[Federal Register: January 25, 2006 (Volume 71, Number 16)]
[Proposed Rules]
[Page 4087-4090]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ja06-27]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0487; FRL-7754-8]
Pesticides: Minimal Risk Tolerance Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to reorganize certain existing
tolerance exemptions. All of these chemical substances were reviewed as
part of the tolerance reassessment process required under the Food
Quality Protection Act of 1996 (FQPA). As a result of that review, 13
chemical substances are now classified as ``minimal risk.'' The Agency
intends to shift the existing tolerance exemptions for these chemicals
to 40 CFR 180.950(e). The Agency is merely moving certain tolerance
exemptions from one section of the CFR to another section: No tolerance
exemptions are lost or added as a result of this action.
DATES: Comments must be received on or before March 27, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0487, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov/.
Follow the on-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 EPA-HQ-OPP-2005-0487.
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 EPA-HQ-OPP-2005-0487.
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 EPA-HQ-OPP-2005-0487. 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
EPA-HQ-OPP-2005-0487. 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: Kathryn Boyle, Registration Division,
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6304; fax number: (703) 305-0599; e-mail address:
boyle.kathryn@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)
Animal production (NAICS code 112)
Food manufacturing (NAICS code 311)
Pesticide manufacturing (NAICS code 32532)
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.
[[Page 4088]]
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 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.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. What is the Agency's Authority for Taking this Action?
This proposed rule is issued under section 408 of FFDCA, 21 U.S.C.
346a, as amended by the Food Quality Protection Act of 1996 (FQPA)
(Public Law 104-170). Section 408(e) of FFDCA authorizes EPA to
establish, modify, or revoke tolerances, or exemptions from the
requirement of a tolerance for residues of pesticide chemicals in or on
raw agricultural commodities and processed foods.
III. What Action is the Agency Taking?
In the Federal Register of May 24, 2002 (67 FR 36534) (FRL-6834-8)
EPA established a new section 180.950 to list the pesticide chemical
substances that are exempted from the requirement of a tolerance based
on the Agency's determination that these chemical substances are of
``minimal risk.'' This proposed rule shifts existing tolerance
exemptions for certain inert ingredients that have been classified by
the Agency as List 4A, ``minimal risk,'' to 40 CFR 180.950(e). The
decision documents supporting the minimal risk, List 4A classification,
are in the docket. Because this action merely moves certain tolerance
exemptions from one section of CFR to another section, it will have no
substantive or procedural effect on the moved tolerance exemptions. No
tolerance exemptions are lost or added as a result of this action.
The Agency is proposing to shift the following tolerance exemptions
to 40 CFR 180.950(e):
From 40 CFR 180.910: Ascorbic acid (CAS Reg, No. 50-1-7);
beeswax; carnauba wax; glycerol; isopropyl alcohol; soap (sodium or
potassium salts of fatty acids); sodium benzoate; sodium bicarbonate;
sorbitol; and sperm oil conforming to 21 CFR 172.210;
From 40 CFR 180.920: Vanillin
From 40 CFR 180.930: Carnauba wax (CAS Reg. No. 8015-86-
9); glycerol(glycerin); isopropyl alcohol; and sodium benzoate
From 40 CFR 180.940(a): 2-propanol(isopropanol); and
sodium bicarbonate
From 40 CFR 180.940(b): 2-propanol(isopropanol)
From 40 CFR 180.940(c): 2-propanol(isopropanol); and
sodium bicarbonate
One of the exemptions (sorbic acid, and potassium salt)
covers two chemicals. One of the chemicals has been determined to be
List 4A and other List 4B. Another tolerance exemption (potassium
carbonate) covers three chemicals. One of the chemicals has been
determined to be List 4A, and the other two are List 4B. Therefore,
these tolerance exemptions are essentially ``split'' with only the 4A
chemicals to be shifted to 40 CFR 180.950, while the 4B chemicals are
to remain where currently established. Therefore, these two existing
tolerance exemptions are to be revised to specify only the List 4B
chemicals.
