## CPSC Testing Burden Reduction Workshop April 3, 2014 | Rockville, Maryland 

# Proposals and Rationales for Exemptions from Phthalate Certification Testing Presented by: Alan P. Kaufman Senior Vice
- President, Technical Affairs2 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# Toy Industry Association (TIA)

 Trade association for North American
- based manufacturers, importers, licensors and toy retailers (regular members)

 Associate members include inventors, designers, testing labs

 Formed in 1916

 Long History of Dedication to Child Safety

 Over 750 members

 Members represent approx 85% of the U.S. market3 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# Toy Industry Association Toy Companies, Licensors, Inventors and Designers, Manufacturers Reps, Retailers4 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# A Snapshot of the U.S. Toy Industry

Average price of a toy is less than US$9.00

US$22+ Billion in direct toy sales ( 2013) An estimated 3 Billion+ units sold each year

Estimated 512,775 FTE toy industry jobs in the United States Total annual economic impact of US$69 Billion5 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# Overview



#  Industry is not seeking any relief regarding compliance, but only relief from testing which does not advance safety6 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# Overview

 TIA has provided information to CPSC on this topic several times previously, but today will present proposals and additional data
• Proposal to revise definition of “accessible”
• Proposal to screen materials based on rigidity
• Proposal to test/exclude materials based on composition
• Rationale

– Evidence from process knowledge/process controls

– Evidence from review of material producer
- supplied bills of substance

– Evidence from absence by test7 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# Proposal 1: Revise definition of “accessible” materials

 Current definition of accessibility based on 16CFR 1500.48/49

 This test method developed for sharp point/edges based on ability to touch them

 Inappropriate for phthalates, where alleged hazard is oral exposure
 Suggest language similar to ASTM F963 Heavy elements section:

 Toys and parts of toys which, due to their inaccessibility, size, mass, function, or other characteristics, cannot be sucked, mouthed or ingested are not subject to this requirement.8 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# Proposal 2: Utilize rigidity as initial means to exclude materials from phthalate testing
 Phthalates are added to materials for plasticization, i.e. to make them flexible
 Rigid materials will not contain appreciable amounts of restricted phthalates
 Shore hardness is excellent proxy for rigidity
 Propose exclusion of rigid materials, defining these as exhibiting Shore “A” Hardness of 90 or greater9 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# Why Even Some Flexible Materials Don’t Require Routine Testing: Considerations

– Most materials listed as not requiring routine testing utilize petroleum and/or natural gas as feedstocks ; these will not contain regulated phthalates

– Polylactic acid produced from corn starch;

– Resin producers tightly control extraneous materials to assure quality and safe reactor operation

– Polyolefins (polyethylene, polypropylene, polybutene, propylene
- ethylene copolymers, ethylene
- butene copolymers, ethylene
- hexene copolymers, ionomers, et al ) are flexible, but not through use of plasticizers; flexibility is obtained in polymerization by manipulating molecular weight and degree of branching of polymer chains, and selection of copolymers. Phthalates are not compatible/miscible with these materials

– Thermoplastic polyesters (PETE, PBT, PCT, PCTA, PCTG) are flexible , but despite the name, do not contain phthalates

– Styrenics (GPS, MIPS, HIPS, SHIPS, ABS, SBR) do not utilize plasticizers to obtain physical properties
- this is accomplished by altering MW, alloying or copolymerizing with acrylonitrile and/or butadiene. Phthalates will attack and degrade these materials if present

– Some materials are plasticized (nylon 11/12, cellulosics ), but not with regulated phthalates10 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# Proposal 3: Exclusions based on Composition

 Polyvinyl Chloride (PVC) - excluding rigid grades (>90 Shore “A” Hardness) – should be tested

 Thermoset polyurethane (excluding some foams) – should be tested

 Polyvinylidene Chloride (PVdC) - excluding rigid grades (>90 Shore “A” Hardness) – should be tested

 Chlorinated PVC (CPVC) - excluding rigid grades (>90 Shore “A” Hardness) – should be tested

