As of July 3, the Food and Drug Administration (FDA) will have increased authority to use administrative detention as an enforcement tool. For this reason, companies that manufacture, prepare, pack or hold food should ensure strong record-keeping practices.

Under the current criteria of the Food Drug and & Cosmetics Act, the FDA may order the detention of human or animal food where there is credible evidence or information indicating an article of food presents a threat of serious adverse health consequences or death to humans or animals.

As of July 3, the rule is amended under the Food Safety Modernization Act (FSMA) providing greater authority to use detention as an enforcement method. The new rule changes the criteria to allow the FDA to order detention if there is reason to believe an article of food is adulterated or misbranded. Foods can be detained for 20 calendar days with a possible 10 calendar day extension if needed.

The goal of the administrative detention of foods is to protect public health and prevent potentially harmful products from being consumed or used. Detaining products where there is doubt concerning safety certainly can reduce risk. The decision making skills of those implementing administrative detention, combined with the ability of companies to create and maintain good records will determine if detention is used to appropriately protect health while avoiding unnecessary burdens, shipments delays and added costs.

The majority of FDA administrative detention decisions historically appear to have been appropriate. According to information published in the Federal Register, the FDA estimated up to 48% of detained imported foods may have been detained because time was needed to determine the facts, and the product was later released as acceptable. This implies 52% of detained imported food was not released after detention. In other words, after investigation, 52% of the detentions were justified. For the public, this implies a majority of the FDA administrative detentions rightfully protected public health concerns.

These estimates are based on imported product because the FDA has not used administrative detention for domestic foods. Other methods have been used, including voluntary recall, instituting a seizure action, or referring the matter to state authorities. The prior use of these other enforcement methods makes it difficult to predict how often the detention of domestic product may be used as of July 3. If future FDA detentions of domestic products are based on similar decision-making skills as those employed for imports, the same 48% rate of potentially unnecessary detentions may be the result. It should be a shared goal between industry and Effective July 3, the FDA has Increased Administrative Detention Authority government to reduce that value to ensure the vast majority of detention actions are necessary and controls are effectively implemented.

The FDA indicates it is more likely to use administrative detention where this is the most effective enforcement tool available and where the use of or exposure to the product may cause temporary or reversible adverse health consequences.

This would be similar to a product potentially subject to a Class II recall. Detention decisions will be made on a case-by-case basis. The Federal Register indicates each circumstance is “fact-specific.” Recording, documenting and ensuring a solid audit trail of the facts accurately is essential to every eligible entity susceptible to such a detention. The amount of time and resources spent gathering the information necessary is a factor of how well the required audit trail has been maintained in order to release the product and save the headache and costs of being forced to keep the product from the market.

A concern for companies engaged in manufacturing or holding human or animal foods is that administrative detention actions no longer need to be justified by credible evidence. Rather, a “reason to believe” could cause potentially unnecessary product loss or shipment delays of wholesome, legal products. Where facts are missing or inappropriately recorded, FDA must act upon available information to form a reason to believe the product is or is not safe. The old adage “when in doubt throw it out” might be changed to “when in doubt, consider the use of enforcement tools.” If sufficient doubt in a product or process exists, actions should be considered by the responsible company before the FDA might do the same.

The FDA has no funds or means of reimbursement for a company facing product loss due to an administrative hold where product is later found to be wholesome. The solution to avoiding potentially unnecessary actions is to ensure case-by-case decisions are based on well -documented fact and not belief.

A thoroughly documented food safety system with validated preventive controls (a HACCP plan) is the best means to avoid unnecessary detention. This can only be achieved with appropriate training, organized record-keeping systems and process management to ensure consistent enforcement of policies. Companies should review their food safety plans or have a third party do so, paying specific attention to record-keeping to ensure communication of accurate and complete data. Electronic quality management systems are highly encouraged, based upon the potential for human error and costs associated with managing a system of manual controls.

