DOI: https://doi.org/10.56669/IBQE2658
ABSTRACT
The paper provided an insight into biopesticides and its role in Malaysian agriculture. It covered aspects on the Research and Development and the regulatory processes. It also provided information on the potential registration scheme for low risk pesticides and a list of registered biopesticides. To promote the industry, the key issues, challenges and the future outlook for biopesticides were also underscored and discussed.
Keywords: biopesticides, regulation, agriculture, Malaysia
INTRODUCTION
A pesticide is generally any substance or mixture that is used to control or repel a pest. What about biopesticides? In scientific literature, there are a number of definitions for a biopesticide which is also sometimes known as biological pesticides. Here, we confine ourselves to the definition by the United States Environmental Protection Agency (US-EPA) i.e. “Biopesticides are certain types of pesticides derived from such natural materials as animals, plants, bacteria, and certain minerals”.
There are generally three categories of biopesticides: microbial, semiochemical and non-conventional pest control products.
Microbial pesticides are pesticides that contain living microorganisms such as bacteria, fungi, viruses and related organisms and associated metabolites (or by-products), that are used to control pests. A common commercially available microbial pesticide is the subspecies and strains of Bacillus thuringiensis, or Bt which targets many lepidopterous larval pests (refer Section 4 below). In addition, the US-EPA also considers another class of biopesticides, the Plant-Incorporated-Protectants (PIPs). These are pesticidal substances that plants produce from genetic materials that has been added to the plant. For example, Bt cotton which is a genetically modified variety of cotton (i.e transgenic cotton). Here, scientists had taken the gene for the Bt pesticidal protein and introduce the gene into the plant's own genetic material. Then the plant expresses the Bt toxin that destroys the pest.
Semiochemicals, which are also known as biochemical pesticides under the US-EPA classes of biopesticides, are chemicals produced by an organism that causes a behavioural response in another organism of the same or different species. Synthetically produced equivalents of these chemicals are also considered to be semiochemical biopesticides. The most common are insect sex pheromones, which are used in monitoring traps, lure-and-kill systems or to disrupt the mating of target pests.
Non-conventional pest control products are substances used by people for a variety of reasons but can also be used as pest control products as they generally pose a low risk to humans and to the environment. Some examples include food items or preservatives such as garlic oil, vinegar, plant extracts (e.g. from neem, Azadirachta indica; also known as botanical pesticides) and oils such as mineral oils; or fertilizers and plant growth supplements such as mineral salts. Biopesticides from plants or botanical pesticides can be an attractive option, particularly with Malaysia’s rich biodiversity.
ROLE OF BIOPESTICIDES IN MALAYSIAN AGRICULTURE
Malaysia launched its 12th Malaysia Plan (12MP; 2021-2025) on 27 September 2021. Underpinning the 12MP are three themes: resetting the economy; strengthening security, wellbeing and inclusivity; and advancing sustainability. The latter, “Advancing sustainability” is targeted towards guaranteeing continuous economic growth while protecting the environment and continuing Malaysia’s commitments to its global targets. This theme builds on two game changers namely circular economy and integrated water resources management, critical in fulfilling the goal of building better, greener and fairer Malaysia in the post-COVID-19 era. For driving the sustainable ‘green’ agenda, it is pertinent to formulate and mainstream processes that enhance the registration of ‘green’ pest management, i.e., biopesticides.
It is in this context that biopesticides will becoming increasingly important as pest management tools in various cropping systems in the country. Generally, biopesticides provide a strategic option towards reaching the goals of sustainable pest management that is becoming increasingly elusive with the ubiquitous chemical pesticide-dominated crop systems which are faced with the usual pesticide treadmill effect of escalating costs, resistance development, and crop and environmental pollution (Heong et al., 2013, 2015; Schreinemachers et al., 2015, 2017). These studies alluded to the fact that strong action will be needed to reduce Malaysia’s reliance solely on chemical pesticides. Mohring et al. (2013) named key challenges for the reduction of environmental and health risks from agricultural pesticide use and developed a framework for improving current policies (Figure 1). Amongst the key drivers suggested were sustainable farming and new technologies and inputs in which biopesticides could play a pivotal role.
There are a number of advantages for using biopesticides. First, largely due to their natural origin, they are usually inherently less toxic than conventional pesticides. They also generally affect only the target pest and closely related organisms, in contrast to a broad spectrum of conventional pesticides that may affect different organisms such as birds, insects and mammals. They are also often effective in very small quantities and often decompose quickly, resulting in lower exposures and largely avoiding the pollution problems caused by conventional pesticides. Considering the advantages, biopesticides when used as a component of Integrated Pest Management (IPM) programs, can significantly reduce the use of conventional pesticides, while crop yields remain high. In addition, the country’s increasing interest in organic agriculture is also a positive trend promoting the increased need for biopesticides.
