Governor Newsom signs legislation to revisit necessity of aquatic toxicity testing

Recent regulatory changes, specifically the Resource Conservation and Recovery Act (RCRA) guidance for hand sanitizers and the new hazardous waste regulations in California, are sparking changes across the industry. Here are a few key takeaways and guidance on how to chart these regulatory waters.

It's important to stay vigilant in understanding and complying with these  regulatory changes. But remember -- we're here to chart these waters with you and for you. Reach out to our team at any time with questions at regulations@smarterx.com  

‍

Understanding RCRA and Hand Sanitizers

The U.S. Environmental Protection Agency (EPA) has revised its stance on the RCRA industrial ethyl alcohol exemption as it relates to alcohol-based hand sanitizers. The previous interpretation treated unused alcohol-based hand sanitizer as regulated hazardous waste but this is now likely to change, with the EPA allowing generators of unused alcohol-based hand sanitizer to consider energy recovery as a disposal path.

• In the wake of possible changes, retailers should confirm their disposal practices comply with TTB and EPA regulations. The Alcohol and Tobacco Tax and Trade Bureau (TTB) regulations apply to recycling of industrial ethyl alcohol. Therefore, retailers should make sure their disposal partners abide by these rules. If unused alcohol-based hand sanitizer is being recycled then the generator must comply with the RCRA legitimacy factors in 40 CFR 260.43.

• For suppliers, make sure to evaluate your disposal process. Unless you are managing unused alcohol-based hand sanitizer as RCRA regulated hazardous waste,  the material must be treated as a valuable commodity when it is under your control. Additionally, you should ensure that your waste hauler understands whether the material is hazardous waste or intended for reclamation. The latest EPA interpretation, published May 5 2023, allows generators of unused alcohol-based hand sanitizer to  consider energy recovery. Reclaimed ethanol can be used as a fuel or fuel additive and can be burned for energy recovery within the U.S., as long as all applicable TTB regulations and RCRA legitimacy factors are complied with throughout the reclamation process. 

‍

Navigating California’s New Hazardous Waste Regulations

In response to California Senate Bill 158, the Department of Toxic Substances Control (DTSC) will now be developing new Hazardous Waste Management Reports and Plans every three years. The bill's primary goals are to establish a baseline understanding of hazardous waste management, identify data gaps, and make plans to fill these gaps.

• With this process change in mind, retailers should take the time to engage with it. You have the opportunity to provide input during the planning process, which may be a valuable chance to express any concerns or potential impacts to business operations. Also, stay updated! Keep abreast of legislative updates, especially regarding potential changes in waste management hierarchy, as it could affect the strategies to reduce hazardous waste generation.

• For suppliers, take the time to align your operations. The new regulations emphasize waste reduction, recycling, and treatment before disposal. Suppliers must ensure their operations align with this hierarchy. Also, participate in and prioritize data collection. As the DTSC seeks to fill data gaps, suppliers may have the opportunity to contribute meaningful data and potentially influence the direction of future waste management strategies in California. And finally, plan for stricter standards. With less than 19 percent of hazardous waste tracked in California classified as hazardous under federal criteria, expect California's regulations to be stricter. Suppliers should be prepared for more stringent rules and broader scopes of hazardous waste identification.

Let’s face it – CPG regulations can be convoluted. They are often (necessarily) filled with complexity and nuance that don’t make it easy to decipher how exactly they may affect you and the products you sell. 

We know how important it is for you to stay up-to-date with anything that could impact your business. That's why we're here to fill you in on some interesting updates that we're keeping a close eye on. These recent updates cover four main areas: DOT PHMSA International Harmonization (HM-215Q), Vermont HB 67, and Washington SB 5144, and MOCRA. So, let's dive in.

DOT PHMSA International Harmonization (HM-215Q)

Get ready for some positive changes: The Department of Transportation's Pipeline and Hazardous Materials Safety Administration (PHMSA) has proposed a rule (HM-215Q) that will make your life easier. The new rule was proposed in May, and is likely to be finalized by EOY. Here's what you need to know:

• Button cell batteries: Good news. You'll still need to test button cell batteries installed in equipment, but you won't have to worry about sharing the Test Summary (TS) report anymore. It's a small change, but it means less paperwork and more streamlined compliance for you.
• Lithium battery markings: Say goodbye to the phone number requirement on the lithium battery mark. This simplification will make labeling lithium batteries easier and removes confusion from the supply chain. 
• PSN and ID8000 updates: There are a few minor updates to the Proper Shipping Name (PSN) and ID8000. These updates will help you properly identify and ship hazardous materials. It's essential to stay informed about these changes to ensure you're on the right track when it comes to shipping regulations.

Vermont HB 67

‍Vermont has some interesting legislation in the works, and it's something you'll want to pay attention to. The legislation was delivered on May 12th and comes with 2025 implementation dates. Here's the lowdown:

• Funding the HHW program: The new law would require manufacturers and brands to step up and fund the Household Hazardous Waste (HHW) program in Vermont.
• Increased responsibility on the consumer for haz-waste vs. non haz-waste: This change could mean that the distinction between Haz-waste and Non-haz-waste would be as important to consumers, waste management entities, recyclers, and brands as it is to Retailers.
• Waste handling fees and brand responsibility: The legislation allows for waste handling fees, which will be redistributed to brands, and is typically based on their market share. Orphaned products (products without a brand owner) would be collectively covered by participating brands. 
• Exemptions and special considerations: The law includes exemptions for certain products like pesticides, cosmetics, drugs, certain paints, and already covered electronics and batteries. Make sure you're aware of these exemptions to avoid any compliance headaches. 

