[Federal Register: April 16, 2003 (Volume 68, Number 73)]
[Rules and Regulations]
[Page 18550-18553]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ap03-9]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0126; FRL-7302-6]
Pesticides; Minimal Risk Tolerance Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This final rule reorganizes 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, certain
chemical substances are now classified as ``minimal risk,'' and are
therefore being shifted to the section of 40 CFR part 180 that holds
minimal risk chemicals. The Agency is merely moving certain tolerance
exemptions from one section of the Code of Federal Regulations to
another. No existing tolerance exemptions are lost or expanded and no
new tolerance exemptions are added as a result of this action.
DATES: This final rule is effective on April 16, 2003.
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 formulate or
market pesticide products. Potentially affected categories and entities
may include, but are not limited to:
[sbull] Crop production (NAICS 111)
[sbull] Animal production (NAICS 112)
[sbull] Food manufacturing (NAICS 311)
[sbull] Pesticide manufacturing (NAICS 32532)
[sbull] Antimicrobial pesticides (NAICS 32561
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 Get Copies Of This Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0126. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI)
[[Page 18551]]
or other information whose disclosure is restricted by statute. The
official public docket is the collection of materials that is available
for public viewing at the Public Information and Records Integrity
Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis
Hwy., 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.
2. Electronic Access. 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 http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.
html, a
beta site currently under development.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to view public comments,
access the index listing of the contents of the official public docket,
and to access those documents in the public docket that are available
electronically. Although not all docket materials may be available
electronically, you may still access any of the publicly available
docket materials through the docket facility identified in Unit I.B.1.
Once in the system, select ``search,'' then key in the appropriate
docket ID number.
II. What Action is the Agency Taking?
In a Federal Register Notice published on May 24, 2002, (67 FR
36534) (FRL-6834-8) EPA established a new Sec. 180.950 to list the
pesticide chemicals that are exempted from the requirement of a
tolerance based on the Agency's determination that these chemicals are
of ``minimal risk.'' As the first step in populating this section, the
Agency shifted the existing tolerance exemptions for commonly consumed
food commodities, animal feed items, and edible fats and oils to this
section.
In a proposed rule published in the Federal Register on November
20, 2002, (67 FR 70036)(FRL-7278-3) the Agency proposed to shift almost
90 tolerance exemptions for certain inert ingredients that have been
classified by the Agency as List 4A, ``minimal risk'' to 40 CFR
180.950. This action merely moves certain tolerance exemptions from one
section of the CFR to another section: no existing tolerance exemptions
are lost or expanded, and no new tolerance exemptions are added, as a
result of this action.
Four comments were received in response to the publication of the
proposed rule. All four sets of comments concerned only the group of
chemical substances referred to as ``weathered materials.'' ``Weathered
materials'' can be described as the materials in and of the earth, that
is, rocks and minerals. This would include substances such as various
clays, limestone, marble, graphite, gypsum, various silicates and
various oxides. These ``weathered materials'' comprise over 40
tolerance exemptions. The Agency will address these comments at a later
date through the publication of another proposed rule. No action on the
Agency's prior proposal regarding weathered materials is being taken in
this final rule.
However, no comments were received on shifting any of the other 44
tolerance exemptions such as the various citrate compounds or the
various cellulose compounds. The decision documents supporting the
minimal risk, List 4A classification were placed in the e-dockets for
the proposed rule. Based on the information contained in those
documents and in the proposed rule, and for the reasons explained
above, 44 tolerance exemptions are being shifted to 40 CFR 180.950.
As explained in the proposed rule, for some of the chemical
substances, EPA is making minor changes to the chemical names that were
previously used, i.e., EPA is using different naming conventions for
the chemicals to be listed in 40 CFR 180.950. Additionally, the Agency
has attempted to identify each of the listed substances using the
Chemical Abstracts Service Registry Number (CAS Reg. No.). The CAS Reg.
No. provides one of the most distinct and universally accepted means of
identifying chemical substances. The lack of a CAS Reg. No. will not
preclude the Agency from including substances in 40 CFR 180.950.
