Archived - Proposal - Maximum Nutrient Values in Swine Feeds

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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 swine 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 swine 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 swine 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 Journal of Animal Science and the Journal of Nutrition); 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 Swine feeds.

Anticipated Outcomes

This modernized regulatory approach to the oversight of maximum nutrient content in swine 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 swine 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.

References: A complete bibliography is available upon request.

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
Email: Sergio.Tolusso@inspection.gc.ca
Fax: 613-773-7565

Appendix I – Proposed Maximum Nutrient Values for Swine Feeds

Class	Current	Proposed
Starter	Up to 10 kg 11-20 kg	3-5 kg 6-10 kg 11-20 kg
Grower	21-60 kg	21-50 kg
Finisher	61-100 kg	51-80 kg >80 kg
Dry Sows	Breeding	Breeding
Lactating Sows	Lactating	Lactating

Rationale:

• Breakdown of the growing phases to allow for more flexibility and tailored diets/phase feeding to make more efficient use of calcium and phosphorus.

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

Calcium (Ca)

Class	Current	Proposed
Starter	2.0	1.0
Grower	2.0	1.0
Finisher	2.0	1.0
Dry Sows	2.0	1.0
Lactating Sows	2.0	1.0

Rationale: Animal Health

• NRC (National Research Council of the National Academies) (2005) recommends maximum tolerable level of 1% with a Ca:P ratio of 1:1-1.2:1.
• Hall et al. (1991): greater than 1.2%&nbspCa affected normal blood clotting mechanisms in growing pigs causing death due to internal hemorrhaging

Phosphorus (P)

Class	Current	Proposed
Starter	2.0	1.0
Grower	2.0	1.0
Finisher	2.0	1.0
Dry Sows	2.0	1.0
Lactating Sows	2.0	1.0

Rationale: Animal Health

• Decline in feed efficiency in pigs fed dietary P in excess of 1%.

Magnesium (Mg)

Class	Current	Proposed
Starter	0.3	0.2
Grower	0.3	0.2
Finisher	0.3	0.2
Dry Sows	0.3	0.2
Lactating Sows	0.3	0.2

Rationale: Animal Health

• Increased frequency of diarrhea above 0.2%&nbspMg (NRC 2005; Tarsitano et al. 2013).

Sodium (Na)

Class	Current	Proposed
Starter	0.8	1.1
Grower	0.8	1.1
Finisher	0.8	1.1
Dry Sows	0.8	1.1
Lactating Sows	0.8	1.1

Rationale: Animal Health

• NRC (2005) states swine readily tolerate 3%&nbspNaCl (approx. 1.1% Na) in diet with water freely available.

Potassium (K)

Class	Current	Proposed
Starter (3 – 5 kg)	2.0	3.0
Starter (6 – 10 kg)	2.0	2.8
Starter (11 – 20 kg)	2.0	2.6
Grower (21 – 50 kg)	2.0	2.3
Grower (51 – 80 kg)	2.0	1.9
Finisher (>80 kg)	2.0	1.7
Dry Sows	2.0	2.0
Lactating Sows	2.0	2.0

Rationale: Animal Health

• NRC (2005) states:
  • Maximum of 1% K in swine feeds.
  • Swine can tolerate up to 10 times their K requirement.
• These values are 10× the requirement indicated in NRC 2012 for swine.

Sulfur (S)

Class	Current	Proposed
Starter (3 – 5 kg)	NRS (No Recommendation Specified)	0.2
Starter (6 – 10 kg)	NRS	0.4
Starter (11 – 20 kg)	NRS	0.4
Grower	NRS	0.4
Finisher	NRS	0.4
Dry Sows	NRS	0.4
Lactating Sows	NRS	0.4

Rationale: Animal Health

• Reduction in pig growth and feed efficiency at higher levels.
• NRC (2005) states maximum of 0.4% S for swine.
• Perez et al. (2011) found proportional reduction in growth and feed efficiency above 0.2% in nursery pigs

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

Cobalt (Co)

Class	Current	Proposed
Starter	5.0	1.0
Grower	5.0	1.0
Finisher	5.0	1.0
Dry Sows	5.0	1.0
Lactating Sows	5.0	1.0

Rationale: Worker Safety / Food Safety

• EFSA 2009 (European Food Safety Authority) recommends maximum Co content of 1 mg/kg complete feed for all non-fish species.
• No necessity for Co supplementation in swine.
• 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.
• Animals fed at maximum tolerable level (25 mg/kg – NRC 2005) may have kidney cobalt concentrations that exceed the standard for human health.

Copper (Cu)

Class	Current	Proposed
Starter	125	250
Grower	125	250
Finisher	125	250
Dry Sows	125	250
Lactating Sows	125	250

Rationale: Therapeutic

• NRC (2005) recommends a maximum tolerable dietary Cu concentration of 250 mg/kg for swine.
• Health Canada's Veterinary Drugs Directorate has indicated that concentrations above 250 mg/kg for pigs are considered therapeutic levels.
• European Commission has maximums of 170 mg/kg for starter swine up to 12 weeks and 25 mg/kg for other swine based on reductions related to environmental concerns.
• Possible environmental concerns have not been fully evaluated for Canada.