When reviewing a data system, consider the following:

• If an activity has an impact on food safety, it should be recorded. For example, lack of evidence of appropriate use of sanitizers combined with the presence of a strong odor could lead to “reason to believe” the product is adulterated.
• The frequency of recorded events should be related to food safety and process stability. Be prepared to consider the product or process from the time of an “out-of-limits” event back to the last acceptable check as unacceptable. For example, if a company checks temperature once per hour, all production for up to one hour could be suspect if the process is discovered to be out of limits. If the same checks are once per shift, up to eight hours of production would be suspect.
• Records are to be completed in ink or signified electronically (21 CFR part 11 compliant) at the time of the event, and by the person conducting the activity.
• Each recorded activity should include either affirmative or negative results accompanied by the signature or initials of the person who completed the action. Don’t only record noncompliance. Record evidence of compliance or control as well. For example, a daily sanitation inspection should document acceptable conditions as well as any unacceptable ones.
• Following a corrective action always document a return to control or appropriate conditions. For example, documentation of unacceptable sanitation should be followed by documentation of re-cleaning and re-inspection including the results of that inspection.

These are some of the steps needed to ensure factual communication which will lead to appropriate decisions and decrease the risk and costs associated with production losses. A reason to believe a product is adulterated could arise from an anonymous call to the FDA reportable food registry, a simple observation or even a customer complaint. Companies need to be prepared to share validated documentation of product status to remove doubt wherever possible.

Administrative detention of foods can be an effective tool beginning this July, if facts support the decisions made. Manufacturers and others who store, distribute, import, or produce food can ensure this by using good record-keeping practices and adopt quality systems and technologies that enable such practices to be enforced and embraced.



Contact the Authors:

Cathy Crawford, Vice President, HACCP Consulting Group, L.L.C.
Cathy@foodsafety1.com | 757.371.5832 | www.haccpcg.com

Ms. Crawford has a broad range of experience in consulting, food manufacturing and food chemistry/microbiology laboratories. She is an enthusiastic trainer who has provided HACCP and other food safety training to a wide variety of businesses, including meat and poultry processors, bakeries, fruit and vegetable processors/packers, and food service establishments. She is a registered auditor for Safe Quality Foods (SQF). Ms. Crawford holds a master’s degree in food safety from Michigan State and a bachelor’s degree in biology from Arizona State University.

James Dobbs, Qualtrax, Inc.
jdobbs@qualtrax.com | 540.382.4234 x103 | www.qualtrax.com

 You are chartering a plane from a local flying service to take you from Denver to Salt Lake City. The flight will be later this evening and the weather doesn’t look all that wonderful. You are shown a very nice twin-engine aircraft and given your choice of three pilot/co-pilot teams. Using your certified, guaranteed, approved and blessed audit check list you proceed to check each pilot pair:

1. Pilot uniform (proper epaulets and shined shoes)
2. Headset (approved noise-cancelling model)
3. Current maps and charts
4. Pilot’s license and current medical certificate
5. Flight log (no apparent discrepancies or odd looking entries)
6. Large, complex wristwatch
7. Large sunglasses with very dark lenses
8. Flight case containing flashlight, flight plan forms, manuals, pencil, pen, antacid tablets, and airsickness bags.

In a brief walk around of the aircraft each team is able to identify and explain the function of the major components of the machine (wings, vertical and horizontal tail components, wing flaps, cowl flaps, etc.).

With all this, if you have significant experience in operational aviation, you still do not have enough information to be comfortable making the decision of whom to fly with tonight. You’ve done some “due diligence”—checking the obvious basic items without which the trip is simply not viable, but you haven’t even begun to touch on the really important details to determine the relative capabilities of the teams.

This is determined only by observing performance and you, as a prospective passenger, generally can’t do that. You are dependent on some outside agency to make the really critical determinations of pilot skills. This is done, and done rather well, in the aviation industry (as I know from the personal experience of having logged more than 3,000 hours with Airline Transport Pilot and Instrument Flight Instructor certificates).

