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[Federal Register: September 21, 2005 (Volume 70, Number 182)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Inert Ingredients; Revocation of 34 Pesticide Tolerance
Exemptions for 31 Chemicals
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: EPA is revoking 34 exemptions from the requirement of a
tolerance that are associated with 31 inert ingredients because
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),
amended by the Food Quality Protection Act of 1996 (FQPA). The 34
tolerance exemptions are considered ``reassessed'' for purposes
FFDCA's section 408(q).
DATES: This regulation is effective September 21, 2005. Objections
requests for hearings must be received on or before November 21,
ADDRESSES: To submit a written objection or hearing request follow
detailed instructions as provided in Unit XI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under
identification (ID) number OPP-2005-0069.
All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket .
listed in the index, some information is not publicly available,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S.
Bell St., Arlington, VA. This docket facility is open from 8:30
4 p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Karen Angulo, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 306-0404; e-mail address: email@example.com .
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
action. Other types of entities not listed in this unit could also
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.
determine whether you or your business may be affected by this action,
you should carefully examine the applicability provisions in Unit
If you have any questions regarding the applicability of this action
a particular entity, consult the person listed under FOR FURTHER
B. How Can I Get Electronic Documents and Other Related Information?
In addition to using EDOCKET at ( http://www.epa.gov/edocket/ ),
you may access this Federal Register document electronically through
EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/ . A frequently updated electronic version of 40 CFR part
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/
II. What Action is the Agency Taking?
In the Federal Register of June 1, 2005 (70 FR 31401) (FRL-7712-7),
EPA issued a proposed rule to revoke 34 exemptions from the requirement
of a tolerance that are associated with 31 inert ingredients because
those substances are no longer contained in pesticide products
registered in the United States. The proposed rule provided a 60-day
comment period that invited public comment for consideration and
support of tolerance exemption retention under the FFDCA standards.
additional 30-day comment period was provided based on a request
certain industry representatives (70 FR 45625, August 8, 2005, (FRL-
In this final rule, EPA is revoking these same 34 tolerance
exemptions. 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
a final rule revoking those tolerances and tolerance exemptions
residues of pesticide chemicals for which there are no active
registrations or uses under FIFRA, unless any person commenting
proposal demonstrates a need for the tolerance to cover residues
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
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
requirements under FQPA.
The Agency received several comments in response
to the proposed
revocation notice. The Fluoride Action Network Pesticide Project
supported EPA's proposal to revoke the exemption from the requirement
of a tolerance for sodium fluoride.
Two commenters requested clarification on EPA's policy concerning
tolerance exemptions for inert ingredients that are reactive
intermediates or reagents. The Agency confirms that the three reactive
inert ingredients being revoked in this final rule (i.e., ethyl
methacrylate, methyl methacrylate, and phosphorus oxychloride) do
require an exemption from the requirement of a tolerance because
are consumed during the manufacture of the final product. EPA intends
to provide additional clarification and guidance in the future for
reactive/reagent chemicals used in the manufacture of pesticide
In addition, two commenters suggested several areas where
additional guidance and policy clarifications would be helpful,
including inert ingredients in non-food use pesticide products,
impurities in technical grade active ingredients and inert ingredients,
and consistency in the nomenclature for inerts. Although not directly
relevant to the proposal to revoke the 34 tolerance exemptions,
Agency appreciates these suggestions and agrees that clear guidance
would be helpful. The Agency intends to provide guidance for topics
such as these in the future.
Therefore, for the reasons stated herein and in the proposed rule,
EPA is revoking the 34 exemptions from the
requirement of a tolerance
that were identified in the Federal Register of June 1, 2005 (70
III. 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
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
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
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
are not necessary to cover residues in or on legally treated foods
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
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.
IV. When Do These Actions Become Effective?
These actions become effective on September 21, 2005. Any
commodities listed in the regulatory text of this document that
treated with the pesticide chemicals subject to this final rule,
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
Drug Administration that: (1) The residue is present as the result
an application or use of the pesticide chemical at a time and in
manner that was lawful under FIFRA, and (2) the residue does not
the level that was authorized at the time of the application or
be present on the food under an exemption from tolerance. Evidence
show that food was lawfully treated may include
records that verify the dates that the pesticide chemical was applied
to such food.
