FDA Issues Draft Guidances under the FDA Food Safety Modernization Act for Animal Foods and the Classification of Activities for Farms and Facilities

As the implementation of the FDA Food Safety Modernization Act (FSMA) continues, the agency today issued two draft guidances to assist the industry with the implementation of the Preventive Controls for Animal Food rule and another draft guidance to assist businesses in determining whether the activities they perform are within the “farm” definition.

Two of the draft guidances are meant to assist domestic and foreign companies in complying with Current Good Manufacturing Practice (CGMP) requirements and with human food by-product requirements under the FSMA Preventive Controls for Animals.

Food Rule.

Draft Guidance for Industry #235 – Current Good Manufacturing Practice Requirements for Food for Animals is intended to help facilities that manufacture, process, pack or hold animal food for consumption in the United States comply with CGMP requirements in areas such as personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations, and holding and distribution. The guidance also includes information on training and related recordkeeping. The CGMPs required under the Preventive Controls for Animal Food rule are flexible to address the diversity of facilities and animal foods, the wide range of animal food activities, and the potential safety risks of some animal foods.

Draft Guidance for Industry #239 – Human Food By-Products for Use as Animal Food will assist facilities that manufacture, process, pack or hold human food and then subsequently provide the human food by-products for use as animal food in determining what requirements in the Preventive Controls for Animal Food rule apply to their human food by-product. Common examples of human food by-products used for animal food include wheat middlings, grain products from grain milling, and vegetable pulp.

FDA plans to host a webinar later in September to discuss these draft guidances in more detail.

Draft Guidance for Industry for the Classification of Activities such as Harvesting, Packing, Holding, or Manufacturing/Processing for

Farms and Facilities are aimed at helping food businesses determine which of the FSMA rules apply to their operations. Businesses that only perform activities within the “farm” definition are not subject to the FSMA Preventive Controls for Human Food or Animal Food rules. Instead, when their activities involve covered produce, farms may be subject to the

FSMA Produce Safety rule. Facilities conducting activities that are outside the farm definition generally need to register with the FDA as food facilities (unless other exemptions (s) apply, such as the exemptions for retail food establishments and restaurants) and may be subject to the FSMA Preventive Controls for Human Food or Animal Food rule. Farms, including those subject to the Produce Safety rule, are not required to register with the FDA as food facilities. The draft guidance includes several examples of hypothetical operations. All three draft guidances will be available for public comment starting August 25, 2016. The FDA will consider all comments received during the periods designated in the Federal Register notices before completing the final veryions of the guidance. (1)

Hepatitis A Virus

Source, symptoms, and infective dose

Hepatitis A virus (HAV) is very small (27 nanometers) in diameter and possesses single-stranded RNA. It is pretty challenging to culture viruses, and knowledge about the hepatitis A virus has been gained by studying isolated virus particles from the feces of infected humans. It has also been found that HAV is resistant to inactivation at milk pasteurization temperatures.

The destruction of the hepatitis A virus in mollusks can be achieved by 1 minute of immersion in boiling water (212 0 F) or by 1.5 minutes of steaming, at which an internal temperature of 1850 to 1900 F was achieved in shellfish (2). It is advisable to eat only cooked shellfish, paying particular attention to the times and temperatures used in the cooking process.

Hepatitis A virus does not grow on food. It replicates itself in the liver of its human host and is passed in the feces, urine, and blood of infected individuals (who may be without symptoms). It is also found in waters containing raw sewage and in seafood taken from these polluted waters. The infective dose is unknown but is probably very low (e.g., 10 to 100 virus particles) (3). HAV is also shed in saliva, and isolation of the virus from this source can be used to simplify investigations of outbreaks

The onset of symptoms is usually abrupt and characterized by fatigue, fever and chills, loss of appetite, nausea, vomiting, pain in the liver area, abdominal pain, jaundice, dark urine, and light-colored stools. Jaundice occurs because the virus invades

the liver and affects its function. As a result, the skin tone of infected individuals takes on a yellow color. Illness may be mild in some cases and lasts only one to two weeks. The most important factor affecting the severity of the disease is age. Children less than a year old rarely show clinical signs of illness. This means that parents and child-care workers handling soiled diapers can catch or transmit the disease without knowing they have been exposed. Hepatitis A symptoms are often unrecognized in children younger than two years of age. In most younger people, there is complete recovery with no long-term effects. (5, 6).

