Document ID: EPA-HQ-OPP-2005-0487-0015
Agency: epa
Document Type: Rule
Title: Pesticides; Minimal Risk Tolerance Exemptions
Posted Date: 2006-05-31T12:46:34Z

[Federal Register: May 31, 2006 (Volume 71, Number 104)]
[Rules and Regulations]               
[Page 30809-30811]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31my06-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0487; FRL-8062-3]

 
Pesticides; Minimal Risk Tolerance Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule reorganizes the existing tolerance exemptions for 12 
chemical substances that are now classified as ``minimal risk.'' The 
Agency is shifting 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:  This regulation is effective May 31, 2006. Objections and 
requests for hearings must be received on or before July 31, 2006, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:  EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2005-0487. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (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 in the electronic docket at http://www.regulations.gov, or, 

if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The telephone number 
for the Docket Facility is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division 
(7505P), 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.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2005-0487 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before July 31, 2006.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket 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.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
telephone number for the Docket Facility is (703) 305-5805.

II. Background and Statutory Findings

A. What is the Agency's Authority for Taking this Action?

    This final rule is issued pursuant to section 408(e) of the Federal 
Food, Drug, and Comestic Act (FFDCA), as amended by Food Quality 
Protection Act (FQPA) (21 U.S.C. 346a(e)). Section 408 of FFDCA 
authorizes the establishment of tolerances, exemptions from the 
requirement of a tolerance, modifications in tolerances, and revocation 
of tolerances for residues of pesticide chemicals in or on raw 
agricultural commodities and processed foods. Without a tolerance or 
tolerance exemption, food containing pesticide residues is considered 
to be unsafe and therefore, ``adulterated'' under section 402(a) of 
FFDCA. If food containing pesticide residues is found to be 
adulterated, the food may not be distributed in interstate commerce (21 
U.S.C. 331(a) and 342 (a)).

B. What Action is the Agency Taking?

    In the Federal Register of January 25, 2006 (71 FR 4087) (FRL-7754-
8), EPA

[[Page 30810]]

issued a proposed rule under section 408(e) of the FFDCA, 21 U.S.C. 
346a, as amended by the FQPA (Public Law 104-170). In that rule, the 
Agency proposed to shift 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).
    One comment was received from the Washington State Department of 
Agriculture (WSDA). WSDA requested that ``EPA consider revoking the 
tolerance exemption for sperm oil'' since it is derived from the sperm 
whale, an endangered species. In light of this comment, the Agency will 
not shift the exemption for sperm oil to 40 CFR 180.950(e), and will 
consider in the future whether to take action to revoke this tolerance 
exemption. No other comments were received.
    Accordingly, based on the reasons set forth in the preamble to the 
proposed rule, EPA is shifting the tolerance exemptions for the 12 
chemical substances specified in the regulatory text to Sec.  
180.950(e).

III. Statutory and Executive Order Reviews

    This final rule re-organizes the tolerance exemptions for 12 
chemical substances. Such reorganization does not impose any new 
requirements, has no impact, and is therefore, not subject to review by 
the Office of Management and Budget (OMB) 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 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) (Pub. L. 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 re-organizing these tolerance 
exemptions 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 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 section 408(n)(4) of the 
FFDCA. 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 practice and procedure, 
Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: May 16, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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 374
0
2. In Sec.  180.910, the table is amended by removing the entries for: 
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 sorbic acid (and 
potassium salt) and alphabetically adding the following entry to the 
table to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

[[Page 30811]]

------------------------------------------------------------------------
      Inert Ingredients                 Limits                Uses
------------------------------------------------------------------------
                                * * * * *
Sorbic acid (CAS Reg. No. 110- .......................  Preservative for
 44-1).                                                  formulations
                                * * * * *
------------------------------------------------------------------------

0
3. In Sec.  180.920, the table is amended by removing the entries for: 
Potassium carbonate and vanillin and adding the following two entries 
to the table 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     .......................  Buffering agent
 salt, trihydrate (CAS Reg.
 No. 18662-52-7).
                                * * * * *
------------------------------------------------------------------------

Sec.  180.930   [Amended]

0
4. In Sec.  180.930, the table is amended by removing the entries for: 
Carnauba wax (CAS Reg. No. 8015-86-9); glycerol (glycerin); isopropyl 
alcohol; and sodium benzoate.

Sec.  180.940   [Amended]

0
5. Section 180.940 is amended as follows:
    a. By removing from the table in paragraph (a) the entries for 2-
propanol (isopropanol) and sodium bicarbonate.
    b. By removing from the table in paragraph (b) the entry for 2-
propanol (isopropanol).
    c. By removing from the table in paragraph (c) the entries for 2-
propanol (isopropanol) and sodium bicarbonate.
0
6. In Sec.  180.950, the table in paragraph (e) is amended by adding 
alphabetically the following 12 entries to read as follows:

Sec.  180.950  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
                                * * * * *
Carbonic acid, monopotassium salt..............                 298-14-6
Carbonic acid, monosodium salt (sodium                          144-55-8
 bicarbonate)..................................
Carnauba wax...................................                8015-86-9
                                * * * * *
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 produced by either the
 saponification of fats and oils, or the
 neutralization of fatty acid).................
Sorbic acid, potassium salt....................               24634-61-5
                                * * * * *
Vanillin.......................................                 121-33-5
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E6-8249 Filed 5-30-06; 8:45 am]

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