FDA Warning Letter - HACCP Issues for NY Seafood Processor

FDA issued a Warning Letter to a NY seafood processor for issues associated with HACCP compliance for their operation.   The company had four common issues noted.

1) Temperature monitoring of a cooling step did not take worse-case scenario for product characteristics as well as did not have an adequate frequency.

"FDA recommends when selecting samples to consider the variables that affect the rate of cooling and represent “worst case” conditions. This can include overlapped or closely placed units, the position of the units in the tray and on the (b)(4) where heat may be retained (e.g., the units in the center of the trays in the middle of the (b)(4)), and the distribution of cold air in the cooling room. In addition, your listed frequency, “at least every (b)(4),” is inadequate to show that your critical limit of “…no more than (b)(4) of those (b)(4) is above (b)(4)” is not exceeded."

2) The company was missing monitoring records.

"...firm did not have post cooking process cooling monitoring records documenting times and temperatures of products that were cooled after cooking between January 3 and January 14, 2019. Review of your firm's Cooking CCP monitoring records during this period revealed that your firm was manufacturing and cooking fish products during this time."

3) The company did not have corrective action records for certain process deviations. 

"a review of your Post Cooking Process Cooling monitoring records revealed that at least on one occasion products were not cooled below the listed critical limit......Your firm’s response dated December 4, 2019 stated that a corrective action was performed at the time of the deviation even though a record was not created."

4) The firm did not take appropriate corrective action in response to certain deviations.

"...firm’s “Cooking” critical control point monitoring records identified deviations from your temperature critical limit on multiple production days. However, you determined these deviations were the result of the improper use of (b)(4) temperature recording devices by employees. You firm did not perform or document any corrective actions."

FDA Warning Letter

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shung-kee-food-co-ltd-598630-03202020
Shung Kee Food Co., Ltd.
MARCS-CMS 598630 — March 20, 2020

RTE Chicken Product Recalled After Complaint of Undercooked Appearance

An Alabama company is recalling cooked RTE chicken products after a customer complaint was made that the product looked undercooked.  There have been no reported illnesses.

Was the product undercooked......hard to say.  Good process control to achieve proper lethality for all product along with verification and record keeping systems demonstrating proper cook would help prevent the need to recall product.

USDA News Release
https://www.fsis.usda.gov/wps/wcm/connect/FSIS-Content/internet/main/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-017-2017-release
Wayne Farms, LLC Recalls Ready-To-Eat Chicken Products Due To Potential Processing Deviation
Class I Recall 017-2017
Health Risk: High Feb 28, 2017
Congressional and Public Affairs Allie Ryan (202) 720-9113 Press@fsis.usda.gov

A metal bristle from a grill brush, an example of a metal hazard

As reported by CBS News New York, a man swallowed a metal bristle and caused a severe laceration of his intestine. The bristle, off the grill cleaning brush, had become embedded in the steak and was unknowingly swallowed as the man ate his steak. As it moved through the intestine, it pierced the intestine, leading to a life threatening infection.

When evaluating hazards in food, there is a tendency to minimize the seriousness of metal hazards. This is a great example of how a piece of metal can be missed during chewing as well the type of damage it can cause.

New Jersey Man Recovering After Eating Metallic Bristle From Grill Brushhttp://newyork.cbslocal.com/2012/05/21/new-jersey-man-recovering-after-eating-metallic-bristle-from-grill-brush/#.T7qpLEQFU1c.mailto

RIVER EDGE, N.J. (CBSNewYork) – Think twice before you put the metal to the barbeque this grilling season.

A New Jersey man’s brush with death last week was apparently due to a grilling tool.

Michael DeStafan went to Hackensack University Medical Center thinking he had appendicitis after experiencing excruciating pain in his stomach.

Doctors conducted tests and found a 1 ½-inch-long metallic object had pierced the 54-year-old’s large intestine.  Doctors thought he had swallowed a nail, fish hook or paper.

DeStafan’s wife figured out one of the metal bristles on his grill brush broke off, got stuck to the grill grate and embedded itself in the shell steak her husband had cooked and eaten days before visiting the hospital.
Doctors performed emergency surgery to remove the wire and repair the hole that it made in DeStefan’s large intestine.

