[Federal Register Volume 64, Number 106 (Thursday, June 3, 1999)]
[Proposed Rules]
[Pages 29823-29831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14070]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 176

[OPP-181051; FRL-5750-1]
RIN 2070-AD15


Tolerances for Pesticide Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing procedures and criteria under which EPA would 
establish tolerances for residues of pesticide chemicals resulting from 
emergency uses of pesticide chemicals authorized by EPA under section 
18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 
This regulation is required by the Federal Food, Drug, and Cosmetic Act 
(FFDCA), which was amended by the Food Quality Protection Act (FQPA) of 
1996. FQPA established a new safety standard with special protections 
for infants and children and extends this new protection to the 
emergency use of pesticide chemicals. Specifically, FQPA requires EPA 
to establish time-limited tolerances, or an exemption from the 
requirement for a time-limited tolerance, for any pesticide uses 
authorized by EPA under section 18 of FIFRA that may result in residues 
in or on food (including animal feed). EPA actions under section 18 of 
FIFRA are taken in response to a petition submitted by a Federal or 
state agency. These proposed procedures and criteria will ensure that 
the Agency is able to address more quickly any tolerance related issues 
in conjunction with any decision made on the petition. EPA believes 
that the procedures proposed in this document will be protective of 
public health, while continuing to ensure availability of pesticides in 
emergency situations.

DATES: Written comments, identified by the docket control number OPP-
181051, must be received on or before August 2, 1999.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION section of this 
notice.

FOR FURTHER INFORMATION CONTACT:
Joseph E. Hogue, Policy and Regulatory Services Branch, Field and 
External Affairs Division (7506C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460, 
telephone number: (703) 308-9072, e-mail address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Important Information

A. Does This Proposed Rule Apply to You?

    You may be potentially affected by this proposed 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 is not limited to:

------------------------------------------------------------------------
              Category                             Examples
------------------------------------------------------------------------
Federal Government.................  Agencies that petition EPA for
                                      section 18 pesticide use
                                      authorization.
State and territorial government     State that petition EPA for section
 agencies charged with pesticide      18 pesticide use authorization.
 authority.
------------------------------------------------------------------------

    This table is not all inclusive, but is intended as a guide for 
entities likely to be regulated by this action. To determine whether 
this proposed rule applies to you, carefully read the applicability 
criteria in a proposed Sec. 176.1. If you have any questions regarding 
the applicability of this action to a particular entity, consult the 
person listed in the FOR FURTHER INFORMATION CONTACT section.

B. How Can I Get Additional Information or Copies of Support Documents?

    1. Electronically. You may obtain electronic copies of this 
document and various support documents are available from the EPA Home 
page at the Federal Register--Environmental Documents entry for this 
document under ``Laws and Regulations'' (http://www.epa.gov/fedrgstr/).
    2. In person. The official record for this proposed rule, as well 
as the public version, has been established under docket control number 
OPP-181051, (including comments and data submitted electronically as 
described below). A public version of this record, including printed, 
paper versions of any electronic comments, which does not include any 
information claimed as CBI, is available for inspection in Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays.

C. How and to Whom Do I Submit Comments to?

    You may submit comments through the mail, in person, or 
electronically:
    1. By mail. Submit written comments to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., S.W., Washington, DC 20460.
    2. In person. Deliver written comments to: Public Information and

[[Page 29824]]

Records Integrity Branch, in Rm. 119, CM #2, 1921 Jefferson Davis 
Highway, Arlington, VA.
    3. Electronically. Submit your comments and/or data electronically 
to: ``[email protected].'' Please note that you should not 
submit any information electronically that you consider to be CBI. 
Electronic comments must be submitted as an ASCII file avoiding the use 
of special characters and any form of encryption. Comments and data 
will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket control number OPP-181051. Electronic comments on this 
proposed rule may also be filed online at many Federal Depository 
Libraries.

D. How Should I Handle Information That I Believe Is Confidential?

    You may claim information that you submit in response to this 
document as confidential by marking any part or all of that information 
as CBI. Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2. A copy of the 
comment that does not contain CBI must be submitted for inclusion in 
the public record. Information not marked confidential will be included 
in the public docket by EPA without prior notice.

II. Authority

    This action is issued under the authority of the Federal Food, 
Drug, and Cosmetic Act as amended by the Food Quality Protection Act of 
1996.

III. Background

    The Food Quality Protection Act of 1996 (FQPA) was signed into law 
August 3, 1996. FQPA amends both the Federal Food, Drug, and Cosmetic 
Act (FFDCA), 21 U.S.C. 201 et seq., and the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. Among 
other things, FQPA amends FFDCA to bring all pesticide tolerance-
setting activities conducted by EPA under a new section 408 with a new 
safety standard and new procedures. FQPA also amends FFDCA by directing 
EPA to establish time-limited tolerances for any pesticide use 
authorized by EPA under section 18 of FIFRA that may result in residues 
in or on food (including animal feed). The FQPA amendments went into 
effect immediately.
    EPA is proposing regulations to govern the establishment of time-
limited tolerances for pesticide uses authorized by EPA under section 
18 of FIFRA. This proposed rule pertains only to regulatory changes 
resulting from enactment of FQPA.

