Green Chemistry Is Back
The Department of Toxic Substances Control (DTSC) released new informal draft regulations whose stated purpose is: "to make safer consumer products ....widespread in California...[and].... provide more protection against toxic chemicals in products on store shelves, while creating market opportunities for industry."
The draft released on October 31, 2011, creates regulations identifying consumer products that contain toxic chemicals. The DTSC claims it will use a science-based process that requires the identification of toxic ingredients and the analysis of alternatives to that ingredient. Based on the results of the analysis, removal of the toxic ingredient and/or posting product information may take place.
The DTSC’s draft regulations encompassed the following:
1) The regulations establish a list of Chemicals of Concern (~3,000) based on the work already done by other authoritative organizations. The rules also allow DTSC to identify additional chemicals as Chemicals of Concern.
2) The regulations require DTSC to develop a list of “Priority Products” that contain Chemicals of Concern for which an alternative assessment must be conducted.
3) The regulations require responsible entities (manufacturers, importers, and retailers) to notify DTSC when their product is listed as a Priority Product. DTSC will post this information on its website. Manufacturers (or other responsible entities) for a product listed as a Priority Product must perform an alternatives assessment (AA) for the product and the Chemicals of Concern in the product to determine how to limit potential exposures or the level of potential adverse public health and environmental impacts posed by the Chemical of Concern in the product.
4) The regulations require DTSC to identify and impose regulatory responses to effectively limit potential adverse public health and/or environmental impacts posed by the Priority Product/Chemical of Concern (if the manufacturer decides to retain the Priority Product), or the potential adverse impacts posed by the alternative chemical/product selected to replace the Priority Product.
A prior proposed set of regulations were introduced in 2010, but additional time was required to refine the concepts. The version released in October greatly shortens timeframes, immediately establishes a list of chemicals of concern, and is intended to stimulate a change in the way products are created by incorporating impacts to health and the environment into the design phase. The regulations will be discussed by DTSC’s Green Ribbon Science Panel on November 14-15 in Sacramento.
UK Foot-and-mouth Disease Study: Impacts for the Future, Not the Past
A May 6 study in Science with the banal title of “Relationship Between Clinical Signs and Transmission of an Infectious Disease and the Implications for Control,” written by a number of scientists at the Institute for Animal Health in Surrey and the Centre for Immunity, Infection and Evolution at the University of Edinburgh, has garnered a lot of publicity. The study involved foot-and-mouth disease, a worldwide scourge for cattle which had had its most virulent outbreak in a developed country in the United Kingdom in 2001.
What is revolutionary about the study may be surprising to non-scientists. What the scientists did with cattle was to study the interaction between infected animals and healthy ones in order to learn exactly when the infected animals were actually transmitting the disease. You may well think, "don't we know this already? Was I coughing into my elbow for no reason at all?" The answer is, we didn't know it at this level of detail, and when fashioning quarantines of people or animals, or mandatory culls of animals, knowing it at this level of detail can save lives and money. As Mark Woolhouse, one of the scientists who co-authored the study, said as quoted in Science Daily,
If you do things like measure virus in the blood, you're taking no account of the clinical state of the animal. People might imagine that the clinical signs of a virus -- the symptoms, such as sneezing -- have something to do with its transmission. But, while there has been a lot of thoughtful speculation on the topic, there haven't been many actual studies.
As a result of the study, for these animals and with this one disease, they estimated that the actual period of transmission was much shorter than had been previously thought, and not necessarily related to the animal showing the outward signs of the disease.
In reading this, I was reminded of a statement in Simon Winchester’s Atlantic, where he points out how much more we know about the surface of the moon than the undersea part of the surface of the earth. The same can be said for the way microorganisms operate in the environment as close as your nose or a cut on your skin. Although it is obviously a different thing to study foot-and-mouth disease for cows, who are unwitting subjects, than, say, influenza on humans, these techniques may be applicable in some ways to study a whole range of diseases, which can refine the public health reaction to a host of outbreaks. The study suggests that if diagnostic tools can be found to pinpoint the moment of contagion, quarantine can be more effective and possibly both shorter and involving fewer subjects, and more destructive means of prevention like culling may be avoided. To quote further from Woolhouse's interview with Science Daily:
We now know that there is a window where, if affected cattle are detected and removed from the herd promptly, there may be no need for pre-emptive culling in the immediate area of an infected farm. We have an opportunity now to develop new test systems which can detect infected animals earlier and reduce the spread of the disease.
This is a two-edged sword, and potentially both edges can be used for good. If we can develop tools to find contagious subjects more exactly, we can take effective steps to quarantine them for just the right period of time. And we would be able to rule out non-contagious subjects that are currently impacted out of an abundance of caution.
