58280 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

FOAM BLOWING—UNACCEPTABLE SUBSTITUTES

End-use Substitute Decision Comments

All foam end-uses: HCFC–141b ................... Unacceptable ................. Alternatives exist with lower or zero 

= ODP. 

—Rigid polyurethane and polyisocyanurate 

laminated boardstock 

—Rigid polyurethane appliance 

—Rigid polyurethane spray and commercial 

refrigeration, and sandwich panels 

—Rigid polyurethane slabstock and other 

foams 

—Polystyrene extruded insulation boardstock 

and billet 

—Phenolic insulation board and bunstock 

—Flexible polyurethane 

—Polystyrene extruded sheet 

Except for: 1

—Space vehicle 

—Nuclear 

—Defense 

—Research and development for foreign customers 

1Exemptions for specific applications are identified in the list of acceptable substitutes. 

[FR Doc. 04–21809 Filed 9–29–04; 8:45 am] 

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 174

[OPP–2004–0249; FRL–7372–6]

Bacillus thuringiensis var. aizawai 

strain PS811 (Cry1F insecticidal 

protein); 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 Bacillus 

thuringiensis var. aizawai strain PS811 

(Cry1F insecticidal protein) and the 

genetic material necessary for its 

production in cotton when applied/used 

as a plant-incorporated protectant. 

DowAgro Sciences, 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 

need to establish a maximum 

permissible level for residues of Bacillus 

thuringiensis var. aizawai strain PS811 

(Cry1F insecticidal protein) and the 

genetic material necessary for its 

production in cotton when used as a 

plant-incorporated protectant.

DATES: This regulation is effective 

September 30, 2004. Objections and 

requests for hearings must be received 

on or before November 29, 2004.

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–2004–

0249. 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 South 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:

Leonard Cole, Biopesticides and 

Pollution Prevention Division (7511C), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5412; e-mail address: 

cole.leonard@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 a person or 

company involved with agricultural 

biotechnology, that may develop and 

market plant-incorporated protectants. 

Potentially affected entities may 

include, but are not limited to:

• Seed companies (NAICS code 111)

• Pesticide manufacturers (NAICS 

code 32532)

• Establishments involved in 

research and development in the life 

sciences (NAICS code 54171)

• Colleges, universities, and 

professional schools (NAICS code 

611310).

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 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 

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58281

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 11, 

2004 (69 FR 48870) (FRL–7673–2), 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 DowAgro Sciences, LLC, 9330 

Zionsville Road, Indianapolis, IN 

46268–1054. The petition requested that 

40 CFR part 174 be amended by 

establishing a temporary exemption 

from the requirement of a tolerance for 

residues of Bacillus thuringiensis var. 

aizawai strain PS811 (Cry1F insecticidal 

protein) and the genetic material 

necessary for its production in cotton 

when used as a plant-incorporated 

protectant.

This notice included a summary of 

the petition prepared by the petitioner 

DowAgro Sciences, LLC. Comments 

were received by The National Cotton 

Council and cotton grower groups. All 

comments were in support of this 

tolerance exemption.

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. 

Data have been submitted to the 

Agency demonstrating the lack of 

mammalian toxicity at high levels of 

exposure to the pure Cry1F protein. 

These data demonstrate the safety of the 

Cry1F protein at levels well above 

maximum possible exposure levels that 

are reasonably anticipated in the crops. 

This is similar to the Agency position 

regarding toxicity and the requirement 

of residue data for the microbial 

Bacillus thuringiensis products from 

which this plant-incorporated 

protectant was 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 (Tier II and Tier III). The acute 

oral toxicity data submitted support the 

prediction that the Cry1F protein would 

be non-toxic to humans. Thus, although 

Cry1F expression level data were 

required for an environmental fate and 

effects assessment, residue chemistry 

data were not required for a human 

health effects assessment of the subject 

plant-incorporated protectant 

ingredients because of the lack of 

mammalian toxicity.

