Risk Assessment/Legal Req/Safety Management Flashcards Preview

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Flashcards in Risk Assessment/Legal Req/Safety Management Deck (49)
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1

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

Legal limits

2

The legal limit type for food packaging materials is:

SML: specific migration limit

3

What is the regulatory limit type for AGROCHEMICALS?

MRL: maximum residue limit

4

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

test compliance with regulations, premarket self-control
(company may lack proper test methods on site)

5

What are MLs? What are they for?

Maximum levels
Food additives, Naturally occurring toxins, contaminants, nutrients

6

What are 4 examples of agrochemicals?

Feed additives
Vet drugs
Pesticides/herbicides
Biocides

7

What should the lab report for contaminant analysis include?

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

8

What is the MRL?

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

9

Allergen limits can either be _____ or _____.

detected/not detected (+/-)
or set limit

10

What are the regulatory agencies that establish MRLs?

Codex Alimentarus
Canada: PCPA (pest control products act)

11

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

True

12

When is a product considered non-compliant?

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

13

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

class 1 hazard
immediate recall

14

MRLs are usually expressed in:

ppm

15

What is risk, in relation to hazards?

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

16

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

risk assessment

17

What is a hazard (in food)?

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

18

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

safe levels
(ADI, or Acute Ref Dose)

19

Assessing ____ ____ is a key step in risk assessment.

dietary exposure

20

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

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

21

How is dietary intake calculated?

(conc in food x intake rate)/body weight

22

Cancer benchmark is:

exposure at which cancer risk is 1 in a million

23

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

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

24

What are ADI and Acute RfD?

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

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

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

26

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

adulterated;

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

27

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

Food Residue Exposure Assessment (Health Canada regulated)

28

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

meat, shellfish, fish, dairy (animal sources)

29

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

- 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

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

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

What are some examples of FSMSs?

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

32

the 3 stages of method development:

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

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

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

34

What is a CCP?

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

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

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

36

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

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

___ ____ is an essential part of quality control

sample analysis

38

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

mean; level of uncertainty

39

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

Sampling
Sample prep
Instrument Analysis
Data treatment
Report

40

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

False: both can be used for compliance testing.
Official methods are used by gov agencies, but acceptable also have official recognition as alternatives.

41

Why is toxicant analysis important? (3)

protect consumers
compliance
demonstrate/maintain quality

42

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

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

43

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

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

44

For regulatory compliance:
How is the problem of inconclusive results arising from UNCERTAINTY in analytical tests prevented?

Established STANDARDIZED PROCEDURES
- official instruments/methods/sampling for each toxin, matrix, etc.
- standardized procedure for results interpretation

45

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

AOAC
ISO
Codex Alimentarus
IUPAC
CEN

46

At what steps are standardized procedures necessary? (4)

sampling
identification
quantification
results interpretation

47

How does an accredited lab differ from other labs?

standardized (follow requirements of ISO, etc)
have LMS - laboratory management system

48

The analytical requirements differ depending on the final _____.

objective (exposure analysis? compliance testing?)

49

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

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