Washington SB 5144

‍Washington has also got some new regulations coming your way. The legislation was signed on May 11th by the governor, with 2027 implementation dates. Here's the scoop:

• Battery stewardship plan: If you are a “producer”of covered batteries or products containing them, you'll need to participate in a state-approved battery stewardship plan. It's all about responsible management and ensuring proper recycling and disposal.
• Who's a producer? The law broadly defines a producer as battery manufacturers, retail brands, third-party brands, licensees of a brand, importers, or anyone selling the product in the state. It's an inclusive, hierarchical definition to ensure accountability throughout the battery supply chain.
• Battery markings and compliance: although coming into force at a later date, “producers” shall supply, and retailers must collect, a certification that the covered batteries have the required "producer" marking along with the battery chemistry. Lawmakers are placing primary responsibility on the producer, but also require due diligence from retailers.

FDA's Modernization of Cosmetics Regulation Act of 2022

‍Although published at the end of 2022, there’s significant regulatory change coming that impacts the cosmetics industry:

• FDA regulations for fragrance allergen rules: The FDA is mandated to promulgate regulations for allergen rules within 18 months of December 29, 2023. Keep an eye out for these regulations to ensure your products comply with the new requirements.
• Fragrance allergen ingredient disclosure: Once the list of fragrance allergens is finalized, brands and manufacturers must disclose these allergens on the cosmetic product label . This means you may see changes in product labeling and information provided to customers.
• Does label disclosure equal FDA disclosure? While label disclosure is an important part of complying with FDA regulations, producers of cosmetic products must also register with the FDA and submit a Cosmetic Product Listing, which includes “...a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient”.  Will this disclosure of information to the FDA be the same information required on the product label? The answer will impact the logistics of information transparency in the supply chain.

Staying informed about regulatory updates doesn't have to be overwhelming. These updates are here to make your life easier. So stay in the loop, adapt your processes as needed, and reach out to our team of experts with questions at any time, and check back next month for more updates. 

Lately, the regulatory spotlight has been shining on one particularly confusing chemical in consumer products: 1,4-dioxane. 

Both California and New York have already issued new guidance targeting 1,4 dioxane. These new restrictions will mean that both retailers and suppliers need to pay attention to where the substance may be, and be ready to confirm that it is not in their products at a certain level.  So, we’ve put together a quick look at the reasons behind the urgency around 1,4 dioxane and some tips for how to stay ahead of the curve.  

1,4 dioxane: What is it? And why does it matter? 

1,4-dioxane is a substance that can be created when making detergents, soaps, and creams, and it’s now considered an environmental contaminant and a probable human carcinogen. 1,4-dioxane contamination can occur rather easily – as a byproduct of the manufacturing processes when making these products. It is also intentionally used at higher concentrations as a solvent in industrial manufacturing processes. Studies have also shown that the harmful substance can easily dissolve in water, which means it could be found in unsafe amounts in drinking water.  

All of this has, naturally, made consumers and regulatory bodies worried about finding it in things they use and its possible effects on our health. However a risk evaluation published by the US EPA in 2020 found no unreasonable risks to consumers or bystanders from any conditions of use, including eight consumer uses of surface cleaners, laundry/dishwashing detergents, and paint/floor lacquer where 1,4-dioxane is present as a byproduct.

Regulatory changes and how to keep up 

While there is still a lot of unknown around the future of 1,4 dioxane, specific new regulations have started to gain traction. The Food and Drug Administration had previously encouraged suppliers to minimize 1,4-dioxane content, but New York has now taken a proactive approach by implementing a restriction on dioxane contamination levels in products. As of December 31, 2022, cleaning and personal care products are limited to 2 parts per million (ppm), while cosmetics are limited to 10 ppm. And the cleaning and personal care limit was set to reduce to 1 ppm by December 31, 2023.

1,4-dioxane has also been getting attention because of the California Cleaning Product Right-To-Know Act of 2017. Under this new regulation, it must be disclosed on a products website as a “nonfunctional constituent” when  it's present at or above 10 parts per million (ppm). Since this chemical is also a carcinogen on the California Proposition 65 list, it might be subject to labeling requirements even below this threshold.

There a few simple - but crucial - steps both suppliers and retailers can take to stay ahead of these changes: 

1. Brush up on which product categories are affected by these bans. You can find product categories that are likely to fall under the ban on the NY State Department of Conservation website. 
2. Suppliers: Be ready with specific evidence proving the dioxane content for your products is below the allowable threshold. If a product uses a “ethoxylated” ingredient (commonly employed in the production of personal care, household care products) it might contain a regulated amount of 1,4 dioxane. Determine which products you have contain these ingredients, so you can narrow down which items you need to obtain evidence for and make sure you have that on-hand. 
3. Retailers: Maintain an open-line of communication with suppliers. Your suppliers know their products’ best and have the information you need to prove that the dioxane levels are below allowable thresholds. 

The NY Dioxane Ban, along with evolving regulatory guidelines, can be confusing to navigate and leave more questions than answers. Lean on your suppliers, retailers and regulatory partners to help translate and prepare for these new guidelines as effectively as possible. 

By staying informed and maintaining close collaboration with your partners, you can successfully navigate these regulations, avoid costly fines or product delays, and provide consumers with safe and transparent choices.