Bacillus thuringiensis eCry3.1Ab Protein in Corn; Temporary Exemption From the Requirement of a Tolerance, 57653-57657 [2011-23813]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 76, Number 180 (Friday, September 16, 2011)]
[Rules and Regulations]
[Pages 57653-57657]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23813]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2009-0609; FRL-8889-2]


Bacillus thuringiensis eCry3.1Ab Protein in Corn; Temporary 
Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation extends the effective date for a temporary 
exemption from the requirement of a tolerance 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 in accordance with the terms of 
Experimental Use Permit (EUP) No. 67979-EUP-8. Syngenta Seeds, Inc. 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting to extend the existing temporary tolerance 
exemption for Bacillus thuringiensis eCry3.1Ab protein in corn that was 
set to expire on March 1, 2013. This regulation eliminates the need to 
establish a maximum permissible level for residues of Bacillus 
thuringiensis eCry3.1Ab protein in corn under the FFDCA. The temporary 
tolerance exemption now expires on December 31, 2013.

DATES: This regulation is effective September 16, 2011. Objections and 
requests for hearings must be received on or before November 15, 2011, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0609. All documents in the 
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at https://www.regulations.gov, or, if only available in hard 
copy, at the Office of Pesticide Programs (OPP) Regulatory Public 
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal 
Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Docket 
Facility telephone number is (703) 305-5805.

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; e-mail 
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 https://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(g), 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-2009-0609 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 
November 15, 2011. 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-2009-0609, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: OPP Regulatory Public Docket (7502P), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of June 8, 2011 (76 FR 33183) (FRL-8874-8), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 
1G7868) by Syngenta Seeds, Inc., P.O. Box 12257, Research Triangle 
Park, NC 27709. The petition requested that 40 CFR part 174 be amended 
by extending the effective date of an existing temporary exemption from 
the requirement of a tolerance for residues of Bacillus thuringiensis 
eCry3.1Ab protein in corn. This notice referenced a summary of the 
petition prepared by the petitioner, Syngenta Seeds, Inc., which is 
available in the docket via

[[Page 57654]]

https://www.regulations.gov. One comment was received on the notice of 
filing. EPA's response to this comment is discussed in Unit VII.C.
    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 section 408(c)(2)(B) of FFDCA, in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C) of FFDCA, which require EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance exemption 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, section 408(b)(2)(D) of FFDCA requires 
that EPA 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 section 408(b)(2)(D) of FFDCA, 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

    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.
    Syngenta Seeds, Inc. developed Event 5307 maize (Zea mays) through 
Agrobacterium-mediated transformation (via plasmid vector PV-ZMIR245) 
to express eCry3.1Ab protein for use as a plant-incorporated protectant 
(PIP). This proposed PIP is a chimeric Bacillus thuringiensis protein, 
composed of portions of Cry1Ab and modified Cry3A proteins. The 
eCry3.1Ab protein was genetically engineered via exchanging the 
variable regions (V1 to V6) between the mCry3A and the Cry1Ab proteins 
for enhanced toxicity against western corn rootworm (WCR, Diabrotica 
virgifera). The eCry3.1Ab protein consists of a fusion between the N-
terminus (Domain I, Domain II, and a portion of Domain III) of mCry3A 
and the C-terminus (a portion of Domain III and variable region 6) of 
Cry1Ab. The eCry3.1Ab protein is 654 amino acid residues in size and is 
approximately 73.7 kilodaltons.

B. Mammalian Toxicity and Allergenicity Assessment

    Syngenta Seeds, Inc. 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 EPA's position regarding toxicity testing 
and the requirement of residue data for the microbial Bacillus 
thuringiensis products from which this PIP 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 (Master Record Identification 
Number (MRID No.) 477539-01) indicated that eCry3.1Ab is nontoxic. Two 
groups of 10 male and 10 female mice were orally dosed (via gavage) 
with 2,000 milligrams/kilograms bodyweight (mg/kg bwt) (eCry3.1Ab 
protein mg/kg bwt) of the eCry3.1Ab-0208 test substance, the microbial-
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 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 
2,000 mg/kg bwt and supports the finding that the eCry3.1Ab protein 
would be nontoxic 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.
    Since eCry3.1Ab is a protein, allergenic sensitivities were 
considered. Currently, no definitive tests exist for 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, see Ref. 7). 
Current scientific knowledge suggests that common food allergens tend 
to be resistant to degradation by acid and proteases; may be 
glycosylated; and 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. Preliminary expression level analysis shows 
that the eCry.1Ab protein is present at relatively low levels. Dietary 
exposure is expected to be correspondingly low. Expression

