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Archived - Discussion Paper - Modernizing Canada's livestock feed regulations

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The consultation closed on 2012-10-05

See Feed Regulatory Renewal Pre-Consultation: What We Heard Report

Purpose

The Canadian Food Inspection Agency (CFIA) is modernizing the feed regulatory framework that applies to the importation, manufacture and sale of livestock feeds in Canada. In doing so the CFIA is engaging Canadians, regulated parties, stakeholders and other government departments, including federal partners, in an electronic consultation. This paper forms part of a two-tiered pre-consultation process designed to inform development of a renewed regulatory framework.

Table of Contents

Scope

Given that the last comprehensive renewal of the Feeds Regulations occurred in 1983, the scope of the project is to develop a modernized risk – and outcome-based regulatory framework for feeds which: attains the most effective and efficient balance between fair and competitive trade in the market; minimizes regulatory burden while safeguarding feeds and the food production continuum.

Objective

The objective of the regulatory renewal project is to develop a modernized risk- and outcome-based framework which:

Background

Animal feed controls play an important role in protecting the health of animals and the safety of food. A key example is commercial and on-farm manufacture and use of medicated feeds. Over-medicated feeds or those not withdrawn from market-ready animals on a timely basis can lead to food safety concerns by way of tissue residues of medications in animal products used as human food. Conversely, under-medicated feeds may not be effective at treating disease conditions and may contribute to the development of antimicrobial resistance in pathogenic organisms that consumers may be exposed to from the handling or consumption of meat and other animal products. In addition, feed controls help to prevent the introduction of contaminants into the human food chain. Contaminants may originate from the processing of feeds and feed ingredients (chemical residues) or environmental sources (such as Salmonella, dioxins and heavy metals).

The current regulatory framework for feed in Canada is shaped by authorities provided by the federal Feeds Act (R.S.C., 1985, c. F-9). "Feed" and "livestock" definitions can be found in Appendix A. The CFIA administers a national feed regulatory program ("Feed Program") and is responsible for the design, delivery and performance reporting of program activities such as pre-market product assessment, ingredient approvals, facility inspection, product sampling and analysis, label compliance inspection and directed inspections associated with complaints and residue tracebacks.

The regulated industries involved in the manufacture, sale and import of feed in Canada include hundreds of suppliers of feed ingredients (such as animal and vegetable proteins and fats, grains, minerals and vitamins); approximately 500 commercial feed mills; 2500 feed distributors and feed retailers; and over 100 000 operators that mix feed on farms for their own livestock, including approximately 20 000 that mix high-risk medicated feeds. It is estimated that feeds that are manufactured on-farm represent approximately 50% of the overall volume required to feed all livestock and poultry in Canada. All of these sectors are subject to the current federal regulatory framework administered by CFIA. There are no provincial/territorial regulations that apply to livestock feed, other than British Columbia and Quebec's select involvement with medicated feeds.

The Feeds Regulations were last subjected to a comprehensive review in the early 1980s and put into effect in 1983. However, a number of regulatory amendments and initiatives associated with the feed regulatory framework in Canada have been completed or elaborated since 1983, including:

Most of the regulatory changes and initiatives since the 1980s have addressed specific issues. The present-day feed regulatory framework contributes to the safety and effectiveness of livestock feeds which play a role in the production of safe food and healthy, efficient livestock as well as a fair and competitive marketplace. A comprehensive review of the feed regulatory framework will ensure that the necessary level of protection for Canadians is maintained while enabling industry to adapt as its practices evolve.

Current Environment

Feed and livestock production sectors in Canada and abroad have evolved, operating in an environment influenced by several factors including:

Several other internal and external drivers and influences are signalling that the time for a renewed feed regulatory framework has come, and require consideration.

