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1007 PD: Quality and feed safety systems for the feed industry

Dave Fairfield Published on 27 September 2007

“Gate to plate” and “farm to fork” are two common phrases that illustrate how during recent years the demands by consumers for greater food safety and animal welfare standards have brought increased attention on all stages of the animal-based food production continuum. The vital link within the food system of feed manufacturers producing safe and wholesome animal feed has not been exempt from this attention.

Historically, feed manufacturers have an exemplary record of producing safe feed products. That record has been documented through FDA and state inspections and enforcement. It also was examined in the September 2000 report on food safety by the General Accounting Office (GAO) – which concluded that, “in the United States, only a relatively few incidents of human illness have been traced to contaminated animal feed.”



The GAO report went on to add: “Public health officials have identified only two incidences of human illness resulting from bacteria-contaminated animal feed in the past 30 years.” Both cases involved Salmonella, one of which was still under investigation at the time GAO issued the report. The GAO report also found that as of July 2000, there had been “no reported cases in the United States of human illness resulting from chemically contaminated animal feed” and that during fiscal years 1998 and 1999, “less than 3 percent of animal feed samples tested for pesticides contained residue levels above established tolerances.”

This record on feed safety is a result of industry’s efforts to implement effective feed quality and safety programs. Many feed manufacturers voluntarily operate quality assurance and safety systems that exceed regulatory requirements to satisfy business needs. The feed industry has adopted these systems because it takes its responsibility to produce safe feed seriously. Moreover, there are powerful incentives to produce feeds that are safe and of high quality to meet customer demands and reduce product liability risks in a highly competitive market.

Current feed safety regulations
As a foundation, a feed manufacturer’s quality and safety program contains certain elements to satisfy state and federal laws designed to minimize animal and public health risks. Current federal feed laws primarily address five areas concerning livestock and poultry feed.

Medicated animal feeds
The federal Food, Drug and Cosmetic Act is the United States’ basic food and drug law. It defines food as “articles used for food or drink for man or other animals … and articles used for the components of any such article.” This law requires animal feeds, like human foods, be pure and wholesome, contain no harmful substances and be truthfully labeled. The Food and Drug Administration (FDA) can deem products that fail to meet these requirements as adulterated or misbranded. Adulteration includes, among other things, food that contains any poisonous or deleterious substance and food that contains unapproved food additives.

The Food, Drug and Cosmetic Act regulates the production of medicated feeds by requiring manufacturing firms to comply with Current Good Manufacturing Practices (CGMPs). FDA first promulgated CGMPs for the feed industry in 1971. Early CGMPs required feed mills to obtain medicated feed applications from FDA for each new animal drug mixed into feed. Both FDA and industry chafed under the administrative burden of those applications, and gradually FDA by successive administrative actions reduced the number of drugs and firms subject to the application requirement. In 1996, Congress passed the Animal Drug Availability Act that changed the regulation of medicated feed from product licenses to establishment licenses.


Today’s CGMPs reflect feed manufacturing practices currently accepted and used by industry and govern the conditions and operations under which medicated feed is produced. Medicated feeds do not necessarily need to be adulterated or contaminated to be in violation of law. If the feed manufacturing conditions and operations do not comply with CGMPs, the resulting medicated feeds are deemed adulterated within the meaning of the law.

Under the current FDA regulations, all animal drugs are classified into one of two categories based on their potency and whether a withdrawal period is required to prevent animal drug residues in the species for which they are intended. The two categories of animal drugs are:

•Category I drugs: Those for which no withdrawal period is required at the lowest approved use level.
•Category II drugs: Those that either have withdrawal times at the lowest approved usage level for one or more species of animals or are regulated on a “no-residue” or “zero-tolerance” basis.

Based upon the use of these animal drug categories, feed mills manufacturing medicated feeds are classified as either licensed or non-licensed.

•Licensed mills: Medicated feed establishments that use one or more high potency – designated as Type A – sources of Category II drugs to manufacture medicated feeds. These firms are required to obtain a license from FDA as a drug establishment. Licensed mills are required to comply with a more stringent set of CGMPs, and are subject to FDA surveillance inspections once every two years.

•Non-licensed mills: Medicated feed firms whose use of animal drugs is limited to Category I drugs and lower potency – designated as Types B and C – sources of Category II drugs. These firms are not required to be licensed by FDA. Feed manufacturers that produce non-medicated feeds also are classified as non-licensed mills. Non-licensed mills that manufacture medicated feeds are required to comply with a less comprehensive and detailed set of CGMPs and are subject to FDA inspections.


