FDA CIRCULAR                    
No. 2022_______  
 
SUBJECT:  Guidelines on the development of a Risk Management Plan for 
Food Manufacturers, Repackers, Traders, and Distributors  
___________________________________________________________________________  
 
I. RATIONALE  
 
Pursuant to Rule 4.1ll of Section 4 Article II of the Implementing Rules and Regulation 
(IRR) of the Food Safety Act of 2013 otherwise known as “The Implementing Rules 
and Regulations of Republic Act No. 10611, “An Act to Strengthen the Food Safety 
Regulatory System in the Country to Protect Consumer Health and Facilitate Market 
Access of Local Foods and Food Products, and for Other Purposes” defines the Risk 
Management Plan (RMP) as a set of food product vigilance activities and interventions 
designed to identify, characterize, prevent or minimize risks relating to food products, 
and the assessment of the effectiveness of those interventions. The same provision 
states th at the RMP is a requirement for the issuance of the appropriate authorization.  
 
Further,  Section 2 Article II Book I of the Implementing Rules and Regulation (IRR) 
of the Republic Act 9711 otherwise known as “The Food and Drug Administration Act 
of 2009 ”, requires all concerned to implement the risk management plan.  
 
Fundamental to food safety is the protection of public health. According to the World 
Health Organization  (WHO) , 1 in 10 people worldwide is stricken with sickness after 
eating contaminated food, and about 420,000 people globally die every year due to the 
consumption of contaminated food, 125,000 of which are children under 5 years of age. 
Furthermore, according to the World Bank Report of 201 8, an estimated  $95.2 billion 
in productivity is lost per year in low and middle -income countries. According to the 
Joint FAO/WHO Consultation report , risks can be mitigated, obviated , and avoided  by 
effectively implementing appropriate measures through fo od risk management.  
 
  
II. OBJECTIVE  
 
General Objective  
 
To guide  the Food Manufacturers, Traders, and Distributors in crafting their Risk 
Management Plans  to guarantee that hazards and risks are prevented or at least 
minimized.  Specific Objectives are as follows:  
 
A. To provide a standard format in the development of a Risk Management Plan . 
B. To ensure that the crafting of their Risk Management is evidence and science -
based   
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 C. To ensure that the RMP is effectively communicated  to the r elevant 
stakeholders.  
 
 
III. SCOPE  
 
This FDA Circular shall apply to all Food Establishments engaged in the manufacture, 
importation, sale, offer for sale , and distribution of food products.  
 
 
IV. DEFINITION OF TERMS  
 
For the purpose of this Circular, the following  terms shall mean:  
 
A. Biological Hazards  – Refers to  hazards that include bacteria, viruses, parasites 
and moulds or fungi. They can pose a threat to human health when they are 
inhaled, eaten , or come in contact with skin. They can cause illnesses such as 
food poisoning, tetanus, respiratory infections , or parasite infections . 
 
B. Chemical Hazards  – Refers to  hazards including water, food contact materials, 
cleaning agents, pest control substances , contaminants (environmental, 
agricultural and process e.g., acrylamide), pesticides, biocides , and food 
additives.  
 
C. Hazard – Refers to the b iological , chemical,  or physical agents in, or conditions 
of food with the potential to cause adverse health effects.  
 
D. Physical Hazards – Refers to hazards are either foreign materials 
unintentionally introduced to food products (ex: metal fragments in ground 
meat) or natural ly occurring objects (ex: bones in fish) that are hazardous to the 
consumer. A physical hazard contaminates a food product at any stage of 
production. Food processors should take adequate measures to avoid physical 
hazards in food.  
 
E. Risk – Refers to the  function of the probability of an adverse health effect and 
the severity of the effect consequential to a hazard(s) in food.  
 
F. Risk Communication – Refers to t he interactive exchange of information and 
opinions throughout the risk analysis process concerning risk, risk -related 
factors , and risk perceptions, among risk assessors, risk managers, consumers, 
industry, the academic community, and other interested parti es, including the 
explanation of risk assessment findings and the basis of risk management 
decisions.  
  
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 G. Risk Communication Team  (RCT)  – Refers to a unit responsible for the 
development of risk communication, preparing and facilitating information 
exchange d uring risk management.  
 
H. Risk Management – Refers to t he process, distinct from risk assessment, of 
weighing policy alternatives in consultation with all interested parties, 
considering risk assessment and other factors relevant to the health protection 
of consumers and the promotion of fair -trade practices, and, if needed, selecting 
appropriate prevention and control options.  
 
I. Risk Management Plan  (RMP)  – Refers to a set of food product vigilance 
activities and interventions designed to identify, characterize, prevent,  or 
minimize risks relating to food products, and the assessment of the effectiveness 
of those interventions.  
 
