[Federal Register Volume 61, Number 246 (Friday, December 20, 1996)]
[Notices]
[Pages 67332-67333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32362]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-42190; FRL-5578-9]
Dibasic Esters--Paint Stripper Chemicals; Notice of Public
Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of public meeting.
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SUMMARY: EPA will hold a public meeting on January 29, 1997, in
Washington, DC, to begin negotiation of an enforceable consent
agreement addressing toxicity testing of, and an evaluation of human
exposure potential to, dibasic esters (DBEs). DBEs include dimethyl
adipate, dimethyl glutarate and dimethyl succinate. These chemical
substances are components of paint stripper products that are sold to
consumers and are also components of some industrial hand cleaners. EPA
requests that persons who intend to attend the meeting please notify
EPA of their intent in writing on or before January 17, 1997.
DATES: The public meeting will be held on January 29, 1997, beginning
at 9:30 a.m. in Washington, DC, at a site to be determined.
ADDRESSES: Persons with an interest in attending the meeting should
notify EPA in writing by January 17, 1997. Written notification of
interest in attending the meeting should be submitted to TSCA Docket
Receipts (7407), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, Rm. G-99, East Tower, 401 M St., SW,
Washington, DC 20460. Notifications should bear the document control
number (OPPTS-42190; FRL-5578-9) and include a telephone number where
the interested person may be contacted or messaged on or before January
23, 1997. Persons wishing to know the location of the meeting may call
the Project Manager identified under ``FOR FURTHER INFORMATION
CONTACT'' on or after January 23, 1997. The public docket supporting
this DBE testing action is available for public inspection in the
Nonconfidential Information Center, Rm. NE-B607, at the above address
from 12 noon to 4 p.m., Monday through Friday, except legal holidays.
FOR FURTHER INFORMATION CONTACT: Susan Hazen, Director, Environmental
Assistance Division (7408), Rm. E543B, 401 M St., SW, Washington, DC
20460; telephone: (202) 554-1404; TDD (202) 554-0551; e-mail: TSCA-
Hotline@epamail.epa.gov. For specific information regarding this action
or related activities, contact George Semeniuk, Project Manager,
Chemical Testing and Information Branch (7405), Rm. E221B, 401 M St.,
SW, Washington, DC 20460; telephone: (202) 260-2134; e-mail:
semeniuk.george@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: Dibasic esters (DBEs) include dimethyl
adipate (DMA, CAS No. 627-93-0), dimethyl glutarate (DMG, CAS No. 1119-
40-0) and dimethyl succinate (DMS, CAS No. 106-65-0). Certain paint
stripping formulations that are sold to consumers contain one or more
of these chemical substances as part of a mixture. Consumers may be
significantly exposed to DBEs during use of these formulations through
inhalation and dermal absorption. DBEs are also components of certain
industrial hand cleaners that may result in additional human exposure
to DBEs.
In a notice published in the Federal Register of March 22, 1995 (60
FR 15143) (FRL-4943-6), EPA set forth its concerns for DBE toxicity and
exposure and solicited proposals from any party who was interested in
conducting DBE toxicity testing under the terms of a Toxic Substances
Control Act (TSCA) section 4 enforceable consent agreement (ECA). The
notice indicated that EPA, in consultation with the Consumer Product
Safety Commission (CPSC), believed that a 2-tier testing regime, as was
described in the notice, was both appropriate and needed in order to
provide a more complete toxicity profile of DBEs. Such a profile would
be used in comparing the hazards of paint strippers based on DBEs to
those of consumer paint strippers that are based on methylene chloride,
N-methylpyrrolidone, or other common paint stripping solvents.
In a letter dated August 7, 1995, the Dibasic Esters Group (DBE
Group), representing Aceto Corporation, Chemie Linz North America,
Inc., Chemoxy International PLC, DuPont Nylon, Monsanto Company and
Morflex Inc., proposed to EPA that an ECA should be based on a more
limited set of studies, than that requested by EPA. Specifically, the
group proposed conducting an enhanced, 13-week subchronic inhalation
study of the individual DBEs and a two-week dermal study of the
individual DBEs and a DBE mixture. The DBE Group also informed EPA of
the use of DBEs in industrial hand cleaners.
While noting that the proposal had potential merit and would expand
the knowledge base of toxicity testing results on DBEs, EPA informed
the DBE Group, in a letter dated March 6, 1996, that the proposal did
not constitute an adequate basis for proceeding with negotiations to
secure an ECA. EPA explained that the studies proposed by the DBE Group
would not provide, by themselves, a sufficient characterization of
numerous toxicological endpoints needed to acquire an adequate
understanding of the hazards and risks of these chemicals. Furthermore,
the proposed testing, as the initial tier of a 2-tier testing approach,
would not provide the information needed to determine which DBE
homologue and which exposure route would be used in follow-on testing
that would be focused on developmental toxicity, reproductive toxicity
and oncogenicity. EPA, however, encouraged the DBE Group to consider
EPA's comments and to submit a revised proposal.
In a letter dated May 24, 1996, the DBE Group informed EPA that it
would be submitting a revised proposal that would include toxicity
testing and exposure evaluation, all of which should be considered
Phase 1 activities. Follow-on testing activities under Phase 2, such as
studies focused on reproductive toxicity, oncogenicity,
pharmacokinetics, toxicological mechanisms and exposure, would be
discussed if warranted by the outcome of the Phase 1 testing.
On October 22, 1996, the DBE group submitted a revised testing
proposal to EPA, which EPA has accepted as a basis for proceeding to
negotiation of an ECA. The DBE Group proposes conducting a
toxicological research program that includes the following elements:
(1) Genetic toxicity testing of the three DBEs individually.
(2) Subchronic 90-day rat inhalation studies of each DBE that would
include specialized endpoint exposure groups to assess neurotoxicity,
spermatogenesis and cellular proliferation.
(3) A rabbit developmental toxicity study using a single DBE.
(4) Two-week dermal toxicity studies of a DBE mixture and the three
DBEs individually.
[[Page 67333]]
In addition, the DBE group has proposed developing a profile of DBE
paint stripper exposure under actual use conditions, utilizing:
(1) Survey techniques to collect information on volume of use,
exposure levels, frequency and duration of use.
(2) Field studies that will quantify exposures.
These matters and other elements of an ECA will be the subject of the
negotiation that will commence at the January 29, 1997, public meeting.
Dated: December 11, 1996.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 96-32362 Filed 12-19-96; 8:45 am]
BILLING CODE 6560-50-F
