EPA's Latest Chemical Proposals Get It Half Right, Recent EPA Toxics Advisor Says

WASHINGTON - The
U.S. Environmental Protection Agency (EPA) proposed one good and one
bad "enhancement" to its Chemical Assessment and Management Program
(ChAMP) during a public meeting today, according to Environmental
Defense Fund (EDF).  EDF welcomed EPA's proposal to require
pre-manufacture notification for any chemical removed from the nation's
list of chemicals in commerce if a company decides to reintroduce it
into the market.  But EDF was
strongly critical of a second proposal to extend a poorly performing
voluntary program for obtaining critical chemical safety information to
inorganic chemicals produced in high volumes.

EDF
strongly opposed the latter proposal to initiate yet another "phased,
multi-year" voluntary program for high-production-volume (HPV)
inorganic chemicals.

"We
know from the failure of both EPA's HPV Challenge and the industry's
half-hearted Extended HPV Program to deliver the quality data sets
needed to make sound decisions that a voluntary approach doesn't work,"
said Dr. Richard A. Denison, a senior scientist at EDF, who until recently

was a member of the National Pollution Prevention and Toxics Advisory Committee (NPPTAC) that advises EPA's toxics office.  "To extend such a flawed model to inorganic chemicals is simply throwing good money after bad."
 

Despite
a decade of effort under the HPV Challenge, final data sets have yet to
be submitted for nearly half of the chemicals sponsored, and remaining
gaps have been identified in at least a third of those data sets that
have been submitted.  Several hundred HPV chemicals were not sponsored
at all under the program.  And since the launch of the Challenge, many
hundreds of additional chemicals have reached HPV production levels,
yet most of those have not been sponsored under the Extended HPV
program, and data sets have been submitted for fewer than two dozen.

[1]

 
Instead
of pursuing yet another voluntary program, EDF urged EPA to immediately
proceed to issue mandatory test rules using its TSCA Section 4
authority for as many inorganic HPV chemicals as possible.  Only for
those chemicals for which it cannot make the requisite findings to
support a test rule should EPA consider other approaches, including
vigorously supporting an expansion of its data generation authorities
through legislative reform of TSCA.
 

In
contrast, EPA has offered a sound proposal setting forth the rules
under which it plans to remove from the Toxic Substances Control Act
(TSCA) Inventory chemicals that companies indicate they are no longer
producing or importing.

"EPA should be commended for thinking through the implications of 'resetting' the Inventory,"

Denison stated. 
"While a few aspects need strengthening, we strongly support the core
element of EPA's proposal: requiring pre-manufacture notification for
any chemical removed from the Inventory if a company decides to
reintroduce it into the market."  [Below this release are additional
comments describing needed clarifications and improvements to EPA's
proposal.]
 

Denison

noted that EPA's rationale for taking this approach closely mirrors an argument EDF made in comments it filed in May 2008, when EPA first proposed an Inventory reset:  it
would allow EPA to assess and, where needed, control potential risks
prior to allowing a chemical back into commerce.  EDF also noted that
applying pre-manufacture notification (PMN) requirements to chemicals
removed from the Inventory would help to minimize incentives for companies
to seek removal of as many chemicals as possible to avoid reporting or
other requirements that apply to Inventory chemicals.
 

Additional comments and needed enhancements to EPA's proposal to reset the TSCA Inventory

•       Any Inventory
resetting must be done using a reporting mechanism that tracks
production/import over a significant period.  EPA's experience with
reporting of production and import data under its Inventory Update Rule
(IUR) - which entails the reporting of only one year's volume once
every five years (recently raised from every four years) - shows that
there is enormous fluctuation from one reporting cycle to the next that
must reflect underlying changes in chemical supply and demand dynamics
and production and use patterns.

[2]. 

These data demonstrate that infrequent and time-limited reporting
yields a highly inaccurate picture of which chemicals are in commerce,
as well as their actual manufacturing levels over time. 

•      
Given experience with IUR reporting, EDF is concerned that use of only
a 3-year window as suggested by EPA could significantly underestimate
the number of chemicals in commerce.
•      
EPA needs to carefully consider the length of the reporting period it
uses to reset the Inventory, and should require reporting of any
production or import that has taken place at any time during the
reporting window. 
•      
While we are concerned that some companies might be able to "game the
system" if a too-short reporting window is employed, this concern will
be alleviated considerably as long as EPA requires (as it has proposed)
that any chemicals removed from the Inventory be subject to PMN
notification prior to their reintroduction.

•      
We support EPA's proposal to conduct a reset on a periodic basis, a
measure that would also help to alleviate our concerns that a reset
with too short a window could miss many chemicals in commerce.

•      
No lower threshold should apply to the reporting used to reset the
Inventory.  Production or import of a chemical in any amount at any
time during the reporting window should trigger its retention on the
Inventory if its original purpose is to be retained.

