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 Foreword  1 
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This Guidance Document, PNS/BAFS ___:2017, intends to provide guidance to food safety 3 
regulatory agencies on the appropriate risk management options based on decisions of the 4 
Codex Alimentarius Commission (CAC) and national situation and trade. I t covers risk 5 
management options to address food and feed safety concerns related to the primary 6 
production, processing, storage and distribution of fresh, primary processed and processed 7 
commodities intended for human consumption.  8 
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A Technical Working Gro up (TWG) for the Adoption of Guidance for Risk Management 10 
Options in light of Different Risk Assessment Outcomes was organized and represented by 11 
several agencies of the Department of Agriculture particularly the Food Safety Regulatory 12 
Agencies, National F ood Authority (NFA), College of Home Economics - University of the 13 
Philippines Diliman, Food and Drug Administration (FDA), Philippine Coconut Authority 14 
(PCA), National Dairy Authority (NDA), National Meat Inspection Services (NMIS), Bureau 15 
of Fisheries an d Aquatic Resources (BFAR), Fertilizer and Pesticide Authority (FPA) and 16 
Sugar Regulatory Authority (SRA).  17 
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The Bureau in collaboration with the members of the TWG conducted a series of technical 19 
reviews and a national public consultation in NCR. Comments  gathered from the public 20 
consultation were carefully assessed and deliberated prior to the finalization and approval 21 
of the standard.  22 
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  39 
Introduction  40 
This document intends to provide guidance to food safety regulatory agencies on the 41 
approp riate risk management options based on  decisions of the Codex Alimentarius 42 
Commission  (CAC)  and national situation and trade . The relevant Joint  FAO/WHO Expert 43 
Committee s perform the  risk assessments upon which the CAC base their risk management 44 
recommenda tions. Relevant research institutions and experts can perform risk assessment 45 
activities as basis for risk management recommendations.  46 
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Codex  embraces the use of risk analysis in the development of risk -based approaches for 48 
the management of public health  hazards in food. Risk analysis is made up of three 49 
interactive components:  50 
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a) Risk Assessment: itself comprised of four components, hazard identification, 52 
hazard characterization (including dose -response  analysis), exposure assessment, 53 
and risk characte rization. While these are recognized as separate components, in 54 
reality, these risk assessment components are not performed in a series of four 55 
subsequent steps (i.e., one component following the other), but are usually 56 
performed interactively and iterativ ely.  57 
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b)  Risk Management:  process, distinct from risk assessment, of weighing policy 59 
alternatives, in consultation with all interested parties, considering risk assessment 60 
and other factors relevant for the health protection of consumers and for the 61 
promotion of fair trade practices, and, if needed, selecting appropriate prevention 62 
and control options. Usual risk management components consist of preliminary risk 63 
management activities, recognizing and evaluating possible risk management 64 
options (based on the risk assessment outcome), implementation of management 65 
decisions, and monitoring and review of subsequent actions to see if the risk 66 
management options implemented are working to protect public health.  67 
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c) Risk Communication:  interactive exchange of i nformation and opinions 69 
throughout the risk analysis process about risk and related issues. It includes all 70 
stakeholders involved in the risk analysis process.  71 
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 For further discussion and detail on the risk analysis process/framework and the 76 
components  of risk analysis, refer to the Codex Procedural Manual, the Environmental 77 
Health Criteria document 240: Principles and Methods for the Risk Assessment of Chemicals in 78 
Food  (EHC 240 (FAO/WHO, 2009)), and the FAO Food and Nutrition Paper 87: Food Safety 79 
Risk Analysis – A Guide for National Food Safety Authorities  (WHO/FAO, 2006), among many 80 
possible references.  81 
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 1 Scope  114 
 115 
This Guidance Document  covers risk management options to address food and feed safety 116 
concerns related to t he primary production, processing, storage and distribution of fresh, 117 
primary processed and processed commodities intended for human consumption.  118 
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2 Terms and definitions  120 
