RG-6 Regulatory Guidance:
Ethanol Distillers' Grains for Livestock Feed

1.0 Scope

This document sets out the policy of the Canadian Food Inspection Agency (CFIA) on the use of Distillers' Grains (DGs), produced as by-products of ethanol manufacturing, that are sold or manufactured in, or imported into Canada as livestock feed. It is important to note that this policy document only serves to clarify how the existing Feeds Regulations apply to DGs, and does not introduce new regulations. It does not set out regulatory requirements for the manufacture of fuel ethanol or potable alcohol, as this is outside of the CFIA's mandate.

2.0 Distillers' Grains: By-Products of Ethanol Production – Background

Potable alcohol produced for human consumption (alcoholic beverages) is a food product, and as such must meet all requirements set forth in the Food and Drugs Act and Regulations, administered by Health Canada (HC). Potable alcohol must use approved food additives (i.e., listed in Division 16 of Part B of the Food and Drug Regulations). If an ingredient used in the manufacture of potable alcohol that is not a food additive is deemed novel (as per Division 28 of Part B of the Regulations), it requires notification and assessment as being safe before it is permitted for use, via a "Letter of No Objection" from HC. Since human beverage ethanol production is already regulated under the Food and Drugs Act and Regulations and must use authorized ingredients, the CFIA does not need to re-assess these additives.

Beyond its beverage applications, ethanol is currently widely being produced as fuel. Ethanol produced for fuel is not covered under the Food and Drugs Act. Instead, fuel ethanol, and many of the additives such as yeasts and enzymes used in producing it, are covered under the Canadian Environmental Protection Act (CEPA, 1999, Part 7, Division 4), jointly administered by Environment Canada (EC) and HC and the additives should be listed on the Domestic Substances List (DSL). For example, yeasts and enzymes not listed on the DSL are regulated by EC and HC under the New Substances Notification Regulations (NSNR) of CEPA, 1999 (Parts 5 and 6). Notifiers wishing to import or manufacture their microorganism or enzyme in Canada for use in an industrial application, such as fuel ethanol production, must submit a notification (as specified in the NSN Regulations) to the New Substances Division of EC prior to manufacturing or importing that new substance. Notifiers can request a "pre-notification consultation" or a notification form by calling the New Substances Program's Hotline at 1 800 567 1999 (toll-free in Canada) or by visiting the New Substances web site.

Some fuel ethanol processing additives may be subject to other legislation, such as the Pest Control Products Act, which is administered by the Pest Management Regulatory Agency of Health Canada. In particular, manufacturers and suppliers of antimicrobial agents should note this.

Distillers' grains used as feed ingredients, produced as by-products of either the beverage alcohol or the fuel ethanol industries, are regulated under the Feeds Act and Regulations administered by the CFIA. In the mid-to late 1980s, a variety of types of distillers' grains, including those from barley, maize (corn), rye, sorghum, and wheat, were listed as approved feed ingredients under Section 5.5, "Brewers' and Distillers' Products," in Schedule IV, Part I, of the Feeds Regulations. These by-products from the ethanol industry have a nutritional value as a protein and/or energy source in livestock rations. These feed ingredient definitions were developed to cover DGs obtained from distilleries producing alcoholic beverages, based on processes using food-grade ingredients and additives. Approval took into account the fact that beverage alcohol producers need to use approved processing additives and are already regulated under the Food and Drugs Act and Regulations.

In recent years, the production of ethanol for fuel has increased dramatically in Canada. This has resulted in the livestock feed industry becoming an outlet for large volumes of DGs generated as a by-product. In 2004, the CFIA's Feed Program began conducting inspections in ethanol-producing plants to obtain an overview of the manufacturing process and the processing additives used. From these inspections and from information supplied by the fuel ethanol industry, it was apparent that some of the additives used in the fuel ethanol manufacturing process are different from those used in the beverage alcohol production process, and some have not been assessed for safety. Because of these differences, DGs resulting from fuel ethanol production are not automatically considered equivalent to the DGs listed in the Feeds Regulations.

Both types of ethanol production are treated in the same manner and must use approved processing additives in the ethanol manufacturing process when the by-product DGs are used as feed. Details on the approved additives can be found in the relevant sections of this document.

The additives that have been identified include antimicrobial agents, enzymes, yeasts and chemicals. Note that for fuel ethanol producers who choose to use only those grains approved for feed and approved additives (e.g., additives already approved by the CFIA for use in feeds), the by-product feed DGs are considered to meet the current ingredient definition in the Feeds Regulations. Fuel ethanol producers need only validate this with the CFIA. Those using unapproved additives and/or grains not currently approved for use in feed (see Section 4) will need to have them assessed for their safety to livestock, humans and the environment.

The CFIA understands the complexity of cross border issues with the U.S., and recognizes the equivalency of the U.S. regulatory system in lieu of duplicating the evaluation of DGs originating from the U.S. In the U.S., manufacturers also need to use approved additives in the ethanol manufacturing process that generates by-product DGs used as feed. As such, the list of approved additives in Canada includes many of those listed by the U.S. Food and Drug Administration.

This policy document is intended to set out the requirements for DGs manufactured in Canada or imported into Canada. Canadian ethanol manufacturers wishing to export their feed DG products to the U.S. will also need to meet U.S. requirements. It is the business decision of the fuel ethanol manufacturer to choose to use only additives (such as antimicrobial agents) that are approved in the U.S. for use in fuel ethanol production of feed DGs, to facilitate export to the U.S.

3.0 Regulation of Livestock Feed Applied to Distillers' Grains

The manufacture, sale and import of livestock feeds are regulated in Canada under the Feeds Act and Regulations. All feeds must be safe, to livestock; to humans (by the potential transfer of residues into human food, i.e., meat, milk and eggs, and via worker/bystander exposure); and to the environment. Feeds must also be shown to be effective for their intended purpose. Approved feed ingredients are listed and defined in Schedules IV and V of the Feeds Regulations, with appropriate guarantees, standards, and label requirements. All imported feeds must meet the same standards as domestic feeds. Similarly, the regulatory framework is also applied to all feeds, including DGs, with respect to contaminants.

