On July 7th, 2011, FDA's Office of Global Regulatory Operations and Policy published a special report entitled: "Pathway to Global Product Safety and Quality.
" This report is available on the FDA website.
Please follow the link at the bottom of this article.
This report should be read by every American food producer and also by every food consumer, as the implications for the future are both broad and disconcerting.
This report speaks to food, drug safety and medical device safety.
I will consider only food safety here.
FDA cites US-GAO statistics, which say that currently, 10% to 15% of all food consumed by U.
S.
households is imported.
Significantly, nearly two-thirds of the fruits and vegetables and 80% of the seafood eaten domestically already come from outside the U.
S.
FDA points out that between 2004 and 2011 food imports have grown by an average of 10% per year.
FDA expects America's dependency upon imported food to accelerate, with complications for its regulatory mission.
Historically, "...
FDA's primary tools for product safety and quality have been inspection of production facilities and ports of entry.
" In the face of this expected onslaught of imports, this report contains the admission that: "...
FDA does not - nor will it - have the resources to adequately keep pace with the pressures of globalization.
Indeed, the current rate at which imports are actually inspected has hovered recently at about 3% or less.
Nevertheless, it is FDA's hope that: "Over the next decade, FDA will transform itself from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders.
" Brave words, but FDA already seems fully aware that it will never be able to meet the expectations of the recently passed FDA Food Safety Modernization Act (FDA-FSMA) which expected FDA to have inspected at least 600 foreign food facilities within the first year of the law's passage and then rapidly ramp up to 19,200 inspections in the sixth year following the law's passage.
So, if FDA has fallen behind in the first year, how does it expect to fulfill its mission? FDA hopes to combine "...
creative international coalitions with cutting-edge investigative tools.
" Together, these are expected to obviate the need for direct FDA inspection.
Unfortunately, virtually nothing is said about exactly what "cutting-edge investigative tools" FDA has in mind.
Apparently, the "international coalitions" are there to provide sufficient information to allow the assessment of risk carried over into the final product from all the ingredients used by every subcontractor involved in the final formulation of a given product.
FDA admits that with greatly increased globalization governments "...
will be called upon to mitigate the sometimes negative impact of globalization on individual citizens," at the same time that "...
it will also become increasingly difficult to prevent and detect the intentional effort by some importers to manipulate the system and avoid scrutiny.
" FDA recognizes that: "...
there are manufacturers around the world for whom the temptation of economic gain is greater than any concern for risk to human health.
" FDA's plan for dealing with this situation is to involve and coordinate various foreign regulatory entities into a global information gathering system all geared toward the assessment of risk and then base food border entry decisions upon this risk assessment, rather than direct inspection and/or testing.
In fact, FDA has already developed a computer program (PREDICT) for this purpose.
In addition, FDA plans to make use of public and private third parties to conduct inspections and other oversight activities.
Parts of this document give the impression of being a smart and incisive response to a global problem (food safety).
Other parts of this document are more than just a little bit disconcerting: • Nowhere in this document does FDA recognize the consumer as a "stakeholder" in food safety evaluation.
• FDA does not choose to recognize that if a foreign nation's economy absolutely depends upon export then that nation's regulatory agencies cannot help but be aligned with such a national goal.
Any such alignment is likely to color any data provided to FDA for its food safety risk assessment.
• The track record of private third party auditors leaves a great deal to be desired.
The consumer, who is also a taxpayer, pays for the entire food manufacturing, delivery and regulatory systems and is therefore the prime stakeholder.
The recent "pink slime" debacle has shown that conclusively.
Beef producers felt that they could boost their profits by separating out the fat content from beef trimmings and then grinding up what was left (veins, arteries, collagen, tendons, lymph nodes, connective tissue, etc.
) so finely as to be unrecognizable and then mixing it with hamburger under the argument that "beef is beef.
" The consumer said "No it's not" and several plants that used to make the stuff have since shuttered.
These days, it is possible for consumers to order testing directly from laboratories willing to work on a "shared cost" basis.
Such consumer-directed testing is already available for certain heavy metals and can be expanded as needed.
It is truly hard to believe that any country whose exports generate needed foreign currency will allow its regulatory system to stand in the way of what that country perceives as its own economic necessity, no matter how "big" of a global player FDA thinks it may become.
