RCI Safety Analysis: Food Safety Modernization Act Review, Part 5
Date Posted: January 24, 2013
This article is reprinted by permission from RCI Safety.
As stated in Article 1, the Food Safety Modernization Act (FSMA) presents the most sweeping reform of our food safety laws in more than 70 years.
The new law is ambitious as is the schedule to promulgate new regulations; however, to date only two proposed rules have been published in draft form.
Despite the delay in rule making, new enforcement tools are largely in place.
The FDA can now:
• Demand to inspect a broaden set of records related to food safety (Part 1),
• Suspend a facility’s registration (Part 1),
• Order the recall of an article of food (Part 2), and
• Order the administrative detention of adulterated foods (Part 2).
Sec. 206. Mandatory Recalls
Product Recalls are the last line of defense in food safety.
The first major food recall in the US occurred in 1920, when an outbreak of botulism linked to improperly canned olives compelled the government and canners to pull the product.
In 2009, the Peanut Corporation of America (PCA) issued one of the largest food recalls involving 2,100 products and more than 200 companies using PCA peanut products tainted with salmonella.
QS 1: Under what circumstance are recalls initiated?
When there is a reasonable probability that an article of food is adulterated or misbranded and exposure to it would cause serious adverse health consequences or death to humans or animals.
QS 2: Under what circumstance would the FDA initiate a mandatory recall?
Only after a company fails to voluntarily recall unsafe food after being asked to by FDA. Companies have the right to an informal hearing before an order to recall is issued. If FDA determines a recall is warranted, the company may then voluntarily recall the article of food. If the company refuses to voluntarily recall such food within the time and manner prescribed, FDA may proceed with a mandatory recall.
QS 3: Has FDA used its power of mandatory recall?
Not to date. FDA anticipates using mandatory recalls in rare cases.
QS 4: What’s the difference between a “product recall” and a “market withdrawal?”
Product Recalls are removals of a marketed product that is considered to be in violation of FDA laws (exposure could cause serious adverse health consequences or death) and is subject to legal action. Market Withdrawals are voluntary removals of a distributed product in which a minor violation (not subject to legal action) or no violation occur. Market withdrawals occur more frequently than product recalls and are attributed to issues such as undeclared ingredients, improper labeling, packaging or minor quality issues.
The difference in levels of severity is significant; however, the media and general public rarely differentiate between product recalls and market withdrawals.
Sec. 207. Administrative detention of food.
The powers of administrative detention were given to the FDA in the Bioterrorism Act of 2002 (effective July 6, 2004).
FSMA strengthened the language by changing “credible evidence” to “reason to believe” and “presents a threat of serious adverse health consequences or death to humans or animals” to “adulterated or misbranded.”
QS 5: What is “administrative detention?”
Administrative detention is when an article of food is ordered detained or held and cannot be marketed or moved unless for security, product integrity or destruction purposes in which the FDA must first approve.
QS 6: What criteria does FDA use to order an administrative detention?
The FDA may order the detention of any article of food found during an inspection or investigation if the officer has reason to believe that the food is adulterated or misbranded.
QS 7: How long can FDA detain food?
No longer than 30 calendar days.
QS 8: What new power does administrative detention provide FDA?
It gives FDA the power to immediately stop the flow of food in commerce without a court order. Suspensions typically precede a court order such as a seizure, injunction or restraining order (see Other FDA Enforcement Tools below).
QS 9: Has FDA used its power of administrative detention?
Yes. FDA first used administrative detention in 2011. Since then detentions have led to four (4) seizures, three (3) in response to severe pest infestations and one (1) due to Listeria contamination.
QS 10: Are there any foods not subject to FDA’s administrative detention?
Yes, food regulated exclusively by the USDA (e.g. meat, poultry products) is not subject to administrative detention.
QS 11: What if the food is perishable and can spoil?
FDA intends to revise its administrative detention regulation; however, provisions in the current standard state if FDA initiates a seizure against a perishable food subject to administrative detention, the seizure recommendation will be sent to the Department of Justice within four (4) calendar days after the administrative detention order is issued, unless extenuating circumstances exist.
QS 12: Is compensation available if a company’s products have been recalled or detained without cause?
Nothing in FSMA changes existing rules regarding such matters, see the Federal Tort Claims Act (FTCA). FTCA permits private parties to sue the United States in a federal court for most torts committed by persons acting on behalf of the United States. The FTCA constitutes a limited waiver of sovereign immunity.
Despite having these new powers, the FDA has used them sparingly. This is partially due to the newness of this authority.
Officials are cautiously acclimatizing the department to these new powers, which is prudent considering few of the new rules authorized under FSMA have been finalized.
Another reason for judicious use is that these actions can have grave consequences on affected parties and entire sectors of the food industry.
Links between food and illness are not always strong and mistakes could have major legal ramifications (e.g. Alar scare in 1989 cost apple growers $375 million).
However, the biggest reason FDA rarely uses these powers is they don’t have to.
The ramifications of foodborne illness are so devastating that companies cannot risk the chance of adulterated food reaching the consumer.
Other FDA Enforcement Tools
Warning letters are used to put companies on notice that FDA has documented violations during an inspection or investigation and that the company is expected to correct the violation or face enforcement action. These violations typically do not present a threat of serious adverse health consequences or death to humans or animals.
Restraining Order or Injunction
If the FDA discovers a violation that presents an immediate threat to public health, they can request a court issue a restraining order or injunction to stop the flow of a food article in interstate commerce. Restraining orders can be issued immediately without notice but typically only last a short time such as 10 days. Injunctions require a hearing but can last for any length of time.
A federal district court may issue a warrant directing U.S. marshals to take possession of foods considered in violation of the FD&C Act for public safety. Seized products may either be destroyed or reconditioned if they can be brought into compliance with the law.
Persons with an organization facing severe violations may be subject to criminal prosecution under the FD&C Act. Prosecution depends on a number of factors, including the severity and scope of the public health threat, and whether the violations are part of a pattern of illegal behavior.
________________________________________ 1 FDA defines perishable food as food that is not heat-treated, not frozen, and not otherwise preserved in a manner to prevent the quality of the food from being adversely affected, if held longer than seven (7) calendar days under normal shipping and storage conditions.
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