FSMA - FDA Extends Deadline for Certain Provisions of Four Major Rules

As you know, the compliance dates are approaching for FSMA.  For Preventive Control for Human Foods, the compliance date for large firms in September 18th, 2016.  (This has not changed.)

But with this much of a major change in regulations, there will be areas where more guidance is needed from FDA for companies to figure out how to comply.  This is the case where these 6 issues resulted in the compliance dates being moved back, essentially 2 years from the proposed compliance date.

• certain related provisions concerning customer assurances when controls are applied downstream in the distribution chain in all four rules. 
• for facilities solely engaged in packing and/or holding activities conducted on raw agricultural commodities (RACs) that are produce and/or nut hulls and shells and for certain facilities that would qualify as secondary activities farms except for the ownership of the facility. 
• for certain facilities that color RACs.  
• for facilities solely engaged in the ginning of cotton. 
• for importation of food contact substances. 
• for certain facilities producing Grade “A” milk and milk products covered by the National Conference on Interstate Milk Shipments (NCIMS) under the Pasteurized Milk Ordinance (PMO) to comply with the CGMP requirements of part 117.

The most impactful for those processing human and animal foods is the customer assurance requirement.  This provision requires the processor to make sure the downstream customer was going to take care of a hazard in the ingredient being sold.   Basically, if Company A is selling to Company B an ingredient containing a hazard, say for example Salmonella, where Company B said they were going to heat process that ingredient.  By Rule, Company A would need assurance that Company B was going to cook it sufficiently.   This, as written, may not be easy information to get.  (Specific sections of the posting below)

The other impactful section being delayed is for facilities holding or packing raw agricultural commodities that are not classified as a farm.  These facilities are more like a farm than a processor, but because of the way the rule was written, it classifies them more as a processor.  To help determine what these facilities need to do, FDA will write a specific guidance for these facilities. (Specific sections of the posting below)

Selected sections from:
The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
Final Rule; Extension And Clarification Of Compliance Dates For Certain Provisions.
 https://www.federalregister.gov/articles/2016/08/24/2016-20176/the-food-and-drug-administration-food-safety-modernization-act-extension-and-clarification-of#t-1

Cottage Food Laws - Sidestepping Food Safety Regulations

Many states are enacting Food Cottage Laws to enable people to sell food that they made in their own kitchen without any oversight by government health and safety professionals.  The intended goal is to help support budding food entrepreneurs and support the local economy.  But at what cost? 

One example is the recently passed Cottage Food Laws of Idaho. The law does limit the type of food to non-potentially hazardous foods (excluding low acid and acidified canned foods) so the risk is lower, however there is little in the regulation that address food safety including the condition of the kitchen in which the food is handled and prepared.  Once made, the food can be sold through a number of channels including farmers' markets and online.

FSMA Preventive Controls Rule for Human Foods - A First Look

The FDA released the final rule for the Preventive Controls for Human Foods. For those who have been tasked with reviewing the PDF file of approximately 930 pages, it is easy to become overwhelmed. However, it is not as bad as it looks. The actual regulation, which starts around page 834, is then roughly only about 100 pages. Considering that the GMP regulation is included (formerly 21CFR part 110) and there are many pages dedicated to discussing on-farm exemptions, the meat of the regulation is rather brief In fact, this version has been skillfully streamlined compared to the last released supplemental version.

So this primer takes a look at new aspects as well as walks through the major sections of the regulation. 
 

USDA Proposes Salmonella and Campylobacter Performance Standards for Poultry Parts and Ground Poultry

 USDA has proposed setting performance standards for poultry processors on raw ground poultry as well as raw poultry parts (breasts, legs, breasts and wings). A performance standard for pathogens is a level of positive samples a facility can have. USDA then tests product at the facility to see whether they are in compliance. This puts pressure on the facility to put measures in place to reduce the prevalence of pathogens thus having a positive impact on safety.

USDA performance standards are in place for whole poultry, but as with the Foster Farms outbreak, numbers can increase during further processing such as cutting into parts or grinding. And these products, ground and parts, represent a big proportion of the product people buy.

These performance standards will allow some level of Salmonella and Campylobacter to still be present, but in lowering the level there, the USDA hopes to reduce the number of illnesses that occur.  That being said, it still important the people handle chicken in a way to prevent cross contamination and cook it to eliminate pathogens that may be present.

