October 30, 2014

NERC and Industry Move in the Right Direction for Greater Reliability

Trey Kirkpatrick, Vice President, Energy & Utilities Compliance, AssurX Inc.

Vice President, Energy & Utilities Compliance, AssurX Inc.

There is a different feel out there in the NERC world, the Electric Reliability Organization (ERO) and the registered entities are working together more than ever since the mandatory implementation of the NERC standards in June 2007. I attended the NERC Member Representatives Committee (MRC) and Board of Trustees (BOT) meetings in Phoenix, AZ on February 5-6, 2014. There are many initiatives that are being implemented and proposed to the registered entities. Not only are the registered entities trying to keep up with very important and impacting standard changes such as COM-002, PRC-005, and the CIP version 5; they are also focused on some serious changes to their existing compliance programs.

Even as we were attending the NERC management meeting in Phoenix, the story of the serious physical attack on a California substation, not far from my own office headquarters, hit the news.

Registered entities have been working hard to manage the ongoing challenges with a struggling economy impacting revenues, more competition, environmental regulations, and cyber security threats. Never has it been more important for large, medium, and small registered entities to focus on risk-management and their internal controls. As the NERC staff was making presentations to the NERC Compliance Committee, the MRC and the NERC BOT, it was obvious that the registered entities have opportunities to improve their overall compliance programs and working relationships with NERC and the Regional Entities.

Some of the ERO’s key initiatives that are:

  • Definition of BES implementation
  • Reliability Assessment Initiative (RAI)
  • Risk-based Registration Assessment Project
  • Cyber Security
  • Human Performance

Electric UtilityIf you have never had the opportunity to experience a NERC MRC and/or BOT meeting, I really encourage you to go to one. You can go to regional workshops and NERC Standards and Compliance workshops, but there is no better way to understand the goals and vision of the ERO unless you are there first hand. There are open discussions, shared industry experience and lessons learned not only from NERC subcommittees, but also the North American Transmission Forum (NATF) and the North American Generator Forum (NAGF) leadership.

Gerry Cauley, NERC President and CEO, also provides a comprehensive overview of the goals, accomplishments, and direction of the ERO. The Regional Entities’ senior management staffs are there and dialogue between industry members is encouraged.

Mr. Cauley highlighted the ERO Enterprise’s top strategic 5 goals:

  • Goal #1: Develop clear, reasonable and technically sound mandatory Reliability Standards in a timely and efficient manner.
  • Goal #2: Be a strong enforcement authority that is independent, without conflict of interest, objective and fair and promote a culture of reliability excellence through risk-informed compliance monitoring and enforcement.
  • Goal #3: Promote a culture of compliance that supports reliability excellence within industry.
  • Goal #4: Identify the most significant risks to reliability, be accountable for mitigating reliability risks and promote a culture of reliability excellence.
  • Goal #5: Improve transparency, consistency, quality and timeliness of results; operate as a collaborative enterprise; and improve efficiencies and cost effectiveness.

These goals have been communicated in prior meetings and workshops, but never to the degree of actual implementation and working with the industry to accomplishing these goals. The real challenge for FERC, the ERO, and the registered entity is the identification of significant risks to reliability and mitigating these risks (Goal #4).

It is extremely important for the registered entities to be engaged in these initiatives and start developing their own risk-management program, the appropriate internal controls, and corrective action programs. Currently, there are pilot programs going on with registered entities and the ERO. Their results along with newly revised auditor handbooks, risk-based registration (not treating every functional entity the same), the RAI program will improve the focus on the critical issues regarding reliability.

After spending years in the industry and consulting with dozens of customers ranging from large to small utilities, co-ops and generators, it is encouraging to see registered entities working to identify their risks, implementing stronger compliance programs from industry experience and lessons learned, and developing internal controls. The transition will be challenging for everyone involved, but companies that build strong internal programs, controls, and focus on human performance will end up as industry leaders, have less burdensome oversight, and most importantly, provide a reliable bulk electric system for their customers and North America.

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Medical Device Makers Urged to Play Nicer by Sharing Data

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

You shouldn’t need Barney the giant purple dinosaur to remind you of the playground mantra “sharing is caring,” but maybe the medical device industry needs to do some quick Netflix streaming of back episodes.

