Document 7Me9jKjBpVKDoL3ZyVr2E6dOB
DRAFT
February ___, 1987
Mr. Ralph Northrop Test Rules Development Branch Office of Toxic Substances Environmental Protection Agency Room 101, Northeast Mall 401 M Street, S.W. Washington, D.C. 20460
Re:
Proposed Test Rule for 1,1-Dichloroethylene (Vinylidene Chloride) QPTS-42081
Dear Mr. Northrop:
On January 15, 1987, the Chemical Manufacturers
Association ("CMA") Vinylidene Chloride Program Panel ("VDC
Panel") submitted comments on EPA's proposed test rule for
1,1-dichloroethylene (vinylidene chloride). The comments
point out that EPA's proposal raises significant scientific
issues regarding interpretation of the extensive existing data
regarding vinylidene chloride. The comments also present
additional pharmacokinetic and metabolism studies and suggest
SL 063085
Mr. Ralph Northrop February ___, 1987 Page 2
that these sfcudioc should be used by EPA in carcinogenicity risk assessment.
The VDC Panel looks forward to discussing these sig nificant scientific issues with EPA scientists at the Febru ary 12, 1987 public hearing on EPA's proposed test rule. In that connection, I am enclosing a suggested agenda for the public hearing which is intended to foster and accommodate a scientific dialogue on these issues among scientists from EPA and from industry. The VDC Panel believes that the public hearing will be most productive if it can serve as a forum in which to commence such a discussion among the appropriate scientists.
The VDC Panel will identify those scientists who could best contribute to a discussion of the issues raised in our comments. We request that EPA furnish by February 9 a list of scientific personnel from offices within the Agency such as OAQPS and OTS, as well as from other relevant federal agencies such as NTP, who plan to attend and participate in the public hearing. The Panel will then attempt to bring scientists who can most appropriately engage in a scientific discussion with the government experts.
The VDC Panel would welcome any suggestions you might have on how best to achieve the objective of conducting a
SL 063086
Mr. Ralph Northrop February ___, 1987 Page 3
meaningful and productive scientific dialogue on the issues raised in our comments. We look forward to seeing you on February 12, 1987.
Sincerely yours.
Enclosure cc: Carol Glasgow
Robert R. Romano, Ph.D. Manager Vinylidene Chloride Program Panel Chemical Manufacturers Association
SL 063087
DRAFT
PROPOSED AGENDA
FOR FEBRUARY 12, 1987 PUBLIC HEARING
ON PROPOSED TEST RULE
FOR 1,1-DICHLOROETHYLENE (VINYLIDENE CHLORIDE)
_____________
QPTS-42082
:ion -- History ~imiJBTrhi rf EPA Proposal ^> Am h~~ % TSC+ -
ummary of VDC Program Panel Comment
>n and Assessment of Existing Toxicity Database
Adequacy of Existing Oncogenicity Studies
Lacy and Utility of Metabolism and PharmaLetic Data in Assessing Existing Oncogenicity tase
Interpretation of metabolism and pharmacokinetic data
dentification of data gaps regarding pharmacokinetics
ission of Exposure and Emissions Data
ttabolism and Pharmacokinetic Data in iTTlcity Risk Assessment--S?
fc-iJify nf pharmaookinetrc-datg "111' lisk asaessment. fTir YD-"--
wtif ica'ti-orr-of ddibiomiA -^Siarmacokinetic
dat aNifeaidg-aseful information for
risk assessment for v5c fifth )*r^-'Y^OC fit rt Amir
x'~-------------
will
^-fouK
SL 063088