Chapter VIII
MICROBIAL AND BIOCHEMICAL PRODUCTS
A. INTRODUCTION TO MICROBIAL AND BIOCHEMICAL PRODUCTS
B. MICROBIAL PESTICIDE PRODUCTS
C. BIOCHEMICAL PESTICIDE PRODUCTS
Chapter VIII
MICROBIAL AND BIOCHEMICAL PRODUCTS
A. INTRODUCTION TO MICROBIAL AND BIOCHEMICAL PRODUCTS
Microbial and biochemical products are non-conventional pesticide products composed of microorganisms or derived
from living organisms. The term "biorationals" was formerly used for these types of products.
The general procedures for obtaining product registration are in Chapter III. The label requirements are in
Chapter II. The general data requirements for most products are outlined in Chapter VI, with the exception of microbial
and biochemical data requirements which are outlined in this chapter.
For most of the data types, DPR will follow the U.S. EPA requirements for these unique products. The data requirements
are outlined in 40CFR Part 158.740
for microbial products and in Part 158.690
for biochemical products. Guidance for conducting the studies is found in the OPPTS Test Guidelines Series 885
and 880, which combine elements of previous sources for testing guidance.
Data, such as exposure studies, may also be required for these types of products in accordance with California
regulation Sections 6176-6193 of CCR.
The requirement to submit these studies is identified during the scientific evaluation process.
Concurrent U.S. EPA and DPR submission is allowed for new microbial and biochemical products, since the potential
risk associated with microbial or biochemical pesticides is considered reduced risk compared to conventional pesticides.
The following information about microbial and biochemical products is of special interest to DPR:
- Information on the ingredients.
- Biological properties (e.g. Bacillus thuringiensis strains).
- Manufacturing process.
- Analytical method.
- Pathogenicity.
- Storage stability and quality control procedures.
B. MICROBIAL PESTICIDE PRODUCTS
Microbial pesticides are composed of living entities such as bacteria, fungi, viruses, and protozoans. Also
included are killed organisms. Each new variety, subspecies, or strain of an already registered microbial pest
control agent must be evaluated and may be subject to additional data requirements. Larger organisms such as insect
predators, nematodes and macroscopic parasites are exempt from the requirements of FIFRA by 40
CFR Part 158.65 and Part 152.20(a).
The types of data required are outlined in 40
CFR 158.740. The guidelines for conducting the studies are in the OPPTS Series 885 Microbial Pesticide Test
Guidelines (formerly Subdivision M). The data requirements apply to all microbial pesticides, including those that
are naturally-occurring as well as those that are genetically modified.
Additional data may be requested depending on results of the minimum requirement tests.
The data requirements for microbial products are as follows. Each study may be required based on the Use Pattern
Index found in 40CFR. If U.S. EPA has granted a waiver of any study, a copy of the waiver should be submitted to
DPR for consideration.
Ingredient Information and Product Analysis
- Name of each active ingredient and the amount of each active and inert ingredient in the product.
- Identification and characteristics of the microorganism including the procedures and criteria used for identification.
Microbial products must be identified to the strain.
- Amount of microbial agent present in the product expressed in recognized units of potency, percentage of weight,
units of viability or other appropriate expression of biological activity expressed in International Units.
- Product identity and manufacturing process. An outline of the production methods and quality control procedures.
- Discussion of formation of unintentional ingredients such as toxins, allergens, microbial contaminants, and
mutant strains.
- Analysis of samples. Analytical methods for identification and quantitative assay of the microbial agent.
- Certification of limits.
- Physical and chemical properties including a one year storage stability study.
Residue Chemistry (This requirement was discontinued in 2004 by Ca Notice 2004-7):
- Certain residue studies listed in 40
CFR 158.740may be required depending on the use pattern.
- Residue data is not required if an exemption from residue tolerance has been established.
Toxicology data.
- Acute oral toxicity/pathogenicity.
- Acute dermal toxicity/pathology.
- Acute pulmonary (inhalation) toxicity/pathogenicity data, if applicable. Ca Notice 91-8 contains modifications
to the U.S. EPA testing requirements.
- Eye irritation data is required by DPR.
- Skin (dermal) irritation data is required by DPR.
- Acute injection toxicity/pathogenicity.
- Hypersensitivity incidents.
- Cell culture.
- Acute toxicology, Tier II.
- Subchronic toxicity/pathogenicity.