The Institute of Medicine (IOM), already working with more than a dozen drugmakers, the FDA and the National Institutes of Health (NIH), wants to see a little more enthusiasm from the medical device community when it comes to data sharing in device clinical trials. To be fair, this requires some delicate balance: Everyone wants to advance the public health, but it’s not fair to expect a drug or device company to just give away all of its hard-earned, costly proprietary data, either.

IOM understands that, it appears. Yet the medical device industry won’t be doing itself any favors by trying to ignore this issue. Beside the bad PR hit the industry could take, what happens if the FDA

info

decides to just swoop in and impose something on industry? The drug folks have had their input; the medical device industry would be well advised to speak up, too.

Industry and anyone else with interest in the issue has a few ways to get involved. Comments on IOM’s proposed framework for getting this right can be sent here until March 24.

For those in the area or looking for a nice trip, there are also two open workshops in Washington D.C. on Feb. 3-4 and May 5.

Seems like the medical device industry has a clear choice here. Speak up now, or don’t complain later.

Reminds me of another useful slogan: Silence is consent.

IOM’s proposed framework is can be found here.

Info on the public workshops is here.

 

 

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Medical Device Industry Identifies Some Problems with Agency’s UDI Initiative

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Let’s start with what most everyone agrees on: The Unique Device Identification (UDI) program is a swell idea.

It gets a little trickier after that.

In extensive comments, the Advanced Medical Technology Association (AdvaMed), Boston Scientific, and Merck, among more than a dozen others, generally voice support for the UDI concept, while finding lots and lots to say about where the FDA’s September Draft Guidance could use improvement.

Noting that implementing UDI will be a “costly proposition,” AdvaMed stresses that the length and complexity of the implementation plan demands a “living document” approach that will allow industry and the FDA to update and improve the guidance as both sides learn more during set-up. AdvaMed follows with 61 specific comments, with suggested changes.

Coviden, manufacturer of medical devices and medical supplies, echoes AdvaMed’s comments, and tosses another 22 into the mix, including a request that the guidance remain open for feedback and comment until the September 24, 2014 implementation deadline.

Merck, among other commenters, requested clarification and summarization regarding the scope of products for which data must be submitted to the Global Unique Identification Database (GUDID). Merck also asked FDA to add information regarding deadlines for submitting data to GUDID.

X-ray of hipBoston Scientific, noting that its medical devices already bear unique identification via HIBCC or GS1 standards, calls FDA out for what it labels “inconsistencies” with the FDA UDI Rule.

To pick one of their examples, and joining several other commenters in making this point, Boston Scientific claims the data elements column “Required?” is unclear because it fails to clarify if it is required to follow the rule based on regulatory requirements or validation requirements. “The meaning of ‘required’ should be clarified so that BOTH regulatory and system validation requirements are clearly identified in this guidance.”

FDA’s got its work cut out for it here, particularly with the recent departure of its UDI guru, Jay Crowley, for the greener fields of consultantdom.

We can offer some small consolation though: Crowley leads a webinar on UDI implementation from his new professional perch. Information is here:

 

Final UDI rule as published in Federal Register

FDA’s UDI page

Previous AssurX blog on UDI

The entire comment letter line-up is available here

 

 

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Interpreting the FDA View of Medical Device Design Controls

Dennis Payton, Vice President of Product Marketing and Development, Expandable Software, Inc.

Dennis Payton, Vice President of Product Marketing and Development, Expandable Software, Inc.

Some of the shortest descriptions in the FDA CFR 21 Part 820 Quality System regulation are found in Sec. 820.30 and Sec. 820.40 totaling about a page of written language around Design Controls and Document Controls. However short, these two sections can be the most complex aspects of Medical Device controls when actual complying with the regulation. Fortunately, the FDA does give a bit more background to help a new medical device company understand these two key elements (see Medical Device Quality Systems Manual, A Small Entity Compliance Guide) but again with the detailed complexities, even those few pages of guidance (covered in section 9 Document and Change Control) fall short of coverage needed to understand the impact a company’s Medical Device Quality System. The good news is that there are some very good tools that can help mitigate these complexities and streamline controls. The bad news is that it still takes a very strong detailed and sustained effort to insure these complex controls are in place for continued success and compliance with regulation.

With a wide variety of Medical Device suppliers there comes a wide variety of processes, procedures and controls that are developed specific to a business and to the Medical Device(s) being produced. It is important to understand how the FDA tries to normalize a specific business to the regulation when auditing that business for Design Control compliance. Having a bit of understanding of their view will help make for a much smoother comparison, analogy and a much cleaner and successful audit of a company’s design processes.