Generally, there will be only one CAS Reg. No. per listed substance;
however, it is possible that more than one CAS Reg. No. may be
appropriate for some substances, such as when there is both a hydrated
and anhydrous form. EPA has both broadened and consolidated names to
account for differing terminologies and current usage status.
The tolerance exemptions shifted from 40 CFR 180.2 to 40 CFR
180.950 are: Citric acid, fumaric acid, and sodium chloride.
The following tolerance exemptions are shifted from 40 CFR
180.1001(c): Animal glue; calcium citrate; [alpha]-cellulose; citric
acid; coffee grounds; corn dextrin; dextrin; guar gum; hydroxyethyl
cellulose; hydroxypropyl methylcellulose; lecithin; licorice root;
methylcellulose; potassium chloride; potassium citrate; silica,
hydrated; silicon dioxide, fumed, amorphous; sodium acetate; sodium
alginate; sodium carboxymethylcellulose; sodium chloride; and xanthan
gum.
The following tolerance exemptions are shifted from 40 CFR
180.1001(d): Cellulose acetate; hydroxypropyl cellulose; locust bean
gum; paper fiber, deinked or recycled; paper fiber, produced by the
kraft (sulfate) or sulfite pulping processes; silicon dioxide, fumed,
amorphous; soapbark (quillaja); sodium citrate, and wool fat (anhydrous
lanolin).
The following tolerance exemptions are shifted from 40 CFR
180.1001(e): Castor oil, u.s.p.; [alpha]-cellulose; citric acid;
dextrin; methyl cellulose; potassium citrate; silica, amorphous, fumed
(crystalline free)...; sodium carboxymethylcellulose, and xanthan gum.
The tolerance exemptions in Sec. 180.1036 (hydrogenated castor
oil) are also being shifted to Sec. 180.950.
Because today's action merely moves certain tolerance exemptions
from one section of the CFR to another section, it will have no
substantive or procedural effect on the moved tolerance exemptions. No
tolerance exemptions are lost as a result of this action.
B. 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. Statutory and Executive Order Reviews
This final rule merely shifts existing exemptions in 40 CFR part
180. This has no substantive effect and hence causes no impact. The
Agency is acting on its own initiative under FFDCA section 408(e) in
shifting these existing tolerance exemptions to a new section. 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 rule
has been exempted from review under Executive Order 12866 due to its
lack of significance, this rule is not subject to Executive Order
13211, Actions
[[Page 18552]]
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). 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) (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).
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et. seq.), the Agency hereby certifies that these proposed
actions will not have significant negative economic impact on a
substantial number of small entities. As noted above, this action will
have no substantive or procedural effect on the tolerance exemptions
affected. However, by grouping tolerance exemptions that have qualified
as minimal risk inerts in one location in the CFR, this action will
make it easier for small entities to efficiently use EPA's tolerance
regulations. 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 final 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 FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this 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 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 rule.
IV. Congressional Review Act
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 practices and procedures,
pesticides and pests, reporting and recordkeeping requirements.
Dated: April 8, 2003.
Peter Caulkins,
Acting Director, Registration Division.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
Sec. 180.2 [Amended]
0
2. In Sec. 180.2, paragraph (a), is amended by removing the terms
``citric acid,'' ``fumaric acid,'' and ``sodium chloride.''
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3. In Sec. 180.950 the table to paragraph (e) is amended by adding
alphabetically the following entries.
Sec. 180.950 Tolerance exemptions for minimal risk active and inert
ingredients.
* * * * *
(e) * * *
------------------------------------------------------------------------
Chemical CAS No.
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Acetic acid, sodium salt............................. 127-09-3
Animal glue.......................................... None
Carob gum (locust bean gum).......................... 9000-40-2
Castor oil........................................... 8001-79-4
Castor oil, hydrogenated............................. 8001-78-3
Cellulose............................................ 9004-34-6
Cellulose acetate.................................... 9004-35-7
Cellulose, carboxy methyl ether, sodium salt......... 9004-32-4
Cellulose, 2-hydroxyethyl ether...................... 9004-62-0
Cellulose, 2-hydroxypropyl ether..................... 9004-64-2
Cellulose, 2-hydroxypropyl methyl ether.............. 9004-65-3
Cellulose, methyl ether.............................. 9004-67-5
Cellulose, mixture with cellulose carboxymethyl 51395-75-6
ether, sodium salt..................................
