• California’s Office of Environmental Health Hazard Assessment (OEHHA) has posted a fact sheet regarding styrene on its Proposition 65 warning website, also known as the Lead Agency Website.
  • OEHHA listed styrene as a carcinogen under Proposition 65 on April 22, 2016, and on May 4, 2017, the state adopted a No Significant Risk Level (NSRL) for styrene of 27 µg per day.
  • Despite stating that “the levels of such residual styrene in polystyrene food packaging materials are generally thought to be fairly low in most cases” when OEHHA issued styrene NSRL, the new fact sheet states, “Small amounts of styrene can be transferred to some food from polystyrene-based food-contact items such as drinking cups, plates, and other containers.”  The fact sheet also states, “If possible, do not store or microwave food in polystyrene-based containers.”
  • The new fact sheet joins a chorus of other state and local laws and initiatives that discourage or ban the use of polystyrene food packaging materials.
  • After years of delay, New York City’s ban on single use expanded polystyrene (EPS) will go into effect on January 1, 2019.  EPS is defined in the rule as “blown polystyrene and expanded and extruded foams that are thermoplastic petrochemical materials utilizing a styrene monomer and processed by any number of techniques including, but not limited to, fusion of polymer spheres (expandable bead foam), injection molding, foam molding, and extrusion-blown molding (extruded foam polystyrene).”  Rigid polystyrene is not included in the definition of EPS.  Affected products include single-use food packaging materials and packing peanuts.
  • Non-profits and small businesses with less than $500,000 in annual revenue can apply for hardship exemptions from the Department of Small Business Services if they can demonstrate that using an alternative product would cause an undue financial hardship.
  • The New York City Departments of Sanitation, of Health and Mental Hygiene, and of Consumer Affairs each have the authority to enforce the ban, which carries penalties ranging from $250 for the first violation up to $1,000 for the third and each subsequent violation, but fines will not be issued during a grace period that ends on July 1, 2019.
  • The original effective date for the ban was January 1, 2015, but implementation was delayed due to a lawsuit by industry.  Industry was unsuccessful at challenging the city’s basis for the ban, which was that it is not environmentally effective or economically feasible to recycle EPS.

San Francisco approves comprehensive ban on sale of polystyrene.

  • Polystyrene food packaging and containers — typically referred to using one trade name, “Styrofoam” — have been the subject of criticism by stakeholders who claim that these non-biodegradable foam products pollute the environment and may harm wildlife.
  • On June 28, 2016, the San Francisco Board of Supervisors voted unanimously to ban the use of a wide variety of polystyrene products.  The legislation covers food packaging, packing peanuts, take-out containers and cups, among other items.
  • The board is expected to issue final approval of the ban on July 12.  Once enacted, the ban will take effect on January 1, 2017 for most products, although a later effective date of July 1, 2017 applies to meat and fish trays.  Although a number of cities have ordinances that restrict the use of polystyrene food service materials and/or packaging, San Francisco’s legislation is being described as the nation’s most extensive ban of this type.

Styrene added to Proposition 65 list.

  • Proposition 65 is a “right to know” California statute that requires companies to provide warning statements where their products cause an “exposure” to carcinogens and/or reproductive toxicants.  California’s Office of Environmental Health Hazard Assessment (OEHHA) maintains an up-to-date list of the chemicals (>900) that trigger warnings.  The warning requirements do not apply where a particular exposure falls within the “safe harbor,” which is defined by reference to:
    • the no significant risk level (NSRL) for listed carcinogens, which is the level of a chemical calculated to result in one excess case of cancer in an exposed population of 100,000, assuming lifetime (70-year) exposure to the chemical at the level in question; or
    • the maximum allowable dose level (MADL) for reproductive toxicants, which is the level at which a chemical would have no observable effect assuming exposure at 1,000 times that level.
  • Effective April 22, 2016, OEHHA has added styrene (CAS No. 100-42-5) to the Proposition 65 list.  The listing action is based on formal identification by the National Toxicology Program (NTP) that the chemical is “reasonably anticipated to be a human carcinogen.”  OEHHA also has proposed an NSRL for styrene of 27 µg per day.
  • The listing of styrene has been in the pipeline for many years, so OEHHA’s current action comes as little surprise to the industry.  We anticipate that many stakeholders have been evaluating the potential impact of the styrene listing on their product lines and warning obligations for some time.  Comments on the proposed NSRL are due by June 6, 2016.