Male and female mice (5 of each) were 

dosed with 15% (w/v) of the test 

substance, which consisted of Bacillus 

thuringiensis var. aizawai Cry1F protein 

at a net concentration of 11.4%. Two 

doses were administered approximately 

an hour apart to achieve the dose 

totaling 33.7 milliliter/kilogram body 

weight (mL/kg bwt). Outward clinical 

signs and body weights were observed 

and recorded throughout the 14–day 

study. Gross necropsies performed at 

the end of the study indicated no 

findings of toxicity. No mortality or 

clinical signs were noted during the 

study. A lethal dose (LD)50 was 

estimated at >5,050 milligram (mg)/kg 

bwt of this microbially produced test 

material. The actual dose administered 

contained 576 mg Cry1F protein/kg bwt. 

At this dose, no LD50 was demonstrated 

as no toxicity was observed. Cry1F 

maize seeds contain 0.0017 to 0.0034 

mg of Cry1F/gram of cotton kernel 

tissue. 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 15L, 3–9 

(1992). Therefore, since no effects were 

shown to be caused by the plantpesticides, even at relatively high dose 

levels, the Cry1F protein is not 

considered toxic. Further, amino acid 

sequence comparisons showed no 

similarity between Cry1F protein to 

known toxic proteins available in public 

protein databases. Finally, regarding 

toxicity to the immune system, the acute 

oral toxicity data submitted support the 

prediction that the Cry1F protein would 

be non-toxic to humans. 

Since Cry1F is a protein, allergenic 

sensitivities were considered. Current 

scientific knowledge suggests that 

common food allergens tend to be 

resistant to degradation by heat, acid, 

and proteases, and may be glycosylated 

and present at high concentrations in 

the food. Data has been submitted 

which demonstrates that the Cry1F 

protein is rapidly degraded by gastric 

fluid in vitro and is non-glycosylated. In 

a solution of Cry1F: Pepsin at a molar 

ratio of 1:100, complete degradation of 

Cry1F to amino acids and small 

peptides occurred in 5 minutes. A heat 

lability study demonstrated the loss of 

bioactivity of Cry1F protein to neonate 

tobacco budworm larvae after 30 

minutes at 75 °C. This indicates that the 

protein is highly susceptible to 

digestion in the human digestive tract 

and that the potential for adverse health 

effects from chronic exposure is 

virtually nonexistent. Furthermore, 

studies submitted to EPA done in 

laboratory animals have not indicated 

any potential for allergic reactions to 

Bacillus thuringiensis or its 

components, including the endotoxin of 

the crystal protein. Additionally, a 

comparison of amino acid sequences of 

known allergens uncovered no evidence 

of any homology with Cry1F, even at the 

level of 8 contiguous amino acids 

residues. Accordingly, the potential for 

the Cry1F protein to be a food allergen 

is minimal. 

58282 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

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 protectant is 

contained within plant cells, which 

essentially eliminates or reduces these 

exposure routes to negligible. Oral 

exposure, at very low levels, may occur 

from ingestion of processed cotton 

products and, potentially, drinking 

water. However, such exposures are 

unlikely to be problematic because of 

the demonstrated lack of mammalian 

toxicity and the digestibility of the 

Cry1F protein. Also, the protein is not 

likely to be present in drinking water 

because the protein is deployed in 

minute quantities within the plant, and 

studies demonstrate that Cry1F protein 

is rapidly degraded in soil. Finally, the 

use sites for the Cry1F protein are all 

agricultural for control of insects. 

Therefore, exposure via residential or 

lawn use to infants and children is not 

expected. Even if negligible exposure 

should occur, the Agency concludes 

that such exposure would present no 

risk due to the lack of toxicity 

demonstrated for the Cry1F protein. 

V. Cumulative Effects

Section 408(b)(2)(D)(v) of the 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.’’ These 

considerations include the possible 

cumulative effects of such residues on 

infants and children. 

