82 FR 45268 - Guidance Document on Hazardous Additive, Non-Polymeric Organohalogen Flame Retardants in Certain Consumer Products

CONSUMER PRODUCT SAFETY COMMISSION

Federal Register Volume 82, Issue 187 (September 28, 2017)

Page Range		45268-45269
FR Document		2017-20733

The Commission announces that it has approved a statement that provides guidance for manufacturers, importers, distributors, retailers, and consumers of certain consumer products that may contain harmful organohalogen flame retardants in an additive form. To protect consumers and children from the potential toxic effects of exposure to these chemicals, the Commission recommends that manufacturers of children's products, upholstered furniture sold for use in residences, mattresses (and mattress pads), and plastic casings surrounding electronics refrain from intentionally adding non-polymeric, organohalogen flame retardants (``OFRs'') to their products. Further, the Commission recommends that, before purchasing such products for resale, importers, distributors, and retailers obtain assurances from manufacturers that such products do not contain OFRs. Finally, the Commission recommends that consumers, especially those who are pregnant or with young children, inquire and obtain assurances from retailers that such products do not contain OFRs.

Federal Register, Volume 82 Issue 187 (Thursday, September 28, 2017)

[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Notices]
[Pages 45268-45269]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20733]


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CONSUMER PRODUCT SAFETY COMMISSION

[CPSC Docket No. CPSC-2015-0022]


Guidance Document on Hazardous Additive, Non-Polymeric 
Organohalogen Flame Retardants in Certain Consumer Products

AGENCY: Consumer Product Safety Commission.

ACTION: Guidance document.

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SUMMARY: The Commission announces that it has approved a statement that 
provides guidance for manufacturers, importers, distributors, 
retailers, and consumers of certain consumer products that may contain 
harmful organohalogen flame retardants in an additive form. To protect 
consumers and children from the potential toxic effects of exposure to 
these chemicals, the Commission recommends that manufacturers of 
children's products, upholstered furniture sold for use in residences, 
mattresses (and mattress pads), and plastic casings surrounding 
electronics refrain from intentionally adding non-polymeric, 
organohalogen flame retardants (``OFRs'') to their products. Further, 
the Commission recommends that, before purchasing such products for 
resale, importers, distributors, and retailers obtain assurances from 
manufacturers that such products do not contain OFRs. Finally, the 
Commission recommends that consumers, especially those who are pregnant 
or with young children, inquire and obtain assurances from retailers 
that such products do not contain OFRs.

FOR FURTHER INFORMATION CONTACT: DeWane Ray, Deputy Director, Safety 
Operations, Consumer Product Safety Commission, 4330 East West Highway, 
Bethesda, MD 20814; telephone: (301) 504-7547, or email: [email protected].

SUPPLEMENTARY INFORMATION: The text of the guidance document is as 
follows:

Guidance for Hazardous Additive, Non-Polymeric Organohalogen Flame 
Retardants in Certain Consumer Products

    Summary: The U.S. Consumer Product Safety Commission \1\ issues 
this guidance to manufacturers, importers, distributors, retailers, and 
consumers to protect consumers (particularly children) from exposure to 
additive, non-polymeric organohalogen flame retardants (``OFRs'') \2\ 
found in the following products: (1) Durable infant or toddler 
products, children's toys, child care articles or other children's 
products (other than children's car seats); (2) upholstered furniture 
sold for use in residences; (3) mattresses and mattress pads; and (4) 
plastic casings surrounding electronics.\3\ OFRs, also referred to as 
halogenated flame retardants, typically are added to foams, textiles, 
and polymers before, during or after production in theory to improve 
their resistance to fire. OFRs are not chemically bound to the 
substrate and may be released from the product, thereby leading to 
potential human and environmental exposures. On June 30, 2015, a 
coalition of consumer advocates and health professionals petitioned the 
Commission to declare four categories of consumer products containing 
OFRs to be ``banned hazardous substances'' under the Federal Hazardous 
Substances Act (``FHSA''). The petitioners claim that due to their 
inherent physical-chemical properties, OFRs, among other things, are 
toxic, migrate widely out of products regardless of how the products 
are used, bioaccumulate, and present a serious public health concern. 
On September 20, 2017, the Commission voted to grant the petition to 
initiate rulemaking under

