Best if printed in landscape.

Recalls and Enforcement

If A Problem is Discovered

The first priority if a food-safety issue arises is to minimize the risk of exposure; this is usually accomplished by removing the food from food system.  This often involves a collaborative effort among the manufacturer, distributors, retail outlets and consumers, depending on how widely the product may have been distributed before the problem was discovered.

Another early step is to provide an awareness of the situation without causing undue or unnecessary alarm or panic. A network of communication among health professionals and regulatory agencies is a key component of that strategy. Accurate and timely information to the public (often via the media) also is an important part of responding to a food safety problem.

FDA has a major role in responding to a food safety problem; However, the product manufacturer, as well as other federal and state agencies, share responsbilitiy in resolving a food safety concern.

This page begins with a review of the rules FDA follows when a food product problem is identified.

FDA's Response

• "The Regulatory Procedures Manual ... provides ... with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters."
• Regulatory Procedures Manual
• Ch. 2 - FDA AUTHORITY
  • This chapter briefly introduces the federal court system and overviews major legislation amending the FDCA.
• Ch. 4 - ADVISORY ACTIONS - Procedures for Warning Letters
• A Warning Letter... is a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act ... Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act.
• An Untitled Letter is an initial correspondence with regulated industry that cites violations that do not meet the threshold of a Warning Letter... Untitled Letters are intended to cover those circumstances where the Agency has a need to communicate with regulated industry about violations that do not meet the threshold of regulatory significance as described above ...
• Business needs to respond to letter or the agency can take further action as described below.

If a serious problem is found, FDA will take steps to stop the business operations. Often this step is taken in collaboration with appropriate state agencies.

If the food product is unsafe, it is removed from the market. Types of product removals:

• Stock recovery -- product is still in the manufacturer's control
• Market removal -- for insignificant violations such as labeling or quality; consumers may return product if they so desire
• Full recall -- remove products from market that may be hazardous to public health

Product (Full) Recall

• Ch. 7 - RECALL PROCEDURES - Procedures for Agency units to initiate, review, classify, publish, audit, and terminate recall actions
• FDA GUIDANCE FOR INDUSTRY Product Recalls, Including Removals and Corrections

• A food business that discovers a problem with its product must report the problem to the appropriate (state?) agency.
• If a recall is necessary, the FDA or USDA must be notified.

• If the problem is discovered by a government agency, the agency must notify the food processor of action required (correction and/or recall).

• Sprouters Northwest, Inc. Recalls Raw Alfalfa Sprouts Due to Possible Health Risk - June 3, 2004 - The Food and Drug Administration has been alerted that Sprouters Northwest, Inc. of Kent Washington is recalling 2, 3, and 5 lbs. institutional trays of its raw alfalfa sprouts sent to various food institutions because they may be linked to a recent increase in Salmonellosis in Oregon and Washington State. To date, 12 cases of Salmonella Bovismorbificans possibly linked to the consumption of raw alfalfa sprouts have been reported. In light of these outbreaks, FDA is reiterating its previous alerts about eating raw sprouts. Those persons who wish to reduce the risk of foodborne illness from sprouts are advised not to eat raw sprouts. This advice is particularly important for children, the elderly, and persons with weakened immune systems, all of whom are at high risk of developing serious illness due to foodborne disease. People in high-risk categories should not eat raw sprouts.

"Salmonella Bovismorbificans is an organism rarely seen in the United Stated that can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis (swelling of the lining the heart) and arthritis. Most cases resolve without the need for medical attention.

"FDA is working closely with state officials and the company to determine the cause of this problem and what steps can be taken to combat it. The agency will provide additional information as it becomes available."

• FDA is not authorized to mandate a recall but works in conjunction with state agencies that may have that authority. FDA also works with firms that voluntarily recall a product.
• Recalls and Market Withdrawals - Background and Definitions
• Exception -- FDA is authorized to recall infant formula (21 CFR 107.200 et. seq.)
• State agencies may have authority to mandate a recall
• State will monitor the effectiveness of the recall, Federal will advise and audit the recall process
• FDA and USDA have authority to seize product (as described below)

"Recalling firms are urged to notify the local FDA District Recall Coordinator as soon as a decision is made that a recall is appropriate and prior to the issuance of press or written notification to customers ... It is recommended that you submit the information outlined in this guidance to your local FDA District Recall Coordinator as soon as possible after the decision to recall is made and the coordinator notified. It is recommended that you do not wait to submit this information until ALL applicable information is prepared and assembled prior to FDA notification. This "early" notification will allow FDA the opportunity to review and comment on your written notification and to offer guidance and assistance in your recall process."

