Food Protection Trends - September 2011 - (Page 575)
General Interest Paper
Implementation of the Food Safety Modernization Act
Effective July 3, 2011, The FDA Has Increased Administrative Detention Authority
CATHY CRAWFORD HACCP Consulting Group, LLC & James Dobbs, Qualtrax Inc.
INTRODUCTION
ABSTRACT
As of July 3, the authority of the Food and Drug Administration (FDA) to use administrative detention as an enforcement tool will increase. For this reason, companies that manufacture, prepare, pack or hold food should ensure that their strong record-keeping practices are strong. Under the current criteria of the Food, Drug, and Cosmetic Act, the FDA may order the detention of human or animal food if there is credible evidence or information indicating that 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), which provides greater authority to use detention as an enforcement method. The new rule allows the FDA to order detention if there is reason to believe that 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 decisionmaking skills of those implementing administrative detention, combined with the ability of companies to create and maintain good records, will determine whether detention will be used appropriately to protect health while avoiding unnecessary burdens, shipment 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 estimates that 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 that 52% of detained imported food was not released after detention. In other words, investigation showed that 52% of the detentions were justified. For the public, this implies that a majority of the FDA administrative detentions rightly protected public health. These estimates are based on imported product, because the FDA has not used administrative detention for domestic foods, for which other methods have been used, including voluntary recall, a seizure action, or referral of 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 starting on July 3. If future FDA detentions of domestic products are based on decision-making skills similiar to those employed for imports, the same rate (48%) of potentially unnecessary detentions may be the result. It should be a shared goal between industry and government to reduce
SEPTEMBER 2011 | FOOD PROTECTION TRENDS
575
http://www.foodprotection.org/files/food-protection-trends/Sep-11-Crawford.pdf
Table of Contents for the Digital Edition of Food Protection Trends - September 2011
Food Protection Trends - September 2011
Contents
Sustaining Members
Food for Thought from Your President
Commentary from the Executive Director
Epidemiological Approaches to Food Safety
Localized Chemical Decontamination of Cattle Hides to Reduce Microbial Loads and Prevalence of Foodborne Pathogens
General Interest Paper – Implementation of the Food Safety Modernization Act
Call for 2012 Secretary Nominations
New Members
What’s Happening in Food Safety
Industry Products
Coming Events
Advertising Index
Journal of Food Protection Table of Contents
Membership Application
Food Protection Trends - September 2011
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