[Federal Register Volume 73, Number 19 (Tuesday, January 29, 2008)]
[Rules and Regulations]
[Pages 5109-5115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-1546]


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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.

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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compounds to report certain unpublished health and safety data to EPA.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 60\th\ 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.

[[Page 5110]]

     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 e-
mail. 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: [email protected].
    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: [email protected].

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 CD-ROM 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

[[Page 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

[[Page 5112]]

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 60\th\ 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 
60\th\ 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:

[[Page 5113]]



                                                  Industry Reporting Costs (Dollars) and Burden (Hours)
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                                                                                      (c) Number of Firms   (d) = (a) x (c) Total  (e) = (b) x (c) Total
        Collection Activity           (a) Unit Burden Hours       (b) Unit Cost      or Sites Per Activity       Burden Hours               Cost
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1. Review of rule                    2 hours                 $126.66                 3,063                  6,126                  $387,960
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2. Site identification               3 hours                 $189.99                 1,317                  3,951                  $250,584
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3. Site file search                  3 hours                 $161.34                 1,361                  4,083                  $219,584
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4. Study title lists                 1 hour                  $26.40                  60                     60                     $1,584
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5. Photocopy studies                 0.5 hour                $13.20                  60                     30                     $792
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6. Robust summaries                  6 hours                 $322.68                 6                      36                     $1,936
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7. CBI review                        1 hour                  $63.33                  60                     60                     $3,800
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8. Post-reporting period submission  1.5 hours               $76.53                  1                      1.5                    $77
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Total                                                                                                       14,347                 $865,949
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Note: Not all respondents perform all activities.
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    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 ten-fold 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/frequentlyaskedquestionsfaqs.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 60\th\ 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

[[Page 5114]]

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 60\th\ 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 justice-related 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.

0
Therefore, 40 CFR chapter I is amended as follows:

[[Page 5115]]

PART 716--[AMENDED]

0
1. The authority citation for part 716 continues to read as follows:

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


0
2. By adding a new paragraph (a)(8) to Sec.  716.21 to read as follows:


Sec.  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.
* * * * *

0
3. In Sec.  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:


Sec.  716.120  Substances and listed mixtures to which this subpart 
applies.

* * * * *
    (c) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       CAS No. (examples for
                      Category                               category)            Special exemptions         Effective date            Sunset date
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      * * * * * * *
Lead and lead compounds.............................  .......................      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
                                                              ...............
    Lead............................................                7439-92-1      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Acetic acid, lead (2+) salt.....................                 301-04-2      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Carbonic acid, lead (2+) salt (1:1).............                 598-63-0      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Lead chloride (PbCl2)...........................                7758-95-4      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Chromic acid (H2Cr04), lead (2+) salt (1:1).....                7758-97-6      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Lead oxide (PbO2)...............................                1309-60-0      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Borate (1-), tetrafluoro-, lead (2+) (2:1)......               13814-96-5      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Phosphoric acid, lead (2+) salt (2:3)...........                7446-27-7      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Silicic acid, lead salt, basic..................               53466-66-3      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Octadecanoic acid, lead salt (1:?)..............                7428-48-0      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Sulfuric acid, lead salt (1:?), basic...........               63653-42-9      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Lead sulfide (PbS)..............................                1314-87-0      Sec.   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