The Food and Drug Administration (FDA has had to face dealing with a growing number of prescription drug shortages caused by various reasons. The health regulating agency issued a
consumer update on its website stating that possible reasons for the shortages may be caused by manufacturing or quality problems, delays, or discontinuations of the drug. When there is a drug shortage, the FDA works with the drug manufacturer to work out the issue and often asks generic drug makers to increase productions.
A
letter of concern was issued to manufacturers in short supply of prescription drugs. The letter was issued on October 31, 2011 and stated that the number of drug shortages has nearly tripled within 5 years. In 2005, there were 61 drug shortages and that number increased to 178 in 2010. About 54% of these drugs shortages were caused by manufacturing problems and the FDA warns that these issues should be taken care of immediately so as to not jeopardize the patient’s health.
There are multiple reasons for drug shortages such as the following:
Interruptions or other adjustments in manufacturing
Delays in obtaining dire raw materials
Manufacturing complications causing supply disruptions
Import suspensions
Unforeseen rises in demand
Many of the drugs in short supply are used to treat life threating conditions such as cancer and anesthesia and are typically the only type on the market. This has raised much attention causing the Obama administration to get involved. An
executive order by the Obama administration was also issued on October 31, 2011.The FDA has taken multiple approaches to dealing with the increase in drug shortages including issuing a letter of concern to the manufacturers of these critical drugs in short supply, increasing staff resources to avoid drug shortages, supporting legislation which will require manufacturers to report drug shortages, and much more.
“It could be possible to reverse the muscle damage seen in children with a form of motor neurone disease,” according to BBC News. The condition in question – spinal muscular atrophy (SMA – causes deterioration of specific nerves and muscles in the body, and is sometimes known as ‘floppy baby syndrome’ due to the weakness it creates in the limbs. The condition reportedly affects 1 in 6,000 babies, with around half of children with the most severe form of this disease dying before the age of two.
Research has already established that the condition affects the nerves, and it has previously been thought that the muscles waste mainly as a result of this nerve damage. However, this news is based on an experiment in mice that suggests the muscles start to undergo changes even before the nerves deteriorate. Crucially, some of these changes could be reversed using a drug called SAHA, which has also been found to increase lifespan in SMA mice in a previous study.
The drug SAHA is already approved by the US Food and Drug Administration for use in a very specific form of cancer. The fact that this drug has already been tried in humans for another condition may make it easier to test in people with SMA. Trials will still need to be carried out before we can say whether this drug is effective and safe in humans. Drug treatments for this condition would be valuable, as there is currently no cure.
Where did the story come from?
BBC News’ coverage referred to two related papers from the same group of researchers based primarily at the University of Edinburgh. One of these research papers looked at the effect of using drugs called HDAC inhibitors on a mouse model of SMA, while the other paper focused only on the biology of a mouse model of SMA, but did not assess the effects of any treatments. This Behind the Headlines appraisal focuses on the former of these papers as online news reports tended to focus on the possibility of developing new treatments.
This HDAC inhibitor study was carried out by researchers from the University of Edinburgh, and other research centres in the UK and Germany. It was funded by SMA Trust, BDF Newlife, the Anatomical Society and Germany’s DFG research fund.
The study was published in the peer-reviewed medical journal Human Molecular Genetics.
The report from BBC News gives a very brief summary of the two studies, and provides more information about the condition SMA itself. It does report the fact that the treatment study was in mice.
What kind of research was this?
Spinal muscular atrophy (SMA is a form of motor neurone disease that is caused by mutations in the SMN1 gene, leading to degeneration of a type of nerve cell found in the spinal cord. These nerve cells, called motor neurones, normally carry messages from the brain to the muscles. In SMA, motor neurone degeneration causes progressive weakness of the limbs and trunk, followed by muscle wasting. About 1 in 6,000 to 1 in 10,000 babies are thought to be affected. Some forms of SMA typically lead to death in the first few years of life, and the condition is reportedly among the most common genetic causes of infant death. Other forms become apparent later in life and are less severe.
