FDA Prevents Sunland Foods from Reopening

FDA flexed its new regulatory muscle as granted through FSMA and shut down Sunland Foods, the maker of contaminated Trader Joe's Peanut Butter.  Sunland was planning to reopen the processing facility this week, but FDA suspended the facility's registration due to a 'reasonable probability' that their product could cause serious health problems.  Numerous issues in the facility had been cited (http://pennstatefoodsafety.blogspot.com/2012/11/fda-investigation-report-on-sunland.html) including FDA's assertion that Sunland knowingly shipped contaminated product.  Sunland denies this claim.  

Now it is up to the company to prove its case in court in order to resume operations.

FDA's decision to shut a facility down begins a new chapter for food processors and their interaction with FDA under FSMA.  Most consumers would probably agree that this facility deserved to be closed.  But we don't know to what degree the facility had made steps to improve since the initial recall back in late September.  (http://pennstatefoodsafety.blogspot.com/2012/09/supplier-of-trader-joes-peanut-butter.html)  Was Sunland Foods unable to get up to standard in the last 2 months, or were there issues so numerous and/or bad that FDA still deemed the facility a risk to consumers?   What will be interesting moving forward is how FDA will use this new power.  Will it be used as a preventive tool, shutting plants down before the products they produce causes illness?  And if so, to what degree of risk will federal inspectors be willing to accept?  Listeria in a drain?  Salmonella in a product that is not fully cooked?  Or will it be used as a punitive action - a way to make a facility involved in an outbreak prove that it has made the necessary changes?

 

FDA halts company's peanut butter operations

The FDA suspended Sunland's registration over salmonella concerns.

http://www.usatoday.com/story/news/nation/2012/11/26/fda-peanut-butter-salmonella/1728017/?sf7473491=1

USAToday Health and Wellness  6:17PM EST November 26. 2012 -
WASHINGTON (AP) — The Food and Drug Administration halted operations of the country's largest organic peanut butter processor Monday, cracking down on salmonella poisoning for the first time with the new enforcement authority the agency gained in a 2011 food safety law.
FDA officials found salmonella all over Sunland Inc.'s New Mexico processing plant after 41 people in 20 states, most of them children, were sickened by peanut butter manufactured at the Sunland plant and sold at Trader Joe's grocery chain. The FDA suspended Sunland's registration Monday, preventing the company from producing or distributing any food.
The food safety law gave the FDA authority to suspend a company's registration when food manufactured or held there has a "reasonable probability" of causing serious health problems or death. Before the food safety law was enacted early last year, the FDA would have had to go to court to suspend a company's registration.
Sunland had planned to reopen its peanut processing facility on Tuesday and a spokeswoman said before the

Dumb Ways to Die - Eating Poisonous Mushrooms

3 people died from eating wild mushrooms.  As you read the story below, please click on youtube link below for a little ditty that provides a nice accompaniment to the story.

http://www.youtube.com/watch?v=IJNR2EpS0jw&sns=em

Nov 21, 7:30 PM EST

3rd person dies in Calif. from mushroom poisoning

By TRACIE CONE
Associated Press

http://hosted.ap.org/dynamic/stories/U/US_MUSHROOM_DEATHS?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT&CTIME=2012-11-21-19-21-28

FRESNO, Calif. (AP) -- A third person has died from eating poisonous mushrooms at a California senior care facility where a caretaker found the fungus in the backyard and used it to make soup, authorities said Wednesday.

The 90-year-old man died on Saturday, state Department of Social Services spokesman Oscar Ramirez told The Associated Press. The Placer County Sheriff's Office identified him as Frank Warren Blodgett.

Ramirez said an official with Gold Age Villa in Loomis called Monday to report the third death. State officials are continuing to investigate the incident that sheriff's investigators have described as a terrible accident.

Three other people were sickened when they ate the soup made from the poisonous mushrooms on Nov. 8, including the caretaker who made it. Their conditions have not been made public.

FDA Investigation Report on Sunland Foods - Findings Very Troubling

FDA released the findings from the Sunland Food investigation.  This investigation was conducted after Trader Joe's peanut butter, which was made by Sunland, was linked to 41 cases of Salmonella in 20 states.
The findings are very troubling. (Each numbered bullet point references a spot in the report).

