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Pew Analysis Highlights Gaps in FDA’s Animal Antibiotics Policy

A year after the U.S. Food and Drug Administration released its Guidance for Industry #213, analysis by the Pew Charitable Trusts finds that gaps in the animal antibiotics policy could allow for some drugs to be used at the same rate.

In order to reduce antibiotic misuse and address the increase in antibiotic-resistant bacteria, FDA released Guidance #213 asking drug makers to remove indications for “feed efficiency” and “weight gain” from antibiotics labels and requiring veterinarians to oversee any addition of antibiotics to feed and water.

The agency released the policy in December 2013 and it’s expected to be fully implemented by the end of 2016.

For their report released Wednesday, Pew reviewed labels of the 287 antibiotic products affected by Guidance #213. They compared the dosage for “growth promotion” and “disease prevention” approved for each drug.

Half had no overlapping dosages. Of the labels with overlapping growth-promotion and disease-prevention dosages, 66 of them can be used in at least one species of livestock (chickens, turkeys, pigs, or cattle) for disease prevention at the same levels as the promotion doses and without a limit on duration.

FDA classifies 29 of these 66 antibiotics as critically important in human medicine and 37 as highly important.

There were 13 additional labels with overlapping dosages but with duration limits, and four that only partially overlapped.

The analysis gives weight to concerns voiced by public health advocates over the past year that, while drug companies comply with the guidance, farmers could still give their animals certain antibiotics at the same rate but call it “disease prevention” instead of “growth promotion.”

“We are concerned that dozens of products could still be added to animal feed or water throughout the animals’ lives in the absence of any threat from a specific bacterial disease,” said Gail Hansen, a senior officer with Pew’s human health and industrial farming project.

Laura Rogers, director of Pew’s campaign on human health and industrial farming, emphasized that many producers are serious about reducing antibiotic overuse and that “our analysis isn’t focused on what companies will or won’t do, we’re focused on the policy, and we’re concerned about the gaps we find on that side.”

But the Animal Health Institute (AHI), which represents the veterinary pharmaceutical industry, argued that the Pew report is wrong.

“There is no loophole,” the organization said in a statement. “Of those approved applications with growth promotion claims, only 17 also have prevention claims on their product labels, and in none of those 17 instances are the dose and duration of use the same for the growth claim and prevention claim.”

Disease prevention is important for both human and veterinary medicine, AHI said, and approved disease prevention claims are “targeted … and veterinarians can only specify their use when there is evidence for the disease or bacterium.”

In its report, Pew recommends that FDA take additional steps for detailed monitoring of antibiotic use, establish a target for reduction of use, and develop a process and timeline for reviewing the adequacy of disease-prevention label claims.

“FDA’s policy is an important step, but there is more work to do, both to effectively eliminate growth promotion and to ensure that antibiotics are prescribed by veterinarians to prevent disease only under well-defined circumstances,” Hansen said.

Food Safety News

Pew Analysis Highlights Gaps in FDA’s Animal Antibiotics Policy

A year after the U.S. Food and Drug Administration released its Guidance for Industry #213, analysis by the Pew Charitable Trusts finds that gaps in the animal antibiotics policy could allow for some drugs to be used at the same rate.

In order to reduce antibiotic misuse and address the increase in antibiotic-resistant bacteria, FDA released Guidance #213 asking drug makers to remove indications for “feed efficiency” and “weight gain” from antibiotics labels and requiring veterinarians to oversee any addition of antibiotics to feed and water.

The agency released the policy in December 2013 and it’s expected to be fully implemented by the end of 2016.

For their report released Wednesday, Pew reviewed labels of the 287 antibiotic products affected by Guidance #213. They compared the dosage for “growth promotion” and “disease prevention” approved for each drug.

Half had no overlapping dosages. Of the labels with overlapping growth-promotion and disease-prevention dosages, 66 of them can be used in at least one species of livestock (chickens, turkeys, pigs, or cattle) for disease prevention at the same levels as the promotion doses and without a limit on duration.

FDA classifies 29 of these 66 antibiotics as critically important in human medicine and 37 as highly important.

There were 13 additional labels with overlapping dosages but with duration limits, and four that only partially overlapped.

The analysis gives weight to concerns voiced by public health advocates over the past year that, while drug companies comply with the guidance, farmers could still give their animals certain antibiotics at the same rate but call it “disease prevention” instead of “growth promotion.”

“We are concerned that dozens of products could still be added to animal feed or water throughout the animals’ lives in the absence of any threat from a specific bacterial disease,” said Gail Hansen, a senior officer with Pew’s human health and industrial farming project.

Laura Rogers, director of Pew’s campaign on human health and industrial farming, emphasized that many producers are serious about reducing antibiotic overuse and that “our analysis isn’t focused on what companies will or won’t do, we’re focused on the policy, and we’re concerned about the gaps we find on that side.”

But the Animal Health Institute (AHI), which represents the veterinary pharmaceutical industry, argued that the Pew report is wrong.

“There is no loophole,” the organization said in a statement. “Of those approved applications with growth promotion claims, only 17 also have prevention claims on their product labels, and in none of those 17 instances are the dose and duration of use the same for the growth claim and prevention claim.”

Disease prevention is important for both human and veterinary medicine, AHI said, and approved disease prevention claims are “targeted … and veterinarians can only specify their use when there is evidence for the disease or bacterium.”

In its report, Pew recommends that FDA take additional steps for detailed monitoring of antibiotic use, establish a target for reduction of use, and develop a process and timeline for reviewing the adequacy of disease-prevention label claims.

“FDA’s policy is an important step, but there is more work to do, both to effectively eliminate growth promotion and to ensure that antibiotics are prescribed by veterinarians to prevent disease only under well-defined circumstances,” Hansen said.

Food Safety News

Pew Analysis Highlights Gaps in FDA’s Animal Antibiotics Policy

A year after the U.S. Food and Drug Administration released its Guidance for Industry #213, analysis by the Pew Charitable Trusts finds that gaps in the animal antibiotics policy could allow for some drugs to be used at the same rate.

