55254 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

Energy Effects 

We have analyzed this rule under 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use. We have 

determined that it is not a ‘‘significant 

energy action’’ under that order because 

it is not a ‘‘significant regulatory action’’

under Executive Order 12866 and is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. The Administrator of the Office 

of Information and Regulatory Affairs 

has not designated it as a significant 

energy action. Therefore, it does not 

require a Statement of Energy Effects 

under Executive Order 13211. 

Technical Standards 

The National Technology Transfer 

and Advancement Act (NTTAA) (15 

U.S.C. 272 note) directs agencies to use 

voluntary consensus standards in their 

regulatory activities unless the agency 

provides Congress, through the Office of 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

Environment 

We have analyzed this rule under 

Commandant Instruction M16475.1D, 

which guides the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have concluded that there are no factors 

in this case that would limit the use of 

a categorical exclusion under section 

2.B.2 of the Instruction. Therefore, this 

rule is categorically excluded, under 

figure 2–1, paragraph (34)(g.), of the 

Instruction, from further environmental 

documentation. This rule establishes a 

safety zone. 

A final ‘‘Environmental Analysis 

Check List’’ and a final ‘‘Categorical 

Exclusion Determination’’ are available 

in the docket where indicated under 

ADDRESSES. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

■ For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. 

Chapter 701; 50 U.S.C. 191, 195; 33 CFR 

1.05–1(g), 6.04–1, 6.04–6, and 160.5; Pub. L. 

107–295, 116 Stat. 2064; Department of 

Homeland Security Delegation No. 0170.1. 

■ 2. Add temporary § 165.T08–999 to 

read as follows: 

§ 165.T08–999 Safety zones; Sector New 

Orleans. 

(a) Location. The following areas are 

safety zones: 

(1) A 25-yard radius surrounding all 

damaged barges located in navigable 

waters within Sector New Orleans. 

(b) Definitions. 

(1) The Captain of the Port New 

Orleans means the Commander, Coast 

Guard Sector New Orleans. 

(2) Damaged barge means a barge 

requiring salvage operations. 

(c) Regulations. 

(1) Salvage operations may not begin 

on any Coast Guard inspected barge 

located within a safety zone established 

by paragraph (a) of this section until the 

Captain of the Port New Orleans, or his 

designee, has approved a salvage plan 

for that barge. 

(2) Salvage operations may not begin 

on any uninspected barge located 

within a safety zone established by 

paragraph (a) of this section that is 

affecting waterway traffic until the 

Captain of the Port New Orleans, or his 

designee, has approved a salvage plan 

for that barge. 

(3) The Captain of the Port New 

Orleans, or his designee, must approve 

a salvage plan for any barge located 

within a safety zone established by 

paragraph (a) of this section when 

salvage operations on that barge will 

affect waterway traffic. 

(4) The salvage plan shall provide the 

information contained in the 

Brownwater Salvage Checklist. To 

receive the checklist, contact the Coast 

Guard Incident Command Post (ICP) in 

Alexandria, Virginia: 

(i) Via phone at: (318) 443–2084, (318) 

448–5351, or (318) 443–0651; 

(ii) Via fax at: (318) 443–2573; or 

(iii) Via e-mail at: 

secnolasalvage@yahoo.com. 

(5) The Captain of the Port New 

Orleans, or his designee, must be 

notified when salvage operations 

commence and are completed on 

uninspected barges located within a 

safety zone established by paragraph (a) 

of this section but not affecting the 

navigation channel or vessel traffic. 

(d) The salvage plan required in 

paragraph (c) above should be faxed to 

Coast Guard Incident Command Post 

(ICP) in Alexandria, LA at (318) 443–

2573, Attention: Salvage Group. You 

may contact the Salvage Operations 

Department at the ICP at (318) 443–

2084, (318) 448–5351, or (318) 443–0651 

for more information. 

(e) Enforcement. The U.S. Coast 

Guard may be assisted in the patrol and 

enforcement of the zone by Federal, 

State and local agencies. 

(f) Effective period. This section is 

effective from September 19, 2005 

through December 31, 2005. 

