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

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.

2020 ◽  
Vol 83 (9) ◽  
pp. 1607-1618
Author(s):  
E. RICKAMER HOOVER ◽  
NICOLE HEDEEN ◽  
AMY FREELAND ◽  
ANITA KAMBHAMPATI ◽  
DANIEL DEWEY-MATTIA ◽  
...  

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


1980 ◽  
Vol 12 (2) ◽  
pp. 77-85 ◽  
Author(s):  
Luther Tweeten ◽  
G. Bradley Cilley ◽  
Isaac Popoola

The trend toward larger and fewer farms has alarmed many persons who view the small farm as an integral part of American society. Advocates of the small farm have called for policies to halt the continuing decline in the number of small farms in the United States. In evaluating the merits of potential policies, understanding the composition of small farms in the U.S. is critical.Appropriate public policy would be very different if small farms were operated solely by households with substantial off-farm income and who need no public assistance, solely by households pursuing an alternative to urban-industrial society's lifestyle and who want no public assistance, or solely by households who are aged and disabled and who want and need public assistance to avoid absolute deprivation.


2020 ◽  
Vol 98 (Supplement_4) ◽  
pp. 64-64
Author(s):  
Yi-Cheng Wang

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.


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 ◽  
...  

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.


2015 ◽  
Vol 41 (2-3) ◽  
pp. 459-482 ◽  
Author(s):  
Christine Donovan

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.


1992 ◽  
Vol 19 (1) ◽  
pp. 51-78 ◽  
Author(s):  
Paul E. Nix ◽  
David E. Nix

This study reviews the literature and the practice of accounting for research and development (R&D) costs from the first reference in 1917 to the current treatment. The conceptual treatment of R&D is compared to current financial accounting rules and explanation of the evolution of the current rules is presented. The economic and social consequences of the current rules which require R&D costs to be expressed are examined. The paper explores possible alternative treatment of R&D costs. As a contrast to U.S. practice, the accounting treatment of R&D costs in other countries is discussed. Given the findings of this paper, a strong case can be made for changing the way that R&D costs are accounted for in the United States.


2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S22-S23
Author(s):  
Theresa Hunter ◽  
Wendy Komocsar ◽  
Richard Colletti ◽  
Chunyan Liu ◽  
Keith Benkov ◽  
...  

Abstract Objectives The objective of this study was to assess current treatment patterns of pediatric ulcerative colitis (UC) and Crohn’s disease (CD) patients, using data in the ImproveCareNow (ICN) registry. Methods Pediatric (2–17 years) patients in the United States who were newly diagnosed with UC or CD between June 1, 2013-December 31, 2019, who had their first recorded ICN visit within 6 months of diagnosis and who were actively followed for at least 12 months (± 90 days) were included in this study. Descriptive statistics of baseline patient demographics were summarized for the overall IBD patient population and separately for UC and CD. Treatment patterns (including use of corticosteroids, 5-aminosalicylic acid (5-ASA), 6-mercaptopurine/azathioprine (6-MP/AZA), methotrexate, tumor necrosis factor inhibitors (TNFi) [adalimumab, infliximab, certolizumab, golimumab, and their biosimilars], ustekinumab, vedolizumab, and other medications [natalizumab and tofacitinib]) were assessed at the initial baseline visit, and at 1-year and 3-year time points. Results A total of 6,504 pediatric IBD patients (UC=1,784; CD=4,720) were included in this study. Patients had a mean age at diagnosis of 13.0 years (UC=13.2; CD=12.9), 57.1% were male (UC=49.6%; CD=60.0%), and 81.0% were White (UC=81.2%; CD=81.0%) (Table 1). At the initial ICN visit, 46.4% of UC patients were prescribed a corticosteroid, while 19.8% received a 5-ASA, 12.6% received a TNFi, 10.4% received a 6-MP/AZA, 3.0% received methotrexate, and 0.3% received vedolizumab. At the initial visit, 40.2% of CD patients were prescribed a corticosteroid, while 29.1% received a TNFi, 18.5% received a 6-MP/AZA, 12.4% received methotrexate, and 3.3% received a 5-ASA. At the 1-year and 3-year time points, rates of 5-ASA and corticosteroid use decreased among UC patients; however, rates of 6-MP/AZA, methotrexate, and TNFi increased (Table 2). Similarly, at the 1-year and 3-year time points, rates of corticosteroids among CD patients decreased; however, rates of methotrexate and TNFi increased (Table 2). There was also an increase in use of ustekinumab and vedolizumab over time among UC and CD patients. Conclusion These results highlight the current treatment patterns of pediatric UC and CD patients in the United States. At the initial ICN visit, the 46% of UC and 40% of CD patients were receiving corticosteroids, however, at 1-year and 3-years after initial visit, over 30% of UC patients and over 60% of CD patients were receiving TNF inhibitors with considerably reduced corticosteroid use.


Author(s):  
Erika Rene Blickem ◽  
Jon W. Bell ◽  
Deborah Mona Baumgartel ◽  
John DeBeer

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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