T-4- 113 - Guidelines to Safety Assessments of Fertilizers and Supplements and to Information to be Submitted in Demonstrating Product Safety
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The purpose of this document is to provide industry with guidance on safety assessments conducted on products regulated under the Fertilizers Act, on the type of information to be submitted by industry in demonstrating product safety, and on the organization of this information.
1.0 Product Safety Assessments Conducted by the Canadian Food Inspection Agency
The Fertilizer Section of the Crop Inputs Division of the Canadian Food Inspection Agency (CFIA) conducts safety assessments of supplements, non-traditional fertilizers, new formulants, etc. under the authority of the Fertilizers Act. These assessments address three main issues which are:
- food safety;
- user/bystander protection; and,
- the environment.
The specific issues to be addressed during the safety assessment of a particular product depend on the constituents of that product and its recommended pattern of use.
Product safety assessments normally include a preliminary stage and a follow-up stage. The preliminary assessment, based essentially on the identification, constituents, and intended use of a product, identifies which of the three issues (food, user and environment) must be addressed for that product. Also, in the absence of a complete data set (i.e., sufficient information pertaining to ALL items in Appendix 1, discussed below) this preliminary review also identifies a smaller "screening level" package of "minimum data requirements". The follow-up assessment is conducted when either a complete information package or a "screening level" information package has been received by Plant Production Division.
The Crop Inputs Division conducts the safety assessments with the assistance of Health Canada and Environment Canada; the food safety aspect of an overall safety assessment is coordinated by the Plant Production Division but conducted by Health Canada.
2.0 Information to be Submitted to Plant Products Division in Demonstrating Product Safety Industry Responsibility
2.1 Administrative and technical information
Attached as Appendix 1 is a list of administrative and technical information which are considered for the purposes of conducting a product safety assessment. All existing information relating to items in this list, for formulated products, ingredients, and significant contaminants, must be submitted.
For compiling the necessary technical information, we recommend that several sources be consulted. These include suppliers and manufacturers of the products or their ingredients, the public literature, databases such as those available through the National Library of Medicine (U.S.), the United States Environmental Protection Agency and the Canadian Centre for Occupational Safety and Health, etc.
2.2 Technical information summary and references
A summary of the information compiled according to Section 2.1 is to be submitted to the Plant Production Division. In this summary, the information is presented in the order in which the items appear in Appendix 1.
All information in the summary must be properly referenced (including document name, date and page numbers, etc.; reference material is to be enclosed in the order in which the item to which it pertains appears in Appendix 1. A bibliography of the reference documents would be appreciated.
Where necessary and appropriate, in lieu of information pertaining to a particular ingredient, information pertaining to a similar substance may be submitted. This requires that a rationale for similarity between the substances and hence between their characteristics (be they physical, chemical, or toxicological) be provided.
Where technical information is not available, and there are reasonable scientific grounds for believing that it is neither necessary for nor applicable to the safety assessment of a product, a request for waiver of that information may be submitted. This request must be accompanied by a sound scientific rationale, and is incorporated into the summary document in proper sequence (see Appendix 1).
Please note that for the Plant Production Division to consider technical information which is enclosed in the reference material, this technical information must be addressed in the summary document.
2.3 Product Safety Demonstration
For the purposes of demonstrating the safety of a product, the information provided under Section 2.2 is reviewed and conclusions are drawn in regard to food safety, worker protection, and the environment. (Again, the particular issues to be addressed for a product depend on its recommended use patterns.) This safety demonstration is provided by industry to the Plant Production Division.
Remarks: Where appropriate preventative measures are used to mitigate worker exposure, and in drawing conclusions as to worker protection, the measures must be clearly identified.
We recommend that the assistance of a toxicologist be sought for compiling and reviewing the data and for preparing the information package to be sent to the Plant Production Division.
Please note that this guideline and these data requirements may apply to formulated products, individual ingredients (e.g. actives or formulants), break-down products, contaminants, etc.