Dated: September 19, 2005. 

Steve Venckus, 

Chief, Office of Regulations & Administrative 

Law, Office of the Judge Advocate General, 

United States Coast Guard. 

[FR Doc. 05–18966 Filed 9–19–05; 1:18 pm] 

BILLING CODE 4910–15–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 174 

[OPP–2005–0211; FRL–7735–4] 

Bacillus Thuringiensis Cry34Ab1 and 

Cry35Ab1 Proteins and the Genetic 

Material Necessary for Their 

Production 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 Bacillus 

thuringiensis Cry34Ab1 and Cry35Ab1 

proteins and the genetic material 

necessary for their production in corn 

on corn, field; corn, sweet; and corn, 

pop when applied/used as a plant–

incorporated protectant. Mycogen Seeds 

c/o Dow AgroSciences LLC submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA), requesting an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 55255 

need to establish a maximum 

permissible level for residues of Bacillus 

thuringiensis Cry34Ab1 and Cry35Ab1 

proteins and the genetic material 

necessary for their production in corn. 

DATES: This regulation is effective 

September 21, 2005. Objections and 

requests for hearings must be received 

on or before November 21, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VIII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2005–

0211. All documents in the docket are 

listed in the EDOCKET index at http:// 

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Mike Mendelsohn, Biopesticides and 

Pollution Prevention Division (7511C), 

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. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

Unit I. 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 Access Electronic Copies 

of this Document and Other Related 

Information? 

In addition to using EDOCKET (http:// 

www.epa.gov/edocket/), you may access 

this Federal Register document 

electronically through the EPA Internet 

under the‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 174 is available at E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. 

II. Background and Statutory Findings 

In the Federal Register of August 31, 

2004 (69 FR 53060) (FRL–7369–7), EPA 

issued a notice pursuant to section 

408(d)(3) of the FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 3F6785) 

by Mycogen Seeds c/o Dow 

AgroSciences LLC, 9330 Zionsville 

Road, Indianapolis, IN 46268. The 

petition requested that a temporary 

exemption from the requirement of a 

tolerance be established for residues of 

Bacillus thuringiensis Cry34Ab1 and 

Cry35Ab1 proteins and the genetic 

material necessary for their production 

in corn. This notice included a 

summary of the petition prepared by the 

petitioner Mycogen Seeds c/o Dow 

AgroSciences LLC. One comment was 

received from a private citizen who 

opposed issuance of a final rule. She 

expressed concern regarding Dow’s 

record, genetically modified corn, the 

impact that killing rootworm would 

have on the environment, and that the 

notice of filing mentioned ‘‘studies’’

without giving a specific number. The 

Agency understands and recognizes that 

some individuals believe that 

genetically modified crops and food 

should be banned completely. Corn 

rootworms are a significant agricultural 

pest and are extensively treated in the 

United States. Pursuant to its authority 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), EPA has 

conducted a comprehensive assessment 

of the Cry34Ab1 and Cry35Ab1 proteins 

and the genetic material necessary for 

their production in corn. EPA has 

concluded that there is a reasonable 

certainty that no harm will result from 

dietary exposure to these proteins as 

expressed in genetically modified corn. 

Specific studies were listed in the 

administrative material provided in the 

docket. 

Section 408(c)(2)(A)(i) of the 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 the 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), 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), 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 the 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 the 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. 

55256 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

Acute oral toxicity data have been 

submitted demonstrating the lack of 

mammalian toxicity at high levels of 

exposure to the pure Cry34Ab1 and 

Cry35Ab1 proteins separately and 

combined. These data demonstrate the 

safety of the products at levels well 

above maximum possible exposure 

levels that are reasonably anticipated in 

the crops. Basing this conclusion on 

acute oral toxicity data without 

requiring further toxicity testing and 

residue data is similar to the Agency 

position regarding toxicity and the 

requirement of residue data for the 

microbial Bacillus thuringiensis 

products from which these plantincorporated protectants were derived 

(See 40 CFR 158.740(b)(2)(i)). For 

microbial products, further toxicity 

testing and residue data are triggered by 

significant acute effects in studies such 

as the mouse oral toxicity study, to 

verify the observed effects and clarify 

the source of these effects (Tiers II and 

III). 

