Wednesday, April 15, 2015

FDA to update guidance on food ingredient safety assessment

The U.S. Food and Drug Administration (FDA) has begun the process of updating its current guidance on food ingredient safety assessment, commonly referred to as the Redbook, and is requesting input from the public. The agency is interested in developing a framework that incorporates the assessment of ingredients present in various products regulated by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). Examples include food additives, food contact substances, ingredients that are generally regarded as safe (GRAS), new plant varieties, dietary supplements and new dietary ingredients, cosmetic ingredients, as well as unavoidable chemical contaminants other than microbial pathogens.

The FDA is particularly interested in comments on:

  • Which parts of the Redbook should be updated, and how the FDA should prioritize updates.
  • The scope of the revised guidance, and what other guidance documents could be addressed or incorporated by reference.
  • New assays, test methods, and endpoints that could be useful for safety assessment, with justifications for why and how these proposed new methods should be considered.
  • Key studies and considerations for study interpretation for each of the regulatory categories of food and cosmetic ingredients and chemical contaminants overseen by CFSAN.
  • Ways to make the guidance more useful to stakeholders.
  • Ways to make its processes and criteria for safety assessment clearer to stakeholders.

The comment period ends on May 11, 2015.

Press release

Thursday, February 19, 2015

Consumer Reports Touts Dearies not Theories in Favor of Mandatory GMO Labeling

Sherlock Holmes in the 2009 movie stated, “It is a huge mistake to theorize before one has data. Inevitably one begins to twist facts to suit to theories instead of theories to suit facts.” When one forms theories before having the data, one grows attached to one’s “dearies” and increases risk of confirmation bias.

The March 2015 issue of Consumer Reports magazine features an article with an ostensible intent to help consumers “sift through the facts” about the purported health and environmental effects of genetically modified organism (GMOs). Unfortunately, the article cites theories that lack supporting facts and in the end only adds to the fog surrounding modern biotechnology.

For instance, Consumers Union opines that, “the jury is still out on the health impact of GMOs.” The jury of public opinion may be out, but the overwhelming conclusion of scientific experts is clear: Every major scientific body in the United States and around the world has reviewed independent research and concluded that genetically engineered crops and food are as safe as those developed by conventional methods.

Consumers Union claims that animal studies “have suggested that GMOs might cause damage to the immune system, liver, and kidneys,” but they fail to support their allegation with a single study. I endeavor to read every study that is touted as showing GMO risk. I have yet to find a single one that indicates a risk different than with conventionally bred varieties.

The column describes recent attempts by U.S. states to require GMO labeling and repeats a misleading mantra, "shoppers have a right to know what’s in their food.” GMO labeling reveals nothing about what is in a food. Genetic engineering is a breeding method not an end product. Rather, to the degree that people believe GMO labeling reveals something about what is in their food, GMO labeling is misleading.

The article did point out an interesting twist to the labeling debate. The food companies strongly opposed to mandatory GMO labeling also produce non-GMO products. Consumer Reports seems so surprised that companies would produce what people are willing to pay for that they missed the importance of the fact — people already have the choice to buy GMO or non-GMO. Consumers can buy organic (which cannot contain GMOs) or products with voluntary “Non-GMO" labeling.

The article concludes that mandatory GMO labeling schemes would add “less than a penny a day” to most grocery bills. This conclusion is based on an assumption that food producers would simply add “GMO” to existing labels with no change in product formulation. This is a naïve assumption considering the expected negative consumer reaction. Many misperceive mandatory GMO labeling as validation of theories about risk. When it is assumed many products will be reformulated to avoid GMO ingredients, other studies put the estimated cost increase for a family of four at $400 to $800 per year.

The Consumer Reports' economic analysis is also superficial because it ignores how the details of a GMO labeling law would affect the costs. For example, a GMO-labeling exemption for organically produced foods could magnify the increase in food costs to consumers. In typical recently proposed GMO-labeling laws, organic food would be exempt from GMO labeling if it contains inadvertent GMO content. Whereas with nonorganic, non-GMO labeled products, companies would face legal repercussions if testing reveals misbranding even if due to inadvertent content. This would likely drive up the cost of non-GMO labeled food because food companies would choose more expensive organic ingredients to avoid potential liabilities (Van Eenennaam). Oh, and this would also benefit organic growers, who are major sponsors of these laws. But I am sure that is just a coincidence.

