FDA Revokes Use of Three Perfluorinated Chemicals

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By Pat Rizzuto

Jan. 5 — The Food and Drug Administration has revoked its previously approved use of three perfluorinated chemicals, grease-proofing agents that coat paper wrappers and containers that come into contact with food.

“Although it appears that manufacturers generally have stopped using these products [chemicals], FDA’s action means that any continued use of the perfluorinated chemicals covered by the regulation is no longer permitted,” the agency said in a statement about its final rule (81 Fed. Reg. 5). 

The rule was effective Jan. 4, the same date it published in the Federal Register.

SPI: The Plastics Industry Trade Association, which represents the BASF Corp. and other companies that have made long-chain perfluorinated chemicals similar to those covered by the FDA's rule, said the chemicals having their allowable uses revoked by the FDA are no longer used as food-contact substances.

Kyra Mumbauer, senior director of global regulatory affairs at SPI, said in a statement, “It is the understanding of SPI's member companies that the materials listed in FDA's final rule are no longer manufactured for food-contact applications and represent an old technology. FDA's action thus does not impact SPI's members.”

FDA's final regulation covers three food-contact substances:

• diethanolamine salts of mono- and bis (1H,1H,2H,2H perfluoroalkyl) phosphates where the alkyl group is even-numbered in the range C8-C18 and the salts have a fluorine content of 52.4 percent to 54.4 percent as determined on a solids basis;
• pentanoic acid, 4,4-bis [(gamma-omega-perfluoro-C8-20- alkyl)thio] derivatives, compounds with diethanolamine (CAS Reg. No. 71608-61-2); and
• perfluoroalkyl substituted phosphate ester acids, ammonium salts formed by the reaction of 2,2-bis[([gamma], [omega]-perfluoro C4-20 alkylthio) methyl]-1,3-propanediol, polyphosphoric acid and ammonium hydroxide.


Common food packages that need the grease-proof surface previously provided by these and other oil-resistant chemicals include: pizza boxes, microwave popcorn bags, fast-food packaging and pet food bags. The coatings prevent oil and grease from leaking through packaging.

Environmental Coalition Petition Prompts Rule

The FDA reviewed the three chemicals in response to a 2014 petition submitted by the Natural Resources Defense Council, Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Children’s Environmental Health Network, Clean Water Action, Environmental Working Group and Improving Kids’ Environment.

The environmental coalition's petition pointed to a safety review the FDA undertook in 2010 of long-chain perfluorocarboxylates, which are structurally similar to the three perfluorinated chemicals regulated Jan. 4. The agency's review raised concerns that the perfluorocarboxylates could harm the male, and possibly, female reproductive systems.

“Based on this conclusion, FDA took the unprecedented step of asking three companies with effective Food Contact Substance notifications (FCN) for perfluorocarboxylates to cease their sale and distribution in the United States. In 2011, all three voluntarily agreed,” the coalition said.

The coalition referred to a voluntary agreement the FDA announced in 2012 with the BASF Corp., DuPont and the Clariant Corp.

In its Jan. 4 rule, the FDA said it concluded the safety concerns it had in 2010 about possible reproductive and developmental toxicity for long-chain perfluorocarboxylic acids and fluorotelomer alcohols would be applicable to long-chain perfluorinated chemicals generally.

Therefore, “we conclude that there is no longer a reasonable certainty of no harm” for the food contact use of these three chemicals, it said. 

Coalition: More FDA Rules Needed

Two of the coalition members, the NRDC and the Environmental Working Group, said the FDA needs to address many more chemicals that are used in or contact food.

“The FDA's belated action comes more than a decade after EWG and other advocates sounded alarms and five years after U.S. chemical companies stopped making the chemicals. It does nothing to prevent food processors and packagers from using almost 100 related chemicals that may also be hazardous, EWG said in a statement.

“Industrial chemicals that pollute people's blood clearly have no place in food packaging,” wrote EWG President Ken Cook. “It's taken the FDA more than 10 years to figure that out, and it's banning only three chemicals that aren't even made any more.

“This is another egregious example of how, all too often, regulatory actions under the nation's broken chemical laws are too little and too late to protect Americans' health. Congress needs to ensure that chemicals that make their way into food, either as deliberate additives or as contaminants from packaging and other outside sources, are thoroughly investigated,” Cook said.

In another statement, Erik Olson, director of the NRDC's Health program, said “the FDA's ban is an important first step—but just a first step—toward improving the safety of our food supply.”

Styrene Among Chemicals Named in Second Petition

“Now it should act on our petition to ban the seven other chemicals we believe—and government agencies such as the toxicology program at the National Institutes of Health have found—cause cancer,” Olson said.

He referred to a second rulemaking petition NRDC, EWG and other advocates filed asking the FDA to revoke its approval of styrene and six other food additives. 

That regulation also should prohibit the presence of these chemicals in food, the coalition said.

The seven food additives are:

• benzophenone (also known as diphenyl ketone) (CAS No. 119-61-9);
• ethyl acrylate (CAS No. 140-88-5);
• eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol) (CAS No. 93-15-2);
• myrcene (also known as 7-methyl-3-methylene-1,6-octadiene) (CAS No. 123-35-3);
• pulegone (also known as p-menth-4(8)-en-3-one) (CAS No. 89-82-7);
• pyridine (CAS No. 110-86-1); and
• styrene (CAS No. 100-42-5).


The coalition that filed the second petition consisted of: the Center for Science in the Public Interest, NRDC, Center for Food Safety, Consumers Union, Improving Kids' Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and an individual, James Huff.

The FDA should no longer allow the seven chemicals to be used as food additives, because new toxicity data show the chemicals are carcinogenic, the coalition's petition said.

Under the Delaney Clause, a 1960 amendment to the Federal Food, Drug, and Cosmetic Act, the FDA cannot approve any food additive if the additive induces cancer when ingested by people or animals.

Comments on the second petition are due March 4.

To contact the reporter on this story: Pat Rizzuto in Washington at prizzuto@bna.com

To contact the editor responsible for this story: Larry Pearl at lpearl@bna.com

For More Information 
The FDA's final rule is available at https://federalregister.gov/a/2015-33026.
The FDA's notice requesting comment on the second rulemaking petition is available at https://www.gpo.gov/fdsys/pkg/FR-2016-01-04/html/2015-33011.htm.


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