FDA warns of Botulism risk from canned green beans
Source of Article: http://www.ift.org/news_bin/news/news_home.shtml
8/03/2007-The U.S. Food and Drug Administration (FDA) is warning consumers not to eat certain brands of French Cut Green Beans in 14.5 ounce cans manufactured by Lakeside Foods Inc, of Manitowoc, Wisconsin because the product may not have been processed adequately to eliminate the potential for botulism toxin. This warning is not related to another recent warning for botulism.
The canned green beans may cause botulism if consumed. FDA is providing this warning to make consumers aware of the possible risk of serious illness from eating these products. As of August 1, 2007, FDA had not received reports of illnesses related to the product.
The botulism toxin is very potent, and botulism is a life-threatening illness. Symptoms of botulism can begin from six hours to two weeks after eating food that contains the toxin. The symptoms may include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth, and muscle weakness that moves progressively down the body, affecting the shoulders first then descending to the upper arms, lower arms, thighs, and calves. Botulism also may cause paralysis of the breathing muscles, which can result in death unless assistance with breathing (mechanical ventilation) is provided. Individuals who show these symptoms and who may have recently eaten the product should seek immediate medical attention.
The affected Lakeside cut green beans are sold nationwide under the following labels: Albertson¡¯s, Happy Harvest, Best Choice, Food Club, Bogopa, Valu Time, Hill Country Fare, HEB, Laura Lynn, Kroger, No Name, North Pride, Shop N Save, Shoppers Valu, Schnucks, Cub Foods, Dierbergs, Flavorite, IGA, Best Choice and Thrifty Maid. The specific codes (top line of can code) involved are: EAA5247, EAA5257, EAA5267, EAA5277, EAB5247, EAB5257, ECA5207, ECA5217, ECA5227, ECA5297, ECB5207, ECB5217, ECB5227, ECB5307.
Consumers who have any of these products or any foods made with these products should dispose of them immediately. If the code on an affected can is missing or unreadable, consumers should throw the product out.
Lakeside Foods has informed FDA that it is voluntarily recalling all of the potentially contaminated products.
Lakeside Foods recommends that consumers with any questions or concerns about the recall should call the company at 800-466-3834 ext. 4090.
someone asking for answers to botulism outbreak and recall questions
Source of Article: http://www.marlerblog.com/
I ran across the following, posted on the Lubbock, Texas, News Radio website today. James Clark wrote the article, Why The Code of Silence On Deadly Botulism? He brings up some really good points about the information available to the media concerning the recall of Castleberry's products after they were found to be contaminated with Clostridium botulinum. After all, the public relies on the media for all of our information about the recall, and if the media can't get answers, who can?
Local news media including News Radio 1420 knew about the local angle of the national food recall story for well more than a week. But knowing it and getting official information for a story are two different issues.
News Radio 1420 asked Lubbock¡¯s public health coordinator, Tigi Ward, why did the general public not hear from the Lubbock Health Department on the issue of botulism and the recall of Castleberry products?
Ward says, ¡°The cases were not in our local jurisdiction. Consequently any information regarding the cases would come from that jurisdiction.¡±
In other words the case did not start in Lubbock. It started in another town. So, if we understand this correctly it is her contention that either Abernathy officials needed to say something about it or the state health department needed to say something about it. The Lubbock Health Department was not the lead agency.
Source of Article: http://www.mercurynews.com/peninsula/ci_6531376
Four people who prompted a
local botulism scare when they said they became ill after eating chili
that was on a recent recall list do not appear to have the illness, county
health officials said Thursday.
"The only thing that these individuals had in common was that they all had received food through Second Harvest," said Peterson, referring to Second Harvest Food Bank of Santa Clara and San Mateo counties.
The private non-profit collects and distributes more than 30 million pounds of food annually to low-income residents of the two counties, according to its Web site.
Several months ago, Second Harvest purchased 3,000 cases - or 36,000 cans - of Morton House chili and began to distribute it to 195 charities and thousands of individuals in San Mateo County.
The problem arose on June 21 when Atlanta, Ga.-based Castleberry Food Co. included the chili Second Harvest had purchased on a list of products it was recalling. The list was an expansion of a previous recall the company had issued days earlier. The foods listed had the potential to be carrying the botulism toxin.
