The panel’s presentation is available here for review. Contact John Conkle to discuss the latest issues affecting the state of the personal care products and cosmetics industries.
The panel’s presentation is available here for review. Contact John Conkle to discuss the latest issues affecting the state of the personal care products and cosmetics industries.
States have come to recognize that, with the U.S. Congress largely gridlocked and federal regulatory agencies in a deregulation mood, the path is open for the states to regulate consumer industries in manners that they deem fit. The result is a continuously evolving patchwork of laws and regulations that can be difficult for industry participants to navigate.
Issues to be discussed at the May 9, 2018 panel presentation include California’s infamous Proposition 65, slack fill laws, and labeling and ingredient disclosure regulations that include even public databases disclosing products’ ingredients found by state governments to be detrimental. Further, state regulations can include ingredient phase-out requirements and outright bans, volatile organic compound limitations to protect air quality, and even animal testing regulations that can affect industry participants’ ability to compete in international trade.
A lively discussion is inevitable given the rich and topical subject matter and the vital industry interests affected. The rest of the Legal and Regulatory Conference program should be just as engaging, covering topics such as employment law, cannabis (THC, CBD, marijuana extracts and hemp) in cosmetics and personal care products. The many other topics to be covered in the three-day conference in Savannah, Georgia can be found in the conference program.
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.
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.”
Businesses will once again be required to report detailed product ingredient information and annual sales for products sold in California during 2015, as they were required to do for chemically formulated consumer and commercial products sold or supplied for use in California during the 2013 and 2014 calendar years. ARB requires the ingredient and sales information to be reported through its online Consumer Products Reporting Tool. Veterans of the two prior Surveys may notice that ARB no longer refers to the mandatory reports as “Surveys,” apparently because that name suggested to some that the reports were somehow optional. They are not optional. Non-compliance will draw letters from ARB and persistent non-compliance will result in referral to ARB’s Enforcement Division.
Reports must be filed by each “responsible party” listed on the label of a consumer or commercial product that was sold or supplied for use in California during the calendar year, if the product falls into one of the many categories listed for 2015. The general categories of consumer products that are subject to reporting are personal care products, adhesives, sealants and related products, household and institutional products, pesticide products, solvent and thinning-related products, vehicle and marine vessel aftermarket products, and aerosol coating products. But for the 2015 Report, ARB has exempted 232 categories of consumer products due to its assessment that the products contain low or no volatile organic compound (VOC) emissions – less than 0.05 tons per day of emissions. A number of beauty products, including facial cleansers and soaps, nail glues and gel nail polishes, are now exempt from reporting for 2015, even though they were required to be reported for 2013 and 2014 Surveys. ARB’s full list of exempt consumer products is available here.
Conkle, Kremer & Engel attorneys assist clients with achieving compliance with California’s many regulatory requirements, including the Consumer and Commercial Products Survey, so that clients can focus on expanding their businesses in valuable markets.
For other businesses, the deadline to report 2013 data has passed. Unless they have been granted an extension from CARB, formulators were required to comply by April 1, 2015 and all other businesses, by March 1, 2015.
The 2013 Consumer and Commercial Products Survey is part of a comprehensive three-year data collection effort by CARB, which is authorized by law to collect data about chemically formulated products. The Survey collects formulation data and sales information for chemically formulated consumer and commercial products sold or supplied for use in California during the 2013 calendar year. Compliance with the Survey is mandatory.
The Survey is remarkable in its breadth, targeting virtually all consumer and commercial products. The Survey requires that each “responsible party” listed on the label of a consumer or commercial product that was sold or supplied for use in California during the calendar year, and falls into a category listed on that year’s Survey Category List, is required to report detailed product ingredient information, as well as annual sales on a per-product basis, to CARB through the online Consumer Products Reporting Tool.
The general categories of consumer products that are subject to reporting in 2013 are personal care products, adhesives, sealants and related products, household and institutional products, pesticide products, solvent and thinning-related products, vehicle and marine vessel aftermarket products, and aerosol coating products.
In addition, updated data for the 2014 and 2015 calendar years must also be reported to CARB. Businesses who are required to report should plan for timely compliance with the 2014 Survey, which opens on July 1, 2015. The deadline for reporting 2014 Survey data – including 2014 sales – is November 1, 2015. In addition, CARB expects to begin collecting 2015 data on July 1, 2016 with all 2015 data due by November 1, 2016.