SMA is an ‘autosomal recessive’ disease, meaning that it only becomes apparent if an individual has two copies of a faulty gene, one inherited from each parent. People with only one faulty copy of the gene will not have the condition but are known as carriers, and can have a child with the condition if their partner is also a carrier. People with the condition have low levels of a protein called SMN.
This was animal research that looked at the changes that occur in the muscles of a mouse model of spinal muscular atrophy (SMA . It also looked at whether the changes could be reversed by a specific type of drug called a histone deacetylase (HDAC inhibitor.
The researchers say that, thus far, most research has looked at how this disease affects the nerves that send messages to the muscles, rather than the muscles themselves. They wanted to look at the effect of the disease on the muscle in mouse models of SMA.
Animal models are very useful for studying aspects of the biology of human diseases that would be hard to study in humans. They are also essential for the initial testing of drugs that might be useful for treating human conditions, to make sure they are safe and effective enough to test in humans. These animal tests should be seen as only the first of many stages, as drugs that show promise in these tests are not always effective or safe in humans, due to differences between the species.
What did the research involve?
In their first set of experiments the researchers used a mouse model of SMA that causes a severe form of the condition.
In SMA the nerves that send signals to the muscles break down, and this then leads to loss of muscle fibres. The researchers looked specifically at one muscle that does not lose its nerve signals early in the disease, so they could see whether any changes in the muscle happen independently of the problems with the nerves.
The researchers looked at what changes happened to the proteins in this muscle before the mice developed any symptoms. They found that the proteins that were affected related to cell death, so they then looked at whether there were signs that more cells were dying in muscles of SMA mice than in muscles of normal mice. They also looked at whether some of the protein changes seen in mice were also seen in samples of muscle taken from human SMA patients.
Previous research has suggested that chemicals called HDAC inhibitors can increase levels of the SMN protein in mouse models of SMA, and reduce muscle loss. Based on this the researchers decided to test whether HDAC inhibitors directly affected the muscle. These experiments used a different mouse model that causes a less severe form of the condition. They say that this model is better for testing the effects of potential treatments for the disease because the mice live slightly longer.
The mice were given an HDAC inhibitor called suberoylanilide hydroxamic acid (SAHA orally from birth. Control mice were given no SAHA. The researchers looked at the effect of this treatment on the levels of the different proteins in the muscles that are affected by SMA. SAHA (Vorinostat is approved by the US Food and Drug Administration for use as a treatment for a specific type of cancer in humans.
What were the basic results?
The researchers found that the muscle from pre-symptomatic SMA mice showed differences in the levels of a number of proteins compared with normal mice. This was despite the fact that the nerves sending messages to the muscle were not yet affected. This finding suggests that the condition starts to affect the muscle even before any deterioration occurs as a result of changes in the nerves.
Many of the proteins affected by the condition were found to be involved in muscle function or cell death. The researchers found that there were also other signs of increased cell death in the muscle of SMA mice compared with normal mice.
The researchers then examined human SMA muscle to look at two proteins found at abnormal levels in SMA mouse tissue: one protein called Vdac2 that was found at higher levels in the SMA mouse muscle and one protein called parvalbumin that was found at lower levels in the SMA mouse muscle. They found that levels of these two proteins were similarly affected in human SMA muscle tissue.
Treating SMA mice with the HDAC inhibitor drug SAHA from birth increased levels of SMN protein in their muscle. SAHA treatment also reversed the changes seen in the levels of the proteins Vdac2 and parvalbumin, although the levels of parvalbumin were still not quite as high as in normal muscle. SAHA treatment also reduced the levels of a protein called H2AX, which is involved in cell death and which was significantly raised in SMA mice.
How did the researchers interpret the results?
The researchers concluded that the molecular effects of SMA on muscle in mice were improved by the existing FDA-approved drug SAHA. They say that their study showed that abnormalities in skeletal muscle tissue proteins are an important and potentially reversible part of SMA.
