Archived - Proposal - Maximum Nutrient Values in Poultry (Chicken and Turkey) Feeds

Purpose

The Canadian Food Inspection Agency (CFIA) has embarked on a comprehensive change agenda to strengthen its foundation of legislation, regulatory programs and inspection delivery. These directions set the context for the renewal of the federal Feeds Regulations (Regulations).

The goal of renewing the Regulations is to develop a modernized risk- and outcome- based regulatory framework for feeds which:

• safeguards feeds and the food production continuum;
• attains the most effective and efficient balance between fair and competitive trade in the market; and
• minimizes regulatory burden.

Modernization of the Regulations provides the opportunity to review feed controls, standards, labelling and other regulatory requirements. The purpose of this proposal is to review the nutrient content standards for poultry (chickens and turkeys) set out in Table 4 of Schedule I, that have been used to exempt complete feeds and some supplements from registration, and recommend possible updates or amendments to the current requirements.

Background and Current Situation

Table 4 of Schedule I was created and incorporated into the Feeds Regulations in the 1980s as a mechanism to exempt certain groups of feeds from registration. The original Table 4 established nutrient ranges (minimums and maximums) as exemption criteria for feeds for chickens, turkeys, swine, beef and dairy cattle, and sheep. In 1990, via two regulatory amendments, the table was first expanded to include horses, goats, ducks, and geese; and then for rabbits, mink, and salmonid fish. Since that time, there have been no other substantive changes to the table or to any of the nutrient ranges.

Currently, if a complete feed provides nutrients which fall within the ranges listed in Table 4, or a supplement has directions for use which would result in a complete feed that provides nutrients which fall within the Table 4 ranges, the feed can be exempted from registration. Feeds that provide nutrients which fall outside the ranges listed in Table 4, and that do not meet any additional exemption criteria, require assessment and registration by the CFIA prior to manufacture and sale.

As indicated in the Feed Regulatory Renewal Consolidated Modernized Framework Proposal, both the CFIA and stakeholders recognize that the values in Table 4 no longer have the same nutritional relevancy that they did when the table was first introduced. Stakeholders have also indicated that they feel that Table 4 prevents innovation for new feed products. However, many of the maximum nutrient limits which are currently set in Table 4 have health and safety implications that must be considered.

Considerations

As mentioned, the domestic feed industry considers that the Table 4 nutrient ranges are out of date, and that this table is no longer an appropriate regulatory tool to control feeds. However, there remains a continued need for an enforceable regulatory framework regarding maximum nutrient concentrations in livestock feeds. For instance, higher levels of certain vitamins in livestock rations (e.g., vitamins A, D, and E) can be harmful to livestock or can be concentrated into tissues that are used for human consumption, thus posing potential risk to human health. Similarly, certain minerals (e.g., copper, phosphorus and zinc) can also contribute to increased environmental risks.

An analysis of poultry nutritional requirements and maximum tolerable dietary nutrient levels was conducted by the CFIA with the following scope:

• to determine those nutrient levels that may impact the health and safety of the respective livestock, humans, and environment;
• to determine those nutrient levels that support a nutritional purpose as opposed to a therapeutic purpose; and,
• to determine those nutrient levels that may produce residues in the resulting food that could be harmful to those consuming the products.

Information sources used in the review of nutrient maximums in poultry feeds included:

• data and information gathered during the review of Table 4 which took place during the mid-2000s;
• recommendations and formal opinions provided by other national authorities and food safety agencies (e.g., the National Research Council of the National Academies, the European Food Safety Authority, etc.);
• research published in peer-reviewed literature (e.g. the Poultry Science); and
• guidance documents on the classification of veterinary drugs and animal feeds.

Proposal

It is proposed that:

1. Table 4 be removed from the Regulations and no longer serve as a trigger for registration of feeds based on specified ranges of nutrient content; and,
2. Maximums be established and incorporated by reference for nutrients for which there are safety or therapeutic use concerns.

This proposed approach addresses stakeholder concerns regarding Table 4 and its relevance in current industry practices, as well as claims that the nutrient ranges provided in Table 4 impede new products from entering the marketplace. Furthermore, it addresses concerns regarding the harmful impact that higher levels of certain nutrients may have on livestock or the resulting food products, and underscores the modernized regulatory framework's focus on health and safety for humans, animals, and the environment. It is further proposed that:

• there will not be any established minimum limits for nutrients, however feeds will still be required to be suitable for their intended purpose and must meet an animal's nutritional requirements;
• maximum limits for certain nutrients will be established by species or classes of species, as appropriate; and,
• nutrient maximum limits will be incorporated by reference in the Regulations to facilitate updating, as necessary.

