### 47287 Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Rules and Regulations

within a 500 yards radius of position

43 ° 06′06′′ N, 082 ° 27′03 ′′ W (NAD 83).

(b) Effective and Enforcement Period. This regulation is effective and enforced from 11:00 a.m. on July 28, 2012 until 11:00 a.m. on August 25, 2012.

(c) Regulations. (1) In accordance with the general regulations in § 165.23 of this part, entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port Detroit or his designated on-scene representative.

(2) This safety zone is closed to all vessel traffic, except as may be permitted by the Captain of the Port Detroit or his designated on-scene representative.

(3) The ‘‘on-scene representative’’ of the Captain of the Port Detroit is any Coast Guard commissioned, warrant or petty officer who has been designated by the Captain of the Port Detroit to act
on his behalf.

(4) Vessel operators desiring to enter or operate within the safety zone shall contact the Captain of the Port Detroit or his on-scene representative to obtain permission to do so. The Captain of the
Port Detroit or his on-scene representative may be contacted via VHF Channel 16. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the Captain of the Port Detroit, or his on-scene representative.

Dated: July 27, 2012. J.E. Ogden, Captain, U. S. Coast Guard, Captain of the

Port Detroit.

[FR Doc. 2012–19347 Filed 8–7–12; 8:45 am]

**BILLING CODE 9110–04–P**

**ENVIRONMENTAL PROTECTION**
**AGENCY**

**40 CFR Part 174**

**[EPA–HQ–OPP–2012–0109; FRL–9357–4]**

**Bacillus thuringiensis eCry3.1Ab Protein in Corn; 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 atolerance for residues of the plantincorporated protectant (PIP), Bacillus thuringiensis eCry3.1Ab protein in corn,
in or on the food and feed commodities of corn; corn, field; corn, sweet; and corn, pop. Syngenta Seeds, Inc., Field Crops NAFTA 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 Bacillus thuringiensis eCry3.1Ab protein in corn.

**DATES :**  This regulation is effective August 8, 2012. Objections and requests for hearings must be received on or before October 9, 2012, 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–2012–0109, is available either electronically through http://www.regulations.gov or in hard copy at the OPP Docket in the Environmental Protection Agency Docket Center (EPA/DC), located in EPA West, 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 :**  Mike Mendelsohn, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 308–8715; email address: mendelsohn.mike@epa.gov.

**SUPPLEMENTARY INFORMATION :** 

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are
not limited to:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of
entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under **FOR FURTHER**

**INFORMATION CONTACT**

. B. How can I 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://ecfr.gpoaccess.gov/cgi/t/text/textidx?&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–2012–0109 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 October 9, 2012. 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 that does not contain any 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA–HQ–OPP–2012–0109, 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 Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW., Washington,

DC 20460–0001.


### 47288 Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Rules and Regulations

• 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 April 4, 2012 (77 FR 20337) (FRL–9340–4), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 1F7857) by Syngenta Seeds, Inc., Field Crops NAFTA, P.O. Box 12257, 3054 E. Cornwallis Road, Research Triangle Park, NC 27709–2257. The petition requested that 40 CFR 174.532 be amended by establishing a permanent exemption from the requirement of a
tolerance for residues of Bacillus thuringiensis eCry3.1Ab protein in corn,
in or on the food and feed commodities of corn; corn, field; corn, sweet; and corn, pop. This notice referenced a summary of the petition prepared by the petitioner Syngenta Seeds, Inc., Field Crops NAFTA, 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

Based on amino acid sequence homology and crystal structures, knownCry proteins have a similar threedimensional structure comprised of three domains, Domain I, II, and III (Refs. 1, 2, 3, and 4). The toxin portions of Cry proteins are characterized by having five conserved blocks (CB) across their amino acid sequence. These are
numbered CB1 to CB5 from the Nterminus to the C-terminus (Ref. 5). The sequences preceding and following these conserved blocks are highly variable and are designated as variable regions V1 to V6. Because Cry proteins share structural similarities, chimeric cry genes can be engineered via the exchange of domains that are homologous between different cry

genes.