Conclusion
This study has shown that in mouse models of spinal muscular atrophy (SMA , before problems develop in the nerves that send messages to the muscles, the muscles themselves have abnormal levels of certain proteins. Human SMA muscle tissue was also found to have some of these abnormalities. Notably, the researchers also showed that, in mice, some of these abnormalities could be reversed using a drug called SAHA, which belongs to a group of drugs called the HDAC inhibitors.
Previous studies have suggested that SAHA treatment increased the lifespan of mice with SMA. The current study did not look at the effect of this drug on symptoms or lifespan in these mice, just at its effect on particular proteins within the muscle.
The drug SAHA is already approved by the US Food and Drug Administration for use in a very specific form of cancer (cutaneous manifestations of cutaneous T-cell lymphoma . The drug does not appear to have been approved for use in Europe for this type of cancer or for other conditions. The fact that this drug has already been tried in humans for another condition may make it easier to test this drug in people with SMA. Such trials will need to be carried out before we can say whether this drug is effective and safe for the treatment of SMA. New treatments for this condition would be valuable, as there is currently no cure.
Analysis by Bazian
Links To The Headlines
Child motor neurone disease treatment clue. BBC News, February 27 2012
Links To Science
Mutsaers CA, Wishart TM, Lamont DJ et al. Reversible molecular pathology of skeletal muscle in spinal muscular atrophy. Human Molecular Genetics (2011 20 (22 : 4334-4344
While notable for its size alone, the 114-ton recall came under scrutiny from some food safety experts for an entirely different reason: More than two months passed between the time the recall occurred on December 31 and the time it was first publicized in the February 8 report.
On the surface, it seemed that a Class I recall -- those involving a product that could cause serious injury or death -- would have been made public as soon as it happened. Instead, this one appeared downplayed and -- to some -- downright stealthy.
In the weeks that have followed, the spinach incident has sparked a discussion about the circumstances under which recalls should or should not be made public. It's a decision that pits the benefits of public knowledge against the perils of public overreaction.
Disclosure or Discretion?
The recall in question, voluntarily issued by Texas-based Tiro Tres Farms, was never linked to any E. coli infections. Tiro Tres does not package spinach for consumers, instead distributing it in bulk to processors who repackage it as their own, and so only the processors were notified of the recall on December 31.
Microbiologist Phyllis Entis first brought the situation to attention on her website,
eFoodAlert, the day after the FDA published its information. She criticized the FDA, saying she could not understand the rationale behind not notifying the public of a Class I recall. The next day, Food Safety News ran a story of its own,
"Big Spinach Recall with No Public Notice."
It's unclear how many processors received the spinach, or how much of it made it to the supermarket and restaurant kitchens. What is known, however, is that it had passed its "best-by" date before Tiro Tres' sample tests came back positive and processors were notified. Tiro Tres had distributed this batch to processors in Colorado, Kentucky, Massachusetts, Pennsylvania, Ontario and Quebec.
One processor in Pennsylvania already knew there was a problem. Avon Heights Mushroom had issued an earlier recall to customers based on its own testing. That recall was announced by the FDA on December 23. That spinach had been sold as fresh packaged spinach with a "best-by" date of December 16 under the brand names Krisp Pak, Better Brands" and Avon Heights Select.
Given that Avon Heights' recall occurred a full eight days before Tiro Tres announced a voluntary recall to other processors, it's possible that Avon's tests prompted Tiro Tres to test.
In
an interview with Fresh Cut Magazine, the owner of Tiro Tres Farms said that Avon's contaminated spinach was linked to a 27,600-pound batch, while the remaining spinach appeared to have been recalled out of caution. After inspecting Avon Heights' facility and spending three days at Tiro Tres, FDA officials could not find a source for the contamination.
No Public Benefit?
When asked why the FDA didn't publicize the Tiro Tres recall, the agency told Food Safety News that it would not have benefitted the public, considering that the spinach was well past its expiration date and was only sent to processors. It would have been up to the processors such as Avon Heights, it seems, to issue a recall to consumers if they thought it was necessary.
