Taylor: FDA realizes it won’t get user fees for FSMA
June 25, 2014 | 10:55 PM
Food and Drug Administration officials are under no illusions that Congress will actually establish the user fees that the Obama administration has proposed to pay for implementation of the Food Safety Modernization Act (FSMA).
Michael Taylor
“We are very realistic about fees. Even we can read the headline writing on the wall about whether fees will fund this program in the future,” Michael Taylor, the FDA deputy commissioner for food and veterinary medicine, said in a speech to the International Dairy Foods Association Regulatory Roundup.
But Taylor added, “There is a significant FSMA funding gap,” and that without additional money from somewhere it will be difficult for the FDA to fulfill the expectations that the law will reduce food-borne illness in the future.
President Barack Obama’s fiscal year 2015 budget proposed user fees to pay part of the cost of implementing FSMA, which was passed in late 2010. The act gives FDA the authority to prevent food-related public health problems for the foods under its jurisdiction, which include almost everything except meat, poultry and processed eggs.
Congressional agriculture leaders and appropriators declared the user free proposal dead on arrival.
Taylor started off his wide-ranging speech by telling the dairy company officials, “I almost feel guilty about the amount of work we are imposing on the industry,” but he quickly added, “It is all for the greater good.”
FDA is “committed” to writing rules that are “flexible and minimize costs to industry” while trying “to avoid new requirements that won’t mean anything to food safety,” he said.
For general guidance, Taylor said company food safety officials should read two documents with what he admitted are bureaucratic titles: the Program Alignment Group recommendations decision memo, and the FSMA operational strategy document.
Under these plans, Taylor said, FDA internally wants to establish vertically integrated specialized commodity programs with staff skilled in food groups, rather than the current teams of investigators who may work on one food one day and another food the next.
Externally, he said, FDA wants to use its new authorities to focus more on preventing problems and less on “the old way” of conducting inspections and declaring violations.
Under the new approach, FDA will try to identify companies where there are problems and devote more of its attention to resolving those.
FDA officials will be looking for the “food safety culture” in companies, Taylor said.
“When you go in you can assess whether top management is interested in food safety, whether they are looking for problems. When you find firms that don’t have that culture, that’s when we need to be spending a few days there,” he added.
This approach, he said, could have identified that the Peanut Corporation of America, whose products led to a major food safety scandal, was a “bad actor” in need of attention before its products reached consumers.
Taylor said the concepts of “high risk” and “risk-based” policy “pervades the statute.”
In other comments, Taylor said:
▪ The produce rule in FSMA applies to farms, not cooking or processing facilities except when there are some “intersections” between field and facility.
▪ The proposed nutrition facts panel would have a two-year implementation, which would give companies time to change their labels.
▪ The domestic supplier verification rule will be aligned with the foreign supplier verification requirements.
▪ The animal residue testing program’s extent is unresolved.
Taylor confirmed a recent statement by FDA Commissioner Margaret Hamburg that FDA is still working on rule to encourage food companies to make voluntary reductions in sodium use.
FDA has been working on that rule since the 2010 Institute of Medicine report that Americans eat too much salt. The report showed that the average American consumes 3,400 milligrams of salt per day, but should consume only 2,300 milligrams.
Reducing the level of sodium consumption “would have enormous public health benefits in reducing deaths and reducing medical expenses,” he said.
Three quarters of the sodium is in processed or restaurant food, Taylor said, and FDA has been “doing its homework” in identifying the categories of food that need reductions. Taste, food safety and other functions of sodium will be taken into consideration in writing the rule, he added.
Speaking of the sodium rule and other FDA proposals that have not been received much publicity lately, Taylor said that “Some issues are on the back burner but not off the stove.”
“We are very realistic about fees. Even we can read the headline writing on the wall about whether fees will fund this program in the future,” Michael Taylor, the FDA deputy commissioner for food and veterinary medicine, said in a speech to the International Dairy Foods Association Regulatory Roundup.
But Taylor added, “There is a significant FSMA funding gap,” and that without additional money from somewhere it will be difficult for the FDA to fulfill the expectations that the law will reduce food-borne illness in the future.
President Barack Obama’s fiscal year 2015 budget proposed user fees to pay part of the cost of implementing FSMA, which was passed in late 2010. The act gives FDA the authority to prevent food-related public health problems for the foods under its jurisdiction, which include almost everything except meat, poultry and processed eggs.
