarifies the intent of the previous
policy statement and responds to the comments. Mobay's primary concern
appeared to be that EPA would deny petitions simply for failure to
comply with timeframes for responding to notices of deficiency or for
submitting data, but this was not EPA's intent, and the timeframes
outlined in the Statement are for etablishing internal administrative
guidelines for final rulings on petitions.
II. Background and Clarification of Policy
EPA is responsible for processing tolerance petitions for residues
of pesticides in or on raw agricultural commodities under section 408
of the FFDCA and petitions for food additive regulations for residues
of pesticides in or on processed food or feed under section 409 of the
FFDCA. Under section 408(d) of the act, the Administrator may establish
a tolerance or an exemption from the requirement of a tolerance for a
raw agricultural commodity upon the request of a person who has
submitted an application for registration of a pesticide under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Under
FFDCA sec. 408(e), the Administrator may on his or her own initiative
or upon the request of an interested person, establish a tolerance or
an exemption from the requirement of a tolerance. Under FFDCA sec.
409(c), the Administrator may establish a food additive regulation for
pesticide residues in or on food or feed upon the request of any
person, or the Administrator may deny a petition.
Over the last 20 years, EPA has accumulated a large inventory of
pending petitions for pesticide tolerances, exemptions from the
requirement of a tolerance, and food or feed additive regulations
(hereafter referred to collectively in this notice as ``pesticide
petitions''). By the end of 1989 the Agency had in its inventory
approximately 1,000 pending petitions. Although the Agency has reviewed
750 of these petitions and notified the petitioners that these
petitions lack sufficient data to establish the requested tolerance,
exemption or food or feed additive regulation, petitioners have failed
to respond in the case of 386 petitions. As a matter of course, EPA has
treated such deficient petitions as pending until the petitioner either
provides the required information or withdraws the petition.
Until the petitioner provides EPA with the required data, the
Agency cannot establish an exemption from the requirement of a
tolerance or establish a tolerance above zero for the use described in
the petition. While it may establish zero tolerances, EPA is reluctant
to do so for the uses described in the hundreds of deficient pesticide
petitions. Use of the zero tolerance concept for so many deficient
pesticide petitions would cause the Agency to establish hundreds of
unnecessary tolerances and clutter the tolerance regulations.
EPA's former policy, which allowed deficient pesticide petitions to
remain extant, and its general reluctance to establish unnecessary zero
tolerances have resulted in a backlog of hundreds of pending petitions.
This backlog has created serious administrative problems for the
Agency. (See 56 FR 43759; Sept. 4, 1991.) To alleviate these problems,
EPA has revised its internal administrative procedures for reviewing
pesticide petitions.
To restate and clarify the policy announced, the Agency requested
that petitioners who had filed petitions that had been pending with EPA
for 5 years or more and for which 4 years had passed since the
petitioner has responded to the Agency's last correspondence to provide
the Agency with a reasonable timetable within 75 days of that notice
for submitting the missing information. If the petitioner did not
respond to the notice, submitted a response found inadequate, or
requested that the petition be reviewed ``as is,'' the Agency announced
that it would generally exercise its discretion and subject the
petition to a final review. EPA may make internal policy decisions,
such as when to subject a pesticide petition to a final review, on a
case-by-case basis. In the Policy Statement, EPA identified in a table
those petitions for which it was requesting some response within 75
days.
In addition, for all other pending and future petitions, as soon as
the Agency identifies a petition as being deficient, the Agency will
notify the petitioner, either by letter or by notice in the Federal
Register, requesting that the petitioner respond within 75 days by
providing a reasonable timetable for supplying the Agency with the
needed data. If the petitioner demonstrates in his or her response that
it will supply the data to the Agency within a reasonable period of
time, the Agency may in its discretion postpone a final review.
However, if the petitioner does not respond or does not respond
adequately, EPA will generally schedule a final review of the petition.
If at the time of any final review there are insufficient
scientific data before the Administrator to establish a tolerance,
exemption from a tolerance, or a food or feed additive regulation
capable of protecting the public health, the petition will be denied.
III. Response to Mobay's Comments
A. Authority to Deny Petitions Under Section 408 of FFDCA.
Mobay comments that unlike FFDCA sec. 409(c)(1)(B), the FFDCA
provides the Agency with no authority to deny petitions submitted
pursuant to section 408(d) or 408(e) of the act.
