Document ID: EPA-HQ-OPPT-2011-0363-0001
Agency: epa
Document Type: Rule
Title: Health and Safety Data Reporting: Addition of Certain Chemicals
Posted Date: 2012-12-03T05:00Z

[Federal Register Volume 77, Number 232 (Monday, December 3, 2012)]
[Rules and Regulations]
[Pages 71561-71567]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28840]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 716

[EPA-HQ-OPPT-2011-0363; FRL-9355-9]
RIN 2070-AJ89

Health and Safety Data Reporting; Addition of Certain Chemicals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule requires manufacturers (including importers) 
of cadmium or cadmium compounds, including as part of an article, that 
have been, or are reasonably likely to be, incorporated into consumer 
products to report certain unpublished health and safety studies to 
EPA. The Interagency Testing Committee (ITC), established under section 
4(e) of the Toxic Substances Control Act (TSCA) to recommend chemicals 
and chemical mixtures to EPA for priority testing consideration, amends 
the TSCA section 4(e) Priority Testing List through periodic reports 
submitted to EPA. The ITC added cadmium and cadmium compounds to the 
Priority Testing List through its 69th ITC Report.

DATES: This final rule is effective January 2, 2013. For purposes of 
judicial review, this final rule shall be promulgated at 1 p.m. eastern 
daylight/standard time on December 17, 2012. (See 40 CFR 23.5.)
    A request to withdraw a chemical from this final rule pursuant to 
Sec.  716.105(c) must be received on or

[[Page 71562]]

before December 17, 2012. (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-2011-0363, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Mail: Document Control Office (2822-1T), Office of 
Chemical Safety and Pollution Prevention, Environmental Protection 
Agency, 1301 Constitution Ave. NW., Washington, DC 20004.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN: 
Docket ID Number EPA-HQ-OPPT-2011-0363. 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 DCO'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-
2011-0363. EPA's policy is that all comments received will be included 
in the docket without change and may be made available online 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 Web site is an ``anonymous access'' system, 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 email comment 
directly to EPA without going through regulations.gov, your email 
address will be automatically captured and included as part of the 
comment that is placed in the 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 at http://www.regulations.gov. 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 
legal 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.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Robert Jones, Chemical Control 
Division (7405M), Office of Chemical Safety and Pollution Prevention, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: 202-564-8161; email 
address: jones.robert@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be affected by this rule if you are a manufacturer 
(including importer) of cadmium or cadmium compounds, including as part 
of an article, that have been, or are reasonably likely to be, 
incorporated into consumer products.
    In addition to this final rule, EPA plans to propose, under a 
separate notice and comment rulemaking, to require the submission of 
TSCA section 8(d) health and safety studies from processors and 
distributors of cadmium or cadmium compounds, including as part of an 
article, that have been, or are reasonably likely to be, incorporated 
into consumer products to report certain unpublished health and safety 
studies to EPA. The proposed rule will be published in a subsequent 
Federal Register document. As provided in this rule, health and safety 
studies regarding cadmium or cadmium compounds in articles must be 
reported, with the exception of studies not subject to reporting as 
described at Sec.  716.20.
    While EPA has broad authority to require submission of health and 
safety studies on chemical substances, for the purposes of this rule 
EPA has limited the scope of this rule to those chemical substances 
within the listed category that have been, or are reasonably likely to 
be, incorporated into consumer products, based on EPA's determination 
of what is necessary to carry out the purposes of TSCA. ``Consumer 
product'' is defined in Sec.  716.21(a)(9)(iii) of this rule to mean 
``any product that is sold or made available to consumers for their use 
in or around a permanent or temporary household or residence, in or 
around a school, or in or around recreational areas.'' This definition 
is based on the definition of ``consumer use'' promulgated in 40 CFR 
710.43 and the definition of ``consumer product'' promulgated in 40 CFR 
721.3. Potentially affected entities may include but are not limited 
to:
     Manufacturers of basic inorganic chemicals (except 
industrial gases, inorganic dyes and pigments, alkalis and chlorine, 
and carbon black) (NAICS code 325188).
     Manufacturers (including importers) of inorganic dyes and 
pigments (NAICS code 325131).
     Manufacturers of basic organic chemical products (except 
aromatic petrochemicals, industrial gases, synthetic organic dyes and 
pigments, gum and wood chemicals, cyclic crudes and intermediates, and 
ethyl alcohol) (NAICS code 325199).
     Establishments primarily engaged in the primary production 
of nonferrous metals by smelting ore and/or the primary refining of 
nonferrous metals by electrolytic methods or other processes (except 
copper and aluminum) (NAICS code 331419).
     Establishments engaging in secondary smelting, refining, 
and alloying of nonferrous metal (except copper and aluminum) (NAICS 
code 331492).
     Wholesalers of toy and hobby goods, establishments with 
product line 12812 (NAICS code 42392).
     Discount department stores (NAICS code 452112).

