83 FR 8340 - Hazardous Substances and Articles; Administration and Enforcement Regulations: Corrections to Animal Testing Regulations

CONSUMER PRODUCT SAFETY COMMISSION

Federal Register Volume 83, Issue 39 (February 27, 2018)

Page Range		8340-8342
FR Document		2018-03916
The Consumer Product Safety Commission (CPSC or Commission) is issuing a direct final rule to correct its animal testing regulations under the Federal Hazardous Substances Act (FHSA). The rule reinserts text that was inadvertently omitted and corrects references.
Federal Register, Volume 83 Issue 39 (Tuesday, February 27, 2018)
[Federal Register Volume 83, Number 39 (Tuesday, February 27, 2018)]
[Rules and Regulations]
[Pages 8340-8342]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03916]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1500

[CPSC Docket No. CPSC-2012-0036]


Hazardous Substances and Articles; Administration and Enforcement 
Regulations: Corrections to Animal Testing Regulations

AGENCY: Consumer Product Safety Commission.

ACTION: Direct final rule.

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SUMMARY: The Consumer Product Safety Commission (CPSC or Commission) is 
issuing a direct final rule to correct its animal testing regulations 
under the Federal Hazardous Substances Act (FHSA). The rule reinserts 
text that was inadvertently omitted and corrects references.

DATES: The rule is effective on April 30, 2018, unless we receive 
significant adverse comment by March 29, 2018. If we receive timely 
significant adverse comment, we will publish notification in the 
Federal Register, withdrawing this direct final rule before its 
effective date.

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2012-
0036, by any of the following methods:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: www.regulations.gov. Follow the instructions for 
submitting comments. The Commission does not accept comments submitted 
by electronic mail (email), except through www.regulations.gov. The 
Commission encourages you to submit electronic comments by using the 
Federal eRulemaking Portal, as described above.
    Written Submissions: Submit written submissions by mail/hand 
delivery/courier to: Office of the Secretary, Consumer Product Safety 
Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; 
telephone (301) 504-7923.
    Instructions: All submissions received must include the agency name 
and docket number for this notice. All comments received may be posted 
without change, including any personal identifiers, contact 
information, or other personal information provided, to: 
www.regulations.gov. Do not submit confidential business information, 
trade secret information, or other sensitive or protected information 
that you do not want to be available to the public. If furnished at 
all, such information should be submitted in writing.
    Docket: For access to the docket to read background documents or 
comments received, go to: www.regulations.gov, and insert the docket 
number CPSC-2012-0036, into the ``Search'' box, and follow the prompts.

FOR FURTHER INFORMATION CONTACT: Alice Thaler, Associate Executive 
Director for Health Sciences, Consumer Product Safety Commission, 5 
Research Place, Rockville, MD 20850; telephone (301) 987-2240; 
[email protected].

SUPPLEMENTARY INFORMATION:

A. Background

    The Federal Hazardous Substances Act (FHSA), 15 U.S.C. 1261-1278, 
requires appropriate cautionary labeling on certain hazardous household 
substances to alert consumers to the potential hazards that a product 
may present. Among the hazards addressed by the FHSA are products that 
are toxic, corrosive, irritants, flammable, combustible, or strong 
sensitizers. The FHSA and the Commission's regulations at 16 CFR part 
1500 provide the definitions and test methods used to determine whether 
a substance is ``hazardous'' under the FHSA. Specifically, Sec.  
1500.3(b) of these regulations restates the statutory definitions that 
are in the FHSA. Section 1500.3(c) interprets, supplements, or provide 
alternatives to the statutory definitions. Section 1500.40 provides the 
method of testing toxic substances.
    On December 10, 2012, the CPSC amended and updated regulations on 
the CPSC's animal testing methods under the FHSA (77 FR 73289). Among 
other things, the amendment to 16 CFR 1500.3 explained that alternative 
test methods exist that avoid, reduce, or refine animal testing to 
determine toxicity. At the same time, the CPSC codified its statement 
of policy on animal testing to reflect new test methods accepted by the 
scientific community, including recommendations of the Interagency 
Coordinating Committee on the Validation of Alternative Methods in a 
new section, 16 CFR 1500.232. (77 FR 73286). Sections 1500.3(c) and 
1500.232 cross-reference each other.
    CPSC staff recently reviewed the animal testing regulations. 
Staff's review showed that when CPSC revised the animal testing 
regulations, the definitions in 16 CFR 1500.3(c)(2)(i), inadvertently 
removed the definition of ``acute toxicity'' (oral, dermal, and 
inhalation). Before the 2012 amendment, this definition appeared at 
Sec.  1500.3(c)(2)(i)(A) through (C). We are amending Sec.  
1500.3(c)(2)(i) to restore the ``acute toxicity'' definition. In 
addition, staff found that two other corrections are needed. As 
explained below, we are reinserting a sentence into the definition of 
``corrosive'' in Sec.  1500.3, and we are correcting a reference that 
appears in the regulation on method of testing toxic substances at 
Sec.  1500.40.

