Tag Archives: Food Safety

FSMA: Consumers are not protected when the FDA’s rules are “stuck in review.”

On March 19, 2012, the Consumer Federation of America announced that its members voted to support a resolution urging the Obama Administration to issue four proposed food safety rules, which have been delayed for over two months. 
 
“On behalf of CFA’s nearly 300 members, we urge the Administration to immediately issue these important food safety proposals,” said Chris Waldrop of CFA’s Food Policy Institute.  “The longer these proposals are delayed, the longer it will take to fulfill the promise of the Food Safety Modernization Act, which is intended to better protect consumers from foodborne illness.”  Simply put, “consumers won’t be adequately protected if the FDA’s proposals are stuck in review.”  See CFA Press Release.
 
Being in the trenches with my food industry clients on a daily basis, I can confirm that the CFA’s position is well aligned with the industry’s current thinking.   However, I would like highlight the importance of the food industry’s comment period and the FDA’s attention to our collective voice.   As we all know, it is critical for the food industry to speak up and use comment opportunities to help shape the very rules that govern our business operations. 
 
To rush this process and force a potentially premature closure to the FDA’s listening period (e.g. when FDA uses the industry’s comments to further modify the proposed rules prior to issuance) invites future litigation to resolve issues of fairness, application, constitutionality, language interpretation, etc.   Although accountability is critical, I always urge people to look at all sides of any given position.
 
With that said, we are all waiting for the FDA to issue its long overdue food safety rules.   

Video Presentations from Freeborn & Peters’ SOLD OUT Food Safety Event

For those of you who could not attend our recent food safety event at the Federal Reserve Bank in Chicago, IL on March 1, 2012, please follow the link below to see take look at the video recordings of the keynote speakers and panel discussions.  

Opportunities and Challenges in Food Importation Event Video Library

This sold out event provided some VERY important and timely information about the Food Safety Modernization Act, the FDA’s food traceability pilot programs, and the current thinking of industry leaders.

FSMA (Section 107): What triggers the facility reinspection fee?

The FDA may assess fees under Section 107 of the FSMA whenever the FDA, or its agent, inspects a domestic or foreign facility and the final classification of the facility is:

            1.         Official Action Indicated, and

            2.         The non-compliance was “materially related to food safety.”

The fee will be assessed for a reinspection of domestic and foreign facilities to determine whether corrective actions have been implemented and are effective and compliance has been achieved to FDA’s satisfaction. 

What does the FDA mean by: “reinspection”?

Domestic Facilities: Reinspection means one or more inspections conducted under the FD&C Act subsequent to an inspection that resulted in a final classification of a facility as OAI and where the non-compliance was materially related to food safety.

Foreign Facilities: Reinspection means one or more inspections conducted by officers or employees duly designated by the Secretary subsequent to an inspection which identified non-compliance materially related to a food safety requirement under the FD&C Act. 

What does the FDA mean by: “materially related to food safety”?

Some examples of non-compliant conditions or practices that “materially relate to food safety” include, but are not limited to:

  • Food borne pathogens in ready to eat products
  • Pesticide residues on food or feed products above established tolerances
  • Failure to declare the presence of a major food allergen in product labels
  • Lack of adequate hazard controls (HACCP)

Who Pays the Facility Reinspection Fees?

The party responsible for paying the Facility Reinspection Fees include:

  • The responsible party for a domestic facility
  • TheU.S.agent for a foreign facility
  • Each importer subject to reinspection

How much will a reinspection fee cost my company?

Rates: For Fiscal Year 2012, the hourly rate per FDA inspector participating in a reinspection is $224.00 per hour if no foreign travel is required and $325.00 per hour if foreign travel is required.

Number of FDA employees or agents assigned to a reinspection: The FDA will make this determination on a case-by-case basis.  Relevant factors for this decision include the size of the firm, number of products, number and nature of the violations observed in the initial inspection and the amount of expected resources needed to evaluate the firm’s corrective actions and current state of compliance with respect to the items identified in the initial inspection.   

Billable Activities: conducting the reinspection at the facility, making preparations and arrangements for the reinspection, traveling to and from the facility, analyzing records, analyzing samples, preparing reports or examining labels and performing any other activity deemed necessary to determine compliance with the regulation or statute found to be violated in the initial inspection.

FSMA – The FDA’s new records access authority

FDA’s INCREASED RECORDS ACCESS AUTHORITY  

Section 101 of FSMA amends the FD&C Act to increase the FDA’s authority to access and copy records.  Prior to the passage of FSMA, the Food Drug & Cosmetic Act (FD&C) provided the FDA access to records relating to food reasonably believed to be adulterated and presents a threat of serious adverse health consequences or death to humans or animals.  FSMA expands this access to records beyond those relating to a specific suspect article of food to records relating to any other article of food the FDA reasonably believes is likely to be affected in a similar manner. 

