Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Rules and Regulations 47287 

within a 500 yards radius of position 

43° 06′06′′ N, 082° 27′03′′ W (NAD 83). 

(b) Effective and Enforcement Period. 

This regulation is effective and enforced 

from 11:00 a.m. on July 28, 2012 until 

11:00 a.m. on August 25, 2012. 

(c) Regulations. 

(1) In accordance with the general 

regulations in § 165.23 of this part, entry 

into, transiting, or anchoring within this 

safety zone is prohibited unless 

authorized by the Captain of the Port 

Detroit or his designated on-scene 

representative. 

(2) This safety zone is closed to all 

vessel traffic, except as may be 

permitted by the Captain of the Port 

Detroit or his designated on-scene 

representative. 

(3) The ‘‘on-scene representative’’ of 

the Captain of the Port Detroit is any 

Coast Guard commissioned, warrant or 

petty officer who has been designated 

by the Captain of the Port Detroit to act 

on his behalf. 

(4) Vessel operators desiring to enter 

or operate within the safety zone shall 

contact the Captain of the Port Detroit 

or his on-scene representative to obtain 

permission to do so. The Captain of the 

Port Detroit or his on-scene 

representative may be contacted via 

VHF Channel 16. Vessel operators given 

permission to enter or operate in the 

safety zone must comply with all 

directions given to them by the Captain 

of the Port Detroit, or his on-scene 

representative. 

Dated: July 27, 2012. 

J.E. Ogden, 

Captain, U. S. Coast Guard, Captain of the 

Port Detroit. 

[FR Doc. 2012–19347 Filed 8–7–12; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 174 

[EPA–HQ–OPP–2012–0109; FRL–9357–4] 

Bacillus thuringiensis eCry3.1Ab 

Protein in Corn; Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the plantincorporated protectant (PIP), Bacillus 

thuringiensis eCry3.1Ab protein in corn, 

in or on the food and feed commodities 

of corn; corn, field; corn, sweet; and 

corn, pop. Syngenta Seeds, Inc., Field 

Crops NAFTA submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of Bacillus 

thuringiensis eCry3.1Ab protein in corn. 

DATES: This regulation is effective 

August 8, 2012. Objections and requests 

for hearings must be received on or 

before October 9, 2012, and must be 

filed in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0109, is 

available either electronically through 

http://www.regulations.gov or in hard 

copy at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Mike Mendelsohn, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8715; email address: 

mendelsohn.mike@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 174 

through the Government Printing 

Office’s e-CFR site at http:// 

ecfr.gpoaccess.gov/cgi/t/text/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, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0109 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before October 9, 2012. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2012–0109, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 28221T, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 


wreier-aviles on DSK5TPTVN1PROD with RULES
47288 Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Rules and Regulations 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

available at 

http://www.epa.gov/dockets. 

II. Background and Statutory Findings 

In the Federal Register of April 4, 

2012 (77 FR 20337) (FRL–9340–4), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

tolerance petition (PP 1F7857) by 

Syngenta Seeds, Inc., Field Crops 

NAFTA, P.O. Box 12257, 3054 E. 

Cornwallis Road, Research Triangle 

Park, NC 27709–2257. The petition 

requested that 40 CFR 174.532 be 

amended by establishing a permanent 

exemption from the requirement of a 

tolerance for residues of Bacillus 

thuringiensis eCry3.1Ab protein in corn, 

in or on the food and feed commodities 

of corn; corn, field; corn, sweet; and 

corn, pop. This notice referenced a 

summary of the petition prepared by the 

petitioner Syngenta Seeds, Inc., Field 

Crops NAFTA, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Pursuant to 

FFDCA section 408(c)(2)(B), in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), which require EPA to give 

special consideration to exposure of 

infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue * * *.’’ Additionally, 

FFDCA section 408(b)(2)(D) requires 

that the Agency consider ‘‘available 

information concerning the cumulative 

effects of a particular pesticide’s 

residues’’ and ‘‘other substances that 

have a common mechanism of toxicity.’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

Consistent with FFDCA section 

408(b)(2)(D), EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability, and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. 