Three acute oral toxicity studies on 

Cry34Ab1 and Cry35Ab1 in mice were 

submitted, which indicated that these 

proteins are non-toxic to humans. 

In an oral toxicity study of Cry34Ab1 

alone, Cry34Ab1 produced from 

microbial culture was administered to 

five male mice (5,000 milligrams/ 

kilogram (mg/kg) body weight) by oral 

gavage as a 20% mixture in a 0.5% 

aqueous methylcellulose vehicle. All 

animals survived the 2–week study. No 

clinical signs were noted for any 

animals during the study. An initial 

weight loss was observed in three mice 

at test days 1 and 2, but they gained 

weight for the remainder of the study. 

The two other animals gained weight 

throughout the study. No treatmentrelated gross pathologic changes were 

observed during the study. Under the 

conditions of this study, the acute oral 

LD50 for the test substance in male CD1 mice is greater than 5,000 mg/kg. 

Since the test substance contained 

Cry34Ab1 at 54% purity, the acute oral 

LD50 for the pure Cry34Ab1 protein is 

greater than 2,700 mg/kg. 

In an oral toxicity study of Cry35Ab1 

alone, Cry35Ab1 produced from 

microbial culture was administered to 

five male mice (5,000 mg/kg body 

weight) by oral gavage as a 20% mixture 

in a 0.5% aqueous methylcellulose 

vehicle. All animals survived the 2–

week study. No clinical signs were 

noted for any animal during the study. 

An initial weight loss was observed in 

two mice at test days 1 and 2, but they 

gained weight for the remainder of the 

study. One animal had fluctuating body 

weight. The other two animals gained 

weight throughout the study. No 

treatment-related gross pathologic 

changes were observed during the 

study. Under the conditions of this 

study, the acute oral LD50 for the test 

substance in male CD-1 mice is greater 

than 5,000 mg/kg. Since the test 

substance contained Cry35Ab1 at 37% 

purity, the acute oral LD50 for the pure 

Cry35Ab1 protein is greater than 1,850 

mg/kg. 

Finally, in an oral toxicity of 

Cry34Ab1 and Cry35Ab1 combined, a 

mixture of the microbially produced 

Cry34Ab1 and Cry35Ab1 proteins (5,000 

mg test material, containing 482 mg 

pure Cry34Ab1 and 1,520 mg pure 

Cry35Ab1 (corresponding to an 

equimolar ratio), per kg body weight) 

was administered by oral gavage to five 

female and five male mice as a 20% 

mixture in 0.5% aqueous 

methylcellulose. All animals survived 

the 2–week study. One female mouse 

exhibited protruding or bulging eyes on 

days 6 and 7, but this resolved 

thereafter. This observation was not 

attributed to the treatment as it was an 

isolated observation (i.e., no other 

animals exhibited this). No other 

clinical signs were noted for any 

animals during the study. An initial 

weight loss was observed in two mice at 

test days 1 and 2, but both gained 

weight for the remainder of the study. 

All other animals gained weight 

throughout the study. No treatment 

related gross pathologic changes were 

noted. Under the conditions of the 

study, the acute oral LD50 of the test 

material in male and female CD-1 mice 

is greater than 5,000 mg/kg body weight, 

corresponding to 2,000 mg/kg of an 

equimolar ratio of the pure proteins. 

When proteins are toxic, they are 

known to act via acute mechanisms and 

at very low dose levels (Sjoblad, Roy D., 

et al. ‘‘Toxicological Considerations for 

Protein Components of Biological 

Pesticide Products,’’ Regulatory 

Toxicology and Pharmacology 15, 3–9 

(1992)). Therefore, since no effects were 

shown to be caused by the plantincorporated protectants, even at 

relatively high dose levels, the 

Cry34Ab1 and Cry35Ab1 proteins are 

not considered toxic. Further, amino 

acid sequence comparisons showed no 

similarity between the Cry34Ab1 and 

Cry35Ab1 proteins to known toxic 

proteins available in public protein data 

bases. 

