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Developments in State Chemicals Policy:

Identifying and Regulating Priority Chemicals



Oregon’s Toxic-Free Kids Act, enacted in 2015, requires the creation of a list of “high priority chemicals of concern for children” and establishes reporting and other requirements relating to those priority chemicals for manufacturers of children’s products. Oregon Revised Statutes § 431A.250—280. The state has promulgated regulations to implement the law, Oregon Administrative Rules 333-016-2000—2030 and 333-016-2035—2090, and plans to issue additional rules in the future. See Oregon Health Authority’s “Rules and Implementation” webpage.

Designation of Priority Chemicals.  The law requires the Oregon Health Authority (OHA) to compile, and periodically review and revise, a list of “high priority chemicals of concern for children’s health when used in children’s products.” Or. Rev. Stat. § 431A.255.  OHA regulations that became operative on January 1, 2016 establish the list and designate 66 high priority chemicals. Or. Admin. R. 333-016-2020.The law requires OHA to review and revise the list every three years (adding no more than five chemicals per revision period). Or. Rev. Stat. § 431A.255. OHA regulations establish required considerations for adding or removing chemicals from the list. Or. Admin. R. 333-016-2030. As required by the law, a copy of the list is posted on the OHA website, along with the potential health effects of each listed chemical. Or. Rev. Stat. § 431A.255. 

Disclosure of Information on Priority Chemicals. The law requires that when a children’s product (as defined in the law) contains a priority chemical in an amount “at or above a de minimis level,” the product’s manufacturer must provide a biennial notice of the chemical’s presence to OHA. Or. Rev. Stat. § 431A.258.The notice must contain the name, registry number, and amount of priority chemical(s) present in the product; the product category; the function of the chemical(s) in the product; contact information for the manufacturer; and “[a]ny other information that the manufacturer deems relevant to the appropriate use of the children’s product.” Manufacturers providing notice under the law also may submit recommendations to OHA “regarding technical, financial, or logistical support deemed necessary for innovation and green chemistry solutions related to high priority chemical(s).” Or. Rev. Stat. § 431A.258.  

The law’s implementing regulations require manufacturers to submit their first notices no later than January 1, 2018. Or. Admin. R. 333-016-2060. The law provides an exemption from the notice requirement for manufacturers with annual worldwide gross sales of less than $5 million. Or. Rev. Stat. § 431A.268. Additional exemptions may be granted on request if the manufacturer demonstrates that: (1) the priority chemical is only present in trace amounts as a contaminant incidental to the manufacturing process; and (2) a “manufacturing control program” meeting OHA’s minimum standards is in place. Or. Rev. Stat. § 431A.258, Or. Admin. R. 333-016-2070.

Regulation of Priority Chemicals. The law requires, with certain exemptions, that when a priority chemical is present in a mouthable children’s product, a children’s cosmetic, or a product for children under 3, the manufacturer “must remove or make a substitution for the chemical” (or seek a waiver) no later than the date of the third biennial notice. Or. Rev. Stat. § 431A.260. If the manufacturer substitutes another chemical in the product, it is required to submit a hazard assessment explaining how the product is “inherently less hazardous” than before the substitution. When a manufacturer removes a priority chemical from a children’s product without substitution, it must provide notice to OHA that it is no longer using that chemical or a substitute. Or. Rev. Stat. § 431A.263. OHA plans to begin developing rules to implement these provisions in 2019. See Oregon Health Authority’s “Rules and Implementation” webpage.

The law authorizes and OHA regulations establish enforcement mechanisms, including a civil penalty provision. Or. Rev. Stat. § 431A.270, 275; Or. Admin. R. 333-016-2090.The law also requires OHA to submit biennial reports to the state legislature on implementation of the law. Or. Rev. Stat. § 431A.280.


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