A. Product Characterization 

Based on amino acid sequence 

homology and crystal structures, known 

Cry proteins have a similar 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. Because Cry proteins 

share structural similarities, chimeric 

cry genes can be engineered via the 

exchange of domains that are 

homologous between different cry 

genes. 

eCry3.1Ab is an engineered chimera 

protein, composed of portions of 

modified Cry3A (mCry3A) protein, a 

protein derived from the native Cry3A 

protein from Bt subsp. tenebrionis, and 

of the Cry1Ab protein from Bt 

thuringiensis subsp. kurstaki HD–1. The 

ecry3.1Ab gene (Entrez Accession 

Number GU327680 NCBI, 2011) 

(Walters et al. 2010) consists of a fusion 

between the N-terminus (Domain I, 

Domain II, and a portion of Domain III) 

of a mcry3A gene and the C-terminus (a 

portion of Domain III and Variable 

Region 6) of a cry1Ab gene (Ref. 5). The 

eCry3.1Ab protein is 654 amino acid 

residues in size and is approximately 

74.8 kilodaltons. 

B. Mammalian Toxicity Assessment 

Syngenta has submitted acute oral 

toxicity data demonstrating the lack of 

mammalian toxicity at high levels of 

exposure to the pure eCry3.1Ab protein. 

These data demonstrate the safety of the 

product at a level well above maximum 

possible exposure levels that are 

reasonably anticipated in the crop. 

Basing this conclusion on acute oral 

toxicity data without requiring further 

toxicity testing and residue data is 

similar to the Agency position regarding 

toxicity testing and the requirement of 

residue data for the microbial Bacillus 

thuringiensis products from which this 

plant-incorporated protectant was 

derived (see 40 CFR 158.2130(d)(1)(i) 

and 158.2140(d)(7)). For microbial 

products, further toxicity testing and 

residue data are triggered by significant 

adverse acute effects in studies, such as 

the mouse oral toxicity study, to verify 

and quantify the observed adverse 

effects and clarify the source of these 

effects (Tiers II & III). 

An acute oral toxicity study in mice 

(MRID No. 477539–01) indicated that 

eCry3.1Ab is non-toxic. Two groups of 

10 male and 10 female mice were orally 

dosed (via gavage) with 2,000 

milligrams/kilograms bodyweight 

(eCry3.1Ab protein mg/kg bwt) of the 

eCry3.1AB–0208 test substance, a 

biochemically and functionally 

equivalent microbially-produced 

eCry3.1Ab protein. All treated animals 

gained weight and had no test materialrelated clinical signs and no test 

material-related findings at necropsy. 

Since there were no significant 

differences between the test and control 

groups related to the oral administration 

of the eCry3.1AB–0208 test material, the 

eCry3.1Ab protein does not appear to 

cause any significant adverse effects at 

an exposure level of up to 2000 mg/kg 

bwt, which supports the finding that the 

eCry3.1Ab protein would be non-toxic 

to mammals. 

When proteins are toxic, they are 

known to act via acute mechanisms and 

at very low dose levels (Ref. 6). 

Therefore, since no acute effects were 

shown to be caused by eCry3.1Ab, even 

at relatively high dose levels, the 

eCry3.1Ab protein is not considered 

toxic. Further, amino acid sequence 

comparisons showed no similarities 

between the eCry3.1Ab protein and 

known toxic proteins in protein 

databases that would raise a safety 

concern. 

C. Allergenicity Assessment 

Since eCry3.1Ab is a protein, 

allergenic sensitivities were considered. 

Currently, no definitive tests exist for 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Rules and Regulations 47289 

determining the allergenic potential of 

novel proteins. Therefore, EPA uses a 

‘‘weight-of-the evidence’’ approach 

where the following factors are 

considered: source of the trait; amino 

acid sequence similarity with known 

allergens; prevalence in food; and 

biochemical properties of the protein, 

including in vitro digestibility in 

simulated gastric fluid (SGF), and 

glycosylation (as recommended by CAC, 

2003) (Ref. 7). Current scientific 

knowledge suggests that common food 

allergens tend to be resistant to 

degradation by acid and proteases; may 

be glycosylated; and may be present at 

high concentrations in the food. 

