by Marion Nestle

Currently browsing posts about: Food-safety

Jul 7 2010

Two GAO reports on FDA’s food safety problems

Food Safety: FDA Has Begun to Take Action to Address Weaknesses in Food Safety Research, but Gaps Remain. GAO-10-182R, April 23, 2010 (23 pages).

Imported food makes up a substantial and growing portion of the U.S. food supply, with 60 percent of fresh fruits and vegetables and 80 percent of seafood coming from across our borders….In January 2007 GAO designated federal oversight of food safety as a high-risk area needing urgent attention and transformation because of the federal government’s fragmented oversight of food safety. The Food and Drug Administration (FDA) is responsible for ensuring the safety of roughly 80 percent of the U.S. food supply–virtually all domestic and imported foods except for meat, poultry, and processed egg products–valued at a total of $466 billion annually, as of June 2008.

Food Safety: FDA Could Strengthen Oversight of Imported Food by Improving Enforcement and Seeking Additional Authorities.  GAO-10-699T, May 6, 2010 (20 pages).

In 2008, FDA inspected 153 foreign food facilities out of an estimated 189,000 such facilities registered with FDA…. FDA estimated that it would conduct 200 inspections in 2009 and 600 in 2010. GAO previously identified several gaps in enforcement that could allow food products that violate safety laws to enter U.S. commerce. For example, FDA has limited authority to assess penalties on importers who introduce such food products, and the lack of a unique identifier for firms exporting food products may allow contaminated food to evade FDA’s review.

As it has been saying for years, GAO wants FDA to ask Congress to give it statutory authority to:

  • Recall products identified as unsafe
  • Require companies to demonstrate that food ingredients are safe before using them
  • Require preventive controls (e.g. HACCP) by firms producing foods that have been associated with repeated instances of serious health problems or death.

Note that the FDA does not have this authority now and must seek it from Congress.  The food safety bill now before Congress does some of this, which is one reason why it should be passed.  Note: the House passed the bill last August.  Eleven months later, the Senate is still sitting on it.  Not helpful.

Addition: Consumers Union has produced a video—starring Eric Schlosser—on why the Senate must pass the food safety bill, and right away.

Update, July 8: President Obama states support of the Senate’s food safety bill.

Jun 26 2010

A how-to guide for companies involved in food recalls

Bill Marler, the Seattle attorney whose firm represents victims of foodborne illness, has seen the best and worst of company behavior when faced with pressures to “voluntarily” recall tainted products.  Here is his guide to good corporate behavior under difficult circumstances.  It begins with “don’t produce tainted products in the first place.”   But, alas, if you do:

First, have a pre-existing relationship with the folks that regulate you. If someone holds your business in the palm of his or her hand, you should at least be on a first name basis. No, I am not suggesting that you can influence your way out of the outbreak, but knowing who is telling you that your company has a problem allows you the ability to get and understand the facts. Do regulators and their investigators make mistakes? Perhaps, but not very often and not often enough to waste time arguing that your company did not poison customers.

Second, stop production of the implicated product and initiate a recall of all products at risk immediately. This procedure should have been practiced, and practiced, and practiced before. All possibly implicated suppliers should be alerted and all retailers should be offered assistance. Consumers need to be engaged too. The goal now is to get poisoned product out of the marketplace and certainly out of the homes of consumers.

Third, launch your own investigation with two approaches, and at the same time. Are the regulators correct? And, what went wrong? Tell everyone to save all documents (you have to anyway). The goal here is to get things right. If it really is not your product, what has happened is bad, but survivable. If it really was your product, then learning what happened helps make sure it is likely to never happen again. More than anything, be transparent. Tell everyone what you find–good or bad.

Fourth, assuming that the outbreak is in fact your fault, publicly admit it. If it is not your fault, then fight it. However, pretending that you are innocent when you are actually at fault will get you nowhere. Asking for forgiveness is not a bad thing when you have something to be forgiven for. Saying you are sorry is not wrong when you are in fact wrong.

Fifth, do not blame your customers. If your food has a pathogen it is not your customers’ responsibility to handle it like it will likely kill them or a member of their family. Hoping that the consumer will fix your mistake takes your eye off of avoiding the mistake in the first place.