The market potential for biopesticides (Local and Export) was estimated to reach US$5.95 million by 2021, growing at a CAGR of 13.2% from 2016 to 2021 (https://www.micromarketmonitor.com/pressreleases/malaysia-biopesticides.html). The fastest growing segment in cash crops (oil palm, rubber, cocoa and rice) on the basis of crop type from 2016 to 2021. The demand is also associated with increasing demand for organically produced crops and the high growth potential with application of microorganisms e.g. seed treatment segment. The future potential growth targets are expected in rice, horticultural crops, plantation crops (e.g. oil palm at 5.73 million ha in 2021). There is also an increasing interest of the government towards the substitution of hard pest control products with bio-based control products as reflected in the National Agro-Food Policy 2.0 (2011-2020) and the 12th Malaysia Plan (2021-2025) which collectively support inclusive and sustainable trade growth and poverty reduction in Malaysia.
R&D ON BIOPESTICIDES
Figure 2 illustrates the steps in production and evaluation of different types of biopesticides. In Malaysia, to date, the focus has been on botanicals (Table 1), microbials and macrobials (e.g. parasitoids and predators) with not much work done with semiochemicals.
Out of the four phases of biopesticides development process, most of the research in Malaysia is still in Phase 1 (Discovery phase) and Phase 2 (Field Research). Currently, there is limited engagement in the next two phases, Phase 3 (Development) and Phase 4 (Utilization). Even within Phase 1, the process of isolating, identifying and evaluating insecticidal properties of these highly diverse microorganisms and plant resources are often met with difficulties. Thus, despite the vast amount of bioresources available especially for plant-based botanical biopesticides (Table 1), commercialization and extended utilization in Malaysia have yet to take off to the desired level (Sivapragasam, 2009).
Despite the market potential for biopesticides, there is not much work done to develop ‘home-grown’ products. Many of the products registered locally (see Section 5 below: List of registered products) are imported. A survey done on a sample of published information in local publications for the period 1990 – 2002 (April) on R&D activities undertaken on biopesticides (excluding arthropod natural enemies) revealed that in terms of the position of key activities in the biopesticides R&D spectrum (Harris and Dent, 2000), the majority of the work is in the front end of the spectrum (Figure 1) i.e., on Exploration, Identification, Bioassay/Efficacy (87.5%) with less engagement in the other areas (Sivapragasam and Sajap, 2002). There was also less R&D activity on the other aspects such as the fermentation, pathogen ecology, socioeconomics, industrial mass production and marketing. This scenario has changed since then with more financial thrust provided through government funding biopesticides R&D and to some extend for commercialization. According to Ganisan et al. (2016), for microbial biopesticides in the past decade, at least 96 research projects were executed by universities and Public Research Institutes (PRIs). The main microorganism types used for biopesticide research were fungi (Metarhizium, Beauveria, Trichoderma and Paecilomyces), bacteria (Bacillus and Pseudomonas) and viruses (Nucleopolyhedrovirus and bacteriophage). The main research focus was bioprospection of microbial biopesticides, biopesticide formulation, mass production of biopesticide products, field application technique and efficacy testing in open field. There were also a significant number of private-sponsored biopesticide projects conducted in collaboration with universities and PRIs for testing the efficacy of their improved products.
REGULATORY ASPECTS ON BIOPESTICIDES
In Malaysia, the Pesticide Act (PA) 1974 is the principle legislation to regulate the management of pesticides. The Act covers subsidiary legislations on registration, importation, labelling, licensing for sale and storage for sale, highly toxic pesticides, advertisement, pest control operators and manufacturing. It also has a provision for the establishment of the Pesticides Board (PB). The PB, chaired by the Director General of the Department of Agriculture, advises the government on policy matters arising from administration of the Act and endorses technical decisions etc. To operationalize the PA, the Registration scheme [Pesticides (Registration) Rules 1976, Amendment 2005 was introduced to: (i) Ensure that pesticides sold and used in the country are effective, good in quality and do not cause unacceptable effects to human and the environment; and (2) Facilitate the process of evaluation and approval by the Pesticides Board for a pesticide, both Commodity and Proprietary, to be imported, manufactured, sold and used in Malaysia. There have been several guidelines developed to facilitate the registration process. These are as follows (year introduced in parenthesis):
1. Guidelines on Pesticides Registration
2. Guidelines on Product Chemistry Data Requirements (2019)
3. Guidelines on Toxicological Data Requirements (2020)
4. Guidelines on Bio-efficacy Data Requirements (1993)
5. Guidelines on Residue Data Requirements (2012)
6. Guidelines on Environmental Fates Data Requirements (2003)
7. Guidelines on Biopesticides Data Requirements (2016)
8. Guidelines on Labelling (2020)
9. Guidelines on Trade Name (2021)
As indicated above, the guidelines for biopesticides was introduced in 2016 by the Pesticide Board of Malaysia (now the Pesticides and Fertilizers Control Division). This is to facilitate the registration of biopesticides to promote the use of safer pesticides, including biopesticides, as components of IPM programs. The guidelines provide information for the registration of micro-organisms/ microbials and botanicals/ plant extract with minimum data requirements. In preparing for these guidelines, references were made to some international and national guidelines such as those published by the Food and Agriculture Organization (FAO) of the United Nations and the Deutsche Gesellschaft für Internationale Zusammenarbeit GmbH (GIZ).
