On the Cusp of TSCA Reform, States Continue to Regulate Chemicals
As legislation to reform the Toxic Substances Control Act nears passage in Congress, states continue to enact and implement a diverse array of their own requirements affecting the use of chemicals in products sold within their borders. Some state requirements have a narrow scope limited to particular chemicals or products, while others institute comprehensive regulatory frameworks that govern the use of many chemicals. States continue to adopt new requirements, notwithstanding the expected passage of TSCA legislation that aims to strengthen the federal program for reviewing and regulating chemicals as appropriate.
Two aspects of state chemicals activity deserve particular emphasis. The first is legislative activity. Many state legislative sessions for 2015 have already ended. The attached chart reports on the status of bills that were introduced this year.
The second aspect worth noting is the growing number of state green chemistry laws. These laws authorize state agencies to address a broad number of chemicals through the regulatory process by requiring notification (with an expected impact on suppliers), as well as, in some cases, alternatives analyses and restrictions. In 2014, Vermont joined California, Washington, Maine, and Minnesota by adopting a green chemistry law. In 2015, Oregon also adopted a green chemistry law. Each state green chemistry law is discussed below. First, a summary of the law or its implementing regulations is provided and then recent developments are summarized.
California’s green chemistry law is the most extensive of all. Unlike the others, it is not limited to children’s products but instead extends to all consumer products and their components. Perhaps because of that breadth, the implementing agency, the Department of Toxic Substances Control (DTSC), has been relatively slow to implement the law.
Under A.B. 1879 (passed in 2008), DTCS was required to issue regulations by January 1, 2011, establishing a process by which chemical ingredients in products placed in commerce in California would be identified and prioritized as being chemicals of concern (CoCs). Also by that date, DTSC was required to issue regulations explaining how it would evaluate products containing CoCs in order to limit exposure and/or reduce hazards. DTSC regulations were meant to establish an outline for how the DTSC planned to regulate products, as appropriate, following evaluation.
After prolonged rulemaking, DTSC regulations, termed Safer Consumer Products (SCP) regulations, took effect on October 1, 2013. The regulations apply to all consumer products and their components that are “placed in the stream of commerce in California.” This scope includes sale, use, or offer to sell in California, as a finished product, or as a component of an assembled product.
The SCP regulations outline a regulatory procedure with four key components. First, DTSC identifies a list of CoCs. Second, DTSC identifies priority products containing one or more of these chemicals. Third, responsible entities are required to notify DTSC if they produce, assemble, import, or sell a priority product containing the specified CoC. Responsible entities may be product manufacturers, importers of products, retailers, or assemblers of products. Product manufacturers are primarily responsible for meeting SCP requirements, but if they do not, importers become responsible. If no one else complies on behalf of primary product-CoC combinations, retailers or assemblers will be held responsible for doing so. Fourth, responsible entities are required to submit alternatives analyses to determine what, if any, methods are available to reduce hazards from CoCs in the products they sell into California.
Unless DTSC indicates otherwise, there is no threshold for intentionally-added components, and unintentionally-added components have a threshold of the practical quantitative limit (PQL). To be exempted from the Alternatives Analysis requirement on the basis of a threshold, the responsible entity must file an Alternatives Analysis Threshold Notification with DTSC. DTSC can restrict priority products after reviewing relevant alternatives analyses.
DTSC keeps an updated list of “Candidate Chemicals,” which can be found at on its website. The list currently contains approximately 1,100 chemicals and chemical groups. If all chemicals within a group are counted, the list contains approximately 2,300 candidate chemicals. These chemicals are only designated as a CoC if and when they are the basis for a product being listed as a Priority Product. Priority Products can only be listed through an agency rulemaking under the California Administrative Procedure Act.
DTSC issued a draft initial Priority Products list on March 13, 2014 that included three categories of products:
- Spray polyurethane foam systems containing unreacted diisocyanates;
- Children’s foam padded sleeping products containing tris(1,3-dichloro-2-propyl) phosphate (TDCPP); and
- Paint and varnish strippers, and surface cleaners with methylene chloride.
DTSC previously stated that it planned to initiate rulemaking to codify the draft list in the latter part of 2014, but no proposed rule has yet been published.
In April 2015, DTSC issued a Priority Product Work Plan, which identifies product categories from which the agency will select Priority Products over the next three years. DTSC plans to use screening approaches and prioritization criteria developed by its Green Ribbon Science Panel to select particular products within these categories that will be further investigated for placement on the Priority Products list. DTSC will solicit input from the regulated community throughout this selection process. The seven categories identified in the Work Plan are:
- Beauty, personal care, and hygiene products;
- Building products;
- Household and office furniture, and furnishings;
- Cleaning products;
- Fishing and angling equipment; and
- Office machinery.
