Mike Mattheisen/DC/USEPA/US 

02/27/2008 04:53 PM	

	To

	James.Votaw@wilmerhale.com

	cc

	Joseph Nash/DC/USEPA/US@EPA, John Schaeffer/DC/USEPA/US@EPA

	Subject

	Fw: EPA-HQ-OPPT-2007-0487  Lead Compounds TSCA §8(d) Rule  - 73 FR
5109 (Jan. 29, 2008)

	

	Mr. Votaw, below are answers that EPA recently gave to four questions
that were submitted by another correspondent on the same general subject
as your questions.  These answers address your questions in general and
provide additional clarification and guidance.  To address your third
question specifically, studies that do not show any measurable lead
content do not have to be reported.  

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 The rule only requires the reporting of unpublished health and safety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two subsets of all possible unpublished health and safety studies.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 03:52 PM -----

"Votaw, James" <James.Votaw@wilmerhale.com> 

02/14/2008 03:11 PM	

	To

	Joseph Nash/DC/USEPA/US@EPA

	cc

	

	Subject

	EPA-HQ-OPPT-2007-0487  Lead Compounds TSCA §8(d) Rule  - 73 FR 5109
(Jan. 29, 2008)

Dear Mr. Nash,

As we briefly discussed, I would be grateful if would advise me of the
Agency's view on three questions raised by the recent TSCA §8(d) rule
for lead and lead compounds:  

 

(1) Given the final rule text at 40 CFR 716.21(a)(8)(i), would a firm be
subject to obligations to search for and to submit covered studies (if
any) if that firm:  (a) imports only lead-free products "intended for
use by children," but (b) otherwise also imports other products, not
"intended for use by children," that do contain measurable lead (e.g.,
car batteries or paint with very low levels of lead)?  

 

(2)  Would the unpublished results of a simple product-content test
analyzing for the potential presence of lead in a product "intended for
use by children" (other than children's metal jewelry) constitute a
reportable "health and safety study"?

 

(3)  Given that studies "relat[ing] to the lead content" of a product
can be negative, and the language of  40 CFR 716.21(a)(8)(ii)
(identifying "studies showing any measurable lead content" as
reportable), would a study showing the absence of lead in a product
(negative result) constitute a reportable "health and safety study"?

 

Thank you.						 +1 202 663 6244 (t)

James G. Votaw					+1 202 663 6363 (f)

WilmerHale						+1 202 641 5527 (c)

1875 Pennsylvania Avenue NW			james.votaw@wilmerhale.com

Washington, DC 20006 USA