A simplistic model can be derived from the 820.30 regulation that the FDA may use to assure design coverage and compliance of a device design and/or manufacture to the regulation. The design and development model can be graphically depicted and loosely linked to the regulation as follows:

FDA Design and Development Planning Model

Diagraming out the design flow is helpful in seeing a more detailed picture of the flow and validation and verification of a product against its intended use model and specifically important to the FDA that each and every stage of the process is well reviewed and documented.

Again, like the FDA regulation on Design Controls, this is a very short summary of complex processes, document definitions, controls and general management & approvals that there have been volumes of books written. The objective should be to have a very good understanding of how the FDA or other regulatory entity views the medical device controls such that a business can demonstrate how their particular controls map into the regulatory model. A logical analogy of a business’ design and development model should be able to map to the regulatory normalized base line model(s), in doing so, will result in smoother audits with a higher degree of success and hopefully (something the regulatory folks don’t really care about but as a business we all do) a lower expense/time in managing through the audit process.

A fuller descriptive paper outlines some key points in the development of a Medtech-specific design control with a product development process and how to maximize the use of enterprise level business tools that accelerate process, streamline audits and make for a much smoother compliance. The brief outline here is a key element to a more streamlined and smoother compliance with regulation keeping in mind not just the business drivers but also the FDA’s “normalized view” of design controls.

Get the full detailed White Paper here

About the Author

Dennis Payton is Vice President of Product Marketing and Development with Expandable Software Inc. He has 24 years of engineering, product management and executive management experience. He holds a BS in electrical engineering from California Polytechnic State University, San Louis Obispo, and post studies at Stanford University, University of California, Santa Cruz, and UC Berkley Haas School of Business.

 

Copyright UBM Canon. Used by permission.

 

 

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FDA VCIP Program: Too Much Stick, Not Enough Carrot?

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

It’s a growing trend in these United States: paying extra for convenience such as bypassing the riffraff in airport security lines, or whizzing past mere mortal motorists on pristine for-pay express lanes.

Where I live in the Washington, D.C. area, the new express road program in Northern Virginia’s clotted traffic arteries appears to be a hit. For a buck or two, you get out of the more crowded free lanes. And you are allowed to go 65 miles an hour, while the peasants are held to 55 mph!

On the other hand, the express lane program at Reagan National Airport doesn’t appear to be generating much traffic.

If the FDA’s new VCIP (Voluntary Compliance Improvement Program) is trying to ride the “pay for convenience” bandwagon, early anecdotal evidence suggests they’re resembling airports more than highways. We’re hearing many in industry say the VCIP program doesn’t offer enough of an incentive to take on the extra work.

Undaunted, FDA released earlier this week a document that reads like a nice, bureaucrat gently trying to convince industry to give the program a try.

The joint pilot project housed in the Center for Devices and Radiological health (CDRH) and Office of Regulatory Affairs (ORA) “differs from the FDA’s traditional oversight model by allowing firms to voluntarily self identify and correct possible regulatory violations instead of undergoing FDA inspection.”

Regulated entities have to apply to participate, but those with violations that raise “imminent” public health concerns needn’t bother.

Here’s the FDA’s big carrot: “The FDA supports using new approaches to help companies come into compliance. These approaches benefit industry and may decrease the number of inspections that the FDA performs or permit the agency to focus on manufacturers with serious and ongoing problems.”

Pacemaker150Hmm. I guess I’m not super surprised that initial industry enthusiasm appears weak. To my knowledge, FDA has not released any statistics about participation. I’m basing my very early days’ assessment on discussions with medical device firms and consultants at recent trade shows and the like. I could be wrong, and VCIP might turn out to be a big hit.

If you want to get picked, know that FDA will identify manufacturers eligible to participate in VCIP through its 2014 inspection work plan and offer them an opportunity to apply rather. For the pilot, the FDA will choose three to five applicants. Of course, their feedback, whether official or in trade show hallway conversations, will tell us a lot about the merits of VCIP.

While it promises some benefits down the road, initial participation in VCIP sounds like it will just add another layer to a device manufacturer’s compliance program. VCIP participants will be required to retain an outside expert consultant to assess their manufacturing and quality assurance systems and to monitor and certify that they are following program requirements. Firms must also demonstrate the ability to define problems, analyze root causes, create appropriate corrective actions, and verify that the actions taken were effective.

