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> **U.S. Department of Agriculture's Assessment of the Canadian Feed
> Ban**

![](media/image2.png){width="6.496527777777778in"
height="5.754166666666666in"}

> **[February 2005]{.underline}**

Table of Contents

[1 Executive Summary 2](#executive-summary)

[2 Background 5](#background)

[2.1 Overview of BSE in Canada 5](#overview-of-bse-in-canada)

[2.2 Animal Industry and Feeding Practices
5](#animal-industry-and-feeding-practices)

[2.3 Feed Industry 7](#feed-industry)

[2.4 Canadian Feed Ban 8](#canadian-feed-ban)

[2.4.1 Comparison to the U.S. System 10](#comparison-to-the-u.s.-system)

[3 Addressing the Effectiveness of Feed Bans
12](#addressing-the-effectiveness-of-feed-bans)

[3.1 Non-traditional Feeds 14](#non-traditional-feeds)

[4 U.S. Audit of the Canadian Feed Ban
15](#u.s.-audit-of-the-canadian-feed-ban)

[4.1 Scope and Methodology 15](#scope-and-methodology)

[4.2 Results 16](#results)

[4.2.1 U.S. Review of the CFIA Verification Program and Processes
16](#u.s.-review-of-the-cfia-verification-program-and-processes)

[4.2.1.1 CFIA Verification Activities at Rendering Facilities
17](#cfia-verification-activities-at-rendering-facilities)

[4.2.1.2 Verification Activities at Commercial Feed Mills and on Farms
18](#verification-activities-at-commercial-feed-mills-and-on-farms)

[4.2.2 Program Reviews by the CFIA Feed Inspection Group
19](#program-reviews-by-the-cfia-feed-inspection-group)

[4.2.3 Validation of Database Records
20](#validation-of-database-records)

[4.2.4 Summary of Electronic Inspection Reports
20](#summary-of-electronic-inspection-reports)

[4.2.4.1 Commercial Feed Mills 21](#commercial-feed-mills)

[4.2.4.2 Rendering Plants 29](#rendering-plants)

[4.2.4.3 On-Farm Feed Mills 31](#on-farm-feed-mills)

[5 Summary of the On-Site Inspection Review
32](#summary-of-the-on-site-inspection-review)

[5.1 Commercial Feed Mills 32](#commercial-feed-mills-1)

[5.2 Rendering Plants 33](#rendering-plants-1)

[5.3 Feed Testing Laboratory 34](#feed-testing-laboratory)

[6 Conclusions 36](#conclusions)

[Appendix 1 --- Feed Ban Rule 39](#appendix-1-feed-ban-rule)

[Appendix 2 --- Inspection Form for Commercial Feed Mills (tasks related
to feed ban)
42](#appendix-2-inspection-form-for-commercial-feed-mills-tasks-related-to-feed-bannumber-range-chapter)

[Appendix 3 \-- Inspection Form for Rendering Facilities (tasks related
to feed ban)
62](#appendix-3----inspection-form-for-rendering-facilities-tasks-related-to-feed-ban)

Appendix 4 \-- Inspection Forms for
On-Farms...........................................................83

**Abbreviations**

APHIS Animal and Plant Health Inspection Service

BSE Bovine Spongiform Encephalopathy

CFIA Canadian Food Inspection Agency

FDA Food and Drug Administration

HACCP Hazard Analysis Critical Control Point

MCAP Multi-Commodity Activity Program

NAI No Action Indicated

OAI Official Action Indicated

SRM Specified Risk Material

UK United Kingdom

USDA U.S. Department of Agriculture

VAI Voluntary Action Indicated

**Definitions**

*Flushing*: To follow a batch of feed through mixers or other equipment
with a sufficient volume of a non-prohibited ingredient, usually bulk
grain or oilseed products, to flush residual material out of the system.

*Prohibited Material*: Protein, or any material that contains such
protein, that originated from a mammal, other than pure porcine or
equine. This does not include milk, blood, gelatin, rendered animal fat
or their products.

*Sequencing*: To predetermine the order of manufacturing different feed
products so that any residual prohibited material is flushed into a feed
product intended for non-ruminant species.

*Specified Risk Material (SRM)*: Tissues that, in BSE-infected cattle,
contain the agent that may transmit the disease. In diseased animals,
the infective agent is concentrated in certain tissues. SRM are defined
as the skull, brain, trigeminal ganglia (nerves attached to the brain),
eyes, tonsils, spinal cord, and dorsal root ganglia (nerves attached to
the spinal cord) of cattle aged 30 months or older (scientific research
has shown that these tissues, in cattle younger than 30 months, do not
contain the infective agent); and the distal ileum (portion of the small
intestine) of cattle of all ages.

# Executive Summary

On January 24, 2005, the U.S. Department of Agriculture sent a team to
Canada to assess Canada's current feed ban and their feed inspection
program to determine if the control measures put in place by the
Government of Canada are achieving compliance with these regulations.
Based on their review of inspection records and on-site observations,
the inspection team found that Canada has a robust inspection program,
that overall compliance with the feed ban is good, and that the feed ban
is reducing the risk of transmission of bovine spongiform encephalopathy
(BSE) in the Canadian cattle population.

The Canadian feed ban is not substantially different than the U.S. feed
ban. Both feed bans prohibit the use of mammalian protein in ruminant
feeds, with exceptions for milk products, blood products, gelatin, and
protein derived solely from porcine or equine sources. Two minor
differences between U.S. and Canadian feed regulations are that the
United States allows plate waste and poultry litter to be used in
ruminant feed, whereas Canadian feed regulations make no such
allowances.

The Canadian feed ban has been implemented in stages since it was first
proposed in 1996. Leading up to Canada's feed ban implementation in
1997, the Canadian Food Inspection Agency (CFIA) began educating the
feed industry, livestock producers, and their own inspectors with regard
to the impending regulations. All feed mills received an initial
inspection between August 1997 and March 1998. At that time, none of the
feed mills were found to be formulating ruminant feeds that contained
prohibited material. From 1997 to 2000, the CFIA continued to educate,
but also continued to conduct inspections to bring the feed industry
into compliance with the feed ban. Rendering facilities were required to
pass an annual inspection before renewing their permit to operate from
1998 onward. In 2000 and 2001, the CFIA modified its compliance programs
by increasing the frequency of inspections of commercial feed mills from
once every three years to every year, and they continued the annual
inspection and permitting of all rendering facilities. Since 2002, the
CFIA has been conducting annual inspections of all rendering and
commercial feed mill facilities, as well as conducting inspections of
some ruminant feeders and retail feed distributors. Verification
activities for Canada's feed ban continue to be focused primarily on
inspecting commercial feed mills and rendering facilities.

In conducting feed mill inspections, CFIA's inspectors evaluate each
firm on its compliance with 86 tasks, of which, 13 are directly related
to the feed ban. An unsatisfactory rating is given for each task in
which the firm is not meeting the standard. Managers of a facility with
an unsatisfactory rating must provide a plan to the inspection staff
within 30 days that identifies corrective actions to be carried out to
remedy the situation. The inspectors then re-inspect the facility within
30 days of the reported correction to verify that the corrective action
has been taken.

Based on the U.S. evaluation of CFIA's data, the percentage of
commercial feed mills in Canada that had unsatisfactory ratings on
individual tasks has declined from 24.9 percent to 14.8 percent between
2002 and 2004, and that most of the non-compliant tasks were related to
documentation and record-keeping. The team's review also indicated that
the overall percentage of tasks rated as unsatisfactory for rendering
facilities (excluding instances where the task was not applicable)
across the 3 years of data, declined from 9.7 percent to 2.7 percent.
The review of both types of firms identified that most of the
unsatisfactory tasks were related to needed improvements for
record-keeping and documentation of procedures.

There has been a movement toward dedicated processing lines in the
rendering facilities or fully dedicated facilities. Also, since the feed
ban's inception in 1997, the industry has moved toward dedicated feed
manufacturing facilities, such that fewer commercial feed mills handle
prohibited material and manufacture feeds for ruminants.

Moreover, approximately one-third of the commercial feed mills
(producing at least 60 percent of the feed produced in commercial mills)
have voluntarily become Hazard Analysis Critical Control Point (HACCP)
-certified. The HACCP program provides a framework wherein feed mills
can incorporate training of employees, developing standard operating
procedures, and maintaining appropriate records relevant to the feed
ban. This proactive measure is further evidence that the feed industry
is increasing their efforts to comply with the feed ban.

The CFIA continues to revise and update their procedures to further
enhance the effectiveness of the feed ban. The CFIA intends to revise
some of the inspection forms to increase the objectivity of the
standards, and to carry out additional training for the inspectors to
improve standardization in the inspection and rating process. Moreover,
the CFIA has proposed the complete removal of specified risk material
(SRM) from animal feeds as an added safeguard to enhance the
effectiveness of the feed ban.

The Canadian government, feed industry, and livestock producers have
substantially increased their efforts to implement and comply with the
Canadian feed ban. Based on the U.S. team's review of the inspection
records for the past three years and on-site inspections of a sampling
of commercial feed mills and rendering facilities, it is evident that
considerable effort is being dedicated in all sectors to carry out the
intent of the Canadian feed ban. It is the U.S. Inspection Team's
determination that these efforts have reduced the risk of transmission
of the BSE agent in feed to ruminant animals.

**[Canadian Feed Ban Risk Analysis]{.underline}**

The information in this report was considered in light of the
assumptions and conclusions of the original risk analysis conducted to
support the minimal risk rule. That risk analysis documented the
regulatory basis for the Canadian feed ban and summarized compliance
efforts as reported by the CFIA. The risk analysis assumed that
compliance with the feed ban was good, and that the feed ban was
effectively enforced. The risk analysis also considered other
epidemiological information as evidence of the effectiveness of the feed
ban.

It should be noted that the risk analysis did not assume 100 percent
compliance with the feed ban, as that is not realistic in any situation.
However, it also noted that effects on disease control can be expected,
even with an imperfect feed ban. Specifically, a feed ban exerts
significant downward pressure on the prevalence of BSE, even with
incomplete compliance.

The information provided by the U.S. team verifies the information cited
in the risk analysis, and supports the conclusion in the risk analysis
that the feed ban is effective. The risk analysis included references
that the CFIA reported a high level of compliance as noted in
inspections. This report supports the same conclusion, noting that
overall greater than 90 percent of individual tasks evaluated in
inspections over the last 3 years were rated as satisfactory or not
applicable. It also notes that the majority of the unsatisfactory
ratings related to minor record-keeping infractions, such as not
including full name and address information on invoices. Another common
reason a facility might receive an unsatisfactory rating is because
written standard operating procedures need additional detail. The report
also confirms what is known from experience in the United States
regarding feed ban enforcement -- that compliance can not be immediately
perfect upon implementation, and that compliance continues to increase
as the program evolves.

# Background

## Overview of BSE in Canada

The sequence of events that led to the introduction of BSE into Canadian
born and reared cattle may never be known. However, the most likely
sequence is that infected cattle were imported from the United Kingdom
(UK) in the 1980s, their carcass(es) were subsequently rendered into
meat and bone meal (MBM), and the MBM was fed to young cattle. Some of
the important events related to the BSE situation in Canada, beginning
with the importation of UK cattle, are as follows:

-   Cattle from the UK were imported into Canada from 1979 until 1990.

-   BSE was first documented in the UK in 1986.

-   Canada prohibited the import of cattle from the UK in 1990.

-   In 1993, a case of BSE was detected in Canada in a cow imported from
    the UK.

-   In 1994, all remaining UK cattle imports were depopulated and tested
    with negative results for BSE.

-   The United States and Canada implemented a mammalian-to-ruminant
    feed ban (with some exemptions) as a precaution in 1997.

-   During this same time, Canada also implemented an inspection program
    for renderers and feed mills to verify compliance with the feed ban.

-   In May of 2003, Canada detected the first case of BSE in a cow born
    and reared in Canada.

-   In December of 2003, BSE was diagnosed in a cow from Canada on a
    Washington State dairy farm.

-   In December 2004, Canada proposed to strengthen their BSE firewalls
    by implementing a complete removal of SRM from animal feed.

-   In January of 2005, two additional cases of BSE were diagnosed in
    Alberta, Canada.

## Animal Industry and Feeding Practices 

Until BSE was detected in May 2003, the Canadian cattle population was
relatively stable at an estimated 15 million head. In 2001, there were
2.2 million dairy cows and 12.4 million beef cows in Canada. About 81
percent of Canada\'s dairy farms are located in Ontario and Quebec, 14
percent in the Western Provinces, and 5 percent in the Atlantic
Provinces. Alberta and Saskatchewan host 70 percent of Canada's beef
cattle.

Most Canadian cattle are raised on either dairy farms or beef cattle
operations, with a relatively small percentage raised on mixed species
farms (Table 1). Approximately 3.7 percent of cattle operations also
have swine on the premises, and approximately 6.5 percent have poultry
on the premises. As a proportion of the total cattle population, 2.7
percent of cattle are raised on mixed cattle and swine operations, while
4.1 percent are raised on mixed cattle and poultry operations.

  ------------------- -------------- ------------ -------------- ---------- -------------- ----------
  **Table 1. Cattle                                                                        
  Operation                                                                                
  Demographics**                                                                           

                      **Operations                **Operations              **Operations   
                      with Cattle                 with Cattle               with Cattle    
                      and Calves**                and Swine**               and Poultry**  

  **Province/Area**   **Number of    **Number of  **Number of    **Number   **Number of    **Number
                      Operations**   Cattle**     Operations**   of         Operations**   of
                                                                 Cattle**                  Cattle**

  Quebec/Atlantic     20,469         1,656,639    948            78,023     1,026          65,944

  Ontario             28209          2,140,731    1384           107,219    2,591          158,485

  Manitoba            11,333         1,424,427    500            44,129     698            62,376

  Saskatchewan        22,555         2,899,502    556            48,822     1,129          102,587

  Alberta             31,774         6,615,201    869            132,961    1,523          193,616

  BC                  7,726          814,949      254            7,994      936            49,013

  Total               122,066        15,551,449   4,511          419,148    7,903          632,021
  ------------------- -------------- ------------ -------------- ---------- -------------- ----------

**Source: 2001 Census of Agriculture, Statistics Canada (prepared by
Agriculture and Agri-Food Canada)**

Prior to 1997, Canadian feed regulations allowed the use of mammalian
protein such as bovine MBM in ruminant feeds; as a result, some feeds
would have contained these ingredients. Nutritional needs of dairy
cattle differ from those of beef cattle, and the nutritional needs of
both vary by age and stage of production. Animal source proteins are
commonly used not only to boost protein levels, but also to balance
specific nutrients (lysine and other amino acids, calcium, and
phosphorus).

Animal proteins are not as commonly used in rations for beef animals as
they are in dairy rations. Before the feed ban, the decision to use MBM
in beef feed formulations depended largely on the nutritional philosophy
of the feed manufacturer and the price and availability of protein
sources such as peas, lupins, lentils, canola, or soybean meal. However,
even before the feed ban, the use of ruminant proteins in feeds for beef
cattle was reported to be rare. As with dairy rations, any ingredients
used in beef rations after August 1997 are required to come from
non-prohibited sources.

## Feed Industry

-   Total sales for Canada's feed industry represent over CDN\$3.5
    billion (global shipments of livestock and poultry feed products,
    excluding pet food.)

-   Approximately 9,000 people are employed by feed industry
    manufacturing units.

-   It takes an estimated 25 to 27 million metric tons of animal feed to
    feed all the livestock and poultry in Canada.

-   The estimated total commercial production of complete feeds,
    supplements, and premixes in Canada is 15 million metric tons.

-   Approximately 50 percent of the overall complete feed equivalent
    volume required to feed all livestock and poultry in Canada is
    manufactured by non-commercial, on-farm mixing establishments.

-   Swine, dairy, and poultry feeds account for approximately 85 percent
    of all feeds manufactured and sold by Canadian commercial feed
    manufacturers.

-   The feed industry relies on imports from the United States, Europe,
    and Asia for the majority of the high-value micro-ingredients, i.e.
    vitamins, trace minerals, amino acids, medicated feed additives, and
    other micro-feed additives used in most feed products. This is a
    result of the lack of production in Canada of vitamins,
    pharmaceuticals and other fine chemicals.

-   Exports to the United States include cross-border movement of
    complete feeds that originate primarily from Ontario and Quebec in
    Eastern Canada and Manitoba, Saskatchewan, and Alberta in Western
    Canada. Exports of value-added specialty products such as milk
    replacers, mink and fox feeds, horse feeds, and some specialty
    micro-premixes are expanding in Mexico, Latin America, South
    America, Europe, and Asia.

-   The Canadian feed industry is comprised of establishments that vary
    in size and manufacturing capacity, from relatively small mills to
    large, sophisticated, and vertically integrated operations. Annual
    sales of operations range from CDN\$1 million to over CDN\$150
    million.

There are four major links in the feed chain that relate specifically to
the use of ruminant derived proteins in animal feeds. (1) Renderers
collect inedible products from slaughter and/or dead stock and transport
these materials to the rendering plant. (2) The rendering plant
processes this inedible material into products, primarily MBM, which is
then transported to feed mills. (3) Feed mills mix the MBM with grains
and other ingredients into numerous types of feed for a variety of
animals, with the highest volume being used in feed for poultry. (4)
These feeds or feed ingredients are distributed to farms where they may
be used with or without further mixing. On a relative scale, in Canada
there are approximately 20 feed mills per renderer and 400 livestock
producers per feed mill (Table 2).

+--------------------+----------------------+-------------------------+
| **Table 2.         |                      |                         |
| Demographics of    |                      |                         |
| Rendering Plants,  |                      |                         |
| Feed Mills, and    |                      |                         |
| Farms**            |                      |                         |
+--------------------+----------------------+-------------------------+
| **Facility Type**  | **Number of Firms**  | **Firms Handling**      |
|                    |                      |                         |
|                    |                      | **Prohibited Material** |
+--------------------+----------------------+-------------------------+
| Rendering Plants   | 29                   | 7                       |
+--------------------+----------------------+-------------------------+
| Commercial         | 550                  | 94                      |
|                    |                      |                         |
| Feed Mills         |                      |                         |
+--------------------+----------------------+-------------------------+
| On-farm Feed       | 25,000               | N/A                     |
|                    |                      |                         |
| Mills              |                      |                         |
+--------------------+----------------------+-------------------------+
| Total Farms        | 246,000              | N/A                     |
+--------------------+----------------------+-------------------------+

**N/A Data not available**

Over time, the feed industry has moved toward fully dedicated facilities
or dedicated processing lines. In 2002/2003, there were 120 commercial
feed mills that used prohibited material to manufacture feeds for
non-ruminants and which also manufactured ruminant feed. However, in
2003/2004, there were 94 such mills. A similar trend is also evident for
Canada's rendering industry (Table 3).

