CK&E Attorneys Lobby California Legislature with PCPC

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On March 20, 2018 Conkle, Kremer & Engel attorneys Eric S. Engel and Aleen Tomassian helped the Personal Care Products Council fulfill part of its mission by organizing and executing an effective lobbying day to advance the legislative interests of the industry.  Led by PCPC Senior Vice President Government Affairs Mike Thompson and PCPC Director of Government Affairs Karin Ross, a group of personal care product industry members, lobbyists and advisors heard presentations by pivotal regulatory agencies and then met with key legislators and their staffs to address issues of importance to the industry.

PCPC Chief Scientist Alex Kowcz seminar to Calif Legislative Staff

The PCPC held a luncheon at which it presented its first Legislator of the Year Awards to congresspersons who have been the most effective in advancing the important interests of both business and consumers in relation to personal care products.  Legislative staff also received an educational presentation from PCPC’s new Chief Scientist, Alex Kowcz, to help bring to Legislators the most current scientific information about issues affecting personal care products.  After a long day of meetings, participants unwound and connected at an informal reception for legislators, the governor’s office and administration officials at Ella, a popular restaurant near the State Capitol.

 

Eric S. Engel and Aleen Tomassian at PCPC Calif Lobby Day Reception

Some of the highlights of the 2018 PCPC California Lobby Day included a presentation by Meredith Williams, Deputy Director of Department of Toxic Substances Control (DTSC), and Rick Brausch, Chief of DTSC’s Policy and Program Support Division, Hazardous Waste Management.  The mission of the DTSC is the Safer Consumer Products (SCP) program, directed toward advancing the design, development and use of products that are chemically safer for people and the environment.  The aim is to reduce toxic chemicals in consumer products and create new business opportunities in green chemistry.

Dr. Williams advised the PCPC group that DTSC’s SCP program intends to focus over the next three years on nail salon products, particularly to assure a safe working environment for salon employees as well as customers, such as by assuring adequate ventilation and safety equipment.  Dr. Williams also noted that Volatile Organic Compounds (VOCs) are not only within the ambit of California’s Air Resources Board (ARB) as to their effect on the environment, but they are also within the scope of DTSC’s authority when regulation of VOCs can meaningfully enhance protection of human health.

On February 8, 2018, DTSC released a draft 2018-2020 Priority Product Work Plan for public review, in which “Beauty, Personal Care and Hygiene Products” are identified as targets for possible regulation.  Of some concern to PCPC, the Priority Product Work Plan includes DTSC’s interest in broad classifications of chemicals without defining exactly which chemicals in what formulations are of concern.  For example, DTSC’s Priority Product Work Plan identifies oxybenzone, BPA, DEA, formaldehyde, phthalates, parabens, triclosan, titanium dioxide, tolulene and VOCs as classes chemicals being considered for possible regulation, but there are a great many specific chemicals, formulations and uses within such classes, and not all of them are likely to be of concern to DTSC.  PCPC expressed its concern that broad classifications can cause confusion among manufacturers and consumers, and unnecessarily inhibit product development and sales.  For example, oxybenzone (aka Benophenone-3) is one of just 16 chemicals approved by the US Food and Drug Administration (FDA) as safe and effective for use as an ultraviolet (UV) filter to achieve broad-spectrum sun protection.  The health benefits of effective UV sunscreens are well documented, but the broad suggestion of “endocrine toxicity” or “dermatoxicity” in DTSC’s identification of oxybenzone is on shaky scientific footing.  Dr. Williams noted that the 2018-2020 Priority Product Work Plan is only in draft form, and that DTSC recognizes the broad nature of the chemical groups identified and is working on identifying specific chemicals of concern rather than entire classes of chemicals.

DTSC’s Richard Brausch spoke of the hazardous waste logistics issues facing the personal care product industry, affecting the entire supply chain from manufacturers to retailers.  The issue often occurs when products are returned from retailers, and questions arise as to whether they may be regarded as hazardous waste if they are no longer considered fit for regular sale, such as when new product labeling is introduced.  Issues can arise as to who has responsibility for proper transportation and disposal of the products, whether by sale in secondary markets, repair or refurbishment, donation to charities or recycling.  It is notable here that improper transportation and disposal has led some local authorities to sue retailers and wholesalers for failing to use hazardous waste transporters.  That in turn has caused retailers to impose anticipatory disposal charges on manufacturers and wholesalers for a wide range of products.  PCPC therefore supports Assembly Member Bill Quirk’s introduction of new legislation, AB 2660, which places the onus on the disposal company to determine the correct method of transportation, as that is not within the expertise expected of retailers.

The overriding hazardous waste concern is that California uses an “aquatic toxicity” (aka “fish kill”) test that is grossly out of alignment with federal law, and which results in most cosmetic products being characterized as hazardous under California law.  The “fish kill” test is exactly like it sounds – it tests only whether quantities of the subject product added to a water tank will kill fathead minnows.  The test is not regarded as especially accurate, notably because high viscosity products that are otherwise harmless can kill the fish by clogging their gills.  Further, the test presents a significant problem for the personal care products industry, which has taken a strong stand against animal testing, so manufacturers generally do not conduct this “fish kill” test on finished products.  PCPC therefore advocates a more modern approach to accomplish the same goal, by use of a more recently developed fish embryo test (FET), in which live fish are not killed.

An interesting side note is that SB 1249 was introduced by Senator Cathleen Galgiani to prohibit importation or retail sale of any cosmetic that was developed or manufactured using animal testing after January 1, 2020.  While PCPC takes a strong stand against animal testing, it could not support the bill as written because it included no exception for products marketed in countries (notably China) which require that products be subject to animal testing.  Rather, the PCPC has been working to obtain an amendment of the proposed legislation to make it conform to that of the European Union, which has strong anti-animal testing regulations but allows for accommodations to make products acceptable for sale in China.