In order to reduce antibiotic misuse and address the increase in antibiotic-resistant bacteria, FDA released Guidance #213 asking drug makers to remove indications for “feed efficiency” and “weight gain” from antibiotics labels and requiring veterinarians to oversee any addition of antibiotics to feed and water.

The agency released the policy in December 2013 and it’s expected to be fully implemented by the end of 2016.

For their report released Wednesday, Pew reviewed labels of the 287 antibiotic products affected by Guidance #213. They compared the dosage for “growth promotion” and “disease prevention” approved for each drug.

Half had no overlapping dosages. Of the labels with overlapping growth-promotion and disease-prevention dosages, 66 of them can be used in at least one species of livestock (chickens, turkeys, pigs, or cattle) for disease prevention at the same levels as the promotion doses and without a limit on duration.

FDA classifies 29 of these 66 antibiotics as critically important in human medicine and 37 as highly important.

There were 13 additional labels with overlapping dosages but with duration limits, and four that only partially overlapped.

The analysis gives weight to concerns voiced by public health advocates over the past year that, while drug companies comply with the guidance, farmers could still give their animals certain antibiotics at the same rate but call it “disease prevention” instead of “growth promotion.”

“We are concerned that dozens of products could still be added to animal feed or water throughout the animals’ lives in the absence of any threat from a specific bacterial disease,” said Gail Hansen, a senior officer with Pew’s human health and industrial farming project.

Laura Rogers, director of Pew’s campaign on human health and industrial farming, emphasized that many producers are serious about reducing antibiotic overuse and that “our analysis isn’t focused on what companies will or won’t do, we’re focused on the policy, and we’re concerned about the gaps we find on that side.”

But the Animal Health Institute (AHI), which represents the veterinary pharmaceutical industry, argued that the Pew report is wrong.

“There is no loophole,” the organization said in a statement. “Of those approved applications with growth promotion claims, only 17 also have prevention claims on their product labels, and in none of those 17 instances are the dose and duration of use the same for the growth claim and prevention claim.”

Disease prevention is important for both human and veterinary medicine, AHI said, and approved disease prevention claims are “targeted … and veterinarians can only specify their use when there is evidence for the disease or bacterium.”

In its report, Pew recommends that FDA take additional steps for detailed monitoring of antibiotic use, establish a target for reduction of use, and develop a process and timeline for reviewing the adequacy of disease-prevention label claims.

“FDA’s policy is an important step, but there is more work to do, both to effectively eliminate growth promotion and to ensure that antibiotics are prescribed by veterinarians to prevent disease only under well-defined circumstances,” Hansen said.

Food Safety News

Pew Analysis Highlights Gaps in FDA’s Animal Antibiotics Policy

A year after the U.S. Food and Drug Administration released its Guidance for Industry #213, analysis by the Pew Charitable Trusts finds that gaps in the animal antibiotics policy could allow for some drugs to be used at the same rate.

In order to reduce antibiotic misuse and address the increase in antibiotic-resistant bacteria, FDA released Guidance #213 asking drug makers to remove indications for “feed efficiency” and “weight gain” from antibiotics labels and requiring veterinarians to oversee any addition of antibiotics to feed and water.

The agency released the policy in December 2013 and it’s expected to be fully implemented by the end of 2016.

For their report released Wednesday, Pew reviewed labels of the 287 antibiotic products affected by Guidance #213. They compared the dosage for “growth promotion” and “disease prevention” approved for each drug.

Half had no overlapping dosages. Of the labels with overlapping growth-promotion and disease-prevention dosages, 66 of them can be used in at least one species of livestock (chickens, turkeys, pigs, or cattle) for disease prevention at the same levels as the promotion doses and without a limit on duration.

FDA classifies 29 of these 66 antibiotics as critically important in human medicine and 37 as highly important.

There were 13 additional labels with overlapping dosages but with duration limits, and four that only partially overlapped.

The analysis gives weight to concerns voiced by public health advocates over the past year that, while drug companies comply with the guidance, farmers could still give their animals certain antibiotics at the same rate but call it “disease prevention” instead of “growth promotion.”

“We are concerned that dozens of products could still be added to animal feed or water throughout the animals’ lives in the absence of any threat from a specific bacterial disease,” said Gail Hansen, a senior officer with Pew’s human health and industrial farming project.

Laura Rogers, director of Pew’s campaign on human health and industrial farming, emphasized that many producers are serious about reducing antibiotic overuse and that “our analysis isn’t focused on what companies will or won’t do, we’re focused on the policy, and we’re concerned about the gaps we find on that side.”

But the Animal Health Institute (AHI), which represents the veterinary pharmaceutical industry, argued that the Pew report is wrong.

“There is no loophole,” the organization said in a statement. “Of those approved applications with growth promotion claims, only 17 also have prevention claims on their product labels, and in none of those 17 instances are the dose and duration of use the same for the growth claim and prevention claim.”

Disease prevention is important for both human and veterinary medicine, AHI said, and approved disease prevention claims are “targeted … and veterinarians can only specify their use when there is evidence for the disease or bacterium.”

In its report, Pew recommends that FDA take additional steps for detailed monitoring of antibiotic use, establish a target for reduction of use, and develop a process and timeline for reviewing the adequacy of disease-prevention label claims.

“FDA’s policy is an important step, but there is more work to do, both to effectively eliminate growth promotion and to ensure that antibiotics are prescribed by veterinarians to prevent disease only under well-defined circumstances,” Hansen said.

Food Safety News

Pew Analysis Highlights Gaps in FDA’s Animal Antibiotics Policy

A year after the U.S. Food and Drug Administration released its Guidance for Industry #213, analysis by the Pew Charitable Trusts finds that gaps in the animal antibiotics policy could allow for some drugs to be used at the same rate.

In order to reduce antibiotic misuse and address the increase in antibiotic-resistant bacteria, FDA released Guidance #213 asking drug makers to remove indications for “feed efficiency” and “weight gain” from antibiotics labels and requiring veterinarians to oversee any addition of antibiotics to feed and water.

The agency released the policy in December 2013 and it’s expected to be fully implemented by the end of 2016.

For their report released Wednesday, Pew reviewed labels of the 287 antibiotic products affected by Guidance #213. They compared the dosage for “growth promotion” and “disease prevention” approved for each drug.