+--------+-------------+-------------------+--------------------------+
| *      |             |                   |                          |
| *Table |             |                   |                          |
| 3.     |             |                   |                          |
| Demogr |             |                   |                          |
| aphics |             |                   |                          |
| of the |             |                   |                          |
| Ren    |             |                   |                          |
| dering |             |                   |                          |
| Indu   |             |                   |                          |
| stry** |             |                   |                          |
+--------+-------------+-------------------+--------------------------+
| **     | **Dedicated | **Facilities      | **Facilities Using**     |
| Year** | F           | Using Dedicated   |                          |
|        | acilities** | Lines**           | **Non-Dedicated Lines**  |
+--------+-------------+-------------------+--------------------------+
| 2002   | 18          | 4                 | 7                        |
+--------+-------------+-------------------+--------------------------+
| 2003   | 19          | 4                 | 6                        |
+--------+-------------+-------------------+--------------------------+
| 2004   | 23          | 4                 | 2                        |
+--------+-------------+-------------------+--------------------------+

Approximately 176 of the estimated 550 commercial feed mills in Canada
are HACCP-certified through a program offered by the Animal Nutrition
Association of Canada. The certification audit is consistent with HACCP
requirements of the U.N. Codex Alimentarius Commission and also
incorporates key elements of the CFIA\'s Food Safety Enhancement
Program, the U.S. Food and Drug Administration (FDA) program, and the
European Union\'s HACCP protocol. Renewal of certificates is based on
results of full audits conducted every three years, and partial audits
conducted annually. These HACCP-certified mills are estimated to produce
60 percent or more of the feed produced in commercial mills. The HACCP
process can be readily adapted to accommodate the elements of the feed
ban.

## Canadian Feed Ban

The CFIA began public discussion of adopting a "feed ban" regulation in
April 1996, and the proposed regulation was published in *Canada Gazette
I* on March 29, 1997. This would be similar to publishing a proposed
rule in the *Federal Register* in the United States. The regulation was
finalized in the *Canada Gazette II* on June 8, 1997, by adding PART XIV
*Food For Ruminants, Livestock And Poultry* (referred to in this report
as the feed ban) to the Health of Animals Regulations. Most of the
regulation came into effect on August 4, 1997, although the part of the
regulation that requires non-ruminant feed containing prohibited
material to be labeled with a warning statement did not go into effect
until October 3, 1997.

The CFIA, the agency within the Canadian Government with primary
responsibility for carrying out these regulations, uses the Feeds Act
and Regulations and the Health of Animals Act and Regulations as the
basis of their authority to regulate animal feeds. The feed ban
regulation was promulgated under the Health of Animals Act and is
incorporated into the Health of Animals Regulations. The CFIA is
empowered to inspect rendering facilities, feed mills, feed
distributors, as well as farms where feeds are manufactured,
distributed, and/or used. Additionally, feed mills are required to be
registered with the CFIA and rendering firms are required to have an
annual permit issued by the CFIA to operate.

Canada's feed ban regulation was implemented on August 4, 1997 -- the
same day the United States implemented a similar set of rules. In both
countries, the feed ban was put in place as a precautionary measure in
the absence of evidence that the domestic cattle herd in either country
harbored BSE.

Canada's feed ban prohibits the feeding of mammalian derived proteins to
ruminant animals with the exception of those that are derived solely
from porcine or equine sources, blood and blood products from any
source, milk products, and gelatin. In addition, the rule requires the
labeling of all products that contain prohibited material with the
caution statement, "Do not feed to cattle, sheep, deer, or other
ruminants." Canadian feed regulations do not allow the feeding of
poultry litter, plate waste, or salvaged pet food to ruminants. The U.S.
feed regulations do not prohibit plate waste and poultry litter from
being used as a ruminant feed and do not prohibit salvage/distressed pet
food from being used if it does not contain prohibited material. Other
than these minor differences, however, the Canadian and U.S. feed bans
are very similar.

Canada's feed ban was implemented with provisions for a phase-in period
so that existing stocks of feed material could be depleted. Feed mills
were allowed a 30-day period to use and distribute existing stocks,
while farms were allowed 60 days to use existing stocks. No recall was
ordered for products that were already in the production or distribution
chain, including those that were present on farms. A 60-day
implementation period was also allowed for the addition of the mandatory
cautionary statement on the labels of those feeds which contained
prohibited materials.

The inspection program corresponding to the Canadian feed ban has
evolved since the feed ban became law. Since 1997, rendering facilities
have been required to have an annual, renewable permit in order to
operate. Moreover, a facility inspection has been required in order for
the plant to operate. In addition, with the adoption of the feed ban,
commercial feed mills were expected to be inspected at three-year
intervals to ensure compliance. Inspections began immediately after
initial implementation of the feed ban, and all commercial feed mills
received an initial inspection between August 1997 and March 1998. At
that time, none of the commercial feed mills were found to be
formulating ruminant feeds with prohibited material. All commercial feed
mills have been inspected annually since 2002.

The CFIA also inspects retail feed outlets to assess compliance with the
feed ban - principally, the labeling requirements. Approximately 100 of
the estimated 1,300 retail outlets are inspected annually. As with the
United States, farms and ruminant feeders are not inspected for
compliance with the feed ban on a regular schedule, but an inspection is
often done when the CFIA visits a livestock producer for some other
purpose, such as a tissue residue traceback. In the period between April
2002 and March 2003, 175 farm inspections were conducted. Over a similar
period for 2003/2004, there were 347 farm inspections. From April 2004
to January 15, 2005, there were 179 farm inspections. Verification
activities for Canada's feed ban are focused primarily on rendering
facilities and commercial feed mills.

In order to help evaluate feed ban compliance, the CFIA has conducted
audits of the Feed Inspection Program. The primary objective of these
audits was to determine whether the delivery of the National Feed
Inspection Program, in each specific area, conformed to established
guidelines. Methods for improving the design of the National Feed
Inspection Program were also identified. Final audit reports dating from
March 1999 to March 2002 were reviewed. The reviews were conducted
nationwide by senior members of the National Feed Team. Auditors
reviewed all feed inspection activities for both rendering plants and
feed mills. Cases of nonconformance were identified and Corrective
Action Reports were issued and followed up by the review team. These
included both corrective actions for the feed mills and rendering plants
and the responsible CFIA authority.

### Comparison to the U.S. System

The FDA has the legal authority in the United States, through the Food,
Drug & Cosmetic Act, to regulate nearly every segment of the feed and
feeding industries. In the past, however, most issues related to
facility permits, licenses, and registrations have been handled by State
agencies under their own laws. Rendering plants and protein blending
facilities historically have not been subject to a Federal permit,
license, or registration, at least not for the purposes of feed
regulation. Medicated feed manufacturers are required to obtain a
license from the FDA if they wish to use category II type A medicated
articles, and these firms have been subject to regular inspections. Feed
mills not wishing to use category II type A medicated articles to
manufacture medicated feeds, pet food manufacturers, and most feed
ingredient manufacturers have not been subject to Federal licensing or
registration, but most States do license or register these firms.
Subsequent to the Bioterrorism Act of 2002, though, all of these firms
have been required to register with the FDA as a feed or food
manufacturing facility.

A significant difference in the approach to feed regulation between
Canada and the United States is the role of the State agencies in the
United States. Feed regulation in Canada is a function of the Federal
government, via the CFIA, and occurs in most cases without significant
assistance from the Provincial governments. In this way, the program
design, training, and implementation are standardized. In contrast, in
the United States, the States have a long history of regulating animal
feeds, and the majority of States have active programs to
license/register facilities that manufacture feeds and feed ingredients
in their States, inspect these facilities, and monitor the retail
distribution of feeds within each State. The FDA works cooperatively
with the States to maintain an accurate inventory of firms that are
subject to the feed ban, and to ensure that all facilities subject to
the feed ban regulations (21 CFR 589.2000) are inspected regularly.
Firms that manufacture feeds containing prohibited material are
inspected annually. All data from these inspections are compiled by the
FDA and entered into a national database.

#  Addressing the Effectiveness of Feed Bans

There are many challenges to ensuring that a feed ban is effective. Some
of the actions to overcome them are discussed below. Achieving full
compliance with a feed ban inevitably takes time, due to the
complexities of the regulations and the industries involved. The
potential for cross-contamination during feed manufacture and transport
is a key area to address. Finally, feed ban regulations cannot reliably
prevent deliberate or unintentional mis-feeding on the farm. These
challenges exist in any country that implements a feed ban, and each
country must address them in a manner commensurate with the estimated
risk and in a way that takes into account existing infrastructures.

During the rulemaking phase leading up to the 1997 feed ban, it was
difficult to convince regulators, the animal feed industry, and
livestock producers of the need for new BSE-related feed regulations.
The feed bans in Canada and the United States were considered by many to
be a proactive measure and by some as totally unnecessary, as BSE had
not been detected in North American cattle. Because the risk in North
America was considered low relative to the risk in Europe, both
countries chose not to impose certain restrictions that eventually
became necessary in Europe. Specifically, Canada and the United States
decided not to prohibit the use of bovine-origin protein in all animal
feed, not to require removal of SRM from animal feeds, and not to
prohibit ruminant feed from being processed with equipment or in
facilities that were used to process feed containing prohibited material
(dedicated equipment/facilities). Instead, the regulations require that
cross-contamination be prevented during feed manufacture and transport,
and require that feed containing prohibited material be labeled to alert
farmers and ranchers that it should not be fed to ruminants. While both
countries intend to amend their feed regulations to require that the
highest risk tissues be removed from all animal feed, much of the effort
to enforce the current regulations continues to be directed at
preventing cross-contamination during feed manufacture and transport,
and preventing mis-feeding on the farm.

Controlling cross-contamination has been an issue in all countries that
have implemented feed bans. The most stringent solution to
cross-contamination is to completely prohibit the use of animal proteins
in feed production. However, this approach creates another set of
problems regarding disposal of carcasses and offal. Current regulations
in Canada and the United States address cross-contamination through
requirements for physical cleaning of equipment, flushing, or sequencing
of feed production as control measures. Facilities may also choose to
dedicate either their entire facility or specific lines within a
facility to production of feed containing only non-prohibited material.
The Canadian feed industry has been moving in the direction of dedicated
facilities over the past several years. If not dedicated, however,
facilities must use one of the control measures previously described.
Flushing and sequencing strategies have been previously established and
used for the control of cross-contamination when mixing medicated feeds.
These same principles are applied in the feed manufacturing processes to
comply with the feed ban. In addition, vacuuming, sweeping, and washing
are commonly used methods of physical cleanout. Firms are required by
the CFIA to have written procedures describing how cross-contamination
is to be controlled at their facility. The existence of these written
documents, as well as compliance with the feed ban is verified during
inspections by CFIA personnel.

Efforts to prevent the introduction of prohibited material into ruminant
feed at the rendering and commercial feed mill level can be undone if
care is not taken at the farm level. In countries such as Canada and the
United States, where prohibited material is allowed to be used in feed
for non-ruminant species, cattle can still be exposed to prohibited
material if livestock producers accidentally or deliberately feed their
cattle a feed product intended for other species; if cattle on
mixed-species farms gain access to feed intended for other species, such
as swine or poultry; or if producers do not fulfill their obligation to
prevent cross-contamination during on-farm mixing or transport.
According to the background material the CFIA provided, there are an
estimated 122,000 farms and ranches with cattle or calves in Canada
(Table 1). Of these, an estimated 3.7 percent also have swine on the
premises and 6.5 percent have poultry on the premises. (Note: these
categories are not mutually exclusive.) The proportion of these mixed
operations that actually use prohibited material in animal diets is
unknown, as is the number and identity of operations with on-farm feed
mixing capability. The proportion of the total cattle population on
these types of operations is relatively small, 2.7 percent and 4.1
percent respectively. Resources are not available to inspect all farms
and ranches for compliance with the feed ban. The CFIA works to ensure
compliance at the farm level by using educational programs conducted by
their own personnel, the extension service, trade associations, and
producer groups. As part of the education campaign, livestock producers
are informed of their requirement to maintain records of their receipt
and use of prohibited material. Further, the requirement that firms
label products containing prohibited material with the caution
statement, "Do not feed to cattle, sheep, deer, or other ruminants" is
intended, in part, to deter farmers and ranchers from accidentally or
intentionally using products containing prohibited material in ruminant
feed.

The feed trace-out investigation conducted in May 2003 provides evidence
that these efforts to ensure on-farm compliance are effective. Before
positive test results were obtained in May 2003, the carcass of Canada's
first BSE case had already been rendered and entered into animal feed
channels. The CFIA subsequently traced a large volume of rendered
product through feed distribution channels. The MBM was traced to
commercial feed mills and feeds manufactured over a 39-day period. From
among the farms that received feeds containing MBM manufactured during
the target dates, a biased sample of 204 farms that were likely to have
ruminant animals was selected for inspection. Of these farms, 170 had
ruminants present. On 150 farms (88.2 percent), no exposure of ruminants
to the suspect feed could be identified. On 13 farms (7.7 percent),
potential opportunities for cattle exposure to the suspect feed were
identified. Exposure was considered possible if appropriate cleanout
procedures for cross-utilized feed manufacturing equipment had not been
performed, or if the farm failed to document that clean-out procedures
had been performed. In addition, there could have been exposure of
ruminants to poultry or hog manure that may have contained some of the
spilled suspect feed. On 7 farms (4.1 percent), there was likely
systematic or routine exposure to the suspect feed. This exposure was
determined based on statements from the producer that the ruminants had
access to spilled or stored feed containing the MBM on a routine basis.
Three of the farms were quarantined and 63 cattle that may have eaten
poultry feed were destroyed. Taking into account the very small
probability of exposure of ruminants on the remaining farms, and
impending enhancements to BSE risk management, the CFIA decided not to
impose specific risk management measures on other farms. This decision
was consistent with the recommendations of the international scientific
experts who reviewed the CFIA's investigation.

## Non-traditional Feeds

Historically, the livestock feeding industry has simultaneously evolved
with the food manufacturing and agricultural processing industries,
resulting in by-products being used as feed ingredients. Therefore, when
referring to the "feed industry", other types of firms beyond feed mills
and renderers need to be included. Other associated industries that
supply materials into the feed supply include meat processing, food
manufacturing, pet food manufacturing, as well as certain types of
industrial operations. Further, a salvage industry has evolved to
collect and find a reasonable use for items such as food and pet food
products that are unable to be sold for their intended use. Under the
CFIA's feed regulations, salvaged/distressed pet food is not considered
an approved feed ingredient, and therefore may not be used in livestock
feed. The CFIA's feed regulations allow a variety of food manufacturing
by-products to be incorporated into livestock feed; however, a specific
clearance process is followed for each ingredient before those
ingredients are permitted. Plate waste is not allowed to be fed to
livestock in Canada. As is the case in any manufacturing system,
occasionally a feed product is mis-manufactured while it is in-process.
The CFIA regulations allow a feed manufacturer to reprocess
mis-manufactured feeds, as long as the manufacturer and product complies
with any and all applicable regulations.

# U.S. Audit of the Canadian Feed Ban

## Scope and Methodology

On January 24, 2005, the U.S. Department of Agriculture sent a team to
Canada to assess Canada's current feed ban and their feed inspection
program to determine if the control measures put in place by the
Government of Canada are achieving compliance with these regulations. On
January 25, 2005, the CFIA provided an overview of processes and
procedures related to the feed ban including: (1) the CFIA structure and
authorities, (2) feed ban implementation in Canada, (3) inspection and
compliance activities, (4) proposed future activities, and (5) the
CFIA's plans for their own audit of the current feed ban.

The U.S. team utilized published materials from the CFIA website,
including the risk assessment conducted in 2001, a description of the
past cases of BSE in Canada, published notices, educational materials,
and the report of the International Review Team from June of 2003. The
team also reviewed historical documentation for the inspection and
compliance procedures related to the implementation of the 1997 feed
ban, including the CFIA directives, various forms used to carry out and
record inspection activities, results of past audits of the inspection
activities, and summaries of historical levels of compliance with the
feed ban.

Additionally, the U.S. team reviewed historical inspection and
compliance data related to the feed ban for the past three years. When
an unsatisfactory rating is given by an inspector, the facility is given
a period of time in which to resolve the problems that resulted in the
rating. The inspector then verifies that the problem has been resolved
and enters a resolution date into the Multi-Commodities Activities
Program (MCAP) database. The U.S. team calculated the times until
resolution for all unsatisfactory tasks and the number of unsatisfactory
tasks that were never fully resolved. In addition to tabulating the
number of tasks rated as unsatisfactory and time to resolution for the
inspected facilities, the U.S. team attempted to categorize the reasons
for the unsatisfactory rating according to criteria used in the United
States by the FDA to determine if there is a need for official action
(OAI) or voluntary action (VAI), to try to make a more direct comparison
of compliance with the U.S. inspection program.

As part of the planned Canadian audit of their feed ban, the CFIA
stratified commercial feed mills and rendering facilities with regard to
potential risk for contamination of feeds, and then selected
establishments to inspect. From the 94 commercial feed mills that used
prohibited material and also manufactured ruminant feeds, they randomly
selected 27 to be inspected. From the remaining feed mills
(approximately 450) that either did not handle prohibited material or
did not manufacture ruminant feeds, they selected 4 to inspect. From the
total population of renderers (n=29) only 7 produced both prohibited and
non-prohibited material. All 7 of these rendering facilities were
selected for inspection. The CFIA inspector for the facility,
accompanied by a CFIA area manager and a member of the CFIA headquarters
staff, conducted the Canadian feed ban audit and inspections of these
facilities.

The U.S. team was provided hardcopies of the previous inspections for
the selected facilities in addition to having access to inspection data
that had been entered into the CFIA MCAP database. The U.S. team
compared the hardcopy inspection records with the electronic database to
determine if there were significant discrepancies.

The U.S. team accompanied the CFIA inspection staff on inspections of 7
of the 31 commercial feed mills selected randomly for inclusion in the
Canadian audit as well as 3 of the 8 rendering facilities to be
inspected. These 10 facilities were chosen by the U.S. team based on
location (geographically distributed in three Canadian provinces). The
U.S. team visited two commercial feed mills and a rendering plant
located in each of Alberta and Saskatchewan, and three commercial feed
mills and a rendering plant located in Ontario. While accompanying the
CFIA inspectors, the U.S. team observed the application of the
inspection standards, including review of records and labels, viewed the
facilities and observed manufacturing practices, and discussed processes
with facility personnel involved in various steps of feed manufacturing.

The U.S. team also visited the Canadian feed testing laboratory in
Ottawa to discuss procedures and processes related to the feed ban,
including the historical use of feed microscopy and other feed
evaluation techniques and future plans for feed testing related to the
feed ban.

## Results

### U.S. Review of the CFIA Verification Program and Processes 

A review of the verification program procedures and processes was
conducted. This included a review of all documents currently stored at
the CFIA office in Ottawa, Ontario that specifically address
verification activities pertaining to the feed ban. These documents
included training documents, inspector checklists, program plans and
projections, and Feed Inspection Review reports. Verification activities
for Canada's feed ban continue to be focused primarily on inspecting
commercial feed mills and rendering facilities. The U.S. team also
focused their review on these areas.