DTSC plans to hold workshops in 2015 to discuss the product categories included in the work plan and its process for determining the Priority Products from those categories.
Washington’s green chemistry program is limited to children’s products. It was established pursuant to the Children’s Safe Products Act (2008), which empowered the Department of Ecology (DoE) to produce a list of Chemicals of High Concern to Children (CHCCs). Through regulation, DoE then established a reporting system requiring manufacturers of children’s products containing CHCCs above the relevant threshold to report annually to DoE. The threshold for intentionally-added CHCCs is the PQL, and the threshold for unintentionally-added CHCCs is 100 ppm.
DoE publishes a report compiling all of the CHCC disclosures. The report is searchable by chemical, company, or product, and can be found on DoE’s website.
DOE has a phased-in reporting schedule for manufacturers to follow. This schedule requires different reporting dates for every manufacturer category (divided by size) and every product tier (divided by exposure levels). For example, Medium Manufacturers producing Tier 3 Products and Small Manufacturers producing Tier 2 Products must report in August 2015.
In Maine, the Toxic Chemicals in Children’s Products Law governs the regulation of chemicals in children’s products. The Department of Environmental Protection (DEP) produced a list of “Chemicals of Concern” pursuant to the law, which contains approximately 1,400 compounds. From this list, the DEP, in coordination with Maine Department of Health and Human Services and Maine Center for Disease Control and Prevention, was directed to produce a list of no more than 70 “Chemicals of High Concern” (CHCs). Currently, DEP has identified 49 CHCs.
Upon further review, DEP may designate CHCs as “Priority Chemicals.” Children’s products containing a Priority Chemical are subject to regulation. Maine has designated several chemicals as Priority Chemicals, most recently certain phthalates and formaldehyde: Manufacturers selling children’s products in Maine which contain a Priority Chemical above a threshold amount must notify DEP. Manufacturers only need to report one time. Maine’s threshold amounts are the same as those in Washington: the PQL for intentionally-added chemicals and 100 ppm for unintentionally-added chemicals. DEP has required notification and, in one case, imposed use restrictions for the following Priority Chemicals when used in children’s products sold in the state:
- The sale of reusable food and beverage containers made with BPA is prohibited;
- The sale of baby food packaging and infant formula packaging made with BPA is prohibited; and
- Manufacturers using BPA in toys, child care articles, and tableware sold in Maine must file a report with DEPwithin 30 days of the product’s availability in Maine;
- NP/NPE: manufacturers using NP/NPE in household and commercial cleaning products, cosmetics and personal care products, and home maintenance products sold in Maine must file a report with DEP within 30 days of the product’s availability in Maine;
- Cadmium: manufacturers using cadmium in certain children’s products sold in Maine must file a report with DEPwithin 30 days of the product’s availability in Maine;
- Mercury: manufacturers using mercury in certain children’s products sold in Maine must file a report with DEPwithin 30 days of the product’s availability in Maine;
- Arsenic: manufacturers using arsenic in certain children’s products sold in Maine must file a report with DEP within 30 days of the product’s availability in Maine;
- Any of 4 phthalates (DEHP, DBP, BBP, and DEP): manufacturers using any of 4 phthalates in certain children’s products sold in Maine must file a report with DEP by December 18, 2015, and thereafter within 30 days of the product’s availability in Maine; and
- Formaldehyde: manufacturers using formaldehyde in certain children’s products sold in Maine must file a report with DEP by December 18, 2015, and thereafter within 30 days of the product’s availability in Maine.
Enacted in 2014, Act 188 governs the disclosure, and potential regulation, of toxic chemicals in children’s products in the state of Vermont. It lists 66 “Chemicals of High Concern to Children” (CHCCs). Manufacturers of children’s products containing CHCCs in the state must notify the Department of Health (DoH) by July 1, 2016. The act empowers DoH to add or remove chemicals from the list through rulemaking. Reporting requirements in the act are triggered at the same thresholds as in Maine and Washington.
DoH issued a proposed rule on February 13, 2015, detailing the reporting procedure and the information to be included in manufacturers’ notifications. Under the proposed rule, manufacturers must disclose in their reports any CHCCs in their products sold in the state, the number of particular CHCCs contained in each unit or product, and the function of the CHCC in the product, among other details. The proposed rule allows manufacturers to disclose in their notifications the amounts of CHCCs in a range rather than an exact amount; the ranges to be used in reporting are stipulated in the text of the rule. The same thresholds as in Washington and Maine apply - the PQL for intentionally-added CHCCs and 100 ppm for unintentionally-added CHCCs.
