FDA pursues enforcement action against California fish processor Fish may put consumers at risk of botulism and other food hazards
The U.S. Food and Drug Administration, in a complaint filed by the Department of Justice, is seeking to stop the processing and distribution of fish products at a California company because of a risk of botulism and other food hazards.
If granted, the permanent injunction against Fujino Enterprises Inc., doing business as Blue Ocean Smokehouse, of Half Moon Bay, Calif., would stop the company from processing and distributing fish and fish products. Blue Ocean’s president Erika Fujino also is named in the government’s complaint.
Blue Ocean processes fresh and smoked fish and fish products including salmon, cod, halibut, Wild King Salmon Candy (a honey-glazed, cold-smoked salmon), hot-smoked tuna, sturgeon and hot-smoked fish cream cheese spreads. Blue Ocean receives fish for processing from outside California, including salmon from Washington state and sturgeon from Oregon.
“This company has ignored warnings by FDA and the California Department of Public Health by continuing to sell seafood that puts consumers’ health at risk,” said Dara A. Corrigan, associate commissioner for regulatory affairs. “We are taking this action, in part, as a result of collaborative enforcement actions with our state partner and as part of our joint efforts to protect the public health.”
The complaint alleges that the company’s fish and fish products are adulterated, because they are processed under conditions that do not comply with the agency’s Hazard Analysis Critical Control Point (HACCP) regulations. HACCP is a science-based system of preventive controls for food safety that is used by commercial seafood processors to identify potential food safety hazards and take steps to keep them from occurring.
The complaint also alleges that Blue Ocean’s fish are adulterated because the conditions under which they are prepared, packed, and held fail to conform to the Current Good Manufacturing Practice requirements for food established to ensure that food is processed in a safe and sanitary manner. An FDA inspection in October 2011 found poor employee sanitation practices and showed that the company’s facility was not maintained in a manner that protected against food contamination.
Blue Ocean’s vacuum-packaged hot and cold smoked fish products may pose a risk for the development of Clostridium botulinum toxin that can cause botulism, a rare but serious illness that may result in paralysis, inhibited respiration, and death. This toxin cannot be removed by cooking or freezing.
Investigators also found Listeria monocytogenes (L. mono) on food-contact and non-food-contact surfaces in the food processing areas of the company’s facility. Listeriosis, the illness caused by L. mono, can cause fatal infections in young children, the elderly, and individuals with weakened immune systems. Pregnant women may suffer miscarriages or stillbirths as a result of the infection.
In addition, Blue Ocean’s tuna products may pose a risk for the development of scombrotoxin (histamine), a toxin that also cannot be removed by cooking or freezing, and that can cause an illness known as scombrotoxin poisoning.
The company’s violations led to its voluntary destruction of almost 1,500 pounds of hot- and cold-smoked fish in October 2011, under the supervision of the FDA and the California Department of Public Health.
The complaint was filed on March 13, 2012, in the U.S. District Court for the Northern District of California.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The influence of physician seniority on disparities of admit/discharge decision
making for ED patients
Published online: 19 March 2012
Kuan-Han Wu, I-Chuan Chen, Chao-Jui Li, Wen-Cheng Li, Wen-Huei Lee
American Journal of Emergency Medicine, The, http://www.ajemjournal.com/article/S0735-6757%2812%2900034-4/abstract
EPs vary in their admit/discharge decision making for general ED patients. More importantly, the most senior EPs were found to have the lowest discharge rates compared with their junior colleagues.
Caterpillar-Associated Rashes in Children — Hillsborough County, Florida, 2011
March 30, 2012 / 61(12);209-211
In March and April 2011, the Hillsborough County Health Department (HCHD) Epidemiology Department (Tampa, Florida) investigated three clusters of rash illness linked to the white-marked tussock moth caterpillar among persons at two child care centers and one elementary school. At least 23 children and one adult were affected; most had direct contact with caterpillars. HCHD provided recommendations on treatment and preventing caterpillar exposure to the three facilities, health-care providers, and local agencies, and through local news media. Child care centers and elementary schools in Hillsborough County previously have experienced caterpillar-associated rash outbreaks in 2004 and 2005 (1). Awareness of this problem, particularly during periods of caterpillar infestation, can minimize morbidity and help to avoid inappropriate diagnoses and treatment by health-care providers.