Conkle, Kremer & Engel provides expert guidance to clients as they navigate compliance with California’s complex and ever-changing regulatory requirements, including the Consumer and Commercial Products Survey.
Additional Extension Requests
The California Air Resources Board (ARB) recognized the substantial resources required to complete the 2013 Consumer and Commercial Products Survey (2013 Survey). In some cases, ARB announced, companies may need extra time to complete reporting of 2013 data beyond the 90 statutorily required days and the additional 90-days ARB staff already issued due to the 2013 Survey scope. Below is a summary of the additional extension request process announced by ARB.
1. Formulators: All formulators will receive a 30-day extension to submit formulation data to ARB. The due date for formulators is extended to April 1, 2015. Formulators automatically receive the extension and do not need to send an email to request one.
2. Small Businesses: Responsible parties who are also a small business have an additional extension until July 1, 2015 for reporting 2013 data. For purposes of the 2013 Survey, a small business is defined as a company or entity with 25 or less full-time, part-time and contract employees combined. The 25 employee count must also include seasonal workers. For example, a salon with their own product line of hair care products with a 12 part-time employees would quality for this extension. Small businesses automatically receive the extension and do not need to send an email to request one.
3. Responsible Parties (other than those who qualify as “Small Businesses”): Responsible party requests will be handled on a case-by-case basis, and must request an extension by email no later than February 27, 2015. To request an extension from the original survey due date of March 2, 2015, responsible parties must email email@example.com by February 27, 2015 to make a request, and the email must have the following title: “2013 Survey Additional Extension Request – Company Name (add your company name here)”. In order to receive an extension, responsible parties will need to provide the following information:
a) When did you learn about the 2013 Survey?
b) When did you start working on the 2013 Survey?
c) When did you finish your data collection effort for the 2013 Survey?
d) Approximately how many products will you report? labels?
e) How far along are you in entering data into the Consumer Products Reporting Tool (CPRT)?
f) How much time are you requesting to complete the 2013 Survey?
ARB staff will notify each company the results of their request via email.
ARB also reminded survey participants to submit complete data reports, as partial data sets will not be accepted.
Conkle, Kremer & Engel attorneys keep abreast of the latest developments in California regulatory laws to guide the firm’s clients through the shifting labyrinth that they must navigate.
CARB recently issued the 2013 Consumer & Commercial Products Survey, which requires companies to report sales and formulation data for all chemically formulated consumer and commercial products that are sold or supplied for use in California.
CARB is authorized by law to collect data about chemically formulated products and from time to time gathers information through mandatory surveys. The last such survey was in 2006.
According to CARB, the purpose of the 2013 Survey is to gather current information on volatile organic compounds (VOC), low vapor pressure VOC (LVP-VOC), and greenhouse gas (GHG) content from consumer and commercial products sold or supplied for use in California. The Survey will also assist CARB in determining the feasibility of further reducing consumer product emissions, updating the consumer products emissions inventory, and evaluating emissions trends for consumer products.
The Survey requirements are detailed and require reporting of a wide variety of chemically formulated consumer and commercial products, even if those products do not contain any VOCs or contain low VOCs. CARB has hosted informational webinars regarding the Survey. The next CARB webinar is on December 15, 2014.
The 2013 Survey officially started on September 1, 2014, and all 2013 data must be reported to CARB by March 2, 2015. But companies can expect to devote substantial resources well into 2016 to comply with CARB’s mandatory reporting requirements. That’s because the Survey covers a three-year period and will require further reporting of sales and product ingredient data for 2014 and 2015, in 2015 and 2016, respectively.
In particular, data from the Survey will be used to help CARB prepare for the new State Implementation Plan (SIP) which by 2016 will be required to meet more stringent standards set by the United States Environmental Protection Agency (US EPA). CARB is collecting data in preparation for the SIP, and is updating its emission inventories by collecting sales and ingredient data for all consumer product categories.
CARB has developed a list of pre-screening questions to help companies determine if they are required to submit survey data to CARB. In general, each responsible party listed on the label of a consumer product that was sold or supplied for use in California during the calendar year, and falls into a category listed on that year’s Survey Category List, is required to report data to CARB.
The categories of consumer products that are subject to reporting are comprehensive: California Air Resources Board 2013 Survey – List of Survey Categories .Highlights from this list of the 2013 Survey categories include:
Conkle, Kremer & Engel monitors the latest developments in legal and regulatory issues to provide the most current legal guidance and counseling to its industry clients.