Internal Drivers

Recognition by the CFIA of the benefits of a renewed feed regulatory framework

The CFIA administers a national feed regulatory program ("Feed Program"), underpinned by authorities and requirements established by the Feeds Act and Regulations. The Agency is responsible for the design, delivery and performance measurement/reporting of program activities (such as pre-market product assessment and registration, policy development, facility inspection, product sampling and analysis, label compliance inspection and directed inspections associated with complaints and residue tracebacks). The CFIA recognizes that the current feed regulatory framework does not offer as broad or flexible a range of compliance and enforcement approaches as some of the more up-to-date frameworks the Agency administers. For example, an internal evaluation of the CFIA's Feed Program prepared for the Audit, Evaluation and Risk Oversight (AERO) of the CFIA in 2007, made a number of recommendations to CFIA management, including, "The CFIA should ... update the Feeds Regulations to reflect the current environment".

In December 2011, the CFIA began a systematic review of its regulatory frameworks for food safety, plant health and animal health. The CFIA has identified the feed regulatory framework among those administered by the Agency as a short-term (1-3 years) priority in its regulatory modernization plan. For additional information regarding the CFIA's proposal please view the multi-year regulatory renewal plan.

CFIA Inspection Modernization

The CFIA currently administers, manages and delivers 14 inspection programs related to food safety, animal health and plant protection. Each program evolves and makes adjustments separately and has its own risk management framework, inspection methods and compliance verification and enforcement approaches.

The CFIA's operating environment has become increasingly complex and the need to modernize is felt internally, domestically and internationally. Regulatory oversight approaches have changed internationally, placing more emphasis on industry's responsibility to establish effective hazard control programs with government providing oversight verification through audit.

As a result, the inspector's role has changed. Inspectors now require more highly specialized science and technological expertise, continuous training and modern tools to perform their duties. These recommendations were made most notably in the Report of the Independent Investigator into the 2008 Listeriosis Outbreak, also known as the Weatherill Report.

It is within this context that the Government of Canada committed $100 million over 5 years to the CFIA in Budget 2011 to improve and modernize food safety in Canada.

The CFIA is moving away from a system of independent commodity specific inspection approaches and inspector training, and paper-based record keeping and interactions with stakeholders to a single and consistent approach across food commodities that are either imported or produced domestically. This approach will be supported by standardized training, modern technology solutions, enhanced and proactive science capacity, and improved service to stakeholders.

The Agency is consulting externally until July 31, 2012 on the rationale and the direction it is taking to modernize food inspection, and also plans to consult on a draft improved food inspection model in Summer 2012. The improvements made to the food inspection model will be applied to animal health and plant health programs, where possible.

Currently, the CFIA has identified five common components and principles of food inspection as a starting point to develop the improved food inspection model.

Components of the improved inspection modelWhat this means for the design of the improved food inspection model
Licensing/registration The model proposes that industry who either import or export food, or who manufacture or process food products for trade between provinces, be required to obtain a license/registration.
Determination of level of oversight The level of the CFIA's oversight should correspond to the level of risk associated with the product/process and the degree of control demonstrated by the regulated party (residual risk).

The CFIA's oversight approach should be flexible enough to encompass a range of compliance verification systems (e.g. direct inspection, systems audit, third-party verification).
Compliance verification Standardized compliance verification approaches across all foods should promote consistent and risk-based application of food safety and other regulatory requirements. Where possible, these standardized compliance verification approaches can be applied to animal and plant health programs.
Compliance and enforcement The CFIA response to non-compliance must be predictable, transparent, graduated and based on risk.
Validation Effective regulatory decision making and program management requires timely and accurate information on risks and trends.

The overall effectiveness of an inspection system should be validated on an on-going basis through the use of objective performance measures.

More information regarding the CFIA's Inspection Modernization initiative can be found on the CFIA's website.

User Fees

As the CFIA moves through its regulatory review, its approach to service standards and user fees associated with regulations will be examined. CFIA user fees have changed very little since 1997 and work has begun to bring fees into alignment with operational costs of delivering services. The process used to determine individual fees was finalized in the Fall 2010.

Where there are private benefits, the CFIA can improve its accountability to regulated parties by ensuring that fees are aligned with the costs of providing the service, linked to service standards and applied consistently across sectors.