IV. Nomenclature Changes
For most of the chemical substances that are being shifted to 40
CFR 180.950(e), EPA is changing the chemical substance names that were
previously used. The Agency has attempted to identify each of the
listed chemical substances using the Chemical Abstracts Service
Registry Number (CAS No.). The CAS No. provides one of the most
distinct and universally accepted means of identifying chemical
substances. Generally, there will be only one CAS No. per listed
substance. EPA has both broadened and consolidated names to account for
differing terminologies and current usage status. These name changes
are not intended to broaden or narrow the scope of the existing
exemption but rather to define the scope of the exemption more
precisely.
V. Statutory and Executive Order Reviews
This proposed rule merely re-organizes existing exemptions in 40
CFR part 180. This has no substantive effect and hence causes no
impact. On its own initiative, the Agency is acting under section
408(e) of the FFDCA in shifting these existing tolerance exemptions to
a different section of CFR. Under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993) this
action is not a ``significant regulatory action'' subject to review and
by the Office of Management and Budget (OMB). Because the 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 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
[[Page 4089]]
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). Pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby
certifies that this proposed action will not have significant negative
economic impact on a substantial number of 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.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Pesticides and pests, Reporting and recordkeeping requirements.
Dated: January 12, 2006.
Lois Rossi,
Director, Registration 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), 346(a) and 374
2. In Sec. 180.910, the table is amended by removing the following
entries: Ascorbic acid (CAS Reg, No. 50-81-7); beeswax; carnauba wax;
glycerol; isopropyl alcohol; soap (sodium or potassium salts of fatty
acids); sodium benzoate; sodium bicarbonate; sorbitol; and sperm oil
conforming to 21 CFR 172.210; and by revising the entry for sorbic acid
(and potassium salt) to read as follows:.
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert Ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Sorbic acid (CAS Reg. No. 110- ....................... Preservative for
44-1). formulations
* * * * * * *
------------------------------------------------------------------------
3. In Sec. 180.920, the table is amended by removing the entry for
vanillin; and the entry for potassium carbonate is removed and replaced
with two new entries to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert Ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Carbonic acid, dipotassium ....................... Buffering agent
salt (CAS Reg. No. 584-08-7).
Carbonic acid, dipotassium ....................... Do.
salt, trihydrate (CAS Reg.
No. 18662-52-7).
* * * * * * *
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Sec. 180.930 [Amended]
4. In Sec. 180.930 the table is amended by removing the following
entries: Carnauba wax (CAS Reg. No. 8015-86-9); glycerol(glycerin);
isopropyl alcohol; and sodium benzoate.
Sec. 180.940 [Amended]
5. In Sec. 180.940, the table in paragraph (a) is amended by
removing the entries for 2-propanol(isopropanol) and sodium
bicarbonate; the table in paragraph (b) is amended by removing the
entry for 2-propanol(isopropanol); and the table in paragraph (c) is
amended by removing the entries for 2-propanol(isopropanol) and sodium
bicarbonate.
6. In Sec. 180.950, the table in paragraph (e) is amended by adding
alphabetically the following entries to read as follows:
[[Page 4090]]
Sec. 180.940 Tolerance exemptions for minimal risk active and inert
ingredients.
* * * * *
(e) * * *
------------------------------------------------------------------------
Chemical Name CAS Reg. No.
------------------------------------------------------------------------
*
* * * * * * *
Ascorbic acid (vitamin C)...................... 50-81-7
Beeswax........................................ 8012-89-3
Benzoic acid, sodium salt...................... 532-32-1
*
* * * * * * *
Carnauba wax................................... 8015-86-9
Carbonic acid, monopotassium salt.............. 298-14-6
Carbonic acid, monosodium salt (sodium 144-55-8
bicarbonate)..................................
*
* * * * * * *
D-Glucitol (sorbitol).......................... 50-70-4
Glycerol (glycerin) (1,2,3-propanetriol)....... 56-81-5
*
* * * * * * *
2-Propanol (isopropyl alcohol)................. 67-63-0
*
* * * * * * *
Soap (The water soluble sodium or potassium None
salts of fatty acids producted by either the
saponification of fats and oils, or the
neutralization of fatty acid..................
Sorbic acid, potassium salt.................... 24634-61-5
Sperm oil...................................... 8002-24-2
*
* * * * * * *
Vanillin....................................... 121-33-5
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[FR Doc. 06-574 Filed 1-24-06; 8:45 am]
BILLING CODE 6560-50-S