According to the FDA's Regulatory Procedures Manual, "It is FDA's policy that press releases are issued for Class I recalls unless specific circumstances indicate that a press release would not be beneficial to the public."
Entis didn't buy it.
"[The U.S. Department of Agriculture], to its credit, notifies the public of any Class I recall [in their jurisdiction], even when the food just goes to food service or institutions. They don't use that excuse," she told Food Safety News. "I don't understand why the FDA does not do the same."
Entis added that with most contemporary pathogens tests returning results in 24 to 48 hours, she does not understand why a farm would be running tests that would not produce results until after their product had shipped out to processors, let alone expired.
Produce industry expert Jim Prevor disagreed with Entis, saying the FDA's move was justified. In a response to the situation on his website,
Perishable Pundit, he argued against announcing recalls of products that don't go directly to consumers, saying nondisclosure was the responsible path. Based on the information available at the time, Prevor said that one could assume that the spinach did not reach any customers.
"When should consumers be notified? Generally speaking, it comes down to one thing and one thing only: Is the product in the hands of a consumer? If it is, then they should issue a public recall," he told Food Safety News.
Prevor noted that recalls affect sales for the entire industry of the food in question, not just the one producer with a contaminated shipment. When the FDA warned the public specifically not to eat Rocky Ford-brand cantaloupes from Colorado in the 2011 cantaloupe Listeria outbreak, cantaloupe farmers' profits suffered across the board. Announcing a big spinach recall, however specific, can hurt sales for all spinach growers.
Even then, for any spinach that might have made it to the store, the fact that the contaminated batch was already well-past its expiration date made slim prospects for catching any leftover product.
"Sometimes things are learned very late in the process, and as a result, the product is so old that it couldn't possibly still be out there to be eaten," Prevor said. "In those situations, the FDA will decide there's nothing to be gained by notifying the public. It's not that it's not announced -- all these things are announced to processors -- they're just not promoted to consumers."
Testing to Check Practices, Not to Protect Consumers
But why test for pathogens if the results don't come back until after the expiration date?
As Prevor explained, the primary purpose of pathogen testing on farms is not to protect consumers, but to make sure that the farm's practices are generally safe over time. Contamination events can be so localized that random testing will never catch every bug, he said, and anything more than random testing becomes too costly for most operations.
"Let's say we have a field of spinach with 200 million spinach leaves. If we went through and randomly picked a few to test, we might get negative tests on all, but there might be a thousand leaves in the field that are positive. To test them all, we'd have to charge $200 for a bag of spinach," he said. "There's no way to guarantee everything is 100 percent safe. If you think that's unacceptable, you're asking that we only sell cooked spinach."
Entis agreed that absolute guarantees for food safety were impossible and pathogens tests on farms were largely meant to monitor consistency in food safety, but she emphasized that a positive test result is never something to ignore.
"Speaking as a microbiologist, finding a pathogen via random testing is so difficult that when you do find one, you know you've got a problem," Entis said. "It's not a theoretical problem. It doesn't matter if someone got sick or not. If the problem is not corrected, it's only going to get worse. We've seen this happen over and over again."
While she also agreed that not all recalls needed publicizing, Entis argued in favor of greater public disclosure for the sake of better scrutiny. If companies have repeated contaminations and recalls, for example, people should have the right to know they could be dealing with an unreliable product.
"I think consumers have a right to know if a company has processed and shipped a product that turned out to be contaminated with a deadly pathogen," she said. "Try to protect the consumer so they can choose if they want to support that product in the future. How else are we supposed to become informed consumers who make informed decisions?"
Following the attention the big spinach recall received, Entis decided to look back through the last four months of FDA enforcement reports for any other unannounced Class I recalls. She
found six such recalls described in enforcement reports since November 2011.
That revelation did not surprise Prevor, who said the FDA takes a number of precautions into account before announcing recalls.
"There are a lot of different values here that have to be balanced," Prevor said. "One value -- without a doubt -- is safe food. But we also don't want broke farmers and people in a panic when they're not at risk, either."
