In April of 2013, Nicholas Kluge wrote an article titled: Government Liability for an Unnecessary Product Recall This article analyzed the recent decision of Los Angeles Salad Co. v. Canadian Food Inspection Agency, 2013 BCCA 34, which is a British Columbia Court of Appeals case. In this…
As reported by The Packer (and announced by the FDA), “the FDA is reopening the comment period for a draft risk assessment for certain food facilities that include farm packing operations for fresh fruits and vegetables.” See FDA Reopens Comment Period on Food Facilities.
The FDA recently issued a DRAFT guidance for the food industry discussing the agency’s current thinking regarding the necessity of food categories in food facility registrations.
DISCLAIMER: The forthcoming discussion relates to draft guidance that is still open for comment, modification and retraction. As such, it is not intended for immediate implementation in its current form and it does not create a legally enforceable responsibility.
Step One: Relevant Rule (FD&C Act & Bioterrorism Act)
Section 305 of the Bioterrorism Act, generally required domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA by December 12, 2003 (See 68 FR 58894). This section also required facilities to submit registrations to FDA containing information regarding applicable food product categories as identified in 21 CFR 170.3.
Step Two: Necessity to be Determined by the FDA Through Guidance
Section 415(a)(2) of the FD&C Act, as added by section 305 of the Bioterrorism Act, provided in relevant part that, when determined necessary by FDA “through guidance,” a registrant must submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in 21 CFR 170.3) of food manufactured, processed, packed, or held at such facility.
Step Three: FDA Issued the Requisite Guidance and Finding of Necessity
On July 17, 2003, FDA issued a guidance stating that the agency had determined that the inclusion of food product categories in food facility registrations was necessary for a quick, accurate, and focused response to an actual or potential bioterrorist incident or other food-related emergency (see 68 FR 42415).
Step Four: Net Result…
Section 305 of the Bioterrorism Act, in relevant part, requires a food facility registrant to submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in 21 CFR 170.3) of food manufactured, processed, packed, or held at such facility.
What’s New Under FSMA?
Step One: The New Relevant Rule
FSMA, enacted on January 4, 2011, amended section 415 of the FD&C Act. Section 415(a)(2) of the FD&C Act, as amended by section 102 of FSMA, now provides in relevant part that, when determined necessary by FDA “through guidance,” a registrant must submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in 21 CFR 170.3 or any other food categories, as determined appropriate by FDA, including by guidance) of any food manufactured, processed, packed, or held at such facility.
Step Two: Necessity to be Determined by FDA Through Guidance
FDA believes that it is necessary for a food facility to submit to FDA a registration containing the general food category as identified in 21 CFR 170.3 and any other food categories as identified below, if applicable, for a quick, accurate, and focused response to a food-safety related issue or an actual or potential bioterrorist incident, other food-related emergency, or food safety incident.
FDA believes that information about a facility’s food categories is a key element to allow for rapid communications between FDA and facilities directly impacted by actual or potential bioterrorist attacks, other food-related emergencies, or food safety incidents. Information about the categories of food a facility handles currently assists FDA in conducting investigations and surveillance operations in response to food-related emergencies. These categories also enable FDA to quickly alert facilities potentially affected by such an incident if FDA receives information indicating the type of food affected.
Section 102 of FSMA, also provides in relevant part that FDA may, through guidance, determine that additional food categories, other than those listed in 21 CFR 170.3, are appropriate for the purposes of food facility registration under section 415 of the FD&C Act.
Step Three: FDA Issued a DRAFT Version of the Requisite Guidance and Finding of Necessity
This draft guidance document also addressed the FDA’s finding of necessity needed to include additional food categories into the food facility registration process. To this end, the “FDA believes that the following additional food categories are appropriate for food facility registration and will include such categories as mandatory fields in the food facility registration form when FDA finalizes this guidance”:
Additional Food Categories for Foods for Human Consumption:
- Acidified Food (see 21 CFR 114.3(b));
- Cheese and Cheese Product Categories: Soft, Ripened Cheese; Semi-Soft Cheese; Hard Cheese; Other Cheeses and Cheese Products;
- Dietary Supplement Categories: Proteins, Amino Acids, Fats and Lipid Substances; Animal By-Products and Extracts; Herbals and Botanicals;
- Fisher/Seafood Product Categories: Fin Fish, Whole or Filet; Shellfish; Ready to Eat (RTE) Fishery Products; Processed and Other Fishery Products;
- Fruit and Fruit Products: Fresh Cut Produce; Raw Agricultural Commodities; Other Fruit and Fruit Products;
- Fruit or Vegetable Juice, Pulp or Concentrate Products;
- Low Acid Canned Food (LACF) Products (see 21 CFR 113.3(n));
- Nuts and Edible Seed Product Categories: Nut and Nut Products; Edible Seed and Edible Seed Products;
- Shell Egg and Egg Product Categories: Chicken Egg and Egg Products; Other Egg and Egg Products;
- Vegetable and Vegetable Product Categories: Fresh Cut Products; Raw Agricultural Commodities; Other Vegetable and Vegetable Products; and
- Baby (Infant and Junior) Food Products Including Infant Formula.
