[Federal Register: September 21, 2005 (Volume 70, Number 182)]
[Proposed Rules]
[Page 55326-55329]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21se05-42]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0344; FRL-7719-7]
C8, C10, and C12 Straight-Chain Fatty Acid Monoesters of Glycerol
and Propylene Glycol; Amendment to Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to amend an exemption from the
requirement of a tolerance for residues of the C8, C10, and C12
straight- chain fatty acid monoesters of glycerol and propylene glycol
on all food commodities when applied/used for both pre-harvest and
post-harvest purposes. On June 23, 2004, EPA established an exemption
from the requirement of a tolerance for these residues but did not
expressly approve post-harvest uses in accordance with 40 CFR 180.1(i).
Therefore, EPA is proposing this regulation, to amend the existing
tolerance exemption to allow for post-harvest uses of C8, C10, and C12
straight-chain fatty acid monoesters of glycerol and propylene glycol
in accordance with section 408(e) of the Federal Food, Drug, and
Cosmetic Act (FFDCA) as amended by the Food Quality Protection Act of
1996 (FQPA).
DATES: Comments, identified by docket ID number OPP-2004-0344, must be
received on or before October 6, 2005.
ADDRESSES: Submit your comments, identified by docket ID number OPP-
2004-0344, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov/.
Follow the on-
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line instructions for submitting comments.
Agency Website: http://www.epa.gov/edocket/. EDOCKET,
EPA's electronic public docket and comment system, is EPA's preferred
method for receiving comments. Follow the on-line instructions for
submitting comments.
E-mail: Comments may be sent by e-mail to
opp-docket@epa.gov, Attention: Docket ID Number OPP-2004-0344.
Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001, Attention: Docket ID Number OPP-2004-0344.
Hand delivery: Public Information and Records Integrity
Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental
Protection Agency, Rm. 119, Crystal Mall 2, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID Number OPP-2004-0344. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
Instructions: Direct your comments to docket ID number OPP-2004-
0344. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
http://www.epa.gov/edocket/, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through EDOCKET,
regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov
websites are ``anonymous access'' systems, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA
without going through EDOCKET or regulations.gov, your e-mail address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the Internet. If
you submit an electronic comment, EPA recommends that you include your
name and other contact information in the body of your comment and with
any disk or CD ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit EDOCKET on-line or see the Federal Register of May 31,
2002 (67 FR 38102) (FRL-7181-7).
Docket: All documents in the docket are listed in the EDOCKET index
at http://www.epa.gov/edocket/. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in EDOCKET or in hard
copy at the Public Information and Records Integrity Branch (PIRIB),
Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This
Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Carol E. Frazer, Biopesticides and
Pollution Prevention Division (7511C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8810; fax
number: (703) 308-7026; e-mail address: frazer.carol@epa.gov.
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 entities may include, but are not limited to:
Crop production (NAICS code 111)
Pesticide manufacturing (NAICS code 32532)
Animal production (NAICS code 112)
Food manufacturing (NAICS code 311)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
C. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM
as CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the rulemaking by docket ID number and other
identifying information (subject heading, Federal Register date, and
page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
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viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
EPA on its own initiative, pursuant to section 408(e) of the FFDCA,
21 U.S.C. 346a(e), is proposing to amend 40 CFR part 180 by adding
post-harvest uses to the language in 40 CFR 180.1250. In the Federal
Register of June 23, 2004 (69 FR 34937) (FRL-7352-6), EPA issued a
final rule pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C.
346a(d)(3), establishing an exemption from the requirement of a
tolerance for residues of the C8, C10, and C12 straight-chain fatty
acid monoesters of glycerol and propylene glycol after reviewing a
petition for a tolerance exemption (PP 1F6314) submitted by 3M
Corporation, 3M Center, St. Paul MN 55144-1000.
The Notice of Filing of a Pesticide Petition to Establish a
Tolerance for a Certain Pesticide Chemical in or on Food (66 FR 64251,
December 12, 2001) (FRL-6809-8) failed to notify the public that the
C8, C10, and C12 straight-chain fatty acid monoesters would be used for
post-harvest applications ``to control spoilage of food and feed crops
after harvest.'' Even though the first page of 3M's petition for a
tolerance exemption stated that its proposed end use products, which
contain the fatty acid monoesters that are the subject of this
tolerance rule amendment, were to be used for the ``treatment of
potatoes after harvest to prevent spoilage in storage,'' the summary of
the petition that was published in the Federal Register Notice did not
specifically mention the post-harvest use. Under 40 CFR 180.1(i),
``[u]nless otherwise specified, tolerances and exemptions established
under the regulations in this part apply to residues from only pre-
harvest application of this chemical.''
In the preamble to the June 23, 2004 rule establishing the
exemption for these monoesters (69 FR 34937) (Unit IV.A.1, Aggregate
Exposures), EPA relies upon the aggregate dietary exposure estimates
generated by 3M using EPA's Dietary Exposure Potential Model. Although
not expressly stated in that rule, those residue estimates included
post-harvest exposures. In order to simulate a worst-case exposure
analysis, 18 different raw agricultural commodities from seeds for
sprouts to leafy vegetables like spinach to solid produce like apple
and potato were obtained from local supermarkets in St. Paul, Minnesota
and soaked in a typical diluted treatment solution for 15 minutes to
provide an idea about post-harvest residues on agricultural
commodities. As can be seen from this, the Agency's evaluation of
residue levels of these chemicals' pesticide usage included both the
extant residues resulting from pre-harvest applications and the
residues resulting from the proposed post-harvest use.
