Home Animals Feeds Consultations Feed Hazard IdentificationCanadian Food Inspection Agency (/eng/1297964599443/1297965645317)

Feed Hazard Identification / Preventive Controls ­Regulatory Framework ProposalThis consultation closed 2014­07­25

Table of Contents1 Purpose2 Background2.1 Change Management at the CFIA (Canadian Food Inspection Agency)2.2 Feed Regulatory Modernization2.3 Principles of CFIA (Canadian Food Inspection Agency) Regulatory Modernization2.4 Consultation Process and the Role of this Proposal3 Current Situation3.1 Feed Hazards3.2 Feed Preventive Controls3.3 Record Keeping3.4 International Situation3.5 Consultation Outcomes to Date4 Proposed Regulatory Framework4.1 Objectives of Hazard Identification and Preventive Control Plans4.2 Scope4.3 Hazard Identification (Modernized)

4.4 Preventive Controls (New)4.5 Record Keeping4.6 Roles and Responsibilities5 Implementing Proposed Regulatory Framework6 Summary6.1 Proposal Synopsis6.2 Next Steps6.3 ContactAnnex 1 ­ FRSG (Feed Regulatory Steering Group) RecommendationsAnnex 2 ­ Proposed Outcome­based Regulatory Requirements1. Product and Process Control2. Sanitation, biosecurity and pest control3. Hygiene, biosecurity and employee training4. Equipment design and maintenance5. Outside premises, surroundings and maintenance6. Receiving, transportation and storage7. Recalls, complaints and record­keeping

1 PurposeThis document outlines the principles, objectives, and proposed direction of a modernized regulatory framework that wouldapply to the identification of hazards in livestock feeds, the management of risks they may pose, and the establishment ofpreventive controls. The Canadian Food Inspection Agency (CFIA) seeks broad stakeholder comments and input on theregulatory proposal.

This proposal is one of a series of modules that have been prepared as part of the Feed Regulatory Renewal project.

2 Background

2.1 Change Management at the CFIA (Canadian Food Inspection Agency)

2.1 Change Management at the CFIA (Canadian Food Inspection Agency)The CFIA (Canadian Food Inspection Agency) has embarked on a comprehensive change agenda to strengthen itsfoundation of legislation, regulatory programs, and inspection delivery. These directions set the context for renewal of theFeed Regulations (Regulations).

In December 2011, the CFIA (Canadian Food Inspection Agency) initiated a systematic, multi­year review of its regulatoryframeworks for food safety, plant health, and animal health. Through this structured and comprehensive review, the Agencyintends to update its regulatory frameworks to

reduce overlap and redundancy,increase responsiveness to industry changes,address gaps, weaknesses, and inconsistencies, andprovide clarity and flexibility to affected regulated parties.

The modernization of the Regulations has been identified as a short­term priority in the first three years of the modernizationinitiative.

The Agency will continue to explore opportunities for modernizing its legislative base as regulatory modernization takesplace. For feeds, Canada's Minister of Agriculture and Agri­Food tabled the Agriculture Growth Act (Bill C­18(http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=6378152&File=53)) in Parliament,proposing to amend several federal agricultural statutes, including the Feeds Act (Act). Among the suite of proposedamendments, a new authority to make regulations "respecting quality management programs, quality control programs,safety programs, preventive control plans (PCPs) or any other similar programs or plans to be implemented by persons whoconduct any activity regulated under this Act" would be provided to the CFIA (Canadian Food Inspection Agency).

The Agency is also engaged in developing a new inspection delivery model, the Integrated Agency Inspection Model (iAIM),which is based on common inspection activities and standard processes for all its inspection programs, and is more focusedon risk as a basis for prioritizing inspection activities. This new model, supported by a renewed training regime, is beingpioneered for food inspection, but will be adapted, as appropriate, to help streamline and create efficiencies for otherinspection activities, including feed.

2.2 Feed Regulatory Modernization

2.2 Feed Regulatory ModernizationModernization of the Regulations strives to reduce compliance burden and to support innovation while maintaining animaland human health, as well as environmental and economic sustainability.

The current feed regulatory framework is product­based, including pre­market assessment and approval, or registration ofsingle feed ingredients and any mixed feeds (comprised of one or more ingredients) that do not meet exemption fromregistration criteria. In addition, the Regulations include requirements for labelling of feeds to provide accurate information.

The Agency maintains marketplace oversight of ingredients and feeds to verify they are compliant with the composition,labelling, and registration standards of these Regulations.

The modernization of the Regulations is being designed to benefit the collective Canadian feed industry, which includescommercial feed manufacturers, retailers, importers, exporters, ingredient manufacturers, livestock producers, andconsumers. As well as aligning, where possible, with other international feed regulatory regimes, modernization alsomaintains the objective of safeguarding animal health, plant health, food safety, and environmental safety for the Canadianpublic.

The ultimate objective of the Regulations' review is to develop a modernized risk­ and outcome­based regulatory frameworkfor feeds that

supports fair and competitive trade in the market;minimizes regulatory burden; andprotects public, animal and plant health, and the environment.

2.3 Principles of CFIA (Canadian Food Inspection Agency) Regulatory ModernizationThe following principles guide the overall CFIA (Canadian Food Inspection Agency) regulatory modernization process:

protecting public safety and confidence in the inspection framework;enabling an environment of improved business opportunity and consumer choice by facilitating innovation andcompetitiveness;establishing clear policy objectives through consultation with partners – including industry, consumers, small business,

other departments, and provinces;finding the appropriate balance between administrative costs and benefits derived from regulatory intervention;developing consistent, transparent and, where appropriate, outcome­based regulations with performancemeasurements;recognizing the vital importance of science and risk management approaches in decision making; andaligning, to the extent possible, with international trading partners and provincial standards.

2.4 Consultation Process and the Role of this ProposalStakeholder consultation is an important component of regulatory modernization.

During 2012, the Agency took a three­tiered approach to initiate pre­consultation on this comprehensive project. First,informal bilateral meetings were held with stakeholder groups. A subsequent discussion paper and survey were madeavailable online to provide all stakeholders with the opportunity to provide feedback. Finally, a two­day multi­stakeholderworkshop was held in September 2012.

Following the September 2012 workshop, there was a need for further stakeholder consultation. An industry and governmentFeed Regulatory Steering Group (FRSG) was formed in November 2012, with members representing the commercial feedmanufacturers, major national livestock producer associations, the CFIA (Canadian Food Inspection Agency), and HealthCanada's Veterinary Drugs Directorate (VDD). Early on, the FRSG (Feed Regulatory Steering Group) determined that feedregulatory modernization was sufficiently complex, and thus should be broken down into the following three components("modules") for further discussion:

1. Feed Ingredient Assessment and Authorization2. Feed Hazard Identification and Preventive Controls (possibly including facility licensing)3. Feed Labelling

Modules 1 and 3 (/animals/feeds/consultations/eng/1343855817011/1343856000143) have been posted for public reviewand comment; consultation closed on December 5, 2013.

A March 2013 workshop was held with interested stakeholders to discuss the topic of feed hazard identification andpreventive controls.

The information provided and gathered from all these activities forms the foundation of this proposal, which outlines whatdirection the Agency envisions for the identification and management of hazards, associated with feeds, on public health,animal and plant health, and the environment.

3 Current SituationThe scope of the Feeds Act applies to the manufacture, sale, and importation of feeds in accordance with regulations that setout registration and labelling requirements and standards for feeds.

Whether manufactured domestically or imported, certain feed ingredients such as vitamin A, D, and E sources currentlyrequire mandatory CFIA (Canadian Food Inspection Agency) registration prior to manufacture, sale, or entry into Canada. Ifnot required to be registered, imported feed ingredients are otherwise permitted entry into Canada, provided they have beenauthorized for use as an ingredient in livestock feed in Canada and comply with standards established for the authorizedingredient.

Domestic mixed feeds are largely exempt from mandatory pre­market assessment and registration by the CFIA (CanadianFood Inspection Agency). Domestic feed manufacturers, retailers, and some farms are inspected by the CFIA (CanadianFood Inspection Agency) on a risk­based frequency to verify compliance with current regulatory requirements, includingcompliance with requirements set out in the Health of Animals Regulations, respecting the restrictions ("feed ban") related topreventing the transmission of bovine spongiform encephalopathy (BSE). All imported mixed feeds must be registered by theCFIA (Canadian Food Inspection Agency) prior to entry into Canada.

Livestock producers who manufacture feeds are exempt from the Act and any of its associated regulations, provided thefeeds they manufacture are neither sold nor contain any drug or other substance that may adversely affect human health orthe environment.

Currently, the requirements in the Feeds Regulations regarding feed safety, composition, and quality focus on the feedproducts themselves and not on processes employed in feed manufacturing. A number of standards are set in regulationregarding the form and composition of the feed.

3.1 Feed Hazards

The CFIA (Canadian Food Inspection Agency) takes a three­tiered approach to identifying hazards and providing guidanceon maximum acceptable levels in feed:

1. In regulation – In some cases, hazards are identified in the Regulations. This includes a list of deleterious substancesthat are mainly prohibited pesticides, a list of prohibited weed seeds, maximum levels for substances that are likely tobe deleterious to livestock such as fluorine and aflatoxin and other extraneous material (e.g. (for example) mould, heatdamage, or sawdust). Further, feed ingredient definitions may contain additional standards such as a standard forglucosinolates or a maximum use rate to allow safe use of the ingredient.

2. In guidance – The CFIA (Canadian Food Inspection Agency) provides administrative guidance on a number of otherhazards in feeds such as mycotoxins, metals, dioxins, furans, and PCBs (Polychlorinated biphenyls). In addition, theguidance sets out action levels for many of the individual contaminants. A feed Action Level is defined as the level atwhich, if exceeded, a contaminant may present a health risk to the animal or result in unacceptable residues in foods ofanimal origin.

3. Ad hoc assessments – The CFIA (Canadian Food Inspection Agency) also undertakes ad hoc assessments ofhazards in feeds for which maximum or action levels are not specified in the Regulations or guidance. Often, theseassessments are undertaken in response to accidental contamination of food and feed products that is reported byregulated parties or identified by sampling.

3.2 Feed Preventive ControlsWith respect to preventive controls for hazards that may be present in feeds, requirements for such controls are not includedin the current Regulations, nor do they contain specific process or other control provisions, or identify who is responsible fortheir administration.

