only: ernisation [email protected] - canadian meat council · 2015-08-07 · cfia ‐mod july 31...
TRANSCRIPT
By e‐mai
cfia‐mod
July 31, 2
Canadian
Regulatio
INTRODU
The Cana
(“CFIA”)
releasing
moderniz
publicati
The Coun
In the fo
gaps and
intent of
or offers
Before li
concern
than the
labelling
next yea
enabling
place Pre
such as p
il only:
dernisation‐a
2015
n Meat Cou
ons
UCTION:
adian Meat
for sharing
gthe prelim
zation initia
on in Part I
ncil congratu
llowing pag
d inconsisten
f certain reg
suggestions
sting specif
that the lab
e food safe
(FLM) mod
r theSafe Fo
regulations
eventive Con
packaging an
acia@inspec
uncil Comme
Council (“Co
its progress
inary text
ative. The
of the Can
ulates the CF
es, the Coun
nciesin the d
ulatory prov
s on matters
ic comment
elling and pa
ety regulatio
ernization i
ood for Cana
. At that tim
ntrol Plans (
nd labelling ‐
ction.gc.ca
ents on the
ouncil”) wis
s to date on
of the con
release oft
nada Gazette
FIAfor settin
ncilhighlight
draft regulat
visions, sugg
s to be cover
ts on the dr
ackaging reg
ons. Improv
nitiatives is
adians Act (S
me, federally
(PCPs) that i
‐ to comply w
April 17, 2
hes to than
theSafe Fo
nsolidated
the prelimi
e is an unco
g a positive
ts concerns
tory text. Th
gests edits to
red in the gu
raft regulati
gulations are
ved alignme
of the utm
SFCA) may h
y‐regulated m
include food
with the new
015 Draft o
k the Canad
od for Cana
regulations
nary regula
onventional
precedent.
with some r
he Council a
o enhance th
uidance docu
ons, the Co
e being deve
ent betwee
most importa
have been p
meat establi
d safety and
w food safet
of Consolida
dian Food In
adians Regul
as part o
atory text p
but welcom
regulatory p
lso seeks cla
he clarity of
uments.
ouncil wishe
eloped on di
n the regu
ance given t
roclaimed in
ishmentswil
d non‐food s
y regulation
ated Food S
nspection Ag
lations (SFC
of its regul
prior to its
me developm
provisions as
arification o
f some provi
s to reiterat
ifferent time
latory and
that by this
nto force wi
l need to ha
safety eleme
ns.
afety
gency
R) by
atory
pre‐
ment.
s well
n the
sions
te its
elines
food
time
th its
ave in
ents ‐
2 | P a g e
We understand the need for consultation on “labelling modernization” and we appreciate that
the CFIA and Health Canada are now doing this jointly. However, we are concerned, that once
the food safety regulations are “Gazetted”, there will be little appetite to make further
regulatory changes that will address outdated ‐ and sometime conflicting ‐ requirements
related to labelling, standards of identity, packaging standards, Ministerial Exemptions for bulk
containers, country of origin marking, etc.
These matters have an important impact on market efficiency, consumer confidence and
business competitiveness.At a minimum, we believe that the standards of identity should be
removed from the Governor in Council’s authority to make regulations and be included in a
document that would be added to theexisting list of documents that are to be incorporated by
reference (IbR) to the food safety regulations.This approach would have the merit of being
consistent with the CFIA’s proposal to streamline the often cumbersome process of recognizing
new regulations related to standards of identity in response to stakeholder feedback on the
FLM initiative.
SPECIFIC COMMENTS ON DRAFT REGULATORY PROVISIONS:
Part 1, Interpretation
Division 1, General
“contaminated”
“contaminated” means, in respect of a food, that the food, among other things,
(a) contains a chemical, drug, food additive, heavy metal, industrial pollutant, ingredient,
medicament, microbe, pesticide, poison, toxin or other substance that is not permitted under or
that is in an amount in excess of limits provided under the FDA; or
(b) contains, or has come in contact with, anythingthat causes the food to become inedible.
When comparing the current draft regulations to the Meat Inspection Regulations, 1990(MIR),
we note that the definition of “adulterated” has been dropped from the proposed regulatory
text and reframedunder paragraph (a) of the proposed definition of “contaminated”. In
essence, “adulterated” and “contaminated” have been merged into one concept. This should
not be allowed to occur.
The definition of “contaminated” describes two circumstances in which a food may be
contaminated. This happens because of the food’s composition (paragraph (a)) or because the
food came into contact with anything that caused it to become inedible (paragraph (b)). The
3 | P a g e
definition, as currently drafted, reflects a degree of vagueness and uncertainty because it fails
to account that harm (or risk) can occur at the point of production or at the point of
consumption.
Considering that one of the key drivers of the food safety legislation modernization efforts in
Canada is the need to align with developments in the United States under the Food Safety
Modernization Act, one would think that the CFIA would emulate the U.S. experience and
ground the mandatory, risk‐based approach to food safety risk management in a definition of
“adulterated food” to support the scheme of the SFCA and the Regulations. Rather, it frames
the definition based on the list of prohibition to the sale of food found at section 4 of the Food
and Drugs Act (FDA). That list makes no distinction between harm (or risk) that results from a
deliberate act or an environmental phenomenon.
In the United States, the definition of “adulterated food” is found in section 342 of the Food,
Drug and Cosmetic Act [21 U.S.C. 301]. The precise language of the definition allows the
regulated party to make a distinction between a naturally occurring hazard and an artificially
occurring hazard. The Council strongly recommends the CFIA to reintroducea definition of
“adulterated” to the regulations to support and reinforce the mandatory, science‐based
preventive controls that will be established by regulated parties for the purposes of regulatory
oversight and enforcement across the food supply.