EPA disagrees with Mobay's conclusion. First, section 408(e) of the
FFDCA states that on its own initiative or upon request by an
interested person, ``the Administrator may *** propose the issuance of
a regulation establishing a tolerance'' or an exemption from a
tolerance requirement. Proposal of a tolerance under FFDCA sec. 408(e),
even one requested by interested persons, is entirely discretionary to
the Administrator. If the Agency is free not to propose a requested
tolerance, it is also permitted to deny such a requested tolerance.
According to the Court in Nader v. EPA, ``[s]o deferential is
subsection (e) that the Administrator is not only free to deny the
requested regulation, she need not even propose it. See 40 CFR
Sec. 180.29(a) (1987).'' 859 F.2d 747, 752 (d.c. Cir. 1988).
Further, although the FFDCA does not provide explicit authority for
denial of section 408(d) petitions, neither does it or its legislative
history discuss whether EPA may deny pesticide petitions that do not
provide sufficient information to establish a tolerance or exemption
capable of protecting the public health. Due to Congress' silence on
this precise issue, any reasonable interpretation that is consistent
with the purpose of the statute is valid. Chevron v. EPA, 467 U.S. 837,
842-844 (1984). See also Young v. Community Nutrition Institute, 476
U.S. 974, 981-982 (1986). Even while Mobay argues against EPA's denial
authority, it admits that denial is a reasonable means for responding
to what it has classified as ``abandoned'' section 408 petitions.
B. Basis for Denial of Section 408 or 409 Petitions
Mobay argues that, even if there is an implicit authority ``to deny
petitions for tolerances under section 408(b), EPA cannot deny a
petition on the basis of administrative convenience and to enhance the
Agency's revenues.'' Mobay also maintains that EPA may deny a petition
for a food additive regulation under section 409 of the FFDCA only if
the scientific data ``fails to establish that the proposed use of the
food additive *** will be safe *** or shows that the proposed use of
the additive would promote deception of the consumer ***.''
Contrary to Mobay's conclusion, EPA does not intend to deny
petitions for administrative convenience or to raise revenues. Rather,
EPA is changing its internal procedures for reviewing pesticide
petitions due to the large number of petitions still pending with the
Agency. EPA will be reviewing the pending petitions identified in Table
1 of the Policy Statement (56 FR 43759; Sept. 4, 1991). In addition, it
will attempt to make a final review of all other pending and future
petitions after 75 days from the receipt of the notice of deficiency if
EPA receives no response or an inadequate response from the petitioner,
or if the petitioner requests that EPA review the petition ``as is.''
Subsequent to such reviews some petitions will be denied where there is
insufficient information for the Agency to find that the proposed
tolerance or exemption is protective of the public health. However, at
no time will pesticide petitions be denied for administrative
convenience or to raise revenues.
C. The Impact of Denial of a Petition Versus Setting a Zero Tolerance
Mobay disagrees with the Agency's position that denial of a
tolerance petition is equivalent, for practical purposes, to setting a
zero tolerance. Mobay provided no explanation as to how the two actions
could have a different impact from a petitioner's perspective.
EPA believes there is no functional difference between the denial
of a petition and establishing a zero tolerance. A commodity bearing a
pesticide residue for which a tolerance has been denied or for which a
zero tolerance has been established would be considered unsafe under
section 408 of the FFDCA and adulterated under section 402(a)(2)(B) of
the FFDCA. No rights or burdens would be created, imposed, or removed
by denying a petition rather than setting a zero tolerance. The legal
and practical implications of both actions are the same.
D. Compliance With Rulemaking Procedures Set Forth in the
Administrative Procedures Act (APA)
Mobay states that ``EPA's decision to deny petitions under Sections
408 and 409 of the FFDCA if a petitioner either fails to (1) respond to
EPA's notice of deficiency within 75 days, or (2) supplement the data
within a 4 year time period is clearly a rule under the Administrative
Procedure Act (APA).'' According to Mobay, EPA's intended action is a
substantive rule requiring compliance with the notice and comment
opportunities provided in section 553 of the APA because EPA's intended
action is of future effect and of general applicability, and acts as an
amendment to 40 CFR 180.7(d) which ``provides a petitioner with an
indefinite period of time to supplement a deficient petition after
notification of deficiencies.''
Contrary to Mobay's assertions, EPA's publication of this policy is
designed to establish internal guidelines for identifying ``stale''
petitions that require formal action. It does not affect any rights of
petitioners or bind EPA's discretion. EPA is not under any obligation
to publish for comment its internal guidelines for review of petitions
and could at any time, and at its sole discretion, take formal action
denying a petition failing to meet statutory criteria.
EPA does not, as Mobay assumed, intend to deny petitions for
failure to comply with the 75 day or 4 year timeframes. As previously
mentioned, these timeframes are internal guidance as to when a petition
is probably stale and thus should be considered for formal action
removing it from the pending status. Any formal action will be based on
the applicable statutory criteria.
