FDA Issues a Warning Letter to CA Bakery for Being Nasty

FDA issued a Warning Letter to a CA bakery for, in short, being nasty.   They missed the memo that they had to comply with FDA regulations.  A problem we have seen with many smaller companies that are now required to have registered with FDA and thus are subject to FDA inspection...especially an issue among bakeries.

"..food manufactured in your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 342(a)(4)) in that it was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.  In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu))." 

The inspection of the company found that they...:

• Did not have a written food safety plan.
• Did not take effective measures to exclude pests from the manufacturing, processing, packing and holding areas to protect against contamination of food on your premises by pest..had rodent excrement and insects in various places.
• Did not clean all food contact surfaces, including utensils and equipment, as frequently as necessary to protect against allergen cross-contact and against contamination
• cutting boards used to prepare products were scarred and heavily stained with a dark residue, and the plastic containers used to hold and dispense various dry ingredients were observed cracked, some being held together with blue tape,
•  ice cream scoop, used to fill lemon poppy muffins which contain almonds and wheat flour, was seen stored in a bucket of water and then used to fill gluten free muffins, which do not contain almonds or wheat flour, without being cleaned between uses
•  prepare products with raw ingredients on the same wooden table that finished products are prepared for further processing and packaging.
• The floors are not constructed in such a manner that they may be adequately cleaned and kept in good repair - specifically, during the inspection our investigators observed standing water and pitted floors with exposed aggregate, immediately adjacent to clean equipment on shelves. 
• Employees working in direct contact with food, food-contact surfaces, and food packaging materials did not conform to hygienic practices 
• Wholesale products are misbranded - the product labels fail to bear the common or usual name of the food, labels fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count, labels fail to include the place of business of the manufacturer, packer, or distributor, and the Lemon Poppy and Strawberry Cupcake Muffin products bear or contains a color additive which is unsafe within the meaning of section

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sweet-production-inc-578494-06172019
WARNING LETTER
Sweet Production Inc.
MARCS-CMS 578494 — Jun 17, 2019

Auditor General - FDA Follow-up to Inspections Found to Be Slow and Lacking

In a report by the Auditor General to the FDA, there was criticism that FDA was not taking enough action fast enough.  "Auditors examined data from 2011 to 2015 and determined the agency was on pace to conduct the required inspections, but hadn’t made sure that all problems were corrected."  In defense, many of the inspections that were longer in response were for dietary supplements - the wild west of FDA's regulatory world.  And with new regulations just coming upon implementation date, there is a huge gap in knowledge for both the firms and the inspectors.

• In the time frame analyzed, inspectors found significant dificiences in 1245 establishments.
• While some type of actions was taken in 78% of the inspctions, in 22% nothing was done.
• "Almost half of the warning letters were sent after the agency’s goal of four months [which is still a long time]. Twenty percent were sent after more than six months, and 2 percent were sent more than a year after the inspection."
• "The agency took an average of 6.7 months to initiate judicial action, the audit said. In one case, a seizure didn’t occur for more than a year, and an injunction didn’t occur for nearly two years."
• "Of 766 facilities that received “advisory” actions, about 1 in 5 were found to have significant violations on follow-up inspections. In about three-quarters of them, the violations were identical to those previously discovered."

The Morning Call (Allentown, PA)

http://www.mcall.com/news/watchdog/mc-nws-food-safety-inspection-problems-watchdog-20171003-story.html
Food safety oversight not well done
by Paul Muschick•Contact Reporter
The Watchdog
October 4, 2017, 8:55 PM

Uber-like Home Cooked Meals? Laws Provide Necessary Hurdles

In the NY Post, a Harvard Law Professor argues that current food laws are not conducive to food entrepreneurs who want to create the next Uber-type industry - home prepared meals.

