Emerging Issues: FDA Food Safety Foreign Suppliers & US Importers Rules Impact and Guidance in 2014
Overview:On July 26, 2013, the Food and Drug Administration (FDA) issued two proposed rules in accordance with Sections 301 and 307 of the FDA Food Safety Modernization Act (FSMA): (1) governing foreign supplier verification and (2) governing third-party audits and certification.
The proposed rules represent a significant change in FDA’s approach and attempt to enhance FDA oversight of all imported human and animal food. Moreover, these rules require most importers to develop and implement a Foreign Supplier Verification Program (FSVP) for all food that they import. Lastly, imports that fail to comply with a FSVP may be subject to refusal of admission.
When finalized, the proposed rules will present a significant set of new compliance obligations for all food and beverage importers. Food companies and importers should have a complete understanding of FDA’s current thinking as reflected in this proposed rule to assess its potential impact on their businesses.
The Knowledge Group has assembled a panel of key thought leaders and practitioners to help you understand the complex issues related to the proposed rule and its impact on your firm and the broader market. The speakers will present their expert opinions in a two-hour LIVE Webcast.
Leslie T. Krasny, Partner
Keller and Heckman LLP
- What has FDA proposed? The proposed foreign supplier verification program (FSVP) establishes risk-based requirements that importers of food must follow to verify that food they bring into the United States is safe. Importers must provide adequate assurances that foreseeable hazards resulting from the manufacturing, processing, packaging, and holding of imported food are appropriately controlled, to meet the same level of public health protection as will be required under FSMA’s hazard analysis and risk-based preventive controls (HARPC) and produce safety rules for domestic food. Importers would have to develop, maintain, and follow an FSVP for each imported food, unless there is a specific exemption.
- Who would be subject to the FSVP? FSMA defines “importer,” for purposes of the FSVP, as the person in the U.S. who has purchased an article of food that is being offered for entry in the U.S. If the article of food has not been sold at the time of U.S. entry, the importer would be the person in the U.S. to whom the article has been consigned at the time of entry. Very small importers and importers with very small suppliers are excluded, and there are product exemptions, including products subject to seafood and juice HACCP.
- Why does it matter? The definition of importer under the FSVP proposed rule is very broad, and could cover entities that are unaware of their obligations under the FSVP. An importer under the proposed rule is not necessarily the importer of record, and the requirements might even apply to food manufacturers that order ingredients.
- This webinar will help you better understand the potential legal and financial implications of the FSVP for entities involved in importing food if the proposed rule is finalized in its current form. The webinar will also discuss comments submitted to FDA during the public comment period regarding key industry concerns.
Maile Gradison Hermida, Attorney
Hogan Lovells US LLP
- What has FDA proposed? FDA proposes creating an auditor accreditation system under the agency’s oversight for inspections of certain foreign facilities. These audits would have considerable transparency to FDA, including submission to FDA of audit reports and notification to FDA of conditions that could present a serious risk to public health.
- Who would this apply to? FSMA intends for this system to be limited in scope, applying only for members of the Voluntary Qualified Importer Program and imports subject to Mandatory Import Certifications. The law does not require use of FDA’s accredited auditors for other purposes—such as audits under FSVP—but FDA’s proposal could impact such audits.
- Why does it matter? FDA’s proposed rule is much broader than FSMA requires – and could affect any use of FDA’s accredited auditors in routine situations such as for supplier audits or internal food safety audits. This would mean that if you hire an FDA-accredited auditor for a reason beyond the scope intended by FSMA, such as for supplier audits, the auditor could be required to provide the audit report to FDA, immediately report serious observations to FDA, and run all testing through FDA-accredited laboratories.
- This webinar will help you better understand this complex proposal, the impact it could have on the current auditing system if finalized as-is, and the main issues addressed in industry comments to FDA during the public comment period.
Who Should Attend:
- Executives from Foreign Food Suppliers, Foreign Food Producers, U.S. Food Importers
- FSMA and Food Safety Lawyers & Attorneys
- Food Safety Compliance Officers
- Personnel/Officers whose Functions are operations, procurement and food safety and quality
- Professionals from the Food and Beverage Industries
- Consultants & Clients in the Food and Beverage Industries
- Other Interested/Related Professionals
Leslie Krasny, Partner at Keller and Heckman in San Francisco, practices regulatory law, focusing on food/dietary supplements with respect to safety, labelling, advertising and substantiation. She represents food companies including growers, processors, distributors, foodservice and retailers, and serves as General Counsel to the Produce Marketing Association. Leslie is a member of the Board of Directors of the Food and Drug Law Institute, serves on its Food and Dietary Supplements Committee, and is on the Editorial Advisory Board of Food Processing Magazine.
Prior to receiving her law degree, Leslie obtained a Masters in Cell and Molecular Biology and worked in pharmacology research at the University of California, San Francisco and at Stanford University, School of Medicine. Her scientific background is valuable in working with clients and with Keller and Heckman's scientific staff on legal matters involving technical complexity.
Leslie Krasny, Partner at Keller and Heckman in San Francisco, practices regulatory law, focusing on food/dietary supplements with respect to …
Maile Gradison Hermida practices with Hogan Lovells in the area of food and agriculture law. She represents food companies, including manufacturers, distributors, retailers, and their trade associations. Her clients are regulated by the Food and Drug Administration, Department of Agriculture, Federal Trade Commission, and other health and safety regulatory agencies at both the federal and state levels.
Maile advises clients on the development of label claims, website and promotional campaigns for products, as well as the various requirements applicable to the labeling of foods. She also provides assistance to trade associations and food companies with fashioning comments and developing strategies in response to agency rulemaking and other public policy issues. Her practice is increasingly focused on counseling companies and trade associations as to the implementation of the FDA Food Safety Modernization Act. Maile also assists clients with responses to Federal Trade Commission, Congressional, and state Attorney General investigations and counsels clients on the development, interpretation, and enforcement of laws and regulations governing food production, processing, and distribution.
Maile Gradison Hermida practices with Hogan Lovells in the area of food and agriculture law. She represents food companies, including …
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About Keller and Heckman LLP
Keller and Heckman counsels clients—from multinational corporations to start-up companies—on compliance with food and drug laws and regulations throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, dietary supplements, tobacco products, and cosmetics. Our attorneys advise clients on labeling and advertising issues, crisis management, compliance with U.S. bioterrorism laws and other laws and regulations affecting the global marketing of food and drug products, and product development and approval strategies. Keller and Heckman clients benefit from the in-depth expertise and extensive experience of our attorneys, many of whom have scientific and technical backgrounds. Our attorneys have worked for private industry; state, federal and international agencies; and consulting firms. And, with a staff of over twenty scientists, we are a leader in the use of interdisciplinary approaches to problem-solving.
About Hogan Lovells US LLP
Players in the food and agriculture sectors address regulatory challenges at every stage of the production cycle, from farm to table. Food production, processing, labeling, distribution, and advertising present issues in which business and regulation intersect. Hogan Lovells helps clients anticipate, shape, and comply with regulations from numerous agencies at the national, state, and local levels. We also assess and implement strategies that ensure compliance while advancing business objectives. Our practice team includes lawyers with high-level experience in government and who have served in senior executive positions within the food industry, including as general counsel to food companies and trade associations. Our experience also extends into science and technology with several of our lawyers having academic degrees and professional backgrounds in these areas.