FDA Announcements: GE Salmon and new FSMA Rules

salmonRecently, the FDA made two long-awaited announcements, both of which are likely to be controversial. One concerns approval of the sale of genetically-modified salmon, and the other concerns new rules for the implementation of food safety goals related to the January 2011 Food Safety Modernization Act (FSMA).  In both cases, the FDA has included a waiting period for public comment before the agency's preliminary decisions officially become regulations.  No doubt, advocacy groups opposed to GE products in general will voice their objections to GE salmon, and some food processors and manufacturers may complain about the expense and difficulty involved in implementing the new FSMA rules. 


GE salmon


Although modern genetically-engineered (GE) plants have been in the American food chain since the 1990s, if GE salmon is approved for sale in the U.S., it would become the first modern genetically-engineered ANIMAL in our food supply.  Shelf Life Advice first covered this story soon after AquaBounty Technologies, a Canadian company, petitioned the FDA for approval to sell GE salmon in the U.S.  Our lengthy article on the subject included details on the process and the pros and cons of allowing the product to be grown and sold in the U.S. 


As the first Shelf Life Advice article on this topic points out, GE salmon is genetically modified to make it grow twice as fast as ordinary salmon.  One widespread concern has been about the effect of the growth hormone administered to GE salmon on people who consume the product. Two reassuring responses to the growth hormone fears: the amount of growth hormone is very small, and it would probably be destroyed by cooking anyway. The FDA has indicated that it considers GE salmon safe to eat. 


Other major concerns are that these modified salmon would be harmful to the wild salmon population and to the environment in general if they escaped from captivity. The FDA's draft environmental assessment document (released on December 21, 2012) states that GE fish "will not have any significant impacts on the quality of the human environment in the United States" and that it is unlikely to harm populations of wild salmon. AquaBounty says the sterile GE salmon would be raised on on-land farms (not net pens in the ocean), so they wouldn't be mingling with wild salmon.  Still, some advocacy groups fear GE salmon could escape and that some would not be sterile and could out-compete wild salmon.


Food scientist Dr. Joe Regenstein responds to the accusations that GE salmon might be destructive to the environment by telling why he believes GE salmon would actually be an environmental improvement: "About 2/3 of our Atlantic salmon are farmed.  Feeding them requires resources. The GE salmon grow faster using less feed.  So there is an environmental advantage.  Also, when farming GE salmon, the grower spends less time with any one set of fish and can use equipment to get more turns per year. All this should lower the cost and is a better use of resources."


Food process engineer Dr. Timothy Bowser lists the advantages of marketing GE salmon as follows: "more available salmon; a better quality product (depending upon one's opinion); and   lower cost."


No federal law requires companies to tell consumers on the label that a product has been genetically modified.  (According to Dr. Regenstein, "All domesticated plants and animals are genetically modified.  That's what it means to be domesticated!")  Genetic modification of animals began at least 2,000 years with the practice of selective breeding and moved into its intermediate phase in the last century with the use of mutagens, "strong chemicals that alter genes," says Dr. Regenstein.  "The hi-tech methods available today are more targeted and more successful at only making the changes that are desired." 


If GE salmon is allowed to be sold in the U.S. (and, at this point, it seems very likely to be approved by the FDA), you can expect that processors of traditional salmon will indicate on their labels that their product has NOT been genetically engineered.  Why? Dr. Bowser says, "The assumption is that consumers may stop purchasing any salmon product if they are uncertain about the genetics of the fish."


Here's the link you need to submit comments on GE salmon to the FDA.  For the required field "organization name," just enter "citizen" unless you are representing an organization.  Comments must be received by February 25.


For more information on GE foods, see "Is Genetically Engineered Food Safe?  Should GE Be on Food Labels?" and "Does the World Need GE Bananas and GE Apples?"



New rules for implementing the FSMA


These are some of the major goals of the FSMA:


1) To establish more  procedures to help prevent outbreaks of foodborne illness:  Although the FDA ha done a good job of tracking down causes and determining appropriate responses once outbreaks occur, the  new goal is to introduce more widespread practices to prevent outbreaks.  When it comes to food safety, the agency wants to be proactive rather than just reactive.