Since Cry34Ab1 and Cry35Ab1 are 

proteins, allergenic potential was also 

considered. Currently, no definitive 

tests for determining the allergenic 

potential of novel proteins exist. 

Therefore, EPA uses a weight-of-theevidence 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. Current scientific 

knowledge suggests that common food 

allergens tend to be resistant to 

degradation by acid and proteases; may 

be glycosylated, and can be present at 

high concentrations in the food. In the 

past, EPA has also considered heat 

stability in assessing allergenicity 

potential; however, the FIFRA Scientific 

Advisory Panel at a March 1–2, 2005 

meeting stated that heat stability based 

on a bioactivity assay is of minimal to 

no value in predicting the allergenicity 

potential of novel proteins, and EPA 

agrees. Therefore, EPA did not consider 

heat stability of these proteins in its 

weight-of-evidence approach. 

1. Source of the trait. Bacillus 

thuringiensis is not considered to be a 

source of allergenic proteins. 

2. Amino acid sequence. A 

comparison of amino acid sequences of 

Cry34Ab1 and Cry35Ab1 with known 

allergens showed no overall sequence 

similarities or homology at the level of 

eight contiguous amino acid residues. 

3. Prevalence in food. Expression 

level analysis indicated that the proteins 

are present at relatively low levels in 

corn; on a dry weight basis, Cry34Ab1 

is present at a concentration of 

approximately 50 nanograms/milligram 

(ng/mg) in grain from Event 59122–7, 

and Cry35Ab1 is present at a 

concentration of approximately 1 ng/mg 

in grain from Event 59122–7. Thus, 

expression of the Cry34Ab1 and 

Cry35Ab1 proteins in corn kernels has 

been shown to be in the parts per 

million range. 

4. Digestibility. Two in vitro 

digestibility studies were conducted to 

determine the stability of the Cry34Ab1 

and Cry35Ab1 proteins in simulated 

gastric fluid (i.e., an acid environment 

containing pepsin; SGF). In the first in 

vitro digestibility study, the proteins 

were incubated in SGF (pepsin 

concentration: 3.2 milligrams/milliliter 

(mg/mL); pH 1.2; 37° C) with a pepsin 

to protein substrate ratio of 

approximately 20:1, molecule/molecule 

(mol/mol) (equivalent to 60:1, w/w for 

Cry34Ab1 and 17:1, w/w for Cry35Ab1). 

Samples taken at 1, 5, 7, 15, 20, 30, and 

60 minutes were analyzed by sodium 

dodecyl sulfate polyacrylamide gel 

electrophoresis (SDS-PAGE) and 

western blot. Cry35Ab1 was no longer 

visible at the 5–minute time-point using 

both SDS-PAGE stained with Coomassie 

Brilliant Blue and western blot 

detection. Cry34Ab1 was visible on the 

stained gel for the 15–minute sample, 

Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 55257 

but not in later sample time points. In 

the western blot analysis, Cry34Ab1 was 

visible in the 20–minute sample, but not 

in later sample time points. In 

conclusion, this first study showed that 

Cry34Ab1 was digested within 30 

minutes and Cry35Ab1 was digested 

within 5 minutes in SGF under the 

conditions of the study. 

Because Cry34Ab1 appeared to be 

somewhat resistant to SGF in the study 

described above that used the time-todisappearance endpoint, Dow submitted 

a second study on the in vitro 

digestibility of Cry34Ab1 in SGF using 

a kinetic approach. The digestion was 

performed under the same conditions as 

the previous study except that reaction 

mixtures were shaken during 

incubation, and samples were analyzed 

at 1, 2, 3, 5, 7.5, 10, 15, and 20 minutes. 