Alternatively, the CFIA (Canadian Food Inspection Agency) has implemented a number of control measures since 1997,using authorities provided by the Health of Animals Act, to address risks associated with the transmission of BSE (bovinespongiform encephalopathy) via feeds along the feed and livestock production chain. The hazards are identified and definedin the Health of Animals Regulations as "prohibited material" (mammalian proteins with some exceptions) and "specified riskmaterial" (certain cattle tissues such as brain and spinal cord from animals over 30 months in age). To manage risks posedby these materials in the production system, preventive control measures are present in the Regulations, requiring that

operators of rendering plants use dedicated production lines, equipment, and conveyances to manufacture anddistribute prohibited and non­prohibited animal protein products to prevent cross­contamination;operators of establishments have procedures to prevent the mixing or contamination of food for ruminants withprohibited material; andmanufacturers, importers, distributers, and vendors of animal food establish and maintain procedures to facilitateeffective recall.

Even though more comprehensive regulatory requirements are not currently in effect, industry group programs havedeveloped and implemented a number of sector­specific food­safety­oriented preventive control programs nationally in recentyears.

Here are some examples:

Animal Nutrition Association of Canada (ANAC) – FeedAssureLivestock sector programs:

Canadian Pork Council – Canadian Quality AssuranceDairy Farmers of Canada – Canadian Quality Milk

Grain and oilseed sector – Hazard Analysis Critical Control Points (HACCP)­based programs:Canada Grains Council – Grains, Oilseeds, Pulses and Special Crops Canadian On­Farm Food Safety Program

For these livestock and grain and oilseed programs, the CFIA (Canadian Food Inspection Agency) provides governmentrecognition via the Agency's Food Safety Recognition Program (/food/safe­food­production­systems/food­safety­enhancement­program/recognition­program/eng/1299860970026/1299861042890), which acknowledges that a food safetyprogram has been developed in line with HACCP (Hazard Analysis Critical Control Points) principles, as defined by theCodex Alimentarius Commission; conforms to federal, provincial, and territorial legislation, policy and protocols; andrecognizes that a Food Safety Management System has been implemented in an effective and consistent manner.

Along with these domestic private industry programs, dozens of other international feed and food safety programs exist;specifically, GMP+, FAMI­QS , GLOBALG.A.P., and the American Feed Industry Association's (AFIA) Safe Feed/Safe FoodCertification Program. Consequently, many commercial and farm­based feed manufacturers are already familiar with theconcepts of preventive controls, have voluntarily enrolled in one of these programs, and are subject to audits to confirm they

are conforming to program requirements. The commitment to improving feed safety, shown by those parties that arechoosing to participate in one of these programs, is commendable and, in fact, demonstrates the progressive role many in thefeed industry are already playing.

3.3 Record KeepingUnder the current Feeds Regulations, record­keeping requirements are limited to the following:

Mixing formulae for customer formula feeds, consultant formula feeds, feeds described in paragraph 5(2)(d) (anycomplete feed, supplement or macro­premix manufactured in Canada that is designed to be fed to beef cattle, dairycattle, sheep, swine, chickens, turkeys, horses, goats, ducks, geese, salmonid fish, mink, or rabbits) and veterinaryprescription feeds; andCopies of customer formulae or veterinary prescriptions under which such feeds are manufactured, together with a listof each date on which the feeds were manufactured.

The Health of Animals Regulations require manufacturers of animal food for ruminants, equines, porcines, chickens, turkeys,ducks, geese, ratites, or game birds to

keep records that containthe formula for the animal food, including the name and weight of each ingredient used for each lot of the animalfood;a mixing sheet that shows that each lot of the animal food has been produced in accordance with the animalfood's formula;information on whether the animal food contains any prohibited material;the date of preparation of the animal food;the lot number and any other information used to identify each lot of animal food; andthe name and address of any person to whom any animal food is distributed or sold, along with a description ofthe food, including the name and quantity;

ensure that persons who import, package, store, distribute, sell, or advertise animal food for sale retain the following:the name, the lot number, and any other information used to identify the animal food;the name and address of any person to whom the animal food is distributed or sold; and

a description of the animal food, including the name and quantity; and information on whether the animal foodcontains any prohibited material;

require that persons who own or have the possession, care, or custody of a ruminant keep copies of all invoices foranimal food that contains prohibited material.

3.4 International SituationThe Codex Code of Practice on Good Animal Feeding (2004) (Code of Practice) provides guidance to help ensure the safetyof food for human consumption by adhering to good animal feeding practice at the farm level and good manufacturingpractices (GMPs) during the procurement, handling, storage, processing, and distribution of animal feed and feed ingredientsfor food­producing animals.

Other jurisdictions already have hazard identification and preventive control requirements in place or are proposing to furtherstrengthen current measures:

The European Union (EU) sets out a range of undesirable substances for animal feed by way of Directive 2002/32/ECAnnex I (1) of the Directive identifies undesirable substances such as heavy metals, aflatoxin, and certain pesticides. Italso sets maximum levels for the identified undesirable substances:

in some cases, for all feeds (ingredients, premixes, complete feeds); orspecific undesirable substances in specific feeds (e.g. (for example) dioxin in citrus pulp).

The EU (European Union) also has had comprehensive legislation and regulations regarding requirements for feed hygienesince 2005 (Regulation [EC (European Commission)] 183/2005 (http://eur­lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005:035:0001:0022:EN:PDF)), where "feed hygiene" is defined as "the measures and conditions necessary tocontrol hazards and to ensure fitness for animal consumption of a feed, taking into account its intended use." Commercialfeed operators are required to put in place, implement, and maintain a permanent written procedure, or procedures, based onHACCP (Hazard Analysis Critical Control Points) principles that are set out in the regulations. At a farm level, livestockproducers are required to comply with a set of good animal feeding practices also set out in the regulations.

In the U.S. (United States), the federal Food, Drug, and Cosmetic Act, administered by the U.S. (United States) Foodand Drug Administration (FDA), requires animal feed to be pure and wholesome, be produced under sanitaryconditions, and not contain harmful substances. Animal feed manufacturers are responsible for ensuring that feed is

truthfully labelled, that it does not contain unsafe additives or contaminants and, if the feed contains drugs, that thedrugs are approved by the FDA (Food and Drug Administration) for use in animal feeds.

The FDA (Food and Drug Administration) considers feed contaminants to be toxic or deleterious substances, grouping intotwo classes:

1. inherent, naturally occurring constituents of an animal food that are not the result of environmental, agricultural,industrial, or other contaminations – for example, some mycotoxins, such as aflatoxin and fumonisin, glucosinolates,and heavy metals such as lead and cadmium; and

2. industrial substances, which are not naturally occurring and are amplified to abnormal levels in the animal food throughmishandling or other acts. Examples include polychlorinated biphenyls (PCBs) and certain pesticides such as DDT(dichlorodiphenyltrichloroethane).

The FDA (Food and Drug Administration) may prohibit any detectable amount of a contaminant or establish a regulatory limitfor the contaminant. Action is based on the protection of public health, the extent to which the presence of the contaminantcannot be avoided, and other ways in which the consumer may be affected by the contaminant.

With respect to preventive controls, the FDA (Food and Drug Administration) has required compliance with a Current GoodManufacturing Practices (CGMP) rule for medicated feed manufacturing (21CFR225(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=225)) since the 1970s. The rulecomprises two tiers: 1) includes a more comprehensive set of CGMPs (Current Good Manufacturing Practices) that apply tofacilities using drug sources that require the facility to be licensed and registered by the FDA (Food and Drug Administration)to manufacture medicated feeds and 2) applies to facilities that use drug sources not requiring facility licensing by the FDA(Food and Drug Administration). Examples of CGMPs (Current Good Manufacturing Practices) requirements for facilities ineither tier are those specified for facilities and equipment, product quality control, and packaging and labelling. Regardless ofthe drug source used, one or the other tier of the rule applies to medicated feeds made either in commercial feed mills or onfarms, even if manufactured for the feeding of a livestock producer's own animals.

In late October 2013, to improve the safety of these products, the FDA (Food and Drug Administration) published a proposedrule to establish more comprehensive CGMPs (Current Good Manufacturing Practices) and Hazard Analysis and Risk­BasedPreventive Controls for Food for Animals (http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm366510.htm#facsheet).The preventive controls provisions of the proposed rule, which are required by the FDA (Food and Drug Administration) Food

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Safety Modernization Act, would apply to domestic and imported animal food, including pet food, animal feed, and rawmaterials and ingredients. Facilities producing animal food would be required to have written plans that identify hazards,specify the steps that will be put in place to minimize or prevent those hazards, identify monitoring procedures and recordmonitoring results, and specify what actions would be taken to correct problems that arise. The comprehensive hazardanalysis rule is intended to address hazards that

pose a risk to animal health (including appropriate nutritional levels, contaminants, and species specific hazardanalysis); andpose a risk to human health, either through consumption of the animal products or direct handling of the animal food inthe home.

The proposed rule would also establish certain CGMPs (Current Good Manufacturing Practices) that specifically addressanimal food. The medicated feed CGMPs (Current Good Manufacturing Practices) rule will remain in effect.

Written comments in response to this regulatory proposal were due to the FDA (Food and Drug Administration) by March 26,2014.

3.5 Consultation Outcomes to DateIn the 1990s, the CFIA (Canadian Food Inspection Agency) developed and consulted extensively with the feed industry andlivestock producer organizations on a proposed set of Medicated Feed Regulations. These regulations were designed tointroduce process controls for the manufacture of feeds containing medications. Results from these consultations have beenused to shape the development of this proposal.

To date, stakeholders have generally supported a process­based approach to feed regulation. During the pre­consultationstage, the following objectives were articulated:

a need for process controlsa need for tiered levels of controlrecognition of existing industry programs

Hazard identification and preventive controls were also included as part of the CFIA (Canadian Food Inspection Agency)'s2012 discussion paper and stakeholder survey.

The survey indicated

support for the inclusion of hazard identification and PCPs (preventive control plans) for feed manufacturing.support for higher levels of control or oversight for medicated feeds than that for non­medicated feeds.a majority of feed and livestock producers are already following a GMP (Good Manufacturing Practice) or HACCP(Hazard Analysis Critical Control Points) system.most were in favour of including risk assessment and identification of undesirable substances in regulation.

