There have been several notable recent developments involving FSMA implementation. Most significantly, FDA proposed to extend the compliance dates for the agricultural water provisions of the Produce Safety rule and announced it will delay the start of Produce Safety rule inspections until spring 2019.  Additionally, FDA has issued another chapter of its Preventive Controls for Human
Foods (PCHF) draft guidance, which addresses the use of heat treatment process preventive controls.

In addition to summarizing these developments, this post also provides a reminder that the next round of FSMA compliance dates for the Preventive Controls rules is September 18, 2017.  Read more.

The European Court of Justice has held that Member States may not adopt emergency measures prohibiting genetically modified food and feed (GMOs) unless there is clear evidence that a particular GMO presents a serious risk to health or the environment in accordance with Article 34 of the GMO Regulation (EC) No 1829/2003.

Ruling in favor of farmers of genetically modified maize, the ECJ held that the precautionary principle, allowing provisional risk management measures where the possibility of harmful effects has been identified (but not conclusively established), should not be interpreted as relaxing the so-called “safeguarding clause” in Article 34. In this case, referred to the ECJ by an Italian District Court, new evidence of potential harm from studies carried out by Italian research institutes was not sufficient to support the requested emergency measures and invalidate the previous authorization of genetically modified maize by the European Food Safety Authority.

While the majority of EU consumers remain averse to GM crops, this ruling shows that Member States will require conclusive scientific evidence in order to rely on the safeguarding clause which has previously been used to prevent the growth of GMOs.

You can read the full judgment of Fidenato and Others (C-111/16) here.

This post originally appeared on Hogan Lovells Focus on Regulation.

The U.S. Food and Drug Administration (FDA) has issued a broad request for comment to assist the agency in identifying regulations and related paperwork requirements that it could modify, repeal, or replace to reduce the regulatory burden on the public. The request is specific to products within the jurisdiction of the Center for Food Safety and Applied Nutrition (CFSAN) (i.e., human food, dietary supplements, and cosmetics) and presents a unique opportunity for industry to identify regulations and/or information collection (paperwork) requirements that are outdated, ineffective, or unnecessary; impose costs greater than their associated benefits; or limit job creation.

FDA issued the request as part of its implementation of Executive Orders (EOs) 13771 and 13777. EO 13771, entitled “Reducing Regulation and Controlling Regulatory Costs,” states that it is the policy of the executive branch to be prudent and financially responsible in the expenditure of funds from both public and private sources and to manage the costs associated with the government imposition of private expenditures required to comply with federal regulations. EO 13777, entitled “Enforcing the Regulatory Reform Agenda,” directs each agency to establish a Regulatory Reform Task Force to evaluate existing regulations and make recommendations regarding their repeal, replacement, or modification. The information the public submits in response to the request for comment will supplement FDA’s review of its regulations.

This post summarizes FDA’s requests and the specified formatting and instructions for providing comments.  Read more. 

Effective September 30, 2017, California’s Office of Environmental Health Hazard Analysis (OEHHA) will require warnings for consumer products containing furfuryl alcohol under the Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65). Furfuryl alcohol is a food contaminant that can occur in a potentially significant number of thermally processed foods because it forms as a result of the Maillard reaction that gives many foods a characteristic brown color. As has been the case with other food contaminants listed under the Proposition 65, we expect private litigants to file lawsuits after the warning requirement becomes effective. Companies marketing or manufacturing food products that undergo a Maillard reaction should consider whether furfuryl alcohol is forming and should evaluate their potential obligations and exposure in anticipation of the September 30 effective date.

Read more.

FDA has started conducting inspections to assess compliance with its Foreign Supplier Verification Programs (FSVP) regulation. The initial FSVP compliance date was May 30, 2017, though FSVP importers may have later compliance dates for their various suppliers that are smaller sized businesses. Inspections started earlier this summer. In this post we provide a brief overview of how these inspections are progressing based on the inspections we have learned about.

Read more.

