Bacillus thuringiensis Cry2Ae Protein in Cotton; Exemption from the Requirement of a Tolerance, 6471-6475 [2012-2595]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 77, Number 26 (Wednesday, February 8, 2012)]
[Rules and Regulations]
[Pages 6471-6475]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2595]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2007-0573; FRL-9333-7]


Bacillus thuringiensis Cry2Ae Protein in Cotton; 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 Bacillus thuringiensis Cry2Ae protein in 
or on the food and feed commodities of cotton; cotton, undelinted seed; 
cotton, gin byproducts; cotton, forage; cotton, hay; cotton, hulls; 
cotton, meal; and cotton, refined oil, when used as a plant-
incorporated protectant (PIP) in cotton. Bayer CropScience LP 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 Cry2Ae protein in cotton 
under the FFDCA.

DATES: This regulation is effective February 8, 2012. Objections and 
requests for hearings must be received on or before April 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0573. 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: Shanaz Bacchus, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8097; email 
address: bacchus.shanaz@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://

[[Page 6472]]

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-2007-0573 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
April 9, 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-2007-0573, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online 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 April 8, 2009 (74 FR 15969) (FRL-8407-
6), 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 9F7514) by Bayer CropScience LP, P.O. Box 12014, 2 T.W. 
Alexander Dr., Research Triangle Park, NC 27709. The petition requested 
that 40 CFR part 174 be amended by establishing an exemption from the 
requirement of a tolerance for residues of Bacillus thuringiensis 
Cry2Ae insect control protein and the genetic material necessary for 
its production in or on all food commodities. This notice referenced a 
summary of the petition prepared by the petitioner, Bayer CropScience 
LP, which is available in the docket via https://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 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

    Bayer CropScience LP (Bayer) developed event GHB119 cotton 
(Gossypium hirsutum) to express Bacillus thuringiensis (Bt) Cry2Ae 
insecticidal protein (hereinafter referred to as Cry2Ae protein) for 
use as a PIP. Event GHB119 cotton was created by Agrobacterium-mediated 
transformation using plasmid pTEM12. This PIP provides event GHB119 
cotton protection against feeding damage by lepidopteran insect larvae. 
The Organisation for Economic Cooperation and Development (OECD) Unique 
Identifier for event GHB119 is BCS-GH005-8. The cry2Ae gene was 
isolated from Bt subspecies dakota and its sequence modified for 
optimal expression in plants. The cry2Ae gene used in plasmid pTEM12 
encodes Cry2Ae insecticidal crystal protein containing 631 amino acids 
with a molecular weight of 71 kilodaltons.
    Bayer's event GHB119 cotton containing the Cry2Ae protein has been 
in experimental trials since September 1, 2008. The Cry2Ae protein in 
this cotton is intended to specifically control the larvae of cotton 
bollworm (CBW, Helicoverpa zea), pink bollworm (PBW, Pectinophora 
gossypiella), tobacco budworm (TBW, Heliothis virescens), and fall 
armyworm (FAW, Spodoptera frugiperda).
    Event GHB119 cotton also expresses the Phosphinothricin 
Acetyltransferase (PAT) enzyme, which is exempt from the requirement of 
a tolerance when used as a PIP inert ingredient in all food commodities 
(40 CFR 174.522; April 25, 2007; 72 FR 20431; FRL-7742-1). This enzyme 
confers tolerance of the cotton plants to the herbicide, glufosinate.

B. Toxicological Profile of Bacillus thuringiensis Cry2Ae Protein

    1. Acute oral toxicity. The toxicological profile of the protein 
was previously described in the Federal Register of September 10, 2008 
(73 FR 52591; FRL-8380-1) to establish the temporary tolerance 
exemption for Cry2Ae protein residues in/on cotton food/feed 
commodities when used as a PIP in cotton (40 CFR 174.530). The 
petitioner has now requested that EPA establish a permanent exemption 
from the requirement of a tolerance for residues of Bacillus 
thuringiensis Cry2Ae protein in or on all food commodities. However, 
because the

