Federal Register / Vol. 76, No. 180 / Friday, September 16, 2011 / Rules and Regulations 57653 

designated by Wisconsin as Limited 

Forage Fish aquatic life use. 

* * * * * 

[FR Doc. 2011–23817 Filed 9–15–11; 8:45 am] 

BILLING CODE 6560–50–P 

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 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: 

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 http:// 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

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 


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http://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 threedimensional structure comprised of 

three domains, Domain I, II, and III 

(Refs. 1, 2, 3, and 4). The toxin portions 

of Cry proteins are characterized by 

having five conserved blocks (CB) across 

their amino acid sequence. These are 

numbered CB1 to CB5 from the Nterminus to the C-terminus (Ref. 5). The 

sequences preceding and following 

these conserved blocks are highly 

variable and are designated as variable 

regions V1 to V6. 

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 materialrelated 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 


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Federal Register / Vol. 76, No. 180 / Friday, September 16, 2011 / Rules and Regulations 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 °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 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). 

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 

http://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 


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57656 Federal Register / Vol. 76, No. 180 / Friday, September 16, 2011 / Rules and Regulations 

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 plantincorporated 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 StructureFunction 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 


erowe on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 76, No. 180 / Friday, September 16, 2011 / Rules and Regulations 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] 

■ 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 174.532 is revised to read 

as follows: 

§ 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 plantincorporated 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0360; FRL–8887–5] 

Tetrachlorvinphos; Extension of TimeLimited Interim Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

extension of time-limited interim 

tolerances for the combined residues of 

the insecticide tetrachlorvinphos [(Z)-2- 

chloro-1-(2,4,5-trichlorophenyl) vinyl 

dimethyl phosphate], including its 

metabolites, 1-(2,4,5-trichlorophenyl)- 

ethanol (free and conjugated forms), 

2,4,5-trichloroacetophenone, and 1- 

(2,4,5-trichlorophenyl)-ethanediol, in or 

on multiple commodities which will be 

identified later in this document, under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). The time-limited 

tolerances expire on March 18, 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–2011–0360. 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 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: 

Carmen Rodia, Registration Division 

(7504P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Avenue, NW., 

Washington, DC 20460–0001; telephone 

number: (703) 306–0327; fax number: 

(703) 308–0029; e-mail address: 

rodia.carmen@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? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the Federal Register listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR cite at http:// 

www.gpoaccess.gov/ecfr. 

C. How can I file an objection or hearing 

request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. The EPA procedural 


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