19
H a r m o n i z a t i o n o f P r o t o c o l s f o r A s s e s s i n g t h e B i o e f f i c a c y a n d b i o s a f e t y o f G e n e t i c E n g i n e e r i n g a n d C o n v e n t i o n a l T e c h n o l o g i e s f o r P e s t M a n a g e m e n t H.C. S h a r m a 1* , S u r e s h W a l i a 2 a n d M.K. D h i l l o n 3 Ab s t r a c tSeveral technologies are in use for the management o f insect pests, wherein, different protocols and guidelines are being followed for testing their bioefficacy and biosafety. Therefore, it is important to have a comparative assessment o f bioefficacy and biosafety o f different pest management technologies viz. synthetic pesticides, biopesticides, natural plant products, natural enemies, and genetically modified organisms (GMOs) to the nontarget organisms in the environment. Toxicology and biosafety data should be generated on p rescrib ed anim als as p er the national and international protocols recommended by the government agencies, FAO, WHO, OECD, and EPA. Natural plant products, natural enemies, and insect-resistant crops developed through conventional and genetic engineering approaches should be viewed differently and safety requirements simplified and relaxed as appropriate, as compared to the synthetic insecticides. Generation o f data on bioefficacy should not only be done in micro-plots at the research stations, but also on the fa rm ers’ field s across a range o f environm ents. E co-safety data requirements and test protocols need a holistic review to ensure that priority risks are addressed and tests are focused on realistic exposure regimes.
1 International Crops Research Institute for the Semi-Arid Tropics, Patancheru 502 324, (Hyderabad), Andhra Pradesh, India.
2 Division o f Agricultural Chemicals, Indian Agricultural Research Institute (IARI), New Delhi 110 012, India.
3 Division of Entomology, Indian Agricultural Research Institute (IARI), New Delhi 110 012, India.
394 Environm ental Safety o f Biotech and Conventional 1PM Technologies
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• M axim um perm issible levels o f chem ical contam inants (synthetic p e s tic id e s /b io c h e m ic a l p e s tic id e s , m y c o to x in s , h e a v y m eta ls, pathogens, etc.).
• Q uality control for ensuring quality.
• Application o f hazard analysis and critical control point (HACCP), and good hygienic practices during production and processing.
• Inform ation on m anufacture and process details.
• Inform ation about raw materials, solvents used for extraction, and reagents entering the manufacturing process.
• Standardized criteria (chemical consumption).
• Stability o f botanicals/botanical preparations (residual and shelf-life time).
Table 2: Information on phytotoxicity, metabolism and persistence in the environment.
Bioefficacy parameter Insecti
cides Botanical pesticides Biopes ticides Effectiveness V V V Phytotoxicity V V V
Effects on parasites and predators yl V V
Translocation in plants V X
Metabolism/degradation in plants, soil, and water V V V
Persistence in soil/water/plant V V V
Compatibility V V V
Residues in plant/soil V V V
Residue tolerance limits V V V
Cost: benefit ratio V V V
Registration status in other countries V V ■V
Bioefficacy parameter Natural
enemies Insect resis tant transge nic crops Insect resis tant cultivars Effectiveness V V V Phytotoxicity X X X
Effects on parasites and predators Indigenous fauna
V X
Translocation in plants X X X
Metabolism/degradation in plants, soil, and water x V X
Persistence in soil/water/plant X V X
Compatibility V V X
Residues in plant/soil X V X
Residue tolerance limits X Transgene
product
X
Cost: benefit ratio V V V
Registration status in other countries V V V
Modified from data requirements by the Central Insecticide Board for Synthetic Pesticides (http://cibrc.nic.in). V = required, x = Not applicable.
Inform ation on ecological testing is used by the Registration Committees to determ ine potential hazards, i f any, to hum an health and nontarget organism s such as birds, livestock, fish, honeybees, etc. in the environment. Potential adverse ecological effects are assessed from the data generated in a tiered fashion, beginning with less expensive acute toxicity tests on a few representative organism s and progressing through more expensive chronic toxicity tests to a final tier o f sim ulated and/or actual field tests. The m inimum data on ecological-effects required to support the registration o f an outdoor-use include toxicity tests on nontarget organism s such as: i) birds, ii) fish, iii) honeybees, iv) livestock, v) spray operators, and vi) industrial workers. Information on use pattern, environmental degradation, and m am m alian toxicity is desirable to determ ine i f additional testing is required to assess the risk further. Such inform ation on risks and fate o f the chem ical/organism in the environm ent assists in deciding the toxicity status o f the product.