+-------+-------+------+------+------+-------+------+------+--------+
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|       |       |      |      |      | ction |      |      |        |
|       |       |      |      |      | Team  |      |      |        |
+-------+-------+------+------+------+-------+------+------+--------+
| ***19 | ***19 | **   | **   | **   | ***20 | **   | **   | ***2   |
| 97*** | 98*** | *199 | *200 | *200 | 02*** | *200 | *200 | 005*** |
|       |       | 9*** | 0*** | 1*** |       | 3*** | 4*** |        |
+-------+-------+------+------+------+-------+------+------+--------+
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+-------+-------+------+------+------+-------+------+------+--------+
| *CFIA |       |      |      |      |       |      |      |        |
| Rend  |       |      |      |      |       |      |      |        |
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| ties* |       |      |      |      |       |      |      |        |
+-------+-------+------+------+------+-------+------+------+--------+

**Chart A - Timeline of Activities.**

#### CFIA Verification Activities at Rendering Facilities

Prior to the feed ban, the need for regulatory oversight of the
rendering industry in Canada was minimal. In 1997, the CFIA began
requiring that rendering plants obtain an annual permit to operate.
Starting in 1998, a rendering plant had to pass an on-site inspection
each year before its operating permit would be renewed. To assist CFIA
inspectors in conducting the annual inspections, the CFIA issued the
*Rendering Plant Audit Protocol* in 1997. According to the audit
protocol, the objective of audits at rendering plants was to confirm
that the plants operated in accordance with the requirements of the
Health of Animals Regulations. The protocol document was "score based",
and was chiefly used as an educational tool to help rendering plants
become knowledgeable and compliant with the regulation. The document has
undergone the following revisions:

-   January 1998 -- revised to include guidance for the inspector
    regarding the number of records and type of activities that should
    be observed. This edition also included a section giving
    instructions to inspectors on what actions to take if noncompliance
    is found. These potential compliance actions ranged from requiring
    additional documented procedures to ordering a recall of
    contaminated product

-   February 2001 - This update of the audit protocol was the *Feed
    Program 1A- Compliance Guide for Rendering Plants* (dated February
    2001). This edition added an introduction, definitions, and
    instructions for the CFIA inspector, and incorporated inspection
    results into the CFIA MCAP database system.

-   January 2003 and January 2004 - These editions included changes that
    pertained to labeling requirements of the Health of Animals
    Regulations along with further clarification of other tasks. The
    January 2004 version is the most current edition.

#### Verification Activities at Commercial Feed Mills and on Farms

Prior to the August 1997 implementation of the feed ban, the CFIA
conducted inspections at feed mills according to the Feeds Act and
regulations. The resulting Inspection Report was a numeric rating device
used to rate the level of compliance to the existing feed regulations.
With the feed ban, the CFIA implemented some changes in their inspection
process to help ensure compliance with the new regulations. This initial
implementation process included the release of the first edition of the
*Mammalian to Ruminant (BSE) Compliance Guide* dated 1997. In addition,
a National Feed and Fertilizer Inspection Workshop was conducted in
November 1997. A Memorandum of Information entitled "Anticipated
Responsibilities of Inspection Staff: Plant Products, Animal Health and
Meat Hygiene Programs", was sent to all inspection personnel. This memo
included background information and definitions, and explained the
CFIA's responsibilities relative to renderers, feed manufacturers,
imported rendered materials and feeds, and livestock producers under the
new regulations.

The *Mammalian to Ruminant (BSE) Compliance Guide* was used during the
initial inspections as a stand alone inspection tool to determine
compliance with the regulation. This guide contained 17 tasks to be
addressed during the audit. This edition provided inspectors with an
explanation of corrective actions to take in the event that they found
products being improperly labeled or mishandled, including holding or
recalling contaminated products.

In March 2000, the *Feed Mill Inspection* *Form* was updated to
incorporate inspection results into the CFIA MCAP database. The form
included tasks to assess compliance with both the Feed Regulations and
Health of Animals Regulations. A total of 46 tasks were to be evaluated
by the inspector. Minor editing changes were made to the inspection
document in December 2001. Then, in October 2002, an updated Commercial
Feed Mill Inspection Report form was released. Although this document
has undergone several revisions it continues to be used to assess a
firm's compliance with requirements from both the Feeds Regulations and
Health of Animals Regulations. The number of tasks that must be
conducted by the CFIA Inspector has increased from 46 to 86. Of those 86
tasks, approximately 13 specifically address the feed ban.

[Training for Inspectors]{.underline}

In September 2002, the first of three modules of a proposed Feed
Inspector Certification Program was released to the inspection staff.
The module was entitled, "Training Modules -- Feed Mill/On-Farm
Inspection" and "Rendering Inspection."

In December 2002, a Feed Ban Traceability Workshop was conducted in
Winnipeg, Manitoba. The Agenda included the following topics: A
Transmissible Spongiform Encephalopathy Overview; Review of the Feed Ban
Regulations; Preparing for On-site; and Preparation of
Reports/Presentations from On-site Tracing. This workshop was held for
Senior Feed Inspectors with the intention of initiating a "Train the
Trainer" process - Trained Senior Feed Inspectors were tasked with
providing training to other field inspectors.

### Program Reviews by the CFIA Feed Inspection Group

In order to ensure program compliance, the CFIA began conducting audits
of the Feed Inspection Program (in 1999). The primary objective of these
audits was to determine whether the delivery of the National Feed
Inspection Program in the specified areas conformed to the established
guidelines. Observations for improvements in the design of the National
Feed Inspection Program were also identified. Final audit reports dating
from March 1999 to March 2002 were reviewed by senior members of the
National Feed Team to determine the level of compliance with program
guidelines. In addition, different areas of Canada were reviewed,
including the Western Area, Atlantic Area, Ontario Area, and Quebec
Area.

The reviews were inclusive of all the feed inspection activities for
both rendering plants and feed mills. The National Feed Team identified
facilities that were noncompliant based on on-site reviews, issued
Corrective Action Reports, and followed up on these facilities. The
findings from these reviews are summarized here:

1.  Mainland-and Interior/Costal Regions, British Columbia -- Western
    Area, March 8-12, 1999. There were no significant issues identified
    in the report.

2.  Final Report Feed Inspection Program, Atlantic Area, October 4-8,
    1999

    a.  Feed mills were not being inspected according to Program 37, one
        mill had not been inspected for over 4 years.

    b.  Some smaller mills had never been inspected.

    c.  The Mammalian to Ruminant Guide was not always completed during
        the feed mill inspections.

3.  Final Audit Report, Feed Inspection Program, Ontario Area, February
    14-18, 2000

    a.  The Mammalian to Ruminant inspections had not been conducted in
        at least 15 commercial feed mills.

    b.  Part 41, on-farm feed mill inspection had not been delivered at
        levels identified in the National Work Plan.

4.  Draft Audit Report, National Rendering Plant Compliance Program,
    Atlantic Area February 18-22, 2002

    a.  No formalized staff training program.

    b.  No process for the formal assessment of the inspector's
        knowledge, skills, and abilities.

    c.  Indicated that not all feed mills still had been inspected.

    d.  No on-farm feed mill inspections for this district where at
        least 19 farms are known to have on-farm feed mill operations.

5.  Audit Report National Rendering Plant Compliance Program, Ontario
    Area, March 4-8, 2002

    a.  No on-farm inspections had been conducted.

6.  Final Audit Report, National Rendering Plant Compliance Program,
    Western Area, March 4-8, 2002. There were no significant issues
    identified in the report.

### Validation of Database Records

The results of inspections performed at rendering plants, feed mills,
and on-farm feed mills have been entered into the CFIA MCAP database
since 2002. The U.S. team reviewed the paper documents of 38
establishments and compared them to the electronic data in order to
verify the authenticity of information and accuracy of data entry. The
information included the tasks that directly addressed the feed ban for
feed mills and rendering plants. The review of these records indicated
that the electronic data accurately reflected what was present on the
hardcopy forms and could be used to perform program verification.

### Summary of Electronic Inspection Reports

The review included records transferred from the MCAP database to excel
files that covered the time period from April 2002 to January 14, 2005
(approximately three years). Tasks specifically identified with the feed
ban were reviewed and included the following:

Rendering Plants -- 18 tasks with a total of 62 standards

Feed Mills -- 13 tasks with a total of 83 standards

On-Farm Mills -- 8 tasks with 62 standards

Each task includes a series of performance standards. In order for a
task to be identified as "Satisfactory" all standards in that task must
be met.

Data for the following number of inspections conducted were indicated by
the data contained in the database:

[Commercial Feed Mills]{.underline}

April 2002 -- March 2003 -- 504^\*^

April 2003 -- March 2004 -- 550

April 2004 -- January 2005 -- 311

^\*^ 162 feed mills were inspected using an older version of the
inspection form and 342 mills were inspected using the current version
of the inspection form.

[Rendering Plants]{.underline}

April 2002 -- March 2003 -- 30

April 2003 -- March 2004 -- 31

April 2004 -- January 2005 -- 8

[On-Farm Feed Mills]{.underline}

A total of 701 on-farm feed mill inspections were conducted during the
past 3 years, 175 in 2003, 347 in 2004, and 179 in 2005. There were a
total of 140 "Unsatisfactory" tasks identified, with the overwhelming
majority pertaining to absence of documented procedures.

#### Commercial Feed Mills 

Overall, there was a low frequency of unsatisfactory ratings for all of
the tasks, especially in the more recent years. The percentage of
inspected facilities that had one or more unsatisfactory tasks was 24.9
percent (85/342) in 2002-2003, 19.6 percent (108/550) in 2003-2004, and
14.8 percent (46/311) in 2004-2005. *(In 2002-2003 162 commercial feed
mills used an earlier edition of the commercial feed mill inspection
form. In that inspection form the tasks evaluated were not necessarily
specific for the feed ban as in some cases they also included
evaluations regarding feed medications and good manufacturing processes
in addition to evaluations for feed ban related issues. For this reason,
even though all feed mills were inspected in each year the 2002-2003
data show only 342 commercial feed mills rather than approximately 550
commercial feed mills. The data are summarized separately below in Chart
B and are not included in the subsequent charts due to differences in
the way the information was supplied.)*

Charts throughout this report show ratings of commercial feed mills
based on task numbers. The focus of each of the tasks is shown in Table
4.

+-----+----------------------------------------------------------------+
| *   |                                                                |
| *Ta |                                                                |
| ble |                                                                |
| 4.  |                                                                |
| I   |                                                                |
| nsp |                                                                |
| ect |                                                                |
| ion |                                                                |
| T   |                                                                |
| ask |                                                                |
| s** |                                                                |
+-----+----------------------------------------------------------------+
| **T | **Task Description**                                           |
| ask |                                                                |
| \   |                                                                |
| #** |                                                                |
+-----+----------------------------------------------------------------+
| **  | Assess adequacy of feed and feed ingredient labels (prohibited |
| 7** | material)                                                      |
+-----+----------------------------------------------------------------+
| **  | Assess adequacy of feed invoices                               |
| 8** |                                                                |
+-----+----------------------------------------------------------------+
| **1 | Assess the adequacy of written procedures and documentation    |
| 3** | for the disposition of returned\* and recalled feeds -         |
|     | "prohibited materials" (\*feeds returned by customers,         |
|     | retailers etc.)                                                |
+-----+----------------------------------------------------------------+
| **1 | Assess the adequacy of written procedures and documentation    |
| 5** | for the disposition of flush or recovered\* materials -        |
|     | "prohibited materials" (\*materials recovered from spillage,   |
|     | dust collectors etc.)                                          |
+-----+----------------------------------------------------------------+
| **6 | Assess the written procedures and records regarding the reuse  |
| 6** | of used packaging (prohibited material)                        |
+-----+----------------------------------------------------------------+
| 1\) |                                                                |
| Ass |                                                                |
| ess |                                                                |
| the |                                                                |
| ad  |                                                                |
| equ |                                                                |
| acy |                                                                |
| of  |                                                                |
| w   |                                                                |
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| ten |                                                                |
| cle |                                                                |
| an- |                                                                |
| out |                                                                |
| p   |                                                                |
| roc |                                                                |
| edu |                                                                |
| res |                                                                |
| and |                                                                |
| p   |                                                                |
| rod |                                                                |
| uct |                                                                |
| ion |                                                                |
| r   |                                                                |
| eco |                                                                |
| rds |                                                                |
|     |                                                                |
| 2\) |                                                                |
| ver |                                                                |
| ify |                                                                |
| t   |                                                                |
| hat |                                                                |
| emp |                                                                |
| loy |                                                                |
| ees |                                                                |
| are |                                                                |
| fol |                                                                |
| low |                                                                |
| ing |                                                                |
| p   |                                                                |
| roc |                                                                |
| edu |                                                                |
| res |                                                                |
| in  |                                                                |
| the |                                                                |
| fol |                                                                |
| low |                                                                |
| ing |                                                                |
| are |                                                                |
| as: |                                                                |
+-----+----------------------------------------------------------------+
| **2 | Receiving equipment                                            |
| 0** |                                                                |
+-----+----------------------------------------------------------------+
| **2 | Ingredient storage and handling equipment                      |
| 4** |                                                                |
+-----+----------------------------------------------------------------+
| **2 | Ingredient processing equipment                                |
| 8** |                                                                |
+-----+----------------------------------------------------------------+
| **3 | Mixing equipment                                               |
| 6** |                                                                |
+-----+----------------------------------------------------------------+
| **4 | Pelleting/extruding equipment (including pellet mill/extruder, |
| 5** | cooler and sifter/shaker                                       |
+-----+----------------------------------------------------------------+
| **5 | Packaging equipment                                            |
| 6** |                                                                |
+-----+----------------------------------------------------------------+
| **7 | Bulk finished feed storage and handling equipment              |
| 6** |                                                                |
+-----+----------------------------------------------------------------+
| **8 | Loading/unloading of bulk delivery vehicles                    |
| 1** |                                                                |
+-----+----------------------------------------------------------------+

Since there was a change in the inspection form that occurred during the
2002-2003 inspection year, the results from the older version of the
form used in 162 commercial feed mills are summarized separately (Chart
B). Again, these tasks being evaluated are not strictly limited to
criteria related to the feed ban.

![](media/image3.wmf)

**Chart B -- The percentage of individual satisfactory or not applicable
tasks for 162 commercial feed mills.**

**\* In the older version of the inspection form these tasks were
evaluated in aggregate.**

Subsequent analyses report on data gathered using the revised inspection
forms over a three year period.

Less than 3 percent of the majority of inspections resulted in an
unsatisfactory rating for each of the tasks in the current year (Chart
C). Task number 8 was most commonly given an unsatisfactory rating.[^1]

Overall, more than 90 percent of the tasks evaluated in each of the past
three years were rated as either satisfactory or they did not apply to
the feed mill. A not applicable rating may be given for a specific task
if the firm does not have the piece of equipment referenced in the task
or if they do not handle prohibited materials. The percentage of
inspections resulting in a satisfactory or not applicable rating has
increased across the three years for almost all tasks.

![](media/image4.wmf){width="6.538194444444445in"
height="2.8131944444444446in"}

**Chart C -- The percentage of individual tasks for the period from 2002
to present that were rated as either satisfactory or not applicable for
the facility. The data for 2002-2003 reflect the findings for the 342
commercial feed mills inspected with the current version of the
inspection form.**

In addition, unsatisfactory tasks are being resolved more quickly over
the past three years, with the average resolution time decreasing from
100 (median = 70 days) to 70.1 (median = 54) days (Chart D). (Since
inspections were on-going at the time of the U.S. team's visit, the
resolution time could not be calculated for the current year.)

![](media/image5.wmf){width="6.122222222222222in" height="2.96875in"}

**Chart D -- The average number of days from the time an unsatisfactory
rating was delivered for a task to the time it was verified as
corrected.**

The percentage of tasks with a rating (not applicable tasks removed)
that were considered unsatisfactory has declined (Chart E).

![](media/image6.wmf){width="6.5368055555555555in"
height="4.468055555555556in"}

**Chart E -- The percentage of individual task rated as unsatisfactory
from 2003 to present. Inspections where the task was considered not
applicable were removed. The data for 2002-2003 reflect the findings for
the 342 commercial feed mills inspected with the current version of the
inspection form.**

The proportion of commercial feed mills with at least one unsatisfactory
task has declined over the 3 year period to the current level of 14.8
percent (Chart F). During the years of 2003-2004 and 2004-2005
approximately one-third of these feed mills received unsatisfactory
ratings because they omitted part or all of the buyer information (name
and address), or the name of the feed on some of the sales invoices, or
because they were putting the cautionary statement, "Do not feed to
cattle, sheep, deer or other ruminants" on feeds that did not contain
prohibited material. Many of the unsatisfactory ratings for the
remaining feed mills with unsatisfactory ratings were related to needed
improvements for record-keeping and documentation of procedures. In some
cases, the feed mill management may have viewed these procedures as
general policy for the mill and therefore, found it unnecessary to
document. For example, a feed mill may have a policy to not reuse
packaging materials. If there is not a written procedure documenting how
used packaging materials are handled, the feed mill would have received
an unsatisfactory rating for that task. Since commercial feed mills that
handle prohibited materials and manufacture ruminant feeds are evaluated
on many more tasks (fewer tasks are not applicable) there are more
opportunities for these feed mills to have an unsatisfactory task. These
feed mills were approximately twice as likely to have an unsatisfactory
task as all commercial feed mills.

**Chart F -- The number and percentage of commercial feed mills where at
least one unsatisfactory task was identified compared to the number of
total number of commercial feed mills inspected. Data for 2002-2003
include feed mills inspected using both versions of the form.
Inspections for 2004-2005 have not yet been completed.**

When an unsatisfactory rating was given on any task the feed mills were
given a period of time to develop a corrective action plan. In some
cases the corrective action was made immediately. In other cases the
corrective action took some time to implement. In any case, once the
corrective action was reported to be complete by the feed mill the
inspector re-inspected the facility to confirm the actions resolved the
issue. The data show a small number of instances where the
unsatisfactory rating was not resolved (Chart G). Given that inspections
are on-going for 2005, it is expected that there will be unresolved
unsatisfactory ratings as sufficient time may not have elapsed to
perform the corrective action or to verify their completion. It is
unclear from the database if the unresolved tasks from the 2002-2003 and
2003-2004 years really represent issues that remained unresolved or if
they represent inattention to record-keeping and the closure of the
identified issues. The CFIA plans to address this issue in their audit
of the feed ban.

![](media/image7.wmf){width="6.376388888888889in"
height="3.9583333333333335in"}

**Chart G -- The number of commercial feed mills audited with tasks that
did not have a resolution date. Data from 2002-2003 include feed mills
inspected using both versions of the form.**

**System used in the U.S. to evaluate feed ban compliance**

U.S. inspections are conducted by FDA or State investigators and are
classified to reflect the compliance status at the time of the
inspection, based upon the objectionable conditions documented. These
inspection conclusions are reported as OAI, VAI, or NAI.