Common modes of toxicity are not 

relevant to a consideration of 

cumulative exposure to the Bacillus 

thuringiensis Cry1F insect control 

protein. The product has demonstrated 

low mammalian toxicity and Bt

insecticidal crystal proteins are known 

to bind to specific receptors in the 

insect gut, such that biological effects do 

not appear to be cumulative with any 

other known compounds. 

Thus, the Agency does not expect any 

cumulative or incremental effects from 

exposure to residues of the Cry1F 

protein and the genetic material 

necessary for its production in cotton 

when applied/used as a plantincorporated protectant as directed on 

the label and in accordance with good 

agricultural practices.

VI. Determination of Safety for U.S. 

Population, Infants and Children

There is a reasonable certainty that no 

harm to the U.S. population, including 

infants and children, will result from 

aggregate exposure to residues of the 

Cry1F protein and the genetic material 

necessary for its production in cotton 

due to its use as a plant-incorporated 

protectant. This includes all anticipated 

dietary exposures and all other 

exposures for which there is reliable 

information. 

A. Toxicity and Allergenicity 

Conclusions

The data submitted and cited 

regarding potential health effects for the 

Cry1F protein include the 

characterization of the expressed Cry1F 

protein in cotton, as well as the acute 

oral toxicity, heat stability, and in vitro

digestibility of the protein. 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 has been submitted to show 

that the Cry1F test material derived 

from microbial cultures was 

biochemically and functionally similar 

to the protein produced by the plantincorporated protectant ingredients in 

cotton. Production of microbially 

produced protein was chosen in order to 

obtain sufficient material for testing. 

The acute oral toxicity data submitted 

supports the prediction that the Cry1F 

protein would be non-toxic to humans.

Both (1) available information 

concerning the dietary consumption 

patterns of consumers (and major 

identifiable subgroups of consumers, 

including infants and children); and (2) 

safety factors which, in the opinion of 

experts qualified by scientific training 

and experience to evaluate the safety of 

food additives, are generally recognized 

as appropriate for the use of animal 

experimentation data were not 

evaluated. The lack of mammalian 

toxicity at high levels of exposure to the 

Cry1F protein demonstrates 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. Regulatory regions are the 

genetic material, such as promoters, 

terminators, and enhancers, that control 

the expression of the genetic material 

encoding the proteins. DNA and RNA 

are common to all forms of plant and 

animal life and the Agency knows of no 

instance where these nucleic acids have 

been associated with toxic effects 

related to their consumption as a 

component of food. These ubiquitous 

nucleic acids, as they appear in the 

subject active ingredient, have been 

adequately characterized by the 

applicant. Therefore, no mammalian 

toxicity is anticipated from dietary 

exposure to the genetic material 

necessary for the production of the 

subject active plant pesticidal 

ingredients.

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) provides that EPA shall 

apply an additional tenfold margin of 

exposure (safety) for infants and 

children in the case of threshold effects 

to account for prenatal and postnatal 

toxicity and the completeness of the 

database on toxicity and exposure, 

unless EPA determines that a different 

margin of exposure (safety) will be safe 

for infants and children. Margins of 

exposure (safety) are incorporated into 

EPA risk assessments either by (1) using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk to humans, or (2) using 

a margin of exposure analysis. 

In this instance, due to the anticipated 

agricultural use pattern for the product, 

non-dietary exposure to infants and 

children is not anticipated. Moreover, 

because all available information 

concerning the Cry1F protein and the 

genetic material necessary for its 

production demonstrates low to no 

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58283

mammalian toxicity, a lack of allergenic 

potential, and a high degree of 

digestability, dietary exposure is 

anticipated to be at very low levels and, 

even then, is not anticipated to pose any 

harm to infants and children. Thus, the 

Agency concludes that the toxicity and 

exposure data are sufficiently complete 

to adequately address the potential for 

additional sensitivity of infants and 

children to residues of the Cry1F 

protein and the genetic material 

necessary for its production in cotton, 

and that there is a reasonable certainty 

that no harm will result to infants and 

children from aggregate exposure to 

residues of the Cry1F protein and the 

genetic material necessary for its 

production in cotton. Accordingly, the 

Agency has determined that the 

additional margin of safety is not 

necessary to protect infants and 

children, and that not adding any 

additional margin of safety will be safe 

for infants and children.

