Currently browsing posts about: Food-safety

I’m catching up with events that occurred while I was out of the country.  One was the release by FDA of two of its long-awaited proposals for food safety rules.

These go into the Federal Register on January 16. But they were announced on January 4, perhaps to commemorate the two-year anniversary of President Obama’s signing the Food Safety Modernization Act authorizing these rules.

The two massive sets of proposed rules, 680 and 547 pages, respectively, are:

• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

• Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Still to come: proposed rules for

• Food importers
• Preventive controls for animal feed
• Accreditation of third-party auditors

Notice that all of these are proposals.  Terrific as it is to have them released, no breath-holding is in order.

Once the proposals appear in the Federal Register, interested parties will have 120 days to comment.  It will probably take a year for the FDA to write final rules.   For the produce standards at least, larger farms get 2 years before implementation kicks in.  Smaller farms get 3 or 4 more years to figure out how to comply.

Some farms, such as those bringing in less than $500,000 per year, are exempt.  Chalk that up to successful lobbying by small farmers.

The FDA estimates that the new rules will cost large farms about $30,000 a year, and small farms $13,000.   It says that following the rules will prevent 1.75 million cases of foodborne illness a year and save more than $1 billion in costs.

The rules for produce focus on prevention of contamination through:

• Agricultural water
• Biological soil amendments
• Poor worker hygiene
• Domesticated and wild animals
• Equipment, tools and buildings.

All food producers will need to develop, submit, and follow a written food safety plan that includes:

•  A hazard analysis
• Preventive controls
• Monitoring procedures
• Corrective action procedures
• Verification procedures
• A recall plan

That’s the basic outline.  The devil is in the details and in this case there are plenty of them (I have much sympathy for whoever has to write these things).  The proposals devote hundreds of pages to definitions.  Here, for example, is FDA’s summary of its definition of farm and farm activities.  Hint: RAC = Raw Agricultural Commodity.

• The basic purpose of farms is to produce RACs and RACs are the essential products of farms.
• Activities that involve RACs and that farms traditionally do for the purposes of growing their own RACs, removing them from the growing areas, and preparing them for use as a food RAC, and for packing, holding and transporting them, should all be within the definition of “farm” in §§ 1.227 and 1.328.
• Activities should be classified based in part on whether the food operated on is a RAC or a processed food, and on whether the activity transforms a RAC into a processed food.
• Activities farms may perform on others’ RACs should appropriately be classified as   manufacturing/processing, packing, or holding in the same manner as these activities are classified off-farm when the RACs are to be distributed into commerce.
• Manufacturing/processing, packing, or holding food– whether RACs or processed foods, from any source–for consumption on the farm should remain within the farm definition.

I include this example to illustrate what food producers are up against.  It explains why practically every group commenting on the proposals said the same things: “we are glad they are out but must reserve comment until we—and our lawyers—have a chance to go over the rules in detail.”

My guess is that we will be hearing plenty more about these reactions when they do.

In the meantime, the elephant in the room issue is funding.  The FDA’s budget is already overstressed.  How can it possibly add monitoring and enforcement responsibilities without additional staff and funding?  How can it get new resources from this Congress?

Recall: the FDA gets its funding from congressional agriculture appropriations committees, not health committees.

The FDA addresses the funding issue in a website Q and A:

G.5.  Does FDA have sufficient funding to implement the new rule?  The funding we have available through the annual budget cycle and fees impacts the number of FTEs we have and will be a factor in the way that FDA handles its significant and far-ranging activities, including the way that this legislation is implemented… Without additional funding, FDA will be challenged in implementing the legislation fully without compromising other key functions. We look forward to working with Congress and our partners to ensure that FDA is funded sufficiently to achieve our food safety and food defense goals.

Indeed.

To submit a comment:

• Go to http://www.regulations.gov.
• Refer to Docket No. FDA-2011-N-0920.
• Do it by May 16.

For my monthly (first Sunday) Food Matters column in the San Francisco Chronicle, I devote the one in January every year to predictions.  Last year I got them all pretty much on target.  It didn’t take much genius to figure out that election-year politics would bring things to a standstill.  This year’s column was much harder to do, not least because the FDA was releasing blocked initiatives right up to the printing deadline.

