[Federal Register Volume 78, Number 27 (Friday, February 8, 2013)]
[Rules and Regulations]
[Pages 9317-9321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

[[Page 9318]]

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: (703) 308-8077; email 
address: [email protected].

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

[[Page 9319]]

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

[[Page 9320]]

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.

[[Page 9321]]

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