[Federal Register Volume 78, Number 27 (Friday, February 8, 2013)]
[Rules and Regulations]
[Pages 9317-9321]
[FR Doc No: 2013-02699]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2012-0795; FRL-9376-4]

Glycine max Herbicide-Resistant Acetolactate Synthase; 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 for residues of the Glycine max herbicide-resistant
acetolactate synthase (GM-HRA) enzyme when used as a plant-incorporated
protectant inert ingredient in or on the food and feed commodities of
soybean. Pioneer Hi-Bred International, Inc. (DuPont Pioneer),
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of Glycine max herbicide-resistant
acetolactate synthase enzyme in or on the food and feed commodities of
soybean.

DATES: This regulation is effective February 8, 2013. Objections and
requests for hearings must be received on or before April 9, 2013, 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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0795, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review

the visitor instructions and additional information about the docket
available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susanne Cerrelli, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 174 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. 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-2012-0795 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
April 9, 2013. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    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 (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0795, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.

    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of November 7, 2012 (77 FR 66781) (FRL-
9367-5), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 2E8059) by Pioneer Hi-Bred International, Inc. (DuPont
Pioneer), 7100 NW., 62nd Avenue, P.O. Box 1000, Johnston, Iowa, 50131.
The petition requested that 40 CFR part 174 be amended by establishing
an exemption from the requirement of a tolerance for residues of
Glycine max herbicide-resistant acetolactate synthase (GM-HRA) when
used as a plant-incorporated protectant (PIP) inert ingredient in or on
the food and feed commodities of soybean. That document referenced a
summary of the petition prepared by the petitioner, Pioneer Hi-Bred
International, Inc. (DuPont Pioneer), which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
    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 exemption 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 FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require 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 * *
*. '' Additionally, FFDCA section 408(b)(2)(D) requires that 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.''
    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.

III. Toxicological Profile

    Consistent with FFDCA section 408(b)(2)(D), 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.

A. Product Characterization Overview

    Acetolactate synthase (ALS) protein, also known as acetohydroxyacid
synthase (AHAS), is a key enzyme that catalyzes the first common step
in the biosynthesis of the essential branched-chain amino acids, and is
obligatory for plant development. The gene that encodes the GM-HRA
protein, gm-hra, is derived from the gm-als I gene, a naturally
occurring soybean gene that encodes for acetolactate synthase I (GM-ALS
I) protein. Changes were made in the DNA gene sequence for gm-als I to
produce gm-hra. The modified gene was then introduced into the plant's
genome through particle bombardment (with the PHP30987A fragment). The
GM-HRA

protein is 604 amino acids in length, with a predicted molecular weight
of 65 kilodaltons (kDa), and is >99% homologous with the native GM-ALS
I protein produced in soybeans. This minor modification of the
endogenous GM-ALS I protein to GM-HRA protein yields an enzyme that is
resistant to ALS-inhibiting herbicides. Thus, the GM-HRA protein will
be useful as a selectable marker in soybean transformation events. As
part of a genetic construct introduced into a plant's genome, GM-HRA
itself does not have insecticidal activity and is therefore
functionally inert as part of a PIP. Potentially, GM-HRA also might
serve as an herbicide-tolerant trait in soybeans, a use over which the
U.S. Department of Agriculture (USDA) has separate regulatory
jurisdiction.

 B. Mammalian Toxicity Assessment

    DuPont Pioneer, has submitted acute oral toxicity data
demonstrating the lack of mammalian toxicity at relatively high levels
of exposure to the pure GM-HRA protein. These data demonstrate the
safety of the product at a level well above maximum possible exposure
levels that are reasonably anticipated in the crop (Ref. 1).
    An acute oral toxicity study in mice indicated that GM-HRA is
nontoxic (Ref. 2). Two groups of five males and five females mice were
orally dosed (via gavage) with 2,000 milligrams/kilograms body weight
(mg/kg bwt) of the test substance, a biochemically and functionally
equivalent, microbially produced GM-HRA protein. There were no adverse
clinical signs or findings at necropsy in the test animals.
    When proteins are toxic, they are known to act via acute mechanisms
and at very low dose levels (Ref. 3). Since no acute oral effects were
shown to be caused by GM-HRA, even at relatively high dose levels (up
to 2,000 mg/kg bwt), the GM-HRA protein is not considered to be toxic.
In support of this conclusion, amino acid sequence comparisons between
the GM-HRA protein and known toxic proteins in protein databases found
no similarities that would contradict the results of the acute oral
study.