Half had no overlapping dosages. Of the labels with overlapping growth-promotion and disease-prevention dosages, 66 of them can be used in at least one species of livestock (chickens, turkeys, pigs, or cattle) for disease prevention at the same levels as the promotion doses and without a limit on duration.

FDA classifies 29 of these 66 antibiotics as critically important in human medicine and 37 as highly important.

There were 13 additional labels with overlapping dosages but with duration limits, and four that only partially overlapped.

The analysis gives weight to concerns voiced by public health advocates over the past year that, while drug companies comply with the guidance, farmers could still give their animals certain antibiotics at the same rate but call it “disease prevention” instead of “growth promotion.”

“We are concerned that dozens of products could still be added to animal feed or water throughout the animals’ lives in the absence of any threat from a specific bacterial disease,” said Gail Hansen, a senior officer with Pew’s human health and industrial farming project.

Laura Rogers, director of Pew’s campaign on human health and industrial farming, emphasized that many producers are serious about reducing antibiotic overuse and that “our analysis isn’t focused on what companies will or won’t do, we’re focused on the policy, and we’re concerned about the gaps we find on that side.”

But the Animal Health Institute (AHI), which represents the veterinary pharmaceutical industry, argued that the Pew report is wrong.

“There is no loophole,” the organization said in a statement. “Of those approved applications with growth promotion claims, only 17 also have prevention claims on their product labels, and in none of those 17 instances are the dose and duration of use the same for the growth claim and prevention claim.”

Disease prevention is important for both human and veterinary medicine, AHI said, and approved disease prevention claims are “targeted … and veterinarians can only specify their use when there is evidence for the disease or bacterium.”

In its report, Pew recommends that FDA take additional steps for detailed monitoring of antibiotic use, establish a target for reduction of use, and develop a process and timeline for reviewing the adequacy of disease-prevention label claims.

“FDA’s policy is an important step, but there is more work to do, both to effectively eliminate growth promotion and to ensure that antibiotics are prescribed by veterinarians to prevent disease only under well-defined circumstances,” Hansen said.

Food Safety News

Pew Analysis Highlights Gaps in FDA’s Animal Antibiotics Policy

A year after the U.S. Food and Drug Administration released its Guidance for Industry #213, analysis by the Pew Charitable Trusts finds that gaps in the animal antibiotics policy could allow for some drugs to be used at the same rate.

In order to reduce antibiotic misuse and address the increase in antibiotic-resistant bacteria, FDA released Guidance #213 asking drug makers to remove indications for “feed efficiency” and “weight gain” from antibiotics labels and requiring veterinarians to oversee any addition of antibiotics to feed and water.

The agency released the policy in December 2013 and it’s expected to be fully implemented by the end of 2016.

For their report released Wednesday, Pew reviewed labels of the 287 antibiotic products affected by Guidance #213. They compared the dosage for “growth promotion” and “disease prevention” approved for each drug.

Half had no overlapping dosages. Of the labels with overlapping growth-promotion and disease-prevention dosages, 66 of them can be used in at least one species of livestock (chickens, turkeys, pigs, or cattle) for disease prevention at the same levels as the promotion doses and without a limit on duration.

FDA classifies 29 of these 66 antibiotics as critically important in human medicine and 37 as highly important.

There were 13 additional labels with overlapping dosages but with duration limits, and four that only partially overlapped.

The analysis gives weight to concerns voiced by public health advocates over the past year that, while drug companies comply with the guidance, farmers could still give their animals certain antibiotics at the same rate but call it “disease prevention” instead of “growth promotion.”

“We are concerned that dozens of products could still be added to animal feed or water throughout the animals’ lives in the absence of any threat from a specific bacterial disease,” said Gail Hansen, a senior officer with Pew’s human health and industrial farming project.

Laura Rogers, director of Pew’s campaign on human health and industrial farming, emphasized that many producers are serious about reducing antibiotic overuse and that “our analysis isn’t focused on what companies will or won’t do, we’re focused on the policy, and we’re concerned about the gaps we find on that side.”

But the Animal Health Institute (AHI), which represents the veterinary pharmaceutical industry, argued that the Pew report is wrong.

“There is no loophole,” the organization said in a statement. “Of those approved applications with growth promotion claims, only 17 also have prevention claims on their product labels, and in none of those 17 instances are the dose and duration of use the same for the growth claim and prevention claim.”

Disease prevention is important for both human and veterinary medicine, AHI said, and approved disease prevention claims are “targeted … and veterinarians can only specify their use when there is evidence for the disease or bacterium.”

In its report, Pew recommends that FDA take additional steps for detailed monitoring of antibiotic use, establish a target for reduction of use, and develop a process and timeline for reviewing the adequacy of disease-prevention label claims.

“FDA’s policy is an important step, but there is more work to do, both to effectively eliminate growth promotion and to ensure that antibiotics are prescribed by veterinarians to prevent disease only under well-defined circumstances,” Hansen said.

Food Safety News

Pew Analysis Highlights Gaps in FDA’s Animal Antibiotics Policy

A year after the U.S. Food and Drug Administration released its Guidance for Industry #213, analysis by the Pew Charitable Trusts finds that gaps in the animal antibiotics policy could allow for some drugs to be used at the same rate.

In order to reduce antibiotic misuse and address the increase in antibiotic-resistant bacteria, FDA released Guidance #213 asking drug makers to remove indications for “feed efficiency” and “weight gain” from antibiotics labels and requiring veterinarians to oversee any addition of antibiotics to feed and water.

The agency released the policy in December 2013 and it’s expected to be fully implemented by the end of 2016.

For their report released Wednesday, Pew reviewed labels of the 287 antibiotic products affected by Guidance #213. They compared the dosage for “growth promotion” and “disease prevention” approved for each drug.

Half had no overlapping dosages. Of the labels with overlapping growth-promotion and disease-prevention dosages, 66 of them can be used in at least one species of livestock (chickens, turkeys, pigs, or cattle) for disease prevention at the same levels as the promotion doses and without a limit on duration.

