Federal Register / Vol. 77, No. 26 / Wednesday, February 8, 2012 / Rules and Regulations 6471 

EPA-APPROVED GEORGIA NON-REGULATORY PROVISIONS

Name of nonregulatory SIP provision Applicable geographic 

or nonattainment area 

State submittal 

date/effective 

date 

EPA approval date 

*******

29. Chattanooga; Fine Particulate Matter 2002 Base 

Year Emissions Inventory.

Catoosa and Walker Counties ........ 10/27/09 2/8/12 [Insert citation of 

publication]. 

Subpart RR—Tennessee 

■ 2. Section 52.2220(e) is amended by 

adding a new entry for ‘‘Chattanooga; 

Fine Particulate Matter 2002 Base Year 

Emissions Inventory’’ at the end of the 

table to read as follows: 

§ 52.2220 Identification of plan. 

* * * * * 

(e) * * * 

EPA-APPROVED TENNESSEE NON-REGULATORY PROVISIONS

Name of non-regulatory SIP provision Applicable geographic or nonattainment area 

State effective 

date EPA approval date Explanation 

*******

Chattanooga; Fine Particulate Matter 2002 Base 

Year Emissions Inventory.

Hamilton County .......................... 10/15/09 2/8/12 [Insert citation of publication].

[FR Doc. 2012–2731 Filed 2–7–12; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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 http://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 

http://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 http:// 


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ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a(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: http:// 

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 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 

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 


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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 weightof-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 nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

The Agency 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 nonoccupational 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 


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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 

http://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. 


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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® 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] 

■ 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. 

■ 2. Section 174.530 is revised to read 

as follows: 

§ 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 plantincorporated protectant in cotton. 

[FR Doc. 2012–2595 Filed 2–7–12; 8:45 am] 

BILLING CODE 6560–50–P 


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