Test and Hold to be Safe
Some farms, however, have taken it upon themselves to test and hold produce before shipping anything out.
Since transforming its food safety program in 2006, California-based Earthbound Farms has become an industry leader in foodborne illness prevention. Earthbound was involved in the 2006 E. coli O157:H7 outbreak in spinach that sickened over 200 people across 26 states and Canada and killed five.
Following the 2006 outbreak, Earthbound decided to adopt a preventative strategy for spinach and other higher-risk produce. Instead of performing random testing, they now test a sample from each pallet they ship, holding the product for 12 to 16 hours until they receive a result.
According to Will Daniels, Earthbound's senior vice president of food safety, the farm's detection system will catch 99.99 percent of E. coli, Salmonella or Shigella passing through its various testing hurdles. Simply put, they have refused to be involved with any more illnesses.
Daniels said paying for their proprietary testing system, holding space, upgraded equipment and a scientific advisory panel ends up costing roughly three additional cents per bag of spinach. The bottom line, however, outweighs any cuts to profits:
"After 2006, we knew we needed to do more," he said. "We're in the business of healthy food and healthy food doesn't carry pathogens that make people sick. This is just the right thing to do."
Like Prevor and Entis, Daniels agreed that random sampling cannot be trusted to prevent foodborne illness outbreaks. But no other farms have yet adopted the test-and-hold method to the extent of Earthbound. Implementing such an extensive system takes time and money, and beyond that, doggedness.
"Contamination is highly sporadic -- it's in one little tiny section of a field when the rest is clean," Daniels said. "When we started doing this, the criticism was, 'You're looking for a needle in a haystack.' But here we are, five years into it, and we are catching contamination and preventing it from going into our processing stream."
Earthbound detects contamination on approximately 0.15 percent of its produce -- 3,000 pounds out of the 2 million it ships each week. Whenever a contamination is detected, not only is the produce saved from potentially harming customers, but the situation gives Earthbound technicians an opportunity to study how the contamination occurred and remedy it. They have amassed a lot of their field lessons into a database of information on how pathogens behave on produce.
"Those people who criticized our program for its vigor back in 2006 are now asking me for the data," Daniels said. "From our perspective, we have lots of great evidence that suggests our program is viable. We're committed to it. We won't back away from it."
As for when recalls should be made public, Daniels kept his viewpoint uncharacteristically simple:
"If the consuming public is at risk of illness," he said, "they should be made aware."
------
Thanks to Daniel B. Cohen for contributing his knowledge of the produce industry. Photo of Will Daniels courtesy Earthbound Farms.
U-Systems wins a date with an FDA advisory panel to move forward on a pre-market application for the somo.v, the first ultrasound device to target breast cancer screening.
U-Systems won a date with the FDA to review its pre-market application for the first ultrasound device indicated for breast cancer screening.
The somo.v Abus device, which is set to undergo agency review on April 11, 2012, is already FDA-cleared for diagnostic use as an adjunct to a mammogram.
510(k ,
Breast Cancer,
Food & Drug Administration (FDA ,
Imaging,
Pre-Market Approval (PMA ,
Ultrasound
Almost all of the administration's budget increase for food safety in Fiscal Year 2013 would be registration fees, even though Congress has struck down fees as a major source of food safety funding at FDA before. Without fees, FDA's resources for food safety would increase by approximately $33 million next year. The Congressional Budget Office estimated that FDA would need $1.5 billion over five years to implement FSMA.
"We urge you to continue to adequately fund the food safety activities of the U.S. Food and Drug Administration (FDA rather than support the imposition of any new food regulatory taxes on consumers and food makers," said food industry groups in a letter to key appropriations lawmakers in the House last week.
The letter, signed by more than 30 trade groups, was sent to appropriations committee chair Hal Rogers (R-KY , ranking member Norm Dicks (D-WA , and agriculture appropriations subcommittee Jack Kingston (R-GA and ranking member Sam Farr (D-CA . The American Meat Institute, the Snack Food Association, the Juice Products Association, and the American Frozen Food Institute were among the groups that cosigned the letter.