At the September 2012 multi­stakeholder workshop, the Code of Practice was used as a framework to guide discussions withstakeholders. The Code of Practice outlines a number of good manufacturing practices that should be followed, both on­farmand in commercial feed and ingredient production. In general, stakeholders were in agreement that the Code of Practiceprovided good starting principles. However, they also identified a need for the following:

all sectors of the industry to undertake complete hazard identificationa tiered risk assessment approachadequate information on acceptable levels of contaminants for some ingredientsrequirements that should align internationallyadditional guidance for smaller industry that does not have experience with PCPs (preventive control plans)

Building further on the results from pre­consultation activities in 2012 and in response to guidance provided by the FRSG(Feed Regulatory Steering Group) in early 2013, the Agency staged a multi­stakeholder technical workshop on feed hazardidentification and preventive controls in Ottawa in March 2013. These were the key points provided to the CFIA (CanadianFood Inspection Agency):

Participants agreed upon three categories of relevant hazards (biological, chemical, and physical) and that animalhealth, food safety, and the environment are appropriately addressed by current identification practices (e.g. (forexample) HACCP (Hazard Analysis Critical Control Points) and good quality assurance and quality control systems).Participants expressed concerns that the Agency is avoiding the use of HACCP (Hazard Analysis Critical ControlPoints) terminology as the accepted way to characterize approaches to proactively identify and prevent hazards.All agreed that, if there are preventive control programs (such as HACCP (Hazard Analysis Critical Control Points)) inplace to monitor hazards, and the government has some confidence in such programs, the appropriate role for thegovernment should be to inspect that a facility or regulated party adheres to the program.

There was consensus about making preventive controls a requirement as long as they are not prescriptive.

In addition to CFIA (Canadian Food Inspection Agency) consultation activities, ANAC (Animal Nutrition Association ofCanada) presented the Agency with a proposal in June 2013 for a Risk­Based Approach to Hazard Identification and Controlfor commercial feed manufacturers. ANAC (Animal Nutrition Association of Canada) proposed that the process be foundedon six principles:

1. mandatory tier­based registration/licensing of facilities2. the use of process systems and controls to mitigate risks3. risk­based regulatory oversight4. increased recognition of industry­led HACCP (Hazard Analysis Critical Control Points) programs, particularly

FeedAssure5. collaboration and transparency between industry and government6. modeled, where appropriate, on demonstrably successful international examples

In October 2013, the CFIA (Canadian Food Inspection Agency) shared its current thinking regarding a proposed regulatoryframework for feed hazard identification and preventive controls with the FRSG (Feed Regulatory Steering Group). Followingthis briefing, the industry association members of the group collaborated to provide the CFIA (Canadian Food InspectionAgency) with feedback and six recommendations (Annex 1). A working draft of this proposal was provided to members of thegroup for their review in February 2014, prior to broader stakeholder distribution, and feedback from the group wasincorporated into this proposal.

This proposal aligns with feedback obtained from the collective consultation activities that have been undertaken by the CFIA(Canadian Food Inspection Agency) to date. The feedback from these consultations has been closely considered in thedevelopment of this proposal.

4 Proposed Regulatory Framework

4.1 Objectives of Hazard Identification and Preventive Control Plans

As the agriculture and food sectors in Canada and around the world continue to become more complex, the CFIA (CanadianFood Inspection Agency)'s relationship with industry needs to evolve. The CFIA (Canadian Food Inspection Agency) willcontinue to work toward a common goal of effectively managing risk. While the Agency can play a greater role in promotingindustry understanding and compliance with requirements, industry is ultimately accountable for ensuring the safety of itsproducts and processes. Regulated parties and consumers have an equally important role in keeping Canada's food supplyand plant and animal resource base safe.

Appropriate hazard identification and preventive control procedures for feeds are an internationally recognized method ofpreventing or mitigating the risks associated with foods and feeds.

Risks associated with feeds and ingredients can be prevented outright or mitigated, either through controls on the finishedproduct or via a systems approach. A systems approach means that the products are produced, transported, and stored in asafe and consistent manner, thus ensuring that each batch of feed that is manufactured will meet the same standards.Product controls only verify that individual products meet standards. Inspecting and enforcing a process­based systemprovides the regulator and the consumer with greater confidence in the feeds that are produced under that system.

4.2 ScopeThis proposal addresses the introduction of requirements in a modernized regulatory framework for hazard identification andpreventive controls and includes discussions on the following:

hazard identification and analysispreventive control plansrecord keepingroles and responsibilities

The mandate of the CFIA (Canadian Food Inspection Agency) and the Feeds Act support the protection of public health, aswell as animal health, plant health, and the environment. With this in mind, the Agency proposes the following scope for arisk­based feed hazard identification and preventive controls framework that would apply to

the manufacture and distribution of feed ingredients and mixed feeds ("feeds") alike, representing an "end­to­end"approach throughout the feed supply chain.

feeds for food­producing animals, including species not currently defined as "livestock" in the Act and Regulations (e.g.(for example) deer, elk, bison, and other mammals and birds that produce food products [milk, eggs] or are slaughteredand processed as a meat product for human consumption and for which an inspection system has been established[according to current "food animal" definition in the Meat Inspection Regulations]).domestically produced and imported feed (a discussion on possible approaches to the application of the framework onimported products is provided in section 5 of this proposal).hazards with human health, animal health, plant health, and environmental implications.

The proposed framework would require all those throughout the feed supply chain to whom the regulatory framework wouldapply to

identify hazards that may be associated with their products and processes.design and implement a PCP (Preventive Control Plan) to address the identified hazards that are appropriate for theirspecific system.

A risk­based framework would acknowledge reducing requirements for lower­risk operations and feeds.

Figure 1 illustrates the feed supply chain and how an integrated hazard identification and preventive control framework wouldapply throughout the continuum. All parties to which the regulatory framework applies would share in the responsibility ofidentifying hazards and putting in place effective preventive controls in their specific part of the chain.

Feed Supply Chain ContinuumFigure 1 ­ Hazard ID (identification) / Preventive ControlClick on image for larger view

(/DAM/DAM­animals­

animaux/STAGING/images­images/anim_feed_hazard_identification_fig1_1402773793829_eng.jpg)

Description for Feed Supply Chain Continuum – Hazard Identification and Preventive Control image

Exemptions

Even with the proposed amendments to the Feeds Act, contained in the Agriculture Growth Act, referred to in sections 2.1and 5 of the proposal, livestock producers who manufacture feeds will remain exempt from the scope of the Act and any of itsassociated regulations, provided the feeds they manufacture are neither sold nor have any drug or other substanceincorporated into them that presents a risk of harm to human or animal health or the environment. Table 1 shows theapplication of the proposed framework to livestock producers.

Table 1: Application of proposed framework on livestock producers

Feeds manufactured by Livestock ProducersCriteria

Will the proposedregulatory frameworkapply?Feed is not sold

Will the proposedregulatory frameworkapply?Feed is sold

Feed does have a drug or other substance that presents a risk ofharm to human or animal health or the environment incorporated intoit.

Yes Yes

Feed does not have a drug or other substance that presents a riskof harm to human or animal health or the environment incorporatedinto it.

No Yes

Sections 4.3 and 4.4 of this proposal detail the feed­specific hazards, their identification, and PCP (Preventive Control Plan)requirements.

This proposal will not address the following:

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For example, specified risk material, as defined in the Feeds Regulations and Health of Animals Regulations, whichis prohibited from being fed to any animals, as it poses risk of transmitting BSE (bovine spongiformencephalopathy).

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facility licensing by the CFIA (Canadian Food Inspection Agency);inspection and/or enforcement approaches that are relative to the oversight of compliance with the requirements ofregulations; orthe role and potential impacts of sector­specific hazard identification and/or preventive control programs (eitherrecognized or not recognized by the CFIA (Canadian Food Inspection Agency)) on CFIA (Canadian Food InspectionAgency) oversight activities.

These compliance and enforcement topics are addressed in the CFIA (Canadian Food Inspection Agency)'s proposedIntegrated Agency Inspection Model (iAIM). This model integrates all three of the Agency's business lines of food safety, andplant and animal health into a single inspection model based on the Improved Food Inspection Model that was posted on theCFIA (Canadian Food Inspection Agency) website in June of 2013. Consultation on the iAIM (Integrated Agency InspectionModel) is currently underway.

4.2.1 The Agency's Approach to Regulation

[adapted from CFIA (Canadian Food Inspection Agency) Foundations of an Outcome­based Approach paper]

Traditionally, the Agency has relied on a combination of three basic approaches to regulation: prescriptive, systems­based,and outcome­based. However, fundamental changes to the production, processing, packaging, distribution, and sale ofagricultural products, coupled with changing consumer demands, industry consolidation, and rapidly evolving science andtechnology have prompted the Agency to re­examine the mix of approaches used to verify the integrity and safety of theagriculture and agri­food supply chain.

In committing to modernize its regulations, the Agency intends to systematically evaluate how best to use outcome­basedand systems­based regulatory approaches.

An outcome­based approach specifies what is to be achieved and how compliance will be measured, but does not prescribehow to achieve an outcome. It affords regulated parties the opportunity for innovation and provides flexibility to introduce newtechnologies, processes, and procedures that enhance safety and/or reduce costs. It is rooted in the need to adapt tochanging scientific, technological, and economic conditions.

With systems­based regulation, regulated parties are obliged to develop internal risk management plans that includeprocedures, training, documentation, and internal risk analyses to identify and mitigate risks in the context of a corporatecompliance system.

The flexibility of an outcome­based approach will help the Agency to regulate, in an environment of change throughinnovation, and to enhance its capability to incorporate scientific and technological advancement without compromisingsafety. For the Agency, the outcome­based approach may also facilitate the assessment of comparability with safety regimesin other jurisdictions that are based on similar outcomes. Ultimately, it is a more progressive way to achieve safety and healthoutcomes for consumers, regulated parties, and the Agency alike. Under systems­based regulation, regulated parties mustcommit time and resources to understand and mitigate risk, rather than simply follow a set of specification and processrequirements. Systems­based regulation lays the groundwork for enhanced accountability on the part of regulated parties.

4.3 Hazard Identification (Modernized)It is proposed that all those involved throughout the feed supply chain complete a hazard identification and assessment withrespect to the feed­related activities in which they are involved. The hazard identification and assessment must be carried outon incoming materials, materials sourced in­house, feed formulation, processes, and transportation by the feed manufacturer.