The data requirements for microbial registration are: (1) Biological and chemical characteristic; (2) Bioefficacy; (3) Packaging and labelling; (4) Infectivity and pathogenicity or toxicity to non-target organisms; (5) Human health exposure, environmental fate and effects; and (6) Residue.
For botanicals or plant extracts, the data requirements are: (1) Biological and chemical characteristic; (2) Toxicological evaluation (toxicological data and environmental and ecotoxicology and safety testing); (3) Efficacy; and (4) Residue.
For both of the above classes of biopesticides, there is also an efficacy test protocol available as part of the Appendices.
Registration of low risk pesticides
Currently, all pesticides in Malaysia must be registered before they are sold. The pesticide registration process consists of a number of steps that generally are done in four phases: pre-registration, registration, post-registration and review of existing registrations. However, there are constraints in the pesticide registration system that need to be overcome, e.g., there is a need to reduce the amount of documentation, reduce the cost and regulatory burden on businesses and the public for pesticides and to focus resources on pesticides that pose greater risk to humans and the environment. Thus, since biopesticides tend to pose fewer risks than conventional pesticides, and generally require much less data to register vis-a-vis a conventional pesticide, the PB is also considering expediting the registration process for biopesticides than the average of about three years for registration based on the existing system. In that context, the PB has, since 2019, been considering a simplified registration process especially with a list of pesticides considered as Low Risk Pesticides (LRPs). This is similar to the US- Environmental Protection Agency (EPA) scheme that determines a product to be a Minimum Risk Pesticide (MRP) when the risk to the public and the environment is sufficiently low as to not require all the data and review necessary for registration. According to the PB, this LRP scheme will also be helpful to screen the current deluge of requests for registration of a number of herbal-based products available in the market and that are yet to be registered. Currently, only products in Schedule 1 of the Pesticide Act, citronella oil, eugenol dan rosemary oil, could be considered for the soon to be endorsed LRP-based registration process.
LIST OF REGISTERED BIOPESTICIDES
In Malaysia, a total of 37 products are registered as biopesticides, out of a total of 3,386 products (as of 5 Oct. 2022; http://www.portal.doa.gov.my/racunberdaftar/). Among the 37 biopesticides, about 81% (N= 30) are for the crop sector and the rest (19%; N=7) for the public health sector. Amongst the sub-species of Bacillus thuringiensis (Bt) registered, most (88%) belong to a single strain Bacillus thuringiensis subsp. kurstaki (predominantly serotype 3a. 3b) followed by a few others such as B. thuringiensis subsp aizawai and B. thuringiensis subsp. Israelensis. The major target crop is oil palm and the target pests include the Bunch moth caterpillar (Tirathaba spp.) and bagworm (e.g. Metisa plana Walker and Pteroma pendula Joannis); this is followed by vegetables, crucifers such as cabbage, kale, radish targeting the diamondback moth, Plutella xylostella. Two (2) neem azadirachtin-based products are registered against the diamondback moth P. xylostella (in mostly crucifers) and the brown planthopper, Nilaparvata lugens (in rice). One entomopathogenic fungal product based on Metarhizium anisopliae var majus (ST-01) is registered against the rhinoceros beetle, Oryctes rhinoceros. To date, only one biopesticide had been registered against diseases, viz., Bacillus amyloliquefaciens strain MBI 600 used in chili and tomato against Colletotrichum capsica. In the public health sector, the mosquito, Aedes aegypti, the species that causes dengue fever, is the target pest. These biopesticides are generally Bt-based viz., Bacillus thuringiensis subsp. Israelensis; or mixtures of pyrethrin and piperonyl butoxide or citronella and citronellol.
For microbial-based biopesticides, Ganisan et al (2016) provided a list sold in the Malaysian market (Table 2).
Most of the above information on the registered biopesticides is currently available in the Department of Agriculture website as indicated above. In addition, to enable greater accessibility, and as part of the continuing global effort to reduce the use of highly hazardous pest control products in agricultural production, the Center for Agriculture and Biosciences International (CABI) has launched an open-access CABI BioProtection Portal (www.bioprotectionportal.com). This portal is targeted primarily at growers and advisors, and available in multiple languages, it offers a free- and simple-to-use central reference point for all information related to nationally registered biological control and biopesticide products. Malaysia will soon be included as a member in this portal to display their biopesticide products. This will enable the broader communication and awareness to many stakeholders, including growers, to extract information on registered biological and biopesticide products from the Malaysian list of registered plant protection control products. Potential information to be displayed on the portal includes the product name, the manufacturer, the target pest(s) and the target crop(s). In this context, the Department of Agriculture will be acknowledged on each product page. The information on the portal will be updated frequently based on an agreement between CABI and the Department of Agriculture. Additional product-specific information, for example, shelf life, mode of action, application method, storage requirements, distributors, etc., will be obtained from the relevant biocontrol manufacturers with which CABI signs partnership agreements. The CABI BioProtection Portal also provides potential benefits to national regulators as it enables them to ensure that information about their registered biological control and biopesticide products is readily available, up-to-date and easily searchable for all key national stakeholders that require it, including growers, advisors, agro-dealers, academics, retailers, etc.