Congressional agriculture leaders and appropriators declared the user free proposal dead on arrival.
Taylor started off his wide-ranging speech by telling the dairy company officials, “I almost feel guilty about the amount of work we are imposing on the industry,” but he quickly added, “It is all for the greater good.”
FDA is “committed” to writing rules that are “flexible and minimize costs to industry” while trying “to avoid new requirements that won’t mean anything to food safety,” he said.
For general guidance, Taylor said company food safety officials should read two documents with what he admitted are bureaucratic titles: the Program Alignment Group recommendations decision memo, and the FSMA operational strategy document.
Under these plans, Taylor said, FDA internally wants to establish vertically integrated specialized commodity programs with staff skilled in food groups, rather than the current teams of investigators who may work on one food one day and another food the next.
Externally, he said, FDA wants to use its new authorities to focus more on preventing problems and less on “the old way” of conducting inspections and declaring violations.
Under the new approach, FDA will try to identify companies where there are problems and devote more of its attention to resolving those.
FDA officials will be looking for the “food safety culture” in companies, Taylor said.
“When you go in you can assess whether top management is interested in food safety, whether they are looking for problems. When you find firms that don’t have that culture, that’s when we need to be spending a few days there,” he added.
This approach, he said, could have identified that the Peanut Corporation of America, whose products led to a major food safety scandal, was a “bad actor” in need of attention before its products reached consumers.
Taylor said the concepts of “high risk” and “risk-based” policy “pervades the statute.”
In other comments, Taylor said:
Taylor confirmed a recent statement by FDA Commissioner Margaret Hamburg that FDA is still working on rule to encourage food companies to make voluntary reductions in sodium use.
FDA has been working on that rule since the 2010 Institute of Medicine report that Americans eat too much salt. The report showed that the average American consumes 3,400 milligrams of salt per day, but should consume only 2,300 milligrams.
Reducing the level of sodium consumption “would have enormous public health benefits in reducing deaths and reducing medical expenses,” he said.
Three quarters of the sodium is in processed or restaurant food, Taylor said, and FDA has been “doing its homework” in identifying the categories of food that need reductions. Taste, food safety and other functions of sodium will be taken into consideration in writing the rule, he added.
Speaking of the sodium rule and other FDA proposals that have not been received much publicity lately, Taylor said that “Some issues are on the back burner but not off the stove.”
“We are very realistic about fees. Even we can read the headline writing on the wall about whether fees will fund this program in the future,” Michael Taylor, the FDA deputy commissioner for food and veterinary medicine, said in a speech to the International Dairy Foods Association Regulatory Roundup.
But Taylor added, “There is a significant FSMA funding gap,” and that without additional money from somewhere it will be difficult for the FDA to fulfill the expectations that the law will reduce food-borne illness in the future.
President Barack Obama’s fiscal year 2015 budget proposed user fees to pay part of the cost of implementing FSMA, which was passed in late 2010. The act gives FDA the authority to prevent food-related public health problems for the foods under its jurisdiction, which include almost everything except meat, poultry and processed eggs.
Congressional agriculture leaders and appropriators declared the user free proposal dead on arrival.
Taylor started off his wide-ranging speech by telling the dairy company officials, “I almost feel guilty about the amount of work we are imposing on the industry,” but he quickly added, “It is all for the greater good.”
FDA is “committed” to writing rules that are “flexible and minimize costs to industry” while trying “to avoid new requirements that won’t mean anything to food safety,” he said.
For general guidance, Taylor said company food safety officials should read two documents with what he admitted are bureaucratic titles: the Program Alignment Group recommendations decision memo, and the FSMA operational strategy document.
Under these plans, Taylor said, FDA internally wants to establish vertically integrated specialized commodity programs with staff skilled in food groups, rather than the current teams of investigators who may work on one food one day and another food the next.
Externally, he said, FDA wants to use its new authorities to focus more on preventing problems and less on “the old way” of conducting inspections and declaring violations.
Under the new approach, FDA will try to identify companies where there are problems and devote more of its attention to resolving those.
FDA officials will be looking for the “food safety culture” in companies, Taylor said.
“When you go in you can assess whether top management is interested in food safety, whether they are looking for problems. When you find firms that don’t have that culture, that’s when we need to be spending a few days there,” he added.
This approach, he said, could have identified that the Peanut Corporation of America, whose products led to a major food safety scandal, was a “bad actor” in need of attention before its products reached consumers.