Animal feed and feed ingredients can act as a route of entry for hazards into human food and for hazards that pose a risk toanimal health, plant health (e.g. (for example) pests and diseases of domestic or international quarantine significance), or theenvironment (e.g. (for example) invasive plant species not known to be present in a local ecosystem). To mitigate theassociated risks, hazards in feeds must be identified and assessed prior to their manufacture, distribution, and feeding toanimals. Multifaceted assessments are often necessary to consider both the safety to animals as the primary consumers ofthe feed and safety to humans as the consumers of resulting food of animal origin (e.g. (for example) meat, milk, fish, andeggs). In some cases, the risk to persons who work with and mix feed, as well as the risk to plant health or the environment,also requires assessments.

The Code of Practice offers the following general guidance, respecting the identification of hazards:

The presence in feed and feed ingredients of undesirable substances [hazards] such as industrial and environmentalcontaminants, pesticides, radionuclides, persistent organic pollutants, pathogenic agents and toxins such asmycotoxins should be identified, controlled and minimised.

The risks of each undesirable substance to consumers' health should be assessed and such assessment may lead tothe setting of maximum limits for feed and feed ingredients or the prohibition of certain materials from animal feeding.

In some cases, hazards may be naturally occurring, accumulated from the environment or introduced into feed ingredientduring their manufacture. Their concentrations in individual ingredients and their cumulative amounts in finished feedscontribute to the overall safety of feeds. The most common contaminants of concern include heavy metals, dioxins, furansand PCBs (Polychlorinated biphenyls), veterinary drug residues, pesticides residues, processing aids, mycotoxins, andpathogenic microbial contaminants.

The feed supply chain has traditionally made use of materials that are by­products from food processing. Over the past twodecades, a number of by­products from the fuel, forestry, mining, and other industrial sectors (e.g. (for example) kiln dust, ballclay), previously used for other purposes or disposed of, are being used in feed. Such by­products may also contain hazardssuch as processing additives and contaminants, other than those identified in Table 2, that are not known or routinelyexpected to be present in feed ingredients.

From a mixed feed perspective, hazards in ingredients may carry forward into mixed feeds. While feed ingredientmanufacturers would be required to identify hazards and apply preventive controls to their products in the framework beingproposed, feed ingredient manufacturing processes are not always capable of removing or reducing certain hazards ifpresent in raw materials or introduced into the ingredient (e.g. (for example) metals, pesticides). As a result, they must beidentified and accounted for in the formulation and production of mixed feed products. In addition, hazards can be introducedwithin feed mills from production practices (e.g. (for example) additives used to process grains and other ingredients, addedmedications and residues of medications remaining in cross­utilized equipment, manufacturing errors resulting in theunintentional addition of medications or ingredients that could be harmful to certain species).

Hazards may also be introduced into feeds and feed ingredients through contamination during transportation, handling,packaging, storage, and distribution. In some cases, they may be the types of contaminants already discussed, but in others,they could be substances such as fertilizers or other bulk materials remaining in rail cars, trailers, silos, or other conveyances

and storage equipment that are not dedicated to the transportation or storage of feed.

With the Codex guidance in mind and with a view to providing guidance to those involved in the feed supply chain, it is furtherproposed that the hazards set out in Table 2, considered as known or reasonably foreseeable in feeds and feed ingredients,are, at a minimum, those that should be considered as part of the hazard identification and assessment process. Note Table2 is provided as a non­exhaustive list of potential hazards by feed category combinations and must be considered in relationto one's individual manufacturing processes. Authorized ingredients, as listed in the Regulations, may contain specificstandards for hazards of relevance to the ingredient.

Table 2: Illustrative List of Common Hazards of Concern by Category of Feed/Ingredient

Feed/Ingredient Category Known or Reasonably Foreseeable Hazards

Grains, oilseeds, forages, fruit andvegetables, and their by­products

PesticidesMycotoxins (e.g. (for example) vomitoxin, aflatoxin B1, ochratoxin A)Processing aids (e.g. (for example) solvents, anticaking agents, boilerchemicals)Pathogenic microorganisms (e.g. (for example) mold, Salmonella spp.(species), E. (Escherichia) coli, total coliform)Anti­nutrients (e.g. (for example) glucosinolates, erucic acid)Weed seeds

Minerals Metals (e.g. (for example) arsenic, cadmium, lead, aluminum, mercury/methylmercury)Dioxins, furans, PCBs (Polychlorinated biphenyls)Processing aids introduced in the extraction process, or manufacturing process.

Animal products and by­products(including fish)

Pathogenic microorganisms (e.g. (for example) mold, Salmonella spp.(species), E. (Escherichia) coli, total coliforms, Listeria spp. (species))

Dioxins, furans, PCBs (Polychlorinated biphenyls)

Veterinary drug residuesProcessing aids (e.g. (for example) tracer dyes, waste­water treatment aids)Prions (e.g. (for example) TSE (transmissible spongiform encephalopathy)s)Mercury/methyl­mercuryOther animal diseases (e.g. (for example) foot­and­mouth disease, infectioussalmon anemia)Marine toxinsVeterinary drug residues

Fermentation productsViable microbes

Pathogenic microorganisms (e.g. (for example) Salmonella spp. (species), E.(Escherichia) coli, total coliform)Inherent microbiological toxinsProcessing aids used in the fermentation process, or in the final processing(e.g. (for example) antibiotics, fermentation ingredients, wastewater treatmentaids)

Mixed feeds Veterinary drugs (e.g. (for example) via carry­over or inadvertent presence)Processing aids (introduced via carry­over, or intentionally introduced throughthe manufacturing process)Pathogenic microorganisms (e.g. (for example) mold, Salmonella spp.(species), E. (Escherichia) coli, total coliform)

TSE = transmissible spongiform encephalopathy

To modernize the current regulatory framework regarding the identification of hazards, the Agency proposes to

review and update the list of prescribed deleterious substances currently contained in section 4 of the Regulations.revise the list of specific hazards and standards identified for feeds, as appropriate.identify specific hazards and maximum limits in feeds in guidance (build on current RG­8).

include known hazards and limits, where appropriate, in ingredient descriptions set out in Schedule IV (4).

As noted previously in section 2.1, the proposed Bill C­18 sets out several new regulation­making authorities for the Act,including

[5] (e.1), prescribing standards for the manufacturing or the safety of feeds.

To this end, the CFIA (Canadian Food Inspection Agency) also proposes to use this provision, should this legislation beadopted, to require all parties involved in the manufacturing, sale, importation, and distribution of feeds and feed ingredientsto complete a hazard identification and assessment for their own system.

As discussed in section 3.2, a number of industry sector feed and food safety programs are in place, and familiarity alreadyexists with having to identify hazards in feeds and feed ingredients as a component of participating in such programs. Toprovide clarity and consistency, the CFIA (Canadian Food Inspection Agency) would support such a regulation by providingguidance on feed­related hazards, their sources, and strategies to prevent or mitigate their risks.

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The CFIA (Canadian Food Inspection Agency) is seeking feedback on the proposal to

require all parties involved in the manufacturing, sale, and distribution of feeds and feed ingredients to complete ahazard identification and assessment for their own system.require that the hazards set out in Table 1 of this proposal, known or reasonably foreseeable in feeds and feedingredients, are those that, at a minimum, should be considered as part of the hazard identification and assessmentprocess for each system.

4.3.1 Feeds Regulations, Range of Nutrient Guarantees for Complete Feeds for Use in the Exemption ofFeeds from Registration (Schedule I (1), Table 4)

Through negotiations and consultations among the federal government, academia, and commercial feed industryrepresentatives, Table 4 of Schedule I was created and incorporated into the Feeds Regulations in the 1980s, as amechanism to exempt certain groups of feeds from registration. This table contains ranges of common essential minerals and

vitamins for complete feeds or those manufactured from more concentrated products (e.g. (for example) supplements andpremixes) that support livestock nutritional requirements while maintaining a margin of safety for human and animal health,and the environment. The original Table 4 established exemption ranges for chickens, turkeys, swine, beef and dairy cattle,and sheep. In 1990, via two amendments, the table was expanded to include nutrient ranges as exemption criteria forcomplete feeds for horses, goats, ducks, and geese; and then for rabbits, mink, and salmonid fish. Since that time, therehave been no other substantive changes to the table or to any of the nutrient ranges. Feeds with nutrient guarantees that falloutside the listed ranges have been subject to assessment and registration by the CFIA (Canadian Food Inspection Agency)prior to manufacture and sale.

Although the table has never intended to establish absolute nutritional limits for livestock feeds or feeding programs, thedomestic feed industry considers its nutrient ranges out of date, and therefore its use as a mechanism to exempt feeds fromregistration is no longer an appropriate regulatory tool.

Higher levels of certain vitamins in livestock rations (e.g. (for example) Vitamins A, D, and E) can be harmful to livestock orcan be concentrated into tissues that are used for human consumption, thus posing potential risk to human health. Similarly,certain minerals (e.g. (for example) copper and zinc) or, as in the case of phosphorus, contain levels in rations that can alsocontribute to risks of harming the environment. To this end, the CFIA (Canadian Food Inspection Agency) proposes toremove Table 4 from the modernized regulatory framework and to replace this mechanism with more outcome­basedregulations and guidance regarding appropriate levels of specific vitamins and minerals for livestock rations.

Have your say

The CFIA (Canadian Food Inspection Agency) is seeking feedback on the proposal to modernize the regulatory frameworkregarding hazards, including the replacement of Table 4 of Schedule I (1) with a more outcome­based objective andguidance, respecting maximum levels of vitamins and minerals used in feeds.

4.3.2 Toxic Substances regulations

The federal Health of Animals Act provides authority to control not only animal diseases but also toxic substances. Thecontrol of "toxic substances" within the scope of the Act serves to enable the response to risks that are posed when animalsthat ingest contaminated feed are exposed to unapproved pest control agents or veterinary drugs, or other accidental orunintended exposures to hazards. The Act provides the authority to prescribe "toxic substances" by way of a separateregulatory amendment.

Current federal regulations enable action to be taken for chemical contaminations of livestock production inputs (e.g. (forexample) feed and veterinary biologics) and food products derived from livestock (i.e. (that is to say) meat, milk, and eggs),but not on live animals. This represents a gap in the CFIA (Canadian Food Inspection Agency)'s regulatory control of the foodcontinuum. CFIA (Canadian Food Inspection Agency) inspectors can go on­farm to control animals for disease outbreaks, butnot for exposure to chemical contaminations.