On March 30, 2011, a local elementary school in Hillsborough County reported a cluster of rash illnesses to HCHD. Among the initial four cases of rash, one child received a diagnosis of molluscum contagiosum, one of viral rash, and two siblings received a diagnosis of varicella. All four children had received the recommended 2 doses of varicella vaccine. By April 6, an additional eight cases of a mild pruritic rash were reported among children at the school. No systemic signs of illness, such as fever, were reported. Because caterpillar-associated rash outbreaks had occurred in previous years, the school nurse was asked about potential exposure to caterpillars or other environmental factors that could cause contact dermatitis among the children, but none were reported.
On April 5, a second rash illness cluster was reported to HCHD by a local child care facility located within 2 miles of the elementary school. The facility reported a mild pruritic rash in three of 34 children and one of three staff members, all with an onset of April 5. The affected staff member had a history of allergic reactions. When asked if caterpillars were present around the facility, the director said the caterpillars were so numerous that staff members had stopped allowing the children on the playground. The description of the caterpillars was consistent with the white-marked tussock moth caterpillar (Orgyia leucostigma) (Figure), which ranges through much of the eastern United States and as far west as Texas and Colorado. The facility was advised to notify parents of affected children about the caterpillars so that they could discuss this with their child’s pediatrician as the potential cause of rash. On April 6, epidemiologists conducted a field visit to the affected elementary school and child care facility to determine the type of caterpillars present and the extent of contact between the children and the caterpillars. White-marked tussock moth caterpillars and their cocoons were observed on the trees and playground equipment at both sites and at the front entrance of the child care facility.
On April 7, 2011, another child care facility called to inquire about recommendations for preventing the spread of methicillin-resistant Staphylococcus aureus (MRSA). A child had been clinically diagnosed with MRSA folliculitis and treated with antibiotics. However, no pustules were noted, and no testing was performed. When asked, the director of the child care facility said the center’s playground had been infested with caterpillars the previous week. The affected child reportedly had captured a caterpillar from the facility playground and likely had touched the caterpillar. Her pruritic rash was located on her abdomen. An additional seven children in the facility also experienced pruritic rashes on their abdomens. HCHD again recommended preventing contact between children and caterpillars. In addition, basic MRSA education was provided, and a request was made that any child testing positive for MRSA be reported to the HCHD epidemiology program.
For the three facilities experiencing outbreaks of rash illnesses in 2011, recommendations included 1) preventing contact between the children and caterpillars or cocoons, 2) notifying parents of the risks associated with caterpillar exposure, and 3) power-washing playground equipment to remove the caterpillars, cocoons, and their hairs. HCHD also implemented a strategy to notify the community and health-care providers about the risks for caterpillar- and cocoon-related illness. Informational sheets with pictures of the caterpillars and basic prevention messages were distributed to the school district, child care licensing, and county Head Start program offices. Interviews with local media were conducted advising the public to avoid contact with caterpillars and cocoons. Information describing the caterpillar and typical symptoms associated with exposure was provided to health-care providers directly by fax and distributed in the HCHD epidemiology department newsletter. The local agriculture extension office also was notified of the situation.
David Atrubin, MPH, Lea Wansbrough, MPH, Kelly Cruse, MPH, CHES, Danielle Stanek, DVM, Carina Blackmore, DVM, PhD, Florida Dept of Health. Corresponding contributor: Carina Blackmore, email@example.com, 850-245-4732.
The 2011 clusters of caterpillar- and cocoon-associated dermatitis follow the pattern of similar outbreaks at child care facilities that were investigated in Hillsborough County in the spring of 2004 and 2005 (1). The association between caterpillars and rash became apparent in 2005, when HCHD observed that three child care facilities had reported rash outbreaks during April of successive years. Attack rates for rash among children at the three facilities ranged from 12.6% to 21.7%. The affected children did not experience an immediate reaction, but rather a self-limiting pruritic, papular rash with distribution on the abdomen, chest, back, arms, or legs. Physical contact with the caterpillars was reported by almost all of the children experiencing a rash illness. Area physicians variously diagnosed the children as suffering from varicella, scabies, flea bites, mosquito bites, scarlet fever, fifth disease, contact dermatitis, or nonspecific viral rash. As a result of these misdiagnoses, the children often were treated inappropriately and excluded from child care unnecessarily. An entomologist for the Florida Department of Agriculture and Consumer Services identified the caterpillar associated with the 2005 rash outbreak as the white-marked tussock moth larva/caterpillar (O. leucostigma). He reported that this caterpillar can cause contact dermatitis and that it previously had been linked to rash outbreaks in the state.
