Federal Register / Vol. 74, No. 96 / Wednesday, May 20, 2009 / Rules and Regulations 23635 

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 action 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 the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by July 20, 2009. 

Filing a petition for reconsideration by 

the Administrator of this final rule does 

not affect the finality of this action for 

the purposes of judicial review nor does 

it extend the time within which a 

petition for judicial review may be filed, 

and shall not postpone the effectiveness 

of such rule or action. This action may 

not be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Lead, Particulate matter, Reporting and 

recordkeeping requirements. 

Dated: May 5, 2009. 

Walter W. Kovalick Jr, 

Acting Regional Administrator, Region 5. 

■ 40 CFR part 52 is amended as follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart Y—Minnesota 

■ 2. In § 52.1220 the table in paragraph 

(d) is amended by removing the entry 

for ‘‘North Star Steel Co.’’ and adding in 

alphabetical order an entry for ‘‘Gerdau 

Ameristeel US, Inc.’’ to read as follows: 

§ 52.1220 Identification of plan. 

* * * * * 

(d) * * * 

EPA-APPROVED MINNESOTA SOURCE-SPECIFIC PERMITS

Name of source Permit No. State effective 

date EPA approval date Comments 

*******

* * 

Gerdau Ameristeel US, Inc ................................................... 12300055–004 09/10/08 05/20/09, [Insert page 

number where the 

document begins].

Only conditions cited 

as ‘‘Title I condition: 

SIP for PM10

NAAQS.’’ 

* * * * * * * 

[FR Doc. E9–11638 Filed 5–19–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 174 

[EPA–HQ–OPP–2009–0101; FRL–8417–3] 

Bacillus thuringiensis Cry1A.105 

protein; Time Limited Exemption from 

the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

18-month exemption from the 

requirement of a tolerance for residues 

of the Bacillus thuringiensis Cry1A.105 

protein in or on the food and feed 

commodities cotton seed, cotton seed 

oil, cotton seed meal, cotton hay, cotton 

hulls, cotton forage and cotton gin 

byproducts when used as a plantincorporated protectant. Monsanto 

Company submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting a 

time-limited exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of Bacillus thuringiensis 

Cry1A.105 protein in or on the food and 

feed commodities cotton seed, cotton 

seed oil, cotton seed meal, cotton hay, 

cotton hulls, cotton forage and cotton 

gin byproducts. This tolerance 

exemption expires and is revoked on 

November 22, 2010. 

DATES: This regulation is effective May 

20, 2009. Objections and requests for 

hearings must be received on or before 

July 20, 2009, 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–2009–0101. 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: 

Denise Greenway, Biopesticides and 

Pollution Prevention Division (7511P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

703–308–8263; e-mail address: 

greenway.denise@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 

23636 Federal Register / Vol. 74, No. 96 / Wednesday, May 20, 2009 / Rules and Regulations 

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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of 40 CFR part 174 

through the Government Printing 

Office’s e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

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–2009–0101 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 July 20, 2009. 

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 

EPA–HQ–OPP–2009–0101, by one of 

the following methods. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of March 4, 

2009 (74 FR 9395) (FRL–8403–5), 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 9F7521) 

by Monsanto Company, 800 North 

Lindbergh Blvd., St. Louis, MO 63167. 

The petition requested that 40 CFR part 

174 be amended by establishing a timelimited exemption from the requirement 

of a tolerance for residues of the plantincorporated protectant Bacillus 

thuringiensis Cry1A.105 protein, in or 

on the food and feed commodities 

cotton seed, cotton seed oil, cotton seed 

meal, cotton hay, cotton hulls, cotton 

forage and cotton gin byproducts. This 

notice included a summary of the 

petition prepared by the petitioner 

Monsanto Company. This petition was 

submitted to deal with a small 

amount—less than an acre—of an 

unauthorized, genetically-engineered 

cotton variety containing an 

unregistered plant-incorporated 

protectant—the Cry1A.105 protein—that 

was inadvertently harvested along with 

54 acres of a commercially-available, 

genetically engineered cotton variety. 

