### 9317 Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Rules and Regulations

the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a ‘‘significant regulatory action’’ subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44

U.S.C. 3501 et seq. );

• is certified as not having a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility Act (5

U.S.C. 601 et seq. );

• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described
in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4);

• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt
tribal law.

B. Submission to Congress and the Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 804, however, exempts from section 801 the following types of rules: rules of particular applicability; rules relating to agency management or personnel; and rules of agency organization, procedure, or practice that do not substantiallyaffect the rights or obligations of nonagency parties. 5 U.S.C. 804(3). Because this is a rule of particular applicability, EPA is not required to submit a rule report regarding this action under

section 801.

C. Petitions for Judicial Review

Under section 307(b)(1) of the CAA, petitions for judicial review of this
action must be filed in the United States Court of Appeals for the appropriate circuit by April 9, 2013. Filing a petition for reconsideration by the Administrator
of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today’s Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this
direct final rule and address the comment in the proposed rulemaking.

This action to approve a revision to the Maryland SIP to remove the Mount Saint Mary’s College 1979 Consent Order from the SIP may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Incorporation by reference, Particulate matter.

Dated: January 25, 2013.
W.C. Early,
Acting Regional Administrator, Region III.

40 CFR part 52 is amended as follows:

**PART 52—[AMENDED]**

■ 1. The authority citation for part 52
continues to read as follows:

Authority: 42 U.S.C. 7401 et seq. **Subpart V—Maryland**

**§ 52.1070 [Amended]**

■ 2. In § 52.1070, the table in paragraph (d) is amended by removing the entry for Mt. Saint Mary’s College.

[FR Doc. 2013–02817 Filed 2–7–13; 8:45 am]

**BILLING CODE 6560–50–P**

**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.

**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 feedcommodities of soybean. Pioneer HiBred 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


### 9318 Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Rules and Regulations

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: cerrelli. susanne@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. 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 thebiosynthesis of the essential branchedchain 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


### 9319 Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Rules and Regulations

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 transformingthe naturally occurring, herbicidesensitive 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 °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 nonoccupational 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


### 9320 Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Rules and Regulations

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 ; 5423–1), and the other provided glyphosate and ALS-inhibiting herbicide tolerance (OECD Unique ID

No. DP–356;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 herbicideresistant 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–;82117– 3) in support of an Exemption from the Requirement of a Tolerance (Petition No.2E8059) when used as a PlantIncorporated 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.


### 9321 Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Rules and Regulations

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]**

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

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

■ 2. Add § 174.533 to subpart W to read
as follows:

**§ 174.533 Glycine max**  **Herbicide-Resistant Acetolactate Synthase (GM–HRA) inert**  **ingredient; exemption from the requirement**

**of a tolerance.**

Residues of Glycine max herbicideresistant 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**