Iodine (I)

Class	Current	Proposed
Starter	10	4.0
Grower	10	4.0
Finisher	10	4.0
Dry Sows	10	4.0
Lactating Sows	10	4.0

Rationale: Animal Health

• Increase in thyroid size, indicative of the goitrogenic effects of chronically high I intake, at feed concentrations above 4 mg/kg (Li et al. 2011; Frank et al. 2008).

Iron (Fe)

Class	Current	Proposed
Starter	750	750
Grower	750	750
Finisher	750	750
Dry Sows	750	750
Lactating Sows	750	750

Rationale: Animal Health

• Increased oxidative stress in diets containing 750 mg/kg of Fe (Porres et al. 1999).

Manganese (Mn)

Class	Current	Proposed
Starter	200	125
Grower	200	125
Finisher	200	125
Dry Sows	200	125
Lactating Sows	200	125

Rationale: Animal Health

• Reduced hemoglobin formation in diets containing 125 mg/kg (Matrone et al. 1959)
• The European Commission EC No1334/2003 establishes a maximum content of manganese of 150 mg/kg for swine.

Selenium (Se)

Class	Current	Proposed
Starter	0.3 (added)	0.5 (total)
Grower	0.3 (added)	0.5 (total)
Finisher	0.3 (added)	0.5 (total)
Dry Sows	0.3 (added)	0.5 (total)
Lactating Sows	0.3 (added)	0.5 (total)

Rationale: Animal Health and Food Safety

• NRC (2005) recommends 4 mg/kg (DM); however, food safety and therapeutic considerations are necessary. A transition from added to total Se is needed for analytical verification and enforcement of maximum content.
• In the EU the maximum authorized content of selenium in complete feeds is 0.5 mg/kg

Zinc (Zn)

Class	Current	Proposed
Starter	500	1,000
Grower	500	1,000
Finisher	500	1,000
Dry Sows	500	1,000
Lactating Sows	500	1,000

Rationale: Therapeutic

• NRC (2005) recommends maximum tolerable dietary Zn concentration of 1,000 mg/kg (DM) for swine.
• Health Canada's Veterinary Drugs Directorate has indicated that Zn can be used for the treatment of diarrhea at a concentration of 2,000 mg/kg and higher.
• EFSA (2014) 1,000-3,000 mg/kg used in piglets for up to 5 weeks to combat post-weaning diarrhea and promote growth.
• European Commission has a maximum of 150 mg/kg swine based on reductions related to environmental concerns.
• Possible environmental concerns have not been fully evaluated for Canada.

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

Vitamin A

Class	Current	Proposed
Starter	20,000	16,000
Grower	20,000	6,500
Finisher	20,000	6,500
Dry Sows	20,000	12,000
Lactating Sows	20,000	7,000

Rationale: Food Safety

• EFSA (2008) Recommended maximums of 16,000 IU vitamin A/ kg for piglets, 6,500 IU vitamin A/kg for pigs for fattening, 12,000 IU/kg to achieve uniform and avoid extreme high tissue concentrations
• NRC (1987) presumed upper safe level for breeding and growing swine based on animal health to be 40,000 and 20,000 IU/kg of diet, respectively.

Vitamin D

Class	Current	Proposed
Starter	1,500	2,200
Grower	1,500	2,200
Finisher	1,500	2,200
Dry Sows	1,500	2,200
Lactating Sows	1,500	2,200

Rationale: Animal Health

• NRC (1987) provides a safe upper dietary level of 2,200 IU/kg for exposures >60 days.

Vitamin E

Class	Current	Proposed
Starter	NRS	1,000
Grower	NRS	1,000
Finisher	NRS	1,000
Dry Sows	NRS	1,000
Lactating Sows	NRS	1,000

Rationale: Animal Health

• NRC (1987) states hypervitaminosis E has been studied indicating maximum tolerable levels in the range of 1,000-2,000 IU/kg diet.
• Presumed safe use level of 75 IU/kg of BW/day [body weight/day] is suggested.

Vitamin C

Class	Current	Proposed
Starter	NRS	Remove
Grower	NRS	Remove
Finisher	NRS	Remove
Dry Sows	NRS	Remove
Lactating Sows	NRS	Remove

Rationale: Not Applicable

• EFSA (2013) considered that setting a maximum content in feed or drinking water for swine to be unnecessary concluding that Vitamin C, in the form of ascorbic acid and sodium calcium ascorbyl phosphate, is safe for all animal species.
• NRC (1987) finds that in growth studies of varying lengths, ascorbic acid intakes of 10 g/kg of feed for swine does not appear to adversely affect the growth of these animals.

References: A complete bibliography is available upon request.