"This is why people more often get sick by eating out than by eating at home. Even if the risk from home-cooked food were as high as or higher than that from restaurant-cooked food, the danger would have to be extraordinarily great to justify a ban.
Instead, home kitchens where food is prepared for sale should be held to separate standards that make sense for the enterprise. Many states already have cottage food laws that allow people to prepare and sell baked goods from home. In those states, the permits could simply be extended to allow the sale of cooked meals over the Internet"

First, a large majority of foodborne illness cases do occur in the home.  While reported cases of illness do not show this, we recognize that reported cases are more likely to be cases related to outbreaks where 2 or more people become ill from eating the same food.  However, the vast majority of cases go unreported with many of these being sporadic cases where one person becomes ill, and it is probable that a good majority of these sporadic cases occur from home practice.

Studies have shown that the many consumers don't have the best practices, including 1) are prone to have cross contamination issues in their kitchen, 2) don't have their refrigerators set at the right temperature, and 3) don't use a thermometer.    What about those live-in 'intruders' making their way into the kitchen space...dogs, cats, and kids.  There have been many instances where food made in the home and then served outside the home have been disastrous.  Just last week, BBQ prepared in a home kitchen was responsible for 32 cases of Staph enterotoxin cases.

Unlike Uber where you get to inspect the car and the driver when it shows up, (and can jump out when things are not going right), you would not have the opportunity to inspect a person's kitchen, or their food handling and preparation skills.   Once you bit into the food, you are not necessarily going to be aware if the food was subject to cross contamination, if it hit the proper end point cooking temperature, or if it was properly stored from time it was prepared to the time it shows up at your door.

Can a concept like this work...sure, but within the laws.  It happened for trucks, maybe homes are next.  I can actually see a company that contracts home cooks to prepare meals.  They would work to make sure the people are properly trained (and have credentials to show) and that the kitchens receive the proper governmental inspections.  The company can help people get the right equipment, develop and implement proper procedures, and provide additional ongoing support and inspection.  The company would establish the internet ordering system (along with pictures of the people preparing the food and the kitchen space in which the food would be prepared).  The company would  then collect a percentage of the fees paid for the food.
One problem is the economics.  Kitchensurfing and Ktichit,  similar concepts except the chef comes to your house, both failed.  The advantage in these cases is that the cooking space was the  customer's own kitchen.  Disadvantage, the need for chef's who were willing to perform their task for an audience, whereas in the concept above, the consumer would be more willing to accept a home cook.   The next and biggest issue is the obtaining the commercial license  for making prepared TCS foods for others.  The company would have to work with the local jurisdiction to determine how this could be achieved within the current regulatory restrictions.  No doubt there would be some costs that go into adapting a kitchen...but again, if it can be done in a truck, why not a kitchen...provided the kitchen meets required standards.

NY Post - Opinion
http://nypost.com/2017/02/21/regulations-make-it-too-hard-to-sell-home-cooked-food/
Regulations make it too hard to sell home-cooked food
By Jacob Gersen
February 21, 2017 | 5:01am

FDA Issues Warning Letter to RTE Facility with LM Issues

FDA issued a warning letter to a Saranac Foods for an inspection completed in February.  We have seen a number of similar types of Warning letters issued.  In this one, inspectors found LM in a facility making RTE product, and  then conditions that would support the spread of that organism (issues with hose usage, condensation, and airflow).  While the company did respond, the response was lacking in terms of a 'complete' corrective action.

 

Listeria

FDA found 3 of 89 samples positive for Listeria monocytogenes. all non-contact but in the ready-to-eat pasta and deli salad production room.

1. Floor near food carts and the 2-compartment sink;
2. The floor alongside of the interior legs of stand mixer;
3. An area of the floor under the 1-compartment sink where a leak is present.

Although the company took corrective action, the FDA stated: FDA is unable to evaluate the adequacy of your response because it does not provide specific details of your corrective actions and steps taken to prevent contamination of food. 

  

GMP Issues

MA Inspector Selling Phony ServSafe Certificates, Allowing Filthy Conditions

A Massachusetts city suspended its inspector after it found that the inspector had been issuing phony ServSafe certificates to establishments.  With this, the city's investigation found that these establishments were nasty with multiple sanitary violations including pests, improperly refrigerated TCS food items, and poor hand washing facilities.  In addition, one facility was selling Viagra and synthetic marijuana. 

