11A - gardiner - the regulation of fert and supp...plant growth regulators, compost and sewage...

Regulation of Fertilizers and Supplements in CanadaIan Gardiner, National Manager, Fertilizer Section, Canadian Food Inspection Agency

Ottawa, ON K1A 0Y9 Email: [email protected]

Regulation of fertilizers and supplements in

CanadaPresented by Ian Gardiner,

National Manager, Fertilizer Section, CFIA

OUTLINE OF THE PRESENTATION

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

Operations

LaboratoriesPrograms

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

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 RegulationsFertilizers Act and Regulations..

This Legislation has been in existence since the early 1900’s

OVERVIEW OF THE FERTILIZER PROGRAM

Scope of Regulation

Only products that are imported into or sold in Canada are regulated

ManufactureTransportationStorageUseDisposal


Are NOT Regulatedunder the Fertilizers Act



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 ofsubstances, other than a fertilizer, that ismanufactured, sold or represented for use in the improvement of the physical condition of soils or to aid plant growth or crop yields

OVERVIEW OF THE FERTILIZER PROGRAM OVERVIEW OF THE FERTILIZER PROGRAM

• Fertilizerinclude 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

OVERVIEW OF THE FERTILIZER PROGRAM OVERVIEW OF THE FERTILIZER PROGRAM

SafetySafety

• 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)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 VerificationLabel Verification• Label review prior to product approval or

registration

• Monitoring of proper representation of products to consumers/users




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

REGULATION VS REGISTRATION REGULATION VS REGISTRATION

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

REGULATION VS REGISTRATION

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

REGULATION OF MICRONUTRIENTS

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 + non-efficacious levels of N, P and K based on the directions for use


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


Registration requirements

• 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




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 yearlyAAA

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

COMPLIANCE AND ENFORCEMENT


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



REGULATORY AMENDMENTS

Specific Regulatory Enhancements to Canada's BSE Feed Controls

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: http://canadagazette.gc.ca/partI/2004/20041211/pdf/g1-13850.pdf

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 -http://www.inspection.gc.ca/english/corpaffr/newcom/2004/20041210e.shtmlBackgrounder -http://www.inspection.gc.ca/english/corpaffr/newcom/2004/20041210bge.shtml

If you require information on the regulation of fertilizers and supplements in Canada please feel free to contact us:

Fertilizer SectionPlant Production DivisionCanadian Food Inspection Agency

59 Camelot Drive, NepeanOntario K1A 0Y9Tel# (613) 225-2342Fax# (613) 228-6629Email: [email protected]

CONTACTS AND INFORMATION CONTACTS AND INFORMATION

Website notification system

To receive an e-mail notification every time we update the Fertilizer website please visit:

http://www.inspection.gc.ca/english/tools/listserv/listsube.shtml

• 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 e-mail that you must reply too within a certain time limit.

11A - gardiner - the regulation of fert and supp...plant growth regulators, compost and sewage...

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