Section 1.0
Authority
This rule is adopted pursuant to
18
V.S.A §
1776.
Section 2.0 Purpose
This rule provides the requirements for the disclosure and
reporting of toxic substances that are intentionally added to a children's
product at a level above the PQL produced by the manufacturer or are present in
a children's product produced by the manufacturer as a contaminant at
concentrations of 100 parts per million or greater. This rule also establishes
the process by which a chemical may be added or removed from the list of
Chemicals of High Concern to Children and the process by which a chemical might
be banned for sale or distribution.
Section 3.0 Scope
This rule applies to manufacturers of children products as
defined by
18 V.S.A. §
1772(7) offered for sale in
the State of Vermont.
Section
4.0 Definitions
Any terms used in this rule but not defined in this section
shall have the meaning found in
18 V.S.A. §
1772. Whenever used in this rule, the
following terms shall be construed as follows:
4.1 "Department" means the Vermont Department
of Health.
4.2 "Commissioner" means
the Commissioner of Health.
4.3
"Chemical of high concern to children" means a chemical listed under section 18
V.S.A. § 1773 or designated by the Department as a chemical of high
concern by this rule.
4.4
"Manufacturer" means any person who manufactures a children's product or whose
name is affixed to a children's product or its packaging or advertising, and
the children's product is sold or offered for sale in Vermont; or any person
who sells a children's product to a retailer in Vermont when the person who
manufactures the children's product or whose name is affixed to the children's
product or its packaging or advertising does not have a presence in the United
States other than the sale or offer for sale of the manufacturer's
products.
4.5 "Practical
quantification limit (PQL)" means the lowest concentration that can be reliably
measured within specified limits of precision, accuracy, representativeness,
completeness, and comparability during routine laboratory operating
conditions.
4.6 "Product component"
means the uniquely identifiable material or coating (including ink or dye) that
is intended to be included as part of a finished children's product.
4.7 "Product model" means the specific
product name used by the retailer or assembler to place the product into the
stream of commerce.
4.8
"Contaminant" means a trace amount of a chemical or chemicals that is
incidental to manufacturing and serves no intended function in the children's
product or component of the children's product, including an unintended
by-product of chemical reactions during the manufacture of the children's
product, a trace impurity in feed-stock, an incompletely reacted chemical
mixture, and a degradation product.
Section 5.0 Chemicals of High Concern to
Children
The following chemicals are designated as chemicals of high
concern to children:
(1) Formaldehyde
and substances that are intentionally added to release formaldehyde, including
5-Bromo-5-nitro-1, 3-dioxane, Bronopol, Diazolidinyl urea, DMDM hydantoin,
Imidazolidinyl urea, Methanol, (phenylmethoxy), Methenamine, Quaternium-15, and
Sodium N-(hydroxymethyl)glycinate
(2) Aniline
(3) N-Nitrosodimethylamine
(4) Benzene
(5) Vinyl chloride
(6) Acetaldehyde
(7) Methylene chloride
(8) Carbon disulfide
(9) Methyl ethyl ketone
(10) 1,1,2,2-Tetrachloroethane
(11) Tetrabromobisphenol A
(12) Bisphenol A
(13) Diethyl phthalate
(14) Dibutyl phthalate
(15) Di-n-hexyl phthalate
(16) Phthalic anhydride
(17) Butyl benzyl phthalate (BBP)
(18) N-Nitrosodiphenylamine
(19) Hexachlorobutadiene
(20) Propyl paraben
(21) Butyl paraben
(22) 2-Aminotoluene
(23) 2,4-Diaminotoluene
(24) Methyl paraben
(25) p-Hydroxybenzoic acid
(26) Ethylbenzene
(27) Styrene
(28) 4-Nonylphenol; 4-NP and its isomer
mixtures including CAS 84852-15-3 and CAS 25154-52-3
(29) para-Chloroaniline
(30) Acrylonitrile
(31) Ethylene glycol
(32) Toluene
(33) Phenol
(34) 2-Methoxyethanol
(35) Ethylene glycol monoethyl ether
(36) Tris (2-chloroethyl)
phosphate
(37) Di-2-ethylhexyl
phthalate
(38) Di-n-octyl phthalate
(DnOP)
(39)
Hexachlorobenzene
(40)
