Federal Register / Vol. 73, No. 19 / Tuesday, January 29, 2008 / Rules and Regulations 5109 

Commodity Parts per million 

Boysenberry, postharvest 1.0 

Buckwheat, grain, 

postharvest .................. 3.0 

Cacao bean, roasted 

bean, postharvest ....... 1.0 

Cattle, fat ........................ 1.0 

Cattle, meat .................... 0.05 

Cattle, meat byproducts 0.05 

Cherry, sweet, 

postharvest .................. 1.0 

Cherry, tart, postharvest 1.0 

Coconut, copra, 

postharvest .................. 1.0 

Corn, field, grain, 

postharvest .................. 3.0 

Corn, pop, grain, 

postharvest .................. 3.0 

Cotton, undelinted seed, 

postharvest .................. 1.0 

Crabapple, postharvest .. 1.0 

Currant, postharvest ....... 1.0 

Dewberry, postharvest .... 1.0 

Fig, postharvest .............. 1.0 

Flax, seed, postharvest .. 1.0 

Goat, fat .......................... 1.0 

Goat, meat ...................... 0.05 

Goat, meat byproducts ... 0.05 

Gooseberry, postharvest 1.0 

Grape, postharvest ......... 1.0 

Guava, postharvest ........ 1.0 

Hog, fat ........................... 1.0 

Hog, meat ....................... 0.05 

Hog, meat byproducts .... 0.05 

Horse, fat ........................ 1.0 

Horse, meat .................... 0.05 

Horse, meat byproducts 0.05 

Loganberry, postharvest 1.0 

Mango, postharvest ........ 1.0 

Milk, fat (reflecting negligible residues in milk) 0.05 

Muskmelon, postharvest 1.0 

Oat, grain, postharvest ... 1.0 

Orange, postharvest ....... 1.0 

Pea, dry, seed, 

postharvest .................. 1.0 

Peach, postharvest ......... 1.0 

Peanut, postharvest ........ 1.0 

Pear, postharvest ........... 1.0 

Pineapple, postharvest ... 1.0 

Plum, prune, fresh, 

postharvest .................. 1.0 

Potato, postharvest ......... 0.05 

Raspberry, postharvest .. 1.0 

Rice, grain, postharvest .. 3.0 

Rye, grain, postharvest .. 3.0 

Sheep, fat ....................... 1.0 

Sheep, meat ................... 0.05 

Sheep, meat byproducts 0.05 

Sorghum, grain, grain, 

postharvest .................. 1.0 

Sweet potato, 

postharvest .................. 0.05 

Tomato, postharvest ....... 1.0 

Walnut, postharvest ........ 1.0 

Wheat, grain, postharvest 3.0 

(2) A tolerance of 1.0 ppm is 

established for residues of the 

insecticide pyrethrins in or on milled 

fractions derived from grain, cereal 

when present as a result of its use in 

cereal grain mills and in storage areas 

for milled cereal grain products. 

(3) A tolerance of 1.0 ppm is 

established for residues of the 

insecticide pyrethrins in or on all food 

items in food handling establishments 

where food and food products are held, 

processed, prepared and/or served. 

Food must be removed or covered prior 

to use. 

(4) Where tolerances are established 

on both the raw agricultural 

commodities and processed foods made 

there-from, the total residues of 

pyrethrins in or on the processed food 

shall not be greater than that permitted 

by the larger of the two tolerances. 

* * * * * 

■ 4. Section 180.314 is amended by 

alphabetically adding the following 

commodity to the table in paragraph (c) 

to read as follows 

§ 180.314 Triallate; tolerance for residues. 

* * * * * 

(c) Tolerances with regional 

registrations. * * * 

Commodity Parts per million 

*****

Wheat, forage ................. 0.05 

*****

* * * * * 

■ 5. Section 180.339 is amended by 

alphabetically adding the following 

commodity to the table in paragraph 

(a)(1) to read as follows. 

§ 180.339 MCPA; tolerances for residues. 

(a)(1) General. * * * 

Commodity Parts per million 

*****

Grain, aspirated fractions 3.0 

*****

* * * * * 

■ 6. Section 180.362 is amended by 

alphabetically adding the following 

commodity to the table in paragraph 

(a)(1) to read as follows. 

§ 180.362 Hexakis (2-methyl-2- 

phenylpropyl)distannoxane; tolerances for 

residues. 

(a) * * *

(1) * * * 

Commodity Parts per million 

*****

Pistachio ......................... 0.5 

*****

* * * * * 

[FR Doc. E8–1535 Filed 1–28–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 716 

[EPA–HQ–OPPT–2007–0487; FRL–8154–2] 

RIN 2070–AB11 

Health and Safety Data Reporting; 

Addition of Certain Chemicals 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This final rule, issued 

pursuant to section 8(d) of the Toxic 

Substances Control Act (TSCA) and its 

regulations, requires manufacturers 

(including importers) of consumer 

products intended for use by children 

who also manufacture (including 

import) lead or lead compounds to 

report certain unpublished health and 

safety data to EPA. This final rule adds 

lead and lead compounds to 40 CFR 

716.120 because the Interagency Testing 

Committee (ITC) added the category of 

lead and lead compounds to the Priority 

Testing List through its 60th ITC Report. 

