Chemical manufacturers, importers, and processors must be aware of the activities of 2017 to be prepared for the 2018 changes or face loss of business
2017 was an active year for the U.S. EPA. Many changes that will impact us in 2018 were started in 2017 or are an outcome of events that occurred in 2017. I would like to take this opportunity to highlight a few of the events that are changing chemicals management in the U.S.
One of the biggest changes in chemicals management was the publication of the FrameworkRules. June was the one-year anniversary of the Toxic Substance Control Act (TSCA) amendment, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA). Also in June, the EPA published three major rules outlining the new chemical evaluation process: updating the TSCA inventory (Inventory Reset); establishing a process and criteria for identifying high and low priority chemicals (Prioritization); and establishing a process for evaluating high priority chemicals (Risk Evaluation). In 2018, the Inventory Reset will be complete, while changes to the Prioritization and Evaluation processes will be ongoing.
According to the legislation, the EPA must identify at least 20 potential high and 20 potential low priority candidates. At least 50% of the high priority chemicals must be selected from the 2014 Update to the TSCA Work Plan. The designation of a chemical as a high priority begins the three-year statutory deadline for completing the risk evaluation. The EPA proposed several prioritization approaches including the processes used to identify chemicalsunder:
The specific approach adopted will influence the future high priority chemicals.
The EPA proposed four new "chemical categories" to the TSCA New Chemicals Program Chemical Categories document last updated in 2010. EPA groups Premanufacture Notice (PMN) chemicals with shared chemical and toxicological properties into categories. The establishment of these categories enables both PMN submitters and EPA reviewers to benefit from the accumulated data and past decisional precedents, streamlining the assessment process for new chemicals by increasing evaluation efficiency and reducing non-essential testing. Establishing these categories has streamlined the process for Agency review of new chemical substances. Categorization aims to When a new substance is identified as being in a category, the chemical is evaluated in the context of any potential health or environmental concerns associated with that category. The four new categories below are proposed to be added to the existing 56 categories:
If the above are added to the list of chemical categories, when submitting a PMN for associated chemicals, notifiers should refer to the Categories document to develop a notification strategy that considers the health or environmental concerns the EPA associates with that category.
The following EPA statement concerning Significant New Use Rules (SNURs) generated much discussion at the December 6 public meeting:
Where the EPA has concerns with reasonably foreseen conditions of use, but not with the intended conditions …the EPA will assess whether those concerns can be addressed through significant new use rules (SNURs).
The EPA's expectation is that SNURs will be effective in addressing concerns for which the EPA previously issued consent orders (CO), will still be protective but will be more efficient. Environmental advocates are concerned about the EPA definition of potential useswhile industry supports the EPA's plans, specifically the need to shorten the PMN reviews. This new direction will have an impact on PMN outcomes in 2018.
Early in the year, the EPA proposed alternative approaches on how to apply "unique identifiers" to confidential chemical identities. A unique identifier is assigned by the EPA when a confidential business information (CBI) claim for chemical identity is approved. One approach ensures any submission on the same chemistry contains the same unique identifier. The other assigns a unique identifier for information submitted by the same person or company, but assigns a different one for submissions by other entities. The EPA has not chosen an option and is still drafting required guidance on generic chemical names. 2018 promises to be another eventful year for the protection of CBI.
In December, the EPA sent a proposed rule establishing revised fees on certain submissions to the Office of Management and Budget (OMB). The EPA plans to release the proposed rule in February and the final rule in September. Industry stressed that the EPA should be mindful not to stifle innovation with high fees for review of new chemicals or confidentiality claims. Please comment on the proposed rule in 2018.
According to the EPA, the PMN backlog experienced following the publication of the LSCA amendment was eliminated in August. Hopefully, this continues to be the case in 2018.
A number of other events occurred over the past year to change our current chemicals management in the U.S. Please join me on March 7 for a webinar where I will discuss in more detail, the above actions and their effects in 2018. We will also discuss state actions, lawsuits challenging parts of the LCSA, definition changes, private actions as prohibited lists and “Who’s Minding the Store” report cards for large retailers, and other topics. I will also include topics discussed at the ChemCon Americas 2018 and Global Chem 2018. Register at: www.intertek.com/knowledge-education/us-tsca-2017-look-back-webinar/
As always, Intertek will be closely monitoring key developments, and will be communicating important opportunities for stakeholder involvement. Intertek offers a range of services to help you navigate your chemicals management and evaluation process including: working with your supply chain, interpreting risk evaluation data and the results of the EPA's risk evaluation. If you have questions about how the regulations may affect your business or for any other human and/or environmental health, scientific, and regulatory services, please contact us.
Today's expert blogger is Rose Passarella. Rose is a Senior Regulatory Manager within the Chemicals Group at Intertek Health, Environmental & Regulatory Services (HERS) with expertise in TSCA and LCSA implementation. Over the last year, she has delivered a series of webinars on the reformed TSCA. All the webinars are available for download and have been designed to provide a brief regulatory overview and provide a "To-Do-List" of actions needed to ensure your business is not negatively impacted. She is well-positioned to help with your chemical management needs due to the unique combination of having a Ph.D. in chemistry, and being a licensed lawyer with extensive experience in the chemical industry.