Overview of the Fertilizer Program and Safety Assessments under the Fertilizers Act - The Canadian Perspective CEC Wo

1. Overview of the Fertilizer Program and Safety Assessments under the Fertilizers Act - The Canadian Perspective CEC WorkshopMexico CityOctober 28-29, 2010

2. Overview • Fertilizer and supplement products are regulated in Canada under the authority of the federal Fertilizers Act (FzA) and Regulations, administered by the Canadian Food Inspection Agency (CFIA) • The Fertilizers Act requires that all fertilizer and supplement products imported into or sold in Canada are: • safe with respect to humans, plants, animals and the environment • efficacious for the intended purpose • properly labelled to avoid misrepresentation and fraud

3. Regulated products • Fertilizers: • Any substance or mixture of substances containing nitrogen, phosphorus, potassium or other plant food, manufactured, sold or represented for use as a plant nutrient. • May include agricultural fertilizers and lawn & garden fertilizers containing: N, P, K, calcium (Ca), magnesium (Mg), sulphur (S), boron (B), Chloride (Cl), Copper (Cu), Iron (Fe), Molybdenum (Mo), Manganese (Mn) or Zinc (Zn) • Supplements • 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. • May include limestone, microbial inoculants (bacteria and fungi), wetting agents, plant growth regulators, compost, etc.

4. Registration vs. Regulation • Most supplements and some fertilizers require registration and are subject to mandatory pre-market assessment prior to importation and sale • Assessments are conducted on case-by-case basis and consist of safety and efficacy assessments and label reviews • Products that are exempt from registration may be sold and/or imported into Canada without prior approval; these products are still regulated and must meet all the prescribed standards Marketplace monitoring includes product inspections, analysis and label verification

5. Overview of Safety Assessments • • The safety of all ingredients (actives, formulants, additives, adjuvants, by-products and contaminants) are assessed by the CFIA • • Safety assessments are conducted on a case-by-case basis; the information required depends on the nature of the product (chemical vs. microbial), history of safe use, use pattern, application rate, etc. • • Safety assessments consist of: • Hazard assessment • Exposure assessment • Risk characterization • Risk mitigation Risk = hazard x exposure

6. Product InformationReview • List of all constituents and CAS #s if known • Proportion in final product • Source/country of origin, manufacturer • Final product manufacturing method, including detailed description of the process • Any pertinent QA/QC procedures demonstrating consistency in production, and purity of final product • Shelf life, and storage conditions that indicate stability of the product over time

7. Hazard assessment: Process by which the inherent potential of the chemical to cause adverse effects on human plant, animal, health and/or the environment is assessed.

8. Factors to consider • Identification of constituent chemicals of concern, or potential degradation products • Inherent chemical toxicity • Identification of the most susceptible and/or ecologically-relevant organisms • Persistence of the product or constituent chemicals in the environment • Potential for bioaccumulation • Potential for plant uptake (systemic translocation and residues in edible portions of the plant) • Potential sources of contamination and nature of contaminant

9. Hazard Assessment - requirements • Toxicity tests (mammalian / aquatic / avian / soil organisms / environmental) include: acute, subchronic and chronic toxicity, mutagenicity, clastogenicity, carcinogenicity (from chronic studies), teratogenicity, developmental toxicity, reproductive toxicity • Epidemiological studies • Results of contaminant analyses (e.g., metals, pathogens, dioxins, furans, dioxin-like PCBs, HCB, etc.) • Submissions in support of product registration/approval may consist of: experimental data, a safety rationale based on peer reviewed scientific literature and/or relevant surrogate data

10. Process by which the intensity, frequency and duration of human, animal and environmental exposure to a chemical is measured or estimated Exposure assessment:

11. Factors to consider • Routes of exposure (oral, dermal, respiratory, etc.) • Type of market the product will be used in (e.g., home-garden, commercial, large scale agriculture etc.) • Application rate (time, frequency and method of application) • Intended use(s)/use patterns (e.g., food use/crop types, non-food use, contained) • Distribution, storage, handling and disposal information • Environmental fate (persistence and partitioning of the chemical in the environment) • Predicted exposure concentrations/exposure studies

12. Human, Animal and Environmental Exposure Characterization • Exposure assessment usually begins with the product application rate • Where applicable, human (applicator and bystander) exposures are modeled based on: • physical state (granular vs. liquid), • product characteristics (volatility), • method of application (incorporation into soil vs. surface treatment) • Environmental exposures may be estimated with the help of models (e.g., US EPA environmental fate models – EPI Suite) • Worst-case scenarios (100% applicant exposure) are used when no other information is available

13. Process by which the probability/likelihood of an adverse effect occurring is assessed based on identified hazards and magnitude of exposure Risk characterization

14. Risk estimate • Summary of product information • Summary of human health, animal and environmental impacts • Overall risk assessment Is the product safe when used according to directions? YES Mitigation measures required. No REGISTRATION

15. Process by which appropriate safety precautions are imposed to ensure safe use of the chemical Risk mitigation

16. Mitigation measures • Risk management can be achieved through the use of appropriate precautionary labelling and/or use restrictions • Protective equipment requirements • Addition of product label precautionary statements: (Conditions for use, handling, storage and application) • Addition of use pattern restrictions to product labels (e.g. “NOT FOR USE ON HUMAN FOOD OR ANIMAL FEED CROPS”) • Adjustment of application rates and frequencies

17. Mitigation measures • Example of a precautionary statement: • “KEEP OUT OF REACH OF CHILDREN. Warning! Harmful if swallowed. Causes irritation. Avoid contact with eyes, skin and clothing. Keep in tightly sealed closed container. Wash thoroughly after handling. CAUTION: This fertilizer contains Zinc, Manganese and Cobalt and should be used only as recommended. It may prove harmful if misused.”

