39540 Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations 

on procedures and requirements for a 

Commission determination or exclusion 

(74 FR 10475 (March 11, 2009)). 

E. Effective Date 

The CPSIA requires the Commission 

to promulgate a rule providing guidance 

on inaccessible component parts by 

August 14, 2009. Although 

interpretative rules do not require a 

particular effective date under the 

Administrative Procedure Act, 5 U.S.C. 

553(d)(2), the Commission recognizes 

the need for providing the guidance 

expeditiously. Accordingly, the 

interpretative rule will take effect on 

August 14, 2009. 

List of Subjects in 16 CFR Part 1500 

Consumer protection, Hazardous 

materials, Hazardous substances, 

Imports, Infants and children, Labeling, 

Law enforcement, and Toys. 

F. Conclusion 

■ For the reasons stated above, the 

Commission amends 16 CFR chapter II 

as follows: 

PART 1500—HAZARDOUS 

SUBSTANCES AND ARTICLES: 

ADMINISTRATION AND 

ENFORCEMENT REGULATIONS 

■ 1. The authority citation for part 1500 

continues to read as follows: 

Authority: 15 U.S.C. 1261–1278, 122 Stat. 

3016. 

■ 2. Add a new § 1500.87 to read as 

follows: 

§ 1500.87 Children’s products containing 

lead: inaccessible component parts. 

(a) The Consumer Product Safety 

Improvement Act (CPSIA) provides for 

specific lead limits in children’s 

products. Section 101(a) of the CPSIA 

provides that by February 10, 2009, 

products designed or intended primarily 

for children 12 and younger may not 

contain more than 600 ppm of lead. 

After August 14, 2009, products 

designed or intended primarily for 

children 12 and younger cannot contain 

more than 300 ppm of lead. On August 

14, 2011, the limit may be further 

reduced to 100 ppm after three years, 

unless the Commission determines that 

it is not technologically feasible to have 

this lower limit. 

(b) Section 101 (b)(2) of the CPSIA 

provides that the lead limits do not 

apply to component parts of a product 

that are not accessible to a child. This 

section specifies that a component part 

is not accessible if it is not physically 

exposed by reason of a sealed covering 

or casing and does not become 

physically exposed through reasonably 

foreseeable use and abuse of the product 

including swallowing, mouthing, 

breaking, or other children’s activities, 

and the aging of the product, as 

determined by the Commission. Paint, 

coatings, or electroplating may not be 

considered to be a barrier that would 

render lead in the substrate to be 

inaccessible to a child. 

(c) Section 101(b)(2)(B) of the CPSIA 

directs the Commission to promulgate 

by August 14, 2009, this interpretative 

rule to provide guidance with respect to 

what product components or classes of 

components will be considered to be 

inaccessible. 

(d) The accessibility probes specified 

for sharp points or edges under the 

Commissions’ regulations at 16 CFR 

1500.48–1500.49 will be used to assess 

the accessibility of lead-component 

parts of a children’s product. A leadcontaining component part would be 

considered accessible if it can be 

contacted by any portion of the 

specified segment of the accessibility 

probe. A lead-containing component 

part would be considered inaccessible if 

it cannot be contacted by any portion of 

the specified segment of the 

accessibility probe. 

(e) For products intended for children 

that are 18 months of age or less, the use 

and abuse tests set forth under the 

Commission’s regulations at 16 CFR 

1500.50 and 16 CFR 1500.51 (excluding 

the bite test of § 1500.51(c)), will be 

used to evaluate accessibility of leadcontaining component parts of a 

children’s product as a result of normal 

and reasonably foreseeable use and 

abuse of the product. 

(f) For products intended for children 

that are over 18 months but not over 36 

months of age, the use and abuse tests 

set forth under the Commission’s 

regulations at 16 CFR 1500.50 and 16 

CFR 1500.52 (excluding the bite test of 

§ 1500.52(c)), will be used to evaluate 

accessibility of lead-containing 

component parts of a children’s product 

as a result of normal and reasonably 

foreseeable use and abuse of the 

product. 

(g) For products intended for children 

that are over 36 months but not over 96 

months of age, the use and abuse tests 

set forth under the Commission’s 

regulations at 16 CFR 1500.50 and 16 

CFR 1500.53 (excluding the bite test of 

§ 1500.53(c)), will be used to evaluate 

accessibility of lead-containing 

component parts of a children’s product 

as a result of normal and reasonably 

foreseeable use and abuse of the 

product. 

(h) For products intended for children 

over 96 months through 12 years of age, 

the use and abuse tests set forth under 

the Commission’s regulations at 16 CFR 

1500.50 and 16 CFR 1500.53 (excluding 

the bite test of § 1500.53(c)) intended for 

children aged 37–96 months will be 

used to evaluate accessibility of leadcontaining component parts of a 

children’s product as a result of normal 

and reasonably foreseeable use and 

abuse of the product. 

(i) A children’s product that is or 

contains a lead-containing part which is 

enclosed, encased, or covered by fabric 

and passes the appropriate use and 

abuse tests on such covers, is 

inaccessible to a child unless the 

product or part of the product in one 

dimension is smaller than 5 centimeters. 

(j) The intentional disassembly or 

destruction of products by children 

older than age 8 years by means or 

knowledge not generally available to 

younger children, including use of tools, 

will not be considered in evaluating 

products for accessibility of leadcontaining components. 

Dated: July 31, 2009. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. E9–18852 Filed 8–6–09; 8:45 am] 

BILLING CODE 6335–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 174 

[EPA–HQ–OPP–2009–0101; FRL–8428–7] 

Bacillus thuringiensis Cry1A.105 

Protein; Time Limited Exemption From 

the Requirement of a Tolerance; 

Correction 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule, correction. 

