Mike Mattheisen/DC/USEPA/US 

02/28/2008 02:07 PM	

	To  Robert L. Falk

	Cc  Joseph Nash/DC/USEPA/US@EPA

	Subject  Fw: TSCA rulemaking re lead in consumer products intended for
children

	

	Mr. Falk, EPA is not considering adopting a "grace period" for
enforcement.  Requests for an extension of time are covered in
716.60(c).  

In addition, below are answers that EPA recently gave to questions
submitted by another correspondent that provide some additional
clarification and guidance.  

1. Persons who must submit include importers of lead and lead compounds
that are in, or part of, articles that are consumer products intended
for use by children.  The phrase “intended for use by children” is
defined in 40 CFR 710.43. 

2. Health and safety studies concerning the lead and lead compounds in
articles that are consumer products intended for use by children are
among those studies that must be submitted. The types of studies that
are reportable are described at 40 CFR 716.21(a)(8)(i).  The phrase
“intended for use by children” is defined in 40 CFR 710.43

3. As a general matter, all known health and safety studies of the types
described at 40 CFR 716.21(a)(8)(i) must be reported, regardless of
their date.  However, analyzed aggregations of monitoring data are not
subject to reporting under this rule if they were based on monitoring
data acquired more than 5 years before a substance was listed under 40
CFR 716.120. 40 CFR 716.20(a)(7).  In addition, 40 CFR 716.25 provides
that persons subject to this rule are not required to search their
records for reportable information dated before January 1, 1977, unless
specifically required to do so in a rule.  Health and safety studies
dated before January 1, 1977, must nevertheless be reported if they are
known.

4. The rule only requires the reporting of unpublished health and safety
studies (defined in 40 CFR 716.3) that relate to any measurable lead
content in, or that assess children’s exposure (including
bioavailability) to lead from, consumer products intended for use by
children (except for children’s metal jewelry as described by the
Consumer Product Safety Commission in 72 FR 920 (Jan. 9, 2007)).  That
is, the amendment at 716.21(a)(8) is intended to limit reporting to only
two subsets of all possible unpublished health and safety studies. 
Whether or not “product content” data constituted a health and
safety study would depend on the extent to which the information met the
considerations in 716.3.  For example, a simple, isolated list of
ingredients or an isolated analysis of product content would not likely
be considered a health and safety study, whereas an analysis of product
ingredients coupled with an evaluation of hazard or human or
environmental exposure or risks would likely be considered a health and
safety study.  Regulations governing studies to be reported and studies
not subject to reporting are found at 40 CFR 716.10 and 40 CFR 716.20,
respectively.  

Mike Mattheisen

Acting Branch Chief

Chemical Information and Testing Branch

Chemical Control Division

US EPA Office of Pollution Prevention and Toxics

202-564-3077

----- Forwarded by Joseph Nash/DC/USEPA/US on 02/26/2008 01:37 PM -----

"Falk, Robert L." <RFalk@mofo.com> 

02/26/2008 01:17 PM	

	To

	Tsca-hotline@EPA, ccb.citb@epa.gov

	cc

	"Linden, Susan P." <SLinden@mofo.com>

	Subject

	RE: TSCA rulemaking re lead in consumer products intended for children

I represent a number of consumer product manufacturers/importers and am
writing to obtain further guidance on the Agency's view concerning who
this rule applies to beyond the following: 

Manufacturers (including importers) of costume jewelry and novelty
manufacturing (NAICS code 339914). 

Manufacturers (including importers) of dolls and stuffed toys (NAICS
code 339931). 

Manufacturers (including importers) of games, toys, and children’s
vehicles (NAICS code 339932). 

Manufacturers (including importers) of fasteners, buttons, needles, and
pins (NAICS code 339993). 

Wholesalers of toy and hobby goods, establishments with product line
12812 (NAICS code 42392). 

Discount department stores (NAICS code 452112). 

Warehouse clubs and supercenters (NAICS code 45291). 

Please provide me with whatever guidance you have and also any
information on whether the Agency is adopting an enforcement "grace
period" for companies (especially those not specifically delineated
above or in the guidance you provide to me) that are unable to submit
the required information by the end of this month.  

P.S.  I also left Mr. Nash with a voicemail message to this effect; a
response to this email will be sufficient and likely easier for all
concerned.

Robert L. Falk

Morrison & Foerster

425 Market Street

San Francisco, California 94105-2482

