Packaging Groups Form Coalition to Fight FDA
- Published: July 31, 2003, By PRESS RELEASE
ALEXANDRIA, VA, USA—Packaging associations, such as the Association of Independent Corrugated Converters (AICC), have formed a coalition to fight the US Food and Drug Administration (FDA), reports a recent AICC release. According to the AICC, the Fibre Box Association, the Paperboard Packaging Council, the American Forest & Paper Association—as well as associations from the glass, plastics, steel can, and foodservice packaging industries—have come together to address the FDA on proposed rules (affecting food and food packaging) slated to go into effect December 12, 2003. AICC's release states:
In a regulatory enhancement of the Congressional language, the FDA proposed in a set of three new regulations meant to protect food from the threat of bioterrorism that the definition of "food" also include "immediate food packaging or components of immediate food packaging that are intended for food use." The coalition was set to meet with the U.S. Office of Management and Budget on Thursday, July 31, to discuss the regulatory burden of these proposed regulations. The FDA does not have a policy of allowing meetings with interested parties after the closing of a comment period.
In June 2002, President Bush signed into law the Bioterrorism Act that among other things requires the Secretary of Health and Human Services to carry out health-related activities to prepare for and respond effectively to bioterrorism and other public health emergencies, including the requirement that domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States register with FDA by December 12, 2003. The law specifically addresses "food for consumption."
On February 3, 2003, and May 9, 2003, the [FDA] issued proposed rules dealing with four provisions in the Bioterrorism Act: registration, recordkeeping, requirements for importers to provide prior notification, and authority to detain food or packaging suspected of contamination.
In three of the four proposed regulations, the FDA includes in the definition of "food": "substances that migrate into food from food packaging and other articles that contact food, including immediate food packaging or components of immediate food packaging that are intended for food use."
This language has been a source of concern for those in the paper and packaging industries. The proposed rules do not even give relief to those companies that manufacture only "outer food packaging", that do not have contact with food, although the FDA had said in stakeholder meetings they meant to give such relief. Thus, this would include all corrugated boxes used to transport or store food, corrugated produce trays, pizza boxes, and any corrugated product in which the product liner has direct contact with food. This would mean that paper mills, corrugator plants, sheet plants, sheet feeders, flexible carton and rigid box manufacturers, among other plastic, glass, aluminum, and steel food packaging suppliers in the U.S. and abroad, would not only have to register their facilities with the FDA but also maintain records as comprehensive as lists of suppliers of food packaging components (board, inks, coatings, etc.), the transporters or carriers used, and customers to show FDA inspectors upon request.
If a food packaging supplier produces even one of these food packaging items, the whole facility would have to be registered and records maintained. It is unclear if suppliers of coatings and inks would have to register as those may be considered "components."
The FDA is concerned that paper fibers could be contaminated by a terrorist and that bio-toxins could migrate into food, although the FDA does not report scientific data to show the feasibility and risk of such an occurrence, and if it were to happen, the potential health threat.
The regulations, however, exempt restaurants and foodservice outlets, although it is at these establishments where the risk of food contamination by bioterrorists is more likely to have a profound harmful effect.
Members of the coalition have commented to FDA on the proposed rules and are concerned that these proposed rules go beyond the intent of Congress, specifically in their definition of "food." The coalition also believes that the FDA has grossly underestimated the number of facilities covered by the proposed rules and therefore the costs to prepare, verify, and provide data for registration and recordkeeping up and down the food chain.
For more information, please contact David Core, AICC Director of Education & Training, at 877-836-2422 or This email address is being protected from spambots. You need JavaScript enabled to view it.. In June 2002, President Bush signed into law the Bioterrorism Act that among other things requires the Secretary of Health and Human Services to carry out health-related activities to prepare for and respond effectively to bioterrorism and other public health emergencies, including the requirement that domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States register with FDA by December 12, 2003. The law specifically addresses "food for consumption."
On February 3, 2003, and May 9, 2003, the [FDA] issued proposed rules dealing with four provisions in the Bioterrorism Act: registration, recordkeeping, requirements for importers to provide prior notification, and authority to detain food or packaging suspected of contamination.
In three of the four proposed regulations, the FDA includes in the definition of "food": "substances that migrate into food from food packaging and other articles that contact food, including immediate food packaging or components of immediate food packaging that are intended for food use."
This language has been a source of concern for those in the paper and packaging industries. The proposed rules do not even give relief to those companies that manufacture only "outer food packaging", that do not have contact with food, although the FDA had said in stakeholder meetings they meant to give such relief. Thus, this would include all corrugated boxes used to transport or store food, corrugated produce trays, pizza boxes, and any corrugated product in which the product liner has direct contact with food. This would mean that paper mills, corrugator plants, sheet plants, sheet feeders, flexible carton and rigid box manufacturers, among other plastic, glass, aluminum, and steel food packaging suppliers in the U.S. and abroad, would not only have to register their facilities with the FDA but also maintain records as comprehensive as lists of suppliers of food packaging components (board, inks, coatings, etc.), the transporters or carriers used, and customers to show FDA inspectors upon request.
If a food packaging supplier produces even one of these food packaging items, the whole facility would have to be registered and records maintained. It is unclear if suppliers of coatings and inks would have to register as those may be considered "components."
The FDA is concerned that paper fibers could be contaminated by a terrorist and that bio-toxins could migrate into food, although the FDA does not report scientific data to show the feasibility and risk of such an occurrence, and if it were to happen, the potential health threat.
The regulations, however, exempt restaurants and foodservice outlets, although it is at these establishments where the risk of food contamination by bioterrorists is more likely to have a profound harmful effect.
Members of the coalition have commented to FDA on the proposed rules and are concerned that these proposed rules go beyond the intent of Congress, specifically in their definition of "food." The coalition also believes that the FDA has grossly underestimated the number of facilities covered by the proposed rules and therefore the costs to prepare, verify, and provide data for registration and recordkeeping up and down the food chain.