1. Company shipped product after their own testing found it to contain Salmonella.  Occurance in 11 lots.
2. Five lots tested and found to be negative by company were actually positive when tested by FDA.
3. 28 environmental samples were found to be positive for Salmonella.
4. The FDA tested and found shelled peanuts contaminated which resulted in Sunland expanding the recall to that product line.
5. Poor employee practice including the lack of hand washing.
6. No records for the documentation of cleaning processing equipment.
7. Reuse of sacks for both raw and finished product without cleaning.
8. Poor plant drainage systems that prohibited good cleaning.
9. Storage of raw peanuts allowed for cross contamination (birds were flying into the uncovered trailers.  Storage conditions also allowed for moisture and pest entry).

FDA Investigates Multistate Outbreak of Salmonella Bredeney Infections Linked to Peanut Butter made by Sunland Inc.

Posted November 21, 2012
http://www.fda.gov/food/foodsafety/corenetwork/ucm320413.htm

Updates

November 14, 2012 - FDA posts observations from recent inspection at Sunland Inc.  
The FDA has made the observations from its recent inspection of Sunland ^Inc.1 publicly available.  This inspection was conducted between September 17 and October 16, 2012, and became part of the investigation of the Salmonella Bredeney outbreak linked to peanut butter made by Sunland Inc.
During this inspection investigators found that conditions in the company’s facility, the company’s manufacturing processes, and the company’s testing program for Salmonella may have allowed peanut butter that contained Salmonella to be distributed by the company.

[1] The FDA found that between June of 2009 and August of 2012, Sunland Inc. had distributed, or cleared for distribution, portions of 11 lots, or daily production runs,  of peanut or almond butter after its own testing program identified the presence of at least one of nine different Salmonella types (Arapahoe, Bredeney, Cerro, Dallgow, Kubacha, Mbandaka, Meleagridis, Newport, and Teddington) in those lots.  Two of these lots showed the presence of the outbreak strain of Salmonella Bredeney.

[2] Equally important, five product samples collected and analyzed by FDA from Sunland Inc. showed the presence of Salmonella, but had not been identified as containing Salmonella by Sunland Inc.’s internal testing.  Among those products were peanut butter and shelled raw peanuts.  Two of these samples showed the presence of the outbreak strain of Salmonella Bredeney.

Fresh Express Recalls Bagged Greens..Again

Fresh Express is recalling bagged spinach for Salmonella after a sample, as part of USDA sampling program, came up positive.  There were no illnesses reported.

This is a reported fifth time a Fresh Express product has been recalled due to a pathogen positive test.  Why so many, the Oregonian Newspaper asks.  To be fair, there seems to be an increase in these type of recalls in produce overall.  Has the amount of testing increased?  Perhaps a government agency that was just a moment from being eliminated has picked up their game.  Or is it that bagged produce more likely to contain pathogens when compared to unprocessed greens?  But are unprocessed greens tested at the same level as bagged greens?  We do know that bagged chopped greens are considered a TCS food (temperature control for safety, or what used to be known as PHF, or potentially hazardous food).  This is because pathogens, if present, have better growth potential in the chopped greens compared to whole greens. So, there is a greater need to have no pathogens present in those products.  But to what degree is it possible to completely eliminate all pathogens while still maintaining a product that does not taste like sanitizer?  Remember, these greens are grown in fields, and birds and other critters will poop there.  So without a silver bullet to completely eliminate this bacterial risk, testing is bound to discover a positive from time to time thus resulting in a recall, and hopefully not an illness.  Processors of this type of product, therefore, need to put in controls and then manage those controls to minimize the risk. Retailers and consumers must control that product through proper refrigeration.

Salmonella in spinach: fifth Fresh Express recall in three months

Published: Friday, November 09, 2012, 9:12 AM Updated: Friday, November 09, 2012, 1:09 PM
Lynne Terry, The OregonianThe Oregonianhttp://www.oregonlive.com/health/index.ssf/2012/11/salmonella_in_spinach_fifth_fr.html
Fresh Express, which sells a variety of bagged greens, is recalling packaged spinach over salmonella.

This is the company's fifth recall of bagged greens since August over bacterial contamination. This time it is pulling spinach with a use-by date of Nov. 7 sold in 9 oz. packages. The potentially tainted spinach was sold to stores in 18 states, including Oregon, Washington Idaho and California.Fresh Express, owned by Chiquita Brands International Inc. in North Carolina, said in its recall notice on the Food and Drug Administration website that the contamination was spotted in a test by the U.S. Department of Agriculture.

Tiffany Breaux, a Chiquita spokeswoman, said in an email that the company reviewed its records and conducted an “intensive investigation" into the contamination. Apparently, its staff was unable to trace the source of the pathogens.

