© 2007 Her Majesty the Queen in Right of Canada

(Canadian Food Inspection Agency), all rights reserved. Use without permission is prohibited.

Guide to Submitting Applications for Registration Under the Fertilizers Act

SUBMISSION PREPARATION TRAINING

Fertilizer Safety SectionFall 2015

Purpose

This training session will lead you through the steps required to

complete a well organized and complete submission package

for registration of a fertilizer or supplement under the Fertilizers

Act

At the end of this session, you will be able to use this

information as a checklist to assist you in preparing your

submission.

2

3

Outline

1) Introduction – Fertilizer Program Mandate

2) Registration - File Types

3) What Requires Registration

4) Information Requirements to support registration

Administrative Forms and Fees

Marketplace Label

Product Specification

Results of Analysis

Safety Rationale and Supplemental Data

5) Submission Layout – required sections (TABS)

6) File Review Process – Review Stages and Service Delivery Standards

7) Do’s and Don’ts

1. Fertilizer Program Mandate

4

5

Regulated Products

Fertilizers and Supplements sold or

imported into Canada are regulated under

the authority of the federal Fertilizers Act

administered by the Canadian Food

Inspection Agency (CFIA).

Fertilizer: any substance or mixture of

substances containing nitrogen, phosphorus,

potassium or other essential 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.

N, P, K fertilizers

Micronutrients

Lawn and garden products

Fertilizer-Pesticides

Chemical supplements

Microbial supplements

Composts

Waste-derived materials

including biosolids

6

Program Objectives

To ensure that all regulated products imported into or sold in Canada are:

1. Safe with respect to human, plant, animal health and the environment;

2. Properly labelled to promote safe use.

NOTE: The CFIA no longer regulates product efficacy or quality – as

such, performance claims and nutrient guarantees are not verified

Regulatory Landscape:

• Canadian Food Inspection Agency Act

• Fertilizers Act and Regulations

• Health of Animals Regulations (for Enhanced Feed Ban)

• Canadian Environmental Protection Act (CEPA 99) Sch. II and IV

• Pest Control Products Act

7

Key Program Activities:

1. Health and Safety

Fertilizer Risk pathways:

Direct: worker, handler, applicator, bystander

Indirect: Food crop production (adsorption and absorption, plant

uptake); Feed, grazing land; Environment (soil, ground water,

waterways)

2. Market Access

• Domestic: Registration and marketplace monitoring

• Import Control: Registration requirements and import inspections

• Exports: Authority to issue export certification was obtained through

Agricultural Growth Act (Feb 2015) – This program is not in place yet.

8

3. Consumer Protection

• Label reviews: Adequate safety information including precautionary

statements to protect the consumer.

• Guaranteed analysis: Determines safe and sustainable product application

(rate, frequency, target crop)

• Product inspection: Marketplace monitoring of regulated products - label

reviews, verification of registration, and sampling/testing for contaminants.

4. Other Activities

• International Standard setting

• Stakeholder engagement

• OGD and FPT cooperation

• Regulatory research and oversight

Key Program Activities:

2. Product Registration

9

Research Files

10

File Types

Research Authorizations (RA):

Purpose: Required prior to the environmental release of all novel

supplements. RAs ensure the safe release of the supplement, prescribe

confinement conditions, protective equipment, and crop disposal methods.

TYPES:

RS – Novel supplements that have not

been previously assessed, are GM, or may present

a risk/unknown to human health or the environment

RN – Poses negligible risk to plant, animal, human

health and the environment, and non-genetically modified (GM)

RE – Renewals of past authorizations

RW – Request for waiver (confined trials i.e. growth chamber, greenhouse)

Research Files

Applications for Registration

11

File Types

Applications for Registration:

Purpose: Required for some fertilizers and supplements prior to

importation or sale.