3,3'-Dimethylbenzidine and Dyes Metabolized to 3,3'-Dimethylbenzidine
(41) Ethyl paraben
(42) 1,4-Dioxane
(43) Perchloroethylene
(44) Benzophenone-2 (Bp-2);
2,2',4,4'-Tetrahydroxybenzophenone
(45) 4-tert-Octylphenol; 4
(1,1,3,3-Tetramethylbutyl) phenol
(46) Estragole
(47) 2-Ethylhexanoic acid
(48) Octamethylcyclotetrasiloxane
(49) Benzene, Pentachloro
(50) C.I. Solvent yellow 14
(51) N-Methylpyrrolidone
(52)
2,2',3,3',4,4',5,5',6,6'-Decabromodiphenyl ether; BDE-209
(53) Perfluorooctanyl sulphonic acid and its
salts; PFOS
(54) Phenol, 4-octyl
(55)
2-Ethyl-hexyl-4-methoxycinnamate
(56) Mercury and mercury compounds including
methyl mercury (22967-92-6)
(57)
Molybdenum and molybdenum compounds
(58) Antimony and Antimony compounds
(59) Arsenic and Arsenic
compounds, including arsenic trioxide (1327-53-3) and dimethyl arsenic
(75-60-5)
(60) Cadmium and cadmium
compounds
(61) Cobalt and cobalt
compounds
(62) Tris
(1,3-dichloro-2-propyl) phosphate
(63) Butylated hydroxyanisole; BHA
(64) Hexabromocyclododecane
(65) Diisodecyl phthalate (DIDP)
(66) Diisononyl phthalate (DINP)
(67) Bisphenol S
(68) Dicyclohexyl phthalate
(69) Diisobutyl phthalate
(70) Triphenyl phosphate
(71) Tris (2,3-dibromopropyl) phosphate
(72) Tri-n-butyl phosphate
(73) Dipentyl phthalate
(74) Perfluorooctanoic acid
(75) Bisphenol F
(76) Ethylhexyl diphenyl phosphate
(77) Tricresyl phosphate
(78) Tris (1-chloro-2-propyl) phosphate
(79) Bis (2-ethylhexyl)
tetrabromophthalate
(80) Bis
(chloromethyl) propane-1,3-diyl tetrakis-(2-chloroethyl) bis (phosphate)
(81) Isopropylated triphenyl
phosphate
(82) Decabromodiphenyl
ethane
(83) Short-chain chlorinated
paraffins; Chlorinated paraffins
(84) 2-ethylhexyl-2,3,4,5-tetrabromobenzoate
(85) Lead and lead compounds
(86) Di-(2-methoxyethyl) phthalate
Section 6.0 Disclosure
Notice
6.1 Any notice submitted under
18 V.S.A.
§
1775 shall contain the following
information:
6.1.1 The name of the chemical
used or produced and its chemical abstracts service registry number (
18 V.S.A.
§
1775(b)(1)
);
6.1.2 A description of the
product or product component containing the chemical. This description must
include Global Product Classification (GPC) product brick description;
6.1.3 The brand name, product
model, and the universal product code (UPC) if the product has such a code (
18 V.S.A.
§
1775(b)(2)
);
6.1.4 The amount of the chemical
contained in each unit of the product or product component, reported by weight
or parts per million as authorized by the Commissioner (
18 V.S.A.
§
1775(b)(3)
);
6.1.5 The name and address of
the manufacturer of the children's product and the name, address, and telephone
number of a contact person for the manufacturer (
18 V.S.A.
§
1775(b)(4)
);
6.1.6 Any other information the
manufacturer deems relevant to the appropriate use of the product (
18 V.S.A.
§
1775(b)(5)
);
6.1.7 The function of the
chemical in the product;
Section 7.0 Reporting Ranges
7.1 A manufacturer may report ranges of the
amount of a chemical in a children's product, rather than the exact amount,
provided that if there are multiple chemical values for a given component in a
particular product category, the manufacturer shall use the largest value for
reporting.
7.2 The ranges are as
follows:
7.2.1 Equal to or more than the PQL
but less than 100 ppm (0.01%).
7.2.2 Equal to or more than 100 ppm (0.01%)
but less than 500 ppm (0.05%).
7.2.3 Equal to or more than 500 ppm (0.05%)
but less than 1,000 ppm (0.1%).
7.2.4 Equal to or more than 1,000 (0.1%) ppm
but less than 5,000 ppm (0.5%).
7.2.5 Equal to or more than 5,000 ppm (0.5%)
but less than 10,000 ppm (1.0%).
7.2.6 Equal to or more than 10,000 ppm
(1.0%).
Section
8.0 Reporting Years and Periods
8.1 On or before January 31, 2022, and
annually thereafter, a manufacturer of a children's product offered for sale or
distribution in Vermont shall submit to the Department the notice described in
Section 6.0 of this rule.
Section
9.0 Reporting Between Annual Reporting Periods
9.1 On or before July 31 of every year, a
manufacture of a children's products shall report all products introduced for
sale or distribution in Vermont between January 31 and July 31 of that year in
accordance with Section 6.0 of this rule.