Both industry and government share the responsibility for safe and effective feeds, feed ingredients and, ultimately, our food. The CFIA uses a number of different tools, including consultation, publication of information (e.g. the CFIA web site), awareness campaigns, and other initiatives to inform regulated parties of the requirements. As well, regulated parties must make themselves aware of the regulatory requirements with which they need to comply.

Under the authority of the Feeds Act and Regulations and the Health of Animals Act and Regulations, the CFIA administers a national feed program. There are two key components relevant to DGs – mandatory pre-sale ingredient evaluation and the National Feed Inspection Program.

3.1 Pre-sale ingredient evaluation

The CFIA evaluates and regulates all feed ingredients, including DGs, in the same manner. Any feed ingredient that is new (i.e., not already listed in the Feeds Regulations), or has been modified such that it differs significantly from a conventional ingredient, is required to undergo a pre-market assessment and approval. The purpose of all feed assessments is the same: to ensure that the feed ingredient is safe (in terms of animal health, human health via food residues and worker/by-stander exposure, and the environment) and effective for its intended purpose prior to marketing. Exposure assessment is a key component of the safety and efficacy evaluation. The evaluation also ensures that the feed is accurately defined in the Feeds Regulations and is labelled appropriately for its safe, effective use and for consumer protection.

The specific requirements for a safety and efficacy assessment are dependent on the nature of the feed in question. Data requirements are tailored based on history of use and complexity of the product. The CFIA provides guidance to stakeholders on how to meet the data requirements for the assessment process through workshops, one-on-one consultations and the publication of guidance documents.

The safety assessment of all feed ingredients is comprehensive and includes an assessment of livestock exposure to the ingredient. With respect to DGs, the evaluation considers the manufacturing process, including an overview of the processing additives used during the fermentation and post-fermentation as well as contaminants that may be present and concentrate in by-product feed DG. The safety assessment for processing additives used in ethanol production evaluates their physical and chemical properties throughout the production process, along with data on toxicity (e.g., mammalian and in vitro toxicity tests and tissue residue data), allergenicity potential and environmental effects. The proposed maximum inclusion rates and toxicological information are evaluated for potential negative health effects to animals, to humans, or to food safety via residues in meat, milk, and/or eggs.

3.2 National Feed Inspection Program

The CFIA verifies regulatory compliance with the provisions of those Acts and Regulations administered and enforced by the CFIA. With respect to feed, the CFIA assesses compliance with the requirements of the Feeds Act and Regulations and the Health of Animals Act and Regulations. Regulatory activities are applied in the same manner to all feeds, including ingredients like DGs. Inspection activities include:

  • inspections of establishments, including ingredient manufacturers, feed mills, farms, and retail outlets, to verify that facilities producing and selling feeds and feed ingredients comply with regulatory requirements;
  • label inspections, to verify compliance with labelling requirements;
  • product sampling, to verify compliance with label guarantees and to monitor for chemical (e.g., drugs, metals, mycotoxins, dioxins, PCBs, pesticides), and biological contaminants (e.g., salmonella);
  • residue traceback of feed and food contamination events;
  • producer and industry complaints (feed-associated animal production losses); and
  • enforcement actions, in cases where non-compliance is identified.

4.0 Assessments of Distillers' Grains

As mentioned above, all feeds must be safe, to livestock; to humans (via food and worker/ bystander exposure); and to the environment, and must be shown to be effective for their intended purposes.

The availability and increased inclusion rates in some livestock rations, in combination with the many species now being fed DGs, increases livestock exposure to DGs. In addition, the process of producing ethanol concentrates additives or contaminants in DGs. This may result in residues which could be transferred to livestock and into human food, i.e., meat, milk and eggs.

For fuel ethanol producers who choose to use only those grains approved for feed and approved additives (e.g., additives already approved by the CFIA for use in feeds), the by-product feed DGs are considered to meet the current ingredient definition in the Feeds Regulations. Fuel ethanol producers need only validate this with the CFIA. To expedite this process, fuel ethanol producers manufacturing DGs in Canada, or their additive suppliers, need to submit an attestation identifying the grains and additives they use with a cross reference that links them to the approved additives identified in the subsections that follow. Once a complete package is received, validating that all additives are already approved, a decision on approval of the distillers' grains from fuel ethanol production as feed can be provided within 15 days.

For feed DG producers who want to use additives that are not contained on any of the approved lists that follow, scientific data will need to be submitted (e.g. by the additive supplier) for a feed safety assessment. DG producers and suppliers of processing additives are encouraged to consult with the Feed Program, CFIA on the specific data required for the safety assessment.

Note that additives used in the manufacture of fuel ethanol are not being approved as feed ingredients per se. The CFIA assessment is limited in scope to the processing additives as a component of the manufacturing process with respect to the safety of the by-product feed DGs. Approval of a processing additive relates only to the by-product feed DGs and does not mean a broad approval for use in any feed process. The CFIA will maintain a list of such approved additives for DGs, available on request.

The following sections highlight those additives and contaminants that need to be addressed in relation to the safety of the feed by-product DGs from the fuel ethanol manufacturing process. Each section describes the evaluation rationale, where to go to find approved sources, and what types of quality control monitoring should be considered in good manufacturing practice.

4.1 Plant Sources for Ethanol Production

Most crops, and by-products derived from them, are listed as approved feed ingredients in Schedule IV of the Feeds Regulations. As indicated previously, any feed ingredient that is new (i.e., not listed in the Feeds Regulations), or has been processed or modified such that it differs from conventional ingredients, is required to undergo a pre-market assessment.

