T-4-116 - Safety data requirements for the registration of  polyacylamide, acrylamide-acrylate copolymer and polyacrylate soil supplements as active ingredients under the Fertilizers Act

December 1997

Polyacrylamide, acrylamide-acrylate copolymer and polyacrylate soil amendments must be registered as supplements under the Fertilizers Act. This Trade Memorandum should be used in conjunction with T-4-107, Registration of Supplements Under the Fertilizers Act, and T-4-113, Guidelines to Assessments of Fertilizers and Supplements and to Information to be submitted in demonstrating Product Safety.

The safety data requirements for the registration of polyacrylamide, acrylamide-acrylate copolymer and polyacrylate soil supplements have been broken down into a series of scenarios based on their intended use patterns and on the size of the packages. In all cases the information requirements and criteria listed in points 1 through 6 on pages 2 and 3 must be met and demonstrated to the Plant Production Division. Beyond this, there are three scenarios for the registration of polyacrylamide and acrylamide-acrylate copolymers and a fourth for the registration of polyacrylates. The nature of the additional criteria depends upon the product packaging and the use patterns.

Please use the guide below to determine the most appropriate scenario for your product.

  • If the polyacrylamide, or acrylamide-acrylate copolymer product is to be sold in packages of less than or equal to 5g, for domestic, indoor, non-food use, go to scenario 1.
  • If the polyacrylamide or acrylamide-acrylate copolymer product is to be sold in packages exceeding 5g, for use only in blending products intended for re-sale, go to scenario 2.
  • For other uses of polyacrylamide or acrylamide-acrylate copolymers, go to scenario 3.
  • For polyacrylates, go to scenario 4.

Note: For the purpose of product labels, domestic is taken to mean for personal/household use.

Information requirements and required specifications for all products and all use patterns:

  1. Accurate identification of the product must be submitted: name, Chemical Abstracts Services (C.A.S.) registry number, presence of any cross-linkage, water solubility, particle size(s) and substantiated percent acrylamide- and/or acrylate monomer content.
  2. Impurities, including residual monomer content, and their concentrations in the product must be identified and reported.
  3. The manufacturing method must be reported and must identify:
    • Ingredients used in the product manufacturing process (actives, inerts and others);
    • Concentration of each ingredient used in the process;
    • Purpose of each ingredient in the product synthesis process (e.g., substance A neutralizes substance B and C, producing substances D and E); and
    • Fate of the ingredients in the final product.

    Note: It is anticipated that the polymerization reaction uses not more than two percent of the cross-linking agent, and that the manufacturing method includes a dust-removal step.

  4. The product granules must not be of respirable diameter.
  5. The product will be sold in non-hydrated form only.
  6. The product label must contain the following information and statements:
    • Avoid skin and eye contact with the product;
    • Wear gloves while handling the product in order to reduce exposure to skin;
    • Other appropriate personal protective equipment and measures (at the company/registrant's discretion);
    • Not for outdoor use (for exceptions see Scenario 3, Situation 1, pg. 5);
    • Not for use on food plants (for exceptions see Scenario 3, Situation 2, pg.
    • Avoid inhalation of dust or particulate matter arising from the handling of the product;
    • Specify inhalation hazards, if any, associated with dusts or particulates arising from the handling of the product (at the company/registrant's discretion);
    • Wear a face mask while handling the product in order to reduce the likelihood of dust/particulate inhalation exposure;
    • Wash with soap and water if skin contact does occur;
    • Clean up spilled product promptly;
    • Seek medical attention promptly if the product is ingested or if skin- or eye irritation develops following exposure to the product;
    • Keep the product away from strong oxidants (e.g. hydrogen peroxide, sodium hypochlorite) since a dangerous reaction may occur (explosion, emission of toxic gases, spontaneous combustion);
    • Use the entire contents of the five-gram packets once they are opened, or, if using a larger package of the product, seal the unused portion in a child-proof container; and
    • Keep the product out of the reach of children.

Registration of both polyacrylamide and acrylamide-acrylate copolymer soil products is permitted under two typical scenarios. These scenarios, along with specific additional criteria that must be met, are outlined below. The nature of the additional criteria depends upon the product packaging and the use patterns.

SCENARIO 1: REGISTRATION OF POLYACRYLAMIDE AND ACRYLAMIDE-ACRYLATE COPOLYMER IN UNIT PACKAGES - LESS THAN OR EQUAL TO FIVE GRAMS IN WEIGHT

In addition to the information requirement and criteria listed in points 1 to 6 above, the following criteria must also be met.

  1. The product package must not exceed five grams in weight;
  2. The product label must:
    • state that the product is intended for domestic use only;
    • recommend that the product be mixed or incorporated into soils; and
    • caution that the entire contents of the bag should be used once it is opened.