More information on the Cost Recovery Policy and Framework can be found on the CFIA's website.

Government of Canada commitments to reduce regulatory burdens and trade barriers

Examples of the commitments include the:

External Drivers

Domestic

As a key stakeholder in the regulatory framework for feed in Canada, the Animal Nutrition Association of Canada (ANAC) has already taken a pro-active step towards expressing its position on the need for regulatory reform. In December 2010, ANAC submitted a white paper to the CFIA for consideration.

The paper "proposes that a modernized regulation should first and foremost focus on three core objectives:

The paper elaborates ANAC's proposals for a modernized regulatory framework, which will be taken under consideration along with the views gathered during this project from other key stakeholders.

International Standards

Codex Code of Practice on Good Animal Feeding (2004) and Ad Hoc Task Force on Animal Feeding (2012)

As the international standard-setting organization for food, the Codex Alimentarius Commission published the Code of Practice on Good Animal Feeding in 2004 to establish a feed safety system for food producing animals which covers the whole food chain, taking into account relevant aspects of animal health and the environment in order to minimize risks to consumers' health. This Code applies in addition to the principles of food hygiene already established by the Codex Alimentarius Commission, taking into account the special aspects of animal feeding.

The objective of the Code is to help ensure the safety of food for human consumption through adherence to:

Not only does the Code provide guidance to sectors involved in the production of feed and food animals, it also sets out guidance regarding inspection and control procedures that oversight organizations such as the CFIA should implement and administer.

While conformance to the The Codex code of practice on good animal feeding - PDF (179 kb) is not mandatory, it can be used by governments and industries alike for guidance on the range of measures that form the basis for feed safety controls which in turn impact on food safety. A more detailed discussion of the guidance provided by the Code is found in the "Safeguarding the Food Supply" section of the paper that follows below.

A second Ad Hoc Task Force on Animal Feeding has been established by the Codex Commission with a 2 year mandate and potential for a third. Two terms of reference have been given:

Progress on the work may be found at the Ad Hoc Codex Intergovernmental Task Force on Animal Feeding website.

Information on the Codex process in Canada and how to provide your input is available through the Codex Canada website.

For other external drivers (BSE, U.S. Food Safety Modernization Act, European Union Audits of Canada's Food Residues and Feed Controls) please see Annex B.

Discussion Topics for Stakeholder Input

In order to take a structured approach to this pre-consultation phase of the feed regulatory renewal project, the CFIA proposes that the following topics provide the basis for comment and feedback by interested parties:

  1. Safeguarding the Food Supply;
  2. Safeguarding the Animal Resource Base;
  3. Consumer Protection Considerations; and
  4. Market Access Considerations

These discussion topics are directly related to the strategic outcomes of the CFIA and are linked to the Government of Canada's priorities for bolstering economic prosperity, strengthening security at the border and of the safety of the food supply, protecting the environment and contributing to the health of Canadians.

In order to gain more information about potential stakeholders in this process the following provides background information which may be helpful in responding to the CFIA's survey on feed regulatory renewal.

Safeguarding the Food Supply

Mitigating risks to food safety is the CFIA's highest priority. The health and safety of Canadians is the driving force behind the design and development of CFIA programs. The CFIA, in collaboration and partnership with industry, stakeholders, consumers, and federal, provincial and municipal organizations, continues to work towards protecting Canadians from preventable health risks related to unsafe food and zoonotic diseases. As mentioned in the "External Drivers – International Standards" section of this discussion paper above, international focus on the links between feed and the safety of food has also increased over the past decade.

The CFIA proposes to use the Codex Code of Practice on Good Animal Feeding - PDF (179 kb) from 2004 to frame the discussion with stakeholders on this topic. The Code represents a neutral, international standard that considers both the impacts on food safety arising from feed manufacturing and distribution, as well as feeding practices at the farm level. The current Feeds Regulations do not address all of the components of this internationally agreed upon standard and thus may pose difficulties for export of Canadian feeds and food to foreign markets.