KEY ISSUES AND CHALLENGES
Despite the vast amounts of bioresources and their great potential for use in sustainable agriculture, biopesticide development, commercialization and use trajectory in Malaysia is yet to take off as desired. As indicated above in Section 5, as of October 2022, there were only 37 biopesticides registered under the Pesticide Board from a total list of about 3,386 pesticides registered. However, on a positive note, we see a gradual increasing trend. Majority of the biopesticides registered locally comprise mostly of imported microbials (Bt-based) as the active ingredient with a narrow spectrum of activity, it is daunting to predict the future growth in this sector.
Harris and Dent (2000) generally attributed the obstacles in the biopesticide development process in developing countries to a lack of expertise, low funding mainly from the public sector, and a lack of involvement of multi-disciplinary expertise needed to develop a biopesticide from start to finish. They believe that by removing these constraints, successful development and application of biopesticides can be achieved. With respect to specifically botanical pesticides, Isman (1997) identified three main barriers to the commercialization of botanical pesticides, viz., (1) Sustainability of the botanical resource; (2) Standardization of chemically complex extracts; and (3) Regulatory approval process as in Malaysia, the approval of biopesticides still follows the normal route as conventional pesticides despite their posing generally minimal risks as advocated in developed countries. This will however soon change with the introduction of the LRP-based registration pathway. Ganisan et al. (2016) also alluded to other limitations in the use of biopesticides such as the inconsistency in performance, to be more competitive, versatile and effective. Overriding these are the high cost considerations and thus the need for collaboration with private companies which will be crucial for efficient transfer of technology and commercialisation. In that context, the government needs to increase incentives to biopesticides companies in support of ‘green technology’ for food safety and societal well-being to encourage private commitment in production and commercialization of these products. From the user-angle, there is also the issue of the paucity of farmer awareness on the longer-term benefits of biopesticides.
FUTURE OUTLOOK
The former Minister of Science, Technology and Environment, Malaysia, Dato’ Seri Law Hieng Ding, in his opening address to delegates during the Third International Conference on Biopesticides held in 2002 in Kuala Lumpur underlined “that Malaysia will one day be the hub of research and production of biopesticides in the world.” However, the question remains as to “how?”. The current scenario towards the commercialization of ‘home-grown’ product(s) may not be realized unless the necessary drivers of the system are in place. The model proposed by Dent and Lomer (1999), which has the attributes of engaging multi-national, multi-institute, multi-disciplinary expertise, should probably be adhered to for the successful development and utilization of biopesticides. For this to be successful, concerted and coordinated efforts by various R&D agencies are therefore needed. Further, the current scenario of persistent resistance development in pests and extensive regulatory requirements has raised the hurdles for the introduction of new active ingredients. In this context, natural products still offer unmatched structural variety, especially when new environmental niches are being explored (Tombo, 1999). The development and use of local resources for developing botanical and other biopesticides could be the strategic option towards meeting the needs of pest management and sustainable agriculture of developing economies, such as in Malaysia. Being one of the mega biodiversity centres of the world, the country is in a unique position to contribute to the discovery of new biopesticides. There is also merit in developing specific natural pesticides to alleviate the increasing costs and dependence on imported fossil fuel-based synthetic pesticides. More importantly, this would encourage the nurturing of local industries in this sector which will result in novel innovations from local flora (Sivapragasam, 2009). It was noted in a market survey by MARDI in 2015 that the biopesticide industry is moderately competitive. Few players are currently involved because the market is not certain. Favourable government policies may help in nurturing the nascent industry to a competitive level. The study also concluded that the market for bio-pesticides in the world is expected to expand into double digits in the future and that biopesticides in Malaysia, albeit a less competitive industry, is growing.
ACKNOWLEDGEMENTS
The author expresses his sincere gratitude to the former Director General of MARDI Datuk Dr. Mohamed Roff for providing this opportunity to write this paper. He also appreciates the support of the Pesticides and Fertilizers Control Division, Department of Agriculture for sharing information on the registered biopesticides and to CAB International for their support for the overall biopesticides agenda. Last, but not least, the editorial comments, if any, by the Food and Fertilizer Technology Center (FFTC) for the Asian and Pacific Region, are duly appreciated.