Last week, California’s Department of Toxic Substances Control (DTSC) hosted a webinar where it presented initial findings from its evaluation of food packaging, conducted under its Safer Consumer Products Regulations.  During the webinar, DTSC noted that it is considering the prioritization of ortho-phthalates (OPs), bisphenol A (BPA), perfluoroalkyl and polyfluoroalkyl substances (PFASs), and/or styrene in food packaging.

The goal of the Safer Consumer Products Regulations is “to create safer substitutes for hazardous ingredients in consumer products sold in California.”  Since the regulations inception in 2013, DTSC has prioritized three products:  Children’s Foam-Padded Sleeping Products with TDCPP or TCEP, Spray Polyurethane Foam Systems with Unreacted Methylene Diphenyl Diisocyanates (MDI), and  Paint or Varnish Strippers with Methylene Chloride.

To receive additional information from stakeholders, DTSC is hosting a public meeting on November 19, 2019 to discuss OPs and BPA.  In addition, DTSC will hold a workshop on PFAS and their alternatives in food packaging on January 14, 2020.

  • During the past month, the governors of Vermont, Maine, Oregon, Delaware and Connecticut signed legislation banning single-use plastic bags and a few months earlier, on April 22, New York’s governor signed similar legislation.
  • New York’s plastic bag ban is scheduled to take effect on March 1, 2020. The law bans most single-use plastic carry-out bags provided by grocery and other stores unless they are exempted. Exemptions include bags used to wrap uncooked meat, fish or poultry; bags to hold food prepared to order; bags used by a customer for bulk items (e.g., fruits and vegetables); bags for carryout or delivered food; and food storage bags. The legislation also allows individual counties to charge five cents for paper bags.
  • Maine’s H.P. 1115 (LD 1352) bans retail establishments from providing customers with most single-use plastic bags, effective January 1, 2020. The legislation lists a number of exemptions, such as bags for prescription medication, bags for use within a store to package loose items, and dry-cleaning bags. Retail establishments may provide a recycled paper bag of reusable plastic bag for a fee of at least five cents per bag.
  • Oregon’s HB 2509 bans retail establishments and restaurants from providing customers single-use checkout bags. Certain bags are exempted, such as bags for produce, meat, fish and dry cleaning. Stores may provide paper checkout bags, reusable fabric checkout bags, or reusable plastic checkout bags for at least five cents each. The ban becomes effective in January 2020.
  • Vermont’s Act No. 69 (S.113) prohibits stores and food establishments from providing single-use plastic bags, effective July 1, 2020. Pharmacy bags for prescription medication; bags used inside a store to package loose items, frozen foods, meat, fish or flowers; and dry-cleaning bags are exempted. The legislation also prohibits food service establishments from providing single-use plastic straws unless requested and bans the sale of expanded polystyrene food service products.
  • Delaware’s HB 130 bans bags that are “made from non-compostable plastic and not specifically designed and manufactured to be reusable” effective January 1, 2021. Exceptions include plastic bags to wrap damp items like frozen foods, bags to transport chemicals, and dry-cleaning bags.
  • Single-use plastic grocery bag are currently banned in California and Hawaii. California has had a statewide plastic bag ban in place since late 2016 and, plastic grocery bags are banned in all counties in Hawaii.
  • A bill to ban plastic grocery bags could be expanded to include paper bags, according to the bill’s sponsor, State Sen. Bob Smith (D-Middlesex). The bill, S2776, currently would prohibit carryout bags made of plastic film, polystyrene foam food service products, single-use plastic straws, and would assess a fee on paper carryout bags. Sen. Smith, who is head of the state Senate Environment and Energy Committee, wants the bill amended to also include a ban on paper bags, according to NJ.com.
  • The bill defines “carryout bag” as “a bag that is provided by a store or foodservice business to a customer at the point of sale for the purpose of transporting groceries, prepared foods, or retail goods.” It was passed by the Environment Committee in September 2018 and is currently waiting consideration by the Senate Budget Committee. Sen. Smith hopes that the bill can be amended this month and pass out of the senate in July, reports NJ.com.
  • Last summer, New Jersey Governor Phil Murphy vetoed a bill (S-3267/A-2600) that would have imposed a five-cent tax on both paper and plastic bags because it did not go far enough. In a statement on the veto, the governor called the bill “incomplete and insufficient” and added that a more “robust and comprehensive method of reducing the number of single-use bags” in New Jersey was needed.
