FST5602-1: FOOD SAFETY MANAGEMENT

Risk Assessment: Instant noodles recalled over presence of

pesticide - Ethylene Oxide

DEVINDRAN A/L MURELIDARAN GS61244

AHMAD HAREEZ BIN MOHAMADIAH GS62315
CASE STUDY
 FILA TABLE
No Fact (known/given info) Ideas Learning Issues Action Plan (What you need
(opinions/idea (What you need to to do)
derived from the know)
facts)
1  The Singapore Food  Instant  What is Ethylene  To study and report the
Agency (SFA) recalls Noodle oxide? background information of
Mie Sedaap brand contaminated  Why can Ethylene oxide and its
instant noodle due to with Ethylene Ethylene oxide contamination in food.
high level of Ethylene oxide be found in  To study and report the
oxide instant noodles Ethylene oxide
product? physicochemical
 Ethylene oxide can  How does properties, and
occur in foods such Ethylene oxide toxicological
as spices, instant contaminate assessments.
noodles because of instant noodles?  To report the hazard
high usage during the  Is it spices? health effects and its
fumigation process,  Is any Ethylene health-based guidance
oxide outbreak value.
reported in  Expected output: Hazard
Malaysia? Identification and Hazard
Characterisation.
 FILA TABLE
No Fact (known/given info) Ideas Learning Issues Action Plan (What you need
(opinions/idea (What you need to to do)
derived from the know)
facts)
2 The Singapore Food SFA was able to  What are the  To study existing methods
Agency (SFA) on detect Ethylene methods for in the analysis of Ethylene
Thursday (Oct 6, 2022) oxide detecting oxide
issued a recall for two contamination in Ethylene oxide  Expected output:
products under the Mie food products. in foods? Information to be included
Sedaap brand instant  Does Malaysia in the background study
noodles brand after could detect
detecting ethylene oxide, Ethylene oxide
a pesticide, in the food in food?
products.
 FILA TABLE
No Fact (known/given info) Ideas Learning Issues Action Plan (What you need
(opinions/idea (What you need to to do)
derived from the know)
facts)
3 Ethylene oxide Ethylene oxide is  What is the  To estimate the health
has mutagenic and significant hazard hazard health risks of exposure from the
carcinogenic to human health. effects of consumption of spices
properties and can Ethylene oxide? and spices-based
therefore be genotoxic or  What is the products
carcinogenic. The current  Expected output:
exposure through food contamination Exposure assessment and
should be kept as low as level of Ethylene Risk Characterisation
possible oxide in spices-
based products?
 Is spices and
spices-based
product safe for
human
consumption?
 FILA TABLE
No Fact (known/given info) Ideas Learning Issues Action Plan (What you need
(opinions/idea (What you need to to do)
derived from the know)
facts)
4 The levels of Ethylene SFA is imposing a  What is the  To study and report the
oxide detected exceeded regulatory limit on regulatory limit existing Regulations or
the maximum limits stated Ethylene oxide in of Ethylene standards related to
in the Singapore Food food. oxide in Ethylene oxide in food.
Regulations. Malaysia and  To report current food
other countries? safety control measures in
SFA has directed Sheng mitigating the
Sheng F&B Industries to  What other contamination of Ethylene
recall Mie Sedaap Korean control oxide in food.
Spicy Soup instant measures to  Expected output:
noodles and Mie Sedaap mitigate this Information to be
Korean Spicy Chicken issue? explained in the risk
instant noodles. managements section
 FILA TABLE
No Fact (known/given info) Ideas Learning Issues Action Plan (What you need
(opinions/idea (What you need to to do)
derived from the know)
facts)
5 Consumers who have SFA was  What should the  To report the importance
purchased the implicated communicating authority do in of risk communication in
product are advised not to the risk to communicating mitigating this food safety
consume it. consumers. the hazard / issue
risk?
While occasional  Expected output:
ingestion of food Information to be
contaminated with explained in the risk
Ethylene oxide is not communication section
expected to cause
appreciable health risk.
HAZARD IDENTIFICATION
• Ethylene oxide (CAS registry number 75-21-8)

• known as E.O., EtO

• a cyclic ether and the simplest epoxide: a three-

membered ring consisting of one oxygen atom and two

carbon atoms.