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Biopesticides and Their Regulation in Malaysia
DOI: https://doi.org/10.56669/IBQE2658
ABSTRACT
The paper provided an insight into biopesticides and its role in Malaysian agriculture. It covered aspects on the Research and Development and the regulatory processes. It also provided information on the potential registration scheme for low risk pesticides and a list of registered biopesticides. To promote the industry, the key issues, challenges and the future outlook for biopesticides were also underscored and discussed.
Keywords: biopesticides, regulation, agriculture, Malaysia
INTRODUCTION
A pesticide is generally any substance or mixture that is used to control or repel a pest. What about biopesticides? In scientific literature, there are a number of definitions for a biopesticide which is also sometimes known as biological pesticides. Here, we confine ourselves to the definition by the United States Environmental Protection Agency (US-EPA) i.e. “Biopesticides are certain types of pesticides derived from such natural materials as animals, plants, bacteria, and certain minerals”.
There are generally three categories of biopesticides: microbial, semiochemical and non-conventional pest control products.
Microbial pesticides are pesticides that contain living microorganisms such as bacteria, fungi, viruses and related organisms and associated metabolites (or by-products), that are used to control pests. A common commercially available microbial pesticide is the subspecies and strains of Bacillus thuringiensis, or Bt which targets many lepidopterous larval pests (refer Section 4 below). In addition, the US-EPA also considers another class of biopesticides, the Plant-Incorporated-Protectants (PIPs). These are pesticidal substances that plants produce from genetic materials that has been added to the plant. For example, Bt cotton which is a genetically modified variety of cotton (i.e transgenic cotton). Here, scientists had taken the gene for the Bt pesticidal protein and introduce the gene into the plant's own genetic material. Then the plant expresses the Bt toxin that destroys the pest.
Semiochemicals, which are also known as biochemical pesticides under the US-EPA classes of biopesticides, are chemicals produced by an organism that causes a behavioural response in another organism of the same or different species. Synthetically produced equivalents of these chemicals are also considered to be semiochemical biopesticides. The most common are insect sex pheromones, which are used in monitoring traps, lure-and-kill systems or to disrupt the mating of target pests.
Non-conventional pest control products are substances used by people for a variety of reasons but can also be used as pest control products as they generally pose a low risk to humans and to the environment. Some examples include food items or preservatives such as garlic oil, vinegar, plant extracts (e.g. from neem, Azadirachta indica; also known as botanical pesticides) and oils such as mineral oils; or fertilizers and plant growth supplements such as mineral salts. Biopesticides from plants or botanical pesticides can be an attractive option, particularly with Malaysia’s rich biodiversity.
ROLE OF BIOPESTICIDES IN MALAYSIAN AGRICULTURE
Malaysia launched its 12th Malaysia Plan (12MP; 2021-2025) on 27 September 2021. Underpinning the 12MP are three themes: resetting the economy; strengthening security, wellbeing and inclusivity; and advancing sustainability. The latter, “Advancing sustainability” is targeted towards guaranteeing continuous economic growth while protecting the environment and continuing Malaysia’s commitments to its global targets. This theme builds on two game changers namely circular economy and integrated water resources management, critical in fulfilling the goal of building better, greener and fairer Malaysia in the post-COVID-19 era. For driving the sustainable ‘green’ agenda, it is pertinent to formulate and mainstream processes that enhance the registration of ‘green’ pest management, i.e., biopesticides.
It is in this context that biopesticides will becoming increasingly important as pest management tools in various cropping systems in the country. Generally, biopesticides provide a strategic option towards reaching the goals of sustainable pest management that is becoming increasingly elusive with the ubiquitous chemical pesticide-dominated crop systems which are faced with the usual pesticide treadmill effect of escalating costs, resistance development, and crop and environmental pollution (Heong et al., 2013, 2015; Schreinemachers et al., 2015, 2017). These studies alluded to the fact that strong action will be needed to reduce Malaysia’s reliance solely on chemical pesticides. Mohring et al. (2013) named key challenges for the reduction of environmental and health risks from agricultural pesticide use and developed a framework for improving current policies (Figure 1). Amongst the key drivers suggested were sustainable farming and new technologies and inputs in which biopesticides could play a pivotal role.
There are a number of advantages for using biopesticides. First, largely due to their natural origin, they are usually inherently less toxic than conventional pesticides. They also generally affect only the target pest and closely related organisms, in contrast to a broad spectrum of conventional pesticides that may affect different organisms such as birds, insects and mammals. They are also often effective in very small quantities and often decompose quickly, resulting in lower exposures and largely avoiding the pollution problems caused by conventional pesticides. Considering the advantages, biopesticides when used as a component of Integrated Pest Management (IPM) programs, can significantly reduce the use of conventional pesticides, while crop yields remain high. In addition, the country’s increasing interest in organic agriculture is also a positive trend promoting the increased need for biopesticides.