The initial toxicity data are required to estim ate acute toxicity (LC50, EC50 and LD 50) o f the active ingredient to aquatic and terrestrial organisms (rat/mice/fish). Further studies m ay be required for evaluation o f toxicity to livestock, and the effects o f a pesticide on parasites and predators. In case o f botanical pesticides, inform ation on acute toxicity, neuro-behavioral and reproductive effects, carcinogenicity, mutagenicity, and effects on spray operators is also necessary for sale and field application. The second tier data on toxicity to birds, honeybee, fish, livestock and spray operators are how ever not required in special cases due to proven safety o f the natural molecule. Inform ation on phytotoxicity is im portant for both natural and synthetic pesticides, as the effectiveness depends upon the inherent toxicity to the host plant. Normally, the effects o f natural pesticides on parasites and predators are not essential, presum ing th at natural products are h a r m le s s . H o w e v e r , th e s e p r o d u ct s m u st b e e v a lu a t e d on a few representative species to determ ine their safety to the natural enemies and other nontarget arthropods. In the case o f neem -based pesticides, long term toxicity data on neuro-behavior toxicity, m utagenicity, carcinogenicity, effect on reproduction, and health records o f workers are also required (Shetty 2004).
Studies on the fate o f pesticides in the environm ent are a pre-requisite, w h e re a s in th e ca se o f n a tu ra l p ro d u cts (b o ta n ic a l p e s tic id e s an d biopesticides), such studies m ay not be required as they degrade in the environm ent faster than the synthetic molecules. However, such decisions m ust be based on the known facts. D ata related to fate in environm ent includes translocation, m etabolism and persistence in soil, plant, and water bodies. Inform ation on the prim ary/secondary m etabolites, degradation/ m etabolic pathw ay(s), h alf-life, persistence in differen t environm ental segments (soil, sediment, water, and air), dissipation, m obility and likely con cen tration s in the environm ent, and bioaccu m u lation is helpfu l to establish persistence o f the pesticide. Aerobic and anaerobic m etabolism
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398 Environm ental Safety o f Biotech and Conventional IP M Technologies
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tests are p e rfo rm e d in soil an d w a ter. E n v iro n m e n ta l tra n sp o rt is determ ined through leaching, adsorption/desorption and volatilization studies. Leaching and adsorption/desorption data are important as it depends on the chem istry o f the active ingredient as well as the form ulants used in the final product, use patterns, and other pertinent factors. These tests are considered basic to an understanding o f likely field-dissipation routes under actual-use conditions at maximum label rates. H arvest tim e residue o f a particular com pound in the soil as w ell as in the produce needs to be estimated. Based on these data, maximum residual lim it (MRL) and waiting period are estim ated. F u rth erm ore, fo r syn th etic m olecu les, effluent treatm ent procedures need to be m entioned for environ m en tal safety (Kapustka et al. 1996). For botanical pesticides, no such data are required fo r re g istra tio n , as th ere are no re p o rts o f th e ir p e rsiste n ce in the environm ent (W aage 2001). Test reports about the quality o f the product should be obtained from a laboratory w ith ISO 9000. The applicant should a lso prov id e sam ple a lon g-w ith sta n d a rd tech n ica l sam ple from the principals/ authorized dealers for chem ical verification. In case o f technical grade pesticides, samples o f standard im purities are also to be provided for chem ical verification. M ethodology for residue estim ation should also be provided along with inform ation on carcinogenicity and genotoxicity.
