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Oahu Hepatitis A Outbreak Spikes to Nearly 100

doh-largeThe Hawaii Department of Health (HDOH) is investigating a cluster of hepatitis A infections on Oahu.  HDOH staff are conducting interviews with the cases in an effort to identify the source of infection.

Identifying the source of infection continues to be a challenge because of the long incubation period of the disease and the difficulty patients have in accurately recalling the foods consumed and locations visited during the period when infection could have taken place.

Healthcare providers have been informed and are asked to notify HDOH immediately if they have a patient they suspect may be infected.

Individuals who are interested in being vaccinated should contact their healthcare providers.

As of July 26, 2016*:Since the last update, HDOH has identified 19 new cases of hepatitis A.  All cases have been in adults, 29 have required hospitalization.

All of the cases were on Oahu during their exposure period. Four individuals now live on the islands of Hawaii, Kauai, and Maui.

CONFIRMED CASES OF HEPATITIS A
93

Onset of illness has ranged between 6/12/16 – 7/19/16.

Unvaccinated contacts of cases should talk to their healthcare providers about the possibility of receiving hepatitis A vaccine or immune globulin, which may provide some protection against the disease if administered within the first two weeks after exposure.

A contact is defined as:

  • All unvaccinated household members
  • All unvaccinated sexual contacts
  • Anyone sharing illicit drugs with a case
  • Anyone sharing food or eating or drinking utensils with a case
  • Anyone consuming ready-to-eat foods prepared by an infectious food handler with diarrhea or poor hygiene

Note: A food handler is any person who directly prepares, serves, or handles food.

Unvaccinated food handlers who are contacts of cases must have a negative hepatitis A IgM test before they return to work.

An employee of the following food service business(es) has been diagnosed with hepatitis A. This list does notindicate these businesses are sources of this outbreak; at this time, no infections have been linked to exposure to these businesses. The likelihood that patrons of these businesses will become infected is very low. However, persons who have consumed food or drink products from these businesses during the identified dates of service should contact their healthcare provider for advice and possible preventive care.

Establishment Island Location Dates of Service
Baskin-Robbins Oahu Waikele Center June 17, 18, 19, 21, 22, 25, 27, 30, and July 1 and 3, 2016
Sushi Shiono Hawaii Waikoloa Beach Resort, Queen’s MarketPlace (69-201 Waikoloa Beach Drive) July 5-8, 11-15, and 18-21, 2016
Taco Bell Oahu Waipio (94-790 Ukee Street) June 16, 17, 20, 21, 24, 25, 28, 29, 30, and July 1, 3, 4, 6, 7, and 11, 2016

 

Hepatitis A:  Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Hepatitis A outbreaks. The Hepatitis A lawyers of Marler Clark have represented thousands of victims of Hepatitis A and other foodborne illness outbreaks and have recovered over $600 million for clients.  Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.  Our Hepatitis A lawyers have litigated Hepatitis A cases stemming from outbreaks traced to a variety of sources, such as green onions, lettuce and restaurant food.  The law firm has brought Hepatitis A lawsuits against such companies as Subway, McDonald’s, Chipotle, Quiznos and Carl’s Jr.

If you or a family member became ill with a Hepatitis A infection after consuming food and you’re interested in pursuing a legal claim, contact the Marler Clark Hepatitis A attorneys for a free case evaluation.

It is Past Time to Vaccinate Restaurant Employees – Hawaii is Latest Example

Pay the $50 to protect your employee and customers – especially in a State that survives in part on tourism.

Last week the Hawaii State Department of Health (DOH) reported a confirmed case of Hepatitis A in a food service employee at the ice cream specialty store, Baskin-Robbins, located at the Waikele Center in Waipahu. The department is advising persons who consumed any food or drink products from this store between June 17 and July 3, 2016 (actual dates: June 17, 18, 19, 21, 22, 25, 27, 30, and July 1 and 3) they may have been exposed to the disease.

