[Federal Register Volume 64, Number 112 (Friday, June 11, 1999)]
[Rules and Regulations]
[Pages 31501-31505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14864]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300690B; FRL-6076-5]
RIN 2070-AB78
Certain Plant Regulators; Cytokinins, Auxins, Gibberellins,
Ethylene, and Pelargonic Acid; Exemptions from the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of the active ingredients cytokinins, auxins,
gibberellins, ethylene, and pelargonic acid in or on all food
commodities, when used as plant regulators and applied to plants,
seeds, or cuttings and on all food commodities after harvest. It does
not apply to residues of these substances that are intended to be
produced and used in living plants (also known as plant-pesticides),
which are being addressed in a future rulemaking. This regulation also
removes any existing crop-specific tolerances and/or exemptions from
the requirement of a tolerance for the subject active ingredients and
such tolerances are considered to be reassessed as required by the Food
Quality Protection Act of 1996 (FQPA). This regulation eliminates the
need to establish maximum permissible levels for residues of the
subject active ingredients. EPA has established this regulation on its
own initiative to facilitate the addition of new crops, application
rates, and uses to the labels of products containing the listed active
ingredients when used as plant regulators.
DATES: This regulation is effective June 11, 1999. Objections and
requests for hearings must be received by EPA on or before August 10,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300690B], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300690B], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, Crystal
Mall 2 (CM #2), 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: [email protected]. Copies of electronic objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of electronic
objections and hearing requests will also be accepted on disks in
WordPerfect 5.1/6.1 file format or ASCII file format. All copies of
electronic objections and hearing requests must be identified by the
docket number [OPP-300690B]. No Confidential Business Information (CBI)
should be submitted through e-mail. Copies of electronic objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Denise Greenway, c/o Product
Manager (PM) 90, Biopesticides and Pollution Prevention Division
(7511C), Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location, telephone number, and e-mail address: 9th
fl., CM #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-8263,
Greenway.D[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected categories and entities may include, but are not
limited to:
[[Page 31502]]
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Examples of
Category NAICS Potentially
Affected Entities
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Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
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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 the table in this unit
could also be affected. The North American Industrial Classification
System (NAICS) codes are provided to assist you in determining whether
or not this action applies to you. If you have questions regarding the
applicability of this action to a particular entity, consult the person
listed in the ``FOR FURTHER INFORMATION CONTACT'' section at the
beginning of this preamble.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain copies of this document and
certain other available support documents from the EPA Internet Home
Page at http://www.epa.gov/. On the Home Page select ``Laws and
Regulations'' 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/, or go directly to the Home Page for the Office of Pesticide
Programs at http://www.epa.gov/pesticides/op/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-300690B. The official
record consists of any documents that are 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), 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. The PIRIB telephone number is 703-305-5805.''
II. Background
In the Federal Register of October 23, 1998 (63 FR 56882) (FRL-
6019-7), EPA issued a proposal pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), as amended by
the Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) to
amend 40 CFR part 180 by establishing exemptions from the requirement
of a tolerance for the active ingredients cytokinins (specifically:
aqueous extract of seaweed meal and kinetin); auxins (specifically:
indole-3-acetic acid and indole-3-butyric acid); gibberellins
[gibberellic acids (GA3 and GA4 + GA7), and sodium or potassium
gibberellate]; ethylene; and pelargonic acid, in or on all food
commodities, when used as plant regulators on plants, seeds, or
cuttings and on all food commodities, after harvest, in accordance with
good agricultural practices. EPA concurrently proposed the revision or
revocation and removal of any existing crop-specific tolerances and/or
exemptions from the requirement of tolerances for the listed active
ingredients when used as plant regulators. In taking this action the
EPA will consider those tolerances and/or exemptions to be reassessed
(FFDCA 408(q) as amended by the FQPA of 1996).
The Agency has selected this group of plant regulators as the
subject of this rule due to their non-toxic mode of action, low
toxicity profile, low application rates, and the expectation that plant
regulator uses will not significantly increase their intake above
normally consumed levels. There are additional plant regulator active
ingredients which may meet the selection criteria. The Agency may, in
the future, propose a similar document addressing other candidate plant
regulator active ingredients.
All of the subject active ingredients are currently registered
plant regulators, with the exception of indole-3-acetic acid. The
Agency discourages the establishment (or existence) of tolerances, or
exemptions from the requirement of a tolerance, for active ingredients
for which there are no registered pesticide products. Therefore, the
proposal stated that any subsequent Final Rule would not include
indole-3-acetic acid (a naturally occurring analog of indole-3-butyric
acid) in the tolerance exemption for auxins, unless during the comment
period specific requests that it be included were received. Such
requests were required to document the commentor's intention to
promptly submit upon publication of the Final Rule an application to
register a plant regulator product containing indole-3-acetic acid as
an active ingredient.