IV. Emergency Exemptions under Section 18

    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.'' This provision was not 
amended by FQPA. EPA has established regulations governing such 
emergency exemptions in 40 CFR part 166. Generally, these regulations 
allow a Federal or state agency to apply for an exemption to allow a 
use of a pesticide that is not registered when such use is necessary to 
alleviate an emergency condition. A state, as defined by FIFRA section 
2(aa), means a state, the District of Columbia, the Commonwealth of 
Puerto Rico, the Virgin Islands, Guam, the Trust Territory of the 
Pacific Islands and the American Samoa. The regulations set forth 
information requirements, procedures, and standards for EPA's approval 
or denial of such exemptions.
    Federal and state agencies may petition EPA for a section 18 
emergency exemption from FIFRA due to a public health emergency, a 
quarantine emergency, or a ``specific'' emergency. Most exemptions from 
FIFRA petitioned for or granted under section 18 fall under the 
category of ``specific exemptions.'' Typical justifications for 
specific exemptions include, but are not limited to, the introduction 
of a new pest; the expansion of the range of a pest; the cancellation 
or removal from the market of a previously registered and effective 
pesticide product; and the development of resistance in pest to a 
registered product, or loss of efficacy in available products for any 
other reasons. Additionally, an emergency situation is generally 
considered to exist when no other viable (chemical or non-chemical) 
means of control exist, and where the emergency situation will cause 
significant economic losses to affected individuals if the exemption is 
not granted.
    When a Federal or state agency petitions EPA under section 18, it 
must submit a request in writing that documents the emergency 
situation, the chemical(s) proposed for the use, the target pest, the 
crop, the rate and number of applications to be made, the geographical 
region where the chemical(s) would be applied, and a discussion of 
risks which may be posed to human health or to the environment as a 
result of the pesticide use (40 CFR 166.20). EPA conducts an expedited 
review of the request, verifying the existence of the emergency, 
assessing risks posed to human health through dietary exposure, 
assessing risks posed to farmworkers and other handlers of the 
pesticide, assessing any adverse effects on non-target organisms 
(including federally listed endangered species), and assessing the 
potential for contamination of ground and surface water. If an 
application for the requested use has been made in previous years, EPA 
does an assessment of the progress toward registration for the use of 
the requested chemical on the requested crop, and considers this status 
in the final determination to grant or deny the exemption. If EPA's 
review concludes that the situation is an emergency, and that the use 
of the pesticide under the exemption will not cause unreasonable 
adverse effects on human health or the environment, then EPA may 
authorize the pesticide to be used under section 18.
    Section 18 pesticide uses for specific and public health exemptions 
can be authorized for periods not to exceed 1 year; uses under 
quarantine exemptions can be authorized for up to 3 years. Since 
actions taken under section 18 are intended to address a time-specific 
crisis or emergency need for temporary relief, most section 18 
exemptions are specific exemptions which are granted for just one 
growing season. Such actions should not, therefore, be reviewed as an 
alternative to registering the use(s) needed for longer periods. If the 
situation addressed with the section 18 exemption persists, or is 
expected to persist, affected entities must take the proper steps to 
amend the existing or seek a new registration to address that future 
need.
    In general, EPA attempts to form and communicate decisions on 
section 18 requests within 50 calendar days of receipt of an exemption 
application; in fiscal year 1998 (October 1, 1997--September 30, 1998), 
EPA's average response time was 56 days. During FY98, EPA received 
requests for 601 exemptions, of which 410 were approved (27 requests 
were denied, 67 requests were withdrawn by states, and 97 requests were 
still pending at the end of the fiscal year).
    EPA maintains lines of communication with the State Departments of 
Agriculture (or applicant) during the application review period so they 
may keep growers informed on the status of the request. The Agency 
works with the State Departments of Agriculture so that in case a 
request might be denied, the affected growers may be able to find 
alternative solutions. In the early stages of the development of this 
proposed rule, EPA consulted with

[[Page 29825]]

representatives from the States of North Carolina and Washington on 
behalf of the State's FIFRA Issues Research and Evaluation Group 
(SFIREG). SFIREG identifies, analyzes and provides State comments to 
the Office of Pesticide Programs on matters relating to pesticide 
registration, enforcement, training and certification, water quality, 
disposal and other areas of environmental concern related to pesticide 
manufacture, use and disposal. In addition, SFIREG provides a mechanism 
for EPA to keep the states informed and up-to-date on its pesticide 
regulatory programs.
    In September 1997, the Office of Pesticide programs formed a minor 
use office which focuses on the special needs of growers of minor use 
crops. EPA has expanded work in this respect with Interregional 
Research Project No. 4 (IR-4), a U.S. Department of Agriculture (USDA) 
program which provides national leadership and coordination for 
information on the clearance of minor use pesticides and generates data 
to support minor-use registrations. IR-4 will often help support minor 
use emergency exemptions petitions.
    The section 18 program can be an important part of developing 
reasonable transition approaches for certain crops, especially minor 
use crops, in moving to safer pest control methods. For example, in 
certain situations, a pesticide needed for emergency use on minor use 
crops might be registered for other use sites which have already filled 
the ``risk cup.'' In order to address the needs of minor use farmers, 
the Agency might work with pesticide registrants and growers to cap the 
existing use on registered crops at a level that allows room in the 
risk cup for use of the pesticide in combating an emergency. Under this 
offset approach, the Agency could achieve either no risk increase or a 
risk reduction and at the same time facilitate and permit critical 
emergency exemptions.
    In continuing efforts to implement FQPA, EPA is working together 
with USDA to ensure that implementation of FQPA is informed by a sound 
regulatory approach, by appropriate input from affected members of the 
public, and by due regard for the needs of our Nation's agricultural 
producers and other pesticide users.