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

biopesticides/pips/ 

btcotton_statement.html). In response to 

EPA’s notice announcing the filing of 

this petition, one comment was received 

from an anonymous person. The 

commenter said there should be zero 

toxic chemical residue left on any 

product and was especially concerned 

about cancer risk from this chemical 

residue. The commenter did not 

provide, however, any information in 

support of his/her position or point out 

what assessment parameter needed 

closer examination for cancer risk. The 

Agency understands the commenter’s 

concerns about the potential effects of 

this particular plant-incorporated 

protectant to humans and the 

environment. Pursuant to its authority 

under the FFDCA, EPA conducted a 

comprehensive assessment of 

Cry1A.105 protein, including a review 

of the data submitted to justify the 

existing tolerance exemption for 

Cry1A.105 protein in corn (73 FR 40756, 

FRL–8369–3) (40 CFR 174.502). The 

information for the corn tolerance 

exemption includes an acute oral 

toxicity test on Cry1A.105 protein, as 

well as data demonstrating that 

Cry1A.105 protein is rapidly degraded 

by gastric fluid in vitro, is not 

glycosylated, does not have amino acid 

sequence similarities to known toxins or 

allergens, and is present at low levels in 

the tissues expressing the plantincorporated protectant. Since the 

Bacillus thuringiensis Cry1A.105 

protein expressed in cotton that is the 

subject of this action has only four 

amino acid differences compared to that 

expressed in corn, the Agency also 

examined data specific to the cottonexpressed Cry1A.105 protein. This 

cotton-specific data was an amino acid 

sequence comparison to known toxins 

and allergens (MRID 477322–01). Based 

on the data from corn, which are also 

applicable for Cry1A.105 protein in 

cotton, as well as the cotton-specific 

data, the Agency has concluded that, for 

the 18-month time period for which this 

tolerance exemption is sought, there is 

a reasonable certainty that no harm will 

result from dietary exposure to residues 

of Bacillus thuringiensis Cry1A.105 

protein in or on the food and feed 

commodities cotton seed, cotton seed 

oil, cotton seed meal, cotton hay, cotton 

hulls, cotton forage and cotton gin 

byproducts when used as a plantincorporated protectant. Thus, under 

the standard in FFDCA section 

408(b)(2), a time-limited, 18–month 

tolerance exemption is appropriate. 

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 

Federal Register / Vol. 74, No. 96 / Wednesday, May 20, 2009 / Rules and Regulations 23637 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Pursuant to 

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

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

408(b)(2)(C) of FFDCA, which require 

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue.* * * ’’ 

Additionally, section 408(b)(2)(D) of 

FFDCA requires that the Agency 

consider ‘‘available information 

concerning the cumulative effects of a 

particular pesticide’s residues ’’ and 

‘‘other substances that have a common 

mechanism of toxicity.’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness, and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. 

Mammalian toxicity and allergenicity 

assessment. Monsanto Company 

previously submitted, and the Agency 

previously evaluated, acute oral toxicity 

data that demonstrate the lack of 

mammalian toxicity at high levels of 

exposure to the pure Cry1A.105 protein. 

Since the study was done with pure 

Cry1A.105 protein, this study can be 

used to address the toxicity of the 

Cry1A.105 protein not only in corn, but 

also in cotton. These data demonstrate 

the safety of the protein at a level well 

above maximum possible exposure 

levels that are reasonably anticipated in 

cotton using submitted Cry1A.105 

expression values for corn and other 

similar Cry proteins expressed in cotton. 

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 residue data 

requirement for the microbial Bacillus 

thuringiensis products from which this 

plant-incorporated protectant was 

derived (See 40 CFR 158.2130). 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 the observed adverse 

effects and clarify the source of those 

effects (Tiers II and III). 

The acute oral toxicity study in mice 

used for the corn tolerance 

determination (MRID 466946–03) 

indicated that pure Cry1A.105 protein is 

non-toxic to humans. The oral LD50 for 

mice was greater than 2,072 milligrams/ 

kilogram of bodyweight (mg/kg bw). 

