57436 Federal Register / Vol. 71, No. 189 / Friday, September 29, 2006 / Rules and Regulations 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VII. 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 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 20, 2006. 

James Jones, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.623 is added to read as 

follows: 

§ 180.623 Flufenoxuron; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide, flufenoxuron, 1-[4-(2- 

chloro-a,a,a-trifluoro-p-tolyloxy)-2- 

fluorophenyl]-3-(2,6- 

difluorobenzoyl)urea, in or on the 

following food commodities. 

Commodity Parts per million 

Apple1 ............................. 0.50 

Cattle, fat1 ....................... 4.5 

Cattle, meat1 ................... 0.10 

Cattle, meat byproducts1 0.50 

Goat, fat1 ........................ 4.5 

Goat, meat1 .................... 0.10 

Goat, meat byproducts1 0.50 

Grape1 ............................ 0.70 

Grape, raisin1 ................. 2.0 

Horse, fat1 ...................... 4.5 

Horse, meat1 .................. 0.10 

Horse, meat byproducts1 0.50 

Milk ................................. 0.20 

Commodity Parts per million 

Milk, fat1 .......................... 4.0 

Orange1 .......................... 0.30 

Orange, oil1 .................... 60 

Pear1 ............................... 0.50 

Sheep, fat1 ...................... 4.5 

Sheep, meat1 .................. 0.10 

Sheep, meat byproducts1 0.50 

1There are no U.S. registrations as of September 30, 2006. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

restrictions. [Reserved] 

(b) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. E6–15931 Filed 9–28–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0480; FRL–8092–4] 

Soybean Oil, Ethoxylated; Tolerance 

Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of soybean oil, 

ethoxylated; when used as an inert 

ingredient in a pesticide chemical 

formulation. Cognis Corporation 

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 soybean oil, ethoxylated. 

DATES: This regulation is effective 

September 29, 2006. Objections and 

requests for hearings must be received 

on or before November 28, 2006, 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–2006–0480. 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 Building), 

2777 S. Crystal Drive, Arlington, VA. 

The 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: 

Bipin Gandhi, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8380; e-mail address: 

gandhi.bipin@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 an electronic 

copy of this Federal Register document 

through the electronic docket 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 180 

through the Government Printing 


sroberts on PROD1PC70 with RULES
Federal Register / Vol. 71, No. 189 / Friday, September 29, 2006 / Rules and Regulations 57437 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

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. 

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–2006–0480 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 28, 2006. 

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–2006–0480, 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 Building), 2777 S. 

Crystal Drive, Arlington, VA. Deliveries 

are only accepted during the Docket’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 telephone number is (703) 305–

5805. 

II. Background and Statutory Findings 

In the Federal Register of June 7, 2006 

(71 FR 32953) (FRL–8071–3), EPA 

issued a notice pursuant to section 408 

of the FFDCA, 21 U.S.C. 346a, as 

amended by the FQPA (Public Law 104–

170), announcing the filing of a 

pesticide petition (PP) 6E7067 by Cognis 

Corporation, 4900 Este Ave., Cincinnati, 

OH 45232. The petition requested that 

40 CFR 180.960 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of soybean oil, ethoxylated; CAS Reg. 

No. 61791–23–9. That notice included a 

summary of the petition prepared by the 

petitioner. There were no comments in 

response to the notice of filing. 

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 tolerance 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. 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 an exemption from the 

requirement of 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...’’ and specifies factors EPA is 

to consider in establishing an 

exemption. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Risk Assessment and Statutory 

Findings 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be shown that the 

risks from aggregate exposure to 

pesticide chemical residues under 

reasonably foreseeable circumstances 

will pose no appreciable risks to human 

health. In order to determine the risks 

from aggregate exposure to pesticide 

inert ingredients, the Agency considers 

the toxicity of the inert in conjunction 

with possible exposure to residues of 

the inert ingredient through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. If 

EPA is able to determine that a finite 

tolerance is not necessary to ensure that 

there is a reasonable certainty that no 

harm will result from aggregate 

exposure to the inert ingredient, an 

exemption from the requirement of a 

tolerance may be established. 