Today DOH has confirmed a new case of hepatitis A infection in a food service employee. The employee worked at the fast food restaurant, Taco Bell, located in Waipio at 94-790 Ukee Street. The department is advising persons who consumed any food or drink products from this store from June 16 through July 11, 2016 (actual dates: June 16, 17, 20, 21, 24, 25, 28, 29, 30, and July 1, 3, 4, 6, 7, and 11) that they may have been exposed to the disease.

These individuals appear to be two in a growing number of ill reported to DOH. Since the outbreak began, there have been 52 cases of hepatitis A reported to and now confirmed by DOH. All cases have been in adults on Oahu, 16 have required hospitalization.  One man is reported to need a liver transplant.

And, it is not like we have not seen this before:

Hardly a month passes without a warning from a health department somewhere that an infected food handler is the source of yet another potential hepatitis A outbreak. Absent vaccinations of food handlers, combined with an effective and rigorous hand-washing policy, there will continue to be more hepatitis A outbreaks. It is time for health departments across the country to require vaccinations of food-service workers, especially those who serve the very young and the elderly.

Hepatitis A is a communicable disease that spreads from person-to-person. It is spread almost exclusively through fecal-oral contact, generally from person-to-person, or via contaminated food or water. Hepatitis A is the only foodborne illness that is vaccine-preventable. According to the U.S. Centers for Disease Control and Prevention (CDC), since the inception of the vaccine, rates of infection have declined 92 percent.

CDC estimate that 83,000 cases of hepatitis A occur in the United States every year, and that many of these cases are related to food-borne transmission. In 1999, more than 10,000 people were hospitalized due to hepatitis A infections, and 83 people died. In 2003, 650 people became sickened, four died, and nearly 10,000 people got IG (immunoglobulin) shots after eating at a Pennsylvania restaurant. Not only do customers get sick, but also businesses lose customers or some simply go out of business.

Although CDC has not yet called for mandatory vaccination of food-service workers, it has repeatedly pointed out that the consumption of worker-contaminated food is a major cause of foodborne illness in the U.S.

Hepatitis A continues to be one of the most frequently reported, vaccine-preventable diseases in the U.S., despite FDA approval of hepatitis A vaccine in 1995. Widespread vaccination of appropriate susceptible populations would substantially lower disease incidence and potentially eliminate indigenous transmission of hepatitis A infections. Vaccinations cost about $50. The major economic reason that these preventive shots have not been used is because of the high turnover rate of food-service employees. Eating out becomes a whole lot less of a gamble if all food-service workers faced the same requirement.

According to CDC, the costs associated with hepatitis A are substantial. Between 11 percent and 22 percent of persons who have hepatitis A are hospitalized. Adults who become ill lose an average of 27 days of work. Health departments incur substantial costs in providing post-exposure prophylaxis to an average of 11 contacts per case. Average costs (direct and indirect) of hepatitis A range from $1,817 to $2,459 per case for adults and from $433 to $1,492 per case for children younger than 18. In 1989, the estimated annual direct and indirect costs of hepatitis A in the U.S. were more than $200 million, equivalent to more than $300 million in 1997 dollars.  A new CDC report shows that, in 2010, slightly more than 10 percent of people between the ages of 19 and 49 got a hepatitis A shot.

Vaccinating employees make sense.  It is moral to protect customers from an illness that can cause serious illness and death. Vaccines also protect the business from the multi-million-dollar fallout that can come if people become ill or if thousands are forced to stand in line to be vaccinated to prevent a more serious problem.

UK E. coli Outbreak Linked to Salad – 155 sick with 2 dead

On 14 July Public Health England (PHE) is continuing to investigate an outbreak of E. coli O157, which appears to be associated with eating mixed salad leaves.