This dose level is above 2,000 mg/kg, 

which is above the limit dose (i.e., the 

highest dose used in acute toxicity 

testing). 

When proteins are toxic, they are 

known to act via acute mechanisms and 

at very low dose levels (Sjoblad, R.D., et 

al., ‘‘Toxicological Considerations for 

Protein Components of Biological 

Pesticide Products,’’ Regulatory 

Toxicology and Pharmacology 15, 3–9 

(1992)). Therefore, since no acute effects 

were shown to be caused by Cry1A.105, 

even at relatively high dose levels, the 

Cry1A.105 protein is not considered 

toxic. Further, amino acid sequence 

comparisons between the Cry1A.105 

protein and known toxic proteins in 

protein databases showed no 

similarities that would raise a safety 

concern. In addition, the Cry1A.105 

protein was shown to be substantially 

degraded by heat when examined by 

immunoassay. This instability to heat 

would also lessen the potential dietary 

exposure to intact Cry1A.105 protein in 

cooked or processed foods. These 

biochemical features along with the lack 

of adverse results in the acute oral 

toxicity test support the conclusion that, 

for the 18–month time period for which 

this tolerance exemption is sought, there 

is a reasonable certainty no harm from 

toxicity will result from dietary 

exposure to residues of Cry1A.105 

protein in or on the identified cotton 

commodities. 

Since Cry1A.105 is a protein, 

allergenic potential was also considered. 

Currently, no definitive tests for 

determining the allergenic potential of 

novel proteins exist. Therefore, EPA 

uses a weight-of-evidence approach 

where the following factors are 

considered: Source of the trait; amino 

acid sequence comparison with known 

allergens; and biochemical properties of 

the protein, including in vitro 

digestibility in simulated gastric fluid 

(SGF) and glycosylation. This approach 

is consistent with the approach outlined 

in the Annex to the Codex Alimentarius 

‘‘Guideline for the Conduct of Food 

Safety Assessment of Foods Derived 

from Recombinant-DNA Plants.’’ The 

allergenicity assessment for corn is 

equally applicable for the Cry1A.105 

protein as expressed in cotton since it 

is based on characteristics of the protein 

itself regardless of the plant expressing 

it. The allergenicity assessment for 

Cry1A.105 protein in cotton follows: 

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 Cry1A.105 with known allergens 

showed no overall sequence similarity 

(35% identity over 80 amino acids) or 

identity at the level of eight contiguous 

amino acid residues, indicating a lack of 

potential linear epitopes found in 

known food allergens. 

3. Digestibility. The Cry1A.105 

protein was digested within 30 seconds 

in simulated gastric fluid containing 

pepsin. The rapid degradation of 

Cry1A.105 in the gastric environment 

suggests little possible exposure to 

intact protein in the intestinal lumen 

where sensitization to food allergens 

occurs. 

4. Glycosylation. Cry1A.105 expressed 

in corn was shown not to be 

glycosylated and no glycosylation 

motifs were present in the cotton variant 

Cry1A.105. 

5. Conclusion. Considering all of the 

available information, EPA has 

concluded that the potential for 

Cry1A.105 to be a food allergen is 

minimal. 

The information on the safety of pure 

Cry1A.105 protein is more than 

adequate to address possible exposures 

to Cry1A.105 protein in or on cotton 

crops. 

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). 