If a firm does not meet its commitments under the VCIP, or if the FDA and the firm disagree about any of the results, then the firm may be removed from the program and undergo FDA inspection, which could lead to regulatory action. If a manufacturer ends its participation in the VCIP, it would be subject to FDA inspection and any resulting regulatory action.

FDA gets to the potentially big benefits toward the end of the new VCIP document. If you are selected and pass the tests, your firm “will not be subject to routine surveillance inspection while program participation is underway.” The exemption will be good for two years after a manufacturer successfully completes the program. FDA says it will also expedite review of export certificate requests and prioritize device and pre-amendment determination requests from program participants.

Clearly it’s too early to judge whether VCIP will be a success. And FDA is to be applauded, I think, for trying something a bit new.

Still, here’s hoping VCIP becomes the equivalent of sailing down the relatively empty highway at 65 mph, while others are slogging through heavy traffic at lower speeds.

 

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Former FDA Inspector’s Crystal Ball: Cloudy With a Chance of Inspected Meatballs

Patrick Stone

Patrick Stone, President, TradeStoneQA

The FDA’s “Food Police” will be in full force to secure budget funds for food safety initiatives for FY 2014 as mandated by congress. More than half of the operating funds will be earmarked for food work. International food inspections will surely be a focus area for the coming year. The inspection goals/FTEs will be set low enough for the field staff to meet or exceed expectations. This again will ensure a steady flow of billions for operating costs. In recent years large chunks of the FDA budget were set for new facilities completion and the dreaded infrastructure technology (IT) upgrades which barely seem to keep up with private industry.

Opioid labeling rules newly penned will assist in identifying and tracking legal drugs, however Internet and backstreet sales will continue to plague the market. Insurance fraud is making it easier for mail-order diversion and out right second hand sales of the legally obtained opioids. So until the insurance scams are tapered this effort will only increase operating cost for the opioid manufacturers.

A medical device tax and new user fees will be required for doing business in our domestic market. It seems that every few years the fee structure increases and becomes more complex. Maybe this is part of the reason our health care cost are always going up exponentially. What will they think of next to add to the user fee list?

compounding pharmacyThe agency has issued product specific sterile drug consent decrees and lengthy 483s for cGMP violations across the nation. There are a few sterile drug manufacturers that judging by the 483 wording will be handed consent decrees very soon. These firms are major market shareholders that have had ample time for remediation without compliance. The recalls from these same firms have been persistent all year.

The great 2013 compounding pharmacy blitz and new regulations request for these manufacturers was not so much as shock and even less awe. The faster FDA defines what compounding drug manufacturing is and provides lengthy guidance on how it should not be done in a compounding pharmacy setting, the faster we will see market self-compliance. Compounding pharmacies must recognize themselves as manufacturing entities and adhere to strict USP <797> and 21 CFR 200 standards that are costly.

Compounding pharmacies are the first line of defense when it comes to the drug shortage so they must operate in strict compliance with sterile the drug cGMP systems approach. More patients will have adverse events and possibly die from non-compliant/contaminated compounded sterile drug preparations if the mindset of the manufacturers is not changed. The State board of Pharmacy cannot shield compounders from civil or criminal liability and the FDA may soon have what it needs for implementing jurisdictional authority.

Here’s to an exciting 2014!

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

 

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Electronic Medical Records: Don’t Feel So Secure

Patrick Stone

Patrick Stone, President, TradeStoneQA

How often do we see HIPAA violations issued because a regulated entity did not secure the electronic records at the hospital and small clinics? Large scale security breaches and, sometimes, the selling of your e-records by various third party sources are in the news. In Massachusetts and New Hampshire an e-record vendor recently admitted to large scale e-record breaches. The FDA has provided some guidance on what is expected for e-records, but no real guidance on security. That may be one of the reasons that so many of the E-Systems I have reviewed meet the minimal requirements but have security vulnerabilities.

The second half of this story will send shivers down your spine, and then make you mad. Your e-records are being sold to insurance companies, debt collectors, and prospective employers. Yes your e-records are for sale to the highest bidder.  The 1996 HIPAA law left provisions for certain entities to access your entire medical record. Some of the stolen or hacked e-records get sold, and that’s terrible of course, but ironically most of the time your e-records are sold it is “legal.” Securing medical e-records comes with a price and even with some of the best security there may still be a breach. In most business models for building e-record systems security is last on the list. Sadly, it doesn’t appear to be much different in the healthcare industry.