Faced with the news, Second
Harvest began contacting the recipients of the canned chili, said Lynn
Crocker, the non-profit's director of marketing and communications. Notices
were sent out by e-mail and regular mail in several languages including
Spanish, Chinese and Vietnamese, she said. "However we could quickly
communicate the message," she said.
However, Peterson said, all indications are that the symptoms were not related to botulism, a rare and potentially fatal paralytic illness. One of the four, he said, had not actually eaten the chili.
The county was notified of the situation about 4 p.m. Tuesday and by 4:30 p.m. environmental health officials were at Second Harvest's San Carlos facility examining its food stock, Peterson said.
The officials did not find anything alarming but pointed out that there were boxes and crates of mixed canned goods waiting to be distributed that could contain more recalled products, Peterson said. Second Harvest responded by launching a thorough re-examination of those goods, he said.
Next, health officials began calling the roughly 195 organizations in the county that receive Second Harvest food to make sure they got the message. Unfortunately, many of them hadn't, Peterson said.
"Quite a few of them did not see the recall notice from Second Harvest, but they did know about the recall from media stories," Peterson said.
Many clients who did get the message returned the chili, and Second Harvest now has a total of 30 cases. That means thousands of cans of the Morton House chili have been distributed to local clients and/or eaten, Crocker said. That no one else has reported symptoms indicates that the chili is probably safe, she said.
Neither Crocker nor Peterson was aware of any news reports of people being sickened from that particular chili - most of those who have fallen ill ate hot dog chili sauce, both said.
However, the scare has prompted Second Harvest to rethink its approach to dealing with such situations.
"We had a recall protocol in place," Crocker said. "On Tuesday we re-looked at it."
"It's always good to improve processes," she said.
to take steps to ease age limit on U.S. beef imports
Japan will go ahead with necessary
measures to ease its age limit on U.S. beef imports, government officials
said Friday after the two countries ended their two-day working-level
talks in Tokyo.
E. coli and
the future health of America
In 2006, Americans learned that a salad could be hazardous to your health. The media flurry and the elected official posturing that followed the September 14 outbreak of E. coli 0157:H7 associated with spinach, is still fresh on American minds and making daily headlines thanks in no small part to the brisk recalls associated with tainted beef.
So is our food supply less safe and are the growers, shippers and various groups and agencies tasked with oversight not doing all they can to protect the consumer from deadly microbes as some believe? While the media and the public at-large lays blame at the doorstop of industry and government, might the brunt of this burden be misplaced? Simply, are we so involved in finger pointing, fences and hairnets that we don¡¯t see the forest for the trees? An evolutionary perspective on the problem suggests, maybe.
Forgetting for a moment that the latest deadly microbe on the scene originates in cows, one needs to come to grips with the fact that the microbes have us out numbered. When a handful of rich soil contains tens of millions of tiny microbes, and that a single leaf of spinach may be covered in millions more, you start to get a feel for the germ warfare we are up against. Even worse, our so-called modern diet which is dominated by highly-processed grains and added sugars and fats, is putting us at significant disadvantage in the battlefield that is us.
But evolution has equipped humans with an ingenious system for defending against this daily microbial onslaught, most of which are harmless. Our very own microbial foot soldiers, which set up shop in our guts the minute we entered this world. There are so many microbes in the human body that if you added up their total number of cells, they would out number our human cells 9 to 1. In other words, we are more microbe than mammal.
The vast majority of the trillions of bacteria that live in our gut, most of which can be found in our large bowel and represent hundreds of species, make it their evolutionary job to keep out the pathogens that seek to do us harm. In this complex bacterial ecosystem, potentially pathogenic bacteria (e.g., E. coli 0157:H7, Salmonella, Listeria) from the ¡°outside¡± world are typically suppressed by a mechanism called colonization resistance. Since the human intestinal tract is a continuous system from mouth to anus, anything present within our gut is technically still outside our body. That said, a deadly strain of E. coli does very little harm as it travels through our gut, it¡¯s when it attempts to attach to the wall of our intestinal tract that problems occur.
In order for deadly pathogens to attach, they must compete for nutrients and colonization sites under a steady fire of microbial substances being hurled at them by our resident gut bugs. No doubt about it, this is germ warfare 101 and our gut bugs want to win. If our microbial foot soldiers are successful, then the pathogen cannot gain a foothold and consequently are swept from the system. If they are not suppressed, we quickly become aware of the lost battle from the all-to-familiar gut ache, cramping, and diarrhea, or even worse, death.