Additional Food Categories for Foods for Animal Consumption:
- Grain or Grain Products (i.e., barley, grain sorghums, maize, oat, rice, rye, wheat, other grains or grain products);
- Oilseed or Oilseed Products (i.e., cottonseed, soybeans, other oilseeds or oilseed products);
- Alfalfa Products or Lespedeza Products;
- Amino Acids or Related Products;
- Animal-Derived Products;
- Brewer Products;
- Chemical Preservatives;
- Citrus Products;
- Distillery Products;
- Fats or Oils;
- Fermentation Products;
- Marine Products;
- Milk Products;
- Minerals or Mineral Products;
- Miscellaneous or Special Purpose Products;
- Molasses or Molasses Products;
- Non-protein Nitrogen Products;
- Peanut Products;
- Recycled Animal Waste Products;
- Vitamins or Vitamin Products;
- Yeast Products;
- Mixed Feed (e.g., poultry, livestock, equine);
- Pet Food;
- Pet Treats or Pet Chews;
- Pet Supplements (e.g., vitamins, minerals); and
- If none of the above food categories apply, print the applicable food category or categories (that does not or do not appear above).
Step Four: Net Result… (coming some in final form)
Once FDA issues the final version of the aforementioned guidance document, the foregoing rules about registrations and additional food category disclosures will become a mandatory requirement for food facilities and a legally enforceable obligation under FSMA.
On July 31, 2012, the FDA announced its fee structure for rates to be assessed under the Food Safety Modernization Act in 2013. The rates for 2013 are $221.00 per hour if no foreign travel is required and $289.00 per hour if foreign travel is required. These new rates will be effective from October 1, 2012 through September 30, 2013, which is when the next fiscal year’s fee schedule will be published.
The good news is that the 2013 rates are lower than the 2012 rates, which were $224.00 per hour is no foreign travel is required and $325.00 per hour if foreign travel is required. Perhaps the rate reduction in 2013 is a sign that the FDA is attempting to implement FSMA in light of the known operational realities and pain tolerances for administrative fees that exist in the food industry.
With that said, it is important to remember that FSMA’s fee structure represents hourly rates charged by each FDA inspector participating any type of billable activity related to a given case. As a reminder, billable activities include 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. Other billable activities include 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. Simply put, even with a reduced fee structure, FSMA related fees can add up quickly and significantly impact businesses.
Will the FDA charge and collect fees under FSMA in 2013?
Because FDA recognizes that for some small businesses the full cost recovery of FDA reinspection or recall oversight could impose severe economic hardship, FDA intends to consider reducing certain fees for those firms. FDA is currently developing a guidance document to outline the process through which firms may request such a reduction of fees. FDA does not intend to issue invoices for reinspection or recall order fees until this guidance document has been published.
Who will be affected by these fees?
Only those parties in the food and feed industry whose non-compliance results in the following activities:
- Facility reinspections – follow-up inspections conducted by FDA subsequent to a previous facility inspection that identified noncompliance materially related to a food safety requirement of the Federal Food, Drug, and Cosmetic Act (the Act). The reinspection must be conducted specifically to determine that compliance has been achieved.
- Recalls – food recall activities performed by FDA that are associated with a recall order with which a responsible party has not complied.
- Importer reinspections — follow-up inspections of a food offered for import conducted by FDA subsequent to a previous inspection that identified noncompliance materially related to a food safety requirement of the Act. The reinspection must be conducted specifically to determine that compliance has been achieved. As discussed in F.2.2., these fees will not be assessed until the agency has resolved issues associated with these fees and the public has been notified by the agency.
Can small businesses have their fees waived?
The FY 2013 fee schedule does not contain any reduced fee rate for small business. However, FDA does not intend to issue invoices for reinspection or recall order fees until a guidance document to outline the process through which firms may request a reduction of fees has been published. Once published, invoices will be issued and firms can apply for reductions as outlined in the guidance.
How does FDA plan to charge these fees?
For facility reinspection fees, FDA will invoice the responsible party for each domestic facility and the United States Agent for each foreign facility for the direct hours, including travel, spent to perform the reinspection at the appropriate hourly rate. For recall order fees, FDA will invoice the responsible party for each domestic facility or an importer who does not comply with a recall order under sections 423 or 412 of the Act for the hours spent to cover food recall activities associated with such order. For importer reinspection fees, FDA will invoice the importer for the direct hours spent to perform the reinspection including travel. Detailed payment information will be included in the invoice.
Which fiscal year rate will be used and when?
The fiscal year in which the reinspection occurs dictates the fee rate to be applied. For example, if a reinspection was conducted in September, 2012 and the invoice was issued in October, 2012, the fee rate to be applied would be the FY 2012 rate. The invoice clearly itemizes the fiscal year, hours and rate used to calculate the total invoice amount.
How long does the responsible party have to pay the fees?
Payment must be made within 90 days of the invoice date.
What happens if the responsible party or U.S. Agent does not pay?
Any fee that is not paid within 30 days after it is due shall be treated as a claim of the United States government subject to provisions of subchapter II of Chapter 37 of Title 31, United States Code.
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 http://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.
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
- 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…