Registration Number: 2015020A Fertilizers Act

A: Supplement; B: Micronutrient; C: Fertilizer -

Pesticide; D: Farm Fertilizer

TYPES:

NEW REGISTRATION: NR No Data & NR Data

RE-REGISTRATION: RR No Data & RR Data

ME-TOO: NR- Me-too

AMENDMENTS: MA (minor) & AM (major)

minor: name/address of registrant/manufacturer;

product name/brand; colour/format of label

major: any other change

3. What Requires Registration

12

13

Single Ingredient

Not in Schedule II

Farm Use Register

Specialty Exempt

Schedule II Exempt

Fertilizers – Single Ingredients

Only N,P,or K;

Only Ca,Mg,or S;

NPK+Ca,Mg, S,B,Cl,Cu,Fe,Mn,

Mo,Zn

Farm Use

Not Customer formula

Nutrients in Mineral

form Exempt

Nutrients in non-mineral

formRegister

Customer formula

Exempt

Specialty Exempt

14

Fertilizers – Combination of Ingredients

Micronutrients Register

Supplements

15

Live organisms Register

Schedule II;

Sold to adjust pH;

Fibrous Organic Material

Exempt

Seeds and potting soils

Treated with or contains a registered

or exempt productExempt

Treated with or contains a product

requiring registration but is not registered

Register

Fertilizer- Pesticides

Fertilizer-Pesticide

Customer formula with registered

pesticideExempt

Lawn and turf application

Decoupled (Disallowed)

Agricultural Use Register

Single ingredient with dual

properties (corn gluten meal and ferrous sulphate)

Register

16

4. Information Requirements to

support registration

17

General

1) Administrative forms and fees

Cover letter

Application form

Signing authority

Fees

2) Marketplace Label

3) Product Specification

List of ingredients

Manufacturing method

QA/QC procedures

Other Qualities

4) Results of Analysis

5) Safety Rationale and Supplemental Data

18

Core information

19

Level I - products with well established history of safe

use and a negligible risk profile = core information only

Level II - products that may be contaminated with

chemical or biological agents = core

information + results of analysis

Level III - unknown or higher risk profile = core

information + results of analysis + safety

rationale and supplemental data

Levels of safety assessment

RIS

K L

EV

EL

SA

FE

TY

DA

TA

RE

QU

IRE

ME

NT

S

4.1 Administrative Forms

20

Administrative Forms (Level I , II and III)

This section outlines the administrative requirements for an application

for registration.

• Cover Letter

• Application Form

• Designation of Signing Authority and Declaration of Canadian Agent

• Pre-Market Application Submission Office (PASO)

21

Administrative Forms (Level I , II and III)

22

Include in the Cover Letter:

• Type of submission (new, renewal, amendment)

• Registration Levels (I, II, or III)

• Reference to any applicable submission control number(s) or

registration number(s)

• Intended end-use of the product (e.g. agricultural, greenhouse,

residential lawn, or indoor plant applications, further manufacturing

etc.)

Administrative Forms (Level I , II and III)

23

Application Form:

• The application form is in Schedule III of the Fertilizers

Regulations

• Complete accurately and in its entirety.

• Information on the application form must match the information

on the label

• Additional guidance: “Guidelines to Completing the Fertilizer or

Supplement Registration Application Form” document available

on the CFIA website.

Administrative Forms (Level I , II and III)

This section outlines the administrative requirements for an application

for registration.

• Cover Letter

• Application Form

• Designation of Signing Authority and Declaration of Canadian Agent

24

Signing Authority:

To be authorized to sign an application form, you need to:

1) Provide a letter of patent or certificate of incorporation with a list of

directors. The person who signs the form must be on the board of

directors or on the certificate of incorporation.

If the person who will sign the registration form is not a member of the

Board of Directors, then a letter is required from a member authorizing this

person to sign on behalf of the company.

2) OR provide a letter signed by an individual with signing authority,

identifying the persons authorized to sign the applications for registration.

A corporation may also appoint a person to be a delegated representative

(may correspond with CFIA but may not sign the application form)

Administrative Forms (Level I , II and III)

This section outlines the administrative requirements for an application

for registration.

• Cover Letter

• Application Form

• Designation of Signing Authority and Declaration of Canadian Agent

25

Resident Canadian Agent:

For applicants residing outside Canada, a resident Canadian Agent must

be designated, by completing the form “Declaration of Resident Agent

Form” found on the CFIA website.