Cellulose, pulp...................................... 65996-61-4
Cellulose, regenerated............................... 68442-85-3
Citric acid.......................................... 77-92-9
Citric acid, calcium salt............................ 7693-13-2
Citric acid, calcium salt (2:3)...................... 813-94-5
Citric acid, dipotassium salt........................ 3609-96-9
Citric acid, disodium salt........................... 144-33-2
Citric acid, monohydrate............................. 5949-29-1
Citric acid, monopotassium salt...................... 866-83-1
Citric acid, monosodium salt......................... 18996-35-5
Citric acid, potassium salt.......................... 7778-49-6
Citric acid, tripotassium salt....................... 866-84-2
Citric acid, tripotassium salt, monohydrate.......... 6100-05-6
Citric acid, sodium salt............................. 994-36-5
Citric acid, trisodium salt.......................... 68-04-2
Citric acid, trisodium salt, dihydrate............... 6132-04-3
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Citric acid, trisodium salt, pentahydrate............ 6858-44-2
Coffee grounds....................................... 68916-18-7
Dextrins............................................. 9004-53-9
Fumaric acid......................................... 110-17-8
Guar gum............................................. 9000-30-0
Lanolin.............................................. 8006-54-0
Lecithins............................................ 8002-43-5
Lecithins, soya...................................... 8030-76-0
Licorice Extract..................................... 68916-91-6
Maltodextrin......................................... 9050-36-6
Paper................................................ None
Potassium chloride................................... 7447-40-7
Silica, amorphous, fumed (crystalline free).......... 112945-52-5
Silica, amorphous, precipitated and gel.............. 7699-41-4
Silica gel........................................... 63231-67-4
Silica gel, precipitated, crystalline-free........... 112926-00-8
Silica, hydrate...................................... 10279-57-9
Silica, vitreous..................................... 60676-86-0
Soapbark (Quillaja saponin).......................... 1393-03-9
Sodium alginate...................................... 9005-38-3
Sodium chloride...................................... 7647-14-5
Xanthan gum.......................................... 11138-66-2
------------------------------------------------------------------------
Sec. 180.1001 [Amended]
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Section 180.1001 is amended as follows:
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4. The table in paragraph (c) is amended by removing the following
entries: Animal glue; Calcium citrate; [alpha]-Cellulose; Citric acid;
Coffee grounds; Corn dextrin; Dextrin; Guar gum; Hydroxyethyl
cellulose; Hydroxypropyl methylcellulose; Lecithin; Licorice root;
Methyl cellulose; Potassium chloride; Potassium citrate (CAS Reg. No.
866-84-2); Silica, hydrated; Silicon dioxide, fumed, amorphous; Sodium
acetate; Sodium alginate; Sodium carboxymethylcellulose; Sodium
chloride; Xanthan Gum.
0
5. The table in paragraph (d) is amended by removing the following
entries: Cellulose acetate (CAS Reg. No. 9004-35-7), minimum number
average molecular weight, 28,000; Hydroxypropyl cellulose; Locust bean
gum; Paper fiber, deinked or recycled, conforming to 21 CFR
109.30(a)(9) and 21 CFR 176.260; Paper fiber, produced by the kraft
(sulfate) or sulfite pulping processes; Silicon dioxide, fumed,
amorphous; Soapbark (quillaja); Sodium citrate, Wool fat (anhydrous
lanolin).
0
6. The table in paragraph (e) is amended by removing the following
entries: Castor oil, U.S.P.; [alpha]-Cellulose; Citric acid; Dextrin
(CAS Reg. No. 9004-53-9); Methylcellulose; Potassium citrate (CAS Reg.
No. 866-84-2); Silica, amorphous, fumed (crystalline free) (CAS Reg.
No. 112945-52-5); Sodium alginate; Sodium carboxymethylcellulose,
Xanthan gum.
Sec. 180.1036 [Removed]
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7. Section 180.1036 is removed in its entirety
[FR Doc. 03-9210 Filed 4-15-03; 8:45 am]
BILLING CODE 6560-50-S