If FDA Does Not Regulate Food, Who Will? A Study of Hormones and Antibiotics in Meat Production

2015 ◽  
Vol 41 (2-3) ◽  
pp. 459-482 ◽  
Author(s):  
Christine Donovan
Keyword(s):  
United States ◽  
Food Safety ◽  
The United States ◽  
Foodborne Illness ◽  
Meat Production ◽  
Regulatory Structure ◽  
Production Methods ◽  
Safety Risks ◽  
Better Regulation ◽  
Foodborne Outbreaks

Approximately 128,000 Americans are hospitalized and 3000 die each year from foodborne illness. A ten-year study of 4589 foodborne outbreaks attributed 46% of these hospitalizations and 43% of the deaths to meat. The Food and Drug Administration (FDA), the primary federal agency tasked with regulating food, is aware of these statistics, and characterizes them as “largely preventable.” It is becoming clear that modern meat production methods allow pathogens to spread with ease, creating great food safety risks. Startling numbers of people continue to get sick each year from food, even though regulators believe the harms are preventable, and know the source of many of the risks. This Note explores why the United States under-regulates its food as compared to other nations, and suggests improvements to the domestic regulatory structure that would facilitate better regulation.

Food Safety and Agriculture

2012 ◽  
Author(s):  
David Vogel
Keyword(s):  
United States ◽  
Food Safety ◽  
Risk Perceptions ◽  
The United States ◽  
Policy Makers ◽  
Production Methods ◽  
Safety Regulations ◽  
Safety Risks ◽  
Public Risk ◽  
The 1960S

This chapter focuses on European and American policies toward the risks of food safety and agricultural production methods. A number of food safety regulations were affected by a divergence in transatlantic public risk perceptions. During the 1960s, 1970s, and 1980s, public concerns about the risks of carcinogens in the food supply were greater in the United States than in Europe, while during the 1980s, the safety risks of beef hormones became highly salient in Europe, but not in the United States. In addition, the criteria used by policy makers in both the United States and Europe to assess and manage risks shifted: American regulatory officials placed increased reliance on scientific risk assessments, while European policy makers began to employ a more precautionary approach to food safety risks.

scholarly journals Restaurant Policies and Practices Related to Norovirus Outbreak Size and Duration

2020 ◽  
Vol 83 (9) ◽  
pp. 1607-1618
Author(s):  
E. RICKAMER HOOVER ◽  
NICOLE HEDEEN ◽  
AMY FREELAND ◽  
ANITA KAMBHAMPATI ◽  
DANIEL DEWEY-MATTIA ◽  
...  
Keyword(s):  
United States ◽  
Food Safety ◽  
The United States ◽  
Safety Training ◽  
Foodborne Illness ◽  
Surveillance Systems ◽  
Safety Certification ◽  
Food Safety Training ◽  
Outbreak Size ◽  
Policies And Practices

ABSTRACT Norovirus is the leading cause of foodborne illness outbreaks in the United States, and restaurants are the most common setting of foodborne norovirus outbreaks. Therefore, prevention and control of restaurant-related foodborne norovirus outbreaks is critical to lowering the burden of foodborne illness in the United States. Data for 124 norovirus outbreaks and outbreak restaurants were obtained from Centers for Disease Control and Prevention surveillance systems and analyzed to identify relationships between restaurant characteristics and outbreak size and duration. Findings showed that restaurant characteristics, policies, and practices were linked with both outbreak size and outbreak duration. Compared with their counterparts, restaurants that had smaller outbreaks had the following characteristics: managers received food safety certification, managers and workers received food safety training, food workers wore gloves, and restaurants had cleaning policies. In addition, restaurants that provided food safety training to managers, served food items requiring less complex food preparation, and had fewer managers had shorter outbreaks compared with their counterparts. These findings suggest that restaurant characteristics play a role in norovirus outbreak prevention and intervention; therefore, implementing food safety training, policies, and practices likely reduces norovirus transmission, leading to smaller or shorter outbreaks. HIGHLIGHTS

Levels and Toxigenicity of Bacillus cereus and Clostridium perfringens from Retail Seafood