USDA News Release
 http://www.usda.gov/wps/portal/usda/usdahome?contentidonly=true&contentid=2015/01/0013.xml
Release No. 0013.15
Contact: Office of Communications (202)720-4623
USDA Proposes New Measures to Reduce Salmonella and Campylobacter in Poultry Products
New Standards Could Help Prevent an Estimated 50,000 Illnesses Annually

WASHINGTON, Jan. 21, 2015 -- The U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) today proposed new federal standards to reduce Salmonella and Campylobacter in ground chicken and turkey products as well as raw chicken breasts, legs and wings. Development of these new standards is a major step in FSIS' Salmonella Action Plan, launched in December 2013 to reduce Salmonella illnesses from meat and poultry products.

Rule Delayed Requiring Labeling of Mechanically Tenderized Meat

A rule requiring the mandatory labeling of mechanically tenderized meat was delayed due to slow government action.

The rule was proposed because of the higher food safety risk associated when meat is tenderized using blades or needles.  The blades or needles can force bacteria deeper into the meat, and so this meat then needs to be cooked a little more in order to destroy those backer and thus ensure safety.  That is, you don't want to serve mechanically tenderized meat rare or medium rare....it needs to be cooked to 155F internal versus 145 F as is done for intact meat (straight cuts of steak).    Of course, many people do not know this, and cook those mechanically tenderized steaks like they would intact steaks..  Labeling would indicate to people that these steaks need to be cooked to 155F internal temperature.


Food Safety Magazine
http://www.foodsafetymagazine.com/news/mandatory-labeling-for-mechanically-tenderized-meat-delayed-until-at-least-2018/
Mandatory Labeling for Mechanically Tenderized Meat Delayed Until At Least 2018
News | January 5, 2015
 By Staff

According to a final rule by the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), mechanically tenderized beef products will not require special safety labels for at least another three years. The tenderization process softens the meat with tools and devices that are known to cultivate pathogens that can lead to foodborne illness.

Changes to FSMA Rule on Preventive Controls - Product Testing, Environmental Monitoring, and Supplier Control

FDA rolled out its revised FSMA Rule for Preventive Controls for Human Foods and is allowing 75 days for comment. Part of the revisions focus on who has to comply and when (there is a broader exemption for farms is made as the defining of a small company), however probably the most important part of this is the inclusion of language on product testing environmental monitoring, and supplier control. While there is not an absolute requirement for all to have these programs in place, there is now language to say when it is required and what will be required.

 In general, if a facility says that they are controlling or verifying control of potential hazards by one of these programs, (programs traditionally termed as prerequisite programs), then that facility must have formalized programs. Below, I have clipped those sections from the proposed regulation for easier reference.

Product Testing and Environmental Monitoring - these are included in the Verification and Corrective Action sections. (117.165 and 117.150 below) Formalized programs will be needed when you are using these programs for verification of control. For example, if you have identified Listeria as a post process contaminate in an RTE food, then a program specific to that pathogen must be developed including written procedures, sampling locations within the facility, testing protocols, and identification of the laboratory conducting the testing.

Supplier Control (117.136) – The receiving company “must establish and implement a risk-based supplier program for those raw materials and ingredients for which the receiving facility has identified a significant hazard when the hazard is controlled before receipt of the raw material or ingredient.” There is a list of requirements as to what must be done including the need for on-site audits.
It would be worth reviewing the sections below.


FDA.gov

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm

FSMA Proposed Rule for Preventive Controls for Human Food Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

 Based on FDA’s outreach efforts and public comments, the FDA is proposing revisions to its proposed rule on preventive controls for human food that are more flexible and less burdensome in key areas.

Commenting

FDA is accepting comments for 75 days after the publication date. The FDA published the original proposed rule on January 16, 2013, and the comment period rule closed on November 22, 2013; no additional comments are being accepted on the originally proposed rule.

