Register Today for FDA's Public Meetings on Two Major FSMA Proposed Rules

Earlier this year, the Food and Drug Administration (FDA) made some progress toward implementing the Food Safety Modernization Act (FSMA) by issuing two new proposed food safety rules. Specifically, the agency published proposed rules to establish standards for (1) growing, harvesting, packing, and holding of produce for human consumption (the “Produce Safety Rule”) and for (2) current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the “Preventive Controls for Human Food Rule”).

These two proposed rules are just the first step for establishing the framework for the modern food safety system called for by FSMA. Eventually, the FDA intends to release additional proposed rules addressing importer foreign supplier verification, preventive controls for animal food, and accreditation of third party auditors. A helpful overview of the proposed Produce Safety Rule and the Preventive Controls for Human Food Rule can be found here.

The FDA is currently in the process of soliciting comments on the proposed rules from industry stakeholders. The public may offer comments to the proposed rules over the course of the next several weeks. To facilitate that process FDA is planning to host two additional public meetings in Chicago, IL and Portland, OR in March. These meetings are the second and third in a series of public meetings announced in the January 31, 2013 Federal Register Notice and on FDA’s FSMA website. The first public meeting will be held February 28-March 1, 2013, at the U.S. Department of Agriculture in Washington, DC.

Stakeholders will be permitted to submit oral comments during the public meetings. In addition, the meetings aim to inform the public about the FDA rulemaking process (including how to submit comments, data and other information to the rulemaking dockets), and respond to questions about the proposed rules. 

In Chicago, the forum will be held on March 11-12, 2013 at The Westin on Michigan Avenue. The meeting in Portland will take place on March 27-28, 2013 at Crown Plaza Portland Downtown Convention Center. To register for either event visit FDA’s registration page:

FDA Releases Two New Proposed Food Safety Rules

On January 4, 2013, exactly two years after the Food Safety Modernization Act (FSMA) was signed into law by President Obama, the Food and Drug Administration (FDA) published two new proposed food safety rules that will be available for public comment for the next 120 days.

The first rule on “Preventive Controls for Human Food” sets safety requirements for facilities that process, package or store food to be sold in the United States, whether produced at a foreign or domestic-based facility, for human consumption. A separate rule will be issued for animal food in the near future. The rule will require that food facilities implement “preventive controls,” a science-based set of measures intended to prevent foodborne illness similar to Hazard Analysis and Critical Control Points (HACCP) systems that are already required by FDA for juice and seafood processors. Each covered facility would be tasked with preparing and implementing a written food safety plan, which would include the following:

  • Hazard analysis;
  • Risk based preventive controls;
  • Monitoring procedures;
  • Corrective actions; verification; and
  • Recordkeeping. 

The FDA is also seeking public comment on a second proposed rule, which proposes enforceable safety standards for the production and harvesting of produce on farms.

This proposed “Standards for Produce Safety” rule proposes science- and risk-based standards that would address the major areas of concern for the fruit and vegetable industry including:

  • Irrigation and other agricultural water;
  • Farm worker hygiene;
  • Manure and other additions to the soil;
  • Intrusion of animals in the growing fields;
  • Sanitation conditions affecting buildings, equipment and tools.

FDA indicated that the effective date of both proposed rules would be 60 days after the final rule is published. However, in order to allow all businesses, particularly small and very small facilities, adequate time to comply with the new requirements of the rule, FDA plans to adjust the compliance dates based on the facility’s size.

Although many in the food industry believe these rules are long overdue, FDA notes that it conducted extensive outreach to the produce industry, the consumer community, other government agencies and the international community. Since January 2011, FDA staff have toured farms and facilities of all sizes nationwide and participated in hundreds of meetings and presentations with global regulatory partners, industry stakeholders, consumer groups, farmers, state and local officials, and the research community. The goal was to develop proposed rules that could be applied to small and large food facilities alike.

FDA intends to release additional proposed rules addressing importer foreign supplier verification, preventive controls for animal food, and accreditation of third party auditors.

The attorneys at Stoel Rives will be providing more details about the proposed rules implementing FSMA here at the Food Liability Law Blog in the coming weeks. Stay tuned.

FDA Extends Food Facility Registration Deadline Until January 31

The Food and Drug Administration (FDA) has extended the deadline for food facilities to submit their registration until January 31, 2013.

Under the FDA Food Safety Modernization Act (FSMA), domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to renew their facility registration by December 31, 2012, and every two years after that. FSMA directed that the food facility registration portal would be available starting on October 1, 2012.