Although the Agency developed and consulted on a proposed list of toxic substances and associated amendments to theRegulations during the mid­ to late 2000s, there have been no amendments to the Health of Animals Regulations to date inthis regard.

The Agency proposes to move forward with the implementation of amendments to the Health of Animals Regulationsregarding toxic substances, enhancing Agency response to situations wherein animals are accidently or unknowinglyexposed to hazards that may have health implications to animals or humans. To prescribe a list of toxic substances in theHealth of Animals Regulations allows the Agency to respond to toxic contamination events in the same way it responds toanimal disease outbreak situations. Given the exemption provided to livestock producers by the Feeds Act where farm­manufactured feeds are not for sale or contain drugs or other harmful substances, as discussed in section 4.3, it isreasonable to enable the regulatory capacity to respond to accidental or unintentional situations involving feed­relatedhazards that could pose risks to human or animal health or the environment.

Examples of key response measures that such amendments would provide are as follows:

mandatory notification and reporting upon suspicion of contamination with a toxic substance;prohibitions on the sale of a contaminated animal without a licence;prohibitions on the sale, the offer for sale, the exposure for sale or transfer ownership of an animal, animal product orby­product that is contaminated with a toxic substance;restriction on the import of animals or their products contaminated with a toxic substance;

the ability to declare an "infected place" in order to limit the movement of animals or food produced from those animals;the declaration of an area as a control area until measures to mitigate the situation may be taken;enhanced sampling measures; andthe ability to order means of disposal or treatment.

The principal change involves listing the toxic substances in a new schedule to the Health of Animals Regulations. Inaddition, minor amendments would be required to add the term "toxic substances" to a number of existing provisions in theHealth of Animals Regulations. Both Governor­in­Council and Ministerial amendments would be needed, and all proposedamendments would be provided for public consultation.

The amendments that form part of this proposal would specifically address the regulations that are necessary to complementthe addition of a toxic substance list. Such amendments would further strengthen the CFIA (Canadian Food InspectionAgency)'s capacity for regulatory control along the feed and food production continuum.

Have your say

The CFIA (Canadian Food Inspection Agency) is seeking feedback on the proposal to move forward with theimplementation of amendments to the Health of Animals Regulations regarding toxic substances to better enable Agencyresponse to situations where animals are accidently or unknowingly exposed to hazards that may have health implications.

4.4 Preventive Controls (New)To maintain a robust approach to human health, animal health, plant health, the environment, and consumer protection, theCFIA (Canadian Food Inspection Agency) is modernizing its approach to inspection. The move toward a more prevention­focused and systems­based approach under the integrated Agency inspection model allows both the CFIA (Canadian FoodInspection Agency) and regulated parties to more readily adapt to emerging global and scientific trends. Canadians willcontinue to be protected by an effective system that is both science­ and risk­based. A key element of the model includesapplying preventive controls by parties that are subject to CFIA (Canadian Food Inspection Agency)­regulated products andactivities.

In keeping with the direction set out in the integrated Agency inspection model, it is proposed that, following the identificationand assessment of hazards within an individual system, regulated parties must develop, implement, and maintain outcome­and performance­based PCPs (preventive control plans) in accordance with the requirements proposed for each preventivecontrol element set out in Annex 2. This requirement would apply to all in the feed supply chain; however, the extent of whichwill depend on the hazards present and the risk of the specific systems.

Preventive controls represent a combination of measures developed, implemented, documented, validated, and maintainedby an establishment to prevent or reduce hazards to an acceptable level that, when taken as a whole, provide a science­based, objective, and auditable system, supporting the manufacture, importation, and distribution of feed and feed ingredientsthat

are safe for their intended uses;meet all regulatory requirements; anddo not impact negatively on human health, animal health, plant health, or the environment.

All potential hazards, as they pertain to human health, animal health, plant health or the environment, are to be identified andassessed with respect to an individual manufacturing system or situation. This approach is consistent with that in the CFIA(Canadian Food Inspection Agency)'s A New Regulatory Framework for Federal Food Inspection: Discussion Document. Thistype approach is already in place in Europe and being developed in the United States. The Code of Practice is aninternationally developed and recognized framework that also supports a preventive controls approach to feed safety. Manyof these other systems only address aspects of feed safety that affect human health and human food safety. Mitigating risksto food safety is the CFIA (Canadian Food Inspection Agency)'s highest priority, and the health and safety of Canadians isthe driving force behind the design and development of CFIA (Canadian Food Inspection Agency) programs. In addition, thecurrent and future economic prosperity of the Canadian agriculture and forestry sectors relies on a healthy and sustainableanimal and plant resource base. As such, to minimize and manage risks, the CFIA (Canadian Food Inspection Agency) iscontinually improving its program design and delivery in the animal health and plant resource areas. In an effort to protect thenatural environment from animal and plant diseases, invasive plant species, and plant pests, the CFIA (Canadian FoodInspection Agency) also performs extensive work related to the protection of environmental biodiversity. For this reason, thescope of feed preventive controls must also address related risks to animal health, plant health, and the environment.

The CFIA (Canadian Food Inspection Agency) proposes that all feed manufacturers – including ingredient manufacturers,commercial feed mills, on­farm feed manufacturers (not subject to exemptions), retailers that repackage feeds, importers, andanyone handling feeds in bulk – be required to develop, implement, and maintain a written PCP (preventive control plan).

As noted in section 2.1, the proposed Bill C­18 sets out several new regulation­making authorities for the Act, including

[5] (h.2) respecting quality management programs, quality control programs, safety programs, preventive controlplans, or any other similar programs or plans to be implemented by persons who conduct any activity regulated underthis Act.

The CFIA (Canadian Food Inspection Agency) proposes to use this provision, should this legislation be adopted, to developregulations in this regard.

For on­farm feed manufacturers that are not subject to exemption, the scope, scale, and level of detail expected in theseplans is anticipated to be minimized (and, consequently, the level of oversight by CFIA (Canadian Food Inspection Agency))where, for example

operations are only producing one species or similar species (e.g. (for example) poultry), as opposed to multi­speciesfarms that have ruminants and non­ruminants; orif medicated feeds are being manufactured that do not require a withdrawal prior to marketing of livestock for foodprocessing.

To elaborate further on its expectations regarding preventive controls, the following subsections to 4.4 provide additionalinformation and guidance in this regard.

4.4.1 Preventive Control Plans

A PCP (Preventive Control Plan) is a written document that sets out how safety and other regulatory requirements (e.g. (forexample) labelling, product composition) will be achieved for an individual system. PCPs (preventive control plans) arerecognized internationally as the best way to demonstrate that risks and hazards are controlled or eliminated, because theyfocus on prevention through a systems­based examination of operations by regulated parties. PCPs (preventive controlplans) will address not only food safety requirements but also related requirements such as animal, plant, and environmentalrisks, and labelling.

4.4.2 Why is a Preventive Control Plan required?

4.4.2 Why is a Preventive Control Plan required?

The key components of a preventive control system­based approach that contribute to the production of safe and compliantfeeds

are consistent with current and future international approaches.facilitate market opportunities.allow for more flexible and efficient compliance verification processes.allow for continuous improvement.contribute to a more effective and consistent approach to follow­up and correction of deviations.

4.4.3 Elements of a Preventive Control Plan

Based on the elements set out in the CFIA (Canadian Food Inspection Agency)'s proposed modernized food regulatoryframework, the integrated Agency inspection model and the Codex Code of Practice on Good Animal Feeding, sevenelements are proposed for PCPs (preventive control plans) for feed:

1. product and process control;2. sanitation, biosecurity, and pest control;3. hygiene, biosecurity, and employee training;4. equipment design and maintenance;5. physical structure and maintenance;6. receiving, transportation, and storage; and7. recalls, complaints, and record keeping.

Domestic Feeds and Feed Ingredients

In developing a PCP (preventive control plan), operators of domestic production and distribution establishments shouldidentify

and describe all hazards in their system, and consider regulatory requirements and their related validated controls byindicating

the planned sequence of measurements and observations to determine whether a control measure is effective

(monitoring procedures).the methods, procedures, tests, and other evaluations, in addition to the monitoring that is used to determinewhether a control measure is, or has been operating as intended (verification procedures).the planned corrective actions when validated controls are ineffective at controlling the hazard and/or whenregulatory requirements are not met (corrective action).

who will be responsible to ensure that there is monitoring, verification, and corrective action by specifyingwho the responsible party is for each step and the required training and competencies.

the frequency of delivering each activity.where, how, and by whom activities will be documented:

Identify appropriate records that demonstrate they are delivering their system.Identify where the records will be generated, who is responsible for their completion, how frequently and how longthey will be retained.

Imported Feeds and Feed Ingredients

Importers have no direct control over production in other countries, and thus need to develop other strategies to addressrisks, including records demonstrating how these strategies are effective. Ultimately, such strategies would need todemonstrate that foreign manufacturers have designed, developed, implemented, and verified PCPs (preventive controlplans) to assure the safety of feed and feed ingredients and compliance with other Canadian regulatory requirements that arecomparable with those required by domestic manufacturers.

Importers should have PCPs (preventive control plans) that include elements which apply to their operation. Importers withoutfacilities, for example, would not be expected to address physical structure and maintenance. However, all importers would,at a minimum, include the following elements in their PCPs (preventive control plans):

Element 1: Process and Product ControlsElement 7: Traceability, recall, and complaints

Importers who are involved in further handling or repackaging of commodities would address all seven elements of the PCP(Preventive Control Plan).

Feeds and feed ingredients for export

An exporter's PCP (preventive control plan) would require that export controls address any foreign regulatory requirements(e.g. (for example) product identification and labelling requirements).

4.4.4 Requirements for each element of a preventive control plan

As additional more substantive guidance regarding feed­related PCPs (preventive control plans), a set of proposed outcome­based regulatory requirements and performance criteria are identified and described for all preventive control elements inAnnex 2.

4.4.5 Preventive Control Plans versus HACCP (Hazard Analysis Critical Control Points) Systems

During the CFIA (Canadian Food Inspection Agency)'s March 2013 Hazard Identification and Preventive Controls stakeholderworkshop, in particular, participants questioned the CFIA (Canadian Food Inspection Agency)'s use of "preventive controlplans" as current terminology in lieu of such other terms as "HACCP (Hazard Analysis Critical Control Points)," "HACCP(Hazard Analysis Critical Control Points)­based," "prerequisite programs" that were commonly used in the context of both theCFIA (Canadian Food Inspection Agency)'s Food Safety Enhancement Program and Quality Management Program (QMP)for fish and seafood in recent years.