“inedible”
“inedible” describes a food that is not fit for use as food, particularly if it
(a) emits a musty or other abnormal odour;
(b) is mouldy; or
(c) in the case of an egg,
(i) has been in an incubator, or
(ii) has any internal defect, other than a meat spot or blood spot that does not
exceed 3.175 mm (1/8 inch) in diameter.
In this definition, it would be important to avoid the use of the overgeneralized statement of
“mouldy” as a contaminant to be avoided. Certain food items are unique because of the use
and presence of mould ‐in essence the moulds served in the fermentation process ‐ gives such
foods unique standards of identity. We are referring toripening and/or aging of the foods to
obtain the special flavor, texture, unique profiles or characteristics associated with the foods ,
4 | P a g e
e.g. cheeses, fermented meat and sausages (salami, pepperoni, etc.), and dry aging of fresh
meats.
“meat” – “meat‐by‐product” – “meat product”
“meat”
“meat” means the edible part of the carcass of a food animal, that is, the muscle associated
with the skeleton, tongue, diaphragm, heart, gizzard or mammalian esophagus, with or without
accompanying and overlying fat, together with those parts of the bones, skin, sinews, nerves,
blood vessels and other tissues that normally accompany the muscle and are not normally
removed in dressing a carcass. It does not include the muscles associated with the lips, snout,
scalp or ears, or mechanically separated meat.
The general definition of “meat” must be as precise as possible rather than illustrative. Meat
includes everything that is edible and, as such, should include a specific list of what should be
included and excluded under the definition. In this perspective, “finely textured meat”must be
referenced, and included in the definition of “meat” as being meat.
“meat‐by‐product”
“meat by‐product” means edible blood or an edible organ or tissue that is derived from the
carcass of a food animal, but does not include meat or mechanically separated meat.
“meat product”
(a) means
(i) the carcass of a food animal,
(ii)the blood of a food animal or a product or by‐product of the carcass of a food animal,
or
(iii) any other food that contains the blood of a food animal or a product or by‐product
of the carcass of a food animal; and […]
The definition of “meat product” when read in conjunction with “meat‐by‐product” is
confusing. As highlighted above in boldtype face, subsections (a) (ii) and (a) (iii) of the definition
5 | P a g e
of “meat product” also include references to by‐products. Why is this required when “meat‐by‐
product” has a separate definition?
We understand that the definition of “meat‐by‐product” is the same as in the Meat Inspection
Act (MIA). We also understand that the definition of “meat product” was added to the Safe
Food for Canadians Regulations (SFCR)to provide for an exemption.
Given that the definition of “meat” should include everything that is edible, we would propose
to delete subsection (a) (i) of the definition of “meat product”and replace it with “the entire
carcass of a food animal including bone and cartilage” to eliminate the confusion between the
definition of “meat” and “meat product”.
“refrigerate”
“refrigerate” means to expose a food to a temperature of 4°C or less, but does not mean to
freeze.
In the Meat Inspection Regulations, 1990 (MIR) "refrigerate" means to lower the temperature of
a meat product to, and to maintain the temperature at, 4°C or lower, but does not include to
freeze.
As section 4.2.1. of Chapter 4 of the Meat Hygiene Manual of Procedure explains “the
mandatory outcome of refrigeration is to retarding outgrowth of pathogens and spoilage
bacteria.” The SFCA is providing for the same outcome. For products stored under refrigerated
conditions, operators will need to have control programs in place to monitor the temperature
of meat products, such that the internal temperature of each product is 4°C or less but not
frozen.
There is no apparent reason why the need to “maintain” the food at a temperature of 4o or less
has been removed from the proposed definition.If this is an oversight, the definition could be
amended with the addition of “andmaintain” after “expose” to read as follows: “refrigerate”
means to expose and maintain a food to a temperature of 4°C or less, but does not mean to
freeze.
6 | P a g e
“work shift”
“work shift” means
(a) in the case of a slaughter shift, a work shift during which no inspection station is operated
for more than 7.5 hours in one day and 37.5 hours in one work week, excluding meal times; and
(b) in any other case, a work shift
(i) during which activities are conducted for not more than 7.5 hours in one day and 37.5
hours in one work week, excluding meal times, or
(ii) during which activities are conducted between 6:00 a.m. and 6:00 p.m.
The proposed definition should be amended to reflect the current practice in the meat industry
(8 hours a day – 40 hours in one week), excluding the 6:00 a.m. and 6:00 p.m. limits since
establishments may work multiple shifts per day or adjust start and end times to reduce heat
stress on employees during the warm months or reduce energy use.
Part 2, Trade
Section 9Any food that is imported must have been manufactured, prepared, stored,
packaged and labelled in a manner and under conditions that provide at least the same
level of protection as that provided by sections 41 to 79.
The rationale for not including the requirement for a written PCP (sections 80‐83) and meeting
traceability requirements (sections 84‐86) is not apparent. Section 9 must also include a
reference to the PCP and traceability provisions for greater clarity.
In the case of imports of meat products, section 123of the MIR states:
123. A meat product may be imported into Canada if
(a) the compositional standards and labelling requirements for the meat product are the
standards and labelling requirements to which the meat product would have to conform
if it were produced in a registered establishment in Canada;
[…]
(f) the meat product was manufactured in an establishment that was operating under a
Hazard Analysis Critical Control Point (HACCP) principles based system determined by
7 | P a g e
the President to be equivalent to the Food Safety Enhancement Program (FSEP)
established by the Agency.