The industry groups point out that an early version of FSMA did contain registration fees to help pay for food safety at FDA but that proposal was rejected by Congress. The bill that was signed into law in January 2011 allows for limited reinspection fees, but not registration fees.
Part of the trepidation from industry comes from the fact that it is not clear what the fee program would look like, or which type of facility would be required to pay.
"We know FDA's proposal will drive up costs for food makers and consumers," said Corey Henry, a spokesman for the American Frozen Food Institute. "What we can't quantify is the severity of those cost increases, because the specifics of FDA's proposal are not fully known. It's unclear how much in additional costs an individual food maker would be forced to bear."
"Funding FSMA implementation requires more resources, and we believe Congress must make food safety a priority and provide appropriate additional resources," Henry added.
When the budget plan was announced earlier this month, Patrick McGarey, Assistant Commissioner for Budget at FDA, said that many details still need to be worked out.
"We're open to working with industry to shape a proposal that meets their objectives and our objectives and meets the public health needs of food safety," added McGarey. "We've not defined the registration fee yet as to which facility and at what amount the fee would be assessed."
The coalition explained
in a letter to FDA Commissioner Margaret Hamburg that more consumers are trying to make better, informed choices about the foods they eat and that FDA has the ability to provide consumers with the informational tools to make smarter decisions.
The letter noted that "[w]hile current regulations stipulate what foods can be labeled 'No Sugar Added' or use a similar phrase, there is currently no requirement that added sugars be shown separately on the 'Ingredients List.' "
The coalition recommends that FDA require any "added sugars" to be listed in the ingredients section as a single food ingredient with a parenthetical list of the specific ingredients that account for those sugars. In line with the rules for labeling ingredients, the specific added sugars would be listed by descending weight and the combined weight of the added sugars will be used to determine where the "added sugars" ingredient will be ranked in the ingredient list.
Americans consume significantly more added sugar than is recommended. The American Heart Association, which signed the letter, notes that the usual intake of added sugars for Americans is 22.2 teaspoons a day. At first glance that may not sound like a lot of added sugar, but 22.2 teaspoons of sugar is the equivalent of 355 calories; the recommended daily limit of added sugars for women is 100 calories and 150 for men.
The connection between sugar intake and the obesity epidemic is also of concern to this coalition. According to the Center for Disease Control and Prevention, more than 33 percent of adults and approximately 17 percent of children and adolescents are obese.
Likely anticipating a response from the sugar and food industry that the burden should fall on the consumer to stay informed to make these decisions rather than impose more government regulation, the coalition stated: "Without specific information on the amount of 'added sugars' on the labels of food products, consumers can hardly exercise that responsibility and make smarter choices in the grocery aisle."
The 14 coalition members are: Environmental Working Group, American Association for Health Education, American Heart Association, Center for Science in the Public Interest, Corporate Accountability International, Defeat Diabetes Foundation, American Association for Health Education, National Association of School Nurses, Young People's Healthy Heart at Mercy Hospital, Indiana Rural Health Association, American Society of Bariatric Physicians, The FGE Food & Nutrition Team, Cambridge/Somerville WIC, and Iowa Public Health Association.
We reported last week that drugmakers were seeking to get a
prescription diet pill passed, and that drug is now one stop closer to your local pharmacy. On Thursday, an FDA panel of outside physicians voted 20-2 in favor of the weight-loss drug Qnexa by Vivus.
With that in mind, they attended a February 21 Town Hall meeting in Burlington, WA -- one of 10 Town Halls hosted by
United Fresh across the nation this month and next.
They didn't go home disappointed.
"There's a lot of new information to learn," Karen said after the meeting. "New things are happening all of the time."
New things like how the
Food Safety Modernization Act will affect the produce industry; what opportunities the government's push for more fruit and vegetables in school lunch and breakfast programs will offer growers; what's up with the 2012 Farm Bill; improved ways to track produce from the farm to the buyer; and even smart phones that can scan bar codes and give consumers information about the farmer who produced the food they're buying.