• The Canadian Agent must be a person,

not a company;

• The Canadian Agent must be a permanent

resident of Canada;

• Any CFIA notice or correspondence may

be sent to the Agent.

The declaration must be signed before a justice of the peace, etc.

Defined: any non-related person who is at or above the age of majority in the relevant province and who is of sound mind.

Administrative Forms (Level I , II and III)

This section outlines the administrative requirements for an application

for registration.

• Cover Letter

• Application Form

• Designation of Signing Authority and Declaration of Canadian Agent

• Registration Fee

• Pre-Market Application Submission Office (PASO)

26

Submit required information either by email (ensure the word

“fertilizer” is in the subject line) or by mail.

Pre-Market Application Submissions Office (PASO)

Canadian Food Inspection Agency

59 Camelot Drive

Ottawa, ON K1A 0Y9 Canada

Phone: 1-855-212-7695

Fax: 613-773-7115

Email: paso-bpdpm@inspection.gc.ca

Email: paso-bpdpm@canada.ca (January 2016)

4.2 Proposed Marketplace Label

27

Marketplace Label (Level I , II and III)

• Name and address of manufacturer or registrant

• Brand name (optional)

• Name of fertilizer or supplement

• Registration number

• Guaranteed minimum analysis

of active ingredients

• Directions for use

• Weight of fertilizer or supplement

• Precautionary statements (MSDS)

• Lot number

• Expiry date, for supplements

28

Labeling requirements vary depending on the product type

Supplement Guaranteed Analysis:

• Active INGREDIENTS expressed

in percent (%);

• Genus and species of active

microorganism;

• Minimum number of active viable

cells per gram (i.e. cfu or spores

/g).

4.3 Product Specification

29

Product Specifications (Level I, II and III)

30

This section outlines basic product description requirements for an

application for registration.

• List of Ingredients

• Method of Manufacture

• Quality Assurance and Quality Control Procedures

• Physical Characteristics

Product Specification (Level I, II and III)

31

This section outlines basic product description requirements for an

application for registration.

• List of Ingredients

List of Ingredients

Identification, description, and purpose of all materials used in the

production of the end-product, including:

• Name and purpose of the material

• Source of materials:

• Manufacturer;

• Country of Origin;

• Origin of material (by-product of another process, mined, synthesized, harvested e.g. seaweed)

• CAS #’s, if applicable

• Concentration of materials in the final product

• MSDS for ingredients and final product

Product Specification (Level I, II and III)

32

This section outlines basic product description requirements for an

application for registration.

• List of Ingredients

For products that contain microorganisms:

Identification of the Microorganism

• Purpose of the microbial strain

• Relationship to known pathogens

• Identification and taxonomic

classification (genus, species,

strain) with an analytical report

substantiating the identification

• Origin: when, where, environmental isolate or certificate from

repository i.e. American Type Culture Collection (ATCC),

Canadian Collection of Fungal Cultures (CCFC)

Product Specification (Level I, II and III)

33

This section outlines basic product description requirements for an

application for registration.

• List of Ingredients

For products that contain GM microorganisms

Additional Data includes:

1. Flow diagram of the genetic modification

2. Description of the gene product(s), function and properties

3. Description of the metabolic pathways altered by the insertion

4. Unintended effects on gene expression

5. Stability of the inserted genetic material

6. Horizontal gene transfer potential

7. Procedures and tests to detect and quantify

the modified microorganism

Product Specification (Level I, II and III)

34

This section outlines basic product description requirements for an

application for registration.

• List of Ingredients

• Method of Manufacture

Manufacturing Process must include:

• Description of production/formulation/blending process

• Description must specify each production step and associated

conditions such as temperature, pressure, process time

• Identify raw materials, and point of incorporation

• Identify chemical reactions, and potential for reaction of by-

products

• A flow chart diagram

Product Specification (Level I, II and III)

35

This section outlines basic product description requirements for an

application for registration.

