In May 2012, the Canadian Food Inspection Agency (CFIA) published a report called The Improved Food Inspection Model: The Case for Change which outlined the agency's current approach to food inspection, the context for a new food inspection approach, and the proposed components of an improved food inspection model.
The report explains that when CFIA was first established in 1997, it brought together food inspection programs from different federal departments with diverse inspection approaches. As a result, CFIA currently administers eight, separate food inspection programs including:
- fish and seafood
- fresh fruits and vegetables
- imported and manufactured food
- processed products (including honey)
Without a standardized food safety inspection model, CFIA has struggled to provide consistent oversight of all regulated food. According to the CFIA report:
Having eight food programs has resulted in the development and use of different risk management frameworks, inspection methods, and compliance verification and enforcement approaches. This challenges the CFIA to manage risks consistently across different types of establishments and different foods. It creates situations in which foods of similar risks may be inspected at different frequencies or in different ways. The eight food programs also result in industry having to meet multiple and different requirements that are challenging to address.
The challenge of maintaining eight different inspection programs coupled with changing methods of global food production, processing and distribution has necessitated the development of an improved and standardized food inspection model.
Earlier this month, CFIA drafted a proposal for a single food inspection model based on risk and prevention of non-compliance that would replace the eight food inspection programs the agency currently operates. The new model has five key components:
- Licensing/registration – A licensing and registration requirement for regulated parties that import or export food or that manufacture or process food for trade between provinces;
- CFIA oversight – Varying levels of CFIA oversight that would be based on the level of risk;
- Inspection – A systems approach to inspection that would assess the preventative control plans and procedures of regulated parties to ensure that food is prepared safely and complies with regulations;
- Compliance and enforcement – One common compliance and enforcement strategy for food; and
- System performance – Mechanisms to evaluate the CFIA’s inspection program for consistency, effectiveness and performance.
CFIA is hopeful that an updated food inspection system will benefit the food industry in a number of ways. For instance:
Inspection modernization will improve market access and give Canadian companies the flexibility to design controls that demonstrate their operations and products comply with all relevant federal standards. It will also create a more level playing field for businesses by streamlining the inspection process into a single system and eliminating the need for businesses to address multiple requirements.
In addition, the new model is also intended to increase transparency thus providing consumers with greater confidence in the safety and wholesomeness of their food.
The CFIA is seeking comments from the public including consumers and industry stakeholders until October 31, 2012 on the proposed draft model and intends to organize extensive outreach activities with CFIA inspectors, consumer associations, industry, and federal, provincial and territorial government counterparts in the fall.
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 reason the food has been determined to be reportable (agent);
- A description of the root cause of the reportable food (if applicable);
- A brief justification of the process used to determine which product(s), lot(s), or batch(es) were affected;
- Whether or not the submitter believes all of the reportable food has been removed from commerce;
- A brief description of the corrective actions taken to avoid repeating the reportable event;
- The commodity type of the reportable food;
- The dates that the product was manufactured;
- Whether or not the reportable food underwent treatment to reduce microorganisms;
- A brief description of the microbial reduction treatment;
- Whether or not a bacterial isolate is available for FDA collection;
- For reportable foods intended for animal consumption, the animal species that the reportable food was intended to be consumed by;
- For reportable foods intended for animal consumption, the life stage of the animal that the reportable food was intended to be consumed by;
- Whether the responsible party has notified all of its immediate previous sources (suppliers) of the reportable food (if applicable); and
- 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.
I authored the following article that appeared in the April 29, 2011 issue of Food Chemical News:
As the clock ticks on the FDA’s 24-hour deadline to report to the FDA’s Reportable Food Registry, a food retailer, manufacturer or supplier is forced to make snap decisions that can profoundly impact business and litigation.
Once a report is submitted, the FDA promptly alerts customers and suppliers of the "reasonable probability" that the product will result in "adverse health consequences or death." 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, food companies are now painfully aware.
But some burning questions regarding FDA’s RFR remain for the food industry, including if and how the agency will:
(1) use the RFR as an enforcement tool;
(2) move toward the concept of "control" and away from "possession" in interpreting one of the key exceptions to the RFR;
(3) address what it perceives as "out of control" undeclared allergen problems; and
(4) use the information obtained through the RFR to shape coming regulations on required preventive controls.
Let’s take a stab at answering some of these questions and a few others.
Will FDA Use RFR as an Enforcement Tool?
The RFR was created by Congress as part of the Food and Drug Administration Amendments Act of 2007 and is codified at 21 U.S.C. §350f. The RFR requires that "as soon as practicable, but in no case later than 24 hours after a responsible party determines that an article of food is a reportable food, the responsible party shall  (A) submit a report to [FDA] ... and (B) investigate the cause of the adulteration if the adulteration of the article of food may have originated with the responsible party." 21 U.S.C. §350f(d)(1).
The reporting includes a "one step up and one step back" requirement. Food companies must identify their suppliers and customers to FDA through the web portal.