Eagle Tribune
http://www.eagletribune.com/news/city-shuts-second-bodega-as-food-safety-investigation-widens/article_525b7a70-a44d-5d94-a5a1-3c995e6784ef.html
City shuts second bodega as food-safety investigation widens
Owner also charged with selling Viagra

PA Ag and State Police Conduct Surprise Inspections of Food Delivery Vehicles

Pennsylvania Dept of Ag along with the PA State Police conducted inspection on 140 refrigerated commercial food delivery vehicles.    According to the release "No citations were issued June 28, although multiple products were discarded due to being outside of acceptable temperature parameters. One warning letter was issued to an out-of-state company clarifying Pennsylvania food code and reasons for product disposal."  As they noted, warm delivery vehicles are a special concern  in the warmer months.

As per the Sanitary Transport of Food rule, temperature must be properly maintained throughout the shipment and delivery of the food items.  It is the shipper's responsibility to ensure this.  But clearly, there are issues that need to be corrected.


PA Gov News Release
http://www.media.pa.gov/pages/Agriculture_details.aspx?newsid=448&utm_content=articles&utm_campaign=NLCampaign&utm_source=Newsletter&utm_term=newsletteredition&utm_medium=email
Code R.E.D. Enforcement Efforts Ensure Safety of Food Supply During Transport
07/18/2016

Whole Foods Takes Warning Letter on the Chin for February Inspection

FDA issued a warning letter on June 8, 2016 to Whole Foods for an inspection completed back in February.  While Whole Foods responded to the inspection findings in March, the Warning was issued this week (June 8th), because FDA did not find the response acceptable.

"We do not consider your response acceptable because you failed to provide documentation for our review, which demonstrates that all your noted corrective actions have been effectively implemented. This documentation may include photographs, invoices, work orders, voluntary destruction records of any affected products, certification of actions performed by contractors, and/or any other useful information that would assist us in evaluating your corrections."

The initial inspection found a number of issues, nothing overly serious. but mostly what could be considered sloppy procedures.  This included multiple condensation issues, improper sanitation procedures with instances where too high a sanitizer concentration was used, potential cross contamination issues, inadequate handwashing water temperatures, and improperly marked sanitizing agents.  Environmental sampling of 100 samples was negative for Listeria monocytogenes, but one sample was positive for a non-pathogenic species of Listeria.

Clearly some bad vibes going on between the agency and the plant.  If issues were so bad, why did a follow-up inspection not occur, or why wasn't this letter issued in March?  A lot to take away from this.

• Tighten up procedures now rather than having an agency inspector tell you.  Inspections are rarely perfect, but the number of issues seen here show a lack of attention to detail.
• Ensure corrective actions to inspection reports are completed as soon as possible.Those corrective actions must be detailed / documented to cover each and every element addressed in the inspection and be able to demonstrate that the risk issues have been adequately  addressed .  Overkill in documentation support was needed here rather than glossing over.  

Boston Globe
https://www.bostonglobe.com/business/2016/06/14/whoole-foods-kitchen-everett-hit-with-food-safety-violations/U2oSoRitbt1FeV9s3hFf4K/story.html
FDA inspectors find evidence of Listeria at Whole Foods kitchen
By Megan Woolhouse Globe Staff June 14, 2016

FDA Investigation Report for Frozen Produce Facility at Center of Recall

The FDA released the inspection report of the CRF facility that was responsible for the massive frozen vegetable recall.  The inspection, conducted in March and transcribed below, found no blaring issues cited, but just some basic hits to the equipment and utensils used.  Surprising?  Not really, because a visual inspection is not going to identify low level contamination issues, such as what we expect was the case at CRF.   While you can find signs of sanitation lapses in an inspection that can lead to harborage issues or indicators of overall poor sanitation, it is really microbial sampling that will provide an idea of control.  Another important inspection is a review of the sampling being conducted by the facility - are they sampling for Listeria, how many samples, what are the results, is there corrective action, when are they sampling, who is doing the testing, how are they sampling, etc. In the end, is the facility really trying to find it, or are they doing testing just to say they are doing testing.