The previous study on pepsin 

digestibility of Cry34Ab1 and 

Cry35Ab1, as well as other pepsin 

digestibility studies used in 

allergenicity assessments, focused on 

the time required for the protein to 

become undetectable, and therefore, the 

results are dependent on the detection 

limit of the analytical method used. In 

this second study, Dow determined the 

rate of pepsin digestion of Cry34Ab1 by 

measuring the relative amounts of 

Cry34Ab1 at each of the time points 

based on SDS-PAGE densitometry 

estimates. Under the conditions of the 

study, the rate of decay fit a first-order 

model (with respect to Cry34Ab1 

concentration), and Dow estimated the 

DT50 (half-life) and DT90 (time until 

90% decay) to be 1.9 minutes and 6.2 

minutes, respectively. In this 

experiment, Cry34Ab1 was visible on 

gels and blots in 15–minute time point 

samples but not in 20–minute time 

point samples. 

Because the digestibility of Cry34Ab1 

was assessed using a different method 

(i.e., the kinetic approach) rather than 

the typical end-point method that has 

been used previously, comparison 

studies using the kinetic approach to 

assess the digestibility of known 

allergens and non-allergens were 

submitted to validate the method and 

allow comparison of the digestibility of 

Cry34Ab1 with known allergens and 

non-allergens. In the comparison study 

where the conditions used were the 

same as those used in the kinetic study 

on the digestibility of Cry34Ab1, two 

allergens and two non-allergens were 

shown to digest similarly to Cry34Ab1. 

From these studies and published 

studies, EPA concludes that Cry35Ab1 

is rapidly digested and Cry34Ab1 is 

digested at a moderate rate in SGF; 

Cry34Ab1 appears to digest slower than 

previously registered proteins and many 

other proteins that are not considered 

allergens but faster than most previously 

tested allergens. 

On March 1–2, 2005, EPA held a 

FIFRA Scientific Advisory Panel (SAP) 

meeting, http://www.epa.gov/oscpmont/ 

sap/#march, to address the scientific 

issues that arose during the human 

health safety assessment of Cry34Ab1 

and Cry35Ab1. EPA asked the SAP to 

comment on EPA’s allergenicity 

assessment of Cry34Ab1. The SAP 

agreed with EPA’s preliminary 

assessment that the allergenicity 

potential of Cry34Ab1 is low. However, 

the Panel based its conclusion in part on 

statements made by Dow that Cry34Ab1 

and Cry35Ab1 do not aggregate in 

solution. The Panel was concerned that 

if the proteins were to aggregate, 

protease binding sites could be masked, 

and the rate of digestion could be slower 

than was observed for the individual 

proteins. Therefore, EPA asked Dow to 

submit data supporting the claim that 

Cry34Ab1 and Cry35Ab1 do not 

associate with one another in solution. 

To support the digestibility studies on 

the individual proteins, Dow submitted 

a study using size exclusion 

chromatography, which demonstrated 

that Cry34Ab1 and Cry35Ab1 do not 

associate with one another in solution 

under acidic conditions. 

5. Glycosylation. Cry34Ab1 and 

Cry35Ab1 expressed in corn were 

shown not to be glycosylated. 

6. Conclusion. Considering all of the 

available information: (1) Cry34Ab1 and 

Cry35Ab1 originate from a nonallergenic source;(2) Cry34Ab1 and 

Cry35Ab1 have no overall sequence 

similarities or homology at the level of 

eight contiguous amino acid residues 

with known allergens; (3) Cry34Ab1 and 

Cry35Ab1 will only be present at low 

levels in food; (4) Cry35Ab1 is rapidly 

digested in SGF, and Cry34Ab1 is 

digested at a moderate rate in SGF; and 

(5) Cry34Ab1 and Cry35Ab1 are not 

glycoslyated when expressed in maize. 

EPA has concluded that the potential for 

the Cry34Ab1 and Cry35Ab1 proteins to 

be food allergens is minimal. The FIFRA 

SAP that met on March 1–2, 2005, 

agreed with this conclusion regarding 

the allergenicity potential of Cry34Ab1. 

There were no triggers to raise concern 

about the allergenicity of Cry35Ab1, so 

the SAP was not asked to comment 

specifically on Cry35Ab1. As noted 

above, toxic proteins typically act as 

acute toxins with low dose levels. 

Therefore, since no effects were shown 

to be caused by the plant-incorporated 

protectants, even at relatively high dose 

levels, the Cry34Ab1 and Cry35Ab1 

proteins are not considered toxic. 