The food safety regulations require everyone importing or preparing food for export or
interprovincial trade to comply with all the requirements of the SFCA and Regulations. The
reference in section 9 that it is sufficient for an imported product to be
manufactured,prepared, stored, packaged and labelled“under conditions that provide at least
the same level of protection as that provided by sections 41 to 79” dilutes that requirement.
One of the stated objectives of the SFCA is to enhance controls over imported food
commodities. The language of the new regulatory provision should follow the approach
established in section 123 of the MIR and explicitly state that the imported product and the
conditions under which it was manufactured, prepared, stored, packaged and labelled must
meet the requirements to which the meat product would have to conform if it were produced
in a licensed establishment in Canada.
If, under the new regulations, the CFIA took action to deny import of a meat product because it
does not think it meets our domestic legal requirements, then it is up to the exporting country
and the trade litigation process to determine whether the conditions under which it was
manufactured do in fact meet the “same level of protection” and whether the trade obligations
are being met. The regulation, as currently drafted, creates a de facto, ex ante assumption that
the imported product achieves the “same level of protection”. We may run the risk of having
that used against us in a trade challenge.
Put differently, if achieving “the same level of protection” is the basic legal test for import
eligibility then why is not the same basic legal test for inter‐provincial trade eligibility or
approval of one Canadian establishment’s manufacturing process/products vs. another
Canadian establishment’s (different) process/products? Or what if a provincially‐licensed meat
plant says their process achieves “the same level of protection” as the SFCA regulations and so,
just as with imports, they are entitled to full access to the Canadian domestic market? To avoid
these and other problems, the direct, explicit need for an imported food to meet Canadian
standards and requirements must be absolutely clear.
Subsection11.(1) Any food that is sent or conveyed from one province to another or is
exported must meet the following requirements:
(a) if the food is manufactured, processed, treated, preserved, graded, packaged or
labelled in Canada, that activity is conducted by a licence holder in accordance
with the Act and these Regulations, unless the activity is the packaging of fresh
8 | P a g e
fruits or vegetables in the field by any person who grows or harvests them if they
are to be sent or conveyed from one province to another to be subsequently
manufactured, processed, treated, preserved or graded by a licence holder; […]
Although “operator” is defined under Part 4 Preventive Controls, “licence holder” is not defined
in the regulations. “Licence holder” should be definedif not in the regulations, then in the
guidance document, to ensure that all that are captured by this definition (e.g., export brokers,
distribution centres, internet sales) are aware of the new requirements and in a position to
comply with the new requirements.
The regulations also employ different terminology with respect to importers and
exporters.They can be an “operator”, “a person who imports” “a person who exports” or, as
described in subsection 78(1) of the regulations, a “holder of a licence to import”. In some
instances, different terms have different legal implications. This needs to be spelled out in the
interest of enhanced clarity.
Subsection 14.(1)A person may send or convey from one province to another or import
a food that does not meet the requirements of the Act or these Regulations, other than
those set out in section 190 as that section relates to fresh fruits or vegetables,
processed fruit or vegetable products or honey, sections 191 to 194, Division 4 of Part 12
and section 498 as that section relates to fresh fruits or vegetables or processed fruit or
vegetable products, if
(a) a label that bears the expression “For further preparation only” or “pour
conditionnement ultérieur seulement” is applied or attached to the food;[…]
The labelling requirement is too prescriptive and does not reflect the labelling practices
currently in use by meat processors. Some use the expression “Further preparation” or “FOR
WIP” (Work in Progress) when the product is sent from one establishment to another. Others
use the expressions “For further transformation” or “Transformation Only”.
Subsection 14.(1)(a) can be redrafted as an outcome based regulation to avoid imposing
unnecessary regulatory compliance costs on regulated parties. This could be easily achieved by
amending subsection 14.(1)(a) to read as follows: a label that bears the expression “For further
preparation only” or “pour conditionnement ultérieur seulement”, or any equivalent expression,
is applied to the attached food; […]
9 | P a g e
Subsection 14.(3) It is prohibited for a person to mix a food referred to in subsection (1)
that is contaminated with a food that is not contaminated so that it meets the
requirements of the Act and these Regulations, unless authorized to do so by the
Minister if he or she is of the opinion that no risk of injury to human health will result.
There is a distinction to be made between bringing a product into compliance by blending or
reworking foods through cooking or pasteurization, for example, and diluting a mixture of a
contaminated food with a non‐contaminated food to bring that food into compliance. Also,
having food additives in excess of amounts of the limits provided under the Food and Drug
Regulations (FDR) is not outside the realm of possibility.
Based on the definition’s current wording, an operator would be prevented to initiate rework of
a food that may be contaminated because of a quality issue (i.e. level of ingredients) “unless
authorized to do so by the Minister”. This implies that the regulated party must ask permission
first and then prove to the CFIA that by mixing contaminated with non‐contaminated food
there will be “no risk of injury to human health”. There is definitely a need to introduce more
precision under subsection 14.(3) with respect to the CFIA’s intent to ensure that an operator
would not be prevented from initiating a rework of a food to address a suitability issue without
CFIA approval.
Regulated parties also need to fully understand the scope of the Minister’s powers. Pathogens,
for example, are moving targets. Constraining criteria are required to guide the exercise of
Ministerial discretion in determining what constitutes “a risk of injury to human health” in this
and other applicable sections of the regulations.
In the case of a food safety incident, for example, this would allow the establishment to ask
questions and frame its discussion with inspectors with a view to understanding what is really
applicable to the situation so that the accurate information may be provided on time.In the
interest of enhanced transparency, information pertaining to “the risk of injury to human
health” should be provided in the guidance documents.