Following the last update on 5 July, PHE can now confirm that 151 cases of this strain of E. coli have been identified (figure correct as at 13 July 2016). This is 144 in England, 6 in Wales and 1 in Scotland, with the South West of England particularly affected. 62 of the cases are known to have received hospital care and sadly, 2 of the individuals with E.coli O157 infection have died.

Dr Isabel Oliver, director of PHE’s field epidemiology service, said:

PHE has been working to establish the cause of the outbreak and has identified that several of the affected individuals ate mixed salad leaves including rocket leaves prior to becoming unwell. Currently, the source of the outbreak is not confirmed and remains under investigation; we are not ruling out other food items as a potential source.

PHE is using various approaches including whole genome sequencing (WGS) technologies to test samples from those affected. WGStechnologies are at the forefront of improving the diagnosis of infectious diseases and this testing has indicated that the strain involved is likely to be an imported strain, possibly from the Mediterranean area.

PHE is also working closely with the Food Standards Agency to trace, sample and test salad products grown in the UK and other parts of Europe. All food sample results to date have been negative for E.coli O157, but it’s important to be aware that where food has been contaminated with E.coli O157, it is not always possible to identify the bacteria on food testing.

As an additional precautionary measure, we have advised a small number of wholesalers to cease adding some imported rocket leaves to their mixed salad products pending further investigations.

Custer Pizza Works Tied to Hepatitis A Worry

pizza-works_1133142A case of hepatitis A has been reported in a food handler at the Pizza Works restaurant in Custer. The food handler worked shifts between June 19 and July 5. Individuals who ate at the restaurant during that time period should contact their health care provider to determine if they need a shot of immune globulin which minimizes their chances of becoming ill or if they should be considered for vaccination.

Pizza Works is cooperating with the department on the investigation.

Hepatitis A is a liver disease caused by a virus. The virus can be carried on an infected person’s hands and can be spread by direct contact, or by consuming food or drink that has been handled by the individual.

Symptoms may include fatigue, poor appetite, fever, abdominal discomfort, and vomiting. Urine may become darker, and then jaundice (a yellowing of the skin and eyes) may appear. The disease is rarely fatal and most people recover in a few weeks without any complications. Infants and young children tend to have very mild symptoms and are less likely to develop jaundice than are older children and adults. Not everyone who is infected will have all of the symptoms.

The single most effective way to prevent the spread of hepatitis A is careful hand-washing after using the toilet. Also, infected people should not handle foods during the contagious period, which begins two weeks before symptoms appear and extends a few days after jaundice appears.

US Attorney Shuts Down Tofo Manufacturer

tofu-featuredThe U.S. District Court for the Eastern District of California entered a consent decree of permanent injunction against Wa Heng Dou-Fu & Soy Sauce Corporation doing business as Wa Heng Dou-Fu & Soy Sauce International Enterprises (Wa Heng) and the firm’s co-owners, Peng Xiang “Martin” Lin and Yuexiao “Opal” Lin, to prevent the distribution of adulterated and misbranded soy products, the Department of Justice announced today.

The Department filed a complaint in the Eastern District of California on June 17, at the request of the U.S. Food and Drug Administration (FDA). The complaint alleged that the defendants violated the Food, Drug and Cosmetic Act by causing food that is held for sale after shipment of one or more of its components in interstate commerce to become adulterated and misbranded. According to the complaint, the defendants have an extensive history of operating their food manufacturing facility under insanitary conditions, failing to follow current good manufacturing practice requirements and misbranding their food products.

“The American public deserves to be assured that companies and individuals preparing and distributing food subject to the Food, Drug and Cosmetic Act are complying with federal law,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Department of Justice’s Civil Division. “The Department of Justice will continue to work aggressively with the FDA to ensure a safe food supply.”

As detailed in the complaint, the company receives, prepares, processes, manufactures, packs, labels, holds and distributes soy products including fried tofu, firm tofu, seasoned tofu and soy drinks. The complaint alleged that Martin Lin’s responsibilities include the firm’s daily operations, raw material purchases, facility and equipment maintenance and production schedule and that Opal Lin’s responsibilities include training employees and overseeing employee performance.

