Crop Protection Products for Organic Agriculture - ACS Publications

Chapter 4

The IR-4 Program for Registration and Development of Organic Products and Biopesticides

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M. P. Braverman, D. L. Kunkel, J. J. Baron and R. E. Holm IR-4 Project, Center for M i n o r C r o p Pest Management, Technology Center of New Jersey, Rutgers, The State University of New Jersey, 681 U.S. Highway Number 1, South, North Brunswick, NJ 08902-3390

This chapter describes the activities of the IR-4 Project with biopesticide products and how IR-4 promotes registration and efficacy research for their adoption and development. It also compares and contrasts biopesticide and organic products as well as discussing specific regulatory issues around labeling organic products.

Background The term biopesticide probably has as many varied definitions as the term organic. Biopesticides are often thought of as being synonymous with organic or natural. While the term organic is officially defined and pesticidal products are designated by the National Organic Program of the United States Department of Agriculture (USDA) (/), biopesticides are officially designated by the Biopesticides and Pollution Prevention Division (BPPD) of the United States Environmental Protection Agency (EPA) (2). The Biopesticide and Pollution Prevention Division of E P A was initiated in 1994. Products that are © 2007 American Chemical Society In Crop Protection Products for Organic Agriculture; Felsot, A., et al.; ACS Symposium Series; American Chemical Society: Washington, DC, 2006.

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currently considered biopesticides have been registered since the 1940's even though the individual division was not developed until 1994. The first record for products that are currently considered biopesticides is for oil of mustard as a repellent, and the first microbial pesticide registered was Bacillus popilliae for control of Japanese beetles. Products with these first biopesticides are still available today. The registration of biopesticides has its own set of requirements that are independent from organic status. A n overview of the registration process for biopesticides has been summarized (5). Biopesticides are certain types of pesticides derived from animals, plants, bacteria, and certain minerals (4). These are defined by E P A ' s B P P D into three main classes as follows: 1. 2.

3.

Microbial pesticides are products consisting of a microorganism such as a bacterium, fungus, virus or protozoan as the active ingredient. Plant-Incorporated-Protectants (PIPs) are pesticidal substances that plants produce from genetic material that has been added to the plant using modern biotechnology methods. Biochemical pesticides are naturally-occurring substances that control pests by a non-toxic mode of action. Biochemical pesticides include substances that create barriers against pest attack, cause suffocation of insects, and pheromones that interfere with mating by leading male insects to traps or otherwise making it harder to locate females. There are also non-pheromone type attractants or scents that are used to lure, trap, or when combined with toxicants to kill insects. Synthetic analogs of biochemicals can also be registered. One of the more recently developed products induces a plant to invoke its defense systems against pathogens. While microbial and PIP products are well defined, the requirement of a non-toxic mode of action is often the key distinction between a biochemical biopesticide and a conventional pesticide. B P P D has a specific group of scientists called the Biochemical Classification Committee that determines whether a substance meets the criteria for classification as a biochemical pesticide.

Plant incorporated protectants such as those that contain genetic material coding for production of Bacillus thuringiensis (Bt) are not considered to be organic under U S D A organic rules (7) but sprayable forms of Bt are listed by the Organic Materials Review Institute (OMRI). In contrast, both Bt in sprayable forms and derived from PIP are regulated as biopesticides by EPA. There are a number of microbial derived or biochemical products that are allowed under organic rules such as tetracycline but most antibiotics are not biopesticides. Products that have organic designations such as spinosyn and pyrethrum are not considered to be biopesticides by E P A , primarily because of their direct toxic mode of action.

In Crop Protection Products for Organic Agriculture; Felsot, A., et al.; ACS Symposium Series; American Chemical Society: Washington, DC, 2006.