“”There was an infection, they just didn’t know how big the infection was, or how much of a hole it had torn inside my intestines, and they didn’t know that until they went in,” DeStafan said. “When I went under he told me I have to do this immediately, because we don’t know what we’re going to find, and there’s a chance that you might not make it.”

DeStafan is hoping his brush with death serves as a warning to others.

“I hope no one will have to go through that,” DeStafan said. “I want people to be aware of the fact that something as simple and innocent as going outside and grilling steaks and hamburgers for your family and friends could potentially be life-threatening.”

The Record reports half a dozen similar cases have been documented in Rhode Island.

DeStafan has since ditched the brush and instead uses a stone to clean the grill.

Revisiting Third Party Food Safety Audits

Once again third party audits take heat for an outbreak, in this case, the Listeria outbreak in Jenson Farms Cantaloupes.. In the USA Today, two viewpoints are presented. Both present valid points, but there is more that can be said. Third party food safety audits provide a snapshot evaluation of the food safety system of an organization and give an assessment of whether that facility is following that food safety system. One important limitation is that audits, as currently completed, are not as good at determining the validity of that system, in other words, how well that system is actually working to make safe food. An astute auditor can see signs that the plan is valid through results of pathogen testing, through the process parameters that are set up, but there are factors that limit this.

•  Auditors often cover a broad range of facilities and process types (even within the same commodity) and so it is difficult to have an in depth understanding of every process in every facility an auditor visits. They will not have the vast knowledge of a given pathogen as compared to a PhD who has studied that pathogen for years.
• Audits are often one day in duration, so there is little time to get into the nuts and bolts of the process. Audits will look at the broad systems that are in place and make sure they are being followed (such as GMP’s, supplier control, pest control, HACCP), but to look at the validity of a process can take days, especially when there is the lack of support documentation such as pathogen testing.
•  In most cases, auditors are not conducting microbiological analysis of the environment or of the finished product. They may look at results that are on file, but they themselves are not swabbing surfaces or pulling product from the end of the line and sending to a qualified laboratory. As was seen in the PCA case, a company may only show select results from a less reputable laboratory. So to what degree can an auditor, in a day or so, evaluate the laboratory being used, the methods that laboratory is using, and the sampling scheme used by the plant?
•  Auditors will count, in part, that the facility actually knows what it is doing. If a facility has been processing cantaloupes for years, it is easy to make the assumption they must have some clue of what they are doing. They can question why a change was made, in this case the change in process, but to make a call on the safety of that change is more difficult.
•  Companies being audited do want to pass the audit. Their business depends on it. When they hire an auditor, it is less likely they will put themselves in a position to fail….and that may mean hiring someone they know who will not put them through the ringer. Indeed, this a conflict of interest. But this practice of having the supplier pay for their own audit was started years ago by the purchasing companies requiring the audits. To get out of paying for audits of every supplier, they had the idea to make the supplier pay for the audit. Sure, the customer company provides a list of audit firms or auditors from which the supplier can choose, but still, the supplier still hires that person.

  

Because of these limitations associated with third party audits, they are not a guarantee of product safety. Rather, they are just a part of the entire food safety system that a company uses to ensure safe food. If a company uses the fact that they passed an audit as sole reason for why they believe their food is safe, then that company probably does not have true food safety systems in place. The goal of the audit for the food company is to assess their systems and provide feedback on where improvement is needed. Each aspect of the audit is there for a reason, so food companies need to embrace the intent of the requirement, not just to throw something in place to pass the audit.

  

While there has been a ratcheting up of requirements through GFSI (SQF and BRC) on both what is required in audits and what is required for someone to be a qualified auditor, some of these issues still exist. Even with government based inspection, there are similar shortcomings. Audits are an important part of our food safety system, whether internal, second party, third party , or government, but the responsibility for food safety ultimately falls on the company producing the food. Food companies must use these audits as guideposts for continual improvement. Employees, managers, and just as importantly, executive management must thoroughly understand their process and product. They must challenge themselves, with the help of auditors, to ensure their food safety system has addressed all possible food safety hazards.