V. Legal Basis of EPA Action

A. Residues in Food Prior to FQPA

    Prior to enactment of FQPA, when EPA granted an emergency exemption 
under section 18 for use of a pesticide that could result in residues 
in or on food, EPA did not establish a tolerance or exemption from the 
requirement for a tolerance under FFDCA. rather, EPA advised the Food 
and Drug Administration (FDA) of the emergency exemption and the level 
of residues that EPA concluded would be present in or on affected foods 
as a result of the emergency use, and requested that FDA refrain from 
enforcing against foods which contained residues of the pesticide due 
to use under the exemption. Similarly, EPA informed the USDA of 
pesticide use under an emergency exemption where residues would result 
in meat, milk, or eggs.

B. FQPA Requirements

    New section 408(l)(6) requires EPA to establish a tolerance or 
exemption from the requirement for a tolerance for pesticide chemical 
residues in or on food that will result from the use of a pesticide 
under an emergency exemption granted by EPA under section 18 of FIFRA, 
and requires that the tolerances be consistent with sections 408(b)(2) 
and (c)(2) and FIFRA section 18. Section 408(l)(6) also requires EPA to 
promulgate regulations governing the establishment of tolerances and 
exemptions under section 408(l)(6). New FFDCA section 408(b)(2)(A)(i) 
allows EPA to establish a tolerance (the maximum legal limit) for a 
pesticide chemical residue in or on a food in accordance with the 
following:
    1. EPA must determine that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' 
Aggregate exposure includes exposure through food and drinking water, 
as well as all non-occupational, non-dietary exposure, such as through 
residential uses.
    2. Section 408(b)(2)(C) requires EPA to give special consideration 
to exposure of infants and children to the pesticide chemical residue 
in establishing a tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue.* * *''
    3. Section 408(b)(2)(D) specifies certain factors EPA is to 
consider in establishing a tolerance. These factors include the use of 
reliable data, nature of toxic effects, human risk involved, dietary 
consumption patterns, cumulative effects of a pesticide residue with 
other substances that have a common mechanism of toxicity, aggregate 
exposure levels, variability of the sensitivities of subgroups of 
consumers, endocrine disrupting effects, and appropriate safety 
factors.
    4. Section 408(b)(3) requires that there is a practical method for 
detecting and measuring levels of the pesticide chemical residue in or 
on food. A tolerance may only be established at a level at or above the 
limit of detection of the designated method.
    5. Section 408(c) governs EPA's establishment of exemptions from 
the requirement for a tolerance using the same safety standard as 
section 408(b)(2)(A) and incorporating the provisions of sections 
408(b)(2)(C) and (D). In this preamble, EPA will use the terms 
``tolerance'' to refer to exemptions from the requirement for a 
tolerance as well.
    Section 408(l)(6) requires EPA to establish tolerances in 
connection with EPA's granting of FIFRA section 18 emergency 
exemptions. When EPA establishes a tolerance under section 408(l)(6), 
it may do so without providing notice or a period for public comment. 
Tolerances established under section 408(l)(6) must also be consistent 
with the safety standards in section 408(b)(2) and (c)(2) that are 
applicable to all tolerances under section 408, and with FIFRA section 
18. Section 408(l)(6) specifies that such tolerances shall have an 
expiration date, but does not specify the duration of the tolerance.

VI. Interim Section 18 Practices

    Since August 3, 1996, EPA has been acting on requests for section 
18 exemptions and has been issuing associated tolerances on a case-by-
case basis under the new safety standard mandated by FQPA. The Agency 
sent a letter to Federal and state agencies in September 1996, 
informing them of the new procedures and issued guidance on interim 
procedures in Pesticide Regulation Notice 97-1 (January 31, 1997). In 
establishing section 18-related tolerances during this interim period 
before issuing the section 408(l)(6) procedural regulation and before 
making broad policy decisions concerning the interpretation and 
implementation of the new section 408, EPA does not intend to set 
precedents for the application of section 408 and the new safety 
standard to other tolerances and exemptions. Rather, these early 
section 18 tolerance decisions are being made on a case-by-case basis 
and will not bind EPA as it proceeds with further rulemaking and policy 
development.

[[Page 29826]]

VII. EPA Proposal

A. Scope

    This proposal deals exclusively with procedures for setting time-
limited tolerances for pesticide chemical residues associated with 
FIFRA section 18 emergency exemptions. The proposal does not modify any 
regulatory policies or procedures associated with the issuance of an 
emergency exemption itself, nor does it affect tolerance procedures 
which fall under other sections of FIFRA or FFDCA.

B. Definitions

    The terms defined in proposed Sec. 176.3 of the regulatory text 
have the same meaning as FIFRA section 2, FFDCA section 201, and 40 CFR 
part 166.

C. Request for a Section 18 Tolerance

    Proposed Sec. 176.5 specifies that EPA will review data to 
establish a time-limited tolerance for a pesticide to be used in an 
emergency or crisis situation under section 18 only after it has 
received the emergency exemption request or a crisis situation has been 
declared.

