Currently browsing posts about: Food-safety

Thanks to reader Michael Bulger for forwarding the Senate staff analysis of the impact of S. 510 on small farms.   Here’s what it says (slightly edited):

No Change in Agency for Regulated Foods: Only foods already regulated by the Food and Drug Administration (FDA) will be subject to S. 510. Section 403 maintains the existing firewall between FDA and the U.S. Department of Agriculture regulated foods and agricultural products.

No Change in Definition of Facility: Under the Bioterrorism Act of 2002, certain food businesses were considered “facilities” and had to register with FDA. Farms and restaurants were exempted. This definition is not changed in S. 510. If an entity does not need to register now, it will not need to register under S. 510.

Flexibility for Small Businesses: Small businesses are given regulatory flexibility throughout S. 510. For example, small processors are given additional time to comply with new food safety practices and guidelines created by the bill and the Secretary may modify or exempt small processors from new hazard analysis and preventive control requirements based on size and risk. The legislation also requires the FDA to publish several user-friendly small entity compliance guides to assist firms with the implementation of new practices.

Scale Appropriate Produce Safety Standards: In coordination with the Secretary of Agriculture, FDA develops science-based standards for the safe production and harvesting of fruits and vegetables. Priority is given to specific fruits and vegetables that have the highest risk of food borne illness outbreaks. Flexibility is given for different growing, production, and harvesting techniques. FDA has the discretion to limit produce safety standards for small and very small entities that produce or harvest food which pose little or no serious risk to human health. Consideration is also given to conservation and environmental standards already established by federal natural resource and wildlife agencies. Exemptions are also available for low risk commodities. FDA must minimize the burden of paperwork and, as appropriate, the number of separate standards for separate foods.

Increased Training Opportunities: The bill requires FDA to coordinate with the extension activities of the National Institute of Food and Agriculture (NIFA) of the U.S. Department of Agriculture in educating growers and small processors about any new practices required by S. 510. Necessary funds are authorized to conduct these extension activities. The bill also provides for the training and education of state, local, and tribal authorities to facilitate the implementation of new standards under the FDA Food Safety Modernization Act. Competitive grants are made available, for up to 3 years, to support these efforts to enhance education, training, and technical assistance.

Risk-Based Traceability: The ability to trace back potentially unsafe food in the event of a food-borne illness outbreak is important. For the purpose of traceability, farms and small businesses that are not food facilities are not expected to create new records. During an active investigation of a foodborne illness outbreak, in consultation with state and local officials, the Secretary may ask a farm to identify potential immediate recipients of food if it is necessary to protect public health or mitigate a foodborne illness outbreak. Limitations are also included for restaurants, commingled agricultural commodities, direct to consumer sales, fishing vessels and products carrying an identity preserved label.

Regulatory Flexibility for Organic Foods: Throughout the bill, consideration is given to the unique agricultural practices and requirements of organic foods under the Organic Foods Production Act of 1990.

Protections for Farmers Markets, Cottage Industries and Direct Farm-to-Market Sales: Small entities that produce food for their own consumption or market the majority of their food directly to consumers or restaurants are not subject to registration or new recordkeeping requirements under S. 510. This includes food sold through farmers’ markets, bake sales, public events and organizational fundraisers.

I hope this helps to calm things down a bit.  This bill needs all the support it can get.  It’s not perfect but it is a reasonable first step, and badly needed.

Yes, the Senate needs to pass S.510 but that is only the first step.  As the inimitable Carol Tucker Foreman puts it in today’s New York Times story on the latest egg recalls:

You have to treat eggs with the assumption that they’re contaminated with salmonella…We may all object to the fact that we have to treat food like toxic waste, but if we don’t want to get sick, and especially if you have someone in your house that’s immune-suppressed, you have to handle things carefully and demand that the standards be set higher.

If you are still unconvinced, take a look at the recalls announced by the FDA just since August 13 (I’ve deleted the ones that do not involve microbial contaminants):

• August 20, 2010 – Hillandale Farms of Iowa Conducts Nationwide Voluntary Recall of Shell Eggs Because of Possible Health Risk

• August 20, 2010 – GloryBee Foods Recalls Whole Raw Pistachio and Whole Raw Pistachio Kernels Because of Possible Health Risk
• August 19, 2010 – COUNTRY Eggs, Inc. Initiates Voluntary Recall of Large AA Loose 15 dozen Fresh Shell Eggs Because of Possible Health Risk
• August 19, 2010 – Austinuts Wholesale, Inc. Announces Voluntary Recall of Pistachio Kernel Products
• August 19, 2010 – Salmonella in Alfalfa Sprouts
• August 18, 2010 – Wright County Egg Expands Nationwide Voluntary Recall of Shell Eggs Because of Possible Health Risk
• August 18, 2010 – Montalvan’s Sales, Inc. Recalls “La Nuestra” Brand Frozen Mamey Because of Potential Health Risk
• August 17, 2010 – NuCal Foods Conducts Recall of Shell Eggs Supplied from Wright County Egg Because of Possible Health Risk
• August 13, 2010 – Goya Foods, Inc. Announces Voluntary Recall of Frozen Mamey Pulp, Produced By Coco, S.A. of Guatemala Because of Potential Health Risk²⁸
• August 13, 2010 – Wright County Egg Conducts Nationwide Voluntary Recalls of Shell Eggs Because of Possible Health Risk