This germ warfare has been raging in the human gut for as long as humans have been around. But recently, breath taking changes in our diet has put us at a disadvantage. In order for our gut bugs to fight the good fight, they need nutrients and a critical component of that nutrient base is dietary fiber. By definition, dietary fiber is any part of a plant that cannot be digested and absorbed in the small intestine and ends up in the large bowel (colon). Once in the colon, dietary fiber is broken down and utilized by our good bugs for their own growth. This means, dietary fiber is not food for us but food for the trillions of bacteria that live in our colons. If you feed them, the bacteria will do their evolutionary job and make life a living hell for foreign pathogens.
Our modern genome and the symbiotic relationship we developed with our gut bugs was selected on a nutritional landscape very different from the one we find ourselves today. Our not-so-distant ancestors consumed between 50, 75 and up to often greater than 100 grams a day of dietary fiber. The average American today consumes between 12 to 15 grams. More importantly, our gut bugs evolved on a diet that included an extraordinary variety of fiber sources from hundreds of plants. Humans and our evolutionary hitchhikers went from a large quantity and diversity of fibers, to a small quantity and a limited diversity. We are literally starving our gut bugs to the point that we have opened the pathogen door just enough for E. coli 0157:H7 and its band of pathogenic brothers to compete successfully for nutrients and attachment sites. Not good.
The decrease in quantity and diversity of nutrient sources (dietary fiber) has created a nutritional tipping point in the germ warfare raging in the American gut. While increased oversight, inspections, sampling and stepping up good agricultural practices are important, there are simply too many contamination variables from plough to plate. So rather than look at the recent spike in outbreaks as a result of more pathogens in the food supply and sloppy farming, might the problem have more to do with our own dietary choices. That is, our breathtaking drop in the diversity and quantity of dietary fiber might be the real problem ? or at least part of the problem. In other words, dare I say, there is some personal responsibility the American public has in this germ warfare.
When someone spends a lifetime smoking two packs a day, are they not aware that if they succumb to lung cancer, that it¡¯s in affect their own fault? So where is the personal responsibility in our national discussion on food-borne illness and the produce industry we seek to blame? Rather than run from spinach, let us run to it.
As the amount of dietary fiber in the American diet continues to decrease ? and probably even more so since last years outbreaks ? and our ignorance of the consumers responsibility in this germ warfare continues, we may be seeing a perfect storm of our own creation ? though unintended. The litigious atmosphere surrounding this perfect storm has already created the potential for a public that sees diarrhea as a result of a nasty microbe as something akin to a winning lottery ticket. And the situation is likely to get worse.
However, the public¡¯s current mistrust of the produce industry may be an opportunity. Though tragic in its realization, the microscope the industry is currently under may provide a platform to explore some positive steps the industry might take in educating the public about how to increase their natural resistance to food-borne pathogens by returning the quantity and diversity of dietary fiber needed to support a healthy population of gut bugs. By consuming more vegetables and fruits, the American public may be able to add another weapon in our arsenal in our battle with food-borne pathogens and importantly, own some of the responsibility in this germ warfare. Currently, the consumer is totally unaware of the important role they play in keeping themselves and their family members healthy.
The produce industry does not need to wait until tomorrow to start this process, but start today. On September 14, 2006 the produce stepped through a door and there is no going back. It¡¯s time to reposition produce in the American conciseness. The antioxidant and other micronutrient wagons the industry has hitched itself to in the past is tired and the American public has been yawning at that message for years. The American public needs a reason to eat more produce, something new, something fresh. Significant gains may be realized if produce is positioned more as fiber ? that is, produce farmers are in fact fiber farmers. This ¡°Fiber Defense Diet¡± may in fact play a role in a much need rallying call for produce in America and give consumers a very important reason to increase intake.
Some may suggest that the fiber defense argument for fighting food-borne pathogens is too simple, and therefore could not possible make a difference. And they may be right. However, the human immune system and accompanying colonization resistance mechanism that is facilitated by our own natural gut bugs, makes all external attempts such as fences, increased inspections, and triple washing look like child¡¯s play. Our best defense has always been and will always be our natural resistance. Not nurturing our gut bugs with the nutrients they need has consequences. Continuing to ignore this basic tenant of human biology will only result in an increasing number of our fellow citizens in the emergency room and decreased sales at the farm gate.