D. Determining Reasonable Certainty of No Harm

    In developing these proposed regulations, EPA considered several 
approaches for assuring timely access to information adequate to ensure 
that a section 18 tolerance, taking into account its limited duration 
and emergency nature, meets the new FFDCA safety standard of reasonable 
certainty of no harm.
    For a number of reasons, EPA proposes to implement the new 
provisions of FFDCA related to section 18 tolerances in Sec. 176.7 by 
evaluating each submission on a case-by-case basis to determine if 
adequate reliable data are available to make the ``reasonable certainty 
of no harm'' finding mandated under section 408 of FFDCA. EPA believes 
that timeliness of review in a manner responsive to the requirements of 
the situation is of critical importance. EPA must be able to conclude 
rapidly whether it has enough reliable data readily available to make a 
safety finding under FFDCA for the requested use. Even if EPA concludes 
that it is unable to establish a time-limited tolerance for the 
requested use, the Agency will strive to make that conclusion in 
sufficient time for the applicant to search for some additional method 
to control the emergency pest situation. This case-by-case evaluation 
is consistent with EPA's traditional approach to section 18 exemption 
requests and with the statutory mandate of FFDCA section 408(l)(6).
    In addition to the practical limits on the time available for 
decision-making, EPA believes it is reasonable to rely on available 
data for several other reasons, even though those data will generally 
be less than those required for the establishment of a permanent 
tolerance. Dietary exposures to pesticide chemical residues from use 
under a section 18 exemption are generally less than those associated 
with permanent tolerances because section 18 uses are of limited 
duration, and because section 18 uses generally do not involve the 
entire U.S. production of any crop since they are granted on a state-
by-state basis. Moreover, substantial hazard and exposure data are 
usually available. Many section 18 exemption requests are for new use 
sites of currently registered pesticides or for uses of previously 
registered pesticides which are no longer in use. Consequently, EPA may 
already have an extensive data base readily available to make the 
reasonable certainty of no harm determination to set the tolerance. 
Using available data is less likely to require significant increases in 
the resources necessary to support exemption requests. It would not 
significantly increase the regulatory burden on applicants by creating 
new data requirements for section 18 exemptions nor significantly 
increase costs to EPA for evaluating the requests. It is important to 
limit the resource requirements of the section 18 program so that both 
the Agency and applicants have sufficient resources to carry out their 
other responsibilities under FIFRA and FFDCA.
    1. Data requirements. Under this approach, EPA will review data 
that has been submitted as required in 40 CFR part 158 for FIFRA 
section 18 requests and whatever additional useful data it has 
available in order to make the safety determination required under 
FFDCA for establishment of a time-limited tolerance for an emergency 
exemption. Pesticide Registration (PR) Notice 97-1, issued January 31, 
1997, provides additional guidance on what data to submit to the Agency 
to enable EPA to make a ``reasonable certainty of no harm'' 
determination in order to issue a tolerance (for a copy of PR Notice 
97-1, please contact the OPP docket, address above, or visit the EPA 
web site). Because EPA already has in its files much of the data it 
will review to make a determination on a section 18 tolerance, the 
Agency does not expect such data to be submitted routinely with an 
exemption request. EPA will exercise its best scientific judgment and 
rely on data submitted to support past and pending registration actions 
for the subject or closely related chemical, or data submitted to EPA 
as part of the reregistration process. When possible, applicants should 
cite studies previously reviewed, and found acceptable by EPA, that 
pertain to the requested use. EPA will not, however, conduct expedited 
reviews of data submitted for permanent tolerances, or for registration 
or reregistration actions, solely in order to ascertain the viability 
of establishing a tolerance for a section 18 exemption request.
    In all cases, applicants must include the earliest anticipated 
harvest date of crops for which the section 18 exemption is being 
requested. This information is useful for EPA to allocate the necessary 
resources to establish the time-limited tolerances in time for the 
harvest, and will also be useful to FDA and USDA in enforcing the 
tolerances.
    2. Agency review under a case-by-case approach. In order to 
determine whether EPA will be able to establish a time-limited 
tolerance for a requested section 18 use, EPA will consider available 
information relevant to the factors listed in FFDCA section 
408(b)(2)(D), including:
    a. Aggregate exposure to the pesticide chemical residue through:
    i. Dietary exposure, including drinking water.
    ii. Non-dietary, non-occupational residential exposure [indoor and 
out-door].
    b. Cumulative effects of the pesticide chemical residue and other 
substances that have a common mechanism of toxicity.
    c. Extra sensitivity of infants and children.
    d. Potential to produce endocrine effects.
    Because there is a significant scientific uncertainty at this time 
about how to aggregate non-dietary risk factors with dietary risk, and 
because generally EPA has limited data with which to evaluate common 
mechanism of toxicity and endocrine disruption capacities of chemicals, 
EPA will make its ``reasonable certainty of no harm determination'' 
based on available and reliable information coupled with best 
scientific judgment as necessary. If EPA concludes that establishment 
of the appropriate tolerance would result in ``a reasonable certainty 
of no harm'' as defined in FFDCA section 408(b), then a tolerance may 
be established for the requested use.
    EPA will be unable to establish a time-limited tolerance for the 
proposed emergency exemption use, and therefore will deny the exemption 
request, if: (1) The Agency finds that the tolerance