Part 3, Licences
• Subsection 33 The Minister may suspend a licence if:
(a) the licence holder does not comply with any provisions of the Act other than
section 15 or with any provisions of these Regulations, the FDA or the FDR; […]
As noted in our comments on the 2014 version of the draft regulations, reference to “any”
provision of the FDA and the FDR is very broad. The SFCA isa food safety legislation which
10 | P a g e
encapsulates the necessary health‐related provisions of the FDA. It also has a strong trade and
commerce focus. If the use of the term “any”is merely a drafting technique that has no
particular reference to the exercise of legislative authority, then perhaps this should be pointed
out in the guidance documents to ensure that the scope of the Minister’s powersis well
understood with respect to the suspension and cancellation of licences.
Subsection 35.(1) Despite section 34, if the Minister is of the opinion that a risk of injury
to human health may result if the licence holder continues to conduct an activity
identified in the licence, the Minister may suspend the licence immediately after the
licence holder receives an inspection report that sets out the grounds for the suspension.
Is the intent of subsection 35(1) to allow the Minister to intervene in extreme cases; to only
cover the production of the implicated food plant? If so, the guidance documents should clarify.
Subsection36 A suspension of a licence remains in effect until an inspector determines
that corrective action has been taken or until the licence is cancelled.
This provision does not address the individual who determines the Corrective Action Request
(CAR).This should be described in the guidance documents or, failing that, the operational
guidance documents (to which regulated parties should be given access subject to the
appropriate redactions) because this deals with a process leading to an enforcement action.
Part 4, Preventive Controls
Section 41 DETERMINATION OF BIOLOGICAL, CHEMICAL AND PHYSICAL HAZARDS
An operator and a holder of a licence to import must determine the biological, chemical
and physical hazards that present a risk of contamination of a food or a food that is
imported, as the case may be, and must control those hazards using control measures
that are validated by evidence to be effective, including, in the case of a meat product,
the control measures that are set out in the document entitled Preventive Control Plan
Requirements for Biological Hazards inMeat Products, prepared by the Agency and
published on its website, as amended from time to time.
When comparing the 2014 version of the draft regulations to the consolidated draft, the
Council notes the addition of a paragraph about the need to undertake a hazard analysis prior
to the establishment of control measures.In light of this change, we would propose the
following consequential amendments:
11 | P a g e
(1) Amend the first line of section 41 by replacing the word “determine” with “identify and
analyze” which more accurately depicts the activity an operator undertakes when
conducting a hazard analysis.
(2) Introduce a definition of “validation” and “control measures” in the consolidated
regulations. Given that the food safetyregulations are designed to be aligned with
Codex principles, the regulations could draw on the Codex definitions1 of “validation”
and “control measures”.From a meat industry perspective, this would have the merit of
encapsulating the Codex‐inspired HACCP principles of the Food Safety Enhancement
Program that provide the foundation for the Preventive Control Plans.
“Control measure” – “Control measure” means any action and activity that can be used
to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
“Validation” – “Validation” means obtaining documented evidence that a control
measure, if properly implemented, is capable of controlling the hazard to a specified
outcome. This may include but is not limited to scientific journal articles and in‐plant
studies.
(3) Not all control measures can be easily validated. It is unreasonable to expect, as the
wording of section 41 does, that validation should apply to all control measures. The
proposed draft regulations should be amended to provide flexibility in the application of
validation by inserting “as applicable” between “control measures” and “that are
validated by evidence […]”.
Subsection 42.(1) An operator must subject a food, as applicable, to […]
(c) any other process or treatment that is necessary to eliminate any biological,
chemical or physical hazard that might be present in that food and that presents a
risk of contamination of that food, including any treatment that is necessary so that
the food meets the standards that are set out in the document entitled Biological,
Chemical and Physical Standards for Food, prepared by the CFIA and published on its
website, as amended from time to time.
1Codex CAC/RCP 1‐1969. General Principles of Food Hygiene www.codexalimentarius.org/input/download/standards/23/CXP_001e.pdf Codex CAC/GL 69‐2008. Guidelines for the validation of food safety control measures www.codexalimentarius.org/input/download/standards/11022/CXG_069e.pdf
12 | P a g e
When comparing paragraph (c) of this subsection to its previous 2014 version, it would appear
that the “elimination” of a hazard is the only result that would be acceptable. The drafting of
the 2014 version was narrower and was only concerned with treatments ‐ as opposed to all
other processes ‐ and recognized that control measures can be used to “reduce” or “to
prevent” hazards. In this perspective, the wording of subsection 42.(1)(c) should be amended to
capture the broad approach embodied in the Codex definition of “control measure” to
recognize all acceptable outcomes. In other words, processes can be used to “prevent” or
“eliminate” a food safety hazard or “reduce” it to an acceptable level in keeping with the Codex
definition of a “control measure”, as reproduced above.
On a related matter, it would appear thatthe physical hazard of magnetic metal particles,
described in Table 3 of the IbR document Biological, Chemical and Physical Standards for Food,
also includes other particles such as plastic.If this is the case, then Table 3 should point this out
explicitly.
Subsection 43.(2) Subsection (1) does not apply if the low‐acid food is refrigerated or
frozen and the statements “Keep Refrigerated” and “garder au froid”, or “Keep Frozen”
and “garder congelé”, as the case may be, are shown on the principal display panel.
This is too prescriptive. If the French version of the statement deviates from the two choices
described above “Garder au froid” or “Garder congelé”, then the establishment runs the risk of
being found in violation of regulatory requirements. Another acceptable, well understood and
frequently used statement in French for “garder au froid” is “garder réfrigéré”.
