Mike Mattheisen/DC/USEPA/US 

02/25/2008 08:59 AM	

	To

	Lawrence_Culleen@aporter.com

	cc

	Jim Willis/DC/USEPA/US@EPA, John Schaeffer/DC/USEPA/US@EPA

	Subject

	refreshing / follow-up

	

	

	

	

Larry, below are the answers to your questions.  

  

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 The rule only requires the reporting of unpublished health and safety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two subsets of all possible unpublished health and safety studies.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

__________________

Mike,

Thanks for speaking with me.  I am sending this in the event your

files don't include my e-mail address (lawrence_culleen@aporter.com)

and phone number.  202/942-5477.

My questions had to do with determining whether the rule specifically

will apply to:

1. persons who must submit (i.e. inclusive of importers of finished

"articles" -- as contrasted with "mixtures"),

2. studies concerning imported articles (as contrasted with studies

pertinent to "mixtures"),

3. that the rule looks backwards and requires submittal of data which

could be as many ten years old,

4. data which pertains strictly to "product content" (i.e., an

analysis of the composition of components in a product, such as paint

applied to a finished article) - even if the data do not address

issues such as toxicity of the chemical constituents or the capacity

of the constituents to be released from the finished article.

Lawrence Culleen                    

Arnold & Porter LLP                 

555 Twelfth Street, NW              

Washington, DC  20004-1206

