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pelargonic acid Tolerance Exemption 10/98


[Federal Register: October 23, 1998 (Volume 63, Number 205)]
[Proposed Rules]               
[Page 56882-56886]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23oc98-22]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300690; FRL-6019-7]
RIN 2070-AC18

 
Certain Plant Regulators, Cytokinins, Auxins, Gibberellins, 
Ethylene, and Pelargonic Acid; Tolerance Exemptions

AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.

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SUMMARY: EPA proposes to establish 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 on plants, seeds, or 
cuttings and on all food commodities after harvest. EPA also proposes 
to remove any existing crop-specific tolerances and/or exemptions from 
the requirement of a tolerance for the subject active ingredients as 
well as considering such tolerances to be reassessed as required by the 
Food Quality Protection Act of 1996 (FQPA). EPA is proposing 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: Comments, identified by the docket control number [OPP-300690], 
must be received on or before December 22, 1998.
ADDRESSES: 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., SW., Washington, DC 20460. In person, deliver comments to: 
Rm. 119, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    Comments and data may also be submitted electronically to: opp-
docket@epamail.epa.gov. Follow the instructions under Unit VI of this 
document. No Confidential Business Information (CBI) should be 
submitted through e-mail.
    Information submitted as a comment concerning this document 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 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. The public docket is 
available for public inspection in Rm. 119 at the Virginia address 
given above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Denise Greenway, c/o Product 
Manager (PM) 90, Biopesticides and Pollution Prevention Division 
(7511C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. Office location, telephone number 
and e-mail address: 9<SUP>th</SUP> fl., Crystal Mall #2, 1921 Jefferson 
Davis Hwy., Arlington, VA 22202; (703) 308-8263; 
greenway.denise@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA proposes 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 (GA<INF>3</INF> 
and GA<INF>4</INF> + GA<INF>7</INF>), 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 proposes 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 EPA 
will consider those tolerances and/or exemptions to be reassessed 
(Federal Food, Drug, and Cosmetic Act, 408(q) as amended by the FQPA of 
1996).
    The Agency has selected this group of plant regulators as the 
subject of this proposal due to their non-toxic mode of action, 
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, any 
Final Rule subsequent to this proposal will 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 are received. Such requests must 
document the intention of the commentor 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 is making this 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...'' (FIFRA sec. 2 (v)). Additionally, plant 
regulators are characterized by their low rates of application; high 
application rates of the same compounds often are herbicidal.

I. Risk Assessment and Statutory Findings

    New section 408(c)(2)(A)(i) allows EPA to establish an exemption 
from the requirement of a tolerance (the legal limit for a pesticide 
chemical residue in or on a food) only if EPA determines that the 
exemption 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

[[Page 56883]]

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 an exemption 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)(v) 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.

 II. Toxicological Profile

    EPA has assessed the toxicology data base for the subject plant 
regulators and has sufficient data to assess the hazards and to make a 
determination on aggregate exposure, consistent with section 408(c)(2), 
for the exemptions from the requirement of a tolerance. EPA's 
assessment of the exposures, including dietary exposure, and risks 
associated with establishing these exemptions follows.

A. Waiver of Data Due to Low Toxicity

    Tolerance exemptions for these types of substances are usually 
based on the results of subchronic feeding, developmental toxicity and 
mutagenicity studies, but for many of the plant regulators some or all 
of these study requirements have been waived because of negligible 
exposure from very low use rates. Such use rates for these active 
ingredients are expected to be effective when these substances are used 
as plant regulators and these low use rates are not expected to 
significantly increase dietary intake over that anticipated from 
consumption of a normal diet because the subject active ingredients are 
naturally occurring (or are synthesized to approximate the naturally 
occurring forms) in plants. Plants are part of a normal human diet. 
These substances are effective plant regulators when applied at low 
rates, but are often herbicidal when applied at high rates. The 
toxicological data presented below demonstrate that testing at high 
doses yields few effects in laboratory animals. Doses high enough to 
cause toxicity in animal studies would represent application rates 
toxic to crops (high, herbicidal rates), whereas the subject of this 
proposal is the plant regulator (low rates) use.
    Human health data requirements for indole-3-butyric acid were 
waived for these reasons. Also, data from the published literature on 
ethylene, and the absence of any reports of significant toxicity from 
its widespread clinical use as an anesthetic were accepted by the 
Agency as sufficient to support the conclusion that ethylene will be 
nontoxic to humans under the conditions of use as a plant regulator 
(including low application rate), and no additional toxicity data on 
ethylene are required. No additional toxicity data are needed for 
cytokinins since they are naturally occurring in numerous plant food 
sources and are available as a food supplement.
    Because there are no registered pesticide products with indole-3-
acetic acid as the active ingredient, no data have been received or 
reviewed. Indole-3-acetic acid is a naturally occurring analog of 
indole-3-butyric acid, for which all human health data were waived for 
the reasons discussed above. Human health data on indole-3-acetic acid 
would be similarly waived.
    A full Tier I data set (40 CFR 158.690) was available and reviewed 
for the gibberellins.
    The 90-day oral toxicity study on pelargonic acid was waived on the 
strength of the absence of toxic effects at or below a limit dose 
(1,000 milligrams/kilogram/day (mg/kg/day)) in the 2-week range finding 
and developmental toxicity test results.

