[Federal Register Volume 65, Number 207 (Wednesday, October 25, 2000)]
[Rules and Regulations]
[Pages 64126-64132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-27405]



[[Page 64125]]

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Part III





Environmental Protection Agency





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40 CFR Part 176



Time-Limited Tolerances for Pesticide Emergency Exemptions; Final Rule

Federal Register / Vol. 65, No. 207 / Wednesday October 25, 2000 / 
Rules and Regulations

[[Page 64126]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 176

[OPP-181051A; FRL-6749-7]
RIN 2070-AD15


Time-Limited Tolerances for Pesticide Emergency Exemptions

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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SUMMARY:  This final rule governs the establishment of time-limited 
tolerances and exemptions for residues of a pesticide chemical 
resulting from its emergency use as authorized under section 18 of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The 
purpose of this rule is to set into place a process that will ensure 
timely decisions on any tolerance related issue in response to a 
request for an emergency use of a pesticide chemical to be used in or 
on food or feed. Under this rule, EPA will implement the provisions of 
the Federal Food, Drug, and Cosmetic Act (FFDCA) related to FIFRA 
section 18 time-limited tolerances by evaluating each petition on a 
case-by-case basis to determine if adequate reliable data are available 
to make the required safety finding mandated under FFDCA section 408. 
This rule pertains only to regulatory changes resulting from the 1996 
enactment of the Food Quality Protection Act (FQPA) which amended 
FFDCA.

DATES:  This rule is effective November 24, 2000.

FOR FURTHER INFORMATION CONTACT:  For general information contact: 
Joseph E. Hogue, Office of Pesticide Programs (7506C), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9072; e-mail address: <a href="/cdn-cgi/l/email-protection#167e79716373387c79735673667738717960"><span class="__cf_email__" data-cfemail="bcd4d3dbc9d992d6d3d9fcd9ccdd92dbd3ca">[email protected]</span></a>.
    For applicability questions contact: Robert Forrest, Chief, Minor 
Use, Inerts and Emergency Response Branch (7505C), Registration 
Division, Office of Pesticide Programs, Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone 
number: (703) 308-9376; e-mail address: <a href="/cdn-cgi/l/email-protection#b8ded7cacaddcbcc96cad7daddcaccf8ddc8d996dfd7ce"><span class="__cf_email__" data-cfemail="badcd5c8c8dfc9ce94c8d5d8dfc8cefadfcadb94ddd5cc">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this final rule if you are the 
Federal government or a State or Territorial government agency charged 
with pesticide authority. Regulated categories and entities may 
include, but are not limited to:

 
------------------------------------------------------------------------
                                                         Examples of
            Category                NAICS codes     potentially affected
                                                          entities
------------------------------------------------------------------------
Federal government               9241               Federal agencies
                                                     that petition EPA
                                                     for FIFRA section
                                                     18 use
                                                     authorization
State or Territorial                                States or
 governments                                         territories charged
                                                     with pesticide
                                                     authority that
                                                     petition EPA for
                                                     FIFRA section 18
                                                     use authorization
------------------------------------------------------------------------

     This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes are provided to assist you and others in determining whether or 
not this action might apply to certain entities. If you have questions 
regarding the applicability of this action to a particular entity, 
consult Sec. 176.1 or the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-181051A. The official 
record consists of the documents specifically referenced in this 
action, any public comments received during an applicable comment 
period, and other information related to this action, including any 
information claimed as Confidential Business Information (CBI). This 
official record includes the documents that are physically located in 
the docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period, is available 
for inspection in the Public Information and Records Integrity Branch 
(PIRIB), Room 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding Federal holidays. The PIRIB telephone number is (703) 305-
5805.

II. Background

A. What Action is the Agency Taking?

    The amendments to FFDCA, as prescribed by FQPA, went into effect 
immediately upon enactment on August 3, 1996. Under these amendments, 
EPA is required to conduct all pesticide tolerance-setting activities, 
including those approved for section 18 emergency exemptions, under an 
amended FFDCA section 408 with a new safety standard and new regulatory 
procedures. In the Federal Register of June 3, 1999 (64 FR 29823) (FRL-
5750-1), EPA published, and opened for public comment, proposed 
regulations for setting time-limited tolerances for section 18 
emergency exemptions. In its proposal, EPA described its current 
emergency exemption program and the interim practices taken to evaluate 
requests for section 18 tolerances or tolerance exemptions, and to 
establish section 18 tolerances, prior to the issuance of this final 
rule.
    In the time period spanning from August 1996 to the present, EPA 
has been evaluating section 18 exemption requests and issuing 
associated tolerances or tolerance exemptions on a case-by-case basis. 
These evaluations have been determined based on materials submitted by 
Federal and State agencies in accordance with EPA guidance and interim 
procedures sent to them in September 1996 and further elaborated in 
Pesticide Registration Notice 97-1, dated January 1997, which

