Source: http://www.foodliabilitylaw.com/tags/food-safety-modernization-act/
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Home > food safety modernization act > FDA Releases Two New Proposed Food Safety Rules
Posted on August 22, 2011 by Ken Odza, former Stoel Rives attorney
As you might have heard, I’m leaving Stoel Rives LLP this month, my professional home for almost 14 years (and parts of three decades). I am honored and humbled to have been asked by The Kellogg Company to join them as their in-house food safety and quality lawyer. My departure from Stoel Rives is bittersweet. I will miss greatly my colleagues, clients and friends. Without doubt, Stoel’s food practice is the strongest in the region. This blog is among the most read in the industry. In my absence, you can look forward to continued discussion of the relevant issues in the industry from these and other Stoel attorneys:
Rick Goldfarb, one the nation’s foremost commercial lawyers, who has decades of involvement with the food industry;
Lee Smith, who is focused on the Food Safety Modernization Act, California Proposition 65 and other regulatory compliance issues; and
Anne Glazer, who is focused on counseling her clients on food labeling and marketing issues.
You can reach me at kmodza@gmail.com or through LinkedIn. If you find yourself in southwest Michigan, please look me up.
Tags: Anne Glazer, General Information, Kellogg Company, california proposition 65, food safety modernization act, fsma, ken odza, lee smith, rick goldfarb, stoel rives
Posted on June 27, 2011 by Ken Odza, former Stoel Rives attorney
Fred Degnan, from King & Spalding, led a very insightful presentation on "Responding to Government Investigations and Warning Letters" at the recent ACI food regulatory summit. His presentation led to an interesting discussion about FDA's close out of investigations.
It was generally agreed that the FDA, in essence, is not notifying parties when it has decided to close out an investigation or take no further action. But, as another conference attendee pointed out, reinspection fees under FSMA section 107 may provide an opportunity to determine whether FDA has completed its investigation. If a facility is required to pay the FDA reinspection fees, it seems logical that FDA will have to inform the facility when it has closed the file and is no longer assessing fees. Whether this becomes reality has yet to be seen.
Tags: Food and Drug Administration, Legislation, Legislation and Regulation, aci food regulatory summit, aci food summit, fda, food safety modernization act, fred degnan, fsma, king & spalding, king and spalding, reinspection fees, section 107
Posted on May 26, 2011 by Ken Odza, former Stoel Rives attorney
Following my talk, Marty Bask from Parker Smith & Feek led a very interesting discussion about the pros and cons of product recall and contamination coverage. A link to our recent discussion on this blog on what to ask when purchasing this kind of coverage is here.
Tags: Compliance, Crisis Management, General Information, Legislation, Legislation and Regulation, Litigation, Upcoming Events, contamination, contamination coverage, fda deputy commissioner, food safety modernization act, fsma, insurance, marty bask, parker smith and feek, product recall, product recall and contamination;, recall, regulatory
Posted on May 10, 2011 by Ken Odza, former Stoel Rives attorney
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.
(C) the responsible party –
Tags: 1, 21 USC 350f, Crisis Management, Legislation and Regulation, Litigation, RFR, class, class I recall" , enforcement tool, fda, fda amendments act, fda deputy commissioner, food chemical news, food safety modernization act, food safety policy, fsma, intra-company transfer exception, michael taylor, reasonable probability, recall', reportable food registry, reporting obligation, third-party warehouse
Posted on April 14, 2011 by Ken Odza, former Stoel Rives attorney
a. May 24 at Parker Smith Feek's offices in Bellevue for a discussion of the new FSMA, the Reportable Food Registry and how to survive a food product recall (event was rescheduled from March 22). Registration is free and coming soon. Contact me if you’re interested and I’ll get a spot reserved.
c. May 12-14 Northwest Food Processors Association’s Executive Business Retreat in Coeur d'Alene, Idaho.
d. June 15-16 ACI Food Safety Regulatory Compliance Summit in Chicago. I'll be speaking specifically on "Curtailing Downstream Liability Arising Out of On-Site Inspections: How to Prepare and What to Do Should the Government Come Knocking." If you register by April 15, I can arrange for a discount. Just let me know.