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For the purposes of this document, the following terms and definitions apply.  122 
2.1  123 
Codex Committee on Contaminants in Foods (CCCF)   124 
primarily responsible for recommending risk management proposals for adoption by the 125 
Codex Alimentarius Commission (CAC)  126 
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2.2  128 
Joint FAO/WHO Expert Committee on Food Additives (JECFA)  129 
primarily responsible fo r performing the risk assessments upon which CCCF and ultimately 130 
the CAC base their risk management recommendations  131 
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2.3 133 
confiscation  134 
action of legally taking or seizing a product from the market done by government or other 135 
public authorities  136 
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2.4  138 
maximum  level (ML)  139 
maximum concentration of that substance recommended by the Codex Alimentarius 140 
Commission to be legally permitted in that commodity  141 
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2.5 143 
primary processed food  144 
food refers to any substance or product whether processed, partially processed or 145 
unp rocessed that is intended for human consumption.  146 
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2.6 148 
public health alerts  149 
statement containing a finding about a hazardous substances/products which pose a 150 
significant risk to human health  151 
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 2.7 155 
recall  156 
actions taken to remove a product from the market  157 
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2.8 159 
risk assessment  160 
itself comprised of four components, hazard identification, hazard characterization 161 
(including dose -response  analysis), exposure assessment, and risk characterization  162 
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2.9 164 
risk communication  165 
the interactive exchange of information and o pinions throughout the risk analysis process 166 
about risk and related issues. It includes all stakeholders involved in the risk analysis 167 
process  168 
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2.10  170 
risk managemen t 171 
process, distinct from risk assessment, of weighing policy alternatives, in consultation w ith 172 
all interested parties, considering risk assessment and other factors relevant for the health 173 
protection of consumers and for the promotion of fair trade practices, and, if needed, 174 
selecting appropriate prevention and control options  175 
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2.11  177 
Food Safety  Regulatory Agencies  (FSRA )  178 
refer to the following national government agencies  under the Department of Agriculture – 179 
the Bureau of Animal Industry, the National Meat Inspection Service, the Bureau of 180 
Fisheries and Aquatic Resources, the Bureau of Plant In dustry, the Fertilizer and Pesticide 181 
Authority, the Philippine Coconut Authority, the Sugar Regulatory Administration, the 182 
National Food Authority and the National Dairy Authority ; and under the Department of 183 
Health – the Food and Drug Administration, the Center for Food Regulation and Research 184 
and the Bureau of Quarantine.  185 
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3 Risk Management Options  191  
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  192 
3.1  General Consideration s 193 
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3.1.1  FSRA  have a number of risk management options it can recommend that could 195 
achieve the desired  level of protection of p ublic health  – based on national situation 196 
and trade . There are risk management options that  FSRA can directly adopt from 197 
CAC and implement, e.g., adoption of an ML for contaminants in specific foods into a 198 
national standard. CAC guidance documents can be used to issue guidance to 199 
industry, e.g., providing guidance for good agricultural practices (G APs) during 200 
production  to minimize contamination.  201 
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3.1.2  In some cases, a single option may have the potential to successfully manage 203 
the risks associated with a part icular food contaminant. In most cases, a 204 
combination of options may be necessary. For example, the setting and enforcement 205 
of MLs  by FSRA may stimulate good practices by food business operators. Also, 206 
where a high level of uncertainty is indicated by the risk assessment,  FSRA may 207 
need to consider whether a graduated implementation is warranted, e.g.,  the 208 
introduction  of gu idance to reduce exposure while  commissioning further work to 209 
refine the estimates.  210 
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3.1.3  The choice of a risk management option will depend  on a number of factors, 212 
including the severity of the health risk, the probability of its occurrence, the 213 
number of individuals potentially affected, the level of protection required or 214 
