Since the new detention regulations are effective since July 03 2011, almost 90% of the law is implemented for food safety. Any food, feed, ingredients, and beverages that are unsafe or unsanitary, adulterated or misbranded can be detained from going to the market, even traceback labeling is being enforced as there are no exemptions. Just a little window dressing like better GAP’s and BMP’s are missing. At the same time every food or feed handler needs a written food safety plan.
Our newsletters always try to inform our readers about the latest FDA rule enforcement, so there will be no surprise. Some of the organizations have recently informed their members as it is getting really serious. Dr. David Acheson (former acting director of FDA) just explained it too, as you can read below.
Keep in mind: PTI is not FDA compliant as it is only a produce organization initiative with a Brand tracking code, much of which applies to Big Box stores in the US and Canada. It still doesn’t work throughout the whole food and feed supply chain. If you ship to other countries you are aware of the significance of this situation.
If the customer of your product is one of the more then 60,000 small and medium size retailers, without the new readers on the check-out counter, it is useless to put them a GTIN code on it. If you are re-sorting, re-packing and commingling you will experience difficulty with GTIN tracking code. We can implement easily a GTIN code on existing labels as there is no science behind it without extra charge if someone has one.
When you have to make a decision which system is the right one for your company, just let them take the pizza test.
Think about all the ingredients in a pizza with all your favorite toppings. Every single ingredient with their compounds has to be traced back to the source.
As a producer you need to think about where your product will end up. Will it become a nut in a candy bar, an anchovy on the pizza, a berry in a jam jar or cake or the flour on breaded fish? Or will it simply be your cheese or your tomato on a hamburger?
The labels have to match the information from the required records and have to be 100% human and machine readable on the case level; soon it will be also on item-level.
The searchable product code has to point to the record to confirm the information on the label like, date harvested, and have proof of origin plus product and PLU code.
Call ScoringAg’s consultants or our main office, if you want to be on the safe side as we provide the complete solution to be compliant with FDA from the necessary recordkeeping and prevention requirements (FDA’s recordkeeping requirements are different from accounting programs), labeling and sanitation solutions. Our customers telling us www.ScoringAg.com is the most comprehensive, easy to use and inexpensive solution for all food handlers for every commodity covered by FDA, not only produce.
Details on New Administrative Detention regulations – FDA Forging ahead with FSMA
November 3, 2011 by Dr. David Acheson
Provisions of the Food Safety Modernization Act are going into effect and the FDA is acting on them.
Effective July 3, the FDA gained added authority for the Administrative Detention of Food for which it published guidance last week. And with the seizing of product at two locations in the last few weeks, it is evident that FDA is acting on its new authorities and using the new and expanded administrative tools being put in its hands.
On October 17, FDA seized food products stored in a warehouse owned by Chetak Chicago LLC, inStreamwood,Ill., citing extensive evidence of unsanitary conditions; on September 20, product held at the food storage and processing facility of Dominguez Foods of Washington, Inc., inZillah,Wash., was seized by FDA. TheWashingtonseizure is of particular note, as the products had been held in administrative detention since early September, after an FDA inspection found evidence of widespread and active rodent and insect infestation in the facility.
According to FDA’s newly published Guidance for Industry: What You Need to Know About Administrative Detention of Foods, “administrative detention provides a means through which FDA can hold adulterated or misbranded food and prevent it from reaching the marketplace, thus further enhancing FDA’s ability to ensure the safety of food forU.S. consumers.”
Both human and animal food are subject to detention, except that which is regulated exclusively by the USDA under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act. According to the guidance, FDA may order the detention of any article of food that is found during an inspection, examination, or investigation if there is reason to believe that the article of food is adulterated or misbranded.
It is the phrase “reason to believe” that presents the greatest change in FDA authority. Previously, FDA’s ability to detain food applied only when the agency had “credible evidence that the food or feed presented a threat of serious adverse health consequences or death” to humans or animals. The expanded authority allows FDA to detain food and feed products that it has “reason to believe are adulterated or misbranded.” Additionally, FDA can detain the food for up to 30 days, if needed, keep it out of the marketplace while it determines if an enforcement action is required. The decision to detain food is taken at the FDA District level so these decisions do not have to pass through FDA headquarters to be initiated.
A detention order can be appealed by any person who would be entitled to be a claimant of the held product, but a notice of intent to file an appeal and request a hearing must be filed within four days for non-perishable foods, and within two days for perishable. The actual appeal, with or without a hearing request, must then be submitted with 10 days of receipt of the detention order.
FDA’s detention of the food inWashington, as cited above, is also of major significance because FDA had never previously administratively detained an article of food. Instead, it had relied on the states to embargo products of concern, as in the Streamwood,Ill., case cited above.
FDA now has a lower bar by which to apply and enforce administrative detention, and it seems that it has no qualms in enacting its authority at this new level. For the consumer, FDA sees the lowered bar as providing additional security against contaminated or adulterated foods which could potentially cause foodborne illness.
For those in the food supply chain, the lowered bar could have significant potential impacts—both economic and brand-related, should a product be subject to such detention. In addition to following GMPs, SSOPs, etc., to keep your product safe, the best ways to stay below the FDA’s new bars of authority are to be aware of all new requirements for the food industry; stay up to date on the continual roll-out of the FSMA provisions; and ensure your facility, processes and product are in compliance.
The bar is lowered and despite fears of static funding FDA is proving its capacity and willingness to enforce it.
-End of Dr. Acheson’s statements-