Document ID: EPA-HQ-OPP-2006-0307-0002
Agency: epa
Document Type: Rule
Title: Inert Ingredients; Revocation of Two Tolerance Exemptions
Posted Date: 2006-08-02T13:23:11Z

[Federal Register: August 2, 2006 (Volume 71, Number 148)]
[Rules and Regulations]               
[Page 43664-43667]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02au06-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0307; FRL-8079-9]

 
Inert Ingredients; Revocation of Two Tolerance Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revoking two exemptions from the requirement of a 
tolerance that are associated with two inert ingredients (ethylene 
glycol monomethyl ether and methylene blue) because these substances 
are no longer contained in active Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) pesticide product registrations. These 
ingredients are subject to reassessment by August 2006 under section 
408(q) of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended 
by the Food Quality Protection Act of 1996 (FQPA). The two 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 August 2, 2006. Objections and requests 
for hearings must be received on or before October 2, 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-2006-0307. 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: Karen Angulo, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0404; e-mail address: angulo.karen@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).

[[Page 43665]]

    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 athttp://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-2006-0307 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 2, 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-2006-0307, 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 
Bldg.), 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 Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

A. What Action is the Agency Taking?

    In the Federal Register of May 3, 2006 (71 FR 26001) (FRL-8068-3), 
EPA issued a proposed rule to revoke two exemptions from the 
requirement of a tolerance that are associated with two inert 
ingredients because those substances are no longer contained in 
pesticide products. The proposed rule provided a 60-day comment period 
that invited public comment for consideration and for support of 
tolerance exemption retention under the FFDCA standards.
    In this final rule, EPA is revoking two exemptions from the 
requirement of a tolerance that are associated with two inert 
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.
    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. Thus, it is EPA's policy to issue a final rule revoking 
those tolerances and tolerance exemptions for residues of pesticide 
chemicals for which there are no active registrations or uses under 
FIFRA, unless any person commenting on the proposal demonstrates a need 
for the tolerance to cover residues in or on imported commodities or 
domestic commodities legally treated.
    Generally, EPA will proceed with the revocation of these tolerances 
and tolerance exemptions on the grounds discussed in Unit II. if one of 
the following conditions applies:
    1. Prior to EPA's issuance of a section 408(f) order requesting 
additional data or issuance of a section 408(d) or (e) order revoking 
the tolerances or tolerance exemptions on other grounds, commenters 
retract the comment identifying a need for the tolerance to be 
retained.
    2. EPA independently verifies that the tolerance or tolerance 
exemption is no longer needed.
    3. The tolerance or tolerance exemption is not supported by data 
that demonstrate that the tolerance or tolerance exemption meets the 
requirements under FQPA.
    No comments were received on the proposed rule. Therefore, for the 
reasons stated herein and in the proposed rule, EPA is revoking the two 
exemptions from the requirement of a tolerance identified in the 
Federal Register Notice of May 3, 2006 (71 FR 26001).

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

[[Page 43666]]

``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 on August 2, 2006. 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 a 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 two inert ingredient tolerance exemptions 
which are counted as tolerance reassessments toward the August 2006 
review deadline under FFDCA section 408(q), as amended by FQPA in 1996.

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. 3501et 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. 601et 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. In a 
memorandum dated May 25, 2001, EPA determined that eight conditions 
must all be satisfied in order for an import tolerance or tolerance 
exemption revocation to adversely affect a significant number of small 
entity importers, and that there is a negligible joint probability of 
all eight conditions holding simultaneously with respect to any 
particular revocation. (This Agency document is available in the docket 
of this final rule). Furthermore, for the pesticides 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.

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

[[Page 43667]]

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, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: July 24, 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), 346a and 371.

Sec.  180.920  [Amended]

0
2. In Sec.  180.920, the table is amended by removing the entries for 
``Ethylene glycol monomethyl ether'' and ``Methylene blue.''

[FR Doc. E6-12344 Filed 8-1-06; 8:45 am]

BILLING CODE 6560-50-S