desired, and the anticipated effectiveness of the proposed risk manag ement 215 
option(s) on the reduction of health risk.  216 
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3.1.4  Risk management options are implemented by a variety of parties, including 218 
government, the food industry, and consumers, each of which has different 219 
responsibilities depending on the risk management option being used. The Codex 220 
Alimentarius assists national authorities with its development of food standards, 221 
guidelines, and related texts. While risk management options recommended by CAC 222 
can relate directly to actions that FSRA s may adopt or adapt and then implement, 223 
there is not always a one -to-one correspondence between a particular risk 224 
management option and a subsequent action by the implementing body (be it a 225 
national authority, industry, or consumers).  226 
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 3.2 Specific Risk Management Options for FSRA   229 
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3.2.1  Regulatory Requirements  231 
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3.2.1.1 One  of the major risk management options for FSRA s is to establish regulatory 233 
requirements, such as regulatory levels. A regulatory level is usually based on the 234 
Codex ML for a contaminant in a food or feed comm odity.  235 
3.2.1.2  The FSRA   establish the regulatory level through a technical regulation  (the 236 
process usually entails proposing the new level in a policy statement and then 237 
soliciting stakeholder/public input on the proposed new policy before instituting th e 238 
regulatory level). The DA usually adopt s or adapt s Codex standards  but it can 239 
establish or maintain a different standard if there is a scientific/public health  risk – 240 
based on  national situation and trade. When an ML is not recommended by the 241 
Codex, nati onal government  agencies  can establish an ML based on national data 242 
available or on data from other countries, if relevant. It should be kept in mind that 243 
the rationale for  the setting  of a national ML should follow the principle of 244 
transparency of Codex, WTO and other international standard setting bodies.  245 
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3.2.2  Guidelines/Guidance /Codes of Practice  249 
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3.2.2.1 The FSRA , the food industry, or a 3rd party expert body can draft more 251 
specific guidances based from Codex to further explain how  the industry  can 252 
implement these good practices. For example, these documents could identify those 253 
points between production and consumption where food safety measures could be 254 
implemented to prevent or limit initial levels of contaminants in raw materials (e.g., 255 
sele ct ingredients that do not contain a known contaminant), reduce potential for 256 
environmental contamination or cross -contamination  (e.g., mandate primary 257 
production  controls), and/or reduce contaminant levels in foods (e.g., physical 258 
inspection processes).  Industry -led quality assurance programs at the producer 259 
level are examples of good practices.  260 
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3.2.2.2 FSRA  can utilize Codex guidelines to publish guidances, notices, or directives 262 
to address food safety issues (these can be new or updated policies that a re not 263 
regulations). For example, notices and directives can be written instructions for  264 
FSRA , but serve as information sources to industry and the public since these 265  
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 guidances generally are publicly available. Furthermore, FSRA  can develop (or 266 
encourage the development of) specific documents and guides on good practices, 267 
e.g., good agricultural practices (GAPs) , good  hygienic practices (GHPs), and Hazard 268 
Analysis and Critical Control Point (HACCP) plans.  269 
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3.3  Other possible actions of FSRA  271 
In addition t o adopting or adapting specific risk management options from CAC (i.e., 272 
MLs, guidances, codes of practice), FSRA  can take a variety of other actions that can 273 
be based on the options provided by CAC .  274 
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3.3.1  Labeling and Advice  276 
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 3.3.1.1  FSRA  can issue adv isory documents on safe intake levels [(for instance, 278 
quantity/portion of specific foods, in the context of the trade -off of risk of consuming 279 
the contaminant and nutritional benefits in food consumption (e.g., methylmercury 280 
in fish versus omega -3 fatty ac ids)] for certain food products across specific 281 
demographics (e.g., pregnant women, children, elderly, immunocompromised). 282 
Pregnant women exposed to methylmercury in fish can be advised through 283 
education campaigns to decrease the consumption of fish with h igh contamination 284 
levels (e.g., predatory fish). This provides information to consumers so that they can 285 