The market potential for biopesticides (Local and Export) was estimated to reach US$5.95 million by 2021, growing at a CAGR of 13.2% from 2016 to 2021 (https://www.micromarketmonitor.com/pressreleases/malaysia-biopesticides.html). The fastest growing segment in cash crops (oil palm, rubber, cocoa and rice) on the basis of crop type from 2016 to 2021. The demand is also associated with increasing demand for organically produced crops and the high growth potential with application of microorganisms e.g. seed treatment segment. The future potential growth targets are expected in rice, horticultural crops, plantation crops (e.g. oil palm at 5.73 million ha in 2021). There is also an increasing interest of the government towards the substitution of hard pest control products with bio-based control products as reflected in the National Agro-Food Policy 2.0 (2011-2020) and the 12th Malaysia Plan (2021-2025) which collectively support inclusive and sustainable trade growth and poverty reduction in Malaysia.
R&D ON BIOPESTICIDES
Figure 2 illustrates the steps in production and evaluation of different types of biopesticides. In Malaysia, to date, the focus has been on botanicals (Table 1), microbials and macrobials (e.g. parasitoids and predators) with not much work done with semiochemicals.
Out of the four phases of biopesticides development process, most of the research in Malaysia is still in Phase 1 (Discovery phase) and Phase 2 (Field Research). Currently, there is limited engagement in the next two phases, Phase 3 (Development) and Phase 4 (Utilization). Even within Phase 1, the process of isolating, identifying and evaluating insecticidal properties of these highly diverse microorganisms and plant resources are often met with difficulties. Thus, despite the vast amount of bioresources available especially for plant-based botanical biopesticides (Table 1), commercialization and extended utilization in Malaysia have yet to take off to the desired level (Sivapragasam, 2009).
Despite the market potential for biopesticides, there is not much work done to develop ‘home-grown’ products. Many of the products registered locally (see Section 5 below: List of registered products) are imported. A survey done on a sample of published information in local publications for the period 1990 – 2002 (April) on R&D activities undertaken on biopesticides (excluding arthropod natural enemies) revealed that in terms of the position of key activities in the biopesticides R&D spectrum (Harris and Dent, 2000), the majority of the work is in the front end of the spectrum (Figure 1) i.e., on Exploration, Identification, Bioassay/Efficacy (87.5%) with less engagement in the other areas (Sivapragasam and Sajap, 2002). There was also less R&D activity on the other aspects such as the fermentation, pathogen ecology, socioeconomics, industrial mass production and marketing. This scenario has changed since then with more financial thrust provided through government funding biopesticides R&D and to some extend for commercialization. According to Ganisan et al. (2016), for microbial biopesticides in the past decade, at least 96 research projects were executed by universities and Public Research Institutes (PRIs). The main microorganism types used for biopesticide research were fungi (Metarhizium, Beauveria, Trichoderma and Paecilomyces), bacteria (Bacillus and Pseudomonas) and viruses (Nucleopolyhedrovirus and bacteriophage). The main research focus was bioprospection of microbial biopesticides, biopesticide formulation, mass production of biopesticide products, field application technique and efficacy testing in open field. There were also a significant number of private-sponsored biopesticide projects conducted in collaboration with universities and PRIs for testing the efficacy of their improved products.
REGULATORY ASPECTS ON BIOPESTICIDES
In Malaysia, the Pesticide Act (PA) 1974 is the principle legislation to regulate the management of pesticides. The Act covers subsidiary legislations on registration, importation, labelling, licensing for sale and storage for sale, highly toxic pesticides, advertisement, pest control operators and manufacturing. It also has a provision for the establishment of the Pesticides Board (PB). The PB, chaired by the Director General of the Department of Agriculture, advises the government on policy matters arising from administration of the Act and endorses technical decisions etc. To operationalize the PA, the Registration scheme [Pesticides (Registration) Rules 1976, Amendment 2005 was introduced to: (i) Ensure that pesticides sold and used in the country are effective, good in quality and do not cause unacceptable effects to human and the environment; and (2) Facilitate the process of evaluation and approval by the Pesticides Board for a pesticide, both Commodity and Proprietary, to be imported, manufactured, sold and used in Malaysia. There have been several guidelines developed to facilitate the registration process. These are as follows (year introduced in parenthesis):
1. Guidelines on Pesticides Registration
2. Guidelines on Product Chemistry Data Requirements (2019)
3. Guidelines on Toxicological Data Requirements (2020)
4. Guidelines on Bio-efficacy Data Requirements (1993)
5. Guidelines on Residue Data Requirements (2012)
6. Guidelines on Environmental Fates Data Requirements (2003)
7. Guidelines on Biopesticides Data Requirements (2016)
8. Guidelines on Labelling (2020)
9. Guidelines on Trade Name (2021)
As indicated above, the guidelines for biopesticides was introduced in 2016 by the Pesticide Board of Malaysia (now the Pesticides and Fertilizers Control Division). This is to facilitate the registration of biopesticides to promote the use of safer pesticides, including biopesticides, as components of IPM programs. The guidelines provide information for the registration of micro-organisms/ microbials and botanicals/ plant extract with minimum data requirements. In preparing for these guidelines, references were made to some international and national guidelines such as those published by the Food and Agriculture Organization (FAO) of the United Nations and the Deutsche Gesellschaft für Internationale Zusammenarbeit GmbH (GIZ).