eCry3.1Ab is an engineered chimera protein, composed of portions of modified Cry3A (mCry3A) protein, a protein derived from the native Cry3A protein from Bt subsp. tenebrionis, and of the Cry1Ab protein from Bt thuringiensis subsp. kurstaki HD–1. The ecry3.1Ab gene (Entrez Accession Number GU327680 NCBI, 2011) (Walters et al. 2010) consists of a fusion between the N-terminus (Domain I, Domain II, and a portion of Domain III) of a mcry3A gene and the C-terminus (a portion of Domain III and Variable Region 6) of a cry1Ab gene (Ref. 5). The eCry3.1Ab protein is 654 amino acid residues in size and is approximately
74.8 kilodaltons. B. Mammalian Toxicity Assessment

Syngenta has submitted acute oral toxicity data demonstrating the lack of mammalian toxicity at high levels of exposure to the pure eCry3.1Ab 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. Basing this conclusion on acute oral toxicity data without requiring further toxicity testing and residue data is similar to the Agency position regarding toxicity testing and the requirement of
residue data for the microbial Bacillus thuringiensis products from which this plant-incorporated protectant was derived (see 40 CFR 158.2130(d)(1)(i) and 158.2140(d)(7)). For microbial products, further toxicity testing and residue data are triggered by significant adverse acute effects in studies, such as the mouse oral toxicity study, to verify and quantify the observed adverse effects and clarify the source of these effects (Tiers II & III).

An acute oral toxicity study in mice (MRID No. 477539–01) indicated that eCry3.1Ab is non-toxic. Two groups of 10 male and 10 female mice were orally dosed (via gavage) with 2,000 milligrams/kilograms bodyweight (eCry3.1Ab protein mg/kg bwt) of the eCry3.1AB–0208 test substance, a biochemically and functionally equivalent microbially-produced eCry3.1Ab protein. All treated animalsgained weight and had no test materialrelated clinical signs and no test material-related findings at necropsy. Since there were no significant
differences between the test and control groups related to the oral administration of the eCry3.1AB–0208 test material, the eCry3.1Ab protein does not appear to cause any significant adverse effects at an exposure level of up to 2000 mg/kg bwt, which supports the finding that the eCry3.1Ab protein would be non-toxic
to mammals.

When proteins are toxic, they are
known to act via acute mechanisms and at very low dose levels (Ref. 6). Therefore, since no acute effects were shown to be caused by eCry3.1Ab, even at relatively high dose levels, the eCry3.1Ab protein is not considered toxic. Further, amino acid sequence comparisons showed no similarities between the eCry3.1Ab protein and known toxic proteins in protein databases that would raise a safety

concern.
C. Allergenicity Assessment

Since eCry3.1Ab is a protein, allergenic sensitivities were considered. Currently, no definitive tests exist for


### 47289 Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Rules and Regulations

determining the allergenic potential of novel proteins. Therefore, EPA uses a ‘‘weight-of-the evidence’’ approach where the following factors are considered: source of the trait; amino acid sequence similarity with known allergens; prevalence in food; and biochemical properties of the protein, including in vitro digestibility in simulated gastric fluid (SGF), and glycosylation (as recommended by CAC, 2003) (Ref. 7). Current scientific knowledge suggests that common food allergens tend to be resistant to degradation by acid and proteases; may be glycosylated; and may be present at high concentrations in the food.

1. Source of the trait. Bacillus thuringiensis is not considered to be a source of allergenic proteins.

2. Amino acid sequence. A comparison of the amino acid sequence of eCry3.1Ab with known allergens showed no significant overall sequence similarity or identity at the level of eight contiguous amino acid residues. This is the appropriate level of sensitivity to detect possible IgE epitopes without high false positive rates.

3. Prevalence in food. Expression level analysis of eCry.1Ab protein demonstrates that it is present at relatively low levels. The expression has been shown to be in the parts per million range. Thus, dietary exposure is expected to be correspondingly low.

4. Digestibility. The eCry3.1Ab protein was rapidly digested in less than 30
seconds in simulated mammalian gastric fluid containing pepsin (pH 1.2)
after incubation at 37 ° C.

