Vermont Genetically Engineered Food Labeling Regulation

JPA has been providing updates regarding Vermont’s regulation (Consumer Protection Rule 121) and law (Act 120) to mandate the labeling of foods containing genetically engineered (GE) ingredients. According to an article recently posted on FoodNavigator-USA.com, available here, Vermont’s Attorney General, William H. Sorrell recently published a one-page memorandum noting there will be a six-month safe harbor period for foods distributed before July 1 and offered for sale through December 31, 2016. The memorandum states:

“Out of recognition that some food products have longer shelf lives, CP 121 creates a six-month “safe harbor” for foods distributed before July 1, 2016, and offered for retail sale through December 31, 2016. During this six-month period, unless there is evidence that a manufacturer distributed a mislabeled product after July 1, 2016, we will not bring an enforcement action or seek fines for those products.

Beginning January 1, 2017, all products must be properly labeled regardless of when they were distributed. In the exercise of this Office’s discretion, however, our enforcement priorities will focus on willful violations of the labeling law. Thus, even after January 1, 2017, we do not expect to bring enforcement cases based solely on a company’s failure to remove improperly labeled products that were distributed before July 1, 2016.”

In addition, the Attorney General has published a “Frequently Asked Questions (FAQ)” document related to the labeling regulation.

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

FDA Warning Letters - Juice HACCP Violation

The FDA recently published a Warning Letter to Burnham Orchards, Inc. (Berlin Heights, Ohio) citing violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 Code of Federal Regulations Part 120) for the apple cider processing facility. A copy of the Warning Letter is available here.

The Agency also issued a Warning Letter to Pressed Juicery (Fresno, California) for violations of the juice HACCP regulation. The Warning Letter is available here.

California’s Proposition 65 – Notice of Proposed Rulemaking on the Clear and Reasonable Warning Language

JPA has provided updates regarding California’s Proposition 65 regulation, which is administered by the California Environmental Protection Agency's (EPA) Office of Environmental Health Hazard Assessment (OEHHA). The Proposition 65 regulations are codified in Title 27 of the California Code of Regulations (CCR) and can be accessed here. In part, businesses must provide a “clear and reasonable” warning before exposing the public to a chemical on the Proposition 65 list of chemicals known to cause cancer, birth defects or other reproductive harm. In January 2015, members were notified that OEHHA had issued a notice of proposed rulemaking to revise Article 6 in Title 27 (“Clear and Reasonable Warnings”) to provide more detailed information on the warning language requirements.

Members were earlier notified that the Agency had been asked by product manufacturers, retail groups and other interested parties to adopt regulatory amendments that provide more guidance related to acceptable methods for providing warnings to consumers and acceptable warning content. It was also requested that OEHHA clarify the responsibilities of product manufacturers and retailers (the obligation to provide warning materials is placed on the producer or packager rather than the retail seller). Members were also notified that OEHHA had issued a notice proposing to repeal the current Article 6 and adopt a new Article 6. OEHHA received substantive comments regarding the proposed Article 6 and in November 2015, the Agency issued a notice announcing the proposed Article 6 had been revised.

On March 25, 2016, OEHHA issued a notice, available here, announcing that after receiving additional comments from the public, Article 6 has been furthered revised. A copy of the document in revision mode is available here. Of particular interest, details regarding the warning requirements for food exposures, including the warning language, are available in § 25607.1, “Food Exposure Warnings – Method of Transmission” (page 14) and § 25607.2, “Food Exposure Warnings – Content” (page 15). Requirements are also described for foods and non-alcoholic beverages sold or served by restaurants. Refer to page 17 for details.

OEHHA is proposing that under certain conditions, a symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline be placed to the left of the text of the warning. This symbol is not required for warnings related to foods and beverages.

A copy of Article 6 with all revisions accepted is available here. OEHHA is accepting comments until April 11, 2016.