18. Metal standards • All fertilizers and supplements, including processed sewage, composts and other by-products must meet the standards for maximum acceptable cumulative metal addition to soil • Standards for Metals in Fertilizers and Supplements (T-4-93) - include limits for:As, Cd, Cr, Co, Cu, Pb, Hg, Mo, Ni, Se, Zn • Standards are based on the total cumulative addition to soil over a 45 year period • Acceptable levels of metals in fertilizer and supplement products are determined using a maximum soil addition and annual application rate indicated on the product label

19. Dioxins, Furans & Dioxin-like PCBs • Tricyclic planar aromatic chlorinated hydrocarbons that: • Are present and persist in the environment • Are known to bioaccumulate, and • Have been shown to produce acute and chronic effects (including carcinogenesis) in mammalian species • Dioxin, furan and dioxin-like PCB may be found as contaminants in processed sewage, pulp and paper sludges, by-products of industrial processes, combustion etc.

20. Interim Safety Standards:Dioxins, Furans & Dioxin-like PCBs • Interim standard for dioxin, furan and dioxin-like PCBs in fertilizer/supplement products is: • 27 ng TEQ / kg product • There are 210 dioxin and furan congeners, and 209 PCB congeners • TEF system (WHO, 1998) considers 7 dioxin congeners, 10 furan congeners and 15 dioxin-like PCBs • The standard is based on: • maximum cumulative addition to soil over 45 years • the estimated mean background soil levels • application rate of 4400 kg product / ha / year

21. Dioxins, Furans & Dioxin-like PCBs – product registration/approval requirements • Results of analyses are required depending on the: • product type / composition • source ingredients (e.g. country of origin) and • manufacturing process • Product proponents are required to submit: four (4) sets of dioxin, furan and dioxin-like PCB analyses, from four (4) separate lots/batches of final product to demonstrate consistency in production and compliance with the (interim) standard

22. HCB: Hexachlorobenzene • By-product of chlorinated solvent and pesticide manufacture, incinerator emissions and industrial processes, etc. • Classified as a possibly carcinogenic (2B carcinogen) • Has been detected as a contaminant in: magnesium, copper and iron salts produced by electrolytic processes • Also detected in waste derived inputs: CKD (cement kiln dust) used for lime (calcium carbonate and other calcium salts), potassium and other micronutrients

23. Interim Safety Standard :HCB: Hexachlorobenzene • Current interim standard for HCB is • 56 mg HCB/kg product (ppm) • The interim standard is based on: • the application rate of 4400 kg product / ha / year • the maximum cumulative addition to soil over 45 years • the interim remediation criteria for soil (CCME, 1991)

24. HCB: Hexachlorobenzene – product registration/approval requirements • Product proponents must submit four(4) sets of HCB analyses from 4 separate lots/batches of final product to demonstrate consistency in production and compliance with the standard • Rationale demonstrating the sources of salts are consistent between batches, hence the contaminant levels are expected to remain constant • Indication of whether the metal constituents in the product are derived through electrolytic production processes

25. Considerations and Challenges: Dioxins, Furans, Dioxin-like PCBs, and HCB • - Contribution of lower chlorinated species to dioxin, furan, dioxin-like PCB, and HCB toxicity? • - Validity of current TEF system and toxic congeners and their applicability to safety standard setting • - Lack of epidemiological data demonstrating chronic human health effects • - Insufficient plant uptake studies which hinder the ability to model translocation from soil to edible portions of plants • The presence of other dioxin-like compounds • Increasing use of waste-derived products on agricultural land as fertilizer • Lack of alternative disposal methods – costs and logistical challenges

26. Next Steps • 1. Re-assess/validate current background soil concentrations • 2. Obtain data (human - occupational exposure, other ?) to support safety assessments conducted by the Fertilizer Safety Office • 3. Collaborate with other jurisdictions and share assessment approaches • 4. Pursue involvement in Task Force work on Dioxins and Furans • 5. Prepare a literature review (in progress), and update interim standard to reflect current science

27. Contact Information • For more information on the regulation of fertilizers • and supplements in Canada: • Crop Inputs Division • Fertilizer Section, Fertilizer Safety Office • 59 Camelot Drive • Ottawa, Ontario • K1A 0Y9 • Email: fertilizer@inspection.gc.ca • Website: www.inspection.gc.ca