Appendix I sets out the proposed maximum nutrient values for Chicken feeds.

Appendix II sets out the proposed maximum nutrient values for Turkey feeds.

Anticipated Outcomes

This modernized regulatory approach to the oversight of maximum nutrient content in poultry feeds would:

• give regulated industry the flexibility to manufacture feeds with nutrient contents that meet their customers' needs without requiring pre-market assessment and authorization;
• allow the CFIA to maintain regulatory oversight for hazards that may negatively impact human or animal health or the environment;
• allow for timely updates to the standards as new information concerning specific nutrients is provided; and,
• reduce the regulatory burden on industry wishing to get innovative products into the marketplace.

While this proposal is specific to chicken and turkey feeds, future proposals will be developed for additional species subject to the Feeds Regulations and include proposed maximum nutrient values for the species in question.

Stakeholders will be provided with an opportunity to comment on all proposals, including the maximum nutrient values being suggested for each species or class of species, before they are incorporated into a regulatory framework.

We strongly encourage you to provide your input and feedback, which is critically important to the success of the regulatory modernization initiative. Written comments may be forwarded by December 23^rd, 2016 to:

Sergio Tolusso
Canadian Food Inspection Agency
Animal Feed Division
59 Camelot Drive
Ottawa, ON K1A 0Y9
E-mail: Sergio.tolusso@inspection.gc.ca
Fax: 613-773-7565

References: A complete bibliography is available upon request

Appendix I – Proposed Maximum Nutrient Values for Chicken Feed

Rationale:

• Breakdown of the growing phases to allow for more flexibility and tailored diets.

Macro-minerals (%, at 88% DM ([Dry Matter])

Rationale: Animal Health

• NRC (2005) [National Research Council of the National Academies] Growing poultry chicks maximum Ca is set at 1.5%
• (Hurwitz et al. 1995) 1.5-2.0% Ca: causes hypercalcemia and hypophosphatemia in fast-growing chicks only (not in slow-growing chicks)
• NRC (2005) High producing laying hens can tolerate 5% calcium diets.
• (Pelicia et al. 2011) found birds fed diets containing 4.5% calcium produced less eggs as compared to those fed 3.0 and 3.75% Ca.
• Bar et al. (2002) found 4.8% Ca increased shell thickness but did not reduce production

Rationale: Animal Health

• National Research Council(2005) The maximum tolerable limits (MTL) in the National Research Council (1980) were 1% for poultry and 0.8% laying hens.
• (Harms et al., 1965; Charles and Jensen, 1975) Depressed egg production and eggshell quality was observed in laying hens fed 0.8-1.2% P.

Rationale: Animal Health

• Based on NRC (1994), Mg requirements in poultry are 5 to 8 fold below the proposed maximum limit.
• NRC (2005) recommends a max of 0.5% in growing birds and 0.75% in laying hens.
• However, only a fraction of dietary Mg is generally absorbed and high amounts can cause an osmotic diarrhea adverse effect in the animal.

Rationale: Animal Health

• NRC (2005) recommends a maximum of 1.7% sodium chloride (= approximately 0.65% Na). High salt diets are a concern to industry in terms of wet droppings.
• (Leeson, S. 2006) proposed to reduce the max level of 0.80 % to 0.45%. Using 0.8% Na would impair bird welfare.
• (Smith et al. 2000) increasing dietary Na; K or P gave linear increases (P<0·001) in water intake of laying hens and linear increases (P<0·01) in moisture content of their excreta.

Rationale: Animal Health

• NRC (2005) recommended a conservative MTL of 1% for non-ruminants.
• Smith and Teeter (1987) Fed heat stressed broilers up to 2% supplemental K as KCl in addition to the 0.73% basal level without negative impact of production.
• (Smith et al. 2000) Linear decrease in feed intake and increase in water intake as percent K increased. Linear increase in weight of water excreted and moisture content of excreta.

Rationale: Animal Health

• (NRC 2005) The MTL in chicks is 0.4%.
• (NRC 1994) refers (Krista et al. 1961) reduced egg production with diet at 0.8% of sulfate.
• (Bobeck et al., 2013) S diet from 0.27 to 0.36% S did not negatively affect the performance of broiler chicks.