Most older children and adults infected with hepatitis A develop a recognizable illness. Approximately 22% of ill adults will be hospitalized. In some cases, the illness can be severely disabling, last for several months, and may cause permanent liver damage. The severity of the illness is usually greatest in elderly people, and convalescence is usually prolonged.

Hepatitis A is highly contagious. The incubation period varies from 10 to 50 days. The average incubation time is 28 to 30 days (7, 3, 6). People are very infected from the latter half of the incubation period to a few days after the onset of jaundice. They pass the virus in their feces, urine, and other body fluids during this time. This means that infectious individuals, such as food handlers or children, can spread the disease before they are even aware of it.

Craig H. Doan, Food Safety and Food Processing Specialist, joins Impact Washington.

Impact Washington would like to announce the newest member of our team. Craig H. Doan has joined us as our Food Safety and Food Processing Specialist.

On August 30, 2015, the FDA published final rules for implementing regulations in the area of preventive controls for human food and animal food

(21 CFR507). The compliance clock was triggered on September 17, 2015, with the following proposed compliance deadlines for human food and animal feed/pet food processors:

1 year for large businesses — September 17, 2016

2 years for small businesses — September 17, 2017

3 years for very small businesses — September 17, 2018

This can be an overwhelming task without guidance, which is why Impact Washington is launching a new practice area focused on Food Safety, which Craig will lead. Our custom program combines LEAN manufacturing best practices, with the best Microbiology experts in the state and specific industry expertise to provide a streamlined, customized approach to help businesses navigate this transition in the most stress-free, cost-effective way.

Craig has 30+ years in the food industry and academics specializing in food safety, food processing, and product innovation. Craig has developed, launched, and/or reformulated over 200 products for the retail, small business, and food service markets. He has authored and co-authored multiple professional journal publications, patents, and technical book chapters. His background includes executive food consultant, senior product research & development manager for the Kraft Heinz Company, and food microbiologist for the State of Idaho and University of Idaho. Craig has served in many capacities for the Institute of Food Technologists and the Washington State University —University of Idaho Combined School of Food Science. While Craig is not writing about the food industry, he enjoys the outdoors, camping, fishing, hunting, and spending time with his family.

Those interested in learning more about Impact Washington’s Food Safety Program should visit our website for details.

Epidemiol. Inf.

FDA. 2009. Bad Bug Book. Foodborne Pathogenic Microorganisms and Natural Toxins Handbook. Hepatitis A virus.

References:

(1)(2)(3)(4)(5)(6)(7)

http:f/wwvvfda qov/FoodiNewsEvents/ConstituentUpdates/ucm502698 source=g ovdellverv

Millard, J., Appleton, H., and Parry, J.V. 1987. Studies on heat inactivation of hepatitis A virus with special reference to shellfish.

Epidemiol. Inf.

FDA. 2009. Bad Bug Book. Foodborne Pathogenic Microorganisms and Natural Toxins Handbook. Hepatitis A virus.

http://wvwvfdagov/Food/FoodSafety/Foodbornelllness/F00dbornelIinessFoodbornePath

ogensNatu ralToxins/BadBuqBook}ucm071294. htm.

Mackiewicz, V., Dussaix, E. , Le Petitcorps, M.F, and Roque-Afonso, A.M. 2004. Detection of hepatitis A virus in saliva. J. Clin.

Microbiol. Sept: 4329-4331.

Heymann, D.L. 2004. Control of Communicable Diseases Manual. 18th ed. American Public Health Assoc. Washington, D.C.

Montville, T.J. and Matthews, K.R. 2008. Food Microbiology: An Introduction. 2nd ed. ASM Press, Washington, D.C.

Cliver, D.O. 2001. In Food Microbiology: Fundamentals and Frontiers. 2nd ed. Doyle, M. P., Beuchat, L. R. , and Montville, T. J, eds.