SCENARIO 2: REGISTRATION OF POLYACRYLAMIDE AND ACRYLAMIDE-ACRYLATE COPOLYMER IN UNIT PACKAGES - EXCEEDING FIVE GRAMS IN WEIGHT FOR USE ONLY IN MANUFACTURING PRODUCTS INTENDED FOR RE-SALE

In addition to the information requirement and criteria listed in points 1 to 6 above the following criteria must also be met:

  1. The product must not be mixed with soil manually;
  2. Contact with skin should be avoided;
  3. Only automated mixing should be performed; and
  4. For commercial (manufacturing) use only, and only for blending into other products intended for re-sale.

When the product does not fit either of the scenarios stated above, the applicant will be required to submit data from exposure, chemical, toxicological and food residue studies, as appropriate, to demonstrate product safety.

Typically, when a polyacrylamide or acrylamide-acrylate copolymer does not fit one of the two scenarios specified above, it falls into one, or both, of the following use patterns.

SCENARIO 3: OTHER USE PATTERNS

SITUATION 1

a)The product is destined for domestic, commercial and/or for research use and:

  • will be sold in bulk; and/or
  • will be mixed via process that is not totally automated (i.e. there may be manual mixing) and
  • will be used only for non-food plants.

b)  The product is intended for uses wherein the user/worker is likely to be the same as the individual who is mixing the polyacrylamide or acrylamide-acrylate copolymer products with the soil (e.g. landscape companies, universities greenhouses, etc.)

In addition to the safety data, listed in points 1 through 6 on pages 2 and 3, the following information must also be provided:

  1. Exposure to the residual acrylamide and/or acrylate monomer must be determined. The determination should include consideration of the following:
    • Residual level of acrylamide and/or acrylate monomer, showing method of   determination, instrument detection limit and monomer recovery data
    • Biodegradation or degradation, if any, of monomers in the polymers prior to usage;
    • The amount of polymer to which one might be exposed in a worst-case scenario;
    • The leachability of monomer from the polymer, in order to estimate the amount of monomer to which one could be inadvertently exposed from direct contact with the polymer; and
    • Studies estimating potential exposures to monomer during product handling.

    Please note that guidelines for conducting exposure studies are available from the Fertilizer Section, Plant Production Division.

  2. If product is proposed for use outdoors then environmental fate and effects will have to be reported (see T-4-113). This should include data on product photo decomposition and degradation under actual field conditions.

SITUATION 2

The product proposed for registration is intended for food crop applications.

In addition to the safety, analytical and exposure data required for products intended for bulk uses (situation 1), the following information must also be submitted for products destined for growing food-crop plants.

  1. A full listing of, and the recovery data for, all impurities present at a concentration exceeding 0.1% w/w in the technical or formulated products;
  2. Concentration data on the monomer;
  3. Recovery and detection limit data for the analysis of monomers in polyacrylamide or polyacrylate;
  4. Analytical methods used in the determination of the concentrations of monomer in plant material. This methodology should have a detection limit of 0.05 ppm or better. Please note that recovery data should be obtained from sample spiking prior to homogenization, not after the first extraction;
  5. Data on product photodecomposition and degradation under actual field conditions; and
  6. Some representative studies to demonstrate the interaction, if any, of the polymer with various pesticides. These studies should examine whether the polymer could extend soil pesticide residue times and consequently increase pesticide residue levels on or in crops.

Please note that depending on the actual concentrations and a toxicological assessment of the monomer, it may be necessary to request plant metabolism studies to evaluate the fate of these residues.

SCENARIO 4: REGISTRATION OF A PRODUCT CONTAINING POLYACRYLATES.

In addition to the safety data requested in points 1 through 6 of pages 2 and 3, the following information must also be submitted:

  1. Exposure to the residual acrylate monomer must be determined. This determination should include consideration of the following:
    • Residual level of acrylate monomer, showing method of determination, instrument detection limit and monomer recovery data;
    • Biodegradation or degradation, if any, of monomers in the polymers prior to usage;
    • The amount of polymer to which one might be exposed in a worst-case scenario;
    • The leachability of monomer from the polymer, in order to estimate the amount of monomer to which one could be inadvertently exposed from direct contact with the polymer; and
    • Calculations or other means of estimating potential exposures to monomer during product handling.

Please note that depending on the actual concentrations and a toxicological assessment of the monomer, it may be necessary to request plant metabolism studies to evaluate the fate of these residues.

For further information on the registration of polyacrylamide and polyacrylate soil supplements under the Fertilizers Act, or to receive an application package, please contact:

Fertilizer Safety Section
c/o 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