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The IR-4 Project The IR-4 Project is funded by the U S D A Cooperative State Research Education and Extension Service (CSREES) and the Agricultural Research Service (ARS) and also receives support from the directors of state agricultural experiment stations. IR-4 is an applied research program whose mission is to help specialty crop producers obtain safe and effective pest control products. The program was initiated in 1963 and historically has focused on registration and reregistration of chemicals and biopesticides for use on specialty crops or for minor uses on major crops. IR-4 broadened its scope in 1982 to include research leading to registration of a wide range of biopesticides including microbial biopesticides, nonviable microbials, genetically altered microbials, transgenic plants and biochemicals . The program is committed to developing alternative pest control products on minor food crops and ornamentals by working cooperatively with public and private sector individuals and organizations. IR-4 interacts with the U S D A , E P A , and product registrants to determine the requirements for registration of proposed uses. The program has the resources to develop research protocols, assist with Experimental Use Permits, coordinate and fund field and laboratory research, assist in the development of Tier I toxicology and non-target organism waivers, and prepare data packages for submission to the E P A . IR4 residue research is conducted according to E P A Good Laboratory Practice regulations utilizing the IR-4 Quality Assurance network. Under the under Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the E P A regulates all materials that claim to have pesticidal properties. In general, the number and type of studies required to register biopesticide products are different from the studies required to register conventional pesticides. IR-4 will consider biopesticides that meet the E P A definition as well as other low exposure, naturally occurring biochemicals which have pest control activity, provided they do not have significant toxicity to man, mammals, fish or birds. Biologicals such as arthropod (insect) parasites and predators or predacious nematodes are not regulated under FIFRA and because of this do not fall under the purview of the IR-4 program.

IR-4 Grants for Biopesticide Research The primary objective of the IR-4 Biopesticide Research Program is to further the development and registration of biopesticides for use in pest management systems for specialty crops or for minor uses on major crops. Areas of IR-4 assistance include: 1.

Arrange preregistration meeting with E P A and developing approved research protocols;


48 2. 3. 4. 5. 6.


7. 8.

Assist in complying with E P A Good Laboratory Practice regulations; Fund small and large scale field efficacy trials; Fund magnitude of residue trials, if needed; Assist in obtaining Experimental Use Permits from E P A ; Prepare and submit petitions to the E P A to support tolerances (maximum levels of substances allowed in raw agricultural commodities) or tolerance exemptions; Develop data to expand registration to include additional crops and uses; Prepare registration documents for submission to the E P A .

In 1995, IR-4 decided to provide some additional financial support; thus, a competitive grant program was initiated at $300,000 a year. Since 1995, the IR4 project has funded approximately $3 million dollars in efficacy research. About 25% of research is on early stage projects and 75% on advanced stage projects. The IR-4 Project defines early stage projects as ones involving products that have no or incomplete toxicology packages and advanced stage projects as ones which generally involve expanding the use o f registered products. This usually involves efficacy studies leading to adding new crops , or new pests and sites to the existing label. While IR-4 has funded biopesticide research on both organic and non-organic products, for the purposes of this paper only the organic products are listed in Table I. For unregistered products IR-4 involves E P A in the review process to increase the likelihood that supported products are capable of making it through the regulatory process. Some state regulatory agencies such as California's Department of Pesticide Regulation require efficacy data for registration purposes. The goal of the IR-4 Biopesticide Research Program is to work with university and U S D A researchers to develop the data that would help support registrations and to also work with key university researchers and extension agents who recommend to growers what biopesticides can be used. In the 13-year period between 1982 and 1994 the IR-4 Biopesticide program emphasized support for regulatory work for registrants and IR-4 support resulted in registration of a substantial number of important biopesticides (5). Products that IR-4 has assisted in submitting registration packages for are listed in Table II. Probably the most important product was and still is several sub-species of Bacillus thuringiensis or Bt. IR-4 continues to assist registrants which are primarily comprised of very small businesses and individual scientists with limited regulatory experience. IR-4's involvement has varied widely depending on the particular registration. In most instances, exemptions from the requirement of a tolerance are obtained from E P A . However, in some cases, IR-4 has conducted magnitude of residue trials. In cases of insufficient data for support of full registration, an Experimental Use Permit was submitted and granted. There have been several registrations in which IR-4 has prepared and submitted entire data waiver justifications, petitions and registration documents to the E P A .


