Document ID: EPA-HQ-OPP-2006-0495-0003
Agency: epa
Document Type: Rule
Title: Sanitizers with No Food-Contact Uses in Registered Pesticide Products; Revocation of Tolerance Exemptions
Posted Date: 2006-08-11T13:23:51Z

[Federal Register: August 11, 2006 (Volume 71, Number 155)]
[Rules and Regulations]               
[Page 46123-46125]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11au06-14]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0495; FRL-8086-1]

 
Sanitizers with No Food-Contact Uses in Registered Pesticide 
Products; Revocation of Tolerance Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revoking eight exemptions from the requirement of a 
tolerance that are associated with six food-contact surface sanitizing 
solutions because these specific tolerance exemptions correspond to 
uses no longer current or registered in the United States under the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and 
because there are insufficient data to make the determination of safety 
required by the Federal Food, Drug, and Cosmetic Act (FFDCA). These 
ingredients are subject to reassessment by August 2006 under section 
408(q) of FFDCA, as amended by the Food Quality Protection Act of 1996 
(FQPA). The eight tolerance exemptions are considered ``reassessed'' 
for purposes of FFDCA's section 408(q) and count as a tolerance 
reassessment toward the August 2006 review deadline.

DATES: This rule is effective 90 days from August 11, 2006. Objections 
and requests for hearings must be received on or before October 10, 
2006, and must be filed in accordance with the instructions provided in 
40 CFR part 178 (see also Unit V. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0495. 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 Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Laura Bailey, Antimicrobials Division 
(7510P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone 
number: 703-308-6212; e-mail address: bailey.laura@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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Unit II. 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

[[Page 46124]]

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-2006-0495 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 October 10, 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-2006-0495, 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 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

A. What Action is the Agency Taking?

    In the Federal Register of June 9, 2006 (71 FR 33416-3419; FRL-
8072-8), EPA issued a proposed rule to revoke 10 exemptions from the 
requirement of a tolerance that are associated with 7 ingredients 
because those substances are no longer contained in pesticide products. 
The proposed rule provided a 30-day comment period that invited public 
comment for consideration and for support of tolerance exemption 
retention under the FFDCA standards.
    EPA received one comment expressing a need to retain two exemptions 
and an interest in providing data to support these exemptions from the 
requirement of a tolerance for one ingredient. Therefore, in this final 
rule, EPA is revoking eight exemptions from the requirement of a 
tolerance that are associated with six ingredients because these 
specific tolerance exemptions correspond to uses no longer current or 
registered under FIFRA in the United States. The tolerance exemptions 
revoked by this final rule are no longer necessary to cover residues of 
the relevant pesticide chemicals in or on domestically treated 
commodities or commodities treated outside but imported into the United 
States.

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

    This final rule is issued pursuant to section 408(d) of FFDCA (21 
U.S.C. 346a(d)). 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 the 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)).
    EPA's general practice is to revoke tolerances and tolerance 
exemptions for residues of pesticide chemicals on crops for which FIFRA 
registrations no longer exist and on which the pesticide may therefore 
no longer be used in the United States. EPA has historically been 
concerned that retention of tolerances and tolerance exemptions that 
are not necessary to cover residues in or on legally treated foods may 
encourage misuse of pesticides within the United States. Nonetheless, 
EPA will establish and maintain tolerances and tolerance exemptions 
even when corresponding domestic uses are canceled if the tolerances, 
which EPA refers to as ``import tolerances,'' are necessary to allow 
importation into the United States of food containing such pesticide 
residues. However, where there are no imported commodities that require 
these import tolerances, the Agency believes it is appropriate to 
revoke tolerances and tolerance exemptions for unregistered pesticide 
chemicals in order to prevent potential misuse.