The ITC was established under section 

4(e) of TSCA to recommend chemicals 

and chemical mixtures to EPA for 

priority testing consideration; the ITC 

periodically amends the TSCA section 

4(e) Priority Testing List through 

periodic reports submitted to EPA. 

DATES: This final rule is effective on 

February 28, 2008. For purposes of 

judicial review, this final rule shall be 

promulgated at 1 p.m. eastern daylight/ 

standard time on February 12, 2008. 

(See 40 CFR 23.5.) 

A request to withdraw a chemical 

from this final rule pursuant to 40 CFR 

716.105(c) must be received on or before 

February 12, 2008. (See Unit IV. of the 

SUPPLEMENTARY INFORMATION.) 

For dates for reporting requirements, 

see Unit III.B. of the SUPPLEMENTARY

INFORMATION. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2007–0487, by 

one of the following methods. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001. 


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5110 Federal Register / Vol. 73, No. 19 / Tuesday, January 29, 2008 / Rules and Regulations 

• Hand Delivery: OPPT Document 

Control Office (DCO), EPA East Bldg., 

Rm. 6428, 1201 Constitution Ave., NW., 

Washington, DC, Attention: Docket ID 

Number EPA–HQ–OPPT–2007–0487. 

The DCO is open from 8 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

DCO is (202) 564–8930. Such deliveries 

are only accepted during the Docket’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPPT–

2007–0487. EPA’s policy is that all 

comments received will be included in 

the public docket without change and 

may be made available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or email. The regulations.gov website is an 

‘‘anonymous access’’ systems, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the public docket and made 

available on the Internet. If you submit 

an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD-ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Docket: All documents in the docket 

are listed in the docket index available 

in regulations.gov. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. Although 

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. Publicly available docket 

materials are available electronically at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

the EPA Docket Center (EPA/DC) at Rm. 

3334, EPA West Bldg., 1301 

Constitution Ave., NW., Washington, 

DC. The EPA/DC Public Reading Room 

hours of operation are 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

Federal holidays. The telephone number 

of the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

Data Submissions: Copies of health 

and safety studies and accompanying 

cover letters, lists of health and safety 

studies, requests for extensions of time, 

and withdrawal requests must be 

submitted in accordance with the 

instructions in 40 CFR 716.30, 716.35, 

716.60, and 716.105, respectively. Each 

submission must be identified by docket 

ID number EPA–HQ–OPPT–2007–0487. 

FOR FURTHER INFORMATION CONTACT: For 

general information contact: Colby 

Lintner, Regulatory Coordinator, 

Environmental Assistance Division 

(7408M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 554–1404; e-mail address: 

TSCA-Hotline@epa.gov. 

For technical information contact: Joe 

Nash, Chemical Control Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–8886; fax number: 

(202) 564–4765; e-mail address: 

ccd.citb@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may potentially be affected by 

this action if you manufacture 

(including import) consumer products 

intended for use by children and also 

manufacture (including import) lead or 

lead compounds. Importers are a subset 

of manufacturers under TSCA. 

Potentially affected entities may 

include, but are not limited to: 

• Manufacturers (including importers) 

of costume jewelry and novelty 

manufacturing (NAICS code 339914). 

• Manufacturers (including importers) 

of dolls and stuffed toys (NAICS code 

339931). 

• Manufacturers (including importers) 

of games, toys, and children’s vehicles 

(NAICS code 339932). 

• Manufacturers (including importers) 

of fasteners, buttons, needles, and pins 

(NAICS code 339993). 

• Wholesalers of toy and hobby goods, 

establishments with product line 12812 

(NAICS code 42392). 

• Discount department stores (NAICS 

code 452112). 

• Warehouse clubs and supercenters 

(NAICS code 45291). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. 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 technical person listed under FOR

FURTHER INFORMATION CONTACT. 

B. How Do I Submit CBI Information? 

Do not submit this information to EPA 

through regulations.gov or e-mail. 

Clearly mark the part or all of the 

information that you claim to be CBI. 

For CBI information in a disk or CDROM that you mail to EPA, mark the 

outside of the disk or CD-ROM as CBI 

and then identify electronically within 

the disk or CD-ROM the specific 

information that is claimed as CBI. In 

addition to one complete version of the 

comment that includes information 

claimed as CBI, a copy of the comment 

that does not contain the information 

claimed as CBI must be submitted for 

inclusion in the public docket. 

Information so marked will not be 

disclosed except in accordance with 

procedures set forth in 40 CFR part 2. 

II. Background 

A. What Action is the Agency Taking? 

EPA is amending its model Health 

and Safety Data Reporting rule under 

TSCA section 8(d) (TSCA section 8(d) 

model rule) to require manufacturers 

(including importers) of consumer 

products intended for use by children 

who also manufacture (including 

import) lead or lead compounds, as 

listed on the ITC’s TSCA section 4(e) 

Priority Testing List, to submit certain 

unpublished health and safety data to 

EPA. The import of children’s products 


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Federal Register / Vol. 73, No. 19 / Tuesday, January 29, 2008 / Rules and Regulations 5111 

that contain lead or lead compounds 

constitutes the manufacture of lead or 

lead compounds under TSCA. EPA 

believes importers of such products are 

the entities most likely to have the type 

of health and safety studies EPA is 

seeking. 