The scientific literature clearly documents the ability of tussock moth caterpillars to cause rashes after physical contact. These include accounts of seven persons who developed rashes after handling the white-marked tussock moth caterpillar in Minnesota in 1921 (O. leucostigma)(2). In 2000, the Douglas-fir tussock moth caterpillar (Orgyia pseudotsugata) was the cause of rash illnesses in Boy Scouts at a summer camp in New Mexico (3).
The pathologic mechanism of caterpillar-associated rash is not understood entirely and depends on the caterpillar species. The mechanism is thought to involve exposure to chemicals on caterpillar or cocoon hairs (spicules) or mechanical irritation (4). Contact with hairs on the body and cocoon of the white-marked tussock moth caterpillars appears to cause skin irritation. Additionally, when caterpillars and cocoons are in high density, particularly susceptible persons can develop a rash when the hairs become airborne. In these situations, the rash might not occur on the area of the skin where caterpillar or cocoon contact occurred; several children at the Florida facilities had rash on the abdomen and back.
Several other types of stinging caterpillars are common in Florida, including the io moth caterpillar (Automeris io), the saddleback caterpillar (Sibine stimulea), and the puss caterpillar (Megalopyge opercularis) (5). Contact with these caterpillars often will cause a more severe sting for which the pain will be apparent immediately to the victim. In contrast, the white-marked tussock moth produces delayed, minor irritation (2). Time from exposure to onset of rash is likely minutes to hours, similar to the onset time reported after exposure to other species of tussock moths. Treatment recommendations include placing adhesive tape over the affected area and repeatedly stripping the tape off to help remove the tiny hairs, washing the area with soap and water, applying ice packs to reduce the stinging sensation, and applying a topical, low potency steroid cream (4). If the eyes are involved; the person has a history of hay fever, asthma, or allergies; or allergic reactions develop, a health-care provider should be contacted.
In light of these outbreaks, exposure to caterpillars and their cocoons should be considered when investigating rash illness outbreaks of unknown etiology during times of the year when the insect larvae are common. Factors that raise suspicion of a caterpillar-cocoon–associated outbreak, especially among children, include 1) mild pruritic rash on the abdomen, chest, back, arms, or legs that is not accompanied by fever; 2) pruritic rash outbreaks that have varied physician diagnoses; and 3) most importantly, the presence of caterpillars and cocoons known to cause pruritic rash combined with the opportunity for exposure.
Tom Loyless, Florida Dept of Agriculture and Consumer Svcs.
Cruse K, Atrubin D, Loyless T. Rash illness outbreaks at daycare facilities associated with the tussock moth caterpillar, April 2004 and April 2005. Florida J Environ Health 2007;195:14–7.
Knight HH. Observations on the poisonous nature of the white-marked tussock moth. J Parisitology 1922;8:133–5.
Redd JT, Vorhees RE, Torok TJ. Outbreak of lepidopterism at a Boy Scout camp. J Am Acad Dermatol 2007;56:952–5.
Goodard J. Physician’s guide to arthropods of medical importance. 5th ed. Boca Raton, FL: CRC Press; 2007:57–9.
This report provides updated autism spectrum disorder (ASD) prevalence estimates from the 2008 surveillance year, representing 14 Autism and Developmental Disabilities Monitoring (ADDM) sites in the United States. For 2008, the overall estimated prevalence of ASDs among the 14 ADDM sites was 11.3 per 1,000 (one in 88) children aged 8 years who were living in these communities during 2008. The extent to which these increases reflect better case ascertainment as a result of increases in awareness and access to services or true increases in prevalence of ASD symptoms is not known.
Problem/Condition: Autism spectrum disorders (ASDs) are a group of developmental disabilities characterized by impairments in social interaction and communication and by restricted, repetitive, and stereotyped patterns of behavior. Symptoms typically are apparent before age 3 years. The complex nature of these disorders, coupled with a lack of biologic markers for diagnosis and changes in clinical definitions over time, creates challenges in monitoring the prevalence of ASDs. Accurate reporting of data is essential to understand the prevalence of ASDs in the population and can help direct research.
Period Covered: 2008.