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 releases Food Code Reference System

FDA has released the Food Code Reference System, (FCRS) a search tool for providing additional information on questions posed to FDA on various provisions in the Food Code. It can be used when looking for specific issues that may come up. For example:
Can a wait staffer or server not involved in food prep have artificial nails? ? Short answer from what was posted – no.
What is the maximum strength allowed for a chlorine hand dip? ? Short answer from what was posted – there is no maximum, only a minimum of 100 mg/L of chlorine?
Are eggs that have been pasteurized in the shell shelf stable? Short answer – no, but they are free from Salmonella.
So this may be a useful site when you have a specific question and are looking for support documentation. However the amount of items in the database is limited and you may not find what you need. And I found that the answers could be somewhat basic. For example, a question on allergens and cooking oil is pretty simplistic in its response. It gets to the fact that allergens from food can be transferred by oils, but does not get to a question that is often posed, ant that is, what is defined as a refined oil.  

Possible reason is that the database has answers that were posted over a 8 or so year range, and so these questions/answers may not provide sufficient depth to some of the more complex questions that arise today. Perhaps as time goes, these questions will be posed to FDA and then this information will become searchable on the database.

Overall, I find that the information listed in the Annex section of the 2013 Food Code (the section that supports the 2013 Food Code) to be a better source for supporting documentation, however, for more specific questions you may come across, the FCRS can be a tool to find that answer.   

One other issue….the FDA website is sooooo slooowwwww.

FDA Constituent Update
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm394144.htm
FDA Releases Searchable Database - Food Code Reference System
Latest effort to strengthen understanding and application of the FDA Model Food Code
April 21, 2014

The U.S. Food and Drug Administration (FDA) has created the Food Code Reference System1 as part of an effort to promote consistent understanding and application of the FDA’s Food Code.

The FDA Food Code -- a model that has been widely adopted by state, local, tribal and territorial regulatory agencies -- provides FDA’s best advice for a uniform system of provisions to address the safety and protection of food offered at retail and in food service. The food code assists food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating the retail and food service segment of the industry. Regulators use the FDA Food Code as a model to develop or update their own food safety rules and to be consistent with national food regulatory policy.

The new Food Code Reference System, a searchable database that answers questions users may have about the Food Code and the application of its model regulations, will help to promote nationwide consistency and increase transparency about the Food Code.

Federal, state, local, tribal, and territorial government agencies; consumers, and stakeholders from academia and industry will benefit from this database as they promote compliance with their respective food safety requirements throughout the United States.

The Food Code Reference System contains entries derived from responses to Food Code-related questions posed to FDA.

Initially, users of the FCRS will find more than 20 entries that clarify many issues including:

The storage of foods that require temperature control for safety.
The design of food establishments and the cleaning of food equipment.
Bare-hand contact with ready-to-eat foods
Preventing contamination of food through proper hand hygiene and employee attire 

The FDA intends to add entries it believes are important to the uniform application of the Food Code and that may have implications across all jurisdictions that regulate food establishments. These entries will reflect questions previously answered by FDA as well as responses to future inquires that FDA receives.

The Food Code Reference Systems contains a User Manual and a Frequently Asked Questions (FAQs) page, both accessible from the log-in page. After an initial registration, system users can search the database using dropdown menus, keyword search, date fields, or a combination of these options. Users can also retrieve, view, and save documents to a local computer system. The materials contained in the Food Code Reference System are developed and issued by the Retail Food Protection Team in FDA’s Center for Food Safety and Applied Nutrition.

More information on FDA’s Food Code Reference System is available at http://www.fda.gov/retailfoodprotection2. Questions about the use of FDA’s Food Code Reference System can also be sent by email to: Retailfoodprotectionteam@fda.hhs.gov.

Colorado's New Food Safety Challange - POT!

With the passing of the law to make marijuana legal , Colorado must now address issues associated with legalization including regulations impacting food safety. Food safety comes into play because THC, the psychoactive component, can be added to a number of different products including pastries, cookies, and candies. So what hazards are associated with the plant and within the process of making these products? How does one control dosage of THC? How should products be labeled?

Looking down the road, the potential exists for other states to pass legal status to marijuana. To what degree does this give Colorado companies a head start in the development, manufacture and distribution of pot and THC? By the time other states get into the game, the Colorado industry will be well developed, giving those existing companies a competitive advantage. Along with that, many of the legal food standards that are set will be established in Colorado.

Some have suggested that marijuana get the Federal okay for use, since it is considered GRAS...oops it is grass, not GRAS (generally recognized as safe).