[[Page 6473]]

submitted exposure analysis was based upon the expression of Bacillus 
thuringiensis Cry2Ae protein in cotton only and because no other uses 
of this protein as a PIP exist in connection with any other food or 
animal feed commodities, the final tolerance exemption for Cry2Ae 
protein residues that the Agency is granting varies from what the 
petitioner sought in as much as it is limited to residues of Cry2Ae 
protein in/on the cotton food/feed commodities specifically listed in 
the tolerance exemption regulatory text when Cry2Ae protein is used as 
a PIP in cotton. Further explanation is provided in Unit VII.C.
    Consistent with section 408(b)(2)(D) of the FFDCA, EPA reviewed the 
available scientific data and other relevant information submitted in 
support of these actions and considered their validity, completeness 
and reliability, and the relationship of this information to human 
risk. The health effects data previously reviewed in support of the 
temporary tolerance exemption (Ref. 1) and additional data on the PIP 
in question that was previously evaluated in 2011 (Ref. 2) support the 
establishment of this permanent tolerance exemption for residues of 
Cry2Ae protein in/on the specifically noted cotton food/feed 
commodities when Cry2Ae protein is used as a PIP in cotton. When 
proteins are toxic, they are known to act via acute mechanisms and at 
very low dose levels (Ref. 3.) An acute oral toxicity (Tier I) study in 
mice indicated that Cry2Ae protein is non-toxic to mammals (Master 
Record Identification (MRID) 47076902; Ref. 1). The acute oral toxicity 
of Cry2Ae protein was assessed by administering 2000 milligrams/
kilogram (mg/kg) body weight of bacterially produced Cry2Ae protein 
test substance to five female mice by oral gavage. All treated animals 
gained weight and had no clinical signs or findings at necropsy related 
to the test material. The acute oral LD50 of the Cry2Ae 
protein is greater than 2,000 mg/kg body weight. (Refs. 1 and 2). These 
data demonstrate the safety of Cry2Ae protein at a level well above 
maximum possible parts per million (ppm) exposure levels that are 
reasonably anticipated in the cotton food/feed commodities covered by 
this tolerance exemption. Since no acute effects were shown to be 
caused by Cry2Ae protein, even at such relatively high dose levels, the 
Cry2Ae protein is not considered toxic. Furthermore, amino acid 
sequence comparisons showed no similarities between the Cry2Ae protein 
and known toxic proteins in protein databases that would raise a safety 
concern.
    For microbial products, Tier II and III toxicity testing and 
residue data are required to verify and clarify any adverse effects 
observed during Tier I testing. Based on the lack of acute oral 
toxicity and the absence of adverse effects in the Tier I acute oral 
toxicity test in mice, EPA did not require Tier II and Tier III testing 
or residue data for Cry2Ae protein. This conclusion is similar to the 
Agency 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)).
    2. Allergenicity assessment. Since Cry2Ae 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-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 of the protein as recommended by the Codex 
Alimentarius Commission, 2003 (Ref. 4).
    Summary level findings of note from the allergenicity assessment 
for Cry2Ae protein (see Refs. 1, 2, and 5) include:
    i. Source of the trait. Bacillus thuringiensis, the microorganism 
from which Cry2Ae protein is derived, is not considered to be a source 
of allergenic proteins (MRID 47125101 and 47641912, Refs. 6 and 7).
    ii. Amino acid sequence. A comparison of the amino acid sequence of 
Cry2Ae protein with known allergens showed no overall sequence 
similarity meeting the standards for potential allergenicity (i.e., 35% 
identity over an 80 amino acid segment, and 100% sequence identity at 
the level of 8 amino acids, the smallest number of amino acids needed 
to cause an allergic response (MRIDs 47641908 and 47641909)). These 
results demonstrated that an individual exposed to the Cry2Ae protein 
in the diet would not be expected to experience an allergic reaction.
    iii. Prevalence in food. Food allergens may be present at high 
concentrations (Ref. 4); however, protein expression level analyses 
showed that Cry2Ae protein in cotton is expressed at relatively low 
levels, in the ppm range (MRID 47641903). Furthermore, cotton products 
comprise only a small part of the human diet. Consequently, dietary 
exposure to Cry2Ae protein expressed in cotton would be extremely 
limited.
    iv. Digestibility. Common food allergens tend to be resistant to 
degradation by acid and proteases (Ref. 4). The Cry2Ae protein was 
rapidly digested (within 30 seconds) in SGF containing pepsin at a pH 
of 1.2 (MRID 47125102). Because it is quickly degraded, dietary 
exposure to the whole protein is low. Consequently, the potential for 
sensitivity is low.
    v. Glycosylation. Current scientific knowledge (Ref. 4) suggests 
that common food allergens may be glycosylated. The Cry2Ae protein 
expressed in cotton is not glycosylated (MRIDs 48471901 and 48480006), 
and so does not share this characteristic of some allergens.
    All these preceding characteristics are part of the weight-of-
evidence approach to determine that a protein is not expected to be an 
allergen. Considering all of the available information, EPA has 
concluded that the potential for Cry2Ae protein to be a food allergen 
is minimal.

