Document ID: EPA-HQ-OPP-2005-0487-0001
Agency: epa
Document Type: Proposed Rule
Title: Pesticides: Minimal Risk Tolerance Exemptions
Posted Date: 2006-01-25T16:46:33Z

[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).
                              * * * * * * *
------------------------------------------------------------------------

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
------------------------------------------------------------------------

[FR Doc. 06-574 Filed 1-24-06; 8:45 am]

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