DTSC Proposes Changes to Candidate Chemicals List – Comments Due November 16th
DTSC has proposed changes to its regulations to update three of the citations to the authoritative lists that comprise its Candidate Chemicals list. Health and Safety Code section 25252 requires DTSC to adopt regulations to establish a process to identify and prioritize those chemicals or chemical ingredients in consumer products that may be considered a Chemical of Concern. This section also requires DTSC to reference and use available information from various sources and identify those sources, including using, to the maximum extent feasible, available information from other nations, governments, and authoritative bodies that have undertaken similar chemical prioritizations processes, so as to leverage the work and costs already incurred by those entities. DTSC originally defined the Candidate Chemical List as Candidate Chemicals that exhibit specific hazard traits and/or environmental or toxicological endpoints and are included in one or more of the 23 authoritative organizations’ lists cited in sections 69502.2(a)(1) and (2) of Title 22 of the CCR that are the basis of the Safer Consumer Products regulations.
DTSC has proposed language changes to its Safer Consumer Products regulations to update three of the citations to the authoritative lists that comprise the Candidate Chemicals list. DTSC proposes to amend Title 22, California Code of Regulations section 69502.2(a)(1) to correct or update citations for three authoritative lists included in the Candidate Chemical List to ensure the authoritative lists used to identify Candidate Chemicals are current, as follows:
1) Amend Section 69502.2(a)(1)(C). This section currently specifies, “chemicals included as Category 1 endocrine disruptors by the European Commission in the candidate list of Substances of Very High Concern accordance with Article 59 of Regulation (EC) 1907/2006.” The references to “chemicals included as Category 1 endocrine disruptors” and the “European Commission” are incorrect. Chemicals with endocrine disrupting properties are included in the European Union candidate list of Substances of Very High Concern on the basis of Article 57(f) for endocrine disrupting properties. The European Union does not use a numerical system to categorize chemicals with endocrine disrupting properties; therefore, the currently cited list does not exist. As a result, DTSC was unable to properly incorporate this list into the Candidate Chemical list. By correcting the original drafting errors, DTSC will be able to incorporate chemicals identified as endocrine disruptors on the list of Substances of Very High Concern into the Candidate Chemical list and also to associate them with the hazard trait of endocrine toxicity for the purposes of the informational Candidate Chemical list. Many of the chemicals on the candidate list of Substances of Very High Concern for endocrine disrupting properties are already incorporated into the Candidate Chemicals list because they appear on one or more of the currently identified authoritative lists. As a result of this correction, DTSC will add the following to the Candidate Chemical list: 1) 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated, 2) 4-nonylphenol, branched and linear, and 3) 4-nonylphenol, branched and linear, ethoxylated, as described on the European Union candidate list of Substances of Very High Concern.
2) Amend Section 69502.2(a)(1)(F). This section currently specifies “chemicals that are identified as ‘known to be’ or ‘reasonably anticipated to be’ a human carcinogen in the 12th Report on Carcinogens, United States Department of Health and Human Services (DHHS), Public Health Service, National Toxicology Program.” On October 2, 2014, DHHS published the 13th Report on Carcinogens. Each biennial report is cumulative, and every new edition replaces the previous report in its entirety. The proposed language updates the reference to the most current version of this report. This proposal does not add new chemicals to DTSC’s Candidate Chemicals list. Three of the four new chemicals added to the 13th edition of this report are already included in DTSC’s Candidate Chemicals list. Two of these chemicals are already associated with the hazard trait of carcinogenicity and the third chemical, 1-bromopropane, will now also be associated with the hazard trait of carcinogenicity in addition to the previously identified hazard traits. The fourth new chemical added to this report is not within the scope of the Safer Consumer Products program because it is solely used as a pesticide.
3) Amend Section 69502.2(a)(1)(G). This section currently specifies, “chemicals included as persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative by the European Commission in the candidate list of Substances of Very High Concern in accordance with Article 59 of Regulation (EC) 1907/2006.” The references to “chemicals included as persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative” and the “European Commission” are incorrect. Persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative chemicals are included in the European Union candidate list of Substances of Very High Concern on the basis of Article 57 (d-f) for persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative properties. The proposed language corrects the original drafting errors. This proposal does not add new chemicals to DTSC’s Candidate Chemicals list or change the way they are listed in the informational list of Candidate Chemicals.
DTSC originally compiled the Candidate Chemicals List from 23 “authoritative lists” identified in the Safer Consumer Products Regulations. The authoritative lists fall into two categories: 1) 15 hazard trait-based lists of chemicals; and 2) eight lists developed based on exposure potential concerns. A chemical that appears on one or more of these lists and that exhibits a “hazard trait and/or an environmental or toxicological endpoint” is a Candidate Chemical. DTSC is required to update the list quarterly to reflect changes in the authoritative lists. The authoritative lists include:
Hazard Trait Lists:
- Prop 65
- EC Annex VI CMR
- EC ED
- IRIS Neurotoxicants
- IRIS Carcinogens
- EC PBT
- Canada PBIT
- EC Annex VI Resp. Sens.
- IARC Carcinogens
- ATSDR Neurotoxicants
- US EPA NWMP PBTs
- NTP OHAT – Repr. Or Dev. Toxicants
- US EPA TRI PBTs
- WA PBTs
- CA NLs
- CA MCLs
- CA TAC’s
- CWA 303(c) and (d)
- OEHHA REL
- CECPB – Priority Chemicals
- OSPAR Priority Actions Part A
- CDC 4th National Exposure Report
Based on existing authoritative lists, DTSC originally established a list of Candidate Chemicals to be used to identify the chemical in a product-chemical combination, which is also known as a Priority Product. Under the SCP regulations, a Candidate Chemical is defined as a chemical that exhibits a “hazard trait and/or an environmental or toxicological endpoint” and is either: found on one or more of the authoritative lists specified in section 69502.2(a); or listed by DTSC using the criteria specified in section 69502.2(b). DTSC must update the Candidate Chemicals list periodically to reflect any changes in the authoritative lists, which are updated by their own authoritative organization (section 69502.3(a)). DTSC originally published a list containing 230 Candidate Chemicals. The original Candidate Chemical list contained approximately 2,300 Candidate Chemicals.
Although DTSC’s publication of the Candidate Chemicals List does not impose immediate reporting or reformulating requirements on the manufacturers of products that contain Candidate Chemicals, the manufacturers should follow this list closely and identify the chemicals on the list that are ingredients or components in products that are covered by the regulation. The manufacturer will be required to notify DTSC, conduct alternatives analyses, etc., when DTSC designates a Candidate Chemical as Chemical of Concern (when it is the basis for a product being listed as a Priority Product). This process of listing a Priority Product with a Chemical of Concern (pursuant to section 69503.5) requires a public rulemaking process under the APA, during which time manufacturers and the public can weigh in.
The proposed amendments will result in three additions to the current Candidate Chemical list. The Candidate Chemicals list changes when there are changes in the authoritative lists. DTSC reviews and updates the informational list quarterly to reflect such changes. Two of the authoritative lists (the 12th Report on Carcinogens, and the Centers for Disease Control 4th National Report) refer to specific versions of published reports. Chemicals that are added to subsequent reports do not become Candidate Chemicals. DTSC may follow the activities of these authoritative organizations and may add subsequent reports only by adopting new regulations.
The rulemaking is in progress and open for comment on CalSAFER until November 16, 2015: https://calsafer.dtsc.ca.gov/Comments/PackageDetail.aspx?PID=1175