The transcription of the report:

FDA Inspection Report from Salad Facility Responsible for Listieria Outbreak

Earlier this year, bagged salads produced by Dole in their Ohio facility, were involved in a Listeria outbreak.  According to the CDC Final Report, issued March 31 2016, 19 people became infected and there was 1 death.  In Canada, the CFIA reported 14 cases  and 3 deaths, although stated that the deaths may or may not be related to Listeria monocytogenes (LM).

FDA conducted an investigation of the facility and during that investigation, completed environmental sampling.   A 483 report was issued, and thanks to the Marler Blog, that report was posted (a 2014 report was also included there, but was not included here).  In reviewing this 483 report, there were some important findings.   A summary of those below as well as reports.
(An FDA 483 Report 'lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance')

OBSERVATION 1
Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination.

Deer Parts Removed from PA Restaurant During Inspection

A restaurant in Lititz, PA was found to have a large amount of deer parts including heads and brains.  In a joint investigation, the Pennsylvania Game Commission and  PA Dept of Ag removed this - "Amount of parts removed included: 4 trash bags, 2 boxes, 3 plastic tubs, one 5 gallon bucket and 9 trash bags of prepared foods."  The owner indicated that it was for his own consumption.

 The inspection was completed after a confidential tip was made to the authorities.  It is not legal to sell meat from wild game animals.  Having deer heads and brains in the establishment is also a risk for CWD - chronic wasting disease.

In addition, inspectors found numerous violations.

  

PennLive.com

http://www.pennlive.com/news/2015/12/deer_brains_heads_parts_confis.html

Deer brains, heads, parts confiscated from Chinese restaurant: Ag department inspection

  

The Pennsylvania Game Commission is investigating a large quantity of deer heads, brains and other, unidentifiable parts found at the New China House restaurant in Lititz Dec. 16, according to an agriculture department inspection report, but the eatery remains open.

 

The restaurant, at 721 S. Broad St., was listed as "out of compliance" by the state Department of Agriculture after an inspector Dec. 16 found 18 violations, including the following:

 

"PA Game Commission confiscated the following from facility walk-in cooler and freezer after operator was unable to provide documentation that game animal meats being used in the facility were from an approved source: deer brains, deer heads, skinned and whole tails, legs, muscle meat, spines, necks and other unidentifiable parts both raw and cooked. Amount of parts removed included: 4 trash bags, 2 boxes, 3 plastic tubs, one 5 gallon bucket and 9 trash bags of prepared foods. In addition, sampling of prepared food found in walk-ins were taken to be tested for species identification."

 

Yogurt Recall - FDA Claims State Inspectors Knew of Issue Prior to Recall

Last year, Chobani recalled yogurt due to extensive mold contamination. The recall was issued after numerous consumer complaints.  According to the FDA Inspection report (page 6 if you really want to see), the Idaho Department of Agriculture knew about the mold issue 2 months before the recall.   Idaho DofA denies this claim.

 MagicValley.com
http://magicvalley.com/news/local/article_686ede3a-0735-5e15-90be-0eb801c48c87.html#.VIMXFpr9qOE.twitter
State Knew Chobani Yogurt was Tainted Months before Recall, FDA Says


December 05, 2013 2:00 am • By Joe Cadotte - jcadotte@magicvalley.com

TWIN FALLS • The Idaho Department of Agriculture saw moldy yogurt during a routine inspection at Chobani two months before the company issued a voluntary recall, says a U.S. Food and Drug Administration report obtained by the Times-News under a Freedom of Information Act request.

The state denies the FDA claim.

Concession Stands at KC Professional Sports Stadiums Cited for Food Safety Issues

Health inspectors discovered a number of food safety issues when conducting inspections of the two professional stadiums in Kansas City.  

Concession operations that are used infrequently (at least not every day) need to take into account that they have a flurry of activity for 4 to 6 hours and then are not used for days or weeks afterwards.  Items that are not cleaned will sit around for days, attracting pests such as cockroaches or mice.  Another issue they face is that the people who work there may be temporary workers or even volunteers.  Getting these people up to speed on food safety fundamentals in an hour or so can be a challenge, especially if there is high turnover from event to event and/or there is lack of long term worries by the employee.

