06- 096 C.M.R. ch. 880, § 4

Current through 2024-51, December 18, 2024

Section 096-880-4 - Designation of priority chemicals

A.Purpose of designation. This section authorizes the commissioner to designate one or more chemicals of high concern as a priority chemical. The designation of a priority chemical serves one or more of the following purposes:

(1) To facilitate the gathering of information on the use of the chemical in children's products and the extent to which children may be exposed to the chemical as a result of that usage;

(2) To facilitate the gathering of information on the safety and availability of alternatives to use of the chemical in children's products; and

(3) To facilitate the consideration of a ban on the sale of children's products to which the priority chemical has been intentionally added when safer alternatives are available.

The designation of a priority chemical does not constitute a determination that the designated chemical poses a greater risk to children than other chemicals on the list of chemicals of high concern. The commissioner may designate any chemical on the list of chemicals of high concern as a priority if at least one of the criteria under paragraph B(2) is met.

B.Prerequisites for designation. The commissioner may designate a priority chemical if the commissioner finds there is credible scientific evidence, in concurrence with the Maine CDC, that:

(1) The chemical appears on the list of chemicals of high concern published by the department pursuant to 38 MRSA §1693 (see section 2 of this chapter); and

(2) One or more of the following criteria are met:

(a) The chemical has been found through biomonitoring to be present in human blood, including umbilical cord blood, breast milk, urine or other bodily tissues or fluids;

(b) The chemical has been found through sampling and analysis to be present in household dust, indoor air or, drinking water or elsewhere in the home environment; or

(c) The chemical is present in a consumer product used or present in the home.

C.Scope of review. The department recognizes that all chemicals on the list of chemicals of high concern are likely to meet the prerequisites for designation as priority chemicals. The department further recognizes that the resources available to the department to investigate priority chemicals are limited. When determining whether to designate a priority chemical, the commissioner shall consider all available and relevant evidence related to the need for and appropriateness of regulatory action by the State including but not limited to:

(1) The need for additional information on the use of the chemical in children's product;

(2) The extent to which the chemical is used in children's products and the likelihood that children will be exposed to the chemical as a result of its presence in children's products;

(3) The need for information on the availability and safety of alternatives to the chemical;

(4) Whether regulatory action is necessary and appropriate in light of actions taken or underway with respect to the chemical in other states and jurisdictions; and

(5) Whether the department and Maine CDC have adequate financial and human resources to accomplish the tasks associated with designation of the priority chemical.

D.Designation by rule required. When designating a priority chemical, the commissionershall do so by adoption of a routine technical rule in accordance with the rulemaking requirements of the Maine Administrative Procedures Act, 5 MRSA §§8001 through 8064. The rule, or the basis statement to the rule, must:

NOTE: The term "basis statement" as used in this subsection refers to the written statement explaining the factual and policy basis for the rule. The Maine Administrative Procedures Act requires state agencies to adopt such a statement at the time of adoption of any rule. See 5 MRSA §8052(5).

(1) Identify the chemical and confirm its presence on the list of chemicals of high concern published by the department;

(2) Specify which of the criteria under subsection B(2) are met;

(3) Include findings of fact sufficient to apprise the chemical manufacturer, the chemical user and any interested member of the public of the basis for the commissioner's decision to designate the chemical as a priority chemical;

(4) Specify the information that must be submitted by manufacturers and distributors of children's product that contain the chemical, the basis for requesting the information and the deadline for submission. The commissioner may not specify a deadline that is sooner than 180 calendar days after the effective date of the rule.

NOTE: This rule seeks to minimize the burden of disclosure on product manufacturers and distributors by: i) requiring the department, in the text of the rule designating a priority chemical, to state with specificity the information it seeks from manufacturers and distributors; and ii) authorizing the department, when adopting such a rule, to waive the submission of chemical use information that otherwise would be required under the law [see 38 MRSA §1695(1) ] if it determines the information already is available or otherwise is not needed. The department recognizes that it is unlikely to need the same type and range of information for each priority chemical and therefore intends, by this rule, to enable the scope of the required disclosure to be determined on a chemical by chemical basis, including, if appropriate, a threshold concentration below which reporting will not be required.

06- 096 C.M.R. ch. 880, § 4