Currently, the crops used in fuel ethanol manufacturing are the same as those used as traditional feed sources (e.g. corn and wheat). However, there is considerable interest today by seed companies and the ethanol industry in new crops, with characteristics that either enhance fuel ethanol production (e.g. high-starch corn), or are not traditional food or feed crops (e.g. switchgrass). These crops, developed for industrial processing, may trigger the need for a pre-market assessment for their acceptability in feed prior to their use in fuel ethanol production, if the resultant DGs are to be used as livestock feeds, or if the new crop could inadvertently end up in livestock feeds. It is important to note that these crops could also be regulated under other legislation such as the Seeds Act and Regulations as Plants with Novel Traits (PNTs), and/or the Food and Drugs Act and Regulations as Novel Foods.

CFIA Directive 95-03, Guidelines for the Assessment of Novel Feeds: Plant Sources, provides guidance with respect to requirements that applicants may need to satisfy in order to receive feed authorization. This directive can be found on the CFIA web site.

4.2 Processing Additives

For the purposes of this Policy Document, processing additives are defined as additives used at low levels to improve the production process. The following subsections discuss the processing additives which must be considered in assessing the safety of DGs for feed.

i) Antimicrobial Agents

During the fermentation process, antimicrobial agents (drugs or other chemicals) are used to combat the growth of organic acid-producing bacteria that compete with yeast, competitively inhibiting ethanol production. The scope of this policy document only relates to the by-product feed DGs to ensure that antimicrobial residues are not present.

The fuel ethanol industry in Canada has indicated to the CFIA that the antimicrobial agents that are currently used or are being considered for use in the production of fuel ethanol contain the following active ingredients either alone or in combination: ampicillin, monensin, penicillin, streptomycin, tylosin, and virginiamycin.

A health risk assessment was conducted estimating livestock exposure to antimicrobial agents used in the ethanol manufacturing process and the impact on by-product feed DGs. These estimates were based on information on the fuel ethanol manufacturing process, including maximum use rates of antimicrobial agents, their proprietary formulations, their potential temperature and processing inactivation during fuel ethanol production, and maximum inclusion rates of DGs in livestock diets for each species (see Appendix II for more information).

The Veterinary Drugs Directorate (VDD) of Health Canada has the expertise for assessing the potential impact that these antimicrobial agents present to animal and human health. Information about the antimicrobial agents, potential residual concentrations and exposure estimates, along with available literature and information provided by the ethanol industry respecting the breakdown of antimicrobial agents during ethanol production, were provided to the VDD to conduct the health risk assessment.

The VDD concluded that the use of ampicillin, penicillin, streptomycin, and virginiamycin, at the maximum inclusion rates indicated during the entire fermentation process Appendix I, Table 1) should not result in detectable residues and, as such, are unlikely to pose adverse health risks to humans and food animals, or to contribute to the development of antimicrobial resistant bacteria.

The VDD has determined that monensin and tylosin raise safety concerns with respect to the DGs, and are considered to be unacceptable without further evaluation, due to:

  • monensin's known toxicity to horses and turkeys, and
  • the high potential use rate of DG in tilapia feed leading to excessive exposure to tylosin.

Therefore, any antimicrobial products containing either of these agents cannot be used in fuel ethanol production when the DGs are intended for use as feed.

Antimicrobial residue monitoring is an important component to minimize the risk of adverse effects on animal and human health and to ensure compliance with established feed and food requirements. Residue monitoring is the responsibility of all feed ingredient producers and feed manufacturers, when establishing quality controls aligned with good manufacturing production practices. Monitoring levels should be aligned with ingredient risks, manufacturing complexity, etc.

In order to validate the health risk assessment, VDD has recommended that data be generated to support the absence of antimicrobial agent residues in DGs to establish a baseline for each antimicrobial. Limits of detection (LODs) should be around 0.2 mg/kg (parts per million, ppm) and would be specific to the active ingredient. While validated antimicrobial-specific residue methods are not available, new detection methods are currently being developed and may be available shortly. Verification of the absence of residues will need to be considered when appropriate methods are available.

If a manufacturer wishes to use approved antimicrobial agents at inclusion rates higher than those listed in Appendix I, Table 1, or antimicrobial agents that are not listed in Appendix I, Table 1, a safety assessment will be required. For this purpose, the applicant would need to provide the CFIA with formulations, usage rates and other pertinent information regarding the antimicrobial agent. DG producers and suppliers of processing additives are encouraged to consult with the Feed Program, CFIA, if they have any specific questions about the data required for the safety assessment. This information will be used to estimate livestock exposure, and will be forwarded to VDD to conduct an assessment and make recommendations. Once accepted, Table 1 (listed in Appendix I) will be updated with any higher inclusion rates or the new antimicrobial agent.

ii) Yeasts and Enzymes

The primary microorganism used for ethanol production is yeast (Saccharomyces cerevisiae), which normally produces ethanol from simple sugars such as glucose through fermentation, but is incapable of producing ethanol from long sugars such as starch. A variety of enzymes are used in the fuel ethanol production process for the purpose of ethanol production or enhancing ethanol yield. The two main enzymes used in the ethanol production process are alpha-amylase and glucoamylase, capable of converting large chain carbohydrates into simple molecules of glucose.

Acceptable yeasts and enzymes in DGs

The CFIA considers yeasts and enzymes as a component of the fuel ethanol manufacturing process that produces by-product feed DGs acceptable when they are:

  • Approved by the CFIA
    a) listed in the Feeds Regulations (Schedule IV, Part II), which is available upon request from the Animal Feed Division, CFIA;
  • In compliance with the Food and Drug Regulations
    b) considered to be a food additive, and listed in the Food and Drug Regulations, Division 16,
    c) considered to be a food, but not considered to be a novel food (as per Division 28 of the Food and Drug Regulations),
    d) considered to be a novel food as per Division 28, and have received a "letter of no objection" for use in food,
    e) considered to be a food additive, and the subject of an Interim Marketing Authorization from HC for use in food, or
    f) an enzyme that is considered to be a processing aid, and that is the subject of a "letter of opinion" issued by HC;
  • In compliance with the New Substance Notification Regulations (Chemicals and Polymers, and Organisms)
    g) enzymes and Saccharomyces cerevisiae strains listed in the Domestic Substances List (DSL) of the Canadian Environmental Protection Act; or
  • Listed in the U.S. Code of Federal Regulations, Title 21, by the U.S. Food and Drug Administration (FDA) and used for the same purpose indicated, specifically:
    h) those listed in Part 573 of Title 21;
    i) those listed in other parts of Title 21, where the Center for Veterinary Medicine (CVM) has given a letter permitting their use in ethanol production when the DGs are for feed applications;
    j) those listed in Part 584 of Title 21, whose Generally Recognized As Safe (GRAS) status has been affirmed in writing by the FDA; and
    k) those listed in Part 582 of Title 21, which the FDA has listed as GRAS based on history of safe use in food or feed.