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Table I. Listing of OMRI* Allowed and Regulated BiopesticidesSupported by IR-4 Efficacy Research 11


Active Ingredients Bacillus pumilus Bacillus subtilis Candida oloephila Coniothyrium minitans Gliocladium virens Hydrogen peroxide Pantoea agglomerans Potassium bicarbonate Psudomonas syringae ESC-10 Rosemary oil Streptomyces griseovirdis Trichoderma harzianum Azadirachtin and neem Bacillus thuringiensis Beauveria bassiana strain GHA Capsaicin Codling Moth Granulosis Virus Garlic Helicoverpa zea + virus kaolin Quillaja aminoethoxyvinyglycine (AVG) gibberellic acid pheromones

c

d

Biotype Fungicide Fungicide Fungicide Fungicide Fungicide Fungicide Fungicide Fungicide Fungicide Fungicide Fungicide Fungicide Insecticide

Trade Name Yield shield Serenade Aspire Contans, Intercept SoilGard StorOX Bloom Time Biological Kaligreen Bio-Save 10 L P Sporan Mycostop Plant Shield, RootShield Aza-Direct, Neemix, Trilogy Numerous Mycotrol 0

Insecticide Insecticide

Millers Hot Sauce Cyd-X

Insecticide Insecticide

BioRepel GemStar Surround Quillaja ReTain

Insecticide Insecticide Insecticide Nematicide Plant Growth Regulator Plant Growth Regulator Pheromone

Falgro Checkmate O F M

a

Organic Materials Review Institute; Box 11558; Eugene, O R 97440

b

Research funding was provided to public research institutions, not O M R I .

c

Trade names are included only as a reference. The actual product(s) evaluated may or may not be that particular commercial product

Listing of research in this manner does not constitute a recommendation for use. Consult the current label for proper use directions.


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Table II. Registration Clearances Obtained by IR-4 on Behalf of Registrants


Product Aspergillus flavus A F 36 Bacillus popilliae Bacillus thuringiensis (Bt) Cinnamaldehyde

Codling Moth Granulosis Virus Formic Acid Gibberellins Grape Berry Moth Pheromone Kaolin Lagenidium giganteum Lysophosphatidylethanolamine (LPE) Methyl Anthranilate Milsana Sucrose Octanoate Thymol Verticillium WCS850 (Dutch Trig) Yeast Hydrolysate

Crop or Use Cotton-AZ and T X Pastures A l l crops (Label Expansions) Mushrooms {Verticillium spot and dry bubble disease control) and for insect and disease control on 53 crops Apple, Pear, Walnut & Plum For mite control in bee hives For P G R use on minor crops Grape Insect control on 48 crops Rice 97 and 98S formulations on 13 fruit crops (EUP) promote ripening and extend storage shelf life. Bird repellent on blueberries, grapes and cherries For powdery mildew control on ornamentals On all commodities for insect and mite control (pending) Section 18 for varroa mite control in beehives Experimental Use Permit for control of Dutch Elm disease Control of greasy spot on citrus and bacterial leaf spot in tomato