IV. Aggregate Exposures

    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).
    The Agency considered available information on the aggregate 
exposure levels of consumers (including major identifiable subgroups of 
consumers) to the PIP residue and to other related substances. These 
considerations include dietary exposure under the tolerance exemption 
and all other tolerances or exemptions in effect for the PIP residue, 
and exposure from non-occupational sources.
    As previously discussed (Unit III.), the oral toxicity studies 
conducted at a dose of 2,000 mg/kg testing showed no adverse effects 
for Cry2Ae protein, which was also shown to be rapidly digested in 
vitro. As previously stated, when Cry2Ae protein is used as a PIP in 
cotton, it is expressed at very low levels in the cotton. Although 
cotton is not a directly consumed food commodity, humans may be exposed 
to extremely low levels in the diet, potentially from ingestion of 
processed cotton products (e.g., cottonseed flour and oil). There is 
also a very remote possibility that Cry2Ae protein can get in the water 
supply the same way that other proteins in crop debris can

[[Page 6474]]

migrate into the ground, and, possibly, drinking water. Because such 
potential dietary exposure from cotton or drinking water is expected to 
be several orders of magnitude lower than the amounts of these proteins 
shown to have no toxicity in mammalian tests, EPA concludes that even 
negligible exposure via food and drinking water would present no harm, 
based on the lack of mammalian toxicity and allergenicity potential, 
and the rapid digestibility demonstrated in SGF for the PIP.
    Non-occupational dermal and inhalation exposure is not expected, 
since the PIP is expressed and contained within cotton plant cells. The 
uses of this PIP are agricultural, so there would be no exposure to 
infants and children from residential, school or lawn use. The amino 
acid sequence homology of known aeroallergens was included in the amino 
acid comparison of Cry2Ae protein with known food allergens, and the 
results indicated that no respiratory allergencity would be expected if 
Cry2Ae protein were inhaled. The amino acid sequence results are 
discussed in more detail in Unit III.B.2.ii., above. 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. 7). This observation is also 
relevant to the low potential for non-occupational inhalation exposure 
at levels far below those expected in occupationally exposed 
populations.
    Taking all these data and information into consideration, EPA 
concludes that even if negligible aggregate exposure should occur it 
would present no harm to the U.S. human population.

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.''
    EPA has not found Bacillus thuringiensis Cry2Ae protein to share a 
common mechanism of toxicity with any other substances, and Bacillus 
thuringiensis Cry2Ae protein 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 Cry2Ae protein does not have a common mechanism of 
toxicity with other substances. 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 U.S. Population, Infants and Children

    To evaluate human risk, EPA considered the validity, completeness, 
and reliability of the available data from the studies cited in Unit 
III. regarding potential health effects for Cry2Ae protein. This 
evaluation included the low levels of expression of Cry2Ae proteins in 
cotton, as well as the lack of acute oral toxicity at high dose levels, 
heat stability, and in vitro digestibility of this protein. EPA also 
considered the minimal potential for allergenicity and the non-toxic 
source of the protein. Because of this lack of demonstrated mammalian 
toxicity, no protein residue chemistry data for Cry2Ae protein were 
required for a human health effects assessment.
    Finally, and specifically with 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 Units III. and IV. in this document, EPA 
concluded 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 the Agency is establishing an exemption from 
the requirement of a tolerance without any numerical limitation. 
Nonetheless, Bayer has submitted an analytical method using enzyme-
linked immunosorbent assay (ELISA) analyses for the qualitative 
detection of Cry2Ae proteins in cotton seed and cotton leaf. Although 
validation studies showed the test kit can detect Cry2Ae protein in 
cotton with sufficient accuracy, precision, and sensitivity, a method 
validation study conducted by an independent third party laboratory to 
evaluate the ELISA test kit's performance as the designated analytical 
method for the detection of Cry2Ae protein residues expressed in event 
GHB119 cotton is still required.

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 
Cry2Ae protein in cotton.