A. Dietary Exposure 

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 

23638 Federal Register / Vol. 74, No. 96 / Wednesday, May 20, 2009 / Rules and Regulations 

other related substances. These 

considerations include dietary exposure 

under the tolerance exemption and all 

other tolerances or exemptions in effect 

for residues of the plant-incorporated 

protectant, and exposure from nonoccupational sources. Exposure via the 

skin or inhalation is not likely since the 

plant-incorporated protectant is 

contained within plant cells, which 

essentially eliminates these exposure 

routes or reduces these exposure routes 

to negligible. In addition, even if 

exposure can occur through inhalation, 

the potential for Cry1A.105 to be an 

allergen is low, as discussed in Unit III 

above. Although the allergenicity 

assessment focuses on the potential to 

be a food allergen, the data (comparing 

amino acid sequence similarity to 

allergens, including aeroallergens) also 

indicate a low potential for Cry1A.105 

to be an inhalation allergen. Exposure 

via residential or lawn use to infants 

and children is also not expected 

because the use sites for the Cry1A.105 

protein are agricultural. Oral exposure, 

at very low levels, may occur from 

ingestion of processed cotton products 

and, theoretically, drinking water. 

However, oral toxicity testing showed 

no adverse effects. 

Food. The data submitted and cited 

regarding potential health effects for the 

Cry1A.105 protein includes information 

on the pure protein and the Cry1A.105 

protein expressed in cotton, as well as 

the acute oral toxicity study, amino acid 

sequence comparisons to known 

allergens and toxins, and in vitro 

digestibility of the pure Cry1A.105 

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. 

Adequate information was submitted 

to show that the Cry1A.105 test material 

derived from microbial culture was 

biochemically and functionally 

equivalent to the protein produced by 

the plant-incorporated protectant in the 

plant. Microbially produced Cry1A.105 

protein was used in the studies so that 

sufficient material for testing was 

available. 

The acute oral toxicity data submitted 

support the prediction that the 

Cry1A.105 protein would be non-toxic 

to humans. As mentioned above in Unit 

III, when proteins are toxic, they are 

known to act via acute mechanisms and 

at very low dose levels (Sjoblad, R.D., et 

al., ‘‘Toxicological Considerations for 

Protein Components of Biological 

Pesticide Products,’’ Regulatory 

Toxicology and Pharmacology 15, 3–9 

(1992)). Since no treatment-related 

adverse effects were shown to be caused 

by the Cry1A.105 protein, even at 

relatively high dose levels (e.g., 2,072 

mg/kg body weight), the Cry1A.105 

protein is not considered toxic. (See 

Unit III above for a fuller discussion of 

the basis for this conclusion.) 

Residue chemistry data were not 

required for a human health effects 

assessment of the subject plantincorporated protectant because of the 

lack of mammalian toxicity. 

Nonetheless, data submitted 

demonstrated low levels of the 

Cry1A.105 protein in corn tissues (5–7 

ppm in grain, 20–570 ppm in forage or 

leaf tissue) and in cotton seed for 

similar Cry proteins (2–45 ppm in 

cotton seed), indicating a low potential 

for dietary exposure. 

Since Cry1A.105 is a protein, 

potential allergenicity is also considered 

as part of the toxicity assessment. 

Considering that Cry1A.105 protein (1) 

originates from a non-allergenic source, 

(2) has no sequence similarities with 

known allergens, (3) is not glycosylated 

in corn and the cotton variant does not 

have glycosylation motifs, and (4) is 

rapidly digested in simulated gastric 

fluid, EPA has concluded that the 

potential for Cry1A.105 protein to be a 

food allergen is minimal. 

The genetic material necessary for the 

production of the plant-incorporated 

protectant active ingredient include the 

nucleic acids (DNA, RNA) that encode 

these proteins and regulatory regions. 

The genetic material (DNA, RNA) 

necessary for the production of the 

Cry1A.105 protein has been exempted 

from the requirement of a tolerance 

under 40 CFR 174.507—Nucleic acids 

that are part of a plant-incorporated 

protectant; exemption from the 

requirement of a tolerance. 

B. Other Non-Occupational Exposure 

Dermal and inhalation exposure. 

Exposure via the skin or inhalation is 

not likely since the plant-incorporated 

protectant is contained within plant 

cells, which essentially eliminates these 

exposure routes or reduces these 

exposure routes to negligible. In 

addition, even if exposure can occur 

through inhalation, the potential for 

Cry1A.105 protein to be an allergen is 

minimal, as discussed above in Unit III. 

