The U.S. Food and Drug Administration has announced that manufacturers of certain per- and polyfluoroalkyl substances (PFAS) used for grease proofing in paper and paperboard for food packaging (for example, as coatings on some fast food wrappers, to-go boxes, and pizza boxes) have voluntarily agreed to phase out sales of these substances for use as food contact substances in the United States, following new analyses of data raising questions about potential human health risks from chronic dietary exposure.

Starting in January 2021, three manufacturers will begin a three-year phase out of their sales of certain substances that contain 6:2 FTOH for use as food contact substances in the U.S. marketplace.  It may take up to 18 months after the phase-out period to exhaust existing stocks of paper and paperboard products containing these food contact substances from the market. A fourth manufacturer informed the FDA in 2019 that they have stopped sales of their short-chain PFAS products in the U.S. market.

According to the FDA, this phase out balances uncertainty about the potential for public health risks with minimizing potential market disruptions to food packaging supply chains during the COVID-19 public health emergency.  Earlier this year, FDA scientists published their analyses of studies on certain PFAS used in food packaging. Their analyses of data from rodent studies raised questions about a subset of short-chain PFAS that contain 6:2 fluorotelomer alcohol (6:2 FTOH)

On August 4, 2020, the Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements Proposition 65 and has the authority to promulgate and amend regulations, released a proposed regulation providing that intake of listed chemicals formed by cooking or heat processing foods would not represent an exposure for the purposes of Proposition 65 if the concentrations are reduced to the lowest level currently feasible. The proposed regulation would also establish maximum concentration levels for acrylamide in specific foods that are deemed by OEHHA to be the lowest levels currently feasible. Concentrations of acrylamide at or below the level identified for the specified products would not require a warning. Public comments concerning this proposed action must be received by OEHHA by October 6, 2020.

Proposition 65 prohibits a person in the course of doing business from knowingly and intentionally exposing any individual to a chemical that has been listed as known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual. An exemption from the warning requirement is provided when the exposure is below established safe harbor levels.

Currently, there are regulatory exceptions from the warning requirement for exposures to naturally occurring chemicals in foods, specific concentrations of naturally occurring arsenic in rice, and for certain exposures to listed chemicals in water or air. The proposed regulation would create an additional exception from the warning requirement for listed chemicals that are unavoidably created in foods during cooking or heat processing and that

As states continue to wrestle with when to reopen, California has unveiled a phased-in plan that gives counties control over how quickly to reopen, and provides guidelines specific to each industry. What does this mean for your business? What procedures should you consider implementing? Joined by Rachel Michelin, president of California Retailers Association, presenters will offer a number of best practices and model guidelines to help retailers, not only in California, but across the U.S., protect against the spread of COVID-19 to keep workers and customers safe.

As part of our continuing series of teleconferences on the impacts of COVID-19, presenters will cover the following topics:

• Creating a worksite specific plan
• Employee Training
• Individual control measures and screening
• Cleaning and disinfecting protocols
• Physical distancing guidelines

Date Wednesday, May 20, 2020 Time 10:30 a.m. to 11 a.m. PDT 11:30 a.m. to 12 p.m. MDT 12:30 p.m. to 1 p.m. CDT 1:30 p.m. to 2 p.m. EDT

Register

One day before allowing “low-risk” retailers to reopen on a limited basis, California Governor Gavin Newsom on Thursday announced guidelines for certain retailers, manufacturers and other businesses to reopen fully during Stage 2 of the state’s reopening plan.

Even prior to full implementation of these guidelines, retailers perceived as presenting a lower risk of spreading COVID-19 can reopen on a limited basis, such as by offering curbside pickup, as early as today.  As we previously reported, Newsom has stated that such retailers include shops that sell items such as clothing, books, music, toys, sporting goods, and flowers.

