Document ID: EPA-HQ-OPP-2006-0307-0001
Agency: epa
Document Type: Proposed Rule
Title: Inert Ingredients; Proposal to Revoke 2 Pesticide Tolerance Exemptions
Posted Date: 2006-05-03T14:32:59Z

[Federal Register: May 3, 2006 (Volume 71, Number 85)]
[Proposed Rules]               
[Page 26001-26004]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my06-28]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0307; FRL-8068-3]

 
Inert Ingredients; Proposal to Revoke 2 Pesticide Tolerance 
Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke 2 inert ingredient exemptions from 
the requirement of a tolerance 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). Upon the issuance of the final rule 
revoking the tolerance exemptions, the 2 tolerance exemptions will be 
counted as ``reassessed'' for purposes of FFDCA's section 408(q).

DATES: Comments must be received on or before July 3, 2006.

ADDRESSES: Submit your comments, identified by docket identification 
(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 (7502C), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPP Regulatory Public Docket, Environmental 
Protection Agency, Rm. 119, Crystal Mall 2, 1801 S. Bell St., 
Arlington, VA. Deliveries are only accepted during the

[[Page 26002]]

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.
     Important Note: OPP will be moving to a new location the 
first week of May 2006. As a result, from Friday, April 28 to Friday, 
May 5, 2006, the OPP Regulatory Public Docket will NOT be accepting any 
deliveries at the Crystal Mall 2 address and this facility 
will be closed to the public. Beginning on May 8, 2006, the OPP 
Regulatory Public Docket will reopen at 8:30 a.m. and deliveries will 
be accepted in Rm. S-4400, One Potomac Yard (South Building), 2777 S. 
Crystal Drive, Arlington, VA 22202. The mail code for the mailing 
address will change to (7502P), but will otherwise remain the same. The 
OPP Regulatory Public Docket telephone number and hours of operation 
will remain the same after the move.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0307. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, 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 regulations.gov or e-
mail. The Federal regulations.gov Web site is an ``anonymous access'' 
system, 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 
regulations.gov, your e-mail address will be automatically captured and 
included as part of the comment that is placed in the 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.
    Docket: All documents in the docket are listed in the docket index. 
Although listed in the index, some information is not publicly 
available, e.g., 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 at 
the location identified under ``Delivery'' and ``Important Note.'' The 
hours of operation for the Docket Facility are 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: 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).
    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. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
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 document by docket ID 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. Background and Statutory Findings

    EPA is proposing to revoke 2 inert ingredient exemptions from the 
requirement of a tolerance because these substances are no longer 
contained in currently registered pesticide products requiring 
reassessment under section 408(q) of FFDCA. It is EPA's general 
practice to revoke tolerances and tolerance exemptions for pesticide 
chemical residues (which includes both active and inert ingredients) 
for which there are no associated active registered uses under FIFRA, 
or for which there are no registered products to which the tolerance or 
tolerance exemption applies, or for tolerances or tolerance exemptions 
that have been superseded, unless a person commenting on the

[[Page 26003]]

proposal indicates a need for the tolerance or exemption to cover 
residues in or on imported commodities or legally treated domestic 
commodities.
    The 2 inert ingredient tolerance exemptions subject to this 
proposal are under 40 CFR 180.920 and are ``Ethylene glycol monomethyl 
ether'' and ``Methylene blue'', the later of which is restricted to use 
as a dye for formulations used on cotton. EPA is proposing that the 
revocation of the 2 tolerance exemptions will become effective on the 
date of the final rule's publication in the Federal Register. For 
counting purposes, and based on this proposed action, 2 exemptions 
would be counted as reassessments toward the August 2006 review 
deadline of FFDCA section 408(q), as amended by FQPA in 1996.