Based on information available to the 

Agency, EPA believes that imported 

items represent a majority of the value 

of sales of toys and games (without 

regard to lead content) in NAICS code 

42392. In addition, EPA has reviewed 

Consumer Product Safety Commission 

(CPSC) recalls of lead-contaminated 

children’s products. None of the recalls 

reviewed implicated products that were 

produced domestically. See CPSC 

Recalls and Product Safety News at 

http://www.cpsc.gov/cpscpub/prerel/ 

prerel.html (Ref. 1). 

Processors are not included in this 

final rule. As explained in Unit II.B., the 

ITC listing procedure and the TSCA 

section 8(d) model rule do not generally 

result in TSCA section 8(d) model rules 

that cover processors. Therefore, a 

domestic company that processes lead 

in the manufacture of children’s 

products would not be covered, unless 

that company also manufactures 

(including imports) lead or lead 

compounds. 

The regulatory text of this document 

lists examples of chemicals and their 

CAS numbers in the category of lead 

and lead compounds. The regulatory 

text also lists the data reporting 

requirements imposed by this 

amendment to the TSCA section 8(d) 

model rule. 

B. What is the Agency’s Authority? 

Section 8(d) of TSCA allows EPA to 

‘‘promulgate rules under which the 

Administrator shall require any person 

who manufactures, processes or 

distributes in commerce or who 

proposes to manufacture, process or 

distribute in commerce any chemical 

substance or mixture’’ to submit lists of 

certain health and safety studies, as well 

as copies of such studies (15 U.S.C. 

2607(d)). Under TSCA, import is 

included in the definition of 

‘‘manufacture’’ (15 U.S.C. 2602(7)). 

The TSCA section 8(d) model rule (15 

U.S.C. 2607(d)) is codified at 40 CFR 

part 716. EPA uses this TSCA section 

8(d) model rule to quickly gather 

current information on chemicals. The 

TSCA section 8(d) model rule requires 

past, current, and prospective 

manufacturers, importers, and (if 

specified by EPA in a particular rule 

under TSCA section 8(d)) processors of 

listed chemicals to submit to EPA 

copies and lists of unpublished health 

and safety studies on the listed 

chemicals that they manufacture, 

import, or (if specified by EPA in a 

particular rule under TSCA section 8(d)) 

process. These studies provide EPA 

with useful information and have 

provided significant support for EPA’s 

decisionmaking under TSCA sections 4, 

5, 6, 8, and 9. 

The TSCA section 8(d) model rule 

provides for the addition of TSCA 

section 4(e) Priority Testing List 

chemicals. Whenever EPA announces 

the receipt of an ITC report, EPA 

amends, unless otherwise instructed by 

the ITC, the TSCA section 8(d) model 

rule by adding the recommended (or 

designated) chemicals. In doing so, EPA 

must provide a 14–day period, which 

starts 14 days after date of publication 

of the amendments to the TSCA section 

8(d) model rule in the Federal Register, 

for persons to submit information 

showing why a chemical substance, 

mixture, or category of chemical 

substances should be withdrawn from 

the amendment. The amendment adding 

these chemicals to the TSCA section 

8(d) model rule is effective 30 days after 

date of publication in the Federal 

Register. If the Administrator withdraws 

a chemical from the amendment, then 

no later than 30 days after the date of 

publication of the amendment in the 

Federal Register, a Federal Register 

document announcing this decision is 

published. 

Explanations of the procedures to 

follow if a respondent to this rule 

wishes to assert a claim of 

confidentiality for a part of a study or 

certain information contained in a study 

are provided at 40 CFR 716.55. 

C. Related Obligations Under TSCA 

Section 8 

Aside from obligations that will arise 

under this final rule, persons who 

manufacture, process, or distribute lead 

may be subject to other requirements 

under TSCA section 8. For example, 

TSCA section 8(e) (15 U.S.C. 2607(e)) 

requires that: 

Any person who manufactures, processes, 

or distributes in commerce a chemical 

substance or mixture and who obtains 

information which reasonably supports the 

conclusion that such substance or mixture 

presents a substantial risk of injury to health 

or the environment shall immediately inform 

the Administrator of such information unless 

such person has actual knowledge that the 

Administrator has been adequately informed 

of such information. 

Toxicity data that indicate a 

substantial risk of injury to health or the 

environment are the most common 

kinds of information received by EPA 

under TSCA section 8(e), but the 

Agency also often receives information 

on exposure, environmental persistence, 

or other kinds of information that 

indicate a substantial risk of injury to 

health or the environment. Of note, 

given the focus of this TSCA section 

8(d) model rule, EPA issued guidance in 

September 2006 (Ref. 2) that may be 

relevant to persons who manufacture, 

process, or distribute lead-containing 

products intended for use by children. 