[[Page 71563]]

     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?

    If you wish to claim information submitted to be CBI, it will be 
handled in accordance with procedures set forth in 40 CFR part 2, 
subpart B. If you do not assert a confidentiality claim at the time of 
submission, the information may be made available to the public by EPA 
without further notice. See 40 CFR 2.203 (Ref. 1). Do not submit this 
information to EPA through regulations.gov or by email. Clearly mark 
the part 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. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2 and in Sec.  716.55. Pursuant to 
Sec.  716.55, to assert a claim of confidentiality for information 
contained in a submitted record, you must submit two copies of the 
document. One copy must be complete, and you must indicate what 
information, if any, is claimed as confidential by marking the specific 
information on each page with a label such as ``company confidential,'' 
``proprietary,'' or ``trade secret'' and briefly state the basis of the 
claim. The second copy must be complete, except that all the 
information claimed as CBI in the first copy must be deleted. The 
second copy will be placed in the public docket. Failure to furnish a 
second copy when information is claimed as CBI in the first copy will 
be considered a presumptive waiver of confidentiality. EPA will notify 
the respondent by certified mail that a finding of a presumptive waiver 
of the claim of confidentiality has been made. The respondent will be 
given 30 days from the date of receipt of notification to submit the 
required second copy. If the respondent fails to submit the second copy 
within the 30 days, EPA will place the first copy in the docket.

II. Background

A. Why is the agency taking this action?

    EPA has classified cadmium as a Group B1, probable human carcinogen 
(Ref. 2). Further, EPA has determined acute (short-term) effects of 
cadmium in humans through inhalation exposure consisting mainly of 
effects on the lung, such as pulmonary irritation. Chronic (long-term) 
inhalation or oral exposure to cadmium leads to a build-up of cadmium 
in the kidneys which can cause kidney disease. Cadmium has been shown 
to be a developmental toxicant in animals, resulting in fetal 
malformations and other effects, but no conclusive evidence exists in 
humans. Animal studies have demonstrated an increase in lung cancer 
from long-term inhalation exposure to cadmium (Refs. 2-4). Due to the 
potential health effects of exposure to cadmium or cadmium compounds, 
EPA and the Consumer Product Safety Commission (CPSC) are concerned 
about the possible presence and bioavailability of cadmium or cadmium 
compounds in consumer products generally and especially those consumer 
products used by or around children (Ref. 5).

B. What action is the agency taking?

    EPA is issuing a final TSCA section 8(d) rule under procedures in 
the Health and Safety Data Reporting rule, 40 CFR part 716, to require 
manufacturers (including importers) of cadmium or cadmium compounds, 
including as part of an article, that have been, or are reasonably 
likely to be, incorporated into consumer products to submit certain 
unpublished health and safety studies to EPA.
    EPA has reviewed CPSC's recalls of cadmium-contaminated children's 
products. Most of the recalled products were produced abroad and 
imported from other countries (Ref. 6). Based in part on this 
information, EPA expects to capture health and safety studies conducted 
by importers of such products through this final rule. These parties 
are located primarily in the United States and may be subject to CPSC 
certification requirements and, depending on the product, may be 
conducting testing using Standard Consumer Safety Specification for Toy 
Safety, ASTM International (ASTM) F-963 (Ref. 7).
    The regulatory text of this final rule lists the category cadmium 
and cadmium compounds. The regulatory text also lists the data 
reporting requirements imposed by this amendment to the TSCA section 
8(d) model rule.