[[Page 64127]]

is available in the OPP Docket (see Unit I.B.2). This non-binding 
interim approach to current section 18 tolerance decisions has remained 
in place while the Agency has developed this FFDCA section 408(l)(6) 
procedural regulation.
    The June 3, 1999 proposal was strictly a procedural scheme and did 
not modify any regulatory policies associated with the approval of the 
emergency exemption itself under FIFRA. EPA proposed to establish a new 
part 176 in the CFR to house exclusively regulations governing the 
setting of time-limited tolerances for emergency exemptions. In 
summary, EPA proposed to:
    1. Review data for establishing a time-limited tolerance only after 
a section 18 request has been submitted;
    2. Evaluate each submission individually on a case-by-case basis to 
determine if adequate reliable information is available to make the 
required safety finding;
    3. Not routinely require additional data to be generated and 
instead rely on submitted data already reviewed and evaluated; and
    4. Strive to make a regulatory decision in a timely manner.
    If a tolerance could not be established then the emergency 
exemption would not be granted. Time-limited tolerances would typically 
be set for a period of 24 months to allow the treated crop from the 
previous year's emergency application to clear the channels of trade.
    In addition to the above proposed procedure, EPA solicited comments 
on several other options for addressing time-limited tolerances. One 
approach was to require a full data set to support section 18 
tolerances in the same manner as is required for the establishment of 
permanent tolerances. EPA also considered requiring a minimum data set 
in which the applicant would need to provide a specific subset of the 
data normally required to establish a permanent tolerance. Under this 
approach, the Agency would evaluate only those defined studies in 
making its safety finding. EPA did not include either approach as its 
primary option because they did not allow for timely decisions. Another 
approach for setting time-limited tolerances was suggested by the 
National Food Processors' Association. If this approach were adopted, 
EPA would not conduct a full-risk assessment for a section 18 
tolerance, but would instead assess the incremental risk of the 
proposed emergency pesticide use, that is, the amount that the proposed 
use would increase dietary risk above the risk from existing uses.

B. What is the Agency's Authority for Taking this Action?

    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' Regulations regarding 
EPA's implementation of FIFRA section 18 are codified in 40 CFR part 
166.
    FQPA amended the FFDCA by directing EPA to establish time-limited 
tolerances or tolerance exemptions for pesticide use authorized by EPA 
under section 18 of FIFRA that may result in residues in or on food or 
feed. Specifically the FFDCA section 408(l)(6) requires EPA to 
establish a tolerance or exemption from the requirement of a tolerance 
for pesticide chemical residues in or on food that will result from the 
use of a pesticide under an emergency exemption. Section 408(l)(6) also 
requires EPA to promulgate regulations governing the establishment of 
tolerances and tolerance exemptions for pesticide uses approved for 
emergency situations under FIFRA section 18. Section 408(e)(1) 
authorizes the Administrator to establish, modify, suspend, or revoke 
any tolerance or exemption from the requirement of a tolerance on her 
own initiative, and to establish general procedures and requirements to 
implement section 408. This final rule is issued under the authority of 
sections 408(e)(1)(c) and 408(l)(6) of FFDCA, as amended by FQPA.

III. Public Comment and EPA Response

    EPA received a total of 10 comments in response to its proposed 
rule. Five States, two growers groups, two pesticide manufacturing 
companies, and one public interest group submitted comments. In 
addition, the National Food Processors' Association attached its 
previously submitted petition requesting that EPA use an incremented 
risk approach to its comments. This petition, entitled ``Petition To 
Issue A Regulation Governing Establishment Of Section 18 Tolerances,'' 
was co-sponsored by 19 associated grower groups. Everyone expressed 
support of EPA's premise that timeliness and rapid review of section 18 
requests is the essence of the program. In this regard, all parties 
agreed that the Agency should only utilize ``available data in its 
section 18 tolerance reviews.''
    EPA, in addition to considering changes based on public comments, 
also made minor changes to Sec. Sec. 176.5 and 176.11(a) in the final 
rule to clarify the provisions and to conform to other regulations 
(particularly 40 CFR part 166). EPA has also changed the text of 
Sec. 176.3 slightly by changing ``a State, U.S. Territory, or Federal 
agency'' to ``any entity, authorized under section 18 of FIFRA to 
request an emergency exemption,'' and by changing ``declares'' a crisis 
exemption to ``issues.'' A similar change has been made to Sec. 176.15. 
These changes will eliminate any future need to amend these rules in 
the event that EPA's regulations or FIFRA are ever changed so that an 
entity other than a State, U.S. Territory, or Federal agency would be 
allowed to request an emergency exemption. Other changes to the final 
rule were made as discussed in this unit. Following is a summary of the 
significant comments received by EPA and its response to these 
comments.

