Here’s The Beef

On September 4, 2012, Canada’s Canadian Food Inspection Agency (CFIA) and USDA’s Food Safety and Inspection Service (FSIS) each, independently, recovered E. coli O157:H7 from a sample of raw beef trimmings from the Brooks, Alberta production establishment of XL Foods Inc., registered with CFIA as Est. 038.

According to the Summary of Events released by CFIA, no recall was initiated, because CFIA determined that neither of the contaminated batches of product (beef trimmings produced on August 24th and 28th) had reached the Canadian marketplace.

Here are a few of the key dates and events that followed the initial findings:

On September 6th, CFIA requested distribution information and testing results from XL Foods for all products from those two production dates.

On September 12th, FSIS reported two more positive E. coli O157:H7 findings to CFIA.

On September 13th, CFIA removed XL Foods from the list of establishments eligible to export meat to the USA. But, despite the multiple findings of E. coli O157:H7 in samples of beef trimmings from the Brooks plant, and despite noting several deficiencies in the plant’s operations and sampling protocols, no public recall was announced – because, in the words of CFIA, of “…the absence of evidence that any affected product from the initial discovery had reached the marketplace.”

Nevertheless, that same day, XL Foods began to advise its customers that it was recalling beef trimmings produced on August 24th, August 28th, and September 5th.

On September 16th, Canadians finally were let into the dirty little secret. CFIA released its initial Health Hazard Alert. It was another four days before FSIS issued its first Public Health Alert for Imported Canadian Raw Boneless Beef Trim from XL Foods. Both CFIA and FSIS have issued multiple updates as the number of production dates under recall increased.

On September 18th, the Public Health Agency of Canada told CFIA that the Alberta Health Services was investigating five cases of E. coli O157:H7 illnesses; there was a possible link, CFIA was informed, between four of those cases and steaks purchased at an Edmonton Costco Wholesale store – steaks that had originated at XL Foods Inc.’s Brooks facility.

On September 27th, CFIA temporarily suspended the operating license for XL Foods Inc. (Establishment 038) in Brooks, AB after determining that “…adequate controls for food safety were not fully implemented in the facility.”

On September 29th, CFIA acknowledged in an updated Health Hazard Alert (for the first time) that four E. coli 0157 illnesses were associated with the consumption of beef products originating from XL Foods Inc. (Est. 38). The following day, CBC News reported that a total of nine cases of E. coli were under investigation, including the four confirmed cases.

So what’s my beef?

1. CFIA should have insisted on a recall of the meat from August 24th and August 28th production dates as soon as it was clear that there was a contamination problem at Brooks that involved more than a single batch of beef trimmings.

2. CFIA’s initial Health Hazard Alert should have been issued as soon as a decision was taken to recall product – NOT THREE DAYS LATER.

3. Neither the Public Health Agency of Canada nor Alberta Health Services have posted any information on their web pages regarding the E. coli O157:H7 illness investigations.

4. FSIS waited four extra days after the Canadian Health Hazard Alert to issue its own Public Health Alert.

5. FSIS still has not released a list of recalled products in the USA; nor has it released names of any of the meat processing or grinding or food service or distribution companies that are impacted by this beef recall – just a list of affected retailers. FSIS is relying, instead, on the individual retailers to post information listing recalled products.

On the plus side, CFIA has been very forthcoming with detailed recall information, including full identification of products by name, UPC, and packing or expiration dates, and retail distribution information by retailer and province/territory.

For a full list of products recalled to date in both Canada and the USA, including retail distribution information, please consult the Canada/USA Beef Recall page.

Canada Moves To Streamline Food Inspection System

“The world in which the CFIA operates is changing and the CFIA needs to change with it.”

– Canadian Food Inspection Agency (CFIA), August 9, 2012

On June 7, 2012 the Canadian government introduced the Safe Food For Canadians Act. This legislation, once passed into law, will ensure that the same food safety criteria apply to both domestic and imported food commodities, and will consolidate several different food inspection regimes into a single, unified approach.