So, what’s to be done?

doctor electronic health recordWill it take a 21st century modernization of HIPAA, written almost twenty years ago and before the e-record mandate? Or will we limp along with legislation that is increasingly showing its age?

In our digital age of e-records our security should be insured since we pay for the care we receive. HHS and congress should be focusing on this but they are currently being distracted by advocating or decrying Obamacare.

And speaking of Obamacare, that new law also has some troubling provisions about who is allowed access to your records, and some “interesting” exceptions to those provisions.

But don’t get me started on Obamacare implentation before we deal with HIPAA.

For now we can only trust (read: hope) but not verify who really has access to our medical e-records that are weakly protected by a 20th century law.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

 

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Eating GMOs Isn’t Kosher For Anyone

Kim Egan

Kim Egan, Founder, Saltbox Consulting

What do China, the State of Maine, the State of Connecticut, Chipotle, and Whole Foods have in common?   They all think you have a right to know whether the food you are eating contains any genetically modified organisms, known as GMOs.

I like that.  Why do I care? Because the genes in GMO plants have been altered in a laboratory to do something that the plant would not normally do.  This means that Mother Nature did not deem it good.  Mother Nature did not deem it good that a tomato should live forever in its fully ripened state, even after traveling around the world in a crate on a truck or boat or a plane and sitting in a grocery store for days if not weeks.  Mother Nature did not deem it good that corn should be able to kill insects while it grows.  Mother Nature created insects.  They are useful, whereas acres and acres of corn are not.  Mother Nature created corn to feed birds and deer and the occasional human.  Not to feed every livestock animal in the country or to sweeten the chemical concoctions that the soft drink makers dream up.

I find it ironic that the vote in Maine on labeling GMOs took place the same month that Edward Snowden demonstrated that he, too, thinks Americans have a right to know.  And that Congress – the greatest legislative body in the world – appears to agree that all Americans have a right to know all the super-top secret stuff the government is up to, but doesn’t think Americans have a right to know if they are eating GMOs.  I know I’m going out on a limb but I don’t think we should expect this Congress to pass a bipartisan bill to require all food manufacturers and restaurants to label GMOs anytime soon.

Okay, next one.  What do Amy’s Kitchen (frozen pizza), Blue Diamond (peanuts and almonds), Arrowhead Mills (stone-ground everything), and Silk (the company that brought tofu to America), have in common?  They all refuse to use GMO ingredients in their products.   Let’s all raise a cheer for these companies!  This is what makes America great!  Government won’t do something the people want?  Do it yourself!  Decide your elected representative is a lazy-good-for-nothing fat cat eating pork out of a barrel?  Take matters into your own hands!

corn_on_the_cobOkay, next one.  What do Judaism, the Church of England and Saudi Arabia have in common?  This one seems a little harder.  But it turns out that all three of the world’s major religions prohibit GMOs.  Saudi Arabia bans them outright, as does Algeria, Brazil, Egypt, the European Union, Peru, and Thailand. The Church of England won’t let any GMO crop trials on any church property, which amounts to 60,000 hectares in England.  A hectare is approximately 2.5 acres, which is 150,000 acres, or the equivalent of about 234 square miles.  That’s what the Church of England owns. The whole of England is only about 50,000 square miles big, from which, if you are a GMO scientist, you must subtract cities, towns, factories, airports, train stations, banks, houses, roads, outbuildings, seaside resorts, castles, Stonehenge, palaces, manor houses, Kew Gardens, etc.  I bet there’s not much left after that.  And lastly, GMOs aren’t kosher.  There’s so much more to it on that one.

There’s more to say about GMOs, such as the fact that the U.S. government regulates GMO corn as a pesticide, not a food (that’s why we want to know what we’re eating, right?!), or that Tasmania has declared GMO rapeseed to be a weed (weeds are bad, not good).

But the worst thing I learned researching this post is that M&Ms, Stoned Wheat Thins, Pringles, and all Pepperidge Farm cookies have GMOs in them.

The horror, the horror.

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FDA Seeks to Plug Swiss Cheese-size Holes in Medical Device Security Systems

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The Internet giveth and the Internet taketh away.