A. EPA Should Adopt an Incremental Risk Approach to Setting Tolerances 
for Emergency Exemptions

     Eight submitters commented on the approach EPA should take to 
establish time-limited tolerances for emergencies. Two commenters 
agreed with EPA's proposed scheme to set tolerances on a case-by-case 
basis using available, reliable information to make the required safety 
finding. Six commenters, while not critical of EPA's proposed approach, 
urged the Agency to instead implement an accelerated review process 
based on the incremental risk of the emergency use. One commenter 
thought that the minimum data set approach was ``intriguing'' and could 
deserve further consideration. This approach, it was stated, had the 
potential to lend clarity and objectivity to the section 18 process and 
eliminate the need for the Agency to use ``best judgement.''
    The proponents of the incremental-risk approach argued that since 
emergency exemptions are by their very nature extreme situations, the 
process for addressing them should take this into account and they 
should be given special treatment. Pesticide use in an emergency is for 
a short term and generally is limited to a single-geographic area, 
therefore there is less exposure to the pesticide and minimal 
associated risk. One commenter noted that the Agency's policy of 
conducting a full-risk assessment for section 18 tolerances does not 
consider the limited scope and duration of the use. The commenter 
stated that performing full risk assessments each time a section 18 
tolerance is requested not only slows down the entire section 18 review 
process, but also diverts Agency resources. According to the commenter

[[Page 64128]]

an incremental-risk approach would eliminate the time pressures and 
would avoid the disruption to EPA's base pesticide regulatory programs.
    In spite of the thoughtful comments on the fourth option, EPA 
believes that the case-by-case approach outlined in its proposal is the 
most practical approach that does not significantly sacrifice 
timeliness or efficiency and is in compliance with the law. It allows 
the Agency to make appropriate decisions quickly while fully protecting 
human health, especially infants and children, and safeguarding the 
environment. Moreover, this approach, coupled with the Agency's newly 
established Threshold of Regulation Policy for pesticide tolerances 
(see Unit IV.) may resolve many concerns expressed by those who favor 
the incremental-risk approach.
    EPA is not prepared at this time to adopt the approach suggested by 
the commenters. In addition to presenting difficult legal issues, the 
incremental-risk approach may not be needed to address the commenters' 
concerns regarding purported EPA denial of section 18 emergency 
exemption petitions or a lack of timely review by the Agency of such 
petitions. EPA's initial implementation of the new tolerance 
requirement necessitated adjusting Agency procedures and involved some 
deviation from past EPA review times in handling section 18 emergency 
exemption requests. Now that EPA has had 4 years experience in setting 
section 18 emergency exemption tolerances, it believes that it has 
adequately adapted the emergency exemption process to deal with the 
longer lead-time inherent in the requirement for establishment of these 
tolerances. Further, as noted in this unit, the Agency's newly 
established Threshold of Regulation Policy for pesticide tolerances 
(see Unit IV.) may address many of the commenters' concerns.