C. Allergenicity Assessment

    Since GM-HRA is a protein, allergenic sensitivities were
considered. Currently, no definitive tests exist for determining the
allergenic potential of novel proteins. Current scientific knowledge
suggests that common food allergens tend to be resistant to degradation
by acid and proteases; they also may be glycosylated, and are present
at high concentrations in food. Using a ``weight-of-evidence''
approach, EPA considered the source of the trait, amino acid sequence
similarity with known allergens, its prevalence in food, and
biochemical properties of the protein, including in vitro digestibility
in simulated gastric fluid (SGF), and glycosylation (Ref. 4). The
results of the EPA's analysis are as follows:
    1. Source of the trait. The donor organism is Glycine max
(soybean), which has an endogenous gene (gm-als I) that encodes for
acetolactate synthase I (GM-ALS I) protein. Although soybean is one of
the major food allergens, none of the known soy allergens is a member
of the ALS protein family, including ALS protein. ALS enzymes are
widely distributed in nature, and als genes have been isolated from
bacteria, fungi, algae and plants (Refs. 5, 6, 7, and 8). Amino acid
sequencing (BLASTP analysis) yielded 12,451 structurally or
functionally related protein accessions (Ref. 9).The gm-hra gene,
coding for the proposed PIP inert ingredient GM-HRA protein, was
produced by transforming the naturally occurring, herbicide-sensitive
gm-als I genetic sequence. The new gene was introduced into the plant,
and the resulting herbicide-tolerant GM-HRA protein differs from the
ALS I protein by only two amino acids. Both of the two amino acid
substitutions in GM-HRA are already present in commercially available
crop varieties (soybean, sunflower, maize, and canola (Refs. 10, 11, 12
and 13)) that are naturally tolerant to ALS-inhibiting herbicides.
    2. Amino acid sequence. A comparison of the amino acid sequence of
GM-HRA with known allergens found no significant overall sequence
similarity or identity at the level of eight contiguous amino acid
residues, the level of sensitivity needed to detect potential
allergens.
    3. Prevalence in food. ALS enzymes have been part of the human diet
by virtue of their presence in soybeans and other commercial food crops
(soybean, maize, wheat, rice, and canola). Some of these enzymes
contain natural mutations that include the same two amino acid
substitutions as GM-HRA protein that render them tolerant to ALS-
inhibiting herbicides (Ref. 12), and no ALS-related food allergies have
been reported.
    4. Digestibility. The GM-HRA protein was rapidly digested (in less
than 30 seconds) in simulated mammalian gastric fluid (which has a
highly acidic pH of 1.2 and includes the protein digesting enzyme,
pepsin, found in gastric fluid) after incubation at 37 [deg]C.
    5. Glycosylation. The GM-HRA protein expressed in soybean is not
glycosylated. Considering all of the available information, EPA has
concluded that the potential for GM-HRA to be a food allergen is
minimal.

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 ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
    The Agency has considered available information on the aggregate
exposure levels of consumers and major identifiable subgroups of
consumers, including infants and children, to the proposed pesticide
PIP inert residue, GM-HRA protein, and to other related substances.
This protein is an enzyme produced in soybean by a gene that was
genetically derived from a naturally occurring soybean gene that
encodes an herbicide-sensitive ALS enzyme. The altered gene is
reinserted into soybean, and the resulting GM-HRA protein has greater
than 99% similarity with the natural herbicide-sensitive protein
enzyme, differing only in two amino acids (Ref. 13). These minor
changes confer resistance of the enzyme to herbicidal pesticides that
inhibit ALS enzymes, which is what allows the GM-HRA protein to be used
as a selectable herbicide-tolerant marker in soybean transformation
events. The two amino acid substitutions found in the engineered GM-HRA
protein also occur as natural mutations in other commercially
available, non-genetically modified crop varieties that are tolerant to
ALS-inhibiting herbicides, and thus human exposure to the naturally
occurring protein, in addition to the proposed PIP inert, is
anticipated. The only route of human exposure that is likely, however,
is through the human diet, since the proposed PIP inert ingredient (and
the related naturally occurring ALS enzymes) is contained within plant
cells, which reduces potential human exposure via other routes to
negligible. Exposure via residential or lawn use is not expected
because the intended use sites are all agricultural. Though highly
unlikely, should residues of GM-HRA appear in drinking water as a
result of its use as a PIP inert ingredient in soybean, the risk to
humans would be very unlikely, based on the protein's lack of mammalian
toxicity demonstrated in the acute oral toxicity study and the lack of
amino acid similarity with

known protein toxins and allergens (see Unit III).

