Risk Assessment/Legal Req/Safety Management

Question 1

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

Answer 1

Legal limits

Question 2

The legal limit type for food packaging materials is:

Answer 2

SML: specific migration limit

Question 3

What is the regulatory limit type for AGROCHEMICALS?

Answer 3

MRL: maximum residue limit

Question 4

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

Answer 4

test compliance with regulations, premarket self-control

company may lack proper test methods on site

Question 5

What are MLs? What are they for?

Answer 5

Maximum levels

Food additives, Naturally occurring toxins, contaminants, nutrients

Question 6

What are 4 examples of agrochemicals?

Answer 6

Feed additives
Vet drugs
Pesticides/herbicides
Biocides

Question 7

What should the lab report for contaminant analysis include?

Answer 7

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

Question 8

What is the MRL?

Answer 8

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

Question 9

Allergen limits can either be _____ or _____.

Answer 9

detected/not detected (+/-)

or set limit

Question 10

What are the regulatory agencies that establish MRLs?

Answer 10

Codex Alimentarus

Canada: PCPA (pest control products act)

Question 11

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

Answer 11

True

Question 12

When is a product considered non-compliant?

Answer 12

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

Question 13

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

Answer 13

class 1 hazard
immediate recall

Question 14

MRLs are usually expressed in:

Answer 14

ppm

Question 15

What is risk, in relation to hazards?

Answer 15

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

Question 16

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

Answer 16

risk assessment

Question 17

What is a hazard (in food)?

Answer 17

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

Question 18

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

Answer 18

safe levels

ADI, or Acute Ref Dose

Question 19

Assessing ____ ____ is a key step in risk assessment.

Answer 19

dietary exposure

Question 20

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

Answer 20

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

Question 21

How is dietary intake calculated?

Answer 21

(conc in food x intake rate)/body weight

Question 22

Cancer benchmark is:

Answer 22

exposure at which cancer risk is 1 in a million

Question 23

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

Answer 23

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

Question 24

What are ADI and Acute RfD?

Answer 24

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

Question 25

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

Answer 25

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

Question 26

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

Answer 26

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

Question 27

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

Answer 27

Food Residue Exposure Assessment (Health Canada regulated)

Question 28

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

Answer 28

meat, shellfish, fish, dairy (animal sources)

Question 29

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

Answer 29

- 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)

Question 30

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

Answer 30

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

Question 31

What are some examples of FSMSs?

Answer 31

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

Question 32

the 3 stages of method development:

Answer 32

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

Question 33

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

Answer 33

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

Question 34

What is a CCP?

Answer 34

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

Question 35

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

Answer 35

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

Question 36

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

Answer 36

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

Question 37

___ ____ is an essential part of quality control

Answer 37

sample analysis

Question 38

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

Answer 38

mean; level of uncertainty

Question 39

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

Answer 39

``` Sampling Sample prep Instrument Analysis Data treatment Report ```

Question 40

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

Answer 40

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

Question 41

Why is toxicant analysis important? (3)

Answer 41

protect consumers compliance demonstrate/maintain quality

Question 42

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

Answer 42

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

Question 43

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

Answer 43

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

Question 44

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

Answer 44

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

Question 45

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

Answer 45

``` AOAC ISO Codex Alimentarus IUPAC CEN ```

Question 46

At what steps are standardized procedures necessary? (4)

Answer 46

sampling identification quantification results interpretation

Question 47

How does an accredited lab differ from other labs?

Answer 47

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

Question 48

The analytical requirements differ depending on the final _____.

Answer 48

objective (exposure analysis? compliance testing?)

Question 49

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

Answer 49

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