Sixth, reach out to your customers and consumers who have been harmed. Offering to pay legitimate losses will save money and your company’s reputation in the long run.

Seventh, teach all what you have learned. Do not hide what you have learned. Make your knowledge freely available so we all limit the risk that something similar will happen again.

In other words, do the right thing.  Excellent advice.

But Mr. Marler cites no examples.  I wonder if there are companies that actually did all this?  It would be good to know who they are.

Jun 1 2010

Thinking about food safety

Food safety is in the news again.

Congressman John Dingell (D-Mich) is calling on the Senate to get busy and pass the food safety bill that it has been sitting on for the last ten months: “I urge my Senate colleagues to acknowledge this important threat and make legislation addressing it a priority. Until the Senate acts, American families will continue to be at risk.”

If this bill ever passes it will require food companies to develop food safety plans, authorize the FDA to order recalls, and give the FDA better access to company records.

But will it do any good?

Here is one view from Dennis Stearns, counsel in the Seattle law firm, Marler & Clark, which represents victims of foodborne illnesses.  In a piece in Food Safety News, “What the oil spill can teach us about food safety,” he notes the endlessly repetitive responses–all talk, no action–to food safety and other crises involving corporate irresponsibility.

He quotes USDA Secretary Vilsack saying, “You can’t have two [food safety] systems and be able to reassure people you’ve got the job covered…This [referring to the peanut recalls of last year] is a grand opportunity for us to take a step back and rethink our approach.'”

Stearns’ piece concludes with this comment on Vilsack’s remarks:

Sadly, this was not the first time that someone had pointed out the need for systemic revision to food safety regulation and inspection in the United States. And neither was it the first time that expressions of outrage over people dying from foodborne illness were followed by no real changes at all. And all I can say about that is: I’m shocked! No, really, I’m shocked!

In contrast, Jim Prevor,who writes as the Perishable Pundit, writes in the online New Atlantis: A Journal of Science and Technology that fixing the FDA will do little to address food safety problems.  Instead, he recommends:

  • Fix the liability system so retailers as well as producers are liable and make it legal negligence, not strict liability.
  • Root out bribery and corruption in food safety certification.
  • Invest in state testing laboratories.
  • Invest in food safety research.
  • Revitalize the Agricultural Extension Service.
  • Educate consumers.

I’m not sure about the legal liability issues, but most of the rest are really good ideas and would help a lot.  Of course consumers should follow food safety procedures but how about getting safe food to them in the first place?

None of this will happen without policy changes, which is why the food safety legislation matters so much.  It’s a national scandal that the Senate is still sitting on that bill.

May 29 2010

USDA’s latest collection of relevant reports

The USDA does terrific research on many useful topics.  Here is a sample of some just in.

STATE FACT SHEETS:  data on population, per-capita income, earnings per job, poverty rates, employment, unemployment, farm characteristics, farm financial characteristics, top agricultural and export commodities.

WIC PROGRAM: research, publications, and data related to WIC (Special Supplemental Nutrition Program for Women, Infants, and Children). WIC served 9.1 million participants per month at a cost of $6.5 billion in 2009.

FEED GRAINS DATABASE: statistics on domestic corn, grain sorghum, barley, and oats; foreign grains plus rye, millet, and mixed grains. You can also get historical information through custom queries.

LIVESTOCK, DAIRY, AND POULTRY OUTLOOK:  current and forecast production, price, and trade statistics.

AGRICULTURAL OUTLOOK STATISTICAL INDICATORS: commodity and food prices, general economic indicators, government program expenditures, farm income estimates, and trade and export statistics.

ASPARAGUS STATISTICS: acreage, yield, production, price, crop value, and per capita use; also world area, production, and trade.

FOODBORNE ILLNESS COST CALCULATOR:   the cost of illness from specific foodborne pathogens, depending on the  annual number of cases, distribution of cases by severity,  use or costs of medical care, amount or value of time lost from work,  costs of premature death, and disutility costs for nonfatal cases.

ORGANIC FARMERS: explains why use of organic practices in U.S. lags behind other countries, differences and similarities between organic and conventional farmers, reduced consumer demand resulting from the weaker U.S. economy,  and potential competition from the “locally grown” label.