In conjunction with the filing of the complaint, the defendants agreed to settle the case and to be bound by a permanent injunction that requires Wa Heng to cease all food preparation, manufacturing and distribution. If the defendants seek to resume preparing, manufacturing and distributing food, they must implement remedial measures set forth in the injunction, notify FDA of the measures taken, and receive written notification from FDA that they appear to be in compliance with the remedial requirements set forth in the injunction and the Food, Drug and Cosmetic Act.

According to the complaint, the defendants had a history of repeated violations. A 2015 inspection by FDA documented that the defendants failed to take reasonable precautions to ensure that production procedures do not contribute to contamination from any source. For example, as alleged in the complaint, FDA observed at least three employees spraying pressurized water from a water hose onto the production area floor, where FDA isolated Salmonella Havana, causing water to splash from the floor onto uncovered tofu and onto food contact surfaces, such as tofu presses and a filtration table. This was a repeat observation from the FDA’s 2012 inspection. In addition, FDA observed employees touching the bottoms of buckets and crates that had been on the floor and then touching tofu. The hand wash sink in the production room had no hot water because the valve had been turned off and the sink was inaccessible due to crates in front of it. This was also a repeat observation from the 2012 inspection.

According to the complaint, the most recent inspection also found that the defendants failed to maintain equipment and utensils in an acceptable fashion through appropriate cleaning and sanitizing. FDA observed spray hose nozzles, air valves, water valves and light switches that contained heavy residue, as well as a tofu cutting knife that was placed on top of a tofu press with greenish-brown buildup and then used to slice tofu.

Further, the complaint alleged that during the 2015 inspection, FDA conducted environmental sampling of the facility and five subsamples tested positive for pathogenic Salmonella Havana. According to the complaint, the positive samples were taken from, among other places, a floor drain near a cooking tank, a caster wheel on a cart carrying tofu and the floor between the packing and processing rooms. As noted in the complaint, FDA isolated a nearly identical strain of Salmonella Havana during its 2011 and 2012 inspections.

During the 2015 inspection, FDA also collected samples of the defendants’ product labeling. The complaint alleges that the defendants’ products are misbranded because, among other things, some of the firm’s soy products fail to include a label containing an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count.

“Firms and individuals that violate federal food safety regulations pose a danger to public health,” said Acting U.S. Attorney Phillip A. Talbert of the Eastern District of California. “The Department will not hesitate to hold companies and individuals accountable in order to protect the American people from adulterated food.”

The government is represented by Trial Attorney Raquel Toledo of the Civil Division’s Consumer Protection Branch, with the assistance of Assistant U.S. Attorney Colleen Kennedy of the Eastern District of California and Associate Chief Counsel for Enforcement Charlotte Hinkle of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.