The data requirements for microbial registration are: (1) Biological and chemical characteristic; (2) Bioefficacy; (3) Packaging and labelling; (4) Infectivity and pathogenicity or toxicity to non-target organisms; (5) Human health exposure, environmental fate and effects; and (6) Residue.
For botanicals or plant extracts, the data requirements are: (1) Biological and chemical characteristic; (2) Toxicological evaluation (toxicological data and environmental and ecotoxicology and safety testing); (3) Efficacy; and (4) Residue.
For both of the above classes of biopesticides, there is also an efficacy test protocol available as part of the Appendices.
Registration of low risk pesticides
Currently, all pesticides in Malaysia must be registered before they are sold. The pesticide registration process consists of a number of steps that generally are done in four phases: pre-registration, registration, post-registration and review of existing registrations. However, there are constraints in the pesticide registration system that need to be overcome, e.g., there is a need to reduce the amount of documentation, reduce the cost and regulatory burden on businesses and the public for pesticides and to focus resources on pesticides that pose greater risk to humans and the environment. Thus, since biopesticides tend to pose fewer risks than conventional pesticides, and generally require much less data to register vis-a-vis a conventional pesticide, the PB is also considering expediting the registration process for biopesticides than the average of about three years for registration based on the existing system. In that context, the PB has, since 2019, been considering a simplified registration process especially with a list of pesticides considered as Low Risk Pesticides (LRPs). This is similar to the US- Environmental Protection Agency (EPA) scheme that determines a product to be a Minimum Risk Pesticide (MRP) when the risk to the public and the environment is sufficiently low as to not require all the data and review necessary for registration. According to the PB, this LRP scheme will also be helpful to screen the current deluge of requests for registration of a number of herbal-based products available in the market and that are yet to be registered. Currently, only products in Schedule 1 of the Pesticide Act, citronella oil, eugenol dan rosemary oil, could be considered for the soon to be endorsed LRP-based registration process.
LIST OF REGISTERED BIOPESTICIDES
In Malaysia, a total of 37 products are registered as biopesticides, out of a total of 3,386 products (as of 5 Oct. 2022; http://www.portal.doa.gov.my/racunberdaftar/). Among the 37 biopesticides, about 81% (N= 30) are for the crop sector and the rest (19%; N=7) for the public health sector. Amongst the sub-species of Bacillus thuringiensis (Bt) registered, most (88%) belong to a single strain Bacillus thuringiensis subsp. kurstaki (predominantly serotype 3a. 3b) followed by a few others such as B. thuringiensis subsp aizawai and B. thuringiensis subsp. Israelensis. The major target crop is oil palm and the target pests include the Bunch moth caterpillar (Tirathaba spp.) and bagworm (e.g. Metisa plana Walker and Pteroma pendula Joannis); this is followed by vegetables, crucifers such as cabbage, kale, radish targeting the diamondback moth, Plutella xylostella. Two (2) neem azadirachtin-based products are registered against the diamondback moth P. xylostella (in mostly crucifers) and the brown planthopper, Nilaparvata lugens (in rice). One entomopathogenic fungal product based on Metarhizium anisopliae var majus (ST-01) is registered against the rhinoceros beetle, Oryctes rhinoceros. To date, only one biopesticide had been registered against diseases, viz., Bacillus amyloliquefaciens strain MBI 600 used in chili and tomato against Colletotrichum capsica. In the public health sector, the mosquito, Aedes aegypti, the species that causes dengue fever, is the target pest. These biopesticides are generally Bt-based viz., Bacillus thuringiensis subsp. Israelensis; or mixtures of pyrethrin and piperonyl butoxide or citronella and citronellol.
For microbial-based biopesticides, Ganisan et al (2016) provided a list sold in the Malaysian market (Table 2).
Most of the above information on the registered biopesticides is currently available in the Department of Agriculture website as indicated above. In addition, to enable greater accessibility, and as part of the continuing global effort to reduce the use of highly hazardous pest control products in agricultural production, the Center for Agriculture and Biosciences International (CABI) has launched an open-access CABI BioProtection Portal (www.bioprotectionportal.com). This portal is targeted primarily at growers and advisors, and available in multiple languages, it offers a free- and simple-to-use central reference point for all information related to nationally registered biological control and biopesticide products. Malaysia will soon be included as a member in this portal to display their biopesticide products. This will enable the broader communication and awareness to many stakeholders, including growers, to extract information on registered biological and biopesticide products from the Malaysian list of registered plant protection control products. Potential information to be displayed on the portal includes the product name, the manufacturer, the target pest(s) and the target crop(s). In this context, the Department of Agriculture will be acknowledged on each product page. The information on the portal will be updated frequently based on an agreement between CABI and the Department of Agriculture. Additional product-specific information, for example, shelf life, mode of action, application method, storage requirements, distributors, etc., will be obtained from the relevant biocontrol manufacturers with which CABI signs partnership agreements. The CABI BioProtection Portal also provides potential benefits to national regulators as it enables them to ensure that information about their registered biological control and biopesticide products is readily available, up-to-date and easily searchable for all key national stakeholders that require it, including growers, advisors, agro-dealers, academics, retailers, etc.