The FDA Food Safety Modernization Act (FSMA) tweaks the RFR and requires the FDA to promulgate new regulations requiring submission of "consumer-orientated information," including a description, product ID codes, contact information and anything else FDA deems necessary to enable consumers to accurately identify whether they are in possession of the reportable food.
The congressional intent behind the RFR is to provide the FDA with a mechanism to track patterns of adulterated product, essentially as an information gathering tool. Many in the industry fear that the FDA also will use the RFR as an enforcement tool. Even an unintentional failure to report in compliance with 21 U.S.C. §350f constitutes a criminal violation of the Food, Drug, and Cosmetic Act (FD&C Act).
It’s not clear if the FDA has initiated any enforcement action based on the RFR yet, but this should be monitored closely by the food industry.
Can You Take Advantage of Intra-Company Transfer Exception to Reporting Obligation?
21 U.S.C. § 350f(d)(2) provides an exception to the reporting obligation if:
The challenge with interpreting this exception centers on the term "transfer." The FDA's current draft guidance says: "A transfer to another person occurs when the responsible person releases the food to another person. 'Person' is defined in section 201(e) of the FD&C Act as including individuals, partnerships, corporations and associations. FDA does not consider an intra-company transfer in a vertically integrated company to be a 'transfer to another person,' where the company maintains continuous possession of the article of food."
The rub is that if the product is shipped to a third-party warehouse, but the responsible party maintains ownership and direct control over distribution, the product is reportable. The FDA’s draft guidance rationalizes that "'[p]erson is defined in section 201(e) of the FD&C Act (21 U.S.C. 321(e)) as including individuals, partnerships, corporations, and associations," and a "warehouse operator is a distinct legal person."
Another scenario under the 21 U.S.C. § 350f(d)(2) exception that is not addressed by the FDA's draft guidance arises if the product is subject to an intra-company transfer but the company uses a common carrier to transport the product. Under the FDA's rationale that use of a third-party warehouse takes a company out of the exception, a common carrier also could be considered a "distinct legal person" to which the product is transferred, eliminating the exception and requiring the company to report.
Many believe that the FDA (and the statute) could not intend that an otherwise unreportable food under 21 U.S.C. §350f(d)(2) become reportable for no reason other than that a company uses a third-party trucking company in an intra-company transfer. Many also question whether the FDA's current position on third-party warehouses is correct if the food company retains complete control over the product.
Neither of these policies reflects the reality of how many food companies operate. From a food safety policy perspective, many believe that food companies should not be forced into the business of trucking and warehousing.
Some believe that the FDA might be moving away from interpreting "transfer" through the lens of possession and broadening its view toward an interpretation based on issues of control. Control might reflect more accurately the reality of food production and promote more effectively food safety and the intent of the RFR. Whether the FDA will move toward a notion of control should be revealed in the FDA's expected amendments to its draft guidance and should be monitored closely by the industry.
In January 2011, the FDA issued its first annual report on the RFR, which provides statistics on the first full year of the RFR (2,240 entries, 229 "primary reports," a breakdown by hazards, etc.) (see FCN Jan. 28, Page 8). Beyond the statistics, companies should take particular note of the FDA’s focus on both allergen controls and creation of food safety plans.
The FDA reported that undeclared allergens/intolerances accounted for 34.9% of its primary reports. Industry experts assert that the FDA believes that the industry does not have good control over the issue of undeclared allergens. These experts believe that the FDA will give special attention to this issue in promulgating regulations under the FSMA's requirements for hazard analysis and preventive controls. In anticipation, manufacturers should consider now how they can change manufacturing processes to address the undeclared allergen issue.
Do You Have A Food Safety Plan? If So, Will It Be Sufficient Under FSMA?
In FDA’s report on its RFR results , FDA Deputy Commissioner for Foods Michael Taylor says “[s]everal key U.S. industries are already re-evaluating their hazard and preventive controls, core principles of the Food Safety Modernization Act recently passed by Congress. We also anticipate improved reporting as we continue our vigorous outreach to food facilities through federal, state, local and foreign agencies, to help us expand the positive effect of the RFR on the safety of the U.S. food supply.”
The RFR will be a guide for the FDA in risk assessment and writing regulations for preventive controls and what companies must include in their food safety plans. The new hazard analysis and preventive controls requirements in FSMA are not required to go into effect until July 4, 2012, 18 months from the date of enactment.
Deputy Commissioner Taylor's comments suggest that industry standards already might be moving in the same direction. To mitigate the risk of FDA enforcement actions, product liability claims, supply chain contract claims and recalls, food manufacturers should anticipate the FDA's eventual rule making, and update or create food safety plans that address the hazard analysis and preventive controls prescribed by the FSMA. One way to anticipate FDA's direction is to mine the information FDA has collected (and continues to collect) as part of the RFR.
(A) the adulteration originated with the responsible party;
(B) the responsible party detected the adulteration prior to any transfer to another person of such article of food; and
(C) the responsible party –
(i) corrected such adulteration; or
(ii) destroyed or caused the destruction of such article of food.