Document ID: EPA-HQ-OPP-2005-0306-0008
Agency: epa
Document Type: Rule
Title: 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
Posted Date: 2008-02-20T05:00Z

[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.

* * * * *

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