CPSC Testing Burden Reduction Workshop

April 3, 2014 | Rockville, Maryland

Lead and Heavy Elements: Proposals for Relief 

from Unnecessary Certification Testing

Presented by: 

Alan P. Kaufman

Senior Vice-President, Technical Affairs
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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. market
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Toy Industry Association

Toy Companies, Licensors, Inventors and Designers, Manufacturers Reps, Retailers
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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 Billion
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Overview

Industry is not seeking any relief 

regarding compliance, but only

relief from testing which does not 

advance safety
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Overview

 TIA will today present proposals and rationales

• Proposal to revise definition of “accessible”

• Proposal to adopt ASTM F963 de minimis mass for lead 

determinations

• Proposal to test/exclude materials based on 

composition

• Rationale

– Evidence from process knowledge/process controls

– Evidence from absence by test
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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 lead or heavy elements, where 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.
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Proposal 2: Adopt ASTM F963 de minimis mass for 

surface coatings and substrates

 ASTM F963 does not require heavy element testing of 

material mass per toy of 10mg or less

 CPSC staff has determined that lead exposure of <2.2ug/day 

will not result in a measurable increase in blood lead level, 

using the assumption of 50% absorption of ingested lead

 Data from ASTM soluble testing indicates absorption may 

be far less than 50% 

 Data collection still in progress; final proposal to be made at 

a future date
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Proposal 3: Exclude Some Materials from Lead and 

Heavy Elements Testing based on Composition

 Most natural (i.e. neat, with no colorants or other additives) 

plastic resins do not contain lead or heavy elements (see 

potential exceptions on next slide)

 Composite wood unlikely to contain significant lead or 

heavy elements

 Data collection still in progress; final proposal to be made at 

a future date
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Materials for Which Data Gaps Exist Regarding Exclusion 

from Lead/Heavy Element Testing

 Polyvinyl Chloride (PVC) – may contain heat stabilizers 

based on lead, cadmium, barium

 Polyvinylidene Chloride (PVdC) - may contain heat 

stabilizers based on lead, cadmium, barium

 Chlorinated PVC (CPVC) - may contain heat stabilizers based 

on lead, cadmium, barium

 Thermoplastic polyesters (PETE, et al) may contain 

antimony (Sb2O3 used as catalyst); not typically soluble
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Why Some Materials Don’t Require Certification 

Testing: Feedstock and Process Considerations

– Most plastic materials listed as not requiring routine 

testing utilize petroleum and/or natural gas as 

feedstocks; these will not typically contain heavy metals

– Polylactic acid produced from corn starch; heavy 

elements unlikely

– Resin producers tightly control extraneous materials to 

assure quality and safe reactor operation 

– Composite wood contains only trace levels due to wood 

itself; this is already exempted from lead testing by 

16CFR 1500.91
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Materials which do not require lead/heavy 

elements 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)

– Nylon/polyamide 

– Olefin thermoplastic elastomers (such as EPDM) 

– Polycarbonate 

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

– Polylactic acid 

– Polyphenylene sulfide 

– Polypropylene 
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Materials which do not require lead/heavy 

elements testing (continued)

– Polystyrene (crystal and general-purpose (GPS), medium-impact (MIPS), 

high-impact (HIPS), and super-high-impact (SHIPS) grades 

– Propylene-ethylene copolymers 

– Styrene-butadiene copolymers 

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

– Styrene-acrylonitrile copolymers (SAN)

– Composite wood (plywood, particleboard, etc.) 
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Rationale

– Testing for lead and heavy elements (in some cases, for 

years) has found them to be absent in many plastic and 

manufactured/composite wood materials

– These data, in combination with knowledge of material 

and process, provide ample rationale for exemption from 

certification testing for these trace elements
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In Summary

 Accessibility determinations should reflect hazard

 Certain materials, as described here, may required continued 

testing

 Other materials should be exempt from certification testing, as 

data from process knowledge and process controls, in addition to 

evidence of the demonstrated absence of restricted elements in 

testing, indicate that this is not necessary to assure compliance.

 Industry is not seeking any relief regarding compliance...but 

rather relief only from testing of certain materials – testing which 

does not advance safety and is unwarranted given the nature of 

these materials and their use.
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Thank You!

 Questions?

Al Kaufman

(646) 520-4868

akaufman@toyassociation.org