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FDA Announces New Food Safety Proposals

FDA Announces New Food Safety Proposals



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A year after President Obama signed the Food Safety Modernization Act into law, the FDA has finally released two new rules that experts say update food safety regulations for the 21st century.

The regulations are aimed at reducing the estimated 3,000 annual deaths from foodborne illnesses. The FDA's first rule proposes that food companies and firms specifically write out plans to identify potential hazards and the necessary steps to address those hazards. Firms must also verify that those methods are working, outlining correction plans for any problems that may arise.

"The FDA Food Safety Modernization Act is a common sense law that shifts the food safety focus from reactive to preventive," said Health and Human Services Secretary Kathleen Sebelius in a press release. Thus the second part of the law established standards for safe growing, harvesting, packing, and holding of produce.

Proposals include water system inspections at the beginning of each growing season, set procedures for using animal composted manure, plus mandatory sanitation facilities for farm workers. Furthermore, basic hygiene practices for workers and sanitation standards for equipment, tools, and buildings have also been spelled out.

While most of these practices have already been implemented in major food companies, the AP reports, the FDA's deputy commissioner for foods and veterinary medicine Mike Taylor called these rules the start of "a new era. We should have fewer outbreaks, fewer illness, and less disruption of the food supply."

Consumers Union has applauded these changes, especially as focus shifts to prevention. "Under the old rules, we’ve been reacting to food contaminations after they happened. The goal here is to prevent deadly outbreaks before people get hurt. We’re anxious to dive deep into these proposed rules so we can review and comment on the details," Ami Gadhia of Consumers Union said in a release.

More rules regarding the safety of imported food will be released in the upcoming months, Taylor told USA Today. The full text of the law can be read on FDA's website.


FDA proposes new food safety rules, aims for more accountability

U.S. regulators proposed new food safety rules on Friday that aim to make food processors and farms more accountable for reducing foodborne illnesses that kill or sicken thousands of Americans annually.

The new rules, required by the Food Safety Modernization Act (FSMA) that was signed into law two years ago, were announced by the U.S. Food and Drug Administration on Friday.

"These proposed regulations are a sign of progress," said Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, who has been a critic of the FDA. "The new law should transform the FDA from an agency that tracks down outbreaks after the fact to an agency focused on preventing food contamination in the first place."

Roughly one in six Americans suffers from a foodborne illness each year, and about 3,000 die, the FDA said. The United States has had numerous outbreaks from foodborne illnesses tied to salmonella, E. coli and listeria.

Food sickness has been linked to lettuce, cantaloupe, spinach, peppers and peanuts.

"We're taking a big step for food safety by proposing the standards that will help us prevent food safety problems rather than just reacting to them," said Michael Taylor, FDA deputy commissioner for foods and veterinary medicine.

Under the new rules, makers of food to be sold in the United States, whether produced at a foreign- or domestic-based facility, would have to develop a formal plan for preventing their products from causing foodborne illness.

The rule would also require them to have plans for correcting any problems that arise.

Companies will be required to document their plans and keep records to verify that they are preventing problems. Inspectors will be able to audit the program to enforce safety standards, which should "dramatically" improve the effectiveness of inspections, Taylor said.

Though many food processors already have documented food safety plans, the new rule sets requirements for "all firms across all commodities," he said.

A second rule proposes safety standard requirements for farms that produce and harvest fruits and vegetables. Farms would be required to meet national standards for the quality of water applied to their crops, as water is often a pathway for pathogens.

Implementing the new rules will add costs for some food companies and farms, Taylor said. As well, the FDA will need money to retrain inspectors and implement the rules, Taylor said.

The Food Safety Modernization Act was the first food safety overhaul in over 70 years in the United States and was signed into law in January 2011.

The proposals followed a series of meetings between FDA officials and consumer groups, corporate interests, researchers, and others.

Critics have charged FDA with dragging its feet in implementing the requirements of the new law. Last August, the Center for Food Safety sued the FDA for missing several deadlines set under the law.

The standards for analyzing and documenting hazards were due last July, and the standards for safe production and harvesting of fruits and vegetables were due last January.