Jeff Leach is a science writer, health advocate and founder of the Paleobiotics Lab (www.paleobioticslab.com).
FDA promotes standards for state agencies
Source of Article: http://www.ift.org/news_bin/news/news_home.shtml
8/01/2007-The U.S. FDA has launched a national program to bring about more uniform and equivalent regulatory programs in state agencies. State agencies are responsible for regulating facilities that manufacture, process, pack, or hold food under FDA¡¯s jurisdiction. Currently, programmatic activities can vary from state to state and such variations can lead to inconsistencies in oversight of food safety, FDA says.
Adoption of voluntary standards for state regulatory programs will, FDA believes, establish a uniform basis for measuring and improving the performance of state programs for regulating manufactured food, and will also help state and federal authorities reduce foodborne illness hazards in food facilities.
"This risk-based program represents a significant step in further integrating our food safety system," said Margaret O¡¯K. Glavin, FDA¡¯s associate commissioner for regulatory affairs. "We realize it will be several years before it¡¯s fully implemented, but we¡¯re confident this program will bring great benefits to the public health."
The Manufactured Food Regulatory Program Standards define best practices for the critical elements of state regulatory programs designed to protect the public from foodborne illness and injury, including:
* the program¡¯s regulatory
Each standard has corresponding self-assessment worksheets. Several standards have supplemental worksheets and forms to assist state regulators in determining whether their state program addresses all of the elements in the standards.
Federal and state regulators worked together over five years to develop the standards.
The program standards have been approved by the U.S. Office of Management and Budget and will be pilot-tested in New York, Oregon, and Missouri before September 30, 2007.
New Program It Says Will Improve Food Safety
Source of Article: http://www.newsinferno.com/archives/1667
The Food & Drug Administration (FDA) has announced a new food safety program that it hopes will improve the coordination of food safety and inspection efforts between state agencies and the FDA. The Manufactured Food Regulatory Program Standards include new guidelines outlining how state regulatory agencies should inspect businesses that manufacture food under FDA jurisdiction. The FDA is heralding the program as a significant step towards integrating the work of state agencies involved in the US food safety system.
According to an FDA press release announcing the program, variations in state regulations create inconsistencies among food inspections in different states. The FDA believes that if states adopt the new standards, food inspections across the country will improve. The FDA contends that such improvement will reduce outbreaks of food borne illnesses throughout the US. The new guidelines are strictly voluntary, however, and it remains to be seen how many state will choose to adopt them.
The new FDA program defines ¡°best practices¡± for several critical elements of state food inspection programs. Included in the program are new guidelines for staff training; inspection; quality assurance; enforcement; education and outreach; resource management; food borne illness incident investigation; food defense preparedness and response; laboratory resources and program assessment. Should a state choose to participate in the program, the FDA would provide the appropriate regulatory agencies with self-assessment work sheets for each standard.
The FDA believes it will be several years before the Manufactured Food Regulatory Program Standards are fully implemented. The FDA will be pilot-testing the program in New York, Oregon and Missouri before September 30.
Drug-Tainted Asian Fish Slip Into U.S., States Find (Update1)
By Justin Blum
Source of Article: http://www.bloomberg.com/apps/news?pid=20601109&sid=aRTNXIGwPyOc&refer=home
A catfish sample is pulverized for testing Aug. 2 (Bloomberg) -- Joseph Basile, an Alabama state scientist, drops a frozen catfish filet into an industrial food processor and pulverizes it into a fluffy white powder.
The grinding in a laboratory in Montgomery is part of a test of imported seafood for drugs that U.S. regulators say can cause cancer or increase resistance to antibiotics. Alabama officials have reported finding banned medicines missed by the U.S. Food and Drug Administration in seafood from China, Vietnam and other Asian countries.
``I'm sure that FDA would probably wish we'd go away,'' says Ron Sparks, commissioner of Alabama's Department of Agriculture and Industries, which conducts the seafood testing, in an interview. ``My wish is that they'd come to the table and work with us.''