SUMMARY: On May 20, 2009 EPA 

published a Final Rule that established 

an 18–month, time-limited 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. Subsequent to 

the publication of the May 20, 2009 

Final Rule, the Agency identified an 

error in the Analytical Methods section 

of that Rule’s preamble. Through this 

action, EPA is republishing the 

tolerance exemption with a new 

effective date and opportunity to request 

a hearing, and a corrected Analytical 

Methods section. The conditions of the 


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Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations 39541 

time-limited tolerance exemption as 

established on May 20, 2009 are 

unchanged: the time-limited tolerance 

exemption expires and is revoked on 

November 22, 2010. 

DATES: This regulation is effective 

August 7, 2009. Objections and requests 

for hearings must be received on or 

before October 6, 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 

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 October 6, 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 commerciallyavailable, genetically-engineered cotton 

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

biopesticides/pips/

btcotton_statement.html). In response to 

EPA’s notice announcing the filing of 

pesticide petition 9F7521, one comment 

was received and was addressed in the 

May 20, 2009, Final Rule, in which EPA 

presented its rationale for establishing 

an 18–month time-limited exemption 

from the requirement of a tolerance. 

Subsequent to the publication of the 

May 20, 2009 regulation, the Agency 

identified an error in the Analytical 

Methods section of the Rule’s preamble 

(Unit VII.B.). Specifically, the text in the 

Analytical Methods section of the 

preamble to the May 20, 2009 Final Rule 

erroneously stated that the Polymerase 

Chain Reaction (PCR) method analyzed 

for Bacillus thuringiensis Cry1A.105 

protein. In fact, the PCR method 

analyzes for Bacillus thuringiensis 


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39542 Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations 

Cry1A.105 DNA. This action corrects 

that error. This action also establishes a 

new effective date and opportunity to 

request a hearing. The conditions of the 

time-limited tolerance exemption as 

established on May 20, 2009 are 

unchanged: it still expires and is 

revoked on November 22, 2010. See 

Section VII.B., below, for the subject 

correction to the Analytical Methods 

section. 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Pursuant to 

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

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

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

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue.... ’’ 

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

FFDCA requires that the Agency 

consider ‘‘available information 

concerning the cumulative effects of a 

particular pesticide’s residues ’’ and 

‘‘other substances that have a common 

mechanism of toxicity.’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

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

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness, and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. 

For a more extensive discussion, see 

the Final Rule of May 20, 2009 (74 FR 

23635, FRL–8417–3). 

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 

Food. See the Final Rule of May 20, 

2009 (74 FR 23635, FRL–8417–3). 

B. Other Non-Occupational Exposure 

Dermal and inhalation exposure. See 

the Final Rule of May 20, 2009 (74 FR 

23635), (FRL–8417–3). 

V. Cumulative Effects 

See the Final Rule of May 20, 2009 

(74 FR 23635), (FRL–8417–3). 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

See the Final Rule of May 20, 2009 

(74 FR 23635), (FRL–8417–3). 

VII. Other Considerations 

A. Endocrine Disruptors 

See the Final Rule of May 20, 2009 

(74 FR 23635), (FRL–8417–3). 

B. Analytical Method 

A Polymerase Chain Reaction (PCR) 

method for the detection and (in the 

context of a tolerance exemption) 

measurement of the Bacillus 

thuringiensis Cry1A.105 DNA in cotton 

has been submitted (MRID 477497–01). 

C. Codex Maximum Residue Level 

See the Final Rule of May 20, 2009 

(74 FR 23635, FRL–8417–3). 

VIII. Conclusions 

See the Final Rule of May 20, 2009 

(74 FR 23635, FRL–8417–3). 

IX. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of 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 exemption in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

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 


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Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations 39543 

(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: July 27, 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; and 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. E9–18860 Filed 8–6–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0601; FRL–8431–8] 

Inert Ingredients; Extension of 

Effective Date of Revocation of Certain 

Tolerance Exemptions with Insufficient 

Data for Reassessment 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: This document moves the 

effective date of the revocation of six 

inert ingredient tolerance exemptions 

with insufficient data for reassessment 

as set forth in the Federal Register on 

August 4, 2008 (73 FR 45312). 

DATES: In the final rule published 

August 9, 2006 (71 FR 45415), and 

delayed on August 4, 2008 (73 FR 

45312): 

1. The effective date is delayed from 

August 9, 2009, to October 9, 2009, for 

the following amendments to § 180.910: 

2.m., n., and cc. 

2. The effective date is delayed from 

August 9, 2009, to October 9, 2009, for 

the following amendments to § 180.930: 

4.t., u., and v. 

Objections and requests for hearings 

must be received on or before October 

6, 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–2009–0601. All documents in the 

docket are listed in the index for the 

docket. 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: 

Kerry Leifer, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8811; e-mail address: 

leifer.kerry@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

II. Background and Statutory Findings 

A. Background 

In a final rule published in the 

Federal Register on August 9, 2006 (71 

FR 45415) (FRL–8084–1), EPA revoked 

inert ingredient tolerance exemptions 

because insufficient data were available 

to the Agency to make the safety 

determination required by Federal Food, 

Drug, and Comestic Act (FFDCA) 

section 408(c)(2). In reassessing the 

safety of the tolerance exemptions, EPA 

considered the validity, completeness, 

and reliability of the data that are 

available to the Agency [FFDCA section 

408 (b)(2)(D)] and the available 

information concerning the special 

susceptibility of infants and children 

(including developmental effects from 

in utero exposure) [FFDCA section 408 


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