B. Data on Acute Toxicity

    The mammalian acute toxicity data for the plant regulators 
considered in this exemption indicate low toxicity following single 
oral, dermal, or inhalation exposures (Toxicity Category III or IV). 
When tested for primary eye irritation, results for some of the subject 
active ingredients (pelargonic acid and indole-3-butyric acid, only) 
placed them in Toxicity Category II, but these findings do not 
adversely affect the proposed tolerance exemptions, which are based on 
dietary exposures. Prevention of eye irritation is addressed through 
protective equipment required by the product labels.

C. Other Toxicity Data

    Subchronic toxicity data and genotoxicity assays were considered 
for gibberellins and pelargonic acid.
    In two subchronic dietary studies of GA<INF>3</INF> and 
GA<INF>4</INF> + GA<INF>7</INF> in rats, the No Observed Adverse Effect 
Levels (NOAELs) approached or exceeded an oral limit dose (1,000 mg/kg/
day), and the Lowest Observed Adverse Effect Levels (LOAELs) were 
twofold to fivefold higher than the limit dose. An oral developmental 
toxicity study with GA<INF>3</INF> in rats resulted in maternal and 
developmental toxicity NOAELs equal to or greater than the oral limit 
dose (highest dose tested), but an oral developmental toxicity study 
with GA<INF>4</INF> + GA<INF>7</INF> in rabbits established maternal 
and developmental toxicity NOAELs at 300 mg/kg/day. The highest dose 
tested (1,000 mg/kg/day) increased incidences of mortality, abortion, 
clinical signs of toxicity and gross pathological observations. 
GA<INF>4</INF> + GA<INF>7</INF> had no genotoxic effects at or below 
limit doses in a reverse mutation assay with Salmonella typhimurium, in 
an in vivo mouse micronucleus test, and in an in vitro UDS (unscheduled 
DNA synthesis) assay at concentrations up to 1,260 <greek-m>g/ml. 
GA<INF>3</INF> was also negative at or below limit concentrations in S. 
typhimurium reverse mutation assays and in an in vitro mouse lymphoma 
cell assay. However, an in vitro cytogenetics assay in human 
lymphocytes demonstrated chromosomal effects at 4,500 <greek-m>g/ml 
with metabolic activation and at 2,500 <greek-m>g/ml without metabolic 
activation which suggested a potential concern for induction of 
chromosome damage in vitro. These two doses reduced the mitotic index 
of test cultures by 69% and 50% compared with control cultures for the 
4,500 and 2,500 <greek-m>g/ml levels, respectively, which indicated 
that these dose levels had excessive cytotoxicity. In addition, dose 
levels equal to or less than 2,500 <greek-m>g/ml with metabolic 
activation or 1,250 <greek-m>g/ml in the absence of metabolic 
activation did not induce chromosomal aberrations.
    A 14-day range finding test with pelargonic acid to determine 
dosing concentrations for a 90-day rat oral toxicity study revealed no 
adverse effects from pelargonic acid at any dose level, including the 
highest dose of 20,000 ppm (2 percent of the diet), or 1,834 mg/kg/day 
(a level exceeding the limit dose of 1,000 mg/kg/day). These results 
and those from the developmental toxicity study described below 
indicated that a 90-day oral toxicity study is not necessary for 
dietary risk assessment. No evidence of maternal or developmental 
toxicity was

