Regulation of fertilizers and supplements in Canada
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1 OUTLINE OF THE PRESENTATION Regulation of fertilizers and supplements in Canada Presented by Ian Gardiner, National Manager, Fertilizer Section, CFIA Overview of the Fertilizer Program The Fertilizer Team Regulatory authority Scope of regulation Product definitions General requirements Regulation vs. registration Products subject to registration Products exempt from registration OUTLINE OF THE PRESENTATION Market Monitoring Canadian Fertilizer Quality Assurance Program (CFQAP) Compliance and Enforcement Product non-compliance Enforcement activities Amendments to Regulations How does it affect the Fertilizer Industry THE FERTILIZER TEAM Three important parts that work together: Programs: Fertilizer Core Team program design and policy product registration, label review, etc. Operations: Inspection staff monitoring (sampling, inspection) compliance and enforcement Laboratories: Laboratory Services analysis of samples method development lab accreditation Programs Operations Laboratories Regulatory authority Products represented for use as fertilizers and supplements are regulated by the Fertilizer Section, CFIA under the authority of the Federal Fertilizers Act and Regulations. This Legislation has been in existence since the early 1900 s Scope of Regulation Only products that are imported into or sold in Canada are regulated Manufacture Transportation Storage Use Disposal Are NOT Regulated under the Fertilizers Act
2 Product Definitions Fertilizer: any substance or mixture of substances, containing nitrogen, phosphorus, potassium or other plant food, manufactured, sold or represented for use as a plant nutrient; Supplement: any substance or mixture of substances, other than a fertilizer, that is manufactured, sold or represented for use in the improvement of the physical condition of soils or to aid plant growth or crop yields Fertilizer include agricultural fertilizers and lawn& garden fertilizers containing: - N, P, K (nitrogen, phosphorus, potassium) - calcium, magnesium and sulfur - boron, copper, iron, manganese, molybdenum and zinc Supplement include limestone, legume inoculants, wetting agents plant growth regulators, compost and sewage sludge General requirements: All fertilizer and supplement products regulated under the Fertilizers Act must be: Safe for - plants, - animals, - humans (food, worker/bystander) - the environment Efficacious when used as directed Properly labelled Safety Safety assessments are conducted prior to product approval and/or registration Market monitoring $ sampling and testing for contaminants - heavy metals in micronutrient fertilizers, compost and sewage sludge - pathogens (Salmonella and E.coil) in bone meal, sewage sludge and compost Efficacy (quality) All efficacy claims must be substantiated by valid scientific data - Results of field studies Market monitoring - Canadian Fertilizer Quality Assurance Program - Fertilizer plant inspections - Sampling and testing for product guarantees Label Verification Label review prior to product approval or registration Monitoring of proper representation of products to consumers/users
3 According to the Fertilizers Act: No person shall sell, or import into Canada, any fertilizer or supplement unless the fertilizer or supplement has been registered as prescribed, conforms to prescribed standards and is packaged and labelled as prescribed Products that are exempt from registration must still meet the safety, efficacy (quality) and labelling standards prescribed by the Fertilizers Regulations Products that are subject to registration fertilizer-pesticide combinations for specialty uses micronutrient fertilizers farm fertilizers with cumulative nutrient content under 18% (organic) and 24% (chemical) most types of supplements Products that are exempt from registration N, P, K fertilizers fertilizer and supplements listed in Schedule II customer formula fertilizers fibrous organic materials such as peat, peat moss supplements sold only for correction of soil acidity or alkalinity e.g. liming materials potting soils containing registered supplements Micronutrient products that require registration products containing ONLY micronutrients (B, Cl, Cu, Fe, Mn, Mo, Zn) products containing micronutrients + Ca, Mg and/or S products containing micronutrients + nonefficacious levels of N, P and K based on the directions for use Registration requirements Registration requirements Registration form (complete list of ingredients, their sources, and the proportion of ingredients used to make the guarantee) Manufacturing method Label 4 sets of analyses - As, Cd, Co, Cr, Cu, Hg, Mo, Ni, PB, Se, Zn - all guarantees Efficacy data - non-edta chelates -oxides - sulphates - oxi-sulphates Safety data - ingredient dependent NOTE: Some forms of micronutrients may not be readily available to the plant (e.g. oxides). The CFIA is currently conducting a review of the efficacy of such products which may affect currently registered products and/or future registration requirements