[[Page 29827]]

does not meet the safety standard of reasonable certainly of no harm as 
defined in FFDCA section 408, or (2) the Agency does not have enough 
reliable data to make a determination that the safety standard is met.
    3. Alternative approaches considered. EPA has identified other 
possible approaches to establishing section 18 tolerances which it 
could pursue. One approach was to require a full data set to support 
section 18 tolerances as is required in 40 CFR part 158, subparts D and 
F, for the establishment of permanent tolerances. However, the Agency 
recognized that adhering rigidly to all data specified in 40 CFR part 
158, as they currently exist and as they may be modified in the future, 
would effectively remove section 18 as a mechanism to address emergency 
pest situations. Review and decisions would not be made in a timely or 
responsive fashion, and the process of data collection, submission and 
review would be equivalent to that required to establish a permanent 
tolerance. This would be unduly burdensome to the applicants that 
request emergency exemptions. They generally do not have resources to 
develop the data themselves and so would have to rely upon data 
developed by the producers of pesticide products. In sum, this approach 
does not consider the emergency nature or short duration of most 
exemption requests. Therefore, EPA believes that it would be 
impractical, given the urgent nature of emergency conditions.
    EPA also considered a minimum data set approach in which the 
applicant would be required to provide a specific subset of the data 
normally required to establish a full tolerance which would be 
sufficient to support a safety determination given the time-limited 
nature of section 18 tolerances and the urgent nature of emergency 
situations. Under this approach, EPA would consider only those defined 
data requirements in making a safety finding. If EPA chose to implement 
the new provisions of FFDCA in this fashion, applicants would likely 
have to provide specific data to EPA to support a section 18 tolerance 
in addition to data which must already be submitted for emergency 
exemption requests in general, outlined in 40 CFR 166.20.
    EPA believes that both the creation of a new, specific minimum data 
set to support section 18 time-limited tolerances, and the practical 
implementation of those requirements, would result in significant 
disruption to the availability of section 18 as a viable response to 
emergency situations requiring use of pesticide products. EPA believes 
that many applicants would have difficulty complying with a minimum 
data set because these requirements would still represent levels of 
technical data which most states do not have access to and currently 
are unable to develop. As EPA's data requirements evolve, a defined 
minimum data set might also require revision. Because a prescribed data 
set is not necessary for the Agency to conclude that a tolerance is 
safe and because it is EPA's belief that the amendments to FFDCA were 
not intended to eliminate or significantly disrupt the availability of 
emergency exemptions, EPA is not proposing to establish a minimum data 
set required for tolerances associated with section 18 requests.
    A fourth approach to setting tolerances under section 18 has been 
suggested to the Agency. This approach was initially presented in a 
paper developed by a work group of the Pesticide Program Dialogue 
Committee and subsequently through a petition submitted by the National 
Food Processor's Association. Under this approach, the Agency would not 
conduct a full risk assessment under FQPA but would assess the 
incremental risk of the proposed section 18 use. If the Agency were to 
find the incremental risk insignificant, it would establish a time 
limited tolerance and grant the section 18 use without conducting a 
full aggregate risk assessment for the existing uses of the pesticide 
chemical. This approach would take into account the limited scope and 
duration of the emergency use of the pesticide. The NFPA petition 
assets that limiting the Agency's review of a section 18 tolerance to 
an incremental risk assessment might decrease the amount of time it 
takes for the Agency to review the emergency exemption application, 
thus taking into account the emergency nature and time sensitivity of 
the use and potentially allowing Agency resources to be used in other 
areas. In addition, the petitioners believe that the use of an 
incremental risk assessment may reduce the time needed to establish a 
tolerance after granting an emergency exemption. Although the Agency is 
proposing to use a case-by-case approach including aggregate risk 
assessment based on available data, the Agency is accepting comments on 
all of these alternative approaches.

E. Publication of Tolerances

    Tolerances established to support emergency exemption uses of 
pesticide products would become effective upon publication of a final 
rule under proposed Sec. 176.9. Shortly after promulgation of a 
tolerance, EPA would publish a final rule in the Federal Register 
establishing the tolerance and specifying the duration of the 
tolerance. Section 408(l)(6) of the FFDCA allows EPA to establish a 
tolerance without prior public notification or comment period. 
Additionally, EPA intends to make tolerances established under FFDCA 
section 408(l)(6) available electronically, so that there can be a 
record of the most up-to-date tolerances, their expiration dates, and 
any other information that can be of practical use to growers, states, 
and other various enforcement agencies.

F. Duration of Tolerances

    Section 408(l)(6) of FFDCA provides that tolerances for emergency 
exemptions shall have an expiration date. Proposed Sec. 176.11 
specifies that tolerances would expire and be revoked automatically at 
such a time as determined by the Administrator. Timing of expiration 
and revocation of the tolerance would be identified at the time of 
establishment of the tolerance.
    EPA anticipates that, typically, tolerances would not be 
established for a period longer than 24 months. In its discretion, and 
at its own initiative or at the request of an applicant, EPA may 
establish a section 408(l)(6) tolerance for longer periods when 
conditions merit such an extended time-frame. If an applicant requests 
a longer time-limited tolerance for a section 18 pesticide use, the 
applicant must adequately justify the requested duration when making 
its emergency exemption request, and EPA would have to consider whether 
the extended tolerance could pose higher risks.