[[Page 56884]]

seen in an oral developmental toxicity screen with pelargonic acid at a 
limit dose (1,500 mg/kg/day). No dermal or systemic toxicity and no 
increased incidence of tumors were observed in a chronic dermal 
toxicity study in mice; the mice were treated twice weekly with 50 mg 
doses of undiluted pelargonic acid for 80 weeks. Pelargonic acid was 
shown not to be genotoxic in bacteria (S. typhimurium) at limit 
concentrations (5,000 <greek-m>g/plate) or in an in vivo mouse 
micronucleus assay at dose levels of 1,250, 2,500 or 5,000 mg/kg. In an 
in vitro mouse lymphoma forward mutation assay pelargonic acid induced 
a mutagenic response at levels greater than or equal to 50 <greek-m>g/
ml with metabolic activation. However, the small sizes of the mutant 
colonies indicated that the genetic damage was associated with 
chromosomal damage instead of specific gene mutations. Pelargonic acid 
in the absence of metabolic activation did not induce gene mutations in 
mouse lymphoma cells at concentrations as high as 1,200 <greek-m>g/ml, 
and higher concentrations were cytotoxic. The in vivo mouse 
micronucleus assay with pelargonic acid did not corroborate the 
chromosomal findings in the in vitro mouse lymphoma assay.

III. Aggregate Exposures

    In examining aggregate exposure, FQPA directs EPA to consider 
available information concerning exposures from the pesticide residue 
in food and drinking water and all other non-occupational exposures, 
including exposure through pesticide use in gardens, lawns, or 
buildings (residential and other indoor uses).

A. Dietary Exposure

    The mammalian toxicology data for these plant regulators indicate 
low acute toxicity following oral exposure (Toxicity Category III or 
IV). At the levels used as plant regulators, human dietary exposure is 
expected to be negligible and acute toxicity from such exposure is not 
expected. Subchronic and developmental toxicity studies indicated that 
toxicity did not occur as a result of repeated oral doses at or above 
1,000 mg/kg of body weight, and no mutagenic activity was observed. 
Therefore, it is unlikely that chronic dietary exposures would be high 
enough to result in effects harmful to humans.
    1. Food. Residue analyses data, if any have been submitted, are not 
a component of this determination since these plant regulators either 
are naturally occurring in many food plants and are therefore a 
component of the normal human diet, and/or are used at very low rates. 
The Agency believes that use of the above plant regulators will result 
in negligible to nonexistent residues in or on foods or feed.
    2. Drinking water exposure. For the purposes of assessing the 
potential dietary exposure under these exemptions, EPA considered that 
under these exemptions the subject active ingredients could be present 
in all food commodities. Other potential sources of dietary exposure of 
the general population to residues of pesticides are residues in 
drinking water. Based on the available studies used in EPA's assessment 
of environmental risk, EPA does not anticipate residues of the subject 
active ingredients in drinking water.

B. Other Non-occupational Exposure

    For the subject active ingredients, the toxicity data demonstrated 
no toxic endpoints upon which to base a risk characterization at or 
below 1,000 mg/kg of body weight/day (the limit dose). Any non-
occupational risk is expected to be insignificant because of the non-
toxic mode of action and low exposure resulting from the low plant 
regulator application rates. Also, the subject active ingredients are 
naturally occurring in foods and turf, or are synthetics approximating 
the natural forms in structure and activity. Additionally, appropriate 
label precautions will mitigate risk from exposure through residential 
(home and garden) use.
    1. Dermal exposure. The mammalian toxicology data for these plant 
regulators indicate low acute toxicity following dermal exposure 
(Toxicity Category III or IV), with the following exception. Acute 
toxicity studies placed technical pelargonic acid in Toxicity Category 
II for primary dermal irritation.
    2. Inhalation exposure. The mammalian toxicology data for these 
plant regulators indicate low acute toxicity following inhalation 
exposure (Toxicity Category III or IV).

IV. Other Considerations

A. Endocrine Disruptors

    The Agency has no information to suggest that the subject plant 
regulators will have an effect on the immune and endocrine systems. The 
Agency is not requiring information on the endocrine effects of these 
biological plant regulators at this time; Congress has allowed 3 years 
after August 3, 1996, for the Agency to implement a screening program 
with respect to endocrine effects. Because of the long-term history of 
natural exposure in the diet, it is not anticipated that the subject 
active ingredients will require endocrine effects screening.