LOCAL FOOD SYSTEMS: defines local food,  market size and reach,  characteristics of local consumers and producers, and  economic and health impacts.  Addresses whether localization reduces energy use or greenhouse gas emissions (inconclusive).

BIOFUELS: Reaches 88 million gallons in 2010 as a result of one plant becoming commercially operational in 2010, using fat to produce diesel. Challenges include reducing high costs and overcoming the constraints of ethanol’s current 10-percent blending limit with gasoline.

Thanks to USDA for producing data that policy wonks like me just love to cite.

May 22 2010

The source of E. coli 0145?

Bill Marler, the Seattle attorney who represents victims of food poisonings, consistently urges federal food safety agencies to reveal what they know so consumers can protect themselves from unsafe food.

He is especially annoyed that the FDA has not revealed the name of the farm in Yuma, Arizona, linked to the bagged romaine lettuce that has sickened more than 30 people in several states so far with the unusual form of E. coli, 0145.

Marler knows how to get information (although not always accurate results, apparently – see update below).  He first offered $5,000–and later offered $10,000–as a reward to anyone who revealed the name of the farm before the FDA did (the money goes to charity).  He got two takers. Both identified a particular firm in California as the source.

Update, May 22:  I received a message today from Leslie Krasny, partner in the law firm of  Keller and Heckman, LLP, San Francisco, which represents the farm named by those sources.  She advises me that there is no evidence linking her client’s romaine lettuce to the outbreak and that her client is not even under investigation by the FDA.  She asks that I delete reference to her client, which I have done.  Mr. Marler also has done so.

May 14 2010

Food (un)safety update: E. coli 0145 in Arizona lettuce and more

It’s deja vu all over again with the recent recall of bagged romaine lettuce contaminated with a toxic form of E. coli.  The lettuce came from a central wash-and-bag facility that sent products out to food service companies in several states making about 30 people sick so far.

The one new development is the strain of E. coli: 0145, not O157:H7.  Despite decades of worry that other STECs (Shiga Toxin-producing strains of E. coli) cause serious human illness, state health departments don’t routinely test for 0145.  Clearly, they need to.

The FDA and CDC are both working on this case.

FoodSafetyNews.com has a complete report on the situation to date.  It examines the possible source of 0145 in a three-part series:

Meanwhile, the USDA issued compliance guidelines for reducing Salmonella and Campylobacter in poultry.  That’s nice, but what about STECs?

And the GAO has just issued a new report, FDA Could Strengthen Oversight of Imported Food by Improving Enforcement and Seeking Additional Authorities (don’t you love those titles?).  The report focuses on weaknesses in FDA’s oversight of food imports.

FoodQualityNews.com has a short but tough summary:

There are about 189,000 registered foreign sites where food is made for sale in the United States, according to the report. Of those, the FDA inspected just 153 in 2008…Meanwhile, the amount of food imported into the United States is increasing, and now accounts for 15 percent of the total food supply, including 60 percent of fresh fruits and vegetables and 80 percent of seafood.

What more evidence do we need for the urgency of passing food safety legislation?  Reminder: the Senate has been sitting on a food safety bill since the House passed it last August.  Apparently, this Congress this food safety can wait.  Tell that to the people who got sick from eating bagged romaine lettuce.

Apr 20 2010

Food safety progress: some good news, some not

On April 16, the CDC published its annual report on foodborne illnesses in a ten-state sample.  CDC writes in passive voice and it’s a struggle to get to the good news:

In comparison with the first 3 years of surveillance (1996–1998), sustained declines in the reported incidence of infections caused by Campylobacter, Listeria, Salmonella, Shiga toxin-producing Escherichia coli (STEC) O157, Shigella, and Yersinia were observed…Compared with the preceding 3 years (2006–2008), significant decreases in the reported incidence of Shigella and STEC O157 infections were observed.

Some consumer groups urge caution in interpreting the drop in toxic E. coli cases, as previous drops have rebounded.

And then there’s the not-so-good news: “The incidence of Vibrio infection continued to increase.”

Vibrio infections reflect the oyster problem I talked about last fall.  The gulf oyster industry is still fighting the FDA over methods to decrease these preventable infections.  Perhaps this bad news will encourage the FDA to get busy and regulate oyster safety.