Why have I gone into all this detail for an unrelated industry? Simply to illustrate a comparison with current systems for confirming the effectiveness of food safety programs in food producing, processing, and packing facilities.


Audit vs. Inspection. It is my observation that review of food safety operations has largely become a review of the requirements for a food safety program, with rather minimal attention to the quality of the execution of the program. I see and hear about increasing amounts of time spent AUDITING notebooks of food safety program plans and objectives with decreasing amounts of time in the production environment actually INSPECTING the functional results of those plans and objectives.

I cannot argue the need for auditing. A rigorous audit of a food facility’s programs and documentation is a necessary basis for evaluating the capability of the operation. It is necessary, but, to borrow from the world of logical analysis, it is not sufficient. To gain an adequate grasp of the overall ability of a facility to produce food within the desired safety guidelines, it is absolutely necessary to review actual operations. This review must be done at close range and involve significant interaction with the personnel responsible for day-to-day operations.

The audit function can be successful as an annual in-depth review of the entire operation with as much checking of periodic documentation as is required to satisfy the auditor. The inspection function should be more frequent and unannounced.

The inspection function should include a full, in-depth review involving equipment teardown and personnel interviews on an annual basis, and, if no discrepancies are found, a more limited semi-annual review. The primary purpose of the semi-annual review would be to provide a reasonable level of confidence that the programs promised in the audit are being delivered on the floor.


Operational Verification. An Operational Verification program addresses exactly the needs defined above. An experienced auditor would conduct an annual in-depth review of the programs and systems used in a facility. This review would assess the adequacy of the programs with regard to meeting the requirements of a variety of recognized national and international food safety programs. It would be an audit of program design and documentation of execution. An in-depth inspection of the facility operations would then be conducted either simultaneously by a different individual or within a short period of time following the program audit.

During the year following the in-depth audit and inspection, two unannounced inspections would be conducted at approximately 180-day intervals. These inspections are less intensive but still provide a thorough review of operations. The focus of these quarterly inspections is “on-the-floor” operations; the only documentation reviewed would be of day-to-day records of operational parameters.

Annual in-depth reviews are reported through the plant’s standard communications in familiar format. The semi-annual inspections can be scored and combined with the annual review for a comprehensive report or, at the discretion of the customer, held confidentially for internal use only.

Development of such an enhanced, combined audit/inspection program for initial qualification and continuing verification of food production facilities would be a significant advance over the current, once-a-year “due diligence” programs, be they announced or unannounced. I am currently involved in development of such a process; if, how, and when it will become operational is yet to be determined. 

Kraft Foods Inc. has announced it intent to create two independent public companies: a high-growth global snacks business with estimated revenue of approximately $32 billion and a high-margin North American grocery business with estimated revenue of approximately $16 billion. The company expects to create these companies through a tax-free spin-off of the North American grocery business to Kraft Foods shareholders.

"As our second quarter results once again show, our businesses are benefiting from a virtuous cycle of growth and investment, which we fully expect will continue," said Chairman and CEO Irene Rosenfeld. "We have built two strong, but distinct, portfolios. Our strategic actions have put us in a position to create two great companies, each with the leadership, resources and strong market positions to realize their full potential. The next phase of our development recognizes the distinct priorities within our portfolio. "

Over the last several years, Kraft Foods has transformed its portfolio by expanding geographically and by building its presence in the fast-growing snacking category. At the same time, the company has continued to invest in product quality, marketing and innovation behind its iconic North American brands, while implementing a series of cost management initiatives. Over the course of Kraft Foods' strategic transformation, the Board of Directors and management have continually explored opportunities to further enhance performance and increase long-term shareholder value and believe that creating two independent public companies is the logical next step. Specifically, detailed review by the Board and management has shown that these two businesses would now benefit from being run independently of each other, rather than as part of the same company.