2008 ◽  
Vol 71 (6) ◽  
pp. 1178-1185 ◽  
Author(s):  
T. RAHMATI ◽  
R. LABBE
Keyword(s):  
United States ◽  
Bacillus Cereus ◽  
Clostridium Perfringens ◽  
Clostridium Botulinum ◽  
The United States ◽  
Foodborne Illness ◽  
Enterotoxin Gene ◽  
Foodborne Outbreaks ◽  
Imported Food ◽  
Hemolysin Bl

For the period 1990 through 2003, seafood was the most commonly identified food linked to foodborne outbreaks in the United States. Fish as a commodity has rarely been examined for the presence of Bacillus cereus in particular. For the present study, 347 fresh and processed retail seafood samples were examined for the presence of Clostridium botulinum, Clostridium perfringens, and B. cereus. The presence of C. botulinum was not confirmed in any of the isolates, but C. perfringens was confirmed in 17 samples. One of the C. perfringens isolates possessed the enterotoxin gene, as determined by PCR. In contrast, 62 confirmed B. cereus isolates were obtained from separate samples at levels ranging from 3.6 to >1,100 CFU/g. Thirty (48%) of 62 isolates produced both the hemolysin BL (HBL) and nonhemolytic (NHE) enterotoxins, and 58 (94%) and 31 (50%) produced NHE or HBL toxins, respectively. The presence of at least one of the three genes of the NHE complex was detected in 99% of the isolates; 69% of the isolates possessed all three genes. In contrast, 71% of the isolates possessed at least one of the three genes of the HBL complex, and 37% possessed all three HBL gene components. Fifty of the 62 B. cereus isolates were from imported seafood, and 19 (38%) of these samples were at levels >100 CFU/g. Twelve of the 14 highest enterotoxin assay results were from isolates from imported food. Only one B. cereus isolate possessed the cereulide synthetase gene, ces; this isolate also possessed the genes for the three-component HBL and NHE complexes. A majority of enterotoxin-producing isolates were resistant to 2 of 10 antibiotics tested, ceftriaxone and clindamycin. Our results demonstrate the potential of seafood as a vehicle for foodborne illness caused by B. cereus, in particular the enterotoxin-producing genotype.

Fresh Produce: A Growing Cause of Outbreaks of Foodborne Illness in the United States, 1973 through 1997

2004 ◽  
Vol 67 (10) ◽  
pp. 2342-2353 ◽  
Author(s):  
SUMATHI SIVAPALASINGAM ◽  
CINDY R. FRIEDMAN ◽  
LINDA COHEN ◽  
ROBERT V. TAUXE
Keyword(s):  
United States ◽  
Foodborne Pathogens ◽  
Fresh Produce ◽  
The United States ◽  
Foodborne Illness ◽  
Healthy Diet ◽  
Escherichia Coli O157 ◽  
Complex Interactions ◽  
Control And Prevention ◽  
Foodborne Outbreaks

Fresh produce is an important part of a healthy diet. During the last three decades, the number of outbreaks caused by foodborne pathogens associated with fresh produce consumption reported to the Centers for Disease Control and Prevention has increased. To identify trends, we analyzed data for 1973 through 1997 from the Foodborne Outbreak Surveillance System. We defined a produce-associated outbreak as the occurrence of two or more cases of the same illness in which epidemiologic investigation implicated the same uncooked fruit, vegetable, salad, or juice. A total of 190 produce-associated outbreaks were reported, associated with 16,058 illnesses, 598 hospitalizations, and eight deaths. Produce-associated outbreaks accounted for an increasing proportion of all reported foodborne outbreaks with a known food item, rising from 0.7% in the 1970s to 6% in the 1990s. Among produce-associated outbreaks, the food items most frequently implicated included salad, lettuce, juice, melon, sprouts, and berries. Among 103 (54%) produce-associated outbreaks with a known pathogen, 62 (60%) were caused by bacterial pathogens, of which 30 (48%) were caused by Salmonella. During the study period, Cyclospora and Escherichia coli O157:H7 were newly recognized as causes of foodborne illness. Foodborne outbreaks associated with fresh produce in the United States have increased in absolute numbers and as a proportion of all reported foodborne outbreaks. Fruit and vegetables are major components of a healthy diet, but eating fresh uncooked produce is not risk free. Further efforts are needed to better understand the complex interactions between microbes and produce and the mechanisms by which contamination occurs from farm to table.