Whole Foods Hit With Food Safety Warning Letter

June 8, 2016
John Mackey, Co-Chief Executive Officer
Walter Robb, Co-Chief Executive Officer
Whole Foods Markets Inc.
550 Bowie Street
Austin, TX 78703
Dear Mr. Mackey & Mr. Robb:
The U.S. Food and Drug Administration (FDA) inspected your multiple food manufacturing facility, Whole Foods Market North Atlantic Kitchen, 9 Commercial St, Suite 300, Everett, MA 02149-5506, on February 10, 11, 16, 18, & 26, 2016. The inspection found serious violations of the FDA’s Current Good Manufacturing Practice (cGMP) regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the food products manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code(U.S.C.) § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You can find the Act and its implementing regulations on FDA’s home page at www.fda.gov.
The serious cGMP violations noted during the inspection were outlined on a Form FDA-483, Inspectional Observations, issued to Mr. Brian Corbley, Facility Team Leader at the close of the inspection. A copy is enclosed for your review. Those violations include the following:
1.    Your firm failed to manufacture, package and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination as required by 21 CFR 110.80(b)(2). Specifically, we observed:
  • On February 10, 2016, you were mixing ready to eat pesto pasta directly under an area in the Assembly Room where condensate from ceiling joints was dripping onto the surface below.
  • On February 16, 2016, you were storing an uncovered rack of ready to eat mushroom quesadilla in the same area of the Assembly Room where condensate from ceiling joints was dripping onto the surface below.
  • On February 10, 2016, your employee transported uncovered ready to eat vegetables through a doorway, from the Veg Prep Room into the Prepared Veg Cooler. A significant amount of condensate had formed above the doorway and was dripping onto the surface below.
  • On February 10, 2016, your employee was cutting chives and beets on a work surface directly underneath a leaking condensate drainage pipe in the Veg Prep Room.
  • On February 16, 2016, you were holding uncovered ready to eat egg salad in large white barrels that were placed in an area below the condenser. Condensate was observed to be dripping at a rate of approximately once per second from the condenser fan bolts in the K8/K9 Room.
  • On February 16, 2016, your employee transported uncovered ready to eat couscous through an area in the K8/K9 Room where condensate was dripping from an area around the condenser fan bolts at a rate of approximately once per second.
  • On February 10, 16, & 18, 2016, you were holding ready to eat vegetables, utensils such as cutting boards, mandolins, stainless colanders and yellow plastic totes in close proximity to hand a washing station in the Veg Prep Room. The hand washing station does not have splash guards and is foot operated releasing water from the faucets with significant pressure causing water to splash outside the sink while employees were observed washing soiled hands. Water splashed onto covered and uncovered ready to eat vegetables, utensils and food containers.
  • On February 16, 2016, your employee measured the strength of peracetic acid from the faucet in the Veg Prep Room with an (b)(4) Peracetic Acid test strip that indicated its strength over 160 ppm (maximum level on the test strip). This concentration exceeds the maximum level recommended by the (b)(4) product information sheet and the maximum level allowed under 21 CFR Part 173.315(a) (5) for use of peracetic acid for surface treatment and soaking and rinsing of vegetables.
  • On February 16, 2016, your employee was performing multiple tasks in the Pre-Pack Room including filling and weighing ready to eat egg salad in retail packs. The employee was observed cleaning and directly contacting work surfaces and then packaging and handling exposed product without hand washing or changing gloves in between tasks.
  • On February 16, 2016, your employee in the Bulk-Pack Room was observed assembling bulk cartons while also packaging exposed ready to eat quinoa cakes without hand washing or changing gloves in between tasks.
  • On February 16, 2016, your employee in the Pre-Pack Room was spraying (b)(4) quaternary ammonium based sanitizer to clean work surfaces while another employee in close proximity was packaging exposed ready to eat mesculin salad. This resulted in the sanitizer being sprayed onto an open colander of salad leafy greens.
  • On February 16, 2016, your employee’s unprotected upper sleeves were frequently touching ready to eat leafy salad greens as leafy salad greens were packaged into retail packs in the Pre-Pack Room.
2.    Your firm failed to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing as required by 21 CFR 110.80(b)(1). Specifically, on February 10, 2016 we collected an environmental sample (INV 911932), which consisted of one hundred (100) swabs/subs, from food contact and non-food contact surfaces throughout your manufacturing facility. FDA laboratory analysis of these subs confirmed the presence of non-pathogenic bacteria Listeria welshimeri in swab #39. Swab #39 was collected from the internal rotating drum portion, a food contact surface, of the (b)(4) vegetable chopping machine located in the Veg Prep Room. The presence of Listeria spp., such as the non-pathogenic Listeria welshimeri, detected on a food contact surface in your manufacturing facility is specifically used as an indicator for the probable presence of Listeria monocytogenes in your processing environment. This finding demonstrates that conditions exist in and on your equipment that would support the presence and growth of Listeria monocytogenes and indicates that your cleaning and sanitation practices may not be adequate. Your firm should consider improving your environmental monitoring program to verify the adequacy of your cleaning and sanitation operation.