These issues can increase the risk that something will not be done correctly including improper clean-up after the event is over, or mishandling food during the event by the less-than-knowledgeable workers.  In the end, this can make the chance of food contamination higher, resulting in consumers contracting foodborne illness or a poor health inspection.  These will lead to bad publicity for the organization, even if that organization had no involvement in making the food.  In this case, the KC Chiefs or Royals.  Further, in light of the high food prices paid at these events,  consumer backlash can be great, and revenue loss even greater (see attached story below).

It is important for any operations that operate temporary food events to have tight controls over handling and clean-up.  Self-inspections during and after the event by facility managers is important in ensuring compliance.


Kansas City Star
http://www.kansascity.com/news/business/article3941505.html
Health inspections find problems at Arrowhead Stadium and Kauffman Stadium

By MARK DAVIS   The Kansas City Star
11/14/2014 6:29 PM    11/14/2014 9:23 PM

Kansas City health officials were concerned and disappointed by conditions they found at Arrowhead and Kauffman stadiums during recent food safety inspections.

Reports itemized 37 critical violations of food safety among 26 concession stands and the main kitchens inside the two parks on Nov. 3, the Monday after the Kansas City Chiefs defeated the New York Jets.

Using Yelp Reviews to Help Fight Foodborne Illness

A study was done to use Yelp, a restaurant review website, as a way to identify restaurants that may have caused foodborne illness.  Investigators went through about 300,000 reviews using word identification software to identify roughly 500 that may have had an illness. From this, investigators further refined the list to 129, of which 27 individuals agreed to answer a survey.

 Great?  I am not seeing it that way.

1. People are not always truthful when writing reviews, especially if they had a bad experience. What a better way to exact revenge on a mean restaurant owner then to complain that you got ill from eating there.   Could this explain the low level of people willing to answer a survey?  Seriously, if you had gotten sick from eating at a restaurant, and then authorities asked me if you would answer a survey, I think most would be more than willing to provide some information.
2. Competitors will also write fake reviews.
3. People attribute illness to the last thing they ate, or an memorable event where they ate, but this is not necessarily what made them ill.   Granted the survey tries to take this into account, but not may miss one way or the other.
4. Yelp is just one of the review websites...so investigators would need to expand the search to include a number websites.

Here is an idea...why not place a health department link on these review websites where one can report an illness if they feel they get it from a certain establishment.  So instead of taking a passive approach that requires numerous employee hours (spending tax payer dollars) to evaluate hundreds of thousands reviews for certain key words that may indicate illness, we add a link to those review websites that states....'If you believe you have gotten ill from eating at this specific restaurant, or have noticed a situation that could lead to foodborne illness, please click on this link'.

No one will report unless that really feel the restaurant was truly at fault.  In fact, a person reading the reviews and seeing a claim of illness could see if someone was truthful enough to actually report the illness to authorities....now that is something you would take that pretty seriously when reading reviews.     I am sure that the review websites  (Yelp, TripAdvisor, UrbanSpoon, etc) would be happy to help.

 
MMWR Report
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6320a1.htm?s_cid=mm6320a1_e
Using Online Reviews by Restaurant Patrons to Identify Unreported Cases of Foodborne Illness — New York City, 2012–2013

Weekly

May 23, 2014 / 63(20);441-445

Cassandra Harrison, MSPH1,2, Mohip Jorder, MS3, Henri Stern3, Faina Stavinsky, MS1, Vasudha Reddy, MPH1, Heather Hanson, MPH1, HaeNa Waechter, MPH1, Luther Lowe4, Luis Gravano, PhD3, Sharon Balter, MD1 (Author affiliations at end of text)

