Mike Mattheisen/DC/USEPA/US 

02/27/2008 08:24 AM	

	To

	jmargulies@fulbright.com

	cc

	Joseph Nash/DC/USEPA/US@EPA

	Subject

	Fw: TSCA 8(d) Proposed Final Rule for Lead in Children's Products, EPA
Docket EPA-HQ-OPPT-2007-0487

Mr. Margulies, below are answers that EPA recently gave to four
questions that were submitted by another correspondent on the same
subject as your question.  These answers address your question and
provide 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 The rule only requires the reporting of unpublished health and safety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two subsets of all possible unpublished health and safety studies.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 02/14/2008 02:21 PM -----

"Margulies, Jeffrey" <jmargulies@fulbright.com> 

02/14/2008 01:48 PM	

	To

	Joseph Nash/DC/USEPA/US@EPA

	cc

	

	Subject

	TSCA 8(d) Proposed Final Rule for Lead in Children's Products, EPA
Docket EPA-HQ-OPPT-2007-0487

Joe,

 

As discussed, I work with a number of companies that are potentially
affected by the new proposed rule requiring submission of unpublished
health and safety studies regarding lead in children's products.   TSCA
section 8(d) requires submission of "health and safety studies," which
are defined as follows:

Health and safety study or study means any study of any effect of a
chemical substance or mixture on health or the environment or on both,
including underlying data and epidemiological studies, studies of
occupational exposure to a chemical substance or mixture, toxicological,
clinical, and ecological or other studies of a chemical substance or
mixture, and any test performed under TSCA.

40 C.F.R. section 716.3.

 

It would appear from this definition that companies are not required to
report simple analytical data regarding the lead content of children's
products, especially where the lead content is below allowable levels
(i.e., below 600 ppm for lead paint in consumer products under 16 C.F.R.
section 1303).  However, the amended regulation is unclear, in that it
references studies that "relate to the lead content of consumer
products," and several articles in the press have created the impression
that EPA is seeking to require manufacturers and importers to submit
such analytical data, even if they are not "health and safety studies"
under TSCA.

 

Adding to the confusion is the fact that EPA's estimate in the Federal
Register of the number of reports it expects to receive under this new
rule is considerably underestimated, perhaps by several orders of
magnitude, if companies are truly required to submit every lead content
analytical test that they receive in order to comply with various
federal, state, and international requirements.

 

We would appreciate clarification regarding this issue, and I would
appreciate any response EPA is able to provide.  If there is any
information that you believe would be helpful for EPA's analysis of this
issue, please let me know.

 

Thanks.

 

Jeff

 

Jeffrey B. Margulies 

FULBRIGHT & Jaworski L.L.P. 

555 South Flower St., 41st Floor 

Los Angeles, CA 90071

tel 213.892.9286 | fax 213.892.9494 

email jmargulies@fulbright.com | web www.fulbright.com/jmargulies

	

	

	

	