3.    Your firm failed to sanitize and thoroughly dry, prior to use, food-contact surfaces which have been wet cleaned as required by21 CFR 110.35(d)(1). Specifically,
  • On February 16, 2016, you filled the dip tank for soaking sheet pans (used for raw meats and ready to eat in process and finished products) with a quaternary ammonium based sanitizing agent. You measured the sanitizer strength using a color based test strip which indicated the sanitizer strength at 100ppm. This strength is not adequate for sanitizing foodcontact surfaces and the manufacturer recommended limit of the sanitizing product you were using was identified as 200-400ppm.
  • On February 16, 2016, you measured the sanitizer strength on the spray nozzle located in the dish washing room that is used for filling the dip tank and for sanitizing larger portable equipment such as the rotating blades of (b)(4) machine and Ribbon Blender parts. The color based test strip indicated the sanitizer strength to be 100ppm. This strength is not adequate for sanitizing foodcontact surfaces and the manufacturer recommended limit of the sanitizing product you were using was identified as 200-400ppm.
  • On February 16, 2016, you did not clean and sanitize the semi-permanent divider curtain in the K8/K9 Room after using a high pressure spray hose to clean and sanitize the ribbon blender and the walls and floors surrounding the ribbon blender.
  • On February 10, 2016, you were storing various utensils and equipment parts inside containers and on rolling carts that had pooling water in or on them.
4.    Your firm failed to take proper precautions to protect food and food-contact surfaces from contamination with chemicals, filth and extraneous materials due to deficiencies in plant design as required by21 CFR 110.20(b)(2). Specifically, we observed:
  • You failed to keep soiled dishes separate from ready to eat products and you are using portable divider curtains and semi-permanent divider curtains to segregate areas between the dishwashing room entrance/exit doors and the Assembly Room where ready to eat products are assembled. Soiled and insanitary equipment from various preparation processes including holding of raw chicken and turkey were observed touching both sides of the portable divider curtains.
  • On February 10 & 16, 2016, your employees in the K8/K9 Room used high pressure hoses to clean the ribbon blender and the semi-permanent divider curtains, causing water and aerosolized spray from the cleaning activity to go beyond the portable divider curtains and the semi-permanent divider curtains into areas where ready to eat food such as couscous and salad dressings were being prepared.  The portable and semi- permanent divider curtains did not provide adequate protection of ready to eat food when high pressure hoses are used to clean and sanitize clean-in-place equipment and the portable and semi-permanent divider curtains.
  • On February 10 & 16, 2016, soiled/unclean equipment , utensils and food containers had accumulated beyond the entrance of the dish washing room and portable divider curtains separating the dish washing room and the Assembly Area. This resulted in soiled/unclean equipment, utensils and food containers to be held for an indefinite period of time in close proximity to ready to eat manufacturing activities such as making of enchiladas, mixing of pesto pasta and quesadillas.
5.    Your firm’s hand-washing facilities lack running water of a suitable temperature as required by 21 CFR 110.37(e). Specifically, on February 16, 2016 the hand washing station located at the entrance of the K8/K9 Room did not have warm/hot water. Your employees returning from break and other non-food related tasks continued to use this tagged “out of service, no hot water, 2/16/16” hand washing sink before returning to preparing and handling ready to eat foods.
6.    Your firm failed to properly identify toxic sanitizing agents in a manner that protects against contamination of food as required by 21 CFR 110.35(b)(2). Specifically, we observed an unmarked drum of an unidentified chemical that was connected to the vegetable preparation sink in the Veg Prep Room. It was verbally identified as peracetic acid to be used to soak vegetables.
The above is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure your establishment is in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective actions may subject your firm and products to further actions, such as injunction, or seizure.
Further, Section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
We acknowledge receipt of your March 17, 2016 written response to the FDA Form-483 Inspectional Observations, issued to your firm on February 26, 2016. This response states that your firm takes these observations seriously and that your senior leadership is committed to take all the necessary measures to correct all the deficiencies. Despite this, FDA has serious concerns that our investigators found your firm operating under these conditions. Further, your response includes retraining of employees as a corrective action for most of the observed violations but you failed to mention adequate supervision over your specialized food processing operations and how retraining will ensure sustained compliance. 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.
Please notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above. As stated above, your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 781-587-7619 or by email at scott.loughan@fda.hhs.gov.
Sincerely,
/S/
Joseph Matrisciano Jr.
District Director
New England District