While PCPs (preventive control plans) (also referred to as GMPs (Good Manufacturing Practices) or prerequisite programs)make up a portion of a HACCP (Hazard Analysis Critical Control Points) system, the intent of a HACCP (Hazard AnalysisCritical Control Points) system is solely to address potential food safety risks and focuses control at critical control points(CCPs). HACCP (Hazard Analysis Critical Control Points) is a well­recognized system for controlling food safety hazards. Anumber of existing private sector feed programs use the principles of HACCP (Hazard Analysis Critical Control Points) in theirsystems.

The requirements for a feed PCP (Preventive Control Plan) extend beyond those that are typically met by a HACCP (HazardAnalysis Critical Control Points) system. Addressed in addition to food safety risk, PCPs (preventive control plans) mandatedwithin the scope of the proposed regulatory framework need to address hazards that pose a risk of harm to animal health,plant health, and the environment. This proposal does not preclude the development and implementation of voluntarilyHACCP (Hazard Analysis Critical Control Points) systems by regulated parties in order to achieve food safety objectives andcompliance with regulatory requirements. If a HACCP (Hazard Analysis Critical Control Points) program does not meet all ofthe proposed regulatory requirements, additional preventive controls may need to be implemented to address these gaps.

Have your say

The CFIA (Canadian Food Inspection Agency) is seeking feedback on the proposals to

require feed manufacturers – including ingredient manufacturers, commercial feed mills, on­farm feed manufacturers,retailers that repackage feeds, importers, exporters and anyone handling feeds in bulk – to develop, implement, andmaintain a written PCP (Preventive Control Plan).Indicate whether there should be exceptions (other than those provided by the Feeds Act to livestock producers) forspecific persons or feed activities. Why?require feed manufacturers, including ingredient manufacturers, distributors, importers and exporters, to include allthe elements of a PCP (Preventive Control Plan) that apply to their operations proposed in section 4.4.3.use the requirements for each element of a PCP (Preventive Control Plan) proposed in section 4.4.4 and Annex 2 ofthe proposal as a framework from which outcome­based regulations, model systems, industry guidance, andguidance to CFIA (Canadian Food Inspection Agency) inspection staff (how to determine whether compliance isbeing achieved) will be developed.

4.5 Record KeepingRecord keeping is a critical part of the system. A system will only be as strong as the records that support it. It is proposedthat record keeping be included as a component of the PCP (Preventive Control Plan).

The CFIA (Canadian Food Inspection Agency) proposes to expand the scope of the currently required records to includethose that pertain to the hazard identification and the PCP (Preventive Control Plan). The PCP (Preventive Control Plan)would need to identify all records associated with each element of the PCP (Preventive Control Plan). It would also indicatethe location and retention period for the records, how frequently they will be updated, and responsibility for their completion.Examples of record­keeping activities include, but are not limited to, the following:

validation of control measures (e.g. (for example) critical limits or tolerances), monitoring (demonstrating control of ahazard or regulatory requirement; for example, shipping, purchase orders, training, equipment calibration and

maintenance, pest/disease management records);verification;complaints and how they were resolved;deviations and corrective actions taken; andmanagement review by regulated party.

In addition, records pertaining to incoming materials and production should be kept to facilitate feed recalls and trace­backs.

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The CFIA (Canadian Food Inspection Agency) is seeking feedback on the proposal to

expand the scope of the required records to include those pertaining to the hazard identification and the PCP(Preventive Control Plan).require a retention period for records.

4.6 Roles and ResponsibilitiesThere are many different participants in the livestock feed and production system, each with an equally important role to play.From government to producer, each participant shares responsibility in addressing and maintaining the safety of Canada'sanimal and plant resource bases, contributing to the production of safe food for all Canadians and our international customersand to the safety of the environment.

4.6.1 Government

The Government has a role in feed safety through the development and enforcement of regulations, and their associatedguidance documents, for feeds. The CFIA (Canadian Food Inspection Agency) will be responsible for

setting standards in regulations and guidance for known hazards.conducting risk analysis of known and emerging hazards in feed and feed ingredients according to the Codex Risk

Analysis Framework to include:risk assessment comprised of hazard identification, hazard characterization, exposure assessment, and riskcharacterization.risk management, including the evaluation and implementation of risk management options, monitoring, andreview.the provision of risk communication advice by documenting the risk assessment and risk management options ina transparent manner;

verifying initial compliance and conducting compliance inspections based on the level of risk associated with a facilitythrough inspection activities;focusing efforts on health and safety aspects of the feed industry along a continuum with higher risk manufacturersreceiving greater oversight;developing education programs to promote understanding by feed manufacturers and producers of their role and theways in which they can lower their risk factors;employing compliance management activities; andresponding to instances of non­compliance through a wide variety of measures that are available to the CFIA (CanadianFood Inspection Agency).

4.6.2 Industry Organizations

Industry involvement is essential to the effective management of a feed safety system. Industry groups are in an excellentposition to provide leadership and direction within their sector by playing a role in

producing safe feed, designing systems and processes (i.e. (that is to say) manufacturing and preventive control) toensure that they meet regulatory requirements;promoting best practices and providing peer support and guidance or knowledge sharing and technical expertise withintheir sector;knowing and complying with relevant legislative requirements to their business;providing complete, accurate, and timely information to the CFIA (Canadian Food Inspection Agency);understanding the role Agency employees perform;being aware of the ethical obligations that govern the actions of CFIA (Canadian Food Inspection Agency) officials whoare part of the broader obligations of regulated parties;

educating the government about the needs of the industry and what can help industry succeed; andworking with government to establish standards, and identify key preventive controls and maximum levels of hazards.

4.6.3 Individual Regulated Parties

Individual regulated parties, such as feed establishment operators and livestock producers, are the purchasers and end­usersof feed products. Their role in the system includes

being knowledgeable of, understanding, and complying with relevant legislative requirements and stewardship practicesrelated to their business.obtaining third­party certification where appropriate.monitoring of feeds and feed manufacturing conditions to verify that requirements are being met.providing complete, accurate, and timely information to the CFIA (Canadian Food Inspection Agency).understanding the role Agency employees perform.

4.6.4 Existing Private Certification Programs

A number of external feed preventive control programs already exist. This includes the feed component of Canadian On FarmFood Safety Programs, ANAC (Animal Nutrition Association of Canada)'s FeedAssure program, private industry programs,and a number of international programs such as GMP+, FAMI­QS, GLOBALG.A.P., and AFIA (American Feed IndustryAssociation)'s Safe Feed/Safe Food program. The commitment to improving feed safety, shown by a number of parties thatare choosing to participate voluntarily in one of these programs, is commendable and demonstrates the progressive rolemany in the feed industry are already playing. In addition to these existing programs, third parties – namely, industry­relatednon­government organizations, academia, or other service providers – have expertise and knowledge in their fields and mayoffer guidance, programs, training, self­assessments, and peer support to equip their members or sectors with the necessarytools to achieve compliance with the proposed changes to the Feeds Regulations. There are significant opportunities toleverage their leadership capacity and expertise through partnerships (e.g. (for example) private sector or public­private).Likewise, other government departments at the federal and provincial, and territorial levels may play an advisory role byproviding expertise and tools.

5 Implementing Proposed Regulatory Framework

5 Implementing Proposed Regulatory FrameworkOn December 9, 2013, Canada's Minister of Agriculture and Agri­Food tabled the Bill C­18 in Parliament, proposing to amendseveral federal agricultural statutes, including the Act. Among the suite of proposed amendments, a new authority to makeregulations "respecting quality management programs, quality control programs, safety programs, PCPs (preventive controlplans) or any other similar programs or plans to be implemented by persons who conduct any activity regulated under thisAct" would be provided to the CFIA (Canadian Food Inspection Agency). This strengthens the regulation­making authoritiesin the Act and would allow the development of modernized regulations, requiring the preparation, implementation, andmaintenance of PCPs (preventive control plans) relative to livestock feeds. For the purposes of the measures set out in thisregulatory framework proposal, the CFIA (Canadian Food Inspection Agency) will move forward with regulatory developmenton the assumption that the proposed Act amendments in Bill C­18 will come into force in the near term.

The Parliament of Canada website provides a copy of Bill C­18 (http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=6378152&File=53).

Should Bill C­18 not pass into law in the near term, the CFIA (Canadian Food Inspection Agency) would explore other optionsfor implementing regulations for process­based feed controls.

6 Summary

6.1 Proposal SynopsisIn aligning with the mandate of the CFIA (Canadian Food Inspection Agency) and the Act, the Agency is proposing afeed preventive control framework that addresses hazards to animal health, plant health and the environment, inaddition to mitigating public health risks.With respect to identifying hazards, the Agency proposes to review the current Regulations, the ingredient Schedulesattached to the Regulations, and regulatory guidance publications with respect to hazards and any maximum limits oraction levels for feeds, and subsequently revise the regulations and policies, as appropriate.As a complementary measure, the Agency proposes to move forward with the implementation of amendments to theHealth of Animals Regulations in respect of toxic substances to enhance Agency response in situations where animals

are accidently or unknowingly exposed to hazards that may have health implications.Other than livestock producers who are specifically exempted from the application of the Feeds Act and Regulations, allregulated parties in the feed supply chain must develop, implement, and maintain outcome­ and performance­basedPCPs (preventive control plans).The CFIA (Canadian Food Inspection Agency) will provide guidance and/or model systems to assist smaller operationswith developing PCPs (preventive control plans) and in guiding inspection staff.

6.2 Next StepsFeedback obtained during this consultation will be combined with feedback from the other two modules. A final consolidatedproposal for feed regulatory modernization will be developed to

integrate the feedback received on the three individual proposals (feed ingredient authorization and assessment, feedlabelling, and feed hazard identification and preventive controls).include information on compliance and enforcement approaches, including the role of private sector programs in risk­based inspection approaches.outline the modernized inspection approach the CFIA (Canadian Food Inspection Agency) will administer, andincorporate the input received from consultations on the integrated Agency inspection model.

Following the development and publication of the proposed overall framework, the CFIA (Canadian Food Inspection Agency)will review its service delivery costs and fees within the Feed Program as part of an Agency­wide User Fee modernizationinitiative. Objectives for the User Fee initiative include promoting effective and responsive service delivery; establishing aconsistent and robust approach to user fee development; and fostering an understanding that user fees may be charged forservices, products, and rights and privileges provided by the Agency. For detailed information, refer to the Cost RecoveryPolicy and Framework.