J. Risk Management Team (RMT)  – Refers to a separate unit that is responsible 
for the implementation and monitoring of the organization’s risk management 
plan.  
 
 
V. GENERAL GUIDELINES  
 
A. Purpose of RMP  
1. The primary objective in developing the RMP shall be for the protection of the 
consumers.  
2. The RMP as a requirement in the A.O. 2020 -0017 and R.A. 10611 shall be 
made available during the inspection of the establishment  for review and 
evaluation.  
3. The RMP shall provide the establishment with a coherent but concise 
procedure for the vigilance activities that will be conducted to mitigate risk.  
B. Intended stakeholders  
1. This guidance document is for the use of the Food Manufacturers, Traders, and 
Distributors in the development of their  RMP.  
2. The RMP shall be required for all Food Manufacturers, Traders, and 
Distributors.  
3. Food Manufacturers, Traders, and Distributors with existing RMP before  this 
issuance shall be reviewed and revised to align  with these guidelines.  
C. Scope of RMP  
The RMT shall focus on the type of risks  that affects consumer health . 
1. The parameters  for the RMP shall include the company’s  environment  such as 
the premises, facilities, equipment, and other areas  or conditions where the 
product is manufactured as  stipulated in the provisions of A.O. on Food 
Hygiene .  
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 2. Other parameters shall also include the product , process, and personnel  where 
risks may be identified.  
3. Other risks that may be identified shall be included in the scope of the RMP.  
D. References in the development of RMP  
1. The establishment shall utilize its manual of operations, procedures, HACCP 
Plan (if available) , and other documented food safety systems . 
2.  The establishment shall also refer to the FDA rules and regulations , including  
A.O. 153 s. 2004. A.O. 2020 -0017 , A.O. 2016 -102, this Circular  and its 
amendments . 
E. Pre-requisite  
1. An understanding of the basic HACCP Principles is imperative to be able to 
develop the RMP.  
2. The RMP shall not replace the established food safety system  or other best 
practices in  the manufacture  of Food products . 
3. The establishment shall be required to have an establishe d food safety  system  
before  the development of the RMP.  
4. Documented food safety system shall also be required to ensure the success of 
RMP development.  
F. Implementation of the R isk Management Option  
1. Enacting e stablished food safety measures  to mitigate risks for the identified 
hazard  shall be regularly performed . 
2. Verification of the food safety system  shall be conducted to confirm if the 
desired food safety objective is being achieved . 
G. Monitoring and Review  of RMP  
1. A periodic review of the RMP shall be conducted and the frequency of its 
evaluation shall be specified.  
2. The establishment shall validate  the effectiveness of  its RMP . 
3. RMP shall also be updated and amended if  the review  of the R MT warrants it.  
H. Communication of Risk  
1. A regular meeting of the RMT shall be conducted  to monitor effective checks.  
2. In case of a risk event, the risk management team shall immediately call for a 
meeting.  
3. The RMT shall evaluate the capability of the establishment to rapidly respond  
to a risk event, coordinate with the competent authority and disseminate 
information.  
4. The RMP shall be transparent, documented, and communicated to all involved.  
 