[[Page 45269]]

the FHSA and directed the staff to convene a Chronic Hazard Advisory 
Panel pursuant to the procedures of section 28 of the Consumer Product 
Safety Act (15 U.S.C. 2077) to further study the effects of these OFRs 
as a class of chemicals on consumers' health. In the meantime, based on 
the overwhelming scientific evidence presented to the Commission to 
date, the Commission has serious concerns regarding the potential 
toxicity of OFRs, and the risks of exposure, particularly to vulnerable 
populations, to OFRs, from the four categories of products listed in 
the petition. Accordingly, the Commission requests that manufacturers 
of children's products, furniture, mattresses, and electronics casings 
eliminate the use of such chemicals in these products. The Commission 
also recommends that, before purchasing such products for resale, 
importers, distributors, and retailers obtain assurances from 
manufacturers that such products do not contain OFRs. Finally, the 
Commission recommends that consumers, especially those who are pregnant 
or with young children, inquire and obtain assurances from retailers 
that such products do not contain OFRs.
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    \1\ The Commission voted 3-2 to publish this Guidance Document 
in the Federal Register. Commissioner Robert S. Adler, Commissioner 
Marietta S. Robinson, and Commissioner Elliot F. Kaye voted to 
approve publication of the Guidance Document. Acting Chairman Ann 
Marie Buerkle and Commissioner Joseph P. Mohorovic voted against 
publication of the Guidance Document.
    \2\ For purposes of this guidance, OFRs refers to additive, non-
polymeric chemicals only; it does not include reactive or polymeric 
OFRs.
    \3\ This guidance is not a binding or enforceable rule and would 
not change any person's rights, duties, or obligations under the 
Federal Hazardous Substances Act or any other Act administered by 
the Commission.
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    Hazard: Scientific evidence to date demonstrates that OFRs, when 
used in non-polymeric, additive form, migrate from consumer products, 
leading to widespread human exposure to mixtures of these chemicals. 
Exposures to OFRs occur because of the semi-volatile property of these 
chemicals that results in migration of the chemicals and the chemicals' 
absorption into household dust and other surfaces where they persist in 
the indoor environment. At this time, there is no known way to direct 
consumers to use affected products in a manner that would guarantee 
reducing exposures to the American population to an acceptable level. 
Numerous peer-reviewed, published studies show that the vast majority 
of consumers have measurable quantities of OFRs in their blood. The 
known adverse health effects of these chemicals to consumers include: 
Reproductive impairment (e.g., abnormal gonadal development, reduced 
number of ovarian follicles, reduced sperm count, increased time to 
pregnancy); neurological impacts (e.g., decreased IQ in children, 
impaired memory, learning deficits, altered motor behavior, 
hyperactivity); endocrine disruption and interference with thyroid 
hormone action (potentially contributing to diabetes and obesity); 
genotoxicity; cancer; and immune disorders. These chemicals have a 
disproportionately negative health effect on vulnerable populations, 
including children.
    Guidance: Under the FHSA, 15 U.S.C. 1261(g) and (f)(1)(A), any 
substance or mixture of substances which is toxic, i.e., that has the 
capacity to produce illness through ingestion, inhalation, or 
absorption through any bodily surface, and may cause substantial injury 
or illness during or as a proximate result of customary or reasonably 
foreseeable handing or use is a ``hazardous substance.'' A product 
intended or packaged for household use containing a hazardous substance 
is required to have precautionary labeling under the FHSA (15 U.S.C. 
1261(p)), but if labeling is not adequate to protect against the 
potential hazard, the Commission may declare the product banned. (15 
U.S.C. 1261(q)(1)(B)). If an article intended for use by children is a 
hazardous substance or bears or contains a hazardous substance that is 
susceptible of access by a child to whom the article is entrusted, the 
article is a banned hazardous substance. Id. 1261(q)(1)(A).
    To date, the Commission has not banned household products 
containing OFRs or required precautionary labeling for such products. 
However, on September 20, 2017, based on the overwhelming scientific 
evidence presented to date, the Commission voted to grant the petition 
to initiate rulemaking under the FHSA and directed the staff to convene 
a Chronic Hazard Advisory Panel pursuant to the procedures of section 
28 of the Consumer Product Safety Act (15 U.S.C. 2077) to further study 
the effects of OFRs as a class of chemicals on consumers' health. Much 
of the evidence currently before the Commission suggests OFRs, as a 
class of chemicals, present a serious public health issue. Therefore, 
the Commission has serious concerns regarding the potential toxicity of 
OFRs, and the risks of exposure, particularly to vulnerable 
populations, to OFRs, from the four categories of products listed in 
the petition.
    For these reasons, the Commission considers the use of OFRs in 
children's products, upholstered furniture sold for use in residences, 
mattresses and mattress pads, and plastic casings surrounding 
electronics to be ill-advised and encourages manufacturers to eliminate 
using them in such products. Further, the Commission recommends that, 
before, purchasing such products for resale, importers, distributors, 
and retailers obtain assurances from manufacturers that such products 
do not contain OFRs. Finally, the Commission recommends that consumers, 
especially those who are pregnant or with young children, inquire and 
obtain assurances from retailers that such products do not contain 
OFRs.