At the press conference on Thursday, it was recommended that retailers offering curbside pickup take precautions such as having employees wear masks and gloves, bringing merchandise to a designated pickup location at the entrance or curbside, and encouraging use of payment methods and devices that reduce contact between employees and customers.

Whether non-essential retailers can reopen will also depend on the county and city where they are located. Seven Bay Area shelter-in-place orders have been extended through May 31. Los Angeles County’s order is set to expire May 15. Governor Newsom has stated that local governments have a right to issue and enforce stricter orders than the state, where warranted.

Under the state’s reopening roadmap, prior to reopening, all businesses are expected to:

• Perform a detailed risk assessment and implement a site-specific protection plan
• Train employees on how to limit the spread of COVID-19, including how to screen
  

California Gov. Gavin Newsom announced on Monday that certain low-risk retail businesses will be allowed to reopen on a limited basis if they meet state guidelines and conditions to be announced on Thursday, including by allowing curbside pickup as early as this Friday.

Newsom said shops that sell items such as clothing, books, music, toys and sporting goods, as well as florists, are as among those who will be allowed to reopen on a limited basis if they meet the state guidelines.  Associated manufacturers that support the retail industry would also be allowed to begin production.

Whether a particular retail location can reopen, and under what conditions, also depends on the county and city where it’s located.  Six Bay Area counties announced last week that their shutdown orders will continue through the end of May: These include Alameda, Contra Costa, Marin, San Francisco, San Mateo, Santa Clara, and the City of Berkeley.  Los Angeles’s county’s order is set to expire May 15, after which the county is expected to phase in reopenings.

Governor Newsom in his briefing acknowledged that counties and cities have the right to issue orders that may be stricter than the state’s order.  However, he said some counties will be allowed to move further into the reopening process depending on certain criteria, including the stability of Covid-19 hospitalizations and the state’s ability to conduct more testing and contact tracing.

The California Retailers Association’s COVID-19 web page links to a summary of county and city orders within

Several U.S. retailers that remained open in the face of state and local shutdown orders have now been forced to close by local law enforcement.

Retailers that remain open should ensure that they qualify as “essential” under applicable state and local orders, that they have proper documentation for their employees and facilities demonstrating that they are essential, and that they comply with any health safety and social distancing requirements. BCLP is tracking these orders and the developing guidance, and a map of states with stay-at-home orders is available here.

Businesses forced to close include several national craft and fabric store chains, and specialty stores that sell video games, sports equipment, furniture, clothing and accessories, shoes, books, music, jewelry, and luggage.

What qualifies as an “essential business” may vary under each order, and the approach taken by enforcement agencies may also vary. For example, stores selling CBD products have been allowed to remain open in some jurisdictions, but forced to close in others.

Law enforcement actions also varied against firearms and ammunition retailers, until the federal government last week updated its Guidance on the Essential Critical Workforce (the “Guidance”) to include “workers supporting the operation of firearm or ammunition product manufacturers, retailers, importers, distributors, and shooting ranges.”

Some statewide orders, such as California, base their definition of an essential business on the Guidance while others, such as Oregon, do not. In updating the Guidance, Christopher Krebs, director of the Cybersecurity and Infrastructure Security Agency (CISA), stated “this advisory list

Seven Bay Area counties renewed and modified their shelter-at-home orders yesterday, extending the shutdown period through May 3, and in all cases but one, requiring that all essential businesses that remain open establish and post social distancing protocols by April 2 at 11:59 p.m.: San Francisco, Marin, Contra Costa, Santa Clara, San Mateo, Alameda, and Santa Cruz.

Santa Cruz County also extended its order through May 3, but does not include the same provision requiring establishment and posting of social distancing protocols.

The orders specify that social distancing protocols must be substantially in this form, and be posted at or near the entrance of the business where it is easily viewable by the public and employees. A copy of the social distancing protocol must also be provided to each employee performing work at the business.