- Reproductive/fertility effects.
- Tier II and Tier III tests are required, if indicated by results of Tier I or Tier II testing. These study
types are listed in 40CFR Part 158.740.
Efficacy
- Efficacy data to support claims made on the label are required by DPR. This includes the biological properties
of the agent with respect to target species, pest host range, life cycle and mode of action.
Fish and Wildlife data (Nontarget Organism and other Environmental Expression)
The following data are required on the active ingredient for products labeled for outdoor application:
- Avian oral Tier I.
- Avian inhalation test, Tier I.
- Wild mammal testing, Tier I.
- Freshwater fish testing, Tier I.
- Freshwater aquatic invertebrate testing, Tier I.
- Estuarine and marine animal testing, Tier I.
- Nontarget plant studies, Tier I.
- Nontarget insect studies, Tier I.
- Honeybee testing, Tier I.
- Tier III testing and other environmental effects data, if applicable are listed in 40CFR 158.740.
C. BIOCHEMICAL PESTICIDE PRODUCTS
Biochemical pesticides include, but are not limited to, products such as semio-chemicals (insect pheromones),
natural plant and insect hormones and regulators (plant growth regulators, insect growth regulators, insect juvenile
growth hormones), and enzymes.
Additional data may be requested depending on results of tests conducted to meet the minimum requirements.
The U.S. EPA data requirements for biochemical products are identified in 40CFR
158.690 as follows. The guidelines for conducting some of the studies are in the OPPTS Series 880 Biochemicals
Test Guidelines (formerly Subdivision M). If U.S. EPA has granted a waiver of any study, a copy of the waiver should
be submitted to DPR for consideration.
Ingredient Information.
- Chemical identity. Name of each active ingredient and the amount of each active and inert ingredient in the
product.
- The amount of biochemical present in the product stated in recognized units of potency or other expression
of biological activity or percent of weight.
- The genus and species of the organism(s) from which the biochemical was separated or with which it is commonly
associated.
- Manufacturing Process.
- Discussion of formation of unintentional ingredients.
- Analysis of samples.
- Certification of limits.
- Analytical methods.
- Physical and chemical properties.
- One year product storage stability study is required by DPR.
Residue chemistry (This requirement was discontinued in 2004 by Ca Notice 2004-7)
- Certain residue studies listed in 40CFR 158.690 may be required depending on the use pattern.
- Residue data is not required if an exemption from residue tolerance has been established.
Toxicology data
- Acute oral toxicity, Tier I.
- Acute dermal (skin) toxicity, Tier I.
- Acute Inhalation LC50, if applicable, Tier I.
- Eye irritation, Tier I.
- Dermal (skin) irritation, Tier I.
- Hypersensitivity study, Tier I.
- Hypersensitivity incidents.
- Genotoxicity detection studies, Tier I.
- Immune response, Tier I.
- 90-day feeding, Tier I.
- 90-day dermal, Tier I.
- 90-day inhalation, if applicable, Tier I.
- Teratogenicity, Tier I.
- Tier II mammalian mutagenicity and immune response tests, if indicated by Tier I testing.
- Tier III chronic exposure and oncogenicity testing if indicated by Tier I or Tier II testing.
Efficacy
- Efficacy data to support claims made on the label are required by DPR.
Fish and wildlife data (nontarget organism and other environmental expression
- Avian oral LD50, Tier I.
- Avian dietary LC50, Tier I.
- Freshwater fish LC50, Tier I.
- Freshwater invertebrate LC50, Tier I.
- Nontarget plants, Tier I.
- Nontarget insects, Tier I.
- Terrestrial wildlife testing, Tier III, if indicated by Tier I or II testing.
- Aquatic animal testing, Tier III, if indicated by Tier I or II testing.
- Nontarget plant, Tier III, if indicated by Tier I or II testing.
- Nontarget insect, Tier III, if indicated by Tier I or II testing.
- Tier II testing for this category of U.S. EPA requirements is listed below in the Environmental Effects section.
Environmental Effects
- Volatility, Tier II.
- Leaching, adsorption, and octanol/water partition, Tier II
- U.V. absorption, Tier II.
- Hydrolysis, Tier II.
- Aerobic soil and aquatic metabolism, Tier II.
- Soil and aquatic photolysis, Tier II.
- Tier I and Tier III are listed in the preceding section on Fish and Wildlife data.