[Federal Register: February 20, 2008 (Volume 73, Number 34)]
[Rules and Regulations]
[Page 9214-9217]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20fe08-19]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0306; FRL-8347-8]
Vitamin E, d-alpha tocopherol, dl-alpha tocopherol, d-alpha
tocopheryl acetate, and dl-alpha tocopheryl acetate; Inert Ingredients;
Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance under 40 CFR 180.910 for residues of vitamin E (CAS Reg.
No. 1406-18-4), d-alpha tocopherol (CAS Reg. No. 9-02-9), dl-alpha
tocopherol (CAS Reg. No.10191-41-0), d-alpha tocopheryl acetate (CAS
Reg. No. 58-95-7), and dl-alpha tocopheryl acetate (CAS Reg. No. 7695-
91-2) in or on raw agricultural commodities when applied or used as
inert ingredients in pesticide formulations. Because these five
substances are chemically-similar, for the sake of simplicity,
discussion of vitamin E in this rule (unless otherwise noted) can be
considered to be vitamin E per se and/or one of the two alcohols (d-
alpha tocopherol, dl-alpha tocopherol) or two acetates (d-alpha
tocopheryl acetate, dl-alpha tocopheryl acetate). BASF Corporation
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act, as amended by the Food Quality Protection Act of 1996, requesting
an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of vitamin E.
DATES: This regulation is effective February 20, 2008. Objections and
requests for hearings must be received on or before April 21, 2008, 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-2005-0306. 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. All documents in the docket are listed in the
docket index available in 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 either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office
of Pesticide Programs (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: Kathleen Martin, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-2857; e-mail address: martin.kathleen@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
[[Page 9215]]
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 40 CFR 152. 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 FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. 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-2005-0306 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 on or before April 21, 2008.
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-2005-0306, 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
In the Federal Register of April 4, 2007 (72 FR 16352) (FRL-8119-
2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 5E6996) by BASF Corporation, PO Box 13528; Research
Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be
amended by establishing an exemption from the requirement of a
tolerance for residues of d-alpha tocopherol, d-alpha tocopheryl
acetate, dl-alpha tocopherol acetate, dl-alpha tocopheryl, and/or
vitamin E. That notice included a summary of the petition prepared by
the petitioner BASF Corporation. Please note that the April 4, 2007
notice amended a previous Notice of Filing for that petition; it was
published on January 18, 2006 (71 FR 2925) and was limited to a single
substance, alpha-tocopherol (CAS Reg. No. 10191-41-0). BASF asked to
amend the petition because it was too narrowly defined: ``Alpha-
tocopherol is known to be the most biologically active form of Vitamin
E. However, the ester of alpha-tocopherol (alpha-tocopheryl acetate) is
also a common source of Vitamin E. Alpha-tocopheryl acetate is
converted to alpha-tocopherol in the body upon ingestion. For purposes
of this rule, BASF requests that the acetate and alcohol forms of
Vitamin E be viewed as equivalent substances and that the existing
petition 5E6996 be amended to include the closely related Vitamin E
substances.'' Between the two notices, one comment was received in
response to the notices of filing; it was addressed.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. The following
provides a brief summary of the risk assessment and conclusions for the
Agency's review of vitamin E. The full decision document for this
action is available on EPA's Electronic Docket at http://www.regulations.gov/
under docket number EPA-HQ-OPP-2005-0306.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The nature of the toxic effects caused by vitamin
E is discussed in this unit.
In brief, the Agency reviewed the available information on vitamin
E submitted by the petitioner as well as additional information
available to EPA in two international, peer-reviewed evaluations of
vitamin E. The toxicity database is sufficient. In summary, vitamin E
has low acute oral toxicity. Alpha-tocopherol has an lethal dose
[[Page 9216]]
(LD)50 greater than 2,000 milligrams/kilograms bodyweight
(mg/kg bw) in mice, rats, and rabbits. In subchronic toxicity testing
vitamin E appears to elicit systemic toxicity to rats only at high
doses, with the target organs being the liver and blood. Vitamin E has
not been shown to be neurotoxic, mutagenic, or carcinogenic. Finally,
no developmental and reproductive effects have been shown.
IV. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from groundwater or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
EPA does not have information available to assess the potential for
exposure to vitamin E in consumer products. Nevertheless, given vitamin
E's known role in human physiology and its presence in various foods
such as nuts and vegetable oils, it is unlikely that residential
exposures of concern would result from the use of vitamin E in
nonpesticide products and as an ingredient in pesticide. Therefore, no
further aggregate assessment is necessary.
Dietary Exposure
1. Food. EPA estimated dietary exposures for use of vitamin E as an
inert ingredient using Dietary Exposure Evaluation Model (DEEM\TM\), a
generic screening model that assumes that the inert ingredient is used
on all commodities and that 100 percent of crops are treated with the
inert ingredient. Generic chronic exposure for the overall U.S.
population was estimated at 0.12 mg/kg/day.
2. Drinking water exposure. Surface water concentration of vitamin
E was estimated at 0.065 parts per billion (ppb); EPA's Pesticide Root
Zone Model - Exposure Analysis Modeling System (PRZM-EXAMS) model was
used. Groundwater concentration was estimated at 0.0015 ppb using EPA's
screening concentration in groundwater (SCI-GROW) model.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to vitamin E (CAS Reg. Nos.
1406-18-4; 59-02-9; 10191-41-0; 58-95-7; and 7695-91-2) and any other
substances and, this material does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that vitamin E (CAS
Reg. Nos. 1406-18-4; 59-02-9; 10191-41-0; 58-95-7; and 7695-91-2) has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs (OPP) concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.
VI. Determination of Safety for U.S. Population, Infants and Children
Based on the information in this preamble, EPA concludes that there
is a reasonable certainty of no harm from aggregate exposure to
residues. Accordingly, EPA finds that exempting from the requirement of
a tolerance will be safe.
VII. Other Considerations
A. Analytical Method(s)
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. International Tolerances
The Agency is not aware of any country requiring a tolerance for
vitamin E (CAS Reg. No. 1406-18-4), d-alpha tocopherol (CAS Reg. No. 9-
02-9), dl-alpha tocopherol (CAS Reg. No.10191-41-0), d-alpha tocopheryl
acetate (CAS Reg. No. 58-95-7), or dl-alpha tocopheryl acetate (CAS
Reg. No. 7695-91-2), nor have any CODEX Maximum Residue Levels (MRLs)
been established for any food crops at this time.
VIII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. 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 final rule has been
exempted from review under Executive Order 12866, this final 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) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). 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., 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).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this final rule. In addition,
this final rule does not 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).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section
[[Page 9217]]
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).
IX. 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: February 6, 2008.
Lois Rossi,
Director, Registration Division, 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.
0
2. In section 180.910 the table is amended by adding alphabetically the
following inert ingredients to read as follows:
Sec. 180.910 Inert ingredients used pre-harvest and post-harvest;
exemptions from the requirement of a tolerance.
* * * * *
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Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
d-Alpha tocopherol (CAS Reg. No. None Safener
9-02-9.
d-Alpha tocopheryl acetate (CAS None Safener
Reg. No. 58-95-7).
dl-Alpha tocopherol (CAS Reg. None Safener
No.10191-41-0).
dl-Alpha tocopheryl acetate (CAS None Safener
Reg. No. 7695-91-2).
* * * * * * *
Vitamin E (CAS Reg. No. 1406-18- None Safener
4).
* * * * * * *
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[FR Doc. E8-3127 Filed 2-19-08; 8:45 am]
BILLING CODE 6560-50-S