Formulator News August 2, 2017
This email is intended to update you on legislative and regulatory subjects of interest to formulator members of ISSA. In this issue, we cover the following:
1. Final TSCA Framework Rules Published July 20: Greater Role for Formulators
2. ISSA Comments on NYS Proposed Ingredient Disclosure Program
3. Minnesota Cleaning Product Ingredient Disclosure
4. EPA to Examine Worker Exposure to Solvents, Liver Damage
5. Pesticide Registration Bill Heads to Senate Floor
6. Acting EPA Chemicals Chief to Retire, Trump Announces Replacement
7. CleanGredients: A Resource for Safer Chemistry
8. ISSA’s Fall Regulatory Webinar Series
Two of the three Toxic Substances Control Act (TSCA) Framework rules EPA Administrator Pruitt signed June 22, 2017 were published in the July 20 Federal Register. These rules establish important foundational elements that are essential for the EPA in implementing the changes to TSCA brought about by the Lautenberg Chemical Safety Act for the 21st Century (LCSA).
It is important to note that these Framework regulations impact formulators of chemical cleaning products (referred to as “processors” under TSCA as amended by LCSA) in addition to raw material manufacturers, importers, and users of chemical substances. The final rules direct how risk assessments will be conducted, “Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act,” and how EPA will prioritize chemical substances for risk assessments, “Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act.”
The LCSA, enacted in June 2016, which reformed TSCA, requires that risk evaluations determine whether a chemical substance presents an unreasonable risk of injury to health or the environment under “conditions of use” without consideration of costs or other non-risk factors. It also requires EPA to consider unreasonable risks to potentially exposed or susceptible subpopulations.
The final rule on “Procedures for Chemical Risk Evaluation” describes EPA’s process for conducting a risk evaluation including opportunities for public review and comment. The process includes identification of the conditions of use, hazards, exposures, and any potentially exposed or susceptible subpopulations that EPA expects to consider; hazard assessment, risk assessment, risk characterization and peer review.
An important component of the risk evaluation process includes considering the “likely duration, intensity, frequency, and number of exposures under the conditions of use”. This aspect of the risk evaluation will require the cooperation and participation of formulators of chemical cleaning products, aka “processors”.
EPA must make a determination at the end of the process that either: (1) the chemical substance does not present an unreasonable risk of injury to health or the environment under the conditions of use or; (2) that the chemical substances presents an unreasonable risk of injury to health or the environment under the conditions of use, in which case EPA must initiate a Section 6(a) rulemaking to address the risk. In this latter case, the EPA initiated rulemaking may consider the gamut of potential actions including limitations on the use of the chemical, labeling directions and precautionary statements for end use products, etc. depending on the results of the risk evaluations.
EPA also published the notice of availability of guidance regarding third party risk evaluations.
The prioritization rule establishes a risk-based screening process and criteria to designate existing chemical substances as either: “High-Priority Substances” requiring comprehensive risk evaluations, or “Low-Priority Substances” that do not warrant additional risk evaluation. By December 2019, EPA must designate at least 20 substances as High-Priority and at least 20 chemical substances as Low-Priority.
The TSCA Inventory reporting requirements final rule has not yet been published in the Federal Register as of this writing.
In April 2017, the New York State Department of Environmental Conservation (DEC) proposed an ingredient disclosure program for both household and commercial cleaning products that would require such information to be placed on a company website in a manner prescribed by the state.
ISSA submitted comments on the proposal based on input from the membership. Of particular importance, ISSA called upon DEC to provide the industry with up to two years by which to come into compliance as opposed to the current proposed 6 month period the state is proposing as sufficient to come into compliance. ISSA argued that 6 months is a woefully insufficient amount of time to provide industry to comply with the extensive information that DEC has proposed be disclosed in conjunction with ingredient information. ISSA noted that not only is DEC requiring ingredients to be disclosed but a whole host of other information such as product and manufacturer information, functional use of each ingredient, whether ingredient is on a “list of concern”, and any health and environmental impact research conducted.