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EPA Label Approval under the National Organic Program The U S D A N O P has the authority to list products they designate as organic, but the pesticidal products labeling still falls under the jurisdiction of E P A . This section is drawn from Pesticide Registration (PR) Notice 2003-1 (6). P R Notice 2003-1 describes how registrants can obtain E P A approval of label language indicating that all ingredients (active and inert) in a pesticide product and all uses of that pesticide meet the criteria defined in the U S D A ' s National Organic Program (NOP) Rule. Registrants of pesticide products are not required to specify on their label that their products can be used in organic agriculture. However, i f a registrant does want to include such language, it must comply with PR Notice 2003-1. Since the U S D A already has a system in place to define organic pesticides, the E P A depends on the U S D A ' s listing for deciding i f a product qualifies for organic use language to be included on its label. Except for exempted products (also known as 25b products) the labeling requirements of registered products fall under the jurisdiction of the E P A as established under FIFRA. Among the requirements enforced by E P A is that the labeling not be false or misleading in any manner. There have been perception problems within the agricultural community as well as the general public over the exact meaning of the term 'organic'. E P A has previously regarded statements such as "organic" to be forms of false or misleading safety claims. After creation of the Federal Organic Food Production Act (7 U.S.C. section 6501 et seq.) and associated N O P Rule, consistent Federal standards for what "organic" means now exist. PR 2003-1 has the phrase "for organic production" as suggested label wording to designate organic products because it only states the ability to use the product within organic agriculture without implying any safety claims. In order for a product to meet the requirements of the NOP, each ingredient in the product, including active and inert ingredients, must be allowable under The National List of Allowed and Prohibited Substances (National List) contained in 7 C F R part 205. A l l uses on the product label must be eligible or the product should not be labeled with a N O P statement. The National List of acceptable products for organic agriculture is available at: http://www.ams.usda.gov/nop/NationalList/FinalRule.html. Inert ingredients (including List 4) (specifically allowable for use in crop and livestock production in the National List) are available at: http://www.epa.gov/opprd001/inerts/inerts list4.pdf. A tolerance is the maximum allowable concentration of a substance in or on a crop. A l l ingredients of pesticide products registered (or exempted from regulation under FIFRA) for use on foods must have either a tolerance or an exemption from the requirement of a tolerance i f residues of such ingredients result in or on the food from such use.



52 The labels for "minimal risk pesticides", also known as 25(b) or exempted products are not reviewed by the E P A , so E P A cannot approve the use of N O P language on 25(b) product labels. Products exempted under FIFRA section 25(b) are not precluded from identifying whether they meet the requirements of the National Organic Program. However, producers of such products are reminded that it is their responsibility that they meet all other E P A requirements and N O P requirements. Although there are various types of wording that are acceptable and there are methods for getting new wording approved by the E P A , the phrase mentioned by the E P A is "For Organic Production". There are methods for utilizing different words and logos, but some phrases in the N O P listing such as "minimizes accumulation in the soil" or statements that are not quantifiable are generally not acceptable. The phrase should be located on the front panel of the label in close proximity to the product name. The phrase should not appear above the product name (in the location normally reserved for a Restricted Use Statement). The font size should be comparable to that of other type and not highlighted by size, color, contrast or placement. Inclusion of an ingredient on the National List is independent of approval of ingredients for use in pesticide products under FIFRA or Federal Food, Drug and Cosmetic Act (FFDCA). Some of the items on the National Organic list are quite vague such as "dairy cultures' and "chlorine materials". Such sweeping inclusions are not approved by B P P D although some specific products may be registered. The National List may include substances that are not currently found in any registered pesticide product; therefore, it is the responsibility of the registrant to ensure that all ingredients are currently approved by the E P A . It is also important that registrants keep abreast of any removal of products from the N O P list or tolerance or registration changes that affect its eligibility for the proper label language.

Profiles of Selected Biopesticide Registrations Facilitated by IR-4 Aspergillus flavus AF36 Aflatoxin is a known carcinogen produced by Aspergillus flavus and other Aspergillus species. Aspergillus flavus AF36 is a naturally occurring strain of A. flavus that does not produce aflatoxin. When AF36 colonized wheat is spread on


53 the soil surface there is a shift in the microbial ecology whereby AF36 predominates the A. flavus population. When AF36 infects developing cotton seed instead of other A . flavus strains there is a reduction in aflatoxin content of cottonseed. It is currently registered in Arizona and Texas.

Bacillus popilliae


Also known as milky spore disease, it is a pathogen of Japanese Beetle. Unlike Bacillus thuringiensis which has an endotoxin, B. popilliae is a parasite causing a disease in beetle larva.

