Anthony Locicero, Associate Editor11.17.17
There have been recent regulatory and legal developments that affect the packaging industry and Chicago-based Attorney Eric Greenberg discussed those reforms "from broad strokes to small details" at the UV/EB Packaging Conference.
"There’s a lot more going on in the regulatory world in the U.S. than 'fill in the blank' in decades," said Greenberg, who is also a columnist, adjunct professor, author and member of the Illinois Food Safety Advisory Committee.
While trying to keep his personal political beliefs aside, Greenberg mentioned the current administration's new philosophy on regulation:
How would it affect those in the room? Greenberg said the most honest answer he could give was, "I don't know."
"Possibly less federal regulatory pressure, [which] may inspire action by individual states," he added.
Greenberg referenced the famous 1984 Chevron case – a Supreme Court decision regarding regulation – and how it is still relevant today.
He said it is a "Rulebook for when courts look at what regulatory agencies did in interpreting laws."
"The courts set forth its generalized approach to reviewing decisions by regulators," Greenberg said. "The approach it adopted was deferential when statutes were ambiguous – that is, if the law’s ambiguous, the court should defer to the regulators’ interpretations unless they are unreasonable. If they’re not ambiguous, just apply the law as written.
"Part of the reasoning was that agencies know their subject matter best," he continued. "[This gave] regulators – unelected, nameless, faceless, unaccountable bureaucrats – the benefit of the doubt when there’s some discretion to exercise."
As a result “Agencies have a lot more power,” Greenberg added, noting that there's "not much recourse."
The attorney said that there is proposed legislation that's already being worked on to “rewire whole thing change law on how agencies do their thing and how courts oversee.”
Essentially, according to Greenberg, it would say “Courts thou shalt not defer.”
But with less power for regulatory agencies, is there an easier or harder road for industry?
"Even from the point of view of private standards, it’s not government imposed," Greenberg said. "Take away standardizing effects, you might end up making things harder for industry."
On May 28, 2019, the requirements of the Food Safety Modernization Act go into effect.
"It said, among many other things, that food companies have to verify the compliance with FDA requirements of foreign food suppliers they get food from," Greenberg said.
However, it begs the question: Are food contact materials ‘food’?
"Legally, yes. Logically, they shouldn’t be," according to Greenberg.
Regarding food supplier verification, the attorney said, "Industry wants to see exemption except in cases of: import alert related to a hazard, FDA warning letter to supplier related to a hazard, a compliance policy guide about the food contact article, known unusual risks associated with the foreign supplier or food contact article.
"There is variety in the way to verify," he added.
Consumer groups allege the FDA is dodging its food safety issue.
Greenberg said that the plaintiffs had arguments against the GRAS (Generally Recognized as Safe) System and filed a lawsuit against the FDA and its commissioner.
Due to the way the system was implemented, the groups believe the FDA is “failing in legal duty to support food suppliers,” according to Greenberg, who added that the case could possibly be thrown out.
Greenberg said that food contact materials carry a tough message – and it’s a tough message to convey to the public:
"Substances getting into food from packaging are not food," Greenberg said.
He provided an example of a brand – Kraft-Heinz – responding to a study that alleges finding phthalates in the company's macaroni and cheese.
"We do not add phthalates to our products," the company said in a statement. "The trace amounts that were reported in this limited study are more than 1,000 times lower than the levels that scientific authorities have identified as acceptable. Our products are safe for consumers to enjoy.”
"There’s a lot more going on in the regulatory world in the U.S. than 'fill in the blank' in decades," said Greenberg, who is also a columnist, adjunct professor, author and member of the Illinois Food Safety Advisory Committee.
While trying to keep his personal political beliefs aside, Greenberg mentioned the current administration's new philosophy on regulation:
- Administrations’ actions to halt or slow rulemakings;
- 2-for-1 sale;
- A simple approach that takes little account of regulations’ purpose or value
How would it affect those in the room? Greenberg said the most honest answer he could give was, "I don't know."
"Possibly less federal regulatory pressure, [which] may inspire action by individual states," he added.
Greenberg referenced the famous 1984 Chevron case – a Supreme Court decision regarding regulation – and how it is still relevant today.
He said it is a "Rulebook for when courts look at what regulatory agencies did in interpreting laws."
"The courts set forth its generalized approach to reviewing decisions by regulators," Greenberg said. "The approach it adopted was deferential when statutes were ambiguous – that is, if the law’s ambiguous, the court should defer to the regulators’ interpretations unless they are unreasonable. If they’re not ambiguous, just apply the law as written.
"Part of the reasoning was that agencies know their subject matter best," he continued. "[This gave] regulators – unelected, nameless, faceless, unaccountable bureaucrats – the benefit of the doubt when there’s some discretion to exercise."
As a result “Agencies have a lot more power,” Greenberg added, noting that there's "not much recourse."
The attorney said that there is proposed legislation that's already being worked on to “rewire whole thing change law on how agencies do their thing and how courts oversee.”
Essentially, according to Greenberg, it would say “Courts thou shalt not defer.”
But with less power for regulatory agencies, is there an easier or harder road for industry?
"Even from the point of view of private standards, it’s not government imposed," Greenberg said. "Take away standardizing effects, you might end up making things harder for industry."
On May 28, 2019, the requirements of the Food Safety Modernization Act go into effect.
"It said, among many other things, that food companies have to verify the compliance with FDA requirements of foreign food suppliers they get food from," Greenberg said.
However, it begs the question: Are food contact materials ‘food’?
"Legally, yes. Logically, they shouldn’t be," according to Greenberg.
Regarding food supplier verification, the attorney said, "Industry wants to see exemption except in cases of: import alert related to a hazard, FDA warning letter to supplier related to a hazard, a compliance policy guide about the food contact article, known unusual risks associated with the foreign supplier or food contact article.
"There is variety in the way to verify," he added.
Consumer groups allege the FDA is dodging its food safety issue.
Greenberg said that the plaintiffs had arguments against the GRAS (Generally Recognized as Safe) System and filed a lawsuit against the FDA and its commissioner.
Due to the way the system was implemented, the groups believe the FDA is “failing in legal duty to support food suppliers,” according to Greenberg, who added that the case could possibly be thrown out.
The GRAS Rule allows potentially unsafe food additives to be used in the food supply (human and animal) without FDA review, approval, oversight, or knowledge, in violation of the FFDCA.
The GRAS Rule allows FDA to abdicate its core duty under the FFDCA to be responsible for the safety of the food supply.
The GRAS Rule allows FDA to abdicate its core duty under the FFDCA to be responsible for the safety of the food supply.
- "To explain to the public about the presence of substance in their food as a result of packing;
- To explain that FDA has clearance procedures for them;
- To explain that there is a such a thing as a vanishingly small amount of substance that presents no safety concern."
"Substances getting into food from packaging are not food," Greenberg said.
He provided an example of a brand – Kraft-Heinz – responding to a study that alleges finding phthalates in the company's macaroni and cheese.
"We do not add phthalates to our products," the company said in a statement. "The trace amounts that were reported in this limited study are more than 1,000 times lower than the levels that scientific authorities have identified as acceptable. Our products are safe for consumers to enjoy.”