The Agency will hold public consultations on user fees related to services provided by the Feed Program. Service recipientswill have an opportunity to comment on the detailed user fee proposal once it is made public.

6.3 Contact

We strongly encourage you to provide your input and feedback, which is critically important to the success of the regulatorymodernization initiative. Written comments may be forwarded to

Sergio TolussoCanadian Food Inspection AgencyAnimal Feed Division59 Camelot DriveOttawa, ON K1A 0Y9Email: Sergio.tolusso@inspection.gc.caFax: 613­773­7565

Annex 1 ­ FRSG (Feed Regulatory Steering Group) RecommendationsIn October 2013, the CFIA (Canadian Food Inspection Agency) shared its current thinking regarding a proposed regulatoryframework for feed hazard identification and preventive controls with its industry/government Feed Regulatory SteeringGroup (FRSG). Following this briefing, the industry association members of the group collaborated to provide the CFIA(Canadian Food Inspection Agency) with the following feedback and six recommendations:

The associations took particular account of the comments made by participants at the stakeholder workshop held inMarch 2013, where a clear majority supported the inclusion of hazard identification and preventive controls in a newCanadian regulation. The associations also considered the current EU (European Union) and proposed U.S. (UnitedStates) rules, both of which require that hazard identification and control plans be documented and implemented inanimal feed production establishments. Finally, the exchange of views was guided by the overriding goal—advancedby CFIA (Canadian Food Inspection Agency) and supported by the agri­food stakeholder community—ofimplementing outcome­based regulations focused on the mitigation of risk.

At the conclusion of discussions, the six associations unanimously agreed to make the following recommendations tothe co­chairs of the FRSG (Feed Regulatory Steering Group):

1. A modernized feed regulation—in concert with regulatory guidance and administrative procedures—shouldinclude measures to promote the implementation of hazard identification and preventive control plans in feedmanufacturing, storage and distribution facilities. Such measures should focus exclusively on feed safety,considering that nutritional requirements are based on commercial arrangements between suppliers and theircustomers.

2. While such plans would need to be appropriately documented, monitored and verified, the form of delivery wouldbe outcome­based. For example, while most commercial facilities will favour ANAC (Animal Nutrition Associationof Canada)'s FeedAssure program, there are other HACCP (Hazard Analysis Critical Control Points)­basedapproaches that might be acceptable, provided they satisfy the intended feed safety outcome.

3. It is recognized that the EU (European Union) and U.S. (United States) feed safety statutes authorize theinclusion of mandatory hazard identification and preventive controls in regulation. However, there appears to besome doubt as to whether the Feeds Act would enable such a requirement in a new Canadian regulation. Theassociations agreed that a mandatory approach along the lines of the EU (European Union) and U.S. (UnitedStates) frameworks, coupled with a risk­based facility licensing system, would be the preferred route for thecommercial feed industry in Canada.

4. If the statutory authority for mandatory hazard identification and preventive control programs is indeed found tobe lacking in Canada, the associations agreed that CFIA (Canadian Food Inspection Agency) should put inplace appropriate incentives to encourage the widespread use of recognized hazard identification and controlplans for the commercial feed industry.

5. In its December 2010 policy paper and again in its June 2013 submission to the regulatory steering group,ANAC (Animal Nutrition Association of Canada) proposed that CFIA (Canadian Food Inspection Agency)refocus its inspection resources to concentrate on establishments without hazard identification and control plansin place, and to adopt a modernized, system­based review of facilities with formal preventive controls andindependent verification programs. In 2010, CFIA (Canadian Food Inspection Agency) officially acknowledgedthat ANAC (Animal Nutrition Association of Canada)'s FeedAssure program meets all the requirements of theAgency's own Food Safety Enhancement Program. However, FeedAssure­certified facilities are given only tokenrecognition, by receiving one less partial inspection per year. The six associations recommend that CFIA(Canadian Food Inspection Agency) provide an incentive for commercial feed facilities to participate in theFeedAssure program by lessening the inspection burden on certified facilities and reallocating scarceenforcement resources to commercial establishments without preventive control plans and thus representing thehighest risk.

6. Finally, the associations recommend to the FRSG (Feed Regulatory Steering Group) co­chairs that CFIA(Canadian Food Inspection Agency) staff expedite any policy or legal inquiries needed to ascertain whether amodernized feeds regulation can, within existing statutory authorities, incorporate provisions for risk­basedlicensing of commercial facilities, and mandatory hazard identification and control plans. In the absence of suchauthorities, the associations further recommend an examination—in consultation with the full FRSG (FeedRegulatory Steering Group)—of methods of adapting the facility inspection system to fit an outcome­basedregulatory environment. The intent would be to provide appropriate incentives which would best encourage theexpansion of FeedAssure or other hazard identification and control programs of equivalent rigour.

Annex 2 ­ Proposed Outcome­based Regulatory Requirements

IntroductionAs identified in section 4.4.3 of the proposal, the following elements are proposed for PCPs (preventive control plans) forfeed:

1. Product and process control

2. Sanitation, biosecurity and pest control3. Hygiene, biosecurity and employee training4. Equipment design and maintenance5. Physical structure and maintenance6. Receiving, transportation and storage7. Recalls, complaints and record­keeping

This Annex is intended to provide a framework from which outcome­based regulations, model systems, industry guidanceand guidance to CFIA (Canadian Food Inspection Agency) inspection staff (as to how to determine if compliance is beingachieved) will be developed. The balance between requirements being established in regulations versus provided inguidance will be determined once the legal drafting of the regulations begins in earnest following consultation. Theperformance criteria outlined for each PCP (Preventive Control Plan) element in this Annex represent examples of measuresthat may be employed to address potential risks posed from hazards identified in materials and processes used tomanufacture, store and distribute feeds and feed ingredients. Flexibility would be provided for regulated parties to use othermeasures not outlined here, provided they are effective in addressing potential risks.

1. Product and Process Control

Outcome

Process and product controls ensure the production of safe feed that is in compliance with applicable regulations.

Standard

The regulated party must develop, implement, monitor and review for their specific system the effectiveness of a PCP(Preventive Control Plan), relative to product and process controls, to assure that:

a hazard identification exercise that considers all potential biological, chemical and physical hazards is completed ;written plans identifying preventive control measures to eliminate, prevent, mitigate, or reduce hazards to an acceptablelevel as well as meeting other regulatory requirements are developed; andeffective control systems relative to incoming ingredients, process controls, product flow and people flow are

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implemented, monitored and reviewed periodically and when operations change.

Process control outcome: performance criteria

a. Incoming inputs (for example, ingredients, raw materials, plants and animals)identification of incoming inputs materials/ingredients and their sourceidentification of incoming inputs, with written specifications, if:

there is a potential hazardan incoming input is critical to biosecurity, product composition, health status and/or nutrition profileverification from source suppliers regarding the potential hazard

documented handling procedures for incoming inputs to maintain integrity and prevent hazard introduction,degradation or contamination

b. Materials originating in the facility (for example, returns, rework, flush, dust collector materials, recycled solids fromwastewater treatments)

identification of incoming inputs materials/ingredients and their sourceidentification of incoming inputs, with written specifications, if:

there is a potential hazardan incoming input is critical to biosecurity, product composition, health status and/or nutrition profileverification from source suppliers regarding the potential hazard

documented handling procedures for incoming inputs to maintain integrity and prevent hazard introduction,degradation or contamination

c. Product formulation and specificationswritten formula for each feed or feed ingredient manufactured in the facilitywritten specifications for each feed or feed ingredient manufactured in the facility that addresses animal health,including appropriate nutrient levels, contaminants that present a risk to animal health, and species specifichazard analysis, in addition to hazards that pose a risk to human healthfeed additives, processing aids and chemicals (including medicating ingredients) used are permitted for use in andon the feed or feed ingredient commodity

d. Processingwritten description of:

processing steps (for example, mixing records), associated control measures and critical limitsmovement of the feed or feed ingredient in the facility (for example, process flow diagram)procedures for production sequencing where multiple feed and feed ingredients are manufactured in afacility

critical limits are validated using scientific data

Product control outcome: performance criteria

a. PackagingAll packaging materials are suitable for the intended use.

b. Labelling, Product identificationThe information on the label is complete, truthful and not misleading.It accurately represents the content of the feed or feed ingredients and its content.It meets regulatory requirements.

c. Finished ProductThe finished feed or feed ingredient is evaluated for compliance with regulatory requirements.Outgoing feed and feed ingredients and their destination are identified, including any feed and feed ingredientsdestined for export (for example, the immediate purchaser is identified).

2. Sanitation, biosecurity and pest control

Outcome

Prevent contamination, control hazards and facilitate hygienic production of feed or feed ingredient through effectivesanitation and pest control.

Standard

Standard

The regulated party must develop, implement, monitor and review the effectiveness of a PCP (Preventive Control Plan),relative to sanitation and pest control, to assure that:

the sanitation of the premises and equipment is maintained at an appropriate level so as not to become a source ofcontamination for feed and feed ingredients before, during and after production; andthe entry of pests (rodents, insects, birds, etc. (et cetera)) inside and outside the facility is controlled (including detectionand elimination of pests).

Sanitation and biosecurity outcome: performance criteria

There is a schedule for cleaning and/or sanitizing, which includes the concentration of chemicals to be used, andtemperature and pressure requirements (if applicable), for:

the facility, including preparation and storage areas;equipment; andfeed and feed ingredient contact surfaces, including containers and utensils.

Equipment used for cleaning and/or sanitizing is capable of delivering the requirements of the sanitation program.Cleaning and/or sanitizing is carried out in a manner that does not contaminate feed, feed ingredients or packagingmaterials commodities (through contact with these) or spread pests or pathogens, during or after cleaning and/orsanitizing.Effectiveness of cleaning, sanitizing is assessed visually or through sampling (for example, environmental, product)using accepted methods or procedures, as applicable.Feed and feed ingredient contact surfaces are free from contamination (for example, the accumulation of dust, dirt, feedor feed ingredient residue and other debris).

Pest control outcome: performance criteria

There is a program for control and removal of pests, including vectors.There is a schedule for monitoring for evidence of pest activity, including vectors.