The Council recommends that subsection 43.(2) be amended to capture all the French terms for
“Keep Refrigerated”: Subsection (1) does not apply if the low‐acid food is refrigerated or frozen
and the statements “Keep Refrigerated” or “garder au froid” or “garder réfrigéré”, or “Keep
Frozen” and “garder congelé”, as the case may be, are shown on the principal display panel.
Section 45.(1)An establishment, and any conveyance or equipment in it that is used in
connection with any activity regulated under the Act, must be clean and in a sanitary
condition.
(2) The cleaning and sanitation of the establishment, and of any conveyance or
equipment in it that is used in connection with any activity regulated under the Act, must
be conducted in a manner that does not present a risk of contamination of a food.
13 | P a g e
This section requires further clarification because it remains unclear if a regulated party must
have the capacity to clean and sanitize any conveyance and any equipment and, if so, at what
frequency.
Section 49.Any conveyance or equipment in an establishment that is used to handle
contaminated materials, waste or any other thing that is inedible must […] (c) meet the
applicable requirements of section 48.
According to Section 48.(i), any conveyance or equipment that is used in the manufacturing,
preparing, storing, packaging or labelling of a food or in the slaughtering of food animals […]
must have food contact surfaces, if any, that are (i) smooth, (ii) free from pitting, cracks and
flakes, and (iii) non‐absorbent”.
In keeping with the overall purpose of Part 4, section 48 has been drafted to list the required
physical characteristics that conveyances and equipment must have to prevent a risk of
contamination to the food. Contrary to what section 49 states, however, an establishment
handling contaminated materials may not need to comply with all the requirements of section
48, especially not as it relates to the requirement to have smooth contact surfaces. The intent
of section 49 should be clarified in the regulations or, failing that, greater precision could be set
in the guidance document.
Section 51.(1) Any land that forms part of an establishment must […] (b) provide or
permit good drainage; […]
Paragraph (b) should be amended to add “maintained” to ensure that the performance
outcome of “good drainage” is fully met.
Section 55Physical or other effective means must be used to separate incompatible
activities in order to prevent contamination of a food.
AND
Section 56 Physical or other effective means must be used to separate a food from
(a) anything that presents a risk of contamination of that food;
(b) any food that does not meet the requirements of the Act or these
Regulations; and
14 | P a g e
(c) anything that is manufactured, prepared, stored, packaged or labelled in
the establishment that is not intended or sold for use as food.
What is the meaning of “other effective means”? The vagueness inherent in this type of
drafting gives the inspector the ability not simply to enforce the rule, but in effect to decide
what the substance of the rule is. Reference to “validated measures” as opposed to “effective
means” would mitigate our concern.
Subsection 58.(3) The stations referred to in subsection 53(4) that are in an
establishment where a licence holder is authorized to conduct a post‐mortem
examination program must be equipped with a minimum of 2000 lx shadow‐free lighting
that has a minimum colour rendering index of 85.
It would appear that only the MPIP carcass rejection program is captured in the regulations.
Given that CFIA intends to keep the High Line Speed program requirements for beef and hog
slaughter outside the scope of the regulations, the guidance document would need to explain
this. To avoid confusion, the guidance document would also need to explain that the Current
Annex C HACCP Based Slaughter Inspection Program (HIP) for beef and hog in the Meat Hygiene
Manual Procedure remains unchanged at a minimum of 1000 lux and that the High Line Speed
program requirements also remain unchanged.
Subsection 61.(2) Contaminated materials and waste must be removed and disposed of
at a frequency that is sufficient to prevent contamination of a food and in a manner that
does not present a risk of contamination of the food.
Further clarification is required to reduce confusion because risk prevention is linked to both
the frequency and manner of disposal of contaminated materials and waste. This clarification
must be included in the guidance document.
Subsection 62.(2)The hand cleaning and sanitizing stations must supply water at a
temperature and pressure that are conducive to the effective cleaning of hands.
AND
Subsection 66.(1)(a)An establishment must be supplied, as appropriate for the food and
the activity being conducted and, if applicable, for the food animals that are to be
slaughtered, with (a) water that is adequate in quantity, temperature, pH and pressure
to meet the needs of the establishment; […]
15 | P a g e
Further clarification of CFIA’s intention is required. In our view, the guidance document will
need to explain whether or not an operator needs to monitor the water pressure on an ongoing
basis or, whether evidence of acceptable results (ATP OR micro) canbe used to justify clean
hands. What are the CFIA’s expectations with respect to PH levels? Does it suffice that water
coming out of the pipe(s) is effective for the cleaning solution being used?
Also when reading subsection66.(1)(a) in conjunction with subsection 65.(1)(b), we wish to
highlight that some provinces have not met the requirements related to the standards for
drinking water.
65.(1)Any water that might come into contact with a food must, unless the water does
not present a risk of contamination of that food, be potable and must […]
(b) meet the standards set out in the document entitled Guidelines for Canadian Drinking
Water Quality – Summary Table, prepared by the Federal‐Provincial‐Territorial
Committee on Drinking Water of the Federal‐Provincial‐Territorial Committee on Health
and the Environment and published by the Department of Health on its website, as
amended from time to time.
Regulations should clarify that if the established standards of a municipality are good enough
for residents of that municipality, the meat establishments should not be held to a higher
standard and be required to conduct additional treatment to meet that standard.
Section 70Every person who is involved in the manufacturing, preparing, storing,
packaging or labelling of a food or in the slaughtering of food animals must have the
competencies and qualifications that are necessary to carry out their duties.
The Council welcomes the performance‐based focusof this regulatory provision. Members are
given the flexibility to adopt the processes, procedures, or standards to meet the desired
outcome. The Council encourages the CFIAto further define its expectations in the guidance
document. For example, meat establishments would need confirmation that the written
training program under HACCP would be sufficient to meet the “competency” requirement of
subsection 70. The Council requests confirmation that meeting the current FSEP requirements
will also meet this expectation.