Even if the exposure resulting from post-harvest use was
significantly higher than exposure based on only pre-harvest use of
monoesters as pesticides, the Agency is not concerned due to the low to
non-existent toxicity level of these fatty acids. The preamble to the
June 23, 2004 rule (69 FR 34937) discusses the long history of
consumption by humans of fatty acids and their monoesters in food and
the Agency knows of no instance where these have been associated with
any toxic effects related to the consumption of the food. Due to this
knowledge of fatty acid monoesters' presence and function in the human
system and the acute testing, EPA believes the fatty acid monoesters
are unlikely to be carcinogenic or have other long-term toxic effects.
The data from the residue information, the toxicity studies, and the
additional information from the scientific literature submitted by the
registrant are sufficient to demonstrate that no substantial risks to
human health are expected from the use of glycerol or propylene glycol
fatty acid monoesters, even when used on crops post-harvest, when used
in accordance with good agricultural practices and in accordance with
all relevant labeling.
B. What is the Agency's Authority for Taking this Action?
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 exemption is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA
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. Pursuant to section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C), which require 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) of the FFDCA 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.''
Section 408(c)(1)(B) of the FFDCA allows EPA to modify a regulation
on its own initiative under section 408(e). Section 408(e) requires EPA
to issue a notice of proposed rulemaking and provide a public comment
period of not less than 60 days. However, this provision also allows
EPA to shorten the comment period if the Administrator for good cause
finds that it would be in the public interest to do so and states the
reasons for the finding in the notice of proposed rulemaking. For this
particular rule, EPA has shortened the public comment period to 15 days
because the Agency believes that it is in the public interest to do so.
The first end-use product using one of these pesticide active
ingredients has been approved, and growers face a potential hardship if
a decision is not made expeditiously.
EPA on its own initiative, under section 408(e) of the FFDCA, 21
U.S.C. 346a(e), is proposing to amend 40 CFR 180.1250.
III. Statutory and Executive Order Reviews
This proposed rule amends an exemption from the tolerance
requirement under section 408(e) of the FFDCA, as an action taken on
the Agency's own initiative to correct an oversight in establishing the
current tolerance exemption for the C8, C10, and C12 straight-chain
fatty acid monoesters of glycerol and propylene glycol to allow for
both pre-harvest and post-harvest uses. 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). Because this proposed rule has been exempted
from review under Executive Order 12866 due to its lack of
significance, this proposed rule is not subject to Executive Order
13211, Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed
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
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unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review
or any Agency action under Executive Order 13045, entitled Protection
of Children from Environmental Health Risks and Safety Risks (62 FR
19885, April 23, 1997). This 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). The Regulatory Flexibility
Act (RFA) (5 U.S.C. 601 et seq.) generally requires an Agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedure
Act or any other statute unless the agency certifies that the rule will
not have a significant impact on a substantial number of small
entities. Small entities include small businesses, small organizations,
and small governmental organizations. After considering the economic
impact of this proposed rule on small entities, the Agency hereby
certifies that this proposed rule will not have significant negative
economic impact on a substantial number of small entities. Establishing
an exemption from the requirement of a pesticide tolerance (or,
amending a tolerance exemption, as is proposed), is in effect, the
removal of a regulatory restriction on pesticide residues in food and
thus such an action will not have any negative economic impact on any
entities, including small entities. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This
proposed rule directly regulates growers, food processors, food
handlers and food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this
proposed rule does not have any ``tribal implications'' as described in
Executive Order 13175, entitled Consultation and Coordination with
Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive
Order 13175, requires EPA to develop an accountable process to ensure
``meaningful and timely input by tribal officials in the development of
regulatory policies that have tribal implications.'' ``Policies that
have tribal implications'' is defined in the Executive Order to include
regulations that have ``substantial direct effects on one or more
Indian tribes, on the relationship between the Federal Government and
the Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.'' This proposed rule
will not have substantial direct effects on tribal governments, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule. The
Agency hereby certifies that this proposed action will not have
significant negative economic impact on a substantial number of small
entities.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 7, 2005.
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 would continue to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. By revising Sec. 180.1250 to read as follows:
Sec. 180.1250 C8, C10, and C12 straight-chain fatty acid monoesters
of glycerol and propylene glycol; exemption from the requirement of a
tolerance.
The C8, C10, and C12 straight-chain fatty acid monoesters of
glycerol (glycerol monocaprylate, glycerol monocaprate, and glycerol
monolaurate) and propylene glycol (propylene glycol monocaprylate,
propylene glycol monocaprate, and propylene glycol monolaurate) are
exempt from the requirement of a tolerance in or on all food
commodities when used for both pre-harvest and post-harvest purposes,
in accordance with approved label rates and good agricultural practice.
[FR Doc. 05-18724 Filed 9-20-05; 8:45 am]
BILLING CODE 6560-50-S