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Report Identifies Chemicals ‘Quietly Added’ to Food Under GRAS

The “generally recognized as safe,” or GRAS, determination for food additives has been getting a lot of attention lately for being a regulatory loophole.

The main issue is that GRAS allows companies to decide whether a substance meets the definition of GRAS without mandating a review by the U.S. Food and Drug Administration before being added to food.

The Natural Resources Defense Council (NRDC) has previously estimated that about 1,000 of the 10,000 additives used today are being used based on undisclosed GRAS safety determinations. NRDC’s latest report attempted to find out more about the chemicals reported as GRAS based solely on a company determination and to examine safety decisions of companies which voluntarily submit additives for FDA review.

The organization was able to identify 275 chemicals from 56 companies that appear to be marketed for use in food based on undisclosed GRAS safety determinations and found that, of the requests for FDA review, about one in five notices is rejected or withdrawn from review.

NRDC stated that communications between FDA and companies seeking agency review – information obtained under the Freedom of Information Act – revealed that FDA carefully reviews notifications and “asks tough questions. The agency’s reviews often raise serious safety concerns or reveal that the company’s scientific analysis is flawed or inconsistent with the law.”

If the agency rejects a GRAS notice, it sends an explanation of the safety concerns in a letter to the company and publishes the letter online.

“But when a company withdraws a notice and asks FDA to stop further review,” the report notes, “the agency issues a letter confirming the withdrawal without publicly explaining any of the concerns that could have prompted the withdrawal.”

Furthermore, such a withdrawal doesn’t prevent the company from marketing the product for use in food. The report details four chemicals with withdrawn GRAS notices – epigallocatechin-3-gallate (EGCG), gamma-amino butyric acid (GABA), theobromine, and sweet lupin protein, fiber, and flour – noting that, despite safety concerns, they have been listed as an ingredient in some food products.

“There are gaping holes in the safety net for chemicals that are added to our food supply,” said Erik Olson, NRDC senior strategic director for health and food.

Ultimately, the report concluded, “A chemical additive cannot be ‘generally recognized as safe’ if its identity, chemical composition, and safety determination are not publicly disclosed.”

NRDC recommends that FDA publish safety concerns even when companies withdraw notices, require that FDA be informed of GRAS determinations, and limit conflicts of interest.

Food Safety News

Germany Identifies First ‘Mad Cow’ Case Since 2009

German officials have identified one beef cow with a case of bovine spongiform encephalitis (BSE), the fatal neurological disorder also known as “Mad Cow Disease.”

This is Germany’s first reported case since 2009. The cow was killed and its body destroyed, with none of the meat entering the human food chain.

Health officials said that the animal showed no symptoms of BSE when it was initially slaughtered for consumption, but, because it was 10 years old, it underwent a BSE test. That’s when it tested positive for an atypical type of BSE, L-type, which develops spontaneously in older cattle.

Epidemiological tracebacks identified seven offspring of the cow, five of whom were already slaughtered. The other two were still on the cow’s farm of origin, where they were tested and subsequently killed, according to protocol for handling BSE cases.

The diseased cow’s herd is under quarantine until clearing further testing, although BSE is not considered contagious.

The incident is not expected to alter Germany’s beef consumption or rules regarding BSE. Germany’s BSE screening protocols require any beef cattle older than eight years to automatically be tested for BSE.

Germany’s first cases of BSE were discovered in 2000. The country has seen a total of 312 cases, compared to the United Kingdom’s 183,000 and the United States’ four.

The first known case of BSE occurred in the U.K. in 1986. Since then, more than 150 people in the U.K. have fallen ill and died from the human counterpart to BSE, variant Creutzfeldt-Jakob Disease (vCJD).

The disease originated with the practice of feeding cattle meat and bone meal to cattle herds as a substitute for soy beans, which can be difficult to grow in Europe.

Humans can contract vCJD from eating meat contaminated with brain or spinal tissue from cattle infected with BSE, which is not destroyed when cooked.

The U.S. Department of Agriculture recently announced plans to ease regulations on beef imports in regard to BSE. The U.S. has banned beef imports from Europe since 1998 due to mad cow scares.

The latest USDA move would align the U.S. with international policies on BSE, while potentially opening up U.S. beef exports to new markets. The U.S. was recently adjusted to the safest classification for BSE risk, according to international standards set by the World Organization for Animal Health.

The most recent case of BSE in the U.S. occurred in 2012 in a California dairy cow who had developed the L-type BSE as in the latest German case. The other three U.S. cases occurred in 2003, 2004 and 2006.

Another 19 BSE cases have occurred in Canada, the first being a 1993 case in a cow imported from the U.K.

In the U.S. and other countries regulating BSE, cattle feed can no longer contain the meat of other ruminant animals. USDA runs a surveillance program for BSE, and slaughterhouses are required to remove the brains and spinal cords from all carcasses.

Food Safety News