July 8, 2015

TO: JPA Members

FROM: Patricia Faison

JPA Regulatory Update

Center for Environmental Health Files Petition Regarding the MADL for Lead

JPA members were earlier notified that the Environmental Law Foundation (ELF) had filed a lawsuit against food processors, including some JPA members alleging lead was found in certain baby foods, processed fruits and juices and violated California’s Proposition 65 warning requirements.

In 2013, the court ruled in favor of the defendants and found that it is appropriate to average exposure to lead over more than one day. ELF subsequently filed an appeal and this year, the court ruled on the appeal finding it is acceptable to average the lead concentration by calculating the geometric mean of the product’s lead level. The court also affirmed it was appropriate to average consumer consumption frequency data over a fourteen-day period. As background, Hogan Lovells' memorandum regarding the court ruling and published earlier this year is available here.

The California Environmental Protection Agency's (EPA) Office of Environmental Health Hazard Assessment (OEHHA) recently published a notice advising that the Center for Environmental Health (CEH) petitioned the Agency to repeal or amend the maximum allowable dose level (MADL) or safe harbor level for lead. As you may recall, the current MADL for lead is 0.5 micrograms (μg) per day. The notice and the CEH petition are available here.

The CEH contends that the current MADL is not protective of public health. In part, CEH refers to the ELF court cases regarding lead in processed fruits and juices, and notes that due to the courts' ruling that producers could average lead exposures from their products over a 14-day period, the MADL for lead would be increased from 0.5 μg/per day to up to 7 μg/per day. According to CEH, a single day exposure of 7 μg averaged over 14 days would result in an exposure of 0.5 μg/per day.

CEH notes the MADL for lead was never scientifically valid, and decades of peer-reviewed studies conducted since the limit was established in 1989 have shown that the level is not sufficiently protective. CEH urges OEHHA to publish a regulation establishing that the MADL for lead is a single day exposure limit and averaging exposure over time is not allowed when assessing compliance to the regulatory limit.

JPA will continue to monitor and provide updates, as information becomes available.

FDA Issues 2013 Food Code Supplement

In November 2013, the Food and Drug Administration (FDA) had announced publication of the 2013 Food Code. The Food Code is updated every four years and serves as model food safety guidelines to provide best practices for restaurants, retail food stores, vending operations and foodservice institutions.

The FDA recently announced publication of the Supplement to the 2013 Food Code, which can be accessed here. According to the FDA, the Supplement updates the Food Code to address recommendations made during the 2014 Biennial Meeting of the Conference for Food Protection. The Constituent Update published by the FDA's Center for Food Safety and Applied Nutrition (CFSAN) providing a brief overview of the changes to the Food Code can be accessed here. According to the Constituent Update, the Supplement revises the 2013 Food Code to:

  • "Expand the duties of the Person in Charge in a food establishment to include overseeing the routine monitoring of food temperature during hot and cold holding.
  • Expand and clarify the type of information that should be included when a Hazard Analysis and Control Point Plan is required by a regulatory authority.
  • Emphasize that cleaning and sanitizing agents should be provided and available for use during all hours of operation.
  • Clarify the difference between Typhoid Fever and nontyphoidal Salmonellosis with regard to the reporting of illness and the exclusion and restriction of ill food employees.
  • Suggest that regulatory authorities ensure that inspection staff has access to the necessary training and continuing education."

Technical corrections were made to two sections related to juice in Chapter 3, "Food": Section 3-404.11, "Treating Juice" and Section 3-801.11, "Pasteurized Foods, Prohibited Re-Service, and Prohibited Food." The next edition of the Food Code is expected to be published in 2017.

Genetically Engineered Food Labeling Initiatives

JPA has been providing updates regarding federal and state-based legislation related to the labeling of foods that are genetically engineered (GE) or contain GE ingredients. According to an article recently published on, available here, 125 Chief Executive Officers (CEOs) and business leaders in the U.S. submitted a letter to President Barack Obama, under the banner of the Just Label It initiative, urging him "to keep his 2007 campaign pledge to give Americans the right to know what is in their food by directing the Food and Drug Administration (FDA) to require food companies to label products that contain genetically modified organisms (GMOs)." The letter notes the group is concerned about the legislation - H.R. 1599. As you may recall, H.R. 1599 is the "Safe and Accurate Food Labeling Act of 2015," which was introduced in the House by Representative Mike Pompeo (R-KS) to prohibit mandatory labeling of GE foods and prohibit initiatives for labeling GE foods at the state level. In the letter, H.R. 1599 is referred to as the "Denying Americans the Right to Know" or DARK Act. President Obama is urged to oppose the legislation and to let Congress know H.R. 1599 will be vetoed if presented to him.

In a related matter, an article recently published in the online edition of the Miami Herald, available here, provides insight from the perspective of proponents and opponents of H.R. 1599. The article notes the House is expected to vote on the legislation by the end of this month.

In other news, according to an article published by Reuters, available here, the White House has directed the three federal agencies (FDA, United States Department of Agriculture (USDA) and Environmental Protection Agency (EPA)) that have oversight responsibilities for biotechnology crops to improve and modernize the regulatory "framework" to boost public confidence. The announcement was made via blog post, available here, on the White House Office of Science and Technology's website. The framework is the federal regulatory policy for ensuring the safety of biotechnology products.

According to the blog post, "the goal of the effort is to ensure public confidence in the regulatory system and improve the transparency, predictability, coordination, and ultimately, efficiency of the biotechnology regulatory system." The framework was last updated in 1992, and since that time, advances in science and technology have been altering the product landscape, according to the blog post.

JPA will continue to monitor and provide updates, as information becomes available.

Ethylene Glycol Added to Proposition 65 List

According to an article recently published by Food Chemical News, ethylene glycol has been listed under California's Proposition 65 regulation as a reproductive toxicant. Ethylene glycol is a precursor used to produce polyester resins such a polyethylene terephthalate (PET) used in the manufacture of packaging films and bottles. The article notes a 2004 report published by the National Toxicology Program's Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR) found that ethylene glycol causes reproductive toxicity in lab animals at high doses. The American Chemistry Council had earlier urged California's Office of Environmental Health Hazard Assessment (OEHHA) not to include the substance under Proposition 65 as eleven peer-reviewed studies had been published since 2004 that were not available for consideration by the NTP-CERHR. In addition, The PET Resin Association (PETRA) had submitted comments to OEHHA noting that PET-based food and beverage packaging should be exempt from labeling based on data provided by the association that shows "PET-based food and beverage packaging, including plastic water bottles, contain ethylene glycol below the No Observed Effect Level (NOEL) that would be set based on the reproductive data cited by OEHHA." The listing became effective on June 19, 2015.

JPA will continue to monitor and provide updates, as information becomes available.

As always, please contact me with questions or comments.

Patricia Faison

JPA Updates & News Scans are provided as a service exclusively to JPA members. Please do not share these communications outside the membership.

JPA Staff
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