C. What is the agency's authority?

    Section 8(d) of TSCA authorizes EPA to 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 health and safety studies conducted or 
initiated by or for such person with respect to such substance or 
mixture at any time, known to such person, or reasonably ascertainable 
by such person; and copies of any study contained on a list submitted 
pursuant to section (8)(d)(1) of TSCA or otherwise known by such 
person. Under TSCA section 3(7), import is included in the definition 
of ``manufacture.''
    The term health and safety study should be interpreted broadly and 
is defined in Sec.  716.3.
    Since the TSCA section 8(d) model rule is codified in 40 CFR part 
716, EPA uses this TSCA section 8(d) model rule to quickly gather 
information on chemical substances. The TSCA section 8(d) model rule 
requires past, current, and prospective manufacturers (including 
importers) and (if specified by EPA in a particular rule or notice 
under TSCA section 8(d)) processors to submit to EPA copies and lists 
of health and safety studies on the listed chemical substances that 
they manufacture, import, or 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 chemical substances or categories of 
chemical substances. EPA s amending the TSCA section 8(d) model rule by 
adding the recommended category of chemical substances consistent with 
Sec.  716.105(b) and (c). In doing so, EPA must provide a 14-day 
period, which starts upon 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 chemical substances to the TSCA section 8(d) 
model rule is effective 30 days after date of publication in the 
Federal Register. If the EPA Administrator withdraws a chemical 
substance 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 will publish.

[[Page 71564]]

D. Why is this action being issued as a final rule?

    EPA is publishing this action as a final rule pursuant to the 
procedures set forth in Sec.  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 chemical substances 
to the Priority Testing List for which EPA should give priority 
consideration. EPA also lacks the authority to remove a chemical 
substance from the Priority Testing List once it has been added by the 
ITC. As explained earlier in this preamble, pursuant to Sec.  
716.105(b) and (c), once the ITC adds a chemical substance to the 
Priority Testing List, EPA adds that chemical substance to the list of 
chemical substances subject to the TSCA section 8(d) model rule 
reporting requirements, unless the ITC designated and recommended more 
than 50 chemical substances or categories of chemical substances in a 
calendar year or EPA withdraws the chemical substance from the TSCA 
section 8(d) model rule for good cause. EPA promulgated this procedure 
in 1985 after having solicited public comment on the need for and 
mechanics of this procedure (Ref. 8). Because that rule established the 
procedure for adding ITC chemical substances to the TSCA section 8(d) 
model rule, it is unnecessary to request comment on the procedure in 
this action. Finally, Sec.  716.105(b) and (c) do provide EPA with the 
discretion to withdraw a chemical substance from the TSCA section 8(d) 
model rule for good cause, including if a party submits to EPA 
information showing good cause that a chemical substance should be 
removed from the TSCA section 8(d) model rule.

III. Final Rule

A. What chemicals are to be added?

    EPA is adding the category of cadmium and cadmium compounds to the 
TSCA section 8(d) model rule as requested by the ITC in the 69th ITC 
Report (Ref. 9). This final rule requires manufacturers (including 
importers) of cadmium or cadmium compounds, including as part of an 
article, that have been, or are reasonably likely to be, incorporated 
into consumer products to report certain unpublished health and safety 
studies to EPA.