However, FDA experienced a delay in implementing the biennial registration renewal for the 2012 cycle. As a result, the registration renewal portal did not become available until October 22, 2012. Food industry members requested that FDA extend the time to register in order to allow companies a full three-month window to complete the renewal requirement. In a new guidance document issued on December 12, 2012, FDA noted that it would exercise its enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013. 

Failure to register a facility, renew the facility registration, or update required registration information can have serious consequences. For instance, the U.S. can bring a civil or criminal action in federal court against a company that handles food without a proper facility registration. In addition, if food being imported or offered for import into the U.S. is from a foreign facility for which registration has not been submitted, the food could be held at the port of entry and may not be delivered to the importer, owner, or consignee of the food until the foreign facility is registered with FDA.

Along with the month-long extension, the FDA released an updated question-and-answer on facility registrations, and a shorter, simplified compliance guidance document for small businesses.

Mark Your Calendars! Biennial Registration of Food Facilities Under FSMA Starts Next Week

Registration of food facilities with the U.S. Food and Drug Administration (FDA) has been a requirement for almost a decade. Since the passage of the Public Health Security and Bioterrorism Preparedness Response Act on June 12, 2002, facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States have been required to register with FDA in order to provide the agency with information on the origin and distribution of food and feed products, thereby aiding in the detection and quick response to actual or potential threats to the U.S. food supply.

Starting next week, however, all food facilities required to register with FDA must begin biennial re-registration to comply with the provisions of the Food Safety Modernization Act (FSMA). Signed into law on January 4, 2011, FSMA now requires that food facilities re-register every 2 years with FDA, during the period beginning on October 1 and ending on December 31 in even numbered years. The first registration renewal cycle under FSMA starts and Monday, October 1 and will continue until Monday, December 31, 2012. Even if a food facility is already registered with FDA, the facility is still obligated to renew registrations during the October 1-December 1 timeframe.

When registering, it is important for food facility representatives to remember that additional information is now required to accompany the registrations under FSMA. Specifically, registrations must contain the e-mail address for the contact person of the facility, or for a foreign facility, the email address of the U.S. agent for the facility, and an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Additionally, if determined necessary by FDA, registrations are required to contain information regarding other applicable food categories, as determined appropriate by FDA, for foods manufactured, processed, packed, or held at registering facilities.

On a related note, under FSMA, the FDA is now, for the first time, explicitly granted the authority to suspend the registration of a food facility in certain circumstances involving food manufactured, processed, packed, received or held by a registered facility that has a reasonable probability of causing serious adverse health consequences or death to humans or animals. FDA did not previously have a process for suspending the registration of a food facility in such circumstances. If the FDA were to exercise this authority and suspend the registration of a food facility, that facility would be prohibited from introducing any food into the stream of commerce in the U.S., including importing or exporting food into the U.S.

Make sure to start submitting your registrations on Monday! To register, update, or renew a registration, food facilities must submit the paper Form 3537 by mail or fax or register online at FDA encourages online registration as the least costly, quickest, and most efficient means for food facility registration.

FDA Updates the Reportable Food Registry

This week, the Food and Drug Administration (FDA) updated the Reportable Food Registry (RFR) to include a Rational Questionnaire incorporating additional data elements as part of an effort to improve the RFR’s information gathering capability.

The additional elements are the following:
  1. The reason the food has been determined to be reportable (agent);
  2. A description of the root cause of the reportable food (if applicable);
  3. A brief justification of the process used to determine which product(s), lot(s), or batch(es) were affected;
  4. Whether or not the submitter believes all of the reportable food has been removed from commerce;
  5. A brief description of the corrective actions taken to avoid repeating the reportable event;
  6. The commodity type of the reportable food;
  7. The dates that the product was manufactured;
  8. Whether or not the reportable food underwent treatment to reduce microorganisms;
  9. A brief description of the microbial reduction treatment;
  10. Whether or not a bacterial isolate is available for FDA collection;
  11. For reportable foods intended for animal consumption, the animal species that the reportable food was intended to be consumed by;
  12. For reportable foods intended for animal consumption, the life stage of the animal that the reportable food was intended to be consumed by;
  13. Whether the responsible party has notified all of its immediate previous sources (suppliers) of the reportable food (if applicable); and
  14. Whether the responsible party has notified all of its immediate subsequent recipients (customers) for the reportable food (if applicable).