Moreover, ISSA noted that manufacturers (even small to medium size companies) typically produce an average of 100 or so cleaning product formulations which would be subject to the DEC disclosure requirements. This multiplier effect will significantly increase the amount of time manufacturers will need to comply. In addition, in order to comply, formulators will need to communicate with their raw material suppliers to obtain ingredient information, all of which can take significant time.
The amount of resources, employee time, and general work required to comply with the draft ingredient disclosure requirements will be substantial, and will need far more than the minimal 6 months offered by DEC.
In other comments, ISSA urged DEC to allow manufacturers the option of providing the information required to be disclosed along with their SDSs in lieu of posting to a website. ISSA noted that the SDSs are the main way that this type of information is disseminated to front line worker who are the most exposed to the products and arguably most in need of the information.
ISSA also called upon DEC to:
- Allow private label distributors the option of not divulging the name of their manufacturer/supplier because this information is often considered confidential;
- Permit manufacturers to only disclose the CAS name and not the CAS number;
- Not require manufacturers to disclose the estimated weight by content based on ranges of concentrations, but rather list ingredients in order of predominace.
New York State is expected to finalize the proposed ingredient disclosure program in 2-3 months and publish as final in the fall of 2017.
The list of states that are considering legislation or regulation that would require the disclosure of ingredients in cleaning products continues to grow, with Minnesota entering the fray most recently.
Minnesota has legislation pending in both the House and Senate that would require manufacturers of cleaning products manufactured on or after January 1, 2019 to: 1) disclose each ingredient contained in the product on the product label; 2) post the product ingredients on the manufacturer’s website; and 3) provide the website and page address on the label of the cleaning product along with a statement directing the consumer to the website for a full list of ingredients contained in the product.
Each ingredient shall have an explanation of its purpose for being in the cleaning product formulation on the manufacturer’s website.
Both the House and Senate bills have been referred to committee for further consideration.
EPA will review whether five commonly used solvents may damage liver or kidney function or cause other harms in exposed workers, the general public or people living near sites where the chemicals are made or disposed, according to risk scoping documents the agency released June 22.
The EPA has up to three years to complete its risk evaluations of these five solvents. If the agency determines at any time during those years that a chemical or a particular use poses an unreasonable risk to people or the environment, the agency will craft regulations or take other actions as appropriate to prevent harm. The five solvents are:
- methylene chloride,
- trichloroethylene, and
The EPA said it needed more time to refine its strategy to assess the risks of these chemicals. It invited interested parties to submit additional information on them through Sept. 19.
The Senate Agriculture Committee unanimously approved a pesticide registration bill June 29, supported by the Pesticide Industry Coalition, of which ISSA is a member.
While the legislation provides for a shorter time period in which pesticide registration fees and timelines are locked in, the Pesticide Industry Coalition, including ISSA, continues to support the legislation because it guarantees that the Agency has sufficient resources to process pesticide registrations (including those of disinfectants and sanitizers) in a timely and predictable fashion. This legislative protection is extremely important considering the Trump Administration’s proposed 30% cut to the EPA’s budget.
The Senate Ag Committee passed the Pesticide Registration Enhancement Act (PREA) of 2017 (H.R. 1029) by voice vote. Agriculture, Nutrition and Forestry Chairman Pat Roberts’ (R-Kan.) amendment would roll back the bill’s expiration date from 2023 to 2020—a move to appease environmental and farmworker organizations that make up the coalition supporting the bill. Both Roberts and Sen. Debbie Stabenow (D-Mich.), Agriculture’s ranking member, praised the bipartisan effort to move the bill to the floor.
H.R. 1029 now heads to the Senate floor, then it will return to the House for a vote on the amended bill.
Effective Aug. 24, Wendy Cleland-Hamnett, acting assistant administrator for chemical safety and pollution prevention, announced that she will retire after working at the Environmental Protection Agency for 38 years. Her departure comes as almost all the agency’s top leadership posts remain vacant. The Trump administration has only nominated one assistant administrator—Susan Bodine, for the Office of Enforcement and Compliance Assurance. She has yet to be confirmed by the Senate.
