34040 Federal Register / Vol. 75, No. 115 / Wednesday, June 16, 2010 / Rules and Regulations 

ethylene oxide blends containing 

HCFC–22, this section lists: (1) 

Sterilants that EPA previously found 

acceptable as substitutes for ethylene 

oxide blends containing HCFC–22; and 

(2) sterilants that EPA is newly finding 

acceptable as substitutes for ethylene 

oxide blends containing HCFC–22. 

At the end of the decision for the end 

use, there is narrative comparing 

environmental, flammability, and 

toxicity information of the newly 

acceptable alternative with other 

currently or potentially available 

alternatives. Flammable and highly 

reactive sterilants are hazardous waste 

when disposed. Sterilants must be 

registered by EPA under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA) prior to use. Also, 

requirements of the Food and Drug 

Administration for medical devices 

apply to equipment using sterilants. 

More environmental and health 

information is also available in the 

original SNAP rule of March 18, 1994, 

the notice of acceptability in which each 

substitute was first listed, or the sector 

table for each of the acceptable 

alternatives to ethylene oxide blends 

containing HCFC–22, in the sterilant 

end use. The sector table is available at 

http://www.epa.gov/ozone/snap/ 

sterilants/index.html. The sector table 

also includes further identification 

information (including composition and 

trade names) for each substitute. 

1. EPA previously found the following 

acceptable as substitutes for ethylene 

oxide blends containing HCFC–22 as 

sterilants: 

• IoGasTM Sterilant Blends 1, 3, and 

6 (blends of CF3I/CO2/EtO) 

• Mini-Max® Cleaner 

2. EPA is newly finding the following 

acceptable as substitutes for ethylene 

oxide blends containing HCFC–22 as 

sterilants: 

• CO2/EtO 

• Hydrogen peroxide gas plasma 

systems 

• Peroxyacetic acid/hydrogen 

peroxide gas plasma systems 

• Pure EtO 

• Steam 

The newly listed substitutes for 

HCFC–22, HCFC–142b, and blends 

thereof listed above in section VII.A.2. 

are non-ozone-depleting, in contrast to 

HCFC–22 blends. They are comparable 

to other acceptable substitutes for 

HCFC–22 blends in their lack of risk for 

ozone depletion. The newly listed 

substitutes have GWPs of one or less, 

comparable to or lower than that of 

other substitutes for HCFC–22 blends. 

For example, the GWP of the IoGas 

blends is less than one. 

Peroxyacetic acid and ethylene oxide 

are considered VOCs under CAA 

regulations (see 40 CFR 51.100(s)) 

addressing the development of SIPs to 

attain and maintain the national 

ambient air quality standards. Ethylene 

oxide is a hazardous air pollutant under 

EPA regulations. EPA’s National 

Emission Standards for Hospital 

Ethylene Oxide Sterilizers apply to this 

substance and blends that contain it (see 

subpart WWWWW of 40 CFR part 63). 

EPA has previously found other blends 

containing ethylene oxide to be 

acceptable as sterilants. Further, blends 

that do not contain ethylene oxide are 

often still reactive. 

Among the newly listed substitutes 

for HCFC–22 blends, pure ethylene 

oxide and peroxyacetic acid, a 

component in a peroxyacetic acid/ 

hydrogen peroxide gas plasma system, 

are flammable. Hydrogen peroxide is 

not flammable per se, but is highly 

reactive and must be handled cautiously 

at the concentrations required for use in 

sterilization equipment. These sterilants 

should be used in equipment designed 

to reduce the risks of flammable or 

highly reactive chemicals. EPA believes 

that the flammability and reactivity 

risks can be addressed by existing 

standards from OSHA, NIOSH, and 

EPA, and/or by guidelines from the 

manufacturer, and other safety 

precautions common during 

sterilization. 

The toxicity risks of the newly listed 

substitutes for HCFC–22 blends are 

comparable to the risks of the IoGas 

blends that EPA previously found 

acceptable as substitutes for blends of 

ethylene oxide and HCFCs. Ethylene 

oxide has an OSHA PEL of 1 ppm on an 

8-hour time-weighted average and a 

NIOSH IDLH of 800 ppm (30-minute). 

This compound may be carcinogenic. 

Hydrogen peroxide, used in gas plasma 

systems, has an OSHA PEL of 1 ppm (8- 

hr TWA) and a NIOSH IDLH value of 75 

ppm (30 min). Peroxyacetic acid, used 

together with hydrogen peroxide in gas 

plasma systems, has an AEGL–1 of 0.17 

ppm from 10 min to 8 hours to avoid 

irritation and an AEGL–2 of 0.5 ppm 

from 10 min to 8 hours to avoid 

‘‘irreversible or other serious, longlasting adverse health effects * * *.’’ 

(Acute Exposure Guideline Levels for 

Selected Airborne Chemicals, 

Committee on Acute Exposure 

Guideline Levels, National Research 

Council of the National Academies, 

2009). EPA anticipates that users will be 

able to meet the workplace exposure 

limits (PELs, IDLHs, and AEGLs) and 

will address potential health risks by 

following requirements and 

recommendations in the MSDSs and 

other safety precautions common when 

working with sterilants. For the above 

reasons, we find the newly listed 

substitutes (in VII.A.2, above) 

acceptable because they do not pose a 

greater overall risk to human health and 

the environment than the other 

substitutes available in the end use. 

You can find a complete chronology 

of SNAP decisions and the appropriate 

Federal Register citations from the 

SNAP section of EPA’s Ozone Depletion 

Web site at http://www.epa.gov/ozone/ 

snap/chron.html. This information is 

also available from the Air Docket (see 

ADDRESSES section above for contact 

information). 