• August 13, 2010 – Merrick Pet Care Recalls Filet Squares & Texas Hold’ems 10oz Bag (Item # 60016 All Lots) Because of Possible Salmonella Health Risk

The FDA has a lot to say about Salmonella risk, but it’s useful to note that all these recalls are voluntary. Hence the need for S.510.

S.510 won’t solve the problem but it is a necessary first step in getting to a food safety system that does a better job of protecting the public against this sort of thing.

Judging from the number of interview requests today, everyone has figured out that the egg recall is not only awful for the people who got sick but also has something to do with our hopelessly inadequate food safety system and dysfunctional Congress.

The CDC has updated its statistics on the number of illnesses.  Here’s what this epidemic looks like:

About 2,000 cases have been reported but the CDC does not yet know whether these are all related to this particular outbreak.

Here’s what’s special about this particular recall:

• Salmonella in eggs never used to be a problem until we had industrial egg production that puts hundreds of thousands of hens in close (very close) proximity.
• The company producing these particular eggs has a long history of rule violations.
• The company was not required to follow standard food safety plans.  Whatever it had to do was voluntary.
• The FDA started writing rules for safe egg production more than 10 years ago.  These were quashed. It finally got them done last July.
• The new safety rules for eggs went into effect this July 9, too late to prevent this outbreak.
• The FDA’s hands are tied by inadequate legislation and resources.

• The House passed legislation last August—one year ago—to give the FDA more authority and more resources.  The Senate has been sitting on S.510 ever since.

The moral?  Voluntary doesn’t work.  We need mandatory food safety rules.

And sooner rather than later, no?

Yesterday, the FDA announced yet another voluntary recall of eggs produced by Wright County Egg in Galt, Iowa.  The first announcement on August 13 covered 228 million eggs.  This one adds 152 million for a grand total of 380 million—so far.

In that first announcement, the Wright company said: “Our farm strives to provide our customers with safe, high-quality eggs – that is our responsibility and our commitment.”

That, however, is not how the New York Times sees it.  According to today’s account, Wright has a long history of “run-ins with regulators over poor or unsafe working conditions, environmental violations, the harassment of workers, and the hiring of illegal immigrants.”

OK, so where are we on safety regulation?  The FDA, after many, many years of trying, finally introduced safety regulations for shell eggs.  These supposedly went into effect on July 9.

I recount the history of FDA’s persistence in the chapter entitled “Eggs and the Salmonella problem” in What to Eat. Check out the table  listing the key events in this history from 1980 to 2005.  It’s not pretty.

Preventing Salmonella should not be difficult.  The rules require producers to take precautions to prevent transmission, control pests and rodents, test for Salmonella, clean and disinfect poultry houses that test positive, divert eggs from positive-testing flocks, refrigerate the eggs right away, and keep records.  These sound reasonable to me, but I care about not making people sick.

Problems with Wright County Eggs started in May before the FDA’s mandatory rules went into effect meaning that the procedures were still voluntary.  The recalls this month are after the fact.  Chances are that most of the recalled eggs have already been eaten.

The CDC is tracking this recall and has logged about 200 reports of illness associated with it so far.  It has plenty to say about Salmonella and its hazards.

According to FoodSafetyNews, the first lawsuits have been filed.

As for food safety legislation that would give the FDA the authority to handle these incidents more efficiently—and, let us hope, maybe even prevent them—it is still sitting in the Senate.  For S.510 watchers, Bill Marler has a helpful new analysis.

The recall, by the way, affects eggs sold under many different brands: Lucerne, Albertson, Mountain Dairy, Ralph’s, Boomsma’s, Sunshine, Hillandale, Trafficanda, Farm Fresh, Shoreland, Lund, Dutch Farms, and Kemps in the first round, and now also James Farms, Glenview, and Pacific Coast.

The good news is that cooking kills Salmonella.  I’m buying eggs at farmers’ markets these days.

Addition: Tom Philpott of Grist on Wright County’s unsavory history.

I’ve been out of town so I missed the New York City Health Department’s grades for restaurant safety.  The agency has a website where you can look these up.

The first restaurant to get an A was happy about it, as you might expect.

All the others are worried that customers won’t go to places that get less than A grades.  But isn’t that the point?  The grades ought to act as an incentive for restaurants to clean up their safety acts.