Alberta E. Mills,
Acting Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. 2017-20733 Filed 9-27-17; 8:45 am]
BILLING CODE P

45268 Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices

Bicycle Helmets (OMB No. 3041–0127). Total Estimated Annual Burden: FOR FURTHER INFORMATION CONTACT:
In the Federal Register of July 21, 2017 24,800 hours (24,000 hours for testing DeWane Ray, Deputy Director, Safety
(82 FR 33875), the CPSC published a and 800 hours for recordkeeping). Operations, Consumer Product Safety
notice announcing the agency’s intent to General Description of Collection: In Commission, 4330 East West Highway,
seek an extension of approval of this 1998, the Commission issued a safety Bethesda, MD 20814; telephone: (301)
collection of information. CPSC standard for bicycle helmets (16 CFR 504–7547, or email: JRay@cpsc.gov.
received no comments in response to part 1203). The standard includes SUPPLEMENTARY INFORMATION: The text of
that notice. Therefore, by publication of requirements for labeling and the guidance document is as follows:
this notice, the Commission announces instructions. The standard also requires
that CPSC has submitted to the OMB a that manufacturers and importers of Guidance for Hazardous Additive, Non-
request for extension of approval of that bicycle helmets subject to the standard Polymeric Organohalogen Flame
collection of information without issue certificates of compliance based Retardants in Certain Consumer
change. on a reasonable testing program. Every Products
DATES: Written comments on this person issuing certificates of Summary: The U.S. Consumer
request for extension of approval of compliance must maintain certain Product Safety Commission 1 issues this
information collection requirements records. Respondents must comply with guidance to manufacturers, importers,
should be submitted by October 30, the requirements in 16 CFR part 1203 distributors, retailers, and consumers to
2017. for labeling and instructions, testing, protect consumers (particularly
certification, and recordkeeping. children) from exposure to additive,
ADDRESSES: Submit comments about non-polymeric organohalogen flame
this request by email: OIRA_ Alberta E. Mills,
retardants (‘‘OFRs’’) 2 found in the
submission@omb.eop.gov or fax: 202– Acting Secretary, Consumer Product Safety
Commission. following products: (1) Durable infant or
395–6881. Comments by mail should be toddler products, children’s toys, child
sent to the Office of Information and [FR Doc. 2017–20779 Filed 9–27–17; 8:45 am]
care articles or other children’s products
Regulatory Affairs, Attn: OMB Desk BILLING CODE 6355–01–P
(other than children’s car seats); (2)
Officer for the CPSC, Office of upholstered furniture sold for use in
Management and Budget, Room 10235, residences; (3) mattresses and mattress
725 17th Street NW., Washington, DC CONSUMER PRODUCT SAFETY
COMMISSION pads; and (4) plastic casings
20503. In addition, written comments surrounding electronics.3 OFRs, also
that are sent to OMB also should be [CPSC Docket No. CPSC–2015–0022] referred to as halogenated flame
submitted electronically at http:// retardants, typically are added to foams,
www.regulations.gov, under Docket No. Guidance Document on Hazardous textiles, and polymers before, during or
CPSC–2010–0056. Additive, Non-Polymeric after production in theory to improve
FOR FURTHER INFORMATION CONTACT: Organohalogen Flame Retardants in their resistance to fire. OFRs are not
Charu S. Krishnan, Consumer Product Certain Consumer Products chemically bound to the substrate and
Safety Commission, 4330 East West AGENCY: Consumer Product Safety may be released from the product,
Highway, Bethesda, MD 20814; (301) Commission. thereby leading to potential human and
504–7221, or by email to: ckrishnan@ environmental exposures. On June 30,
ACTION: Guidance document.
cpsc.gov. 2015, a coalition of consumer advocates
SUPPLEMENTARY INFORMATION: CPSC has SUMMARY: The Commission announces and health professionals petitioned the
submitted the following currently that it has approved a statement that Commission to declare four categories of
approved collection of information to provides guidance for manufacturers, consumer products containing OFRs to
OMB for extension: importers, distributors, retailers, and be ‘‘banned hazardous substances’’
Title: Safety Standard for Bicycle consumers of certain consumer products under the Federal Hazardous
Helmets. that may contain harmful organohalogen Substances Act (‘‘FHSA’’). The
OMB Number: 3041–0127. flame retardants in an additive form. To petitioners claim that due to their
Type of Review: Renewal of protect consumers and children from inherent physical-chemical properties,
collection. the potential toxic effects of exposure to OFRs, among other things, are toxic,
Frequency of Response: On occasion. these chemicals, the Commission migrate widely out of products
Affected Public: Manufacturers and recommends that manufacturers of regardless of how the products are used,
importers of bicycle helmets. children’s products, upholstered bioaccumulate, and present a serious
Estimated Number of Respondents: 38 furniture sold for use in residences, public health concern. On September
manufacturers and importers will mattresses (and mattress pads), and 20, 2017, the Commission voted to grant
maintain test records of an estimated plastic casings surrounding electronics the petition to initiate rulemaking under
200 models total annually, including refrain from intentionally adding non-
1 The Commission voted 3–2 to publish this
older models and new models. Testing polymeric, organohalogen flame
Guidance Document in the Federal Register.
on bicycle helmets must be conducted retardants (‘‘OFRs’’) to their products. Commissioner Robert S. Adler, Commissioner
for each new production lot and the test Further, the Commission recommends Marietta S. Robinson, and Commissioner Elliot F.
records must be maintained for 3 years. that, before purchasing such products Kaye voted to approve publication of the Guidance
Estimated Time per Response: 200 for resale, importers, distributors, and Document. Acting Chairman Ann Marie Buerkle
and Commissioner Joseph P. Mohorovic voted
hours/model to test 40 new models retailers obtain assurances from against publication of the Guidance Document.
(including new prototypes) and an manufacturers that such products do not 2 For purposes of this guidance, OFRs refers to
estimated 100 hours/model to test new contain OFRs. Finally, the Commission additive, non-polymeric chemicals only; it does not
production lots of 160 older models. recommends that consumers, especially include reactive or polymeric OFRs.
3 This guidance is not a binding or enforceable
Additionally, manufacturers and those who are pregnant or with young
rule and would not change any person’s rights,
importers may require 4 hours annually children, inquire and obtain assurances duties, or obligations under the Federal Hazardous
per model for recordkeeping for from retailers that such products do not Substances Act or any other Act administered by
approximately 200 models. contain OFRs. the Commission.