16 | P a g e
Section 71Every person who enters or is in an area where a food is manufactured,
prepared, stored, packaged or labeled or where food animals are slaughtered must wear
clothing, footwear and coverings, including gloves, a hairnet, a beard net and a smock,
that are sound, clean and in sanitary condition and that are appropriate for the food and
the activity being conducted.
In our comments pertaining to the 2014 version of this section, we questioned the risk‐based
justification for the hygiene requirements for “stored” and “packaged” products. “Stored”
product is already packaged and sealed, thereby reducing the risk of contamination of the food.
Requiring employees to wear gloves instead of frequently washing hands be used as permitted
in foodservice can create potential employee safety issues. For example, ergonomic studies
have demonstratedthat pulling leaf fat from a pig carcass is preferable without gloves as it puts
less stress on the hands. This practice is accepted by FSIS in U.S. establishments and should not
cause an equivalency issue.
The key section of paragraph 71 is “appropriate for the food and the activity being conducted”.
The guidance document could help promote compliance by describing situations where the
clothing, gloves, a beard net and a hairnet are or are not required.
Section 73Every person who enters or is in an area where a food is manufactured,
prepared, stored, packaged or labelled or where food animals are slaughtered must
refrain from spitting, chewing gum, using tobacco products, eating, drinking any
beverage other than water, having unnecessary contact with the food and doing any
other act that presents a risk of contamination of the food.
FSIS allows operating plants to supply energy drinks to employees in company controlled
coolers on the “kill floor” and in other warm or hot areas to keep employees hydrated,
especially in warm and hot months. Some of our members have adopted that practice. The
Council encourages the CFIA to consider modifying this regulatory provisionby building in an
exemption forfederally‐regulated establishments that wish to adopt the FSIS practice and
supply energy drinks to employees in controlled situations.
17 | P a g e
Subsection76An operator must prevent any person who is suffering from, or is a known
carrier of, a communicable disease or who has an open or infected lesion from being in
an area of an establishment where a food is manufactured, prepared, stored, packaged
or labelled or where food animals are slaughtered, if the person’s condition presents a
risk of contamination of the food.
The Council encourages the CFIA to provide a list of communicable diseases in the guidance
documents or refer regulated parties to its website or that of local or provincial health
authorities. This approach would provide regulated parties with access to an objective, credible
third‐party scientific assessment of what constitutes a “communicable disease” and contribute
to shield them against an employee’s potentially mistaken belief they are making a subjective ‐
and possibly discriminatory – judgement call.
Subsection 77.(2) If the results of the investigation indicate that the food presents a risk
of injury to human health, the operator or the holder of a licence to import, as the case
may be, must notify the Minister without delay.
Based on the assumption that the PCP is operating correctly, corrective actions will be taken
and the food will not be released into commerce. In a risk‐based inspection environment, care
should be taken to ensure that the enforcement action is proportionate to the risk sought to be
addressed. The Council recommends that the wording of subsection 77.(2)be amended to
indicate that the immediate notification is required only in cases where the food has left the
control of the operator orthe holder of the licence to import.
Also, there is a need to define “without delay”. Does that mean “immediate notification?”
Expressions “without delay” and “as soon as possible” are scattered throughout the regulatory
text. The Council suggests that the CFIA clarify those expressions in the guidance documents to
help facilitate understanding of the regulatory requirements.
Subsection 79.(2)The operator and the holder of a licence to import must conduct a
recall simulation based on the recall procedure at least once per year.
This requirement raises many practical implications for the operators or importers that are
contemplating applying for multiple licences. Depending on the scale of the operations, one
yearly recall simulation per licence may be unwieldy.
18 | P a g e
In cases where the holder of a licence to import has multiple sites, does a recall simulation need
to be completed for each site? What if the licence holder held the import license on a corporate
basis? Would only a recall simulation at the corporate level be required?
If an operator holds a licence at the corporate level and lists multiple plants, could the recall
simulations at the plant level be staggered on a yearly basis to address different plants?
Alternatively, could an operator bundle plants for recall simulations?
Those are some examples of the combinations and permutations that are to be considered as
the CFIA defines the requirements. Greater clarification of the CFIA’s expectations would be
required as our members plan for the transition to a licensing regime. This could be easily
achieved in the context of a meeting designed to address some of the operational implications
linked to the introduction of a licensing regime under the new regulatory framework.
Part 5, Traceability
In keeping with its recommendations on the 2004 version, the Council welcomes the reduction in the retention period for documents in subsection 84(3) from three (3) to two (2) years. Subsection 85.(1) remains problematic because of the potential to generate unnecessary business costs.
Subsection 85.(1) A person must, at the Minister’s request, provide the Minister with
any document referred to in section 84, or any part of such a document,
(a) within 24 hours after receipt of the request, or within a shorter time limit if the
Minister considers that it is necessary to identify or respond to a risk of injury to human
health associated with a food commodity; and
(b) if provided electronically, in a single file and in plain text that can be imported into
and manipulated by standard commercial software.
(2) In paragraph (1)(b), “plain text” means data whose semantic content is available
without the use of cryptographic techniques.
With respect to the requirements under subsection 85.(1)(a), a turnaround time within the
span of 24 hours or a shorter time limit to produce the required documents may not be
achievable depending on the scope of the information required. Judging by the language of this
subsection, it would appear that the CFIA is making a distinction between documents that are
being requested for a routine CFIA intervention as opposed to a food safety incident. Again,
this raises the issue of proportionality. If the enforcement response is to be dictated by the
19 | P a g e
level of non‐compliance, then an explanation of the criteria that will guide the retrieval time
limits of the documents being requested by the Minister would be most helpful.