It's unclear where the greens were grown and where and how they were packaged. Breaux indicated that the recalls have not prompted any change in the company's food safety system.

In the past three months, Fresh Express has pulled bagged greens after positive bacterial tests by federal authorities. In October, the company recalled hearts of romaine salad tainted with salmonella. In September, it again pulled hearts of romaine salad but over listeria contamination. Also in September, it pulled leafy green romaine salad over listeria, and in August it recalled hearts of romaine over listeria.

Both salmonella and listeria can cause serious gastro-intestinal symptoms and even death. Listeria poses a particular threat to pregnant woman, causing still births and miscarriages.

Both bacteria can end up in a variety of food but bagged greens are considered high risk because of the possibility of contamination spreading when one tainted leaf of lettuce, for example, is mixed with other greens and packaged.

But so many recalls by one company in such a short time frame is unusual. The last time before August that Fresh Express pulled contaminated greens from the market was in April 2011 when it recalled 9 oz. bags of spinach tainted with salmonella.

 

Fresh Express Recalls Limited Quantity of 9 oz. Spinach Due to Possible Health Risk

http://www.fda.gov/Safety/Recalls/ucm327401.htm

Contact
Consumer
1 - (800) 242-5472

Media
Tiffany Breaux 1 - (704) 280-5938
Barbara Hines 1 - (972) 724-3049

FOR IMMEDIATE RELEASE - November 7 , 2012 - Charlotte, North Carolina - Fresh Express Incorporated is conducting a voluntary, precautionary recall of a limited quantity of Fresh Express Spinach with a Use-by Date of November 7 and Product Code of S299B25 due to a possible health risk from Salmonella.

No illnesses or consumer complaints have been reported to Fresh Express at this time in association with this recall. No other Fresh Express products are subject to this recall.

The recall notification is being issued out of an abundance of caution due to an isolated instance in which a random sample yielded a positive result for Salmonella under U.S. Department of Agriculture's random sample testing program. Fresh Express is coordinating closely with regulatory officials.

Fresh Express customer service representatives are already contacting relevant retailers to confirm the recalled product has been removed from store shelves and inventories and that none is available for consumer purchase. Customers with questions are instructed to contact their usual Fresh Express customer service representative. The recalled salads were distributed primarily in the Western region of the U.S.

Consumers who may have purchased the recalled salad are asked not to eat it, but to throw it out instead. Fresh Express is offering a full refund. Consumers with questions or who would like to secure a refund may call the Fresh Express Consumer Response Center at (800) 242-5472 during the hours of 8 a.m. to 7 p.m. Eastern Daylight Time.

Specific recall information follows:

• Product Being Recalled: Fresh Express Spinach in 9 oz. package
• Product Code: S299B25 (located in upper right corner on front of package)
• Use-by Date: November 7 (also located in upper right hand corner of package)
• Distribution: Primarily in the Western region of the U.S.

Salmonella is an organism that may cause fever, nausea, vomiting, abdominal pain and possibly bloody diarrhea in healthy individuals. It can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Consumers with these symptoms should consult their health care provider.

Fresh Express Precautionary Salad Recall-11/7/12
(No other Fresh Express Salads are included in this recall)

Brand	Product Name	Size	UPC	Production Code	Best If Used By Date	POSSIBLE DISTRIBUTION STATES
Fresh Express	Spinach	9 OZ.	0 71279-13204 4	S299B25	NOV7	AZ, CA, CO, HI, I D, KS, MO, MT, NE, NV, NM,OK,OR,SD, TX, UT, WA,WY

Nestle recalls Nesquick Chocolate Powder

Nestle is recalling Nesquick Chocolate Powder after the supplier of one the product’s ingredient issued a recall.  The ingredient, calcium carbonate, was being recalled due to the possible presence of Salmonella.  There have been no reports of illness.

 

Nestlé USA Announces Voluntary Recall of NESQUIK® Chocolate Powder

http://www.fda.gov/Safety/Recalls/ucm327533.htm

FOR IMMEDIATE RELEASE - November 8, 2012 - Nestlé USA announced the voluntary recall of limited quantities of Nestlé NESQUIK® Chocolate Powder in the 10.9, 21.8 and 40.7 ounce canisters. The voluntary recall is limited to only NESQUIK Chocolate Powder, which was distributed nationally. No other varieties of NESQUIK powder or any sizes or flavors of NESQUIK ready-to-drink are affected by this recall.