V. Objections and Hearing Requests
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
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments
the FFDCA by the FQPA, EPA will continue to use those procedures,
appropriate adjustments, until the necessary modifications can be
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption
the requirement of a tolerance issued by EPA under new section 408(d)
of the FFDCA, as was provided in the old FFDCA sections 408 and
the FFDCA. However, the period for filing objections is now 60 days,
rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2005-0069 in the subject line on the
first page of your submission. All requests must be in writing,
must be mailed or delivered to the Hearing Clerk on or before November
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issue(s) on which
hearing is requested, the requestor's contentions on such issues,
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of
information as CBI. Information so marked will not be disclosed
in accordance with procedures set forth in 40 CFR part 2. A copy
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from
a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit XI.A.,
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2005-0069, to: Public
Information and Records Integrity Branch, Information Resources
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy
your request via e-mail to: firstname.lastname@example.org. Please use an ASCII
file format and avoid the use of special characters and any form
encryption. Copies of electronic objections and hearing requests
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issue(s) in the manner sought
by the requestor would be adequate to justify the action requested
VI. Statutory and Executive Order Reviews
This final rule establishes an exemption from the tolerance
requirement under section 408(d) of the FFDCA in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB)
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October
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
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction
(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).
does it require any special considerations under Executive Order
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16,
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks
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). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of the FFDCA, such as the exemption
this final rule, do not require the issuance of a proposed rule,
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
seq.) do not apply. The Agency hereby certifies that this rule will
have significant negative economic impact on a substantial number
small entities. In addition, the Agency has determined that this
will not have a substantial direct effect on States, on the
relationship between the national government and the States, or
distribution of power and responsibilities among the various levels
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA
develop an accountable process to ensure ``meaningful and timely
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
rule directly regulates growers, food processors, food handlers
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
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian
Governments (59 FR 22951, 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,
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.
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the
to each House of the Congress and to the Comptroller General of
United States. EPA will submit a report containing this rule and
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States
to publication of this final 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
Dated: September 14, 2005.
Meredith F. Laws,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
Sec. 180.1045 and Sec. 180.1066 [Removed]
2. Sections 180.1045 and 180.1066 are removed.
Sec. 180.910 [Amended]
3. Section 180.910 is amended by removing from the table the entries
for Ethylene methylphenyglycidate; Phosphorus oxychloride; Sulfurous
acid; and 1,1,1-Trichloroethane.
Sec. 180.920 [Amended]
4. Section 180.920 is amended by removing from the table the entries
b. Almond, bitter;
c. Aluminum 2-ethylhexanoate;
d. 1,3-Butylene glycol dimethyacrylate;
e. Calcium and sodium salts of certain sulfonated petroleum
fractions (mahogany soaps); calcium salt molecular weight (in amu)
1,020, sodium salt molecular weight (in amu) 400-500;
f. Copper salts of neodecanoic acid and 2-ethylhexanoic acid;
g. Diallyl phthalate;
h. Dipropylene glycol dibenzoate;
i. Ethyl methacrylate;
j. Furfural byproduct (a granular steam-acid sterilized,
lignocellulosic residuum in the extraction of furfural from corn
sugarcane bagasse, cottonseed hulls, oat hulls, and rice hulls);
l. Methyl isoamyl ketone;
m. Methyl methacrylate;
n. X-(p-Nonylphenyl)-v-hydroxy-poly(oxyethylene) sulfosuccinate
isopropylamine and N-hydroxyethyl isopropylamine salts of: The
poly(oxyethylene) content averages r moles;
o. Propylene dichloride;
p. Sodium fluoride;
q. Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecyl-sulfosuccinamate;
r. (2,2'(2,5-Thiophenediyl)bis(5-tert-butylbenzoxazole)) (CAS Reg.
No. 7128-64-5); and
s. Tri-tert-butylphenol polyglycol ether (molecular weight (in amu)
Sec. 180.930 [Amended]
5. Section 180.930 is amended by removing from the table the entries
a. Acetylated lanolin alcohol;
b. Calcium and sodium salts of certain sulfonated petroleum
fractions (mahogany soaps); calcium salt molecular weight (in amu)
1020, sodium salt molecular weight (in amu) 400-500;
c. Cumene (isopropylbenzene);
d. Dibutyltin dilaurate (CAS Reg. No. 77-58-7);
e. 4,4'-Isopropylidenediphenol alkyl (C12-
C15) phosphites (CAS Reg. No. 92908-32-2);
f. Polyethylene esters of fatty acids, conforming to 21 CFR 172.854;
h. Triethylene glycol diacetate (CAS Reg. No. 111-21-7); and
i. Tri-tert-butylphenol polyglycol ether (molecular weight (in amu)
[FR Doc. 05-18831 Filed 9-20-05; 8:45 am]
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