• List of Ingredients

• Method of Manufacture

• Quality Assurance and Quality Control Procedures

QA/QC Procedures:

Provide Quality Assurance / Quality Control (QA/QC)

procedures used during the manufacture of the product

to ensure consistency in production, and purity of the

final product. For example:

• Indication of materials being tested (raw, intermediary or final product)

• Testing frequency (per batch or unit time)

• Monitoring manufacturing conditions (time, pressure, moisture content)

• Point of sampling/monitoring during production

• Substantiation of the conformance of raw materials to standards (with

analysis or accreditation i.e. ISO)

• Sensitivity of test methods; and identification of “pass” criteria

Product Specification (Level I, II and III)

36

This section outlines basic product description requirements for an

application for registration.

• List of Ingredients

• Method of Manufacture

• Quality Assurance and Quality Control Procedures

Purity of Inoculum

• QA/QC used to monitor, identify,

and purify the microorganism from

the seed stock (primary inoculum),

including company name/address

that keeps the seed stock

• QA/QC used to monitor the final

inoculum (used as an ingredient in

the final product)

• QA/QC used to monitor the final

product

Primary inoculum

QA/QC 1

Final Inoculum

Fermentation or spore

production

Addition of other ingredients

Maintenance

QA/QC 2

Microbial Supplement

QA/QC 3

Product Specifications (Level I, II and III)

37

This section outlines basic product description requirements for an

application for registration.

• List of Ingredients

• Method of Manufacture

• Quality Assurance and Quality Control Procedures

• Physical Characteristics

Other Qualities

• Physical characteristics of the final product (e.g. granular, liquid, particle size,

colour and odour, density, melting point, boiling point, pH, solubility, size guide

number etc.)

4.4 Results of analysis

38

Results of Analysis (Level II and III)

39

This section specifies the product-based results of analysis (RoA) that

are required for product registration.

• Metals

• Dioxins and Furans

• Indicator Organisms

Reminder:

1. Samples must be taken at intervals enabling

assessment of the consistency in production

(e.g. regular time intervals, upon receipt of raw

materials, per lot/batch, every 2 weeks for

continuous or semi-continuous batches)

2. Indicate the number of batches produced

annually and the manufacturing date of each

batch analyzed.

3. RoA to be printed on lab letterhead, bear

signature of the analyst, indicate sample

preparation methods, method of analysis, and

limits of detection

Results of Analysis (Level II and III)

40

TYPE ANALYSIS

Metals Arsenic (As), Cadmium (Cd), Cobalt (Co), Copper (Cu),

Chromium (Cr), Mercury (Hg), Molybdenum (Mo), Nickel (Ni),

Lead (Pb), Selenium (Se), and Zinc (Zn).

The number of metals analyses corresponds to the total

number of batches/lots of product manufactured within a three

(3) year interval

Indicator

Organisms

Salmonella (must be absent / non-detectable).

Faecal coliform (levels must be below 1000 MPN per gram).

4 sets of analyses from 4 different lots/batches of the final

product for Faecal coliforms and Salmonella.

Dioxins and

Furans

1 set of analysis for the seventeen (17) most toxic congeners

Products/Ingredients Requiring RoA

Fertilizer or Supplement Compliance Analysis

Micronutrients Metals

Biochar Metals, Dioxins and furans

Humic and Fulvic Acids Metals

Seaweed Metals, Indicator organisms

Cement kiln dust Metals, Dioxins and furans

Compost and meals Metals, Indicator organisms

Processed sewage including

composts thereof, pulp and paper

sludge

Metals, Indicator organisms,

Dioxins and furans

Wood ash Metals, Dioxins and furans

Microorganisms Indicator organisms

41

Not a comprehensive list and source dependent

4.5 Safety Rationale and

Supplemental Data

42

Risk assessment framework (Level III)

1. HAZARD ASSESSMENT

Identification and characterization of potential adverse effects on human,

animal and plant health, and the environment.

2. EXPOSURE ASSESSMENT

Predicts the extent and duration of the exposure.

3. RISK ASSESSMENT AND MITIGATION MEASURES

The risk assessment is based on the hazard, and what is known about

exposure.

