The Food and Drug Administration (FDA) recently issued Draft Guidance on its interpretation of what constitutes a refusal of inspection by a foreign food establishment or foreign government. Though the target audience is foreign food establishments and foreign governments, the Draft Guidance provides insight into FDA’s perspective on the legal obligations that apply to all food facility inspections. In particular, FDA describes refusal to permit photography during an inspection as a refusal of inspection. We provide an overview of the Draft Guidance, including the various actions FDA considers to constitute a refusal of inspection and the repercussions when foreign food establishments or foreign governments refuse inspection. FDA requests that comments on the Draft Guidance be submitted by February 26, 2018.
Enforcement
FSMA Implementation Update: Written Assurances, Food Defense, Human Food By-Products, and More
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on
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.
Sunset of the Proposition 65 Interim BPA Warning Regulation
By Martin Hahn & Xin Tao on
The Proposition 65 Interim BPA warning regulation that allows companies to rely on a generic warning posted in California retail establishments will sunset on December 30, 2017. Food and beverage companies that have BPA containing packages in California and that have been relying on the interim BPA warning regulation for compliance should reassess their Proposition 65 warning obligations prior to December 31, 2017.
By way of brief background, effective May 11, 2016, OEHHA started requiring warnings for consumer products containing BPA under the Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65 or Prop 65). Due to the high percentage of the canned and bottled food and beverages that were packaged with BPA-containing materials in California at that time, OEHHA adopted an emergency regulation that allowed the temporary use of a standard point-of-sale warning message (e.g., posting of warnings at checkout stands in retail stores) for BPA. In July 2016, OEHHA proposed an interim rule that essentially extended the temporary regulation through December 30, 2017. The interim regulation also required food companies that exercised this option to provide OEHHA with a list of all food products in which BPA was intentionally used in the manufacture of the can lining or jar or bottle seals.
As of today, there are a total of over 23,000 entries of canned or bottled food products listed in the publicly-accessible OEHHA database for products packaged with BPA-containing materials. The sheer number of listed products in the database suggests that many food and beverage companies have been relying on the interim BPA warning regulation for compliance. On December 31, 2017, those food and beverage companies with products listed in the OEHHA database that have not phased out the use of BPA in their packaging should assess their options for compliance with Proposition 65. Companies should consult with legal counsel when assessing whether they will have an obligation to provide a Prop 65 warning and if so, the type of warning that should be required.
UK ‘Sugar Tax’ – Draft Regulations Published
By Richard Welfare & Jane Summerfield on
Posted in Enforcement
The UK tax authority HM Revenue and Customs (HMRC) has published draft Regulations setting out further details on the new UK ‘Soft Drinks Industry Levy’, which will apply from 6 April 2018.
The new levy applies to all soft drinks packaged in or imported to the UK that contain added sugar and at least 5 grams of sugar in total (both naturally occurring and added sugar) per 100ml of prepared drink (“chargeable drinks”). A levy of 18p per liter will apply, rising to 24p per liter for chargeable drinks containing 8 grams or more of sugar per 100ml.
FDA Issues Guidance on Co-Manufacturer Supplier Verification Under FSMA
By Joe Levitt, Maile Hermida & Elizabeth Fawell on
The U.S. Food and Drug Administration (“FDA”) recently issued a guidance document entitled “Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for
Human Food and Animal Food: Guidance for Industry.” This guidance is directed toward participants in “co-manufacturing” agreements in which a brand owner arranges for a second party
(the “co-manufacturer”) to manufacture food on its behalf and, as explained below, will affect contracts between brand owners and co-manufacturers, and brand owners and suppliers.
UK Food Standards Agency Reviewing Feed Law Code and Guidance
By Jane Summerfield & Josefine Crona on
Posted in Enforcement, Food Safety
The UK Food Standards Agency (FSA) is consulting on its proposals to amend the Feed Law Code of Practice and Practice Guidance. The Code and Guidance have to be taken into account by local authorities when enforcing feed law requirements in England (there are separate documents for Wales, Scotland and Northern Ireland).
The FSA is developing an innovative “whole system strategy” to feed law control and enforcement. The proposed amendments to the Code and Guidance aim to improve consistency of enforcement and reduce the regulatory burden for feed businesses, while maintaining a high level of public and animal protection.
Click here to read more.