An OAI inspection classification occurs when significant objectionable
conditions or practices are identified and regulatory sanctions are
warranted in order to address the establishment\'s lack of compliance
with the regulation. An example of an OAI inspection classification
would be findings of manufacturing procedures insufficient to ensure
that ruminant feed is not contaminated with prohibited material.
Inspections classified with OAI violations will be promptly re-inspected
following the regulatory sanctions to determine whether adequate
corrective actions have been implemented.

A VAI inspection classification occurs when objectionable conditions or
practices identified do not meet the threshold of regulatory
significance, but do warrant advisory actions to inform the
establishment of findings that should be voluntarily corrected.
Inspections classified with VAI violations are more technical violations
of the Ruminant Feed Ban. These include provisions such as minor
record-keeping lapses and conditions involving non-ruminant feeds.

A NAI inspection classification occurs when no objectionable conditions
or practices are identified during the inspection or the significance of
the documented objectionable conditions identified do not justify
further actions.

**Results as scored using the U.S. system**

Given the differences between the CFIA's inspection program and the
FDA's inspection program, it is difficult to make a direct comparison
between deviations from the Canadian regulations found in Canadian
facilities, and deviations from the U.S. regulations found in facilities
in the United States. Nevertheless, the team felt it would be
informative to try to evaluate the CFIA's inspection findings using the
same scoring system that the FDA uses.

We attempted to score each unsatisfactory task in the MCAP database
using criteria for classifying inspection findings as found in the FDA
Compliance Program Guidance Manual (CPGM) 7371.009 "BSE/Ruminant Feed
Ban Inspections" for guidance in classifying these tasks. The CPGM
contains some specific guidance on classifying inspectional findings
that deviate from the U.S. regulations. Differences in the way
inspections are conducted and documented in the United States and
Canada, as well as the small amount of information the database
contained about some of the unsatisfactory tasks made scoring the
Canadian findings difficult in some cases. The team was not able to have
some of the inspection results from Quebec translated from French to
English quickly enough to be included in this report. Additionally, some
tasks that had been scored as unsatisfactory were found to be unrelated
to the feed ban. The lines of data recorded in French, as well as the
lines which contained comments unrelated to the feed ban, are contained
in the "undetermined" column below (Table 5).

Finally, the FDA classifies the firm based on the outcome of the entire
inspection, not on the individual elements or tasks that make up the
inspection. We did not have the entire inspection report from each firm
to use for our evaluation, so we scored each unsatisfactory task
individually, then evaluated composite results for each firm. Feed mills
with one or more unsatisfactory task that was scored OAI was then
classified as an OAI facility. In the absence of any OAI unsatisfactory
task, if a facility had one or more VAI unsatisfactory task then the
facility was designated as a VAI facility.

Based on this method of evaluating the data, and considering the
caveats, the percent of all feed milling facilities found in OAI status
at the time of the inspection was 5.8 percent, 1.0 percent, and 3.8
percent for the recent three years of inspections (Table 5).

  --------------- ------------- ------------- -------------- ----------------- ------------------- --------- --------- -----------------
  **Table 5.                                                                                                           
  Commercial Feed                                                                                                      
  Mill Inspection                                                                                                      
  Results**                                                                                                            

  **Year**        **Feed Mills  **Tasks       **Tasks        **Feed Mills with **Unsatis-factory   **Feed    **Feed    ***Undetermined
                  Inspected**   Evaluated**   Applicable**   Unsatis-factory   Tasks**             Mills     Mills     tasks\****
                                                             Tasks**                               with at   with at   
                                                                                                   least one least one 
                                                                                                   FDA OAI** FDA VAI** 

  2002-2003\*\*   342           4446          1482           85                291                 20 / 5.8% 51 /      *45*
                                                                                                             14.9%     

  2003-2004       550           7150          1714           108               253                 6 / 1.0%  73 /1.2%  *58*

  2004-2005       311           4043          1135           46                99                  12 / 3.8% 22 / 7.0% *39*
  --------------- ------------- ------------- -------------- ----------------- ------------------- --------- --------- -----------------

\* Unsatisfactory tasks that FDA was unable to classify.

\*\* Using data from the current version of the inspection form.

#### Rendering Plants

Overall, the percentage of tasks rated as satisfactory or not applicable
increased substantially over 2002-2003 levels (Chart H).

![](media/image8.wmf){width="5.25in" height="2.3333333333333335in"}

**Chart H -- The percentage of feed ban related tasks rated as
satisfactory.**

The percentage of rendering plants had one or more unsatisfactory task
ratings has declined from 23 percentage in 2002-2003 to 12.5 percentage
in 2004-2005 (Chart I). Most of the unsatisfactory tasks related to a
need to improve record--keeping and written procedures.

![](media/image9.wmf){width="5.9375in" height="2.6458333333333335in"}

**Chart I -- The number of rendering plants where at least one task
related to the feed ban that was identified as unsatisfactory.**

As with the feed mill inspections, when a task is rated as
unsatisfactory, the rendering facilities are given a period of time to
correct the problem, and are then re-inspected to confirm the
resolution. When the issue has been resolved, a resolution date is
assigned. Over the three years of inspections in some cases the
renderers have had unsatisfactory tasks that are shown in the database
as unresolved (Chart J). Unresolved tasks are expected for the 2004-2005
year as there has not been sufficient time for the facilities to address
all of the issues. Again, it is unclear if the unresolved unsatisfactory
tasks represent issues that were truly unresolved or if they represent
lack of follow through to update the MCAP database.

![](media/image10.wmf){width="5.895833333333333in"
height="2.7333333333333334in"}

**Chart J -- The number of renderers with unresolved unsatisfactory
tasks.**

**Rendering plant results as scored using the U.S. system**

As was done with the feed mills, the U.S. audit team thought it would be
informative to score the rendering plant inspection results according to
the system used by the FDA. Again, given the differences between the
CFIA's inspection program and the FDA's inspection program, it is
difficult to make a direct comparison between inspection results from
the two countries.

In order to handle the rendering plant inspection data in a manner
consistent with the feed mill data, we attempted to score each
unsatisfactory task in the MCAP database using FDA CPGM 7371.009 for
guidance. There were far fewer rendering plant inspection records in the
database than there were records for commercial feed mill inspections. A
number of the explanatory comments were in French and could not be
translated in time for this analysis. In looking at the results of 60
inspections over three years that could be used, there were only two
inspections, both conducted in 2002-2003, that would be classified as
OAI by the FDA criteria.

#### On-Farm Feed Mills

A review of the on-farm inspection data indicated that the majority of
the tasks pertaining to the feed ban were considered to be not
applicable. Of the total number of tasks reviewed during the audits
(n=5610), the majority (n=5091) did not apply; only 519 tasks
specifically addressed the feed ban issues. In all years, a high
percentage of the tasks (approximately 97 percent) were rated as
satisfactory or were not applicable. The overwhelming majority of
unsatisfactory tasks pertained to a lack of documented standard
operating procedures.

![](media/image11.wmf){width="6.536111111111111in" height="3.06875in"}

**Chart K -- The percentage of individual tasks rated as either
satisfactory or not applicable.**

# Summary of the On-Site Inspection Review

The U.S. team accompanied the CFIA inspectors to seven commercial feed
mills and three rendering facilities. These particular firms were
selected for the site visits because they process and distribute feed or
feed ingredients containing prohibited material, and because these firms
are distributed over a wide geographic area across three Canadian
provinces. The objectives of the U.S. team's on-site visits were to
observe the CFIA's inspection process, assess CFIA's enforcement of the
feed ban regulations, and evaluate industry compliance with Canada's
feed ban.

Prior to the visits, the CFIA contacted the facilities to arrange a time
for the inspection, to assure that the personnel that needed to
represent the firm on-site would be present at the inspection, and to
minimize the time required to retrieve historical records. The
facilities were asked to collect records for two specified dates in 2003
and two specified dates in 2004. While at the facilities, the team
requested records from two additional dates for review. Production
records and standard operating procedures were reviewed, and a tour of
each facility was conducted to evaluate if the procedures were being
followed. Employees in several areas of each facility were interviewed
to determine their familiarity with the operating procedures relative to
the feed ban.

Inspection forms provided by the CFIA were used to rate each facility on
each of the described tasks (Appendices 2-4). In most cases the tasks
required a verbal response by the facility manager or an employee, as
well as a review of records or written documentation of operating
procedures. Rarely did the field inspector have their rating for a task
changed by the CFIA headquarters representative. The inspectors
demonstrated a strong knowledge of the feed industry, feed manufacturing
processes, and requirements of the Animal Health Regulations and Feeds
Regulations as they pertain to feed ban. The inspectors were well
prepared with the latest edition of the task checklist, and a copy of
the findings from the previous inspection, in order to compare changes
in activity and identify and evaluate compliance with Canada's feed ban.

## Commercial Feed Mills

Overall, for the seven commercial feed mills 90 percent of the tasks
received a satisfactory rating. However, six of the feed mills received
one or more unsatisfactory task ratings. Three of the feed mills had a
single unsatisfactory task and one feed mill had two unsatisfactory
tasks. The other feed mills had three and five unsatisfactory tasks.
Most of the tasks rated "unsatisfactory" related to record-keeping
issues (duration of records retention, completeness of invoice
information) or deficiencies in written standard operating procedures
(lack of complete documentation for current practices). Specific
examples include one feed mill in which invoices for cash sales lacked
buyer information (the only unsatisfactory task for this feed mill),
another mill did not have production records available for the full two
year history as required (resulting in four of the five unsatisfactory
tasks for this feed mill), and another feed mill listed "meat meal" on
their master formulas and batch sheets instead of "prohibited meat meal"
as required (resulting in two unsatisfactory tasks for this feed mill).
However, inspection findings in two mills were considered more serious.
One finding was for a historical issue that was corrected in 2003. A
review of historical production records at one mill showed that after a
batch of poultry feed containing prohibited material was processed on
January 31, 2003, no flush or other cleanout procedures were used before
processing a batch of soybean meal. The feed mill should have used
cleanout procedures or else labeled the soybean meal with the required
cautionary statement (Do not feed to cattle, sheep, deer or other
ruminants), even though the soybean meal was destined for a hog farm to
be used in swine feed. This deficiency had been previously identified
during a January 15, 2003 CFIA inspection, but had not been corrected
until February 24, 2003. Production records from March 27, 2003 showed
that revised standard operating procedures requiring a flush between
batches were being correctly followed. No further incidents were noted
in subsequent records reviewed.

While reviewing production records at another feed mill, the inspector
identified one instance where a flush was not recorded between a batch
of poultry feed containing prohibited material and a batch of cattle
feed. The flush is normally executed automatically by the computerized
batch mixing system. The plant management's tentative assessment was
that in this particular case, the operator may have changed to manual
mode in order to deal with an equipment problem. The CFIA requested that
the plant investigate the incident further and report its findings to
CFIA. In addition, CFIA inspectors returned to the feed mill two days
later to check production records for other instances where the feed
mill failed to perform a required flush. The plant's investigation
concluded that the batch mixing system had in fact been switched to
manual mode in order to deal with an equipment problem. A manual flush
was not performed when the equipment was brought back on-line. The CFIA
has required the feed mill to develop a corrective action plan to
preclude future similar occurrences. CFIA is also considering additional
enforcement action in this case.

Other than these situations, most of the issues identified required only
minor modifications to existing written procedures and forms, or
involved improvement in record maintenance or record retention time.

The U.S. team also noted that at several of the feed mills, haulers
delivering feed ingredients to the mill were required to sign an
affidavit that the previous load of material they had hauled did not
contain prohibited material. In addition, when trucks were being loaded
with finished feeds at the feed mills, most of those mills visited
routinely inspected the interior of the trucks to assure there was not
residual feed that could contaminate the feed products being loaded.

## Rendering Plants

Among the three rendering facilities visited, two plants had one or more
tasks rated as unsatisfactory. One unsatisfactory rating was for failure
to keep a log of errors that had occurred in processing. The other
unsatisfactory rating was due to the need for a standard operating
procedure to be written that would require an external truck operator to
sign-off that the truck had been cleaned if it had previously hauled
prohibited material and was not going to haul non-prohibited material.
All three rendering firms were aware of the requirements to comply with
the feed ban and used a combination of dedicated facilities, flushing,
and other procedures to decrease the risk of cross-contamination. When
there is cross-utilization of equipment in the rendering facilities, it
appears that the amount of equipment used for both prohibited and
non-prohibited material is minimized. For example, in one facility only
the cooker was cross-utilized, while in another facility only the
load-out equipment was used for both types of products. For the cooker
that was cross-utilized, a flush of one hour production (approximately
6250 kg) of non-prohibited material is currently being diverted into the
bin with the prohibited material to prevent carryover contamination of
non-prohibited material. All three rendering plants had good standard
operating procedures to meet feed ban requirements, and good
documentation of these procedures. In each inspection, minor corrections
were needed, mostly concerning clarifications to the firm's standard
operating procedures, or reformatting existing record forms to provide
additional information. The inspectors discussed these issues with firm
management and firm management committed to making changes. In many
cases, these changes were above and beyond what is required by the
regulations. As was the case with the feed mill inspections, the CFIA
inspectors were thorough, and possessed the skills necessary to help
ensure compliance with the Canadian feed ban. Inspectors demonstrated
good working knowledge of the inspection process and good familiarity
with the feed and rendering industries.

## Feed Testing Laboratory

The U.S. team visited the CFIA's Ottawa Laboratory of the Bioanalysis
Unit, Feed and Fertilizer Section, to determine the extent to which feed
testing is used to enforce Canada's feed ban. Part of the reason for the
U.S. visit was because the CFIA's pilot program, to evaluate the
usefulness of feed microscopy as a feed ban enforcement tool, was the
subject of recent news reports. These reports featured two consumer
groups who claimed that test results on feed samples collected between
January and March 2004, obtained through the Access to Information Act,
raised doubt regarding the effectiveness of Canada's feed ban.

During their visit, the U.S. team found that the Ottawa Laboratory is
well equipped for feed microscopy, and has experienced analysts. For
over ten years the lab has routinely used feed microscopy on complaint
samples to test for contaminants, extraneous and/or injurious material,
unlabeled ingredients, and noxious weed seeds. Feed microscopy also
evaluates the presence of insects, mold, dust, and heat damage. The
laboratory maintains an extensive computer reference library of
photomicrographs of hair, muscle, and bone from a large number of animal
species. The laboratory also maintains a reference collection of these
tissues mounted on microscope slides, as well as a reference collection
of vials of feed and feed ingredients of interest.

During the U.S. team's visit to Canada, the CFIA completed a report on
the analytical results of the 110 feed samples that had been mentioned
in media reports. The report also provided results of follow-up
investigations at establishments where feeds that tested positive for
animal proteins had been processed. The CFIA has posted a copy of the
report to their website.

According to their report, the CFIA concluded that limitations of the
feed microscopy method outweigh its utility as a feed ban enforcement
tool. In the United States, the FDA acknowledges that this analytical
method has some limitations. Feed microscopy can reliably detect the
presence of bone, hair, and muscle, but cannot reliably determine the
animal species of origin. Therefore, feed microscopy alone is usually
not sufficient to determine if feed contains prohibited material. The
FDA uses feed microscopy on a limited basis to test domestic feed.
Follow-up investigations at feed manufacturers and distributors are
needed before a determination can be made that positive samples contain
prohibited material. Both the United States and Canada are evaluating
polymerase chain reaction analysis, commercially available test kits
using enzyme-linked immunoassay technology, and combinations of these
methods in an effort to find a test protocol that can reliably detect
prohibited material in feed.

# Conclusions

The Canadian feed ban is not substantially different than the U.S. feed
ban. Both feed bans prohibit the use of mammalian protein in ruminant
feeds, with exceptions for milk products, blood products, gelatin, and
protein derived solely from porcine or equine sources. Two minor
differences between U.S. and Canadian feed regulations are that the
United States allows plate waste and poultry litter to be used in
ruminant feed, whereas Canadian feed regulations make no such
allowances. The inspection program in Canada is administered by the CFIA
without significant involvement by the Provincial governments, in
contrast to the United States where the FDA and States work
cooperatively.

Shortly after the feed ban was first proposed in 1996, the CFIA began
educating the feed industry, livestock producers, and their own
inspection force about the impending regulations. Although the Canadian
feed ban became effective on August 4, 1997, full implementation was a
stepwise process. The feed ban allowed a short phase-in period for the
feed industry to deplete their existing product supplies and begin to
conform to labeling and record-keeping requirements. As in the United
States, there was no systematic recall of feeds already in marketing
channels or on farms that may have been affected by the regulation. From
1997 to 2000, the CFIA continued to educate, but also continued to
conduct inspections to bring the feed industry into compliance with the
feed ban. Rendering facilities were required to pass an annual
inspection before renewing their permit to operate from 1998 onward. In
2000 and 2001, the CFIA modified its compliance programs by increasing
the frequency of inspections of commercial feed mills from once every
three years to every year, and continuing the annual inspection and
permitting of all rendering facilities. Since 2002, the CFIA has been
conducting annual inspections of all rendering and commercial feed mill
facilities and some ruminant feeders and retail feed distributors.
Similar to the approach used in the United States, the CFIA made the
most efficient use of resources by focusing their efforts to implement
the feed ban at the feed manufacturing level, rather than at the farm
level. The feed industry has also taken aggressive steps to comply with
the feed ban. For example, approximately one-third of the commercial
feed mills (producing at least 60 percent of the feed produced in
commercial mills) have become HACCP-certified through a program of the
Animal Nutrition Association of Canada. Under this program feed mills
have incorporated elements of the feed ban into their HACCP plan,
including training employees, developing standard operating procedures,
and maintaining appropriate records.

The U.S. team's review of electronic records for the inspection and
compliance program showed that some feed mills and rendering plants were
not fully compliant with the requirements of the feed ban. Thirteen
inspection tasks out of the 86 tasks that make up a full commercial feed
mill inspection are related to feed ban requirements. Plants are scored
as satisfactory on a task only if they meet every subtask requirement.
In the event of an unsatisfactory rating on any of the tasks, the
facility management is required to provide the inspection staff, within
a specified period of time, with a corrective action plan. The
inspectors then must verify that the corrective action has been taken.
In the records reviewed, most unsatisfactory ratings on individual tasks
were for documentation problems. Most of these unsatisfactory ratings
were related to record-keeping issues such as not retaining the
purchaser name and address, or for incomplete written documentation of
operating procedures. The percentage of commercial feed mills in Canada
that had unsatisfactory ratings on individual tasks has declined from
24.9 percent (85/342) in 2002-2003 to 14.8 percent (46/311) in
2004-2005.

Based on scoring of the facilities in a manner similar to that used by
the FDA to score U.S. facilities 5.8 percent, 1.0 percent, and 3.8
percent would have been classified as having an OAI respectively for the
years of 2002-2003, 2003-2004, and 2004-2005.