Bacillus

thuringiensis

There are several isolates and formulations of Bt. It is considered to have the largest market among individual biopesticide active ingredients. While IR-4 was not involved in the initial registration of this product, in 1976 the IR-4 Project submitted a petition which resulted in a blanket tolerance exemption for Bt in beeswax, honey and all other raw agricultural commodities and greatly expanded the uses of Bt and eliminated the need to apply for a tolerance exemption on a crop by crop basis.

Cinnamaldehyde As the name implies this product is found in cinnamon, particularly cinnamon oil, but it is also present in other oils as well. The initial registration work by IR-4 was on mushrooms (Verticillium spot and dry bubble disease control) and was later expanded to insect, mite and disease control on 53 crops. This product has both pesticidal activity and activity as an attractant.

Codling M o t h Granulosis Virus This is an important tool in the protection of pome fruits from codling moth. The IR-4 submitted the registration and tolerance exemption package for this product. It is a baculovirus which infects the larvae. The protein coating of the virus is dissolved in the alkaline environment of the larval midgut. The virus is then released into the infected host.


54 Formic Acid and Thymol These two active ingredients are used for the control of varroa mite which is a parasite of honeybees. These substances are volatile and fumes disseminate throughout the hive. Formic acid is also part of honeybee venom and thymol is a constituent of several herbs. The national registration for formic acid was submitted by IR-4. IR-4 also organized the current Section 18 for thymol.


Gibberillic Acid There are several forms of this plant growth regulator which is also known as G A . The form G A is the most widely utilized to increase plant elongation, fruit set and size. Similar to Bt, the IR-4 Project developed a blanket exemption from tolerance on all food crops. 3

Grape Berry Moth Pheromone The active ingredient in this pheromone is (Z)-dodec-9-enyl acetate. It is a female sex pheromone that attracts males. Innundative releases of pheromone in vineyard air makes it harder for grape berry moth males to locate females thus reducing mating and egg production.

Kaolin Kaolin is a type of clay. Fine white clay particles coat the trees and act as a protective barrier. The primary use is on pome fruit, especially for the control of pear psylla in the Pacific Northwest. In addition to insect and mite control, the white color tends to cool leaf and fruit surfaces reducing heat stress and sunburn.

Lagenidium giganteum This is a fungus that controls mosquito larvae in rice fields and other bodies of fresh water. IR-4 submitted the tolerance petition for this product.

Lysophosphatidylethanolamine ( L P E ) L P E is a product derived from egg yolks. It improves crop quality and accelerates ripening, and increases shelf life of stored crops and cut flowers by


55 inhibiting an enzyme that causes aging and deterioration. When used as a product applied to fruit trees, L P E increases the rate of ripening by promoting the plant to produce more ethylene, which is an endogenous ripening substance. L P E is also has use as a postharvest storage product, inhibiting one of the major enzymes that breaks down membrane phospholipids. By inhibiting this enzyme and thereby helping to keep the membranes healthy, L P E increases the shelf life of stored produce and cut flowers.


Methyl Anthranilate This is a natural product which was originally isolated from grapes. It repels many kinds of birds, including geese, gulls, blackbirds, crows, and starlings

Milsana Milsana is an extract of giant knotweed (Reynoutria sachanilensis) which activates plant defenses against powdery mildew and other diseases. It also intensifies green leaf color. While it is currently labeled only in ornamentals, IR4 has funded efficacy studies and recently submitted a request for an exemption from tolerance in food crops.

Spinosad Spinosad is a mixture of spinosyns A and D which are fermentation products of the organism Saccharopolyspora spinosa. This product is not considered a biopesticide by E P A but does have an organic formulation. While the initial registration was handled by the registrant, the IR-4 Project developed logical associations among various crops and crop groups (7) which greatly reduced the number of residue trials needed to establish tolerances. IR-4 has conducted many residue trials and submitted them to E P A . Some specialty crops were also included based on extensions of data developed by the registrant. This unique approach which was approved by E P A (8) was largely facilitated by the reduced risk status and favorable environmental attributes of this product in combination with a comprehensive research plan (9) that created a large database of residue studies. This has led to its registration on over 200 specialty crops.