Risk = Hazard x Exposure

43

Toxicological Hazard Characterization

The applicant is responsible to identify all potential hazards associated

with each ingredient in the product, including:

1. Human Health Hazards:

Acute (oral, dermal, inhalation); Subchronic (oral); Irritation (ocular, dermal); carcinogenicity; reproductive and developmental toxicityendocrine disruption

2. Environmental Hazards:

Aquatic hazard profile (toxicity to vertebrates, invertebrates, benthic organisms, and algae)

To assist in this characterization, ALL fields in Appendix 4 (in the

supporting Guide) must be completed for all ingredients.

44

Toxicological Exposure Assessment

The applicant is responsible to provide the exposure assessment for all

ingredients and potential contaminants. Factors to consider include:

• Routes of exposure: direct (applicator/user) and indirect (bystander,

groundwater, contaminated soil contact, and food/feed consumption)

• Intended use patterns (e.g., agricultural field use vs potting mixes; ornamental

plant species vs. food crops)

• Application rate and frequency of application

• Protective measures, such as personal protective equipment, re-entry

restrictions, and post-harvest intervals

• Must consider worst case exposure scenarios/studies

ALL fields in Appendix 5 (in the supporting Guide) for all constituent materials for

which a high hazard level has been identified (Appendix 4) must be completed.

45

The applicant is responsible to provide estimates of risk by combining

the hazard characterization with exposure assessment.

The risk estimates derived by the applicant are subject to review and

validation by the Fertilizer Safety Section (FSS) and additional

information/ test data may be required in order to refine the exposure

and hazard assessments and/or further mitigative measures may be

imposed to facilitate safe use of the product.

46

Toxicological Risk Assessment

Risk = Hazard x Exposure

Microbial Hazard Assessment

The applicant is responsible to identify all potential hazards associated

with the microorganism, including:

1. Human, Animal and Plant Health Hazards:

• Toxin production potential

• Pathogenicity profiles

• Allergenicity / Sensitization potential

2. Environmental Hazards:

• Effects on target and non-target species

• Resistance to adverse environmental conditions (e.g., cold tolerance)

• Resistance to selectable traits (antibiotic, heavy metal resistance)

• Invasiveness

To assist in this characterization, ALL fields in Appendix 6 (in the

supporting Guide) must be completed.

47

Microbial Exposure Assessment

The applicant is responsible to provide the exposure assessment of

the microorganism. Factors to consider include:

• Natural occurrence (e.g. geographical distribution, hosts)

• Physiological properties (e.g. growth parameters – temp, pH)

• Description of the life cycle, including potential for dispersal

• Product use pattern, and expected

routes of exposure (e.g. dermal,

inhalation, ingestion)

To assist in the exposure assessment, applicants must complete ALLfields in Appendix 7 (in the supporting Guide).

48

Microbial Risk Assessment

The risk assessment conclusion is based on the hazard and exposure.

The FSS will review and validate the risk estimates derived by the

applicant and additional safety data may be required.

Considerations for classification of microbial hazard severity and

exposure levels are summarized in Appendix 8 of the guide, for your

information.

Where appropriate, any preventative risk mitigation measures may be

required.

49

Example of a Precautionary Statement:

“This product may contain fungi and/or bacteria and may cause adverse

effects in individuals who are allergic to certain microorganisms including

moulds and otherwise immunocompromised individuals. Avoid exposure

through inhalation or open wounds and eyes. Wear standard protective

clothing and equipment during product handling and storage. Use this product

in well ventilated areas”

Surrogate Data

In cases where information or elements of it are not available for a

given ingredient, information pertaining to a similar substance or

microorganism may be submitted (surrogate data).

This requires a rationale demonstrating similarity between the

substances of interest and its surrogate including all relevant

characteristics (physical, chemical, or toxicological).

Surrogate data for microorganisms must be substantiated by a

comparison of the organism under review and its surrogate with

respect to pathogenicity, toxigenicity and its behaviour in the

environment (persistence, life cycle, invasiveness etc.)

