Tag Archives: FSMA

Jason Klinowski Presents at the 3rd Advanced Summit on Food Safety Regulatory Compliance

Recently, I had the privilege of speaking at the American Conference Institute’s 3rd Advanced Summit on Food Safety Regulatory Compliance, which was held in Chicago, Illinois on June 26-27 2012.  My presentation discussed: “How to Prepare and Implement Effective Remediation and Corrective Action Plans Post-Inspection.”  Notable conference attendees included counsel and/or representatives from ConAgra Foods, H.J. Heinz Company, J.M. Smucker Company,  Whole Foods Market and others.  Freeborn & Peters LLP was a proud sponsor of this event.

My presentation provided a practitioner’s point of view (as outside general counsel to numerous food companies) on how to prepare a proper response to a FDA 483 Report of Investigation, which including drafting tips, best practices and response strategies.  Following this same format, I also discussed how to prepare effective corrective action plans  and reconditioning plans.

For those of you who may be interested, here is a link to my presentation:

Jason Klinowski’s – ACI Presentation

FSMA Update: FDA Releases New Information Related to Food Facility Registration

The FDA recently published information answering three frequently asked questions:

QUESTION:  What form do I use to renew a food facility registration?

ANSWER:  FDA Form 3537.

Registrants must use Form 3537 to register, update, or renew a registration. Form 3537 is being updated to meet registration renewal needs. The next registration renewal cycle begins October 1, 2012. Facilities may register online via the Internet at www.fda.gov/furls, which operates during business hours from 7:00 am to 11:00 pm U.S. Eastern Standard Time.

QUESTION: Am I required to renew a food facility registration online? 

ANSWER:  No!  Registrants can renew food facility registrations online or submit the paper Form 3537 by mail or fax. A business with multiple facilities may also register on a CD-ROM by mail. FDA encourages online registration as the least costly, quickest, and most efficient means for food facility registration. With online registration, a food facility must enter all of the required information before the system will accept the submission. After all required information has been entered, a registrant will receive confirmation of registration and a registration number. Paper registration is a more costly and less efficient process to supply FDA with registration information and to provide food facilities with their registration numbers. Further, paper registration may have a higher number of errors or omissions on the form, which may require additional time to complete the registration process.

QUESTION: Why wait until October 1, 2012 to start the registration renewal process? 

ANSWER:  Because you will be required to do it again between Oct. 1 and Dec. 31, 2012.   The FDA Food Safety Modernization Act (FSMA) mandates that all food facilities that are required to register must renew their registrations every other year during the period beginning on October 1st and ending on December 31st of each even-numbered year. The first registration renewal cycle will occur from October 1 to December 31, 2012.

As always, more information may be found at: Food Safety Modernization Act – FAQ Page

Please keep in mind that the FDA does not provide answers to questions of registration strategy, information disclosure and impact of registration choices on frequency of inspections and the classification of a food facility as high risk or non-high risk.  These are ALL very important issues that need to be addressed.

FSMA Update: FDA Releases New Information Related to Food Facility Registration

The FDA recently published information answering two frequently asked questions:

QUESTION:  Does the Food Safety Modernization Act require a food facility to submit additional information to FDA in order for the facility to receive a food facility registration number?

ANSWER:  Yes!  Section 102 of FSMA amends section 415(a)(2) of the Federal Food, Drug, and Cosmetic Act by requiring food facilities to submit registrations to FDA containing additional information. Specifically, registrations are required to contain the e-mail address for the contact person of the facility, or for a foreign facility, the email address of the United States 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.

QUESTION: Will food facilities already registered with FDA under section 415 of the FD&C Act be required to renew their registrations during the October 1 – December 2012 registration renewal period? 

ANSWER:  Yes!  All facilities that are required to register must renew their registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. The first registration renewal cycle will be held from October 1 to December 31, 2012. Registrants are required to submit registrations to FDA containing the new information added by section 102 of FSMA. As new requirements and guidance go into effect related to facility registration renewal, FDA will post the information on this FSMA website.

As always, more information may be found at: Food Safety Modernization Act – FAQ Page

FSMA: Comment Period Opened on Food Facility Information Collection Program

The Food and Drug Administration (FDA) recently announced an opportunity for public comment on the proposed collection of certain information by the Agency.  This notice solicits comments on the information collection provisions of FDA’s program of voluntary submission of food facility profile information and the new Form FDA 3797, which may be submitted electronically via the FDA Industry Systems Website. 

Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188) (the “Bioterrorism Act”) FDA was further authorized to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. The Bioterrorism Act added section 415 of the FD&C Act (21 U.S.C. 350d), which requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA.  (emphasis added).  FDA regulations at 21 CFR 1.230 through 1.235 set forth the procedures for registration of food (including animal food/feed) facilities.

The types of information the FDA proposes to collect in its voluntary food facility profile includes, among other things:

  • The facility type (i.e. manufacturer/processor, re-packer/packer, warehouse/holding facility)
  • The products and related hazards (i.e. biological, physical, chemical), along with preventive control measures associated with said products
  • Facility information (i.e. food safety training, facility size, number of employees, operational schedule, etc.)

With respect to the collection of information, FDA invites comments on the following topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

The deadline to submit either electronic or written comments on the collection of information summarized above is July 10, 2012.  Please take full advantage of this opportunity.  These rules will affect how the industry operates and establishs another key standards against which a food facility will be measured.  As such, it is important to voice your concerns to the FDA during these comment periods.

Jason Klinowski Published in Food Safety Magazine

The April 2012 edition of Food Safety Magazine’s eDigest includes a Food Safety Modernization Act Update Article that I co-authored along with John Shapiro. 