On the food-safety front, the Fuentes said they're working toward
Good Agricultural Practices certification, which is designed to establish food-safety practices on the farm.
"It might sound overwhelming at first," Karen said, referring to GAP certification, "but not if you think of it as a step-by-step process."
Their interest in food safety mirrors United Fresh's interest in food safety. It was the first topic on the docket during the Town Hall session the couple attended.
"Top of the mind" for the produce industry is how Robert Guenther, senior vice president of Public Policy for United Fresh, described the
Food Safety Modernization Act, signed into law by President Obama last year. "It's probably the most significant law to change our industry," Guenther said.
To be implemented over 3 years, the law, which calls for 12 new U.S. Food and Drug Administration regulations, gives the FDA additional responsibilities, among them enhanced inspections, recordkeeping and reporting requirements, traceback pilot and training programs, and mandatory recall authority.
But underlying the act itself is a fundamental shift in food-safety policy: The focus will be on prevention instead of on responding to outbreaks.
For growers and processors, it comes down to meeting science-based standards.
But the new regs won't be a top-down set of rules, according to Guenther. Instead, there will also be significant amount of collaboration with states and various local authorities.
What about the proposed rules?
Although the law said that the FDA needed to release a set of proposed rules, one of them dealing with produce, by Jan. 4, that date came and went without any sign of the proposed rules.
However, drafts of the proposed rules have been sent to the Office of Management and Budget. Guenther said that the proposed rules will likely be released in the Federal Register in late March.
No one in the produce industry has seen the drafts.
Guenther predicts that considering the procedures that must be followed, including public comment periods that last 90 to 120 days, before the final rules are adopted, it will probably be 2013 before that happens, instead of July 2012 as originally expected.
What about the produce rule?
Guenther told the group that the produce industry has a lot of questions about what the final produce rule will look like. For example, will it spell out requirements for specific fruits and vegetables or will it be a sweeping practice-based rule that covers all produce?
As for Congress's role in all of this, Guenther said that in the current economic climate, elected officials are not eager to pass new rules that impact businesses.
"They be watching this closely," he said. "It (budget woes could slow this down during the election year."
Healthier food for kids
Guenther praised the new
"school-meal rule" as a "bright spot" for the industry because the nutrition standards for the National School Lunch and Breakfast Program double the amount of fruits and vegetables school children will be served in their lunches. In addition, a doubling of fruits served in the breakfast program will be phased in over the next 3 years.
"It's a big victory for our industry," he said.
Even so, as produce-industry reps often point out, schools will be very vigilant about making sure the growers and processors they buy from are following strict food-safety practices.
2012 Farm Bill
Until 2008, the produce industry regarded the
Farm Bill as legislation geared to benefit subsidized commodity crops such as wheat, rice and corn and therefore of little interest to the produce industry. But Guenther said that in the mid-2000s, the industry started looking at the Farm Bill as a possible opportunity.
The question that provoked that new interest came down to this: "Why is 50 percent of plant-based agriculture not included in the farm bills?"
Thanks to a unified effort on the part of many agriculture associations across the country, the 2008 Farm Bill contained what Guenther described as "unprecedented funding" for specialty crops. (Examples of speciality crops are fruits and vegetables.
The $3 billion in funding included money for state block grants, targeted research programs, and increased access for fresh produce in federal nutrition programs.
Guenther said the produce industry benefited from this additional funding all the way through the distribution chain, from the farm to the retail level. And he pointed to food safety as a good example of how these different sectors of the industry benefited from the funding.
But with ongoing budget woes, coupled with the fact that the nation currently has a strong farm economy, there are questions about how the specialty crops will fare in the 2012 Farm Bill -- or even if there will be a Farm Bill this year.
"Election year politics have divided committees on this," Guenther said, referring to the Farm Bill.
Another problem for the produce industry is that research funding through the previous Farm Bill stops this year.