 There was an outbreak of Salmonella associated with Marijuana in 1982 (below)

Colorado Imposes Food Safety Rules On Marijuana Industry
By Luke Runyon
http://kvnf.org/post/colorado-imposes-food-safety-rules-marijuana-industry
Fri January 24, 2014
kvnf.com

Colorado made history when it opened up licensed marijuana retail shops this year. Aside from just legalizing the purchase of smoke-able marijuana, it also means pot brownies have the potential to be big business.

Food products infused with marijuana’s psychoactive ingredient, THC, are available in stores across the state.

Marijuana, though, is still considered illegal by the federal government. The existing food safety system, which relies heavily on support from federal agencies, can’t ensure that marijuana-infused foods are safe.

FDA Issues 2013 Food Code

The FDA issued the new 2013 Food Code, the model for handling and preparation of food offered to consumers. This model establishes the most up-to-date food safety practices based on current scientific thinking The Food Code applies to retail and foodservice operations and the agencies who inspect those facilities. The food code is adopted in full or in part the states and local jurisdictions in developing their own regulations. Pennsylvania adopts the entire Food Code as it is updated. The Food Code is also used by the food processing industry in that it provides support documentation for practices used within FDA food operations (cooking, cooling, etc). Click here for summary of changes.

There are only a few significant changes from the 2009 version, however there are many minor changes that update the language of the previous version.

• Language changes include:

o PHF or Potentially Hazardous Food is now Temperature Control for Safety Food (TCS), and the Potentially Hazardous Foods is completely eliminated.

o Defines Shiga Toxin Producing E. coli (STEC) to include all E. coli that are capable of producing Shiga toxin. 

• One of the biggest changes is the inclusion of non-typhoidal Salmonella in the list of reportable illnesses. In the past versions, from all the Salmonella species, only the highly contagious Salmonella typhi was considered in the list. So now all species of Salmonella that cause illness are reportable, and thus require to be addressed in employee health controls (exclusion from the operation, return to work requirements, etc). (In Annex 3 – Table 2-20112 provides a table on exclusion and return to work for this and the other reportable pathogens).
• A section was added to provide provisions for refilling containers brought from home from refill. (Of course, this would cover the refilling of growlers).
• Section 3-501.11 requires that frozen fish package in ROP packaging be removed from that packaging PRIOR to starting the thawing process.
• With regard to ROP packaging - All TCS foods packaged in ROP packaging require a HACCP plan, but only TCS food that is ROP packaged that do not control for growth of and toxin formation by C. botulinum and growth of Listeria monocytogenes needs a variance. Note that ROP packed non-TCS foods are not included (so if one is vacuum packing hard candy or dried beans, no requirement for a HACCP plan...outside of FSMA).
• More on ROP Packaging - Section 3-502-12 Reduced Oxygen Packaging without a Variance – Criteria - this whole section discusses ROP packaging and should be referenced by anyone who is planning to vacuum pack product. Additional support information is provided in Annex 3 - Section 3-502-12 . Along with 3-502-12, section 8-201.14 requires the permit holder to submit a properly prepared HACCP plan before engaging in processing Reduced Oxygen Packaging foods.

In FDA's Constituent Update, there post some additional changes.
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm374979.htm
These include

• Restaurants and food stores must post signs notifying their customers that inspection information is available for review.
• Revisions to the minimum cooking temperatures associated with procedures such as non-continuous cooking and circumstances under which bare-hand contact with ready-to-eat foods is permitted.
• Stronger requirements for cleaning and sanitizing equipment used in preparing raw foods that are major food allergens.

FDA proposes fee structure for re-inspections and recalls as part of FSMA

As part of the provisions in FSMA, FDA is setting a fee schedule for re-inspections of a facility when that facility had non-compliance/food safety issues during the initial inspection and for conducting a recall when the company fails to comply with a recall order.

For 2014 (which begins Oct 1, 2013), the fee rate is $237 an hour ($302 when foreign travel is required).

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm257982.htm?source=govdelivery

So for an all day visit (8 hours - arriving at 8 am and leaving at 4 am, no lunch), a facility is looking at a roughly a $1900 bill from Uncle Sam. Their goal will be to determine that corrective action was aken to resolve the noncompliance issue. Hopefully they can be convinced actions in 30 minutes the the corrective action was successful.