This policy does not amend the EPA regulation which allows
petitioners to supplement deficient petitions. While 40 CFR 180.7(d)
permits a petitioner to correct a deficiency prior to filing, nothing
in that section prescribes when EPA can or must make a decision on a
pesticide petition that has been filed. Neither the statute nor
regulations in 40 CFR part 180 give a petitioner the right to maintain
a deficient petition before the Agency indefinitely. In fact, FFDCA
sec. 408 anticipates EPA final action on petitions in 180 days, a
considerably shorter timeframe than those outlined in this policy for
scheduling a final review. The goal of reviewing petitions within 4
years and the proposed internal procedure of sending deficiency notices
with a request for a response do not affect in any meaningful way the
petitioner's ability to supplement deficient petitions. An adequate
response to the Agency's request within 75 days preserves the
petitioner's right to provide supplemental data for up to 4 years
without the Agency's taking formal action to review the petition. Given
that the statute contemplates an Agency decision within 180 days, the
Agency's policy of allowing a petition to remain extant up to 4 years
from the date EPA approves the schedule for generation of data is
reasonable, even generous.
E. Incomplete Petitions and the Potential for Error in EPA's Files
Mobay argues that the Agency has not presented any compelling
reason why incomplete versus abandoned petitions should be denied.
Further, Mobay comments that, even should the Agency have some
compelling reason to deny incomplete petitions, the inaccuracy of the
Agency's files and records is evidence that the ``potential for
erroneous decisions far outweighs any need the Agency may have to
cleanse its records.''
Mobay's comment assumes a distinction between incomplete and
abandoned pesticide petitions not made by EPA in this policy, and Mobay
does not explain the distinction. As previously noted, EPA is applying
the policy announced in this Notice to reform its internal procedures
for timing the final review of all pesticide petitions. At the point at
which EPA determines that a petition is deficient, it will notify the
petitioner. Failing an adequate response, the deficient petition will
be subject to a final review. Upon a final review, EPA will deny those
pesticide petitions which do not provide sufficient data to establish a
tolerance, exemption from a tolerance, or food or feed additive
regulation capable of protecting the public health.
Further, the potential inaccuracies in EPA's files argue in favor
of instituting this policy rather than against it. One of the main
objectives of the policy is to ensure that EPA has accurate records to
determine which pending petitions are still active and what their
deficiencies may be. The accuracy of EPA's files will be increased by
regularizing the Agency's monitoring of the status of pesticide
petitions. If EPA has made an error, then the petitioner has the
opportunity to notify EPA of the error well before a final review of
the petition.
IV. Implementation
EPA will be subjecting to a final review those pending petitions
identified at 56 FR 43759 in Table 1 of the Policy Statement for which
it received no response, an inadequate response, or a request to review
the petition ``as is.'' In addition, EPA will notify all other
petitioners of any deficiencies in their petitions and allow 75 days to
respond to the notification. EPA will attempt to make a final review of
all other pending and future petitions after 75 days from the receipt
of the notice of deficiency if EPA receives no response or an
inadequate response from the petitioner, or if the petitioner requests
that EPA review the petition ``as is.'' If EPA determines, upon a final
review, that a petition does not include sufficient information to find
that the requested tolerance or exemption from a tolerance is
protective of the public health, it will notify the petitioner by
letter or FR notice that the petition is being denied.
V. Format of Submissions
A. Request to Withdraw a Pesticide Petition
All requests to withdraw a pesticide petition should be submitted
on company letterhead and specify the pesticide petition number which
the Agency assigned to the petition, the active ingredient of the
chemical, and the raw agricultural commodities and food or feed items
involved.
B. Requests to Retain Petitions
All requests to retain a pesticide petition should be submitted on
company letterhead and specify the pesticide petition number which the
Agency assigned to the petition, the active ingredient of the chemical,
and raw agricultural commodities and food or feed items involved. The
request should contain a timetable listing data deficiencies identified
by EPA letters and the date the company expects to submit these data.
This timeframe should not exceed a 4-year period.
C. Where to Send Requests
All requests should be submitted to the following address: Front
End Processing Staff, Registration Division (7505C), 401 M St., SW.,
Washington, DC 20460.
List of Subjects
Environmental protection, Agricultural commodities, Food additives,
Feed additives, Pesticides and pests.
Dated: December 23, 1993.
Stephen L. Johnson,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 94-3758 Filed 2-18-94; 8:45 am]
BILLING CODE 6560-50-F