Smithsonian’s National Petting Zoo Closed Due to E. coli

The Smithsonian’s National Zoo has temporarily closed the Kids’ Farm exhibit because E. coli stx 1 gene bacteria was discovered in a few of the animals. The animals are now being managed under quarantine protocols. At this time, no staff have been affected and no animals are showing any signs of disease. While E. coli exists all around us, and even in us, some types of E. coli are “pathogenic,” meaning they can cause illness.

Zoo veterinarians detected the original presence of the E. coli stx 1 gene bacteria in the goats through a routine fecal screening process Feb. 18. The goats were moved into the barn and managed separately from the other animals and visitors. Individual fecal cultures were performed Feb. 22. Last Friday, Feb. 26, results revealed that four goats and one cow were positive. Based on these results, the Kids’ Farm was immediately quarantined and staff started appropriate protective measures, including treating all the farm animals with antibiotics. The animal care team is consulting with experts from the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service and the D.C. Department of Health.

All public contact animals–goats, cows, alpacas and donkeys–were negative for E. coli stx 1 at the last routine testing in December 2015. The bacteria is passed fecal-orally, and it could have been transferred to the goats and cow from a wild animal, from humans or through a food source. The types of E. coli that can cause diarrhea in humans can be transmitted through contaminated water or food, or through contact with infected animals or persons.

“As most people know, E. coli is everywhere in our environment,” said Brandie Smith, associate director of animal care sciences. “Because it is so common, we routinely test our animals. It’s unfortunate that we have to close the Kids’ Farm temporarily, but we’re taking the right preventative measures for our guests, staff and the animals.”

The team will monitor all the animals extremely closely, continue weekly fecal testing and provide the usual high-quality care during this quarantine period. When Zoo veterinarians receive three consecutive weeks of negative test results, the team will start the planning for lifting the quarantine and reopening the Kids’ Farm.

Sandy Cinema Link in Hepatitis A Worry

logoClackamas County Public Health officials are investigating an incident of potential exposure to Hepatitis A at a Sandy movie theater.

People who attended the Sandy Cinema, at 16605 Champion Way in Sandy, and ate or drank from the concession stand during certain days and hours earlier this month may have been exposed.

The specific days and hours in question are:

  • Feb. 12: 11 a.m. to closing
  • Feb. 13: 6 p.m. to closing
  • Feb. 14: 2 p.m. to closing
  • Feb. 15: 1:30 p.m. to closing

Clackamas County Public Health is advising people who may have been exposed to check their immunization status, and if they have not been immunized against Hepatitis A, to obtain medication that can decrease their chances of becoming ill. These are effective for up to two weeks after exposure.

The medication should not be given if more than two weeks have passed.

  • Those individuals aged 1 to 40, who have not previously received the Hepatitis A vaccine, are recommended to get a single dose of the vaccine. Twinrix (which is a combination Hepatitis A and B vaccine) is not appropriate for this purpose.
  • For those individuals less than 12 months old or over 40, vaccine is not approved. They are recommended to receive immune globulin shots.

Clackamas County Public Health also has established a call-in line to provide information. The call-in number is 503-742-5320. The call center will be active through 7 p.m. tonight and from 9 a.m. to 4 p.m. Saturday.