FDA Proposed Rules for Food Safety Plans and Produce Food Safety

On Friday, Januray 4, 2013, the FDA rolled out two proposed rules.

 

1) Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food 

• Preventive Controls – applies to facility that manufacture, process, pack or hold food that fall under FDA jurisdiction. This rule requires that facilities have food safety plans in place for the preventive control of potential hazards, both within the process (HACCP) and those associated with the prerequisite programs. The document is 680 pages.
• http://www.ofr.gov/OFRUpload/OFRData/2013-00125_PI.pdf

 

2) Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

• Proposed Standards for Produce Safety – covers those fruits and vegetables that are likely to be consumed raw (spinach not potatoes). This document is 547 pages.
• http://www.ofr.gov/OFRUpload/OFRData/2013-00123_PI.pdf

 

Being proposed rules, there is a comment period before a final rule is issued. Then there will be a period of time from when the final rule is published until it is enacted

Problems at NECC facility that led to meningitis outbreak

This is not food related, but the issues seen at this facility that made the contaminated epidurals that led to the fungal meningitis outbreak provide lessons in product and environmental control.

 · Firm shipped product before receiving sterility results (results were negative however).

· Firm didn't follow established standards for autoclaving and didn't keep products in the autoclave for the minimum 20 minutes needed to ensure sterility

· Firm didn't thoroughly clean powder hoods used to protect pharmacists while they prepare compounded substances. Investigators observed residual powder within the hood, which could lead to contamination of medications
· Mats designed to trap dirt and other contaminants were visibly soiled, and a leaking boiler next to the clean room caused water to pool around it and adjacent walls, creating conditions that could support contaminant growth, according to the findings.

In the report below, Massachusetts Governor Patrick states that over the years, some pharmacies have evolved from neighborhood drug stores to large-scale manufacturers that sell products across state lines, and that regulations in Massachusetts and at the federal level have not kept pace with the changes. He said that he had directed the pharmacy board to start making unannounced inspections of compounding pharmacies that make sterile injectable medications and strengthen penalties for pharmacies that don't comply with rules.

Not sure I want my local pharmacy making medicine, especially ones that can be injected in me. Dispensing medicine is one thing, but making it, no thanks.  

We see this type of thing in food companies as well…the firm expands into a niche outside of their core competency and grow the business, but never become technically competent in that new business. They fail to spend the capital on the facility needed to meet the requirements of producing that product. Then, as more product is shipped, the inevitable production error occurs, impacting far too many.


Report airs problems at firm linked to fungal meningitis outbreak
Lisa Schnirring Staff Writer
http://www.cidrap.umn.edu/cidrap/content/other/news/oct2412fungal2-jw.html

Oct 24, 2012 (CIDRAP News) – Massachusetts officials yesterday said New England Compounding Center (NECC), the firm linked to a multistate fungal meningitis outbreak, sent shipments from two of the recalled lots before it received sterility testing results. 

Investigators also found black particulate matter in several unopened vials of the recalled methylprednisolone acetate, which was used in epidural injections for back pain and injections for peripheral joint problems, according to a report of preliminary investigation findings.

Federal officials have said that as many as 14,000 patients could have been exposed to the recalled injections.

Nine more infections have been reported in the outbreak, raising the number of infections to 317, the US Centers for Disease Control and Prevention (CDC) said today in its latest update. One more death was reported, putting that total at 24, and the number of affected states held steady at 17. 

The CDC reported one more joint infection linked to the contaminated steroids, raising that number to five, and it said 54 cases have now been confirmed with lab tests. So far all but two of the infections involve Exserohilum rostratum, a type of black mold that hadn't previously been known to cause meningitis. 

In a press conference with reporters yesterday, Madeleine Biondolillo, MD, who directs the Massachusetts Department of Public Health's Bureau of Health Care Safety and Quality, said the investigation began on Sep 25 and involves collaboration with their colleagues at the US Food and Drug Administration (FDA) since Oct 1. She said the investigation is ongoing and that authorities have obtained evidence, reviewed NECC's standard operating procedures, probed the company's records, and interviewed its employees.

NECC didn't label the medications for specific patients, a violation of Massachusetts licensing regulations for compounding pharmacies, Biondolillo said.