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    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.''
    Based on the results of acute toxicity testing, EPA concluded that
the proposed PIP inert, GM-HRA, is not toxic. EPA also concluded that
no toxic or allergenic metabolites are produced in soybean or other
edible crops from the activity of this catabolic enzyme. In addition,
GM-HRA as encoded by the gm-hra gene was previously evaluated for its
safety by the U.S. Food and Drug Administration (FDA) in two other
transgenic soybean events. In one event, the gene was modified to
produce high oleic soybean oil (OECD Unique ID No. DP-3[Oslash]5423-1),
and the other provided glyphosate and ALS-inhibiting herbicide
tolerance (OECD Unique ID No. DP-356[Oslash]43-5) (Refs.14 and 15).
Based upon the information submitted, FDA concluded that the safety
profiles of these soybean events, the GM-HRA protein were not
materially different from that of other marketed soybean varieties, and
no safety concerns with the protein were identified (Refs.16 and 17).
    EPA concludes that there are no cumulative effects associated with
GM-HRA expected from the proposed use as a PIP inert ingredient in
soybean. 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 EPA's Web site at http://www.epa.gov/pesticides/cumulative.

VI. Determination of Safety for U.S. Population, Infants and Children

    The data submitted and cited regarding potential health effects for
the GM-HRA protein include the characterization of the expressed GM-HRA
protein in soybean, as well as the acute oral toxicity, amino acid
sequence comparisons, and in vitro digestibility study. The results of
these studies were used to evaluate human risk, and the validity,
completeness, and reliability of the available data from the studies
was considered.
    As discussed in unit III, the acute oral toxicity data submitted
supports the prediction that the GM-HRA protein would be nontoxic to
humans. Moreover, amino acid sequence analysis demonstrated that GM-HRA
was not similar to any known protein toxin or allergen. Other data
considered as part of the allergenicity assessment included: The
structural and functional similarity of GM-HRA protein with naturally
occurring ALS proteins from soybean and other food crops; the ALS
proteins are not associated with food allergenicity; the protein
rapidly degraded in the highly acidic digestibility study; and GM-HRA
protein not glycosylated when expressed in the plant. GM-HRA protein is
therefore not expected to be a human allergen.
    Finally, and specifically with regard to infants and children,
FFDCA section 408(b)(2)(C) provides that EPA shall assess the available
information about consumption patterns among infants and children,
special susceptibility of infants and children to pesticide chemical
residues, and the cumulative effects on infants and children of the
residues and other substances with a common mechanism of toxicity. In
addition, FFDCA section 408(b)(2)(C) provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA determines
that a different margin of safety will be safe for infants and
children.
    Based on its review and consideration of all the available
information, the Agency concludes that there is a reasonable certainty
that no harm will result to the U.S. population, including infants and
children, from aggregate exposure to residues of the GM-HRA protein and
the genetic material necessary for its production when used as a PIP
inert ingredient in or on food and feed commodities of soybean. This
includes all anticipated dietary exposures and all other exposures for
which there is reliable information. The Agency has also concluded, for
the reasons discussed in more detail above, that there are no threshold
effects of concern and, as a result, that an additional margin of
safety for infants and children is unnecessary in this instance.

VII. Other Considerations

A. Analytical Enforcement Methodology

    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 Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for GM-HRA protein in soybean.

VIII. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established for residues of Glycine max herbicide-resistant
acetolactate synthase (GM-HRA) enzyme in or on the food and feed
commodities of soybean when used as a plant-incorporated protectant
inert ingredient.

IX. References

1. U.S. EPA. 2012. Review of Product Characterization and Human
Health Data for Glycine max Herbicide-Tolerant Acetolactate Synthase
(GM-HRA) protein expressed in Event 82117 soybean (OECD Unique ID.
DP-[Oslash]82117-3) in support of an Exemption from the Requirement
of a Tolerance (Petition No. 2E8059) when used as a Plant-
Incorporated Protectant (PIP) Inert Ingredient in soybean.
Memorandum from A. Waggoner, and J. Kough, Ph.D. to S. Cerrelli.
(Dated December 20, 2012).
2. Finlay, C. (2006) GM-HRA: Acute Oral Toxicity Study in Mice.
Study Report No. PHI-2006-008, Unpublished study prepared by E.I. du
Pont de Nemours and Company, August 9, 2006. 41 pgs. MRID No.
48872004.
3. Sjoblad, R.D., J.T. McClintock, and R. Engler (1992)
``Toxicological Considerations for Protein Components of Biological
Pesticide Products,'' Regulatory Toxicology and Pharmacology 15:3-9.
4. CAC (2003) Alinorm 03/34: Joint FAO/WHO Food Standard Programme.
Codex Alimentarius Commission, Twenty-Fifth Session, 30 July 2003.
Rome, Italy. Appendix III: Guideline for Conduct of Food Safety
Assessments of Foods Derived from Recombinant-DNA Plants; Appendix
IV: Annex on Assessment of Possible Allergenicity. CAC, 47-60.