 Q: I just looked at your 2012 crystal ball column. Your predictions were spot on. But what about 2013? Any possibility for good news in food politics?

A: Food issues are invariably controversial and anyone could see that nothing would get done about them during an election year. With the election over, the big question is whether and when the stalled actions will be released.

The Food and Drug Administration has already unblocked one pending decision. In December, it released the draft environmental assessment on genetically modified salmon – dated May 4, 2012. Here comes my first prediction:

The FDA will approve production of genetically modified salmon: Because these salmon are raised in Canada and Panama with safeguards against escape, the FDA finds they have no environmental impact on the United States. The decision is now open for public comment. Unless responses force the FDA to seek further delays, expect to see genetically modified salmon in production by the end of the year.

Pressures to label genetically modified foods will increase: If approval of the genetically modified salmon does nothing else, it will intensify efforts to push states and the FDA to require GM labeling.

Whatever Congress does with the farm bill will reflect no fundamental change in policy: Unwilling to stand up to Southern farm lobbies, Congress extended the worst parts of the 2008 farm bill until September. Don’t count on this Congress to do what’s most needed in 2013: restructure agricultural policy to promote health and sustainability.

The FDA will start the formal rule-making process for more effective food safety regulations: President Obama signed the Food Safety Modernization Act in January 2011. Two years later, despite the FDA’s best efforts, its regulations – held up by the White House – have just been released for public comment. Lives are at stake on this one.

The FDA will issue rules for menu labels: The Affordable Care Act of 2010 required calorie information to be posted by fast-food and chain restaurants and vending machines. The FDA’s draft applied to foods served by movie theaters, lunch wagons, bowling alleys, trains and airlines, but lobbying led the FDA to propose rules that no longer covered those venues. Will its final rules at least apply to movie theaters? Fingers crossed.

The U.S. Department of Agriculture will delay issuing nutrition standards for competitive foods: When the USDA issued nutrition standards for school meals in January 2012, the rules elicited unexpected levels of opposition. Congress intervened and forced the tomato sauce on pizza to count as a vegetable serving. The USDA, reeling, agreed to give schools greater flexibility. Still to come are nutrition standards for snacks and sodas sold in competition with school meals. Unhappy prediction: an uproar from food companies defending their “right” to sell junk foods to kids in schools and more congressional micromanagement.

The FDA will delay revising food labels: Late in 2009, the FDA began research on the understanding of food labels and listed more relevant labels as a goal in its strategic plan for 2012-16. Although the Institute of Medicine produced two reports on how to deal with front-of-package labeling and advised the FDA to allow only four items – calories, saturated and trans fat, sodium and sugars – in such labels, food companies jumped the gun. They started using Facts Up Front labels that include “good” nutrients as well as “bad.”

Will the FDA insist on labels that actually help consumers make better choices? Will it require added sugars to be listed, define “natural” or clarify rules for whole-grain claims? I’m not holding my breath.

Supplemental Nutrition Assistance Program participation will increase, but so will pressure to cut benefits: Demands on Snap – food stamps – reached record levels in 2012 and show no sign of decline. Antihunger advocates will be working hard to retain the program’s benefits, while antiobesity advocates work to transform the benefits to promote purchases of healthier foods. My dream: The groups will join forces to do both.

Sugar-sweetened beverages will continue to be the flash point for efforts to counter childhood obesity: The defeat of soda tax initiatives in Richmond and El Monte (Los Angeles County) will inspire other communities to try their own versions of soda tax and size-cap initiatives. As research increasingly links sugary drinks to poor diets and health, soda companies will find it difficult to oppose such initiatives.

Grassroots efforts will have greater impact: Because so little progress can be expected from government these days, I’m predicting bigger and noisier grassroots efforts to create systems of food production and consumption that are healthier for people and the planet. Much work needs to be done. This is the year to do it.

And a personal note: In 2013, I’m looking forward to publication of the 10th anniversary edition of “Food Politics” and, in September, my new editorial cartoon book with Rodale Press: “Eat, Drink, Vote: An Illustrated Guide to Food Politics.”

My post-hurricane Manhattan apartment still does not have telephone, internet, or television service, so I followed the election results on Twitter.

I knew that President Obama had been reelected when the Empire State Building turned on blue lights.

What’s ahead for food politics?

