RIP William Keene

Sad news out of Oregon

Much of the work of detecting the cause of outbreaks is art, not science, and by all accounts he was an artist. 

Genetically Engineered Wheat Found in Oregon

Yesterday, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a news release (PDF) announcing that a genetically engineered (GE) variety of wheat was found growing on an Oregon farm. APHIS was first notified of the issue by an Oregon State University (OSU) scientist who reported that initial tests of wheat samples from an Oregon farm indicated the possible presence of GE glyphosate-resistant wheat plants.

Here’s what you need to know:

Earlier in April 2013, an Oregon farmer noticed wheat plants that had germinated and developed in a place where they had not been intentionally planted, so-called “volunteer” plants. The farmer also found that these wheat plants were resistant to glyphosate, a systemic herbicide used to kill weeds known to compete with commercial crops. The farmer then sent the samples to OSU for analysis, which later tested positive for the glyphosate trait.

The OSU scientist contacted APHIS on May 3, 2013 to inform the agency of her findings. After immediately launching an investigation and conducting further sampling and testing, APHIS officials announced that the samples taken showed the presence of the same GE glyphosate-resistant wheat variety that Monsanto was authorized to field test in 16 states from 1998 to 2005. Specifically, over this seven year period, APHIS authorized over 100 field tests with this specific glyphosate-resistant wheat variety in Arizona, California, Colorado, Florida, Hawaii, Idaho, Illinois, Kansas, Minnesota, Montana, Nebraska, North Dakota, Oregon, South Dakota, Washington, and Wyoming.

This news has come as a surprise to many since there are no GE wheat varieties for sale or in commercial production in the U.S. The reason being that, unlike some other commercial crops such as GE sugar beets and corn that have been deregulated by APHIS, there are currently no GE wheat varieties that have obtained deregulated status from APHIS. In addition, to date, GE wheat varieties are not authorized for commercial sale or planting in any country.

However, despite the fact that GE wheat is not approved for planting in the U.S., government officials have confirmed that detection of this wheat variety does not pose a food safety concern. According to an investigation report (PDF) issued by APHIS in connection with the GE glyphosate-resistant wheat found in Oregon, the Food and Drug Administration (FDA) completed a voluntary consultation on the safety of food and feed derived from this GE glyphosate-resistant wheat variety in 2004. FDA ultimately determined that the GE glyphosate-resistant wheat variety is as safe as non-GE wheat currently on the market. FDA’s consultation summary, which includes the developer’s conclusion that “this wheat variety is not materially different in composition, safety, or any other relevant parameter from wheat now grown, marketed, and consumed,” can be found here.

Michael Firko, Acting Deputy Administrator for APHIS’ Biotechnology Regulatory Services, explained that the agency is taking the situation and the continuing investigation very seriously. APHIS is collaborating with state, industry, and trading partners to understand how the situation might have arisen and whether there are any more affected areas.

What is yet to be seen is how this event may influence Washington state voters come November. Initiative 522, also known as the “Mandatory Labeling of Genetically Engineered Food Measure,” is an initiative to the legislature on the ballot in Washington that will be decided in the general election on November 5, 2013. Similar to California’s Proposition 37 that failed with voters last year, Initiative 522 would require GMO labeling on raw or processed food offered for sale to consumers if the food is made from plants or animals produced through genetic engineering.

If Initiative 522 passes in November, this particular event would likely not trigger in liability for a producer or retailer’s failure to label the GE wheat. Initiative 522 specifically exempts from labeling any “raw agricultural commodity or food that has been grown, raised, produced, or derived without the knowing and intentional use of genetically engineered seed or food.” (emphasis added). However, there could be other legal ramifications if officials determine that the cause of the incident amounts to a violation of the Plant Protection Act (PPA). Under the PPA, if a violation is found, APHIS has the authority to seek penalties for such a violation including civil penalties up to $1,000,000 and potential criminal prosecution.

Oregon to Adopt 2009 FDA Food Code

The Oregon Public Health Division’s (OPHD) Foodborne Illness Prevention Program announced that it is moving forward with the adoption of the 2009 Food and Drug Administration (FDA) Food Code.  The new rules will take effect on September 4, 2012. Oddly, however, the agency noted that it would not be adopting the “No Bare Hand Contact” section of the Food Code.

In creating the “No Bare Hand Contact” rule for food handlers, the FDA pointed out that when hands are heavily contaminated, even effective handwashing practices may not be enough to prevent the transmission of pathogens from the hands to ready-to-eat (RTE) foods, such as sandwiches, salads, and other foods that are eaten without further washing or cooking. Accordingly, the rule requires the use of “suitable utensils such as scoops, spoons, forks, spatulas, tongs, deli tissue, single-use gloves, or dispensing equipment” when handling RTE food items to reduce foodborne illness.

Discussion of implementing the “No Bare Hand Contact” rule in Oregon was met with fierce opposition by restaurateurs who raised concerns over the cost of complying with the rule and whether it would actually increase food safety. In response, OPHD explained that over the next few months it will assemble a workgroup of interested parties (restaurateurs, government inspectors, consumers, etc.) to review and provide recommendations on addressing norovirus and fecal contamination of food, and to identify the best options to reduce illness.

Oregon’s process of adopting the 2009 FDA Food Code began in August 2010 when a Food Code Review Workgroup was established to work with the Oregon Department of Agriculture, food service and retail industry groups and regulators to develop recommendations regarding the new rules. Earlier this year, OPHD also provided training for regulators and industry on the 2009 Food Code in preparation for the September effective date.