C. When do These Actions Become Effective?

    These actions become effective 90 days following publication of a 
final rule in the Federal Register to ensure that all affected parties 
receive notice of EPA's actions. For this rule, the revocations will 
affect exemptions for active or inert ingredients which have not been 
used in registered products, in some cases, for many years. The Agency 
believes that existing stocks of pesticide products containing active 
or inert ingredients covered by the exemptions have been completely 
exhausted and that treated commodities have had sufficient time for 
passage through the channels of trade. However, if EPA is presented 
with information that existing stocks would still be available and that 
information is verified, the Agency will consider extending the 
expiration date of the exemption. If you have comments regarding 
existing stocks and whether the effective date allows sufficient time 
for treated commodities to clear the channels of trade, please submit 
comments as described under SUPPLEMENTARY INFORMATION.
    Any commodities listed in the regulatory text of this document that 
are treated with the pesticide chemicals subject to this final rule, 
and that are in the channels of trade following the tolerance exemption 
revocations, shall be subject to FFDCA section 408(1)(5), as 
established by the FQPA. Under this section, any residues of these 
pesticide chemicals in or on such food shall not render the food 
adulterated so long as it is shown to the satisfaction of the Food and 
Drug Administration that:
    1. The residue is present as the result of an application or use of 
the pesticide chemical at a time and in a manner that was lawful under 
FIFRA, and
    2. The residue does not exceed the level that was authorized at the 
time of the application or use to be present on the food under an 
exemption from tolerance. Evidence to show that food was lawfully 
treated may include records that verify the dates that the pesticide 
chemical was applied to such food.

D. What Is the Contribution to Tolerance Reassessment?

    By law, EPA is required by August 2006, to reassess the tolerances 
and exemptions from tolerances that were in existence on August 2, 
1996. This document revokes eight tolerance exemptions for food-contact 
surface sanitizing solutions under FFDCA section 408(q), as amended by 
FQPA in 1996.

[[Page 46125]]

III. Statutory and Executive Order Reviews

    In this final rule, EPA is revoking specific tolerance exemptions 
established under section 408(d) of FFDCA. The Office of Management and 
Budget (OMB) has exempted this type of action 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 final 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) (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 the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), the Agency previously assessed whether revocations of tolerances 
might significantly impact a substantial number of small entities and 
concluded that, as a general matter, these actions do not impose a 
significant economic impact on a substantial number of small entities. 
This analysis was published on December 17, 1997 (62 FR 66020), and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration. Taking into account this analysis, and available 
information concerning the pesticide listed in this rule, the Agency 
hereby certifies that this final action will not have a significant 
economic impact on a substantial number of small entities. 
Specifically, as per the 1997 notice, EPA has reviewed its available 
data on imports and foreign pesticide usage and concludes that there is 
a reasonable international supply of food not treated with pesticides 
containing the ingredients being revoked in this notice. Furthermore, 
for the pesticide named in this final rule, the Agency knows of no 
extraordinary circumstances that exist as to the present revocations 
that would change the EPA's previous analysis. 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 FFDCA. 
For these same reasons, the Agency has determined that this final 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 final 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 final rule.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Antimicrobial, Sanitizers, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 2, 2006.
Frank Sanders,
Director, Antimicrobials 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), 346a and 371.

Sec.  180.940  [Amended]

0
2. Section 180.940 is amended as follows:
0
i. In the table to paragraph (a) by removing the entry for ``Potassium 
Permanganate'' (CAS Reg. No.7722-64-7).
0
ii. In the table to paragraph (b) by removing the entry for ``Sodium 
mono-and didodecylphenoxy-benzenedisulfonate'' (CAS Reg. No. None).
0
iii. In the table to paragraph (c) by removing the entries for ``Alkyl 
(C12-C15) monoether of mixed (ethylene-propylene) 
polyalkylene glycol, cloud point of 70-77 [deg]C in 1% aqueous 
solution, average molecular weight (in amu), 807;'' (CAS Reg. No. 
None); ``Benzensulfonamide, N-chloro-4-methyl, sodium salt;'' (CAS Reg. 
No. 127-65-1); ``Benzenesulfonic acid, oxybis[dodecyl-'' (CAS Reg. No. 
30260-73-2); ``Calcium bromide'' (CAS Reg. No. 7789-41-5); ``Potassium 
Permanganate'' (CAS Reg. No.7722-64-7); and ``Sodium mono-and 
didodecylphenoxy-benzenedisulfonate'' (CAS Reg. No. None)

[FR Doc. E6-13173 Filed 8-10-06; 8:45 am]

BILLING CODE 6560-50-S