 All of these materials are potentially plasticized with restricted orthophthalate esters11 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# Proposal 3 (cont): Materials which do not require certification testing

– Acetal/polyoxymethylene (POM) homopolymer

– 1,3,5
- trioxane, copolymer with 1,3
- dioxolane (acetal/polyoxymethylene (POM) copolymer)

– Acrylic (polymethylmethacrylate and polyacrylonitrile)

– Acrylonitrile butadiene styrene terpolymers (ABS)

– Butadiene
- ethylene resins

– Butene
- ethylene copolymers

– Ethylene copolymers

– Ethylene acrylic acid copolymers

– Ethylene
- propylene copolymers

– Ethylene vinyl acetate copolymers

– Ethylene vinyl acetate vinyl alcohol copolymers

– Ionomers12 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# Proposal 3 (cont): Materials which do not require certification testing

– Polystyrene (crystal and general
- purpose (GPS), medium
- impact (MIPS), high
- impact (HIPS), and super
- high
- impact (SHIPS) grades

– Polytetramethylene glycol
- dimethyl terephthalate
- 1,4
- butanediol copolymer (polyester elastomer)

– Propylene
- ethylene copolymers

– Silicone rubber (pure)

– Styrene
- butadiene copolymers

– Styrene
- butadiene
- styrene rubbers (SBS/SBR)

– Styrene
- acrylonitrile copolymers (SAN)

– Vinylidene chloride/methyl acrylate copolymers

– CMYK Process Inks (exception: those applied to flexible substrates; inkjet inks)13 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# Proposal 3 (cont): Materials which do not require certification testing

– Liquid crystal polymers (hydroxybenzoic acid copolymers)

– Nylon/polyamide

– Olefin thermoplastic elastomers (such as EPDM)

– Polybutene

– Polybutylene terephthalate (PBT)

– Polycarbonate

– Polyethylene (LLDPE, LDPE, MDPE, HDPE and UHMWPE)

– Polyethylene terephthalate (PET or PETE) and its variants: PETG (polyethylene terephthalate, glycol
- modified); PCT (polycyclohexylene dimethylene terephthalate); PCTG (polycyclohexylene dimethylene terephthalate, glycol
- modified); and PCTA (polycyclohexylene dimethylene terephthalate, acid
- modified)

– Polylactic acid

– Polyphenylene sulfide

– Polypropylene14 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# Rationale: Test, BOM, and BOS Data SUMMARY OF DATA:

– Testing for regulated phthalates (in some cases, for years) has found them to be absent in many plastic materials

– Additionally, TIA members have evaluated bills of material from toy suppliers and corresponding bills of substance supplied by resin producers for phthalate presence:

• 600,000+ data points : Automated evaluations against a list of restricted substances including the six restricted phthalates
-- plus eight additional phthalates (to confirm that currently unrestricted phthalates have not been substituted for restricted ones)
• Of the 600,000+ analyses, one or more of the 14 target phthalates were detected in samples in only 34 cases : once in phenol
- formaldehyde thermoset resin, once in a non - polymer liquid formulation, and the balance in PVC.



### – These data, in combination with knowledge of material and process, provide ample rationale for exemption from routine testing for phthalates15 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# Rationale: Test, BOM, and BOS Data (cont)

– Evaluated Phthalates:

CASRN Common name Acronym Total 28553-12-0 di-''isononyl'' phthalate DINP 14 117-81-7 bis(2-ethylhexyl) phthalate DEHP 8 84-74-2 dibutyl phthalate DBP 7 85-68-7 benzyl butyl phthalate BBP 4 68515-48-0 1,2-Benzenedicarboxylic acid, di-C8-10-branched DINP 1 117-84-0 dioctyl phthalate DnOP 1 131-11-3 dimethyl phthalate DMP 1 131-18-0 dipentyl phthalate DPP 0 68515-49-1 1,2-Benzenedicarboxylic acid, di-C9-11-branched DIDP 0 84-66-2 diethyl phthalate DEP 0 84-69-5 diisobutyl phthalate DIBP 0 84-75-3 dihexyl phthalate DnHP 0 26761-40-0 di-''isodecyl'' phthalate DIDP 0 3648-21-3 diheptyl phthalate DnHpP 016 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# Rationale: Test, BOM, and BOS Data (cont)