Trace Minerals (mg/kg, at 88% DM)

Rationale: Worker Safety / Food Safety

• (NRC 2005) MTL is 25 mg/kg diet for chicks. Animals fed at MTL may have kidney Co concentration that exceeds standard for human health.
• EFSA 2009 [European Food Safety Authority] FEEDAP [Panel on Additives and Products or Substances used in Animal Feed] recommends max. Co of 1 mg/kg complete feed for all non-fish species
• (NRC 2005) Non-ruminant animals do not require a dietary source of Co
• Dusting potential of Co compounds, and the genotoxicity of Co (II) compounds and their presumed carcinogenicity after inhalation exposure during the use of Co when mixing feed.

Rationale: Food Safety

• NRC (2005) recommends MTL is 250 mg/kg for all poultry except ducks based on animal health and not on human health. Lower levels are necessary to avoid excessive accumulation in edible tissues; specifically in the liver.
• EC No. 1334/2003 and EFSA (2016) set the maximum content of Cu in the complete feed for chicken at 25 mg/kg.
• Possible environmental concerns have not been fully evaluated for Canada.

Rationale: Food Safety

• NRC (1994) Iodine dietary requirement in broiler is 0.35 mg/kg feed.
• EFSA (2005) (Table 2 GfE) The I dietary requirement for broiler is 0.5 mg/kg
• EFSA (2013) refers Rottger et al. (2012) lower levels necessary to avoid excessive accumulation in edible tissues. Concentration of supplemental iodine is directly related to the iodine content of eggs.

Rationale: Animal Health

• (NRC 2005) MTL for poultry is set at 500 mg/kg (approximately 450 mg/kg complete feed at 88% DM).
• EFSA (2015) and EFSA (2014), the FEEDAP Panel recommends max Fe content in complete poultry feed of 450 mg Fe/kg (88% DM).

Rationale: Worker Safety

• (EFSA, 2016) exposure to manganese in dust of all additives and to nickel (except manganous chloride and manganous oxide) poses a risk to users by inhalation
• (Agency for Toxic Substances and Disease Registry ATSDR, 2012; in EFSA, 2013a) inhaled manganese is especially hazardous because it may bypass the liver entirely, and be transported directly to the brain.
• The EU current authorised max total content of manganese in complete feed is set at 150 mg/kg for poultry (EC No. 1334/2003)
• (NRC 1994) The estimated manganese requirement of broiler from 0 to 8 weeks is set at 60 mg Mn/kg Feed.

Rationale: Food Safety

• NRC (2005) The MTL for poultry is set at 3 mg of Se/kg.
• (NRC 1994) refers (Ort and Latshaw 1978) feeding selenite increased the Se in tissues of laying chickens. At 1 mg/kg Se increase in liver and breast. At 3 mg/kg Se increase in kidney.
• In the EU the maximum authorized content of selenium in complete feeds is 0.5 mg/kg

Rationale: Animal Health / Environment

• NRC (2005) MTL for poultry is set at 500 mg/kg
• In the EU the maximum authorized content of zinc in complete feeds is 150 mg/kg (EC No. 1334/2003)
• EFSA (2014) FEEDAP Panel recommends 100 mg/kg. Reports indicate decreased feed intake and performance, including laying, above 100 mg/kg.
• (Leeson, S. 2006) comments: There is growing concern about accumulation of zinc in soil and water.

Vitamins (IU/Kg, at 88% DM) (IU = international units)

Rationale: Animal Health / Food Safety

• (Leeson, S. 2006) proposed the maximum of 20,000 IU/Kg for broiler breeder as vitamin A is potentially toxic and may interfere with metabolism of vitamin D3.
• (NRC 1994) The requirement estimates vary from 900 to 2,200 IU/Kg.
• EFSA (2008, and 2014) recommends the maximum contents of vitamin A in feed for food producing animals to achieve uniform and avoid extreme high tissue concentrations:
  • 0 to 14 days of life for chickens reared for fattening at 20,000 IU/Kg
  • After 14 days for chicken reared for fattening, rearing and breeding at 10,000 IU/Kg.

Rationale: Animal Health

• NRC (1987) provides a safe upper dietary level of Vitamin D3 for chicken of:
  • 40,000 IU/Kg diet for exposures of <60 days and
  • 2,800 IU/Kg for exposures >60 days
• (Leeson, S. 2006) proposed to increase the max to 6,500 IU/Kg as modern strains of chicken of all ages, have a need for at least 1,500 IU/Kg D3 and for high-producing laying hens it may be necessary to feed in excess of the current maximum.