Citrus Greening Research

The Environmental Protection Agency (EPA) recently issued a notice in the Federal Register (81 FR 17455; March 29, 2016) announcing an application has been submitted to the Agency by Southern Gardens Citrus requesting an experimental use permit (EUP) for Citrus tristeza virus that has been modified to contain combinations of the defensin genes (SoD2, SoD7, and SoD8) derived from spinach (Spinacia oleracea L.). The notice states modified Citrus tristeza virus will be applied to citrus trees in Florida in order to confer resistance to citrus greening disease. According to the EPA, the permit may be of regional and national significance. The Agency has established April 28, 2016 as the deadline for comment. Following the comment period, the Agency will determine whether the permit should be granted for the trial

USDA Report on Food Import Refusals

A recent article published by Food Safety News reports that the United States Department of Agriculture’s (USDA) Economic Research Service (ERS) has published a new study, which examines the food import shipments that were refused entry into the U.S. by the Food and Drug Administration (FDA) from 2005 to 2013. The report, “FDA Refusals of Imported Food Products by Country and Category, 2005 – 2013,” found that the FDA refused entry of 87,552 shipments of food into the U.S., and the following the food categories contributed to the majority of import refusals:

• Fishery and seafood products (20.5 percent of all refusals)
• Vegetables and vegetable products (16.1 percent)
• Fruit and fruit products (10.5 percent)

In this category, for 2005-2013, 1,532 shipments were refused entry, with 1,099 refusals in 2013 compared to 1,140 refusals in 2012. There were a total of 15,138 total violations in this category. (See Table 1, page 6, for details.) The most common violations cited for this category include filth (2,320 violations from 2005-2013) and pesticides (1,707 violations from 2005-2013). (Refer to Table 2 on page 8 for details.)

• Spices, flavors, and salts (7.7 percent)
• Candy without chocolate and chewing gum (7.2 percent)

According to the report, “The number of food shipments refused by FDA inspectors has remained relatively stable, despite an increasing volume of food imports over 2005-13. Thus, the number of shipments refused declined relative to the volume of imports. This decline may reflect improvements in compliance with U.S. laws among foreign producers and importers, or it may reflect FDA’s limited resources and capacity to inspect, detain, and refuse imported food.”

Mexico, India and China were the countries with the most food shipments refused entry by the FDA. (Details begin on page 19.)

New Report Examines BPA in Food Packaging

JPA staff has been providing periodic updates regarding Bisphenol A (BPA), a substance used in the manufacture of some plastics and the lining of cans used for foods and beverages. Some concerns have been raised due to possible health risks associated with this substance. According to an article published by CTVNews (Canada), available here, a new report has been published, which analyzes the interior lining of canned foods for the presence of BPA. The report, “Buyer Beware: Toxic BPA and Regrettable Substitutes in the Linings of Canned Food,” was sponsored by the Breast Cancer Fund; Campaign for Healthier Solutions; Clean Production Action; Ecology Center; Environmental Defence (Canada); and Safer Chemicals, Healthy Families’ Mind the Store campaign. In part, the goal of the study was to determine the extent BPA-based epoxy linings are used by national brands and retailers in canned food linings and to determine the types of substitutes used in “BPA-free” can linings. The interior coatings and lids of 192 cans containing vegetables, fruits, soups, broth, gravy, milk and beans were analyzed. Samples were collected in 19 U.S. states and one province in Canada. In the canned fruit category, 20 cans were analyzed with 75 percent containing BPA-based epoxy in the lining.

The study found that 67 percent (129 out of 192) of the cans tested contained BPA-based epoxy in the body and\or the lid. Five major coating types were identified in the cans analyzed: acrylic resins, BPA-based epoxy, oleoresin, polyester resins, and polyvinyl chloride (PVC) copolymers. The report raises concern about the safety of some of these alternate coatings. In part, the study recommends that national brands, retailers, grocery stores and dollar stores commit to eliminate BPA, use safer lining alternatives and label all chemicals used in can liners. Suppliers of can-linings should disclose the chemical composition of the lining and ensure the impacts on environmental and human health have been assessed. The report also recommends that Congress adopt the “Ban Poisonous Additives Act” to reform the FDA’s system for reviewing and approving the safety of packaging materials.

As a number of major brands are mentioned in the report, please review to determine if your company has been named.