56 Sucrose octanoate This is a fatty acid ester of the sugar sucrose. It appears that this product has surfactant-like qualities causing suffocation or dewaxing of the insect cuticle resulting in dessication of insects. It was developed through the U S D A - A R S Appalachian Fruit Research Station. It has activity on soft bodied insects and mites and is also marketed for varroa mite control in bees.


Verticillium W C S 850 (V. albo-atrum) Current evidence indicates that this species is actually albo-atrum. This is a hyaline mutant and therefore does not produce microsclerotia and does not persist in the environment. It is injected into the trunk of American elm causing induced systemic resistance against Dutch Elm disease. It is currently under an Experimental Use Permit.

Yeast hydrolysate Yeast extract hydrolysate is from Saccharomyces cerevisiae, and is also known as brewers yeast. It induces resistance in treated plants against bacterial and fungal diseases. It was sold as part of a fertilizer product for many years until the disease control abilities were recognized. It appears to act by enhancing the plant's natural defense mechanisms. The active ingredient is approved for use on all food crops, as well as on turf and ornamental plants, but is only currently marketed in citrus and tomato.

Acknowledgements The authors would like to thank Dr. Keith Dorschner of the IR-4 Project for his useful comments concerning spinosad.

References 1.

Anonymous. The National Organic Program. Definitions-Preamble Subpart Α-Definitions. U S D A , Agricultural Marketing Service 7CFR Part 205, 2000 Washington D.C. U R L http://www.ams.usda.gov/nop/NationalList/FinalRule.html


57 2.

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Andersen, J. Overview of EPA's Biopesticide and Pollution Prevention Division Regulatory Activities. N A F T A Biopesticide Registration Workshop. Arlington, VA 2001. U R L http://ir4.rutgers.edu/RWP/TueJAnderson-EPA%20Over.htm Braverman, M . P. ; Nelson, W.; Torla, B . ; Mendelshon, M.; Matten, S.; Jones, R.; Steinwand, B . ; Roberts, A . Understanding the Registration Process at EPA. N A F T A Biopesticide Registration Workshop. Supplemental Material. Arlington , VA 2001. URL:http://ir4.rutgers.edu/RWP/PowerPoint/Understanding%20the%20Reg istration%20Process%20at%20EPA.pdf Matten, S. R. EPA Biopesticide Submission Process N A F T A Biopesticide Registration Workshop. Arlington, VA 2001. U R L http://ir4.rutgers.edu/RWP/Tue-SMatten-EPA%20Bio%20SP.htm Hartman, C. L . ; Markle, G . M. In Biopesticides: Use and Delivery; Hall, F. R.; Menn, J. J. Ed.; Methods in Biotechnology; Humana Press: Totowa, N J , 1998; V o l . 5, pp. 443-452. Anonymous. Pesticide Registration (PR) Notice 2003-1. Notice to Manufacturers, Formulators, Producers and Registrants of Pesticide Products. U.S. Environmental Protection Agency. Washington D.C. 2003 pp. 1-12. U R L http://www.epa.gov/PR_Notices/pr2003-l.pdf Markle, G . M.; Baron, J. J.; Schneider, B . A . In Food and Feed Crops of the United States, 2 ed. Meister Publishing: Willoughby, O H , 1998; pp. 327356. Herndon, J. G . Spinosad on Various Commodities. IR-4 Proposal for Reduced Residue Chemistry Data Set. 40 C F R 180.495. Memorandum, Health Effects Division, U.S. Environmental Protection Agency. Washington, D.C. 1999 pp. 1-13. Dorschner, K . IR-4 Spinosad Registration Plan. In Petition Proposing tolerances for Spinosad use on Bulb Vegetables. Rutgers University: New Brunswick, ΝJ, 2003; N J Agricultural Experiment Station Publication Number A-27200-70-03. nd

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9.


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