Some elements of the proposed law include:

Licensing of all food commodity importers, exporters and domestic producers;
Puts the onus on importers to ensure that their off-shore suppliers produce foods under conditions that meet Canadian domestic production requirements;
Provides inspectors with full authority to examine any documents – including those stored on computers – during the course of an inspection;
Prohibits anyone from selling a food commodity that is the subject of a recall order;
Reaffirms CFIA’s mandatory recall authority;
Allows the Government to recover costs incurred during “…the inspection, moving, seizure and detention, forfeiture, disposal, return or release…” of any item; and
Protects those exercising their functions from liability for their good faith actions while performing their duties.

Under Canada’s parliamentary system, with a strong majority government in place, the Safe Food for Canadians Act will almost certainly become law with very few amendments.

The Canadian Food Inspection Agency (CFIA) – charged with enforcing food safety laws in Canada – already is preparing for the new mandates. On August 9th, CFIA released for comment a draft of an Improved Food Inspection Model.

I find a lot to like in this draft document, such as:

Mandatory licensing of food production facilities, importers, and exporters, providing for annual renewals, and for suspension or cancellation of licenses, where certain criteria are met.
Places the onus on an importer to verify that its supplier complies with the same criteria as domestic food producers/processors.
Applies a risk-based set of criteria to determine the intensity and frequency of oversight.
Clearly describes the inspection process.
Enunciates the mandatory components of a licensed facility’s preventative control plan.
Establishes that it is the responsibility of industry to comply with food safety laws, and it is the responsibility of CFIA to police/enforce that compliance.

What’s not to like?

Lip service to transparency: suspensions and cancellations of licenses “may” be posted on the CFIA’s external website.

Wiggle room for old or sub-standard facilities to be “grandfathered”: Although the draft policy clearly requires that the “design and layout of food establishments prevents cross-contamination…” there is a provision allowing for procedures to “mitigate the risk” in cases where plant design does not meet standards for reducing contamination.

What would I like to see?

1. CFIA should commit to the following transparency initiatives:

timely posting of basic information on all licensed facilities, including name, contact information, activities, product and process information and compliance status;
timely posting of all license suspensions and cancellations, including the reason(s) for suspension or cancellation of a license;
regular updates to the current compliance status / inspection outcome for all licensed facilities;
recall notices should explain whether the recall was triggered as a result of a company’s own food safety verification, actions carried out by a government agency (e.g, routine surveillance program), customer complaints, or third-party testing;
recall notices should state whether a pathogen was found in a sample of the specific product under recall, whether it was found in a different production batch, or whether it was present in the production environment, instead of reporting that the recalled product “may be contaminated with…” a pathogen; and
retail-level distribution information should be provided for all Class I recalls and Allergy Alerts.

2. CFIA should phase out the grandfathering of old, outdated, or non-compliant facilities by making full compliance a condition of license renewals.

I have long been an advocate for a single food safety agency system in the USA – one that would consolidate the food enforcement arms of FDA, USDA, and the several other federal agencies that also dabble in this arena. The Safe Food for Canadians Act, coupled with CFIA’s Improved Food Inspection Model proposal represents a major advance in the right direction.

Government Transparency – An Oxymoron: Updated

Oxymoron – a rhetorical device or figure of speech in which contradictory or opposite words or concepts are combined for effect

On June 27, 2012, FDA posted the following notice on its Enforcement Report web page:

FDA is pleased to present a new format for its weekly Enforcement Report. When you select the link below for this week’s report, you will hopefully find a simpler, clearer report that offers downloadable data for analyses while also providing savings and encouraging future innovation for Government. This data-driven report provides FDA a baseline as it moves forward in its efforts to integrate the Agency’s compliance and enforcement data.

The new reporting format is, indeed, easier to use – so much easier, in fact, that it highlights the purely cosmetic nature of FDA’s interest in transparency.

One of my pet peeves with FDA is its refusal to release retail distribution information for food safety recalls. The agency claims that this information is proprietary to the companies who “voluntarily” recall their products. In contrast, USDA’s Food Safety and Inspection Service (FSIS) maintains a policy of releasing retail distribution lists within seven days of a recall announcement. Same government. Different department. Different policy.