  

by Martin Bucknavage 12/1/12

Food Safety Bill Passes

It has been a long time coming, but the Food Safety Modernization Act is just a President's signature away.  But does it mean our food will be safer once that ink is dry...not by a long shot.  As in the LA Times article (link below), there are funding concerns.  And then, the FDA has to convert this into an actual regulation.  The battles will continue as it transformed into a document that will be actually implemented.  What will the FDA require as far as food safety plans....will it be similar to Seafood HACCP, or will it be watered down to a point that it has little resemblance to what we know as HACCP?  There is much debate to come. 

And once in place, will our food be safer? Not totally.   Putting regulations in place does not guarantee that some owner won't knowingly ship contaminated product, or that some farmer inadvertently irrigates his leafy greens with contaminated water.  But in most likelihood, it will improve the overall food safety system, thus reducing the overall risk.  The increased probability of an inspection for an establishment that never had an inspection before may make the owner maintain a cleaner establishment.  Having more control on imported good will reduce the risk of another melamine incident. Requiring a food safety plan, or HACCP, not only means that a company has to really think about how they will control food safety, but this plan serves as a guide for the inspector who audits the facility.  More importantly, requiring HACCP may lead to the need for training for the people making food.  In order to develop an acceptable plan, companies will need to learn more about the hazards associated with their process, and this will be a step towards bringing all companies up to a higher level of understanding food safety risks.

So don't look for this new legislation to eliminate foodborne illness altogether, but rather, it will be a step towards reducing risks and thus increasing the safety of the food throughout the supply continuum.

M. Bucknavage

Food-safety bill backed by House

http://www.washingtonpost.com/wp-dyn/content/article/2010/12/21/AR2010122106190.html

 By Lyndsey Layton

Washington Post Staff Writer
Wednesday, December 22, 2010

The House passed a measure to overhaul the nation's food-safety laws by a vote of 215 to 144 Tuesday afternoon, and President Obama is expected to sign it into law as soon as Wednesday.

The vote marked the final hurdle for a bill that cleared an unusual number of obstacles, despite enjoying bipartisan support and backing from a wide array of groups across the political spectrum, from the Consumers Union to the Chamber of Commerce.

"This is a big victory for consumers that finally brings food-safety laws into the 21st century," said Jean Halloran of Consumers Union. "This win is a powerful testament to the people across the country who came to Washington to tell their lawmakers how contaminated food had killed their loved ones or left them horribly sick. This win is for them and all Americans."

But some critics said the new legislation will expand the reach of the federal government without making food safer. "The federal food bureaucracy needs to get smarter and better coordinated, not more omnipotent," said Rep. Tom Price (R-Ga.).

The proposal survived filibuster threats in the Senate, constitutional confusion and tensions between big agricultural companies and the burgeoning local food movement.

The setbacks repeatedly sent the bill back to both chambers, where new challenges arose. In the end, the House voted on it three times and the Senate twice.
The legislation will affect all whole and processed foods except meat, poultry and some egg products, which are regulated by the U.S. Department of Agriculture.

It is the first major change to the nation's food safety laws since 1938, and comes after a series of national outbreaks of food-borne illnesses linked to a wide varietyof foods, including spinach, peanuts and eggs.
"I beg you, the safety of your constituents is at stake," Rep. John D. Dingell (D-Mich.) said during debate on the House floor.

Unlike the current system, which relies on federal officials to trace the source of an outbreak to its origin after consumers have become ill, the new requirements are designed to create a system in which manufacturers and farmers come up with strategies to prevent contamination, then continually test to make sure they work.

The bill includes an exemption for small farmers and food processors, and those who sell directly to the public at farmers markets and farm stands. That exemption was pushed by advocates for local food, who argued that small producers would not be able to afford the testing and record-keeping required by the legislation. But it drew objections from major agricultural producers, which argued that no one should be exempt from producing safe food.

The exemptions "will limit the ability of the [Food and Drug Administration] to assure consumers that all foods they purchase, whether at grocery stores, restaurants, farm markets or elsewhere, have met the same food-safety standards," said Robert Guenther of United Fresh Produce Association, which represents the major fruit and vegetable growers.

