Document ID: EPA-HQ-OPP-2012-0109-0004
Agency: epa
Document Type: Rule
Title: Exemptions from Requirements of Tolerances: Bacillus thuringiensis eCry3.1Ab Protein in Corn
Posted Date: 2012-08-08T04:00Z

[Federal Register Volume 77, Number 153 (Wednesday, August 8, 2012)]
[Rules and Regulations]
[Pages 47287-47291]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19319]

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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.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the plant-incorporated 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/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-2012-0109 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.

[[Page 47288]]

     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, known 
Cry proteins have a similar three-dimensional 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 N-terminus 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 animals gained weight and had 
no test material-related 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

[[Page 47289]]

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 [deg]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 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) 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

[[Page 47290]]

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 Structure-Function 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, Jansens S, Peferoen M, Visser B. 
1991. The C-Terminal 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

[[Page 47291]]

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]

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. Section 174.532 is revised to read as follows:

Sec.  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