B. Amendments

1. Definition of ``Toxic''

    The FHSA defines the term ``toxic.'' 15 U.S.C. 1261(f). The 
Commission has issued regulations that supplement the FHSA's statutory 
definition under 16 CFR 1500.3(c). Before 2012, the regulatory 
definitions included a definition of ``acute toxicity,'' which provided 
guidance on the toxicity of substances falling in different toxicity 
ranges for oral, dermal, and inhalation exposures. The Commission 
intended to retain those paragraphs in the CFR under Sec.  
1500.3(c)(2)(i) when it amended the animal testing regulations. 77 FR 
73293. However, the subsequent

[[Page 8341]]

versions of the CFR omitted those subparagraphs. These provisions are 
necessary because they give specificity to the definition of ``toxic.'' 
The paragraphs that were omitted included guidance on when a substance 
might be considered for exemption from some or all of the labeling 
requirements of the FHSA. In addition, the omitted provisions provided 
guidance on the toxicity of substances falling within the toxicity 
range of 500 mg and 5 grams per kilogram of body weight. Without this 
text in the CFR, the CPSC cannot reference the testing criteria that 
help to determine acute toxicity. The animal testing policy under 16 
CFR 1500.232(b)(1)(i) also refers to these paragraphs (16 CFR 
1500.3(c)(1) and (2)) to describe the traditional animal testing 
methods.
    Accordingly, the Commission amends Sec.  1500.3(c)(2)(i) to 
reinstate the omitted paragraphs to give specificity to the definition 
of ``toxic.''

2. Interpretation of ``Corrosive''

    Section 1500.3(c)(3) provides a regulatory definition of 
``corrosive'' that supplements the statutory definition of 
``corrosive'' under the FHSA. Before the 2012 amendment of the animal 
testing regulations, 16 CFR 1500.3(c)(3) included a citation to the 
relevant section of the FHSA that defined the term ``corrosive,'' 15 
U.S.C. 1261(h)(2)(i), and a cross-reference to 16 CFR 1500.3(b)(7), 
which restated the statutory definition of ``corrosive.'' However, that 
text was removed in the subsequent editions of the CFR. The Commission 
believes that reinserting that sentence in Sec.  1500.3(c)(3) will help 
clarify what is meant by ``corrosive'' by providing the references to 
the statutory definition under the FHSA. Accordingly, the Commission 
amends Sec.  1500.3(c)(3) to reference the definition of ``corrosive'' 
under 15 U.S.C. 1261(h)(2)(i), as cross-referenced in 16 CFR 
1500.3(b)(7).

3. Method of Testing Toxic Substances

    The method of testing toxic substances for acute dermal toxicity is 
set forth in 16 CFR 1500.40. Currently, the method of testing the toxic 
substances references ``Sec.  1500.3(c)(1)(ii)(C) and (c)(2)(iii).'' 
However, Sec.  1500.3(c)(2)(iii) does not exist. Accordingly, the 
Commission is amending Sec.  1500.40 to correct the references for 
testing toxic substances, which are Sec.  1500.3(c)(1) and (2).