"We remain fearful that this profound error will come back to haunt Congress, public health agencies and even those who thought they would benefit from food safety exemptions, but more importantly, we are fearful of what may slip through the food safety loopholes . . . and adversely affect consumers."
The measure also gives the FDA the authority to recall food; now, it must rely on food companies to voluntarily pull products off the shelves. And the bill would give the FDA access to internal records at farms and food-production facilities.

The bill would for the first time require importers to verify that their products from overseas meet U.S. safety standards.

One in six Americans becomes ill from tainted food each year, and 3,000 die, according to government estimates. Businesses spend billions of dollars as a result of lost sales, recalls and legal expenses triggered by the problem.

The measure is expected to cost $1.4 billion over the next four years, including the expense of hiring 2,000 new FDA inspectors.

LA Times Article
http://www.latimes.com/business/la-fi-food-safety-20101222,0,5901585.story

Food Modernization Act Passes Senate

The Food Safety Modernization Act took another step forward by passing the Senate.  It must now go to the House where there will be debate on whether to pass as is or to wrangle  some more.  If there is more wrangling on the provisions, it may die.  A few important notes:

·         This does not affect USDA facilities.

·         The House had its own version, but it additional components that would render it less likely to pass, including fees to food companies for registration.

·         There are questions how it would impact small farmers

·         Require all facilities to have a HACCP type system in place.  While this gets little notice by the press, I see this as a major benefit.

·         Provide more record access to FDA during food emergencies

·         Improve import food safety

Senate Passes Overhaul of Food Safety Regulations

By GARDINER HARRIS and WILLIAM NEUMAN in the New York Times

Published: November 30, 2010

WASHINGTON — The Senate on Tuesday passed a sweeping overhaul of the nation’s food-safety system, after recalls of tainted eggs, peanut butter and spinach sickened thousands and led major food makers to join consumer advocates in demanding stronger government oversight.

The legislation, which passed by a vote of 73 to 25, would greatly strengthen the Food and Drug Administration, an agency that in recent decades focused more on policing medical products than ensuring the safety of foods. The bill is intended to get the government to crack down on unsafe foods before they harm people rather than after outbreaks occur.

Despite unusual bipartisan support on Capitol Hill and a strong push from the Obama administration, the bill could still die because there might not be enough time for the usual haggling between the Senate and House of Representatives, which passed its own version last year. Top House Democrats said that they would consider simply passing the Senate version to speed approval.

Both versions of the bill would grant the F.D.A. new powers to recall tainted foods, increase inspections, demand accountability from food companies and oversee farming. But neither version would consolidate overlapping functions at the Department of Agriculture and nearly a dozen other federal agencies that oversee various aspects of food safety, making coordination among the agencies a continuing challenge.

While food-safety advocates and many industry groups preferred the House version because it includes more money for inspections and fewer exceptions from the rules it sets out, most said the Senate bill was far better than nothing.

“This is an historic moment,” said Erik Olson, deputy director of the Pew Health Group, an advocacy group. “For the first time in over 70 years, the Senate has approved an overhaul of F.D.A.’s food safety law that will help ensure that the food we put on our kitchen tables will be safer.”

Among the Senate bill’s last major sticking points was how it would affect small farmers and food producers. Some small-farm and organic food advocates warned that the legislation would destroy their industry under a mountain of paperwork, and Senator Jon Tester, a Democrat of Montana, pushed for a recent addition to the bill that exempts producers with less than $500,000 a year in sales who sell most of their food locally.

That provision led the United Fresh Produce Association, a trade group, to announce recently that it would oppose the legislation since small food operations have been the source of some food recalls in recent years.

But Randy Napier of Medina, Ohio, said the Senate bill was better than nothing. Mr. Napier’s 80-year-old mother, Nellie Napier, died in January 2009 after the nursing home in which she lived continued to feed her contaminated peanut butter even after she got sick.

“I am appalled at what I have found out since my mother’s death about how poorly food is regulated and how these companies cut corners to save money,” Mr. Napier said.

The staunch opposition of Senator Tom Coburn, an Oklahoma Republican, forced months of delay and eventually required Senate Majority Leader Harry Reid of Nevada to call a series of time-consuming procedural votes to end debate. Mr. Coburn offered his own version of the legislation eliminating many of its requirements because he said less regulation was needed, not more, but that version failed.