The guidance discusses the 

circumstances under which reporting 

under TSCA section 8(e) should be 

considered for substantial risk 

information obtained that indicates: 

1. Previously unknown and 

significant human exposure to a 

chemical known to cause serious health 

effects (e.g., absorption of a chemical 

from manufactured products or articles) 

or 

2. The presence of a previously 

unknown hazardous or toxic constituent 

in a product, including manufactured 

articles. Other guidance and information 

relevant to TSCA section 8(e) reporting 

are available on the TSCA section 8(e) 

website at http://www.epa.gov/oppt/ 

tsca8e/index.htm. 

D. Why is this Action Being Issued as a 

Final Rule? 

EPA is publishing this action as a 

final rule without prior notice and an 

opportunity for comment pursuant to 

the procedures set forth in 40 CFR 

716.105(b) and (c). EPA finds that there 

is ‘‘good cause’’ under the 

Administrative Procedure Act (APA) (5 

U.S.C. 553(b)(3)(B)) to make these 

amendments without prior notice and 

comment. EPA believes notice and an 

opportunity for comment on this action 

are unnecessary. TSCA directs the ITC 

to add chemicals to the Priority Testing 

List for which EPA should give priority 

consideration. EPA also lacks the 

authority to remove a chemical from the 

Priority Testing List once it has been 

added by the ITC. As explained earlier 

in this preamble, pursuant to 40 CFR 

716.105(b) and (c), once the ITC adds a 

chemical to the Priority Testing List, 

EPA in turn is obliged to add that 

chemical to the list of chemicals subject 

to the TSCA section 8(d) model rule 

reporting requirements, unless 

requested not to do so by the ITC. EPA 

promulgated this procedure in 1985 

after having solicited public comment 

on the need for and mechanics of this 

procedure (Ref. 3). Because that rule 

established the procedure for adding 

ITC chemicals to the TSCA section 8(d) 

model rule, it is unnecessary to request 

comment on the procedure in this 

action. Finally, 40 CFR 716.105(b) and 

(c) do provide EPA with the discretion 

to withdraw a chemical from the TSCA 


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5112 Federal Register / Vol. 73, No. 19 / Tuesday, January 29, 2008 / Rules and Regulations 

section 8(d) model rule if a party 

submits to EPA information showing 

good cause that a chemical should be 

removed from the TSCA section 8(d) 

model rule. 

III. Final Rule 

A. What Chemicals Are to be Added? 

In this document, EPA is adding the 

category of lead and lead compounds to 

the TSCA section 8(d) model rule as 

requested by the ITC in its 60th ITC 

Report (Ref. 4). This final rule requires 

manufacturers (including importers) of 

consumer products intended for use by 

children who also manufacture 

(including import) lead or lead 

compounds to report certain 

unpublished health and safety data to 

EPA. 

B. What Are the General Reporting 

Requirements and Deadlines? 

The general provisions regarding the 

submission of copies and lists of studies 

under EPA’s TSCA section 8(d) model 

rule are located at 40 CFR 716.30 and 

716.35, respectively, and additional 

reporting requirements and exemptions 

are described elsewhere in 40 CFR part 

716. The reporting schedule and 

reporting period for persons subject to 

this final rule are described at 40 CFR 

716.60 and 716.65. Chemical specific 

reporting requirements appear at 40 CFR 

716.21. 

C. What Are the Chemical Specific 

Reporting Requirements? 

Pursuant to 40 CFR 716.20(b)(5), this 

amendment specifies the types of 

environmental fate, health, and/or 

environmental effects studies that must 

be reported and the chemical grade/ 

purity requirements that must be met or 

exceeded in individual studies for lead 

and lead compounds. The amendment 

requires the submission of all 

unpublished health and safety studies 

that: 

1. Relate to the lead content of 

consumer products that are ‘‘intended 

for use by children’’ as that term is 

defined at 40 CFR 710.43 (excluding 

children’s metal jewelry, as described 

by CPSC in its ANPRM) (Ref. 5), or 

2. Assess children’s exposure to lead 

from such products (including studies 

of bioavailability). With regard to grade/ 

purity requirements, studies showing 

any measurable lead content in such 

products must be submitted. 

The exclusion for children’s metal 

jewelry functions to exempt studies on 

those products already being directly 

addressed by CPSC. For more 

information on CPSC’s actions, please 

see CPSC’s Advance Notice of Proposed 

Rulemaking (ANPRM) regarding 

children’s jewelry containing lead (Ref. 

5). 

This final rule does not require 

reporting of any other health and safety 

studies. 

This amendment also specifies 

manufacturers subject to these reporting 

requirements: Manufacturers (including 

importers) of consumer products 

intended for use by children who also 

manufacture (including import) lead or 

lead compounds. 

D. Economic Analysis 

The economic analysis for the 

addition of lead and lead compounds to 

the TSCA section 8(d) model rule is 

entitled, TSCA Section 8(d): Economic 

Impact Analysis for Adding Lead and 

Lead Compounds from the 60th Report 

of the TSCA Interagency Testing 

Committee to the Health and Safety 

Data Reporting rule. November 14, 

2007. (Ref. 6). 