List of Subjects in 40 CFR Part 82 

Environmental protection, 

Administrative practice and procedure, 

Air pollution control, Reporting and 

recordkeeping requirements. 

Dated: June 10, 2010. 

Brian J. McLean, 

Director, Office of Atmospheric Programs, 

Office of Air and Radiation. 

[FR Doc. 2010–14510 Filed 6–15–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 174 

[EPA–HQ–OPP–2009–0609; FRL–8829–9] 

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 establishes a 

temporary 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, when used 

as a plant-incorporated protectant in 

accordance with the terms of 

Experimental Use Permit 67979-EUP-8. 

Syngenta Seeds, Incorporated submitted 

a petition to EPA under the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

requesting a temporary 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 under the 

FFDCA. The temporary tolerance 

exemption expires on June 1, 2012. 

DATES: This regulation is effective June 

16, 2010. Objections and requests for 

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Federal Register / Vol. 75, No. 115 / Wednesday, June 16, 2010 / Rules and Regulations 34041 

hearings must be received on or before 

August 16, 2010, 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), 

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:// 

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 August 16, 2010. 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 September 

30, 2009 (74 FR 50196) (FRL–8433–3), 

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 9F7561) 

by Syngenta Seeds, Incorporated, P.O. 

Box 12257, Research Triangle Park, NC 

27709. The petition requested that 40 

CFR part 174 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of Bacillus thuringiensis eCry3.1Ab 

protein in corn. This notice referenced 

a summary of the petition prepared by 

the petitioner Syngenta Seeds, 

Incorporated, which is available in the 

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

Comments were received on the notice 

of filing. EPA’s response to these 

comments 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 

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34042 Federal Register / Vol. 75, No. 115 / Wednesday, June 16, 2010 / Rules and Regulations 

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, Incorporated 

developed Event 5307 maize (Zea mays) 

through Agrobacterium-mediated 

transformation (via plasmid vector PVZMIR245) 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 mCry3 A 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 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 

eCry.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. 

Theestimated 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 

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Federal Register / Vol. 75, No. 115 / Wednesday, June 16, 2010 / Rules and Regulations 34043 

mCry3A in maize, (see 40 CFR 174.511, 

effective Apr. 25, 2007 and 40 CFR 

174.505, effective Apr. 25, 2007, 

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 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 eCry3.1Ab 

protein to share a common mechanism 

of toxicity with any other substances, 

and eCry3.1Ab protein does not appear 

to produce a toxic metabolite produced 

by other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that eCry3.1Ab protein 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 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 website 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 and are under 

review by the Agency. 

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 

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34044 Federal Register / Vol. 75, No. 115 / Wednesday, June 16, 2010 / Rules and Regulations 

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 

eCry3.1Ab protein in corn. 

C. Response to Comments 

One comment was received from an 

anonymous individual who objected in 

general terms to EPA’s registration of 

any pesticides and its approval of any 

tolerance or tolerance exemption, 

claiming that no safety testing is 

required or undertaken. While the 

Agency understands that some 

individuals are opposed to all pesticide 

use, relavant 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. Conclusions 

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, 

a temporary exemption is established 

for residues of Bacillus thuringiensis 

eCry3.1Ab protein in or on corn. 

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 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 d-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 StructureFunction Relationship. Agricultural 

Biological Chemistry. 54: 715–724. 

8. Sjoblad R D, 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 establishes a tolerance 

exemption under section 408(d) of 

FFDCA in response to a petition 

submitted to the Agency. The Office of 

Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled Regulatory Planning and 

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

Because this final rule has been 

exempted from review under Executive 

Order 12866, this final rule is not 

subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001), or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance exemption in this final 

rule, do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes. 

As a result, this action does not alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999), and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000), do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 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). 

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Federal Register / Vol. 75, No. 115 / Wednesday, June 16, 2010 / Rules and Regulations 34045 

List of Subjects in 40 CFR Part 174 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 1, 2010. 

Steven Bradbury, 

Acting 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. Add § 174.532 to subpart W 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 June 

1, 2012. 

[FR Doc. 2010–14330 Filed 6–15–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0739; FRL–8825–2] 

Sodium 1,4-Dialkyl Sulfosuccinates; 

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 sodium 1,4- 

dialkyl sulfosuccinates including 

sodium 1,4-dihexyl sulfosuccinate (CAS 

Reg. No. 3006–15–3); sodium 1,4- 

diisobutyl sulfosuccinate (CAS Reg. No. 

127–39–9); and sodium 1,4-dipentyl 

sulfosuccinate (CAS Reg. No. 922–80–5) 

when used as an inert ingredient in 

pesticide formulations for pre-harvest 

and post-harvest uses, as well as, for 

application to animals under 40 CFR 

180.910 and 40 CFR 180.930, 

respectively. The Joint Inerts Task Force 

(JITF), Cluster Support Team 13 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of the 

sodium 1,4-dialkyl sulfosuccinates. 

DATES: This regulation is effective June 

16, 2010. Objections and requests for 

hearings must be received on or before 

August 16, 2010, 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–2008–0739. 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: 

Karen Samek, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8825; e-mail address: 

samek.karen@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 cite at http:// 

www.gpoaccess.gov/ecfr. To access the 

OPPTS harmonized test guidelines 

referenced in this document 

electronically, please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods and Guidelines.’’ 

C. 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 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2008–0739 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 August 16, 2010. 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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

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