The CFIA does not consider acceptable those additives whose GRAS status has been determined on the basis of self-affirmation and has not been formally evaluated or confirmed by the FDA. In order to determine if an additive falls within the acceptable category, companies should contact the FDA's Center for Veterinary Medicine, Division of Animal Feeds, at 240-453-6848 or 240-453-6849.

For more information about these lists, please see Appendix III.

For feed DG producers who want to use yeasts or enzymes that are not contained on any of the approved lists above, scientific data will need to be submitted (e.g. by the additive supplier) for a feed safety assessment. DG producers and suppliers of processing additives are encouraged to consult with the Feed Program, CFIA on the specific data required for the safety assessment.

iii) Chemicals

Based on information provided by fuel ethanol companies, a variety of chemicals are being used as processing aids. These include, for example, antifoams, which are used in the fermenter to control foaming, and boiler chemicals, used to generate steam.

Acceptable chemicals in DGs

Processing aids that have undergone an assessment for feed or food use by a government body will be considered acceptable as components of the ethanol manufacturing process that produces by-product feed DGs. Since chemicals listed on the Domestic Substances List (DSL) of CEPA may be used for a variety of industrial purposes, they may not be suitable for use in feed/food and will need to be assessed on a case-by-case basis if they are to be used in ethanol production, when the DGs are feed ingredients. The chemicals acceptable for use in feed DGs include those that are:

  • Approved by the CFIA
    a) listed in the Feeds Regulations (Schedule IV), which is available upon request from the Animal Feed Division, CFIA;
  • In compliance with the Food and Drug Regulations
    b) listed in the Food and Drug Regulations, Division 16,
    c) the subject of a "letter of no objection" for use in food, or
    d) the subject of an Interim Marketing Authorization from HC for use in food;
  • Listed in the "Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products"; or
  • Listed in the U.S. Code of Federal Regulations, Title 21, by the U.S. Food and Drug Administration (FDA), specifically:
    e) those listed in Part 573 of Title 21, for the same purpose indicated in the CFR;
    f) those listed in other parts of Title 21, where the Center for Veterinary Medicine (CVM) has given a letter permitting their use in ethanol production where the DGs are for feed applications;
    g) those listed in Part 584 of Title 21, whose Generally Recognized As Safe (GRAS) status has been affirmed in writing by the FDA; and
    h) those listed in Part 582 of Title 21, which the FDA has listed as GRAS based on history of safe use in food or feed.

The CFIA does not consider acceptable those additives whose GRAS status has been determined on the basis of self-affirmation and has not been formally evaluated or confirmed by the FDA. In order to determine if an additive falls within the acceptable category, companies should contact the FDA's Center for Veterinary Medicine, Division of Animal Feeds, at 240-453-6848 or 240-453-6849.

For more information about these lists, please see Appendix III.

For feed DG producers who want to use chemicals that are not contained on any of the approved lists above, scientific data will need to be submitted (e.g. by the additive supplier) for a feed safety assessment. DG producers and suppliers of processing additives are encouraged to consult with the Feed Program, CFIA, on the specific data required for the safety assessment.

4.3 Contaminants

Due to the nature of the production process, some contaminants may concentrate in DGs to levels that could pose a risk to livestock consuming them and/or to human safety, via food produced from these animals or by worker/bystander exposure.

The agriculture industry is well aware of the impact of contaminants (e.g. mycotoxins, pesticides, drugs) in feed on animal health and production. To minimize the risk of adverse effects on animal health and to ensure compliance with established feed and food requirements, manufacturers recognize their responsibility for monitoring contaminants. Monitoring levels are aligned with ingredient risks, manufacturing complexity, etc. Ethanol manufacturers generating by-product feed DGs, like any feed ingredient producer or manufacturer, are responsible for establishing quality control and monitoring procedures aligned with their good manufacturing and production practices. The CFIA also monitors contaminants in feed, including feed ingredients like DGs, for regulatory compliance through the National Feed Inspection Program. This regulatory monitoring, however, is not a substitute for the responsibility feed manufacturers have to ensure that their feed is safe.

Key contaminants in DGs include mycotoxins. Mycotoxins are toxic compounds produced by moulds that have historically been a feed safety consideration as they can cause adverse effects on animal health. Studies have shown that most mycotoxins are highly stable compounds that remain intact and retain their activity throughout fermentation and distillation and may be concentrated up to three-fold in DGs, since the total quantity of solids is reduced. Hence, mycotoxins which may be present in grain end up in the grain by-products (DGs). Some types may be transmitted to humans through residues in foods of animal origin.

The mycotoxins of highest toxicity in animal feed are the trichothecenes deoxynivalenol (DON), T-2 toxin, HT-2 toxin, diacetoxyscirpenol (DAS), and nivalenol (NIV); zearalenone (ZEA); the fumonisins; the aflatoxins; and ochratoxin A (OTA). Guidelines and/or legislation are currently in place in several countries to limit the levels of these mycotoxins in animal feed. For more information on mycotoxins and on the Canadian regulatory guidelines for mycotoxins in feed, please refer to the CFIA Mycotoxins Fact Sheet.

