Food and Drug Administration (FDA) approval of anti-microbial chemicals used in food packaging has ground to a temporary halt because of legal concerns stemming from Congress's passage in 1996 of the Food Quality Protection Act (FQPA). In fact it now appears that new product petitions have been yanked from the softer hands of the FDA and tossed into the thornier mitts of the Environmental Protection Agency (EPA) at least for a temporary period.
The packaging additives in question are materials such as hydrogen peroxide solutions for aseptic packaging slimicides for paper making latex coatings adhesives and a few other additives. Sandy Varner an FDA official says there are 14 or 15 petitions at the agency awaiting action. In addition there are another seven "threshold of regulation" applications which are for additives that pose no dietary hazard and are approved almost routinely.
The EPA and the FDA have apparently resolved the jurisdictional issue which caused the standstill. That had to do with the FQPA's provisions on the Delaney Clause which barred the use of cancer-causing pesticides in raw foods. Because anti-microbials are not used in raw agricultural commodities the FDA had been setting tolerances for hydrogen peroxide solutions and other packaging additives. The FQPA however gave EPA the responsibility to set tolerances for all anti-microbials regardless of their end-use.
"The impact on packaging additives was a totally unintended consequence" explains John Dubeck an attorney with Keller and Heckman the Washington firm that represents the Society for the Plastics Industry and many individual manufacturers of packaging and packaging additives. "No one in Congress gave it any thought."
What the FDA and EPA have apparently agreed on is that the EPA will approve anti-microbial packaging additive petitions until sometime in 1998. Between now and then the EPA and FDA will go through a public rulemaking that will ostensibly result in the FDA reclaiming jurisdiction.
Bill Jordan associate director of the EPA's anti-microbial division says of the transfer to FDA "I hope not too long into 1998." The FDA's Varner says the fate of the 14 to 15 petitions already in the FDA's hands is unclear.
During that transition period the EPA will be approving "tolerances"-the maximum amount of a chemical that can be contained in a product while allowing the product to remain safe-for anti-microbials used in food packaging. At least theoretically additive manufacturers must pay much higher fees to the EPA for new product approvals and those new product petitions have to be backed up with much more safety data.
The EPA's Jordan says his agency has the authority to waive or reduce fees charged to companies for tolerances. At the top end there is $60 per petition. "I presume these companies will not be shy about asking for that reduction" Jordan says. "And since the kind of review we do for anti-microbials is less extensive than for agricultural chemicals a reduction in fees might make some sense."
Labeling of sanitizers
The FQPA included provisions designed to force anti-microbial manufacturers to use for want of a better term more accurate labels.
The EPA's Jordan says there are about 4 products in this "sanitizer" category. They will have to conform to the FQPA label copy regimen which relates label language to levels of product efficacy. Warnings relating to the possibility of eye skin and other bodily irritations will also have to be added to some labels.
Jordan says that "a lot" of products already comply with these new upcoming requirements which will be spelled out in a proposed rule from the EPA scheduled for issue in the fall of 1997. Right now there is a draft of that rule kicking around.