However, the Trump Administration was quick to indicate that it has chosen Michael Dourson as the new head of EPA’s chemical safety and pesticides office. The Office of Chemical Safety and Pollution Prevention is overseeing the implementation of last year’s legislative reforms to the Toxic Substances Control Act made by the Lautenberg Chemical Safety Act (LCSA), which tightens the regulation of new and existing chemicals on the market.
Trump’s announcement about Dourson has received praise from industry groups such as the American Chemistry Council. Trump made his announced his intent to nominate Dourson on July 17. Dourson is currently a professor of environmental health at the University of Cincinnati and founder of the Risk Science Center. Dourson spent 15 years at the Environmental Protection Agency’s offices in Cincinnati, Washington, D.C., and Region 5 headquarters in Chicago under Presidents Ronald Reagan, George H. W. Bush, and Bill Clinton.
After leaving the agency in 1995, he founded Toxicology Excellence for Risk Assessment (TERA), a regulatory and chemical risk analysis firm that became the Risk Science Center when it joined with the University of Cincinnati in 2015.
As a politically appointed position, Dourson must be confirmed by the Senate. As of this writing, no information was available on when the Senate might begin considering Dourson’s nomination.
Since 2006, CleanGredients has supported the Safer Choice program (originally known as Design for the Environment) by providing product formulators access to a database of safer chemical ingredients pre-screened by third-party toxicologists against criteria established by Safer Choice. Because ingredients listed in CleanGredients are already verified as meeting the Safer Choice standard, formulators who use the database don’t have to pay third-party reviewers to review the ingredients again when they are used in a product formulation, and reduce the risk of having a product fail a review for the Safer Choice certification. This resource helps formulators get safer products to market faster and at a lower cost, increasing availability of products with safer ingredients in the marketplace.
CleanGredients recently launched a new website, highlighting the role we play in supporting EPA’s Safer Choice program. We have expanded our site to include a blog and news hub for sharing information about the Safer Choice program, environmental health issues, and the latest developments in green chemistry.
We are also making it easier to find Safer Choice-certified products, starting by providing direct access to the EPA’s product search tool. In the future, we plan to add a product search tool within CleanGredients, which will allow consumers and purchasers to discover Safer Choice-certified products and to learn where to find them.
CleanGredients is proud to support Safer Choice’s work to recognize products with safer ingredients. Our new site will be a community hub for those interested in safer chemistry and looking for information on safer products, so visit us at CleanGredients.org to stay in the loop.
Promotion Extended: ISSA members can save 20% on a new CleanGredients subscription through 8/31/17 using promo code ISSA20. Learn more by visiting CleanGredients.org, or follow us on Twitter at @CleanGredients. CleanGredients is a project of GreenBlue.
ISSA announces its Fall Regulatory Webinar Series exclusively for ISSA members. This series of affordably priced webinars focuses on emerging issues and subjects that are of interest to the commercial cleaning industry.
- $49 per webinar session (ISSA members only)
- $245 for the complete series of six webinars—six programs for the price of five!
When and What: Please see the list below for the schedule of programs and subject matter to be addressed. All webinar programs will be conducted at 11:00 a.m. Central on the dates listed below, and will be recorded so that they can be viewed by attendees at any time shortly after the original broadcast.
- Sept. 26: Ingredient Disclosure for Cleaning Products: A Review of 3 State Initiatives
- Oct. 3: Disinfectant Claims for Emerging Viral Pathogens / Update on GHS
- Oct. 10: What’s New with the Major Ecolabel Programs for the Cleaning Industry
- Oct. 17: Update on Antibacterial Washes and Rubs
- Oct. 24: California: Prop 65 Revisions and Safer Consumer Products Regulations
- Oct. 31: Update on California and State VOC Regulations