Mississippi, Arkansas and Louisiana also have found banned drugs in imported seafood, according to statements by regulators in those states. The tests, conducted after the products cleared U.S. ports and were sent on for sale in grocery stores or restaurants, show the FDA isn't adequately protecting consumers from tainted fish, food safety advocates said.
The FDA says it does a good job of keeping unsafe products out of the food supply. In June, the agency began blocking imports of some farm-raised seafood from China until importers provide test results showing shipments are free of banned drugs.
41 of 94 Samples
Yet, of 94 samples of Chinese catfish checked by Alabama since March, the state reports that 41 tested positive for fluoroquinolones, antibiotics banned in the U.S. for seafood. Of 13 more samples of species similar to catfish, including one called basa, five tested positive for the antibiotic. The exporting countries included Vietnam, Thailand and Malaysia.
Eating seafood with fluoroquinolones can increase resistance to similar antibiotics used in humans to fight infections, according to the FDA.
Fish farmers in China and elsewhere use medications banned in the U.S. to prevent disease among animals raised in crowded and unsanitary conditions, according to a report in July by Food & Water Watch, a nonprofit consumer group in Washington.
Seafood from abroad accounted for 83 percent of seafood consumed in the U.S. last year, compared with 57 percent in 1996, according to the Commerce Department. The U.S. imported 5.4 billion pounds of seafood in 2006, up 69 percent from 1996.
Alabama's farmers are threatened by increased competition from Asian producers whose costs are lower. There are more than 190 catfish farms in the state, generating $99 million in sales as of 2006, second in domestic production to Mississippi, according to the U.S. Agriculture Department.
On a Catfish Farm
An hour and a half drive west of Montgomery, on a farm near Marion Junction with about 430 acres of dark green catfish ponds, owner Dean ``Butch'' Wilson stands on a metal walkway tossing feed pellets into the water.
Wilson's business produces 6,500 pounds of catfish an acre annually, and he's worried that contaminated imports will depress sales of domestic fish.
Alabama's testing promotes a ``level playing field'' because overseas producers would have to spend more money to clean their water if they didn't use outlawed drugs, he said.
``They couldn't grow fish if they didn't use those antibiotics,'' Wilson said.
Alabama is testing imported seafood because of safety concerns, not to protect the local industry, said Sparks, the agriculture commissioner.
Starting With Shrimp
The state started analyzing shrimp in 2002 after learning that Canada and the European Union found contaminants in imported products. In that year, the state got positive results for chloramphenicol, a drug used to treat infections that has been associated with aplastic anemia, a potentially fatal disease in which the body doesn't produce enough blood cells.
Three years later, Alabama inspected seafood from Vietnam, found outlawed drugs, and said the farm-raised products couldn't be sold until they are tested. Earlier this year, Alabama took a similar step for catfish from China.
Since Alabama began its investigations, the state has found positive results for other drugs, including malachite green, said Lance Hester, director of the food safety division of the Alabama agriculture department. That drug is an anti-fungal product used by fish farmers that can cause cancer after long-term exposure, according to the FDA.
China has promised to improve the safety of seafood and other exports. The country executed its chief food and drug regulator last month, citing corruption.
``Some of the fish exported to the U.S. probably do have problems,'' said Liu Rui, deputy secretary general of the government-affiliated China Aquatic Products Processing and Marketing Association in Beijing, in an interview. ``Not all the fish sold to the U.S. is tainted, but only that from one or two firms.''
At the Alabama lab in Montgomery last month, Basile, a state chemist, had a backlog of seafood to run through the food processor. After chopping up the fish, Basile starts a week-long battery of tests. Basile checks so many samples that the lab has run out of storage space.
During five years of testing, Basile has seen overseas seafood farmers move from one drug to another as regulators in different parts of the world crack down.
``It used to be a big deal,'' Basile said in an interview. ``You'd say, `Oh my God, I've got another positive.' Now, with the fluoroquinolones, almost half are coming back positive.''
U.S. Checking Less
As Americans eat more imported seafood, the FDA is checking a smaller share of it for contaminants. The regulators took samples for lab testing of 0.6 percent of 859,323 shipments of imported seafood last year, according to the agency. That's down from 0.9 percent in 2003, according to a Food & Water Watch report that was based on an analysis of FDA records.
