[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]


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ENVIRONMENTAL PROTECTION AGENCY
[OPP-300224A; FRL-4751-3]

 

Abandoned and Incomplete Pesticide Petitions; Policy Statement

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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