Despite Mr. Coburn’s opposition, the bill is one of the only major pieces of bipartisan legislation to emerge from this Congress. Some Republican and Democratic Senate staff members — who in previous terms would have seen each other routinely — met for the first time during the food negotiations. The group bonded over snacks: specifically, Starburst candies from a staff member of Senator Mike Enzi, a Wyoming Republican, and jelly beans from a staff member of Senator Richard J. Durbin, an Illinois Democrat. And in the midst of negotiations, the negotiators — nearly all women — took a field trip to a nearby food market so that a Republican staff member could teach the Democrats how to buy high-quality steaks.

“This legislation means that parents who tell their kids to eat their spinach can be assured that it won’t make them sick,” said Senator Tom Harkin, a Democrat from Iowa who, as chairman of the Senate health committee, shepherded the legislation through months of negotiations.

Health advocates are hoping the legislation will rekindle the progress — now stalled — that the nation once enjoyed in reducing the tens of millions of food contamination illnesses that occur each year. In the case of toxic salmonella, infections may be creeping upward.

Part of the problem is the growing industrialization and globalization of the nation’s food supply. Nearly a fifth of the nation’s food supply and as much as three-quarters of its seafood are imported, but the F.D.A. inspects less than one pound in a million of such imported foods. The bill gives the F.D.A. more control over food imports, including increased inspection of foreign processing plants and the ability to set standards for how fruits and vegetables are grown abroad.

And as food suppliers grow in size, problems at one facility can sicken thousands all over the country. The Peanut Corporation of America’s contaminated paste was included in scores of cookies and snacks made by big and small companies. The legislation would raise standards at such plants by demanding that food companies write plans to manufacture foods safely and conduct routine tests to ensure that the plans are adequate.

The bill would give the F.D.A. the power to demand food recalls. The Bush Administration for years opposed such powers, saying that food manufacturers invariably complied when asked by the government to undertake a recall. But last year, the F.D.A. asked a distributor of pistachios to recall its entire 2008 crop after tests showed salmonella contamination at its processing plant. Days passed before the company complied.

The legislation greatly increases the number of inspections the F.D.A. must conduct of food processing plants, with an emphasis on foods that are considered most high risk — although figuring out which ones are riskiest is an uncertain science. Until recently, peanut butter would not have made the list.

Whether the agency gets the money to conduct such inspections is far from certain. The House version would require food producers to pay a modest annual fee to help fund inspections, but that provision was excluded from the Senate version. The Senate bill also requires grocery stores to post prominently a list of recently recalled foods or alert consumers in other ways, a provision championed by Senator Kirsten Gillibrand, a Democrat from New York.

Neither version of the bill applies to slaughterhouses or most meat and poultry processing plants, which are under the jurisdiction of the agriculture department. Both versions would affect about 80 percent of the food supply, including fresh fruits and vegetables, eggs, dairy products and processed foods that do not contain meat.

Industry organizations backed the legislative push because of the high costs for many companies of the food scares of recent years. Egg sales fell nationwide after the massive egg recall this summer, even though only two producers were implicated. Several years ago, contaminated spinach from one small producer led the entire industry’s crop to be destroyed.

Judith McGeary, executive director of the Farm and Ranch Freedom Alliance, an advocacy group that sees government regulation as a threat to small farms, said she was satisfied with changes made to the bill to reduce paperwork for small farmers and exempt them from some requirements.

“We still have concerns about the scope of the power that F.D.A. has and its tendency to write rules and regulations that favor agribusiness instead of small farmers,” Ms. McGeary said.

Scott Faber, a spokesman for the Grocery Manufacturers Association, a trade group that represents most large food processors, said that food sales in the United States and abroad depended on people believing that food is safe.

“Consumer trust is the foundation of everything food companies do, and the industry recognized we needed a stronger partner at F.D.A. if we were going to restore trust in the safety of our food supplies,” Mr. Faber said.

Consumer advocates were jubilant.

“Everyone who eats will benefit,” said Caroline Smith DeWaal, food safety director of the Center for Science in the Public Interest, an advocacy group. “F.D.A. will have new tools to help ensure that we have a safer food supply that causes fewer outbreaks and illnesses.”