The social distancing protocol must explain how the business is achieving the following, as applicable:

• Limiting the number of people who can enter into the facility at any one time to ensure that people in the facility can easily maintain a minimum six-foot distance from one another at all times, except as required to complete the Essential Business activity;
• Where lines may form at a facility, marking six-foot increments at a minimum, establishing where individuals should stand to maintain adequate social distancing;
• Providing hand sanitizer, soap and water, or effective disinfectant at or near the entrance of the facility and in other appropriate areas for
  

Effective March 17, 2020, San Francisco and six other Bay Area counties passed “Shelter in Place” ordinances preventing workers not engaged in providing Essential Activities, working at Essential Businesses or providing Essential Government Services from leaving their homes to go to work. Such laws are now being considered throughout the country. This alert provides actionable steps companies can take to ensure that Shelter in Place laws in their jurisdictions do not inadvertently block employees from getting to work at their Essential Businesses.

First, be proactive, contact your state and local government officials to make sure they understand why your business is essential. If your product or service is truly essential, no government official is going to want to be blamed for inadvertently causing a shortage of that product. Note the Bay Area Orders define Essential Businesses to include “Businesses that supply other essential businesses with the support or supplies necessary to operate.” If your business falls into that category, you may want to have that business explicitly enumerated as an Essential Business rather than rely on a judgment call that this catch all provision applies. To proceed, identify to make sure they know. BCLP can help (a) identify the appropriate officials at the State and local level and reach out to them, (b) develop the message to be delivered as to why your employees should not be required to Shelter In Place and (c) draft language to clarify why your business and its supply chain should be exempt from the

PFAS are currently the subject of significant regulatory action, research, litigation, and public debate based on recent reports which claim that two PFAS, Perfluorooctanoic Acid (“PFOA”) and Perfluorooctane Sulfonate (“PFOS”), that were formerly used in a variety of industries may be carcinogens or reproductive toxicants. Several states have begun investigating and regulating the levels of PFAS in drinking water, and in some cases, for example Minnesota and New York, have sued manufacturers of the chemicals themselves or products that historically contained PFOA and PFOS, bringing claims for the recovery of natural resource damages, trespass, nuisance, and negligence.

EPA has historically addressed these chemicals through a stewardship program under which the companies that manufactured PFOA and PFOS agreed to voluntarily stop their production, and companies that used PFOA and PFOS agreed to stop importing them. Now, however, Acting Administrator Wheeler is under increasing bipartisan pressure to take federal regulatory action.

Into the teeth of this debate, EPA unveiled its much-anticipated PFAS Action Plan (the Plan) on February 14, 2019. The full Action Plan can be found here, and a helpful one page summary is also available here. The Action Plan does not actually make any determinations, or propose or set any new regulatory standards for this wide group of chemicals. Instead, it provides a comprehensive preview of the next several years’ worth of federal investigation into, and regulation of these diverse chemicals which are used in a variety of industries to make products including water resistant clothing and athletic equipment, non-stick cookware,

Retailers and manufacturers should take steps now to ensure they are compliant with the new California Proposition 65 warning regulations that take effect on August 30, 2018.

Proposition 65 prohibits retailers and manufacturers from knowingly and intentionally exposing California consumers to a chemical known to the State of California to cause cancer or developmental or reproductive harm without first providing a “clear and reasonable warning.”  (Cal. Health & Safety Code § 25249.6.) The regulations provide examples of “safe harbor” warnings that are deemed to be clear and reasonable under the new amendments. Notably, the use of the specific “safe harbor” warnings included in the regulations is not actually required. Retailers and manufacturers can use any clear and reasonable warning; however, using the examples provided ensures that the warning is sufficient.

As we previously reported, amendments to the warning regulations were issued in August 2016. The 2016 and the more recent November 2017 amendments change the form and content of the “safe harbor” warnings. The amendments also clarify who has responsibility for providing warnings.