Within the next few months, FDA hopes to issue a proposed rule on preventative controls for animal feed as well as proposed regulations related to importer accountability for food safety.

The FDA is also setting requirements for the safe transport of food, and to set standards for trying to prevent intentional contamination of food.


FDA proposes sweeping new food safety rules

The Food and Drug Administration has proposed sweeping rules to curtail food-borne illnesses that kill thousands of Americans annually — and, in the process, to transform itself into an agency that prevents contamination, not one that merely investigates outbreaks.

The rules, drafted with an eye toward strict standards in California and some other states, enable the implementation of the landmark Food Safety Modernization Act that President Obama signed two years ago in response to a string of deadly outbreaks of illness from contaminated spinach, eggs, peanut butter and imported produce.

The first proposed rule would require domestic and overseas producers of food sold in the U.S. to craft a plan to prevent and deal with contamination of their products. The plans would be open to federal audits. The second rule would address contamination of fruit and vegetables during harvesting.

One in six Americans suffers from a food-borne illness annually, a “substantial burden” on the country, according to the FDA. Of those who get sick, about 130,000 end up hospitalized and 3,000 die.

A salmonella outbreak in peanut butter last fall prompted the FDA to shut down a New Mexico production facility of Sunland Inc. and initiate a mass recall from retailers such as Trader Joe’s. A listeria outbreak in several states last year also killed dozens of people.

“The FDA Food Safety Modernization Act is a common-sense law that shifts the food safety focus from reactive to preventive,” Health and Human Services Secretary Kathleen Sebelius said Friday in releasing the proposals.

The outbreaks of the last several years pushed consumer advocates and much of the food industry to back more stringent standards.

Many welcomed the proposed rules, although consumer advocates pointed out that the standards were delayed in the White House a year past their congressionally mandated due date, giving rise to concerns that the Obama administration sought to avoid any political fallout in an election year.

The 2011 food safety act, the most comprehensive overhaul of the food industry in 70 years, was to be built on three sets of regulations, not just the two issued Friday, said Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, a Washington consumer advocacy group.

The third rule, which has yet to be issued, would establish how food importers would verify that the products they bring in meet U.S. standards.

Last year more than 800 cases of illness were caused in the U.S. by contaminated imported tuna flakes, cantaloupes, mangoes and ricotta cheese, DeWaal said, citing data from the Centers for Disease Control and Prevention.

“It’s supposed to be a three-legged stool in terms of consumer protection,” DeWaal said, “and one leg is still missing.”

The FDA said developing the complex new rules took time as it consulted “consumers, government, industry, researchers and many others,” and “studied, among many other sources, the California leafy greens marketing agreement.” Additional rules will “follow soon,” the agency said.

The California Leafy Green Products Handler Marketing Agreement, formed in 2007 after an E.coli outbreak tied to spinach crops, mandates that farmers fund government audits of their food safety processes. Melon growers in California have a similar agreement and last year made it mandatory, said Stephen Patricio, president of Westside Produce in Firebaugh, Calif., which grows, packs and ships melons.

“California has the most stringent requirements,” Patricio said. “It’s the culture of food safety that is important, and California farmers have been working on the culture of food safety for a decade.”

As a result, the proposed federal regulations aren’t expected to force substantial changes in the way many crops in California are handled. Melons in the state also have a mandatory code on every box that is shipped that would allow authorities to track where the fruit came from and when it was harvested, a policy that was proposed in the new regulations.

Eric Hanagan already has implemented some of the policies suggested in the proposed guidelines.

Hanagan’s 1,500-acre farm, which grows melons and vegetables in the Rocky Ford area of Colorado, was hit hard when a nearby farm was blamed for a 2011 listeria outbreak that killed 25 people. In response, Hanagan and other farmers adopted rules that they hoped would restore the region’s reputation.

His vegetables are now shipped with codes that allow them to be tracked, and every winter he and other regional farmers go to classes about food safety. Hanagan’s farm is inspected twice a year by the state, one of the inspections unannounced. Inspectors talk to each worker individually and regulate what kind of shoes, clothes and jewelry they can wear.

