Join us in London for a food seminar, “New U.S. food manufacturing, labeling, and inspection requirements – What you need to know to export foods ”

On 19 April, Hogan Lovells will offer a seminar on recent developments in U.S. food law that affect all food companies exporting food to the U.S.

U.S. partners Maile Hermida and Elizabeth Fawell will be visiting London from Washington, DC to discuss the latest U.S. food law developments that affect foreign companies that sell food in the U.S. This session will address recent changes for food safety, nutrition labeling, import filings, and facility inspections, addressing what these developments mean for exporters and how they are affected by the political climate in the United States. Both Maile and Elizabeth have extensive experience helping companies navigate these new requirements and developing effective business solutions for managing compliance.

Topics for this two hour seminar include:
— New U.S. Food Safety Requirements (FSMA)
— New Nutrition Labeling Rules
— Impacts from and Forecast for Trump Administration
— Inspections and Enforcement

 Click here for more information and to register.

On February 9, 2018, the U.S. Cattlemen’s Association (USCA) submitted a petition requesting the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) to establish labeling requirements that would exclude synthetic products made from alternative proteins and lab-grown meat from animal cells from being marketed as “beef” and/or “meat.” The petition requests that new regulations be adopted limiting the term “beef” to describe the tissue or flesh from animals born raised, harvested, and processed in the “traditional” way, and limiting the term “meat” to the tissue or flesh of animals that have been harvested in the “traditional” manner.

Read the update.

Today, the European Commission published a new Regulation tightening the restrictions on the use of Bisphenol A (BPA) in food contact materials.

BPA is used in a number of food contact applications, such as polycarbonate plastic produced for articles that are intended to be reused, such as water dispensers, kitchenware, plastic bottles, etc.  BPA is also used to manufacture coatings for food and drink cans.  BPA can migrate into food from the material or article with which it is in contact, resulting in exposure to BPA for consumers of those foods.

Currently a prohibition on the use of BPA in the manufacture of polycarbonate infant feeding bottles is in place in the EU on the basis of the precautionary principle.  The new Regulation extends this ban by also prohibiting the use of BPA to manufacture infant cups as well as the migration of BPA from coated materials containing food intended for infants and children 0–3 year olds.
Based on an updated review of exposure data carried out by the European Food Safety Authority (EFSA), the new Regulation lowers the regulatory limit (specific migration limit or ‘SML’) for BPA and extends this restriction to coating materials, which are used to line food and drink cans.  A specific migration limit of 0,05 mg of BPA per kg of food (mg/kg) has been set for the migration into or onto food of BPA from varnishes or coatings applied to materials and articles. In addition, the new Regulation provides that no migration of BPA is permitted from varnishes or coatings applied to materials and articles specifically intended to come into contact with infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed to satisfy the nutritional requirements of infants and young children or milk-based drinks and similar products specifically intended for young children.

The new Regulation will apply from 6 September 2018.  As from that date, business operators will have to ensure, among other, that varnished or coated materials and articles are in compliance with the new rules and are accompanied by a written declaration of compliance containing:

  • details on the business operator issuing the declaration of compliance;
  • details on the business operator which manufactures or imports the coated material or article;
  • details on the varnished or coated material or article itself;
  • confirmation that the varnish or coating applied meets applicable restrictions; and
  • specifications on the use of the coated material or article (e.g., the type of food with which it is intended to be in contact, the time and temperature of treatment and storage in contact with food, the highest food contact surface area to volume ratio for which compliance has been verified).

At the present time, no total ban on the use of BPA applies as there is insufficient information on replacement substances and more assessment would need to be carried out on their safety and effectiveness before BPA could be fully replaced.  At the same time, the European Commission has mandated EFSA to undertake a full re-evaluation of BPA again on the basis of the results of anticipated new studies and scientific data to address the remaining uncertainties. This work is due to start in spring 2018.  Upon completion,  the Commission will decide what if any further action is necessary to protect consumers as regards BPA in food contact materials.

On January 11, 2018, the Food and Drug Administration issued its 2018 Strategic Policy Roadmap (the Roadmap) in an effort to provide transparency about the FDA’s policy undertakings. The Roadmap outlines key priorities that the Agency will pursue in 2018 to advance its public health mission. The Roadmap covers all FDA-regulated product areas and includes the following priorities related to food:

  • Empower consumers to make better and more informed decisions about their diets and health; and expand the opportunities to use nutrition to reduce morbidity and mortality from disease
  • Strengthen FDA’s scientific workforce and its tools for efficient risk management

FDA notes that there are areas of overlap both between all priorities mentioned as well as with other aspects of work at FDA. Importantly, for food regulation, FDA outlined how it will continue to focus on implementing the new Nutrition Facts Panel and menu labeling regulations and associated guidance, as well as continuing to implement FSMA and the associated field realignment that now
has a dedicated cadre of food (and feed) inspectors. Other noteworthy inclusions on the nutrition and labeling side are revisions to the “healthy” claims regulations, updating food standards to promote public health, providing new opportunities to make ingredient information more helpful to consumers, and advancing guidance on dietary sodium reduction. On the food safety side, FDA will
continue to build its pathogen database networks and, under FSMA, implement preventive controls rules and pay particular attention to implementing the produce safety rule through increased training and collaboration with the states.

We provide an overview of FDA’s priority areas, and the corresponding goals and action items, most relevant to food policy.

Click here to read our overview.