FDA classifies 29 of these 66 antibiotics as critically important in human medicine and 37 as highly important.

There were 13 additional labels with overlapping dosages but with duration limits, and four that only partially overlapped.

The analysis gives weight to concerns voiced by public health advocates over the past year that, while drug companies comply with the guidance, farmers could still give their animals certain antibiotics at the same rate but call it “disease prevention” instead of “growth promotion.”

“We are concerned that dozens of products could still be added to animal feed or water throughout the animals’ lives in the absence of any threat from a specific bacterial disease,” said Gail Hansen, a senior officer with Pew’s human health and industrial farming project.

Laura Rogers, director of Pew’s campaign on human health and industrial farming, emphasized that many producers are serious about reducing antibiotic overuse and that “our analysis isn’t focused on what companies will or won’t do, we’re focused on the policy, and we’re concerned about the gaps we find on that side.”

But the Animal Health Institute (AHI), which represents the veterinary pharmaceutical industry, argued that the Pew report is wrong.

“There is no loophole,” the organization said in a statement. “Of those approved applications with growth promotion claims, only 17 also have prevention claims on their product labels, and in none of those 17 instances are the dose and duration of use the same for the growth claim and prevention claim.”

Disease prevention is important for both human and veterinary medicine, AHI said, and approved disease prevention claims are “targeted … and veterinarians can only specify their use when there is evidence for the disease or bacterium.”

In its report, Pew recommends that FDA take additional steps for detailed monitoring of antibiotic use, establish a target for reduction of use, and develop a process and timeline for reviewing the adequacy of disease-prevention label claims.

“FDA’s policy is an important step, but there is more work to do, both to effectively eliminate growth promotion and to ensure that antibiotics are prescribed by veterinarians to prevent disease only under well-defined circumstances,” Hansen said.

Food Safety News

Pew Analysis Highlights Gaps in FDA’s Animal Antibiotics Policy

A year after the U.S. Food and Drug Administration released its Guidance for Industry #213, analysis by the Pew Charitable Trusts finds that gaps in the animal antibiotics policy could allow for some drugs to be used at the same rate.

In order to reduce antibiotic misuse and address the increase in antibiotic-resistant bacteria, FDA released Guidance #213 asking drug makers to remove indications for “feed efficiency” and “weight gain” from antibiotics labels and requiring veterinarians to oversee any addition of antibiotics to feed and water.

The agency released the policy in December 2013 and it’s expected to be fully implemented by the end of 2016.

For their report released Wednesday, Pew reviewed labels of the 287 antibiotic products affected by Guidance #213. They compared the dosage for “growth promotion” and “disease prevention” approved for each drug.

Half had no overlapping dosages. Of the labels with overlapping growth-promotion and disease-prevention dosages, 66 of them can be used in at least one species of livestock (chickens, turkeys, pigs, or cattle) for disease prevention at the same levels as the promotion doses and without a limit on duration.

FDA classifies 29 of these 66 antibiotics as critically important in human medicine and 37 as highly important.

There were 13 additional labels with overlapping dosages but with duration limits, and four that only partially overlapped.

The analysis gives weight to concerns voiced by public health advocates over the past year that, while drug companies comply with the guidance, farmers could still give their animals certain antibiotics at the same rate but call it “disease prevention” instead of “growth promotion.”

“We are concerned that dozens of products could still be added to animal feed or water throughout the animals’ lives in the absence of any threat from a specific bacterial disease,” said Gail Hansen, a senior officer with Pew’s human health and industrial farming project.

Laura Rogers, director of Pew’s campaign on human health and industrial farming, emphasized that many producers are serious about reducing antibiotic overuse and that “our analysis isn’t focused on what companies will or won’t do, we’re focused on the policy, and we’re concerned about the gaps we find on that side.”

But the Animal Health Institute (AHI), which represents the veterinary pharmaceutical industry, argued that the Pew report is wrong.

“There is no loophole,” the organization said in a statement. “Of those approved applications with growth promotion claims, only 17 also have prevention claims on their product labels, and in none of those 17 instances are the dose and duration of use the same for the growth claim and prevention claim.”

Disease prevention is important for both human and veterinary medicine, AHI said, and approved disease prevention claims are “targeted … and veterinarians can only specify their use when there is evidence for the disease or bacterium.”

In its report, Pew recommends that FDA take additional steps for detailed monitoring of antibiotic use, establish a target for reduction of use, and develop a process and timeline for reviewing the adequacy of disease-prevention label claims.

“FDA’s policy is an important step, but there is more work to do, both to effectively eliminate growth promotion and to ensure that antibiotics are prescribed by veterinarians to prevent disease only under well-defined circumstances,” Hansen said.

Food Safety News

Pew Analysis Highlights Gaps in FDA’s Animal Antibiotics Policy

A year after the U.S. Food and Drug Administration released its Guidance for Industry #213, analysis by the Pew Charitable Trusts finds that gaps in the animal antibiotics policy could allow for some drugs to be used at the same rate.

In order to reduce antibiotic misuse and address the increase in antibiotic-resistant bacteria, FDA released Guidance #213 asking drug makers to remove indications for “feed efficiency” and “weight gain” from antibiotics labels and requiring veterinarians to oversee any addition of antibiotics to feed and water.

The agency released the policy in December 2013 and it’s expected to be fully implemented by the end of 2016.

For their report released Wednesday, Pew reviewed labels of the 287 antibiotic products affected by Guidance #213. They compared the dosage for “growth promotion” and “disease prevention” approved for each drug.

Half had no overlapping dosages. Of the labels with overlapping growth-promotion and disease-prevention dosages, 66 of them can be used in at least one species of livestock (chickens, turkeys, pigs, or cattle) for disease prevention at the same levels as the promotion doses and without a limit on duration.

FDA classifies 29 of these 66 antibiotics as critically important in human medicine and 37 as highly important.

There were 13 additional labels with overlapping dosages but with duration limits, and four that only partially overlapped.

The analysis gives weight to concerns voiced by public health advocates over the past year that, while drug companies comply with the guidance, farmers could still give their animals certain antibiotics at the same rate but call it “disease prevention” instead of “growth promotion.”