Methods of analysis for mycotoxins in DGs include both rapid methods, such as Enzyme-Linked ImmunoSorbent Assays (ELISAs) and Lateral Flow Tests, as well as laboratory-based chromatography methods, such as Liquid Chromatography and Gas Chromatography. Acceptable methods are those that have been validated for mycotoxins in DGs. Laboratories, which can be located in Canada or in another country, should be accredited by a reputable accreditation agency and actively participate in a relevant proficiency program.

4.4 Nutritional components

Information to date indicates that DGs from beverage alcohol and fuel ethanol production are significant sources of energy (including fat) and protein, as well as some mineral nutrients such as sulphur, sodium and phosphorus. It also appears that the levels of these nutrients can vary significantly from lot to lot depending upon the manufacturing process, quality and type of grains used (feedstock), etc. As a result it is strongly recommended that critical nutrients be regularly monitored to maximize animal production efficiency and minimize animal production losses when formulating rations with DGs.

Distillers grains from ethanol production may contain elevated levels of sulphur, phosphorus and sodium, which could cause adverse health effects in livestock if the amounts fed are not managed properly. Although levels are typically very low in grains, elevated levels of sodium, sulphur and phosphorus in DGs are mainly due to the concentration of these nutrients, present in the grain used as starting material. During the production process nutrients, including minerals, are concentrated up to three-fold in DGs. Additional contributing factors for sulphur and sodium are the high sulphur content in water from localized areas and the use of sodium-and sulphur-based additives during the process of manufacturing fuel ethanol. (Note that these additives are not used in the production of potable alcohol.) Impaired performance and adverse health consequences may occur in livestock when the total dietary intake of the animal reaches an excessive level. When balancing livestock diets, producers and nutritionists need to consider all sources in determining the overall intake. Elevated phosphorus levels in livestock feed may also result in elevated phosphorus levels in the manure, which requires proper nutrient management at the farm level so as to minimize deleterious environmental effects of phosphorus pollution.

5.0 Schedule IV Definition Amendments and Labelling Requirements

The CFIA's Feed Program is amending the definitions in Schedule IV of the Feeds Regulations to cover DGs from fuel ethanol production (Section 5.5 "Brewers and Distillers' Products"). Note that the amended definition includes one additional nutritional guarantee, namely per cent minimum crude fat. Guarantees required on feed ingredient labels are generally based on the approved use of the ingredient in livestock feeds, and the minimum crude fat guarantee has been added based on the use of DGs as an energy source.

For example, the revised Schedule IV ingredient definition for dried grains is:
space to insert name distillers grains dehydrated (or dried space to insert name distillers' grains) is the byproduct obtained after the removal of ethyl alcohol (ethanol), for the production of human beverage or fuel, by distillations from the yeast fermentation of space to insert name or a whole grain mixture in which space to insert name predominates by separating the resultant coarse grain fraction of the whole stillage and drying it by methods employed in the ethanol production industry. The fermentation and production processes shall be conducted using approved grains and processing additives. It shall be labelled with guarantees for minimum crude protein, minimum crude fat, maximum moisture and maximum crude fibre.

Note: Other ingredient definitions for DGs describing their different physical forms (e.g., liquid form) will also be amended in Schedule IV of the Feeds Regulations.

The labelling provisions for single ingredient feeds such as DGs are outlined in the Feeds Regulations, under sections 24(3), 26(1), 26(8), 27, 28, 30 and 33. DG labels must include the ingredient name, guarantees and statements as per the ingredient definition in Schedule IV, as well as the net amount (in metric units) and the name and address of the manufacturer. Brand names are optional. Additional guarantees or claims are not permitted unless approved by the CFIA via the "Application for Feed Registration" process.

The introduction of new ingredients and processing additives, including genetically modified grains, and modernizations in the technology and process used to produce ethanol, will create new challenges. As these new developments occur, the Feed Program will continue to assess novel/new ingredients or processing additives to determine if they meet DG definitions. The Feed Program will also continue to evaluate the safety and efficacy of the resultant DGs for feeding to livestock.

6.0 Definitions

The following definitions are included specifically for this document.

Chemicals: means chemicals used in the ethanol manufacturing process. They include: milling/cooking (e.g., phosphoric acid, and ammonium hydroxide), saccharification (e.g., sulphuric acid), fermentation (e.g., ammonium hydroxide), distillation, cleaning agents (e.g., sodium hydroxide, EDTA), or used as antifoams (e.g., KFO-205), or boiler chemicals.

Distillers' Grains: refers to by-products of ethanol manufacturing for use as livestock feed. Distillers' Grains include: Dried Distillers' Grains with Solubles (DDGS), Dried Distillers' Grains (DDG), Distillers' Solubles Condensed (CDS), Wet Distillers' Grains (WDG), and Wet Distillers' Grains with Solubles (WDGS).

Feed: means any substance or mixture of substances containing amino acids, anti-oxidants, carbohydrates, condiments, enzymes, fats, minerals, non-protein nitrogen products, proteins or vitamins, or pelletizing, colouring, foaming or flavouring agents and any other substance manufactured, sold or represented for use
(a) for consumption by livestock,
(b) for providing the nutritional requirements of livestock, or
(c) for the purpose of preventing or correcting nutritional disorders of livestock, or any substance for use in any such substance or mixture of substances (Feeds Act).

Fermentation Enzymes: means enzyme(s) used in the ethanol production process for the purpose of ethanol production or enhancing ethanol yield. The two main enzymes used in the ethanol production process are alpha-amylase and glucoamylase, capable of converting large chain carbohydrates into simple molecules of glucose.

Fuel Ethanol: means ethanol manufactured through fermentation for the purpose of being used as a component of fuel.

Livestock: includes horses, cattle, sheep, goats, swine, foxes, fish, mink, rabbits and poultry (Feeds Act).

Mycotoxins: means metabolites produced by certain fungi growing on foodstuffs or feedstuffs. Mycotoxins may be toxic to humans and animals. Mycotoxins can be produced from many fungi species including Aspergillus spp. (e.g., aflatoxins) and Fusarium spp. (DON, ZEA, T2, HT-2, NIV, DAS, 3ADON, 15ADON, and fumonisins).

