IFPA helps members understand new bioterrorism law
IFPA helps members understand new bioterrorism law
Produce companies struggling to understand the kind of records they need to maintain under the bioterrorism law got an opportunity to ask top legal experts during a Jan. 26 teleconference sponsored by the International Fresh-cut Produce Association.
The bioterrorism law requires food companies to keep records on their products and, for the first time, hands the Food & Drug Administration new powers to access what was largely shielded manufacturing and processing information from a wide variety of companies that handle food. FDA can demand to see any records if it has a reasonable belief that a food is adulterated and presents a serious threat.
The regulation, which FDA released last month, spells out the need to maintain a web of records that would help FDA identify the previous sources and recipients of foods (one step back, one step forward) in the event of a food safety scare. Records must identify the source of each ingredient that was used to make every lot of finished product and identify how the food was transported through the distribution chain.
There have been a lot of comments to FDA about the need to provide companies with substantial information about a suspected threat when federal inspectors come to plants asking for these records, Mel Drozen, an attorney with Keller & Heckman, said during the teleconference. FDA?s draft guidance is somewhat vague about this, and IFPA has asked FDA to give food companies more than a short summary before they are asked to release records, he said.
Mr. Drozen fielded calls from IFPA members about the types of businesses that would be exempt from the recordkeeping rule. Foreign suppliers would not need to keep bioterrorism records, said Mr. Drozen, but their U.S. customers would need to maintain records on the finished products. Companies that donate produce to a food bank " first refused by a retailer " would need to keep records, even though the food bank would not.
But other scenarios are far from cut-and-dry. Customs brokers who never hold the merchandise may not fall under the recordkeeping rule. Other brokers who store or distribute shipments would probably need to comply. FDA is expected to clarify this issue in a guidance document due out soon, said Eve Cadenas, an attorney with Keller & Heckman, who also answered questions at the IFPA teleconference.
Companies that make food packaging need to maintain "fairly minimal? records if their product comes into direct contact with the finished product, said Mr. Drozen. But facilities that manufacture outer packaging products would not come under the rule.
Even the definition of farm can be thorny. Farms are exempt from the rule, as are growing/harvesting activities such as washing, trimming of outer leaves and cooling produce. But if, for example, a company harvests broccoli florets from another farm and packages them, then that would be considered processing and would trigger the recordkeeping requirements, said Mr. Drozen.
In response to another question, Mr. Drozen said farms that spray a certain amount of cleaning agent on bulk lettuce before shipping to a processor, for example, may also trigger the recordkeeping requirements. Businesses do not have much time to sort out how they will comply with the new rule. Large businesses must have all records in place by December. Small businesses will have until 2006 to have their records in order, he said.
The bioterrorism law requires food companies to keep records on their products and, for the first time, hands the Food & Drug Administration new powers to access what was largely shielded manufacturing and processing information from a wide variety of companies that handle food. FDA can demand to see any records if it has a reasonable belief that a food is adulterated and presents a serious threat.
The regulation, which FDA released last month, spells out the need to maintain a web of records that would help FDA identify the previous sources and recipients of foods (one step back, one step forward) in the event of a food safety scare. Records must identify the source of each ingredient that was used to make every lot of finished product and identify how the food was transported through the distribution chain.
There have been a lot of comments to FDA about the need to provide companies with substantial information about a suspected threat when federal inspectors come to plants asking for these records, Mel Drozen, an attorney with Keller & Heckman, said during the teleconference. FDA?s draft guidance is somewhat vague about this, and IFPA has asked FDA to give food companies more than a short summary before they are asked to release records, he said.
Mr. Drozen fielded calls from IFPA members about the types of businesses that would be exempt from the recordkeeping rule. Foreign suppliers would not need to keep bioterrorism records, said Mr. Drozen, but their U.S. customers would need to maintain records on the finished products. Companies that donate produce to a food bank " first refused by a retailer " would need to keep records, even though the food bank would not.
But other scenarios are far from cut-and-dry. Customs brokers who never hold the merchandise may not fall under the recordkeeping rule. Other brokers who store or distribute shipments would probably need to comply. FDA is expected to clarify this issue in a guidance document due out soon, said Eve Cadenas, an attorney with Keller & Heckman, who also answered questions at the IFPA teleconference.
Companies that make food packaging need to maintain "fairly minimal? records if their product comes into direct contact with the finished product, said Mr. Drozen. But facilities that manufacture outer packaging products would not come under the rule.
Even the definition of farm can be thorny. Farms are exempt from the rule, as are growing/harvesting activities such as washing, trimming of outer leaves and cooling produce. But if, for example, a company harvests broccoli florets from another farm and packages them, then that would be considered processing and would trigger the recordkeeping requirements, said Mr. Drozen.
In response to another question, Mr. Drozen said farms that spray a certain amount of cleaning agent on bulk lettuce before shipping to a processor, for example, may also trigger the recordkeeping requirements. Businesses do not have much time to sort out how they will comply with the new rule. Large businesses must have all records in place by December. Small businesses will have until 2006 to have their records in order, he said.