The number of firms that will be 

affected by this final rule could not be 

estimated directly by EPA in the 

Economic Analysis. In most previous 

instances, the TSCA section 8(d) 

analysis has focused on the firms that 

manufacture the chemicals, as shown in 

the EPA-maintained Chemical Update 

System (CUS) database. In this instance, 

the CUS database does not include those 

companies that manufacture (including 

import) consumer products intended for 

use by children as well as manufacture 

(including import) lead or lead 

compounds. Importers are a subset of 

manufacturers under TSCA. 

Reporting requirements are further 

limited to those studies that relate to the 

lead content of consumer products 

(excluding metal toy jewelry) that are 

intended for use by children or studies 

that assess children’s exposure to lead 

from such products (including studies 

of bioavailability). 

The U.S. Census Bureau’s Economic 

Census does not separately identify 

these firms. As a result, it is difficult to 

estimate the number of firms affected by 

this rule. The Agency has chosen to 

estimate the number of affected firms by 

using census data of the number of firms 

included in certain NAICS categories, 

selected with the expectation that these 

categories include firms which may be 

engaged in manufacturing or importing 

children’s products. The selected 

categories and the number of firms in 

each are: 

• NAICS code 339914—Costume 

jewelry and novelty manufacturing (651 

firms). 

• NAICS code 339931—Doll and 

stuffed toy manufacturing (134 firms). 

• NAICS code 339932—Game, toy, 

and children’s vehicle manufacturing 

(733 firms). 

• NAICS code 339993—Fastener, 

button, needle, and pin manufacturing 

(180 firms). 

• NAICS code 42392—Toy and hobby 

goods and supplies merchant 

wholesalers (establishments with 

product line 12812) (1,310 firms). 

• NAICS code 452112—Discount 

department stores (39 firms). 

• NAICS code 45291—Warehouse 

clubs and supercenters (16 firms). 

It is expected that some number of 

firms within those categories will not 

need to respond, and that some other 

unknown number of firms not within 

those categories will be required to 

respond. This tabulation is meant to be 

suggestive of the potential number of 

respondents, given the available 

information, and cannot be expected to 

be an accurate point estimate. 

The number of studies that might be 

submitted in response to this final rule 

is also difficult to estimate. The number 

of firms involved is likely to be larger 

than for other chemicals that have been 

listed under amendments to the TSCA 

section 8(d) model rule. However, the 

nature of the studies required to be 

submitted are restricted to a specific 

category. 

An earlier examination of studies 

submitted under previous amendments 

to the TSCA section 8(d) model rule 

over an 8 year period prior to April 2002 

reported an average of 5.66 studies per 

chemical. An examination of more 

recent experience with amendments to 

the TSCA section 8(d) model rule 

reported an average of 1 study per 

chemical. Based both on past EPA 

experience and on the professional 

judgment of Agency personnel 

responsible for the TSCA section 8(d) 

program, EPA estimates an average of 5 

studies will be submitted for each of the 

12 chemicals listed as examples of 

chemicals in the lead and lead 

compounds category, for a total of 60 

studies. However, in consideration of 

the uncertainty of this per chemical 

estimate and the fact that relevant 

studies on lead compounds other than 

the listed 12 example compounds may 

be reported, the Economic Analysis also 

estimates the costs in a case where 10 

times that number, or 600, studies are 

submitted (Ref. 6). 

Given the assumptions in this unit, 

the industry reporting costs and burden 

associated with this rule are estimated 

in the Economic Analysis (Ref. 6) to be 

the following: 


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Federal Register / Vol. 73, No. 19 / Tuesday, January 29, 2008 / Rules and Regulations 5113 

INDUSTRY REPORTING COSTS (DOLLARS) AND BURDEN (HOURS) 

Collection Activity (a) Unit Burden 

Hours (b) Unit Cost 

(c) Number of 

Firms or Sites Per 

Activity 

(d) = (a) x (c) 

Total Burden 

Hours 

(e) = (b) x (c) 

Total Cost 

1. Review of rule 2 hours $126.66 3,063 6,126 $387,960 

2. Site identification 3 hours $189.99 1,317 3,951 $250,584 

3. Site file search 3 hours $161.34 1,361 4,083 $219,584 

4. Study title lists 1 hour $26.40 60 60 $1,584 

5. Photocopy studies 0.5 hour $13.20 60 30 $792 

6. Robust summaries 6 hours $322.68 6 36 $1,936 

7. CBI review 1 hour $63.33 60 60 $3,800 

8. Post-reporting period submission 1.5 hours $76.53 1 1.5 $77 

Total 14,347 $865,949 

Note: Not all respondents perform all activities. 

The sensitivity analysis conducted to 

estimate the costs if 600 studies are 

submitted suggests that the burden 

estimate for this TSCA section 8(d) 

action is relatively insensitive to the 

estimate of the number of studies. A tenfold error in that estimate is calculated 

to lead to an increase of roughly 1,500 

burden hours (or less than 12%), and an 

increase of about $74,000 in cost (or less 

than 10%). The burden and cost 

estimates are largely determined by the 

estimate of the number of responding 

firms, and is relatively insensitive to the 

estimate of the number of studies. 