Nestlé is removing the canisters from distribution because the company was notified by an ingredient supplier, Omya Inc. that it has issued a recall of certain lots of its ingredient, calcium carbonate due to possible presence of Salmonella. Calcium carbonate is used in NESQUIK as an ingredient. There have been no reports of any illnesses or adverse health effects associated with the affected product.

To ensure the safety of consumers, Nestlé is recalling selected NESQUIK Chocolate Powder. The recall is limited to the following sizes, UPC and production codes of NESQUIK Chocolate Powder:

Size	UPC Code	Production Codes
40.7 oz. Chocolate (72 servings)	0 28000 68230 9	2282574810 2282574820
21.8 oz. Chocolate (38 servings)	0 28000 68090 9	2278574810 2278574820 2279574810 2279574820 2284574820 2284574830 2285574810 2285574820 2287574820 2289574810 2289574820
10.9 oz. Chocolate (19 servings)	0 28000 67990 3	2278574810

The affected NESQUIK Chocolate Powder was produced during early October, 2012. To locate the production code, consumers should look on the bottom of the canister, adjacent to the consumer expiration date. All affected products have an expiration date of BEST BEFORE Oct 2014.

Consumers who may have purchased the affected NESQUIK Chocolate Powder should not consume it, but instead should return it to the place of purchase for a full refund or contact Nestlé Consumer Services at (800) 628-7679.

The most common symptoms of Salmonella infection are diarrhea, abdominal cramps and fever, which develop within eight to 72 hours of eating or drinking contaminated food. The illness usually lasts for four to seven days and most people recover without treatment. However, salmonellosis can be severe or even life threatening for infants, older people, pregnant women and those with weakened immune systems. Individuals experiencing these symptoms should seek medical attention.

Nestlé is dedicated to the health and safety of its consumers. For these reasons, the company initiated this voluntary recall. We apologize to our consumers and sincerely regret any inconvenience created by this incident.

Wegmans spinanch salad mix and Bolthouse sliced carrots recalled

There are two produce related recalls.

 - Wegman’s is recalling it Organic Spinach and Spring Mix Blend after it was linked to now 19 cases of E. coli O157:H7 cases in New York. The product was co-packed for Wegman’s by Massachusetts based Spring Garden. The product was sold between Oct 14th and Nov 1st.

 - Bolthouse Foods of Bakersfield CA is recalling carrot chips. A sample of the carrot chips were tested by NC Health and found to be positive for Salmonella. There have been no reported illnesses. Product was co-packed for store brands including Safeway Farms and Supervalu’s Farm Stand.


Three more E. coli cases added to outbreak
Wegmans recalled spinach and spring mixes due to outbreak

Democrat and Chronicle.com 10:05 PM, Nov 5, 2012http://www.democratandchronicle.com/article/20121105/NEWS01/311050058

Three additional cases of E. coli have been linked to organic spinach and spring mix blends sold by Wegmans Food Markets.

Guideance for Food Operations Exposed to Floods and Hurricanes

When a major disaster strikes, the safety of food becomes a major question.  In some cases refrigeration is lost for several days, in other cases, food is exposed to contaminated water.

For consumers, careful evaluation is needed for those foods stored in a the refrigerator or freezer that has lost electrical power ( http://extension.psu.edu/food-safety/news/2012/power-outages-and-freezer-failures , http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm076881.htm) and what to do when returning to a home that has been in a hurricane or flood (http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm076993.htm).

For businesses that handle food, FDA provides guidance for disasters.

·        Handling of food items exposed to flood waters (http://www.fda.gov/Food/FoodDefense/Emergencies/FloodsHurricanesPowerOutages/ucm112723.htm).  It is important to note that jars with screw tops and bottles with crimp lids (beer and soda bottles) be destroyed.  The reason for this is that debris may become lodged in the space between the cap and jar.   

·        Disposal of food items (http://www.fda.gov/Food/FoodDefense/Emergencies/FloodsHurricanesPowerOutages/ucm112717.htm)

·        Restaurants and Grocers reopening after flood or hurricane (http://www.fda.gov/Food/FoodDefense/Emergencies/FloodsHurricanesPowerOutages/ucm112713.htm)

·        Decontamination of transport vehicles (http://www.fda.gov/Food/FoodDefense/Emergencies/FloodsHurricanesPowerOutages/ucm112728.htm).

·        Water subject to a boil advisory (http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodDefenseandEmergencyResponse/ucm211373.htm).

·        Crops (http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodDefenseandEmergencyResponse/ucm274683.htm).

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.