Novel Feed: means a feed composed of, or derived from, a microorganism, plant or animal source that:
a) is not approved as livestock feed in Canada (i.e. is not listed in Schedule IV or V of the Feeds Regulations). These include non-traditional sources, such as Bacillus coagulans; feeds used or approved in other countries; and products approved for other uses in Canada; and/or
b) contain a novel trait (see following definition).

With respect to novel feeds, novelty is the trigger for a mandatory pre-market assessment. Once a novel feed (including those containing a novel trait) has received authorization (i.e., it gets listed in Schedule IV or V or is determined to be substantially equivalent to an ingredient already listed in the Schedules), it is no longer considered to be novel.

Novel Trait: means a characteristic of the feed that:
a) has been intentionally selected, created or introduced into the feed through a specific genetic change, and
b) based on valid scientific rationale, is not substantially equivalent in terms of its specific use and safety both for the environment and for human and animal health, to any characteristic of a similar feed that is set out in Schedule IV or V (Feeds Regulations).

Processing Additives: for the purpose of this document, means additives employed in the manufacture of fuel ethanol for a production effect, to enhance the process and ethanol output or DG production. They include: antimicrobial agents, yeasts and enzymes, and processing aids (chemicals – see definition above). Additives need authorization from the appropriate government body based on scientific evaluation demonstrating that the additive is not harmful to human and animal health and the environment. On request, the Feed Program, CFIA may assess additives as for their acceptability as a component of the ethanol process from which the by-product feed DGs are derived.

Appendix I

Table 1: List of ACCEPTABLE antimicrobial agents by brand name and company, assessed by the CFIA to date, identifying the active ingredients and maximum inclusion rates to be used in ethanol production in parts per million (ppm)

Brand Name of
Antimicrobial Agent
Company Active Ingredients Maximum inclusion
rates (ppm)
Allpen Special Lallemand Biofuels & Distilled Spirits Penicillin G 6.00
Bactenix V50 Lallemand Biofuels & Distilled Spirits Penicillin G
Streptomycin
Virginiamycin
2.36
Bactenix V60 Lallemand Biofuels & Distilled Spirits Penicillin G 3.75
Bactenix V60SP Lallemand Biofuels & Distilled Spirits Penicillin G 3.00
Bactenix V300 Lallemand Biofuels & Distilled Spirits Erythromcyin Thiocyanate 0.625
Bactenix V300SP Lallemand Biofuels & Distilled Spirits Erythromcyin Thiocyanate 0.50
FermGuard Ferm Solutions Inc. Ampicillin Trihydrate 0.50
FermGuard Xtreme Ferm Solutions Inc. Erythromcyin Thiocyanate 0.50
Lactoside 247 Lallemand Biofuels & Distilled Spirits Penicillin G
Virginiamycin
2.70
Lactoside V Lallemand Biofuels & Distilled Spirits Virginiamycin 6.00
Lactrol Phibro Virginiamycin 6.00
PhibroPen Phibro Ethanol Performance Group Penicillin G 3.00

Appendix II

Determining livestock exposure estimates for antimicrobial agents as a component of fuel ethanol manufacture for by-product DGs as feed

The following information on the fuel ethanol manufacturing process, including maximum use rates of antimicrobial agents, and maximum inclusion rates of DGs in livestock diets for each species was based on data supplied to the CFIA by fuel ethanol manufacturers and published literature. This information was used in conducting a health risk assessment estimating livestock exposure to antimicrobial agents used in the ethanol manufacturing process and the impact on by-product feed DGs.

Ethanol Manufacturing Process

The manufacturing process of fuel ethanol involves the grinding of dried grain. Corn and wheat are the major grain commodities used for ethanol production, corn in the eastern and wheat in the western provinces. The ground dried grain is then mixed with water, chemicals, and enzymes that are added to begin the process of reducing the viscosity of the slurry. The slurry is heated to approximately 110°C to 125°C for 15 minutes, then cooled and held at 85°C to 89°C for 45 minutes where additional enzymes are added when the mash goes to the liquefaction tank. (Note that process times and temperatures given throughout this Appendix are for illustration purposes only, and are not meant to imply any regulatory requirements.) Enzymes are used for two main purposes, a) to break down the starch into simple sugars which are fermented by the yeast into alcohol and carbon dioxide, and b) to reduce the viscosity of the mixture.

After the mash leaves the liquefaction tank, it is cooled down to approximately 32°C before it goes to the fermenters where additives such as active dried yeast, enzymes, antibiotics, urea, and antifoams are added. The amount of time required for the fermentation process to reach its maturity depends upon the volume of product being fermented and can range from approximately 40 hours to 75 hours. After fermentation is completed the alcohol content is about 13 per cent by volume. The total product is then transferred to the beer-well to begin distillation. The "beer" contains alcohol, water and grain fibre, which is pumped into a distillation column where the separation of the solids and most of the water from the alcohol takes place. Since alcohol boils at a lower temperature than the water and solids, it is stripped off and rises to the top of the distillation column. The water and remaining fibre falls and collects at the bottom of the column. This mixture of water and fibre is referred to as "stillage". This stillage is passed through a reboiler which is warmed up with steam and supplies the distillation column with the necessary heat to boil off the alcohol to the top. The base temperature of the column, containing the stillage, is between 103°C and 115°C.

The solids and water stream leave the bottom of the beer column, which is called "whole stillage" (also known as "spent mash"). The whole stillage is then routed to a centrifuge that serves to separate the suspended solids from the remainder of the aqueous stream. The suspended solids leave the centrifuge as a cake containing approximately 30 per cent solids and 70 per cent moisture, while the separated centrate (aqueous stream) contains approximately 8 per cent solids and is referred to as "thin stillage", which in some cases is added to the water bowls as a source of water for cattle. A portion of this stream may be recycled to the liquefaction stage of the facility (as backset), and the remainder may be fed to an evaporator which concentrates the solids to approximately 35 per cent, at which point the concentrated product from the evaporator is called "syrup" (also known as "condensed distillers solubles" (CDS)). In some cases, the unsold portion of syrup product may be mixed with the wet cake stream leaving the centrifuge, to produce "wet distillers grains with solubles" or the wet cake with solubles can be further dried, to produce "dried distillers grain with solubles".