During the site visits, the U.S. team found a higher proportion of
facilities that had unsatisfactory ratings for individual tasks than was
seen in the overall historical records. Most of these cases were the
result of record-keeping deficiencies or the lack of fully documented
standard operating procedures.

The Canadian feed ban provides protection against the spread of BSE in
the Canadian cattle population. Although appropriate safeguards are in
place and are effectively enforced, the potential for
cross-contamination at facilities that handle prohibited material and
also process ingredients for ruminant feed is always a concern. There
has been a movement toward dedicated processing lines in the rendering
facilities or fully dedicated facilities. Also, since the feed ban's
inception in 1997, the industry has moved toward dedicated feed
manufacturing facilities, such that fewer commercial feed mills handle
prohibited material and manufacture feeds for ruminants. In addition,
the CFIA has proposed to remove SRM from all animal feed, which will
significantly reduce the risks associated with cross-contamination, and
also address risk associated with on-farm mis-feeding.

The CFIA has not been able to dedicate extensive resources to evaluating
on-farm feed manufacturing or feeding practices to determine the level
of compliance with the feed ban. Instead, an educational approach has
been used to encourage the appropriate handling of feeds that contain
prohibited material. These efforts, along with those aimed at preventing
cross-contamination and providing adequate labeling of feeds containing
prohibited material, are meant to decrease the likelihood of inadvertent
exposure of ruminants to prohibited material.

The CFIA continues to revise and update their procedures and processes
to further enhance the effectiveness of the feed ban. Based on the
results of the current Canadian audit, the CFIA intends to revise some
of the inspection forms to increase the objectivity of the standards,
and carry out additional training for the inspectors to improve
standardization in the inspection rating process. The CFIA will also
make adjustments to the program to continue to improve compliance with
the feed ban. Moreover, inspectors performing reviews for the program
are full-time agency personnel. These employees are provided the most
current information and tools, ongoing individual training, and direct
supervision by CFIA management personnel. In addition, the CFIA has
proposed the complete removal of SRM from animal feeds. Recognizing that
there are opportunities for cross-contamination to occur along the feed
manufacturing chain, on December 10, 2004, Canada proposed new
regulations to further enhance the effectiveness of the feed ban.

The Canadian government, feed industry, and livestock producers have
substantially increased their efforts to implement and comply with the
Canadian feed ban. Based on the U.S. team's review of the inspection
records for the past three years and on-site inspections of a sampling
of commercial feed mills and rendering facilities, it is evident that
considerable effort is being dedicated in all sectors to carry out the
intent of the Canadian feed ban. It is the U.S. team's determination
that these efforts have reduced the risk of transmission of the BSE
agent in feed to ruminant animals.

# Appendix 1 --- Feed Ban Rule {#appendix-1-feed-ban-rule .Appendix-1}

PART XIV

FOOD FOR RUMINANTS, LIVESTOCK AND POULTRY

*Prohibited Material*

[**162.**](http://laws.justice.gc.ca/fr/H-3.3/C.R.C.-ch.296/152189.html#article-162)
(1) In this Part, \"prohibited material\" means anything that is, or
that contains any, protein that originated from a mammal, other than a
porcine or an equine. It does not include milk, blood, gelatin, rendered
animal fat or their products.

\(2\) Prohibited material that has been treated in a manner approved by
the Minister to inactivate the agents that cause transmissible
spongiform encephalopathies is no longer prohibited material.
SOR/97-362, s. 4.

[**163.**](http://laws.justice.gc.ca/fr/H-3.3/C.R.C.-ch.296/152189.html#article-163)
(1) A person who identifies prohibited material by means of adding to it
a marker or tracer substance that has been approved by the Minister in
the manner specified in that approval, is not required to keep the
records referred to in subsections 165(2) and 166(2) and section 171.

\(2\) Every person who identifies prohibited material in accordance with
subsection (1) shall maintain a record of the manner in which the marker
or tracer substance was added to the prohibited material. SOR/97-362, s.
4.

*Feeding Prohibited Material to a Ruminant.*

[**164.**](http://laws.justice.gc.ca/fr/H-3.3/C.R.C.-ch.296/152189.html#article-164)
No person shall feed prohibited material to a ruminant. SOR/97-362, s.
4.

*Rendering Plants*

[**165.**](http://laws.justice.gc.ca/fr/H-3.3/C.R.C.-ch.296/152189.html#article-165)
(1) No person shall operate a rendering plant unless the person does so
under and in accordance with a permit issued pursuant to section 160.

\(2\) Every person who operates a rendering plant shall keep a record of

(*a*) the date of production of all products of the rendering plant;

(*b*) whether or not any product of the rendering plant is, or contains
any, prohibited material;

(*c*) the name, and quantity of, and any other information that is
sufficient to identify, the products of the rendering plant; and

(*d*) the name and address of any person to whom any product of the
rendering plant is distributed or sold and the information referred to
in paragraph (*c*) with respect to that product.

\(3\) No person who operates a rendering plant shall distribute or sell
any product of a rendering plant that contains prohibited material
unless the documentation required by these Regulations relating to the
product and any label on any packaging or container containing the
product is marked conspicuously, legibly and indelibly with a statement
approved by the Minister that indicates that the product shall not be
fed to ruminants. SOR/97-362, s. 4.

*Importation of Products of Rendering Plants*

[**166.**](http://laws.justice.gc.ca/fr/H-3.3/C.R.C.-ch.296/152189.html#article-166)
(1) No person shall import any product of a rendering plant unless the
person does so under and in accordance with a permit issued pursuant to
section 160.

\(2\) Every person who imports or has the possession, care or control of
any product of a rendering plant shall keep a record of

(*a*) the name and address of the rendering plant and the date of
production of the product;

(*b*) the name and address of the exporter;

(*c*) the name and quantity of, and any other information that is
sufficient to identify, the product;

(*d*) the name and address of any person to whom any product is
distributed or sold and the information referred to in paragraph (*c*)
with respect to that product; and

(*e*) whether or not the product is, or contains any, prohibited
material. SOR/97-362, s. 4.

*Importation or Sale of Products of Rendering Plants*

[**167.**](http://laws.justice.gc.ca/fr/H-3.3/C.R.C.-ch.296/152189.html#article-167)
No person who imports or has the possession, care or control of a
product of a rendering plant shall sell or distribute the product unless
the documentation required by these Regulations relating to the product
and any label on any packaging or container containing the product is
marked conspicuously, legibly and indelibly with the statement referred
to in subsection 165(3). SOR/97-362, s. 4.

*Food and Food Ingredients*

[**168.**](http://laws.justice.gc.ca/fr/H-3.3/C.R.C.-ch.296/152189.html#article-168)
No person shall import, manufacture, package, label, store, distribute,
sell or advertise for sale any animal food for ruminants that contains
prohibited material. SOR/97-362, s. 4.

[**169.**](http://laws.justice.gc.ca/fr/H-3.3/C.R.C.-ch.296/152189.html#article-169)
No person shall import, manufacture, package, store, distribute, sell or
advertise for sale any animal food for equines, porcines, chickens,
turkeys, ducks, geese, ratites or game birds that contains prohibited
material unless the documentation required by these Regulations relating
to the animal food and any label on any packaging or container
containing the animal food is marked conspicuously, legibly and
indelibly with a statement approved by the Minister that indicates that
the animal food shall not be fed to ruminants. SOR/97-362, s. 4.

**170.** (1) No person shall have any prohibited material or anything,
including an animal food for equines, porcines, chickens, turkeys,
ducks, geese, ratites or game birds, that contains prohibited material
on the same premises or in the same conveyance as a product of a
rendering plant that does not contain prohibited material or any animal
food for ruminants, without having procedures to prevent the mixing or
contamination of the rendering plant product or animal food for
ruminants, with prohibited material.

\(2\) In a case referred to in subsection (1), the person shall

(*a*) ensure that the procedures are followed from the time the product
or animal food is received until it leaves their possession, care or
control; and

(*b*) keep records to establish that the procedures were followed.

\(3\) If a person fails to follow the procedures required by subsection
(1),

(*a*) the person shall change the records to show that all of the
product or animal food is prohibited material and any label on any
packaging or container containing the product or animal food shall be
marked conspicuously, legibly and indelibly with a statement approved by
the Minister that indicates that the product or animal food shall not be
fed to ruminants; and

(*b*) all of the product or animal food shall be considered to be
prohibited material for the purposes of section 164. SOR/97-362, s. 4.

*Records*

[**171.**](http://laws.justice.gc.ca/fr/H-3.3/C.R.C.-ch.296/152189.html#article-171)
(1) Every person who manufactures animal food for ruminants, equines,
porcines, chickens, turkeys, ducks, geese, ratites or game birds shall
keep records that contain

(*a*) the formula for the animal food, including the name and weight of
each ingredient used for each lot of the animal food;

(*b*) a mixing sheet that shows that each lot of the animal food has
been produced in accordance with the formula referred to in paragraph
(*a*);

(*c*) information as to whether or not the animal food contains any
prohibited material;

(*d*) the date of preparation of the animal food;

(*e*) any information used to identify each lot of animal food; and

(*f*) the name and address of any person to whom any animal food is
distributed or sold and a description of the food, including the name
and quantity.

\(2\) Every person who imports, packages, stores, distributes, sells or
advertises for sale animal food for ruminants, equines, porcines,
chickens, turkeys, ducks, geese, ratites or game birds shall keep
records that contain

(*a*) the name or other information used to identify the animal food;

(*b*) 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

(*c*) information as to whether or not the animal food contains any
prohibited material.

\(3\) Every person who owns or has the possession, care or custody of a
ruminant shall keep copies of all invoices for animal food that contains
prohibited material. SOR/97-362, s. 4.

# Appendix 2 --- Inspection Form for Commercial Feed Mills (tasks related to feed ban)Number range CHAPTER![](media/image12.wmf){width="1.5in" height="0.7055555555555556in"} {#appendix-2-inspection-form-for-commercial-feed-mills-tasks-related-to-feed-bannumber-range-chapter .Appendix-1}

***Information may be accessible or protected as required under the
provisions of the Access to Information Act.***

***Copy to: Feed Review Team***

***Area Operations Contact***

***Feed Program Specialist***

**PART I - OPENING MEETING**

**At the outset of the inspection, inspectors will conduct an opening
meeting with management to explain the purpose of this review activity
and answer any questions (see Attachment I for additional information).
At the same time, the inspector should, with the help of management
collect the tombstone information on the facility.**

+--------------------------------+-------------------------------------+
| **GENERAL INFORMATION**        |                                     |
+--------------------------------+-------------------------------------+
| Type of Facility \[ \] Single  |                                     |
| Species Commercial Feed Mill   |                                     |
|                                |                                     |
| > \[ \] Multi-species          |                                     |
| > Commercial Feed Mill         |                                     |
+--------------------------------+-------------------------------------+
| Date of Inspection:            | Date of Last Inspection:            |
+--------------------------------+-------------------------------------+
| MCAP Client Code (if           | Inspector:                          |
| available):                    |                                     |
+--------------------------------+-------------------------------------+
| Name, Address, Phone/Fax       |                                     |
| Number of Feed Mill (should be |                                     |
| identical to information in    |                                     |
| MCAP system):                  |                                     |
+--------------------------------+-------------------------------------+
| Manager's Name:                | Nutritionist(s) Name(s):            |
+--------------------------------+-------------------------------------+
| After Hours Contact            |                                     |
| (Name/Phone #):                |                                     |
+--------------------------------+-------------------------------------+

+--------------------------------+-------------------------------------+
| **PRODUCTION INFORMATION**     |                                     |
+--------------------------------+-------------------------------------+
| Total Feed Produced/Year       |                                     |
| (tonnes):                      |                                     |
+--------------------------------+-------------------------------------+
| Bulk Feed Produced/Year        | Bagged Feed Produced/Year (tonnes): |
| (tonnes):                      |                                     |
+--------------------------------+-------------------------------------+
| Medicated feed produced/year   | Non-medicated feed produced/year    |
| (tonnes):                      | (tonnes):                           |
+--------------------------------+-------------------------------------+
| Animal Feeds Produced (check   |                                     |
| all that apply):               |                                     |
+--------------------------------+-------------------------------------+
| \[ \] Beef \[ \] Buffalo       |                                     |
|                                |                                     |
| \[ \] Dairy \[ \] Deer         |                                     |
|                                |                                     |
| \[ \] Ducks \[ \] Elk          |                                     |
|                                |                                     |
| \[ \] Geese \[ \] Game Birds   |                                     |
|                                |                                     |
| \[ \] Goats \[ \] Ratites      |                                     |
| (e.g., ostrich, emu)           |                                     |
|                                |                                     |
| \[ \] Horses \[ \] Other       |                                     |
| (please specify)               |                                     |
|                                |                                     |
| \[ \] Laying Hens              |                                     |
|                                |                                     |
| \[ \] Meat Chickens            |                                     |
|                                |                                     |
| \[ \] Rabbits                  |                                     |
|                                |                                     |
| \[ \] Sheep                    |                                     |
|                                |                                     |
| \[ \] Swine                    |                                     |
|                                |                                     |
| \[ \] Turkeys                  |                                     |
+--------------------------------+-------------------------------------+
| **USE OF PROHIBITED            |                                     |
| MATERIALS**                    |                                     |
+--------------------------------+-------------------------------------+
| Does this facility receive     |                                     |
| feeds that contain "prohibited |                                     |
| materials"?                    |                                     |
|                                |                                     |
| > \[ \] Yes \[ \] No           |                                     |
+--------------------------------+-------------------------------------+
| Does this facility manufacture |                                     |
| feeds that contain "prohibited |                                     |
| materials"?                    |                                     |
|                                |                                     |
| > \[ \] Yes \[ \] No           |                                     |
+--------------------------------+-------------------------------------+
|                                |                                     |
+--------------------------------+-------------------------------------+

+------------------+---+------------------------------------------------+
| Is this facility |   |                                                |
| in compliance    |   |                                                |
| with all         |   |                                                |
| requirements of  |   |                                                |
| the Health of    |   |                                                |
| Animal           |   |                                                |
| Regulations      |   |                                                |
| respecting the   |   |                                                |
| ban on the       |   |                                                |
| feeding of       |   |                                                |
| mammalian        |   |                                                |
| tissues to       |   |                                                |
| ruminant         |   |                                                |
| animals?         |   |                                                |
|                  |   |                                                |
| \[ \] Yes \[ \]  |   |                                                |
| No               |   |                                                |
|                  |   |                                                |
| If No, please    |   |                                                |
| list all related |   |                                                |
| tasks which were |   |                                                |
| non-compliant at |   |                                                |
| the time of the  |   |                                                |
| initial          |   |                                                |
| inspection:      |   |                                                |
|                  |   |                                                |
| **Note: All      |   |                                                |
| non-compliant    |   |                                                |
| tasks must be    |   |                                                |
| addressed by     |   |                                                |
| feed mill        |   |                                                |
| management in a  |   |                                                |
| timely**         |   |                                                |
|                  |   |                                                |
| **manner to      |   |                                                |
| fully achieve    |   |                                                |
| compliance.**    |   |                                                |
+------------------+---+------------------------------------------------+
| **FEED           |   |                                                |
| INGREDIENTS**    |   |                                                |
+------------------+---+------------------------------------------------+
| **Indicate each  |   |                                                |
| of the following |   |                                                |
| feed ingredients |   |                                                |
| that is used in  |   |                                                |
| the manufacture  |   |                                                |
| of feeds in this |   |                                                |
| facility**       |   |                                                |
|                  |   |                                                |
| **Note: Salvaged |   |                                                |
| pet food is not  |   |                                                |
| approved for use |   |                                                |
| as a livestock   |   |                                                |
| feed             |   |                                                |
| ingredient.**    |   |                                                |
+------------------+---+------------------------------------------------+
| **Salvaged Pet   |   | **Porcine Meat and Bone Meal**                 |
| Food (unapproved |   |                                                |
| ingredient)**    |   | **(Part I - no registration requirement)**     |
+------------------+---+------------------------------------------------+

+-----------------------------------------------------------------------+
| **FEED MANUFACTURING EQUIPMENT**                                      |
+-----------------------------------------------------------------------+
| **Feed Processing Equipment**                                         |
|                                                                       |
| \[ \] Rollermill \[ \] Hammermill \[ \] Flaking \[ \] Other           |
| (describe)                                                            |
|                                                                       |
| **Feed Type**                                                         |
|                                                                       |
| \[ \] Dry \[ \] Moist \[ \] Liquid \[ \] TMR \[ \] Modified TMR       |
|                                                                       |
| **Feed Mixing Equipment (Please provide details on each piece of      |
| equipment )**                                                         |
|                                                                       |
| \[ \] Proportioner Mill/Volumetric Mixer                              |
|                                                                       |
| \[ \] Batch Mixer Type \[ \] Horizontal \[ \] Vertical \[ \] Tumble   |
|                                                                       |
| Capacity\_\_\_\_\_\_\_ tonnes                                         |
|                                                                       |
| \[ \] TMR Mixer Type \[ \] Horizontal \[ \] Vertical \[ \] Truck      |
|                                                                       |
| Capacity\_\_\_\_\_\_\_ tonnes                                         |
|                                                                       |
| \[ \] Continuous Mixer (molasses blender, screw auger, cut and fold   |
| mixer)                                                                |
|                                                                       |
| **Further Processing Equipment**                                      |
|                                                                       |
| \[ \] Pelleter(s) \[ \] Extruder(s) \[ \] Expander(s)                 |
|                                                                       |
| \[ \] Fat Coater \[ \] Molasses Blender \[ \] Bagging/Packaging       |
| Equipment                                                             |
+-----------------------------------------------------------------------+

Inspector's Signature/Date Signature of Feed Mill Management/Date

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

  -----------------------------------------------------------------------
  **TABLE OF CONTENTS**

  -----------------------------------------------------------------------

Part I......OPENING MEETING AND COLLECTION OF TOMBSTONE DATA 1

Part II...\...REVIEW OF WRITTEN PROCEDURES AND PRODUCTION RECORDS 5

Part III.....ON-SITE INTERVIEWS WITH MILL OPERATIONAL STAFF 12

Part IV.....SUMMARY AND COMMENTS 16

Please note:

I The following tasks do not apply to manufacturers who do not use
"prohibited material" or who do not manufacture feeds for any of
following species: ruminants, equines, porcines, chickens, turkeys,
ducks, geese, ratites or game birds.

> Tasks 7, 13, 15, 20, 24, 28, 36, 45, 56, 66, 76, & 81.

II For the tasks where records are required to be reviewed (e.g., Tasks
1, 2, 7 and 8 inclusive and all tasks where historical production
records are reviewed, the tonnage of feed manufactured in the facility
should be used to determine the [minimum]{.underline} number of records
to be reviewed as follows:

> 0 - 100 tonnes = 2 records
>
> 101 - 1000 tonnes = 3 records
>
> 1001 - 70,000 tonnes = 5 records
>
> \> 70,000 tonnes = 8 records
>
> At least one of the records of each type reviewed should be for the
> same feed, e.g., follow one feed from the master formula through to
> the label and invoice to get a better overall picture of compliance.
> If there are compliance issues identified with the first set of
> records reviewed, additional records should be reviewed.