Los Angeles has been doing this for ages.  It’s reassuring to see the A on the door.

My personal test for whether a restaurant is likely to be paying attention to safety: handwashing.  I am always reassured to see restaurant restrooms with (1) hot water, (2) soap, and (3) towels.  With those, it’s easier for employees to wash their hands so they are more likely to do so.

I’m always amazed at how many restaurants do not have all three.   Check out the restrooms and see for yourself?

Yesterday, I posted comments from the Consumers Federation of America about the latest version of S.510. With luck, the Senate will vote to pass this bill in September and will reconcile its version with the House bill passed a year ago.  Here are two comments based on Senator Harkins’ staff analyses:

1.  The National Sustainable Agriculture Coalition (NSAC) says that the latest version of the bill includes these improvements (my emphasis):

• The amendment sponsored by Senator Bernie Sanders (I-VT) pertaining to farms that engage in value-added processing or that co-mingle product from several farms.  It will provide the Food and Drug Administration (FDA) with the authority to either exempt farms engaged in low or no risk processing or co-mingling activities from new regulatory requirements or to modify particular regulatory requirements for such farming operations. Included within the purview of the amendment are exemptions or flexibilities with respect to requirements within S. 510 for food safety preventative control plans and FDA on-farm inspections.
• The amendments sponsored by Senator Michael Bennet (D-CO) to reduce unnecessary paperwork and excess regulation.  The Bennet language pertains to both the preventative control plan and the produce standards sections of the bill.  FDA is instructed to provide flexibility for small processors including on-farm processing, to minimize the burden of compliance with regulations, and to minimize the number of different standards that apply to separate foods.  FDA will also be prohibited from requiring farms and other food facilities to hire consultants to write food safety plans or to identify, implement, certify or audit those plans. With respect to produce standards, FDA will also be given the discretion to develop rules for categories of foods or for mixtures of foods rather than necessarily needing to have a separate rule for each specific commodity or to regulate specific crops if the real food safety issue involved mixtures only.
• The amendment sponsored by Senator Debbie Stabenow (D-MI) to provide for a USDA-delivered competitive grants program for food safety training for farmers, small processors and wholesalers.  The training projects will prioritize small and mid-scale farms, beginning and socially disadvantaged farmers, and small food processors and wholesalers. The program will be administered by USDA’s National Institute for Food and Agriculture.  As is the case for all of the provisions in S. 510, funding for the bill and for this competitive grants program will happen through the annual agriculture appropriations bill process.
• The effort championed by Senator Barbara Boxer (D-CA) to strip the bill of wildlife-threatening enforcement against “animal encroachment” of farms is also in the manager’s package.  It will require FDA to apply sound science to any requirements that might impact wildlife and wildlife habitat on farms.
• An amendment proposed by Senator Sherrod Brown (D-OH) to amend the traceability and recordkeeping section of the bill that will exempt food that is direct marketed from farmers to consumers or to grocery stores and exempt food that has labeling that preserves the identity of the farm that produced the food. The amendment also prevents FDA from requiring any farm from needing to keep records beyond the first point of sale when the product leaves the farm, except in the case of farms that co-mingle product from multiple farms, in which case they must also keep records one step back as well as one step forward.

2.  Bill Marler provides additional information:

Here is Chairman Harkin’s mark-up and section by section summary – this is the version of the bill voted out of the HELP Committee in mid-November and here is the most recently approved version as of last night.

Senator Feinstein has not released a copy of her BPA amendment — however, she is now saying it will only be baby bottles, sippy cups, baby food, and infant formula.

Here’s the Senator Tester amendments as they were introduced in April (I’m sure the version they’re working with now looks quite different after months of negotiations, but the principle is likely the same).

Marler also points out that only foods that are already regulated by FDA will be subject to S. 510, as its Section 403 maintains the existing firewall between FDA and USDA-regulated foods and agricultural products.

Keep reading.  This is critically important legislation to help the FDA ensure food safety.

It looks like S. 510, the Senate’s version of the food safety bill passed by the House a year ago, may actually have a chance of passing. According to summaries by Bill Marler and by Food Safety News, there is now bipartisan agreement on the bill’s key provisions:

Hazard analysis and preventive controls: Requires facilities that manufacture, process, pack, or hold food to have in place risk-based preventive control plans to address identified hazards and prevent adulteration, and gives FDA access to these plans and relevant documentation. These requirements do not apply to restaurants or most farms.

Imports: Requires importers to verify the safety of foreign suppliers and imported food.  Allows FDA to require certification for high-risk foods, and to deny entry to a food that lacks certification or that is from a foreign facility that has refused U.S. inspectors.  Creates a voluntary qualified importer program in which importers with a certification of safety for their foreign supplier can pay a user-free for expedited entry into the U.S.

