[Federal Register Volume 68, Number 73 (Wednesday, April 16, 2003)]
[Rules and Regulations]
[Pages 18550-18553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9210]


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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: 
[email protected].

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]

0
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.''

0
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) * * *

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                       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]

0
Section 180.1001 is amended as follows:
0
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]

0
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