Description of System: The Autism and Developmental Disabilities Monitoring (ADDM) Network is an active surveillance system that estimates the prevalence of ASDs and describes other characteristics among children aged 8 years whose parents or guardians reside within 14 ADDM sites in the United States. ADDM does not rely on professional or family reporting of an existing ASD diagnosis or classification to ascertain case status. Instead, information is obtained from children’s evaluation records to determine the presence of ASD symptoms at any time from birth through the end of the year when the child reaches age 8 years. ADDM focuses on children aged 8 years because a baseline study conducted by CDC demonstrated that this is the age of identified peak prevalence. A child is included as meeting the surveillance case definition for an ASD if he or she displays behaviors (as described on a comprehensive evaluation completed by a qualified professional) consistent with the American Psychiatric Association’s Diagnostic and Statistical Manual-IV, Text Revision (DSM-IV-TR) diagnostic criteria for any of the following conditions: Autistic Disorder; Pervasive Developmental Disorder–Not Otherwise Specified (PDD-NOS, including Atypical Autism); or Asperger Disorder. The first phase of the ADDM methodology involves screening and abstraction of comprehensive evaluations completed by professional providers at multiple data sources in the community. Multiple data sources are included, ranging from general pediatric health clinics to specialized programs for children with developmental disabilities. In addition, many ADDM sites also review and abstract records of children receiving special education services in public schools. In the second phase of the study, all abstracted evaluations are reviewed by trained clinicians to determine ASD case status. Because the case definition and surveillance methods have remained consistent across all ADDM surveillance years to date, comparisons to results for earlier surveillance years can be made. This report provides updated ASD prevalence estimates from the 2008 surveillance year, representing 14 ADDM areas in the United States. In addition to prevalence estimates, characteristics of the population of children with ASDs are described, as well as detailed comparisons of the 2008 surveillance year findings with those for the 2002 and 2006 surveillance years.
Results: For 2008, the overall estimated prevalence of ASDs among the 14 ADDM sites was 11.3 per 1,000 (one in 88) children aged 8 years who were living in these communities during 2008. Overall ASD prevalence estimates varied widely across all sites (range: 4.8–21.2 per 1,000 children aged 8 years). ASD prevalence estimates also varied widely by sex and by racial/ethnic group. Approximately one in 54 boys and one in 252 girls living in the ADDM Network communities were identified as having ASDs. Comparison of 2008 findings with those for earlier surveillance years indicated an increase in estimated ASD prevalence of 23% when the 2008 data were compared with the data for 2006 (from 9.0 per 1,000 children aged 8 years in 2006 to 11.0 in 2008 for the 11 sites that provided data for both surveillance years) and an estimated increase of 78% when the 2008 data were compared with the data for 2002 (from 6.4 per 1,000 children aged 8 years in 2002 to 11.4 in 2008 for the 13 sites that provided data for both surveillance years). Because the ADDM Network sites do not make up a nationally representative sample, these combined prevalence estimates should not be generalized to the United States as a whole.
Interpretation: These data confirm that the estimated prevalence of ASDs identified in the ADDM network surveillance populations continues to increase. The extent to which these increases reflect better case ascertainment as a result of increases in awareness and access to services or true increases in prevalence of ASD symptoms is not known. ASDs continue to be an important public health concern in the United States, underscoring the need for continued resources to identify potential risk factors and to provide essential supports for persons with ASDs and their families.
Public Health Action: Given substantial increases in ASD prevalence estimates over a relatively short period, overall and within various subgroups of the population, continued monitoring is needed to quantify and understand these patterns. With 5 biennial surveillance years completed in the past decade, the ADDM Network continues to monitor prevalence and characteristics of ASDs and other developmental disabilities for the 2010 surveillance year. Further work is needed to evaluate multiple factors contributing to increases in estimated ASD prevalence over time. ADDM Network investigators continue to explore these factors, with a focus on understanding disparities in the identification of ASDs among certain subgroups and on how these disparities have contributed to changes in the estimated prevalence of ASDs. CDC is partnering with other federal and private partners in a coordinated response to identify risk factors for ASDs and to meet the needs of persons with ASDs and their families.
Ooltewah, Tenn., March 24, 2012 — One of the many homes completely destroyed from the March storms in Tennessee. FEMA is encouraging everyone with storm damages to register for disaster assistance. Photo by Tim Burkitt/FEMA
MISSISSAUGA, Canada — “Mississauga base…… ORNGE air ambulance made an emergency landing Friday night because one of its doors opened and a window blew out in midflight, which could have been “catastrophic.”
The chopper took off from the Billy Bishop island airport….en route to pick up a patient west of Toronto. Shortly after the helicopter was airborne, one of the doors opened, forcing the helicopter’s two pilots to search for a spot to land……It isn’t known if the window ejected and caused the door to open or vice versa…..”