The key elements of the Code are as follows (references to section number, paragraph number of the Code):

General Principles and Requirements
Feed ingredients (4.1, 9)

Feed labelling (4.2, 10)

Traceability/product tracing and record keeping of feed and feed ingredients (4.3, 12)

Inspection and control procedures (4.4, 15-16)

Health hazards associated with animal feed (4.5)
Feed Additives and Veterinary Drugs (4.5.1, 18-22)

Production, Processing, Storage, Transport and Distribution of Feed and Feed Ingredients (5, 27-50)

On-farm Production and Use of Feed and Feed Ingredients (6, 52-80)

Safeguarding the animal resource base

The current and future economic prosperity of the Canadian agriculture sector relies on a healthy and sustainable animal resource base. The CFIA contributes to its well-being by reducing risks to Canada's animals (including livestock, terrestrial and aquatic animals) from regulated diseases, managing animal disease emergencies and incidents and mitigating and managing risks to livestock and derived food products associated with feed. Feed represents a significant input cost to the production of livestock. Feed also plays an important role in contributing to the health and productivity of livestock.

The feed regulatory framework in Canada has for some time been used to establish standards for feeds (ingredients approved for use in feeds, controls on the use of medications in feeds, standards of safety, composition, nutrition etc.) and require the mandatory registration of specific feeds so that the CFIA can confirm that feeds meet such standards prior to their marketing. Since 1983, however, the categories and numbers of feed ingredients and feeds requiring mandatory registration have declined significantly to the point that an estimated 95% of marketed feeds are exempted from this requirement. Feeds exempted from registration must still comply with the standards and other requirements for feeds set out in the Regulations.

Consumer Protection

The CFIA has developed and implemented regulatory frameworks over time that address risks to consumers in order to verify that labelling information is truthful and not misleading and to verify that imports meet Canadian requirements. The CFIA's programming has contributed to protecting consumers from unfair market practices as it relates to food and certain agricultural products, including feeds.

Consumer demands are changing as consumers seek more choices and information on:

However, for feeds, regulations and programming regarding consumer protection have been identified as potential barriers to timely domestic market access and innovation.

Market Access

The CFIA's international collaboration and market access activities aim to contribute to a coherent, predictable, and science-based regulatory framework relating to food safety, animal health, and plant health that facilitates trade for the benefit of the Canadian economy. The CFIA supports Canadian agriculture and agri-food businesses' ability to enter domestic and global markets and their successful competition therein. The CFIA works to facilitate continued and new market access for Canadian agriculture, fishery, forestry, and food products by verifying that Canadian products meet domestic regulations and international standards and by reflecting Canada's interests when negotiating technical arrangements and standards in the international arena.

Based on market demand, the CFIA negotiates and certifies against export conditions in order to access export markets. The Agency, working with industry and interested stakeholders, continues to develop and maintain export certification standards (which vary from country to country and commodity to commodity), conducts inspections, and issues export certificates.

Regulatory Renewal Guiding Principles

As set out in the CFIA's proposed multi-year regulatory renewal plan, regulatory modernization across CFIA-administered frameworks will be guided by a series of overarching principles that will set the stage for a more coherent and consistent approach for the next generation of regulatory frameworks. In proceding with the feed regulatory renewal project, a modernized framework is to:

At any given time, the CFIA's role as a regulatory body includes acting as the "guardian" of existing regulations and enforcing compliance with them to achieve the objectives of the national feed regulatory program. When in regulatory review mode, the CFIA also acts as the "change agent" in facilitating processes to enable open discussion on change and the development and implementation of amended frameworks.

CFIA as a Stakeholder in Feed Regulatory Renewal

The feed regulatory framework can be viewed as a national code of practice that reflects the interests of a diverse set of stakeholders, including livestock producers, the commercial feed industry, feed ingredient suppliers and manufacturers, animal and food processors, food consumers and the CFIA. Beyond the roles CFIA plays as guardian of existing regulatory frameworks and change agent for renewed ones, the CFIA has interests associated with the regulatory frameworks it administers. Among the overarching principles set out in the Agency's proposed multi-year regulatory modernization plan, one of the CFIA's key interests is:

Throughout regulatory modernization, food safety and protection of the animal and plant resource bases will remain paramount.