IV **Reminder:** All N/A ratings require a comment as to why the
particular task does not apply. Only need to show for first one in a
series of tasks when the reason is the same, e.g., pelleting area if the
feed mill has no pellet mill

**PART II - REVIEW OF WRITTEN PROCEDURES AND PRODUCTION RECORDS**

**Section 1. MANUFACTURING CONTROLS AND DOCUMENTATION**

**Task 1 Assess adequacy of on site master formulae**

**Rating Type Compliance *Health of Animals Regulations* Section
91(3)(a) & 171(1)(a)**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.

**Standard** To receive a satisfactory rating, master formulae must:

\[ \] include the name of the feed;

\[ \] include the name and weight of each ingredient used in the
manufacture of the feed;

\[ \] include information as to whether the feed contains any
"prohibited material"; and

\[ \] be kept for a period of at least two years from the last date of
manufacture of that feed.

**Task 2 Assess adequacy of on site mixing sheets**

**Rating Type** **Compliance *Health of Animals Regulations* Section
91(3)(a) & 171(1)(b)**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.

**Standard** To receive a satisfactory rating, mixing sheets must:

\[ \] include the name of the feed;

\[ \] include the manufacturing date;

\[ \] include the name and weight of each ingredient used in the
manufacture of the feed;

\[ \] include the information used to identify each lot of feed;

\[ \] include information as to whether the feed contains any
"prohibited material"; and

\[ \] be kept for a period of at least two years from the last date of
manufacture of that feed.

**Task 7 Assess adequacy of feed and feed ingredient labels\*
(prohibited material)**

**Rating Type Compliance *Health of Animals Regulations* - Section 169**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.

**Standard** To receive a satisfactory rating:

> Labels of feeds for equines, porcines, chickens, turkeys, ducks,
> geese, ratites or game birds that contain "prohibited materials" must
> bear the required statement "Do not feed to cattle, sheep, deer or
> other ruminants".
>
> Labels for rendered products that contain "prohibited material" must
> bear the required statement "Do not feed to cattle, sheep, deer or
> other ruminants".

\* The regulatory definition of a "label" is a follows:

> A label includes any legend, word, mark symbol or design applied or
> attached to, included in, belonging to or accompanying any feed or
> package.
>
> Labels will typically be attached to bags, or attached to the invoice
> for bulk shipments. However, an invoice for bulk shipments can be a
> label if all the information as required by regulations is on the
> invoice.

**Task 8 Assess adequacy of feed invoices**

**Rating Type Compliance *Health of Animals Regulations* Section
91(3)(a), 171(1) and 171(2) .**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.
>
> **This requirement applies to ALL commercial feeds intended for
> feeding to ruminants, equines, porcines, chickens, turkeys, ducks,
> geese, ratites or game birds.**

**Standard** To receive a satisfactory rating, invoices must contain the
following information:

\[ \] the name and address of the person to whom the feed is distributed
or sold;

\[ \] a description of the feed, including the name and quantity;

\[ \] the name or other information used to identify the lot of feed;

\[ \] information as to whether or not the feed contains any "prohibited
material" and

where the feed contains "prohibited material", the required statement,
"Do not feed to

cattle, sheep, deer or other ruminants" and,

\[ \] copies of invoices must be kept for a period of at least two years
from the last date of

manufacture of that feed.

**Task 13a Assess the adequacy of written procedures and documentation
for the disposition**

**of returned\* and recalled feeds - "prohibited materials"** (\*feeds
returned by

customers, retailers etc.)

**Rating Type Compliance *Health of Animals Regulations* Sections
170(1)&(2)**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.

**Standard** To receive a satisfactory rating, the establishment must
have written procedures which require that returned and recalled feeds
must be handled as follows:

\[ \] disposal in accordance with local environmental regulations;

\[ \] if the feed contains "prohibited materials" it may only be used as
an ingredient in

nonruminant feeds labelled as containing "prohibited material";

\[ \] when stored, the returned/recalled feed must be labelled with the
required statement "Do

not feed to cattle, sheep, deer or other ruminants" and any other
pertinent information;

and

\[ \] the establishment must have evidence documenting these procedures.

**Task 15a Assess the adequacy of written procedures and documentation
for the disposition of flush or recovered\* materials - "prohibited
materials"** (\*materials recovered from spillage, dust collectors etc.)

**Rating Type Compliance *Health of Animals Regulations* Sections
170(1)&(2)**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.

**Standard** To receive a satisfactory rating, the establishment must
have written procedures which require that flush and recovered material
must be handled as follows:

\[ \] disposal in accordance with local environmental regulations;

\[ \] if the feed is or contains "prohibited materials" it may only be
used as an ingredient in

nonruminant feeds labelled as containing "prohibited material";

\[ \] when stored, the flush/recovered material must be labelled with
the required statement

"Do not feed to cattle, sheep, deer or other ruminants" and any other
pertinent

information; and

\[ \] the establishment must have evidence documenting these procedures.

**Sections 3 - 6 CLEAN-OUT PROCEDURES AND PRODUCTION RECORDS**

**Tasks Assess the adequacy of written clean out procedures and
production records for:**

-   **(Task 20a) receiving equipment**

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-   **(Task 24a) ingredient storage and handling equipment**

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```
-   **(Task 28a) ingredient processing equipment**

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```
-   **(Task 36a) mixing equipment**

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-   **(Task 45a) pelleting/extruding equipment (including pellet
    mill/extruder, cooler**

**and sifter/shaker)**

-   **(Task 56a) packaging equipment**

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```
-   **(Task 76a) bulk finished feed storage and handling equipment**

```{=html}
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```
-   **(Task 81a) loading/unloading of bulk delivery vehicles (including
    contract**

**vehicles)**

**Rating Type Compliance - *Health of Animals Regulations* Sections
91(3)(a), 170(1), 170(2) & 171(1)**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.
>
> **This task only applies to establishments who use common equipment to
> manufacture "prohibited materials"/feeds containing "prohibited
> materials" and who manufacture ruminant feeds.**

**Standard**. To receive a satisfactory rating, the manufacturer must
maintain written clean out procedures and production records for
manufacturing equipment which contains the following information:

**Production records**

\[ \] the name of the piece of equipment to which the production record
refers;

\[ \] the manufacturing date(s);

\[ \] the name of the feeds in the order which they pass through the
equipment;

\[ \] the information used to identify each lot of feed;

\[ \] the amount of each feed;

\[ \] include information as to whether the feed contains any
"prohibited material";

\[ \] details of any feed safety precautions taken between batches of
feed, e.g., equipment

clean out procedures including the amount and type of flush material;
and

\[ \] copies of production records must be kept for a period of at least
two years from the last

date of manufacture of that feed.

**Equipment Cleanout Procedures**

\[ \] written equipment clean out procedures must indicate that feeds
must be sequenced

such that ruminant feeds never immediately follow feeds containing
"prohibited materials"

unless the equipment is physically cleaned (swept/vacuumed) or flushed
prior to

manufacturing the ruminant feeds.

**Task 66a Assess the written procedures and records regarding the reuse
of used packaging**

**(prohibited material)**

**Rating Type Compliance *Health of Animals Regulations* Sections
170(1)&(2)**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of the noncompliance.

**Standard** To receive a satisfactory rating, the establishment must
have written procedures and records which require/demonstrate that used
packaging is handled as follows:

\[ \] not reuse packaging of unknown origin; and

\[ \] not reuse packaging that contained non-ruminant feeds for ruminant
feeds.

**PART III - ON-SITE INTERVIEWS WITH MILL OPERATIONAL STAFF**

**After reviewing written procedures and historical production records,
inspection staff should conduct interviews with production staff at the
applicable steps in the manufacturing process to confirm that the staff
are aware of, and, are following the written procedures. In addition, a
minimum of one record of each type for the date of inspection should be
reviewed.**

**Task 13b Confirm through interviews with production staff that written
procedures are being followed and production records completed properly
for the disposition of returned\* and recalled feeds - "prohibited
materials"** (\*feeds returned by customers, retailers etc.)

**Rating Type Compliance *Health of Animals Regulations* Sections
170(1)&(2)**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.

**Standard** To receive a satisfactory rating, the establishment must be
following their written procedures which require that returned and
recalled feeds be handled as follows, and, maintaining records that
document these procedures:

\[ \] disposal in accordance with local environmental regulations;

\[ \] if the feed contains "prohibited materials" it may only be used as
an ingredient in

nonruminant feeds labelled as containing "prohibited material"; and

\[ \] when stored, the returned/recalled feed must be labelled with the
required statement "Do

not feed to cattle, sheep, deer or other ruminants" and any other
pertinent information.

**Task 15b Confirm through interviews with production staff that written
procedures are being followed and production records completed properly
for the disposition of flush or recovered\* materials - "prohibited
materials"** (\*materials recovered from spillage, dust collectors etc.)

**Rating Type Compliance *Health of Animals Regulations* Sections
170(1)&(2)**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.

**Standard** To receive a satisfactory rating, the establishment must be
following their written procedures which require that flush and
recovered material be handled as follows, and, maintaining records that
document these procedures:

\[ \] disposal in accordance with local environmental regulations;

\[ \] if the feed is or contains "prohibited materials" it may only be
used as an ingredient in

nonruminant feeds labelled as containing "prohibited material"; and

\[ \] when stored, the flush/recovered material must be labelled with
the required statement

"Do not feed to cattle, sheep, deer or other ruminants" and any other
pertinent

information.

**Sections 3 - 6 CLEAN-OUT PROCEDURES AND PRODUCTION RECORDS**

> **Confirm through interviews with production staff that written clean
> out procedures are being followed and production records completed
> properly for:**

-   **(Task 20b) receiving equipment**

```{=html}
<!-- -->
```
-   **(Task 24b) ingredient storage and handling equipment**

```{=html}
<!-- -->
```
-   **(Task 28b) ingredient processing equipment**

```{=html}
<!-- -->
```
-   **(Task 36b) mixing equipment**

```{=html}
<!-- -->
```
-   **(Task 45b) pelleting/extruding equipment (including pellet
    mill/extruder, cooler**

**and sifter/shaker)**

-   **(Task 56b) packaging equipment**

```{=html}
<!-- -->
```
-   **(Task 76b) bulk finished feed storage and handling equipment**