With the election out of the way, maybe the FDA can now:

• Release final food safety rules (please!)
• Issue proposed rules for front-of-package labels
• Issue proposed rules for revising food labels
• Require “added sugars” to be listed on labels
• Define “natural”
• Clarify “whole grain”
• Release rules for menu labeling in fast-food restaurants

Maybe the USDA can

• Release nutrition standards for competitive foods served in schools

And maybe Congress can pass the farm bill?

As for lessons learned:

• The food industry has proven that it can defeat consumer initiatives by spending lots of money: $45 to $50 million on California’s Proposition 37 (GMO labeling), $4 million on soda tax initiatives in Richmond and El Monte.
• But if enough such initiatives get started, food companies might get the message?

I’ve written previously about the holdup on implementation of the FDA Food Safety Modernization Act by the White House Office of Management and Budget, reportedly because anything regulatory is likely to be a campaign issue in this especially contentious election year.

To get things moving, The Center for Food Safety and the Center for Environmental Health have sued the FDA to implement the rules on the grounds that the law requires federal agencies to conclude matters presented to them “within a reasonable amount of time.”

The suit complains that the FDA is failing to meet required deadlines for at least seven new food regulations and that nine more are coming due in 2013.  It asks the court to order the agency to enforce the law right now.

In several instances, the FDA has attempted to make FSMA’s deadlines only to have its work held up at the White House Office of Management and Budget. FDA reported sending its proposed Foreign Supplier Verification Program to the OMB in November and its proposed produce safety standards in December, though the OMB has yet to release either regulation. Both were required by FSMA on Jan. 4.

FSMA also required FDA to establish standards for analyzing and documenting hazards and implementing preventative measures by July 4 of this year, the suit recounts.

The plaintiffs are especially alarmed that the FDA is not enforcing policies that are “self-executing,” meaning the new preventive standards for example.

From where I sit, the preventive standards are the critical factor in stopping outbreaks of foodborne illness before they happen.

While we are waiting for politics to resolve, the CDC keeps adding new outbreak home pages.

• Multistate Outbreak of Salmonella Braenderup Infections Associated with Mangoes is the latest.
• Multistate Outbreak of Salmonella Typhimurium Infections Linked to Cantaloupe isn’t over yet.

Would implementation of preventive standards help?  Yes it would, especially if the problem is in the packing houses (packing houses can be cleaned).

A full-page ad in Tuesday’s New York Times (July 17) alerts readers to the astonishing 18-month delay in issuing food safety rules authorized by the Food Safety Modernization Act passed by Congress at the end of 2010.

The sponsor of the ad, Make Our Food Safe, is a coalition of highly respected public health and advocacy groups working on food safety issues.

According to the New York Times report, they are baffled by the delay.

But the F.D.A. rules that are needed to carry out the law have been under review by the Office of Management and Budget in the White House since December, and consumer health advocates say there has been no explanation for what they describe as a lengthy delay.

….Before the rules become official, the F.D.A. still has to circulate them for public comment, adding more months to the process. The rules for importers were expected in January and for domestic food processors in July, advocates said.

Could the delay be due to election-year politics?  Advocates wonder if

Democrats may want to avoid the impression that government regulation is growing, a popular cause for attacks by Republicans.

The Office of Management and Budget denies this.

Moira Mack, a spokeswoman for the Office of Management and Budget, said that the agency coordinates suggestions from many institutions across the federal government, and that it is not unusual for the review process to take months. A regulation last year on dangerous snakes, for example, took about 10 months to clear, she said.

Oh come on.  These rules are about protecting the public from dangerous microbes.  They need to move.

The Make Our Food Safe website makes it easy to write President Obama to release the FDA’s proposed rules.    Add your voice!

Yesterday’s international edition of USA Today (I picked it up at Heathrow) carried a full-page ad from the Ad Council, which donates its services to worthy causes every now and then.  This one, entirely in grey and white, displays logos from the Ad Council, USDA, and the Department of Health and Human Services (DHHS), the parent agency of FDA.

In inch-high letters, all caps: DO YOU WANT THAT SAFE OR MEDIUM-SAFE?

In quarter-inch letters, also caps: USE A FOOD THERMOMETER TO MAKE SURE YOU COOK RAW MEAT AND POULTRY TO A BACTERIA-KILLING TEMPERATURE.

