The Food and Drug Administration (FDA) recently made two notable announcements regarding implementation of the FDA Food Safety Modernization Act (FSMA). First, FDA released a tool to assist companies with meeting supplier verification requirements under FSMA. A new section of the FDA’s Data Dashboard will help companies that perform supplier verification under FSMA by functioning as a “one stop shop” for identifying compliance and enforcement information related to specific suppliers. Second, FDA announced that the Voluntary Qualified Importer Program (VQIP) will not launch until the Fiscal Year (FY) 2020 benefit year—i.e., October 1, 2019. VQIP is a voluntary, fee-based program that offers expedited review and entry of food into the United States.
The Office of Management and Budget (OMB) recently released the Spring 2018 Unified Agenda of Regulatory Actions for federal agencies, which outlines the rulemaking actions currently under development in each federal agency. This post summarizes the major actions that may be of particular interest to the food industry that are being planned by the U.S. Food and Drug Administration (FDA), Food Safety and Inspection Service (FSIS), Animal and Plant Health Inspection Service (APHIS), Food and Nutrition Service (FNS), and Agricultural Marketing Service (AMS). After highlighting the most significant priorities, we provide charts for each agency that provide additional details on their plans.
Food product labels are under intense scrutiny from consumers, regulators, class action lawyers, and non-governmental organizations (NGOs). Demands for more information, as well as changes to or prohibitions on labels’ use of certain terminology, are on the rise. But do label-reform advocates fully appreciate the legal and regulatory complexities and burdens food-labeling revisions impose on the industry, especially when those changes involve state-specific rules? Martin Hahn and Samantha Dietle discuss in the Washington Legal Foundation’s Legal Backgrounder.
The Food and Drug Administration (FDA) has released an Excel file that lists all general inspection citations included on every FDA Form 483 (Inspectional Observations) issued for almost the past ten years, from October 2008 through February 2018. The information is specific to each establishment that has been inspected by FDA across all areas of the agency’s jurisdiction, including food facilities. We encourage all food companies to review their data so that they are aware of the information that is now readily available for review by the public.
The release of these inspection citations is connected to the Open Government Initiative issued by President Obama on January 21, 2009. Pursuant to this initiative, the agency’s stated purpose for now releasing this data set is to “improve the public’s understanding of how the FDA works to protect the public health, provide the public with a rationale for the Agency’s enforcement actions, and to help inform public and industry decision-making.” Pursuant to this initiative, the data set provides information on general inspection citations under all areas of FDA jurisdiction.
The Food and Drug Administration (FDA) recently posted a document on its website that lists all importers that have been identified at entry in connection with the Foreign Supplier Verification Programs (FSVP) regulation. As discussed in the link below, this posting is a statutory requirement under the FDA Food Safety Modernization Act (FSMA). The list simply provides all of the FSVP importer names that have been declared at entry, which means that some companies are listed multiple times with slight variations in their name. We expect the list is too general to help most companies determine whether there are any entries for which they have been declared as the FSVP importer without permission. However, the list could be helpful to companies that have never knowingly been declared as an FSVP importer so they can become aware they were declared and therefore may be subject to an FSVP inspection.
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.
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.
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.
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.