The estimated annual cost of the 

TSCA section 8(d) model rule to the 

Federal Government is approximately 

the time of one full-time employee, or 

2,080 hours. Based on previous TSCA 

section 8(d) analyses and Agency 

professional judgment, this particular 

data collection is expected to represent 

25% of 1 year’s burden, or the 

equivalent of approximately 520 hours. 

That will amount to a cost to Federal 

Government of $25,285. 

IV. Requesting a Chemical be 

Withdrawn from the Rule 

As specified in 40 CFR 716.105(c), 

EPA may remove a chemical substance, 

mixture, or category of chemical 

substances from this final rule for good 

cause prior to the effective date of this 

final rule. Any person who believes that 

the reporting required by this final rule 

is not warranted for a chemical 

substance, mixture, or category of 

chemical substances listed in this final 

rule, must submit to EPA detailed 

reasons for that belief. You must submit 

your request to EPA on or before 

February 12, 2008 and in accordance 

with the instructions provided in 40 

CFR 716.105(c), which are briefly 

summarized here. In addition, to ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPPT–2007–0487 on your request and 

submit that request in accordance with 

the instructions in 40 CFR 716.105(c). If 

the Administrator withdraws a chemical 

substance, mixture, or category of 

chemical substances from the 

amendment, in accordance with 40 CFR 

716.105(c), a Federal Register document 

announcing this decision will be 

published no later than February 28, 

2008. 

V. Materials in the Docket 

The official docket for this final rule 

has been established under docket ID 

number EPA–HQ–OPPT–2007–0487. 

The official public docket is available 

for review as specified in ADDRESSES. 

The following is a listing of the 

documents referenced in this preamble 

that have been placed in the official 

docket for this final rule: 

1. CPSC. Recalls and Product Safety 

News. Available on-line at: http:// 

www.cpsc.gov/cpscpub/prerel/ 

prerel.html. 

2. EPA. Toxic Substances Control Act 

(TSCA) Section 8(e) Notices—Frequent 

Questions—September 2006—Health 

and Safety - Questions 25 and 26. 

Available on-line at: http:// 

www.epa.gov/oppt/tsca8e/pubs/ 

frequentlyaskedquestions

faqs.htm#health2. 

3. EPA. Chemical Information Rules; 

Additional Automatic Reporting; Final 

Rule. Federal Register (50 FR 34809; 

August 28, 1985). 

4. ITC. Sixtieth Report of the ITC. 

Federal Register (72 FR 41414, July 27, 

2007) (FRL–8137–6). Available on-line 

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

5. CPSC. Children’s Jewelry 

Containing Lead; Advanced Notice of 

Proposed Rulemaking; Request for 

Comments and Information. Federal 

Register (72 FR 920, January 9, 2007). 

6. EPA. TSCA Section 8(d): Economic 

Impact Analysis for Adding Lead and 

Lead Compounds from the 60th Report 

of the TSCA Interagency Testing 

Committee to the Health and Safety Data 

Reporting rule. November 14, 2007. 

VI. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

The Office of Management and Budget 

(OMB) has exempted actions under 

TSCA section 8(d) related to the TSCA 

section 8(d) model rule from the 

requirements of Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993). 

B. Paperwork Reduction Act 

The information collection 

requirements contained in TSCA section 

8(d) model rules have already been 

approved by OMB under the provisions 

of the Paperwork Reduction Act (PRA), 

44 U.S.C. 3501 et seq., and OMB control 

number 2070–0004 (EPA ICR No. 0575). 

The collection activities in this final 

rule are captured by the existing 

approval and do not require additional 

review and/or approval by OMB. 

EPA estimates that the information 

collection activities related to health 

and safety data reporting for the 

category of lead and lead compounds in 

this final rule will result in a total 


rwilkins on PROD1PC63 with RULES
5114 Federal Register / Vol. 73, No. 19 / Tuesday, January 29, 2008 / Rules and Regulations 

public reporting burden of 14,348 hours, 

or roughly 4.7 hours per firm. Of that 

total, an estimated 6,126 hours are 

estimated to be spent performing an 

initial review of the final rule. The 

remaining hours are associated with the 

actual required reporting activities (Ref. 

6). As defined by the PRA and 5 CFR 

1320.3(b), ‘‘burden’’ means the total 

time, effort, or financial resources 

expended by persons to generate, 

maintain, retain, or disclose or provide 

information to or for a Federal Agency. 

This includes the time needed to: 

Review instructions; develop, acquire, 

install, and utilize technology and 

systems for the purposes of collecting, 

validating, and verifying information, 

processing and maintaining 

information, and disclosing and 

providing information; adjust the 

existing ways to comply with any 

previously applicable instructions and 

requirements which have subsequently 

changed; train personnel to be able to 

respond to a collection of information; 

search data sources; complete and 

review the collection of information; 

and transmit or otherwise disclose the 

information. 

Under PRA, an Agency may not 

conduct or sponsor, and a person is not 

required to respond to, an information 

collection request unless it displays a 

currently valid OMB control number. 