Inspection: Gives FDA additional resources to hire new inspectors and requires FDA to inspect food facilities more frequently.

Mandatory Recall Authority: Gives FDA the authority to order a mandatory recall of a food product if the food will cause serious adverse health consequences or death and a company has failed to voluntarily recall the product upon FDA’s request.

Regulatory Balance: Achieves new requirements without being excessively burdensome.  The legislation provides training for facilities to come into compliance with new safety requirements and includes special accommodations for small businesses and farms.  It does not interfere with current organic farming practices and does not change the current definition of farm under the 2002 Bioterrorism Act.  Any farm that is not currently required to register with FDA will not be required to do so under this legislation.

Surveillance: Enhances surveillance systems to detect foodborne illnesses.

Traceback: Requires FDA to establish a pilot project to test and evaluate new methods for rapidly tracking foods in the event of a foodborne illness outbreak.

Increased FDA Resources: Increases funding for FDA’s food safety activities through increased appropriations and targeted fees for food facility reinspection, food recalls, and the voluntary qualified importer program.

Carole Tucker Foreman of Consumers Federation of America (CFA), sends its statement on the bill.  CFA, like many others, is disappointed in some of the bill’s provisions but supports it because the FDA so desperately needs more authority and resources:

Consumer Federation of America commends the Senate HELP Committee for reaching a bipartisan agreement that should remove any further barriers to bringing S. 510, the FDA Food Safety Modernization Act, to the floor of the Senate in early September.   At a time when bipartisanship is in short supply, this is a notable achievement.

We are extremely disappointed that the Senate, in order to reduce the estimated cost of the legislation, reduced the frequency of FDA inspections of food processing facilities. Regular and frequent inspection is a basic part of prevention.

Inspectors are cops on the beat—checking to be sure that corporate process controls are operating as intended.  Even the most sophisticated and well intentioned company can make a mistake and history shows some plants are careless and not concerned with protecting their customers.

CFA advocated increasing the number of inspections that were required in the bill reported by the Committee last year.  Instead, the Senate has reduced the frequency to once every five years for high risk plants and once every seven years for other facilities.

Despite our dismay with this glaring weakness, CFA supports passage of  S. 510 and will encourage our members to communicate with their Senators urging its passage.  We believe that establishing an affirmative legal mandate for FDA to prevent foodborne illness will help save lives.

The current version of the Senate bill is available for scrutiny.  If passed, it still needs to go to the House for reconciliation of the two versions.  So it is still interim and worth reading carefully.  Read it and decide for yourself what it says and is likely to mean.

You have to pity the poor supplement industry.  It is taking a real beating these days.

First, the Government Accountability Office told a Senate committee that the dietary supplement industry routinely uses “questionable and deceptive” marketing practices and gives potentially dangerous advice.

USA Today agreed.  In an editorial, it noted that:

Industry spokesmen have gotten away for years with minimizing all this as just the work of a handful of bad apples. Lobbyists say responsible makers and distributors should not be burdened with more government oversight. But the problem is big enough that another GAO study last year found nearly 1,000 reports in a 10-month period of specific health problems linked to supplements, including nine deaths, 64 life-threatening illnesses and 234 hospitalizations. Nobody knows how many other incidents never got reported.

In defense, an industry spokesman blamed the FDA:

As FDA Deputy Commissioner Joshua Sharfstein acknowledged last week, DSHEA strikes the right balance, but FDA needs to do more to maintain that equilibrium. FDA must use the tools it was given under the law to address the issues that hurt the credibility of responsible companies and undermine consumer confidence.

And now, the September issue of Consumer Reports list the “Dirty Dozen” supplements that research links to nasty problems such as cancer, coma, heart problems, kidney damage, liver damage, or death: aconite, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow, germanium, greater celandine, kava, lobelia, and yohimbe.  The FDA has been warning about the ones shown in red for years.  But these and the others are still on the market.

Among other suggestions, Consumer Reports advises:

Beware of these categories. Supplements for weight loss, sexual enhancement, and bodybuilding have been problematic, the FDA said, because some contain steroids and prescription drugs.

Don’t assume more is better. It’s possible to overdose even on beneficial vitamins and minerals. Avoid any product that claims to contain “megadoses.”

Report problems. Let your doctor know if you experience any symptoms after you start taking a supplement…do it yourself at www.fda.gov/medwatch or by calling 800-332-1088.

Research in the right places. Be skeptical about claims made for supplements in ads, on TV and by sales staff. If a claim sounds too good to be true, it probably is.

Consumer Reports provides online links for assessing supplements at www.ConsumerReportsHealth.org.

Yes, I know half the U.S. adult population takes supplements and nearly everyone who takes them claims to feel better as a result.  The science, however, consistently produces reasons for skepticism, if not caution.

I discuss this discrepancy in Food Politics. Take a look and decide for yourself!