• FDA Industry Guidance:  Recalls
• FSIS Food Recalls Fact Sheet
• Consumers are notified of recall through media announcements

• FDA Enforcement Report --weekly FDA publication containing "information on actions taken in connection with agency regulatory activities."
• FSIS Recalls Current recall news -- "Look here first for current [FSIS] recall news."

Recall Regulations 21 CFR 7.40 to 7.59

• Recall policy (21 CFR 7.40)
• Evaluation of class for the recall (21 CFR 7.41)
• Classes of Full Recalls (21 CFR 7.41(b))
• Class I - use will cause serious adverse health consequences
• Class II - may cause temporary or medically reversible health effects
• Class III - not likely to cause any health problems, usually product quality issue
• Recall strategy (21 CFR 7.42)
• Role of the firm involved -- report progress of recall to the agencies (21 CFR 7.53)
• Only FDA or USDA can terminate a recall (21 CFR 7.55)
• General Industry Guidance for Recalls (21 CFR 7.59)
• Have a written recall plan /strategy
• Have a product code system which can trace all products to facilitate a recall
• Establish a code system to identify date and time when product was manufactured, the line on which it was manufactured, where and how the product was distributed
• Maintain records of all products distributed and sold

Steps Beyond Recall

• Ch. 5 - ADMINISTRATIVE ACTIONS - Procedures for: Citation; ... Detentions of Foods
• See 21 USC 335 (also referred to as Section 305 Notice); opportunity to meet before criminal proceeding is initiated (a section 305 meeting). Also see 21 CFR 7.84 to 7.87.
• FDA is authorized "to detain meat, poultry and egg products as delegated to FDA under the provisions of the Federal Meat Inspection Act (MIA), the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)."
• FDA was also granted authority to administratively detain foods under Subtitle A of the Bioterrorism Act, and is in the process of preparing regulations to implement this new authority.
• "The detention process is another regulatory tool to achieve compliance with the Act. It should be considered when such products are encountered during regular District operations, on assignment, or as a follow-up to complaints. This procedure becomes most appropriate when no immediate arrangements can be made for local or state authority to take control of the product, and/or it appears that the product will not be held voluntarily."

• "WASHINGTON, DC - July 15, 2004 - The Food Safety and Inspection Service (FSIS) today began to detain an undetermined amount of fried pork fat that was produced in a federal establishment without the presence of USDA inspectors. These products are considered to be adulterated and FSIS encourages consumers to avoid eating them and discard them.
  ". FSIS has also withheld the marks of inspection and suspended the assignment of inspectors from the establishment. Without federal inspection, products cannot legally be distributed into commerce.
  "On July 13, FSIS program employees were refused entry to examine the facilities, inventory and records at this establishment. This is a violation of the Federal Meat Inspection Act. When an establishment applies for a grant of inspection, it is understood that every applicant will be held responsible for adhering to this law and other applicable regulations if inspection is granted.
  "FSIS' detention of these products is underway in multiple states. FSIS wants to caution consumers that despite the mark of inspection printed on the packaging, these products were not produced under USDA inspection and are considered to be adulterated. FSIS continues to investigate the incident and is taking the necessary action to remove the products from commerce."

• Ch. 6 - JUDICIAL ACTIONS - Procedures for: Seizures; Injunctions; etc

• Penalties (21 U.S.C. §333) -- first violation - imprisoned for not more than one year or fined not more than $1,000, or both; subsequent violation or committed with intent to defraud or mislead - imprisoned for not more than three years or fined not more than $10,000, or both.