For products manufactured before August 30, 2018, retailers and manufacturers can choose whether to rely on the current or new safe harbor warnings, as both are deemed sufficient under the regulations.  Products manufactured after August 30, 2018, however, should include the new warning in order to ensure compliance. Parties to existing court-approved consent judgments can continue to provide warnings that comply with those orders.

New Content

The new regulations specify that safe harbor warnings for consumer

The next wave of lawsuits involving California Proposition 65 and food products may allege exposure to furfuryl alcohol, a chemical commonly found in a wide variety of thermally processed foods and listed as a carcinogen under Proposition 65. The warning requirement for furfuryl alcohol took effect on September 30, 2017.  As of the date of this post, there have been no 60-day notices alleging exposure without a warning. Given the prevalence of this chemical, however, future enforcement actions seem likely.

Furfuryl alcohol forms when amino acids react with sugar in a process known as the “Maillard reaction” that gives many foods a golden brown color.  Much like acrylamide, which has been the subject of numerous 60-day notices and lawsuits, furfuryl alcohol can be found in a wide variety of foods, including:

• baked goods
• coffee
• pasteurized milk
• alcoholic beverages such as wine and beer
• ice cream
• juice beverages
• toasted nuts

It remains to be seen whether furfuryl alcohol is created in other foods commonly associated with acrylamide, such as French fries and vegetable chips.

No safe harbor level: Proposition 65 requires businesses to provide a warning before exposing consumers to a chemical known to California to cause cancer or reproductive harm. For some of the listed chemicals, California’s Office of Health Hazard Assessment (OEHHA) has established safe harbor levels, in the form of No Significant Risk Levels (NSRLs) for carcinogens and Maximum Allowable Dose Levels (MADLs) for chemicals causing reproductive harm. Exposure below these levels does not require a

The Prop. 65 Clearinghouse held its annual conference in San Francisco recently, and the speakers and panelists had a number of recommendations for both retailers and manufacturers following the adoption of Proposition 65’s new warning regulations.

The New Warning Regulations

As we reported on September 7th, the Office of Environmental Health Hazard Assessment (OEHHA) has adopted new warning regulations which take effect in two years on August 30, 2018.  Businesses can choose to comply with either the current or new regulations in the interim, but all retailers and manufacturers who sell products in California should review their Prop. 65 compliance protocols to ensure that they will continue to comply.

The new regulations seek to put the primary responsibility for providing warnings on product manufacturers or suppliers, who must either label their products with any required warnings or provide notice and warning materials to retailers.

The regulations expressly provide, however, that parties can continue to contractually allocate who has responsibility for providing warnings. Retailers should therefore analyze and consider revising their terms and conditions to clarify who is responsible for providing warnings and in what manner, whether retailers will accept and post shelf warnings provided by vendors, and to whom the notice and warning materials should be sent.

Complying With New Warning Regulations

The first panel – which included the chief counsel of OEHHA, the presidents of two enforcement groups, an industry lobbyist, and a defense attorney — focused on some of the challenges that the new regulations

The California Proposition 65 warning requirement for Bisphenol-A (“BPA”) takes effect on May 11, 2016, and retailers, manufacturers, and distributors should act now to reduce potential liability.

BPA is used in a wide variety of plastic consumer products, including the epoxy lining in food and beverage cans and bottle lids, some reusable food and drink containers, CDs and DVDs, and electronics and sports equipment made from polycarbonate plastics.  California has not yet adopted a safe harbor level for exposure to BPA below which no warning is required, but recently proposed a safe harbor level of 3 micrograms per day for dermal BPA exposure from solid materials.  The safe harbor level will not be adopted prior to May 11, however, when the warning requirement takes effect.

In the meantime, California’s Office of Environmental Health Hazards Assessment (OEHHA) has proposed an emergency regulation to allow temporary use of a standard point-of-sale warning message for BPA exposures from canned and bottled foods and beverages only. All other products that contain BPA may subject the sellers to liability if they are sold in California on or after May 11 without a warning.

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