B. What are the general reporting requirements and deadlines?

    This final rule, issued pursuant to TSCA section 8(d) and its 
regulations, requires manufacturers (including importers) of cadmium or 
cadmium compounds, including as part of an article, that have been, or 
are reasonably likely to be, incorporated into consumer products to 
report certain unpublished health and safety studies to EPA. Listed in 
this unit are the reporting requirements for the chemical substances 
being added by this action to the TSCA section 8(d) model rule.
    The following types of persons need to report:
    1. Persons who, in the 10 years preceding the date a chemical 
substance is listed at Sec.  716.120, either have proposed to 
manufacture or import or have manufactured or imported the listed 
substance must submit to EPA, during the 60-day reporting period 
specified in Sec.  716.65 and according to the reporting schedule set 
forth at Sec.  716.60, a copy of each health and safety study which is 
in their possession at the time the chemical substance is listed.
    2. Persons who, at the time the chemical substance is listed, 
propose to manufacture or import, or are manufacturing or importing the 
listed chemical substance must submit to EPA during the 60-day 
reporting period specified in Sec.  716.65 and according to the 
reporting schedule set forth at Sec.  716.60:
    i. A copy of each health and safety study which is in their 
possession at the time the chemical substance is listed.
    ii. A list of the health and safety studies known to them but not 
in their possession at the time the chemical substance is listed.
    iii. A list of the health and safety studies that are ongoing at 
the time the chemical substance is listed and are being conducted by or 
for them.
    iv. A list of the health and safety studies that are initiated 
after the date the chemical substance is listed and will be conducted 
by or for them.
    v. A list of unpublished studies which have been sent to a Federal 
agency with no claims of confidentiality or copies of each such study.
    vi. A copy of each health and safety study that was previously 
listed as ongoing or subsequently initiated (i.e., listed in accordance 
with reporting requirements described at Unit III.B.2.iii. and iv. 
respectively) when complete--regardless of completion date.
    3. Persons who, after the time the substance is listed, propose to 
manufacture or import the listed chemical substance must submit to EPA 
during the reporting period specified in Sec.  716.65 and according to 
the reporting schedule set forth at Sec.  716.60:
    i. A copy of each health and safety study which is in their 
possession at the time they propose to manufacture or import the listed 
chemical substance.
    ii. A list of the health and safety studies known to them but not 
in their possession at the time they propose to manufacture or import 
the listed chemical substance.
    iii. A list of the health and safety studies that are ongoing at 
the time they propose to manufacture or import the listed chemical 
substance, and are being conducted by or for them.
    iv. A list of the health and safety studies that are initiated 
after the time they propose to manufacture or import the listed 
chemical substance, and will be conducted by or for them.
    v. A list of unpublished studies which have been sent to a Federal 
agency with no claims of confidentiality or copies of each such study.
    vi. A copy of each health and safety study that was previously 
listed as ongoing or subsequently initiated (i.e., listed in accordance 
with reporting requirements described in Unit III.B.3.iii. and iv. 
respectively) when complete--regardless of the completion date.
    Generally, the reporting described in Unit III.B. is required by 
March 4, 2013. Any person who manufactures or imports, or who proposes 
to manufacture or import, the listed chemical substance as described in 
Unit III.B. from January 2, 2013 to March 4, 2013 must inform EPA by 
submitting a list of any studies initiated during the period from 
January 2, 2013 to March 4, 2013 within 30 days of their initiation, 
but in no case later than April 2, 2013. In addition, if any such 
person has submitted lists of studies that were ongoing or initiated 
during the period from January 2, 2013 to March 4, 2013 to EPA, such 
person must submit a copy of each study within 30 days after its 
completion, regardless of the study's completion date. See Sec. Sec.  
716.60 and 716.65.
    Detailed requirements for reporting unpublished health and safety 
studies are published in 40 CFR part 716. Also found there are 
explanations of the reporting exemptions.