• Seizure (21 U.S.C. §334)
• "The [FDA files in court] a Complaint for Forfeiture [requesting] a warrant for arrest, [that is, a court order] directing the United States Marshal to seize (take possession or [control]) the article. The theory in a Complaint for Forfeiture is that the article seized is the defendant, and [the legal action is against the article, not against a person or business. However, any] interested party, owner, or agent may appear to claim the article by filing a verified claim stating the nature of his/her interest in the article."

"FDA Seizes Adulterated Crabmeat in Louisiana - July 7, 2004 - At the request of the Food and Drug Administration (FDA), U.S. Marshals seized approximately 1,144 cases of Bernard's brand frozen crabmeat, while it was being held for sale at Southern Cold Storage Company, Baton Rouge, La, on July 2, 2004 because it was adulterated with an unapproved food additive, chloramphenicol.

"The U.S. Marshals seized approximately 304 cases of pasteurized special white crabmeat; 200 cases of pasteurized special claw crabmeat; and 640 cases pasteurized jumbo lump crabmeat. Imported from China, the frozen crabmeat can be identified by lot number 1302 with the sell by date of January 18, 2007. The seized crabmeat has an estimated value of $86,944.

"In accordance with the Federal Food, Drug and Cosmetic Act, food products that contain chloramphenicol are adulterated and are not permitted to be sold in or imported into this country. "

• Also see Chapter 6 for discussion of 1) the firm's responses, 2) disposal, 3) consent decree, 4) bond, and 5) reconditioning.

• Injunction (21 U.S.C. §332)

FDA pursues a court order requiring the business to not distribute product that is in violation of the law and to correct the underlying problem, such as manufacturing or storing product in conditions that may result in contamination.

• "An injunction is a civil process initiated to stop or prevent violation of the law, such as, to halt the flow of violative products in interstate commerce, and to correct the conditions that caused the violation to occur. It is not mandatory to demonstrate that the law has been violated to seek an injunction, only that there is likelihood that it may be violated if an injunction is not entered."
• See http://www.cfsan.fda.gov/~comm/cdfish.html

• FDA prefers that the firm voluntarily complies by correcting the situation (even recalling product), rather than forcing FDA to pursue judicial action. For example, see 9 CFR §7.40.

Communication

An important strategy when unsafe food -- or the potential for unsafe food -- is discovered is to communicate that information to the public and other agencies.

One aspect of resolving a food problem is providing effective communication with causing unnecessary panic.  The challenge is how to communicate the appropriate level of urgency without raising undue fears or concerns?  The business firm does not want “a public relations disaster,” nor do the agencies want unwarranted public fear.

• With respect to the public, public announcements via the mass media are a common technique.
• e.g. 9 CFR §7.50 Public notification of recall.

Role of Centers for Disease Control

• PulseNet at http://www.cdc.gov/pulsenet/
• Foodborne and Diarrheal Diseases Branch at http://www.cdc.gov/foodborne/
• Food Safety Office at http://www.cdc.gov/foodsafety/

Role of state agencies

CDC guide for local governments; see http://www.bt.cdc.gov/planning/pdf/cdcresponseguide.pdf

• Inter-agency communication is somewhat more formalized; e.g., Foodnet and PulseNet as communication processes.
• "FoodNet provides a network for responding to new and emerging foodborne diseases of national importance, monitoring the burden of foodborne diseases, and identifying the sources of specific foodborne diseases."
• "PulseNet is an early warning system for outbreaks of foodborne disease. It is a national network of public health laboratories that performs DNA "fingerprinting" on bacteria that may be foodborne."

Ethical consideration for industry personnel – how to respond after discovering a potential problem in a facility or product?

• Example: Ethical issues in food and agriculture
• When do I disclose a possible food safety issue, especially one that would be no more than a class III recall? Is the risk of penalty enough to offset the risk of loss due to bad publicity, especially if the risk of harm to consumers and the chance of detection by others (such as FDA) are low?

Last updated April 16, 2010

E-Mail agecinf@ndsuext.nodak.edu
Published by Agribusiness and Applied Economics
Morrill Room 217, P.O. Box 5636
North Dakota State University, Fargo, ND 58105-5636
Phone: (701) 231-7441
Fax: (701) 231-7400