GxP Perspectives

FOOD SAFETY UPDATE: Check out the website “FDA, Food Safety, and Related Topics” on the link below. Also, Sid’s book reviews on the page above. Also, the new FDA WL page next to Sid’s book reviews.

Congress is moving forward with a bill that will increase FDA’s authority and funding to conduct food safety inspections. Most of us would agree that’s a pretty good idea. With a globalization of the food industry and E. coli becoming a household word, one would wonder why it has taken so long. Well, food is Big Business and there are a lot of the proverbial “special interests” interested in what a food safety bill will or will not allow FDA to do. The current Senate bill is a result of a lot of compromise. Enough concessions were made to allow wide bipartisan support in a political climate where the word “bipartisan” is considered by many to be an obscenity.

The bill, Senate 510, authored by Senators Dick Durbin and Tom Harkin, Chair of the Senate Health, Education, Labor and Pensions Committee, has major bipartisan support as well as support from many food companies and food trade organizations. Republicans are on board including Senator Mike Enzi of Wyoming, the Republican committee leader, who asked for quick approval of the bill. “I’m hoping the bipartisan approach will continue right on through the floor work,” he says.

Unfortunately, the bill doesn’t receive the support of small, local farmers. The San Francisco Chronicle’s newsblog reports that “Small farms and the sustainable agriculture movement raised alarms today about Senate legislation that they say would stifle family farms with ‘heavy-handed and costly attempts’ to battle food-borne illness but in fact would reduce the nutritional value of food.” The small farmers who produce the locally grown fruits and vegetables we find at our hometown farmers’ markets say the bill rigs the system in favor of agribusiness.

In addition, amendments were withdrawn that address major food safety issues. Senator Jack Reed of Rhode Island withdrew an amendment that would have addressed many concerns regarding antibiotics in livestock. Committee chairman Harkin said that more study was needed to determine the risks to human health from the non-therapeutic use of antibiotics in livestock.

“Non-therapeutic use of antibiotics?” Why in the world would anyone use an antibiotic for anything but a therapeutic use? Well it seems that this is a widespread practice in the feedlots that give us our T-bones and Big Macs. When livestock live in close quarters at the feedlots, eating out of bunks and not in a natural habitat, then they get sick. And to keep them from getting sick they receive medicated feed loaded with antibiotics.

FDA has long conducted “tissue residue” inspections to keep antibiotics out of the food supply. There is supposed to be a period of time that animals don’t receive antibiotics and other drugs before slaughter, so the drugs don’t end up in your roast beef. Overuse and misuse of antibiotics is one of the more serious public health problems worldwide. Senator Harkin should know that many people are allergic or sensitive to antibiotics. He should also know about MRSA and drug resistant TB. However, there are a lot of feedlots in Iowa, so the good senator seems to have a different risk/benefit assessment from the rest of us. He should read some FDA Warning Letters on the subject. Here is an excerpt from a 2007 inspection in Muleshoe, Texas:

“Our investigation also found that you hold animals under conditions that are inadequate such that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drug from edible tissues.”

That’s dry, technical language that means they may have slaughtered animals too sick to make it to the slaughterhouse. I’ve heard stories about animals being helped in with a forklift from some Vet Med inspectors I used to work with. This Warning Letter cited a number of drugs in slaughtered animals and it isn’t an isolated circumstance. Go to the FDA website and search for Warning Letters by subject: “Animals for Slaughter / Adulterated,” and you’ll find page after page of similar violations. I have attached a tissue residue Warning Letter at the top on a new page, “FDA WL.”

The food safety legislation being considered by Congress would give FDA broader authority including the ability for mandatory recalls, trace backs of contaminated fresh produce, funding for more food inspections, and new authority over food imports. I think that’s a good thing. However, we need food safety laws that have FDA focusing on agribusiness and the feedlots, not small farmers. We need a risk-based approach that targets well-documented problems, including the overuse of antibiotics. Anytime you have such widespread support from the giants of the food industry for food safety legislation you should take a closer look. A much closer look.