```{=html}
<!-- -->
```
-   **(Task 81b) loading/unloading of bulk delivery vehicles (including
    contract**

**vehicles)**

**Rating Type Compliance - *Health of Animals Regulations* Sections
91(3)(a), 170(1), 170(2) & 171(1)**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.
>
> **This task only applies to establishments who use common equipment to
> manufacture "prohibited materials"/feeds containing "prohibited
> materials" and who manufacture ruminant feeds.**

**Standard**. To receive a satisfactory rating, the manufacturer must be
following their written clean out procedures and have current production
records for manufacturing equipment which contain the following
information:

**Production records**

\[ \] the name of the piece of equipment to which the production record
refers;

\[ \] the manufacturing date(s);

\[ \] the name of the feeds in the order which they pass through the
equipment;

\[ \] the information used to identify each lot of feed;

\[ \] the amount of each feed;

\[ \] include information as to whether the feed contains any
"prohibited material";

\[ \] details of any feed safety precautions taken between batches of
feed, e.g., equipment

clean out procedures including the amount and type of flush material;
and

\[ \] copies of production records must be kept for a period of at least
two years from the last

date of manufacture of that feed.

**Equipment Cleanout Procedures**

\[ \] written equipment clean out procedures must indicate that feeds
must be sequenced

such that ruminant feeds never immediately follow feeds containing
"prohibited materials"

unless the equipment is physically cleaned (swept/vacuumed) or flushed
prior to

manufacturing the ruminant feeds.

**Task 66b Confirm through interviews with production staff that written
procedures are being followed and production records completed properly
regarding the reuse of used packaging (prohibited material)**

**Rating Type Compliance *Health of Animals Regulations* Sections
170(1)&(2)**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of the noncompliance.

**Standard** To receive a satisfactory rating, the establishment must be
following their written procedures and have current records which
require/demonstrate that used packaging is handled as follows:

\[ \] not reuse packaging of unknown origin; and

\[ \] not reuse packaging that contained non-ruminant feeds for ruminant
feeds.

**PART IV - CLOSING MEETING**

**When the inspection has been completed, inspectors will conduct a
closing meeting with management to discuss any areas of non-compliance
and establish timeframes for their corrective action plans to be
developed and implemented. At the same time, the inspector should record
any comments that the management might have on the inspection
activity.**

**Task 85 Additional Comments from Inspector**

**Rating Type N/A**

**Standard** Inspection staff should capture any additional comments on
the facility in the comment field provided for future reference.

**Task 86 Feedback from Mill Management**

**Rating Type N/A**

**Standard** Inspection staff should capture any feedback received from
establishment personnel in the comment field provided for future
reference.

# Appendix 3 \-- Inspection Form for Rendering Facilities (tasks related to feed ban) ![](media/image12.wmf){width="1.5125in" height="0.7701388888888889in"} {#appendix-3----inspection-form-for-rendering-facilities-tasks-related-to-feed-ban .Appendix-1}

**[FEED INSPECTION PROGRAM 1A - RENDERING PLANTS]{.underline}**

**(Health of Animals Regulations Sections 162 - 171)**

  -----------------------------------------------------------------------
  **TABLE OF CONTENTS**

  -----------------------------------------------------------------------

**PART I** **OPENING MEETING GENERAL INFORMATION, SURVEYS &
RECOMMENDATION** [69](#__RefHeading___Toc96825682)

**TABLE 1 - General Information** [69](#__RefHeading___Toc96825683)

**TABLE 2 - Raw Material Survey** [70](#__RefHeading___Toc96825684)

**TABLE 3 - Processing & Production Survey**
[74](#__RefHeading___Toc96825685)

**[Inspector's Recommendation]{.underline}**
[75](#__RefHeading___Toc96825686)

**PART II REVIEW OF WRITTEN PROCEDURES AND PRODUCTION RECORDS**
[77](#__RefHeading___Toc96825687)

1.  Collect and record general information, raw material, processing /
    production and product from the Operator in Tables 1 -3.

2.  **Upon COMPLETION OF THE INSPECTION, complete the [Inspector's
    Recommendation]{.underline} page.**

3.  Please forward completed copies of all of Section 1 which includes:
    general inspection information (Table 1), raw material survey (Table
    2), processing/production survey (Table 3), and Inspector's
    Recommendation to:

> Sergio Tolusso
>
> Feed Program Coordinator
>
> Feed Section, Animal Health & Production Division
>
> Canadian Food Inspection Agency
>
> 59 Camelot Drive Ph: (613) 225-2342
>
> Ottawa, Ontario Fax: (613) 228-6614
>
> K1A 0Y9 E-mail: stolusso@inspection.gc.ca

4\. The tonnage of the feed manufactured in the facility should be used
to determine the [minimum]{.underline} number of records to be reviewed
as follows: \* 1 record shall be day of inspection record \*

0 - 100 tonnes = 2 records 101 - 1000 tonnes = 3 records

1001 - 70,000 tonnes = 5 records \> 70,000 tonnes = 8 records

**5**. **All other ratings, comments, action plans etc. associated with
each inspection task are to be entered into the CFIA Multi Commodity
Activities Program (MCAP) system for Feed Inspection "Program 1A-2003
Rendering Plants".**

  -----------------------------------------------------------------------
  **PART I OPENING MEETING GENERAL INFORMATION, SURVEYS &
  RECOMMENDATION**[]{#__RefHeading___Toc96825682 .anchor}

  -----------------------------------------------------------------------

**At the onset of the inspection, inspectors will conduct an opening
meeting with management to explain the purpose of this review activity
and answer any questions. At this time, the inspector should with the
help of the management collect the tombstone information on the
facility**.

+----------------------------------------+-----------------------------+
| **TABLE 1 - General                    |                             |
| Infor                                  |                             |
| mation**[]{#__RefHeading___Toc96825683 |                             |
| .anchor}                               |                             |
|                                        |                             |
| *(Please forward completed copy of     |                             |
| this Table to Feed Section)*           |                             |
+----------------------------------------+-----------------------------+
| **Inspector's Name**                   | **Date of Inspection**      |
+----------------------------------------+-----------------------------+
| **Name and Address of Rendering        | **Operator\'s Name**        |
| Plant**                                |                             |
|                                        |                             |
| **Telephone:**                         |                             |
|                                        |                             |
| **Fax:**                               |                             |
|                                        |                             |
| **E-mail:**                            |                             |
+----------------------------------------+-----------------------------+
| **Date of Last Inspection**            |                             |
+----------------------------------------+-----------------------------+
| **Current Rendering Plant Permit       |                             |
| Number**                               |                             |
+----------------------------------------+-----------------------------+

+-----------------------------------------------------------------------+
| **[For the information of Operators]{.underline}**                    |
|                                                                       |
| **Information collected in Tables 1-3 of this inspection report may   |
| be accessible or protected as required under the provisions of the    |
| *Access to Information Act*.**                                        |
+-----------------------------------------------------------------------+

+----------------------+---------------+------------+----------------+---+---+---+
| **TABLE 2 - Raw      |               |            |                |   |   |   |
| Material             |               |            |                |   |   |   |
| Survey**[]{#__RefH   |               |            |                |   |   |   |
| eading___Toc96825684 |               |            |                |   |   |   |
| .anchor}             |               |            |                |   |   |   |
|                      |               |            |                |   |   |   |
| *(Please forward     |               |            |                |   |   |   |
| completed copy of    |               |            |                |   |   |   |
| this Table to Feed   |               |            |                |   |   |   |
| Section)*            |               |            |                |   |   |   |
+======================+===============+============+================+===+===+===+
| *Identify each raw   |               |            |                |   |   |   |
| material type and    |               |            |                |   |   |   |
| quantity processed   |               |            |                |   |   |   |
| by the rendering     |               |            |                |   |   |   |
| plant during the     |               |            |                |   |   |   |
| past year. \[e.g.,   |               |            |                |   |   |   |
| offal - (identify    |               |            |                |   |   |   |
| species), feathers,  |               |            |                |   |   |   |
| blood, dead stock,   |               |            |                |   |   |   |
| restaurant grease    |               |            |                |   |   |   |
| etc.\]*              |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Description of       | Quantity      | Particle   | Quantity       |   |   |   |
|                      | Processed     | S          | Imported for   |   |   |   |
| Raw Material         | (tonnes/year) | ize**^1^** | Processing     |   |   |   |
|                      |               |            |                |   |   |   |
|                      |               | \(cm\)     | (tonnes/year)  |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| **Abattoir offal**   |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Cattle               |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Other ruminant       |               |            |                |   |   |   |
| *(specify)*:         |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Swine                |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Poultry              |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Other *(specify)*:   |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Other *(specify)*:   |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Other *(specify)*:   |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| **Dead stock & other |               |            |                |   |   |   |
| inedible animal      |               |            |                |   |   |   |
| tissues**            |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Cattle               |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Other ruminant       |               |            |                |   |   |   |
| *(specify)*:         |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Swine                |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Poultry              |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Wildlife *specify*   |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Fur animal carcasses |               |            |                |   |   |   |
|                      |               |            |                |   |   |   |
| (e.g. mink, fox)     |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Other *(specify)*:   |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Other *(specify)*    |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
|                      |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| **Other Raw          |               |            |                |   |   |   |
| Materials**          |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Blood                |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Feathers             |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Hair                 |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Chain bone & fat     |               |            |                |   |   |   |
| **^2^**              |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Restaurant grease &  |               |            |                |   |   |   |
| other used fats      |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Plate waste          |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Wastewater treatment |               |            |                |   |   |   |
| solids               |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Other *(specify)*:   |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+
| Other *(specify)*:   |               |            |                |   |   |   |
+----------------------+---------------+------------+----------------+---+---+---+

**^1^ Size raw material(s) is reduced to by grinding, chopping,
screening etc. [prior]{.underline} to cooking.**

**^2^ Meat trimmings from butcher shops, grocery stores etc.**

+---------------+-----+----------+----+-----+---------------+---+---+
| **TABLE 3 -   |     |          |    |     |               |   |   |
| Processing &  |     |          |    |     |               |   |   |
| Production    |     |          |    |     |               |   |   |
| Survey**[]{#  |     |          |    |     |               |   |   |
| __RefHeading_ |     |          |    |     |               |   |   |
| __Toc96825685 |     |          |    |     |               |   |   |
| .anchor}      |     |          |    |     |               |   |   |
|               |     |          |    |     |               |   |   |
| ***(Please    |     |          |    |     |               |   |   |
| forward       |     |          |    |     |               |   |   |
| completed     |     |          |    |     |               |   |   |
| copy of this  |     |          |    |     |               |   |   |
| Table to Feed |     |          |    |     |               |   |   |
| Section)***   |     |          |    |     |               |   |   |
+===============+=====+==========+====+=====+===============+===+===+
| **Finished    | **  | **Cooker | ** |     |               | * | * |
| Rendered      | Pro | Type**   | Pr |     |               | * | * |
| Products**    | duc |          | oc |     |               | I | E |
|               | tio | **(Batch | es |     |               | m | x |
|               | n** | or       | si |     |               | p | p |
|               |     | Conti    | ng |     |               | o | o |
|               | **  | nuous)** | Co |     |               | r | r |
|               | (to |          | nd |     |               | t | t |
|               | nne |          | it |     |               | s | s |
|               | s/y |          | io |     |               | * | * |
|               | ear |          | ns |     |               | * | * |
|               | )** |          | ** |     |               |   |   |
|               |     |          |    |     |               | * | * |
|               |     |          |    |     |               | * | * |
|               |     |          |    |     |               | ( | ( |
|               |     |          |    |     |               | t | t |
|               |     |          |    |     |               | o | o |
|               |     |          |    |     |               | n | n |
|               |     |          |    |     |               | n | n |
|               |     |          |    |     |               | e | e |
|               |     |          |    |     |               | s | s |
|               |     |          |    |     |               | / | / |
|               |     |          |    |     |               | * | * |
|               |     |          |    |     |               | * | * |
|               |     |          |    |     |               |   |   |
|               |     |          |    |     |               | * | * |
|               |     |          |    |     |               | * | * |
|               |     |          |    |     |               | y | y |
|               |     |          |    |     |               | e | e |
|               |     |          |    |     |               | a | a |
|               |     |          |    |     |               | r | r |
|               |     |          |    |     |               | ) | ) |
|               |     |          |    |     |               | * | * |
|               |     |          |    |     |               | * | * |
+---------------+-----+----------+----+-----+---------------+---+---+
|               |     |          | ** | **T | **Cooker      |   |   |
|               |     |          | Ti | emp | Pressure:**   |   |   |
|               |     |          | me | era |               |   |   |
|               |     |          | ** | tur | **Ambient (0  |   |   |
|               |     |          |    | e** | bars)**       |   |   |
|               |     |          | *  |     |               |   |   |
|               |     |          | *( | **  | **Pressure (+ |   |   |
|               |     |          | mi | (°C | bars) Vacuum  |   |   |
|               |     |          | nu | )** | (- bars)**    |   |   |
|               |     |          | te |     |               |   |   |
|               |     |          | s) |     |               |   |   |
|               |     |          | ** |     |               |   |   |
+---------------+-----+----------+----+-----+---------------+---+---+
| **Protein     |     |          |    |     |               |   |   |
| Meals**       |     |          |    |     |               |   |   |
+---------------+-----+----------+----+-----+---------------+---+---+
| **Ruminant    |     |          |    |     |               |   |   |
| meat & bone   |     |          |    |     |               |   |   |
| meal**        |     |          |    |     |               |   |   |
+---------------+-----+----------+----+-----+---------------+---+---+
| **Porcine     |     |          |    |     |               |   |   |
| meat & bone   |     |          |    |     |               |   |   |
| meal**        |     |          |    |     |               |   |   |
+---------------+-----+----------+----+-----+---------------+---+---+
| **Poultry     |     |          |    |     |               |   |   |
| byproduct     |     |          |    |     |               |   |   |
| meal**        |     |          |    |     |               |   |   |
+---------------+-----+----------+----+-----+---------------+---+---+
| **Mixed meat  |     |          |    |     |               |   |   |
| & bone meal** |     |          |    |     |               |   |   |
+---------------+-----+----------+----+-----+---------------+---+---+
| **Other meat  |     |          |    |     |               |   |   |
| & bone meal   |     |          |    |     |               |   |   |
| *             |     |          |    |     |               |   |   |
| (specify)*:** |     |          |    |     |               |   |   |
+---------------+-----+----------+----+-----+---------------+---+---+
| **Feather     |     |          |    |     |               |   |   |
| meal**        |     |          |    |     |               |   |   |
+---------------+-----+----------+----+-----+---------------+---+---+
| **Blood       |     |          |    |     |               |   |   |
| meal**        |     |          |    |     |               |   |   |
+---------------+-----+----------+----+-----+---------------+---+---+
| **Other       |     |          |    |     |               |   |   |
| protein meal  |     |          |    |     |               |   |   |
| *             |     |          |    |     |               |   |   |
| (specify)*:** |     |          |    |     |               |   |   |
+---------------+-----+----------+----+-----+---------------+---+---+
| **Other       |     |          |    |     |               |   |   |
| protein meal  |     |          |    |     |               |   |   |
| *             |     |          |    |     |               |   |   |
| (specify)*:** |     |          |    |     |               |   |   |
+---------------+-----+----------+----+-----+---------------+---+---+
| **Fats &      |     |          |    |     |               |   |   |
| Oils**        |     |          |    |     |               |   |   |
+---------------+-----+----------+----+-----+---------------+---+---+
| **Tallow^1^** |     |          |    |     |               |   |   |
+---------------+-----+----------+----+-----+---------------+---+---+
| **Poultry     |     |          |    |     |               |   |   |
| fat^1^**      |     |          |    |     |               |   |   |
+---------------+-----+----------+----+-----+---------------+---+---+
| **Yellow      |     |          |    |     |               |   |   |
| grease^2^     |     |          |    |     |               |   |   |
| (restaurant   |     |          |    |     |               |   |   |
| grease)**     |     |          |    |     |               |   |   |
+---------------+-----+----------+----+-----+---------------+---+---+
| **Other fats  |     |          |    |     |               |   |   |
| or oils       |     |          |    |     |               |   |   |
| (             |     |          |    |     |               |   |   |
| *specify*):** |     |          |    |     |               |   |   |
+---------------+-----+----------+----+-----+---------------+---+---+

> [Feeds Regulations, Schedule IV, Part I]{.underline}
>
> **^1^ = 4.5.1** [Animal fat (or Feeding fa]{.underline}t)
>
> **^2^ = 4.5.2** [Animal vegetable fat (or Animal vegetable feeding
> fa]{.underline}t)

+----------------------------------------------------------+-----------+
| **[Inspector's                                           |           |
| Rec                                                      |           |
| ommendation]{.underline}**[]{#__RefHeading___Toc96825686 |           |
| .anchor}                                                 |           |
|                                                          |           |
| *(Please forward completed copy of this Recommendation   |           |
| to Feed Section **once all \"Compliance\"-rated Tasks    |           |
| are \"Satisfactory\"**)*                                 |           |
+----------------------------------------------------------+-----------+
| Pursuant to Section 162(1) of the *Health of Animals     |           |
| Regulations***:**                                        |           |
|                                                          |           |
| **" 'prohibited material'** means anything that is or    |           |
| that contains any, protein that originated from a        |           |
| mammal, other than a porcine or an equine. It does not   |           |
| include milk, blood, gelatin, rendered animals fat or    |           |
| their products."                                         |           |
+----------------------------------------------------------+-----------+
| **A Permit to Operate for this rendering plant may be    | ***Check  |
| issued for the manufacture of :**                        | one:***   |
+----------------------------------------------------------+-----------+
| **ONLY** Protein Meals defined as "Prohibited Material"  | \[ \]     |
+----------------------------------------------------------+-----------+
| **ONLY** Protein Meals NOT defined as "Prohibited        | \[ \]     |
| Material"                                                |           |
+----------------------------------------------------------+-----------+
| **BOTH** Protein Meals defined as "Prohibited Material"  | \[ \]     |
| and those not                                            |           |
|                                                          |           |
| defined as "Prohibited Material"                         |           |
+----------------------------------------------------------+-----------+
| **Endorsement**                                          | **DATE**  |
+----------------------------------------------------------+-----------+
| Inspector's Signature:                                   |           |
+----------------------------------------------------------+-----------+
| Operator's Signature:                                    |           |
+----------------------------------------------------------+-----------+

  -----------------------------------------------------------------------
  **PART II REVIEW OF WRITTEN PROCEDURES AND PRODUCTION
  RECORDS**[]{#__RefHeading___Toc96825687 .anchor}

  -----------------------------------------------------------------------

**Task 2 Assess the adequacy of on-site production records.**

**Rating Type Compliance**

> **Health of Animals Regulations Section 165(2)**
>
> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of non-compliance.

**Standard** To receive a satisfactory rating, on-site production
records must contain:

> \[ \] date of production of each rendered product;
>
> \[ \] information as to whether each product is or contains
> "prohibited material";
>
> \[ \] the name, and quantity of, and any other information that is
> sufficient to identify the products of the rendering plant
>
> Example records that may be inspected include raw material receiving
> records, cooking records, storage records, sequencing/flushing or
> other equipment clean out records.
>
> ***If the records do not contain the information specified, have the
> Operator modify production records immediately and/or suspend the
> Permit to Operate until the Operator fully complies with regulatory
> requirements***

**Task 3 Assess the adequacy of distribution records - prohibited
material (product**

> **invoices, bills of lading etc. for bulk and bagged product
> deliveries)**

**Rating Type Compliance**

> **Health of Animals Regulations Section 171(1) and 171(2)**
>
> All unsatisfactory ratings require a record of compliance action taken
> 0and/or a signed action plan for correction of non-compliance. Note
> details for all non-conforming invoices in the comments box, and
> describe reason for non-conformance.

**Standard** To receive a satisfactory rating, distribution records must
contain the following information; (check at least one invoice for each
animal protein product manufactured to a maximum of 10 invoices (no more
than 3 for the same finished product)):

\[ \] the name and address of the person to whom the product is
distributed or sold;

\[ \] a description of the finished product, including the name and
quantity;

\[ \] information used to identify the product lot;

> \[ \] information as to whether or not the product is, or contains
> "prohibited material";

\[ \] where the product either is, or contains "prohibited material",
the required statement, ["Do not feed to cattle, sheep, deer or other
ruminants"]{.underline}; and

\[ \] be available for inspection for the previous two (2) years and .

> *Statement is required regardless of whether distributions are to
> domestic or export customers*. ***Detain rendered products containing
> "prohibited material" if modification of invoices to include required
> statement is necessary.***

**Task 4 Assess the adequacy of labelling - prohibited material (if
labels used to accompany bulk deliveries or on bags)**

**Rating Type Compliance**

> **Health of Animals Regulations Section 171(1) and 171(2)**
>
> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance. Note
> details for all non-conforming labels in the comments box, and
> describe reason for non-conformance.

**Standard** To receive a satisfactory rating, all products distributed
by the rendering plant must be labelled in accordance with the Health of
Animals Regulations

> Check at least 1 label for each "prohibited material" product to a
> maximum of 10 labels (no more than 3 for the same finished product) to
> confirm that they:
>
> \[ \] contain the required statement: ["Do not feed to cattle, sheep,
> deer or other ruminants"]{.underline} if the product is or contains
> "prohibited material";
>
> ***Statement is required regardless of whether distributions are to
> domestic or export customers. Detain rendered products containing
> "prohibited material" if modification of labels to include required
> statement is necessary.***

**Task 6 Assess the adequacy of written procedures and records for clean
out of all**

> **processing lines and equipment used in the manufacture of finished
> products**.

**Rating Type** **Compliance Health of Animals Regulations Section
170(1) & (2)**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.
>
> **This task only applies to establishments who manufacture both
> "prohibited material" and "non-prohibited material" in the same
> production line.**

**Standard** To receive a satisfactory rating **where non-dedicated
lines are used to manufacture both "prohibited material" and
"non-prohibited material"** on the same premises, the operator must have
written procedures and records to demonstrate:

> \[ \] physical cleaning (washing, sweeping, vacuuming etc.) and/or
> flushing of the processing equipment after processing batches or runs
