Antimicrobial Product Chemistry
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Toxic Substances Control Act (TSCA), antimicrobial products designed to protect public health in the United States, regulated as pesticides, must be registered with the United States Environmental Protection Agency (EPA).
To support these registrations, the EPA requires registrants to provide the following data designed to support purported label claims:
- Toxicology data
- Antimicrobial efficacy data
- Product chemistry data
EPA Product Chemistry Category
Under the “product chemistry” category, applicants must supply technical information describing the product’s active and inert ingredients, manufacturing or formulating processes, and physical and chemical characteristics. This article is designed to provide simplified general guidance on these seemingly complex product chemistry requirements.
EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), formerly known as the Office of Prevention, Pesticides and Toxic Substances (OPPTS), has issued a series of harmonized test guidelines designed to guide the development of test data that must be submitted to satisfy FIFRA and TSCA. The EPA intends that these guidelines provide meaningful information to applicants, registrants, and the general public regarding the product chemistry data requirements for registration of a pesticide.
The Series 830 - Product Properties Test Guidelines provide the detail associated with data development to meet agency requirements and federal regulations. The Agency classifies the test guidelines under two main categories: Identity, Composition, and Analysis and Physical/ Chemical Properties. The following sections summarize the intent of the guidelines used to generate data to support the conclusions expressed in the product’s Confidential Statement of Formula (CSF).
Identity, Composition, and Analysis Guidelines
Physical and Chemical Characteristics Guidelines (OPPTS 830.6302 - 830.7950)
|Guideline||Title||Intent of Guideline|
A variety of products may be exempt (with substantiation) from many of these physical chemistry guidelines. However, the EPA may still require data to be produced by some guidelines to provide supportive information on the identity of ingredients within products or supportive information regarding the manufacturing or formulating process used to produce the product. For example, marked raising or lowering of pH, melting or boiling points, vapor pressure, density, or solubility may provide evidence of significant changes in manufacture or formulation, and could indicate the need to investigate product composition further.
Furthermore, information such as color, odor, physical state, pH, and viscosity is needed by the EPA to respond to emergency requests for identification of unlabeled pesticides involved in accidents or spills. Physicians, hospitals, and poison control centers may also request such information when apparently-poisoned victims cannot identify specific pesticide products to which they have been exposed.
Additionally, some physical and chemical characteristics data are used directly in hazard assessment. These may include pH, stability, oxidizing and reducing potential, flammability, explodability, storage stability, corrosion characteristics, and dielectric breakdown voltage.
In addition to physical characteristics testing, the EPA requires a study of the corrosion characteristics of a pesticide be performed to evaluate the effect of the product formulation for corrosion on the end-use container lids, liners, seams, or container sides which may be caused during storage, transportation, handling, or use. Alongside this assessment, the Agency requires a storage stability study be performed to provide data on change (or lack of change) in product composition over time. This study can also assist in determining if certain ingredients decompose or if other new chemicals are formed whose toxicity and other characteristics need to be considered.
Finally, certain data in this series are needed as basic or supportive evidence in initiating or evaluating studies required by other disciplines. For example, the octanol/water partition coefficient is used as a criterion in determining whether certain fish and wildlife toxicity studies must be conducted. Data on vapor pressure are used directly in determination of reentry intervals for products that may be used in situations where residues in air pose a potential hazard. Data on viscosity and miscibility provide supportive information on tank mix products and spray application instructions. Determination of the UV/visible absorption spectrum of a pesticide provides some indication of the wavelengths at which the compound may be susceptible to photochemical degradation. Since photochemical degradation is likely to occur in both the atmosphere and aquatic environment, spectra appropriate to these media will provide information concerning the need for further persistence testing. It is important to understand the use and fate of your product when determining which guidelines might be required for registration
|830.6314||Oxidation/Reduction: Chemical Incompatibility|
|830.6321||Dielectric Breakdown Voltage|
|830.7300||Density/Relative Density/ Bulk Density|
|830.7370||Dissociation Constants in Water|
|830.7520||Particle Size, Fiber Length, Diameter Distribution|
|830.7550 830.7560 830.7570||Partition Coefficient (n-octanol/water)|
|830.7840 830.7860||Water Solubility|
Regulatory consultants with experience registering antimicrobial products can assist applicants in determining which product chemistry guidelines might apply to the registration. With some exceptions to chemical characterization of the final product, the U.S. EPA requires that chemistry studies performed be conducted under conditions that meet Good Laboratory Practice (GLP) standards (40 CFR Part 160). Guidelines for studies of product chemistry can be found in 40 CFR Part 158.
More in the White Paper
- 830.1550 - Product and Composition
- 830.1600 - Description of Materials Used to Produce the Product
- 830.1620 - Description of Production Process
- 830.1650 - Description of Formulation Process
- 830.1670 - Discussion of Formulation of Impurities
- 830.1700 - Preliminary Analysis
- 830.1750 - Certified Limits
- 830.1800 - Enforcement Analytical Method
- 830.1900 - Submittal of Samples
Since the chemistry and efficacy testing needed for EPA registration of antimicrobial products does not have a “one size fits all” template, a multifaceted testing strategy and approach is needed. These details are often dictated by active ingredient and product composition. Our experience in executing test methodologies and understanding of regulatory requirements enables us to provide clients with the guidance needed to successfully navigate product development and registration activities.
Download the White Paper
Please complete the form below to download our Antimicrobial Product Chemistry white paper.