Dr. Michael Benjamin, Air Resources Board Chief of Air Quality Planning and Science spoke about the substantial product data that ARB had collected from product manufacturers selling in California, through extensive annual surveys conducted over the past three years.  From that data, ARB is working to identify trends in emissions of VOCs.  Of particular interest is a February 15, 2018 publication in the academic journal Science of a study of VOC emissions from consumer products.  The Science publication (Volatile Chemical Products Emerging as Largest Petrochemical Source of Urban Organic Emissions, by Brian C. McDonald, Joost A. de Gouw, Jessica B. Gilman and others), Science Vol. 35, Issue 6377, pp. 760-764 (Feb. 16, 2018)) caught popular attention and some popular press because it found that vehicle emissions had become so much cleaner over the past decades that they were now responsible for less than half of VOC emissions.  Overall, the total volume of VOCs had diminished greatly.  Further, while the Science article authors made many assumptions on which they based their assessment of VOC contributions of consumer products, Mr. Benjamin pointed out that ARB has the actual data from its industry surveys to determine whether the author’s assumptions and conclusions are well founded.  ARB therefore intends to do its own assessment of the points made in the Science article to determine what further action is appropriate.

PCPC’s first Legislator of the Year Awards were presented to Senator Ed Hernandez, Assembly Member Bill Quirk and Senator Galgiani.  In his comments to PCPC members, Senator Hernandez emphasized, “We want business to stay here in California, we want businesses to be successful.  There’s a lot of people here that purchase your products.”   Assemblyman Quirk addressed the need for common sense limitations on legislation such as Proposition 65, remarking that “[Someone] sent me a package of Coors beer with a Prop 65 warning on it.  We now have cases in court where people want Prop 65 warnings on coffee. * * * One study after another shows it’s not a health risk. * * * We’ve got to do something about this.  I’m definitely going to be working as time goes on in the legislature so that we don’t end up with things that are harmless being labeled.”  Finally, Senator Galgiani observed that good legislative policy is not a zero sum game:  “It’s not about having a proposal that’s just good for the environment or just good for business but we can meet in the middle and have regulations and policies that work for both sides and help everybody involved.  It’s just harder to get there – it takes more work, it takes more time and it takes patience, and all of you [at PCPC] have done a great job.”

 

 

 

 

 

 

 

 

 

 

See the Beauty Industry Report article on the PCPC California Lobby Day here.

 

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Sunscreen Ingredient Restrictions in Maui, Hawaii?

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Sunscreen manufacturers and distributors should take note:  Maui County in the state of Hawaii could become the first county in the United States to ban the sale and use of sunscreen products containing oxybenzone and octinoxate, two active ingredients approved by the U.S. Food and Drug Administration (FDA) for use in sunscreens.

In November, a Maui Hawaii County Council committee introduced and recommended for approval a bill for an ordinance that would prohibit the sale and use of sunscreen containing the ingredients oxybenzone and octinoxate. These ingredients are commonly used in commercial chemical sunscreens as protection against ultraviolet (UV) light radiation.  The county-level move came after Senate Bill 1150 – introduced in 2017 by Hawaii Senator Will Espero to ban the use and application of sunscreens containing oxybenzone throughout the state of Hawaii – stalled at the end of the legislative session.

The FDA currently approves of only 16 active ingredients for use in over-the-counter (OTC) sunscreens, generally recognizing them as safe and effective.  Among the ingredients are oxybenzone and octinoxate, which are commonly found in commercial sunscreen products, including from major sunscreen brands such as L’Oreal, Neutrogena and Supergoop.  The European Union already imposes strict limits on the use of oxybenzone in sunscreen products as well as warning requirements.

The Maui County proposal was prompted by environmental concerns and intended to promote the health and welfare of Maui’s coral reefs and marine life. The bill’s supporters claim that oxybenzone and octinoxate have a significant impact on the marine environment, noting that both ingredients have been detected in the ocean surrounding Maui at levels that well exceed the toxicity range for coral reefs.  Opponents of the ban, on the other hand, contend that the ingredients are safe for use, as they have been approved for use by the FDA.

The proposal to ban sunscreen products containing oxybenzone and oxtinoxate, other than prescription products, is now before the full Maui County Council. If approved, manufacturers, retailers and distributors of sunscreen products containing oxybenzone and oxtinoxate would have a year to ensure that their products no longer contain the banned ingredients. Businesses or persons found in violation of the law would be subject to civil penalties and administrative enforcement procedures. As of now, the bill does not contain a private right of action to allow consumers to bring actions for violations.  If passed, Maui’s outright ban could still face enforcement and legal challenges – including state preemption and federal Commerce Clause challenges.

While this is a unique development, local efforts to protect against health and environmental concerns are nothing new, but they do not always remain confined to their original purpose.  For example, California’s Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65, was originally passed to protect the state’s drinking water sources from being contaminated with chemicals known to cause cancer or reproductive harm.  However, Proposition 65 does not act to ban the use of any chemicals; instead, it imposes warning requirements prior to consumer exposure to certain chemicals known to the state to cause cancer or reproductive harm.  The 2012 listing of benzophenone to the state’s list of regulated chemicals has already caused many sunscreen manufacturers using octocrylene, another FDA-approved active ingredient that may contain small amounts of benzophenone, to reformulate or use a more purified form of the ingredient.

Conkle, Kremer & Engel has many years of experience representing clients in the beauty and skin care industry address challenging regulatory compliance issues.  CK&E attorneys help clients stay out of legal crosshairs by working with them to ensure their products continue to meet all legal requirements, and helping them plan for foreseeable changes in the law.

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