C. What are the chemical specific reporting requirements?

    Pursuant to Sec.  716.20(b)(5), the types of health, and/or 
environmental effects studies that need to be reported and the chemical 
substance grade/purity

[[Page 71565]]

requirements that need to be met or exceeded in individual studies for 
cadmium and cadmium compounds are as follows:
    1. For the category ``cadmium and cadmium compounds'' (defined as 
compounds including any unique chemical substance that contains cadmium 
as part of that chemical's structure), reporting would extend to all 
unpublished health and safety studies generally reportable under 
Sec. Sec.  716.10 and 716.20, for example but not limited to those 
that:
    i. Relate to the cadmium content (either from cadmium or cadmium 
compounds) of consumer products (including the specific cadmium 
compound (defined in Unit III.A.) used in the products such as surface 
coatings and filler), data related to the product formulations, and 
function of the cadmium (e.g., stabilizer, colorant, etc.) in the 
products.
    ii. Relate to the assessment of consumer exposure to cadmium from 
such products (including studies of bioavailability, description of the 
consumer use (e.g., paints used on plastics), physical form of the 
product containing cadmium, method of consumer product application 
(e.g., spray applied, etc.), number of potentially exposed consumers).
    iii. Include data on cadmium migration from products (e.g., 
conducted using acid extraction or saline solution tests).
    iv. Include bio-monitoring data on cadmium presence in tissues.
    v. Focus on route, duration, and frequency of exposure to cadmium 
in products.
    vi. Provide toxicity data on cadmium or cadmium compounds including 
in vitro, in vivo, epidemiological, computational, or other studies on 
effects of exposure to or use of the cadmium-containing product, 
material, or component.
    vii. Discuss the function or use of cadmium or cadmium compounds in 
a product, material or component including typical concentration.
    viii. Include data conducted in compliance with ASTM certification 
standards and studies focusing on the effects of the cadmium or cadmium 
compounds in consumer products on the health and safety of children.
    2. With regard to purity, studies showing any measurable content of 
cadmium or cadmium compounds must be submitted.

D. What are the economic implications of this action?

    EPA's economic analysis for the addition of cadmium and cadmium 
compounds to the Health and Safety Data Reporting rule is entitled 
``TSCA Section 8(d): Economic Impact Analysis for the Addition of 
Manufacturers and Importers of Consumer Products Containing Cadmium and 
Cadmium Compounds From the Sixty-Ninth Report of the TSCA Interagency 
Testing Committee to the Health and Safety Data Reporting Rule'' (Ref. 
10), and can be found in the docket for this rule.
    EPA has estimated that 1,384 firms are subject to the rule and that 
28 firms will have relevant studies to submit to EPA. EPA believes 
firms that are subject to the rule will need to perform various 
activities in order to comply with its requirements. The estimated cost 
of this TSCA section 8(d) rule to firms is approximately $481,000.
    The estimated cost of this TSCA section 8(d) rule to the Federal 
Government is approximately the time of 300 hours. That will amount to 
a cost to the Federal Government of approximately $23,500.

IV. Requesting a Chemical Substance Be Withdrawn From the Final Rule

    As specified in Sec.  716.105(c), EPA may remove a chemical 
substance 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, or the category of chemical 
substances listed in this final rule may submit to EPA reasons for that 
belief. You must submit your request to EPA on or before December 17, 
2012 and in accordance with the instructions provided in Sec.  
716.105(c) and (d), which are briefly summarized here. In addition, to 
ensure proper receipt by EPA, you should identify docket ID number EPA-
HQ-OPPT-2011-0363 on your request and must submit that request in 
accordance with the instructions in Sec.  716.105(c) and (d). If the 
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention, withdraws a chemical substance or the category of chemical 
substances from this TSCA section 8(d) amendment, in accordance with 
Sec.  716.105(c), a Federal Register document announcing this decision 
will be published no later than January 2, 2013.