B. The Timely Establishment of a Tolerance After Granting an Emergency 
Exemption is Crucial

    Several commenters said that EPA should establish a tolerance at 
the time of the section 18 approval. The underlying concern was that 
the Agency would not be able to establish a tolerance before the crop 
is harvested or the commodity enters into interstate commerce. One 
person remarked that in addition to the presence of an emergency 
condition, growers are subject to increased uncertainty and anxiety the 
longer it takes the Agency to establish a tolerance. The commenters 
were concerned that crops treated in the course of an emergency would 
be considered adulterated and seized for the lack of an established 
tolerance.
    As a general matter, the Agency agrees with the submitter. For new 
pesticides, the Agency grants a registration and establishes the 
required tolerances simultaneously. However, due to the urgent nature 
of pest emergencies, growers need to be able to lawfully apply a 
pesticide as soon as possible or face significant economic loss for 
that year. If the Agency concludes that it is unable to establish a 
time-limited tolerance for that use, it will notify the applicant 
immediately so that some other method of control for the emergency pest 
situation can be sought. EPA often has to balance its workload between 
establishing tolerances and processing section 18 requests. During peak 
periods for emergency exemption requests, resources used to set a 
tolerance could result in the delay of another State's section 18 
application. Nonetheless, EPA is committed to working toward the goal 
of being able to set a tolerance at the same time as granting the 
emergency exemption. For example, in Fiscal Year (FY) 1999, EPA's 
average time to establish a tolerance once the exemption was granted 
was 66 days. This is significantly faster than the average of 87 days 
it took the Agency in FY 1998.
    FFDCA section 408(l)(5) explains the conditions upon which foods 
and feeds may be subject to enforcement action due to pesticide 
residues. Under this subsection, if a tolerance is no longer in effect, 
i.e., it has been revoked or has expired, the crop may continue to be 
marketed if:
    1. The crop was treated with an approved use of the pesticide at 
the time of treatment, and
    2. The level of the residues do not exceed the tolerance in effect 
at the time the pesticide was applied.
 In the second instance, it is important to note that the tolerance 
must be in place at the time the pesticide is used. This is why many 
States often submit section 18 emergency exemption requests several 
months prior to the onset of the emergency in anticipation of the 2-3 
month time between issuing the exemption and establishing the 
tolerance. They acknowledge that for residues resulting from the use to 
be considered lawful once the tolerance has expired, the tolerance must 
be in place at the time of application, not the time of harvest. 
Nonetheless, EPA's policy of setting tolerances for longer duration 
than the exemption ensures that crops treated during an emergency 
situation should lawfully clear trade channels while the tolerance is 
still in effect.

C. All Emergency Exemptions Issued Under Section 18 Should Be Covered 
Under the ``Pipeline'' Provision

    Many of those who submitted comments thought that the ``pipeline'' 
provision of 408(l)(5) should apply to exemptions declared under crisis 
situations. The ``pipeline'' can be described as those crops that have 
been treated legally with a pesticide that are still in the channels of 
trade when the tolerance is either revoked or, as in the case of an 
emergency exemption, has expired. Those who commented on this felt that 
although a tolerance is not in place at the time the unregistered 
pesticide is used, since the pesticide use was legal under FIFRA 
section 18, any resulting pesticide residues should also be considered 
legal and not subject to enforcement actions.
    Crisis exemptions are by definition unpredictable. In instances 
where an emergency condition occurs suddenly and there is no time to 
formally request a specific emergency exemption, a State or Federal 
agency may issue a crisis exemption and permit the use of an 
unregistered pesticide (40 CFR 166.40). Under a crisis exemption a 
pesticide is almost always used in the field prior to the establishment 
of a tolerance. However, this situation can occur for specific 
exemptions as well. In many instances, a specific exemption request 
(especially with first-time tolerance requests) is granted and the 
pesticide may be used in the field prior to the establishment of the 
time-limited tolerance, where appropriate. EPA later conducts a full 
review and establishes the time-limited tolerance. If the time-limited 
tolerance is not set at a length of time to allow for crops to clear 
trade channels, or is not extended and therefore expires, commodities 
treated under these circumstances could be adulterated and subject to 
seizure.
    In both of these instances the ``pipeline'' provision does not 
apply because a tolerance was not set at the time the pesticide is 
applied. The statutory requirement of FFDCA section 408(l)(5)(B) is not 
met. EPA cannot alter the requirements in the FFDCA through 
regulations. Nonetheless, as noted in this unit, EPA's policy of 
setting tolerances for longer duration than the section 18 exemption 
generally ensures that crops treated during an emergency situation 
should clear trade channels while the tolerance is still in effect.
    Some commenters expressed concern that even though they legally 
applied a pesticide under a crisis emergency exemption, if after EPA 
review the

[[Page 64129]]

necessary tolerance level would exceed the safety standard and by law 
could not be set, their entire crop could be subject to Federal 
enforcement measures. To avoid this potentially dire situation, States 
and Federal agencies are urged to consult with the Agency to determine 
whether the pesticide in question has particular safety issues or 
concerns before declaring a crisis.