To this end, feed contributes to food safety in that unsafe feeds (containing or contaminated by harmful pathogens, chemical residues, drugs and other risk materials) may adversely affect the safety of meat, milk, eggs and other animal products used for human consumption. The CFIA's Feed Program recognizes these risks and current inspection programs and activities serve to identify and respond to actual or potential feed safety issues. Feed also plays important roles in contributing to the health and productivity of livestock and, by way of controls on the release of novel plants and feedstuffs derived there from, protecting the animal resource base.

Consumer protection and market access issues are also within the scope of CFIA interests in the context of several regulatory programs, including feed. Assessing and providing guidance on the misrepresentation or mislabelling of feed products in a domestic market context and mechanisms to certify Canadian feedstuffs for international market access context are also activities delivered as part of the current Feed Program.

Project Plan

The project plan for feed regulatory renewal has five (5) phases:

Phase 1

In preparation for a regulatory renewal project market trends, regulatory best practices and international regulatory frameworks for feed in the EU and U.S. were examined.

The world population is expected to reach 9 billion by 2050, however the majority of the population growth will be seen in developing countries. This means that if there is an increase in Canadian livestock products production, it will mainly be destined for export markets. As the feed to food continuum gains international importance, feeds for animals intended for export increasingly require regulatory oversight. Canadian farms are also changing. There is an increase in the number of animals per farm, and an increase in the number of farms that are part of a singly owned supply chain. A single business will own the feed mill, farm for raising animals and facilities for processing the animal products. An integrated approach like this presents new challenges.

The U.S. and the EU are our two biggest trading partners as well as competitors for feed and livestock products and in other markets abroad. As such, the way in which feed is regulated in these countries must be considered. In the U.S., feed is regulated at both the federal and state level. The federal Food and Drug Administration has control over feed for import, export and for interstate commerce. Their control focuses on health and safety for both humans and animals. In addition to FDA oversight, individual states have feed controls. State level feed control focuses more on the trade and commerce within the state and consumer protection aspects. In the EU there are several levels of regulations. The EU and each country have their own feed regulations. Feed control may also occur within the country at state or regional levels.

In Canada, the Cabinet Directive on Streamlining Regulations along with a number of other sources provides the pillars for regulatory principles. Stakeholder engagement and consultation is one of the most important factors in developing regulations. There are a number of regulatory tools which range from performance-based regulations which specify the required outcome, to process-based regulations which require an approved process to be developed. In addition, there are alternatives to regulation such as co-regulation, economic instruments (e.g. taxes or subsidies) and voluntary approaches. Determining the proper balance of these tools is critical for effective regulation.

Phase 2

Phase 2 of the project has been initiated. It comprises a two-tiered approach to a pre-consultation with stakeholders to gather information regarding interests in a renewed feed regulatory framework, current and future trends, opportunities and challenges facing stakeholders as they might relate to feed to:

Feedback on discussion questions and comments may be provided using the online Survey Form.

Information and comments gathered from this on-line consultation and bilateral meetings with interested parties together with multi-stakeholder meetings will form the basis of Phase 2. The first of the face-to-face meetings is envisioned in the late summer of 2012. The output of stakeholder engagement will serve to inform drafting of a proposed regulatory framework. The input received from stakeholders will be used to help identify convergence and divergence of positions regarding what a renewed feed regulatory framework should encompass, identify any issues or topics that may need further discussion, and help establish activities to complete this phase. In arriving at a shared vision for a modernized framework, stakeholders will provide the CFIA with input on how to proceed with the development of the regulatory framework during Phase 3 of the project.

Summary

The CFIA has initiated a multi-year review of the regulatory frameworks for food safety, plant health and animal health it administers. The CFIA has identified the feed regulatory framework among the frameworks administered by the Agency as a priority for regulatory modernization.