5. Glycosylation. The eCry3.1Ab protein expressed in corn was shown not to be glycosylated.

6. Conclusion. Considering all of the available information, EPA has concluded that the potential for eCry3.1Ab 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) to the pesticide chemical residue and to other related substances. First, with respect to other related substances, the eCry3.1Ab protein is a chimeric Bacillus thuringiensis protein, composed of portions of Cry1Ab and mCry3A proteins, both of which are registered PIPs that were previously assessed as having a lack of mammalian toxicity at high levels of exposure. Exemptions from the requirement of a tolerance already have been established for Cry1Ab in food and mCry3A in maize,
see 40 CFR 174.505 and 40 CFR 174.511, respectively. Second, and specific to the eCry3.1Ab protein, EPA has considered dietary exposure under the tolerance exemption and all other tolerances or exemptions in effect for the plant-incorporated protectant chemical residue and exposure from non-occupational sources. Exposure via the skin or inhalation is not likely since the plant-incorporated protectant is contained within plant cells, which essentially eliminates these exposure routes or reduces these exposure routes to negligible. The amino acid similarity assessment included similarity to known aeroallergens. It has been
demonstrated that there is no evidence of occupationally related respiratory symptoms, based on a health survey on migrant workers after exposure to Bt pesticides (Ref. 8). Exposure via
residential or lawn use to infants and children is also not expected because the use sites for the eCry3.1Ab protein are all agricultural for control of insects. Oral exposure, at very low levels, may occur from ingestion of processed corn products and, potentially, drinking

water.

However, oral toxicity testing done at a dose of 2 gm/kg showed no adverse effects. Furthermore, the expected dietary exposure from corn is several orders of magnitude lower than the amounts of eCry3.1Ab protein shown to have no toxicity. Therefore, even if negligible aggregate exposure should occur, the Agency concludes that such exposure would present no harm due to the lack of mammalian toxicity and the rapid digestibility demonstrated for the eCry3.1Ab protein.

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.’’

Since eCry3.1Ab is not considered toxic, EPA has not found eCry3.1Ab to share a common mechanism of toxicity with any other substances, and eCry3.1Ab does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that eCry3.1Ab does not have a common mechanism of toxicity with other substances. Following from this, therefore, EPA concludes that there are
no cumulative effects associated with eCry3.1Ab that need be considered. 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 eCry3.1Ab protein include the characterization of the expressed eCry3.1Ab protein in corn, as well as the acute oral toxicity, heat stability,
and in vitro digestibility of the proteins.
The results of these studies were used to evaluate human risk, and the validity, completeness, and reliability of the
available data from the studies were also
considered.

As discussed more fully in Unit III. B. above, the acute oral toxicity data submitted supports the prediction that the eCry3.1Ab protein would be nontoxic to humans. Moreover, eCry3.1Ab showed no sequence similarity to any known toxin. Because
of this lack of demonstrated mammalian toxicity, no protein residue chemistry data for eCry3.1Ab were required for a
human health effects assessment. Even so, preliminary expression level analysis showed eCry3.1Ab protein is present at relatively low levels. Dietary exposure is expected to be correspondingly low.

Since eCry3.1Ab is a protein, its potential allergenicity is also considered as part of the toxicity assessment. Data considered as part of the allergenicity assessment include that the eCry3.1Ab protein came from Bacillus thuringiensis which is not a known allergenic source, showed no sequence similarity to known allergens, was readily degraded by pepsin, and was not glycosylated when expressed in the plant. Therefore, there is a reasonable certainty that eCry3.1Ab protein will not be an allergen.

Considered together, the lack of mammalian toxicity at high levels of exposure to the eCry3.1Ab protein and the minimal potential for that protein to be a food allergen demonstrate the safety of the product at levels well


### 47290 Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Rules and Regulations

above possible maximum exposure levels anticipated in the crop.

Finally, and specifically in regards 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, as discussed in more detail above, 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 eCry3.1Ab protein and the genetic material necessary for its production in corn. This includes all anticipated dietary exposures and all other exposures for
which there is reliable information. The Agency has also concluded, again 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. Nonetheless, Syngenta has submitted
validation method studies on two qualitative lateral flow strip kits for the analytical detection of eCry3.1Ab protein in corn grain, leaf and seed corn
matrices. Results showed the test kits are able to detect eCry3.1Ab protein
residues in corn with sufficient accuracy, precision, and sensitivity.

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 establishing
a difference tolerance.

The Codex has not established a MRL
for Bacillus thuringiensis eCry3.1Ab protein in corn.