 
VI. SPECIFIC GUIDE LINES  
 
The components of the Risk Management Framework shall include the following:  
A. Organiz ation of  the Risk Management Team  (RMT) .  
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 1.  The RMT shall be a separate unit that will identify, evaluate,  and assess risk 
to come up with a risk management option, review  the management decision , 
and implement and monitor the risk management plan.  
2. The roles and responsibilities of the Risk Manager, Risk Assessor, Risk 
Communicator, and the members of the RMT shall be defined . Likewise , it 
shall also identify the names, and contact numbers . 
3. For the Microenterprise, the roles of each person nel related to food safety shall 
be defined.  
4. The competencies of the members of the RMT shall be assessed  and training  
shall be  documented.  
B. Establish  the areas of possible risk occurrence.  
1. Description of the Site  
a. To be able to establish  possible  areas of  risk occurrence, a d etailed 
description of the manufacturer’s/distributors site  shall be documented.  
b. The second element of the RMP shall also include a site description to 
establish the condition where risk may occur.  
c. This shall provide a clear description of the physical attributes of the 
premises, grounds, and design of the facility . 
2. Description of t he Product  
a. Information on the product shall enable the RMT to understand the 
product characteristic and the possible factors that may affect its quality, 
safety, and purity, hence possible  areas  of risk occurrence.  
b. The characteristics of the product manufactured/distributed  shall be 
included in the RMP  which includes the following:  
i. Product details  
ii. Source of raw materials  
iii. Label  
c. Food Manufacturers with multiple products shall group the products 
with the same processes  and provide a product profile for each product . 
3. Description of all departments/offices with relevant responsibilities to food 
safety  
a. The RMT shall describe in detail the relevant departments/offices 
responsible for ensuring  the product safe from manufacturing, storage, 
and distribution.  
b. The RMT shall describe the trainings/orientation received by the 
personnel . 
4. Listing of  Food safety measures/Quality Assurance Schemes  
a. The RMT shall document an exhaustive list of  food safety 
measures/quality assurance schemes . 
b. The list shall be reviewed an d updated  regularly.  
C. Identification  and Evaluation of Risk /Hazard  
1. The RMT shall identify the risk/hazard that may be present on the site  of 
production, storage , or distribution .  
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 2. The RMT shall identify risks /hazards  that may be present in the product and 
affect the quality and purity of the food product  being produced/distributed . 
The following shall be conducted:  
a. Identification of all possible hazards/risks through the listing of all 
ingredients and their inherent risks.  
b. Identify all possible hazards/risks by listing  all the processes and steps  
and their inherent risks.  
c. Apart from the ingredient and process, the  RMT shall identify risks that 
may cause  a possible hazard to the consumer  through labeling and 
packaging.  
3. The RMT shall identify the possible risks/hazards in the  existing 
department /offices involved in food safety . 
4. The RMT shall identify the possible risks /hazards in the existing  food safety 
measure or quality assurance schemes.  
D. Identification of Risk Management Options  
1. After identification and evaluation of risks, the Risk Manager may opt to 
choose one or combinations of the following risk management options to 
mitigate risks:  
b. Entirely Avoid  the risk identified e.g., do not use the ingredient  
c. Reduce  the Hazard e.g., stringent sanitation  
d. Accept  the presence of Risk e.g., the presence of an allergen  
e. Prevent  the presence of Hazards  e.g., detection of metal fragments from 
raw materials  
2. In the case when risks have not been identified and addressed at the 
manufacturer leve l, and they reached the trader or consumer level, the RMT 
shall initiate a product recall as a risk management option.  
3. To achieve the food safety objective, every risk must be addressed through the 
identified risk management option.  
E. Choosing and Evaluation of Risk Management Option  
1. Is it effective  – The RMT shall evaluate if the risk management option will 
reduce the food safety risk to an acceptable level.  
2. Is it acceptable - The RMT shall evaluate if the risk management option aligns 
with the current food safety measure or quality assurance schemes.  
3. Is it feasible  – The RMT  shall evaluate if the risk management option is 
practical  but will deliver the needed outcome.  
4. The lowest score in the matrix shall be the best risk management option . 
F. Risk Communication  
1. Apart from the RMT, a Risk Communication Team (RCT) shall be created.  
2. The R CT shall communicate the RMP to the establishment  once developed 
and approved by the Team . 
3. The R CT shall communicate to the establishment the changes and revisions  
made in the RMP.   
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 4. Information on the changes/revisions made in the RMP shall be disseminated 
to all personnel involved in the manufacturing, storage, and distribution of the 
product . 
5. The R CT shall establish a risk communication plan  for the coordination and 
dissemination of  information to the stakeholders  and regulatory agency in the 
case of a risk event.  
a. Mode of communication may be the following:  
i. Electronic mail  
ii. Posting through the company website  
iii. Social media accounts  
iv. Telephone  
v. Fax 
vi. Other modes  
b. Identify the focal person  responsible for coordinating and  disseminating 
information clearly and calmly during a risk event . 
c. The risk communicator shall be trained for the specific skill needed in the 
task. 
d. Risk communication shall be timely, efficient and factual.  
G. Review And Monitoring  of the RMP  
a. A validation report shall be written and reviewed by the RMT . 
b. To check if the RMP developed contains all the required information and is 
compliant with the existi ng FDA rules and regulations the checklist in 
Annex es of this Circular shall be used.  
c. Mock exercises shall be conducted to evaluate the effectiveness of the RMP.  
 
 
VII. SEPARABILITY CLAUSE  
 
If any provision of this Circular is declared invalid or unconstitutional, the remaining 
portions shall remain legal and in full force.  
 
 
VIII.  EFFECTIVITY CLAUSE  
 
This Circular shall take effect fifteen (15) days after its publication in the  Official 
Gazette or in any newspaper of general circulation and upon filing  with the University 
of the Philippines Law Center Office of the National  Administrative Register.  
 
 
                                         DR. SAMUEL A. ZACATE  
                                           Director General  
 
 
DTN:  20220601161620