Code of Maine Rules
06 - DEPARTMENT OF ENVIRONMENTAL PROTECTION
096 - DEPARTMENT OF ENVIRONMENTAL PROTECTION - GENERAL
Chapter 880 - REGULATION OF CHEMICAL USE IN CHILDREN'S PRODUCTS
Section 096-880-6 - Authority to ban the sale of products containing a priority chemical

Universal Citation: 06 ME Code Rules ยง 096-880-6

Current through 2024-13, March 27, 2024

A. Prerequisites for a ban. The board may adopt rules prohibiting the manufacture, sale or distribution of one or more children's products containing a priority chemical in an amount greater than the de minimis level if the board finds that:

(1) Distribution of the children's product directly or indirectly exposes children and vulnerable populations to the priority chemical; and

(2) One or more safer alternatives to the priority chemical are available at a comparable cost.

Analternative is"available at comparable cost" if it is offered for sale in the U.S. at a price that is affordable as demonstrated by the number of product units sold. In the case of an alternative that is technically feasible but not yet offered for sale in the U.S., "available at comparable cost" means capable of being produced and sold at a price that is not likely to be a barrier to purchase by users of the product. If several available and safer alternatives are identified, the rule may prohibit the sale of children's products that do not contain the safer alternative that is least toxic to human health or least harmful to the environment.

Rules adopted pursuant this section are major substantive rules as defined in 5 MRSA §8071(2)(B) and therefore may be finally adopted by the board only after approval by the Legislature as provided under 5 MRSA §8072. The final rule must specify the effective date of the sales prohibition, which may not be sooner than 12 months after notice of the proposed rule has been published by the Secretary of State as provided under 5 MRSA §8053(5).

B. Assessment of alternatives; scope of review. Indetermining if safer alternatives to one or more specific uses of a priority chemical are available at a comparable cost, the board shall consider all relevant evidence to that effect including, but not limited to, alternatives assessments submitted by product manufacturers, alternatives assessments conducted by or on behalf of the department or other government agencies, and alternatives assessments conducted by non-governmental organizations and educational institutions.

(1) Availability. For the purpose of determining whether an alternative is available at comparable cost, the board shall consider all relevant evidence to that effect including but not limited to:
(a) The extent to which the alternative currently is available in the marketplace;

(b) The affordability of the alternative as demonstrated by sales volumes;

(c) The purchase price differential between the product containing the priority chemical and the alternative; and

(d) In the case of an alternative that is not already offered for sale, information bearing on the ease with which the alternative could be substituted for the use of the priority chemical and introduced into the U.S. market.

The board is not obligated to consider information related to the redesign, retooling or other costs incurred by a product manufacturer to discontinue the use of the priority chemical. The essential inquiry for the board is the cost to consumers to substitute a technically-feasible alternative.

(2) Safety. An alternative is safer if, when compared to a priority chemical that it could replace, the alternative has not been shown to pose the same or greater potential for harm to human health or the environment as the priority chemical. In determining if an alternative chemical is safer, the board shall consider all relevant evidence to that effect including but not limited to:
(a) The propensity of the chemical to be released from the product during use;

(b) The likelihood that children will be exposed to the chemical as a result of its use in the product and the predicted magnitude of that exposure;

(c) The persistence of the chemical and its tendency to bioaccumulate;

(d) The potential human health effects from exposure to the chemical; and

(e) The ecotoxicity of the chemical.

If available safer alternatives are identified, the board may, as resources allow, evaluate the alternatives to identify the alternative or alternatives least toxic to human health or least harmful to the environment.

(3) Presumptions. The board may, inthe absence of persuasive evidence to the contrary:
(a) Presume that an alternative is safer if the alternative does not contain a chemical of concern;

(b) Presumethat an alternative is available if the alternative is sold in the United States;

(c) Presume that an alternative is both safer and available if:
(i) The product containing the priority chemical has been banned by another U.S. state based on the availability of a safer alternative; or

(ii) The product containing the priority chemical is an item of apparel or novelty.

C. Exemptions from sales prohibitions. The manufacturer or distributor of a children's product subject to a prohibition adopted under subsection A may apply for an exemption for one or more specific uses of the priority chemical by filing an application with the commissioner. The exemption application must, at a minimum:

(1) Identify the specific product or products for which the exemption is sought;

(2) Identify the alternatives considered for substitution of the priority chemical;

(3) Explain the basis for concluding that substitution of the alternatives is not technically or economically feasible; and

(4) Set forth the steps that have and will be taken to minimize the use of the priority chemical.

Department staff shall determine whether the application is complete for processing within 15 days after it is received by the department. If the application is determined to be incomplete, staff shall notify the applicant in writing and specify the additional information needed to make complete the application. The commissioner shall deny or grant an exemption request within 60 days after receipt of a complete application.

The commissioner may grant an exemption with or without conditions upon finding that there is a need for the product in which the priority chemical is used and there is no technically or economically feasible alternative to the use of the priority chemical in the product. An exemption may be granted for a term not to exceed 5 years and may be renewed for one or more additional 5-year terms upon written application demonstrating that a technically or economically feasible alternative remains unavailable.

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