Clackamas County is updating inventories in the region to assure there is adequate supply. For questions about where to find vaccine please contact the call center.

Medications will also be made available Tuesday, Wednesday and Thursday, Feb. 23 through Feb. 25 at Legacy Medical Group Firwood, 36860 Industrial Way, Sandy, from 6:30 to 9 p.m.

The Hepatitis A case was first reported to Clackamas County Public Health late on February 17.

Public Health officials said theater owners have been fully cooperative and stressed that the risk to the public is extremely low and there is no continued risk to the public.

“This recommendation for treatment doesn’t apply to people who ate at Sandy Cinema on other days,” said Dr. Sarah Present, Clackamas County Public Health Officer. ”We know the likelihood of infection is low but we are recommending vaccinations for exposed persons because the risk is not zero and there are effective medications that can further decrease the risk of illness.”

Hepatitis A is a viral disease of the liver that is contagious. It is spread from person to person, often by inadequate handwashing after using the toilet or changing diapers, or eating food prepared by an infected person.

Typical symptoms include fatigue, fever, and loss of appetite, abdominal pain, nausea, vomiting, or jaundice (a yellowing of the skin or eyes). Some infections may be mild but it can develop into severe liver disease. Symptoms usually develop 3-4 weeks after exposure but it may be up to 50 days.

For more information, go to the Clackamas County Public Health Division web page at: www.clackamas.us/publichealth/

Johnny Ray’s Implicated in Salmonella Outbreak

Screen Shot 2016-01-08 at 5.38.48 PMThe Alabama Department of Public Health is investigating a foodborne outbreak in Pelham, Ala.

Four individuals who had eaten at Johnny Ray’s in Pelham, Alabama (309 Huntley Parkway) tested positive for Salmonella. Two have matching patterns of a rare Salmonella Enteritidis.  Other potential cases of Salmonella are being investigated. As of January 8, 2016, the restaurant was closed by emergency order, following visits by the Bureau of Environmental Services on December 15 and 22, and January 6.

Symptoms of salmonellosis include diarrhea, nausea and vomiting, abdominal cramping, and fever and usually occur within 6 and 72 hours after ingestion.  Most people recover without treatment.

Dr. Mary G. McIntyre, State Epidemiologist, recommends that people reduce their risk of Salmonella by avoiding raw or undercooked eggs, poultry or other meats, thoroughly washing produce, and following safe food handling practices during food preparation. Hand washing, keeping uncooked food away from cooked food, and using clean plates and utensils are some important ways to minimize food contamination.  People should also wash their hands after contact with animals and animal feces.

The investigation is ongoing and final test results will be available at a later date.

Hundreds, Thousands, Get Hepatitis A Vaccines After McDonalds Exposure

5647ba128ed92.imageMike Hibbard of the Finger Lakes Times reports that if there was any question about how seriously people are taking a confirmed case of hepatitis A in a McDonald’s worker, it was answered by a drive to Mynderse Academy on Saturday afternoon.

Parking lots at the school were full and a long line snaked out of a school entrance as hundreds — if not thousands — of people flocked to the school for a vaccine clinic. That came after the Seneca County Public Health Department confirmed the case Thursday.

“If they have a concern, they will get immunized,” said Vickie Swinehart, the county’s director of public health. “Luckily, we’ve never had something like this happen in the 23 years I’ve been here.”

Officials from both the county and state Department of Health are stressing there is a low risk of contracting illness. However, people who have not been previously vaccinated for hepatitis A and who consumed food/drink from the McDonald’s on Mound Road on certain dates should consider treatment.

Those dates are Oct. 31, Nov. 2, 3, 5, 6 and 8. Saturday’s clinic ran from 1 to 8 p.m, and anyone who ate at the McDonald’s on Oct. 31 should have attended that clinic as the vaccine must be given within two weeks of possible infection.