“We are concerned that dozens of products could still be added to animal feed or water throughout the animals’ lives in the absence of any threat from a specific bacterial disease,” said Gail Hansen, a senior officer with Pew’s human health and industrial farming project.

Laura Rogers, director of Pew’s campaign on human health and industrial farming, emphasized that many producers are serious about reducing antibiotic overuse and that “our analysis isn’t focused on what companies will or won’t do, we’re focused on the policy, and we’re concerned about the gaps we find on that side.”

But the Animal Health Institute (AHI), which represents the veterinary pharmaceutical industry, argued that the Pew report is wrong.

“There is no loophole,” the organization said in a statement. “Of those approved applications with growth promotion claims, only 17 also have prevention claims on their product labels, and in none of those 17 instances are the dose and duration of use the same for the growth claim and prevention claim.”

Disease prevention is important for both human and veterinary medicine, AHI said, and approved disease prevention claims are “targeted … and veterinarians can only specify their use when there is evidence for the disease or bacterium.”

In its report, Pew recommends that FDA take additional steps for detailed monitoring of antibiotic use, establish a target for reduction of use, and develop a process and timeline for reviewing the adequacy of disease-prevention label claims.

“FDA’s policy is an important step, but there is more work to do, both to effectively eliminate growth promotion and to ensure that antibiotics are prescribed by veterinarians to prevent disease only under well-defined circumstances,” Hansen said.

Food Safety News

Pew Analysis Highlights Gaps in FDA’s Animal Antibiotics Policy

A year after the U.S. Food and Drug Administration released its Guidance for Industry #213, analysis by the Pew Charitable Trusts finds that gaps in the animal antibiotics policy could allow for some drugs to be used at the same rate.

In order to reduce antibiotic misuse and address the increase in antibiotic-resistant bacteria, FDA released Guidance #213 asking drug makers to remove indications for “feed efficiency” and “weight gain” from antibiotics labels and requiring veterinarians to oversee any addition of antibiotics to feed and water.

The agency released the policy in December 2013 and it’s expected to be fully implemented by the end of 2016.

For their report released Wednesday, Pew reviewed labels of the 287 antibiotic products affected by Guidance #213. They compared the dosage for “growth promotion” and “disease prevention” approved for each drug.

Half had no overlapping dosages. Of the labels with overlapping growth-promotion and disease-prevention dosages, 66 of them can be used in at least one species of livestock (chickens, turkeys, pigs, or cattle) for disease prevention at the same levels as the promotion doses and without a limit on duration.

FDA classifies 29 of these 66 antibiotics as critically important in human medicine and 37 as highly important.

There were 13 additional labels with overlapping dosages but with duration limits, and four that only partially overlapped.

The analysis gives weight to concerns voiced by public health advocates over the past year that, while drug companies comply with the guidance, farmers could still give their animals certain antibiotics at the same rate but call it “disease prevention” instead of “growth promotion.”

“We are concerned that dozens of products could still be added to animal feed or water throughout the animals’ lives in the absence of any threat from a specific bacterial disease,” said Gail Hansen, a senior officer with Pew’s human health and industrial farming project.

Laura Rogers, director of Pew’s campaign on human health and industrial farming, emphasized that many producers are serious about reducing antibiotic overuse and that “our analysis isn’t focused on what companies will or won’t do, we’re focused on the policy, and we’re concerned about the gaps we find on that side.”

But the Animal Health Institute (AHI), which represents the veterinary pharmaceutical industry, argued that the Pew report is wrong.

“There is no loophole,” the organization said in a statement. “Of those approved applications with growth promotion claims, only 17 also have prevention claims on their product labels, and in none of those 17 instances are the dose and duration of use the same for the growth claim and prevention claim.”

Disease prevention is important for both human and veterinary medicine, AHI said, and approved disease prevention claims are “targeted … and veterinarians can only specify their use when there is evidence for the disease or bacterium.”

In its report, Pew recommends that FDA take additional steps for detailed monitoring of antibiotic use, establish a target for reduction of use, and develop a process and timeline for reviewing the adequacy of disease-prevention label claims.

“FDA’s policy is an important step, but there is more work to do, both to effectively eliminate growth promotion and to ensure that antibiotics are prescribed by veterinarians to prevent disease only under well-defined circumstances,” Hansen said.

Food Safety News

Pew Analysis Highlights Gaps in FDA’s Animal Antibiotics Policy

A year after the U.S. Food and Drug Administration released its Guidance for Industry #213, analysis by the Pew Charitable Trusts finds that gaps in the animal antibiotics policy could allow for some drugs to be used at the same rate.

In order to reduce antibiotic misuse and address the increase in antibiotic-resistant bacteria, FDA released Guidance #213 asking drug makers to remove indications for “feed efficiency” and “weight gain” from antibiotics labels and requiring veterinarians to oversee any addition of antibiotics to feed and water.

The agency released the policy in December 2013 and it’s expected to be fully implemented by the end of 2016.

For their report released Wednesday, Pew reviewed labels of the 287 antibiotic products affected by Guidance #213. They compared the dosage for “growth promotion” and “disease prevention” approved for each drug.

Half had no overlapping dosages. Of the labels with overlapping growth-promotion and disease-prevention dosages, 66 of them can be used in at least one species of livestock (chickens, turkeys, pigs, or cattle) for disease prevention at the same levels as the promotion doses and without a limit on duration.

FDA classifies 29 of these 66 antibiotics as critically important in human medicine and 37 as highly important.

There were 13 additional labels with overlapping dosages but with duration limits, and four that only partially overlapped.

The analysis gives weight to concerns voiced by public health advocates over the past year that, while drug companies comply with the guidance, farmers could still give their animals certain antibiotics at the same rate but call it “disease prevention” instead of “growth promotion.”

“We are concerned that dozens of products could still be added to animal feed or water throughout the animals’ lives in the absence of any threat from a specific bacterial disease,” said Gail Hansen, a senior officer with Pew’s human health and industrial farming project.

Laura Rogers, director of Pew’s campaign on human health and industrial farming, emphasized that many producers are serious about reducing antibiotic overuse and that “our analysis isn’t focused on what companies will or won’t do, we’re focused on the policy, and we’re concerned about the gaps we find on that side.”