KEY ISSUES AND CHALLENGES
Despite the vast amounts of bioresources and their great potential for use in sustainable agriculture, biopesticide development, commercialization and use trajectory in Malaysia is yet to take off as desired. As indicated above in Section 5, as of October 2022, there were only 37 biopesticides registered under the Pesticide Board from a total list of about 3,386 pesticides registered. However, on a positive note, we see a gradual increasing trend. Majority of the biopesticides registered locally comprise mostly of imported microbials (Bt-based) as the active ingredient with a narrow spectrum of activity, it is daunting to predict the future growth in this sector.
Harris and Dent (2000) generally attributed the obstacles in the biopesticide development process in developing countries to a lack of expertise, low funding mainly from the public sector, and a lack of involvement of multi-disciplinary expertise needed to develop a biopesticide from start to finish. They believe that by removing these constraints, successful development and application of biopesticides can be achieved. With respect to specifically botanical pesticides, Isman (1997) identified three main barriers to the commercialization of botanical pesticides, viz., (1) Sustainability of the botanical resource; (2) Standardization of chemically complex extracts; and (3) Regulatory approval process as in Malaysia, the approval of biopesticides still follows the normal route as conventional pesticides despite their posing generally minimal risks as advocated in developed countries. This will however soon change with the introduction of the LRP-based registration pathway. Ganisan et al. (2016) also alluded to other limitations in the use of biopesticides such as the inconsistency in performance, to be more competitive, versatile and effective. Overriding these are the high cost considerations and thus the need for collaboration with private companies which will be crucial for efficient transfer of technology and commercialisation. In that context, the government needs to increase incentives to biopesticides companies in support of ‘green technology’ for food safety and societal well-being to encourage private commitment in production and commercialization of these products. From the user-angle, there is also the issue of the paucity of farmer awareness on the longer-term benefits of biopesticides.
FUTURE OUTLOOK
The former Minister of Science, Technology and Environment, Malaysia, Dato’ Seri Law Hieng Ding, in his opening address to delegates during the Third International Conference on Biopesticides held in 2002 in Kuala Lumpur underlined “that Malaysia will one day be the hub of research and production of biopesticides in the world.” However, the question remains as to “how?”. The current scenario towards the commercialization of ‘home-grown’ product(s) may not be realized unless the necessary drivers of the system are in place. The model proposed by Dent and Lomer (1999), which has the attributes of engaging multi-national, multi-institute, multi-disciplinary expertise, should probably be adhered to for the successful development and utilization of biopesticides. For this to be successful, concerted and coordinated efforts by various R&D agencies are therefore needed. Further, the current scenario of persistent resistance development in pests and extensive regulatory requirements has raised the hurdles for the introduction of new active ingredients. In this context, natural products still offer unmatched structural variety, especially when new environmental niches are being explored (Tombo, 1999). The development and use of local resources for developing botanical and other biopesticides could be the strategic option towards meeting the needs of pest management and sustainable agriculture of developing economies, such as in Malaysia. Being one of the mega biodiversity centres of the world, the country is in a unique position to contribute to the discovery of new biopesticides. There is also merit in developing specific natural pesticides to alleviate the increasing costs and dependence on imported fossil fuel-based synthetic pesticides. More importantly, this would encourage the nurturing of local industries in this sector which will result in novel innovations from local flora (Sivapragasam, 2009). It was noted in a market survey by MARDI in 2015 that the biopesticide industry is moderately competitive. Few players are currently involved because the market is not certain. Favourable government policies may help in nurturing the nascent industry to a competitive level. The study also concluded that the market for bio-pesticides in the world is expected to expand into double digits in the future and that biopesticides in Malaysia, albeit a less competitive industry, is growing.
ACKNOWLEDGEMENTS
The author expresses his sincere gratitude to the former Director General of MARDI Datuk Dr. Mohamed Roff for providing this opportunity to write this paper. He also appreciates the support of the Pesticides and Fertilizers Control Division, Department of Agriculture for sharing information on the registered biopesticides and to CAB International for their support for the overall biopesticides agenda. Last, but not least, the editorial comments, if any, by the Food and Fertilizer Technology Center (FFTC) for the Asian and Pacific Region, are duly appreciated.
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