Global snacks will consist of the current Kraft Foods Europe and Developing Markets units as well as the North American snacks and confectionery businesses. As an independent company, global snacks would have estimated revenues of approximately $32 billion and a strong growth profile across numerous fast-growing, attractive markets. Approximately 75 percent of revenues would be from snacks around the world, and approximately 42 percent would come from developing markets, including a diversified presence in numerous highly attractive emerging markets. The business would have a strong presence in the fast-growing and high-margin instant consumption channel. The non-snacks portion of the portfolio would consist primarily of powdered beverages and coffee, which have a strong growth and margin profile in developing markets and Europe.

The North American grocery business would consist of the current U.S. Beverages, Cheese, Convenient Meals and Grocery segments and the non-snack categories in Canada and Food Service. With approximately $16 billion in estimated revenue, this business would be one of the largest food and beverage companies in North America. Its portfolio would include many of the most popular food brands on the continent, with leadership positions in virtually every category in which it competes. North America's strategic priorities would be to build on its leading market positions by growing in line with its categories while maintaining a sharp focus on its cost structure. Capitalizing on the investments that the company has made during its transformation, an independent North American business would be managed to deliver reliable revenue growth; strong margins and free cash flow; and a highly competitive dividend payout.

Management is targeting capital structures to maintain investment-grade ratings with access to commercial paper for each new entity. In addition, management is developing detailed plans for the Board's further consideration and final approval. To execute the transaction requires further work on structure, management, governance, and other matters, which will take approximately 12 or more months. The current target is to launch the new companies before year-end 2012. The company will provide interim updates as appropriate. Throughout the process, management will remain focused on continuing to realize the benefits of the Cadbury integration and delivering strong business results.

Any transaction would be subject to customary conditions, including receipt of regulatory approvals, an opinion from tax counsel and a favorable ruling from the Internal Revenue Service to ensure the tax-free status of the spin-off of the North American grocery business to our shareholders, execution of inter-company agreements, further due diligence as appropriate, and final approval by the company's Board of Directors.

Nancy Culotta, NSF International’s Vice President for Food Safety Product Certification and Consumer Products, has announced plans to retire this summer, following a noteworthy 25-year career.

During her career, Culotta played a key role in globally expanding NSF’s public health services to Europe and the Asia-Pacific region.  She spearheaded several new and innovative initiatives, including launching NSF’s Drinking Water Treatment Unit program, the retail food safety program, and NSF’s Home Product Certification program.

“We are extremely grateful to Nancy for her leadership and commitment to NSF International’s public health mission for more than 25 years,” said Kevan P. Lawlor, NSF President and Chief Executive Officer. “Nancy has played a significant role in the evolution of NSF, including the development of new services and NSF’s global expansion, and her many contributions will be felt for a long time to come.”

Culotta joined NSF International in 1985 as a product certification field auditor and went on to become the General Manager of NSF’s Drinking Water and Wastewater programs. She left NSF for a year to develop a local community health organization, returning in 2000 to launch NSF’s food safety auditing services.  In this role, she was instrumental in the acquisition of Cook & Thurber and Fresh Check supermarket food safety businesses. In 2004, Culotta was promoted to Vice President of Retail Food Safety and in 2007 took the assignment as Vice President, Food Safety Product Certification, with responsibility for NSF’s Foodservice Equipment, Nonfood Compounds and Bottled Water Certification programs. In 2010, Culotta launched the NSF Home Product Certification program, bringing NSF’s considerable public health and safety expertise to the world of household kitchen appliances and other home products.

“It has been my honor to work with so many people who are dedicated to our mission of protecting and improving the public’s health and safety,” Culotta said.  “I am proud to say that each day over my 25-year career I had an opportunity to work with others in making a very real impact on public health.  I’ve had the good fortune to meet many exceptional professionals, both at NSF and throughout many industry and stakeholder organizations, and will always value the long-standing relationships I’ve developed along the way.”