For years, we’ve been hearing about the benefits online tools will bring to the medical industry, especially at hospitals and physicians’ offices.  Many of those promises have come true, and its been a benefit for patients and industry.

But that sound you are hearing could be the other shoe dropping.

Perhaps reacting in part to a sobering year-long series by The Washington Post finding big, big holes in medical device security systems, the FDA this week (June 17) issued a new safety communication suggesting the hospitals take this threat to medical devices seriously.

Meantime, the FDA have been busy beavers. Last week the agency issued an alert and notices bulletin advising the industry to shore up key medical device security provisions.

Among its recommendations for responsible medical device manufacturers:

  • Swiss CheeseKick the tires on your program designed to limit unauthorized device access to trusted users.
  • Utilize stronger security controls such as user authentication, user ID and password, smartcard or biometrics; strengthening password protection by avoiding hard-coded passwords and limiting public access to passwords used for technical device access; physical locks; card readers; and guards.
  • Use design approaches that maintain a device’s critical functionality, even when security has been compromised, known as “fail-safe modes.”
  • Provide methods for retention and recovery after an incident where security has been compromised

No, neither Woodward or Bernstein were involved in The Post piece, but its pretty thorough and damning for the medical device industry nonetheless.

Security analysts at cyber security firm Cylance found it was depressingly easy to figure out hundreds of passwords for sensitive surgical equipment, patient monitors, among others.

“We stopped after we got to 300,” Billy Rios, who found the passwords with his colleague Terry McCorkle, told The Post.

They tell me Swiss cheese holes are the result of bacteria popping (some use a grosser word). I’m no foodie, leaving that to fellow blogger Kim Egan and celebrity chefs, but I do understand that these are “good” holes.

Holes in medical device security programs are not among them.

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Taste’s Like Chicken — With a Side of Bacteria

Kim Egan

Kim Egan, Founder, Saltbox Consulting

FDA’s latest Annual Meat Report is out.   It analyzes foodborne bacteria in retail meat, particularly salmonella, campylobacter, enterococcus and E. coli.   Salmonella causes typhoid.  Campylobacter causes spontaneous abortions in animals and opportunistic infections in humans.  Enteroccus can cause meningitis and E. coli is the most common source of food poisoning.

Suffice to say, the news is bad.

The number of antibiotic resistant microbes in retail meat is going up, not down.   Over half of all retail meats – 55.7 percent — test positive for E. coli.  Contrary to popular belief, pork chops have the lowest prevalence – 30.4 percent – while ground turkey has the highest at 76.7 percent.  In fact, pork and beef came out rather well in this report, relatively speaking, compared to retail chicken and ground turkey.  Chicken and turkey do so badly, in fact, that it is amazing anyone eats retail poultry at all.

T-boneThe report also analyzes the extent to which these food contaminants are resistant to antibiotics, and assigns p values to measure statistical significance.  In other words, FDA made sure its findings are real and not the result of chance.  It turns out that:

  • Over a third (33.5 percent) of the contaminants in retail chickens and almost a fourth (22.4 percent) of those in ground turkey are resistant to third-generation cephalosporins.   Third-generation cephalosporins are supposed to be effective against hospital-acquired infections, pneumonia, and meningitis.
  • Almost half (40.5 percent) of contaminants in retail chickens and over half (58.4 percent) of those in ground turkey are resistant to ampicillin.  Ampicillin is supposed to be effective against staph infections, strep, and the flu. FDA said the change in ampicillin resistance in turkey from 2002 to 2011 is a “highly statistically significant” result.
  • Tetracycline resistance in poultry is up.   Tetracycline combats cholera.  So, that’s more bad news.
  • Gentamicin resistance in retail chicken and turkey is higher than that in beef and pork, or 20 percent compared to 5 percent.  We use gentamicin to fight staph infections, along with  the pathogens found in decomposing animal matter, sewage, manure soil, and human and animal feces.

On the theory that The Truth Will Set You Free, we can expect FDA to do something about this, right?  No.  Prediction: All FDA will do is write more reports and approve ever more powerful antibiotics for animals.

Makes you a little sick to the stomach, doesn’t it?

Kim Egan is the Founder of Saltbox Consulting, a firm that provides legal and compliance advice to entities regulated by FDA and USDA.  She can be reached at kim.egan@saltboxlaw.com and on Twitter at @saltboxlaw.

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