If you can't make these events or would like a customized in-house presentation on FSMA, the Reportable Food Registry, recalls or other food liability topics, please let me know. Also, stay tuned for new blog entries addressing such topics as the Reportable Food Registry (RFR), restaurant menu labeling, and strategies to defeat food marketing/labeling putative class claims.
Tags: ACI, General Information, Insurance Coverage, Legislation, Legislation and Regulation, Litigation, RFR, Upcoming Events, aci food safety regulatory compliance summit, aon, food liability, food product recall, food safety modernization act, fsma, northwest food processors association, parker smith feek, recalls, reportable food registry, restaurant menu labelling
Posted on March 11, 2011 by Ken Odza, former Stoel Rives attorney
Tags: Agriculture, American Cheese Society, Food Law, HAACP, Legislation, Legislation and Regulation, Product Liability, food safety modernization act, fsma, hazard analysis, ken odza, limited annual monetary value of sales, preventative controls, qualified end users, qualified facilities, section 103, small business, tester amendment
"Recall: A Financial Death Sentence?" An Upcoming Free Seminar in Bellevue, WA
Posted on March 2, 2011 by Ken Odza, former Stoel Rives attorney
If you're in the Seattle area March 22, please join me at Parker, Smith & Feek's offices in Bellevue for a discussion of the new Food Safety Modernization Act, the Reportable Food Registry, and how to survive a food product recall. Here is the full announcement of the event, including a link to registration (no charge). Hope to see you there.
Tags: USDA, Upcoming Events, fda, food product recalls, food safety modernization act, food safety seminar, fsma, parker smith feek, recall, reportable food registry
Posted on January 20, 2011 by Ken Odza, former Stoel Rives attorney
Yesterday (while taking a break from the Sustainable Food Summit in San Francisco), I traveled to Modesto, California to speak to the Manufacturer's Council of the Central Valley. I spoke about the new Food Safety Modernization Act (FSMA). The focus of my talk was how the FSMA changes the status quo for food businesses. And when I mean changes the status quo, I mean not only what a food company needs to do to comply with the FSMA, but also how the FSMA is likely to affect exposure from recalls and product liability. I also discussed in some detail the dilemmas faced by food businesses and the FDA by the Reportable Food Registry (RFR) and its fallout. Here is a link to my slide deck.
I'm willing to tailor this talk to your company or trade association; just let me know.
Please also consider attending the ABA's Food and Supplements CLE at Coke World Headquarters in Atlanta on February 17. I'll be moderating with Ricardo Carvajal a panel of experts on the FSMA including Robert Brackett (formerly head of CFSAN), Art Liang from CDC, Miriam Guggenheim and Fred Degnan. At the upcoming GMA food litigation conference in Scottsdale, Arizona, I'll be speaking with my law partner Lee Smith about specific strategies and action steps to take to reduce the increased risks from FDA compliance, and recalls and product liability exposures created by the FSMA and the RFR. We'll also touch on strategies to deal with some current trends in marketing and labeling putative class claims.
Tags: ABA, Food litigation tips, Legislation, Legislation and Regulation, Litigation, The, Upcoming Events, art liang, central, cfsan, council, fda, food and supplements cle, food safety modernization act, fred degnan, fsma, gma food litigation conference, lee smith, manufacturer, miriam guggenheim, of, reportable food registry, ricardo carvajal, robert brackett, s, sustainable food summit, valley'
The FDA's Own 30,000 Foot Take on the Food Safety Bill
Posted on December 22, 2010 by Richard Goldfarb
For what it's worth, this is the link to the FDA's own interpretation of what the new food safety bill means. Tags: Legislation, fda, food safety bill, food safety legislation, food safety modernization act
Posted on December 21, 2010 by Ken Odza, former Stoel Rives attorney
Tags: FDA recall powers, Legislation, Legislation and Regulation, food regulation overhaul, food safety bill, food safety legislation, food safety modernization act