Please see a link to the article below:

Food Safety Magazine – FSMA Legislative Update

This article looks at the “FSMA One-Year Progress Report” and discusses where we are with the implementation of this historic act.

FSMA: Is There Penalty for Non-Compliance with a Recall Order?

YES!  The FDA may assess fees under Section 107 of the FSMA for non-compliance with a recall order under Section 423(d) or 412(f) of the FD&C Act. 

Non-compliance may include:

             1.         Not initiating a recall as ordered by the FDA

            2.        Not conducting the recall in the manner the FDA specifies in the recall order

            3.         Not providing the FDA with requested information regarding the ordered recall

Who Pays the fee for non-compliance with a recall order?

The party responsible for paying the non-compliance with a recall order fees include:

  • The responsible party for a domestic facility
  • An importer who does not comply with a recall order

The party paying the fee would be the party that received the recall order.  Importantly, this means that a distribution or storage company who owns or operates a food facility to provide services to others may be subject to this penalty even though they may not own the food. 

How much will a non-compliance with a recall order fee cost my company?

Rates: For Fiscal Year 2012, the hourly rate per FDA inspector participating in a reinspection is $224.00 per hour is 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 anticipated number of direct hours spent on taking action in response to the company’s failure to comply with a recall order.  

Billable Activities: conducting recall audit checks, reviewing periodic status reports, analyzing the status reports and the results of the audit checks, conducting inspections, traveling to and from locations, and monitoring product disposition.

How can my company guard against or minimize its exposure to these  fees?

BE PREPARED!

  • Successful inspections are the result of comprehensive preparation.
  • Assess your company’s compliance with all relevant statutory and regulatory requirements.
  • Understand the FDA’s inspection process and know your rights at every stage
  • Be prepared to manage and control the inspection process… don’t let it control you.

Jason Klinowski Published in The Produce Professionals’ Quarterly Journal

The Blue Book Services recently published the April/May/June 2012 issue of its Blueprints – Produce Professionals’ Quarterly Journal publication and included a Food Safety Modernization Act Update that I authored.  Please see a link to the article below:

 FSMA: What Importers Need to Know

This article is VERY timely.  I hope you find it informative and useful.

 

 

FSMA: Am I Operating a High-Risk Food Facility?

According to a recent FDA guidance document, the FDA’s risk-based model for prioritizing inspections of food establishments utilizes technology to analyze traditionally available information and to set the agency’s priorities for allocating domestic inspection resources. 

What does this mean in layman’s terms?

It means the FDA is going to analyze the data it already collects, tracks and monitors to determine the agency’s priorities when it comes to identifying food facilities to inspect. 

How does the FDA identify a high-risk facility?

The answer to this question is two fold.  First, the FDA looks at inherent risk factors at the industry wide level.  The industry wide risk factors include, but are not limited to:

  • foodborne illness outbreaks
  • recalls
  • reports of adverse events associated with a specific industry of category of food (i.e. cantalope, sprouts, etc.) 

Secondly, (and most importantly) the FDA looks at inherent risk factors at the firm or company level.  The firm or company level risk factors include, but are not limited to:

  • the known safety risks of the food manufactured, processed, packed or held at the facility.  (i.e. if your facility handles high-risk food(s) your facility will be deemed a high-risk facility based on that fact alone)
  • compliance history of the firm or company (i.e. food recalls, outbreaks of foodborne illnesses and prior violations of food safety standards)
  • the rigor and effectiveness of your hazard analysis and risk-based preventative controls.
  • whether the food manufactured, processed, packed or held at the facility meets the criteria for priority under section 801(h)(1) of the FD&C Act, which relates to the prioritization to detect intentional adulteration in food offered for import into the U.S.  (applies only to foreign food facilities)
  • whether the food or the facility the manufactured, processed, packed or held such food has received a certification from the FDA under the foreign supplier verification program or the voluntary qualified importer program.
  • anything else the FDA deems necessary and appropriate.  Two known examples include the establishment type / type of activity conducted at the facility (i.e. manufacturer/processor, repacker/packer, etc.) and the number of years since last inspection.

How is the information used to determine inspection priority?

The FDA’s decision-making process is based primarily on the first two bullets and the last.  The balance of the risk factors will be incorporated into the FDA’s decision-making process as they continue to develop their data collection and testing tools and will be laid out in the forthcoming Preventative Controls regulation.

In addition, the FDA may inspect facilities more often than the frequency mandate as a result of emerging public health information, follow-up to violative inspections and/or samples, etc.

From a technical position, the FDA is utilizing “a software program that assesses the characteristics of each facility in the agency’s inventory.”  This “software provides data access, analysis and reporting from the agency’s internal data systems.”   See Domestic Facility Risk Categorization

What does all of this mean to my business?

The FDA estimates that there are approximately 22,325 domestic high-risk (HR) food facilities and about 60,000 non high-risk (NHR) domestic food facilities.  FSMA calls for all HR domestic food facilities to be inspected within five years of the date the bill was signed into law.  Thereafter, all HR food facilities will be inspected once every three years and all NHR food facilities will be inspected once every five years.  Importantly, FSMA limits its inspection of food facilities to only those required to register under the Section 415 of the FD&C Act, which is the Bioterrorisim Act.

Food companies would be well advised to start preparing for inspections NOW before the USDA comes knocking.   A company may proactively mitigate many of the FDA’s risk factors through preparation.  For example, there should be no excuse for a food company not to:

  • be properly registered under the Bioterrorism Act.
  • have the proper food safety plans and related standard operating procedures prepared and ready for inspection. 
  • be in compliance with many of the already known food safety rules.  
  • possess a solid understanding of how to manage a FDA inspection
  • and more…

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.