While investigating an outbreak of gastrointestinal disease associated with a restaurant, the New York City Department of Health and Mental Hygiene (DOHMH) noted that patrons had reported illnesses on the business review website Yelp (http://www.yelp.com) that had not been reported to DOHMH. To explore the potential of using Yelp to identify unreported outbreaks, DOHMH worked with Columbia University and Yelp on a pilot project to prospectively identify restaurant reviews on Yelp that referred to foodborne illness. During July 1, 2012–March 31, 2013, approximately 294,000 Yelp restaurant reviews were analyzed by a software program developed for the project. The program identified 893 reviews that required further evaluation by a foodborne disease epidemiologist. Of the 893 reviews, 499 (56%) described an event consistent with foodborne illness (e.g., patrons reported diarrhea or vomiting after their meal), and 468 of those described an illness within 4 weeks of the review or did not provide a period. Only 3% of the illnesses referred to in the 468 reviews had also been reported directly to DOHMH via telephone and online systems during the same period. Closer examination determined that 129 of the 468 reviews required further investigation, resulting in telephone interviews with 27 reviewers. From those 27 interviews, three previously unreported restaurant-related outbreaks linked to 16 illnesses met DOHMH outbreak investigation criteria; environmental investigation of the three restaurants identified multiple food-handling violations. The results suggest that online restaurant reviews might help to identify unreported outbreaks of foodborne illness and restaurants with deficiencies in food handling. However, investigating reports of illness in this manner might require considerable time and resources.

FDA Issues Warning Letter for Inadequate Response To Violations

This article published in the Packer (below) is a cautionary tale on the need for follow-up documentation on ‘actions taken’ in response to violations identified in a regulatory inspection. In summary, after the company had a Listeria contamination recall, they were inspected by FDA. The FDA inspection found Listeria contamination on finished product as well as on food contact surfaces. FDA issued a report to the company. The company responded in a letter about actions that they would take, but did not follow up again that those actions were actually taken and implemented. Because of this, FDA issued a Warning Letter (below) to the company (and we the public get to read about it).



UPDATED: FDA hasn’t closed books on Missa Bay listeria incident
The Packer - 02/06/2013 10:47:10 AM
Coral Beachhttp://www.thepacker.com/fruit-vegetable-news/FDA-hasnt-closed-books-on-Missa-Bay-listeria-incident-190030841.html?utm_source=dlvr.it&utm_medium=twitter

UPDATED COVERAGE, Feb. 7) A warning letter from the Food and Drug Administration, made public Feb. 5, indicates the agency is still concerned about listeria contamination found in July at a fresh-cut facility that supplied apple slices to McDonald’s and Burger King restaurants.
The warning letter to Missa Bay LLC — dated Dec. 10 — gave company officials 15 days to respond.

Tamara Ward, FDA press officer, said Feb. 7 the company responded to the December letter but that she could not release details because the investigation is ongoing.

FDA enacts new strategy to ensure safety of imported foods

The FDA’s news release regarding their new import strategy comes at the same time as a NY Times report that is critical of the FDA’s performance on handling of questionable food at port.  Clearly, the ever increasing level of imports into the US is challenging FDA’s ability to monitor and react to questionable food.  FDA will begin to focus on becoming a more global organization – extending its reach through developing partnerships with foreign regulators and developing systems to share real time information.  It will use information to focus on higher risk situations.

This is all fine and dandy, but still, someone in the US – a broker, a food company, or food retailer – has to bring that product into the US. These folks also need to be held responsible and pay the price of ensuring compliance of these imported foods to US standards…and I would argue that they are in a better position to do so than the FDA .  If that adds cost to the imported product (through the broker inspecting their foreign supplier), then so it should.  Why should foreign product have a price advantage over domestic product when it comes to questionable standards?   

FDA unveils new global strategy to help ensure safety and quality of imported products

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm259848.htm

Strategy calls for coalitions of international regulators, increased data sharing
The U.S. Food and Drug Administration today unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the "Pathway to Global Product Safety and Quality."
“Global production of FDA-regulated goods has exploded over the past ten years.  In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D.  "There has been a perfect storm - more products, more manufacturers, more countries and more access.  A dramatic change in strategy must be implemented." 
The FDA report calls for the agency to transform the way it conducts business and to act globally in order to promote and protect the health of U.S. consumers. Highlights of the report include four key elements needed to make the change:
1. The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.
2. The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.
3.  The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.
4. The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.
"FDA regulated imports have quadrupled since 2000,” Hamburg said. "The FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face.  The FDA must further collaborate and leverage in order to close the gap between our import levels and our regulatory resources. This report is an important step in ensuring we are able to fulfill our critical public health mission."
The change in strategy will address trends expected to be seen worldwide in upcoming years:

• Western economies will increase their productivity to compete with emerging markets and economies, leading to more imports and increased pressure to reinvent manufacturing processes.
• Money, goods, data and people will increasingly and more quickly cross borders. Today, a typical U.S. manufacturing company relies on more than 35 different contract manufacturers around the world.
• Growing demand, constrained supply, and increased regulatory and social scrutiny will determine what resources are used, how they are used, and the cost. Manufacturers will adopt new manufacturing processes and emerging technologies in response.
• Governments worldwide will increasingly be called upon to mitigate the sometimes negative impacts of globalization on their citizens, making the operating environment for companies more complex.