D. Time-Limited Tolerances Should Be Set for Longer Than 24 Months

    A few commenters thought EPA should consider establishing time-
limited tolerances for longer than 2 years. One commenter remarked that 
certain exemptions will likely be needed for 3 or more years because 
issues such as new pest pressures or the development of resistance are 
not likely to go away once they have appeared. The commenter suggested 
EPA set tolerances for 3 years upon initially granting the section 18 
request based on circumstances which are likely to persist over several 
years. The commenter added that an exemption such as one based on 
unusual weather patterns probably will not reoccur in succeeding years 
and a 2-year tolerance is adequate in this situation.
    Under EPA's regulations, specific exemptions and public health 
exemptions can be authorized for periods of up to 1 year (40 CFR 
166.28(a)). Since actions taken under this section are intended to 
address an emergency need for temporary pest relief, most section 18 
exemptions are granted for one growing season. In the preamble to the 
proposed rule, EPA stated that it will typically set a time-limited 
tolerance for a 2-year period. This is expected to allow treated crops 
from the previous year to clear the channels of trade. The Agency is 
flexible on this point and may set time-limited tolerances for longer 
time periods if warranted. In addition, EPA may modify or extend a 
time-limited tolerance at any time on its own initiative or at the 
applicant's request. EPA has changed Sec. 176.13 in the final rule to 
clarify that it may extend the duration of a tolerance for various 
reasons. EPA strongly recommends that if an applicant believes that 24 
months is insufficient for a time-limited tolerance, the applicant 
should request a more appropriate length of time in the initial section 
18 request. This will permit the Agency to judge whether a longer 
period would be appropriate.
    One commenter noted that in the proposed regulatory text, the words 
``unless extended'' should be added to Sec. 176.11(b) to be consistent 
with the language in Sec. 176.13. Section 176.11(b) states that ``(b) 
Tolerances will automatically expire and be revoked, without further 
action by EPA, at the time set out in the Federal Register notice 
establishing the tolerance.'' EPA agrees with this suggestion and has 
added the phrase to this section.

E. This Rulemaking Should Be Considered a ``Significant Action'' that 
Requires OMB Review

    Two commenters disagreed with the determination that the proposed 
rule was not a ``significant regulatory action'' as defined under 
section 3(f) of Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), and stated it should have 
therefore undergone review by the Office of Management and Budget 
(OMB), and that the final rule should be reviewed by OMB. One commenter 
stated that emergency exemptions are by definition ``of economic 
importance.'' In addition, crop losses associated with emergency 
exemptions are routinely multi-million dollar situations and that 
individual States and individual growers are ``significantly'' impacted 
by a cumbersome tolerance setting process. It was suggested that OMB 
review the potential impacts associated with delays in establishing 
tolerances.
    E.O. 12866 defines as ``significant'' a regulatory action that is 
likely to:
    1. Have an annual effect on the economy of $100 million or more, or 
adversely and materially affect a sector of the economy; productivity; 
competition; jobs; the environment; public health or safety; or State, 
local, or tribal governments or communities;
    2. Create serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    3. Materially alter the budgetary impacts of entitlements, grants, 
user fees, or loan programs; or
    4. Raise novel legal or policy issues.
    The determination of whether or not a regulatory action should be 
reviewed by OMB under E.O. 12866 is made in consultation with OMB. 
Since this rule is a procedural rule that codifies the internal process 
by which EPA will set emergency tolerances, OMB determined that it was 
not a significant regulatory action that required OMB review under E.O. 
12866. As stated in the proposal's preamble, EPA estimates that the 
direct cost of this rule will be minimal because only EPA and 
applicants are directly affected, and this action does not require 
applicants to submit new or additional information.
    The Agency determined that this rule, once promulgated, is not 
expected to significantly change applicant activities, such that it 
would increase the current burden to applicants and therefore is 
unlikely to have a major economic impact on the States or Federal 
agencies that apply for section 18 exemptions. In addition, EPA affirms 
that promulgation of this rule will have no direct impact on any other 
sector of the economy, or on any other government entities, programs, 
or policies. A copy of the economic analysis is available in the public 
version of the official record for this rule (see Unit I.B.2.).

IV. Is a Tolerance Needed?

    On October 27, 1999, EPA published in the Federal Register a notice 
of availability of a policy entitled, ``Threshold of Regulation 
Policy--Deciding Whether a Pesticide With a Food Use Pattern Requires a 
Tolerance'' (64 FR 57881) (FRL-6388-2). This policy pertains to the use 
of a pesticide (including an emergency use) on, in, or near food which 
does not result in residues that are detectable in food. EPA is 
adopting this policy which sets forth criteria to consider in 
evaluating whether there is no ``need'' to establish a tolerance, i.e., 
there is no reasonable expectation of finite residues of the pesticide 
in the food. If the criteria are met, there is no requirement for a 
tolerance or tolerance exemption. The Threshold of Regulation policy 
will be applicable for pesticide uses that result in no detected 
residues in food and for which the degree of potential risk posed by 
any theoretically possible residues is so minimal that tolerance 
setting serves no purpose.
    The Threshold of Regulation Policy can apply to time-limited 
tolerances for section 18 emergency exemptions. In these instances, the 
Agency will consider surrogate data in the case of emergency exemption 
requests where all the data needed on the performance of the analytical 
method or the magnitude of the residue as determined by field trial 
studies on the subject commodity are unavailable. Given the emergency 
circumstances, EPA may consider accepting data from a different crop to 
establish eligibility for the threshold of regulation. Persons wishing 
a Threshold of Regulation policy decision should make the request in 
writing and submit materials and information that are ordinarily 
required to support time-limited tolerances or tolerance exemptions.