C. Direct Final Rule Process

    The Commission is issuing this rule as a direct final rule. The 
Administrative Procedure Act (APA) generally requires notice and 
comment rulemaking. 5 U.S.C. 553. The direct final rule process is an 
appropriate process for expediting the issuance of non-controversial 
rules. In Recommendation 95-4, the Administrative Conference of the 
United States (ACUS) endorsed direct final rulemaking as an appropriate 
procedure to expedite promulgating rules that are noncontroversial and 
that are not expected to generate significant adverse comment. See 60 
FR 43108 (August 18, 1995). Consistent with the ACUS recommendation, 
the Commission is publishing this rule as a direct final rule because 
we believe the corrections will not be controversial. The rule will not 
impose any new obligations, but rather, will reinstate text that was 
inadvertently omitted and correct references. Therefore, the Commission 
believes this rulemaking is a non-controversial matter that is not 
likely to engender any significant comments.
    Unless we receive a significant adverse comment within 30 days, the 
rule will take effect on April 30, 2018. In accordance with ACUS's 
recommendation, the Commission considers a significant adverse comment 
to be one where the commenter explains why the rule would be 
inappropriate, including an assertion challenging the rule's underlying 
premise or approach, or a claim that the rule would be ineffective or 
unacceptable without change.
    Should the Commission receive significant adverse comment, the 
Commission would withdraw this direct final rule. Depending on the 
comments and other circumstances, the Commission may then incorporate 
the adverse comment into a subsequent direct final rule or publish a 
notice of proposed rulemaking, providing an opportunity for public 
comment.

D. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires that 
agencies review proposed and final rules for their potential economic 
impact on small entities, including small businesses, and prepare 
regulatory flexibility analyses. 5 U.S.C. 603 and 604. When CPSC issued 
the animal testing regulations in December 2012, staff assessed the 
potential effect the regulations would have on small businesses, and 
the Commission certified that the rule would not have a significant 
impact on a substantial number of small entities. 77 FR 73293. The 
corrections to the regulations do not make any substantive changes. 
Therefore, the Commission certifies that the direct final rule will not 
have a significant impact on a substantial number of small entities.

E. Paperwork Reduction Act

    This rule would not impose any information collection or disclosure 
requirements. Accordingly, the rule is not subject to the Paperwork 
Reduction Act, 44 U.S.C. 3501-3520.

F. Environmental Considerations

    This rule makes corrections to regulatory definitions and 
references. As such, the rule will not affect the human environment. 
See 16 CFR 1021.5.

List of Subjects in 16 CFR Part 1500

    Consumer protection, Hazardous substances, Imports, Infants and 
children, Labeling, Law enforcement, Reporting and recordkeeping 
requirements, Toys.

    Accordingly, 16 CFR part 1500 is amended as follows:

PART 1500--[AMENDED]

0
1. The authority citation for part 1500 is revised to reads as follows:

    Authority:  15 U.S.C. 1261-1278.


0
2. Amend Sec.  1500.3 by:
0
a. Revising paragraph (c)(2)(i); and
0
b. Adding a sentence to the beginning of paragraph (c)(3).
    The revision and addition read as follows:


Sec.  1500.3  Definitions.

* * * * *
    (c) * * *
    (2) * * *
    (i) Acute toxicity. Toxic means any substance that produces death 
within 14 days in half or more than half of a group of:
    (A) White rats (each weighing between 200 and 300 grams) when a 
single dose of from 50 milligrams to 5 grams per kilogram of body 
weight is administered orally. Substances falling in the toxicity range 
between 500 milligrams and 5 grams per kilogram of body weight will be 
considered for exemption from some or all of the labeling requirements 
of the act, under Sec.  1500.82, upon a showing that such labeling is 
not needed because of the physical form of the substances (solid, a 
thick plastic, emulsion, etc.), the size or closure of the container, 
human experience with the article, or any other relevant factors;
    (B) White rats (each weighing between 200 and 300 grams) when an 
atmospheric concentration of more than 200 parts per million but not 
more than 20,000 parts per million by volume of gas or vapor, or more 
than 2 but not more than 200 milligrams per liter by