B iosafety o f b iop esticid es
T h e W o r ld H e a lth O r g a n iz a t io n (W H O ) m e m o r a n d u m p r o v id e s recom m en d ed sa fety tests for ap p lica tion to b io lo g ica l agen ts under consideration for widespread use in pest control (W HO 1979). The basic principles utilized in developing these recom m endations are: i) the hazards presen ted by m icrobial pesticides are in h eren tly differen t from those associated w ith the use o f chem ical pesticides, and the tests used to determ ine poten tial hazard to hum ans should be reflected , ii) a high proportion o f negative results is likely, iii) tiered testing system s should be used, negative data obtained at any level w ould obviate the need for further testing, and iv) the prim ary tier testing protocols should be designed to expose test animals to the microbial agents under conditions that provide m axim um opportunity for expression o f any adverse effects (Burges et al. 1981).
Inform ation on identity, host range, m ode o f action in natural hosts, and optimum and maximum temperatures for growth o f the organism should be elicited, especially in relation to hazard assessment early in the research phase. The suggested tests for bacteria and fungi are given in Fig. 1 (Chapter V). These tests are arranged in three tiers, any o f w hich can lead directly to an assessment o f the potential hazard. I f all the tests in the first tier produce negative results, the organism can be considered safe for use as directed, without further experim entation. Inform ation on the safety o f m aterial added subsequently to improve adherence and longevity need to be obtained
separately. The biosafety tests include: i) oral intraperitoneal, respiratory exposure, eye and derm al exposure, allergenicity, hypersensitivity and m utagenicity tests, and tier 2 and 3 tests. The em phasis should be on infectivity rather than toxicity, since spores o f protozoa and viruses are not kn ow n to be associated w ith toxin s. It is th erefore n ecessa ry to use m am m alian tissue cultures in Tier 1, as they provide a sensitive test for infectivity. In addition, they provide m aterial w ith w hich the tests through incorporation o f viral DNA into the host genom e need to be conducted. M icrosporidial insecticides m ay be related to a natural m icrosporidan p a thogen o f m am m als, w h ich is kn ow n to a ttack the n ervous tissue. Therefore, the intracranial route should be included in the Tier 1 tests with insect microsporida.
B iosafety requirem ents fo r natural enem ies
The Food and Agriculture Organization (FAO) code o f conduct is being used to address the application o f biocontrol m easures prior to im port and export o f the n atural enem ies, w h ich also provides in tern a tion a lly accepted procedures. The International Standards for Phytosanitary Measures (ISPM 3; Code o f conduct for the im port and release o f exotic biological control agents) has been further revised and published by the Secretariat o f the International Plant Protection Convention (IPCC in 2005 as “Guidelines for the export, shipment, im port and release o f biocontrol agents and other beneficial organism s”). The developing countries that have recently started the use o f biocontrol agents or those w ith an opportunity to use biological control have benefited m ost from ISPM 3. This is expected to becom e the standard for all biocontrol introductions worldwide. ISPM 3 has ensured that environm ental issues are addressed properly, and w ould provide a m echanism for form alizing good practice and setting standards for decision m aking w ithin an internationally recognized framework.
The environm ental im pact o f biocontrol agents can be defined as any m easurable effect on a nontarget species resulting from the introduction o f an exotic organism. The results could be complex, w ith effects on several species in the food-web spanning three trophic levels. A n indirect effect could be increased com petition for host or prey w ith the native natural enem ies or habitat modification (van Lenteren 1997). Till now, very few problem s have been reported concerning negative effects o f releases o f arthropods for controlling arthropods, despite more than 5,000 introductions in at least 196 countries or islands. Though ISPM 3 gives the regulations to be follow ed for release o f biological control agents, it does not provide m ethods for assessm ent o f environm ental risks, van Lenteren et al. (2006) and B igler et al. (2006) have tried to develop com prehensive and quick scan environm ental risk assessm ent m ethods for biological control agents, van Lenteren et al. (2003) listed five risk factors: host range, establishment, dispersal, direct nontarget effects, and indirect nontarget effects. The risk assessm ent involves three phases:
H arm onization o f P rotocols fo r A ssessin g the B ioefficacy and B iosafety 401
• Risk identification and evaluation.
• Risk m anagement, including risk m itigation or reduction. • Risk/benefit analysis o f the proposed release.
