Section 096-880-5 - Disclosure of information on priority chemicalsThe 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 §401et 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.
06- 096 C.M.R. ch. 880, § 5