•      
Exemptions available from reporting conducted under TSCA Section 8(a)
should not apply.  Numerous classes of chemicals have been granted full
or partial exemptions from IUR reporting by EPA, some of which are
based on presumptions of low environmental or health concern.  Because
the purpose of the Inventory is to list chemicals in commerce
independent of any sort of risk consideration, such exemptions are
wholly inappropriate. 
Specifically, EPA should not provide Inventory
reset exemptions for:

•       Polymers (exempted from IUR reporting under CFR 710.46(a)(1))

•       Microorganisms (CFR 710.46(a)(2))

•       Naturally occurring substances (CFR 710.46(a)(3))

•       Certain forms of natural gas (CFR 710.46(a)(4))

•       Petroleum process streams (CFR 710.46(b)(1))

•       Specific exempted chemical substances (CFR 710.46(b)(2))
Also
inconsistent with the Inventory's purpose would be providing exemptions
for small manufacturers; for this reason, EDF supports EPA's proposal
to conduct the Inventory reset using its Section 8(b) rather than
Section 8(a) authority.

•      
A publicly available list of all chemicals removed from the Inventory
must be maintained.   Many such chemicals, even if not in active
production, may nevertheless still be stockpiled, present in products
as ingredients, byproducts or residuals, or present as pollutants in
air, water, soil, sediment or waste sites.  And of course, they may
return to active production in the future.  Maintenance of a public
list of all chemicals removed from the Inventory would serve as a
compliance tool (see more on compliance below).  It is critical,
therefore, that EPA retain -- and the public still have access to -- an
inventory of, and any and all information available on, any chemicals
removed from the Inventory.

•      
Any chemicals removed from the Inventory must be subject to TSCA
Section 5 notification requirements.  As discussed at length in our May
2008 comments and noted above, we strongly support EPA's proposal in
this regard.  We support EPA's "clean" reset option, under which EPA
would set forth this requirement as unambiguous policy via a Federal
Register notice:  As has been the case historically, any chemical not
on the Inventory is subject to Section 5 requirements. 
We
do not support the alternative EPA discusses of seeking to issue a
Significant New Use Rule (SNUR) to cover such chemicals.  This approach
would be more cumbersome and not offer any advantages over the more
direct proposed approach.

•      
Processors should be included in the Inventory reset.  The language of
Section 8(b) is unambiguous:  EPA is required to "compile, keep
current, and publish a list of each chemical substance which is
manufactured or processed in the United States."  We see no basis or rationale for excluding processors from certification under an Inventory reset.
EPA
should not allow companies to certify "future" manufacture or
production as a means to retain a chemical on the Inventory.  Such an
approach would necessarily be based on speculative or uncertain
information that could easily change, leaving chemicals listed on the
Inventory that are not actually in commerce, thereby frustrating the
entire purpose of the reset.  This approach could also create a
perverse incentive for companies to seek to retain listings for
chemicals not currently in production so as to avoid Section 5
notification and review requirements, thereby frustrating what we see
as a key advantage to the core element of EPA's proposed approach.

•      
EPA needs to require, not merely invite, certification and take
additional steps to ensure compliance.  We are troubled by EPA's
statement that it would merely "invite" companies to certify their
production or import (73 FR 70642; paragraph 3 of the Inventory reset
background document).  Elsewhere EPA more appropriately refers to
"requiring certification" (paragraph 9(a) of the Inventory reset
background document).  If the Inventory reset exercise is to be - and
be perceived as - credible, it must include all reasonable steps to
ensure compliance by all companies that produce, import or process
chemicals:

•      
EPA must require companies to certify as to which chemicals they
produce, import or process.  Such a certification should be signed by a
senior officer and be legally binding.

•      
EPA should also require that a company certification indicate that the
chemicals it identifies are the only chemicals listed on the Inventory
that it produces, imports or processes.

•      
EPA should commit to undertake additional steps to assess the extent of
compliance achieved under the reset, and to promptly initiate actions,
including robust enforcement, to address any non-compliance.  EPA
should cross-check its reset Inventory chemical lists with other
sources of reported information (e.g., IUR and other Section 8
reporting; PMN submissions, etc.) as one means to identify
discrepancies.  It should use its enforcement authorities (access to
company records, audits, inspections, etc.) on at least a spot basis to
ensure full compliance.

•      
EPA should provide public access to up-to-date versions of both the
reset Inventory and the list of removed chemicals.  As proposed by EPA,
these lists should also include entries for any chemicals with
identities claimed as confidential business information, providing as
much identifying information as possible consistent with allowed
protections for legitimate CBI.

[1] 
See EDF's recent report on the HPV Challenge and Extended HPV Program, High Hopes, Low Marks, available at www.edf.org/hpvreportcard.

[2]
USEPA, National Pollution Prevention and Toxics Advisory Committee
(NPPTAC), Broader Issues Work Group, "Initial Thought-Starter: How can
EPA more efficiently identify potential risks and facilitate risk
reduction decisions for non-HPV existing chemicals?" Draft dated
October 6, 2005, pp. 3-4, at www.epa.gov/oppt/npptac/pubs/finaldraftnonhpvpaper051006.pdf;
and Environmental Defense comments on Proposed Rule, TSCA Inventory
Update Reporting Revisions (70 Fed. Reg. 3658, 26 January 2005), Docket
ID No. EPA-HQ-OPPT-2004-0106, accessible at www.regulations.gov (search for docket number).