[Federal Register: June 1, 2005 (Volume 70, Number 104)]
[Proposed Rules]
[Page 31401-31405]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jn05-20]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0069; FRL-7712-7]
Inert Ingredients; Proposal to Revoke 34 Pesticide Tolerance
Exemptions for 31 Chemicals
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to revoke 34 exemptions from the requirement
of a tolerance that are associated with 31 inert ingredients 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 34
tolerance exemptions will be counted as ``reassessed'' for purposes of
FFDCA's section 408(q).
DATES: Comments must be received on or before August 1, 2005.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number OPP-2005-0069, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov/.
Follow the on-line instructions for submitting comments.
Agency Website: http://www.epa.gov/edocket/. EDOCKET,
EPA's electronic public docket and comment system, is EPA's preferred
method for receiving comments. Follow the on-line instructions for
submitting comments.
E-mail: Comments may be sent by e-mail to
opp-docket@epa.gov, Attention: Docket ID Number OPP-2005-0069.
Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001, Attention: Docket ID Number OPP-2005-0069.
Hand Delivery: Public Information and Records Integrity
Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental
Protection Agency, Rm. 119, Crystal Mall 2, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID Number OPP-2005-0069. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
Instructions: Direct your comments to docket ID number OPP-2005-
0069. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
http://www.epa.gov/edocket/, 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 EDOCKET,
regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov
websites are ``anonymous access'' systems, 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 EDOCKET or regulations.gov, your e-mail address
will be automatically captured and included as part of the comment that
is placed in the public 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. For additional information about EPA's public
docket visit EDOCKET on-line or see the Federal Register of May 31,
2002 (67 FR 38102) (FRL-7181-7).
Docket: All documents in the docket are listed in the EDOCKET index
at http://www.epa.gov/edocket/. Although listed in the index, some
information is not publicly available, i.e., 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
[[Page 31402]]
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 a.m. to 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 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. 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 and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
C. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
EDOCKET, 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 rulemaking 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(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 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)).
III. What Action is the Agency Taking?
EPA is proposing to revoke 34 exemptions from the requirement of a
tolerance for 31 inert ingredients because those 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 proposal
indicates a need for the tolerance or exemption to cover residues in or
on imported commodities or legally treated domestic commodities.
Listed below are the 31 inert ingredients and their associated 34
tolerance exemptions that are subject to this proposal. EPA is
proposing that the revocation of these 34 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, 34 exemptions would be counted as reassessments toward the
August 2006 review deadline of FFDCA section 408(q), as amended by FQPA
in 1996.
1. Acetonitrile (40 CFR 180.920).
2. Acetylated lanolin alcohol (40 CFR 180.930).
3. Almond, bitter (40 CFR 180.920).
4. Aluminum 2-ethylhexanoate (40 CFR 180.920).
5. 1,3-Butylene glycol dimethyacrylate (40 CFR 180.920).
6. Calcium and sodium salts of certain sulfonated petroleum
fractions (mahogany soaps); calcium salt molecular weight (in amu) 790-
1,020, sodium salt molecular weight (in amu) 400-500 (40 CFR 180.920
and 930).
7. Chlorotoluene (40 CFR 180.1045).
8. Copper salts of neodecanoic acid and 2-ethylhexanoic acid (40
CFR 180.920).
9. Cumene (isopropylbenzene) (40 CFR 180.930).
10. Diallyl phthalate (40 CFR 180.920).
11. Dibutyltin dilaurate (CAS Reg. No. 77-58-7) (40 CFR 180.930).
[[Page 31403]]
12. Dipropylene glycol dibenzoate (40 CFR 180.920).
13. O,O-Diethyl-O-phenylphosphorothioate (40 CFR 180.1066).
14. Ethyl methacrylate (40 CFR 180.920).
15. Ethylene methylphenyglycidate (40 CFR 180.910).
16. Furfural byproduct (a granular steam-acid sterilized,
lignocellulosic residuum in the extraction of furfural from corn cobs,
sugarcane bagasse, cottonseed hulls, oat hulls, and rice hulls) (40 CFR
180.920).
17. Isopropylbenzene (40 CFR 180.920).
18. 4,4'-Isopropylidenediphenol alkyl (C12-C15) phosphites (CAS
Reg. No. 92908-32-2) (40 CFR 180.930).
19. Methyl isoamyl ketone (40 CFR 180.920).
20. Methyl methacrylate (40 CFR 180.920).
21. X-(p-Nonylphenyl)-v-hydroxy-poly(oxyethylene) sulfosuccinate
isopropylamine and N-hydroxyethyl isopropylamine salts of: the
poly(oxyethylene) content averages r moles (40 CFR 180.920).
22. Phosphorus oxychloride (40 CFR 180.910).
23. Polyethylene esters of fatty acids, conforming to 21 CFR
172.854 (40 CFR 180.930).
24. Propylene dichloride (40 CFR 180.920).
25. Sodium fluoride (40 CFR 180.920).
26. Sulfurous acid (40 CFR 180.910).
27. Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecyl-sulfosuccinamate
(40 CFR 180.920).
28. (2,2'(2,5-Thiophenediyl)bis(5-tert-butylbenzoxazole)) (CAS Reg.
No. 7128-64-5) (40 CFR 180.920).
29. 1,1,1-Trichloroethane (40 CFR 180.910 and 930).
30. Triethylene glycol diacetate (CAS Reg. No. 111-21-7) (40 CFR
180.930).
31. Tri-tert-butylphenol polyglycol ether (molecular weight (in
amu) 746), (40 CFR 180.920 and 930).
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 Notice.
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.C. 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.C. 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.
IV. 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
[[Page 31404]]
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 (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 proposed 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 pesticides named in this proposed rule, the Agency
knows of no extraordinary circumstances that exist as to the present
proposal that would change EPA's previous analysis. Any comments about
the Agency's determination should be submitted to 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
recordkeepingrequirements.
Dated: May 12, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended
asfollows:
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. 180.1045 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 forEthylene 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 for:
a. Acetonitrile;
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) 790-
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 cobs,
sugarcane bagasse, cottonseed hulls, oat hulls, and rice hulls);
k. Isopropylbenzene;
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
[[Page 31405]]
s.Tri-tert-butylphenol polyglycol ether (molecular weight (in amu)
746).
Sec. 180.930 [Amended]
5. Section 180.930 is amended by removing from the table the
entries for:
a. Acetylated lanolin alcohol;
b. Calcium and sodium salts of certain sulfonated petroleum
fractions (mahogany soaps); calcium salt molecular weight (in amu) 790-
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;
g. 1,1,1-Trichloroethane;
h. Triethylene glycol diacetate (CAS Reg. No. 111-21-7); and
i. Tri-tert-butylphenol polyglycol ether (molecular weight (in amu)
746).
[FR Doc. 05-10680 Filed 5-31-05; 8:45 am]
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