Hanagan estimates that the regulations cost medium-sized farms about $5,000 to $7,500 a year, which includes the cost of time for training workers and attending classes. But, he said, it’s worth every penny.

“We need to have safe food, because if you get a consumer sick, you’re done,” he said. Jensen Farms, the Colorado farm blamed for the listeria outbreak, filed for bankruptcy in May.

The FDA will gather public comment for 120 days before finalizing the rules. Large farms would have 26 months to comply with most of the new requirements after the final rules are published smaller farms would have longer.


FDA Plans to Revamp Proposals on Food Safety Rules After Backlash

Kelsey Gee

The U.S. Food and Drug Administration on Thursday said it would revamp new food-safety rules for fruits and vegetables after its first proposal met with opposition from farm groups and some members of Congress.

The FDA said it would make significant revisions to the rules, which are part of what the agency has called the biggest overhaul in 70 years of the government's oversight of food safety. The produce rules, required under the 2011 Food Safety Modernization Act, are aimed at minimizing the risk of contamination of raw fruits and vegetables on the farm or during their handling by food processors.

The agency's initial proposal, released in January, drew opposition from small produce growers, who argued that the rules were onerous, didn't reflect existing science and could cause some to go out of business. Large farm operations, meanwhile, argued the requirements provided too many exemptions for smaller growers. By the FDA's count, the 21% of fruit and vegetable farms for which the rules apply make up almost 90% of the produce acres in the country.

Among the rules heavily criticized by smaller farms was a requirement that farmers test and treat the water they use to raise crops once a week to ensure it is free of salmonella and other bacteria. Farm groups complained the rules were based on federal standards governing water used in recreation, and wouldn't ensure that water sources would be safe.

In November, about 75 members of Congress wrote a letter to FDA Commissioner Margaret Hamburg urging the agency to issue a second draft of the rules. The lawmakers said they were concerned the rules would "force some producers and processors to shutter their operations."


Shutterstock

Use hand sanitizer often when at the grocery store, and wash your hands when you get home. The FDA says it's also best to clean surfaces often when preparing a meal—whether the food you're working with is raw or not. Doing so not only gets rid of bacteria but also other germs from outside your home that may have found there way inside.

Want some specific tips on how to keep your cooking space clean? Here are the best 50 kitchen cleaning tips right now.


RURO Introduces FreezerPro ColdTrack RFID Kit

New product designed for labs specializing in the collection and management of frozen samples, company said.

FREDERICK, Md. - RURO, a developer or research productivity tools, is now offering its FreezerPro ColdTrack RFID Kit, a fully-integrated RFID solution for labs of any size specializing in the collection and management of frozen samples, the company reports.

The FreezerPro ColdTrack RFID Kit is designed to electronically track large collections of samples kept at ultra-low temperatures in biobanks and biorepositories. The kit consists of RURO's FreezerPro software, RFID-tagged ColdTrack vials and a BoxMapper - a USB-powered scanner that provides rapid mapping of samples to the rows and columns in a freezer box.

The BoxMapper can map the entire contents of a standard size freezer box in less than a second and is unaffected by frost and ice, except in cases of extreme ice accumulation. Since scanning is quick, integrity is maintained because sample heating is kept to a minimum.


FDA proposes sweeping new food-safety rules to prevent contamination

The Food and Drug Administration on Friday proposed two sweeping rules aimed at preventing the contamination of produce and processed foods, which has sickened tens of thousands of Americans annually in recent years.

The proposed rules represent a sea change in the way the agency polices food, a process that currently involves taking action after food contamination has been identified. It is a long-awaited step toward codifying the food safety law that Congress passed two years ago. Changes include requirements for better record-keeping and contingency plans for handling outbreaks to measures that would prevent the spread of contaminants in the first place. While food producers would have latitude in determining how to execute the rules, farmers would have to ensure that water used in irrigation met certain standards and food processors would need to find ways to keep fresh food that may contain bacteria from coming into contact with food that has been cooked.