V. Regulatory Assessment Requirements

A. Executive Order 12866

    Pursuant to Executive Order 12866, entitled Regulatory Planning and

[[Page 64130]]

Review (58 FR 51735, October 4, 1993), it has been determined that this 
action is not a ``significant regulatory action'' and is therefore not 
subject to review by OMB. OMB has made this determination because this 
final rule is a procedural rule that codifies the internal process by 
which EPA will set emergency tolerances. Applicants for section 18 
emergency exemptions (i.e., Federal and State agencies) are the only 
parties, other than EPA, directly affected by this action. According to 
the economic assessment conducted by the Agency, the applicants of 
section 18 emergency exemptions are not expected to experience any 
adverse impacts as a result of this rule because the rule does not 
require any new or additional data from applicants.
    A copy of the economic assessment is available in the public 
version of the official record for this rule (see Unit I.B.2.).

B. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that this 
regulatory action does not have a significant economic impact on a 
substantial number of small entities. Applicants for section 18 
emergency exemptions are U.S. States, territories, or Federal agencies 
which, by definition, are not small entities under the RFA. Applicants 
for section 18 emergency exemptions are the only parties, other than 
EPA, directly affected by this action.
    Information regarding this determination will be provided to the 
Chief Counsel for Advocacy of the Small Business Administration (SBA) 
upon request.

C. Paperwork Reduction Act

    Pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., an agency may not conduct or sponsor, and a person is not 
required to respond to, an information collection request unless it 
displays a currently valid OMB control number. The OMB control numbers 
for EPA's regulations, after appearing in the preamble of the final 
rule, are listed in 40 CFR part 9 and 48 CFR chapter 15, and included 
on the related collection instrument. This regulatory action does not 
contain any new information collection requirements that would require 
additional OMB review and approval.
    The information collection activities related to the procedures for 
emergency exemptions under section 18 of FIFRA, which are contained in 
40 CFR part 166, are already approved by OMB under OMB control number 
2070-0032 (EPA ICR No. 596), and the process and informational needs 
for requesting that the Agency establish or provide an exemption from 
the establishment of a tolerance or maximum-residue level for the use 
of a pesticide on food or feed crops, which are contained in 40 CFR 
part 180, are already approved by OMB under OMB control number 2070-
0024 (EPA ICR No.597). As described in the information collection 
instruments, the annual respondent burden for the information 
collection activities in 40 CFR part 166 is estimated to average 103 
hours per application, including time for reading the regulations, 
processing, compiling and reviewing the requested data, generating 
application correspondence or summary reports, and storing, filing, and 
maintaining the data. The annual respondent burden for the information 
collection activities in 40 CFR part 180 is estimated to average 1,726 
hours per petition, including time for reading the regulations, 
processing, compiling and reviewing the requested data, generating the 
request, storing, filing, and maintaining the data.
    As defined by the PRA and 5 CFR 1320.3(b), ``burden'' means the 
total time, effort, or financial resources expended by persons to 
generate, maintain, retain, or disclose or provide information to or 
for a Federal agency. This includes the time needed to review 
instructions; develop, acquire, install, and utilize technology and 
systems for the purposes of collecting, validating, and verifying 
information, processing and maintaining information, and disclosing and 
providing information; adjust the existing ways to comply with any 
previously applicable instructions and requirements; train personnel to 
be able to respond to a collection of information; search data sources; 
complete and review the collection of information; and transmit or 
otherwise disclose the information.

D. Environmental Justice Considerations

    This final rule does not involve special considerations of 
environmental-justice issues pursuant to Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994). 
The Agency has determined that this final rule does not affect the 
environmental and health conditions in low-income and minority 
communities because this rule codifies the internal process by which 
EPA will set emergency tolerances, and only applies to applicants for 
section 18 emergency exemptions (i.e., Federal and State agencies). In 
general, low-income and minority communities are more likely to benefit 
from the risk assessment process needed for the establishment of 
tolerances for section 18 actions that might impact their community.