The comment period on the proposed rule ended in March. The next step is for the Legislative Committee on Administrative Rules (LCAR) to decide whether to approve the rule. LCAR is a governmental body, consisting of eight members of Vermont’s General Assembly, that votes to approve, approve with modifications, object to, or extend the eight-month adoption deadline of administrative rules in the state. The draft final rule has yet to be officially filed with LCAR, but when it is, LCAR will have 45 days to make its decision on approval.
Minnesota’s Toxic Free Kids Act (adopted in 2009) is solely a listing statute. It requires the Department of Health (DoH) produce and update two lists of chemicals: a Chemicals of High Concern (CHC) list and a Priority Chemicals list.
DoH is required to review and, if needed, revise the CHC list every three years. The first CHC list was published in 2010, and an update was published on July 1, 2013.
The Priority Chemicals List designates selected CHCs that pose an elevated risk to the public. A CHC must meet one of three technical requirements in order to be added to the Priority Chemicals list:
- It has been found through biomonitoring to be present in human blood, including umbilical cord blood, breast milk, urine, or other bodily tissues or fluids;
- It has been found through sampling and analysis to be present in household dust, indoor air, drinking water, or elsewhere in the home environment; or
- It has been found through monitoring to be present in fish, wildlife, or the natural environment.
The Priority Chemicals List includes the following chemicals:
- Bisphenol A (BPA);
- Decabromodiphenylether (decaBDE);
- Hexabromocyclododecane (HBCD);
- Lead; and
- 3 phthalates (BBP, DBP, and DEHP).
There are no updating requirements for the Priority Chemicals List in the Toxic Free Kids Act.
On July 1, 2013, DoH issued a report on the progress and future plans of the CHC program, in which DoH stated that it was considering the addition of a candidate chemical and a candidate chemical group for the Priority Chemicals list: tris(1, 3-dichloro-2-propyl)phosphate (TDCPP) and nonylphenol, including its ethoxylates. Two years later, DoH has not made a final decision on the designation of these CHCs as Priority Chemicals.
Unlike the green chemistry laws in Washington, Maine, Vermont, and Minnesota, Oregon’s Toxic-Free Kids Act (SB 478) is a reporting statute with a strong regulatory component. It was approved by the Governor on July 27, 2015, and became immediately effective.
The statute requires the Oregon Health Authority (OHA) to produce a list of High Priority Chemicals of Concern (HPCCs) including, at the least, all chemicals on Washington’s Chemicals of High Concern List. The Oregon list must be published by January 1, 2016. Every three years, OHA must revise the list, but it must not add more than 5 new chemicals to the list at a time. The Act requires that, in updating the list, OHA consider which chemicals were added or removed from Washington’s list, which likely means that Oregon’s list will closely track that of Washington.
Manufacturers of children’s products sold in Oregon that contain any HPCC above a threshold amount must submit biennial reports to OHA. The thresholds are the same as those in Washington, Maine, and Vermont. Manufacturers must submit their first reports for use of chemicals included in the January 1, 2016 list by January 1, 2018. A catalog of all disclosure reports will be published, in a searchable form, on OHA’s website.
Unlike the notification requirements under Washington, Maine, Vermont, and Minnesota, in Vermont, the manufacturer must do one of the following on or before submitting the third biennial report: remove the listed chemical from its product, make a substitution for the chemical, or seek a waiver under the Act. This requirement only applies to products that are mountable, marketed for use by or to children less than 3 years of age, or are a children’s cosmetic.
If a manufacturer decides to make a substitution for a listed chemical, it must submit a Hazard Assessment to OHA “that explains how the children’s product and any substitute chemical the children’s product contains, is inherently less hazardous than before the substitution was made.” If a manufacturer decides to remove the listed chemical, it must give notice to OHA that its products no longer contain the chemical above de minimis amounts.
A waiver of the Act’s removal/substitution requirements is available if the manufacturer submits either an adequate Alternatives Assessment or Quantitative Exposure Assessment. An Alternatives Assessment is an analysis “demonstrating that removal of the high priority chemical of concern for children’s health used in children’s products is not financially or technically feasible,” while a Quantitative Exposure Assessment is an analysis “demonstrating that the high priority chemical of concern for children’s health used in children’s products is not reasonably anticipated to result in exposure based upon an analysis of leachability and bioavailability of the high priority chemical of concern for children’s health used in children’s products.” If either of these documents is approved by OHA, a waiver of the removal/substitution requirement is granted.