FSMA Implementation Update: “Solely Engaged” Draft Guidance, Animal Food cGMP Guidance, Sanitary Food Transportation Training for Carriers, and Compliance Dates
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on
FDA is continuing to release resources intended to assist industry with implementation of the FDA Food Safety Modernization Act (FSMA). This post discusses four such documents that were released recently. First, FDA released Draft Guidance explaining the meaning of the phrase “solely engaged,” which is used in the regulations to establish several exemptions from the Preventive Controls for Human Food (PCHF) and Preventive Controls for Animal Food (PCAF) rules. Second, FDA finalized its Guidance on current Good Manufacturing Practice (cGMP) requirements for animal food. Third, FDA developed a training program for carriers who are subject to the Sanitary Food Transportation rule. Finally, FDA released a new web page that lists compliance dates for rules that form the foundation of FSMA.
FSMA Preventive Controls for Human Food Training Course in Beijing, China
By Maile Hermida & Xin Tao on
October 25 – 27
Hogan Lovells Office, Beijing, China
The new Preventive Controls for Human Food regulation issued by the U.S. Food and Drug Administration (FDA) under the FDA Food Safety Modernization Act (FSMA) is the most significant change to food regulation since the 1930s. FDA has started conducting inspections for compliance with the rule, both domestically and internationally.
The rule requires that key food safety management activities must be completed by a “preventive controls qualified individual” who has “successfully completed training in the development and application of risk-based preventive controls.” This requirement typically applies even if a company is located outside of the U.S., so long as it manufactures food for U.S. consumption.
Hogan Lovells attorneys Maile Hermida (Partner) and Xin Tao (Associate), both Food Safety Preventive Controls Alliance (FSPCA) lead instructors for this regulation, will present the training program developed by the FSPCA. This is the “standardized curriculum” recognized by FDA. Successfully completing this course is one way to meet the requirement to become “preventive controls qualified individual.”
Webinar: FDA’s New Enforcement Path for Listeria in the Food Processing Environment
By Joe Levitt & Elizabeth Fawell on
October 31, 2017
12:00pm-1:30pm ET
Listeria monocytogenes bacteria sickens an estimated 1,600 people each year and of those about 260 die. The dangers of Listeria foodborne illness impacting U.S. consumers are very real and the implications of an outbreak can be enormously costly to the food processing industry.
FDA is currently reviewing public comments to the “Draft Guidance to the Industry on Control of Listeria Monocytogenes” which was published in January 2017. The industry can expect final Guidance from FDA soon. The new Guidance coupled with the Preventive Controls for Human Food (PCHF) enforcement is already resulting in a much more targeted approach by FDA with focus on both industry and FDA environmental swabbing. Positive swabs for L. mono. or indicator organisms could trigger aggressive FDA enforcement action.
Join presenters representing FDA, attorneys from Hogan Lovells and an EAS Independent Consultant and internationally known research microbiologist for a webinar focusing on the challenges and new FDA regulatory requirements for the detection and elimination of L. mono. This will provide attendees with leading edge and cross-cutting information on regulatory expectations as well as control mechanisms for L. mono. With this information, the food processing industry can improve existing L. mono. control programs, ultimately benefiting the consuming public. This webinar shares the perspectives of the new FDA enforcement strategy (preventive) from FDA’s view, a microbiologist sharing the latest information about L. mono as well as food industry counsel’s view. It is a “must attend” event for anyone with responsibility for complying with FDA’s new enforcement approach.
What do we know today about the “new” dangers of Listeria? What key monitoring and corrective action measures should the industry pay attention to, adopt and implement and how can we turn today’s risk assessment results into a safer and proactive approach to Listeria control?
OIG Report Scrutinizes FDA’s Domestic Food Facility Inspection Program
By Joe Levitt, Maile Hermida & Leigh Barcham on
The Department of Health and Human Services’ Office of Inspector General (OIG) issued a report last week detailing the results of its review the Food and Drug Administration’s (FDA’s) inspection of domestic food facilities, as well as its advisory and enforcement actions taken in response to significant inspection violations. The key takeaway from the report is that FDA should do more to ensure the food supply is safe by taking “swift and effective action” to ensure facilities promptly correct problems identified during inspections. We summarize the OIG’s key findings and recommendations and also discusses how the report may affect facility inspections and subsequent agency actions in the future. Read more.