Due to the nature of the manufacturing process of ethanol (treatment of the grain with enzymes, additions of yeast, antifoams, antibiotics, and fermentation and distillation of alcohol), all additives used in the process may be present in the residual by-products and have the potential to concentrate in the distillers by-products (i.e., condensed distillers solubles, dried distillers grains, dried distillers grains with solubles). Following the fermentation and distillation processes, the whole stillage is then centrifuged to produce thin stillage (8 per cent solids content) and wet distillers' grains (30 per cent solids content). Thin stillage is further processed to condensed distillers solubles (35 per cent solids content, concentrated by a factor of four (4)), while the wet distillers grains may be dried to produce dried distillers grains (90 per cent solids content, concentrated by a factor of three (3)). Figure 1 depicts the ethanol production process including the production of co-products.

As such, exposure estimates of antimicrobial agents assumes a four (4) times concentration factor as compared to the inclusion rate at the fermentation step. It should be noted that satisfactory data supporting the breakdown of antimicrobial agents during the ethanol production process may be taken into account.

Estimating Livestock Exposure

Livestock exposure to antimicrobial agents was then estimated considering the maximum inclusion rates of DGs in the diets of livestock species, based on published literature, as indicated below.

Livestock Species Maximum Inclusion Rate of DG byproducts
in the diet (Dry Matter Basis)
Salmon 10%
Laying hens 15%
Horse, Lambs, Broiler chickens, Turkeys 20%
Trout Fish 22.5%
Lactating ewes 25%
Catfish 30%
Dairy 40%
Swine, Beef Cattle 50%
Tilapia 82%

Figure 1: Fuel Ethanol and Co-Products Production

Click on Image for Larger View

Fuel Ethanol and Co-Products Production

Description for Figure 1: Fuel Ethanol and Co-Products Production

Figure 1 shows the steps involved in fuel ethanol and co-products production, beginning with receiving grain and ending with the production of fuel ethanol, carbon dioxide, and distillers' grains, including wet distillers' grains, dried distillers' grains, and condensed distillers solubles. It was taken from an ethanol industry web site and subsequently modified by the Canadian Food Inspection Agency.

* Dry mill production process presented at http://www.icminc.com/ethanol/production%5Fprocess/ and subsequently modified by CFIA

Appendix III

Official listings of approved processing additives (yeasts, enzymes and chemicals)

Yeasts and enzymes

Yeasts and enzymes that are considered acceptable by the CFIA in DGs for feed purposes are listed under the following Acts and Regulations:

Feeds Act and Regulations
a) Schedule IV of the Feeds Regulations lists ingredients approved for use as livestock feed. The complete listing is a large document, with many types of ingredients from traditional grains to additives to processing agents. Schedule IV is continuously being updated as new ingredients are approved. It is not currently available on the CFIA web site. A complete listing of Schedule IV may be requested from the Animal Feed Division by sending an e-mail to the following address: Afd_daa@inspection.gc.ca.

The only approved yeast currently listed in Schedule IV of the Feeds Regulations is Saccharomyces active, dehydrated (Part II, # 8.13). Each source of live Saccharomyces must be approved by the CFIA; a current list of registered yeast strains is available upon request.

Food and Drugs Act and Regulations
b) Health Canada (HC) regulates food additives and novel foods under the Food and Drugs Act and Regulations. Food additives that may be used as food enzymes and are acceptable in DGs are listed in Table V of Division 16, pages 249-260a (pages 90-104 in the printable version).

c) Not a Novel Food: To determine if a food is novel, consult Division 28 of the Food and Drug Regulations.

d) Novel Foods: A "letter of no objection" for the sale of a novel food in Canada must be issued by Health Canada before such foods can be sold. Fermentation additives given a letter of no objection are considered acceptable in DGs. No specific list of approved novel foods appears in the Regulations, however HC publishes on its web site a list of approved products, each summarized by a decision document.

e) Interim Marketing Authorization: As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization (IMA) can be issued by HC. The IMA bridges the time between the completion of the scientific evaluation of certain enabling regulatory amendments, and official publication of the approved amendments in the Canada Gazette, Part II. Fermentation additives given an IMA are considered acceptable in DGs. A list of current IMAs is available on the HC web site.

f) Letters of opinion: Upon request, HC will conduct a pre-market assessment and offer advisory comments, in the form of a letter of opinion, on the status of a substance as a processing aid, and its acceptability for use in manufacturing or processing. Enzymes for which a positive letter of opinion (i.e., a letter of no objection) has been issued by HC are considered acceptable in DGs. Currently, HC does not maintain a list of food processing aids for which it has issued a positive letter of opinion. More information is available at www.hc-sc.gc.ca/fn-an/pubs/policy_fa-pa-eng.php.

Canadian Environmental Protection Act (CEPA, 1999)
g) Environment Canada and Health Canada jointly administer the New Substances Program, including assessment of enzymes and yeasts not present on the Domestic Substances List (DSL), as well as late additions and deletions of substances to the DSL. Yeasts are listed on the DSL.

Enzymes also are listed on the DSL. Note that the enzymes are listed as registry numbers only, and need to be cross-referenced with the enzyme nomenclature.

Code of Federal Regulations (CFR), Title 21: Food and Drugs
Additives that are considered acceptable by the CFIA for use, for the same purpose indicated by the U.S. Food and Drug Administration (FDA), in ethanol production when the DGs are for feed applications, include:

h) Additives that are considered safe and listed by the FDA, in the U.S. Code of Federal Regulations (CFR), Title 21, Part 573.

i) Additives listed in other parts of Title 21 of the CFR, where the FDA's Center for Veterinary Medicine (CVM) has given a letter permitting their use in ethanol production when the DGs are for feed applications.

j) Additives whose Generally Recognized As Safe (GRAS) status has been affirmed in writing by the FDA, and are listed in Title 21, Part 584, of the CFR.

k) Additives that the FDA has listed as GRAS based on history of safe use in food or feed, and listed in Title 21, Part 582, of the CFR.

