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, 9214-9217 [E8-3127]
Download as PDF
9214
Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Rules and Regulations
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 rule. In addition, This 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
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).
Polymer
CAS Reg. No.
*
*
*
*
1-propanesulfonic
107568-12-7
acid, 2-methyl-2[(1-oxo-2-propenyl)amino]-,
monosodium salt,
polymer with
ethenol and ethenyl
acetate, minimum
number average
molecular weight
(in amu) 50,000.
*
*
*
*
*
*
[FR Doc. E8–3126 Filed 2–19–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
XII. Congressional Review Act
[EPA–HQ–OPP–2005–0306; FRL–8347–8]
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 rule in the Federal
Register. This rule is not a ‘‘major rule’’
as defined by 5 U.S.C. 804(2).
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
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.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
sroberts on PROD1PC70 with RULES
Authority: 21 U.S.C. 321(q), 346a and 371.
I 2. In §180.960, the table is amended
by alphabetically adding the following
polymer to read as follows:
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
*
*
VerDate Aug<31>2005
*
15:54 Feb 19, 2008
Jkt 214001
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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
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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 https://
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 https://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
E:\FR\FM\20FER1.SGM
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Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Rules and Regulations
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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://
www.gpoaccess.gov/ecfr.
sroberts on PROD1PC70 with RULES
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:
VerDate Aug<31>2005
15:54 Feb 19, 2008
Jkt 214001
• Federal eRulemaking Portal: https://
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: ‘‘Alphatocopherol 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. Alphatocopheryl acetate is converted to alphatocopherol 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
PO 00000
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Fmt 4700
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9215
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
https://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
E:\FR\FM\20FER1.SGM
20FER1
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Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Rules and Regulations
(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 nonoccupational 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.
sroberts on PROD1PC70 with RULES
Dietary Exposure
1. Food. EPA estimated dietary
exposures for use of vitamin E as an
inert ingredient using Dietary Exposure
Evaluation Model (DEEMTM), 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
VerDate Aug<31>2005
15:54 Feb 19, 2008
Jkt 214001
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 https://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), dalpha 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 dlalpha 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
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Frm 00046
Fmt 4700
Sfmt 4700
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
E:\FR\FM\20FER1.SGM
20FER1
Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Rules and Regulations
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).
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).
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
List of Subjects in 40 CFR Part 180
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0193; FRL–8349–4]
Carfentrazone-ethyl; Pesticide
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
sroberts on PROD1PC70 with RULES
AGENCY:
SUMMARY: This regulation establishes a
tolerance for residues of carfentrazoneethyl, (ethyl-alpha-2-dichloro-5-[4(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1-yl]-4fluorobenzene propanoate) and the
metabolite carfentrazonechloropropionic acid (alpha, 2-dichloro5-[4-(difluoromethyl)-4,5-dihydro-3methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4fluorobenzenepropanoic acid) in or on
barley, bran at 0.80 ppm; barley, flour at
0.80 ppm; grain, aspirated grain
fractions at 1.8 ppm; grain, cereal, group
15 (except rice grain and sorghum grain)
at 0.10 ppm; grain, cereal, stover at 0.80
ppm; grain, cereal, straw at 3.0 ppm;
hog, fat at 0.10 ppm; hog, meat at 0.10
ppm; hog, meat byproducts at 0.10 ppm;
millet, flour at 0.80 ppm; oat, flour at
0.80 ppm; poultry, meat byproducts at
0.10 ppm; rice, grain at 1.3 ppm; rice,
Jkt 214001
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In section 180.910 the table is
amended by adding alphabetically the
following inert ingredients to read as
follows:
I
§ 180.910 Inert ingredients used preharvest and post-harvest; exemptions from
the requirement of a tolerance.
*
*
*
*
*
Therefore, 40 CFR chapter I is
amended as follows:
I
Limits
BILLING CODE 6560–50–S
15:54 Feb 19, 2008
1. The authority citation for part 180
continues to read as follows:
I
Dated: February 6, 2008.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
*
*
*
d-Alpha tocopherol (CAS Reg. No. 9–02–9 ...........................
d-Alpha tocopheryl acetate (CAS Reg. No. 58–95–7) ...........
dl-Alpha tocopherol (CAS Reg. No.10191–41–0) ...................
dl-Alpha tocopheryl acetate (CAS Reg. No. 7695–91–2) .......
*
*
*
Vitamin E (CAS Reg. No. 1406–18–4) ...................................
*
*
*
VerDate Aug<31>2005
PART 180—[AMENDED]
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Inert ingredients
[FR Doc. E8–3127 Filed 2–19–08; 8:45 am]
9217
*
Uses
*
Frm 00047
*
*
*
*
*
Safener
Safener
Safener
Safener
*
*
None
Safener
*
*
hulls at 3.5 ppm; rye, bran at 0.80 ppm;
rye, flour at 0.80 ppm; sorghum, grain
at 0.25 ppm; soybean, seed at 0.10 ppm;
sugarcane at 0.15 ppm; wheat, bran at
0.80 ppm; wheat, flour at 0.80 ppm;
wheat, germ at 0.80 ppm; wheat,
middlings at 0.80 ppm; and wheat,
shorts at 0.80 ppm. FMC Corporation
requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
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–2007–0193. To access the
electronic docket, go to https://
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.
PO 00000
*
None
None
None
None
Fmt 4700
Sfmt 4700
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
https://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:
Joanne I. Miller, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–6224; e-mail address:
miller.joanne@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 those engaged in the
following activities:
• Crop production (NAICS code 111),
e.g., agricultural workers; greenhouse,
E:\FR\FM\20FER1.SGM
20FER1
Agencies
[Federal Register Volume 73, Number 34 (Wednesday, February 20, 2008)]
[Rules and Regulations]
[Pages 9214-9217]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3127]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://
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 https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://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 https://
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: https://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 https://
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 https://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).
* * * * * * *
------------------------------------------------------------------------
[FR Doc. E8-3127 Filed 2-19-08; 8:45 am]
BILLING CODE 6560-50-S