C. Revisions to Petitioned-for Tolerance Exemption

    The petitioner requested that EPA establish a permanent exemption 
from the requirement of a tolerance for residues of Bacillus 
thuringiensis Cry2Ae protein in or on all food commodities. A temporary 
tolerance exemption was previously granted to Bayer for cotton food/
feed commodities in association with an Experimental Use Permit, EPA 
Reg. No. 264-EUP-143 published on September 10, 2008 (73 FR 52591; FRL-
8380-1). That exposure analysis and evaluation of additional data to 
establish this permanent exemption from tolerance are based upon the 
expression of Bacillus thuringiensis Cry2Ae protein in cotton. No other 
uses of this protein as a PIP in other food or animal feed commodities 
exist. As a result, there has been no effort to date to ensure that 
transformation events in plants other than cotton that express Cry2Ae 
protein have the same safety characteristics as those described in this 
evaluation.

[[Page 6475]]

Consequently, the final tolerance exemption for Cry2Ae protein residues 
that the Agency is granting varies from what the petitioner sought in 
as much as it is limited to residues of Cry2Ae protein in/on certain 
cotton food/feed commodities when Cry2Ae protein is used as a PIP in 
cotton.

VIII. Conclusions

    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 Cry2Ae 
protein in cotton food/feed commodities. An exemption from the 
requirement of a tolerance is therefore established for residues of 
Bacillus thuringiensis Cry2Ae protein in or on the food or feed 
commodities of cotton; cotton, undelinted seed; cotton, gin byproducts; 
cotton, forage; cotton, hay; cotton, hulls; cotton, meal; and cotton, 
refined oil, when used as a PIP in these food and feed commodities.

IX. References

1. U.S. EPA BPPD memorandum (R. Edelstein to S. Bacchus), February 
12, 2008.
2. U.S. EPA BPPD memorandum (A. Waggoner to S. Bacchus), November 
30, 2011. Review of Product Characterization and Human Health Data 
in support for Sec. 3 Registration of Plant-Incorporated Protectant 
(PIP) event GHB119 cotton [EPA File Symbol No. 264-RNOL] expressing 
Bacillus thuringiensis Cry2Ae insecticidal protein and Combination 
PIP TwinLink[supreg] cotton [EPA File Symbol No. 264-RNOA], 
developed by conventional breeding of its constituent parental 
events GHB119 x T304-40, expressing Bt Cry2Ae and Cry1Ab proteins, 
respectively.
3. Sjoblad, Roy D. et al. (1992) Toxicological Considerations for 
Protein Components of Biological Pesticide Products Regulatory 
Toxicology and Pharmacology 15: pp. 3-9.
4. CAC. 2003. Alinorm 03/34: Joint FAO/WHO Food Standard Programme. 
Codex Alimentarius Commission, Twenty-Fifth Session, July 30, 2003. 
Rome, Italy. Appendix III: Guideline for Conduct of Food Safety 
Assessments of Foods Derived from Recombinant-DNA Plants; Appendix 
IV: Annex on Assessment of Possible Allergenicity. CAC, pp. 47-60.
5. Federal Register. September 10, 2008. (73 FR 52591) (FRL-8380-1). 
Bacillus thuringiensis Cry2Ae in Cotton: Temporary Exemption from 
the Requirement of a Tolerance.
6. Mendelsohn, M., et al. 2003. Are Bt Crops Safe? Nat Biotechnol 
21(9): pp. 1003-1009.
7. Bernstein, I.L., et al. 1999. Immune responses in farm workers 
after exposure to Bacillus thuringiensis pesticides. Environ Health 
Perspect. 107(7): pp. 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 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, 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: January 26, 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: 7 U.S.C. 136-136y; 21 U.S.C. 346a and 371.


0
2. Section 174.530 is revised to read as follows:


Sec.  174.530  Bacillus thuringiensis Cry2Ae protein in cotton; 
exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry2Ae protein in or on the food 
and feed commodities of cotton; cotton, undelinted seed; cotton, gin 
byproducts; cotton, forage; cotton, hay; cotton, hulls; cotton, meal; 
and cotton, refined oil, are exempt from the requirement of a tolerance 
when Bacillus thuringiensis Cry2Ae protein is used as a plant-
incorporated protectant in cotton.

[FR Doc. 2012-2595 Filed 2-7-12; 8:45 am]
BILLING CODE 6560-50-P