According to the Massachusetts Department of Public Health (MDPH) investigation report, NECC's sterility tests on the shipments sent before results came in didn't show contamination. However, investigators said they were still exploring the adequacy of NECC's testing methods.

In addition, authorities found that the company didn't follow established standards for autoclaving and didn't keep products in the autoclave for the minimum 20 minutes needed to ensure sterility.

The report also says NECC didn't thoroughly clean powder hoods used to protect pharmacists while they prepare compounded substances. Investigators observed residual powder within the hood, which could lead to contamination of medications.

Mats designed to trap dirt and other contaminants were visibly soiled, and a leaking boiler next to the clean room caused water to pool around it and adjacent walls, creating conditions that could support contaminant growth, according to the findings.

At the media briefing, Massachusetts governor Deval Patrick said federal officials have launched a criminal investigation into NECC's actions and he announced more steps the state and its Board of Pharmacy have taken in response to the steroid contamination, including permanently revoking NECC's operating license and those of its three principal pharmacists.

"Those whose laboratory practices caused this outbreak should never practice pharmacy or manufacture in Massachusetts again," he said.

Patrick said that, over the years, some pharmacies have evolved from neighborhood drug stores to large-scale manufacturers that sell products across state lines, and that regulations in Massachusetts and at the federal level have not kept pace with the changes. He said that he had directed the pharmacy board to start making unannounced inspections of compounding pharmacies that make sterile injectable medications and strengthen penalties for pharmacies that don't comply with rules.

The state will now require compounding pharmacies in Massachusetts to submit annual production, volume, and distribution reports to make it easier for authorities to flag operations that are acting more like manufacturers, which require federal licensing and extra scrutiny, Patrick said. He added that the state will require compounding pharmacies to report interactions with federal regulators and will form a special commission to examine best practices in other states and what changes may be needed at the federal level.

Summary of the FDA Requirements for Food Facility Registration

The FDA has updated the registration process for food facilities and that registration is now open. According to the FDA, “Biennial Registration Renewal for Food Facilities began at 12:01 AM on October 22, 2012. The updated food facility registration system is accepting food facility registration renewals.” The registration, initially required under the Bioterrorism Act of 2002 was updated as part of the Food Safety Modernization Act of 2011.  

· It is required for any facilities, domestic or foreign that manufacture, process, pack, or hold food for human or animal consumption in the US, including those companies who produce products that do not enter interstate commerce.

· If you registered before, you must re-register

· Facilities must register from Oct 1 to Dec 31 of even numbered years (2012, 2014, etc) 

· Who does not need to register? Farms (that do not process), retail food establishments, restaurants, and non-profit that complies with 21 CFR 1.227(b) (7) and facilities that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the Federal Meat Inspection Act the Poultry Products Inspection Act or the Egg Products Inspection Act.);

· Email address for facility contacts now must be included.

· Registration information http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm


Food Facility Registration Requirements under the FDA Food Safety Modernization Act
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm324801.htm
October 19, 2012

The U.S. Food and Drug Administration (FDA) today issued further information and guidance regarding registration requirements for domestic and foreign manufacturers, processors, packers or holders of food for human or animal consumption based on changes made by the FDA Food Safety Modernization Act (FSMA) to the Federal Food, Drug, and Cosmetic Act (FD&C Act). The updated food facility registration system will become available at 12:01 a.m. Monday morning, October 22, 2012.

Food producers and manufactures have long been required to register with the Food and Drug Administration. There is no fee to register or renew the registration of a food facility. Facilities can register online, via mail or fax. FDA encourages online registration as a quick and efficient means for food facility registration.

The Food Safety Modernization Act improves the registration process by ensuring, among other things, that the FDA has accurate contact information for each facility. The new registration form also includes new categories of foods. These new categories will help FDA rapidly communicate with the right facilities in the event of an emergency.  

Biennial registration renewal will become available at 12:01 a.m. Monday morning, October 22, 2012. To submit a registration renewal to FDA, a food facility is required to submit required registration information to FDA, including the additional registration information described above. To facilitate this process, the agency is offering technical assistance online and through the help desk. Please check FDA’s food facility registration website for more information and to register online.

Underweight meat items results in fine

Kraft recently received some bad publicity for selling packages of food that were deemed underweight by Wisconsin Department of Agriculture. One can be certain that the company was not trying to take advantage of the consumer. Rather, issues happened during processing that impacted pack weight, in this case, the product may have been cooked a little more and thus drove off more moisture.