VII. Other Considerations

A. Endocrine Disruptors 

EPA is required under FFDCA section 

408(p), as amended by FQPA, to 

develop a screening process to 

determine whether pesticide chemicals 

(and any other substance that may have 

an effect that is cumulative to an effect 

of a pesticide chemical) ‘‘may have an 

effect in humans that is similar to an 

effect produced by a naturally occurring 

estrogen, or other such effects as the 

Administrator may designate.’’

Following the recommendations of its 

Endocrine Disruptor Screening and 

Advisory Committee (EDSTAC), EPA 

determined that there was no scientific 

basis for including, as part of the 

program, the androgen-and thyroid 

hormone systems, in addition to the 

estrogen hormone systems. EPA also 

adopted EDSTAC’s recommendation 

that the Program include evaluations of 

potential effects in wildlife. For 

pesticide chemicals, EPA will use 

FIFRA and, to the extent that effects in 

wildlife may help determine whether a 

substance may have an effect in 

humans, FFDCA authority to require the 

wildlife evaluations. As the science 

develops and resources allow, screening 

of additional hormone systems may be 

added to the Endocrine Disruptor 

Screening Program (EDSP). When the 

appropriate screening and/or testing 

protocols being considered under the 

Agency’s EDSP have been determined, 

Cry1F proteins may be subjected to 

additional screening and/or testing to 

better characterize any effects related to 

endocrine disruption.

To date, however, and based on the 

weight of available data, the Agency has 

no information to suggest that the Cry1F 

protein and the material necessary for 

its production in cotton has an effect on 

the endocrine system. The Cry1F 

pesticidal active ingredient is a protein, 

derived from sources that are not known 

and not expected to exert an influence 

on the endocrine system. Similarly, 

given the rapid digestibility of the Cry1F 

insecticidal crystal protein, no chronic 

effects are expected. Accordingly, there 

is no impact via endocrine-related 

effects on the Agency’s safety finding as 

set forth in this final rule for the Cry1F 

protein and the genetic material 

necessary for its production in cotton 

when applied/used as a plantincorporated protectant. Therefore, the 

Agency is not requiring information on 

the endocrine effects of this plantincorporated protectant at this time.

B. Analytical Method(s)

A validated method for extraction and 

direct enzyme linked immunosorbent 

assay analysis of Cry1F in cotton meal, 

cotton seed oil, and cotton by products 

has been submitted and found 

acceptable by the Agency.

C. Codex Maximum Residue Level

No Codex maximum residue levels 

exists for the plant-incorporated 

protectant Bacillus thuringiensis Cry1F 

protein and the genetic material 

necessary for its production in cotton.

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–2004–0249 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 29, 2004.

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 VIII.A.1., 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–2004–0249, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

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 eVerDate jul<14>2003 17:06 Sep 29, 2004 Jkt 203001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\FR\FM\30SER1.SGM 30SER1
58284 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

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 

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, 

Pesticides and pests, Plant-incorporated 

protectant, Reporting and recordkeeping 

requirements.

Dated: September 23, 2004.

James Jones,

Director, Office of Pesticides 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. 

321(q), 346a and 371.

■ 2. Section 174.455 is added to subpart 

W to read as follows:

§ 174.455 Bacillus thuringiensis Cry1F 

protein and the genetic material necessary 

for its production in cotton; exemption from 

the requirement of a tolerance.