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. In the 

case of certain chemical substances that 

are defined as polymers, the Agency has 

established a set of criteria to identify 

categories of polymers that should 

present minimal or no risk. The 

definition of a polymer is given in 40 

CFR 723.250(b). The following 

exclusion criteria for identifying these 

low risk polymers are described in 40 

CFR 723.250(d). 

1. The polymer, soybean oil, 

ethoxylated, is not a cationic polymer 

nor is it reasonably anticipated to 

become a cationic polymer in a natural 

aquatic environment. 

2. The polymer does contain as an 

integral part of its composition the 

atomic elements carbon, hydrogen, and 

oxygen. 

3. The polymer does not contain as an 

integral part of its composition, except 

as impurities, any element other than 

those listed in 40 CFR 723.250(d)(2)(ii). 

4. The polymer is neither designed 

nor can it be reasonably anticipated to 

substantially degrade, decompose, or 

depolymerize. 

5. The polymer is manufactured or 

imported from monomers and/or 

reactants that are already included on 

the TSCA Chemical Substance 

Inventory or manufactured under an 

applicable TSCA section 5 exemption. 

6. The polymer is not a water 

absorbing polymer with a number 

average molecular weight (MW) greater 

than or equal to 10,000 daltons. 


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57438 Federal Register / Vol. 71, No. 189 / Friday, September 29, 2006 / Rules and Regulations 

Additionally, the polymer, soybean 

oil, ethoxylated, also meets as required 

the following exemption criteria 

specified in 40 CFR 723.250(e). 

7. The polymer’s number average 

molecular weight (MW) of 1,290 is 

greater than 1,000 and less than 10,000 

daltons. The polymer contains less than 

10% oligomeric material below MW 500 

and less than 25% oligomeric material 

below MW 1,000, and the polymer does 

not contain any reactive functional 

groups. 

Thus, soybean oil, ethoxylated meet 

all the criteria for a polymer to be 

considered low risk under 40 CFR 

723.250. Based on its conformance to 

the above criteria, no mammalian 

toxicity is anticipated from dietary, 

inhalation, or dermal exposure to 

soybean oil, ethoxylated. 

V. Aggregate Exposures 

For the purposes of assessing 

potential exposure under this 

exemption, EPA considered that 

soybean oil, ethoxylated could be 

present in all raw and processed 

agricultural commodities and drinking 

water, and that non-occupational nondietary exposure was possible. The 

number average MW of soybean oil, 

ethoxylated is 1,290 daltons. Generally, 

a polymer of this size would be poorly 

absorbed through the intact 

gastrointestinal tract or through intact 

human skin. Since soybean oil, 

ethoxylated conform to the criteria that 

identify a low risk polymer, there are no 

concerns for risks associated with any 

potential exposure scenarios that are 

reasonably foreseeable. The Agency has 

determined that a tolerance is not 

necessary to protect the public health. 

VI. Cumulative Effects 

Section 408 (b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance or tolerance exemption, the 

Agency consider ‘‘available 

information’’ concerning the cumulative 

effects of a particular chemical’s 

residues and ‘‘other substances that 

have a common mechanism of toxicity.’’

EPA does not have, at this time, 

available data to determine whether 

soybean oil, ethoxylated has a common 

mechanism of toxicity with other 

substances. Unlike other pesticides for 

which EPA has followed a cumulative 

risk approach based on a common 

mechanism of toxicity, EPA has not 

made a common mechanism of toxicity 

finding as to soybean oil, ethoxylated 

and any other substances and soybean 

oil, ethoxylated does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

not assumed that soybean oil, 

ethoxylated has a common mechanism 

of toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

VII. Additional Safety Factor for the 

Protection of Infants and Children 

Section 408 of the FFDCA provides 

that EPA shall apply an additional 

tenfold margin of safety for infants and 

children in the case of threshold effects 

to account for prenatal and postnatal 

toxicity and the completeness of the 

data base unless EPA concludes that a 

different margin of safety will be safe for 

infants and children. Due to the 

expected low toxicity of soybean oil, 

ethoxylated, EPA has not used a safety 

factor analysis to assess the risk. For the 

same reasons the additional tenfold 

safety factor is unnecessary. 