The CFIA does not consider acceptable those additives whose GRAS status has been determined on the basis of self-affirmation and has not been formally evaluated or confirmed by the FDA. In order to determine if an additive falls within the acceptable category, companies should contact the FDA's Center for Veterinary Medicine, Division of Animal Feeds, at 240-453-6848 or 240-453-6849.

For the additives listed above, the manufacturing of yeasts and enzymes should meet current principles of Good Manufacturing Practices. Yeasts and the microbial strains used to produce the enzymes should be non-pathogenic. The culture (media) used for the production of these additives must not contain any ingredients or substances that could cause any human or animal safety concerns. For example, careful consideration should be given when using ingredients such as peptone, tryptone, or extracts originating or derived from ruminant-sourced materials. In order to minimize the risk of transmission of Transmissible Spongiform Encephalopathy (TSE) agents, material of ruminant origin should be avoided if possible. If it is necessary to use material of ruminant origin, it must comply with all requirements of the Health of Animals Act and Regulations as they relate to the mammalian-to-ruminant feed ban, and the requirements for importation should the product be from a non-domestic source. Additionally, enzyme products should be free of antimicrobial activity and not be a source of viable microbial cells. For more information, or to determine if a material complies with the requirements, contact the Animal Feed Division of the CFIA.

Chemicals

Chemicals used as processing aids that are considered acceptable by the CFIA in DGs for feed purposes are listed under the following official documents:

Feeds Regulations
a) Schedule IV of the Feeds Regulations lists ingredients approved for use as livestock feed. The complete listing is a large document, with many types of ingredients from traditional grains to additives to processing agents. Schedule IV is continuously being updated as new ingredients are approved. It is not currently available on the CFIA web site. A complete listing of Schedule IV may be requested from the Animal Feed Division by sending an e-mail to the following address: Afd_daa@inspection.gc.ca.

Many of the chemicals used in the manufacturing of ethanol are already listed as approved feed ingredients in Schedule IV. The following table is a list of some approved ingredients of particular significance to the fuel ethanol manufacturing process Footnote 1:

Schedule IV Number Name of ingredient
5.71 Anhydrous ammonia
5.7.3 Urea
6.27 Cupric sulfate anhydrous
6.6 Phosphoric acid
6.83 Sulfuric acid solution
8.5 Bentonite calcium
8.6 Bentonite sodium
8.7 Benzoic acid
8.13 Calcium silicate
8.15 Citric acid
8.16 Diatomaceous earth
8.17 Disodium ethylenediamine tetraacetate
8.18 Ethoxyquin
8.49 Silicon dioxide
8.57 Sodium hydroxide solution
8.71 Ammonium hydroxide
8.87 Kaolin
8.89 Montmorillonite clay
8.109 Talc
8.118 Attapulgite clay
8.128 Polydimethylsiloxane
8.129 Polyoxyethylene stearate

Food and Drug Regulations
b) Many processing chemicals are approved for use in food production. Those of particular relevance may be found in the Food and Drug Regulations, Division 16 on the HC web site.

Specific Tables to review from Division 16 of the Food and Drug Regulations include:

  • Table 1: Anti-caking agents, pages 205-208 (pages 46-49 in the printable version);
  • Table VIII: Miscellaneous food additives, pages 265-281 (pages 109-125 in the printable version);
  • Table X: pH adjusting agents, acid-reacting materials, and water correcting materials, pages 287-301 (pages 131-145 in the printable version);
  • Table XI: Preservatives, pages 303-325 (pages 147-169 in the printable version); and
  • Table XII: Sequestering agents, pages 327-330 (pages 171-174 in the printable version).

c) Letter of No Objection: Chemical additives given a "letter of no objection" for contact with food by Health Canada are considered acceptable for the intended purpose in DGs.

d) Interim Marketing Authorization As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization (IMA) can be issued by HC. The IMA bridges the time between the completion of the scientific evaluation of certain enabling regulatory amendments, and official publication of the approved amendments in the Canada Gazette, Part II. Chemical additives given an IMA are considered acceptable in DGs. A list of current IMAs is available on the HC web site.

Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products

This is a current list of materials and non-food chemicals which have been found by the CFIA to be acceptable for use in establishments operating under the authority of the Agency. Processing agents that are specifically relevant to fuel ethanol production include anti-foam agents and boiler chemicals.

Acceptable anti-foam products

Acceptable boiler chemicals

Code of Federal Regulations (CFR), Title 21: Food and Drugs
Additives that are considered acceptable by the CFIA for use, for the same purpose indicated by the U.S. Food and Drug Administration (FDA), in ethanol production when the DGs are for feed applications, include:

e) Additives that are considered safe and listed by the FDA, in the U.S. Code of Federal Regulations (CFR), Title 21, Part 573.

f) Additives listed in other parts of Title 21 of the CFR, where the FDA's Center for Veterinary Medicine (CVM) has given a letter permitting their use in ethanol production when the DGs are for feed applications.

g) Additives whose Generally Recognized As Safe (GRAS) status has been affirmed in writing by the FDA, and are listed in Title 21, Part 584, of the CFR.

h) Additives that the FDA has listed as GRAS based on history of safe use in food or feed, and listed in Title 21, Part 582, of the CFR.

The CFIA does not consider acceptable those additives whose GRAS status has been determined on the basis of self-affirmation and has not been formally evaluated or confirmed by the FDA. In order to determine if an additive falls within the acceptable category, companies should contact the FDA's Center for Veterinary Medicine, Division of Animal Feeds, at 240-453-6848 or 240-453-6849.

Footnotes

Footnote 1

Note that this list is not intended to be comprehensive. To verify whether a specific ingredient is approved, please consult Schedule IV.

Return to footnote 1 referrer