scholarly journals 325 Biosensors and Intelligent Packaging to Improve Food Safety

2020 ◽  
Vol 98 (Supplement_4) ◽  
pp. 64-64
Author(s):  
Yi-Cheng Wang
Keyword(s):  
United States ◽  
Food Safety ◽  
Economic Loss ◽  
The United States ◽  
Foodborne Illness ◽  
Future Prospects ◽  
Intelligent Packaging ◽  
Novel Technologies ◽  
The Future ◽  
Food Safety And Quality

Abstract Food safety is a critical and enduring challenge. Each year in the United States alone, about 48 million people get sick, and among them, 3,000 die due to foodborne illness. The associated economic loss is estimated at $15.6 billion. Researchers are developing a range of novel technologies to address this issue. Two of these are biosensors, devices that can be used to detect foodborne contaminants; and intelligent packaging, which can send messages about food safety and quality to producers, distributors, and consumers. This talk will introduce these two engineering-based approaches, using examples of how they can potentially be used, and describes the future prospects for each of them.

The Food Safety Modernization Act: Implications for U.S. Small Scale Farms

2015 ◽  
Vol 41 (2-3) ◽  
pp. 395-405 ◽  
Author(s):  
Kathryn A. Boys ◽  
Michael Ollinger ◽  
Leon L. Geyer
Keyword(s):  
United States ◽  
Food Safety ◽  
The United States ◽  
Current Treatment ◽  
Unintended Consequences ◽  
Foodborne Illness ◽  
Special Treatment ◽  
Small Scale ◽  
Small Farms ◽  
Small Farm

The Food Safety Modernization Act (FSMA) reforms law governing the safety of human and animal foods produced for consumption in the United States. Recognizing the challenges that the proposed regulations would impose on small farms, Congress included an amendment to exempt small farms from the full scope of FSMA requirements. This special treatment and other issues left unaddressed by FSMA, however, present challenges for buyers of small farm products and is inducing a private sector response to these regulatory gaps. This Article reviews the current treatment of small farms under FSMA and explores some key impacts and implications of FSMA on these organizations. Particular consideration is given to the unintended consequences of the Tester-Hagan Amendment and the unaddressed issue of liability for foodborne illness.

Integrating the Food and Drug Administration Office of the Coordinated Outbreak Response and Evaluation Network’s foodborne illness outbreak surveillance and response activities with principles of the National Incident Management System

2021 ◽  
Vol 19 (2) ◽  
pp. 131-141
Author(s):  
Sharon Seelman, MS, MBA ◽  
Stelios Viazis, PhD ◽  
Sheila Pack Merriweather, MPH ◽  
Tami Craig Cloyd, DVM ◽  
Megan Aldridge, MPH ◽  
...  
Keyword(s):  
United States ◽  
Food Safety ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
The United States ◽  
Foodborne Illness ◽  
Incident Management ◽  
Outbreak Response ◽  
National Incident Management System ◽  
Outbreak Investigations