A. What Can I Do if I Wish to Maintain an Exemption that the Agency is 
Proposing to Revoke?

    EPA's records show that the inert ingredients subject to this 
notice are not contained in any currently registered pesticide products 
with uses that would require tolerances or tolerance exemptions under 
section 408 of FFDCA. Parties who believe that EPA's records are 
incorrect and that one or more of these ingredients are indeed 
contained in a currently registered pesticide product are encouraged to 
submit documentation to EPA in the form of the currently registered 
pesticide product's accepted Confidential Statement of Formula. Parties 
who know of a pending registration action for a product that contains 
an inert ingredient subject to this notice may submit documentation to 
EPA in the form of a copy of the Agency's letter confirming the receipt 
of an application for registration or registration amendment for such 
product. In addition, parties who are currently in the process of 
developing a pesticide product containing an inert ingredient subject 
to this notice may submit to EPA a letter asserting their intention to 
apply for a FIFRA section 3 registration of said product within 2 
years. This letter must include documentation of the inclusion of the 
inert ingredient in the proposed pesticide product, such as a 
description of the formulation's ingredients, and must confirm their 
intention to submit an application for registration or registration 
amendment within 2 years from the publication date of this Proposed 
Rule.
    EPA is aware that inert ingredients are also contained in pesticide 
adjuvant products which are not subject to registration under FIFRA. 
The Agency does not keep records of currently used adjuvants or their 
ingredients, therefore, it has been unable to conclusively confirm the 
use of adjuvants containing one of these inert ingredients. Parties who 
know of currently used adjuvant products that contain an inert 
ingredient subject to this proposal are encouraged to submit 
documentation to EPA in the form of the adjuvant product's current 
label and/or documentation of the registration of the adjuvant product 
with a State adjuvant registration program.
    Also, inert ingredient tolerance exemptions will be retained if the 
tolerances or exemptions (which EPA refers to as ``import'' tolerances) 
are necessary to allow importation into the United States of food 
containing such residues. Through this proposed rule, the Agency is 
inviting individuals who need these import tolerance exemptions to 
identify those exemptions that are needed to cover imported 
commodities.
    EPA will retain an inert ingredient tolerance exemption if the 
documentation described above is submitted to EPA by the end of the 
comment period as specified under DATES in this document, and the 
Agency can verify the existence of a currently registered pesticide 
product, a registration action pending at EPA, an import tolerance, or 
a currently used adjuvant product that contains the ingredient in 
question.
    Parties interested in the retention of any of the tolerance 
exemptions subject to this notice should be aware that because these 
ingredients are currently subject to reassessment under section 408(q) 
of FFDCA, additional data may be needed to support retention of the 
exemption. Reassessment activities for such ingredients must be 
completed by August 2006. If the Agency is unable to determine that the 
exemptions for these ingredients meet the FFDCA standard for 
reassessment, the Agency will revoke the exemptions.

B. When Do These Actions Become Effective?

    EPA is proposing that revocation of these tolerance exemptions 
become effective on the day the final rule revoking these tolerance 
exemptions is published in the Federal Register. If you have comments 
regarding whether the effective date allows sufficient time for treated 
commodities to clear the channels of trade, please submit comments as 
described under Unit I.B. Similarly, if you have comments regarding 
these tolerance exemption revocations or the effective date of the 
revocations, please submit comments as described under Unit I.B. Any 
commodities treated with the pesticide products containing an inert 
ingredient subject to this proposal, and in the channels of trade 
following the tolerance revocations, shall be subject to FFDCA section 
408(i)(5), as established by 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 (FDA) that:
    1. The residue is present as the result of an application or use of 
the pesticide 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 a 
tolerance or exemption from tolerance. Evidence to show that food was 
lawfully treated may include records that verify the dates that the 
pesticide was applied to such food.

VI. Statutory and Executive Order Reviews

    In this proposed rule, EPA is proposing to revoke specific 
tolerance exemptions established under section 408(d) of FFDCA. 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 
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 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

[[Page 26004]]

(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 pesticides listed in this rule, the Agency 
hereby certifies that this proposed 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 proposed for revocation in this notice. 
Furthermore, for the pesticide named in this proposed rule, the Agency 
knows of no extraordinary circumstances that exist as to the present 
proposal that would change the EPA's previous analysis. Any comments 
about the Agency's determination should be submitted to the EPA along 
with comments on the proposal, and will be addressed prior to issuing a 
final rule. 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 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, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: April 27, 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 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

Sec.  180.920  [Amended]

    2. Section 180.920 is amended by removing from the table the 
entries for:
    i. Ethylene glycol monomethyl ether; and
    ii. Methylene blue
[FR Doc. E6-6671 Filed 5-2-06; 8:45 am]

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