[[Page 8342]]

volume of mist or dust, is inhaled continuously for 1 hour or less, if 
such concentration is likely to be encountered by man when the 
substance is used in any reasonably foreseeable manner; and/or
    (C) Rabbits (each weighing between 2.3 and 3.0 kilograms) when a 
dosage of more than 200 milligrams but not more than 2 grams per 
kilogram of body weight is administered by continuous contact with the 
bare skin for 24 hours by the method described in Sec.  1500.40.
    (D) The number of animals tested shall be sufficient to give a 
statistically significant result and shall be in conformity with good 
pharmacological practices. Toxic also applies to any substance that can 
be labeled as such, based on the outcome of any of the approved test 
methods described in the CPSC's animal testing policy set forth in 
Sec.  1500.232, including data from in vitro or in silico test methods 
that the Commission has approved; or a validated weight-of-evidence 
analysis comprising all of the following that are available: Existing 
human and animal data, structure activity relationships, 
physicochemical properties, and chemical reactivity data.
* * * * *
    (3) The definition of corrosive in section 2(i) of the act 
(restated in paragraph (b)(7) of this section) is interpreted to also 
mean the following: * * *
* * * * *


Sec.  1500.40  [Amended]

0
3. Amend the last sentence of the introductory text of Sec.  1500.40 by 
removing the citation ``Sec.  1500.3(c)(1)(ii)(C) and (c)(2)(iii)'' and 
adding in its place ``Sec.  1500.3(c)(1) and (2).''

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2018-03916 Filed 2-26-18; 8:45 am]
BILLING CODE 6355-01-P
Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Rules and Regulations 8341