The Food Safety Modernization Act mandates building a national Integrated Food Safety System, which represents a seamless partnership among federal, state, local, territorial, and tribal agencies. During multistate foodborne illness outbreak investigations, local and state partners, the Centers for Disease Control and Prevention, the United States Food and Drug Administration (FDA), or the United States Department of Agriculture Food Safety Inspection Service, depending on the regulated food product, become engaged and assist in coordinating the efforts between partners involved and determine the allocation of resources. The FDA Center for Food Safety and Applied Nutrition (CFSAN) Office of the Coordinated Outbreak Response and Evaluation (CORE) Network coordinates foodborne illness outbreak surveillance, response, and post-response activities related to incidents involving multiple illnesses linked to FDA-regulated human food, dietary supplements, and cosmetic products. FDA has implemented the National Incident Management System (NIMS) Incident Command System (ICS) principles across the agency to coordinate federal response efforts, and CORE has adapted NIMS ICS principles for the emergency management of multistate foodborne illness outbreaks. CORE’s implementation of ICS principles has provided several benefits to the operational cycle of foodborne illness outbreak investigations, including establishing a consistent, standardized, and transparent step-by-step approach to outbreak investigations. ICS principles have been instrumental in the development of a national platform for rapid and systematic laboratory, traceback, and epidemiologic information sharing, data analysis, and decision-making. This allows for partners across jurisdictions to reach a consensus regarding outbreak goals and objectives, deploy resources, and take regulatory and public health actions.

scholarly journals The United States’ Regulatory Environment Is Evolving to Accommodate a Coming Boom in Gene Therapy Research

2019 ◽  
Vol 24 (3) ◽  
pp. 147-152 ◽  
Author(s):  
Daniel Eisenman
Keyword(s):  
United States ◽  
Gene Therapy ◽  
Clinical Trials ◽  
The United States ◽  
Regulatory Environment ◽  
Evidence Based ◽  
Regulatory Structure ◽  
Regulatory Changes ◽  
Current State ◽  
Therapy Field

Introduction: A dramatic increase in the number of clinical trials involving gene-modified cell therapy and gene therapy is taking place. The field is on the verge of a boom, and the regulatory environment is evolving to accommodate the growth. Discussion: This commentary summarizes the current state of the field, including an overview of the growth. The United States (US) regulatory structure for gene therapy will be summarized, and the evolution of the oversight structure will be explained. Conclusion: The gene therapy field has recently produced its first FDA-approved therapeutics and has a pipeline of other investigational products in the final stages of clinical trials before they can be evaluated by the FDA as safe and effective therapeutics. As research continues to evolve, so must the oversight structure. Biosafety professionals and IBCs have always played key roles in contributing to the safe, evidence-based advancement of gene therapy research. With the recent regulatory changes and current surge in gene therapy research, the importance of those roles has increased dramatically.

An Analysis of Tuna Recalls in the United States, 2002 through 2020

2021 ◽  
Author(s):  
Erika Rene Blickem ◽  
Jon W. Bell ◽  
Deborah Mona Baumgartel ◽  
John DeBeer
Keyword(s):  
United States ◽  
Food Safety ◽  
Hazard Analysis ◽  
The United States ◽  
Chemical Contamination ◽  
Treatment Groups ◽  
Critical Control Points ◽  
Fresh Frozen ◽  
Foreign Materials ◽  
Shelf Stable

This manuscript reviews 18 years of voluntary recalls for commercially sold tuna in the United States. This recall information is a valuable indicator of the failure to implement procedures for food safety. The voluntary recalls involve fresh, frozen, processed, hermetically sealed and retorted in a shelf stable pack (i.e., canned tuna), and formulated into other tuna products. The FDA regulations that regulate the capture, processing, transportation, and sale of raw and processed seafood are discussed. These regulations include the current Good Manufacturing Practices, the Food Modernization Act, the Emergency Permit Control, Low Acid Canned Foods, the Seafood Hazard Analysis and Critical Control Points, Food Labeling, and Sanitary Food Transportation. The importance of traceability and Food Safety Culture to successfully prevent or implement recalls is also discussed. The recalls themselves were separated into product treatment groups: uncooked, canned shelf-stable items, and using tuna as an ingredient. The recalls were further categorized and summarized by reason or cause, such as biological and chemical contamination, undeclared ingredients, under-processing, and foreign materials. The primary causes of recalls of the reviewed tuna products were, in order, Listeria monocytogenes , undeclared allergens, elevated histamine levels, and under-processing of retorted tuna items. The recalls for elevated levels of histamine primarily occurred in uncooked (raw) tuna. Recalls for Listeria sp. and undeclared allergens were considered to be primarily Class I recalls, while recalls for elevated levels of histamine and under-processing were almost always assigned to the less serious Class II designation.

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