[[Page 57655]]

in Event 5307 leaf is 35 parts per million (ppm); root is 6 ppm; and 
pollen is 0.15 ppm. Thus, the expression has been shown to be in the 
parts per million range.
    4. Digestibility. The eCry3.1Ab protein was rapidly digested in 
simulated mammalian gastric fluid containing pepsin at a pH of 1.2 at 
37 [deg]C. The estimated degradation rate (DT50) is less 
than 1 minute for eCry3.1Ab protein.
    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 Exposure

    In examining aggregate exposure, section 408 of FFDCA 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).
    EPA 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 have 
been established for Cry1Ab in food and mCry3A in maize (see 40 CFR 
174.511 and 40 CFR 174.505, respectively). Second, and specific to the 
eCry3.1Ab protein, these considerations include dietary exposure under 
the tolerance exemption and all other tolerances or exemptions in 
effect for the PIP chemical residue and exposure from non-occupational 
sources. Exposure via the skin or inhalation is not likely since the 
PIP is contained within plant cells, which essentially eliminates these 
exposure routes or reduces these exposure routes to negligible. The 
amino acid homology 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 Bacillus thuringiensis 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, EPA 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 exemption, EPA 
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 Bacillus 
thuringiensis eCry3.1Ab protein in corn to share a common mechanism of 
toxicity with any other substances, and Bacillus thuringiensis 
eCry3.1Ab protein in corn does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has assumed that Bacillus thuringiensis 
eCry3.1Ab protein in corn does not have a common mechanism of toxicity 
with other substances. Following from this, EPA concludes that there 
are no cumulative effects associated with eCry3.1Ab that need to 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  https://www.epa.gov/pesticides/cumulative.

VI. Determination of Safety for United States (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 protein. 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., 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.
    In addition, since eCry3.1Ab is a protein, its potential 
allergenicity was 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 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 database 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 in this unit, EPA concludes 
that there is a reasonable certainty that no harm will result to the 
U.S. population, including infants and

[[Page 57656]]

children, from aggregate exposure to residues of the Cry3.1Ab 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. EPA has also concluded, again for 
the reasons discussed in more detail in this unit, 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

    EPA has determined that an analytical method is not required for 
enforcement purposes since it is establishing an exemption from the 
requirement of a tolerance without any numerical limitation. 
Nonetheless, a method for extraction and two test strip commercial kits 
to detect eCry3.1Ab protein via enzyme-linked immunosorbent assay 
analysis in corn have been submitted.

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. In this 
context, 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 U.N. 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 Bacillus thuringiensis 
eCry3.1Ab protein in corn.

C. Response to Comments

    One comment was received from an anonymous individual who objected 
to the use or approval of Bacillus thuringiensis-based corn. The 
individual further stated that the subject Bt corn was toxic and 
harmful and that animals eating it would be poisoned. No basis was 
given for these comments. While EPA understands that some individuals 
are opposed to all pesticide use and/or biotechnology based products, 
relevant data discussed in this unit did serve as the basis for EPA's 
conclusion in this instance that there is a reasonable certainty of no 
harm from residues of Bacillus thuringiensis eCry3.1Ab protein in corn.

VIII. Conclusion

    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 Bacillus thuringiensis eCry3.1Ab 
protein in corn and the genetic material necessary for its production. 
Therefore, the 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 in accordance with the terms of 
Experimental Use Permit (EUP) No. 67979-EUP-8 is modified by extending 
the expiration date to December 31, 2013.

IX. References

1. 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.
2. 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.
3. 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.
4. 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.
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 modifies a tolerance exemption under section 408(d) 
of FFDCA in response to a petition submitted to EPA. 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 modified on the basis of a 
petition under section 408(d) of FFDCA, such as the tolerance 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. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, EPA 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, EPA 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

[[Page 57657]]

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 EPA 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: September 8, 2011.
Keith Matthews,
Director, Biopesticides and Pollution Prevention Division, 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: 7 U.S.C. 136-136y; 21 U.S.C. 346a and 371.


0
2. Section 174.532 is revised to read as follows:


Sec.  174.532  Bacillus thuringiensis eCry3.1Ab protein in corn; 
temporary 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 temporarily from the requirement of a tolerance 
when Bacillus thuringiensis eCry3.1Ab protein in corn is used as a 
plant-incorporated protectant in accordance with the terms of 
Experimental Use Permit 67979-EUP-8. This temporary exemption from the 
requirement of a tolerance expires on December 31, 2013.

[FR Doc. 2011-23813 Filed 9-15-11; 8:45 am]
BILLING CODE 6560-50-P