IV. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of the 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. These 

considerations include dietary exposure 

under the tolerance exemption and all 

other tolerances or exemptions in effect 

for the plant-incorporated protectants 

chemical residue, and exposure from 

non-occupational sources. Exposure via 

the skin or inhalation is not likely since 

the plant-incorporated protectants are 

contained within plant cells, which 

essentially eliminates these exposure 

routes or reduces these exposure routes 

to negligible. Exposure via residential or 

lawn use to infants and children is also 

not expected because the use sites for 

the Cry34Ab1 and Cry35Ab1 proteins 

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 

showed no adverse effects. Furthermore, 

the expression of the Cry34Ab1 and 

Cry35Ab1 proteins in corn kernels has 

been shown to be in the parts per 

million range, which makes the 

expected dietary exposure several 

orders of magnitude lower than the 

amounts of Cry34Ab1 and Cry35Ab1 

proteins shown to have no toxicity. 

Therefore, even if negligible aggregate 

exposure should occur, the Agency 

concludes that such exposure would 

result in no harm due to the lack of 

mammalian toxicity and low potential 

for allergenicity demonstrated for the 

Cry34Ab1 and Cry35Ab1 proteins. 

V. Cumulative Effects 

Pursuant to FFDCA section 

408(b)(2)(D)(v), EPA has considered 

available information on the cumulative 

effects of such residues and other 

substances that have a common 

mechanism of toxicity. These 

considerations included the cumulative 

effects on infants and children of such 

residues and other substances with a 

common mechanism of toxicity. 

Because there is no indication of 

mammalian toxicity, resulting from the 

55258 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

plant-incorporated protectants, we 

conclude that there are no cumulative 

effects for the Cry34Ab1 and Cry35Ab1 

proteins. 

VI. Determination of Safety for U.S 

Population, Infants and Children 

A. Toxicity and Allergenicity 

Conclusions 

The data submitted and cited 

regarding potential health effects for the 

Cry34Ab1 and Cry35Ab1 proteins 

include the characterization of the 

expressed Cry34Ab1 and Cry35Ab1 

proteins in corn, as well as the acute 

oral toxicity, and in vitro digestibility of 

the proteins. The results of these studies 

were determined applicable to evaluate 

human risk, and the validity, 

completeness, and reliability of the 

available data from the studies were 

considered. 

Adequate information was submitted 

to show that the Cry34Ab1 and 

Cry35Ab1 proteins test material derived 

from microbial cultures was 

biochemically and, functionally similar 

to the protein produced by the plantincorporated protectant ingredients in 

corn. Production of microbially 

produced protein was chosen in order to 

obtain sufficient material for testing. 

The acute oral toxicity data submitted 

support the prediction that the 

Cry34Ab1 and Cry35Ab1 proteins 

would be non-toxic to humans. As 

mentioned above, when proteins are 

toxic, they are known to act via acute 

mechanisms and at very low dose levels 

(Sjoblad, Roy D., et al. ‘‘Toxicological 

Considerations for Protein Components 

of Biological Pesticide Products,’’

Regulatory Toxicology and 

Pharmacology 15, 3–9 (1992)). Since no 

effects were shown to be caused by the 

Cry34Ab1 and Cry35Ab1 proteins, even 

at relatively high dose levels, the 

Cry34Ab1 and Cry35Ab1 proteins are 

not considered toxic. Basing this 

conclusion on acute oral toxicity data 

without requiring further toxicity testing 

and residue data is similar to the 

Agency position regarding toxicity and 

the requirement of residue data for the 

microbial Bacillus thuringiensis 

products from which these plantincorporated protectants were derived. 

(See 40 CFR 158.740(b)(2)(i)). For 

microbial products, further toxicity 

testing and residue data are triggered by 

significant acute effects in studies such 

as the mouse oral toxicity study to 

verify the observed effects and clarify 

the source of these effects (Tiers II and 

III). 