Tracking the produce
"We want consumers to always feel comfortable that what they're going to buy or consume is safe," said Dan Vache, vice president of Supply Chain Management for United Fresh, in describing the reason why traceability is so important.
The 2006 E. coli outbreak from fresh cut spinach, which caused 276 illnesses and 3 deaths -- not to mention huge financial losses for spinach growers and packers -- was a wake-up call for the industry. Once awakened, many in the industry joined together to launch the Produce Traceability Initiative in 2007. The goal was to take away some of the questions there might be about where a product was grown, packed, distributed, and even who handled it.
Vache said that even though the 2006 outbreak was caused by spinach in just one location in California's Salinas Valley, "it caused havoc for our industry overall."
Fast forward to today and the FDA wants electronic records, a common language (known as GS1 , and quick information.
"They want it within 24 hours; we're finding that sometimes we can do it in a matter of hours," said Vache.
Milestones in the initiative's progress include a 14-digit number that shows, by lot number, who you are and what products are being shipped. In addition, information about who "touched" the product throughout the distribution chain can be accessed. For example, in the case of inbound shipments, a bar code stores information about that.
This year, the goal is to be able to trace outbound cases of food.
Citing last year's cantaloupe Listeria outbreak, which killed more than 30 people, as an example of why outbound information is important, Vache said that no one was tracking where the contaminated cantaloupes grown in Colorado were being shipped.
He said that the lack of consumer confidence in cantaloupes due to the Listeria outbreak had growers in other states plowing under hundreds of acres of perfectly good cantaloupes.
Vache referred to that reaction on the part of the consumers as "consumer psyche."
"It's all about consumer confidence," Vache said, referring to traceability.
Shipping produce
For a produce grower or broker, there's nothing worse than having the produce, which was in excellent condition when it was sent on its way, show up at its final destination in poor shape. That can happen if the produce wasn't handled properly every step of the way during shipping.
With that in mind, the
North American Produce Transportation Working Group, which is made up of volunteers from more than 25 national and regional produce industry associations, transportation providers, grower/shippers and perishable receivers, has crafted a set of best practices pertaining to the handling and transportation of fresh produce.
These best practices, which can be updated should changes in the industry arise, were developed to identify problem areas in the marketing chain where increased communication and agreed-upon procedures can prevent many issues in the marketing chain before they result in a problem at the final destination.
The goal is to prevent disputes.
What about small-scale producers?
In an interview directly after the Town Hall meeting in Burlington, WA, Vache and Guenther said that small-scale growers need to recognize that the world has changed.
Pointing out that the final rules in the Food Safety Modernization Act will serve as a "framework for safe practices," Guenther said these food-safety practices will be demanded by most customers.
"It will be important for growers to be able to explain to consumers that their food is safe," Guenther said. "They'll need to have a good message about what they're doing on the farm. It's very important for them to use current tools to get up to date."
As for bugs (foodborne pathogens such as E. coli, Salmonella and Listeria that can sicken or even kill people , Guenther said the bugs don't know if they're on a big or small farm.
"If you're selling to consumers, you need safeguards to protect your crops from potential contamination," he said.
Town Hall meetings
Go here for more information about United Fresh's Town Hall meetings, its 2012 Fresh Impact Tour, and its 2012 annual convention in Dallas, TX.
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Top photo of Robert Guenther, lower photo of Dan Vache
The Missouri Department of Health and Senior Services received the following news release regarding single capsule packet RegenErect, labeled as a dietary supplement. The product contained Tadalafil which is not listed on the label.
RegenErect, is a blue capsule sold individually in foil packets with a UPC code of 816860010055.
Use of these products may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Regeneca, Inc. has distributed RegenErect via sales made over the internet to consumers in the U.S. and has provided samples at public events.
Regeneca, Inc. advises any customers in possession of the RegenErect product above to return any unused product for an exchange, or a full refund, to the company directly.
The full recall can be found at
www.fda.gov/Safety/Recalls/ucm293376.htm.
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