Taylor said the concepts of “high risk” and “risk-based” policy “pervades the statute.”
In other comments, Taylor said:
▪ The produce rule in FSMA applies to farms, not cooking or processing facilities except when there are some “intersections” between field and facility.
▪ The proposed nutrition facts panel would have a two-year implementation, which would give companies time to change their labels.
▪ The domestic supplier verification rule will be aligned with the foreign supplier verification requirements.
▪ The animal residue testing program’s extent is unresolved.
Taylor confirmed a recent statement by FDA Commissioner Margaret Hamburg that FDA is still working on rule to encourage food companies to make voluntary reductions in sodium use.
FDA has been working on that rule since the 2010 Institute of Medicine report that Americans eat too much salt. The report showed that the average American consumes 3,400 milligrams of salt per day, but should consume only 2,300 milligrams.
Reducing the level of sodium consumption “would have enormous public health benefits in reducing deaths and reducing medical expenses,” he said.
Three quarters of the sodium is in processed or restaurant food, Taylor said, and FDA has been “doing its homework” in identifying the categories of food that need reductions. Taste, food safety and other functions of sodium will be taken into consideration in writing the rule, he added.
Speaking of the sodium rule and other FDA proposals that have not been received much publicity lately, Taylor said that “Some issues are on the back burner but not off the stove.”
| Michael Taylor |
But Taylor added, “There is a significant FSMA funding gap,” and that without additional money from somewhere it will be difficult for the FDA to fulfill the expectations that the law will reduce food-borne illness in the future.
President Barack Obama’s fiscal year 2015 budget proposed user fees to pay part of the cost of implementing FSMA, which was passed in late 2010. The act gives FDA the authority to prevent food-related public health problems for the foods under its jurisdiction, which include almost everything except meat, poultry and processed eggs.
Congressional agriculture leaders and appropriators declared the user free proposal dead on arrival.
Taylor started off his wide-ranging speech by telling the dairy company officials, “I almost feel guilty about the amount of work we are imposing on the industry,” but he quickly added, “It is all for the greater good.”
FDA is “committed” to writing rules that are “flexible and minimize costs to industry” while trying “to avoid new requirements that won’t mean anything to food safety,” he said.
For general guidance, Taylor said company food safety officials should read two documents with what he admitted are bureaucratic titles: the Program Alignment Group recommendations decision memo, and the FSMA operational strategy document.
Under these plans, Taylor said, FDA internally wants to establish vertically integrated specialized commodity programs with staff skilled in food groups, rather than the current teams of investigators who may work on one food one day and another food the next.
Externally, he said, FDA wants to use its new authorities to focus more on preventing problems and less on “the old way” of conducting inspections and declaring violations.
Under the new approach, FDA will try to identify companies where there are problems and devote more of its attention to resolving those.
FDA officials will be looking for the “food safety culture” in companies, Taylor said.
“When you go in you can assess whether top management is interested in food safety, whether they are looking for problems. When you find firms that don’t have that culture, that’s when we need to be spending a few days there,” he added.
This approach, he said, could have identified that the Peanut Corporation of America, whose products led to a major food safety scandal, was a “bad actor” in need of attention before its products reached consumers.
Taylor said the concepts of “high risk” and “risk-based” policy “pervades the statute.”
In other comments, Taylor said:
- The produce rule in FSMA applies to farms, not cooking or processing facilities except when there are some “intersections” between field and facility.
- The proposed nutrition facts panel would have a two-year implementation, which would give companies time to change their labels.
- The domestic supplier verification rule will be aligned with the foreign supplier verification requirements.
- The animal residue testing program’s extent is unresolved.
Taylor confirmed a recent statement by FDA Commissioner Margaret Hamburg that FDA is still working on rule to encourage food companies to make voluntary reductions in sodium use.
FDA has been working on that rule since the 2010 Institute of Medicine report that Americans eat too much salt. The report showed that the average American consumes 3,400 milligrams of salt per day, but should consume only 2,300 milligrams.
Reducing the level of sodium consumption “would have enormous public health benefits in reducing deaths and reducing medical expenses,” he said.
Three quarters of the sodium is in processed or restaurant food, Taylor said, and FDA has been “doing its homework” in identifying the categories of food that need reductions. Taste, food safety and other functions of sodium will be taken into consideration in writing the rule, he added.
Speaking of the sodium rule and other FDA proposals that have not been received much publicity lately, Taylor said that “Some issues are on the back burner but not off the stove.”
