Search results: fda new food safety rules

The FDA has finally released safety rules for imported foods, two years after Congress passed the food safety law.  OK.   We now have them.  At last.

Here’s what the FDA is up against:

• 150 different countries ship foods to the U.S.
• These account for about 15% of the food supply, but 50% of fresh fruits and 20% of fresh vegetables.
• The agency has the capacity to inspect about 2% of imported foods.

To deal with this disconnect, the FDA proposes to hold importers accountable for the safety of what they ship to us.

The proposed rules allow two ways to do this: Importers can do their own onsite safety audit, or they can verify that their suppliers did so.

Both methods involve verification by certified verifiers that suppliers used “prevention-oriented food safety practices” (HACCP in other words), and achieved the same level of food safety as domestic growers and processors.

Neither requires inspection by FDA, although importers may use inspection.

The proposed rule and the third-party accreditation proposed rule are available for public comment for the next 120 days.

The previous proposed rules, for produce safety and food production facilities (see below), have been given another 60 days for public comment.  Comments on all proposals will now be due at the same time.  The FDA expect to issue the rules 12 to 18 months after the comments come in and then it will take another 18 months for rules to go into effect.

What does all this mean?

The FDA hardly has the resources to manage U.S. inspections so expecting it to do foreign inspections is unrealistic.  This plan shifts the regulatory burden to producers and shippers (why does this sound like foxes guarding henhouses?).

The FDA also intends to certify third-party auditors.  These invariably involve conflicts of interest, although that system  seems to have worked fairly reasonably well for organic foods.  But we are talking about the safety of imported foods here, and lives are at stake.

This is undoubtedly the best the FDA can do given its limited resources and its problems with Congress.  This Congress is hardly likely to view food safety as a national priority and give the FDA what it needs.

Recall: FDA appropriations go through agricultural appropriations committees, not health appropriations.  And this Congress cannot even pass a decent farm bill.

Congratulations to the FDA for making the best of a bad situation.  And fingers crossed that the proposals survive, get implemented by 2015, and nothing bad happens in the interim.

The document collection:

• FDA Food Safety Modernization Act (FSMA)
• 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
• Fact Sheet: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
• Fact Sheet: Proposed Rule on Accreditation of Third-Party Auditors 
• Consumer Update

For a detailed discussion of the pros, cons, and questions, see the account in Food Safety News

Food Chemical News has discovered a stunning set of documents, made available by the Department of Health and Human Services as part of a transparency initiative, that prove FDA was forced by the White House Office of Management and Budget to remove certain elements from the draft of its FDA Food Safety Modernization Act preventive controls proposal. It had long been speculated among FDA watchers that the agency intended to include requirements for product testing, maintaining supplier verification programs and tracking consumer complaints in its FSMA proposal, published in the Federal Register Jan. 16, but the eight documents we found this week, while searching for other information, confirm it.

Food Chemical News is reporting that documents released on regulations.gov on Feb. 28 reveal cuts made by the White House Office of Management and Budget (OMB) to the implementing regulatory package for the Food Safety Modernization Act (FSMA).Those apparent cuts include striking out requirements for food companies to test for microbial contamination of environments and finished food products, as well as rules for companies to maintain supplier verification programs and track consumer complaints.

We encourage readers to review the documents here and comment on anything of interest in our comment section.

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.”

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!

I am a daily reader of FoodNavigator-USA.com, a newsletter aimed at the food industry.  Occasionally the site collects posts on one subject.   This collection deals with food safety since Congress passed the new law more than a year ago.  The Interactive Timeline is particularly useful.

• Interactive timeline: The Food Safety Modernization Act:  A year ago, President Obama signed the Food Safety Modernization Act into law. FoodNavigator-USA tracks its development and implementation – as well as all the controversy along the way – in our exclusive interactive timeline.
• Expect ‘considerable growing pains’ as FSMA kicks in, warns lawyer : While the Food Safety Modernization Act (FSMA) will undoubtedly “raise the floor” and increase confidence in the US food supply, experts are predicting “considerable growing pains” as the industry gets to grips with the new legislation.
• Life under the Food Safety Modernization Act: Tracing, tracking and brand protection:  The ability to track and trace ingredients is likely to be a major focus for food manufacturers as the Food Safety Modernization Act (FSMA) is rolled out – but the most important consideration for companies is brand reputation, according to a FSMA specialist at ADT Security Services.
• FDA: We’ll publish FSMA foreign supplier verification rules ‘soon’: The FDA has missed its January 4 deadline for publishing details of how it will regulate imported food under the Food Safety Modernization Act (FSMA), but says it will update the industry “soon”.
• FDA hails ‘significant progress’ under year-old food safety law:  The Food and Drug Administration claims it has made significant progress with regulatory developments related to the Food Safety Modernization Act since the bill was signed into law a year ago, according to its one-year progress report.

In an astonishing display of what can only be described as chutzpah* Del Monte sued the FDA for insisting on a recall last March of its cantaloupes likely to be contaminated with a toxic form of Salmonella Panama. Now Del Monte is also suing the State of Oregon.

On what grounds?

Notably, “[t]he FDA investigation ultimately found no connection between Del Monte Fresh cantaloupes and any cases of Salmonella Panama, including in Oregon,” the company says. “FDA issued a notice ending the recall on July 29, 2011.”

The CDC thinks otherwise.  Its investigations pointed to imported Del Monte cantaloupes as the source of an outbreak that affected 20 people in several states:

Twelve of 16 ill people reported eating cantaloupe in the week before illness. Eleven of these 12 ill people ate cantaloupes purchased at eight different locations of a national warehouse club. Information gathered with patient permission from membership card records helped determine that ill persons purchased cantaloupes sourced from a single farm. Product traceback information indicated these cantaloupes were harvested from single farm in Guatemala.

FoodSafetyNews reviews the history of this particular recall.  It agrees with Del Monte that tests performed in April on cantaloupe samples from the Guatemala farm came out negative for Salmonella and that the FDA has now ended the recall.  But:

Del Monte had announced the recall in March, after the suspect melons had passed their shelf-life date. It is not clear whether any of the cantaloupes tested were actually the suspect melons. In foodborne illness investigations, samples of the food from the same batch eaten may no longer available by the time the connection to an outbreak is made. Epidemiology, rather than a contaminated sample, is the evidence that points to a likely source.

For these reasons, attorney Bill Marler terms the lawsuit “frivolous.”  He is suing Del Monte on behalf of a sick client.

Public health agencies doing their jobs to protect the public now have to defend against lawsuits like this?  Putative cause is no longer enough to order recalls?

U.S. courts are not famous for understanding epidemiology or other aspects of public health and I’m wondering what effect this suit will have on public protection against foodborne illness.  What standard of proof will the courts require?

Lawsuits are chilling.  Congress has just granted the FDA the authority to order recalls.  Food producers were not happy about that provision.  This is one way to get around Congress and the FDA.

It is worth asking who gains and who loses from lawsuits like this.

*Hence: chutzpah, which if you aren’t familiar with the term, is the Yiddish word for outrageous audacity.