Clarification with respect to the on‐site record retention times would also be welcome to help
address this issue. How long must records remain on site? Can records be stored off‐site as
long as they can be retrieved and provided within 24 hours of the Minister’s request? We
believe that the CFIA should clarify issues in relation to the storage and retrieval of documents
in the guidance documents.
Council members understand that reference to standard commercial software under 85.(1)(b)
refers to currently available technology such as the Windows platform. Members would
appreciate assurances that this requirement will not create undue expectations that meat
establishments must remain at the forefront on the latest technological developments to
communicate with CFIA.
Part 6, Commodity Specific Requirements
Section 130A licence holder must provide a food animal with sufficient space to avoid
the suffering, injury or death of the animal.
Section 131 A licence holder must provide a food animal with sufficient ventilation to
avoid the suffering, injury or death of the animal.
What does sufficient mean? We note that the glossary of terms at Chapter 4 of the Meat
Hygiene Manual of Procedures, Meat Processing Controls and Procedures,defines the use of the
expressions “where necessary” and “where appropriate” or the terms “adequate” and
“sufficient” as follows:
Where this chapter of the Meat Hygiene Manual of Procedures uses the
terminology "where necessary", "where appropriate", "adequate", or
"sufficient", it is up to the operator of a registered establishment in the first
instance to decide whether a requirement is necessary, appropriate,
adequate, or sufficient to achieve the objectives of the Meat Inspection
Regulations, 1990. In determining whether a requirement is necessary,
appropriate, adequate, or sufficient to achieve the objectives of the
Regulations, account should be taken of the nature of the operation/activity
and of its intended use. The operator may justify his choice under the procedures
based on the Hazard Analysis Critical Control Points (HACCP) principles or under
the operational procedures of a registered establishment.
20 | P a g e
It is hoped that the guidance document will adopt a similar approach with respect to the
explanation of the term “sufficient” in the context of the humane treatment of animals. A
glossary of terms to provide guidance to the operator in its determination of the requirements
that must be met to achieve the objectives of the SFCA and the Regulations would be most
helpful.
Section 135.(2)The licence holder must conduct the examination under the supervision
of an official veterinarian within 24 hours before the time of slaughter.
Section 135.(2) pertains to an Ante‐Mortem Examination and Inspection. Please define “under
the supervision of an official veterinarian”. Does this mean that the physical presence of both
the inspector and the veterinarian is required during the examination or that the veterinarian
may be on site but not present with the inspector while the inspector conducts the
examination?
The Council believes that greater clarity of intent is required. There is a need to revise the
drafting of the section and explain the meaning in the guidance document.
Section 157 A licence holder or an inspector who is authorized to apply an inspection
legend in accordance with section 180 must apply it to a dressed, whole carcass or
dressed, half carcass that is identified as edible under section 123, other than such a
carcass or half carcass of a domesticated rabbit or a bird that is not an ostrich, rhea or
emu, after the post‐mortem inspection or examination and before refrigeration, by
(a) stamping it directly onto the carcass or half carcass; or
(b) applying to the carcass or half carcass a label that bears the inspection legend,
includes a unique identifier and the date of slaughter of the food animal from
which the carcass is derived and that is displayed on the carcass or half carcass.
The Council appreciates that an inspection legend can be applied to a carcass either through a
stamp or a label. In reviewing the requirements of subsection 157 further, the Council is of the
view that an inspection legend is not required on a carcass that is cut at the same facility that
slaughters the food animal. The ink can cause issues in the finished product or lead to
additional trim loss while a label can become a foreign object. In keeping with a practice
accepted by FSIS, the Council recommends that an establishment that slaughters food animals
then cuts all carcasses from those animals in the same establishment be exempt from the
21 | P a g e
requirements of subsection 157. Any carcasses that are shipped from the establishment in
quarter, half or full carcass form must be stamped as in subsection 157.
In this and/or subsection 180 (at pages 22‐23), the Council believes that the guidance
document should clarify the meaning of the inspection legend, i.e. the inspection legend means
that the product has been produced under CFIA oversight.
Subsection 158.(a)A licence holder may send or convey from one province to another an edible meat product with a label that does not comply with these Regulations if (a) it is a prepackaged meat product, other than a consumer prepackaged meat product, that is sealed with a tamper‐resistant seal or it is in a conveyance that is sealed with a tamper‐resistant seal;
To avoid confusion, the Council suggests that the CFIA maintain the term “tamper‐evident” of
the MIR rather than introduce the new term of “tamper‐resistant”, especially if there are no
policy reasons for doing so.
Subsection 164.(1)A licence holder must obtain documents containing the following
information from the person who owned or had the possession, care or control of the
food animal that is an equine or a bird other than an ostrich, rhea or emu prior to its
slaughter: […]
(a) the name and contact information of the person who owned it and any person
who had the possession, care or control of it immediately before its arrival at the
establishment […]
(g) in respect of the last 120 days of the life of a bird that has been used for breeding
or egg production or in respect of the life of any other bird,[…]
Does subsection 164.(1)(a) apply catchers, drivers, et al? If so, it should only apply to growers.
Subsection 164.(1)(g) requires information for the 120 days of a bird’s life. For chickens used in
breeding or egg production, eggs are co‐mingled in the hatchery so the receiving plant won’t
have that information. Packers can typically identify producers that contributed to a set of birds
entering their facility but not a specific animal to a specific producer.
22 | P a g e
Subsection 166(d)the meat product is delivered for inspection, without delay, to an
establishment where it is stored and handled in its imported condition by a licence
holder.