Democratic lawmakers on the Energy and Commerce Committee (Henry Waxman, D-CA; Dianna DeGette, D-CO; John Dingell, D-MI; and Frank Pallone, D-NJ) have, in January of this year, sent a letter to FDA Commissioner Margaret Hamburg asking how it happened that, during the recent outbreak of Listeria in Colorado cantaloupes, perhaps the deadliest outbreak of foodborne illness in this country in 100 years, FDA's own officials had identified serious problems at Jensen Farms, yet that company was given a "superior" rating by a third-party auditor (Primus Labs) just weeks before that Listeria outbreak became national news.
Other examples may easily be found ( http://www.
foodsafetynews.
com/2012/01/democrats-urge-fda-to-reform-third-party-auditing-system/?utm_source=newsletter&utm_medium=email&utm_campaign=120111 ).
The apparent lack of any Republican support for this food safety initiative may be significant.
In its planning for the "Brave New World" it believes is headed this way, FDA has implied that the safest food currently available to the American consumer is food that is produced here.
At the same time, FDA foresees American food manufacturers being swept aside by cheaper, harder to regulate and riskier foreign competitors.
In short, FDA seems the future playing field so tilted against domestic food manufacturers that their numbers will decline significantly.
American food manufacturers who don't wish to be pushed out of the market they themselves helped create may be well advised to make common cause with consumers who have chosen to share in the cost of testing the food they buy at retail.
One food manufacturer denouncing the safety of a competitor's product may easily be dismissed as a conflict of interest.
However, a food manufacturer who helps defray the grass roots testing efforts of consumers, some but not all of whom may be his own customers, is in a different category altogether.
Such a food manufacturer: • Demonstrates faith in his own product(s).
• Documents concern for food safety.
• Is seen not to fear transparency.
• Helps customers recognize value beyond mere pricing.
• Has verified and vindicated, in public, relevant HACCP plans pertaining to the tested product(s) and established a record of testing product safety not just before distribution but where it really matters - at the retail level.
Advertising like this, can only be earned, it can never be bought.
Read FDA's plan for the future of food safety for yourself at: http://www.
fda.
gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.
htm Copyright 2012 M.
Mychajlonka
" This report is available on the FDA website.
Please follow the link at the bottom of this article.
This report should be read by every American food producer and also by every food consumer, as the implications for the future are both broad and disconcerting.
This report speaks to food, drug safety and medical device safety.
I will consider only food safety here.
FDA cites US-GAO statistics, which say that currently, 10% to 15% of all food consumed by U.
S.
households is imported.
Significantly, nearly two-thirds of the fruits and vegetables and 80% of the seafood eaten domestically already come from outside the U.
S.
FDA points out that between 2004 and 2011 food imports have grown by an average of 10% per year.
FDA expects America's dependency upon imported food to accelerate, with complications for its regulatory mission.
Historically, "...
FDA's primary tools for product safety and quality have been inspection of production facilities and ports of entry.
" In the face of this expected onslaught of imports, this report contains the admission that: "...
FDA does not - nor will it - have the resources to adequately keep pace with the pressures of globalization.
Indeed, the current rate at which imports are actually inspected has hovered recently at about 3% or less.
Nevertheless, it is FDA's hope that: "Over the next decade, FDA will transform itself from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders.
" Brave words, but FDA already seems fully aware that it will never be able to meet the expectations of the recently passed FDA Food Safety Modernization Act (FDA-FSMA) which expected FDA to have inspected at least 600 foreign food facilities within the first year of the law's passage and then rapidly ramp up to 19,200 inspections in the sixth year following the law's passage.
So, if FDA has fallen behind in the first year, how does it expect to fulfill its mission? FDA hopes to combine "...
creative international coalitions with cutting-edge investigative tools.
" Together, these are expected to obviate the need for direct FDA inspection.
Unfortunately, virtually nothing is said about exactly what "cutting-edge investigative tools" FDA has in mind.
Apparently, the "international coalitions" are there to provide sufficient information to allow the assessment of risk carried over into the final product from all the ingredients used by every subcontractor involved in the final formulation of a given product.