New safety measures might include requiring that farmworkers wash their hands, installing portable toilets in fields and ensuring that foods are cooked at temperatures high enough to kill bacteria.

Whether consumers will ultimately bear some of the expense of the new rules was unclear, but the agency estimated that the proposals would cost food producers tens of thousands of dollars a year.

A big question to be resolved is whether Congress will approve the money necessary to support the oversight. President Barack Obama requested $220 million in his 2013 budget, but Margaret Hamburg, commissioner of the FDA, said "resources remain an ongoing concern."

Nonetheless, agency officials were optimistic that the new rules would protect consumers better.

''These new rules really set the basic framework for a modern, science-based approach to food safety and shift us from a strategy of reacting to problems to a strategy for preventing problems," Michael R. Taylor, deputy commissioner for foods and veterinary medicine, said in an interview. The Food and Drug Administration is responsible for the safety of about 80 percent of the food Americans consume. The rest falls to the Agriculture Department, which is responsible for meat, poultry and some eggs.

One in six Americans becomes ill from eating contaminated food each year, the government estimates most of them recover without concern, but roughly 130,000 are hospitalized and 3,000 die. The agency estimated the new rules could prevent about 1.75 million illnesses each year.

Congress passed the Food Safety Modernization Act in 2010 after a wave of incidents involving tainted eggs, peanut butter and spinach sickened thousands of people and led major food makers to join consumer advocates in demanding stronger government oversight.

But it took the Obama administration two years to move the rules through the regulatory agency, prompting complaints that the White House was more concerned about protecting itself from Republican criticism than about public safety.

Taylor said the delay was a function of the wide variety of foods and the complexity of the food system. "Anything that is important and complicated will always take longer than you would like," he said.

The first rule would require manufacturers of processed foods sold in the United States to come up with ways to reduce the risk of contamination. Food companies would be required to have a plan for correcting problems and for keeping records that government inspectors could audit.

An example might be to require the roasting of raw peanuts at a temperature guaranteed to kill salmonella, which has been a problem in nut butters in recent years. Roasted nuts would then have to be kept separate from raw nuts to further reduce the risk of contamination, said Sandra B. Eskin, director of the safe food campaign at the Pew Charitable Trusts.

''This is very good news for consumers," Eskin said. "We applaud the administration's action, which demonstrates its strong commitment to making our food safer."

The second rule would apply to the harvesting and production of fruits and vegetables in an effort to combat bacterial contamination like E. coli, which is transmitted through feces. It would address what advocates refer to as the "four Ws" — water, waste, workers and wildlife.

Farmers would establish separate standards for ensuring the purity of water that touches, say, lettuce leaves and the water used to irrigate soil, which reaches plants only through their roots.

A farm or plant where vegetables are packaged might, for example, add lavatories to ensure that workers do not urinate in fields and post signs similar to those in restaurants that remind employees to wash their hands.

The food industry cautiously applauded the proposals, with most companies and industry groups noting that they would be poring over them and making comments as necessary in the coming weeks.

"Consumers expect industry and government to work together to provide Americans and consumers around the world with the safest possible products," the Grocery Manufacturers Association said in a statement. The group added that the food safety act and putting it into effect "can serve as a role model for what can be achieved when the private and public sectors work together to achieve a common goal."

The association noted that the government would have to issue more than 50 regulations to fully carry out the new law.

The businesses that must comply with the proposals may face new costs, but how much remains to be seen. Hamburg said that the measures might save businesses money in the long run, and that in many cases, they already take such precautions voluntarily.

The agency estimated that it would cost large individual farms as much as $30,000 a year to comply with the new rules, and the food manufacturing industry as a whole as much as $475 million a year. It said it would finance the regulations in part from savings within its budget and from fees for things like reinspections, which Congress has authorized.

In a conference call with reporters, Taylor, the deputy commissioner, said some foods would require more attention than others. Fruits and vegetables destined for canning operations, for instance, might be subject to less stringent guidelines because they are processed using heat that would kill bacteria, unlike produce intended for raw consumption. Vegetables that are much more likely to be consumed cooked, like potatoes and artichokes, would be exempt from the rules, Taylor said.