U.S. exporters of dairy products to China are subject to importing country listing requirements for manufacturers or processors as a precondition of market access.  Recently, the U.S. Food and Drug Administration (FDA) has signed a Memorandum of Understanding (MOU) with the Certification and Accreditation Administration of the People’s Republic of China (CNCA), formally establishing a registration process for U.S. food manufacturers who export certain foods to China.  FDA also issued guidance for industry on how to establish and maintain a list of U.S. milk and milk products, infant formula, and formulas for young children manufacturers or processors.

In this post we summarize the key legal requirements for exporting dairy products to China.

Read more.

Partner Roy Zou and Senior Associate Jessie Xie from our Beijing office contributed to this post. 

There have been several recent developments regarding implementation of the FDA Food Safety Modernization Act (FSMA) of interest to the food industry. In this post, we summarize the following topics:

  • Delayed start date for inspections for compliance with the preventive controls requirements under the Preventive Controls for Animal Food (PCAF) rule and under the Foreign Supplier Verification Programs (FSVP) rule for animal food importers;
  • Guidance for low-acid canned food (LACF), seafood, and juice manufacturers regarding compliance and exemptions under FSMA;
  • Updated domestic and foreign reinspection fee rates for fiscal year (FY) 2018;
  • Release of new Food Safety Plan Builder software to assist with development of food safety plans; and,
  • Clarification regarding the definition of “retail food establishment” for purposes of the waiver from requirements under the Sanitary Transportation of Human and Animal Food rule.

Click here to read our update.

Effective July 7, 2017, California’s Office of Environmental Health Hazard Analysis (OEHHA) has listed glyphosate as a carcinogenic chemical under the Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65).  Glyphosate is one of the most heavily used weed control chemicals in food and agricultural production. It is reported that each year more than 300 million pounds of glyphosate-based herbicides are sprayed on food crops, lawns and home gardens in the U.S. We summarize the key issues presented by the listing of glyphosate for the food industry.

Click here to continue reading.

There have been several recent developments regarding implementation by the Food and Drug Administration (FDA) of the FDA Food Safety Modernization Act (FSMA) that should be of interest to the food industry. In this post, we summarize the following topics:

  • Regarding imports:
    • FDA’s recognition of Australia’s food safety system as comparable to the United States, which allows for modified Foreign Supplier Verification Programs (FSVP) requirements of certain foods imported from Australia;
    • Information from FDA to importers about key things they need to know about compliance with the FSVP rule and what to expect during upcoming inspections;
    • Launch of a website where organizations can apply for recognition as a third-party accreditation body.
  • Information from FDA on the agency’s implementation of the Sanitary Transportation of Human and Animal Food (Sanitary Food Transportation) rule;
  • FDA’s plans to extend the compliance dates for the agricultural water requirements of the Produce Safety regulation; and
  • Inflation-adjusted values applicable to several very small business-related definitions used in the FSMA rules.

    Click here to read more.

The Food and Drug Administration (FDA) announced today on its website that it intends to extend the compliance date for the Nutrition Facts Panel (NFP) final rules.  The agency action provides much needed clarity and assurance to the industry that an extension will be granted.

The current compliance dates are July 26, 2018 for large businesses and July 26, 2019 for manufacturers with less than $10 million in annual food sales.  The agency intends to extend the compliance date via a forthcoming Federal Register notice.  In a March 2017 letter to Secretary of Health and Human Services (HHS) Dr. Tom Price, a number of trade associations requested that FDA extend the compliance date until May 2021, or 5 years after the date the final rules were published.  It is unclear whether FDA will provide the requested 5-year compliance period.

The intended extension comes in response to the difficulties many companies were experiencing with getting compliant labels on food products given the absence of clear guidance from FDA on added sugars, dietary fiber, and other elements of the new requirements and the limited capacity of the packaging suppliers to print new labels for the entire food industry in the limited period of time granted by the original final regulation.  We will provide additional details on the compliance date extension once available.  Please do not hesitate to contact us with any questions.