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Foods (PCHF) draft guidance, which addresses the use of heat treatment process preventive controls.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 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unique opportunity for industry to identify regulations and/or information collection (paperwork) requirements that are outdated, ineffective, or unnecessary; impose costs greater than their associated benefits; or limit job creation.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. 

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.

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.

Earlier this spring, the White House Office of Management and Budget (OMB) issued additional guidance for agencies on implementing Executive Order (EO) 13771, entitled “Reducing Regulation and Controlling Regulatory Costs.”  EO 13771 established the expectation that for every new regulatory action an agency issues, it must offset the cost of the regulatory action with two deregulatory actions. OMB’s guidance supplements the interim guidance the agency issued on February 2, 2017.

Like the previous guidance, OMB’s most recent guidance addresses how agencies should implement Section 2 of EO 13771, which concerns agency actions during fiscal year (FY) 2017. However, it also addresses Section 3(d), which established that for FY 2018 and subsequent years, the White House will set for each agency a total amount of incremental costs that will be allowed when it issues new regulations and repeals regulations for the next fiscal year. The new guidance defines key terms such as an “EO 13771 regulatory action” and “EO 13771 deregulatory action” and provides further clarification of the scope of the EO, how agencies should calculate cost, and addresses how the requirements  apply in particular circumstances.

OMB also recently issued a memorandum to the heads of executive departments and agencies that lays out the next steps agencies must take as a part of the comprehensive plan to reform the federal government and reducing the federal civilian workforce. OMB’s memorandum officially ends the federal hiring freeze implemented shortly after the Trump administration took office; however, the memorandum directs each agency to develop a long-term workforce reduction plan, in addition to making near-term workforce reductions and other measures to implement the government-wide reform plan, as discussed further below. We summarize the topics covered in OMB’s guidance and memorandum of most relevance to food and agriculture companies.

Click here to read more.

On May 22, 2017, the Center for Food Safety (CFS), Breast Cancer Prevention Partners (BCPP), Center for Science in the Public Interest (CSPI), and Environmental Defense Fund (EDF), filed a complaint for declaratory and injunctive relief against the U.S. Food and Drug Administration (FDA) for the agency’s final rule regarding substances that are Generally Recognized as Safe (GRAS) for use in human and animal foods (the Final Rule). The Plaintiffs take issue with the voluntary nature of the GRAS notice program and allege the Final Rule is an “unlawful[ ] sub-delegation of authority,” an arbitrary and capricious agency action, and an abdication of statutory duty that violates the Administrative Procedure Act (APA) and the Federal Food, Drug, and Cosmetic Act (FFDCA).

By way of brief background, on August 17, 2016, FDA published the Final Rule to comply with a consent decree with CFS from another lawsuit that claimed the agency violated the APA by “indefinitely operating under a proposed rule in lieu of promulgating a final rule.”  The Final Rule clarified the criteria for when the use of a substance is GRAS and exempt from premarket approval requirements of the FFDCA for food additives. It also finalized the administrative procedure for any person to voluntarily notify FDA the basis of a conclusion that a substance is GRAS.

Click here to read more.

The Trump Administration recently released its Fiscal Year (FY) 2018 budget request. The FY 2018 budget request is notable because it proposes dramatic cuts to both the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA), among other agencies. Presidential budget proposals are at most a starting point – with Congress ultimately responsible for deciding what funds to appropriate – but often provide valuable insight into an administration’s priorities.

The FY 2018 budget request earmarks a total of $5.1 billion for FDA as a whole – an increase of $456 million or 10 percent above the funding provided by Congress in the FY 2017 Continuing Resolution. This increase, however, would consist of reducing FDA’s total budget authority by $854 million, while proposing an increase in user fees of $1.3 billion in non-food programs (which are unlikely to pass, as explained below).

The FY 2018 budget request proposes $137 billion to USDA, a decrease of $12 billion or 8 percent from an estimated $149 billion in FY 2017, and outlines plans to lower spending on USDA programs by roughly $230 billion over a decade. This memorandum discusses FDA and USDA’s plans for reducing expenditures as they relate to food safety.

As described in more detail below, the proposed FY 2018 budget calls for a sizeable reduction ($82.8 million) in FDA’s food safety program and a modest increase ($25 million) in the Food Safety and Inspection Services (FSIS) food safety program at USDA. Notably, no new user fees are proposed for either FDA or FSIS food safety budgets, although the USDA budget alludes to a desire for legislation authorizing user fees, as have past budgets.

Click here to read more.