FDA admits that with greatly increased globalization governments "...
will be called upon to mitigate the sometimes negative impact of globalization on individual citizens," at the same time that "...
it will also become increasingly difficult to prevent and detect the intentional effort by some importers to manipulate the system and avoid scrutiny.
" FDA recognizes that: "...
there are manufacturers around the world for whom the temptation of economic gain is greater than any concern for risk to human health.
" FDA's plan for dealing with this situation is to involve and coordinate various foreign regulatory entities into a global information gathering system all geared toward the assessment of risk and then base food border entry decisions upon this risk assessment, rather than direct inspection and/or testing.
In fact, FDA has already developed a computer program (PREDICT) for this purpose.
In addition, FDA plans to make use of public and private third parties to conduct inspections and other oversight activities.
Parts of this document give the impression of being a smart and incisive response to a global problem (food safety).
Other parts of this document are more than just a little bit disconcerting: • Nowhere in this document does FDA recognize the consumer as a "stakeholder" in food safety evaluation.
• FDA does not choose to recognize that if a foreign nation's economy absolutely depends upon export then that nation's regulatory agencies cannot help but be aligned with such a national goal.
Any such alignment is likely to color any data provided to FDA for its food safety risk assessment.
• The track record of private third party auditors leaves a great deal to be desired.
The consumer, who is also a taxpayer, pays for the entire food manufacturing, delivery and regulatory systems and is therefore the prime stakeholder.
The recent "pink slime" debacle has shown that conclusively.
Beef producers felt that they could boost their profits by separating out the fat content from beef trimmings and then grinding up what was left (veins, arteries, collagen, tendons, lymph nodes, connective tissue, etc.
) so finely as to be unrecognizable and then mixing it with hamburger under the argument that "beef is beef.
" The consumer said "No it's not" and several plants that used to make the stuff have since shuttered.
These days, it is possible for consumers to order testing directly from laboratories willing to work on a "shared cost" basis.
Such consumer-directed testing is already available for certain heavy metals and can be expanded as needed.
It is truly hard to believe that any country whose exports generate needed foreign currency will allow its regulatory system to stand in the way of what that country perceives as its own economic necessity, no matter how "big" of a global player FDA thinks it may become.
Democratic lawmakers on the Energy and Commerce Committee (Henry Waxman, D-CA; Dianna DeGette, D-CO; John Dingell, D-MI; and Frank Pallone, D-NJ) have, in January of this year, sent a letter to FDA Commissioner Margaret Hamburg asking how it happened that, during the recent outbreak of Listeria in Colorado cantaloupes, perhaps the deadliest outbreak of foodborne illness in this country in 100 years, FDA's own officials had identified serious problems at Jensen Farms, yet that company was given a "superior" rating by a third-party auditor (Primus Labs) just weeks before that Listeria outbreak became national news.
Other examples may easily be found ( http://www.
foodsafetynews.
com/2012/01/democrats-urge-fda-to-reform-third-party-auditing-system/?utm_source=newsletter&utm_medium=email&utm_campaign=120111 ).
The apparent lack of any Republican support for this food safety initiative may be significant.
In its planning for the "Brave New World" it believes is headed this way, FDA has implied that the safest food currently available to the American consumer is food that is produced here.
At the same time, FDA foresees American food manufacturers being swept aside by cheaper, harder to regulate and riskier foreign competitors.
In short, FDA seems the future playing field so tilted against domestic food manufacturers that their numbers will decline significantly.
American food manufacturers who don't wish to be pushed out of the market they themselves helped create may be well advised to make common cause with consumers who have chosen to share in the cost of testing the food they buy at retail.
One food manufacturer denouncing the safety of a competitor's product may easily be dismissed as a conflict of interest.
However, a food manufacturer who helps defray the grass roots testing efforts of consumers, some but not all of whom may be his own customers, is in a different category altogether.
Such a food manufacturer: • Demonstrates faith in his own product(s).
• Documents concern for food safety.
• Is seen not to fear transparency.
• Helps customers recognize value beyond mere pricing.
• Has verified and vindicated, in public, relevant HACCP plans pertaining to the tested product(s) and established a record of testing product safety not just before distribution but where it really matters - at the retail level.
Advertising like this, can only be earned, it can never be bought.
Read FDA's plan for the future of food safety for yourself at: http://www.
fda.
gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.
htm Copyright 2012 M.
Mychajlonka