This new grant of authority permits FDA inspectors to significantly expand the scope of their investigation as they are no longer confined to specific articles of food identified in a complaint as being potentially adulterated.

When the FDA may access and copy records:

Under FSMA, the FDA may access and copy records from domestic and foreign food companies who manufacture, process, pack, transport, distribute, receive, hold, or import food in either of the following two situations: (1) the FDA has a reasonable belief the food, and any other food articles likely to be affected in a similar manner, are (i) adulterated, and (ii) presents a threat of serious adverse health consequences or death to humans or animals; or (2) the FDA believes there is a reasonable probability that the use or exposure to an article of food, and any other article of food likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. 

Importantly, FSMA grants the FDA access to the records of both the domestic importer and its foreign supplier.  This is consistent with FSMA’s goal of making importers responsible for ensuring food from abroad is as safe as any of our domestic products. 

To be more clear, FSMA’s enlargement of FDA authority to access and copy records extends to those records required to be kept by law (e.g., FD&C Act, Bioterrorism Act, etc.), as well as any other records related to the manufacture, processing, packing, transportation, distribution, receipt, holding, or importation of the suspect food.  This applies to records maintained by or on behalf of the company in any format and at any location.  Examples of records the FDA can access include raw materials receipts; customer distribution lists; manufacturing, test, and recall records; and complaint and adverse event records.

Records the FDA may NOT access and copy:

Notwithstanding FSMA, the FDA may NOT access and copy the following types of records:

  • Records from farms, which include facilities that pack, hold, or manufacture/process food, provided all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership
  • Records from restaurants
  • Records relating to food that is within the exclusive jurisdiction of the Secretary of Agriculture
  • Recipes, which are defined as formulas that include: (i) ingredients; (ii) quantities, and; (iii) instructions necessary to manufacture a food
  • Financial, pricing, personnel, or research data
  • Sales data (other than shipment) regarding sales

Privacy protection

The FDA may lawfully obtain information under FSMA that includes non-public confidential or trade secret information. This reality must be reconciled with those laws that govern the FDA’s disclosure of information to the public. For example, can third parties gain access to non-public confidential information provided to the FDA with a Freedom of Information Act request?  The answer: YES… It could happen.  As it stands now, the FDA will only confirm that its personnel will comply with all applicable protections, procedures, and legal requirements that are intended to protect against the unauthorized or accidental disclosure of nonpublic information. 

Refusing to turn over records to the FDA

A refusal to permit the FDA access to or copying of records is prohibited by FSMA; in response, the FDA may initiate a regulatory, civil, or criminal action in connection with the records access request, refuse admission of food offered for import into theU.S., etc.  Separate and apart from a records access request, the FDA may also pursue actions such as suspension of a food facility’s registration (preventing imports/exports or selling food domestically), administrative detention or seizure of food, issuance of a mandatory recall order, or an injunction against the company.

The Opportunity and Challenge of Food Importation

Freeborn & Peters’ Food Industry Team is proud to sponsor the Global Midwest Alliance’s Chicago Winter Food Industry and Technology Event on March 1, 2012.

Featuring Keynote Speaker Dr. Robert E. Brackett, Vice President and Director, The Institute for Food Safety and Health at the Illinois Institute of Technology.  Dr. Brackett will discuss: How Importers Can Prepare for the Impact of the Food Safety Modernization Act.

Also featuring Industry Update Speaker Tejas Bhatt, Staff Scientist, The Institute of Food Technologists.   Mr. Bhatt will discuss: The FDA’s Food Safety Pilot Program: Meeting the Challenge of Traceability.

***This event is the part of the Global Midwest Alliance Food Trade and Technology Series.

http://foodindustry.eventbrite.com

Quoted Today in Chicago Lawyer for “Legal Complications Exist for Food Trucks to Find Success”

I was very happy to have been interviewed recently by Amanda Robert of the Chicago Lawyer for an article on the legal challenges associated with “food trucks” – a burgeoning method of on-the-street distribution in the downtown loop of Chicago, as well as in many other major cities.

Among my several comments, I noted that just because food trucks drive around the streets of Chicago, it does not make them immune from the requirements that would be imposed on a stationary restaurant:

“Food truck owners need to operate out of a home base that is registered and regularly inspected by county or state health departments,” I said.  “They need to give employees access to restrooms and to sinks so they can wash their hands.  They must also follow rules on what they can serve, how they refrigerate or warm food and how they keep trucks clean.”

I can clearly see that some of my restaurant clients might be upset by competition from food trucks.  But I think that the onus is plainly on the food trucks to “amp up” their offerings.  They are not going to be a substantial presence until they can offer both value and quality – certainly not in the midst of a Chicago winter!

You can find a copy of the article on the Freeborn & Peters website.  (Yes, we purchased reprint rights from Chicago Lawyer!)