versions of the CFR omitted those generally requires notice and comment not have a significant impact on a
subparagraphs. These provisions are rulemaking. 5 U.S.C. 553. The direct substantial number of small entities.
necessary because they give specificity final rule process is an appropriate
E. Paperwork Reduction Act
to the definition of ‘‘toxic.’’ The process for expediting the issuance of
paragraphs that were omitted included non-controversial rules. In This rule would not impose any
guidance on when a substance might be Recommendation 95–4, the information collection or disclosure
considered for exemption from some or Administrative Conference of the requirements. Accordingly, the rule is
all of the labeling requirements of the United States (ACUS) endorsed direct not subject to the Paperwork Reduction
FHSA. In addition, the omitted final rulemaking as an appropriate Act, 44 U.S.C. 3501–3520.
provisions provided guidance on the procedure to expedite promulgating F. Environmental Considerations
toxicity of substances falling within the rules that are noncontroversial and that
toxicity range of 500 mg and 5 grams per are not expected to generate significant This rule makes corrections to
kilogram of body weight. Without this adverse comment. See 60 FR 43108 regulatory definitions and references. As
text in the CFR, the CPSC cannot (August 18, 1995). Consistent with the such, the rule will not affect the human
reference the testing criteria that help to ACUS recommendation, the environment. See 16 CFR 1021.5.
determine acute toxicity. The animal Commission is publishing this rule as a List of Subjects in 16 CFR Part 1500
testing policy under 16 CFR direct final rule because we believe the
1500.232(b)(1)(i) also refers to these corrections will not be controversial. Consumer protection, Hazardous
paragraphs (16 CFR 1500.3(c)(1) and (2)) The rule will not impose any new substances, Imports, Infants and
to describe the traditional animal testing obligations, but rather, will reinstate children, Labeling, Law enforcement,
methods. text that was inadvertently omitted and Reporting and recordkeeping
Accordingly, the Commission amends correct references. Therefore, the requirements, Toys.
§ 1500.3(c)(2)(i) to reinstate the omitted Commission believes this rulemaking is Accordingly, 16 CFR part 1500 is
paragraphs to give specificity to the a non-controversial matter that is not amended as follows:
definition of ‘‘toxic.’’ likely to engender any significant
comments. PART 1500—[AMENDED]
2. Interpretation of ‘‘Corrosive’’ Unless we receive a significant
Section 1500.3(c)(3) provides a ■ 1. The authority citation for part 1500
adverse comment within 30 days, the
regulatory definition of ‘‘corrosive’’ that rule will take effect on April 30, 2018. is revised to reads as follows:
supplements the statutory definition of In accordance with ACUS’s Authority: 15 U.S.C. 1261–1278.
‘‘corrosive’’ under the FHSA. Before the recommendation, the Commission ■ 2. Amend § 1500.3 by:
2012 amendment of the animal testing considers a significant adverse comment ■ a. Revising paragraph (c)(2)(i); and
regulations, 16 CFR 1500.3(c)(3) to be one where the commenter explains ■ b. Adding a sentence to the beginning
included a citation to the relevant why the rule would be inappropriate, of paragraph (c)(3).
section of the FHSA that defined the including an assertion challenging the The revision and addition read as
term ‘‘corrosive,’’ 15 U.S.C. rule’s underlying premise or approach, follows:
1261(h)(2)(i), and a cross-reference to 16 or a claim that the rule would be
CFR 1500.3(b)(7), which restated the ineffective or unacceptable without § 1500.3 Definitions.
statutory definition of ‘‘corrosive.’’ change. * * * * *
However, that text was removed in the Should the Commission receive (c) * * *
subsequent editions of the CFR. The significant adverse comment, the (2) * * *
Commission believes that reinserting Commission would withdraw this direct (i) Acute toxicity. Toxic means any
that sentence in § 1500.3(c)(3) will help final rule. Depending on the comments substance that produces death within 14
clarify what is meant by ‘‘corrosive’’ by and other circumstances, the days in half or more than half of a group
providing the references to the statutory Commission may then incorporate the of:
definition under the FHSA. adverse comment into a subsequent (A) White rats (each weighing
Accordingly, the Commission amends direct final rule or publish a notice of between 200 and 300 grams) when a
§ 1500.3(c)(3) to reference the definition proposed rulemaking, providing an single dose of from 50 milligrams to 5
of ‘‘corrosive’’ under 15 U.S.C. opportunity for public comment. grams per kilogram of body weight is
1261(h)(2)(i), as cross-referenced in 16 administered orally. Substances falling
D. Regulatory Flexibility Act in the toxicity range between 500
CFR 1500.3(b)(7).
The Regulatory Flexibility Act (RFA) milligrams and 5 grams per kilogram of
3. Method of Testing Toxic Substances generally requires that agencies review body weight will be considered for
The method of testing toxic proposed and final rules for their exemption from some or all of the
substances for acute dermal toxicity is potential economic impact on small labeling requirements of the act, under
set forth in 16 CFR 1500.40. Currently, entities, including small businesses, and § 1500.82, upon a showing that such
the method of testing the toxic prepare regulatory flexibility analyses. 5 labeling is not needed because of the
substances references U.S.C. 603 and 604. When CPSC issued physical form of the substances (solid,
‘‘§ 1500.3(c)(1)(ii)(C) and (c)(2)(iii).’’ the animal testing regulations in a thick plastic, emulsion, etc.), the size
However, § 1500.3(c)(2)(iii) does not December 2012, staff assessed the or closure of the container, human
exist. Accordingly, the Commission is potential effect the regulations would experience with the article, or any other
amending § 1500.40 to correct the have on small businesses, and the relevant factors;
Commission certified that the rule (B) White rats (each weighing between
daltland on DSKBBV9HB2PROD with RULES

references for testing toxic substances,
which are § 1500.3(c)(1) and (2). would not have a significant impact on 200 and 300 grams) when an
a substantial number of small entities. atmospheric concentration of more than
C. Direct Final Rule Process 77 FR 73293. The corrections to the 200 parts per million but not more than
The Commission is issuing this rule regulations do not make any substantive 20,000 parts per million by volume of
as a direct final rule. The changes. Therefore, the Commission gas or vapor, or more than 2 but not
Administrative Procedure Act (APA) certifies that the direct final rule will more than 200 milligrams per liter by

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Document Created: 2018-02-27 01:14:39
Document Modified: 2018-02-27 01:14:39
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Direct final rule.
Dates		The rule is effective on April 30, 2018, unless we receive significant adverse comment by March 29, 2018. If we receive timely significant adverse comment, we will publish notification in the Federal Register, withdrawing this direct final rule before its effective date.
Contact		Alice Thaler, Associate Executive Director for Health Sciences, Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; telephone (301) 987-2240; [email protected]
FR Citation		83 FR 8340
CFR Associated		Consumer Protection; Hazardous Substances; Imports; Infants and Children; Labeling; Law Enforcement; Reporting and Recordkeeping Requirements and Toys