CASRN Name Frequency 9003-56-9 ABS 84,919 9002-88-4 PE 56,333 9003-22-9 Pevikon/Bakelite (PVC/phenolic) 46,172 9002-86-2 PVC 46,138 9003-01-4 2-Propenoic acid, homopolymer (polyacrylic acid, carbomer, acrylates polymer) 37,366 24969-26-4 Copolymer of dioxolane and trioxane 34,723 9010-79-1 Ethylene/propylene copolymer 25,344 25054-06-2 Formaldehyde, polymer with cyclohexanone (phenol-formaldehyde resin) 20,741 25038-59-9 PETE 19,982 25608-33-7 Butyl methacrylate methyl methacrylate polymer 17,876 9009-54-5 Polyurethane foam 16,432 9003-55-8 1,3-Butadiene, polymer with styrene 15,270 9002-89-5 Polyvinyl Alcohol 11,595 24937-78-8 EVA 9,839 9003-07-0 PP 8,577 70955-45-2 Rosin, polymer with formaldehyde, glycerol, octylphenol and polymd. rosin 7,341 25038-54-4 Nylon 4,003 26160-89-4 Formaldehyde, polymer with 6-phenyl-1,3,5-triazine-2,4-diamine (benzoguanamineformaldehyde resin) 3,508 9010-94-0 2-Propenoic acid, 2-methyl-, methyl ester, polymer with 1,3-butadiene, ethenylbenzene and 2- propenenitrile (ABS-PMMA copolymer) 3,162 9011-14-7 2-Propenoic acid, 2-methyl-, methyl ester, homopolymer (polymethylmethacylate) 3,105 25085-34-1 2-Propenoic acid, polymer with ethenylbenzene (styrene/acrylic acid copolymer) 2,859 various 230 additional polymers 132,000 9004-34-6 wood/cellulose 483017 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# Rationale: Test, BOM, and BOS Data (cont)

28553-12-0 PVC 28553-12-0 Phenol formaldehyde resin 117-81-7 PVC 68515-48-0 PVC 68515-48-0 PVC 68515-48-0 PVC 68515-48-0 PVC 68515-48-0 PVC 28553-12-0 PVC 28553-12-0 PVC 28553-12-0 PVC 28553-12-0 PVC 28553-12-0 PVC 28553-12-0 PVC 28553-12-0 PVC 28553-12-0 PVC 28553-12-0 PVC 28553-12-0 PVC 28553-12-0 PVC 28553-12-0 PVC 84-74-2 PVC 84-74-2 PVC 84-74-2 PVC 84-74-2 PVC 84-74-2 PVC 84-74-2 PVC 84-74-2 PVC 84-74-2 PVC 85-68-7 PVC 85-68-7 PVC 85-68-7 PVC 85-68-7 PVC 131-11-3 ingredient in non-polymer liquid formulation 117-84-0 PVC18 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# In Summary

 Accessibility determinations should reflect hazard

 Certain materials, as described here, should always be tested

 Other materials should be exempt from routine certification testing, as data from process knowledge and process controls, from review of bills of substance, and from evidence related to their absence in testing in over 600,000 cases (70,000+ unique materials) indicate that this is not necessary to assure compliance.

 Cost to industry to test these materials: $25million +

 Industry is not seeking any relief regarding compliance ...but rather relief only from testing of certain materials -- which does not advance safety and is unwarranted given the nature of these materials and their use.19 CPSC Testing Burden Reduction Workshop | April 3, 2014 

# Thank You!

 Questions? Al Kaufman (646) 520
- 4868 akaufman@toyassociation.org