G. Lawful Residues After Expiration of Tolerances

    Section 408(l)(5) of FFDCA specifies that, if a tolerance for a 
pesticide chemical residue in or on a food has been revoked under 
section 408, food containing the residue is not unsafe if ``the residue 
is present as the result of an application or use of a pesticide at a 
time and in a manner that was lawful'' under FIFRA and ``the residue 
does not exceed a level that was authorized at the time of the 
application or use to be present on the food under a tolerance * * * 
then in effect under [FFDCA]. * * * ''
    Taking sections 408(l) (5) and (6) together, EPA has concluded that 
the best way to effect an ``expiration date'' for a tolerance 
established in connection with EPA's granting of a FIFRA section 18 
emergency exemption is to specify that the tolerance will expire and be 
revoked automatically, without further

[[Page 29828]]

action by EPA, as of a specified date. That date will generally be 24 
months or less from the date of issuance of the emergency exemption. 
After a tolerance is automatically revoked, food that contains residues 
of a pesticide chemical will still be legally marketable so long as the 
residues are the result of lawful use of the pesticide under the terms 
of the section 18 emergency exemption and are at levels within the 
tolerance established under section 408(l)(6).
    Occasionally, use of the pesticide might occur before EPA actually 
establishes the necessary time-limited tolerance, such as in the case 
of a crisis exemption. When a time-limited tolerance is established 
after the time that use of the pesticide product is authorized, the 
residues on the subject commodity are only legal during the period of 
time prior to the expiration and revocation of the tolerance. In other 
words, there would be no ``pipeline'' provision for treated commodities 
if use occurred before a tolerance was set. In case of such a gap, EPA 
will consider setting a longer duration for the time-limited tolerance 
to ensure that the commodity will leave channels of trade before the 
tolerance expires.
    EPA believes that handling the section 18-related tolerances in 
this manner will allow EPA to respond promptly to emergency conditions 
and will ensure that food containing pesticide residues as a result of 
use under an emergency exemption will not be considered adulterated.

H. Limitations of 408(l)(6) Tolerances

    Time-limited tolerances established under the authority of FFDCA 
section 408(l)(6) apply to pesticide chemical residues resulting from 
pesticide applications authorized by EPA under provisions of FIFRA 
section 18. In addition, time-limited tolerances established under this 
section will cover commodities imported into the United States during 
the duration of the tolerance.
    The previous establishment of a 408(l)(6 ) tolerance does not alter 
the requirement for applicants to submit formal emergency exemption 
requests to EPA for review. Issuing a tolerance does not grant 
authority to use a pesticide, but rather provides a legal limit on 
residues of the pesticide on food shipped in interstate commerce. Even 
if a time-limited tolerance for a pesticide has been established in 
response to one applicant's (a state, U.S. territory, or Federal 
agency) emergency exemption, other applicants must obtain an emergency 
exemption for the use of that pesticide if they experience a pest 
emergency which requires the use of that pesticide.

VIII. Additional Section 18 Concerns Not Addressed in This Proposed 
Rule

    On November 21 and 22, 1996, EPA hosted a public workshop to 
discuss a range of issues related to emergency exemptions from FIFRA. 
The purpose of the meeting was to informally establish a dialogue 
amongst and solicit the opinions of a variety of individuals and groups 
affected by section 18 decisions. During this meeting, EPA encouraged 
discussion of various changes that may be made to regulations governing 
section 18. Although the meeting had been planned prior to the passage 
of FQPA because the new law had recently been enacted, some portions of 
the meeting were devoted to discussions of how implementation of FQPA 
could or would affect the section 18 process. Based on the November 21-
22 meeting, there may be additional concerns regarding the section 18 
program aside from the tolerance setting procedures set forth in this 
proposed rule that are of great interest to many section 18 
stakeholders. EPA may, at a later date, prepare a formal proposal to 
make changes to the section 18 regulations.
    Although this proposed rule only addresses procedures for setting 
tolerances in connection with section 18 exemptions, the following 
recommendations were presented to EPA by the National Association of 
State Departments of Agriculture (NASDA) and the Association of 
American Pesticide Control Officials (AAPCO) in a letter dated February 
28, 1997, addressed to Assistant Administrator for Prevention, 
Pesticides and Toxic Substances, Dr. Lynn R. Goldman, M.D. NASDA and 
AAPCO prepared this letter to capture the recommendations of their 
membership following EPA's November 1996 Section 18 Stakeholder 
Meeting. Specifically, NASDA and AAPCO recommend that EPA implement the 
following changes to the section 18 emergency exemption process:
    1.  Seek changes to current regulations which will allow EPA the 
flexibility to base decisions on crop yield as opposed to crop value 
(or profit loss) in situations where that is a better indicator of pest 
damage.
    2.  Provide states general guidance regarding the appropriate 
documentation of an ``urgent, non-routine situation'' and allow states 
to certify that the ``urgent, non-routine situation'' exists based on 
the guidance.
    3.  Implement a performance audit program to ensure compliance with 
the guidance and give states justification to resist pressure to 
certify an ``urgent, non-routine situation'' when it does not exist.
    4.  Delegate to the states authority to reissue the section 18 
exemption for a second or third year, based on the state's 
confirmation/certification that the basis for an emergency continues to 
exist.
    5.  Actively support and coordinate regional section 18 requests.
    6.  Enter into discussions with the states to establish reasonable 
monitoring criteria and approaches for wildlife and endangered species.
    7.  Support specific exemptions for resistance management where 
there is documented scientific evidence of resistance to currently 
registered pesticide or where valid research demonstrates that a 
dynamic process of resistance is developing.
    8.  Amend 40 CFR 166.2 to include ``reduced risk'' as an acceptable 
basis for granting a section 18 exemption. The definition of ``reduced 
risk,'' and the requirements for this request should allow states the 
ability to request a section 18 to allow for a pesticide use that will 
result in a lower potential for an adverse impact on human health or 
any other non-target species, including but not limited to, pest 
predators, pollinators, endangered species, and other organisms of 
special concern. Requests should be limited to only those situations 
where the ``reduced risk'' request will not result in additional risk 
to any aspect of the environment. Such requests should only be 
permitted where the proposed use is highly effective so that the 
potential for an increase in pesticide applications is extremely low.
    As stated above, by including the recommendations of NASDA and 
AAPCO in this document, the Agency is not proposing to alter existing 
regulations which govern implementation of FIFRA section 18, nor is the 
Agency prepared to take a position on the propriety of any of the 
recommendations. EPA will accept comments on the eight recommendations 
presented by NASDA and AAPCO, should individuals or organizations wish 
to comment at this time. Comments on these recommendations must be 
identified by the docket control number, OPP-181052, rather than the 
docket number for this proposed rule.
    EPA does not expect to address any comments resulting from these 
eight issues in promulgating final rules establishing procedures for 
setting tolerances under FFDCA section 408(l)(6), nor does the Agency 
intend to allow these issues to delay implementation of the tolerance 
setting