But the Animal Health Institute (AHI), which represents the veterinary pharmaceutical industry, argued that the Pew report is wrong.

“There is no loophole,” the organization said in a statement. “Of those approved applications with growth promotion claims, only 17 also have prevention claims on their product labels, and in none of those 17 instances are the dose and duration of use the same for the growth claim and prevention claim.”

Disease prevention is important for both human and veterinary medicine, AHI said, and approved disease prevention claims are “targeted … and veterinarians can only specify their use when there is evidence for the disease or bacterium.”

In its report, Pew recommends that FDA take additional steps for detailed monitoring of antibiotic use, establish a target for reduction of use, and develop a process and timeline for reviewing the adequacy of disease-prevention label claims.

“FDA’s policy is an important step, but there is more work to do, both to effectively eliminate growth promotion and to ensure that antibiotics are prescribed by veterinarians to prevent disease only under well-defined circumstances,” Hansen said.

Food Safety News

Pew Analysis Highlights Gaps in FDA’s Animal Antibiotics Policy

A year after the U.S. Food and Drug Administration released its Guidance for Industry #213, analysis by the Pew Charitable Trusts finds that gaps in the animal antibiotics policy could allow for some drugs to be used at the same rate.

In order to reduce antibiotic misuse and address the increase in antibiotic-resistant bacteria, FDA released Guidance #213 asking drug makers to remove indications for “feed efficiency” and “weight gain” from antibiotics labels and requiring veterinarians to oversee any addition of antibiotics to feed and water.

The agency released the policy in December 2013 and it’s expected to be fully implemented by the end of 2016.

For their report released Wednesday, Pew reviewed labels of the 287 antibiotic products affected by Guidance #213. They compared the dosage for “growth promotion” and “disease prevention” approved for each drug.

Half had no overlapping dosages. Of the labels with overlapping growth-promotion and disease-prevention dosages, 66 of them can be used in at least one species of livestock (chickens, turkeys, pigs, or cattle) for disease prevention at the same levels as the promotion doses and without a limit on duration.

FDA classifies 29 of these 66 antibiotics as critically important in human medicine and 37 as highly important.

There were 13 additional labels with overlapping dosages but with duration limits, and four that only partially overlapped.

The analysis gives weight to concerns voiced by public health advocates over the past year that, while drug companies comply with the guidance, farmers could still give their animals certain antibiotics at the same rate but call it “disease prevention” instead of “growth promotion.”

“We are concerned that dozens of products could still be added to animal feed or water throughout the animals’ lives in the absence of any threat from a specific bacterial disease,” said Gail Hansen, a senior officer with Pew’s human health and industrial farming project.

Laura Rogers, director of Pew’s campaign on human health and industrial farming, emphasized that many producers are serious about reducing antibiotic overuse and that “our analysis isn’t focused on what companies will or won’t do, we’re focused on the policy, and we’re concerned about the gaps we find on that side.”

But the Animal Health Institute (AHI), which represents the veterinary pharmaceutical industry, argued that the Pew report is wrong.

“There is no loophole,” the organization said in a statement. “Of those approved applications with growth promotion claims, only 17 also have prevention claims on their product labels, and in none of those 17 instances are the dose and duration of use the same for the growth claim and prevention claim.”

Disease prevention is important for both human and veterinary medicine, AHI said, and approved disease prevention claims are “targeted … and veterinarians can only specify their use when there is evidence for the disease or bacterium.”

In its report, Pew recommends that FDA take additional steps for detailed monitoring of antibiotic use, establish a target for reduction of use, and develop a process and timeline for reviewing the adequacy of disease-prevention label claims.

“FDA’s policy is an important step, but there is more work to do, both to effectively eliminate growth promotion and to ensure that antibiotics are prescribed by veterinarians to prevent disease only under well-defined circumstances,” Hansen said.

Food Safety News

Pew Analysis Highlights Gaps in FDA’s Animal Antibiotics Policy

A year after the U.S. Food and Drug Administration released its Guidance for Industry #213, analysis by the Pew Charitable Trusts finds that gaps in the animal antibiotics policy could allow for some drugs to be used at the same rate.

In order to reduce antibiotic misuse and address the increase in antibiotic-resistant bacteria, FDA released Guidance #213 asking drug makers to remove indications for “feed efficiency” and “weight gain” from antibiotics labels and requiring veterinarians to oversee any addition of antibiotics to feed and water.

The agency released the policy in December 2013 and it’s expected to be fully implemented by the end of 2016.

For their report released Wednesday, Pew reviewed labels of the 287 antibiotic products affected by Guidance #213. They compared the dosage for “growth promotion” and “disease prevention” approved for each drug.

Half had no overlapping dosages. Of the labels with overlapping growth-promotion and disease-prevention dosages, 66 of them can be used in at least one species of livestock (chickens, turkeys, pigs, or cattle) for disease prevention at the same levels as the promotion doses and without a limit on duration.

FDA classifies 29 of these 66 antibiotics as critically important in human medicine and 37 as highly important.

There were 13 additional labels with overlapping dosages but with duration limits, and four that only partially overlapped.

The analysis gives weight to concerns voiced by public health advocates over the past year that, while drug companies comply with the guidance, farmers could still give their animals certain antibiotics at the same rate but call it “disease prevention” instead of “growth promotion.”

“We are concerned that dozens of products could still be added to animal feed or water throughout the animals’ lives in the absence of any threat from a specific bacterial disease,” said Gail Hansen, a senior officer with Pew’s human health and industrial farming project.

Laura Rogers, director of Pew’s campaign on human health and industrial farming, emphasized that many producers are serious about reducing antibiotic overuse and that “our analysis isn’t focused on what companies will or won’t do, we’re focused on the policy, and we’re concerned about the gaps we find on that side.”

But the Animal Health Institute (AHI), which represents the veterinary pharmaceutical industry, argued that the Pew report is wrong.

“There is no loophole,” the organization said in a statement. “Of those approved applications with growth promotion claims, only 17 also have prevention claims on their product labels, and in none of those 17 instances are the dose and duration of use the same for the growth claim and prevention claim.”

