Hazardous Substances and Articles; Administration and Enforcement Regulations: Corrections to Animal Testing Regulations, 8340-8342 [2018-03916]
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§ 1420.1
Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Rules and Regulations
[Amended]
2. In the second sentence of § 1420.1,
remove the words, ‘‘April 30, 2012’’,
and add in their place ‘‘January 1,
2019’’.
■ 3. Revise § 1420.3(a) to read as
follows:
■
§ 1420.3
ATVs.
Requirements for four-wheel
(a) Each ATV shall comply with all
applicable provisions of the American
National Standard for Four-Wheel AllTerrain Vehicles (ANSI/SVIA 1–2017),
ANSI-approved on June 8, 2017. The
Director of the Federal Register
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in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain a copy
from Specialty Vehicle Institute of
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ext. 3023; www.svia.org. You may
inspect a copy at the Office of the
Secretary, U.S. Consumer Product
Safety Commission, Room 820, 4330
East-West Highway, Bethesda, MD.
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*
*
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Alberta E. Mills,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2018–03904 Filed 2–26–18; 8:45 am]
BILLING CODE 6355–01–P
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
Consumer Product Safety
Commission.
ACTION: Direct final rule.
AGENCY:
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
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SUMMARY:
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19:20 Feb 26, 2018
Jkt 244001
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; athaler@cpsc.gov.
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
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at 16 CFR part 1500 provide the
definitions and test methods used to
determine whether a substance is
‘‘hazardous’’ under the FHSA.
Specifically, § 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
§ 1500.3(c)(2)(i)(A) through (C). We are
amending § 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 § 1500.3, and we are
correcting a reference that appears in
the regulation on method of testing toxic
substances at § 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 § 1500.3(c)(2)(i) when it amended
the animal testing regulations. 77 FR
73293. However, the subsequent
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Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Rules and Regulations
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
§ 1500.3(c)(2)(i) to reinstate the omitted
paragraphs to give specificity to the
definition of ‘‘toxic.’’
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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 § 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
§ 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
‘‘§ 1500.3(c)(1)(ii)(C) and (c)(2)(iii).’’
However, § 1500.3(c)(2)(iii) does not
exist. Accordingly, the Commission is
amending § 1500.40 to correct the
references for testing toxic substances,
which are § 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)
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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
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8341
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]
1. The authority citation for part 1500
is revised to reads as follows:
■
Authority: 15 U.S.C. 1261–1278.
2. Amend § 1500.3 by:
a. Revising paragraph (c)(2)(i); and
b. Adding a sentence to the beginning
of paragraph (c)(3).
The revision and addition read as
follows:
■
■
■
§ 1500.3
Definitions.
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(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
§ 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
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Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Rules and Regulations
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 § 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
§ 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.
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(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:
* * *
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*
*
*
§ 1500.40
[Amended]
3. Amend the last sentence of the
introductory text of § 1500.40 by
removing the citation
‘‘§ 1500.3(c)(1)(ii)(C) and (c)(2)(iii)’’ and
adding in its place ‘‘§ 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
SECURITIES AND EXCHANGE
COMMISSION
17 CFR Parts 270 and 274
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[Release No. IC–33010; File No. S7–03–18]
RIN 3235–AM26
Investment Company Liquidity Risk
Management Programs; Commission
Guidance for In-Kind ETFs
Securities and Exchange
Commission.
Interim final rule; request for
comment; interpretation.
ACTION:
The Securities and Exchange
Commission is adopting an interim final
rule that revises the compliance date for
the requirements of rule 22e–4 for
classification, highly liquid investment
minimum, and board approval, as well
as related reporting requirements of Part
D on Form N–LIQUID and liquidity
disclosures on Form N–PORT under the
Investment Company Act of 1940. The
revised compliance date will be June 1,
2019, for larger entities (revised from
December 1, 2018) and December 1,
2019, for smaller entities (revised from
June 1, 2019). The Commission is not
extending the compliance date for the
other provisions of rule 22e–4 and Form
N–LIQUID, and liquidity-related
changes to Form N–CEN—which remain
December 1, 2018 for larger entities and
June 1, 2019 for smaller entities. The
Commission also is not extending the
compliance date for the liquidity-related
provisions of Form N–1A, which has
already passed. Finally, the Commission
is providing guidance to assist funds
that will not be engaging in full
portfolio classification before the
revised compliance date, and In-Kind
ETFs, which are not required to engage
in full portfolio classification, in
identifying illiquid investments for
purposes of complying with the 15%
illiquid investment limit.