[[Page 29829]]

regulations. EPA does intend to develop a proposed rule which would 
make various changes to the regulations governing section 18 exemptions 
at a later date. At that time, the Agency will describe in much greater 
detail these recommendations and any other changes it has considered, 
and comments will be officially solicited and addressed as part of that 
process.
    The Agency is also seeking ideas on how to reduce the time from 
when the emergency exemption is granted to when the tolerance is 
established per the request of the NFPA petition.

IX. Regulatory Requirements

A. Executive Order 12866

    Pursuant to Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), it has been determined that this 
proposed action is not a ``significant regulatory action'' and is 
therefore not subject to review by the Office of Management and Budget 
(OMB). Applicants for section 18 emergency exemptions are the only 
parties, other than EPA, directly affected by this proposed action. 
According to the economic assessment conducted by the Agency, the 
direct costs of this action are insignificant to the applicants 
(Federal and state agencies) of section 18 emergency exemptions because 
additional data are not readily accessible under case-by-case approach 
of determining a reasonable certainty of no harm. A copy of the 
economic assessment is available in the public docket for this proposed 
rule.

B. Regulatory Flexibility Act

    Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the 
Agency has determined that this regulatory action does not impose any 
direct adverse economic impact on small entities. Applicants for 
section 18 emergency exemptions are U.S. states, territories, or 
Federal agencies which, by definition, are not small entities. 
Applicants for section 18 emergency exemptions are the only parties, 
other than EPA, directly affected by this proposed action. Therefore, 
pursuant to section 605(b), the agency hereby certifies that this 
action will not have a significant adverse impact on a substantial 
number of small entities. Information regarding this determination will 
be provided to the Chief Counsel for Advocacy of the Small Business 
Administration (SBA) upon request. Any comments regarding the impacts 
that this action may impose on small entities should be submitted to 
the Agency at the address listed above.

C. Paperwork Reduction Act

    This proposed regulatory action does not contain any new 
information collection requirements that would require additional 
approval by OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 
et seq. The information collection requirements that are related to 
this proposed rule have already been approved by OMB under control No. 
2070-0032 (EPA ICR No. 596) and control No. 2070-0024 (EPA ICR No. 
597). Specifically, EPA regulations at 40 CFR part 166 allow a state, 
U.S. territory, or Federal agency to apply for an emergency exemption 
pursuant to section 18 of FIFRA, which would allow for a pesticide to 
be used for a use for which that pesticide is not registered when such 
use is necessary to alleviate an emergency condition. The regulations 
set forth information requirements, procedures, and standards for EPA's 
approval or denial of such exemptions. OMB has approved the information 
collection requirements contained in part 166 under OMB control No. 
2070-0032 (EPA ICR No. 596). In addition, EPA regulations in 40 CFR 
part 180 described the process and informational needs for requesting 
that the Agency establish or provide an exemption for the establishment 
of a tolerance or maximum residue level for the use of a pesticide on 
food crops. OMB has approved the information collection requirements 
contained in part 180 under OMB control No. 2070-0024 (EPA ICR NO. 
597).
    The public reporting and recordkeeping burden for the collection of 
information related to a section 18 exemption is estimated to average 
103 hours per response annually. This estimation is based on the number 
of requests for section 18 exemptions that the Agency received in 
fiscal year 1996 (October 1, 1995-September 30, 1996), and the 
estimated burden associated with submitting information related to a 
request for the establishment of a tolerance or an exemption for a 
tolerance. In FY 1996, EPA received requests for 478 emergency 
exemptions pursuant to section 18. According to EPA ICR No. 597, the 
Agency has estimated the annual burden to be 1,442 hours for providing 
information in support of a full tolerance request under section 3 of 
FIFRA.
    In general, ``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. The 
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. An Agency may not conduct or sponsor, and a person is not 
required to respond to a collection of information that requires 
approval under the PRA, unless it displays a currently valid OMB 
control number. The OMB control numbers for EPA's regulations are 
listed in 40 CFR part 9 and 48 CFR chapter 15.
    Comments are requested on the Agency's need for this information, 
the accuracy of the provided burden estimates, and any suggested 
methods for minimizing respondent burden, including through the use of 
automated collection techniques. Send comments on the ICR to EPA as 
part of your overall comments on this proposed action at the address 
provided above, or to the Director, OPPE Regulatory Information 
Division, Environmental Protection Agency (Mail Code 2137), 401 M St., 
SW., Washington, DC 20460, with a copy of any ICR comments to the 
Office of Information and Regulatory Affairs, Office of Management and 
Budget, 725 17th St., NW., Washington, DC 20503, marked ``Attention: 
Desk Officer for EPA.'' Please remember to include the ICR number in 
any correspondence. In developing the final rule, the Agency will 
address any comments received regarding the information collection 
requirements contained in this proposal.