1. Source of the trait. Bacillus 

thuringiensis is not considered to be a 

source of allergenic proteins. 

2. Amino acid sequence. A 

comparison of the amino acid sequence 

of eCry3.1Ab with known allergens 

showed no significant overall sequence 

similarity or identity at the level of eight 

contiguous amino acid residues. This is 

the appropriate level of sensitivity to 

detect possible IgE epitopes without 

high false positive rates. 

3. Prevalence in food. Expression 

level analysis of eCry.1Ab protein 

demonstrates that it is present at 

relatively low levels. The expression has 

been shown to be in the parts per 

million range. Thus, dietary exposure is 

expected to be correspondingly low. 

4. Digestibility. The eCry3.1Ab protein 

was rapidly digested in less than 30 

seconds in simulated mammalian 

gastric fluid containing pepsin (pH 1.2) 

after incubation at 37 °C. 

5. Glycosylation. The eCry3.1Ab 

protein expressed in corn was shown 

not to be glycosylated. 

6. Conclusion. Considering all of the 

available information, EPA has 

concluded that the potential for 

eCry3.1Ab to be a food allergen is 

minimal. 

IV. Aggregate Exposures 

In examining aggregate exposure, 

FFDCA section 408 directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other 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 has considered available 

information on the aggregate exposure 

levels of consumers (and major 

identifiable subgroups of consumers) to 

the pesticide chemical residue and to 

other related substances. First, with 

respect to other related substances, the 

eCry3.1Ab protein is a chimeric Bacillus 

thuringiensis protein, composed of 

portions of Cry1Ab and mCry3A 

proteins, both of which are registered 

PIPs that were previously assessed as 

having a lack of mammalian toxicity at 

high levels of exposure. Exemptions 

from the requirement of a tolerance 

already have been established for 

Cry1Ab in food and mCry3A in maize, 

see 40 CFR 174.505 and 40 CFR 

174.511, respectively. Second, and 

specific to the eCry3.1Ab protein, EPA 

has considered dietary exposure under 

the tolerance exemption and all other 

tolerances or exemptions in effect for 

the plant-incorporated protectant 

chemical residue and exposure from 

non-occupational sources. Exposure via 

the skin or inhalation is not likely since 

the plant-incorporated protectant is 

contained within plant cells, which 

essentially eliminates these exposure 

routes or reduces these exposure routes 

to negligible. The amino acid similarity 

assessment included similarity to 

known aeroallergens. It has been 

demonstrated that there is no evidence 

of occupationally related respiratory 

symptoms, based on a health survey on 

migrant workers after exposure to Bt 

pesticides (Ref. 8). Exposure via 

residential or lawn use to infants and 

children is also not expected because 

the use sites for the eCry3.1Ab protein 

are all agricultural for control of insects. 

Oral exposure, at very low levels, may 

occur from ingestion of processed corn 

products and, potentially, drinking 

water. 

However, oral toxicity testing done at 

a dose of 2 gm/kg showed no adverse 

effects. Furthermore, the expected 

dietary exposure from corn is several 

orders of magnitude lower than the 

amounts of eCry3.1Ab protein shown to 

have no toxicity. Therefore, even if 

negligible aggregate exposure should 

occur, the Agency concludes that such 

exposure would present no harm due to 

the lack of mammalian toxicity and the 

rapid digestibility demonstrated for the 

eCry3.1Ab protein. 

V. Cumulative Effects From Substances 

With a Common Mechanism of Toxicity 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

Since eCry3.1Ab is not considered 

toxic, EPA has not found eCry3.1Ab to 

share a common mechanism of toxicity 

with any other substances, and 

eCry3.1Ab does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that eCry3.1Ab does not have 

a common mechanism of toxicity with 

other substances. Following from this, 

therefore, EPA concludes that there are 

no cumulative effects associated with 

eCry3.1Ab that need be considered. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/ 

cumulative. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

The data submitted and cited 

regarding potential health effects for the 

eCry3.1Ab protein include the 

characterization of the expressed 

eCry3.1Ab protein in corn, as well as 

the acute oral toxicity, heat stability, 

and in vitro digestibility of the proteins. 

