Personal Care Not Likely First Target Of California Consumer Product Regs

A new draft of California’s Safer Consumer Product Regulations could change how the state’s Department of Toxic Substances Control selects priority products for potential reformulation. DTSC may now select products for review only if they contain chemicals of concern that meet new criteria, which may exclude many substances found in personal-care products, according to PCPC’s Tom Myers.

The latest draft of California’s Safer Consumer Product Regulations indicates that personal-care products may not be among the first product categories prioritized for evaluation and possible reformulation with ingredient alternatives, as previously suggested.

The draft regulation, released Jan. 29 by California’s Department of Toxic Substances Control, proposes more in-depth criteria for zeroing in on chemicals of concern, and has been “framed in a way that almost certainly is going to exclude our products,” according to Tom Myers, associate general counsel with the Personal Care Products Council.

PCPC intends to submit comments on the regulation “and will continue advocating at various levels, agency and otherwise, to make changes.” – Associate General Counsel Tom Myers

Under the revised draft, substances would have to appear on existing lists of potentially hazardous chemicals – such as the National Toxicology Program’s 12th Report on Carcinogens or the European Cosmetics Directive’s list of ingredients classified as carcinogens, mutagens and/or reproductive toxicants – to be prioritized as chemicals of concern.

That criterion was similarly described in previous versions of the draft regulation.

However, substances would now also have to meet an additional layer of concern, as identified by various entities across a spectrum of legislative instruments and chemical databases for reasons that may exceed human health and focus more on environmental impact.

For example, substances identified by the state as toxic air contaminants or chemicals identified as priority pollutants under the federal Clean Water Act, may register at this second level of scrutiny.

“So now you have to meet both criteria … and if you examine what the criteria are, it’s less likely those are going to encompass us,” Myers said in a recent interview with “The Rose Sheet.” Chemicals not only have to raise flags due to human exposure and health concerns, but also on account of “environmental issues and significant widespread impact,” he added.

The change is a boon for the personal-care industry, which previously anticipated that personal-care products, and nail products in particular, could be among the first categories targeted to undergo ingredient alternatives analyses and potentially require reformulation (Also see "Nail Care Likely To Face Scrutiny Under California Reg" - HBW Insight, 6 Aug, 2012.).

DTSC will devise a list of up to five priority product/chemical-of-concern combinations 180 days after the regulation is final.

“We had a couple of products that we thought would be first on the hit parade, mostly because of exposure issues,” Myers explained. He accredited the revision to pressure PCPC and other organizations have been putting on DTSC and California Governor Jerry Brown’s office.

“We had a number of high-level folks from our companies that went in there and were very aggressive and talking about how we were being targeted, and that frankly our products should not be among the first to be regulated, if at all, because of the safety profiles that we already have in place and the work that we do to keep our products so safe,” Myers said. “I think that finally resonated, and I think that went a long way to some of the changes that we’re seeing.”

The attorney noted that it will be three years until DTSC releases the next priority products list, which is more likely to draw in personal-care products.

Certified Assessors Requirement Scrapped

From Myers’ point of view, another positive in the latest draft was the elimination of a provision that would have required manufacturers of priority products to hire an outside “certified assessor” to conduct the alternatives analysis required under the regulation.

Eliminating that provision was one of PCPC’s priorities, as it would have been cost-prohibitive for many businesses and potentially jeopardized trade secrets.

The revised draft regulation also includes language to avoid regulatory duplication, which may exempt certain product categories from the regulation altogether, although the details are hazy, according to Myers.

In the last public comment period, PCPC and the Consumer Healthcare Products Association urged DTSC to exempt OTC drug products (Also see "Industry Pushes For OTC Exemption In California’s Green Regs" - HBW Insight, 29 Oct, 2012.).

“If you can show you are regulated by a state, federal or international program which basically addresses the same concerns that would be addressed as a priority product listing, then you can get out” of the California regulation, he said. “The problem with that is it would have to be almost a duplicate of this program in another agency in order to get out.”

DTSC also notes in the draft that California’s regulation does not supersede another agency’s regulations.

“For OTC drugs, which follow a monograph or labeling requirements … you could make the argument that [DTSC] would be superseding FDA’s authority to regulate OTC drugs,” Myers suggested. “I think there are arguments to be made to limit or possibly exempt some of our products, but the likelihood of success is probably limited” as FDA regulations do not take environmental concerns into consideration, unlike the Safer Consumer Product Regulations.

Small Quantities Consideration Nixed

Myers said that industry’s primary disappointment with the draft regulation consists in the sweeping changes made regarding ingredients used in small quantities.

While previous versions of the Safer Consumer Products Regulations called for establishing minimum thresholds for chemicals of concern, which would have exempted priority products containing small amounts of select substances, the latest iteration essentially does away with that (Also see "California Refines Consumer Products Regs, Exempting Trace Contaminants" - HBW Insight, 4 Feb, 2013.).

Instead, DTSC will issue what it calls a “practical quantitation limit” for chemicals of concern only if it deems it necessary.

PCPC is concerned that such limits will be based on the lowest detectable level of individual substances, whereas industry would prefer a de minimis level of 0.1% for each substance, which would “give a lot of certainty to formulators, rather than having some ad hoc [limit] for certain chemicals,” Myers said.

Moreover, having a 0.1% limit would help harmonize regulations on a federal and international level, he noted.

“This was the single biggest change I see that still needs to be pushed on for the agency,” he said.

Advocacy Continues

DTSC will accept comments on the latest iteration of the regulation through Feb. 28.

Myers said that PCPC intends to submit comments, “and will continue advocating at various levels, agency and otherwise, to make changes.”

He also noted that this draft will be the last opportunity for stakeholders to comment on the regulation, “unless [DTSC] really has substantial changes,” and said he expects the final regulation to be issued in April.

As the regulation now stands, DTSC will issue its list of candidate chemicals of concern, and its list of priority product/chemical-of-concern combinations, 30 days and 180 days after the regulation is final, respectively.

Sixty days after the priority products list is published, firms manufacturing priority products that contain the targeted chemicals of concern would need to file their first response with DTSC.