B. Analytical Method(s)

    The Agency proposes to establish exemptions from the requirement of 
a tolerance without any numerical limitation; therefore, the Agency has 
concluded that analytical methods are not required for enforcement 
purposes for any of the subject active ingredients.

C. Codex Maximum Residue Level

    There are no CODEX tolerances nor international tolerance 
exemptions established for the subject active ingredients, when used as 
plant regulators, at this time.

V. Safety Determination for U.S. Population, Infants and Children

    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of exposure (safety) for infants and children in the 
case of threshold effects to account for pre- and post-natal toxicity 
and the completeness of the data base, unless EPA determines that a 
different margin of exposure (safety) will be safe for infants and 
children.
    Margins of exposure (safety) are often referred to as uncertainty 
(safety) factors. In this instance, the Agency believes that there are 
reliable data to support the conclusion that the subject active 
ingredients when used as plant regulators are practically non-toxic to 
mammals, including infants and children, and, thus, there are no 
threshold effects, and EPA has not used a margin of exposure (safety) 
approach to assess their safety. As a result, the provision requiring 
an additional margin of exposure (safety) does not apply.
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action.
    Based on the information and data considered, the Agency has 
determined that use of these pesticides as plant growth regulators will 
not pose a dietary risk under reasonably foreseeable circumstances.
    As to cytokinins, auxins, and ethylene, the lack of concern 
regarding toxic effects (as evidenced by the waivers of data on indole-
3-butyric acid and cytokinins, and the reliance upon public literature 
on ethylene), plus the low plant regulator application rates, and the 
expectation that plant regulator uses will not significantly increase 
intake of these active ingredients above normally consumed levels 
demonstrate that there is reasonable certainty of no harm from their 
use as plant regulators.

[[Page 56885]]

    As to gibberillins, although there were some positive results at 
cytotoxic doses from genotoxicity assays, the negative results from the 
other genotoxicity assays with gibberellins, low plant regulator 
application rates, and the expectation that plant regulator uses will 
not significantly increase intake of gibberellins above normally 
consumed levels demonstrate that there is reasonable certainty of no 
harm from use of gibberellins as plant regulators.
    As to pelargonic acid, the results of the toxicity studies, 
negative results in two of the three genotoxicity assays, low plant 
regulator application rates, and the expectation that plant regulator 
uses will not significantly increase intake of pelargonic acid above 
normally consumed levels demonstrate that there is reasonable certainty 
of no harm from use of this substance as a plant regulator.
     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. The 
safety of infants and children is supported by oral toxicity data 
indicating that, for the subject active ingredients, the doses must 
exceed 1,000 mg/kg/day before toxicity occurs.

VI. Public Record and Electronic Submissions

    The official record for this rulemaking, as well as the public 
version, has been established for this rulemaking under docket control 
number [OPP-300690] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The official rulemaking record is located at the Virginia 
address in ``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    opp-docket@epamail.epa.gov

    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-300690]. Electronic comments on this 
proposed rule may be filed online at many Federal Depository Libraries.

VII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This action proposes exemptions from the tolerance requirement 
under FFDCA section 408(d). 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). In addition, this proposed action 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).
    In addition, 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 Intergovernmental 
Partnerships (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 proposed 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 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 proposed 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 section 3(b) of Executive Order 13084 do not apply to 
this rule.

List of Subjects in 40 CFR Part 180

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


[[Page 56886]]


    Dated: October 13, 1998.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.
    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 371.

Sec. 180.224 [Removed]

    2. By removing Sec. 180.224 Gibberellins; tolerances for residues.
    3. In Sec. 180.1016 by revising paragraph (a) 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 Aqueous extract of seaweed meal; 
exemption from the requirement of a tolerance.
    5. By revising Sec. 180.1098, to read as follows:


 Sec. 180.1098  Gibberellins [Gibberellic Acids (GA<INF>3</INF> and 
GA<INF>4</INF> + GA<INF>7</INF>), 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 (GA<INF>3</INF> and 
GA<INF>4</INF> + GA<INF>7</INF>), 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 Indole butyric acid (IBA); exemption 
from the requirement of a tolerance.
    7. In Sec. 180.1159 by revising paragraph (a) 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.
*      *      *      *      *
    8. By adding new Sec. 180.1157 and Sec. 180.1158 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.

[FR Doc. 98-28360 Filed 10-22-98; 8:45 am]
BILLING CODE 6560-50-F