• colourless, highly reactive gas at room temperature

and pressure.

• It has a high-water solubility.

• EtO is an organic compound with the formula C2H4O

 HAZARD IDENTIFICATION

• EtO was found not in the noodles but in

spices (flavoring packet).

• American Spice Trade Associations

estimates that between 40% - 85% of

spices in the U.S. are treated with EtO

each year.

• main advantage - no significant

impact on the appearance or flavour

of the spice.
HAZARD CHARACTERIZATION

•Many parts of the world, including the EU, prohibited the use of EtO as a

pesticide in 1991 due to its very hazardous nature, including Malaysia

•Codex also has not set Maximum Residue Limits (MRLs) for EtO.

•In some countries, it is permitted to use as a microbial reduction technique; for

example, in the U.S., 7 ppm residue tolerance of EtO on spices (ASTA,2009).

SFA also permitted EtO to be used in sterilizing spices under Singapore Food

Regulations which the MRLs of EtO should not exceed 50mg/kg (50ppm)
HAZARD CHARACTERIZATION

According to (ASTDR), such health effects of EtO comprises of:

•Respiratory Effects.

Bronchitis, pulmonary edema, and emphysema have been reported in workers after acute-duration high-

level exposure of EtO (Thiess 1963), but respiratory problems have not been reported to occur with

relatively low-level chronic-duration exposure (estimated long-term average of 5–10 ppm) (Joyner 1964).

•Haematological Effects.

Decreases in hemoglobin, haematocrit, erythrocyte count, packed cell volume, and/or increased

reticulocytes were reported in experimental animals (rats, mice, dogs) repeatedly exposed to ethylene

oxide vapor at 250–500 ppm for 6–13 weeks (Fujishiro et al. 1990; Jacobson et al. 1956; Snellings et al.

1984a).
HAZARD CHARACTERIZATION

•Endocrine Effects.

Pale coloration and enlargement of adrenals, and numerous fat vacuoles in the adrenal cortex were

reported in rats and guinea pigs exposed two or three times to ethylene oxide vapor at 841 ppm for 7

hours per exposure (Hollingsworth et al. 1956).

•Neurological Effects.

Central nervous system effects are frequently associated with human exposure to EtO in occupational

settings. Headache, nausea, and vomiting have been reported for >50 years (Blackwood and Erskine

1938; Sexton and Henson 1949; von Oettingen 1939). Reliable exposure levels are generally not available

in these cases.
HAZARD CHARACTERIZATION

•Reproductive Effects.

Limited human data are available. Possible associations between exposure to EtO and spontaneous

abortion have been explored in epidemiological studies of sterilizer workers (Gresie-Brusin et al. 2007;

Hemminki et al. 1982; Rowland et al. 1996). Limitations in these studies preclude drawing conclusions

regarding the associations between ethylene oxide exposure and pregnancy outcomes.

•Developmental Effects.

No data on potential human developmental effects of EtO exposure have been located. However, embryo

and fetal toxicity were reported in the offspring of rats exposed to 100–150 ppm during gestation; the

neonates were smaller in both length and weight and had reduced ossification of the skull and sternebrae

(Neeper-Bradley and Kubena 1993; NIOSH 1982; Snellings et al. 1982a). Therefore, the offspring of

humans exposed to EtO may be at risk for fetal and embryo toxicity.
HAZARD CHARACTERIZATION

•Cancer.

The carcinogenicity of ethylene oxide has been evaluated in several cohorts (EtO production and/or uses

in sterilization). Results of several studies show associations between exposure to ethylene oxide and

increased risk of selected cancer types (e.g., lymphona). The Department of Health and Human Services

(HHS) has classified ethylene oxide as known to be a human carcinogen (NTP 2016). The EPA

characterized ethylene oxide as “carcinogenic to humans” by the inhalation exposure route (EPA 2016).