The ad also displays the Cook, Clean, Chill, Separate logo and the admonition to “Keep your family safer from food poisoning.  Check your steps at foodsafety.gov.”

Mind you, I’m highly in favor of following food safety procedures at home.

But most food safety problems are not due to the failure of home cooks to use thermometers.

They are caused by failures to observe food safety procedures during commercial production and preparation.

Shouldn’t meat and poultry be safe when you buy it in the supermarket?

This ad implies that the principal responsibility for food safety lies with the end user—you.

If you get sick it’s your fault because you didn’t use a meat thermometer?

USDA and DHHS:  how about getting the Ad Council to encourage meat and poultry producers to make sure their products are safe in the first place.

In response to my post on tuna scrape, Professor Alan Reilly, Chief Executive, Food Safety Authority of Ireland (the equivalent of our FDA) sent this photograph of an actual tuna scrape label.

After I forwarded it to Bill Marler, he noticed that it is one of several photographs posted on the FDA’s tuna scrape recall web page).

The type is too small to read so I’ve done some cropping:

Professor Reilly asks:

What is puzzling me is why this product “minced tuna” was used in sushi products. The label (copy attached) clearly states that the product must be cooked before consumption and it is for industrial uses only (labelled not for retail).

Those are good questions, but here’s another, equally alarming.  What’s that strangely formatted Nutrition Facts label? It does not precisely follow FDA design or content requirements.

This is a red flag.  If the company is not following labeling rules, it might not be  following other rules either—safety, for example.

Safety?  Uh oh.

Bill Marler reports that the FDA “483 Inspection Report” on the Indian tuna processing facility is now available.  Read these quotes and shudder:

• Tanks used for storage of process waters have apparent visible debris, filth and microbiological contamination.
• There is no laboratory analysis for water used in ice manufacturing at the [redacted] facility to show the water used to make ice is potable.
• Apparent bird feces were observed on the ice manufacturing equipment at Moon Fishery; insects and filth were observed in and on the equipment.
• Tuna processed at your facility, which is consumed raw or cooked, comes in direct contact with water and ice.

I draw several lessons from this episode:

• Food is safer when cooked.
• Labels need to be read—and followed—carefully.
• Raw sushi is a high risk product, especially if it doesn’t cost much.
• The FDA needs to be doing a lot more inspecting of overseas facilities, and before they cause problems.

All of this means that we need a better food safety system, one that can address the enormous proportion of our food supply that comes to us from countries with weaker food safety standards.

Addition, May 17: Ben Embarek, a food safety scientist at the World Health Organization notes that the 483 report reveals that Moon’s HACCP plan did not list appropriate critical control points.  Anyone auditing the plan should have picked up the problems on paper, which is easier and less expensive to do than an on-site inspection.  But the FDA does not pre-audit international HACCP plans.  They are supposed to be cleared by exporting companies registered by FDA.  Comment: it’s hard to imagine that the current system can work, and it clearly does not.

The Government Accountability Office is complaining again about the inadequacies of the American food safety system, and with good reason.

Its 2012 Annual Report, Opportunities to Reduce Duplication, Overlap and Fragmentation, Achieve Savings, and Enhance Revenue, says that the food safety system is:

fragmented and results in inconsistent oversight, ineffective coordination, and inefficient use of resources.

In 2007, GAO added food safety to its list of high-risk areas that warrant attention by Congress and the executive branch.

More recently GAO found that this fragmentation extends to the responsibilities across multiple agencies to defend food and agricultural systems against terrorist attacks and natural disasters…Many of these activities are everyday functions or part of the broader food and agriculture defense initiative and would be difficult for the agencies to separately quantify.

This report repeats what the GAO has been saying since the early 1990s:

there is no centralized coordination to oversee the federal government’s overall progress in implementing the nation’s food and agriculture defense policy.

Because the responsibilities outlined in this policy (HSPD-9) are fragmented and cut across at least nine different agencies, centralized oversight is important to ensure that efforts are coordinated to overcome this fragmentation, efficiently use scarce funds, and promote the overall effectiveness of the federal government.

Reminder: the present food safety system is mainly divided between two agencies: USDA (meat and poultry) and FDA (everything else).

Centralized oversight of food safety?  What a concept.