The Association of Food and Drug Officials (AFDO), under contract to the FDA, has been gathering data on the progress of FDA Food Code adoptions by States, Territories, Local and Tribal Nation agencies. AFDO reported that 49 of the 50 States adopted codes patterned after the 1993, 1995, 1997, 1999, 2001, 2005, or 2009 versions of the Food Code, representing 96% of the U.S. population. Specifically:

  • Four States adopted the 1993, 1995 or 1997 Food Code, representing 4% of the US population.
  • Ten States adopted the 1999 Food Code, representing 13%of the US population.
  • Eleven States adopted the 2001 Food Code, representing 38% of the US population.
  • Twenty one States adopted the 2005 Food Code, representing 39%of the US population.
  • Three States adopted the 2009 Food Code, representing2% of the US population.

In September, Oregon will join Mississippi, New Hampshire, and Delaware in adopting the 2009 version of the food code. Until the final rules take effect, food industry members can review the Fact Sheets provided by OPHD to ensure compliance and see what other changes may affect their business in the coming weeks.

Raw Milk Redux (and Ken Redux for an Instant)

Our former colleague and still good friend Ken Odza was in our offices last week; I was in a meeting and just had the chance to say hello. 

By pure coincidence, one of Ken's favorite topics was in the news this week. Ken had written two big pieces on raw milk for this blog, which can be found here and here.  Tyler wrote about another development here

What happened in Oregon is sad:  20 people were apparently sickened in a single outbreak, including four children, and two of the victims may have long-term complications.  E.Coli O157:H7 is not fun for anyone. 

The real issue, as the article points out, is what the right level of regulation would be.  It's not easy to answer.  Drinking raw milk is simply dangerous; it's like playing Russian roulette without knowing how many chambers are in the gun or how many are filled.  Ban it and the users go underground.  Legalize it and yes, some bad batches will not be caught by inspectors (this happens with a lot of other foods, too, in case you hadn't noticed).  You can try to educate people about it, but if there's anything we know now it is that official education on almost any topic will lead to dissent.  There's no perfect solution in a free society. 

FDA Issues Warning on Alcoholic Energy Drinks; States Move to Ban "Blackout in a Can"

Note: The following is authored by guest blogger Jake Storms, from the Alcoholic Beverages Law Blog.

Amidst rising incidences of hospitalizations in college and teenage drinkers linked to consumption of alcoholic energy drinks, the Washington State Liquor Control Board banned their sale effective tomorrow, November 18, 2010. The move came on the heels of a request by Washington Governor Christine Gregoire, whose office stated in a November 10 press release that they were “…particularly concerned that these drinks tend to target young people.”

The Liquor Control Board placed the ban in an emergency ruling which will last for 120 days. During that time, the Liquor Control Board will move to make the ban permanent. Liquor Control Board Chairperson Sharon Foster stated, “[t]he Board is acting in the public safety…the Board is acting now to ensure these products do not contribute to a tragedy before the Food and Drug Administration or Legislature can act.” Earlier this year, the Liquor Control Board had lobbied for State legislative action to ban the sale of caffeinated malt beverages in Washington but those efforts were unsuccessful. A list of particular products affected by the Liquor Control Board’s ruling can be seen here.

Washington’s ban is merely the most recent action in an ever increasing movement by states to control the sale of caffeinated alcoholic beverages. The Oregon Liquor Control Commission Chairman stated in an October press release that, “…alcoholic energy drinks should be removed from the market until further research isdone.” The OLCC also stated that it is currently looking into possible regulatory efforts with the state legislature and is reaching out to community organizations to warn them of the dangers of the beverages.

While California’s Department of Alcoholic Beverage Control has not yet made a statement regarding the drinks, Connecticut announced Monday that it had reached agreements with state distributors to voluntarily stop shipments of caffeinated alcoholic beverages starting December 10, 2010. Michigan has banned one particular brand of caffeinated alcoholic beverage, Four Loko. New York has reached an agreement with Phusion Projects LLC, the manufacturer of Four Loko, to stop sales in the state until “…emerging science, regulatory developments or other relevant changes in circumstances arise." Utah and Oklahoma have followed Washington’s lead in banning the sale of any brands altogether. Massachusetts’ Alcoholic Beverage Control Commission stated that it will file an emergency ruling, similar to Washington’s, on Monday, November 22, 2010.

At the federal level, the Food and Drug Administration (“FDA”) is currently reviewing whether caffeine is a safe additive to alcoholic beverages. A negative finding would essentially ban the sale of caffeinated alcoholic beverages nationwide. It is widely assumed the FDA will, in fact, reach a negative finding. NY Senator Chuck Schumer, who has been lobbying for a ban on the drinks, stated that the FDA decision “…should be the nail in the coffin of these dangerous and toxic drinks.” The FDA decision is expected within the week.

Salmonella in a Different Language

When the news of salmonella in something as American as peanut butter needs to get out, spreading the word is fairly routine.  What happens when salmonella rissen is found in white pepper distributed mainly to Chinese and other Asian restaurants on the west coast?

Union Internatonal Food Company of Union City, California has voluntarily recalled dry spices after 42 cases of salmonella rissen have been reported in California, Oregon, Washington and Nevada.  White and black pepper are particularly suspect.  The company's products were marketed almost entirely to restaurants in those states and Arizona. 

But it is likely that many of the people most likely to using the products do not have English as their first language.  Accordingly, the FDA and Union International itself issued some of their material in Chinese, including this complete notice