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Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 45269

the FHSA and directed the staff to disproportionately negative health effect recommends that consumers, especially
convene a Chronic Hazard Advisory on vulnerable populations, including those who are pregnant or with young
Panel pursuant to the procedures of children. children, inquire and obtain assurances
section 28 of the Consumer Product Guidance: Under the FHSA, 15 U.S.C. from retailers that such products do not
Safety Act (15 U.S.C. 2077) to further 1261(g) and (f)(1)(A), any substance or contain OFRs.
study the effects of these OFRs as a class mixture of substances which is toxic,
of chemicals on consumers’ health. In i.e., that has the capacity to produce Alberta E. Mills,
the meantime, based on the illness through ingestion, inhalation, or Acting Secretary, U.S. Consumer Product
overwhelming scientific evidence absorption through any bodily surface, Safety Commission.
presented to the Commission to date, and may cause substantial injury or [FR Doc. 2017–20733 Filed 9–27–17; 8:45 am]
the Commission has serious concerns illness during or as a proximate result BILLING CODE P
regarding the potential toxicity of OFRs, of customary or reasonably foreseeable
and the risks of exposure, particularly to handing or use is a ‘‘hazardous
vulnerable populations, to OFRs, from substance.’’ A product intended or
the four categories of products listed in packaged for household use containing DEPARTMENT OF DEFENSE
the petition. Accordingly, the a hazardous substance is required to
Commission requests that have precautionary labeling under the Department of the Air Force
manufacturers of children’s products, FHSA (15 U.S.C. 1261(p)), but if
furniture, mattresses, and electronics labeling is not adequate to protect Record of Decision for the KC–46 Third
casings eliminate the use of such against the potential hazard, the Main Operating Base (MOB 3)
chemicals in these products. The Commission may declare the product Beddown
Commission also recommends that, banned. (15 U.S.C. 1261(q)(1)(B)). If an
before purchasing such products for article intended for use by children is a AGENCY: Department of the Air Force.
resale, importers, distributors, and hazardous substance or bears or
contains a hazardous substance that is ACTION:Notice of Availability (NOA) of
retailers obtain assurances from a Record of Decision (ROD).
manufacturers that such products do not susceptible of access by a child to whom
contain OFRs. Finally, the Commission the article is entrusted, the article is a
banned hazardous substance. Id. On September 8, 2017, the United
recommends that consumers, especially
1261(q)(1)(A). States Air Force signed the ROD for the
those who are pregnant or with young
To date, the Commission has not KC–46 Third Main Operating Base
children, inquire and obtain assurances
banned household products containing (MOB 3) Beddown. The ROD states the
from retailers that such products do not
OFRs or required precautionary labeling Air Force decision to beddown up to
contain OFRs.
for such products. However, on twelve (12) KC–46 Primary Aerospace
Hazard: Scientific evidence to date September 20, 2017, based on the Vehicles Authroized (PAA) in one
demonstrates that OFRs, when used in overwhelming scientific evidence squadron at Seymor Johnston Air Force
non-polymeric, additive form, migrate presented to date, the Commission Base, where the Air Force Reserve
from consumer products, leading to voted to grant the petition to initiate Command (AFRC) leads the Mobility
widespread human exposure to rulemaking under the FHSA and Air Force Mission.