V. References

    The docket for this final rule has been established under docket ID 
number EPA-HQ-OPPT-2011-0363. The 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 docket for 
this final rule:

    1. EPA. Requests for Information; Confidentiality of Business 
Information; Final Rule. Federal Register (41 FR 36902, September 1, 
1976).
    2. EPA. Integrated Risk Information System. Cadmium (CASRN 7440-
43-9) IRIS Summary. June 1992. Available online at: http://www.epa.gov/iris/subst/0141.htm.
    3. Agency for Toxic Substances and Disease Registry (ATSDR), 
U.S. Department of Health and Human Services (HHS). ATSDR 
Toxicological Profile for Cadmium (Draft). September 2008. Available 
online at: http://www.atsdr.cdc.gov/toxprofiles/tp.asp?id=48&tid=15.
    4. Technology Transfer Network Air Toxics Web Site, Cadmium 
Compounds (A). January 2000. Available online at: http://epa.gov/ttn/atw/hlthef/cadmium.html.
    5. ITC. Sixty-Eighth Report of the TSCA Interagency Testing 
Committee to the Administrator of the Environmental Protection 
Agency; Receipt of Report and Request for Comments; Notice. Federal 
Register (76 FR 46174, August 1, 2011) (FRL-8879-3). Available 
online at: http://www.gpo.gov/fdsys/pkg/FR-2011-08-01/pdf/2011-19414.pdf.
    6. CPSC. Recalls and Product Safety News. Available online at: 
http://www.cpsc.gov/cgi-bin/haz.aspx and select ``Cadmium.''
    7. Standard Consumer Safety Specification for Toy Safety, ASTM 
F-963. Available online at: http://www.astm.org/Standards/F963.htm 
and also available online at: http://www.regulations.gov in docket 
ID number EPA-HQ-OPPT-2011-0363.
    8. EPA. Chemical Information Rules; Additional Automatic 
Reporting; Final Rule. Federal Register (50 FR 34809, August 28, 
1985).
    9. ITC. Sixty-Ninth Report of the TSCA Interagency Testing 
Committee to the Administrator of the Environmental Protection 
Agency; Receipt of Report and Request for Comments; Notice. Federal 
Register (77 FR 30856, May 23, 2012) (FRL-9346-3). Available online 
at: http://www.gpo.gov/fdsys/pkg/FR-2012-05-23/pdf/2012-12493.pdf.
    10. EPA. TSCA Section 8(d): Economic Impact Analysis for the 
Addition of Manufacturers and Importers of Consumer Products 
Containing Cadmium and Cadmium Compounds From the Sixty-Ninth Report 
of the TSCA Interagency Testing Committee to the Health and Safety 
Data Reporting Rule. May 14, 2012.

VI. Statutory and Executive Order Reviews

A. Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), 
entitled ``Regulatory Planning and Review,'' this action is not a 
``significant regulatory action'' and was therefore not reviewed by the 
Office of Management and Budget (OMB) under Executive Orders 12866 and 
13563, entitled ``Improving

[[Page 71566]]

Regulation and Regulatory Review'' (76 FR 3821, January 21, 2011).

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 cadmium and 
cadmium compounds in this final rule will result in a total public 
reporting burden of 7,019 hours. Of that total, an estimated 2,768 
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. 10). As defined by 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

    This final rule is not subject to the Regulatory Flexibility Act 
(RFA), which generally requires an agency to prepare a regulatory 
flexibility analysis for any rule that will have a significant economic 
impact on a substantial number of small entities. RFA applies only to 
rules subject to notice and comment rulemaking requirements under the 
Administrative Procedure Act (APA) or any other statute. This rule is 
not subject to notice and comment requirements under the APA or any 
other statute because although the rule is subject to the APA, the 
Agency has invoked the ``good cause'' exemption under 5 U.S.C. 
553(b)(3)(B), therefore it is not subject to the notice and comment 
requirement.