''We were directed by Congress to establish risk-based standards that are practical, and we think this approach targets what will be significant from a public health standpoint," he said. "If we get evidence to the contrary, we will make adjustments."

While such precautions may seem obvious and some food producers and makers may already be taking them, there has not been any legal requirement they even consider doing so.

''We're not going to relinquish all risk of contamination, but these steps will make us think more about what we can do to reduce it," Taylor said.

After a 120-day period for public comment, the agency will complete the rules.

Other rules are pending, including one that would cover importers' responsibilities for the safety of food products grown or made overseas. About 15 percent of food eaten by Americans — and an even higher percentage of produce — is imported.


FDA Releases Major New Food Safety Proposals

Affected parties should familiarize themselves with proposed rules for safe food processing and handling and on-farm produce safety comments to FDA are due by May 16.

On January 4&mdashthe second anniversary of the enactment of the Food Safety Modernization Act (FSMA)&mdashthe U.S. Food and Drug Administration (FDA) announced the upcoming publication of proposed rules establishing two of the major elements of the modernized system of food safety control contemplated by the FSMA.[1] The first rule, "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food" (Preventive Control Rule), would mandate the adoption, implementation, and ongoing documentation of the operation of a science-based preventive food safety system for most processing, handling, and warehousing operations.[2] The second rule, "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption" (Produce Rule), would focus on produce safety and mandate the on-farm adoption of various risk-prevention measures by growers, farms, and mixed-type facilities.[3]

FDA contemplates official publication of the proposed rules in the January 16, 2013, edition of the Federal Register. Comments on the official record associated with the rules can be submitted for a period of 120 days until May 16, 2013.

All interested parties should consider active participation in the rulemaking process since FDA is required to carefully evaluate all public input before issuing any final regulations. It should also be noted that, even after any such rules are ultimately finalized, FDA contemplates a phase-in period that will take several years to complete. At the same time, however, the food and farm industries should also recognize that these proposed rules&mdashas well as other companion proposals on issues such as foreign supplier verification, which should be issued by FDA shortly&mdashinclude extensive discussions of what FDA now considers to be food safety control measures that are both feasible and effective. As such, these documents will unavoidably have an immediate impact upon the commercial, legal, and regulatory environment in which all food and food-related businesses presently function.

Through the enactment of the FSMA, Congress directed FDA to issue regulations and take various additional measures designed to enhance food safety, thereby minimizing the risk of foodborne illnesses to the American consumer. In broad terms, the FSMA shifts the focus of both the regulator and the regulated toward prevention of, as opposed to reaction to, food safety problems. FDA, again in broad terms, is responding to the mandate by proposing the establishment of a system that, to the fullest extent possible, would guarantee that any food reaching the consumer has been properly filtered through such a preventive system.

A more detailed discussion of the Preventive Control Rule is available here. In general, the rule would require all "facilities" that manufacture, process, pack, or store human food to design and implement effective preventive food safety systems. Various exemptions from this extremely broad category of affected businesses, including those accommodating some small businesses as well as other types of operations, are proposed. Traditional farming operations are also not directly covered by the proposal. For operations that are covered, the proposed rule generally recognizes the need for flexibility as it attempts to capture an enormous range of products, processes, and methods of storage and distribution within its scope. At the same time, however, it also specifies an extensive list of items, such as supplier verification, establishment of a recall plan, allergen controls, sanitation, and many other components of what it presumes should be included in any such food safety plans.

A more extensive discussion of the Produce Rule is available here. While the proposed rule's details are obviously of greatest interest to growers and handlers of fruits and vegetables, it also should be read within the context of both the Preventive Control Rule and FDA's overall efforts to implement the FSMA. FDA proposes an alternative scheme to address issues associated with those food products that are generally transmitted from the farm directly to the consumer without being captured by any preventive food safety plan (i.e., from further commercial processing that adequately reduces the presence of microorganisms of public health concern). Under these circumstances, FDA shifts the focus to mandatory on-farm control measures. In doing so, it proposes the establishment of a number of standards generally associated with the mitigation of the risk posed by microbiological contaminants involving (1) agricultural water (2) biological soil (3) health and hygiene (4) animals in the growing area and (5) equipment, tools, and buildings.