The new strategy also builds on changes already set in motion by the FDA. The FDA increased the number of foreign drug manufacturing inspections by 27 percent between 2007 and 2009 and has opened a series of international offices in key locations.  FDA has also collaborated with its counterparts in the European Union and Australia on drug inspections, worked to harmonize certain aspects of drug regulation via the International Conference on Harmonization, and joined the Pharmaceutical Inspection Cooperation/Scheme (PIC/S) which is an organization of the drug manufacturing inspectorates from 39 countries.  The FDA and other global leaders are also creating an expanded global regulators forum for medical devices. 
The FDA is also broadening its food safety efforts under the FDA Food Safety Modernization Act (FSMA). This new law creates a new foods safety system, in which FDA has a legislative mandate to require comprehensive preventive controls across the food supply chain and has new tools to hold players in the supply chain responsible.  There are also new inspection mandates, including a mandate leading to the inspection of more than 19,000 foreign food facilities in the year 2016.
The FSMA recognizes the importance of partnerships in the success of this new food safety system, particularly in the area of imports.  For example, importers now have an affirmative obligation to verify the safety of the food they bring into the United States.  In addition, the FDA will establish a program for qualified third parties to certify that foreign food facilities are in compliance with U.S. requirements and can require certification as a condition of entry into the United States.  And, FSMA explicitly encourages arrangements with foreign governments to leverage resources.
“In order to cope with the fundamental global shifts on the horizon, the FDA will have to substantially and fundamentally revise our approach to global product safety.  We can no longer rely on historical tools, activities and approaches,” said Acting Principal Deputy Commissioner of Food and Drugs John M. Taylor, J.D.  “Implementing this strategy is vital to the public health.”
For more information, visit:

• Pathway to Global Product Safety and Quality¹
• FDA Food Safety Modernization Act²

FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Recalls of Imported Foods Are Flawed, a Government Audit Reports

By GARDINER HARRIS  NY Times

Published: June 21, 2011

http://www.nytimes.com/2011/06/21/business/21recall.html?_r=1&partner=rss&emc=rss

Government food officials are often sloppy and inattentive in their efforts to ensure that contaminated foods from abroad are withdrawn promptly and completely from the nation’s food supply, according to government investigators.

In an audit of 17 recalls, investigators found that the Food and Drug Administration often failed to follow its own rules in removing dangerous imported foods from the market, according to Daniel R. Levinson, inspector general of the Department of Health and Human Services. The products included cantaloupes from Honduras contaminated with salmonella, frozen mussel meat from New Zealand infected with listeria and frozen fish from Korea that contained the bacterium that causes botulism.

(go to link for complete news story).

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

Grading Policies for Restaurants - Allegheny County

I am all for food safety and restaurant inspections, but I am not keen on the application of grade scores to audits.  The goal of an inspection or an audit should be to identify gaps within the establishment’s food safety system and have the establishment correct those gaps.  The auditor or inspector can be somewhat objective in determining which practices are higher risk.  But the degree of risk can be subjective.  And as they apply the score to the entire process, it becomes more subjective.  And then that score is on the books until the next inspection.  Even a clean kitchen can have a momentary food safety lapse by an employee potentially putting a  projected good score in jeopardy and more importantly, affecting that establishment’s ability to do business.

This scoring practice also puts pressure on the inspector.  While the inspector should be working with the owner on how to improve food safety, the scoring component may lead to a more confrontational relationship.  Will the inspector be willing to write an issue down knowing that the establishment’s grade will drop from a B to a C?