It has been recommended to avoid using generalists or adventive species, expand host-specificity testing, incorporate more ecological information, consider ecological risk in target selection, prioritize agents, and pursue genetic data on adaptation with which we can further increase the safety o f biocontrol agents.
B iosafety assessment o f en tom opathogenic nem atodes
Studies on the safety o f entomopathogenic nematodes (EPN) to nontarget organisms have been reviewed by Akhurst and Smith (2002). Available evidence clearly indicates that EPN are safe biocontrol agents, which are more specific, and pose lower risk to the environment than the chemical insecticides. Since the first use o f EPN for insect control as early as in 1935 (Glaser and Farrel 1935), no environmental or health hazard associated with their use has been reported, despite their widespread use particularly over the past two decades. In general, the protocols followed for the use o f natural enemies can be adapted for the production and release o f entomopathogenic nematodes.E n v ir o n m e n ta l r is k s a s s o c ia t e d w ith in s e c t -r e s is ta n t
cultivars
Organization for Economic Cooperation and Development in 1993 made first attempt to consider environmental safety issues associated with growing or using a particular plant as food, fiber, fuel, or for any other purpose (OECD 1993). G ene transfer, w eediness, trait effects, gen etic and phenotypic variability, expression o f genetic material from pathogens, and worker safety are the six important issues that need to be addressed for environmental safety. Environment Protection Agency (EPA) in 1994 proposed that traits intended for pest control be subjected to regulation under the Federal Insecticide, Fungicide and Rodenticide A ct (FIFRA) as plant pesticides. The regulation has still not been approved, as a consortium o f 11 scientific societies challenged the concept that the traits used in plants for defense against pests cannot be equated with pesticides applied to plants. Some plant defense chemicals also affect the food quality. Gossypol and related compounds are toxic to non-ruminant vertebrates (Lambou et al. 1966). Rutin, chloroginic acid, tomatine, and phenols m ay have toxic effects on humans, and some o f these compounds m ay also have carcinogenic and mutagenic effects.
One o f the m ajor environmental impacts o f deployment o f insect-resistant genotypes has been development o f virulent insect populations overcoming host resistance. Selection o f inseect populations for virulence limits the utility o f resistance genes. Nearly 86 biotypes in 22 insect species feeding on nine crops have been reported (Smith 2005). To cope w ith the problem o f emerging biotypes, the foremost requirement is systematic surveillance and monitoring
4 02 Environm ental Safety o f Biotech and Conventional IP M Technologies
o f biotypes, which is helpful in breeding pest-resistant cultivars. There is a need for developing short- and long-term strategies to breed for insect resistance, with a focus to broaden the genetic basis o f resistance, involving both m ajor and minor genes. This includes identification o f donors o f new resistance genes, sequential release o f varieties with major genes, pyramiding o f m ajor genes, development o f multilines and synthetics through horizontal resistance, wide hybridization, and gene rotation.
B iosafety assessment o f transgenic crop s
No transgenic crop can be used com m ercially until its agronomic superiority is assessed vis-a-vis compared with traditional best checks in farmers’ fields. A series o f open field trials are m andatory to meet regulatory requirements for agronom ic performance, once safety and efficacy has been established. The open field trials are divided into: confined field trials, multi-location research trials, and large-scale field trials. These trials are spread over a period o f 5 to 6 years. The initial inform ation is generated under laboratory and greenhouse conditions with the permission o f the Institutional Biosafety Com m ittee (IBSC). The environmental im pact studies are undertaken as per the norms stipulated by the Genetic Engineering Approval Committee (GEAC) o f the Department o f Biotechnology (DBT) by different public sector institutions and accredited private laboratories (DBT 2007). These include pollen flow , germ ination, aggressiveness and w eediness, soil analysis covering effect on soil micro-biota and the presence o f transgene protein in soil, effects on nontarget and beneficial insects, and baseline susceptibility studies (Table 5).
Table 5: Assessment of environmental biosafety/impact of genetically engineered crops.
Test Remarks
Greenhouse evaluation
Pollen flow and gene transfer Germination, aggres siveness, weediness Effects o f rhizoshpere Impact on nontarget organisms Baseline susceptibility
The greenhouse and confined field trials are conducted for selection o f elite events and to assess preliminary biosafety, food safety and environmental effects.