The Agency made the proposal upon its own initiative to facilitate
the addition of new crops, application rates, and uses to the labels of
products containing the listed active ingredients when used as plant
regulators. A plant regulator is defined by EPA as ``...any substance
or mixture of substances intended, through physiological action, for
accelerating or retarding the rate of growth or rate of maturation, or
for otherwise altering the behavior of plants or the produce
thereof...'' (Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), section 2(v)).
Additionally, plant regulators are characterized by their low rates
of application; high application rates of the same compounds often are
herbicidal.
III. Response to Public Comments
In the Federal Register of January 8, 1999 (64 FR 1157), the Agency
reopened and extended by 30 days the original comment period associated
with the proposal of October 23, 1998. The 30-day extension was in
response to requests from the public for additional time to comment on
the Proposed Rule. There were thirteen comments: eight in support, two
pledging to register indole-3-acetic acid, two concerned with data
compensation issues and one seeking the addition of 1-naphthaleneacetic
acid (NAA) to the list of subject active ingredients.
The American Phytopathological Society (APS), the California Citrus
Quality Council, and the Wilbur-Ellis Company wrote in general support
of the Proposed Rule. The Interregional Research Project No. 4 (IR-4)
wrote in
[[Page 31503]]
support of the inclusion of the gibberellins. Westbridge Agricultural
Products; Atlantic Laboratories, Inc.; and Acadian Seaplants Limited
supported the proposal in general, and the inclusion of cytokinins in
particular. Aqua-10 Laboratories supported the proposal in general, and
the inclusion of cytokinins, auxins, and gibberellins in particular.
The APS letter also offered the view that the subject plant
regulator active ingredients ought not be regulated by EPA under FIFRA.
Agency Response: Deregulation of the subject active ingredients
under section 25(b) of FIFRA (exemption) is beyond the scope of this
Final Rule.
Plant Biotech, Inc. and JH Biotech, Inc. alerted the Agency of
their intention to submit applications for the registration of products
containing the active ingredient indole-3-acetic acid. This was in
response to the Agency's statement that indole-3-acetic acid would not
be included as an auxin exempted from the requirement of a tolerance in
the Final Rule unless a documented commitment to register pesticide
products containing it as an active ingredient was received during the
comment period.
Agency Response: The auxin indole-3-acetic acid has been retained
as a subject active ingredient exempted from the requirement of a
tolerance by this Final Rule.
AMVAC Chemical Corporation wrote in support of the proposal, and
also requested that the Agency add to the Final Rule, under auxins,
plant regulators based on 1-naphthaleneacetic acid (NAA). The company
argued that, ``the NAA products met the Agency's specified criteria for
inclusion in the Rule.''
Agency Response: First, the proposal and this Final Rule address
active ingredients, not the end-use products formulated from the
subject active ingredients. Second, the reach of the Final Rule cannot
exceed that of the proposal; NAA and related compounds were not
addressed in the proposal and so cannot be included in the Final Rule.
Third, the proposal acknowledged that active ingredients other than
those included may meet the selection criteria, and stated that such
active ingredients may be considered in the future should the Agency
prepare a similar document. Fourth, the data sets reviewed for the
subject active ingredients are complete in that all were registered
post FIFRA 1984, thus meeting the current data requirements, or were
(or are a naturally occurring analog of) the subject of an existing
Reregistration Eligibility Document (RED). Only upon the completion of
the pending NAA RED can a decision on its candidacy for a broad
tolerance exemption be assessed.
Abbott Laboratories and Agtrol International wrote seeking
assurance that their FIFRA data compensation privileges for
gibberellins data would not be lost as a result of the establishment of
the exemption from tolerance for that plant regulator active
ingredient.
Agency Response: The standard for establishment of a tolerance
exemption under section 408(c)(2) does not include a consideration of
the effects such exemption may have regarding FIFRA compensation
rights. In addition, the establishment of an exemption from the
requirement of a tolerance for residues of a pesticide under FFDCA does
not alter existing FIFRA data requirements or the need to comply with
the data compensation provisions of FIFRA. Applicants for FIFRA
registrations will continue to be required to submit or cite supporting
data on the subject plant regulator active ingredients, or obtain
waivers from the data requirements. The citation of compensable data
(as defined by FIFRA section 3(c)) still must be accompanied by an
offer to pay.
IV. Risk Assessment and Statutory Findings
New section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(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.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. 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...''Additionally, section 408 (b)(2)(D) requires that the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
Based on the information and data considered and discussed in the
proposal, the Agency has determined that use of these pesticides as
plant regulators will not pose a dietary risk under reasonably
foreseeable circumstances. Accordingly, EPA concludes that, in amending
40 CFR part 180, to establish the exemptions as proposed, there is a
reasonable certainty that no harm to the general population, including
infants and children, will result from aggregate exposure to the
pesticide chemical residues of the subject active ingredients, when
used as plant regulators.