VIII. Conclusions

For all the reasons summarized above,
EPA 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 plant incorporated protectant (PIP) Bacillus thuringiensis eCry3.1Ab protein in corn and the genetic material necessary for its production. Therefore, the current temporary exemption for residues of Bacillus thuringiensis eCry3.1Ab protein in corn, in or on the food or feed commodities of corn; corn, field; corn, sweet; and corn, pop, when used as a plant-incorporated protectant is
amended in order to remove its expiration date and make it a permanent exemption.

IX. References

1. Nakamura K, Oshie K, Shimizu M, Takada Y, Oeda K, Ohkawa H. 1990.
Construction of Chimeric Insecticidal
Proteins Between the 130-kDa and 135-
kDa Proteins of Bacillus thuringiensis subsp. aizawai for Analysis of StructureFunction Relationship. Agricultural Biological Chemistry. 54: 715–724. 2. Li J, Carroll J, Ellar DJ. 1991. Crystal
Structure of Insecticidal delta-Endotoxin
from Bacillus thuringiensis at 2.5 A
resolution. Nature. 353: 815–821. 3. Ge A, Rivers D, Milne R, Dean DH. 1991.
Functional Domains of Bacillus thuringiensis Insecticidal Crystal
Proteins. Refinement of Heliothis

virescens and Trichoplusiani Specificity Domains on Cry1A(c). Journal of Biological Chemistry. 266: 17954–17958. 4. Honee G, Convents D, Van Rie J, JansensS, Peferoen M, Visser B. 1991. The CTerminal Domain of the Toxic Fragment
of a Bacillus thuringiensis Crystal Protein Determines Receptor Binding. Molecular Microbiology. 5: 2799–2806. 5. Hofte H, Whitley HR. 1989. Insecticidal Crystal Proteins of Bacillus thuringiensis. Microbiology Review. 53: 242–255. 6. Sjoblad RD, McClintock JT, Engler R. 1992. Toxicological Considerations for Protein Components of Biological Pesticide
Products. Regulatory Toxicology and Pharmacology. 15(1): 3–9. 7. 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. Codex Alimentarius Commission, 47–60. 8. Bernstein IL, Bernstein JA, Miller M, Tierzieva S, Bernstein DI., Lummus Z, Selgrade MK, Doerfler DL, Seligy VL. 1999. Immune responses in farm workers after exposure to Bacillus thuringiensis pesticides. Environmental Health Perspectives. 107(7):575–82.

X. Statutory and Executive Order

Reviews

This final rule establishes a tolerance exemption under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866,
entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993).
Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, 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 exemption 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


### 47291 Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Rules and Regulations

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) (Pub. L. 104–4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note).

XI. Congressional Review Act

The Congressional Review Act, 5

U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 174

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

Dated: July 30, 2012. 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. Section 174.532 is revised to read
as follows:

**§ 174.532 Bacillus thuringiensis eCry3.1Ab protein in corn; exemption from the**  **requirement of a tolerance.**

Residues of Bacillus thuringiensis eCry3.1Ab protein in corn, in or on the food and feed commodities of corn; corn, field; corn, sweet; and corn, pop are exempt from the requirement of a
tolerance when Bacillus thuringiensis eCry3.1Ab protein in corn is used as a plant-incorporated protectant.

[FR Doc. 2012–19319 Filed 8–7–12; 8:45 am]

**BILLING CODE 6560–50–P**

**ENVIRONMENTAL PROTECTION**
**AGENCY**

**40 CFR Part 180**

**[EPA–HQ–OPP–2011–0139; FRL–9356–6]**

**Residues of Didecyl Dimethyl Ammonium Chloride; 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 Didecyl dimethyl ammonium chloride (DDAC) in or on broccoli grown from treated seeds when applied by immersion. Pace Chemicals Ltd. 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 DDAC
in or on broccoli seed.

**DATES :**  This regulation is effective August 8, 2012. Objections and requests for hearings must be received on or before October 9, 2012, 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–2011–0139, is available either electronically through http://www.regulations.gov or in hard copy at the OPP Docket in the Environmental Protection Agency Docket Center (EPA/DC), located in EPA West, 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 :**  Tracy Lantz, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 308–6415; email address: lantz. tracy@epa.gov.

**SUPPLEMENTARY INFORMATION :** 

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are
not limited to:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under **FOR FURTHER**

**INFORMATION CONTACT**

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

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing
Office’s e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/textidx?&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–