Document ID: EPA-HQ-OPP-2007-1125-0002
Agency: epa
Document Type: Rule
Title: Pesticide Inert Ingredients; Revocation of Tolerance Exemption for Sperm Oil
Posted Date: 2009-11-04T05:00Z

[Federal Register: November 4, 2009 (Volume 74, Number 212)]
[Rules and Regulations]               
[Page 57076-57078]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no09-9]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-1125; FRL-8350-6]

 
Pesticide Inert Ingredients; Revocation of Tolerance Exemption 
for Sperm Oil

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: EPA is issuing this final rule to revoke the existing obsolete 
tolerance exemption for residues of sperm oil conforming to 21 CFR 
172.210. There have not been any active Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA) pesticide product registrations containing 
this inert ingredient 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corresponds to uses no longer current or registered under FIFRA in the 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 revoking the existing tolerance exemption under 
40 CFR 180.910 because it is no longer necessary.

DATES: This regulation is effective November 4, 2009. Objections and 
requests for hearings must be received on or before January 4, 2010, 
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-2007-1125. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. 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 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. 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 Federal Food, Drug, and Cosmetic Act, 
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect 
of this regulation and may also request a hearing on those objections. 
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-
2007-1125 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 as required by 40 CFR part 178 on or before January 4, 
2010.
    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-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 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.

II. Background and Statutory Findings

A. What Action Is the Agency Taking?

    EPA is revoking the existing 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

[[Page 57077]]

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 issued a proposed rule in the Federal Register of May 16, 2008 
(73 FR 28391) (FRL-8363-6) proposing to revoke the tolerance exemption 
under 40 CFR 180.910 for residues of sperm oil conforming to 21 CFR 
172.210. There were no comments received in response to the proposed 
rule.
    EPA believes it is appropriate to revoke the tolerance exemption 
associated with this inert ingredient because there are no longer any 
active FIFRA pesticide product registrations for pesticide products 
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 pesticides containing 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 pesticides containing sperm oil imported into the United 
States.
    Therefore, for the reasons stated herein, EPA is revoking 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.

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

     This rule is issued pursuant to section 408(l) of FFDCA (21 U.S.C. 
346a(l)). Section 408(l) 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?

    This action becomes effective on the date of publication of this 
final rule in the Federal Register. Any commodities listed in the 
regulatory text of this document that are treated with Sperm oil, and 
that are in the channels of trade following the tolerance exemption 
revocations, shall be subject to FFDCA section 408(l)(5), as 
established by the FQPA. Under this section, any residues of this 
pesticide chemical 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 chemical at a time and in a manner that was lawful under 
FIFRA.
    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.

III. Statutory and Executive Order Reviews

    In this final rule, EPA is revoking a specific tolerance exemption 
established under FFDCA section 408. EPA establishes tolerances under 
FFDCA section 408(e), and also modifies and revokes specific tolerances 
established under FFDCA section 408. The Office of Management and 
Budget (OMB) has exempted this type of action (i.e., a tolerance 
revocation for which extraordinary circumstances do not exist) 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 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

[[Page 57078]]

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 rule will not have a significant 
economic impact on a substantial number of small entities. Furthermore, 
for the inert ingredient named in this final rule, the Agency knows of 
no extraordinary circumstances that exist as to the present revocation 
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 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 9, 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., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, to each House of the Congress and 
to 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 this final rule in the 
Federal Register. This final 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: October 23, 2009.
Donald J. Rosenblatt,
Acting Director, 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.  180.910  [Amended]

0
2. Section 180.910 is amended by removing from the table the entry for 
``Sperm oil conforming to 21 CFR 172.210.''
[FR Doc. E9-26540 Filed 11-3-09 8:45 am]

BILLING CODE 6560-50-S