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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300690A; FRL-6019-8]

RIN 2070-AC18

Certain Plant Regulators: Cytokinins, Auxins, Gibberellins,

Ethylene, and Pelargonic Acid; Tolerance Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: EPA is reopening and extending by 30 days the original 60-day

comment period associated with its October 23, 1998, proposal (63 FR

56882) 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 proposed 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 proposed the 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. This 30-day extension is in

response to requests from the public for additional time to comment on

the Proposed Rule.

DATES: Comments, identified by the docket control number [OPP-300690A],

must be received on or before February 8, 1999.

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 22202.

Comments and data may also be submitted electronically to: opp-

[email protected]

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 22202.

Comments and data may also be submitted electronically to: opp-

[email protected]. Follow the instructions under Unit I 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: 9th fl., Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA 22202; (703) 308-8263; e-mail:

[email protected]

ON 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: 9th fl., Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA 22202; (703) 308-8263; e-mail:

[email protected].

SUPPLEMENTARY INFORMATION: In the October 23, 1998, issue of the

Federal Register (63 FR 56882)(FRL-6019-7) the Office of Pesticide

Programs issued a Proposed Rule 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 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 60-day comment period originally associated with the

proposal, which expired on December 22, 1998, is being reopened and

extended by 30 days in response to requests from the public for

additional time to comment

lators. 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 60-day comment period originally associated with the

proposal, which expired on December 22, 1998, is being reopened and

extended by 30 days in response to requests from the public for

additional time to comment.

The Agency selected this group of plant regulators as the subject

of the 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 the 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 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

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 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***'' (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. 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-300690A] (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:

[email protected]

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-300690A]. Electronic comments on this

proposed rule may be filed online at many Federal Depository Libraries.

II. Regulatory Assessment Requirements

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-300690A]. Electronic comments on this

proposed rule may be filed online at many Federal Depository Libraries.

II. 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

ing 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

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.

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.

Dated: December 29, 1998.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of

Pesticide Programs.

[FR Doc. 99-429 Filed 1-7-99; 8:45 am]

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