Section 10.0 Evaluation of Chemicals for
Listing as a Chemical of High Concern to Children
10.1 Adding a Chemical The Commissioner may
by rule add additional chemicals to the list of chemicals of high concern to
children, provided that the Commissioner of Health, on the basis of credible,
scientific evidence, including peer-reviewed studies, has determined that a
chemical proposed for addition to the list meets both of the following:
10.1.1 An authoritative governmental entity
or accredited research university has demonstrated that the chemical:
10.1.1.1 Harms the normal development of a
fetus or child or causes other developmental toxicity;
10.1.1.2 Causes cancer, genetic damage, or
reproductive harm;
10.1.1.3
Disrupts the endocrine system;
10.1.1.4 Damages the nervous system, immune
system, or organs or causes other systemic toxicity; or
10.1.1.5 Is a persistent bioaccumulative
toxic as defined in
18 V.S.A. §
1772(14).
10.1.2 The chemical has been found
through:
10.1.2.1 Biomonitoring to be present
in human blood, umbilical cord blood, breast milk, urine, or other bodily
tissues or fluids;
10.1.2.2
Sampling and analysis to be present in household dust, indoor air, drinking
water, or elsewhere in the home environment; or
10.1.2.3 Monitoring to be present in fish,
wildlife, or the natural environment.
10.2 Removing a Chemical
The Commissioner may by rule remove a chemical from the list
of chemicals of high concern to children established under
18 V.S.A. §
1773 and this rule if the Commissioner
determines that the chemical no longer meets the criteria found
therein.
10.3 Process and
Procedure to Add or Remove a Chemical
The Commissioner shall prepare a summary of evidence on the
basis of credible, scientific evidence, including peer-reviewed studies. The
summary shall reference all sources and shall be available to the public. The
Commissioner may consult with the Chemicals of High Concern to Children Working
Group for feedback on the summary of evidence.
Section 11.0 Prioritization for Chemical
Review
11.1 Beginning on July 1, 2017 and
biennially thereafter, the Commissioner of Health shall recommend at least two
chemicals of high concern to children in children's products for review by the
working group.
11.2 The
Commissioner may recommend chemicals for review based on the degree of human
health risks, exposure pathways, and impact on sensitive populations presented
by a chemical of high concern to children, including but not limited to the
following criteria:
11.2.1 Whether the
chemical has been listed as a chemical of concern in statute or regulation or
otherwise restricted by other states, the federal government, other countries,
or other governmental bodies;
11.2.2 The disclosure data submitted to the
Department of Health for the chemical.
Section 12.0 Regulation of Sale or
Distribution
12.1 The Commissioner, after
consultation with the Chemicals of High Concern to Children Working Group, may
adopt a rule to regulate the sale or distribution of a children's product
containing a chemical of high concern to children upon a determination that:
12.1.1 Children may be exposed to a chemical
of high concern to children in the children's product; and
12.1.2 There is a possibility that, due to
the degree of exposure or frequency of exposure of a child to a chemical of
high concern to children in a children's product, exposure could cause or
contribute to one or more of the adverse health impacts listed under subsection
9.1.1.
12.2 In
determining whether children may be exposed to a chemical of high concern in a
children's product, the Commissioner shall review available, credible
information regarding:
12.2.1 The market
presence of the children's product in the State;
12.2.2 The type or occurrence of exposures to
the relevant chemical of high concern to children in the children's product;
12.2.3 The household and workplace
presence of the children's product; or
12.2.4 The potential and likelihood of
exposure of children to the chemical of high concern to children in the
children's product.
12.3
A rule adopted under this section may:
12.3.1
Prohibit the children's product containing the chemical of high concern to
children from sale, offer for sale, or distribution in the State; or
12.3.2 Require that the children's product
containing the chemical of high concern to children be labeled prior to sale,
offer for sale, or distribution in the State.
12.4 In any rule adopted under this
subsection, the Commissioner shall adopt reasonable time frames for
manufacturers, distributors, and retailers to comply with the requirements of
the rules. No prohibition on sale or manufacture of a children's product in the
State shall take effect sooner than two years after the adoption of a rule
adopted under this section unless the Commissioner determines that an earlier
effective date is required to protect human health and the new effective date
is established by rule.
Section
13.0 Notice of Removal of Chemical
A manufacturer that submitted the notice required by law may
at any time submit to the Department notice that a chemical of high concern to
children has been removed from the manufacturer's children's product or that
the manufacturer no longer sells, offers for sale, or distributes in the State
the children's product containing the chemical of high concern to children.
Upon verification of a manufacturer's notice, the Commissioner shall promptly
remove from the Department website any reference to the relevant children's
product of the manufacturer.
Section
14.0 Disclosure of Information on Chemicals of High Concern
Notice of chemical of high concern to children. A
manufacturer of a children's product or a trade association representing a
manufacturer of children's products shall submit notice to the Department for
each chemical of high concern to children in a children's product if a chemical
of high concern to children is:
(1)
intentionally added to a children's product at a level above the PQL produced
by the manufacturer; or
(2) present
in a children's product produced by the manufacturer as a contaminant at a
concentration of 100 parts per million or greater.