E. Unfunded Mandates Reform Act

    Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) 
(Public Law 104-4), EPA has determined that this action does not 
contain a Federal mandate that may result in expenditures of $100 
million or more for State, local, and tribal governments, in the 
aggregate, or the private sector in any 1 year. As applicants for 
section 18 emergency exemptions, Federal and State agencies are the 
only parties, other than EPA, directly affected by this action. The 
potential impact on State agencies, however, is expected to be minimal 
because this action does not require applicants to submit new or 
additional information. In addition, EPA has determined that this rule 
does not significantly or uniquely affect small governments. 
Accordingly, this action is not subject to the requirements of sections 
202, 203, 204, and 205 of UMRA.

F. Federalism

    Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999), requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule will not have substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132. Since this rule 
codifies an internal process for the Agency, and does not impose 
requirements on others, the Agency determined that this rule will not 
adversely impact the entities that apply for section 18 exemptions. The 
process established by this final rule will more likely benefit 
applicants and others by establishing an effective and efficient 
process for the Agency to take the necessary tolerance actions in a 
timely manner. Thus, the requirements of

[[Page 64131]]

section 6 of the Executive Order do not apply to this rule. 
Nevertheless, the Agency provided an opportunity for Federal and State 
agencies to review and provide comments on the proposed process. A 
discussion of the comments EPA received, which includes comments from 
several State and local officials, and how those comments are addressed 
in the final rule, is provided in Unit III.

G. Consultation and Coordination with Indian Tribal Governments

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. This final 
rule implements requirements specifically set forth by the Congress in 
FFDCA section 408(l)(6) without the exercise of any discretion by EPA. 
The final rule does not significantly or uniquely affect the 
communities of Indian tribal governments. Accordingly, the requirements 
of section 3(b) of Executive Order 13084 do not apply to this final 
rule.

H. Children's Health Protection

    This final rule is not subject to Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997), because this is not an economically 
significant regulatory action as defined by Executive Order 12866 (see 
Unit V.A.). In addition, this final rule is procedural in nature and 
does not involve decisions on environmental health or safety risks that 
may disproportionately affect children.

I. National Technology Transfer and Advancement Act

    This regulatory action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). Section 12(d) directs EPA to use voluntary 
consensus standards in its regulatory activities unless to do so would 
be inconsistent with applicable law or otherwise impractical. Voluntary 
consensus standards are technical standards (e.g., materials 
specifications, test methods, sampling procedures, business practices, 
etc.) that are developed or adopted by voluntary consensus standards 
bodies. The NTTAA requires EPA to provide Congress, through OMB, 
explanations when the Agency decides not to use available and 
applicable voluntary consensus standards.

J. Civil Justice Reform

    In issuing this rule, EPA has taken the necessary steps to 
eliminate drafting errors and ambiguity, minimize potential litigation, 
and provide a clear legal standard for affected conduct, as required by 
section 3 of Executive Order 12988, entitled Civil Justice Reform (61 
FR 4729, February 7, 1996).

K. Constitutionally Protected Property Rights

    EPA has complied with Executive Order 12630, entitled Governmental 
Actions and Interference with Constitutionally Protected Property 
Rights  (53 FR 8859, March 15, 1988), by examining the takings 
implications of this rule in accordance with the ``Attorney General's 
Supplemental Guidelines for the Evaluation of Risk and Avoidance of 
Unanticipated Takings'' issued under the Executive Order.

VI. Submission to Congress and the General Accounting Office

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This action is not 
a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 176

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: October 16, 2000.
Carol M. Browner,
Administrator.


    Therefore, 40 CFR chapter I is amended by adding new part 176 to 
read as follows:

PART 176--Time-Limited Tolerances for Emergency Exemptions

Sec.
176.1   Scope and applicability.
176.3   Definitions.
176.5   Establishment of a time-limited tolerance or exemption.
176.7   Information needed to establish a tolerance.
176.9   Publication of a tolerance.
176.11   Duration of a tolerance.
176.13   Modification of a time-limited tolerance.
176.15   Effect of a tolerance.

     Authority:  21 U.S.C. 346a and 371.


Sec. 176.1  Scope and applicability.

    This part describes the procedures and criteria under which EPA 
will establish time-limited tolerances and exemptions from the 
requirement of a tolerance for pesticide chemical residues associated 
with use of pesticides under emergency or crisis exemptions under FIFRA 
section 18. This part applies only to tolerances issued on the 
initiative of EPA as the result of the issuance of an emergency 
exemption or the declaration of a crisis exemption. This part does not 
cover time-limited tolerances in any other circumstances.


Sec. 176.3  Definitions.

