Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Rules and Regulations 71561 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

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) (15 U.S.C. 272 note). 

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 

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 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: November 21, 2012. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.479 revise the table in 

paragraph (a)(1) and add alphabetically 

the following new entries to the table in 

paragraph (a)(2). 

The revised and added text read as 

follows: 

§ 180.479 Halosulfuron-methyl; tolerances 

for residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

Cattle, fat ................................ 0 .05 

Cattle, meat ............................ 0 .05 

Cattle, meat byproducts ......... 1 .0 

Goat, fat .................................. 0 .05 

Goat, meat .............................. 0 .05 

Goat, meat byproducts ........... 1 .0 

Hog, meat byproducts ............ 0 .1 

Horse, fat ................................ 0 .05 

Horse, meat ............................ 0 .05 

Horse, meat byproducts ......... 1 .0 

Milk ......................................... 0 .05 

Sheep, fat ............................... 0 .05 

Sheep, meat ........................... 0 .05 

Sheep, meat byproducts ........ 1 .0 

(2) * * * 

Commodity Parts per 

million 

*****

Grass, forage, fodder, and 

hay, group 17, forage ......... 20 

Grass, forage, fodder, and 

hay, group 17, hay .............. 0 .5 

*****

Millet, proso, forage ................ 10 

Millet, proso, grain .................. 0 .01 

Millet, proso, hay .................... 0 .01 

Millet, proso, straw ................. 0 .01 

*****

* * * * * 

[FR Doc. 2012–29105 Filed 11–30–12; 8:45 am] 

BILLING CODE 6560–50–P 

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 

§ 716.105(c) must be received on or 


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71562 Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Rules and Regulations 

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: TSCAHotline@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 § 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 § 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). 


emcdonald on DSK67QTVN1PROD with RULES
Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Rules and Regulations 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 § 716.55. Pursuant 

to § 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 § 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 

§ 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. 


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71564 Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Rules and Regulations 

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 § 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 § 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, 

§ 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 § 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 § 716.65 and according to 

the reporting schedule set forth at 

§ 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 § 716.65 and according to 

the reporting schedule set forth at 

§ 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 

§ 716.65 and according to the reporting 

schedule set forth at § 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 §§ 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 § 716.20(b)(5), the types of 

health, and/or environmental effects 

studies that need to be reported and the 

chemical substance grade/purity 


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Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Rules and Regulations 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 §§ 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 § 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 

§ 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 § 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 

§ 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/cgibin/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 


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71566 Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Rules and Regulations 

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 lowincome 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 


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Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Rules and Regulations 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] 

■ 1. The authority citation for part 716 

continues to read as follows: 

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

■ 2. In § 716.21, add new paragraph 

(a)(9) to read as follows: 

§ 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 § 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: 

§ 716.120 Substances and listed mixtures 

to which this subpart applies. 

* * * * * 

(c) * * * 

Category 

CAS No. 

(examples for 

category) 

Special 

exemptions Effective date Sunset date 

*******

Cadmium and cadmium compounds 

(any unique chemical substance that 

contains cadmium as part of that 

chemical’s structure).

................ ................................ January 2, 2013 ......................... March 4, 2013. 

Manufacturers (including importers) ...... ................ § 716.21(a)(9) 

*******

* * * * * 

[FR Doc. 2012–28840 Filed 11–30–12; 8:45 am] 

BILLING CODE 6560–50–P 


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