The U.S. Food and Drug Administration (FDA) has taken two important steps to launch the Voluntary Qualified Importer Program (VQIP) under the FDA Food Safety Modernization Act (FSMA). First, FDA has started accepting applications for participation in VQIP, a voluntary, fee-based program which offers expedited review and entry of human and animal food into the United States. Second, FDA has recognized the first accreditation body under the voluntary Accredited Third-Party Certification Program created by FSMA, a step needed to implement VQIP. This post discusses both developments.

Click here to read more.

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., and U.S. Department of Agriculture (USDA) Secretary Sonny Perdue announced a formal agreement on January 30, 2018, intended to increase coordination and collaboration between the two agencies. The high-level agreement is limited on details, but includes commitments to developing interagency working groups for the following three “issues of shared concern.”

  • Dual-Jurisdiction Food Facilities: The agreement states that FDA and USDA share the goal of streamlining oversight of dual-jurisdiction facilities by identifying and potentially reducing the number dual-jurisdiction facilities. The agencies also aim to bring greater clarity and consistency to jurisdictional decisions under USDA and FDA’s respective authorities and decrease unnecessary regulatory burdens.
  • Produce Safety: FDA and USDA express their commitment to enhancing their collaboration and cooperation on produce safety activities, including the implementation of FDA’s Produce Safety regulation under the FDA Food Safety Modernization Act (FSMA).
  • Federal Regulation of Biotechnology Products: The agreement states that the agencies are committed to modernizing the Coordinated Framework for the Regulation of Biotechnology, as well as the U.S. agricultural biotechnology regulatory system to develop efficient, science-based regulatory practice by working in partnership with other federal agencies. Both agencies have commitments for improving the regulation of biotechnology that are outlined in the September 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products and a recent Task Force on Agriculture and Rural Prosperity Report.

Click here to read more.

The U.S. Food and Drug Administration (FDA) has issued five FDA Food Safety Modernization Act (FSMA) final and draft guidance documents relating to supplier verification under both the Foreign Supplier Verification Program (FSVP) and the Preventive Controls for Human Food (PCHF) rules, as well as draft guidance regarding the Preventive Controls for Animal Food (PCAF) rule.
We briefly summarize the issues addressed in each of the following documents:

  • FSVP Draft Guidance;
  • Chapter 15 (Supply-Chain Program) of the Hazard Analysis and Risk-Based Preventive Controls for Human Food Draft Guidance;
  • Guidance on the Application of FSVP Regulation to Importers of Grain Raw Agricultural Commodities;
  • Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507 Draft Guidance;
  • FSVP Small Entity Compliance Guide (SECG); and,
  • Hazard Analysis and Risk-Based Preventive Controls for Animal Food Draft Guidance.

We encourage a close review of each of the documents, as they address important issues affecting compliance with the major FSMA regulations. Note that comments can be submitted at any time on guidance documents. FDA has established dates by when comments are requested to be submitted on the draft guidance document

Click here to read the summary.

On January 4, 2018, the Food and Drug Administration (FDA) announced through Guidance that it does not intend to enforce particular provisions of the Preventive Controls for Human Food (PCHF), Preventive Controls for Animal Food (PCAF), Produce Safety, and Foreign Supplier Verification Programs (FSVP) regulations issued under the FDA Food Safety Modernization Act (FSMA). This post provides an overview of the situations in which FDA will exercise enforcement discretion, specifically:

  • Written assurance provisions in all four rules related to the downstream control of identified hazards or microorganisms that are a potential risk to public health;
  • FSVP requirements for importers of food contact substances (FCS);
  • PCAF requirements for certain manufacturing/processing activities performed on human food by-products for use as animal food; and
  • Certain facilities that are similar to farms, but that do not meet the “farm” definition.

Click here to read more.

FDA recently shared information regarding a number of ongoing FDA Food Safety Modernization Act (FSMA) implementation issues. This post summarizes updates and developments regarding the following matters:

1. The written assurance requirements under several FSMA regulations;
2. Industry concerns regarding the Intentional Adulteration regulation;
3. Regulation of human food by-products for use as animal food when these materials are further processed to facilitate storage and distribution;
4. Various initiatives regarding implementation of the Produce Safety rule; and
5. Compliance with the Sanitary Food Transportation rule.

Click here to read more.

On December 1, 2017, the United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS or the agency) issued its Fiscal Year 2018 Annual Plan.  The Annual Plan, which is directly aligned with the agency’s 2017 – 2021 Strategic Plan, outlines the ways FSIS plans to achieve its strategic goals over the next fiscal year. It serves as an operational guide for FSIS, where the agency explains the progression of activities from the key milestones the agency achieved in FY 2017, outlines what it plans to achieve in FY 2018 and why, and describes how it will assess progress by using Strategic and Annual Plan measures and targets.

Overall, the agency anticipates focusing on prevention of product contamination and foodborne illness, modernizing systems and approaches, and streamlining to enhance business. Continuing priorities for FY 2018 include further implementation of the New Poultry Inspection System (NPIS) and Siluriformes fish inspection, effectively using Public Health Risk Evaluations (PHREs) and pathogen reduction performance standards for Salmonella and Campylobacter in poultry, and modernizing swine and egg products inspection systems. The agency plans to continue increasing use of whole genome sequencing, further develop key informational tools and resources for inspection personnel, and work with public health partners to prevent Listeria monocytogenes in retail  delicatessens. The agency will also encourage industry continued adoption of food defense and humane handling practices, and consumer adoption of safe food-handling practices.

Click here to read more.