    The terms have the same meaning as in the Federal Insecticide, 
Fungicide, and Rodenticide Act section 2, and in the Federal Food, 
Drug, and Cosmetic Act section 201 and Sec. 166.3 of this chapter. In 
addition, the following terms are defined for the purposes of this 
part.
    Agency means the U.S. Environmental Protection Agency.
    Applicant means any entity authorized under section 18 of FIFRA to 
request an emergency exemption that requests such an exemption under 
Sec. 166.20 of this chapter, or issues a crisis exemption under 
Sec. 166.40 of this chapter.
    Crisis exemption means an exemption authorized under FIFRA section 
18, in accordance with Sec. Sec. 166.40 through 166.53 of this chapter.
    Emergency exemption means a specific, quarantine, or public health 
exemption authorized under FIFRA section 18 and the regulations at 
Sec. Sec. 166.20 through 166.35 of this chapter.
    EPA means the U.S. Environmental Protection Agency.

[[Page 64132]]

    FFDCA means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 
et seq.).
    FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act 
(7 U.S.C 136 et seq.).
    Tolerance means the maximum amount of a pesticide chemical residue 
that may lawfully be present in or on a raw agricultural commodity, or 
processed food, or animal feed, expressed as parts per million by 
weight of the pesticide chemical residue in the food or feed.
    Tolerance exemption means a formal determination by the Agency 
pursuant to FFDCA section 408(c), 21 U.S.C 346a(c), that no tolerance 
is needed for a given pesticide chemical residue in or on a particular 
food commodity. For purposes of this part, the term ``tolerance'' shall 
include an exemption from the requirement of a tolerance.


Sec. 176.5   Establishment of a time-limited tolerance or exemption.

    EPA will establish a time-limited tolerance for pesticide chemical 
residues in or on raw or processed food or feed resulting from the use 
of a pesticide chemical, if EPA authorizes an emergency exemption or a 
crisis exemption. EPA will consider establishing such a tolerance only 
if an applicant acting under authority of FIFRA section 18 either has 
requested an emergency exemption, has stated its intention to issue a 
crisis exemption, or has issued a crisis exemption for a use that may 
result, directly or indirectly, in pesticide chemical residues in food 
or feed.


Sec. 176.7   Information needed to establish a tolerance.

    (a) EPA will establish a time-limited tolerance only if EPA can 
determine that the tolerance is safe, that is, there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue. EPA will base its determination upon data 
submitted by the applicant and other readily available data. If, taking 
into account the limited duration and emergency nature of a section 18 
application, and based on the available data the Agency cannot conclude 
that there is a reasonable certainty that no harm will result from the 
use proposed by the applicant or granted pursuant to a crisis 
exemption, EPA will not establish a tolerance.
    (b) Data and other relevant information to support the 
establishment of a time-limited tolerance may be submitted by the 
applicant, or by any other person, in support of the time-limited 
tolerance. The applicant may also cite relevant data previously 
submitted to the Agency.


Sec. 176.9  Publication of a tolerance.

    (a) If EPA issues an emergency exemption or crisis exemption under 
FIFRA section 18, and EPA concludes that the tolerance for residues 
resulting from use of the pesticide under the exemption will be safe, 
then EPA will establish the tolerance by publishing an amendment to 40 
CFR part 180 in the Federal Register.
    (b) A tolerance under this part may be established without prior 
publication of a proposed tolerance or comment period.


Sec. 176.11  Duration of a tolerance.

    (a) Tolerances issued under this part will become effective upon 
publication in the Federal Register, unless otherwise specified by the 
Administrator.
    (b) Unless extended, tolerances will automatically expire and be 
revoked, without further action by EPA, at the time set out in the 
final rule published in Federal Register.
    (c) The Administrator may revoke a tolerance at any time if the 
Administrator determines that the tolerance is no longer safe.


Sec. 176.13  Modification of a time-limited tolerance.

    If additional emergency or crisis exemptions are authorized that 
would extend use beyond the date originally authorized, or if EPA 
determines that the duration of a time-limited tolerance is 
insufficient to allow treated commodities to clear the channels of 
trade, EPA may modify the time-limited tolerance by publication of a 
final rule in the Federal Register. EPA will use the same criteria and 
procedures for modification as for establishing tolerances under this 
part.


Sec. 176.15  Effect of a tolerance.

    The establishment of a tolerance under this part does not alter the 
requirement that any applicant comply with procedures established in 
part 166 of this chapter for emergency exemptions of FIFRA.

[FR Doc. 00-27405 Filed 10-24-00; 8:45 am]
BILLING CODE 6560-50-S


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