Inspections should identify food safety gaps and provide opportunity for the establishment to get them corrected.  While a mandated grading policy might push some operators into proactive improvement, this system can be far too subjective resulting in unfair punishment. 

Controversial Allegheny health grading policy could return

By Adam Brandolph
PITTSBURGH TRIBUNE-REVIEWMonday, November 8, 2010

A controversial health inspection system for restaurants and other food servers could return to Allegheny County in the spring after being scrapped more than 15 years ago.

The county Health Department is drafting food safety guidelines that officials say will include a system to give customers a sense of how clean kitchens are. The rating -- based on "demerit" points accumulated for violations -- could be recorded as a letter grade, a numerical score or both. Restaurants would be required to post their rating for all to see.

"It could be a death blow to a lot of restaurants," said Brian Carey, owner of Cappy's Cafe on Walnut Street in Shadyside. "How do you get your rating changed is a concern. You don't want to have a 'C' rating for a whole year."

The Health Department issued letter grades beginning in the 1970s but changed to a pass/fail system in 1994 because restaurants complained the system was unfair.

"The old system took into account structural deficiencies and didn't measure cleanliness effectively," said Dr. Bruce Dixon, director of the department. "If you had structural issues, you always had a 'B.' One of the better restaurants had a 'B' because they had wooden floors in the kitchen."

The new system would "provide clear and understandable information," said Paul M. King, chairman of the health board. The department's Food Safety Division conducts annual inspections and investigates complaints at about 9,000 food establishments in the county, including street vendors, hospitals and school cafeterias.

The state Department of Agriculture inspects food services and restaurants in counties that don't have local health departments.

The new regulations would be vetted by the department's Food Advisory Committee and open for public comment before they're approved, King said. Last week, an early draft of the rules was sent back to the committee for review. Officials refused to provide that draft to the Tribune-Review.

The revised rules are to be ready in January and could be voted on in March.

Jeff Cohen, owner of the Smallman Street Deli in the Strip District and director of the Western Chapter of the Pennsylvania Restaurant Association, said he'd prefer a system based on points rather than a letter grade.

"The way the new system is proposed, a one-point difference between a score of an 89 and a score of a 90 could be the difference between of an A and a B," said Cohen, who sits on the Health Department's subcommittee charged with revising the restaurant inspection program.

"We're meeting in a few weeks to hash out a correct strategy," Cohen said. "I don't think the current system is broke now. I always find they're very fair. I think the Health Department's goal is to make sure everyone's getting a 90 or above."

Roger Kaplan, manager of a McDonald's restaurant on McKnight Road in Ross, didn't think his customers would pay attention to ratings.

"People come to McDonald's because they know they can get good food fast and cheap," he said. "And I think people will be surprised about how well we score."

Rhett Schlegel, a bartender at Rolands in the Strip District, said he doesn't know whether he'd support a change, but he thinks most restaurants would be against it.

"If it becomes law, they're just going to have to watch their Ps and Qs and keep everything perfect," he said.

Dixon said that's exactly the point.

"If a restaurant can't do things the right way and they have a 'C,' I think people are entitled to know that, aren't they? (Restaurants) should aspire to maintain quality standards so people feel comfortable with where they eat."

Rating systems have received "mixed reviews" nationwide, said Vito Palazzolo, manager of program compliance at the National Restaurant Association, an industry lobbying group.

Under laws that went into effect in August, New York City gives restaurants letter grades based on points accrued for violations. Many restaurants opposed the changes, said Andrew Rigie, director of the New York State Restaurant Association.

"A restaurant is either safe and sanitary enough to serve the public or it's not," Rigie said. "We felt an 'A' or 'F' system should be implemented because of the complexities of the health code and because of the subjectivity of the inspectors."

While critics say grading systems are gimmicky and unfair, Charles Campalong, general manager of Benkovitz Seafoods in the Strip District, said he prefers them because they differentiate especially clean kitchens from those that just pass inspection.

"Why should I bust my (butt) when other places are dirty and everybody gets the same thing?" Campalong said.

Kevin McCullogh, general manager of Church Brew Works in Lawrenceville, said new regulations would "get the restaurants that aren't doing a good job to do better."