Rationale: Animal Health

• NRC (1987) – 1,000 IU/Kg is the presumed upper safe level for chickens
• EFSA (2010) high doses (generally well above the 1,000 IU) of Vitamin E may reverse the principal beneficial effects of Vitamin E
• Reversal of immunomodulation at dietary concentration in the 200 IU range in poultry (Leshchinsky and Klasing 2001)

Rationale: Not Applicable

• EFSA (2013) The FEEDAP Panel did not see any reason to introduce a maximum content in feed for Vitamin C in the form of ascorbic acid to ensure animal safety.

Appendix II – Proposed Maximum Nutrient Values for Turkey Feeds

Rationale:

• Breakdown of the growing phases to allow for more flexibility and tailored diets.

Macro-minerals (%, at 88% DM)

Rationale: Animal Health

• NRC (2005) When animals are fed calcium above the MTL over a longer period of time, the main effects observed would include interference with use of other minerals, especially phosphorus and zinc, and/or significant reduction in feed intake affecting performance.
• (Leeson, S. 2006) suggest max of 2.5% (S) (G) (BG) and 4% (B).
• NRC (2005) Growing poultry chicks max Ca is set at 1.5%.
• (Hurwitz et al. 1995) In fast-growing chickens (1 week age to 3 weeks), diet at 2 % calcium caused hypophosphatemia and reduced growth rate, but not in slow-growing diet.
• (Harms and Waldroup, 1971) The NRC (2005) High producing laying hens can tolerate 5% calcium diets.
• (Bar et al. 2002) Increasing dietary Ca to 4.8 % to 5.0% did not affect egg production but increased shell weight and/or shell thickness.
• (Pelicia et al. 2011) Dietary Ca levels significantly affected lay, with birds fed diets containing 4.5% calcium producing less eggs as compared to those fed 3.0 and 3.75% Ca.

Rationale: Animal Health / Environment

• NRC (2005) The MTL in the NRC (1980) were 1% for poultry and 0.8% laying hens.
• (Harms et al., 1965; Charles and Jensen, 1975) Depressed egg production and eggshell quality was observed in laying hens fed 0.8-1.2% P.

Rationale: Animal Health

• NRC (2005) recommends a max of 0.5% in growing birds and 0.75% in laying hens.
• Based on NRC (1994), Mg requirements in poultry are 5 to 8 fold below the proposed maximum limit.
• Only a fraction of dietary Mg is generally absorbed and high amounts can cause an osmotic diarrhea adverse effect in the animal.

Rationale: Animal Health

• NRC (2005) recommends a maximum of 1.7% sodium chloride (NaCl) equivalent to approximately 0.65% sodium (Na). High salt diets are a concern to industry in terms of wet droppings.
• (Leeson, S. 2006) proposed to reduce the maximum level of 0.80 % to 0.45%. Using 0.8% Na would impair bird welfare.

Rationale: Animal Health

• NRC (2005) recommended a conservative MTL of 1% for non-ruminants.
• Smith and Teeter (1987) Fed heat stressed broilers up to 2% supplemental K as KCl in addition to the 0.73% basal level without negative impact of production.

Rationale: Animal Health

• (NRC 2005) The MTL in poultry is 0.4%.

Trace Minerals (mg/kg, at 88% DM)

Rationale: Worker Safety

• EFSA 2009 recommends max. Co content of 1 mg/kg complete feed for all non-fish species
• Non-ruminant animals do not require a dietary source of Co
• Animals fed at the MTL (25 mg/kg – NRC 2005) may have kidney Co concentration that exceeds standard for human health.
• Dusting potential of Co compounds, and the genotoxicity of Co (II) compounds and their presumed carcinogenicity after inhalation exposure during the use of cobalt when mixing feed

Rationale: Animal Health / Environment

• NRC (2005) recommends MTL is 250 mg/kg for all poultry except ducks based on animal health and not on human health. Lower levels are necessary to avoid excessive accumulation in edible tissues; specifically in the liver.
• (Kashani et al., 1986) Turkeys up to 8 weeks of age at 120 or 240 mg/kg causes reduction of body weight and 120 mg/kg for 24 weeks had decreased growth
• (SCAN EC-2003) In poultry, copper output in excreta is higher than in mammals.
• EC No. 1334/2003 and EFSA (2016) set the maximum content of Cu in the complete feed for turkey at 25 mg/kg.
• Possible environmental concerns have not been fully evaluated for Canada.