DATES:
Effective Dates: The effective date of
the interim final rule is March 29, 2018.
The effective date for 17 CFR 270.22e–
4 and 270.30b1–10 and the amendments
to Form N–PORT (referenced in 17 CFR
274.150) published at 81 FR 82267
(November 18, 2016) remains January
17, 2017, and the effective date for
amendments to Form N–CEN
(referenced in 17 CFR 274.101)
published at 81 FR 82267 (November
18, 2016) remains June 1, 2018.
Compliance Dates: The compliance
date for 17 CFR 270.22e–4(b)(1)(ii)
except to the extent referenced in 17
CFR 270.22e–4(a)(8),1 17 CFR 270.22e–
4(b)(1)(iii), 17 CFR 270.22e–4(b)(2)(i)
and (iii), certain elements of 17 CFR
270.22e–4(b)(3) related to the delayed
provisions of rule 22e–4, and the
liquidity-related amendments to Form
N–PORT (discussed in section I.C
below) and Part D of Form N–LIQUID
have been extended until June 1, 2019
for larger entities, and December 1, 2019
for smaller entities, as defined in section
I below.
Comment Date: Comments should be
received on or before April 27, 2018.
SUMMARY:
AGENCY:
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18:04 Feb 26, 2018
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1 See
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infra footnote 71.
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Comments may be
submitted by any of the following
methods:
ADDRESSES:
Electronic Comments
• Use the Commission’s internet
comment form (https://www.sec.gov/
rules/interim-final-temp.shtml);
• Send an email to rule-comments@
sec.gov. Please include File Number S7–
03–18 on the subject line; or
Paper Comments
• Send paper comments to Brent J.
Fields, Secretary, Securities and
Exchange Commission, 100 F Street NE,
Washington, DC 20549–1090.
All submissions should refer to File
Number S7–03–18. This file number
should be included on the subject line
if email is used. To help us process and
review your comments more efficiently,
please use only one method. The
Commission will post all comments on
the Commission’s internet website
(https://www.sec.gov/rules/interim-finaltemp.shtml). Comments are also
available for website viewing and
printing in the Commission’s Public
Reference Room, 100 F Street NE,
Washington, DC 20549, on official
business days between the hours of
10:00 a.m. and 3:00 p.m. All comments
received will be posted without change.
Persons submitting comments are
cautioned that we do not redact or edit
personal identifying information from
comment submissions. You should
submit only information that you wish
to make available publicly.
Studies, memoranda, or other
substantive items may be added by the
Commission or staff to the comment file
during this rulemaking. A notification of
the inclusion in the comment file of any
such materials will be made available
on the Commission’s website. To ensure
direct electronic receipt of such
notifications, sign up through the ‘‘Stay
Connected’’ option at www.sec.gov to
receive notifications by email.
FOR FURTHER INFORMATION CONTACT:
Zeena Abdul-Rahman, Senior Counsel,
or Thoreau Bartmann, Senior Special
Counsel, at (202) 551–6792, Division of
Investment Management, Securities and
Exchange Commission, 100 F Street NE,
Washington, DC 20549–8549.
SUPPLEMENTARY INFORMATION: The
Securities and Exchange Commission
(‘‘Commission’’) is extending the
compliance dates associated with
following provisions of rule 22e–4 [17
CFR 270.22e–4]: Rule 22e–4(b)(1)(ii) [17
CFR 270.22e–4(b)(1)(ii)] except to the
extent it is referenced in rule 22e–4(a)(8)
[17 CFR 270.22e–4(a)(8)]; rule 22e–
4(b)(1)(iii) [17 CFR 270.22e–4(b)(1)(iii)];
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Agencies
[Federal Register Volume 83, Number 39 (Tuesday, February 27, 2018)]
[Rules and Regulations]
[Pages 8340-8342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03916]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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