FDA & USDA Related Articles

FDA Implements the Recordkeeping Authority in the Bioterrorism Act

On December 9, 2004, the FDA issued the last of the four regulations that it promulgated pursuant to the Bioterrorism Act of 2001.  (In the Winter 2003 and Summer 2004 issues of FMLU, we discussed the first three regulations pertaining to facilities registration, import notification, and product detention.) 

Virtually all businesses involved in the processing, manufacturing, transporting, or storage of food will be required to maintain records that can be produced, essentially upon demand, to FDA employees in the event that FDA has a reasonable belief that food handled by the business might present “serious adverse health consequences or death to humans or animals” (a.k.a. “SAHCODHA” to avid FMLU readers).  Note that “food” includes ingredients, dietary supplements, alcoholic beverages, animal feed, as well as finished raw or processed food products.

This rule requires that domestic businesses establish and maintain the records to be discussed below if they engage in any one or more of the following activities involving food:

  • manufacture

  • process

  • pack

  • transport

  • distribute

  • receive

  • import, or

  • placement directly in contact with its finished container.

The final rule also applies to foreign businesses that transport food within the U.S.  It does not apply to foreign owned businesses that operate outside the U.S.

In general, businesses covered by this rule must have available records that show the immediate previous sources (e.g. ingredient suppliers) and immediate subsequent recipients of food (e.g. purchasers of finished product).  The types of records that businesses must maintain depends upon whether they are “transporters” or “nontransporters.”  Transporters include truckers, railroads and public warehouses.  Nontransporters include manufacturers, processors, packers and importers.

Transporters must maintain records of:

  • the immediate previous source and immediate subsequent recipient of food

  • the origin and destination of the food

  • the dates the food was received and released

  • a description of the food, and

  • the quantity of food. 

When nontransporters receive food, they must maintain records of:

  • contact information for the transporter

  • the immediate previous nontransporter source (e.g. supplier) of the food

  • a description of the type of food

  • the date the food was received

  • the quantity, and

  • how the food was packaged.

When nontransporters ship food, they must maintain records of:

  • contact information for the transporter who receives the food

  • contact information for the immediate subsequent nontransporter recipient of the food

  • a description of the type of food

  • the date the food  was released

  • the quantity, and

  • information that identifies the specific source of each ingredient in the finished product.

Depending on the type of food, the rule has different standards as to how long records must be kept.  The retention period depends upon the spoilage (i.e. shelf life) of the food.  Food subject to spoilage:

  • within 60 days shelf life after shipment–the record retention period for both transporters and nontransporters is six months.

  • between 60 – 90 days shelf life after shipment–the record retention period for both transporters and nontransporters is one year.

  • no less than 6 months shelf life after shipment–the record retention period for nontransporters is two years while for transporters is one year.

The new rule contains numerous qualifiers and exceptions.  For example, it does not cover farms or retail sales, it does not include products regulated exclusively by the USDA, and in the case of packaging materials, it distinguishes between direct food contact and indirect food contact packaging. 

Records may be maintained in either paper or electronic form and they must be retained either onsite or at a reasonably accessible location offsite.  Depending on the size of the business, the final compliance date with this new recordkeeping regulation ranges from December 9, 2005 to December 9, 2006.  Violators of the rule are subject to both criminal and civil actions. 

COMMENT:  Don’t try to figure out compliance at home!  The rule is complicated and convoluted.  The online version of the new rule and its accompanying comments is 344 double-spaced pages.  Zackler & Associates strongly recommends that you examine your business operations to determine how you will be affected by these recordkeeping requirements. If you are uncertain how this rule or any other aspects of the Bioterrorism Act will impact your business, we are available to assist you in auditing and modifying your current business practices to assure compliance with all of the new Bioterrorism Rules.


FDA Withdraws Proposed Actions Over 5 Years Old -

On November 26, 2004 the FDA quietly withdrew about fifty proposals that were published in the Federal Register more than five years ago because they were no longer considered practical for final action.  The FDA withdrew the proposals so that the agency could reduce its backlog and concentrate on higher priority activities.

A sample of the withdrawn proposals that may be of interest to FMLU readers include the following subjects:

  • GRAS affirmation for brown and yellow mustard and their derivatives
  • Deletion of GRAS status of caffeine
  • Caffeine in nonalcoholic carbonated beverages
  • Quality standards for bottled water
  • Proposals to amend Standards of Identity of pineapple juice and canned pineapple
  • Petitions to establish Standards of Identity of yogurt products
  • Food labeling– compliance with net quantity of contents, nutrient content claims and health claims, available fat content, and serving sizes.

The FDA noted that the withdrawn proposals could be reinstated at a later date and that their withdrawal does not change FDA’s position on the subject matter of the withdrawn proposals.