Rationale: Food Safety

• (NRC 2005) MTL in turkey is 300 mg/kg. Lower levels are necessary to avoid excessive accumulation in edible tissues.
• (NRC 1994) content of I in animal tissues and products is related to I intake and thus I concentration in feed.
• (EFSA, 2005-updated 2014)
  1. Under Directive 70/524/EEC, the max level of inclusion in Poultry feeding stuffs from I salts is at 10 (total) mg I/kg. Minimum requirements are between 0.05 and 0.1 mg I/kg DM for poultry.
  2. Reference in Table 2: NRC 1994 and GfE dated 2004, I dietary requirement for turkey is suggested at 0.35 to 0.44 mg/kg feed at 88% DM.

Rationale: Animal Health

• (NRC 2005) MTL for poultry is set at 500 mg/kg (approximately 450 mg/kg complete feed at 88% DM).
• EFSA (2015) and EFSA (2014), the FEEDAP Panel recommends max Fe content in complete poultry feed of 450 mg Fe/kg (88% DM).

Rationale: Animal Health

• (EFSA, 2016) exposure to Mn in dust of all additives and to nickel (except manganous chloride and manganous oxide) poses a risk to users by inhalation
• (ATSDR, 2012; in EFSA, 2013a) inhaled Mn is especially hazardous as it may bypass the liver entirely and be transported directly to the brain.
• (EFSA Journal 2013; 11(8):3325). The EU current authorised max total content of Mn in complete feed is set at 150 mg/kg for poultry
• (NRC 1994) The estimated Mn requirement of broiler from 0 to 8 weeks is set at 60 mg Mn/kg Feed.

Rationale: Food Safety

• (NRC 2005) The MTL for poultry is set at 3 mg of Se/kg of feed.
• NRC (2005) Adverse effects (growth/performance) for chickens at 4 mg/kg and egg hatchability at 5 mg/kg
• (NRC 1994) refers (Ort and Latshaw 1978) feeding selenite increased the Se in tissues of laying chickens. At 1 ppm Se increase in liver and breast.
• In the EU the maximum authorized content of selenium in complete feeds is 0.5 mg/kg

Rationale: Animal Health / Environment

• NRC (2005) MTL for poultry is set to 500 mg/kg.
• EFSA (2014) FEEDAP Panel recommends 100 mg/kg. Decreased feed intake and performance >100 mg/kg.
• In the EU the maximum authorized content of zinc in complete feeds is 150 mg/kg (EC No. 1334/2003)

Vitamins (IU/Kg, at 88% DM) (IU = international units)

Rationale: Animal Health / Food Safety

• (Leeson, S. 2006) proposed the maximum of 20,000 IU/Kg for broiler breeder as vitamin A is potentially toxic and may interfere with metabolism of vitamin D3.
• (NRC 1994) The requirement estimates vary from 900 to 2,200 IU/Kg.
• EFSA Journal (2008) 873, 40-81 recommends the maximum contents of Vitamin A in feed for food producing animals:
  • 0 to 28 days of life for turkeys reared for fattening at 20,000 IU/Kg
  • After 28 days for turkeys reared for fattening, rearing and breeding at 10,000 IU/Kg.

Rationale: Animal Health

• NRC (1987) provides a safe upper dietary level of Vitamin D3 for chicken of:
  • 40,000 IU/Kg diet for exposures of <60 days and
  • 2,800 IU/Kg for exposures >60 days
• (Leeson, S. 2006) proposed to increase the max to 6,500 IU/Kg as modern strains of chicken of all ages, have a need for at least 1,500 IU/Kg D3 and for high-producing laying hens it may be necessary to feed in excess of the current maximum.

Rationale: Animal Health

• NRC (1987) – 1,000 IU/Kg is the presumed upper safe level for chickens
• EFSA (2010) high doses (generally well above the 1,000 IU) of Vitamin E may reverse the principal beneficial effects of Vitamin E.
• Reversal of immunomodulation at dietary concentration in the 200 IU range in poultry (Leshchinsky and Klasing 2001)

Rationale: Not Applicable

• (EFSA Journal, 2013) The FEEDAP Panel did not see any reason to introduce a maximum content in feed for Vitamin C in the form of ascorbic acid to ensure animal safety.

References: A complete bibliography is available upon request