IFR responds to HPA Consultation on Safety of Ready-to-Eat Foods

General comment

Paragraph 5.0 states that “the primary purpose of these guidelines is to assess the microbiological safety of ready-to-eat food at any point in the retail chain, i.e. retail, wholesale, catering and port of entry”. It is stated that the situations where food samples may be collected include the following:

1. during predefined sampling programmes such as LACORS/HPA studies
2. samples taken during food inspections
3. samples to confirm previous findings
4. samples collected during outbreaks
5. complaints relating to spoilage.

Microbiological criteria to be complied with by food business operators are stated in EC regulations No. 2073/2005 , and No. 1441/2007 and include Food Safety Criteria  for ready-to-eat foods that apply throughout the shelf-life of the foods (Scientific Panel on Biological Hazards, 2007). The guidance relating to pathogens given in the HPA draft guidelines differs from the food safety guidelines stated in the EC regulations.

The food safety criteria for ready-to-eat foods  stated in the EC regulations should be reproduced in the HPA document, and the aim should be to use the sampling and testing regimes specified in those regulations, particularly during LACORS/HPA studies and during food inspections.

5

1.0

Para. 1 states that these guidelines have a different emphasis from the previous guidelines. It is difficult to see what change of emphasis is intended or needed. It is stated that the revised guidelines are risk-based, focussing on public health and consumer protection.  All microbiological safety guidelines that are concerned with pathogens should be risk-based and relate to public health and consumer protection, as do the EC guidelines. The purpose of the previous (2000) guidelines was stated as “to help food examiners and environmental health officers to determine the bacteriological quality of various ready-to-eat foods at the point of sale and to indicate the level of contamination that is considered to represent a significant potential risk to health”. It is difficult to see how the approach in the present draft guidelines differs from that in the 2000 guidelines in relation to food safety.

5

1.0

It is stated that “low numbers of pathogens, such as ……Listeria monocytogenes in ready-to-eat products probably represent a very low risk to immunocompetent people…”. But it is important to recognise that about 20% of the population may NOT be  immunocompetent; these include people aged over 60-65, people receiving drug treatment  for chronic diseases, people receiving chemotherapy or radiotherapy treatment for cancer, organ transplant patients, and pregnant women. 

6

1.0

The statement that “There may also be a need for action when detecting low numbers of these organisms in ready-to-eat foods because there is a variation in host susceptibility and interstrain differences in the pathogenicity of these bacteria” fails to give clear guidance. There is a need for clear directions about the actions to be taken.

7

1.0

The paragraph discusses the limits of sampling, but fails to make clear how this problem is dealt with; this is not helpful here and will lead to uncertainty about actions to be taken. Specifications for microbiological criteria state the number of units comprising the sample, the size of the sample,  as well as  the reference method used for detection of the organism (EC 2073/2005; ICMSF 2002).  These specifications have been made after consideration of the limits of sampling. It would be appropriate to make this information clear in the HPA guidelines. The comment in the guidelines that “Results should therefore be interpreted in context taking such factors into account and in discussion with a Food Examiner” gives insufficient help  to those for whom this document is intended, who include Food Examiners.

7

1.1

Food within the scope of the guidelines is stated to be ready-to-eat food sampled at any point in the retail chain, i.e. retail, wholesale and food service sectors. This is stated to include food in distribution terminals, catering operations, factory canteens, institutional catering, food service operations, shops and wholesale outlets and also ready-to-eat imported foods sampled at points of entry.

But, according to the EC regulation (EC) 2073/2005 as amended in (EC) 1441/2007, the EC food safety criteria are applicable to products placed on the market and throughout the shelf-life of the product. Therefore these EC food safety criteria  should be stated in the present draft guidelines. The EC food safety criteria do not include criteria for E.coli O157 and other verocytotoxin-producing E.coli, but inclusion of similar criteria to those for Salmonella, as in the present draft HPA document, is reasonable.

8

1.3

It is stated that European regulations are a legal requirement…. and that the present guidelines have no legal basis but provide public health microbiological criteria. But the present guidelines differ from the EC criteria in the following respects

- the draft guidelines fail to include sampling plans or reference methods for detection of pathogens and other microorganisms
 
-  the EC regulations include a Food Safety criterion for staphylococcal enterotoxins in cheeses etc (RTE foods) and Process Hygiene criteria for coagulase-positive staphylococci in cheese, milk powder and whey powder.

In contrast, the HPA draft guidelines for pathogens do not specify a test for Staphylococcal enterotoxins, but specify a test for Staphylocoocus aureus and other coagulase-positive staphylococci.

- EC1441/2007 gives clear food safety criteria for Listeria monocytogenes in RTE foods  and makes clear that a limit of 100 cfu/g applies throughout the shelf-life.  In contrast the HPA guidelines are less clear, and the interpretation and action required if L.monocytogenes is detected by enrichment does not agree with the EC guidelines

10

1.6

It is stated that “However, for public health investigations, for reasons of increased speed or sensitivity, different methods as well as sample sizes may be utilized”. This comment needs modification. The EC food safety criteria for RTE foods should be reproduced in the present document; these criteria include specifications for number of units comprising a sample, sample size, and reference method for detection/enumeration and they apply throughout the shelf-life of the food. If “public health investigations” means investigation of a possible outbreak, then sampling and methods may need to be modified, but the aim should be to obtain the number of samples specified in the EC food safety criteria, and to use methods that have been demonstrated to give equivalent results to the reference method.

10-11

1.7

This section recommends that environmental sampling should be used “for follow-up of microbiological results that are either unsatisfactory of potentially injurious for health”.