voluntarily limit exposure.  286 
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3.3.1.2  FSRA  can require labeling to inform consumers how to avoid specific 288 
contaminant levels (e.g., provide specific cooking dir ections to minimize acrylamide 289 
formation).  290 
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3.3.1.3  Proper labeling includes information that instructs the consumer regarding 292 
safe handling practices and, where appropriate, briefly informs the consumer of the 293 
food safety issue.  294 
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3.3.2   Mitigation Strategies   296 
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3.3.2.1  FSRA  may work with industry to reduce human exposure to contaminants by 298 
setting appropriate targets and establishing strategies to promote reaching such 299 
targets. Risk -based inspection of establishments, collection and analysis of samples, 300 
and/or mo nitoring of products can be implemented to ensure mitigation of any 301 
potentially harmful exposures to contaminants (e.g., monitoring of dioxin in foods so 302  
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 dioxin sources could be tracked and identified and then targeted for reduction). This 303 
may likely requi re extensive advocacy and awareness creation.  304 
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3.3.2.2 FSRA  may also ensure mitigation of risk via sampling and monitoring for 306 
enforcement of HACCP, GMP, GAP, and compliance with MLs .  307 
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   3.3.3         Recalls  and c onfiscation   309 
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FSRA  (where they have the  authority and sufficient evidence) can invoke recalls and 311 
confiscation of commodities when they are determined to be unsafe food products. 312 
Industry may also exercise voluntary recalls of their products if determined to be 313 
unsafe . Monitoring of adverse eve nt reports and consumer complaints help 314 
determine if there are exposures to potentially unsafe food products.  315 
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FSRA may adopt established procedures for recall , confiscation  and disposal  of 317 
products.  318 
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3.3.4            Public Health Alerts  320 
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Appropriate risk comm unication activities shall be undertaken by FSRA (where they 322 
have the authority and sufficient evidence) to protect the public from the posed 323 
hazards. Such advisory shall be posted in FSRA website and/or other forms of media 324 
to alert the public.  325 
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  3.3.5   Education/Training  327 
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3.3.5.1 An important risk management action is education and training for all 329 
stakeholders involved in food safety. Education can occur for those in  regulatory agencies , 330 
industry, public health or consumer interest groups, agriculture,  trade and the public at 331 
large. Appropriate training for those in food safety should be a priority for FSRA  and 332 
industry to institutionalize. Extension services, including provisions for practical 333 
educational training at colleges and universities, could be  mobilized to support  the 334 
education  of relevant groups. Every possible avenue for reaching out to stakeholders 335 
should be considered to maximize the education message(s), e.g., on -line capabilities and 336 
networks, public meetings, advisories.  337 
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3.3.5.2  Consum er education can provide guidance in terms of dietary advice for avoiding 339 
or limiting exposure to certain foods (e.g., methylmercury in fish; educating local fish- 340  
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 eating  communities), advice on cooking practices (e.g., correct preparation of kidney 341 
beans t o break down phytohaemagglutinin or cassava to avoid hydrogen cyanide), and 342 
consumer education for handling foods in the home. For acrylamide, approaches could 343 
include educational campaigns among the population aimed at controlling the degree of 344 
cooking of  home -made fried or roasted potatoes (lighter colored potatoes have lower 345 
acrylamide levels) and at decreasing the consumption of fried potatoes.  346 
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  3.3.5.3 Technical training on proper food safety practices is paramount in ensuring safe   348 
food. Every pos sible avenue of reaching out to technical personnel should be considered to 349 
maximize training, e.g., webinars, on -line modules, on -site training, front line  supervisor 350 
training  and stakeholder meetings.  351 
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 3.3.5.4 Industry's input and/or contribution to au thorities are also  important source s of 353 
information to develop training programs and evaluate existing risk in food processing - 354 
related processes.  355 