Cry34Ab1 and Cry35Ab1 proteins 

residue chemistry data were not 

required for a human health effects 

assessment of the subject plantincorporated protectant ingredients 

because of the lack of mammalian 

toxicity. However, data submitted 

demonstrated low levels of the 

Cry34Ab1 and Cry35Ab1 proteins in 

corn tissues. 

Since Cry34Ab1 and Cry35Ab1 are 

proteins, their potential allergenicity is 

also considered as part of the toxicity 

assessment. Considering all of the 

available information (1) Cry34Ab1 and 

Cry35Ab1 originate from a nonallergenic source; (2) Cry34Ab1 and 

Cry35Ab1 have no overall sequence 

similarities or homology at the level of 

eight contiguous amino acid residues 

with known allergens; (3) Cry34Ab1 and 

Cry35Ab1 are not glycoslyated when 

expressed in maize; (4) Cry34Ab1 and 

Cry35Ab1 will only be present at low 

levels in food; and (5) Cry35Ab1 is 

rapidly digested in SGF, and Cry34Ab1 

is digested at a moderate rate in SGF; 

EPA has concluded that the potential for 

the Cry34Ab1 and Cry35Ab1 proteins to 

be food allergens is minimal. The FIFRA 

Scientific Advisory Panel (SAP) that 

met on March 1–2, 2005 agreed with 

this conclusion regarding the 

allergenicity potential of Cry34Ab1. 

There were no triggers to raise concern 

about the allergenicity of Cry35Ab1, so 

the SAP was not asked to comment 

specifically on Cry35Ab1. 

Neither available information 

concerning the dietary consumption 

patterns of consumers (and major 

identifiable subgroups of consumers 

including infants and children) nor 

safety factors that are generally 

recognized as appropriate for the use of 

animal experimentation data were 

evaluated. The lack of mammalian 

toxicity at high levels of exposure to the 

Cry34Ab1 and Cry35Ab1 proteins, as 

well as the minimal potential to be a 

food allergen demonstrate the safety of 

the product at levels well above possible 

maximum exposure levels anticipated 

in the crop. 

The genetic material necessary for the 

production of the plant-incorporated 

protectant active ingredients are the 

nucleic acids (DNA, RNA) which 

comprise genetic material encoding 

these proteins and their regulatory 

regions. The genetic material (DNA, 

RNA), necessary for the production of 

the Cry34Ab1 and Cry35Ab1 proteins 

have been exempted under the blanket 

exemption for all nucleic acids (40 CFR 

174.475). 

B. Infants and Children Risk 

Conclusions 

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) also provides that EPA shall 

apply an additional tenfold margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database unless 

EPA determines that a different margin 

of safety will be safe for infants and 

children. 

In this instance, based on all the 

available information, the Agency 

concludes that there is a finding of no 

toxicity for the Cry34Ab1 and Cry35Ab1 

proteins and the genetic material 

necessary for their production. Thus, 

there are no threshold effects of concern 

and, as a result, the provision requiring 

an additional margin of safety does not 

apply. Further, the provisions of 

consumption patterns, special 

susceptibility, and cumulative effects do 

not apply. 

C. Overall Safety Conclusion 

There is a reasonable certainty that no 

harm will result from aggregate 

exposure to the U.S. population, 

including infants and children, to the 

Cry34Ab1 and Cry35Ab1 proteins and 

the genetic material necessary for their 

production. This includes all 

anticipated dietary exposures and all 

other exposures for which there is 

reliable information. 

The Agency has arrived at this 

conclusion because, as discussed above, 

no toxicity to mammals has been 

observed, nor any indication of 

allergenicity potential for the plantincorporated protectants. 

VII. Other Considerations 

A. Endocrine Disruptors 

The pesticidal active ingredients are 

proteins, derived from sources that are 

not known to exert an influence on the 

endocrine system. Therefore, the 

Agency is not requiring information on 

the endocrine effects of the plantincorporated protectants at this time. 

B. Analytical Method(s) 

Validated enzyme-linked 

immunosorbent assays for the detection 

and quantification of Cry34Ab1 and 

Cry35Ab1 in corn tissue have been 

submitted and found acceptable by the 

Agency. 

Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 55259 

C. Codex Maximum Residue Level 

No Codex maximum residue levels 

exist for the plant-incorporated 

protectants Bacillus thuringiensis 

Cry34Ab1 and Cry35Ab1 proteins and 

the genetic material necessary for its 

production in corn. 

VIII. Objections and Hearing Requests 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, 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. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to the 

FFDCA by the FQPA, EPA will continue 

to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

The new section 408(g) of the FFDCA 

provides essentially the same process 

for persons to ‘‘object’’ to a regulation 

for an exemption from the requirement 

of a tolerance issued by EPA under new 

section 408(d) of the FFDCA, as was 

provided in the old sections 408 and 

409 of the FFDCA. However, the period 

for filing objections is now 60 days, 

rather than 30 days. 

A. What Do I Need to Do to File an 

Objection or Request a Hearing? 

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2005–0211 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before November 21, 2005. 

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issues(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice. 

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255. 

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit IX.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2005–0211 , to: Public Information 

and Records Integrity Branch, 

Information Technology and Resource 

Management Division (7502C), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001. In person or by courier, bring a 

copy to the location of the PIRIB 

described in ADDRESSES. You may also 

send an electronic copy of your request 

via e-mail to: opp-docket@epa.gov. 

Please use an ASCII file format and 

avoid the use of special characters and 

any form of encryption. Copies of 

electronic objections and hearing 

requests will also be accepted on disks 

in WordPerfect 6.1/8.0 or ASCII file 

format. Do not include any CBI in your 

electronic copy. You may also submit an 

electronic copy of your request at many 

Federal Depository Libraries. 

B. When Will the Agency Grant a 

Request for a Hearing? 

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

IX. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the tolerance 

requirement under section 408(d) of the 

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 rule has been exempted 

from review under Executive Order 

12866 due to its lack of significance, 

this rule is not subject to Executive 

Order 13211, Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use (66 

FR 28355, May 22, 2001). 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., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

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). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of the FFDCA, 

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. In 

addition, the Agency has determined 

that this action will not have a 

substantial direct effect on States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

55260 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. 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 the 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to 

ensure‘‘meaningful and timely input by 

tribal officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

X. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, 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: August 29, 2005. 

James Jones, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 174—[AMENDED] 

■ 1. The authority citation for part 174 

continues to read as follows: 

Authority: 7 U.S.C. 136–136y; 21 U.S.C. 

346a and 371. 

■ 2. Section 174.457 is added to subpart 

W to read as follows: 

§ 174.457 Bacillus thuringiensis Cry34Ab1 

and Cry35Ab1 proteins and the genetic 

material necessary for their production in 

corn; exemption from the requirement of a 

tolerance. 

Bacillus thuringiensis Cry34Ab1 and 

Cry35Ab1 proteins and the genetic 

material necessary for their production 

in corn are exempted from the 

requirement of a tolerance when used as 

plant-incorporated protectants in the 

food and feed commodities of corn; 

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

[FR Doc. 05–18582 Filed 9–20–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0248; FRL–7736–1] 

Myclobutanil; Re-Establishment of a 

Tolerance for Emergency Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation re-establishes 

a time-limited tolerance for combined 

residues of the fungicide myclobutanil 

and its metabolite in or on artichoke, 

globe at 1.0 parts per million (ppm) for 

an additional 2c year period. This 

tolerance will expire and is revoked on 

December 31, 2007. This action is in 

response to EPA’s granting of an 

emergency exemption under section 18 

of the Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA) 

authorizing use of the pesticide on 

artichoke, globe. Section 408(l)(6) of the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA) requires EPA to establish a 

time-limited tolerance or exemption 

from the requirement for a tolerance for 

pesticide chemical residues in food that 

will result from the use of a pesticide 

under an emergency exemption granted 

by EPA under FIFRA section 18. 

DATES: This regulation is effective 

September 21, 2005. Objections and 

requests for hearings must be received 

on or before November 21, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit III. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2005–

0248. 

All documents in the docket are listed 

in the EDOCKET index at http:// 

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Stacey Milan Groce, Registration 

Division (7505C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 305–2505; e-mail 

address:milan.stacey@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