Disease prevention is important for both human and veterinary medicine, AHI said, and approved disease prevention claims are “targeted … and veterinarians can only specify their use when there is evidence for the disease or bacterium.”

In its report, Pew recommends that FDA take additional steps for detailed monitoring of antibiotic use, establish a target for reduction of use, and develop a process and timeline for reviewing the adequacy of disease-prevention label claims.

“FDA’s policy is an important step, but there is more work to do, both to effectively eliminate growth promotion and to ensure that antibiotics are prescribed by veterinarians to prevent disease only under well-defined circumstances,” Hansen said.

Food Safety News

Genome analysis helps in breeding more robust cows

Genome analysis of 234 bulls has put researchers, including several from Wageningen Livestock Research, on the trail of DNA variants which influence particular characteristics in breeding bulls. For example, two variants have proven responsible for disruptions to the development of embryos and for curly hair, which is disadvantageous because more ticks and parasites occur in curly hair than in short, straight hair. These are the first results of the large 1000 Bull Genomes project on which some 30 international researchers are collaborating. They report on their research in the most recent edition of the science journal Nature Genetics.

Most breeding characteristics are influenced by not one but a multiplicity of variants. It is therefore important to be able to use all the variants in breeding, say the Wageningen researchers. In order to make this possible, Rianne van Binsbergen, PhD researcher at the Animal Breeding and Genomics Centre of Wageningen UR, investigated whether the genomes of all the common bulls in the Netherlands can be filled with the help of these 234 bulls. Currently, these bulls have been genotyped with markers of 50,000 or 700,000 DNA variants. The positive results indicate the direction for further research into the practical use of genome information in breeding.

Dairy and beef cattle The project demonstrates how useful large-scale DNA analyses can be, says Professor Roel Veerkamp, Professor of Numerical Genetics at Wageningen University and board member of the 1000 Bull Genomes project. He emphasises that the requirements for dairy and beef cattle are becoming ever more exacting: “Until the mid nineties, a cow primarily had to produce a lot of milk. But since then, expectations have gone up. Farmers are looking for more robust cows. In practice, that means good fertility, longer life, udders that give good protection against infections, improved claws and more efficient feed utilisation. That adds up to a lot of characteristics, which are governed by all kinds of genes. In order to bring them together in a cow in the best and fastest way possible, genomic selection is important for breeding organisations such as CRV, and by means of genome analysis we want to improve this further,” says Veerkamp.

Bull genome The genome of a bull consists of 3 billion ‘letters’. In the 234 bulls studied, the researchers found a total of over 28 million positions on the DNA which displayed variation, in other words where the animals have different letters. Currently, CRV uses approximately 50,000 variants, the so-called single nucleotide polymorphisms (SNP) for genomic selection, by linking SNP patterns of a very large number of animals to characteristics which are important for robustness. Together with CRV and the other partners in the Breed4Food programme, the researchers are investigating whether the new genome information can help to predict even better which characteristics the offspring will have.

The bull analysis presented at this time is the first phase of the 1,000 Bull Genomes project, a database which is planned to incorporate the genomes of a thousand bulls from all over the world. The bulls analysed to date are primarily from Australia, the Netherlands, Germany and France. “However, there are now many more countries involved and we have already exceeded 1000 bulls,” says Professor Veerkamp.

Story Source:

The above story is based on materials provided by Wageningen University and Research Centre. Note: Materials may be edited for content and length.

Agriculture and Food News — ScienceDaily

Albertsons rolls out space analysis platform

AB Acquisition LLC, which operates Albertson’s LLC and New Albertson’s Inc., has hired Digitalrep LLC for space analysis and reporting services for all divisions, the Portland, Ore.-based service provider said Tuesday.


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The Albertson’s LLC legacy stores have been using Digitalrep since the chain’s inception in 2006. Going forward, Digitalrep will host schematic diagrams for the entire chain to enable the stores to analyze shelf space to assist in inventory control; to understand changes over time and how those changes relate to sales performance; and to provide tools that automate repetitive tasks so planogrammers and category managers can focus on strategy.

“The Albertsons team is already far advanced in its category management practices, with capabilities most retailers haven’t realized, and Digitalrep intends to raise the bar,” said Terry Wolvert, Digitalrep’s founder and chief technology officer.

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Analysis: Easier Raw Milk Sales Could Double Illness Outbreaks in Maryland

Maryland’s Department of Legislative Services says that making raw milk sales legal through individual cow-share or herd-share schemes could increase sporadic or isolated cases of illnesses from unpasteurized milk from almost none today to 100-165 per year.

In addition, the independent fiscal and policy analysis of House Bill 3 predicts raw milk-borne outbreaks in the state would double, reaching two to four per year from the current one to two per year.

Maryland is the second state bordering raw milk-exporting Pennsylvania to be considering a cow- or herd-share bill during the current legislative session. West Virginia is the other.

Maryland’s “Consumer-Owned Livestock” bill, heard two weeks ago, has not moved since the independent fiscal and policy note was issued by legislative services. It says that HB 3 exempts the sale of raw milk and raw milk products from regulations governing production, processing, labeling and distribution if the final consumer has an ownership interest in the animal or herd that produced the raw milk.

No exemption would apply to restaurant, retail, commercial, wholesale or other sales of raw milk and raw milk products to subsequent buyers.

Making raw milk sales legal through cow-share or herd-share ownership agreements would cost the state at least $ 66,100 in fiscal year 2015, according to fiscal estimates. That amount would pay for an additional employee to respond to increased raw milk disease outbreaks and sporadic cases.

The Maryland Association of County Health Officers told legislative services that more outbreaks would raise local costs as well. Additional cases and more outbreaks would increase costs for state laboratory services.

Under current law, Maryland prohibits selling raw milk for human consumption unless it’s used for making farmstead cheese. Milk must now be sold to processors, who pasteurize it before it can be distributed and sold to consumers.

Like West Virginia, however, raw milk does reach consumers in Maryland from neighboring Pennsylvania, where the sale of unpasteurized milk is legal and where, from time to time, the state line is not a barrier to distribution.