Chemicals outcome: performance criteria

A listing of chemicals or specification sheets for chemicals used in biosecurity, sanitation, treatment, and pest control ismaintained.The use of chemicals does not contaminate feed or feed ingredients, equipment, utensils or feed and feed ingredientscontact surfaces.Chemicals are suitable for their intended use.Chemicals are properly stored, controlled, and labelled.Chemicals are dispensed, handled, used and applied by trained personnel.

3. Hygiene, biosecurity and employee training

Outcome

All persons in the feed manufacturing facility adhere to sound hygiene practices so as to not contaminate feed. All staffinvolved in the manufacture, storage and handling of feed and feed ingredients are adequately trained and supervised andaware of their role and responsibility in ensuring safe and compliant feed.

Standard

The regulated party must develop, implement, monitor and review the effectiveness of a PCP (Preventive Control Plan) thatincludes measures to assure that people who come directly or indirectly into contact with feed (employees and visitors) do notbecome a source of contamination of feed, including requirements that people:

maintain an appropriate degree of personal cleanliness;behave and operate in an appropriate manner (includes appropriate protective clothing, health program);have training to a level appropriate to the operations they are to perform;are following effective bio­security practices; andare provided with proper hygiene and bio­security instruction (staff and visitors).

Hygiene and biosecurity outcome: performance criteria

Effective biosecurity practices are in place, including:

controlled accessemployee facilities, hand­washing and sanitizing stationsuse of sanitary clothing and footwear

Hygienic practices are in place, including:proper hand­washing or use of sanitizers/gloves or boot washrules for employee conductprecautions for personnel with open wounds or a communicable disease

Employee training outcome: performance criteria

A written description of training requirements and training records for employees responsible for activities under thePCP (Preventive Control Plan) are maintained.Employees are trained to carry out the range of tasks and duties they are required to perform.Effectiveness of training is verified by the regulated party.

4. Equipment design and maintenance

Outcome

Equipment, utensils and containers are effective for their intended purpose and are designed, constructed, installed andmaintained in a manner that prevents feed contamination.

Standard

The regulated party must develop, implement, monitor and review the effectiveness of a PCP (Preventive Control Plan) toassure that:

equipment, utensils and containers are:of adequate and appropriate design, constructed, installed and maintained (including calibration) such that they donot become sources of contamination for feed and are effective for their intended purpose;easily cleaned, accessible for servicing and inspection or easily disassembled for those purposes, as required;

constructed of materials with no toxic effect in intended usescales and metering devices used in the manufacture of feed and feed ingredients are appropriate for the range ofweights and volumes to be measured, and tested regularly for accuracymixers used in the manufacture of feed and feed ingredients are appropriate for the range of weights or volumes beingmixed and are capable of manufacturing suitable homogeneous mixtures and homogeneous dilutions, and testedregularly to verify their performance; andother equipment used in the manufacture of feed and feed ingredients is appropriate for the range of weights orvolumes being processed and monitored regularly.

Equipment design and maintenance ­ performance criteria

All equipment, utensils, containers, and controlling and measuring devices used in the preparation and storage of feedand feed ingredients are:

used only for the facility's intended purpose,functioning as intended,maintained in a good state of repair,cleanable, andproperly stored.

Controlling or measuring devices used in the preparation of feed and feed ingredients are calibrated and maintained toensure measurement accuracy and effectiveness.

5. Outside premises, surroundings and maintenance

Outcome

The design and layout of feed facilities prevents cross­contamination between and during operations and facilitates effectivemaintenance and sanitation.

Standard

The regulated party must develop, implement, monitor and review the effectiveness of a PCP (Preventive Control Plan) toassure that physical structures are:

constructed in a manner that permits ease of operation, maintenance and cleaning and minimizes feed contamination;maintained in a manner to assure the facility does not become a source of contamination for feeds, including:

appropriate product and people flow;water and steam meet potability standards and be of suitable quality for animals and the food chain; andsewage, waste feed and feed ingredients, wastewater, and other material containing unsafe levels of hazards aredisposed of in a manner which avoids contamination of equipment, feed and feed ingredients.

Buildings outcome: performance criteria

a. Exterior building structuresThe exterior of the building is maintained to prevent entry of pests and contaminants.

b. Interior building structures are appropriate for intended useFloors, walls and ceilings are:

cleanablemade of materials that will not contaminate regulated commoditiesin good repair

In feed and feed ingredient preparation areas:floors are constructed and maintained to permit adequate drainageglass, where breakage may contaminate feed and feed ingredients, is properly protected

c. Hygienic flow and separationWhere there is potential for cross­contamination, incompatible operations are controlled by physical separation orother effective means.

d. LightingThere is sufficient light to allow the intended activity to be conducted effectively.

Lighting equipment (bulbs and fixtures) that is located where breakage could contaminate feed and feedingredients is protected, as needed.

e. VentilationVentilation provides sufficient air exchange to control moisture and minimize condensation.Ventilation systems are designed and constructed to prevent contamination (for example, air flow into clean areasis not contaminated).Ventilation systems are adequately maintained and cleaned.

f. Employee facilitiesWhen present, the location and design of employee facilities such as washrooms, lunch rooms and change roomsdo not contribute to or cause contamination of feed and feed ingredients or production areas.An adequate means of hygienically washing and drying hands and personal protective equipment (for example,boots) is provided (including wash basins and a supply of safe water):

The location of hand­washing and sanitizing stations does not contribute to or cause contamination of feedand feed ingredients.

Water, ice and steam outcome: performance criteria

a. Water, ice and steam safetyWater, ice and steam that come in contact with feed and feed ingredients or feed and feed ingredients contactsurfaces meet safety requirements as defined in Health Canada's Guidelines for Canadian Drinking Water Quality– Summary Table (http://www.hc­sc.gc.ca/ewh­semt/pubs/water­eau/sum_guide­res_recom/index­eng.php) or aresafe for intended use.There is no cross­contamination between safe and unsafe water supplies.Safety of water must be confirmed using recognized methods at a frequency adequate to confirm its safety:

Where municipal sources are used, municipal test results may be accepted.

b. Water and steam handling equipment

Equipment is designed, installed and maintained in a manner that will not jeopardize the safety of water.

Waste disposal outcome: performance criteria

Waste storage areas and containers are identified, of suitable capacity, secured and cleaned to avoid attracting pests.Waste disposal, including effluent lines, does not contaminate commodities, feed and feed ingredient preparation areasor the environment.Drainage and sewage systems are adequate for the volume and type of effluent being produced during normalprocessing and cleaning operations, and backflow is prevented.

6. Receiving, transportation and storage

Outcome

Feed is protected from potential sources of contamination and any damage that is likely to render the feed unsuitable forconsumption or use during receiving, transportation and storage. Growth of pathogenic micro­organisms is controlled.

Standard

The regulated party must develop, implement, monitor and review the effectiveness of a PCP (Preventive Control Plan) thatassures:

measures to eliminate, prevent, mitigate, or reduce hazards to an acceptable level during receiving, transportation andstorage (including incoming and outgoing materials) are implemented, monitored and periodically reviewed, including:

feed and feed ingredients are received, transported and stored in a manner that maintains their identity andintegrity, minimises deterioration, contamination and cross­contamination and enables the correct feed to be sentto the right animal group;chemical fertilizers, pesticides and other materials not intended for use in feed and feed ingredients are identified,transported, handled and stored in a manner to avoid the potential for manufacturing errors and contaminationand cross­contamination of feed and feed ingredients

The regulated party needs to consider both finished products and by­products which are intended for other uses that areregulated by the CFIA (Canadian Food Inspection Agency) (e.g. (for example) fertilizer).

Receiving, transportation and storage: performance criteria

Conveyances, when used for the transport of feed and feed ingredients:are clean and protect feed and feed ingredients from contamination, damage, pest propagation and deterioration,(including temperature and humidity controls) (for example, refrigeration); andare not being used to transport any material or substance that might cross­contaminate or adulterate feed andfeed ingredients.

Feed and feed ingredients in need of temperature and humidity controls (for example, refrigeration or freezing) aremaintained (for example, not left out at ambient temperatures for prolonged periods).Conveyances are loaded, arranged and unloaded in a manner that prevents damage and contamination of the incomingmaterials and ingredients and/or finished feed and feed ingredients.Storage areas allow the:

separation of feed and feed ingredients and other materials, including returned feed and feed ingredients;control of temperature and humidity to prevent deterioration and spoilage; andstock to be rotated to maintain suitability, quality and safety.

7. Recalls, complaints and record­keeping

Standard

The regulated party must develop, implement, monitor and review the effectiveness of a PCP (Preventive Control Plan) forrecalls, complaints and record­keeping, including controls relative to:

traceability of feed and feed ingredients and by­products (one step forward, one step back) is supported by properrecords regarding the production, distribution and use of feed and feed ingredients;notification of the CFIA (Canadian Food Inspection Agency) of any unsafe or non­compliant products in Canada orabroad;identification, investigation, correction and reporting of product complaints; and

procedures to effectively and rapidly identify, locate, control distribution and/or remove feed and feed ingredients fromthe marketplace if known or probable adverse effects on human health, animal health, plant health or the environmenthealth are identified.

Traceability and recall outcomes: performance criteria

The traceability and recall system must be able to:

identify sources of inputs incoming materials (ingredients) for the implicated feed and feed ingredients;stop any further distribution and sale;trace feed and feed ingredients (including by­products, if implicated) to the next point of distribution;contact customers and the CFIA (Canadian Food Inspection Agency);retrieve the implicated feed and feed ingredients; andmaintain accurate traceability records in accordance with certain applicable standards.

For more information, see the food recall and emergency response (/food/safe­food­production­systems/food­recall­and­emergency­response/eng/1300375639646/1300376138588) page of the CFIA (Canadian Food Inspection Agency)'s website.

Complaints outcome: performance criteria

Complaints are documented and investigated by the regulated party are investigated to determine if there is non­compliance with legislative requirements.Corrective action is taken for non­compliance, to address the implicated feed and feed ingredient, and any changesrequired to processes or procedures to prevent recurrence

FootnotesU.S. (United States) FDA (Food and Drug Administration) Food and Drug Administration. For Consumers.(http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm164473.htm)

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Share this pageDate modified:2014­08­07

U.S. (United States) Food and Drug Administration. Animal & Veterinary Page. Contaminants.(http://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/Contaminants/default.htm)

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The regulated party needs to consider both finished products and by­products which are intended for other usesthat are regulated by the CFIA (Canadian Food Inspection Agency) or another regulatory body (e.g. (for example),fertilizer, pesticides).

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