> of "prohibited material" are employed. As a guideline, an acceptable
> minimum flush procedure must comprise the complete filling of the
> entire processing system with a "non- prohibited material" (e.g.
> porcine offal, poultry offal  meal) serving as the flush material
> which is subsequently handled, and stored as "prohibited material"
> before the processing of any "non-prohibited material" begins. Any
> clean out procedure employed by the Operator that fails to meet this
> guideline must have been supported by acceptably validated alternative
> clean out procedures and the procedures have been sent, evaluated and
> approved by the Feed Section);
>
> \[ \] inspection and physical cleaning (washing, sweeping, vacuuming
> etc.) are employed for any equipment or vehicles used in common to
> store, convey and distribute "prohibited material" and "non-prohibited
> material";
>
> **Written procedures and records are must be inspected for any of the
> following points and equipment in the manufacturing process that are
> used in common to make "prohibited material" and "non-prohibited
> material":**
>
> \[ \] raw material delivery vehicles/equipment **Requirements are
> described in Task 32**
>
> \[ \] raw material receiving **Requirements are described in Task 31**
>
> \[ \] raw material handling and storage **Requirements are described
> in Task 29**
>
> \[ \] cooking **Requirements are described in Task** **27**
>
> \[ \] pressing and milling **Requirements are described in Task 25**
>
> \[ \] finished product packaging **Requirements are described in Task
> 22** **& 23**
>
> \[ \] finished product handling and storage **Requirements are
> described in Task 20**
>
> \[ \] finished product bulk loading and shipping **Requirements are
> described in**

**Task 18**

> \[ \] finished product delivery vehicles/equipment operated by the
> rendering plant **Requirements are described in Task 15**
>
> \[ \] finished product delivery vehicles/equipment **not** operated by
> the rendering plant
>
> **Requirements are described in Task 16**
>
> ***When appropriate controls are not in place to prevent the
> introduction of "prohibited material" with "non-prohibited material",
> all rendered products must be considered to contain "prohibited
> material" and be labelled with the required statement. The Permit to
> Operate must be amended to indicate that the facility may only
> distribute "prohibited material" until the Operator has developed and
> follows documented procedures.***

**Task 8 Assess the adequacy of written procedures and records for
identifying and handling flush material**

**Rating Type** **Compliance Health of Animals Regulations Section 170**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.
>
> **This task only applies to establishments who manufacture both
> "prohibited materials" and "non-prohibited materials."**

**Standard**. If the rendering plant does not employ common production
lines to manufacture "prohibited material" or "non-prohibited material",
check "Not Applicable" in the Comment box below.

> To receive a satisfactory rating, the Operator must have written
> procedures and records to demonstrate that all flush material:
>
> \[ \] if it contains "prohibited material", it is only used as an
> ingredient in another product that is or contains "prohibited
> material" **OR**
>
> \[ \] is disposed of in accordance with local environmental
> regulations;
>
> \[ \] is stored separately and identified or labelled as "prohibited
> material"; **OR**
>
> \[ \] is handled, stored and delivered as "prohibited material"
>
> ***When appropriate controls are not in place to prevent the
> introduction of flush material into "non-prohibited material", all
> rendered products must be considered to contain "prohibited material"
> and be labelled with the required statement. The Permit to Operate
> must be amended to indicate that the facility may only distribute
> "prohibited material" until the Operator has developed and follows
> documented procedures.***

**Task 9 Assess the adequacy of records of manufacturing errors and
corrective actions taken**

**Rating Type Compliance Health of Animals Regulations, s. 170(3)**

> All unsatisfactory ratings require a comment and/or a signed action
> plan for correction of deficiency.

**Standard** To receive a satisfactory rating, the operator must
maintain a file or other records which include the following
information:

\[ \] the date of the manufacturing error;

\[ \] the name or other information used to identify the product lot;

\[ \] provides details of the manufacturing error;

\[ \] provides details of the manufacturer's investigation of the error;

\[ \] provides details of the corrective actions taken including
disposition of the recovered/rework/returned/recalled material.

> ***When appropriate controls are not in place to prevent the mixing or
> cross-contamination of "non-prohibited material" with "prohibited
> material", all rendered products must be considered to contain
> "prohibited material" and be labelled with the required statement. The
> Permit to Operate must be amended to indicate that the facility may
> only distribute "prohibited material" until the Operator has developed
> and follows documented procedures.***

**Task 10 Assess the adequacy of written procedures and records for the
handling and**

> **end-use of recovered\* materials within the rendering plant.-
> prohibited material (\* materials recovered from spills, leaks,
> manufacturing errors \[rework, returns, recalls\], waste water
> treatment etc.)**

**Rating Type Compliance Health of Animals Regulations Sections
170(1)&(2)**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.
>
> **This task only applies to establishments who manufacture only
> "prohibited materials" and both "prohibited materials" and
> "non-prohibited materials."**

**Standard** To receive a satisfactory rating, the Operator must have
written procedures and records to demonstrate that recovered materials
are handled as follows:

> \[ \] disposal in accordance with local environmental regulations;
>
> \[ \] if the material contains "prohibited material" and is
> re-processed in the rendering plant it must be used as an ingredient
> in the processing of other "prohibited material"
>
> \[ \] if the material is or contains "prohibited material" and is not
> re-processed, it may only be used as an ingredient in finished
> products identified as "prohibited material";
>
> \[ \] when stored, the recovered material must be labelled with
> identifying information and any pertinent information respecting
> composition, i.e., contains "prohibited material";
>
> ***When appropriate controls are not in place to prevent the mixing or
> cross-contamination of "non-prohibited material" with "prohibited
> material", all rendered products must be considered to contain
> "prohibited material" and be labelled with the required statement. The
> Permit to Operate must be amended to indicate that the facility may
> only distribute "prohibited material" until the Operator has developed
> and follows documented procedures.***

  -----------------------------------------------------------------------
  **PART III - ON-SITE INTERVIEWS WITH MILL OPERATIONAL STAFF**

  -----------------------------------------------------------------------

**After reviewing written procedures and historical production records,
inspection staff should conduct interviews with production staff at the
applicable steps in the manufacturing process to confirm that the staff
are aware of, and, are following the written procedures. In addition, a
minimum of one record of each type for the date of inspection should be
reviewed.**

**Task 10(a) Confirm through interviews with production staff that
written procedures are being followed and production records completed
for the handling and end-use of recovered\* materials within the
rendering plant.- prohibited material (\* materials recovered from
spills, leaks, manufacturing errors \[rework, returns, recalls\], waste
water treatment etc.)**

**Rating Type Compliance Health of Animals Regulations Sections
170(1)&(2)**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.
>
> **This task only applies to establishments who manufacture only
> "prohibited materials" and both "prohibited materials" and
> "non-prohibited materials."**

**Standard** To receive a satisfactory rating, the Operator must have
written procedures and records to demonstrate that recovered materials
are handled as follows:

> \[ \] disposal in accordance with local environmental regulations;
>
> \[ \] if the material contains "prohibited material" and is
> re-processed in the rendering plant it must be used as an ingredient
> in the processing of other "prohibited material"
>
> \[ \] if the material is or contains "prohibited material" and is not
> re-processed, it may only be used as an ingredient in finished
> products identified as "prohibited material";
>
> \[ \] when stored, the recovered material must be labelled with
> identifying information and any pertinent information respecting
> composition, i.e., contains "prohibited material";
>
> ***When appropriate controls are not in place to prevent the mixing or
> cross-contamination of "non-prohibited material" with "prohibited
> material", all rendered products must be considered to contain
> "prohibited material" and be labelled with the required statement. The
> Permit to Operate must be amended to indicate that the facility may
> only distribute "prohibited material" until the Operator has developed
> and follows documented procedures.***

**Task 15 Confirm through interviews with production staff (and visual
inspection where possible) that written procedures are being followed
and production records completed for the inspection & cleaning of
finished product delivery vehicles operated by the rendering plant**

**Rating Type Compliance Health of Animals Regulations Section 170.**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.

**Standard** To receive a satisfactory rating, delivery vehicles
operated by the rendering plant must:

> \[ \]be managed according to written procedures for finished product
> delivery vehicle
>
> \[ \]be inspected to ensure cleanliness (including separating walls
> and covering tarpaulins) of delivery vehicles;
>
> \[ \] be dedicated to the delivery of "prohibited material" and
> "non-prohibited material" separately **OR**, if used to deliver both
> "prohibited material" and "non-prohibited material", be inspected and
> cleaned according to clean out procedures (flushing, physical clean
> out) between loads of "prohibited material" and "non-prohibited
> material";
>
> \[ \] if shipping multiple products in bulk, procedures are followed
> to prevent the overflow or other introductions of "prohibited
> material" and "non-prohibited material" between compartments during
> loading and delivery.
>
> ***When appropriate controls are not in place, all loads of rendered
> products must be considered to contain prohibited materials and be
> labelled with the required statement. The Permit to Operate must be
> amended to indicate that the facility may only ship prohibited
> material until the Operator has developed and follows documented
> procedures.***

**Task 16 Confirm through interviews with production staff (and where
possible visual inspection) that written procedures are being followed
and production records completed for the inspection & cleaning of
delivery vehicles [not]{.underline} operated by the rendering plant**

**Rating Type Compliance Health of Animals Regulations Section 170.**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.

**Standard** To receive a satisfactory rating, the Operator requires
delivery vehicles not operated by the rendering plant to:

> \[ \] be managed according to written procedures for
> non-company-operated vehicles;
>
> \[ \] be inspected to ensure cleanliness (including separating walls
> and covering tarpaulins) of delivery vehicles
>
> \[ \] be dedicated vehicles for the delivery of "prohibited material"
> or "non-prohibited material" only **OR**, if used to deliver both
> "prohibited material" and "non-prohibited material", be inspected and
> cleaned according to clean out procedures (flushing, physical clean
> out) between loads of "prohibited material" and "non-prohibited
> material";
>
> \[ \] if non-company delivery vehicles are not clean, notify the
> operator of the vehicle of the problem;
>
> \[ \] have operators of non-company delivery vehicles carry records
> regarding previous load(s) and clean out procedures used to prevent
> cross contamination.
>
> ***When appropriate controls are not in place to prevent the
> contamination of "non-prohibited material" with "prohibited material",
> all loads of rendered products must be considered to contain
> prohibited materials and be labelled with the required statement. The
> Permit to Operate must be amended to indicate that the facility may
> only ship prohibited material until the Operator has developed and
> follows documented procedures.***

**Task 18 Confirm through interviews with production staff and visual
inspection that written procedures are being followed and production
records completed for of finished product loading equipment - prohibited
material**

**Rating Type** **Compliance Health of Animals Regulations Section
170.**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.
>
> **This task only applies to establishments who manufacture both
> "prohibited materials" and "non-prohibited materials."**

**Standard** To receive a satisfactory rating, the loading equipment
must:

> \[ \] use dedicated loading equipment for "prohibited material" and
> "non-prohibited material", **or** follow written procedures for clean
> out/flushing of the loading equipment between batches of "prohibited
> material" and "non-prohibited material".
>
> \[ \] be managed to handle spills and leaks of finished products in
> accordance with written recovered material handling procedures to
> prevent cross-contamination of "non-prohibited material" with
> "prohibited material";
>
> ***When appropriate controls are not in place to prevent the
> introduction of "prohibited material" with "non-prohibited material",
> all rendered products must be considered to contain "prohibited
> material" and be labelled with the required statement. The Permit to
> Operate must be amended to indicate that the facility may only
> distribute "prohibited material" until the Operator has developed and
> follows documented procedures.***

**Task 20 Confirm through interviews with production staff and visual
inspection that written procedures are being followed and production
records completed for finished product handing & storage area(s) and
equipment - prohibited material**

Rating Type Compliance Health of Animals Regulations Section 170

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.
>
> **This task only applies to establishments who manufacture both
> "prohibited materials" and "non-prohibited materials."**

**Standard** To receive a satisfactory rating, finished product storage
(bins, tanks, silos etc.) and handling equipment (pipes, conveyors, drag
lines, elevators, etc.) must:

> \[ \] use dedicated bins and handling equipment for "prohibited
> material" and "non-prohibited material", **or** follow written
> procedures for clean out/flush the storage bins and equipment between
> batches of "prohibited material" and "non-prohibited material".
>
> \[ \] be managed to handle spills and leaks of finished products in
> accordance with written recovered material handling procedures to
> prevent cross-contamination of "non-prohibited material" with
> "prohibited material";
>
> ***When appropriate controls are not in place, all rendered products
> must be considered to contain prohibited materials and be labelled
> with the required statement. The Permit to Operate must be amended to
> indicate that the facility may only ship prohibited material until the
> Operator has developed and follows documented procedures.***

**Task 22 Confirm through interviews with production staff and visual
inspection that written procedures are being followed and production
records completed for finished product packaging equipment - prohibited
material**

**Rating Type Compliance Health of Animals Regulations Section 170**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.
>
> **This task only applies to establishments who manufacture both
> "prohibited materials" and "non-prohibited materials."**

**Standard** To receive a satisfactory rating, finished product
packaging equipment must :

> \[ \] use dedicated equipment to package "prohibited material" and
> "non-prohibited material", **or** follow written procedures for clean
> out/flushing of the packaging equipment between batches of "prohibited
> material" and "non-prohibited material".
>
> \[ \] be managed to handle spills and leaks of finished products in
> accordance with written recovered material handling procedures to
> prevent cross-contamination of "non-prohibited material" with
> "prohibited material";
>
> ***When appropriate controls are not in place, all rendered products
> must be considered to contain prohibited materials and be labelled
> with the required statement. The Permit to Operate must be amended to
> indicate that the facility may only ship prohibited material until the
> Operator has developed and follows documented procedures.***

**Task 23 Confirm through interviews with production staff that written
procedures are being followed and production records completed for
packaging materials**

**Rating Type Compliance Health of Animals Regulations Section 170**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance

**Standard** To receive a satisfactory rating the Operator must:

> \[ \] only use new packaging materials; or
>
> \[ \] dedicate bags to "prohibited material" and "non-prohibited
> material" only if bags are reused.
>
> ***When appropriate controls are not in place, all packaged rendered
> products must be considered to contain prohibited materials and be
> labelled with the required statement.*** ***Detain rendered products
> containing "prohibited materials" if modification of labels to include
> required statement is necessary.***

**Task 25 Confirm through interviews with production staff and visual
inspection that written procedures are being followed and production
records completed for the pressing and milling area(s) and equipment -
prohibited material**

**Rating Type Compliance Health of Animals Regulations Section 170**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.
>
> **This task only applies to establishments who manufacture both
> "prohibited materials" and "non-prohibited materials."**

**Standard** To receive a satisfactory rating, pressing and milling
areas and equipment must :

> \[ \] use dedicated equipment to press and mill "prohibited material"
> and "non-prohibited material", **or** follow written procedures for
> clean out/flushing of the packaging equipment between batches of
> "prohibited material" and "non-prohibited material".
>
> \[ \] be managed to handle spills and leaks of finished products in
> accordance with written recovered material handling procedures to
> prevent cross-contamination of "non-prohibited material" with
> "prohibited material";
>
> ***When appropriate controls are not in place, all rendered products
> must be considered to contain prohibited materials and be labelled
> with the required statement. The Permit to Operate must be amended to
> indicate that the facility may only ship prohibited material until the
> Operator has developed and follows documented procedures.***

**Task 27** **Confirm through interviews with production staff and
visual inspection that written procedures are being followed and
production records completed for the cooking area and equipment -
prohibited material**

**Rating Type Compliance Health of Animals Regulations Section 170**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.
>
> **This task only applies to establishments who manufacture both
> "prohibited materials" and "non-prohibited materials."**

**Standard** To receive a satisfactory rating, the cooking area and
equipment must:

> \[ \] use dedicated equipment to cook "prohibited material" and
> "non-prohibited material", **or** follow written procedures for clean
> out/flushing of the cooking equipment between batches of "prohibited
> material" and "non-prohibited material".
>
> \[ \] be managed to handle spills and leaks of finished products in
> accordance with written recovered material handling procedures to
> prevent cross-contamination of "non-prohibited material" with
> "prohibited material";
>
> ***When appropriate controls are not in place, all rendered products
> must be considered to contain prohibited materials and be labelled
> with the required statement. The Permit to Operate must be amended to
> indicate that the facility may only ship prohibited material until the
> Operator has developed and follows documented procedures.***

**Task 29 Confirm through interviews with production staff and visual
inspection that written procedures are being followed and production
records completed for the raw material handling & storage area(s) and
equipment - prohibited material**

**Rating Type Compliance Health of Animals Regulations Section 170**

> All unsatisfactory ratings require a record of compliance and/or a
> signed action plan for correction of noncompliance.
>
> **This task only applies to establishments who manufacture both
> "prohibited materials" and "non-prohibited materials."**

**Standard** **To receive a satisfactory rating, the raw material
handling and storage area(s) and equipment must:**

> \[ \] use dedicated equipment to receive "prohibited material" and
> "non-prohibited material", **OR** be managed according to written
> clean out/flush procedures if shared equipment is being used handle or
> store raw "prohibited material" and "non-prohibited material";
>
> \[ \] be managed to handle spills and leaks of raw products in
> accordance with written recovered material handling procedures to
> prevent cross-contamination of "non-prohibited material" with
> "prohibited material";
>
> ***When appropriate controls are not in place to prevent the
> introduction of raw "prohibited material" into raw "non-prohibited
> material", all rendered products must be considered to contain
> prohibited materials and be labelled with the required statement. The
> Permit to Operate must be amended to indicate that the facility may
> only ship prohibited material until the Operator has developed and
> follows documented procedures.***

**Task 31 Confirm through interviews with production staff and visual
inspections that written procedures are being followed and production
records completed for the raw materials receiving area(s) and
equipment - "prohibited material".**

**Rating Type Compliance Health of Animals Regulations Section 170**

> All unsatisfactory ratings require a record of compliance and/or a
> signed action plan for correction of noncompliance.
>
> **This task only applies to establishments who manufacture both
> "prohibited materials" and "non-prohibited materials."**

**Standard** To receive a satisfactory rating, the raw material
receiving area must:

> \[ \] be managed to prevent cross-contamination of raw "non-prohibited
> material" with "prohibited material"
>
> \[ \] be managed to handle spills and leaks of raw materials in
> accordance with written recovered material handling procedures to
> prevent cross-contamination of "non-prohibited material" with
> "prohibited material";
>
> ***When appropriate controls are not in place, all rendered products
> must be considered to contain prohibited materials and be labelled
> with the required statement. The Permit to Operate must be amended to
> indicate that the facility may only ship prohibited material until the
> Operator has developed and follows documented procedures.***

**Task 32 Confirm through interviews with production staff that written
procedures are being followed and production records completed for the
inspection & cleaning of vehicles used to deliver raw materials to the
rendering plant**

**Rating Type Compliance Health of Animals Regulations Section 170.**

> All unsatisfactory ratings require a record of compliance action taken
> and/or a signed action plan for correction of noncompliance.

**Standard** To receive a satisfactory rating, raw material delivery
vehicles must::

> \[ \] be inspected, cleaned and sanitized according to written
> procedures for raw material delivery vehicles
>
> \[ \] be managed to prevent cross-contamination of raw "non-prohibited
> material" with "prohibited material"
>
> ***When appropriate controls are not in place, all rendered products
> must be considered to contain prohibited materials and be labelled
> with the required statement. The Permit to Operate must be amended to
> indicate that the facility may only ship prohibited material until the
> Operator has developed and follows documented procedures.***

**PART IV - CLOSING MEETING**

**When the inspection has been completed, inspectors will conduct a
closing meeting with management to discuss any areas of non-compliance
and establish timeframes for their corrective action plans to be
developed and implemented. At the same time, the inspector should record
any comments that the management might have on the inspection
activity.**

**Task 33 Additional Comments from Inspector**

**Rating Type Not Applicable**

**Standard** Inspection staff should capture any additional comments on
the facility in the comment field provided for future reference.

**Task 34 Additional Comments from Rendering Plant Management**

**Rating Type Not Applicable**

**Standard** Inspection staff should capture any additional feedback
received from Rendering Plant personnel in the comment field provided
for future reference.

# Appendix 4 --- Inspection Form for On-Farms ![](media/image13.png){width="5.997222222222222in" height="7.621527777777778in"}![](media/image14.png){width="6.496527777777778in" height="8.98611111111111in"}![](media/image15.png){width="6.756944444444445in" height="9.239583333333334in"}![](media/image16.png){width="6.485416666666667in" height="9.365972222222222in"}![](media/image17.png){width="6.611111111111111in" height="9.246527777777779in"}![](media/image18.png){width="6.629166666666666in" height="9.120833333333334in"}![](media/image19.png){width="6.492361111111111in" height="9.23263888888889in"}![](media/image20.png){width="6.493055555555555in" height="8.9875in"}![](media/image21.png){width="6.490972222222222in" height="8.99375in"}![](media/image22.png){width="6.492361111111111in" height="8.988194444444444in"}![](media/image23.png){width="6.491666666666666in" height="8.988194444444444in"}![](media/image24.png){width="6.491666666666666in" height="8.994444444444444in"}![](media/image25.png){width="6.492361111111111in" height="8.9875in"}![](media/image26.png){width="6.620138888888889in" height="8.99375in"}![](media/image27.png){width="6.620833333333334in" height="8.986805555555556in"}![](media/image28.png){width="6.492361111111111in" height="8.993055555555555in"}![](media/image29.png){width="6.491666666666666in" height="8.994444444444444in"}![](media/image30.png){width="6.490972222222222in" height="8.9875in"}![](media/image31.png){width="6.493055555555555in" height="8.986805555555556in"}![](media/image32.png){width="6.491666666666666in" height="8.9875in"}![](media/image33.png){width="6.492361111111111in" height="8.9875in"}![](media/image34.png){width="6.492361111111111in" height="8.9875in"}![](media/image35.png){width="6.493055555555555in" height="8.9875in"}![](media/image36.png){width="6.4944444444444445in" height="8.988194444444444in"}![](media/image37.png){width="6.492361111111111in" height="8.995833333333334in"}![](media/image38.png){width="6.493055555555555in" height="8.9875in"}![](media/image39.png){width="6.491666666666666in" height="8.9875in"}![](media/image40.png){width="6.4944444444444445in" height="8.986805555555556in"}![](media/image41.png){width="6.4944444444444445in" height="8.986805555555556in"}![](media/image42.png){width="6.4944444444444445in" height="8.986805555555556in"}![](media/image43.png){width="6.491666666666666in" height="8.995138888888889in"}![](media/image44.png){width="6.49375in" height="8.988194444444444in"}![](media/image45.png){width="6.49375in" height="8.988194444444444in"}![](media/image46.png){width="6.49375in" height="8.988194444444444in"}![](media/image47.png){width="6.49375in" height="8.986805555555556in"}![](media/image48.png){width="6.491666666666666in" height="8.9875in"}![](media/image49.png){width="6.492361111111111in" height="8.9875in"}![](media/image50.png){width="6.49375in" height="8.988194444444444in"}![](media/image51.png){width="6.492361111111111in" height="8.995138888888889in"}![](media/image52.png){width="6.491666666666666in" height="8.995138888888889in"}![](media/image53.png){width="6.49375in" height="8.995138888888889in"}![](media/image54.png){width="6.493055555555555in" height="8.986805555555556in"}![](media/image55.png){width="6.620833333333334in" height="8.98611111111111in"}![](media/image56.png){width="6.4944444444444445in" height="8.9875in"}![](media/image57.png){width="6.491666666666666in" height="8.99375in"}![](media/image58.png){width="6.491666666666666in" height="8.993055555555555in"} {#appendix-4-inspection-form-for-on-farms .Appendix-1}

[^1]: This task deals with feed invoices, including the need to have the
    name and address of the person to whom the feed is distributed or
    sold; a description of the feed, including the name and quantity;
    the name or other information used to identify the lot of feed;
    information as to whether or not the feed contains any prohibited
    material and where the feed contains prohibited material, the
    required statement, "Do not feed to cattle, sheep, deer or other
    ruminants." Copies of invoices must be kept for a period of at least
    two years from the last date of manufacture of that feed.