Found it,Here's what happens when you get nailed by FDA,
:Establishment and Maintenance of Records:
key features,
This requires both domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States to establish and maintain records. These records must be made available to the Secretary for Inspection to allow the Secretary to identify the immediate previous sources and immediate subsequent recipients of food, including its packaging, in order to address credible threats of serious adverse heath consequences (both to humans and animals).
FDA wants to describe the specific information a covered entity must keep, but not specify the form or type of system in which those records must be maintained.
For manufacturers, processors, packers, distributors, receivers, holders and importers of food (that is those other than transporters), the records would need to:
Identify the immediate non-transporter previous sources, whether foreign or domestic, of all foods received, including the name of the firm and the responsible individual; address; telephone number; fax number and email address, if available; type of food, including brand name and specific variety (e.g. Brand X Cheddar Cheese, not just cheese); date received; lot number or other identifier if available; quantity and type of packaging (e.g., 12oz bottles); and the name, address, telephone number and if available fax number and e-mail address of the transporter who brought it. The record must include information that is reasonably available to identify the specific source of each ingredient that was used to make every lot of finished product.
Identify the immediate non-transporter subsequent recipients of all foods released, including the name of the firm and the responsible individual; address; telephone number; fax number and email address, if available; type of food, including brand name and specific variety; date released; lot number or other identifier if available; quantity and type of packaging; and the name, address and telephone number and, if available, fax number and e-mail address of the transporter who transported the food from you. For transporters, the records for each food transported would have to include:
The name of the firm and the responsible individual who had the food before you and their address, telephone number, and, if available, fax number and e-mail address, and the date you receive it.
The name of the firm and responsible individual who had the food immediately after you and their address; telephone number, and, if available, fax number and e-mail address, and the date you delivered it.
The type of food, including brand name and specific variety; lot number or other identifier if available, quantity, and type of packaging.
Identification of each and every mode of transportation used (e.g., company truck, private carrier, rail, air etc.) and the individual responsible from when the food was first received until it was delivered.
The proposed rule requires that records are created when food is received, released or transported. Records for perishable foods not intended for processing into non-perishable foods, as well as records for animal food including pet food, would have to be retained for one year after from the date they were created. Records for all other foods would have to be retained for two years after the date they were created.
The records must be easily accessible. When the FDA has a reasonable belief that an article of food is adulterated and presents a serious threat, any records or other information to which the FDA has access must be available for inspection and photocopying or other means of reproduction within 24 hours if the request is made between 8:00am and 6:00pm, Monday to Friday, or within 24 hours if the request is made at any other time.
The following details are excluded from these regulations: recipes, financial data, pricing data, personnel data, research data and sales data. The definition of a recipe is the quantitative formula used in the manufacturing of the food product, but not the identity of the individual ingredients of the food.
Failure to maintain the required records or failure to make them available to the FDA will be a prohibited act. The Federal government has the power to bring a civil action in Federal Court to enjoin persons who commit a prohibited act; or the Federal government can bring a criminal action in Federal court to prosecute persons who commit a prohibited act.
The proposed rule would require all businesses, except small and very small businesses, to comply with the final rule 6 months from its publication in the Federal Register. Small businesses (fewer than 500 but more than 10 full-time equivalent employees) would have to comply within 12 months from publication of the final rule, and very small businesses (10 or fewer full-time equivalent employees) would have to comply within 18 months from the publication of the final rule.
Administrative Detention: key features
This authorises the FDA to detain an article of food for which there is credible evidence or information indicating such article presents a threat of serious adverse health consequences to either humans or animals.
The definition of food in this proposed rule references the definition of food in section 201 (f) of the Federal Food, Drug and Cosmetic Act. It includes food and beverages for human and animal consumption. Food regulated exclusively by USDA under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act would not be covered by the administrative detention regulation. All other food would be subject to this regulation whether or not it enters interstate commerce.
Highlights are outlined below:
An officer or qualified employee of FDA may order the detention of domestic or imported food for up to 30 days if the FDA has credible evidence or information that the food presents a threat of serious adverse health consequences or death to humans or animals.
The FDA District Director in the district in which the article of food is located or an FDA official senior to such director must approve a detention order.
The FDA may require that the detained article of food be labelled or marked as detained with official FDA tags or labels. The FDA tag or label will include, among other information, a statement that the article of food must not be consumed, moved, altered, or tampered with in any manner for the period shown, without the written permission of an authorised FDA representative.
A violation of a detention order or the removal or alteration of the tag or label is a prohibited act.
FDA will state in the detention order the location and any applicable conditions under which the food is to be held.
FDA may direct that the article of food be moved to a secure facility, if appropriate. An article of food moved to a secure facility remains under detention before, during and after such movement.
FDA may approve a request for a limited conditional release of a detained article of food for purposes of destruction, movement to a secure facility, preservation of the detained article of food, or any other purpose that FDA believes is appropriate. An article of food transferred under a limited conditional release remains under detention before, during and after the transfer.
Any transfer of a detained article of food in violation of a detention order is a prohibited act.
Any person who would be entitled to be a claimant for the article of food, if seized, may appeal a detention order and, as part of that appeals process, may request an informal hearing. If a hearing is granted, an FDA Regional Food and Drug Director (RFDD) or another official senior to an FDA District Director will serve as the presiding officer of the hearing.
The proposed rule includes appeal and hearing timeframes for both perishable and non-perishable detained articles of food.
Perishable food:
An appeal must be filed within 2 calendar days of receipt of the detention order.
If a hearing is requested in the appeal, and the FDA grants the request, the hearing will be held within 2 calendar days after the date the appeal is filed.
FDA's decision on appeal will be issued 5 days after the appeal is filed.
Non-perishable food:
A notice of intent to file an appeal and to request a hearing must be filed within 4 calendar days of receipt of the detention order.
An appeal must be filed within10 calendar days of receipt of the detention order.
If a hearing is requested in the notice of intent and appeal, and FDA grants the request, the hearing will be held within 3 calendar days after the appeal is filed.
The FDA's decision on appeal will be issued 5 days after the appeal is filed.
The proposed expedited procedures for certain enforcement action with respect to perishable foods require FDA to send a seizure recommendation to the Department of Justice within 4 calendar days after the detention order is issued, unless extenuating circumstances exist.
Confirmation of a detention order by the FDA presiding officer is considered final agency action.
A copy of the detention order will be issued by the FDA to the owner, operator or agent in charge of the place where the article of food is located. If the owner of the article of food is different from the owner, operator or agent in charge of the location of the food, FDA must provide a copy of the detention order to the owner of the article of food if the owner's identity can be determined readily.
The FDA must issue the detention order in writing, in the form of a detention notice, signed and dated by the officer or qualified employee of FDA. The order will include the following information:
the detention order number;
the date and hour of the detention order;
identification of the detained article of food;
the period of the detention;
a statement that the article of food identified in the order is detained for the period shown;
a brief, general statement of the reasons for the detention;
the address and location where the article of food is to be detained and the appropriate storage conditions;
any applicable conditions of transportation of the detained article of food;
a statement that the article of food is not to be consumed, moved, altered, or tampered with in any manner during the detention period, unless subject to a limited conditional release;
a statement that any informal hearing on an appeal of a detention order must be conducted as a regulatory hearing;
the mailing address, telephone number, email address, and fax number of the FDA district office and the name of the FDA District Director in whose district the article of food is located; and
a statement indicating the manner in which approval of the detention order was obtained i.e., orally or in writing
Also,Advice to Importers an Exporters ,keep good accurate records.