Bacillus thuringiensis Cry1F protein 

and the genetic material necessary for 

its production in cotton are exempt from 

the requirement of a tolerance when 

used as a plant-incorporated protectant 

in food and feed commodities of cotton. 

‘‘Genetic material necessary for its 

production’’ means the genetic material 

which comprise: Genetic material 

encoding the Cry1F protein and its 

regulatory regions. ‘‘Regulatory regions’’

are the genetic material, such as 

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58285

promoters, terminators, and enhancers, 

that control the expression of the 

genetic material encoding the Cry1F 

protein.

[FR Doc. 04–21877 Filed 9–29–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0318; FRL–7680–8]

Dichlormid; Time-Limited Pesticide 

Tolerances

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

the inert ingredient (herbicide safener) 

dichlormid (Acetamide, 2,2-dichloroN,N-di-2-propenyl-) in or on sweet corn 

commodities at 0.05 parts per million 

(ppm). Dow AgroSciences requested this 

tolerance under the Federal Food, Drug, 

and Cosmetic Act, (FFDCA) as amended 

by the Food Quality Protection Act of 

1996 (FQPA). The tolerances will expire 

on December 31, 2005.

DATES: This regulation is effective 

September 30, 2004. Objections and 

requests for hearings must be received 

on or before November 29, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. After submitting your 

original written objection or hearing 

request as instructed in Unit VI., you 

can use EDOCKET or regulations.gov to 

submit the requested copy (see also Unit 

VI.A.2.). EPA has established a docket 

for this action under Docket 

identification (ID) number OPP–2004–

0318. 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:

Kathryn Boyle, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

703–305– 6304; e-mail 

address:boyle.kathryn@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:

• Industry (NAICS 111), e.g., Crop 

Production, e.g., agricultural workers; 

greenhouse, nursery, and floriculture 

workers; farmers.

• Industry (NAICS 112), e.g., Animal 

Production, e.g., cattle ranchers and 

farmers, dairy cattle farmers, livestock 

farmers.

• Industry (NAICS 311), e.g., Food 

Manufacturing, e.g., agricultural 

workers; farmers; greenhouse, nursery, 

and floriculture workers; ranchers; 

pesticide applicators.

• Industry (NAICS 32532), e.g., 

Pesticide Manufacturing, e.g., 

agricultural workers; commercial 

applicators; farmers; greenhouse, 

nursery, and floriculture workers; 

residential users.

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 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 180 is available at E-CFR 

Beta Site Two at http://

www.gpoaccess.gov/ecfr/. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines athttp://www.epa.gpo/

opptsfrs/home/guidelin.htm/. 

II. Background and Statutory Findings

In the Federal Register of November 

21, 2003 (68 FR 65708) (FRL–7333–7), 

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 petition (PP 3E6676) by Dow 

AgroSciences LLC, 9330 Zionsville Rd., 

Indianapolis, IN 46268. This notice 

included a summary of the petition 

prepared by Dow AgroSciences, the 

petitioner.

The petition requested that 40 CFR 

180.469 be amended by establishing 

time-limited tolerances for residues of 

the herbicide safener dichlormid, (N,Ndiallyl-2,2-dichloroacetamide or 

Acetamide, 2,2-dichloro-N,N-di-2-

propenyl-) (CAS Reg. No. 37764 –25–3), 

in or on sweet corn commodities at 0.05 

parts per million (ppm). There were no 

comments received in response to the 

notice of filing.

Section 408(b)(2)(A)(i) of the FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’

Section 408(b)(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. Section 

408(b)(2)(C) of the FFDCA requires 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....‘‘

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 

FFDCA and a complete description of 

the risk assessment process, see the final 

rule on Bifenthrin Pesticide Tolerances 

(62 FR 62961, November 26, 1997) 

(FRL–5754–7). 

III. Aggregate Risk Assessment and 

Determination of Safety

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

of the FFDCA, EPA has reviewed the 

available scientific data and other