The RFR, created by Congress as part of the FDA Amendments Act of 2007, is an electronic portal for industry to report when there is "reasonable probability" that an article of food will cause "serious adverse health consequences." It covers all human and animal food/feed regulated by FDA except infant formula and dietary supplements for which FDA has other mandatory reporting systems.

In addition, the RFR does not accept submissions regarding drugs or other medical products, reports about products under the U.S. Department of Agriculture’s jurisdiction, or reports from consumers. Registered food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States under section 415(a) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 350(d)) are required to submit an electronic report to the FDA within 24 hours of discovering reportable adulterated food.

When a reportable food report is submitted to the Safety Reporting Portal, it is sent to the FDA Risk Control Review (RCR) team for review. The team includes representatives from the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), the Office of Emergency Operations (OEO), and the Office of Regulatory Affairs (ORA). In addition, the FDA District Office for the geographic area from which the report originated receives a copy and participates in the review. Each report is then reviewed by the RCR team to assess whether the subject food or feed meets the definition of a reportable food, and to identify appropriate follow-up actions.

For reports that FDA considers to meet the definition of reportable food, an FDA District Office investigator is assigned to contact the firm or individual submitting the report to obtain additional information. The District Office investigator may visit the firm to conduct a follow-up investigation. When necessary, District Offices will advise the firm to alerts its supplier and/or its customers of the reportable food.

It is important to point out that submitting a report to the portal can have serious implications for food companies. As Ken Odza, a former Stoel Rives attorney and continued friend of the firm, wrote in a previous post, “Even if a recall has not yet been issued, an RFR report often has the consequences of a Class I recall. While RFR reports can be amended or withdrawn based on new information, in the world of food products, the bell almost never can be unrung.”

For more information about the RFR and its impact on industry, check out some of our other Food Liability Law blog posts on here.

FDA Issues Interim Regulation and Input on Document Inspection Requirements under FSMA

Effective March 1, 2012, the FDA implemented an Interim Final Rule on the “Establishment, Maintenance, and Availability of Records” under the Food Safety Modernization Act, “FSMA”.

The FSMA statute among other new provisions, expanded the FDA’s authority to access and demand records from relating to the specific suspect article of food records, to include those relating to any other article of food that the FDA “reasonably believes is likely to be affected in a similar manner.” Although they are already in effect, the comment period for these rules is May 23, 2012. . These rules were not subject to the normal public review procedure because the FDA found that it was contrary to the public interest to delay them as  the FSMA statute called for that access from its inception. The FDA has always indicated that” reasonable belief” determinations are made on a case by case basis because such decisions are fact-specific.

The expanded rule continues to reflect the requirement that records “must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee only designated by the Secretary of Health and Human services who presents appropriate credentials and a written notice.”

Also issued in February was a “Draft Guidance for Industry: FDA Records Access Directly Under Sections 414 and 704 of the Federal Food, Drug & Cosmetic Ad.”

 The guidance makes clear that records request may:

  1. Apply to either human and animal food;
  2. Apply to both domestic and foreign persons;
  3. The scope of records are those that are “needed to assist FDA in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to human or animals,” and they may access records needed to assist in determining whether there is a reasonable probably that the use of or exposure to the food will cause serious adverse health consequences or death to human or animals.

There is also a listing of what FDA believes are examples of the circumstances under which they would access documents for related food articles. They include:

  1. Salmonella outbreaks with multiple foods implicated;
  2. Multiple articles of food on an identical processing line;
  3. Articles of food in shared use equipment;
  4. Articles of food prepared, packed or held under similar conditions.

They also list examples of the type of records they could/would access:

  1. Manufacturing records;
  2. Raw materials (ingredients and packing) receipt records;
  3. Product distribution records;
  4. Product inventory records;
  5. Test records;
  6. Recall records;
  7. Reportable food records;
  8. Customer distribution lists;
  9. Complaint and adverse event records.

The FDA also lists the types of records the FDA cannot access:

  1. Records from farms;
  2. Records from restaurants;
  3. Recipes;
  4. Financial data;
  5. Pricing data;
  6. Personnel data;
  7. Research data;
  8. Sales data other than shipment data researching sales.

In the document they also address actions they make take for refusal to provide records, including civil administration actions, suspension of registration, administrative detention, seizure of the food, issuance of a recall and injunction against the firm.

Finally, the FDA also issued a 52-page guidance for Industry, Edition 5, for Questions and Answers Regarding Establishment and Maintenance of Records by Persons who Maintain, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food. This document contains numerous scenarios to provide industry with a better understanding of how the rules play out in practice.