The OMB control numbers for EPA’s 

regulations, including its regulations 

implementing TSCA section 8(d) at 40 

CFR part 716, are listed in the table in 

40 CFR part 9 and included on the 

related collection instrument. This 

listing of the OMB control numbers and 

their subsequent codification in the CFR 

satisfies the display requirements of 

PRA and OMB’s implementing 

regulations at 5 CFR part 1320. 

C. Regulatory Flexibility Act 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA), 5 

U.S.C. 601 et seq., the Agency hereby 

certifies that this final rule will not have 

a significant adverse economic impact 

on a substantial number of small 

entities. The factual basis for the 

Agency’s determination is presented in 

the small entity impact analysis 

prepared as part of the Economic 

Analysis (Ref. 6) for this final rule, and 

is summarized here. 

To estimate the impact of the final 

rule on a business, EPA used the ‘‘sales 

test,’’ wherein costs for any individual 

firm are measured as a percent of annual 

sales. The average cost per company for 

the final rule is estimated to be $283. At 

an average cost for any one firm of $283, 

the firm’s total sales would have to be 

less than $30,000 for this final rule to 

have an impact of even 1% of sales. 

Because of the uncertainty regarding the 

number and identity of the firms who 

will be required to respond to this data 

collection, it is not possible to directly 

compare the estimated cost to the actual 

sales volume of those firms. But due to 

the low level of the impact, it is not 

expected that this action will have a 

significant impact on a substantial 

number of small entities. 

D. Unfunded Mandates Reform Act 

Pursuant to Title II of the Unfunded 

Mandates Reform Act of 1995 (UMRA), 

Public Law 104–4, EPA has determined 

that this final rule does not contain a 

Federal mandate that may result in 

expenditures of $100 million or more 

for State, local, and tribal governments, 

in the aggregate, or the private sector in 

any 1 year. In addition, EPA has 

determined that this final rule will not 

significantly or uniquely affect small 

governments. Accordingly, the final rule 

is not subject to the requirements of 

UMRA sections 202, 203, 204, or 205. 

E. Executive Orders 13132 and 13175 

Based on EPA’s experience with past 

TSCA section 8(d) model rules, State, 

local, and tribal governments have not 

been impacted by these rules, and EPA 

does not have any reasons to believe 

that any State, local, or tribal 

government will be impacted by this 

final rule. As a result, these rules are not 

subject to the requirements in Executive 

Order 13132, entitled Federalism (64 FR 

43255, August 10, 1999) or Executive 

Order 13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

6, 2000). 

F. Executive Order 13045 

Executive Order 13045, entitled 

Protection of Children from 

Environmental Health Risks and Safety 

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

not apply to this final rule, because it is 

not ‘‘economically significant’’ as 

defined under Executive Order 12866, 

and does not concern an environmental 

health or safety risk that may have a 

disproportionate effect on children. This 

final rule requires the reporting of 

health and safety data to EPA by 

manufacturers (including importers) of 

certain chemicals requested by the ITC 

to be added to the TSCA 8(d) model rule 

in its 60th ITC Report (Ref. 4). 

G. Executive Order 13211 

This final rule is not subject to 

Executive Order 13211, entitled Actions 

that Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001), because this action is not 

expected to affect energy supply, 

distribution, or use. 

H. National Technology Transfer and 

Advancement Act 

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). Section 12(d) 

of NTTAA directs EPA to use voluntary 

consensus standards in its regulatory 

activities unless to do so would be 

inconsistent with applicable law or 

otherwise impractical. Voluntary 

consensus standards are technical 

standards (e.g., materials specifications, 

test methods, sampling procedures, and 

business practices) that are developed or 

adopted by voluntary consensus 

standards bodies. The NTTAA directs 

EPA to provide Congress, through OMB, 

explanations when the Agency decides 

not to use available and applicable 

voluntary consensus standards. 

I. Executive Order 12898 

This action does not involve special 

considerations of environmental justicerelated issues pursuant to Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

VII. 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 the 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 716 

Environmental protection, Chemicals, 

Children, Hazardous substances, Health 

and safety, Lead, Reporting and 

recordkeeping requirements, Toys. 

Dated: January 22, 2008. 

Charles M. Auer, 

Director, Office of Pollution Prevention and 

Toxics. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 


rwilkins on PROD1PC63 with RULES
Federal Register / Vol. 73, No. 19 / Tuesday, January 29, 2008 / Rules and Regulations 5115 

PART 716—[AMENDED] 

■ 1. The authority citation for part 716 

continues to read as follows: 

Authority: 15 U.S.C. 2607(d). 

■ 2. By adding a new paragraph (a)(8) to 

§ 716.21 to read as follows: 

§ 716.21 Chemical specific reporting 

requirements. 

(a) * * * 

(8)(i) Reporting requirements apply 

only to manufacturers (including 

importers) of consumer products 

intended for use by children who also 

manufacture (including import) lead or 

lead compounds. For the category ‘‘lead 

and lead compounds,’’ all unpublished 

health and safety studies that: 

(A) Relate to the lead content of 

consumer products that are ‘‘intended 

for use by children’’ as that term is 

defined at 40 CFR 710.43 (excluding 

children’s metal jewelry), or 

(B) Assess children’s exposure to lead 

from such products (including studies 

of bioavailability). 

