The manufacturer or distributor of a children's product for
sale in the State that contains a priority chemical in an amount greater than
the de minimis level shall submit the information specified in the rule
designating the priority chemical and any additional information requested by
the commissioner pursuant to subsection D below. The information must be
submitted to the department by the deadline specified in the rule. Submissions
may be made by regular or electronic mail. The requirements of this section do
not apply to a priority chemical that occurs in a product component only as a
contaminant if the manufacturer had in place a manufacturing control program
and exercised due diligence to minimize the presence of the contaminant in the
component, as outlined in
38 MRSA
§1697(11).
A.
Information on chemical use.
The information to be disclosed shall include the following information on
chemical use unless waived by the department in the rule designating the
priority chemical:
(1) A description of the
children's product or products containing the priority chemical;
(2) The number of product units sold or
distributed for sale in the State or nationally during the most recent full
year (fiscal or calendar year is dependent on filer accounting system) prior to
the specified reporting date of the chemical reporting requirement;
(3) The amount of the priority chemical in
each unit of the children's product; and
(4) The function of the chemical in the
children's product.
The department may waive submission of all or part of the
information required under paragraphs (1) through (4) if it determines that
substantially equivalent information already is publicly available, the
specified use is minor in volume or the information otherwise is not
needed.
B.
Supplemental information. The information to be disclosed shall
also include the following supplemental information if specified in the rule
designating the priority chemical or by the commissioner as authorized under
subsection D below:
(1) Information on the
propensity for the chemical to be released from the product during use, the
likelihood of child exposure to the chemical as a result of its use, the
pathways (e.g. inhalation, ingestion) by which exposure could occur and the
predicted magnitude of the exposure;
(2) Information on the extent to which the
chemical is present in the environment or humans; and
(3) If information provided to or obtained by
the department indicates that children or other vulnerable populations are
exposed to a priority chemical in a product as a result of its distribution, an
assessment of the availability, cost, feasibility and performance, including
potential for harm to human health and the environment, of alternatives to the
priority chemical and the reason the priority chemical is used in the
manufacture of the children's product in lieu of identified alternatives. If an
assessment acceptable to the department is not timely submitted, the department
may assess fees as provided under 06-096 CMR
881 to cover the cost of preparing
an independent assessment. An acceptable assessment is one that:
(a) Describes the function of the priority
chemical in the product and list the specific characteristics of the chemical
(e.g., physical or chemical properties, price, availability) that led to its
selection to fulfill that function;
(b) Identifies the specific chemical and
non-chemical alternatives considered in lieu of the priority chemical, and
describes why the priority chemical was selected over each identified
alternative;
(c) Identifies and
describes any known emerging chemical and non-chemical alternatives to use of
the priority chemical in the product and, for each such alternative, provides
the following information:
(i) The status of
research and development;
(ii) The
current barriers to introduction of the alternative into the
marketplace;
(iii) The projected
timeframe for introduction of the alternative into the marketplace;
and
(iv) The advantages and
disadvantages of using the alternative in lieu of the priority chemical,
assuming the alternative is successfully introduced into the
marketplace;
(d)
Identifies the key, distinguishing human health and environmental hazards (or
"endpoints") associated with the priority chemical;
(e) Evaluates the human health and
environmental hazard posed by the priority chemical and each identified
chemical alternative using the GreenScreen[TM] or
other evaluation methodology approved by the department; and
(f) Provides copies of all peer-reviewed
studies or government-generated studies identified through a search of publicly
accessible databases and lists the search terms used. The search must be
conducted for the priority chemical and for each chemical alternative
identified pursuant to subparagraph (b) and (c) and must, at a minimum, include
as search terms the endpoints identified pursuant to subparagraph
(d).
C.
Extension of submission deadline; waiver of disclosure by the
commissioner. The commissioner may extend the deadline established by
rule for submission of information on children's products that contain a
priority chemical if the commissioner determines that more time is needed to
comply with the request or the information is not needed by the original
deadline. The commissioner also may waive submission of all or part of the
information required in the rule designating the priority chemical if the
commissioner subsequently determines that substantially equivalent information
already is publicly available, the specified use is minor in volume as
demonstrated by the total number of products units sold in Maine during the 3
most recent calendar years or the information otherwise is not
needed.
D.
Commissioner
authority to request additional information. Upon review of information
submitted pursuant to a rule designating a priority chemical, the commissioner
may request the manufacturer or distributor of a children's product provide
additional information not specified in the rule, if the commissioner
determines that the information is needed for the department to complete its
evaluation of the priority chemical. The commissioner shall set a deadline for
receipt of such information that is no sooner than 30 days after making the
request.
Within 30 days after making a request for additional
information under this subsection, the commissioner shall:
(1) Arrange for notice of the request to be
published using the most widely available and accessible media for interested
parties; including but not limited to, electronic news publications and the
department sponsored website; and
(2) Mail notice electronically or via postal
carrier to any trade group, professional association, interest group, or other
person who either has notified the commissioner of their interest in the matter
or, in the opinion of the commissioner, is likely to be interested.
The notice must identify the products covered by the request
and must include directions on how manufacturers and distributors of children's
products that contain the priority chemical or other interested persons may
submit information related to the request for consideration by the department.
The deadline for receipt of information may be no sooner than 30 days after the
notice is published.
E.
Compliance options; minimizing
duplicative submissions. A manufacturer or distributor fulfills its
obligation under this section when it:
(1)
Submits the required information;
(2) Relies on information submitted on behalf
of the manufacturer or distributor by a trade association, chemical
manufacturer or other third party provided the information is presented in a
form acceptable to the commissioner; or
(3) Obtains approval from the commissioner to
rely on information submitted by another person.
To the extent practical and appropriate, the commissioner
shall establish procedures to minimize the submission of duplicative
information and shall develop, as appropriate, procedures for the equitable
sharing of the costs of compiling the information and conducting assessments of
alternatives.
F.
Data protection. Records containing chemical use information of
the type listed in subsection A above are presumptively public records under
Maine's Freedom of Access Act ("FOAA"), 1 MRSA §401
et
seq. Any records submitted to the department pursuant to this chapter
that the submitting party believes are not subject to disclosure under FOAA
must be clearly marked as "claimed confidential." Any request to the department
under FOAA seeking records submitted under this chapter and marked as "claimed
confidential" will be processed in accordance with 38 MRSA §1310-B,
subsection 2.
This subsection does not authorize a manufacturer or
distributor to refuse to disclose to the department information required under
this chapter.
NOTE: Therequirement todisclose information on
the use of and exposure to priority chemicals in children's products is
fundamental to the effective study and control of those chemicals, and is a key
feature of the law on Toxic Chemicals in Children's Products. The public
release of chemical use information submitted to the department pursuant to
this requirement furthers the purpose of the law by providing consumers with
more complete information on the products available to them and encourages the
development of safer alternatives. However, records submitted to
the department under this chapter that are either confidential by statute or
otherwise exempt from the definition of "public records" set forth in 1 MRSA
§402 are not subject to public disclosure.