This discussion paper and on-line survey are intended for consultation with interested parties as part of the feed regulatory renewal project. They provide the opportunity to submit information and comments in response to a series of questions provided for consideration. Information and comments gathered from this on-line consultation and bilateral meetings with interested parties together with multi-stakeholder meetings will form the basis of Phase 2. The output of stakeholder engagement will serve to inform drafting of a proposed regulatory framework. In arriving at a shared vision for a modernized framework, stakeholders will provide the CFIA with input on how to proceed with the development of the regulatory framework during Phase 3 of the project.

Annex A – Background Information

Definitions and Data

Feed is defined in the Feeds Act as follows:

"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;

The animals for which feeds are subject to regulation are set out in the definition of "livestock" in the Act as well:

"livestock" means horses, cattle, sheep, goats, swine, foxes, fish, mink, rabbits and poultry and includes such other creatures as may be designated by regulation as livestock for the purposes of this Act.

The Act allows for the making of regulations, including regulations regarding the:

Annex B – Trading Partner Considerations

Bovine Spongiform Encephalopathy (BSE)

With the detection of Canada's index case in 2003 and subsequent BSE cases, international delegations have been coming to Canada regularly in recent years with intentions to consider restoring or expanding market access to Canadian ruminants, beef and other animal products and by-products in their home countries that may have been impacted by the findings of BSE here. In their evaluations of Canadian animal and food production systems, the nature of feeds, feed controls and feeding practices employed in Canada have become an integral part of their assessment of Canada's overall animal health and food safety systems. Coupled with the attention being paid to feed by the Codex Commission and its initiatives as discussed above, it is likely the feed-to-food safety link will increase in prominence in market access/trade considerations into the future.

United States (U.S.) Food Safety Modernization Act (FSMA)

The Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4, 2011, and represents the most sweeping reform of U.S. federal food safety laws in more than 70 years. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. Implementation of FSMA is the responsibility of the U.S. Food and Drug Administration (FDA). In the first year since the FSMA was signed into law, FDA has made significant progress laying the foundation for a food safety system that is grounded in prevention from farm-to-table.

In the context of the federal Food, Drug and Cosmetics Act that FDA administers and FSMA has amended, food for animals is defined within the scope of the definition of food in this legislation so FDA acts as the federal feed regulator in the U.S. In modernizing their food safety controls, programs and activities, FDA will make changes to its feed safety regulatory controls, programs and activities in the next 2-5 years with the full implementation of FSMA reforms. Given that Canada is a major exporter of food products to the U.S., the increased integration of feed safety and food safety measures implemented by FDA will require the attention of Canadian government and industry organizations alike.

European Union (EU) Audits of Canada's Food Residues and Feed Controls (2011)

During August and September, 2011, two teams of auditors from the EU's Food and Veterinary Office (FVO) were in Canada to assess whether feed additives and premixtures of feed additives as well as food exported to the EU provide guarantees at least equivalent to those set out by EU Regulations. A number of recommendations were made to the Canadian competent authorities, aimed at rectifying the shortcomings identified and enhancing the implementing and control measures in place.

The food residues audit, to "evaluate the monitoring of residues and contaminants in live animals and animal products", was aimed at the control of residues and contaminants in live animals and animal products, in order to assess whether these systems offer adequate assurance that the products and animals concerned are within the specified residue limits laid down in EU legislation. The audit identified that feed system controls are necessary to underpin food exports to the EU. A copy of the EU report and Canada's responses is available online.

The feed audit, to "evaluate the implementation of requirements for feed additives and premixtures", was aimed to assess whether the feed additives and premixtures exported to the EU can be considered at least equivalent to those laid down by Regulation (EC) No 183/2005 on feed hygiene and in other EU rules for feed. The audit identified that although there is control of feed in Canada, the regulations regarding feed additives are not sufficient to meet the EU standards. A copy of the EU report and Canada's responses is available online.

In order to facilitate export of Canadian feed and animal products/food, attention to the EU requirements will be required by the Canadian government.

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