Mike Mattheisen/DC/USEPA/US 

02/27/2008 08:13 AM	

	To

	enottoli@allenmatkins.com

	cc

	Joseph Nash/DC/USEPA/US@EPA

	Subject

	Fw: TSCA Health and Safety Data Reporting

	

	

Ms. Nottoli, below are the answers that EPA recently gave to four
questions that were submitted by another correspondent on the same
subject as your question.  These answers provide additional
clarification and guidance, and address your question.  Feel free to
contact me should you have any other questions.  

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. 

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

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.

The rule only requires the reporting of unpublished health and safety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two subsets of all possible unpublished health and safety studies.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 02/13/2008 04:26 PM -----

"Nottoli, Eileen" <enottoli@allenmatkins.com> 

02/13/2008 04:24 PM	

	To

	Joseph Nash/DC/USEPA/US@EPA

	cc

	

	Subject

	TSCA Health and Safety Data Reporting

	

	

	

	

Mr. Nash: 

I have read the Final Rule on Health & Safety Data Reporting published
in the Federal Register on January 29, 2008.  I would like clarification
on whether  EPA intends to have manufacturers/importers submit all
analytical data showing lead content of materials used to make products
intended for children?  In reading the preamble at 5112, it appears that
EPA seeks all "studies showing any measurable lead content".

Eileen M. Nottoli 

Allen Matkins Leck Gamble Mallory & Natsis LLP /

Three Embarcadero Center, 12th Floor, San Francisco, CA 94111 /

Phone: 415-273-7481 / Fax: 415-837-1516 

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