Morgan Lewis will provide further information and analysis of the FSMA initiative and its current and future impacts over the coming weeks. If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis attorneys:


FDA Prepares to Enact New Food-Safety Law

The Food and Drug Administration is preparing to enact provisions of the new food-safety bill that was passed by Congress in the waning days of 2010 and is expected to be signed into law Tuesday.

The FDA is already working to write the regulations needed to enact the bill, Commissioner Margaret Hamburg said Monday.

"Today, one out of six Americans gets sick from food-bourn illness each year with 128,000 people ending up in the hospital and 3,000 people dying every year," Health and Human Services Secretary Kathleen Sebelius told reporters Monday.

Congress will need to appropriate an additional $1.4 billion over five years for the FDA to fully implement the bill, Ms. Hamburg said, but there are also plenty of improvements to the way FDA oversees food safety that can made in the meantime.

"There's a lot that we can do both quickly and meaningfully," Ms Hamburg said. The FDA is already crafting the new safety standards for fruits and vegetables that is called for in the law, she said.


FDA proposes sweeping new food safety rules

1 of 2 FILE - This Sept. 28, 2011 file photo shows the sign leading to the Jensen Farms near Holly, Colo. The U.S. Food and Drug Administration on Friday proposed the most sweeping food safety rules in decades, requiring farmers and food companies to be more vigilant in the wake of deadly outbreaks in peanuts, cantaloupe and leafy greens. (AP Photo/Ed Andrieski, File) Ed Andrieski/STF Show More Show Less

2 of 2 FILE - This Sept. 28, 2011 file photo shows cantaloupes rotting in the afternoon heat on a field on the Jensen Farms near Holly, Colo. The U.S. Food and Drug Administration on Friday proposed the most sweeping food safety rules in decades, requiring farmers and food companies to be more vigilant in the wake of deadly outbreaks in peanuts, cantaloupe and leafy greens. (AP Photo/Ed Andrieski, File) Ed Andrieski/STF Show More Show Less

WASHINGTON - The Food and Drug Administration on Friday proposed the most sweeping food safety rules in decades, requiring farmers and food companies to be more vigilant in the wake of deadly outbreaks in peanuts, cantaloupe and leafy greens.

The long-overdue regulations are aimed at reducing the estimated 3,000 deaths a year from foodborne illness.

Just since last summer, outbreaks of listeria in cheese and salmonella in peanut butter, mangoes and cantaloupe have been linked to more than 400 illnesses and as many as seven deaths, according to the Centers for Disease Control.

The actual number of those sickened is likely much higher.

The FDA's proposed rules would require farmers to take new precautions against contamination, to include making sure workers' hands are washed, irrigation water is clean, and that animals stay out of fields.

Food manufacturers will have to submit food safety plans to the government to show they are keeping their operations clean.

Many responsible food companies and farmers are already following the steps that the FDA would now require them to take.

But officials say the requirements could have saved lives and prevented illnesses in several of the large-scale outbreaks that have hit the country in recent years.

In a 2011 outbreak of listeria in cantaloupe that claimed 33 lives, for example, FDA inspectors found pools of dirty water on the floor and old, dirty processing equipment at Jensen Farms in Colorado where the cantaloupes were grown.

In a peanut butter outbreak this year linked to 42 salmonella illnesses, inspectors found samples of salmonella throughout Sunland Inc.'s peanut processing plant in New Mexico and multiple obvious safety problems, such as birds flying over uncovered trailers of peanuts and employees not washing their hands.

Under the new rules, companies would have to lay out plans for preventing those sorts of problems, monitor their own progress on those safety efforts and explain to the FDA how they would correct them.

"The rules go very directly to preventing the types of outbreaks we have seen," said Michael Taylor, FDA's deputy commissioner for foods.

The FDA estimates the new rules could prevent almost 2 million illnesses annually, but it could be several years before the rules are actually preventing outbreaks.