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Inert (other) ingredient: EPA terminology equivalent to the term formulant6 g2$  "Current Formulant Practices  4Formulants are categorized to Lists 1, 2, 3, 4A, 4B List 3, 4 formulants are acceptable List 2 formulants are generally acceptable for established use pattern (Data may be required to expand use pattern) Registrants are advised of future regulatory action for List 2s, Allergens and Formulation Preservatives556 4  #HCurrent Formulant Practices (cont d)%   zIdentity of Formulant Mixtures must be disclosed to PMRA New Formulant data requirements established on case by case basis{{, ( 5$Removal of List 1 Formulants Letter sent to registrants Sept./2001 outlining options: Immediate voluntary discontinuation OR Substitution/removal with interim labelling OR Immediate or submission by Dec. 31/2002 Support continued use of List 1 formulant Submission by Dec. 31/20029V(*9$,(*   .Renewal SPSF Project (update SPSF initiative)(/((Verify SPSF Request clarification for minor deficiencies Indicate acceptance or non-acceptance Request amendments for formulation changes Request info on formulants as necessary in final letter PMRA Master File on Formulants Initiative underway to update master file Verify trade name formulants and mixtures Will lead to improved internal formulants database PMRA will publish Lists of Canadian formulants>; , .  Formulants Policy Formulants categorization (Lists) Regulatory action required for certain formulants Process for addressing regulatory requirements (e.g., Notification)$ ? E Formulants Categorization LFormulants assigned to Lists based on level of concern List 1, 2, 3, 4A, 4BMM C 7List 1 - Formulants of Toxicological Concern - Criteria88$ %Carcinogenicity Neurotoxicity and Chronic Effects Adverse Reproductive Effects Ecological Effects Toxic Substances Management Policy Montreal Protocolz DList 2 - Potentially Toxic Formulants with High Priority for TestingEE   lBased on structural similarity to List 1 formulants or data suggestive of toxicity Utilizes U.S. EPA List 2 mm( :  0List 4A - Formulants of Minimal Risk or Concern11  YIncludes formulants commonly consumed as foods, on U.S. GRAS or Minimum Risk Inerts ListsZZ, 9 List 3  Formulants that do not meet Criteria for Lists 1, 2, 4A, or 4BHH  5XFormulants contained in registered pest control products that are not on any other list YY O !Regulatory Actions on Formulants Submission of Statement of Product Specification Form (SPSF) Immediate for ALL applications for new products, amendments or research permits Will continue to be required with applications for registration renewal Will ensure up-to-date specs.,== List 1 - Regulatory ActionVoluntary discontinuation of product OR Substitution/removal and interim labelling OR Support continued use of formulant of concern and interim labellingp%+D%,Dn " List 2 - Regulatory ActionInterim labelling (requirement under new PCP Act) Coordinate with EPA Reassessment Activities Registrants may submit data/information in advance of ReassessmentList 3 - Regulatory ActionpRe-classify to other lists as data are available Subject to future reassessment Most will likely move to List 4BqqList 4a - Regulatory Action*None Considered safe for use in pesticides++$Proprietary Formulants and Mixtures  Components of mixtures must be disclosed to PMRA (Treated as confidential business information) Supplier or manufacturer can disclose composition directly to PMRA Components of mixture subject to formulants policy Formulants Unique to Canada Contained in Canadian registered control products but do not appear on U.S. EPA Lists Will be added to Lists as data on formulant is received Can be formulant mixture or trade name whose identity is yet to be determined.,w  ?Regulatory Actions Formulation preservatives Protects formulation from being denatured or degraded by pests e.g., malathion, formaldehyde Label statement on primary panel will be required  Contains (x) at y% as a preservative Revised label and SPSF with application for amendment?3'6?3'6_ 6Regulatory Actions (cont d)  Allergens known to cause anaphalactic type reactions e.g., peanuts, wheat Mandatory primary panel label statement will be required  Warning, may contain (x) Consistent with recommendation for food labellingX5N25N2 New Formulants Data requirements are under consideration Goal is to be harmonized with U.S. EPA tiered data approach  Methodology for Lower Toxicity Pesticide Chemicals PMRA to issue regulatory proposal on requirements for new formulants &Regulatory Action through Notification-Label disclosure for: List 1 List 2 Allergens*3Minor Formulation Changes Allowable by NotificationAddition, deletion or substitution of acceptable colorants and fragrances Change in nominal concentration and certified limits of formulants Change in formulation process Change in supplier of formulant (same CAS#) , 4  !SummaryCurrent Practices Removal of List 1 formulants Verifying/updating Product Specification Forms through Renewal Updating PMRA Master File for formulants,$ ^ Summary of Formulants Policy   Based on U.S EPA approach to inerts Formulants categorized according to level of concern and subject to conditions/requirements specific to the list Requires updated product specification forms Requires labelling of allergens and formulation preservatives Questions K  ` ̙33` ` ff3333f` 333MMM` f` f` 3>?" dd@,[|?" dd@ [  " @ ` n?" dd@   @@``PR    @ ` ` p>> A 0 yq  (     6< "P  T Click to edit Master title style! !$  0 "  RClick to edit Master text styles Second level Third level Fourth level Fifth level!     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