The International Agency for Research on Cancer (IARC) has designated ethylene oxide as carcinogenic

to humans (Group 1) (IARC 1987, 2012).

 EXPOSURE ASSESSMENT

•No data for food intake expose for EtO residual contents in samples of

food products in Malaysia,

•However we are using data taken from research paper by (Jensen, 1988)

for these studies and compare with Malaysian Adult Nutrition Survey.

•After performing all the necessary calculation exposure in the Microsoft

Excel and the exposure mg/kg bw per week was generated which is 0.0004

as shown in Table 1.
 EXPOSURE ASSESSMENT

•No data for food intake expose for EtO residual contents in samples of

food products in Malaysia,

•However we are using data taken from research paper by (Jensen, 1988)

for these studies and compare with Malaysian Adult Nutrition Survey.

•After performing all the necessary calculation exposure in the Microsoft

Excel as shown in Table 1.

 EXPOSURE ASSESSMENT

•the exposure mg/kg bw per week was generated which is 0.0004

 EXPOSURE ASSESSMENT

• Since provisional tolerable weekly intake (PTWI) for EtO was not found, we

use the margin of exposure (MOE) approach:

• MOE = BMDL10/EXPOSURE

• an exposure to a genotoxic and carcinogenic substance that would

correspond to a MOE larger than 10 000 would be of low concern from a

public health point of view (RIVM, 2020)

 EXPOSURE ASSESSMENT

Sickness BMDL10 Value MOE

Lymphoma 9.1 ppm 182000

Mammary carcinoma 6.6 ppm 132000

•Hence since the MOE Assessment been carried out, and the result shown is

MOE > 10000 hence there is low concern risk with the assessment carried
RISK CHARACTERIZATION
•The qualitative and or quantitative estimation, including attendant uncertainties, of the probability of

occurrence and severity of known or potential adverse health effects in each population based on the

hazard identification, hazard characterization and exposure assessment. EtO can be genotoxic or

carcinogenic due to its mutagenic and cancer-causing characteristics. It has proven impossible to

establish an intake level without a risk to health since it is a so-called "carcinogen without threshold

value." Therefore, it is generally agreed upon that substance residues in meals are bad.

General Population

Using the MOE approach since there is no PTWI data available, it can conclude that level of low

concern as the amount resulting from applying a safety factor of 10,000

 RISK CHARACTERIZATION
Vulnerable Group

• Children are especially vulnerable to the harmful effects of EtO. EtO sensitivity is higher in

children than in adults.

• This is because EtO can damage DNA, and growing children are more vulnerable to DNA damage

than adults because their cells divide more quickly (Frequent Questions About Ethylene Oxide

(EtO), 2022).

• A single year of EtO exposure contributes more to lifetime cancer risk if that year occurs

during childhood.

• It is anticipated that the exposure will be on average somewhat higher than in the adult

population, since children usually have a higher exposure to substances in food than

adolescents and adults, because of their higher food intake/kg bw.

 RISK COMMUNICATION
• From the finding, spices are safe from EtO contamination in general, according

(EPA,2020), since research shows that no EtO residues will be present in spices at

the time of consumption.

• The safety evaluation (risk assessment) was also used based on the calculation of

MOE assessment in food. It is calculated based on the amount of food consumed

compared to the concentration of EtO from available data. The results show MOE

higher than 10000, which shows low concern risk from a public health point of view.

• The routine food safety surveillance program will be ongoing to ensure public

health protection.
 RISK MANAGEMENT

•To achieve the risk management objective, necessary to focus on efforts and

resources to reduce exposure to EtO in ways that make the most difference for

population health over the long term. Initiatives are described below:

 The need for international harmonization of EtO limit in food.

 Since EtO is genotoxic in almost all available studies, and the weight of

evidence supports a mutagenic mode of action for the carcinogenicity of EtO,

there is a need to do studies on dietary exposure assessment as

currently there is much news regarding EtO being detected in food.

THANK YOU