D. Unfunded Mandates Reform Act

    Pursuant to Title II of the Unfunded Mandates Reform Act, 2 U.S.C. 
1531-1538, 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. Federalism

    Under Executive Order 13132, entitled ``Federalism'' (64 FR 43255, 
August 10, 1999), EPA has determined that this final rule does not have 
federalism implications because it will not 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, as specified 
in the Executive Order. The rule establishes reporting requirements 
that apply to manufacturers (including importers) of a category of 
cadmium and cadmium compounds. The requirements of this final rule are 
not expected to apply to States and localities and would not affect 
State and local governments.

F. Indian Tribal Governments

    This action will not have tribal implications as specified in 
Executive Order 13175, entitled ``Consultation and Coordination With 
Indian Tribal Governments'' (65 FR 67249, November 9, 2000). EPA has 
determined that this final rule will not have tribal implications 
because it will not have substantial direct effects on tribal 
governments, 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, as specified in the 
Executive Order. EPA has no information to indicate that any tribal 
government manufactures or imports the chemical substances covered by 
this action.

G. Protection of Children

    This action is not subject to Executive Order 13045, entitled 
``Protection of Children From Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), because this action is not an 
economically significant regulatory action as defined by Executive 
Order 12866. However, cadmium and cadmium compounds are used in toys 
that are intended for use by children, and thus presents a 
disproportionate risk to children. The agency adequately considered 
children's health issues during rule development.

H. Effect on Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in 
Executive Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply Distribution'' (66 FR 28355, May 22, 
2001), because this action is not an economically significant 
regulatory action as defined by Executive Order 12866, and it is not 
likely to have a significant adverse effect on the supply, 
distribution, or use of energy.

I. Technical Standards

    Because this action will not involve any technical standards, 
section 12(d) of the National Technology Transfer and Advancement Act, 
15 U.S.C. 272 note, does not apply to this action.

J. Environmental Justice

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898, entitled 
``Federal Actions To Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994). This action is expected to have a positive impact on children in 
low-income and minority communities by increasing the amount of cadmium 
health and safety data available to EPA and consumers.

VII. Congressional Review Act

    Pursuant to the Congressional Review Act, 5 U.S.C. 801 et seq., 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

[[Page 71567]]

publication of the rule in the Federal Register. This action 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, Hazardous substances, Health 
and safety studies, Reporting and recordkeeping requirements.

    Dated: November 20, 2012.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.

    Therefore, 40 CFR chapter I is amended as follows:

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. In Sec.  716.21, add new paragraph (a)(9) to read as follows:

Sec.  716.21  Chemical specific reporting requirements.

    (a) * * *
    (9) (i) Reporting requirements for the category ``cadmium and 
cadmium compounds'' apply only to persons that manufacture (including 
import) cadmium or cadmium compounds that have been, or are reasonably 
likely to be, incorporated into consumer products.
    (A) All unpublished health and safety studies generally reportable 
under 40 CFR 716.10 and 716.20 must be reported.
    (B) [Reserved]
    (ii) With regard to purity, studies showing any measurable content 
of cadmium or cadmium compounds in such products must be reported.
    (iii) For the purposes of this paragraph (a)(9), consumer product 
means any product that is sold or made available to consumers for their 
use in or around a permanent or temporary household or residence, in or 
around a school, or in or around recreational areas.
* * * * *
    3. In Sec.  716.120, add, before the entry ``Chlorinated benzenes, 
mono-, di-, tri-, tetra-, and penta-,'' the category ``Cadmium and 
cadmium compounds'' and its entry in alphabetical order to the table in 
paragraph (c) to read as follows:

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

* * * * *
    (c) * * *

----------------------------------------------------------------------------------------------------------------
                                       CAS No.
            Category                (examples for   Special exemptions     Effective date        Sunset date
                                      category)
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Cadmium and cadmium compounds     ................  ..................  January 2, 2013....  March 4, 2013.
 (any unique chemical substance
 that contains cadmium as part
 of that chemical's structure).
Manufacturers (including          ................                Sec.
 importers).                                              716.21(a)(9)
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. 2012-28840 Filed 11-30-12; 8:45 am]
BILLING CODE 6560-50-P