The pollen flow studies are carried out to estimate outcrossing frequencies, determine possibility o f gene transfer into closely related species, and assess weediness characteristics o f GM crops. These studies are undertaken to confirm that the introduced gene will not confer any fitness disadvantage to the wild species. These studies include effects o f expressed protein on soil microflora and invertebrates. These studies cover different agro- climatic zones as per protocols approved by the regulatory authorities.
Given the importance of beneficial insects, it is mandatory to conduct studies on the effect o f GM crops on nontarget organisms. Data on baseline susceptibility should be generated as a part o f post-release requirements to assess development o f resistance following large-scale release o f the transgenic crop.
H arm onization o f P rotocols fo r A ssessin g the B ioefficacy an d B iosafety 403
The regulatory authorities have specified a num ber o f defined safety tests to determ ine potential im pact o f genetically engineered crops on hum an and anim al health based on the m odification o f the proteins in the plant or based on the use o f transgene {e.g. Bt protein). The transgenic crop under evaluation is subjected to toxicity, allergenicity and feeding te sts, w h ich in clu d e s a cu te, su b -ch ro n ic an d ch ro n ic testin g . M ore precisely, the hum an/anim al health safety testing is done on fish, chicken, rabbit, rats, goats and cows, and on other m odel anim als as recom m ended on a case-by-case basis. The transgenic crops are also tested for toxicity to a scerta in th a t it con tain s no new allerg en ic com pou n d s and is non- allergenic. The foliage and fruit feeding studies are undertaken in goat and cow. O ther studies include protein expression and quantification, su bstan tial eq u iva len ce, an d protein estim a tion in cook ed food. The toxicity, allergenicity, and food and feed safety evaluation tests are listed below.
• Acute oral toxicity studies in Sprague daw ley rats. • M ucous mem brane irritation test in fem ale rabbit. • Prim ary skin irritation test in rabbit.
• Substantial equivalence (com positional analysis) studies. • Sub-chronic oral toxicity study in Sprague dawley rats.
• Assessm ent o f allergenicity o f protein extracts using brow n Norway rats.
• Dietary feed tests on common carp for evaluating growth performances. • Food cooking and protein estim ation in cooked food.
• Sub-chronic feeding studies using New Zealand white rabbit. • Effect on perform ance and health o f broiler chickens.
• Sub-chronic feeding studies in goats.
• Feeding studies in lactating crossbred dairy cows. • Protein expression studies.
Ef f e c t s o f Va r i o u s Cr o p Pr o t e c t i o n Te c h n o l o g i e s o n Hu m a n
He a l t h
Hum an health effects are caused through: i) skin contact, ii) inhalation, and 3) ingestion through food or in water. Industry and farm workers are exposed to inhalation and skin contact during preparation and application. H o w e v e r , fo r th e m a jo r ity o f p o p u la t io n , th e p r in c ip a l s o u r c e o f contamination is through food and water. The harm ful effects o f pest control technologies on hum an beings are:
• Death.
• Cancers, tumors, and lesions. • Reproductive inhibition.
4 0 4 Environm ental Safety o f Biotech and Conventional IP M Technologies
• D isruption o f immune and endocrine system. • Cellular and D N A damage.
• Teratogenic effects (physical deformities).
• Poor health m arked by low red to white blood corpuscles ratio. • Intergenerational effects that are more pronounced in subsequent
generations.
M any o f these m ay not be due to direct effects, but associated w ith a co m b in a tio n o f e n v iro n m e n ta l stresses su ch as e u tr o p h ic a tio n and pathogenesis (Baker and W ilkinson 1990; M argni et al. 2002). Although several docum ents on safety assessment o f pesticides as ingredients in food and food supplem ents are available, the relevant legislative fram ew ork and guidance for risk assessm ent have not yet been established. For transgenic crops, the standard tests for biosafety o f transgenic crops for hum an health include: i) mammalian toxicity, ii) digestibility, iii) allergenicity and homology w ith k now n food allergen s and toxins, iv) com position al analysis, v) nutritional assessm ent (concentrations and effects on bioavailability), and vi) unexpected or unanticipated effects. A com prehensive evaluation o f the new technology in terms o f its environmental impact that contributes towards sustainable agriculture forms an integral part o f India’s regulatory system for the approval o f transgenic crops.