The results of these studies were used 

to evaluate human risk, and the validity, 

completeness, and reliability of the 

available data from the studies were also 

considered. 

As discussed more fully in Unit III. B. 

above, the acute oral toxicity data 

submitted supports the prediction that 

the eCry3.1Ab protein would be 

nontoxic to humans. Moreover, 

eCry3.1Ab showed no sequence 

similarity to any known toxin. Because 

of this lack of demonstrated mammalian 

toxicity, no protein residue chemistry 

data for eCry3.1Ab were required for a 

human health effects assessment. Even 

so, preliminary expression level 

analysis showed eCry3.1Ab protein is 

present at relatively low levels. Dietary 

exposure is expected to be 

correspondingly low. 

Since eCry3.1Ab is a protein, its 

potential allergenicity is also considered 

as part of the toxicity assessment. Data 

considered as part of the allergenicity 

assessment include that the eCry3.1Ab 

protein came from Bacillus 

thuringiensis which is not a known 

allergenic source, showed no sequence 

similarity to known allergens, was 

readily degraded by pepsin, and was not 

glycosylated when expressed in the 

plant. Therefore, there is a reasonable 

certainty that eCry3.1Ab protein will 

not be an allergen. 

Considered together, the lack of 

mammalian toxicity at high levels of 

exposure to the eCry3.1Ab protein and 

the minimal potential for that protein to 

be a food allergen demonstrate the 

safety of the product at levels well 


wreier-aviles on DSK5TPTVN1PROD with RULES
47290 Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Rules and Regulations 

above possible maximum exposure 

levels anticipated in the crop. 

Finally, and specifically in regards to 

infants and children, FFDCA section 

408(b)(2)(C) provides that EPA shall 

assess the available information about 

consumption patterns among infants 

and children, special susceptibility of 

infants and children to pesticide 

chemical residues, and the cumulative 

effects on infants and children of the 

residues and other substances with a 

common mechanism of toxicity. In 

addition, FFDCA section 408(b)(2)(C) 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base, unless 

EPA determines that a different margin 

of safety will be safe for infants and 

children. 

Based on its review and consideration 

of all the available information, as 

discussed in more detail above, the 

Agency concludes that there is a 

reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to residues of the eCry3.1Ab 

protein and the genetic material 

necessary for its production in corn. 

This includes all anticipated dietary 

exposures and all other exposures for 

which there is reliable information. The 

Agency has also concluded, again for 

the reasons discussed in more detail 

above, that there are no threshold effects 

of concern and, as a result, that an 

additional margin of safety for infants 

and children is unnecessary in this 

instance. 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

Nonetheless, Syngenta has submitted 

validation method studies on two 

qualitative lateral flow strip kits for the 

analytical detection of eCry3.1Ab 

protein in corn grain, leaf and seed corn 

matrices. Results showed the test kits 

are able to detect eCry3.1Ab protein 

residues in corn with sufficient 

accuracy, precision, and sensitivity. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for establishing 

a difference tolerance. 

The Codex has not established a MRL 

for Bacillus thuringiensis eCry3.1Ab 

protein in corn. 

VIII. Conclusions 

For all the reasons summarized above, 

EPA concludes that there is a reasonable 

certainty that no harm will result to the 

U.S. population, including infants and 

children, from aggregate exposure to 

residues of the plant incorporated 

protectant (PIP) Bacillus thuringiensis 

eCry3.1Ab protein in corn and the 

genetic material necessary for its 

production. Therefore, the current 

temporary exemption for residues of 

Bacillus thuringiensis eCry3.1Ab 

protein in corn, in or on the food or feed 

commodities of corn; corn, field; corn, 

sweet; and corn, pop, when used as a 

plant-incorporated protectant is 

amended in order to remove its 

expiration date and make it a permanent 

exemption. 

IX. References 

1. Nakamura K, Oshie K, Shimizu M, Takada 

Y, Oeda K, Ohkawa H. 1990. 