The Inspector General of the Department of Health and Human Services is worried about FDA’s inspection ability:

  • On average, FDA inspects less than a quarter of food facilities each year, and the number of facilities inspected has declined over time.
  • Fifty-six percent of food facilities have gone 5 or more years without an FDA inspection.
  • The number of facilities that received OAI [Official Action Indicated] classifications has declined over time.  In addition, nearly three-quarters of the facilities that received OAI classifications in FY 2008 had a history of violations. Two percent of facilities that received OAI classifications refused to grant FDA officials access to their records.
  • FDA took regulatory action against 46 percent of the facilities with initial OAI classifications; for the remainder, FDA either lowered the classification or took no regulatory action.
  • For 36 percent of the facilities with OAI classifications in FY 2007, FDA took no additional steps to ensure that the violations were corrected.

This is also bad news.  Worse, is congressional inaction over food safety.  The House passed its food safety bill–one designed to fix the FDA–last August.  The Senate has yet to deal with its version.  Can food safety wait?  No, it must not.

Apr 10 2010

GAO on FDA and USDA: irradiation, food safety, and humane treatment of animals

It’s the weekend and I’m cleaning out my e-files.  The Government Accountability Office (GAO), the congressional watchdog agency, has just released a bunch of reports complaining about the way the FDA and USDA do business:

Food Irradiation: FDA Could Improve Its Documentation and Communication of Key Decisions on Food Irradiation Petitions (GAO-10-309R, February 16, 2010, 23 pages).

labels on food products subject to FDA jurisdiction do not have to be reviewed and preapproved by FDA before marketing. Rather, the processor is responsible for properly labeling its products. In fact, FDA officials told us that they do not collect information on how irradiated foods are labeled and marketed. In contrast, USDA reviews and preapproves all labels before use on meat and poultry products and has denied label submissions that do not meet its requirements…FDA does not require the product’s ingredient list to disclose that a particular ingredient has been irradiated, while USDA generally does.

Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS) (GAO-10-246, February 3, 2010, 69 pages).

FDA only reviews those GRAS determinations that companies submit to the agency’s voluntary notification program…the agency has not systematically reconsidered GRAS substances since the 1980s… FDA has largely not responded to concerns about GRAS substances, such as salt and the trans fats in partially hydrogenated vegetable oils, that individuals and consumer groups have raised through 11 citizen petitions submitted to the agency between 2004 and 2008…FDA’s approach to regulating nanotechnology allows engineered nanomaterials to enter the food supply as GRAS substances without FDA’s knowledge. In contrast to FDA’s approach, all food ingredients that incorporate engineered nanomaterials must be submitted to regulators in Canada and the European Union before they can be marketed.

Food safety note #1: This arrives in the middle of the latest set of FDA recalls, this time of nearly 100 products made with a flavor enhancer, hydrolyzed vegetable protein, contaminated with Salmonella.

Food safety note #2: the Produce Safety Project at Georgetown University has estimated the cost of foodborne illness:  $152 billion annually, of which $39 billion is due to leafy greens and other vegetables.

Food and Drug Administration: Opportunities Exist to Better Address Management Challenges. (GAO-10-279, February 19, 2010, 54 pages).

Through reviewing reports…GAO determined that FDA’s management challenges include recruiting, retaining, and developing its workforce; modernizing its information systems; coordinating internally and externally; communicating with the public; and keeping up with scientific advances…While FDA has taken steps to align its activities and resources to strategic goals, these efforts in its centers and offices are not clear, making it difficult to connect the agency’s use of resources to the achievement of its goals.

If you feel gossipy (or want to interpret the raw data for yourself), you can read what FDA staff actually told GAO interviewers.

Humane Methods of Slaughter Act: Actions Are Needed to Strengthen Enforcement (GAO-10-203, February 19, 2010, 60 pages). [The actual survey responses are here.  And a shorter version given as testimony is here.]

The guidance does not clearly indicate when certain enforcement actions should be taken for an egregious act–one that is cruel to animals or a condition that is ignored and leads to the harming of animals. A noted humane handling expert has stated that FSIS inspectors need clear directives to improve consistency of HMSA enforcement. According to GAO’s survey, FSIS’s training may be insufficient.

This, one can only assume, is an understatement.

The GAO does important work, no?  Now if only government agencies would listen to it.