Each year, a company of two will be caught selling underweight units and then publicly chastised by the press. Each case occurs in roughly the same way. State officials, who regulate retail, pull a dozen or so product units from the store shelf and then weigh the contents of the package to see if those packages meet label weight. In this case, a number of units were below weight.   

In general, the companies try to minimize the give-away (weight above the stated label weight). Weight loss must be factored in (moisture loss through the package, purge, etc). Process variation must be calculated. Taking all this into account, a target weight is determined. Now there will be a few packages that are underweight, but in general, these conditions must be met. For any sample lot (a dozen or so units from a lot), the average weight must exceed label weight, the number of containers at or above weight must be greater than the number of units below weight, and no containers must be more than the MAV (maximum allowable variance).

Those who package food should be aware of Handbook 133 (good document to download and keep on file)
http://dps.sd.gov/licensing/weights_and_measures/images/NISTHandbook133.pdf


Kraft fined for underweight Oscar Mayer packageshttp://www.usatoday.com/money/industries/food/story/2012-05-08/kraft-fined-over-oscar-meyer-packaging-weight/54844906/1

MADISON, Wis. (AP)–Kraft Foods Group has paid a fine of nearly $37,000 to settle allegations of short-weight Oscar Mayer meats found in Wisconsin stores.

State inspectors found 24 packages of Oscar Mayer meats that were below their stated weight. The packages were found in Wisconsin stores between last August and this February.
An official of the Wisconsin Department of Agriculture, Trade and Consumer Protection calls the shortages "very significant."

None were packaged at the Madison factory of Oscar Mayer, which is based in Madison.

A Kraft spokeswoman tells the Wisconsin State Journal some oven heat changes and other manufacturing changes "resulted in unplanned and unwanted variances." She says corrections have been made.

As part of the civil forfeiture agreement, Northfield, Ill.-based Kraft did not admit to violating any Wisconsin laws.

Expanding the list of bad [foodborne disease causing] bacteria?

There is currently a push to put a zero tolerance on four strains of drug-resistant salmonella in uncooked meat (link below). This comes after the 2011 outbreak of Salmonella linked to ground beef where 20 people were reported to become ill. (http://www.cdc.gov/salmonella/typhimurium-groundbeef/020112/index.html). The responsible organism was a multi-drug resistant strain of Salmonella Typhimurium.

Another recent expansion was the addition of 6 strains of E. coli non-O157 STEC. Although the testing program was to go into effect in March of 2012, it was pushed pack to June of 2012. The reason relates to the lack of validated test methods to detect the specific pathogenic strains (link below).

Looking for a given bacterial species is difficult enough, but when we have to look for strains of bacteria containing specific genes, reliable testing is not always easy. Throw in the fact that the product being tested is raw, and that the prevalence of bacteria is very low, and it makes one question to what degree can we track and eliminate the sources. (For example, FSIS reports the prevalence of Salmonella in ground beef is about 2% (http://www.fsis.usda.gov/PDF/Progress_Report_Salmonella_Testing.pdf), and in a 2009 study by ARS, the level for MDR Salmonella was only 0.6% (http://www.ncbi.nlm.nih.gov/pubmed/19201965)).  

Will consumers benefit? Will public health be better served? Will regulatory requirements for zero tolerance be enforceable or achievable?

Interesting note, a consumer group recently requested that FDA put a zero tolerance of Vibrio vulnificus on oysters (http://cspinet.org/new/201202091.html) to help protect those who choose to consume raw oysters. Vibrio vulnificus is a natural contaminate in waters where oysters are harvested, especially in the warmer months. In most all cases, the organism affects those who have underlying medical condition, primarily past or present alcohol abuse. Are oyster fisherman going to start testing oysters before delivering to the local shuck house? Why not just make it illegal to consumer raw oysters?

Salmonella Outbreak Spurs Call to Expand List of Banned Bacteria
February 08, 2012, 1:59 PM EST
Bloomberg Businessweek
http://www.businessweek.com/news/2012-02-08/salmonella-outbreak-spurs-call-to-expand-list-of-banned-bacteria.html
By Stephanie Armour

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.”