In reaching this conclusion, EPA considered the potential
cumulative effects from substances with a common mechanism of toxicity.
The subject plant regulator active ingredients are found in most
plants, and some are synthesized structural analogs which function like
those occurring naturally. The amounts found in or applied to plants
are low enough to regulate growth by a variety of different modes of
action without being toxic to the plant (non-toxic modes of action). In
addition, toxicological studies on the subject plant regulators at high
dose levels (at or above limit doses) identified no toxic endpoints for
risk assessment, and these substances are naturally occurring in the
normal human diet. Therefore, EPA concluded there was no significant
potential for cumulative effects for the subject active ingredients.
V. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a regulation for an exemption from the
requirement of a tolerance issued by EPA under new section 408(d) and
as was provided in the old section 408 and in section 409. However, the
period for filing objections is 60 days, rather than 30 days. EPA
[[Page 31504]]
currently has procedural regulations which govern the submission of
objections and hearing requests. These regulations will require some
modification to reflect the new law. However, until those modifications
can be made, EPA will continue to use those procedural regulations with
appropriate adjustments to reflect the new law.
Any person may, by August 10, 1999, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the hearing clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement
``when in the judgement of the Administrator such a waiver or refund is
equitable and not contrary to the purpose of this subsection.'' For
additional information regarding tolerance objection fee waivers,
contact James Tompkins, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Rm. 239, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA,
(703) 305-5697, [email protected]. Requests for waiver of tolerance
objection fees should be sent to James Hollins, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues(s) on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the objector (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is a genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issues(s) in the manner sought by the requestor would be
adequate to justify the action requested (40 CFR 178.32). Information
submitted in connection with an objection or hearing request may be
claimed 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 information
that does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential may be disclosed publicly
by EPA without prior notice.
VI. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes exemptions from the tolerance
requirement under section 408(d) of the FFDCA. The Office of Management
and Budget (OMB) has exempted these types of actions from review under
Executive Order 12866, entitled Regulatory Planning and Review (58 FR
51735, October 4, 1993). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require any special considerations as required by Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994), or require OMB review in accordance with Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997).
Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.),
the Agency previously assessed whether establishing tolerances,
exemptions from tolerances, raising tolerance levels or expanding
exemptions might adversely impact small entities and concluded, as a
generic matter, that there is no adverse economic impact. The factual
basis for the Agency's generic certification for tolerance actions
published on May 4, 1981 (46 FR 24950), and was provided to the Chief
Counsel for Advocacy of the Small Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (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. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
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. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of
[[Page 31505]]
section 3(b) of Executive Order 13084 do not apply to this rule.
VII. Submission to Congress and the Comptroller General
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 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 rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 17, 1999.
Susan B. Hazen,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
Sec. 180.224 [Removed]
2. By removing Sec. 180.224.
3. Section 180.1016 paragraph (a) is revised to read as follows:
Sec. 180.1016 Ethylene; exemption from the requirement of a tolerance.
* * * * *
(a) For all food commodities, it is used as a plant regulator on
plants, seeds, or cuttings and on all food commodities after harvest
and when applied in accordance with good agricultural practices.
* * * * *
Sec. 180.1042 [Removed]
4. By removing Sec. 180.1042.
5. By revising Sec. 180.1098, to read as follows:
Sec. 180.1098 Gibberellins [Gibberellic Acids (GA3 and GA4 + GA7), and
Sodium or Potassium Gibberellate]; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of gibberellins [gibberellic acids (GA3 and GA4 + GA7), and
sodium or potassium gibberellate] in or on all food commodities when
used as plant regulators on plants, seeds, or cuttings and on all food
commodities after harvest in accordance with good agricultural
practices.
Sec. 180.1099 [Removed]
6. By removing Sec. 180.1099.
7. By adding new Secs. 180.1157 and 180.1158 to subpart D to read
as follows:
Sec. 180.1157 Cytokinins; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of cytokinins (specifically: aqueous extract of seaweed meal
and kinetin) in or on all food commodities when used as plant
regulators on plants, seeds, or cuttings and on all food commodities
after harvest in accordance with good agricultural practices.
Sec. 180.1158 Auxins; exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of auxins (specifically: indole-3-acetic acid and indole-3-
butyric acid) in or on all food commodities when used as plant
regulators on plants, seeds, or cuttings and on all food commodities
after harvest in accordance with good agricultural practices.
8. Section 180.1159 paragraph (a) is revised to read as follows:
Sec. 180.1159 Pelargonic acid; exemption from the requirement of
tolerances.
(a) An exemption from the requirement of a tolerance is established
for residues of pelargonic acid in or on all food commodities when used
as a plant regulator on plants, seeds, or cuttings and on all food
commodities after harvest in accordance with good agricultural
practices.
* * * * *
[FR Doc. 99-14864 Filed 6-10-99; 8:45 am]
BILLING CODE 6560-50-F