(ii) With regard to purity, studies 

showing any measurable lead content in 

such products must be submitted. 

* * * * * 

■ 3. In § 716.120, the table in paragraph 

(c) is amended by adding in alphabetical 

order the category ‘‘Lead and lead 

compounds’’ and its entries to read as 

follows: 

§ 716.120 Substances and listed mixtures 

to which this subpart applies. 

* * * * * 

(c) * * * 

Category CAS No. (examples for 

category) Special exemptions Effective date Sunset date 

* * * * * * * 

Lead and lead compounds .............. ...................................... § 716.21(a)(8) February 28, 2008 April 28, 2008 

Lead .......................................... 7439–92–1 § 716.21(a)(8) February 28, 2008 April 28, 2008 

Acetic acid, lead (2+) salt ......... 301–04–2 § 716.21(a)(8) February 28, 2008 April 28, 2008 

Carbonic acid, lead (2+) salt 

(1:1) ....................................... 598–63–0 § 716.21(a)(8) February 28, 2008 April 28, 2008 

Lead chloride (PbCl2) ............... 7758–95–4 § 716.21(a)(8) February 28, 2008 April 28, 2008 

Chromic acid (H2Cr04), lead 

(2+) salt (1:1) ........................ 7758–97–6 § 716.21(a)(8) February 28, 2008 April 28, 2008 

Lead oxide (PbO2) .................... 1309–60–0 § 716.21(a)(8) February 28, 2008 April 28, 2008 

Borate (1-), tetrafluoro-, lead 

(2+) (2:1) ............................... 13814–96–5 § 716.21(a)(8) February 28, 2008 April 28, 2008 

Phosphoric acid, lead (2+) salt 

(2:3) ....................................... 7446–27–7 § 716.21(a)(8) February 28, 2008 April 28, 2008 

Silicic acid, lead salt, basic ...... 53466–66–3 § 716.21(a)(8) February 28, 2008 April 28, 2008 

Octadecanoic acid, lead salt 

(1:?) ....................................... 7428–48–0 § 716.21(a)(8) February 28, 2008 April 28, 2008 

Sulfuric acid, lead salt (1:?), 

basic ...................................... 63653–42–9 § 716.21(a)(8) February 28, 2008 April 28, 2008 

Lead sulfide (PbS) .................... 1314–87–0 § 716.21(a)(8) February 28, 2008 April 28, 2008 

* * * * * * * 

* * * * * 

[FR Doc. E8–1546 Filed 1–28–08; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 229 

[Docket No. 080123076–8078–01] 

RIN 0648–XF27 

Taking of Marine Mammals Incidental 

to Commercial Fishing Operations; 

Atlantic Large Whale Take Reduction 

Plan 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule. 

SUMMARY: The Assistant Administrator 

for Fisheries (AA), NOAA, announces 

temporary restrictions consistent with 

the requirements of the Atlantic Large 

Whale Take Reduction Plan’s 

(ALWTRP) implementing regulations. 

These regulations apply to lobster trap/ 

pot and anchored gillnet fishermen in 

an area totaling approximately 2,637 

nm2 (9,045 km2), south of Rockland, 

Maine, for 15 days. The purpose of this 

action is to provide protection to an 

aggregation of northern right whales 

(right whales). 

DATES: Effective beginning at 0001 hours 

January 31, 2008, through 2400 hours 

February 14, 2008. 

ADDRESSES: Copies of the proposed and 

final Dynamic Area Management (DAM) 

rules, Environmental Assessments 

(EAs), Atlantic Large Whale Take 

Reduction Team (ALWTRT) meeting 

summaries, and progress reports on 

implementation of the ALWTRP may 

also be obtained by writing Diane 

Borggaard, NMFS/Northeast Region, 

One Blackburn Drive, Gloucester, MA 

01930. 

FOR FURTHER INFORMATION CONTACT: 

Diane Borggaard, NMFS/Northeast 

Region, 978–281–9300 x6503; or Kristy 

Long, NMFS, Office of Protected 

Resources, 301–713–2322. 

SUPPLEMENTARY INFORMATION: 

Electronic Access 

Several of the background documents 

for the ALWTRP and the take reduction 

planning process can be downloaded 

from the ALWTRP Web site at http:// 

www.nero.noaa.gov/whaletrp/. 

Background 

The ALWTRP was developed 

pursuant to section 118 of the Marine 

Mammal Protection Act (MMPA) to 

reduce the incidental mortality and 

serious injury of three endangered 

species of whales (right, fin, and 

humpback) due to incidental interaction 

with commercial fishing activities. In 

addition, the measures identified in the 

ALWTRP would provide conservation 

benefits to a fourth species (minke), 

which are neither listed as endangered 

nor threatened under the Endangered 

Species Act (ESA). The ALWTRP, 

implemented through regulations 

codified at 50 CFR 229.32, relies on a 

combination of fishing gear 

modifications and time/area closures to 

reduce the risk of whales becoming 


rwilkins on PROD1PC63 with RULES