The components of both sets of CGMPs include:

1. a strong emphasis on good business practices
2. housekeeping requirements
3. inventory control standards for proper drug handling and medicated feed production
4. record-keeping requirements to document history of feed production
5. proper feed labeling
6. adequate procedures to trace, locate and recall products

Prohibited proteins
FDA regulations prohibit the feeding of certain mammalian proteins to ruminants to prevent the establishment or spread of bovine spongiform encephalopathy (BSE) in the United States. This law requires renderers, protein blenders, feed manufacturers, distributors and others that manufacture, process, blend and distribute products that contain or may contain prohibited proteins to implement strict procedures to prevent the feeding of these proteins to ruminants.

The components of this regulation include:

1. labeling of ingredients and feeds that contain or may contain prohibited proteins
2. implementing measures to avoid commingling or cross-contamination of non-prohibited proteins with prohibited proteins to include the use of separate or designated equipment to handle prohibited proteins or written equipment clean-out procedures
3. maintaining all records associated with the purchase, use, or sale of products that contain prohibited proteins for a minimum of one year

FDA and EPA address two classes of feed contaminants. The first class includes harmful substances that may be a naturally occurring constituent of animal feed. Examples of this class include some of the mycotoxins such as aflatoxin, and the heavy metals like lead and cadmium. The second class is made up of industrial substances that are harmful, which do not naturally occur and may enter into animal feed through mishandling or other intervening acts. Examples of this class are the polychlorinated biphenyls (PCBs) and certain pesticides like DDT. FDA may prohibit any detectable amount of a contaminant or establish a regulatory limit for the contaminant, taking into account the protection of the public health and the extent to which the presence of the contaminant cannot be avoided.

To control contaminantss, FDA either issues policy guidance or establishes regulatory limits. When issuing policy guidance, FDA has determined “advisory levels” or “action levels” for contaminantss. FDA uses “advisory levels” to provide guidance to the industry concerning levels of a substance present in animal feed believed by the agency to provide an adequate margin of safety to protect animal and human health.

Typically, FDA does not take regulatory action based on advisory levels. FDA uses “action levels” when it wants to specify a precise level of contamination at which the agency is prepared to take regulatory action. FDA issues regulatory limits for the presence of contaminantss in animal feed following public notice-and-comment rule-making procedures. To control harmful mycotoxins, FDA has established advisory levels for vomitoxin and fumonisin in animal feeds. The agency also has established action levels for aflatoxin.

For harmful industrial substances, FDA and EPA have established regulatory limits for PCBs and pesticides in animal feed and feed ingredients. In addition, the FDA has taken regulatory action when abnormally high levels of dioxin have been found in animal feed or feed ingredients.

Feed ingredients
Ingredients for use in animal feed can gain approval in the U.S. by several different methods. These methods focus on:

1. safety of the ingredient, usually for a specific use
2. ingredient effectiveness, if claimed for specific uses
3. the manufacturing chemistry of the ingredient, if any

The following describes three of the most common options available to approve ingredients for use in animal feeds:

•Association of American Feed Control Official (AAFCO) Ingredient Definition

The 2004 Official Publication of AAFCO – the professional organization of state and federal feed regulatory officials – describes the ingredient definition process. During this process, the ingredient sponsor works with an AAFCO ingredient investigator to receive a “regulatory discretion letter” from FDA that states the agency does not anticipate taking regulatory action against that ingredient in feed as long as safety problems do not develop and use of the ingredient stays within the limits established in the AAFCO ingredient definition.

•Food Additive Petition
The ingredient sponsor submits a petition to the FDA to have the ingredient approved as a “food additive”, a process governed by another set of FDA regulations.

•New Animal Drug Application (NADA)
Under this FDA process, drugs approved by new animal drug applications are available to use in feed only within the boundaries established by its NADA.

New feed safety regulatory initiatives
As consumer demands for safe food and public health concerns among regulators increase, existing U.S. feed laws are coming under scrutiny and a more comprehensive, risk-based regulatory program for all sectors of the feed industry are being considered by both federal and state feed control officials.

Food and Drug Administration activities
FDA conducted its fourth public hearing on May 22, 2007 to discuss the development of a comprehensive, risk-based Animal Feed Safety System (AFSS) that would describe how animal feeds (individual ingredients and mixed feeds) should be manufactured and distributed to minimize risks to animals and humans consuming food products from animals.

During this process, FDA has identified these key components of its AFSS:

1. a thorough analysis of manufacturing and distribution for each product
2. identifying risks associated with the process and product
3. identifying/implementing controls to effectively prevent identified risks
4. employee training programs
5. controls focused on critical steps
6. assurances such steps are accurately and consistently performed
7. record-keeping and validation of the system

The agency currently is completing work on a “risk-ranking” model that will evaluate the relative health risks to animals and humans of a variety of potential feed contaminants. The agency has stated that it intends to use the outcomes from its “risk-ranking” model to develop process control regulations to covering the procurement, receipt, manufacture and distribution of all animal feed, including pet food, and feed ingredients.