mixtures of these chemicals. Exposures directed the staff to convene a Chronic
to OFRs occur because of the semi- The decision was based on matters
Hazard Advisory Panel pursuant to the
volatile property of these chemicals that procedures of section 28 of the discussed in the Final Environmental
results in migration of the chemicals Consumer Product Safety Act (15 U.S.C. Impact Statement (FEIS) for the KC–46
and the chemicals’ absorption into 2077) to further study the effects of Third Main Operating Base (MOB 3)
household dust and other surfaces OFRs as a class of chemicals on Beddown (http://www.kc-46a-
where they persist in the indoor consumers’ health. Much of the beddown.com/); contributions from the
environment. At this time, there is no evidence currently before the public and regulatory agencies; and
known way to direct consumers to use Commission suggests OFRs, as a class of other relevant factors. The FEIS was
affected products in a manner that chemicals, present a serious public made available to the public on April
would guarantee reducing exposures to health issue. Therefore, the Commission 14, 2017 through a NOA in the Federal
the American population to an has serious concerns regarding the Register (82 FR 17991) with a 30-day
acceptable level. Numerous peer- potential toxicity of OFRs, and the risks wait period that ended on May 15, 2017.
reviewed, published studies show that of exposure, particularly to vulnerable Authority: This NOA is published
the vast majority of consumers have populations, to OFRs, from the four pursuant to the regulations (40 CFR part
measurable quantities of OFRs in their categories of products listed in the 1506.6) implementing the provisions of
blood. The known adverse health effects petition. the NEPA of 1969 (42 U.S.C. 4321, et
of these chemicals to consumers For these reasons, the Commission seq.) and the Air Force’s Environmental
include: Reproductive impairment (e.g., considers the use of OFRs in children’s Impact Analysis Process (32 CFR parts
abnormal gonadal development, products, upholstered furniture sold for 989.21(b) and 989.24(b)(7)).
reduced number of ovarian follicles, use in residences, mattresses and
reduced sperm count, increased time to mattress pads, and plastic casings FOR FURTHER INFORMATION CONTACT: Mr.
pregnancy); neurological impacts (e.g., surrounding electronics to be ill-advised Hamid Kamalpour, AFCEC/CZN, 2261
decreased IQ in children, impaired and encourages manufacturers to Hughes Ave., Ste. 155, Lackland AFB,
memory, learning deficits, altered motor eliminate using them in such products. TX 78236–9853. Ph: (210) 925–2738.
behavior, hyperactivity); endocrine Further, the Commission recommends
disruption and interference with thyroid that, before, purchasing such products Henry Williams, Jr.,
hormone action (potentially for resale, importers, distributors, and Acting Air Force Federal Register Liaison
contributing to diabetes and obesity); retailers obtain assurances from Officer.
genotoxicity; cancer; and immune manufacturers that such products do not [FR Doc. 2017–20822 Filed 9–27–17; 8:45 am]
disorders. These chemicals have a contain OFRs. Finally, the Commission BILLING CODE 5001–10–P

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Document Created: 2017-09-28 01:32:35
Document Modified: 2017-09-28 01:32:35

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		Notices
Action		Guidance document.
Contact		DeWane Ray, Deputy Director, Safety Operations, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone: (301) 504-7547, or email: [email protected]
FR Citation		82 FR 45268