D. Environmental Justice Considerations

    Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994), 
entitled Federal Actions to Address--Environmental Justice in Minority 
Population and Low-Income Populations, the Agency has considered 
environmental justice related issues with regard to the potential 
impacts of this action on the environmental and health conditions in 
low-income and minority communities. The Agency has found that this 
proposed rule does not directly affect minority populations or low-
income groups, but will be more protective of certain subpopulations 
such as infants and children.

E. Unfunded Mandates Reform Act

    Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) 
(Pub. L. 104-4), EPA has determined that this action does not contain a

[[Page 29830]]

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 one year. The costs associated with this action 
are described in the Executive Order 12866 section above. Therefore, 
this action is not subject to the requirements of sections 202 and 205 
of the UMRA.

F. Enhancing Intergovernmental Partnerships

    Under Executive Order 12875, entitled Enhancing Intergovernmental 
Parnterships (58 FR 58093, October 28, 1993), EPA may not issue a 
regulation that is not required by statute and that creates a mandate 
upon a State, local or tribal government, unless the Federal government 
provides the funds necessary to pay the direct compliance costs 
incurred by those governments. Today's proposal would implement 
requirements specifically set forth by the Congress in FFDCA section 
408(l)(6) without the exercise of any discretion by EPA. EPA consulted 
with various state officials during the development of this proposal, 
including representatives from the States of North Carolina and 
Washington, who acted as representatives of SFIREG.

G. Consultation and Coordination With Indian Tribal Governments

    Under Executive Order 13084, entitled Consulatation 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. Today's proposal would implement requirements specifically 
set forth by the Congress in FFDCA section 408(l)(6) without the 
exercise of any discretion by EPA. The proposal 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 proposal.

H. Children's Health Protection

    This proposed 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 that is not an 
economically significant regulatory action as defined by Executive 
Order 12866 (see Unit IX.A.). In addition, this proposed rule is 
procedural in nature and does not involve decisions on environmental 
health risks or safety risks that may disproportionately affect 
children.

I. National Technology Transfer and Advancement Act

    This proposed 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. EPA invites public 
comment on this conclusion.

List of Subjects in 40 CFR Part 176

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

    Dated: May 24, 1999.
Carol M. Browner,
Administrator.
    Therefore, it is proposed that 40 CFR chapter I be 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  Publications 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 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.

    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 a State, U.S. Territory, or Federal Agency that 
requests an emergency exemption under Secs. 166.20 through 166.35 of 
this chapter or declares a crisis exemption under Secs. 166.40 through 
166.53 of this chapter.
    Crisis exemption means an exemption authorized under FIFRA section 
18, in accordance with Secs. 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 
Secs. 166.20 through 166.35 of this chapter.
    EPA means the U.S. Environmental Protection Agency.
    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 subpart, 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

[[Page 29831]]

or feed resulting from the use of a pesticide chemical when EPA 
authorizes an emergency exemption or a crisis exemption. EPA will 
consider establishing such a tolerance only if an applicant under FIFRA 
section 18 either has requested an emergency exemption, or has stated 
its intention to declare a crisis exemption under FIFRA section 18 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, the available data are not adequate to support a 
reasonable certainty of no harm determination, 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 concludes that the tolerance will be safe, it may issue 
a regulation establishing the tolerance and publish a notice to that 
effect in the Federal Register.
    (b) A tolerance under this part may be established without prior 
public notification of a proposed tolerance or comment period.


Sec. 176.11  Duration of a tolerance.

    (a) Tolerances under this part become effective upon publication in 
the Federal Register, unless otherwise specified by the Administrator.
    (b) Tolerances will automatically expire and be revoked, without 
further action by EPA, at the time set out in the Federal Register 
notice estabishing the tolerance.
    (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 of expiration or revocation of a time-
limited tolerance, EPA may modify the time-limited tolerance by 
extending its duration. 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 State, U.S. Territory, or Federal Agency comply 
with procedures established in part 166 of this chapter for emergency 
exemptions of FIFRA.
[FR Doc. 99-14070 Filed 6-2-99; 8:45 am]
BILLING CODE 6560-50-M