4 Labelling of micronutrients Guaranteed analysis - actual - chelated micronutrient - minimum allowable for guarantees Directions for use - complete directions for blending or - advice from county agricultural representative or consultant WHIMIS CAUTION statement for B, Cu, Mn, Mo, Zn MARKET MONITORING Compliance of products with the prescribed standards is monitored by the CFIA The Fertilizer Section administers 10 different market monitoring programs As part of these programs inspectors inspect and sample various products sold across Canada Inspectors visit wide range of facilities: manufacturers, blenders, retailers, wholesalers, distributors, seed coaters etc. MARKET MONITORING Canadian Fertilizer Quality Assurance Program voluntary program for fertilizer blenders samples are submitted by both inspectors and the companies samples are sent to accredited laboratories for guarantee analysis results are evaluated by CFIA and a plant rating is assigned ratings are published yearly AAA Product non-compliance Sale (or importation) of an unregistered fertilizer or supplement that requires registration is a contravention of the Fertilizers Act Products that are registered as prescribed but fail to meet the safety, efficacy or labelling standards are also considered non-compliant Products that are exempt from registration and fail to meet the safety, efficacy and labelling standards are also considered non-compliant Product non-compliance Non-compliant products are subject to regulatory action The goal of any follow up action is to: (1) Bring the product back into compliance (2) Identify the source of non-compliance (3) Ensure that such problems do not occur in the future Enforcement activities On site visitation/education Verbal/written warning Removal of imports from Canada Restriction or prohibition of movement of products Seizure and detention of products Issuance of quarantine notices Forfeiture of seized or unclaimed products Disposal of products Prosecution
5 The Canadian Food Inspection Agency (CFIA) is proposing the enhancement of the existing ruminant feed ban by requiring the removal of Specified Risk Materials (SRM) from all fertilizer and supplement products. This action is required to ensure that this material does not accidentally re-enter the animal food chain by means of animals consuming fertilizers. SRM are tissues that, in Bovine Spongiform Encephalopathy (BSE)-infected cattle, harbor the BSE agent. Deadstock and condemned ruminant animals will also be considered as SRM. Classes/types of fertilizers and supplements that could potentially contain material of animal origin will require registration and new enhanced warning statements on labels. Animal by-products are used to produce both feed and fertilizer. Through the registration of these products, the government can proactively ensure the safety of products in the marketplace. The CFIA is also proposing to require lot numbers on fertilizers, excluding customer-formula fertilizers. If an issue ever arises that requires the recall of a batch of product, the addition of the lot numbers will limit the recall to the affected batches and lots thereby reducing the potential cost of disposal of more product, and allow the investigators to followup with the purchasers of the products. The Enhanced Feed Ban amendments now appears in the online version of Canada Gazette Part I. It appears on page 3674 at the following web address: Additional information on the proposed regulatory amendments can be found in the News Release and Backgrounder documents located on the CFIA web page. News Release - Backgrounder - CONTACTS AND INFORMATION If you require information on the regulation of fertilizers and supplements in Canada please feel free to contact us: Fertilizer Section Plant Production Division Canadian Food Inspection Agency 59 Camelot Drive, Nepean Ontario K1A 0Y9 Tel# (613) Fax# (613) fertilizer@inspection.gc.ca CONTACTS AND INFORMATION Website notification system To receive an notification every time we update the Fertilizer website please visit: Check the appropriate box at the top of the page and fill out your information. Put a checkmark in the box beside "Updates to the Fertilizer Program" under the PLANT heading. Submit, you will receive a confirmation that you must reply too within a certain time limit.
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