This is too narrow an approach, as sampling of the production and processing environment can be a useful tool to identify and prevent the presence of pathogenic microorgansims in foodstuffs (EC No. 2073/2005).  In the case of Listeria monocytogenes, which persists in the environment of food production areas, environmental sampling should be recommended as the most effective method to detect Listeria in a food production area, and to assess the risk of product contamination from the environment  (ICMSF, 2002; CFA/BRC, 2006).    Thus procedures can be adopted to eliminate the bacterium from the environment and to prevent contamination of food.

Therefore, where possible, environmental sampling should be used in order to prevent food safety problems, for example in food inspections.

12

2.0

It should be made clear here that, according to EC No. 2073/2005 as amended, food business operators are required to ensure that foodstuffs comply with the relevant microbiological criteria set out in the Annexe to that regulation.  These food safety criteria  should, therefore,  be included in the present draft document. We suggest that Food Safety criteria for RTE foods given in  EC No. 1441/2007 be reproduced as a Table  in the draft HPA document, and a separate Table be included for microorganisms that are not included in the EC document. 

13

2.2

This section states that low numbers of some pathogens (listed in Table 2.1)  in foods may pose a greater risk to vulnerable groups who are more susceptible and at greater risk of developing more serious disease.  It states that “action may be justified…”. This comment is of limited help to users of these guidelines. As stated above, the vulnerable groups probably constitute over 20% of the population.

14

Table 2.0

See the comments above, on page 12, item 2.0.

-Also, in the EC regulations a criterion for Cronobacter sakazakii (Enterobacter sakazakii) is only applied to dried infant formula and dried dietary foods for special medical purposes intended for infants below six months of age; further evidence is needed  to justify the application of this criterion to a wide range of RTE foods.

-Where a pathogen is detected, the risk category is listed as “High”. The Action heading in each case states “Immediate investigation…consider product recall.”.

Surely. high priority should be given to withdrawal or recall of the product or batch of foodstuffs, as stated in  EC 178/2005 Article 7.

16

Table 2.1

This should be replaced. See comments on page 12  item 20.
If Listeria monocytogenes is detected at 10-100/g in a food that allows growth of the bacterium, the following action should be included:
-  check that the records of the food business operator who produced it show that before the food left the control of the producer it showed an absence of L.monocytogenes in 25g
-  determine whether the number of L.monocytogenes is likely to be >100/g at the end of shelf-life.
Help with this assessment can be found via the Combase System (http://combase.cc) which is sponsored by the Food Standards Agency.(FSA, 2008).

23

2.5.6

The sentence “V.parahaemolyticus is killed by most heat treatments” would be better replaced with a more precise indication of sensitivity to heat.

26

Table 3

The Table should make clear that if Listeria spp. are detected then the number or presence of Listeria monocytogenes should be tested for, and the criteria in (EC) No. 1441/2007 apply.

29

4.0

Paragraph 2. the statement “storage below 8°C will prevent growth of most food-borne pathogens” should be followed by “with the notable exceptions of Listeria monocytogenes and Yersinia enterocolitica”.

29

4.0

Paragraph 3.  We suggest a modification of the sentence starting “In meat products for example..” to read
“In meat products, for example, the flora frequently consists almost entirely of lactic acid bacteria (mainly lactobacilli and streptococci) strains of which will grow well at refrigeration temperatures”.

32

Table 4.0

Food group 1 Examples. We suggest that this should read “Canned  products such as tuna, salmon, corned beef, soups, stews, desserts, fruit”

32

Table 4.0

Food group 3. Examples. We suggest that “Cooked foods such as” be inserted before “whole pies……etc” , that “cakes with dairy cream” should be removed to Food Group 7, because the dairy cream carries the main risk and is not cooked, and that the following be added to the Examples “canned, pasteurized foods including soups, fruit juices”

32-33

Table 4.0

Some of the types of food listed in Table 2 of the 2000 guidelines do not appear to come within the food groups specified in Table 4.0  e.g. tripe, taramasalata, humous, tzatziki and other dips, mayonnaise dressings, samosa, satay

33

Footnote Table 4.0

Footnote d should be amended to read “most canned  foods are commercially sterile” . This is because thermophilic spore-forming bacteria may survive the heat treatment given to canned foods, but will not grow at temperate, ambient storage conditions, and their presence does not mean that the food is unsatisfactory  (special heat treatment may be required for canned foods destined for tropical conditions).

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5.0

Section 5, A section on  “How to use the guidelines” should be placed at the start of the document.

35

5.1

We query the statement that “Detection of pathogens in ready-to-eat foods is very uncommon”; there are indications that  detection of Listeria monocytogenes is NOT uncommon. The statement “It is therefore essential that appropriate action is taken in a timely way” is a non sequitur; action is essential because pathogens pose a food safety hazard.

References cited in the comments above:

Chilled Food Association (CFA)/British Retail Consortium (BRC) (2006) Guidance on the practical implementation of the EC regulation on microbiological criteria for foodstuffs. Ed. 1.2.

EC Regulations cited in HPA draft document

Food Standards Agency (FSA) (2008) Predicting bacteria in food. FSA News, December.

International Commission on Microbiological Specifications for Foods (ICMSF) (2002) Microorganisms in foods 7. Microbiological testing in Food Safety Management. Kluwer Academic/Plenum Publishers, New York, p199.

Scientific Panel on Biological Hazards (2007)  Opinion of the Scientific Panel on Biological Hazards on microbiological criteria and targets based on risk analysis. EFSA Journal 462, 1-29.