5. Friden, P., Donegan, J., Mullen, J., Tsui, P., Freundlich, M.,
Eoyang, L., Weber, R., and Silverman, P.M. (1985) The ilvB locus of
Escherichia coli K-12 is an operon encoding both subunits of
acetohydroxyacid synthase I. Nucleic Acids Research 13: 3979-3993.
6. Falco, S.C., Dumas, K.D., and Livak, K.J. (1985) Nucleotide
sequence of the yeast ILV2 gene which encodes acetolactate synthase.
Nucleic Acids Research 13: 4011-4027.
7. Reith, M. and Munholland, J. (1995) Complete nucleotide sequence
of the Porphyra purpurea chloroplast genome. Plant Molecular Biology
Reporter 7: 333-335.
8. Mazur, B., Chiu, C.F., and Smith, J.E. (1987) Isolation and
characterization of plant genes coding for acetolactate synthase,
the target enzyme for two classes of herbicides. Plant Physiology
85: 1110-1117.
9. Krauss, A. (2012) Evaluation of the Amino Acid Sequence
Similarity of the GM-HRA Protein to the NCBI Protein Sequence
Datasets. Study Report No. PHI-2006-071/070. Unpublished study
prepared by Pioneer Hi-Bred International, Inc., January 23, 2012.
8251 pgs. MRID No. 48872006.
10. Sebastian, S.A., Fader, G.M., Ulrich, J.F., Forney, D.R.,
Chaleff R.S. (1989) Semidominant Soybean Mutation for Resistance to
Sulfonylurea Herbicides. Crop Science 29:1403-1408.
11. Lee, K.Y., Townsend, J., Tepperman, J., Black, M., Chiu, C.F.,
Mazur, B., Dunsmuir, P., and Bedbrook, J. (1988) The molecular basis
of sulfonylurea herbicide resistance in tobacco. EMBO Journal 7(5):
1241-1248.
12. Tan, S., Evans, R., and Singh, B. (2006) Herbicidal inhibitors
of amino acid biosynthesis and herbicide-tolerant crops. Amino Acids
30: 195-204.
13. Locke, M., Cressman, B., Lu, A., Mathesius, C., Rood, T., and
Sanders, C. (2012) Description, Derivation, Mode of Action and
Familiarity of the GM-HRA Enzyme. Study Number: PHI-2012-020.
Unpublished study prepared by Pioneer Hi-bred International, Inc.,
June 25, 2012. 22 pgs. MRID No. 48872003.
14. US-FDA (2007a) Biotechnology Consultation Note to the File BNF
No. 000108. U.S. Food and Drug Administration, http://www.fda.gov/Food/Biotechnology/Submissions/ucm155604.htm.
15. US-FDA (2009a) Biotechnology Consultation Note to the File BNF
No. 000110. U.S. Food and Drug Administration, http://www.fda.gov/Food/Biotechnology/Submissions/ucm155595.htm.
16. US-FDA (2007b) Biotechnology Consultation Agency Response Letter
BNF No. 000108. U.S. Food and Drug Administration, http://www.fda.gov/Food/Biotechnology/Submissions/ucm155575.htm.
17. US-FDA (2009b) Biotechnology Consultation Agency Response Letter
BNF No. 000110. U.S. Food and Drug Administration, http://www.fda.gov/Food/Biotechnology/Submissions/ucm155567.htm.

X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under FFDCA section 408(d)
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, entitled ``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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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 9, 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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

XI. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 174

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: January 17, 2013.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 174--[AMENDED]

0
1. The authority citation for part 174 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  174.533 to subpart W to read as follows:

Sec.  174.533  Glycine max Herbicide-Resistant Acetolactate Synthase
(GM-HRA) inert ingredient; exemption from the requirement of a
tolerance.

    Residues of Glycine max herbicide-resistant acetolactate synthase
(GM-HRA) enzyme in or on the food and feed commodities of soybean are
exempt from the requirement of a tolerance when used as a plant-
incorporated protectant inert ingredient.

[FR Doc. 2013-02699 Filed 2-7-13; 8:45 am]
BILLING CODE 6560-50-P