As noted above in our comments under subsection 77.(2) at page 17, there is a need to define
“without delay”.
Subsection 180.(1)A licence holder or an inspector is authorized to apply the inspection
legend set out in Figure 1 of Schedule 1 to a meat product, whether prepackaged or not,
and to use that inspection legend in connection with that product if the following
conditions are met:
(a) the meat product was manufactured, processed, treated, preserved, packaged or
labelled by the licence holder in accordance with the Act and these Regulations;
(b) if the meat product or any meat product that it contains was manufactured,
processed, treated, preserved, graded, stored, packaged or labelled in Canada,
that activity was conducted by a licence holder in accordance with the Act and
these Regulations;
(c) any meat, meat by‐product or mechanically separated meat that the meat
product contains
(i) is derived from food animals that were slaughtered by a licence holder
in accordance with the Act and these Regulations, or
(ii) was imported by a licence holder in accordance with the Act and these
Regulations;
(d) the meat product meets the requirements of paragraphs 10(a) to (d), Division 5
of Part 6 and Division 7 of Part 12; and
(e) the inspection legend is applied or used in the establishment identified in the
licence holder’s licence, unless the meat product is to be exported and the
inspection legend is applied to the conveyance or used in connection with the
conveyance in which the meat product is exported.
(2) The licence holder or inspector is authorized to apply and use the inspection legend set
out in Figure 2 of Schedule 1 instead of the one set out in Figure 1 of that Schedule if the
meat product is a prepackaged meat product and its container
23 | P a g e
(a) is a hermetically sealed package that is labelled in a legible and permanent
manner so as to make it possible to identify the establishment identified in the
licence holder’s licence;
(b) is a casing or bag that is closed by a clip, if the licence holder’s licence number is
legibly engraved on the clip and is visible when the clip is closed; or
(c) bears the licence holder’s licence number on any part of the label except the part,
if any, that is applied or attached to the bottom of the container.
This subsection raises several issues of concerns for our members.
To begin, we notice that CFIA’s efforts at harmonization include a change in the visual depiction
of the inspection legend from a crown to an outline of the maple leaf. Is this necessary? At a
minimum, our members should be givenfive years to make the necessary changes to minimize
thecosts of compliance.
Subsection 180, as currently drafted, appears to suggest that a transfer of a meat product to
another establishment, whether prepackaged or not, would no longer be permissible. The
Council requests that the CFIA clarify whether this interpretation is correct. If so, this will
represent a significant departure from the currently accepted practice. We fail to understand
the rationale for the change when historically a letter was accepted to enable reconciliation.
The regulation should be amended accordingly.
The wording of subsection 180.(1)(e) appears to suggest that the inspection legend must be on
the conveyance rather than the product while the wording of subsection 180.(2)(a) appears to
suggest the opposite. Subsection 180.(2)(a) is a more accurate depiction of reality; meat is
shipped in combos for the purposes of commerce.
The use of the word “permanent” under subsection 180.(2)(a) would appear to suggest that a
sticker cannot be a used “to identify the establishment”. Again, clarification of CFIA’s intent is
required.
The Council encourages the CFIA to review subsection 180 as a whole to ensure that its efforts
at harmonization do not dilute the accepted practices and procedures of the meat industry.
CONCLUSION:
When dealing with outcome based as opposed to prescriptive regulation, vagueness becomes a
challenge to address to ensure that the regulations set out an objective standard of sufficient
clarity to permit the regulated party to know in any given circumstance whether or not he/she
24 | P a g
is compl
food safe
use of
“contam
We also
licensing
enabling
understa
CFIA to c
website.
complem
friendly v
section(s
facilitate
experien
This con
safety re
We wou
more det
the conte
Regards,
Suzanne
Director,
g e
iant. This co
ety regulatio
horizontal
inated” requ
note that s
, trade, prev
statute, i
anding of the
consider po
This projec
ment the use
version of th
s) of the SFCA
understand
ce in dealing
cludes the c
gulations. O
ld be please
tail. Please
ent of the Co
Sabourin
Legal and R
oncern is pa
ons are drive
outcome b
uires priority
sections of t
ventive cont
n this case
e regulation
sting a user
ct could be
e of plain la
he regulation
A or of the r
ding of its co
g with regula
comments o
Once again, t
ed to answe
don’t hesita
ouncil’s subm
Regulatory A
articularly pr
en by proac
based perfo
y attention.
the regulati
trols), make
e the SFCA
s. We ‐as o
r‐friendly ve
e conducted
anguage in t
ns would con
regulation its
ontent, espe
ations.
of the Cana
thank you fo
er any quest
ate to conta
mission.
Affairs
revalent in o
ctive approa
ormance st
ons dealing
extensive u
A, and to
others may h
ersion of the
d under CFI
the interpre
ntain pop‐up
self to enha
ecially for th
dian Meat
or the oppor
ion that you
act me if you
our comme
ches to food
tandards.As
with the h
se of cross‐r
the regula
have already
e regulation
A’s complia
tative guida
p links to the
nce the clar
hose stakeh
Council on
rtunity to pro
u may have
u wish to ha
nts given th
d safety con
noted, th
orizontal re
references t
ation itself.
y done so ‐ w
ns (when in
ance promo
ance docum
e language o
ity of the reg
olders that
the consolid
ovide our co
or discuss o
ave follow‐u
hat the prop
ntrol through
he definitio
equirements
to sections o
This frust
wish to invit
force) on C
otion strateg
ents. That
of the refere
gulatory tex
have little o
dated draft
omments.
our commen
up discussion
posed
h the
n of
(e.g.
of the
trates
e the
CFIA’s
gy to
user‐
enced
xt and
or no
food
nts in
ns on