Co n c l u s i o n s
There is an urgent need for standardization and harm onization o f protocols fo r a sse ssm e n t o f b io e ffic a c y an d b io sa fe ty o f s y n th e tic p e sticid e s, biopesticides, natural plant products, natural enem ies, and GMOs to the nontarget organism s in the environment. Toxicology and biosafety data sh ou ld be g en era ted on p rescrib ed an im als as p e r the n a tion a l and international protocols recommended b y the governm ent agencies, FAO, W HO, OECD, and EPA. R egulatory m easures need to be reinforced to prevent use o f spurious pesticides, and check adulteration o f botanical and microbial products w ith undesirable materials. Plant products intended as pesticides should be devoid o f undesirable substances toxic to hum ans and dom estic anim als. U nintended pathogenicity and lon g-term im pact o f m icrobials towards non-pathogens and other nontarget organism s should also be studied properly. Natural plant products, natural enemies, and insect- resistant crops developed through conventional and genetic engineering approaches should be viewed differently and safety requirements simplified, and relaxed as appropriate as com pared to the synthetic insecticides.
Expert groups o f researchers, academ ia, practitioners, and regulatory bodies should be established at the national and international levels to prevent injudicious use o f pest control technologies and m onitor nontarget effects on the environment. Generation o f data on bioefficacy should not only be done in micro-plots at the research stations, but also on the farm ers’
H arm onization o f P rotocols fo r A ssessin g the Bioefficacy an d B iosafety 405
fields across a range o f environments. There is a need to develop a database on p r o to c o ls an d e ffe c ts o f p e s t m a n a g e m e n t te c h n o lo g ie s on the environm ent to m ake inform ed decisions about the possible and safer interventions for pest m anagement. Eco-safety data requirem ents and test protocols need a holistic review to ensure that priority risks are addressed and tests are focused on realistic exposure regimes.
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Akhurst R, Smith K. 2002. Regulation and safety. In: Entomopathogenic Nematology (Gaugler R, ed.). CABI Publishing, Oxon, UK. pp. 311-332.
Baker SR, Wilkinson CF. 1990. The effects o f pesticides on human health. In: Advances in Modern Environmental Toxicology. Princeton Scientific Publishing Inc., Princeton, New Jersey, USA. 438 pp.
Bigler F, Barbendier D, Kuhlmann U (eds.). 2006. Environmental Impact o f Invertebrates in Biological Control o f Arthropods: Methods and Risk Assessment. Commonwealth Agricultural Bureau International (CABI), Wallingford, UK. 68 pp.
Burges HD, Copplestone JF, Dubitskij A, Hamon J, Mackenzie DWR, Rogoff MH, Ajibola Taylor T, Tinsley TW, Vandekar M, Vernes AJM, Wright AE. 1981. Mammalian safety o f microbial agents for vector control: A WHO Memorandum. Bulletin o f the World Health Organization 59: 857-863.
Department o f Biotechnology (DBT). 2007. Safety A ssessm ent o f GM Food Crops. Department o f Biotechnology, New Delhi, India.
Glaser RW, Farrell CC. 1935. Field experiments with the Japanese beetle and its nematode parasite. Journal o f the New York Entomological Society 43: 345.
ISAAA. 2009. India Operationalizes Event Based Approval Mechanism. ISAAA, New York, USA. http://www.isaaa.org/kc/cropbiotechupdate/article/default.asp?ID=3900 Kapustka LA, Williams BA, Fairbrother A. 1996. Evaluating risk predictions at population and com m u n ity levels in p esticid e re g istra tio n -h y p oth e ses to be tested. Environmental Toxicology and Chemistry 15: 427—431.
Lambou MG, Shaw RL, Decossas KM, Vix HLE. 1966. Cotton seeds role in a Hungry world. Economic Botany 20: 256-267.
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