Document ID: EPA-HQ-OPP-2007-1125-0001
Agency: epa
Document Type: Proposed Rule
Title: Pesticide Inert Ingredient; Proposal to Revoke the Obsolete Tolerance Exemption for Sperm Oil
Posted Date: 2008-05-16T04:00Z

[Federal Register: May 16, 2008 (Volume 73, Number 96)]
[Proposed Rules]               
[Page 28391-28394]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16my08-14]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-1125; FRL-8363-6]

 
Pesticide Inert Ingredient; Proposal to Revoke the Obsolete 
Tolerance Exemption for Sperm Oil

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke the existing obsolete tolerance 
exemption under 40 CFR 180.910 for residues of sperm oil conforming to 
21 CFR 172.210 as part of a broader administrative effort to correct 
errors and clarify permitted uses of pesticide inert ingredients in the 
Code of Federal Regulations. There have not been any active Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) pesticide product 
registrations containing this substance for many years. In addition, 
the sperm whale (from which sperm oil is derived) is a federally listed 
endangered species, and taking (or harming) this species is prohibited 
under the U.S. Endangered Species Act. Therefore, since this exemption 
corresponds to uses no longer current or registered under FIFRA in the 
United States, EPA is proposing to revoke the existing tolerance 
exemption under 40 CFR 180.910 because it is no longer necessary.

DATES: Comments must be received on or before June 16, 2008.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2007-1125, 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

[[Page 28392]]

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 Dr., 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.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-1125. 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 regulations.gov website 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 
available in regulations.gov. To access the electronic docket, go to 
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 
Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov 
website to view the docket index or access available documents. 
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 either 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 hours of operation of this 
Docket Facility are 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 Samek, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone 
number: (703) 347-8825; e-mail address: samek.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

    This proposed rule is issued pursuant to section 408(e) of FFDCA 
(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 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)).

[[Page 28393]]

III. What Action Is the Agency Taking

    EPA, acting on its own initiative, is proposing to revoke the 
existing obsolete tolerance exemption under 40 CFR 180.910 for residues 
of sperm oil conforming to 21 CFR 172.210 as part of a broader 
administrative effort to correct errors and clarify permitted uses of 
pesticide inert ingredients in the Code of Federal Regulations. It is 
EPA's general practice to revoke tolerances and tolerance exemptions 
for pesticide chemical residues (which include 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.
    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.
    Generally, EPA will proceed with the revocation of these tolerance 
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.
    EPA believes it is appropriate to propose the revocation of the 
tolerance exemption associated with this inert ingredient because there 
are no longer any active Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) pesticide product registrations containing 
sperm oil. Additionally, since sperm oil is derived from the sperm 
whale and the sperm whale is a federally listed endangered species, 
taking (or harming) this species to obtain sperm oil is prohibited by 
the Endangered Species Act. EPA does not expect there to be existing 
stocks of sperm oil in the hands of users because the sperm whale has 
been listed as an endangered species since 1970. Also, EPA is not aware 
of any food or feed commodities treated with sperm oil imported into 
the United States.
    Therefore, for the reasons stated herein, EPA is proposing to 
revoke the existing exemption from the requirement of a tolerance for 
residues of sperm oil conforming to 21 CFR 172.210 under 40 CFR 
180.910.

IV. When Does This Action Become Effective?

    EPA is proposing that revocation of this tolerance exemption become 
effective on the day the final rule revoking this tolerance exemption 
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 
this tolerance exemption revocation or the effective date of the 
revocation, please submit comments as described under Unit I.B. Any 
commodities treated with the pesticide products containing the inert 
ingredient subject to this proposed rule, and in the channels of trade 
following the tolerance revocation, shall be subject to section 
408(1)(5) of FFDCA, 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.

V. Statutory and Executive Order Reviews

    In this proposed rule, EPA is proposing to revoke a specific 
tolerance exemption established under section 408(d) of the 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) (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 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 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 canceled 
pesticides. 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

[[Page 28394]]

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 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 9, 2000). Executive 
Order 3175, 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: May 6, 2008.
Deborah McCall,
Acting 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.  180.910  [Amended]

    2. Section 180.910 is amended by removing the following exemption 
and any associated Limits and Uses from the table: Sperm oil conforming 
to 21 CFR 172.210.
[FR Doc. E8-10922 Filed 5-15-08; 8:45 am]

BILLING CODE 6560-50-S