Wednesday, January 28, 2015

New EU Legislation Will Let European Union Member States Ban a Gene-Engineered Crop

It violates the spirit of the World Trade Organization agreements.

It upends the status of science as the neutral arbiter.

Nonetheless, I am optimistic about the new legislation in the European Union that will give member states the power to ban gene-engineered crops (GMOs) for various social and policy reasons. The legislation was approved by the European Parliament is expected to be approved by the European Council.

Up to now, GMOs are banned only for health and safety concerns. Under the future rules even after the European Food Safety Authority has found a GMO safe, members states may ban the GMO in their territory, “based on a wide range of reasons such as: environmental or agricultural policy objectives, town and country planning, land use, socio-economic impacts, avoidance of GMO presence in other products, or public policy, to name a few.”

I am optimistic this law will help clean up a polluted scientific communication environment. No longer will it be necessary to distort the facts and magnify the risks to justify a ban.

Perhaps we are already seeing some refreshing honesty as a result. The Scottish government has recently asserted its opposition to planting of GMOs. The reasons:
1. “[T]here is no evidence of significant demand for GM products by Scottish consumers.”
2. "To grow GM crops in Scotland would damage our clean and green brand.”

You have to respect that. No disingenuous framing. No wildly implausible theories. Just preference and protection of marketing.

Monday, November 17, 2014

My article on partially hydrogenated oils, GRAS, and Pigs in a Poke

In the current issue of Food Technology I have an article on partially hydrogenated oils, GRAS, and pigs in a poke. You can read the whole article here.

Monday, August 25, 2014

Is the Russian Ban on US and EU Food Imports a Violation of the WTO Agreements?

I doubt the US would ever challenge the Russian ban on United States and European Union food imports as a violation of the World Trade Organization (WTO) agreements because the ban will likely hurt Russia more than the US.

Russia might argue the ban was based on a security interest that was permissible under the Sanitary and Phytosanitary Agreement exceptions. Regardless of the defense, a complaint almost certainly would be tied up in dispute resolution for a long time. In short, this is far beyond what WTO was designed to handle. 

Thursday, May 01, 2014

Vermont bill requiring GMO labeling

English: Vermont State House, December 2005.
English: Vermont State House, December 2005. (Photo credit: Wikipedia)
The Vermont General Assembly passed a bill that will require most (but not all) foods produced with genetic engineering to be labeled as such. The law, which would go into effect July 1, 2016, is the first in the nation to require labeling products of genetic engineering. GMO labeling laws passed recently in Connecticut and Maine are contingent on a variety of other factors being in place, including more than four surrounding states enacting similar requirements.

The Vermont bill includes a provision for a special fund for legal defense. Litigation seems likely and may challenge the law on a number of grounds, especially violation the First Amendment guarantees for free speech and as interference with interstate commerce in violation of the Commerce Clause. A weaker challenge may be made based on field pre-emption by federal law. Another weaker challenge could come under the Establishment Clause because the Vermont bill includes a purpose of informing those with religious beliefs against GMOs.
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Monday, April 28, 2014

Michigan Bill for Tail to Wag the Dog — Prohibition on Federal Food Safety Law Enforcement

English: First page of Constitution of the Uni...
English: First page of Constitution of the United States Česky: První strana originálu Ústavy Spojených států amerických Español: La página primera de la Constitución de los Estados Unidos de América (Photo credit: Wikipedia)

Michigan Representatives McMillin, Hooker, and Lund have introduced Michigan House Bill 5336, which would prohibit enforcement of federal law regulating food that was “produced in and remains in” Michigan. Violations of the state law would be punishable by fines or imprisonment or both.

Potential law school exam question: “Discuss the errors in understanding of the United States Constitution reflected in this bill? In particular, explain the scope of the Commerce Clause. Discuss the tail wagging the dog.”

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