2) To reduce the number of outbreaks caused by produce: Produce causes more foodborne illness outbreaks than any other major category of food.


3)  To reduce the amount of contaminated food that is imported into the U.S.:  The goal is to verify that food products grown and/or processed overseas are as safe as those produced in the U.S. This requires better inspection of food-handling facilities outside the U.S. and of food coming into the U.S.  Approximately 15% of the food consumed in the U.S. is imported, and the percentage is much greater for higher risk food categories such as fresh produce.


It has taken over two years for the FDA to announce the two proposed rules listed below that clarify how these goals might be achieved. The FDA's January 4 news release describes the rules thusly:

 Rule #1 requires makers of food to be sold in the U.S. to develop a formal plan for preventing their food products from causing illness and to have plans for correcting any problems that arise. These plans would be required one year after the final rules are published in the Federal Register. (Very small businesses would be allowed additional time to comply.)  Many companies already have such plans.


Rule #2 "proposes enforceable safety standards for the production and harvesting of fruits and vegetables."  Larger farms would have to be in compliance 26 months after the finalized rule is published in the Federal Register, but very small farms would be allowed extra time, and "all farms would have additional time to comply with certain requirements related to water quality."  Important areas of risk that are addressed are water used for irrigation; soil contamination; hygiene of domesticated and wild animals; and sanitation of equipment, tools, and buildings.


To learn more, visit these FDA sites:

Fact Sheet on the Proposed Rule for Preventive Controls for Human Food

Fact Sheet on the Proposed Standards for Produce Safety

Fact Sheets on the Subparts of the Proposed Produce Safety Standards Rule


Coming soon from the FDA: the publication of the proposed rules for animal feed and pet food safety and ways to improve the quality of private food safety audits conducted overseas.


Everyone is in favor of food safety, but the tough question is this: is anyone willing to pay for it? And, if so, how much?  Will Congress allocate adequate funds annually for the FDA to employ more inspectors in the U.S. and abroad?  Will food manufacturers and processors--especially smaller companies--claim that the precautions the rules require them to take are too costly and too difficult?  If enforced, will the new rules force small companies out of business?


An FDA representative quoted in Supermarket News says that these rules could prevent as many as a million and a quarter illnesses. (Another FDA estimate is 1.75 million.) The New York Times says that currently one out of every six Americans suffers from a foodborne illness each year.  Of these, approximately 130,000 are hospitalized and about 3,000 die.


Food scientist Dr. Catherine Cutter says we must "level the playing field." She urges that the final rules require even small produce companies to have a formal plan showing how they will avoid the hazards of contaminating food.  According to Dr. Cutter, small meat processors are required to have a plan, so there's no reason why small produce processors shouldn't also.  If exceptions are allowed, she says, "one foodborne illness outbreak could wipe out a whole industry."


The FDA has allowed 120 days from the time of the announcement of the rules (January 4, 2012) for comments from the public. Here's a link to the FDA website where all dockets (i.e., the formal documents for comment) are listed related to the FSMA: http://www.fda.gov/Food/FoodSafety/FSMA/ucm261689.htm#open




Timothy J. Bowser, Ph.D., Oklahoma State University, Dept. of Biosystems and Agricultural Engineering


Catherine N. Cutter, Ph.D., Pennsylvania State University, Dept. of Food Science


Joe Regenstein, Ph.D., Cornell University, Dept. of Food Science


foodsafetynews.com ""Fast-Growing Salmon Causes a Splash"

http://www.foodsafetynews.com/2010/10/gmo-salmon/ - .UPGOOqVQ0yE 


noyonews.net "Obama administration gives tentative approval to GE salmon"



 fda.gov  "FDA proposes new food safety standards for foodborne illness prevention and produce safety"



supermarketnews.com "FDA Releases New FSMA Rules"



nytimes.com  "F.D.A. Offers Sweeping Rules to Fight Food Contamination" 



fda.gov  "Overview of the FSMA Proposed Rules on Produce Safety Standards and Preventive Controls for Human Food"




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