Although the allergenicity assessment 

focuses on the potential to be a food 

allergen, the data also indicate a low 

potential for Cry1A.105 to be an 

inhalation allergen. 

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 from the plantincorporated protectant, we conclude 

that there are no cumulative effects for 

the Cry1A.105 protein. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

FDCA 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. 

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 

Cry1A.105 protein, 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. 

Based on all the available 

information, the Agency finds that there 

is no toxicity associated with the 

Cry1A.105 protein. Thus, there are no 

threshold effects of concern and, as a 

result, the Agency has concluded that 

the additional tenfold margin of safety 

for infants and children is unnecessary 

in this instance. Further, the 

considerations of consumption patterns, 

special susceptibility, and cumulative 

effects do not apply. 

VII. Other Considerations 

A. Endocrine Disruptors 

The pesticidal active ingredient is a 

protein, derived from a source that is 

not known to exert an influence on the 

endocrine system. Therefore, the 

Agency is not requiring information on 

Federal Register / Vol. 74, No. 96 / Wednesday, May 20, 2009 / Rules and Regulations 23639 

the endocrine effects of the plantincorporated protectant at this time. 

B. Analytical Method(s) 

A Polymerase Chain Reaction (PCR) 

method for the detection and (in the 

context of a tolerance exemption) 

measurement of the Bacillus 

thuringiensis Cry1A.105 protein in 

cotton has been submitted (MRID 

477497–01). 

C. Codex Maximum Residue Level 

No Codex maximum residue level 

exists for the plant-incorporated 

protectant Bacillus thuringiensis 

Cry1A.105 protein. 

VIII. Conclusions 

There is a reasonable certainty that, 

during the 18-month time period during 

which this tolerance exemption will be 

effective, no harm will result from 

aggregate exposure to the U.S. 

population, including infants and 

children, to residues of the Cry1A.105 

protein in or on all food and feed 

commodities of cotton seed, cotton seed 

oil, cotton seed meal, cotton hay, cotton 

hulls, cotton forage and cotton gin 

byproducts when the Cry1A.105 protein 

is used as a plant-incorporated 

protectant in such food and feed 

commodities of cotton in accordance 

with good agricultural practices. 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 is 

there any indication of allergenicity 

potential for the plant-incorporated 

protectant. 

IX. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

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 in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

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). 

X. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 174 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 13, 2009. 

W. Michael McDavit, 

Acting Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 174—[AMENDED] 

■ 1. The authority citation for part 174 

continues to read as follows: 

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

■ 2. Section 174.502 is revised to read 

as follows: 

§ 174.502 Bacillus thuringiensis Cry1A.105 

protein; exemption from the requirement of 

a tolerance. 

(a) Residues of Bacillus thuringiensis 

Cry1A.105 protein in or on the food and 

feed commodities of corn; corn, field, 

flour; corn, field, forage; corn, field, 

grain; corn, field, grits; corn, field, meal; 

corn, field, refined oil; corn, field, 

stover; corn, sweet, forage; corn, sweet, 

kernel plus cob with husk removed; 

corn, sweet, stover; corn, pop, grain and 

corn, pop, stover are exempt from the 

requirement of a tolerance when the 

Bacillus thuringiensis Cry1A.105 

protein is used as a plant-incorporated 

protectant in these food and feed corn 

commodities. 

(b) A time-limited exemption from the 

requirement of a tolerance is established 

for residues of Bacillus thuringiensis 

Cry1A.105 protein in or on the food and 

feed commodities of cotton; cotton, 

forage; cotton, gin byproducts; cotton, 

hay; cotton, hulls; cotton, meal; cotton, 

refined oil; and cotton, undelinted seed 

when the Bacillus thuringiensis 

Cry1A.105 protein is used as a plantincorporated protectant in these food 

and feed cotton commodities. The 

exemption from the requirement of a 

tolerance expires and is revoked on 

November 22, 2010. 

[FR Doc. E9–11759 Filed 5–19–09; 8:45 am] 

BILLING CODE 6560–50–S