In addition to establishing new process control regulations, FDA states that the AFSS also will:

1. formalize and enhance the feed ingredient approval process
2. evaluate and establish, as needed, new limits for animal feed contaminants
3. establish a risk-based inspection process which focuses the agency’s resources on those segments of the feed industry that present the highest potential risk to safety
4. enhance the coordination between federal and state feed control officials

FDA envisions proposing its new AFSS regulations during calendar year 2008.

Association of American Feed Control Officials activities
AAFCO’s current strategic plan states that developing a Feed Safety Program is its top priority. In doing so, AAFCO states that the plan will incorporate on-farm feed manufacturing, in coordination with FDA’s AFSS initiatives.

During its August 2007 mid-year meeting, AAFCO’s Feed Manufacturing Committee modified and approved a set of good manufacturing practices (GMP) based regulations entitled, Model Good Manufacturing Practice Regulations for Feed and Feed Ingredients. These regulations for feed and feed ingredients would create a basic set of GMP-based regulations that would apply to all sectors of the feed and feed ingredient industry.

The model GMP regulations are to be reviewed by AAFCO’s Model Bill and Regulations Committee to ensure they conform to the organization’s overall Model Feed Regulations, which as the name implies, are adopted or used as the framework for state feed regulation. Once this review is complete, a vote to approve the model regulations by the entire AAFCO membership likely will take place in July 2008.

Feed safety – what’s next?
What kind of changes will feed manufacturers need to make to their quality and safety systems in the future to respond to consumer demands and potential government regulations? Obviously, the regulatory process will need to play out before the feed industry can know how to react to any new mandates. But indications are clear the new regulatory approaches being developed will attempt to address all sectors of the industry, not just medicated feed manufacturers. Also, the signs are clear that higher safety standards are on the horizon that will require systems to focus on processes to minimize and prevent feed and food safety risks.

Within the human food industry, any discussion about risk-based food safety systems quickly leads to Hazard Analysis and Critical Control Point (HACCP) programs. Current U.S. regulatory standards require companies that produce low-acid canned foods, meat, seafood and vegetable and fruit juices to have HACCP programs to help ensure the safety of these products.

HACCP is a program used to identify, evaluate and control food safety hazards. HACCP focuses on preventing hazards that could cause food-borne illnesses by applying science-based controls throughout the manufacturing process, starting with raw material and ending with product consumption.

Traditionally, the food industry and its regulators have depended on spot-checks of manufacturing conditions and random sampling of final products to ensure safe food. However, within some manufacturing settings, this inspection-sampling approach may tend to be reactive, rather than preventive. By contrast, HACCP is a real-time control system applied to the ongoing manufacturing process, which minimizes the need for finished product sampling.

Some feed manufacturers are considering implementing voluntary HACCP programs as a major component of their feed safety systems. Some potential benefits of implementing a HACCP plan are:

1. reduction of non-conforming products
2. less rework of products
3. fewer customer complaints
4. reduction of product liability

Disadvantages associated with HACCP may include:

1. cost and time to implement the program
2. ongoing costs to maintain the program
3. extensive documentation and record-keeping requirements
4. man-power requirements

The seven HACCP principles
HACCP provides a systematic approach involving seven principles for identifying, monitoring and controlling possible sources of microbiological, chemical and physical contaminants in food products. The seven HACCP principles adopted by the international food standards setting organization Codex Alimentarius Commission are:

•Principle 1: Identify the potential hazards at all product stages, from growth, processing, manufacture and distribution, until the point of consumption. Assess the likelihood of the hazard (s) occurrence, potential severity, and identify preventive measures for their control.
•Principle 2: Determine the points/procedures/operational steps that can be controlled to prevent or eliminate the hazard or minimize its likelihood of occurrence (i.e. “critical control point” (CCP)).
•Principle 3: Establish target levels and tolerances that must be met to ensure the CCP is under control.
•Principle 4: Establish a monitoring system to ensure control of CCP by scheduled testing or observations.
•Principle 5: Establish corrective action to take when monitoring indicates a particular CCP is not under control.
•Principle 6: Establish procedures for verification, which include supplementary tests and procedures to confirm HACCP is working effectively.
•Principle 7: Establish documentation concerning all procedures and records appropriate to these principles and their application.

HACCP certification
In the absence of a HACCP regulatory requirement for the feed industry, there currently are no mandated hazards that a feed HACCP plan must address. Any HACCP certification programs offered for the feed industry certify plans in accordance with that program’s requirements, whatever they might be. However, any certification audit should follow HACCP requirements of the Codex Alimentarius Commission and incorporate key elements of FDA regulations. After initial certification, firms typically maintain their certified status by completing annual partial audits and additional comprehensive audits every three years. PD

References omitted but are available upon request at

—Excerpts from 3rd Mid-Atlantic Nutrition Conference Proceedings