Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Rules and Regulations 14289 

16.0 Plant-Verified Drop Shipment 

16.1 Description 

* * * * * 

16.1.2 Function 

Under PVDS: 

* * * * * 

[Revise item 16.1.2c as follows:] 

c. For Standard Mail, Parcel Select 

(except Parcel Select Regional Ground), 

and Package Services, postage and fees 

are paid under a valid permit at the Post 

Office serving the mailer’s plant, or as 

designated by the district manager. 

* * * * * 

21.0 Optional Combined Parcel 

Mailings 

21.1 Basic Standards for Combining 

Parcel Select, Package Services, and 

Standard Mail Parcels 

21.1.1 Basic Standards 

[Revise the introductory text of 21.1.1 

as follows:] 

Package Services parcels, Parcel 

Select parcels (except Parcel Select 

Regional Ground), Standard Mail 

parcels and Not Flat-Machinables 

(NFMs) in a combined parcel mailing 

must meet the following standards: 

* * * * * 

708 Technical Specifications 

* * * * * 

6.0 Standards for Barcoded Tray 

Labels, Sack Labels, and Container 

Placards 

* * * * * 

6.2 Specifications for Barcoded Tray 

and Sack Labels 

* * * * * 

6.2.4 3–Digit Content Identifier 

Numbers 

* * * * * 

Exhibit 6.2.4 3-Digit Content Identifier 

Numbers 

CLASS AND MAILING CIN HUMAN– 

READABLE CONTENT LINE 

* * * * * 

[Revise Exhibit 6.2.4 by modifying the 

Parcel Select section as follows:] 

Package Services 

* * * * * 

[Revise Package Services by adding 

new Parcel Select Regional Ground 

section directly after Parcel Select— 

Irregular (Nonmachinable) Parcels as 

follows:] 

Parcel Select Regional Ground 

Machinable Parcels 

ONDC sacks ....... 683 PSVC MACH 

NDC. 

MXD ONDC 

sacks.

683 PSVC MACH 

WKG. 

OSCF sacks ........ 684 PSVC MACH 

WKG. 

* * * * * 

Index and Appendices 

* * * * * 

Labeling Lists 

* * * * * 

[Revise the title of L600 as follows:] 

L600 Standard Mail, Package 

Services, and Parcel Select Regional 

Ground 

L601 Network Distribution Centers 

(NDCs) 

[Revise L601 by adding new item g as 

follows:] 

g. Parcel Select Regional Ground 

nonpresorted, machinable parcels or 

sacks on pallets to ONDC destinations. 

For labeling ONDC sacks and pallets, 

mailers must use Column B information 

of the ONDC serving the 3-digit ZIP 

Code prefix of the Post Office at which 

the mail is entered. 

* * * * * 

We will publish an appropriate 

amendment to 39 CFR Part 111 to reflect 

these changes. 

Neva R. Watson, 

Attorney, Legislative. 

[FR Doc. 2011–6057 Filed 3–15–11; 8:45 am] 

BILLING CODE 7710–12–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 174 

[EPA–HQ–OPP–2009–0609; FRL–8866–5] 

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 a 

temporary exemption from the 

requirement of a tolerance for residues 

of Bacillus thuringiensis eCry3.1Ab 

protein in corn or on the food and 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 

temporary tolerance exemption that was 

set to expire on June 1, 2012. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of Bacillus thuringiensis 

eCry3.1Ab protein in corn. The 

temporary tolerance exemption now 

expires on March 1, 2013. 

DATES: This regulation is effective 

March 16, 2011. Objections and requests 

for hearings must be received on or 

before May 16, 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 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). 


ebenthall on DSK69SOYB1PROD with RULES
14290 Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Rules and Regulations 

• 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:// 

www.gpoaccess.gov/ecfr. 

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 May 16, 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: Office of Pesticide Programs 

(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 January 21, 

2011 (76 FR 3885) (FRL–8855–4), 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 0G7756) 

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 

a 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, 

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 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 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 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. 3, 5, 6 and 7). 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. 4). 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 


ebenthall on DSK69SOYB1PROD with RULES
Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Rules and Regulations 14291 

protein is 654 amino acid residues in 

size and is approximately 73.7 

kilodaltons. 

B. Mammalian Toxicity and 

Allergenicity 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 

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. 8). 

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. 2). 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 

eCry3.1Ab protein is present at 

relatively low levels. Dietary exposure is 

expected to be correspondingly low. 

Expression 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 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 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). 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 Bt 

pesticides (Ref. 1). 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 Bacillus 


ebenthall on DSK69SOYB1PROD with RULES
14292 Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Rules and Regulations 

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 the 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. 

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. 

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 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 

The Agency 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, 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 in 

general terms to EPA granting 

registrations or experimental use 

permits of Bacillus thuringiensis-based 

pesticides or its approval of any 

corresponding tolerance exemptions, 

claiming that insufficient safety testing 

has been required. While the Agency 

understands that some individuals are 

opposed to all pesticide use, relevant 

data (discussed above) 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 

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 eCry3.1Ab 

protein in corn and the genetic material 

necessary for its production. Therefore, 

the temporary tolerance exemption for 

residues of Bacillus thuringiensis 

eCry3.1Ab protein in or on corn is 

modified by extending the expiration 

date to March 1, 2013. 

IX. References 

1. 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. 

2. 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 


ebenthall on DSK69SOYB1PROD with RULES
Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Rules and Regulations 14293 

Allergenicity. Codex Alimentarius 

Commision, 47–60. 

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. Hofte H, Whitley HR. 1989. Insecticidal 

Crystal Proteins of Bacillus thuringiensis. 

Microbiology Review. 53: 242–255. 

5. 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. 

6. 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. 

7. Nakamura K, Oshie K, Shimizu M, 

Takada Y, Oeda K, Ohkawa H. 1990. 

Construction of Chimeric Insecticidal 

Proteins Between the 130-kDa and 135-kDa 

Proteins of Bacillus thuringiensis subsp. 

aizawai for Analysis of Structure-Function 

Relationship. Agricultural Biological 

Chemistry. 54: 715–724. 

8. Sjoblad RD, McClintock JT, Engler R. 

1992. Toxicological Considerations for 

Protein Components of Biological Pesticide 

Products. Regulatory Toxicology and 

Pharmacology. 15(1): 3–9. 

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 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 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, 

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: March 3, 2011. 

Keith A. 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 and is revoked on 

March 1, 2013. 

[FR Doc. 2011–6035 Filed 3–15–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2011–0002; Internal 

Agency Docket No. FEMA–8173] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities, where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP), that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 

management requirements of the 

program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 


ebenthall on DSK69SOYB1PROD with RULES