Construction of Chimeric Insecticidal 

Proteins Between the 130-kDa and 135- 

kDa Proteins of Bacillus thuringiensis 

subsp. aizawai for Analysis of StructureFunction Relationship. Agricultural 

Biological Chemistry. 54: 715–724. 

2. Li J, Carroll J, Ellar DJ. 1991. Crystal 

Structure of Insecticidal delta-Endotoxin 

from Bacillus thuringiensis at 2.5 A 

resolution. Nature. 353: 815–821. 

3. Ge A, Rivers D, Milne R, Dean DH. 1991. 

Functional Domains of Bacillus 

thuringiensis Insecticidal Crystal 

Proteins. Refinement of Heliothis 

virescens and Trichoplusiani Specificity 

Domains on Cry1A(c). Journal of 

Biological Chemistry. 266: 17954–17958. 

4. Honee G, Convents D, Van Rie J, Jansens 

S, Peferoen M, Visser B. 1991. The CTerminal Domain of the Toxic Fragment 

of a Bacillus thuringiensis Crystal 

Protein Determines Receptor Binding. 

Molecular Microbiology. 5: 2799–2806. 

5. Hofte H, Whitley HR. 1989. Insecticidal 

Crystal Proteins of Bacillus thuringiensis. 

Microbiology Review. 53: 242–255. 

6. Sjoblad RD, McClintock JT, Engler R. 1992. 

Toxicological Considerations for Protein 

Components of Biological Pesticide 

Products. Regulatory Toxicology and 

Pharmacology. 15(1): 3–9. 

7. CAC. 2003. Alinorm 03/34: Joint FAO/ 

WHO Food Standard Programme. Codex 

Alimentarius Commission, Twenty-Fifth 

Session, 30 July 2003. Rome, Italy. 

Appendix III: Guideline for Conduct of 

Food Safety Assessments of Foods 

Derived from Recombinant-DNA Plants; 

Appendix IV: Annex on Assessment of 

Possible Allergenicity. Codex 

Alimentarius Commission, 47–60. 

8. Bernstein IL, Bernstein JA, Miller M, 

Tierzieva S, Bernstein DI., Lummus Z, 

Selgrade MK, Doerfler DL, Seligy VL. 

1999. Immune responses in farm workers 

after exposure to Bacillus thuringiensis 

pesticides. Environmental Health 

Perspectives. 107(7):575–82. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

exemption under section 408(d) of 

FFDCA in response to a petition 

submitted to the Agency. The Office of 

Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993). 

Because this final rule has been 

exempted from review under Executive 

Order 12866, this final rule is not 

subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the exemption in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Rules and Regulations 47291 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

XI. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 174 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 30, 2012. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 174—[AMENDED] 

■ 1. The authority citation for part 174 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 174.532 is revised to read 

as follows: 

§ 174.532 Bacillus thuringiensis eCry3.1Ab 

protein in corn; exemption from the 

requirement of a tolerance. 

Residues of Bacillus thuringiensis 

eCry3.1Ab protein in corn, in or on the 

food and feed commodities of corn; 

corn, field; corn, sweet; and corn, pop 

are exempt from the requirement of a 

tolerance when Bacillus thuringiensis 

eCry3.1Ab protein in corn is used as a 

plant-incorporated protectant. 

[FR Doc. 2012–19319 Filed 8–7–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0139; FRL–9356–6] 

Residues of Didecyl Dimethyl 

Ammonium Chloride; 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 Didecyl 

dimethyl ammonium chloride (DDAC) 

in or on broccoli grown from treated 

seeds when applied by immersion. Pace 

Chemicals Ltd. 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 DDAC 

in or on broccoli seed. 

DATES: This regulation is effective 

August 8, 2012. Objections and requests 

for hearings must be received on or 

before October 9, 2012, and must be 

filed in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0139, is 

available either electronically through 

http://www.regulations.gov or in hard 

copy at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Tracy Lantz, Antimicrobials Division 

(7510P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–6415; email address: lantz.

tracy@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 180 

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, 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– 


wreier-aviles on DSK5TPTVN1PROD with RULES