VIII. Determination of Safety 

Based on the conformance to the 

criteria used to identify a low risk 

polymer, EPA concludes that there is a 

reasonable certainty of no harm to the 

U.S. population, including infants and 

children, from aggregate exposure to 

residues of soybean oil, ethoxylated. 

IX. Other Considerations 

A. Endocrine Disruptors 

There is no available evidence that 

soybean oil, ethoxylated is an endocrine 

disruptor. 

B. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

C. International Tolerances 

The Agency is not aware of any 

country requiring a tolerance for 

soybean oil, ethoxylated nor have any 

CODEX Maximum Residue Levels 

(MRLs) been established for any food 

crops at this time. 

X. Conclusion 

Accordingly, EPA finds that 

exempting residues of soybean oil, 

ethoxylated from the requirement of a 

tolerance will be safe. 

XI. 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 


sroberts on PROD1PC70 with RULES
Federal Register / Vol. 71, No. 189 / Friday, September 29, 2006 / Rules and Regulations 57439 

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. 

XII. 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 rule in 

the Federal Register. This rule is not a 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 25, 2006. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.960 the table is amended 

by adding the following entry, 

alphabetically, under ‘‘polymers’’ to 

read as follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

Polymer CAS No. 

* * * * * 

Soybean oil, 

ethoxylated; the 

poly(oxyethylene) 

content averages 

10 moles or greater.

61791–23–9 

* * * * * 

[FR Doc. 06–8384 Filed 9–28–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 712 and 716 

[EPA–HQ–OPPT–2005–0014 and EPA–HQ–

OPPT–2005–0055; FRL–8096–5] 

RIN 2070–AB08 and 2070–AB11 

Withdrawal of Certain Chemical 

Substances from Preliminary 

Assessment Information Reporting 

and Health and Safety Data Reporting 

Rules 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This final rule, issued 

pursuant to sections 8(a) and 8(d) of the 

Toxic Substances Control Act (TSCA), 

withdraws certain chemical substances 

from the category of voluntary High 

Production Volume (HPV) Challenge 

Program orphan (unsponsored) 

chemical substances that would be 

subject to reporting requirements under 

TSCA section 8(a) and 8(d). On August 

16, 2006, EPA published two final rules 

both effective September 15, 2006, with 

certain exceptions: A Preliminary 

Assessment Information Reporting 

(PAIR) rule under TSCA section 8(a) (40 

CFR part 712), which requires 

manufacturers (including importers) of 

chemical substances in the category of 

voluntary HPV Challenge Program 

orphan (unsponsored) chemical 

substances on the Interagency Testing 

Committee’s (ITC) TSCA section 4(e) 

Priority Testing List to submit a onetime report on general production/ 

importation volume, end use, and 

exposure-related information to EPA, 

and a Health and Safety Data Reporting 

rule under TSCA section 8(d) (40 CFR 

part 716), which requires manufacturers 

(including importers) of chemical 

substances in this category of HPV 

Challenge Program orphan 

(unsponsored) chemical substances to 

submit certain unpublished health and 

safety data to EPA. On September 15, 

2006, EPA published a final rule that 

delayed the effective date of the rules 

published August 16, 2006, until 

September 29, 2006. The chemical 

substances listed in this final rule are 

being withdrawn from 40 CFR parts 712 

and 716 for good cause as specified in 

40 CFR 712.30(c) and 40 CFR 716.105(c) 

and, consequently, these listed chemical 

substances will not be subject to the 

reporting requirements imposed by the 

TSCA section 8(a) and 8(d) rules 

published on August 16, 2006. 

DATES: This final rule is effective 

September 29, 2006. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) numbers EPA–HQ–

OPPT–2005–0014 and EPA–HQ–OPPT–

2005–0055. All documents in the 

dockets are listed on the regulations.gov 

website. 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. The 

EPA Docket Center (EPA/DC) suffered 

structural damage due to flooding in 

June 2006. Although the EPA/DC is 

continuing operations, there will be 

temporary changes to the EPA/DC 

during the clean-up. The EPA/DC Public 

Reading Room, which was temporarily 

closed due to flooding, has been 

relocated in the EPA Headquarters 

Library, Infoterra Room (Room Number 

3334) in EPA West, located at 1301 


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