The FDA rejected 0.1 percent of seafood shipments last year because they contained banned drugs, were filthy or failed to meet other U.S. standards, according to data provided by the agency. Imports rejected by the FDA in June included shrimp from Vietnam contaminated with salmonella and eel from China containing banned drugs, according to the FDA's Web site.
The agency said yesterday that it has postponed plans to close seven of 13 field laboratories in the U.S. that test the safety of food and other products after opposition from members of Congress. The FDA has described the lab closings as an effort to make more efficient use of space and provide money to pay for more modern equipment.
Lab Closings Questioned
The closings would weaken the agency's ability to detect tainted food imports, said Representative John Dingell, chairman of the House Energy and Commerce Committee. Dingell and Representative Bart Stupak, both Democrats from Michigan, asked the agency in a letter whether ``the underlying purpose'' of the closings is to turn over food testing to private companies.
The FDA should increase lab testing and inspect more seafood processing operations overseas, said Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, a Washington group often critical of the agency. The FDA had the equivalent of 11 employees conducting overseas inspections of all types of food in the last fiscal year, according to the agency. The inspections can be done only if countries allow them.
``The fact that the states can go in and readily find violations means the FDA isn't stopping contaminated products from coming in,'' DeWaal said in an interview. ``If other states were testing, they would probably find very similar results.''
The FDA screens imported seafood based on an assessment of the risk it poses, the country it comes from and the track record of the company exporting the products, said William Jones, the FDA's director of seafood safety.
In addition to blocking the imports from China, regulators have been working with their counterparts in Vietnam and elsewhere to reduce use of banned medications, he said. The FDA's system works, although some contaminated fish may slip through, Jones said.
``You can't test every single entry,'' Jones said. ``If you did, you wouldn't have any food.''
International Conference for Food Safety and Quality (Nov.
6-7, 2007), South San Francisco Convention Center
Introduces New Hygiene Monitoring Test for Food Surfaces
The Lumitester¢çPD-10N/LuciPac¢âW system is a unique patented platform with a proprietary enzymatic recycling technology that enables detection of both AMP and ATP. It offers significant advantages over other hygiene monitoring systems on the market, which, due to the unstable nature of ATP, may not give a true indication of cleaning efficiencies. AMP is a stable, persistent molecule with the ability to give users a more precise, reproducible indication of the effectiveness of both cleaning and sanitation programs.
Strategic Diagnostics¡¯ Lumitester¢çPD-10N/LuciPac¢âW system possesses several key advantages over competitive methods, including:
SDI¡¯s test provides extremely accurate results even when only small amount of residual biological material is present. This allows the user to take action to produce cleaner surfaces at a lower cost when appropriate cleaning methods are applied. Clean surfaces stay cleaner longer, cost less to maintain, and reduce the risk of inadvertent pathogen contamination.
The patented reagents are detergent tolerant, another distinguishable advantage over competitive methods. The Lumitester¢çPD-10N/LuciPac¢âW system sees residual biological material competitive methods can miss when cleaning chemicals interfere with the sample detection.
food safety developments
Inspection and quarantine authorities are required to make positive records on Chinese food exports, which must be submitted regularly to the media.
China is under pressure to strengthen regulations after a series of food safety scares including the melamine in feed and tainted seafood.
Exporters that provide fake quality certificates or evade inspections will be fined three times the value of the products in question.
Meanwhile, China has said it will provide quarterly reports on food safety to the European Union.
Almost half the 1,000 products barred from European markets after safety alerts last year came from China, according to the European Commission.
The reports aim to ease tensions between the bloc and China, which has doubled its exports to the EU between 2003 and 2006.
Another measure introduced by China is to pay large rewards whistleblowers who report illegal practices within the food industry.
The Beijing Municipal Food Safety Committee last week said it was increasing the maximum reward available fivefold to Y50,000 ($6,579).
The new rewards program, which came into force last week, will also guarantee the anonymity to protect and encourage those who report illegal practices.
The Committee is also considering ways of preventing malicious reports of wrongdoing by rival companies.
Recent policy changes add to a raft of measures introduced and announced by China in a bid to improve its food safety for domestic and export markets.
Earlier this year, a recall framework forcing companies to recall and collect tainted products that pose risks to the public, was announced.
Procedures for tracing contaminated food should be in place by the end of the year, by which time thousands of new and amended regulations will have taken affect.
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