Risk Assessment/Legal Req/Safety Management Flashcards

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1
Q

Safety Agencies define ___ ____ for food products, which is the level that is determined to be safe for consumers.

A

Legal limits

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2
Q

The legal limit type for food packaging materials is:

A

SML: specific migration limit

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3
Q

What is the regulatory limit type for AGROCHEMICALS?

A

MRL: maximum residue limit

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4
Q

why would a company send their product to a lab to be tested?

A

test compliance with regulations, premarket self-control

company may lack proper test methods on site

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5
Q

What are MLs? What are they for?

A

Maximum levels

Food additives, Naturally occurring toxins, contaminants, nutrients

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6
Q

What are 4 examples of agrochemicals?

A

Feed additives
Vet drugs
Pesticides/herbicides
Biocides

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7
Q

What should the lab report for contaminant analysis include?

A

parameters (product, residue analysis)
method/equipment
results
specification (compare w/ legal limits)

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8
Q

What is the MRL?

A

max residue limit: max amount of contaminant PERMITTED in the product (concentration)

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9
Q

Allergen limits can either be _____ or _____.

A

detected/not detected (+/-)

or set limit

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10
Q

What are the regulatory agencies that establish MRLs?

A

Codex Alimentarus

Canada: PCPA (pest control products act)

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11
Q

True/False: the MRL is different for different food commodities

A

True

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12
Q

When is a product considered non-compliant?

A

If the mean (+/- uncertainty) exceeds the MRL level

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13
Q

Undeclared allergens are classified as a _______ hazard, and the consequence is:

A
class 1 hazard
immediate recall
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14
Q

MRLs are usually expressed in:

A

ppm

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15
Q

What is risk, in relation to hazards?

A

relates PROBABILITY of occurence and MAGNITUDE of adverse effects for a hazard

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16
Q

Evaluating known/potential adverse effects due to exposure to hazards in food is:

A

risk assessment

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17
Q

What is a hazard (in food)?

A

An agent (phys/chem/bio) or property of the food that could have adverse health effects

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18
Q

Risk assessment in threshold toxins is done by comparing exposure to:

A

safe levels

ADI, or Acute Ref Dose

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19
Q

Assessing ____ ____ is a key step in risk assessment.

A

dietary exposure

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20
Q

What should you consult to compare trademarked names of chemicals, especially on imported goods?

A

CAS: chemical abstracts service (registry number for each chemical)

21
Q

How is dietary intake calculated?

A

(conc in food x intake rate)/body weight

22
Q

Cancer benchmark is:

A

exposure at which cancer risk is 1 in a million

23
Q

How does risk assessment for threshold/non-threshold toxins differ?

A

threshold: compare dose with SAFE levels
nonthreshold: compare dose with SPECIFIC RISK LEVELS (ex: cancer benchmark)

24
Q

What are ADI and Acute RfD?

A

ADI: acceptable daily intake (range)
Acute RfD: acute ref dose; acceptable amount within 24 hrs
both refer to safe dose estimate for a threshold toxin

25
Q

Dioxins are classified as ____, due to their (hydrophobic/hydrophilic) nature, and what other features? (3)

A

POPs (persistent organic pollutants)
hydrophobic
bioaccumulative (in fatty tissue), persistant (long half life, hard to destroy), widespread

26
Q

Canada Food and drug regulations states that food with chlorinated dibenzo-p-dioxins is _____. The zero tolerance policy is now impractical because: (2)?

A

adulterated;

  1. improved analytical techniques (can detect lower concentrations)
  2. dioxins are almost omnipresent in the environment and are persistent
27
Q

When a new pest control substance is introduced, what must be done before it is used?

A

Food Residue Exposure Assessment (Health Canada regulated)

28
Q

Over 90% of dioxin exposure in humans is from food, from what sources?

A

meat, shellfish, fish, dairy (animal sources)

29
Q

What parts of a Food Safety Management System require food toxin analysis? (5)

A
  • regulatory compliance testing
  • analyze water supply
  • analyze suppliers (ingredients)
  • Critical points (assess @ multiple points in system where contamination could occur)
  • Crisis management (response to recall/outbreak, find source)
30
Q

What is a zero tolerance policy? Why might it no longer be relevant in some cases?

A

Zero tolerance: any trace of the contaminant indicates that the product is unsuitable for consumption

Analytical methods/instruments are improving; able to sense much lower concentrations than older methods. Need to re-establish safety limits

31
Q

What are some examples of FSMSs?

A
HACCP
ISO22000
FSSC22000
BRC (British Retail Consortium)
GFSI (Global Food Safety Initiative)
32
Q

the 3 stages of method development:

A
  1. Literature review: search for appropriate method, past work done on similar compounds
  2. Method optimization: adjust methods for your parameters
    Method validation: confirm that it works
33
Q

The food industry is required to provide ________ to confirm the absence of contaminants, migration from packaging, etc.

A

Certificate of conformance
or certificate of analysis
or letter of guarantee
or test/safety records (done by approved methods)

34
Q

What is a CCP?

A

critical control point
point in process where:
- risk of contamination/exposure to hazard beyond safe levels
- acts as a key step in PREVENTING or REDUCING hazard levels to safe levels
- require quality control & monitoring to ensure safety

35
Q

Can a food company do their own safety testing for regulatory compliance purposes?

A

Yes, if they are able to follow APPROVED methods with the required instrumentation necessary for the toxin(s) of concern

36
Q

What is sampling? What factors affect the sampling size and method?

A

Taking a representative portion of a population for analysis

type of product, edible portion, homogeneity, size of population, type of toxin (level of risk), processing procedure

37
Q

___ ____ is an essential part of quality control

A

sample analysis

38
Q

When comparing results of a test to the regulatory limits, both the ____ and the ___ should be considered.

A

mean; level of uncertainty

39
Q

List the steps to a complete analytical method: (5)

A
Sampling
Sample prep
Instrument Analysis
Data treatment
Report
40
Q

True/False: Official Methods are better to use than Acceptable methods.

A

False: both can be used for compliance testing.

Official methods are used by gov agencies, but acceptable also have official recognition as alternatives.

41
Q

Why is toxicant analysis important? (3)

A

protect consumers
compliance
demonstrate/maintain quality

42
Q

True/False: If the mean levels in a product are above the regulatory limit, then it is 100% non-compliant.

A

False; if UNCERTAINTY levels are within the limit, then cannot conclude that product is non-compliant.

43
Q

What would a standardized procedure document tell you? (4)

A

Scope of the method (when applicable)
Reagents/amounts needed
Instrumentation
steps of procedure

44
Q

For regulatory compliance:

How is the problem of inconclusive results arising from UNCERTAINTY in analytical tests prevented?

A

Established STANDARDIZED PROCEDURES

  • official instruments/methods/sampling for each toxin, matrix, etc.
  • standardized procedure for results interpretation
45
Q

What are the organizations with established standardized procedures? (5)

A
AOAC
ISO
Codex Alimentarus
IUPAC
CEN
46
Q

At what steps are standardized procedures necessary? (4)

A

sampling
identification
quantification
results interpretation

47
Q

How does an accredited lab differ from other labs?

A

standardized (follow requirements of ISO, etc)

have LMS - laboratory management system

48
Q

The analytical requirements differ depending on the final _____.

A

objective (exposure analysis? compliance testing?)

49
Q

what role do accredited labs play in the food production chain?

A

As part of regulatory agencies
As part of food companies
As third party labs - can be hired by clients for official analytical testing