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3.3.6   Research  357 
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Research can provide additional data for refining risk assessments and contribute to bette r 359 
risk management decision(s) for determining food safety and can provide education and 360 
training opportunities. It can develop/improve methods for detecting contaminants in 361 
food, determine toxicological effects of food contaminants, determine effects of pr ocessing 362 
techniques on food composition, help elucidate factors that influence contamination, and 363 
elaborate preventive measures and mitigation strategies . 364 
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4   Risk Communication Considerations  366 
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4.1 An important risk management action is to ensure good communi cation with all 368 
stakeholders and impacted parties regarding the food safety measure(s) being 369 
taken. Communication can take many guises, through advisories, public meetings 370 
(often to inform and also to solicit input), technical meetings (with industry, 371 
othe r agencies, consumer groups; usually to solicit input), and constituent 372 
updates. This is also an opportunity for the constituents to become educated 373 
about new risk-related developments .  374 
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4.2 Public meetings may be structured as simply informative, e.g., the FSRA  announce 376 
a new policy and invites written and oral comment. Public meetings can be also in 377 
the form of break -out groups as experts from all sectors are invited to participate 378  
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 in deliberative exchanges or sessions with the outcome in the form of propose d 379 
action items for one or all parties to take or a revised policy. The FSRA   can solicit 380 
input from a neutral 3rd party expert group  (e.g., DA pool of experts) where risk 381 
management options to deal with a particular food safety issue are discussed and 382 
techn ical experts from academ e/ research/ industry/ government are brought 383 
together to consider all relevant scientific information presented and provide 384 
recommendations.  385 
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4.3 FSRA  can hold regular meetings with constituent groups for the purpose of 387 
allowing them to ask specific questions to the authority relative to a new or 388 
change in policy or regulation. This is an opportunity for the constituents to 389 
become informed about new risk management options/policies.  390 
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4.4 Because of international trade, communication is al so important between 392 
authorities of different countries. One of the aims of Codex Alimentarius is to 393 
promote coordination of food standards.  394 
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4.5 An important aspect of communications is to assess if it is effective or not. The 396 
conduct of impact studies to ev aluate the effects of risk communication on 397 
consumers, for example, would be very useful to see if the message(s) had any 398 
impact.  399 
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 REFERENCES:  411 
Codex General Standard for Contaminants and Toxins in Food and Feeds (CODEX STAN 412 
193-1995).  413 
FAO/WHO (F ood and Agriculture Organization of the United Nations/World Health 414 
Organization). 2009. Environmental Health Criteria 240: Principles and methods for the 415 
risk assessment of chemicals in food.  416 
At: http://www.who.int/ipcs/food/principles/en/index1.html    417 
 418 
GSCTFF (General Standard for Contaminants and Toxins in Food and Feed). 2005. Codex 419 
General Standard for Contaminants and Toxins in Food and Feed. CODEX STAN 193 -1995.  420 
IPCS (Internatio nal Programme on Chemical Safety). 2005. Chemical -specific adjustment 421 
factors for interspecies differences and human variability:  a guidance  document for use of 422 
data in dose/concentration -response assessment. Geneva, World Health Organization, 423 
Harmonizatio n Project Document No. 2.  424 
At: http://whqlibdoc.who.int/publications/2005/9241546786_eng.pdf    425 
 426 
WHO/FAO (World Health Organization/Food and Agriculture Organization of the United  427 
Nations). 2006. FAO Food and Nutrition Paper 87: Food safety risk analysis, a guide for 428 
national food safety authorities.  429 
At: http://www.fao.org/docrep/012/a0822e/a0822e.pdf     430 
 431 
WHO (World H ealth Organization). 2004. Harmonization Project Document No. 1: IPCS 432 
Risk Assessment Terminology.  433 
At: 434 
http://www.who.int/ipcs/methods/harmonization/areas/ipc sterminologyparts1and2.pdf    435 
 436 
WHO (World Health Organization). 2006. WHO Technical Report Series 930. Evaluation of 437 
certain food contaminants: Sixty -fourth report of the Joint FAO/WHO Expert Committee on 438 
Food Additives.  439 
At: http://whqlibdoc.who.int/trs/WHO_TRS_930_eng.pdf   440 
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