50

Products Requiring a Safety Rationale and

Supplemental Data (Level III assessment)

Fertilizer or Supplement:

Polymeric soil stabilizers and

wetting agents

Inoculant extenders sold with an

inoculant

Registerable supplement(s) Viable microorganisms

Nano-encapsulated fertilizers and

nano-materials

Metabolites of organisms

Abiotic stress protectants (other

than IBA)

Plant signalling compounds (e.g.

LCOs, Hesperetin, Naringenin)

51

Note: this is not a comprehensive list

5. Submission Layout

52

53

All products require mandatory submission of

information in TAB 1, 2, and 3 (Level I or Core

Information).

Tab 4 (Level II) and Tab 5 (Level III) depend on

the nature of the product and its risk profile.

Safety Rationale and

Supplemental Data

Safety assessment levels and required

sections by TAB

54

Safety Assessment

Level I

Tabs 1 - 3

Level II

Tabs 1 - 4

Level III

Tabs 1 - 5

6. File Review Stages and Service

Delivery Standards

55

Review Stages

Pre-screen (PASO)

First Response

Completeness Check

Close and refund

First Review

Second Review

Third Review

Register or Close

Admin check; Label review; Safety

assessment

Confirm and review requested info

Confirm and review requested info

Close

My File Was Closed!

A file will be closed if:

1. Submission is cancelled by the company

2. The product does not meet the requirements after all three

reviews

3. No reply is received by deadline date

4. The information comes back incomplete,

or if there are substantive changes received,

at any review stage

57

Service Delivery Standards (T-4-122)

58

Type Pre-

screen

ART 1st

Review

ART 2nd

Review

ART 3rd

Review

Total

Me-too 45 30 20 N/A 95

Minor 45 30 20 30 10 N/A 135

RR- no

data

45 30 120 90 60 N/A 345

NR- no

data

45 30 150 90 90 30 30 465

NR -

data

45 30 200 90 90 30 45 530

RR -

data

45 30 200 90 90 30 45 530

Major 45 30 200 90 90 30 45 530

ART: Applicant response time; Pre-screen includes first response; time is in working days

NR-data could be

issued within 245 days

instead of 530 days, if

there are no

deficiencies

7. Do’s and Don’ts

59

Do’s and Don'ts of Submission Packages

60

DO’S:

1. Familiarize yourself with the

registration requirements PRIOR

to submitting an application

2. Structure your submission in

accordance with the Tab format

3. Make sure all documentation is

in place and accurate

(application form that matches

the label, signing authority etc.)

4. Use scientific literature or

experimental data to support

your safety rationales

5. Use accredited laboratories to

conduct the analysis

DON’TS:

1. Apply for registration before

researching the regulatory

requirements

2. Submit documentation for

registration piecemeal, in no

particular order or structure

3. Submit an application form that is

partially filled out or does not

align with information on the

label

4. Use anecdotal evidence;

testimonials or personal

experience (i.e. using it on my

lawn) in support of your product

safety

Do’s and Don'ts Continued

61

DO’S:

6. List references used

7. Respond to CFIA questions

fully and within the specified

time frame and provide as

much detail as possible

8. Consult and obtain advice

from scientific professionals

(e.g., toxicologists,

microbiologists)

DON’TS:

5. Fail to conduct appropriate

analysis or implement

appropriate QA/QC procedures

to substantiate consistency in

production and purity of the

final product

6. Use poor quality input

materials

7. Respond to some but not all

CFIA questions, provide partial

answers with no detail and with

a delay

8. Attempt to address technical

questions without having the

expertise in house

Reference Materials

These are the references available for more information on the

file submission process:

• Fertilizers Act and Regulations

• Guide to submitting applications for registration under the

Fertilizers Act

• Guidelines to completing the Application Form

• Trade Memoranda

• Identification and Taxonomic Classification of Microorganism(s)

• Good Laboratory Practices Protocol

• Submission Checklists

• Pre-Submission Consultations

62

All reference material is available through the CFIA website:

www.inspection.gc.ca

63

Questions ??

64