Another of my gripes is FDA’s equally adamant refusal to provide a list of countries to which a recalled product was exported, unless the company itself releases that information. Particularly frustrating was the recent series of Diamond Pet Foods Salmonella recalls.

Diamond Pet Foods – and several other companies for whom Diamond manufactured dry dog food – recalled a long list of products after three separate batches of the pet food were linked to a Salmonella Infantis outbreak that sickened 49 people (47 in the USA and 2 in Canada). One of the companies caught up in the recalls was Natural Balance Pet Foods.

On May 4th, Natural Balance recalled 833 tons of dry dog foods in response to the Diamond Pet Foods recall notice. At the time of the recall, consumers were told that the products “may have been” distributed in Alabama, Arkansas, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Wisconsin, West Virginia, Wyoming and Canada.

Consumers were NOT told that the recalled Natural Balance products also were shipped to Taiwan and Israel. That information, which was in FDA’s hands at the time of the May 4th recall, was released today (July 25th) in FDA’s Weekly Enforcement Report.

What is the logic in refusing to release an international (country-level) distribution list at the time of a recall, when the information will eventually be made public anyway?

On June 27th, when FDA introduced its new Weekly Enforcement Report format, I sent the following request to the agency’s Office of Public Affairs:

I’ve been thinking of using the new format of the FDA Weekly Enforcement Report as the jump-off for a blog story about the recall process. I would greatly appreciate answers to a couple of questions. Specifically,

1. What are the criteria that determine when information on a specific recall is included in a Weekly Enforcement Report?

2. Why does FDA not release retail distribution lists for Class I recalls (as FSIS does)? When does consumer protection trump “proprietary” interests?

3. Why does FDA not release information (when it is available) on the foreign countries to which a recalled product was exported? While I realize that FDA’s primary responsibility is to US citizens, the FDA web site is often the SOLE source of this type of information for people (including expatriate US citizens) living in many foreign countries.

I plan to comment on each of these issues in my article, and would appreciate a clear statement of FDA’s current policies and the reasons for these policies.

I received an acknowledgment of my request the next day, asking for my deadline. I indicated that I would appreciate a reply by the end of June. On July 12th, I sent a reminder. As of today, I’m still waiting for answers.

FDA is not the only culprit – or even the worst culprit – when it comes to timely public disclosure of recall and outbreak information. Canada’s federal and provincial health and agriculture agencies are just as bad. Information requests sent to Health Canada, the Public Health Agency of Canada, the Canadian Food Inspection Agency and some of the provincial departments often are ignored completely – acknowledged at times, but rarely answered substantively. Some US states are equally at fault. Idaho, for example, requested that the name of an Idaho mail-order hatchery be withheld from a CDC Outbreak Investigation Report. And the EU publishes a daily list of food and animal feed safety notifications (Rapid Alert System for Food and Feed) without providing any identifying information – neither brand names nor lot numbers – even when the food is implicated in a disease outbreak.

Government agencies are inherently secretive. They can’t help it; it’s in their DNA. President Obama’s earlier promises notwithstanding, we shall never see true transparency from US government departments. Not today. Not next year.

Sadly, the best we can hope for is a reduction in government opacity.

FDA’s response

After sending a link to this article to FDA’s Office of Public Affairs, I received the following replies to my questions:

1. What are the criteria that determine when information on a specific recall is included in a Weekly Enforcement Report?

When the recall is classified it is available for the weekly (by CFR part 7 section 21 CFR) published Enforcement Report.

2. Why does FDA not release retail distribution lists for Class I recalls (as FSIS does)?

Freedom of Information regulations do not permit us to release this commercial confidential information (CCI) information. The following link should be helpful and will provide greater clarity. http://www.archives.gov/federal-register/codification/executive-order/12600.html. In addition, I would need to refer you to USDA of which FSIS is a subpart.

When does consumer protection trump “proprietary” interests?

Congressional mandate when the Freedom of Information Act was passed.

3. Why does FDA not release information (when it is available) on the foreign countries to which a recalled product was exported? While I realize that FDA’s primary responsibility is to US citizens, the FDA web site is often the SOLE source of this type of information for people (including ex-patriate US citizens) living in many foreign countries.