Raw milk policy is one of the most divisive health issues the states face. The public is divided between the vast majority who accept pasteurization as a prudent defense against a host of pathogens and the small but vocal minority who insist raw milk is antimicrobial and more nutritious than pasteurized milk.

As a result, the states are divided. Thirty of them allow raw milk sales only from on the farm to restaurants and retail stores, while the other 20 ban it for all but the farm families which own and milk the cows.

The federal Centers for Disease Control and Prevention (CDC) in Atlanta reported 148 outbreaks of disease from 1998 to 2011, causing 2,384 illnesses, 284 hospitalizations and two deaths. CDC found states that permit sales of raw milk have a higher incidence of milk product-related illnesses than those that don’t.

For its part, Maryland’s legislative services figures that each sporadic or isolated case involves eight to 16 hours of investigative time, in addition to the time and cost to state Laboratories Administration.

It was on that basis, the fiscal note stated, that additional staff should be hired if raw milk policy is liberalized in Maryland. Investigations typically involve patient interviews and the examination and processing of evidence. The estimate provided to the legislature states that 100 samples of milk tested for pathogens cost the state $ 10,000.

The U.S. Food and Drug Administration (FDA) warns that raw milk can contain harmful bacteria that may cause illness and death. Pathogens included E. coli O157:H7, Salmonella, Listeria, Campylobacter and Brucella. Both FDA and CDC say the health risks of raw milk far outweigh any possible benefits that the beverage may provide.

If passed by the Maryland Legislature, HB 3 would make the state the 14th to permit on-the-farm sales of raw milk. If approved, raw milk is expected to sell on the farm through share arrangements for $ 7 to $ 8 per month based on current prices paid for the product through Pennsylvania sources.

Food Safety News

Global trade analysis shows Chile still at the top of the list

Global trade flow in fruits and vegetables is shaped by various factors, including geographic proximity, trading arrangements, and historical and political elements. This trade has grown rapidly since the 1980s, and that growth has been accompanied by changes in the commodity composition and spurred by varying regional varieties and seasons for fruits and vegetables, which stimulates trade.

According to Global Trade Patterns in Fruits and Vegetables, archived in April-June 2008, a report lead by Sophia Wu Huang, an economist with the Market & Trade Economics Division, Economic Research Service, U.S. Department of Agriculture, Southern Hemisphere countries play a vital role in making the year-round supply of fresh fruits possible.

Wu Huang stated in her report that the crop production cycle opposite to that of the Northern Hemisphere makes the year-round supply of fresh fruits possible.

“These countries have taken advantage of the seasonal differences to expand their exports, particularly for many temperate-climate fruits,” she stated. “The market for off-season fruit imports in the Northern Hemisphere continued growing in the 1990s, after a fast expansion in the 1980s, as several Southern Hemisphere countries boosted their fruit production.”

The report noted that during 1999-2001, Southern Hemisphere fresh fruit shipments accounted for 19 percent of the value purchased by the world’s top 30 fresh fruit importers. Two major destinations for these fresh fruit exports were the European Union [43 percent] and NAFTA [24 percent, of which over 21 percent were to the United States]. The remaining import countries are in Asia and South America.

At the time of her report, Wu Huang noted that no country in the region has succeeded in topping Chile as the region’s leading exporter.

“Chile accounted for nearly 35 percent of the value of fresh fruits exported by the Southern Hemisphere countries in 1999-2001,” her report noted.

Although at the time of her research and report, nearly 60 percent of Chile’s exports to the United States were grapes, constituting close to 70 percent of U.S. imported grapes during that period, Chile also accounted for virtually all U.S. imports of fresh plums, peaches and cherries. In comparison, three-fourths of Chile’s fresh fruit exports to the E.U. were grapes, apples and pears.

However, things have changed somewhat since Wu Huang’s research and report. In Nov. 2011, the Chilean Fresh Fruit Association, an independent committee operating under the umbrella of the Chilean Exporters Association A.G., or ASOEX, reported that blueberry imports from Chile were gaining momentum. In the 2011-12 season imports increased nearly 12 percent over the prior year to 78,000-tons, with more than three-quarters of the total volume going to the United States.

The Produce News | Today’s Headlines

Fruit analysis set to get easier

Fruit analysis set to get easier

Felix Instruments, the Applied Food Science subsidiary of CID Bio-Science, is set to introduce a tool that can analyze fruit without affecting the actual fruit. The F-750 brix and dry matter meter, which can assess fruit maturity and skin color, will be available for purchase within the year.

Assessing the quality and maturation of fruit, at least for apples and pears, has largely relied on a starch test. That requires cutting the fruit in half and using iodine, which reacts to the starch content in the fruit and stains the flesh, to assess the stage of maturation. Several years ago, Australian researchers developed an alternative measurement tool that used near infrared spectrometry to assess fruit in a non-destructive manner. While easier and more accurate than the starch test, it proved too expensive for many in the produce industry.

“We licensed the technology from Central Queensland University and we re-engineered it using newer, more capable electronics and software,” said Leonard Felix, Founder of Felix Instruments. “Our version is easier to use and is less expensive.” One of the primary reasons the first iteration failed was that the high price limited the size of the prospective market.  The F-750 will retail for about half the price of earlier iterations of the fruit assessment technology.

Because it will measure dry matter (the percentage of fruit that’s not water), the sugar content, and gauge quality, Felix believes the tool will have a wide market. “It will be useful for growers and crop consultants who want to determine the ideal time to pick a crop,” said Felix. “It can also be used by folks who purchase or sell fruit because they’ll be able to quickly and easily assess fruit quality.”

“This technology was extremely popular when it came out five years ago, especially in the mango industry, and they were selling as many units as they could build,” said Felix. “So we fully expect the F-750 with its lower price and better performance to deliver superior results.”

For more information:
Leonard Felix
CID Bio-Science, Inc.
Felix Instruments

Tel: (360) 833-8835 ext. 202
Fax: (360) 833-1914
E-mail: [email protected]
www.cid-inc.com
www.felixinstruments.com

Publication date: 10/24/2013
Author: Carlos Nunez
Copyright: www.freshplaza.com


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