This guideline should be used in conjunction with other guidance documents, where appropriate, including: Trade Memo T-4-107 "Registration of Supplements Under the Fertilizers Act", Trade Memo T-4-103 "Guidelines for Research Authorizations for Testing of Novel Supplements".
1.0 Identification and Use of the Product
- Other names
- Uses and use patterns
- Unit amount
- Product Label
- Material Safety Data Sheet (MSDS)
2.0 Identification of Ingredients Including Impurities
- Chemical name and synonyms
- Chemical formula (molecular and structural)
- Chemical Abstract Service (CAS) Number
- Specify presence/absence of ingredients on/from Environment Canada's Domestic Substances List
- Material Safety Data Sheet
- Concentrations in the finished product (% or ppm)
- Outline of manufacture of the product
- Mode of action of the components
- For biochemicals and biopolymers: Taxonomic description of production organism and biological impurities in the product, concentrations of these in the final product (CFU/g), methods used to remove the production organism, description of any introduced genetic material, known biological (e.g. enzymatic) activity and adverse human or environmental health effects associated with products of the introduced genetic material.
- Please note that if any production organism or biological impurities remain in the final product, these are to be addressed using the "Microbial Guidelines for the Identification and Evaluation of Microbial Products Intended for Field Application or Registration Under the Fertilizers Act".
3.0 Physico-Chemical Data
- Molecular weight
- Physical state
- Appearance (e.g. granular, gelatinous)
- Particle size
- Colour and odour
- Density/specific gravity
- Melting point
- Boiling point
- Vapour pressure
- Solubility in water
- Octanol-water partition coefficient
- Olfactory detection limit
- Flash point
- Auto-ignition temperature
- Vapour density
- Solubility in other solvents
4.0 Toxicity Data
- Acute toxicity:
- acute median lethality,
- skin/eye irritation,
- skin sensitization,
- Mutagenicity (e.g. point mutation, chromosomal aberrations, DNA repair, with and without activation)
- Short-term repeated dose toxicity (e.g. 28-day study, 90-day study)
- Long-term toxicity (e.g. 1 and 2 year studies)
- Delayed neurotoxicity (for all O-P compounds)
- Developmental toxicity
- Reproductive toxicity (multi-generation study)
- Epidemiological studies
- Rate and degree of absorption
- Distribution, metabolism and excretion data
- Chemical interaction
- Special studies
5.0 Human Exposure Data and Exposure Estimation
- Major routes of exposure depending on the formulation, method of application and uses.
- Amount of product handled by workers and consumers
- Frequency and duration of exposure
- Exposure concentrations (dilution factor for use of the product, if applicable)
- Precautionary clothing or other measures recommended to users
- Exposure studies, if available
6.0 Food Safety Data
- Crops for which the substance is intended
- Application rates, timing, intervals to harvest
- Product, metabolite and/or contaminant residue studies, for each food plant
- Analytical methods for metabolism and residue studies (including recovery and detection limits)
- Environmental fate data relevant to possible food residues (e.g. persistence/degradation in soil)
- Plant metabolism data (given detectable residues) specifying levels and identity of metabolites, routes of degradation, etc. (e.g. radio-labelled studies, routes and degradation of major metabolites)
- Suggested maximum residue limit or tolerance, based on the toxicity data
7.0 Environmental Fate
- Vapour pressure and volatilization
- Photodegradation(UV Spectrum)
- Solubility in water
- Octanol-water partition coefficient
- Ready biodegradability (unless more sophisticated tests are available)
- Dissociation constant
- Biotransformation in soil (aerobic/anaerobic)
- Biotransformation in aquatic systems (aerobic/anaerobic)
8.0 Environmental Effects
- Toxicity to aquatic organisms:
- fish LC50
- daphnid LC50
- Algae LC50
- fish and daphnid EC50, NOEL AND LOEL
- Toxicity to birds and mammals
- Toxicity to soil organisms
Note: Additional data may be required under the circumstances.
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