Which brings us back to the past. Now that we know what we know, what of the thousands of British cows slaughtered in 2001, including those at farms where the cows showed no symptoms but were located next to the outbreaks? The study certainly suggests that this was unnecessary. But before any British cattle farmers consider calling in a solicitor, however, they need to understand a couple of things. First, public health officials have historically always been given a lot of leeway in terms of making decisions to promote the general welfare. When the cows are showing signs of disease, no one has the time to do a ten-month study; you do what you can right then. Second, and most germane, liability, if any, would be based on the state of knowledge at the time of the incident. It could hardly be treated any other way. This both acknowledges the state of (or lack of) knowledge and encourages the advance of scientific learning. If you try one solution and it seems like it could be improved, you’re less likely to improve it if you might end up being liable for how your first attempt worked out.
Facts Alleged in CSPI Sodium Suit Incongruent with Claims Asserted
Thought to be the first putative class action against a restaurant chain related to disclosure of sodium content on menus, Center for Science in the Public Interest (CSPI) has filed what appears to be a test case against Denny’s. Best guess is the case will fail on its merits (though for CSPI, success in litigation may not be the point).
The case, DeBenedetto v. Denny’s Corporation, asserts claims under New Jersey law for consumer fraud, N.J.S.A. 56:8-1, et seq., and breach of the implied warranty of merchantability under the New Jersey U.C.C., N.J.S.A. 12A:2-314(1)-(2). The theory advanced in CSPI’s complaint is that consumers have been “duped” about sodium content and that the “ordinary consumer, unschooled in nutrition and perhaps preoccupied with other matters, would not reasonably expect to encounter these high levels of sodium in one meal.”
Big incongruency in the complaint is that Denny’s does disclose sodium content in its meals. CSPI admits that Denny’s provides this information both online and in store pamphlets, but it complains that the information is “incomprehensible.” A review of Denny’s online disclosures shows a detailed nutritional chart, including sodium levels for every item on its menu. Here's an excerpt of Denny's online disclosures:
But, CSPI's complaint does not really seem to be that disclosures are not clear enough. Indeed, CSPI argues that regardless of such disclosures by restaurants, studies show that “almost no one reads the nutrition information . . . .”
What CSPI is really saying is that sellers of salty foods (not unlike foods contaminated with E. coli) are strictly liable no matter the disclosures. If this were the law (which as of now, it is not), few restaurants (or food manufacturers) would be exempt from paying the medical bills of their customers who develop heart disease. No doubt CSPI's real goal is "regulation through litigation" and the jury is still out whether CSPI's penchant for the court system will affect change.
Nebraska Governor's Conference on E. Coli
The third annual Nebraska Governor’s Conference on Food Safety Issues related to E. coli is May 5-7 in Lincoln, Nebraska.
Together with Bill Marler, I have been invited to speak to agricultural stakeholders about legal issues and ramifications of Shiga toxin-producing E. coli outbreaks. In the past, the emphasis for this conference has ranged from basic science to applied science, and this year's conference will emphasize issues ranging from animal and plant management strategies to regulatory issues. Given the inevitable changes that will be coming in food safety regulation under the Obama administration, this should be a lively conference.
Back to School
In the next couple of weeks, I have the unique opportunity to travel back to Cornell University, my law school alma mater, to spend time getting acquainted with its world renowned food science program.
While in "gorges" Ithaca, I plan to audit courses such as “Food Safety Assurance” and “Current Topics in Food Science & Technology.” I also plan to speak to graduate students in the program about “life in the trenches.” This should be interesting as the intersection of science and law is never boring.
I expect to have plenty to write about upon my return. In the meantime, if you are shopping for some of the best maple syrup or dairy products available, be sure to visit the Cornell Dairy Store where you can order online to stimulate the upstate New York economy.
Happy New Year and Thank You
Happy New Year. Thank you for your support, readership and feedback for this site. Since we launched the blog in late February of 2008, the growth in readership has been extraordinary. I'm overwhelmed at the response. My hope is that the blog has provided some measure of assistance to those in the food industry. As always, I welcome your feedback, suggestions and critiques.
In the coming year, I hope to spend more time on the blog exploring trends in liability, insurance coverage and consumer claims related to the food industry. I also hope to discuss more deeply the anatomy of consumer-based food borne illness and labeling litigation.
You may notice a drop-off in the frequency of postings between February and April as I will be spending more time on the road. I apologize in advance. One of the things I will be doing (and posting about) is visiting with students and faculty at the Cornell Food Science program in Ithaca, New York. I hope to learn more about emerging technologies related to food production and safety.