  • As we previously reported on this blog, a group of non-government organizations (NGOs) sued FDA in an effort to compel the Agency to act on a Food Additive Petition (FAP) concerning seven synthetic flavoring food additives. The FAP, which the NGOs submitted to FDA, requested that FDA remove the clearances for these seven synthetically derived substances in 21 C.F.R. 172.515 (“Synthetic flavoring substances and adjuvants”) because the substance are carcinogens and therefore violate the Delaney Clause of the Federal Food, Drug, and Cosmetic Act.
  • The seven substances that are the subject of the NGOs’ FAP include: benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, styrene and pyridine.
  • We also previously reported that the Styrene Information and Research Center (SIRC) submitted its own FAP to FDA requesting that the clearance for styrene in Section 172.515 be removed because its use as a flavor additive has been permanently abandoned.
  • FDA responded to the NGOs’ FAP, as well as SIRC’s FAP, in two separate notices in today’s Federal Register. In response to the petition from the NGOs, FDA announced that it is amending Section 172.515  to remove the clearances in that regulation for benzophenone, ethyl acrylate, eugenyl methyl ether (methyl eugenol), myrcene, pulegone, and pyridine (83 Fed. Reg. 50490). FDA explained that this action was being taking under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act since the petitioners provided evidence that these substances caused cancer in animals. However, FDA stated in the Federal Register notice:
    • “…the use of these synthetic flavoring substances and adjuvants does not affect the legal status of foods containing natural counterparts or non-synthetic flavoring substances extracted from food, and there is nothing in the data FDA has reviewed in responding to the pending food additive petition that causes FDA concern about the safety of foods that contain natural counterparts or extracts from such foods.”
  • FDA also granted SIRC’s FAP to amend the food additive regulations to no longer provide for the use of styrene as a flavoring substance and adjuvant due to its abandonment by industry. (83 Fed. Reg. 50487). Since styrene was delisted due to abandonment, FDA did not consider whether styrene is a carcinogen.
  • Eight non-profit organizations (Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Environmental Defense Fund, Environmental Working Group, Natural Resources Defense Council, and WE ACT for Environmental Justice) are suing FDA to seek a prohibition on the use of various flavors in food.  The lawsuit is the latest non-profit effort to compel FDA action after the Agency has not acted on a citizen petition.  In this case, a citizen petition was filed in 2016 requesting that FDA amend its regulations to no longer authorize the use of the same synthetic flavoring food additives and to establish zero tolerances for the additives.
  • The seven flavors at issue, which are cleared under 21 CFR 172.515 (“Synthetic flavoring substances and adjuvants”), are benzophenone (also known as diphenylketone), ethyl acrylate, eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol), myrcene (also known as 7-methyl-3-methylene-1,6-octadiene), pulegone (also known as p-menth-4(8)-en-3-one), pyridine, and styrene.  The complaint, filed in the U.S. Court of Appeals for the Ninth Circuit, alleges that these substances cannot be added to food because they are carcinogens under the Delaney Clause, as set out in Section 409(c)(3)(A) of the Federal Food, Drug, and Cosmetic Act.
  • The Styrene Information and Research Center (SIRC)  has submitted a petition to FDA, requesting that the Section 172.515 listing for styrene be removed because its use as a flavoring has been permanently abandoned.  It will be interesting to see whether additional abandonment petitions are filed for any of the other six flavors targeted in the suit.
  • As part of its Green Chemistry Initiative and the Safer Consumer Products (SCP) implementing regulations, California’s Department of Toxic Substances Control (DTSC) has released its Draft Three Year Priority Product Work Plan (2018-2020).  The Plan indicates that it will “address exposures from harmful chemicals that migrate from consumer products into food.”
  • DTSC identifies as “Candidate Chemicals” in food contact materials:  (1) Bisphenol A and Bisphenol S as a “constituent in plastic resin lining food and beverage cans,” (2) perfluoroalkyl and polyfluoroalkyl substances which “create grease-proof and water-proof coatings for food packaging;” (3) phthalates as plasticizers; and (4) styrene as a “constituent of polystyrene and rubber products.”
  • Five NGOs (i.e., the Center for Environmental Health (CEH), Environmental Working Group (EWG), Clean Water Action (CWA), Breast Cancer Prevention Partners, and UpStream) submitted comments supporting the inclusion of food contact materials in the Draft Work Plan.  DTSC will now develop information through research, information call-ins, and public workshops to decide whether to regulate food packaging as a Priority Product.  To date, only children’s foam-padded sleeping products containing tris (1,3-dichloro-2-propyl) phosphate (TDCPP) or tris (2-chloroethyl) phosphate (TCEP) have been officially regulated as a Priority Product, effective July 1, 2017.)