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PUT IT IN WRITING Date 19 JULY 1974_____________
r.To_ From
(
[(
J. D. KRAMER
G. B. H. SPEED ) Take Action ) For Your Comments
Subject
( ) For Your Approval ( ) As Requested
VC1 REDUCTION - PROFIT IMPROVEMENT
PROJECTS
( } For Your Info ( ) File
( ) Discuss With Me ( ) Note & Return
r This book contains the profit improvement projects currently being considered with a goal of attaining a 10 ppm maximum exposure to VC1 on a TWA. Additional projects will be added as new ideas develop. The program is divided into six major areas as follows:
I - Improve Area Monitoring for VC1 Leaks
II - Projects to Remove Operator from Exposure
III - Process Modifications for the Containment or Removal of VC1
IV - Reduction of PVC Particulates
V - Reduce Lost Batches
VI - Operator Training
Included in the book is a summary of the projects, a time table for
project completion, details of the individual projects and a sample of the weekly report forms.
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SUMMARY
VC1 IMPROVEMENT PROJECT
4
IMPROVED AREA MONITORING FOR VC1 VAPORS
PROJECT NUMBER
I-A
PROJECT
Initiate Formal Leak Patrol 1. Set up procedure S record
keeping 2. Select maintenance man for job 3. Instruct man in job 4. Start patrol
PERSON RESPONSIBLE
Draffen/Speed
COST
CE NO.
$80,000/yr.
I-B
Review Sample Point Locations
Speed
1. Review
2. Relocate
$ 2,000
Maintenance
I-C Add Alarm Lights Horn
Dunning/Speed
$100,000
1. Design system, prepare cost
estimate CE
2. Order equipment
3. Install equipment.
I-D
Add Second Bendix Chromatograph
L.Thompson/Speed $41,000
CC #288
1. Prepare CE
2. Order equipment
3. Install
I-E Review need for alarm lights
horn on Becknan Analyzer
Speed
$25,000
I-F
Collect Chromatograph Data on
L.Thompson/Speed $100,000
Computer
1. Design system, prepare cost
estimate CE
2. Order equipment
3. Install system
I
AP00001281
SIMMY VC1 IMPROVEMENT PROJECT PROJECTS TO REM3VE OPERATOR FROM EXPOSURE
PROJECT NUMBER II-A
II-B II-C
PROJECT
Time and Motion Studies 1. Top Floor Operator
a. Charging Nos. 16,17 18 reactors
' b. Charging Nos. 1,2 3 reactors
c. Charging No. 19 reactor d. Making up solution 2. Stripper Operator a. Horaopolymer batch b. Copolymer batch c. 400 batch d. 19th reactor 3. Bottom Floor Operator 4. Finishing Operator
Communications 1. Determine system,prepare
cost estimate CE 2. Equipment delivery 3. Install equipment
Automation of Process 1. Prepare P I flow sheets
a. Monomer charging b. DM water charge c. Solution charge d. VAc charge e. Propylene charge f. Drop header g. North recovery h. Center recovery i. South recovery j. Air k. Refrigerated water 2. Automation, or remote control of process a. From C-l above, determine
amount of automation or remote control required b. Design system, prepare cost estimate
PERSON RESPONSIBLE F. L. Riddle
J.D.Pearson/ G.B.H. Speed W.E .Dunning/ G.B.H.Speed
COST
$75,000
$2,000,000
CE NO.
AP00001282
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Lr PROJECT NUMBER
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SUMMARY VC1 IMPROVEMENT PROJECT PROJECTS TO REMOVE OPERATOR FROM EXPOSURE
PROJECT
PERSON RESPONSIBLE
Automation of Process (continued)
3. Television monitoring of equip ment a. From C-l above and survey of equipment determine number and location of television cameras b. Design system prepare cost estimate
4. Enclosed control roan a. Determine location b. Determine cost of relocating equipment if required c. Design control rocm including control panel, etc. and prepare cost estimate
5. Prepare total cost package for items C-2, 3 and 4 prepare CE
6. Equipment delivery 7. Install
Breathing Air System 1. Revise existing temporary system
for adequacy and modify if necessary 2. Install fresh air breathing station at T/C unloading
3. Install permanent breathing air system a. Prepare cost estimate $ CE b. Equipment delivery c. 1) Installation of filter
$ connections 2) Installation of compressor
dryer
D.L.Walker/ G.B.H.Speed
COST $200,000
CE NO.
\
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APOOOOf283
SUMMARY VC1 IMPROVEMENT PROJECT PROCESS MODIFICATIONS FOR THE CCNTAINMENT OR REMOVAL OF VC1
PROJECT NUMBER III-A III-B
III-C III-D
III-E
III-F III-G
III-H
PROJECT
PERSON RESPONSIBLE
Third Steam Jet 1. Design system 2. Determine cost 5 prepare CE 3. Install
D.L .Walker
Charge Pot Drain System
1. Design system 2. Determine cost 3 prepare CE 3. Install
F.N.Sublette
Sweco Screen Exhaust Fan 1. Design system 2. Determine cost 3 prepare CE 3. Install
Reactor 3 Third Floor Exhaust System 1. Design system 2. Determine cost 3 prepare CE 3. Install
F.N.Sublette D.L.Walker
First 3 Second Floor Exhaust System 1. Design system 2. Determine cost 3 prepare CE 3. Install
D.L.Walker
New Stripper Transfer Pumps
1. Design system 2. Determine cost 3 prepare CE 3. Install
F.N.Sublette
Improve Ventilation Pattern 1. Redesign blower discharge
nozzles 2. Conduct air flow studies
with smoke
R.W .McGinnis
Monomer Recovery Drain System 1. Revise existing drain system
3 equipment 2. Modify or add drain as required 3. Equipment delivery as required 4. Install additional instruments
as required
F.N.Sublette/ G.B.H.Speed
COST $ 10,000
CE NO. Maintenance
$ 10,000
Maintenance
$ 10,000
Maintenance
$140,000
VFCE #508
Included in III-D
VFCE #508
$50,000
Maintenance
$25,000
$25,000
Maintenance
AP00001284
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SUNMARY
VCl IMPROVEMENT PROJECT
PROCESS MODIFICATIONS FOR THE CONTAINMENT OR REMOVAL OF VCl
PROJECT
PERSON RESPONSIBLE
Charge Pot Rupture Disc Vent Lines 1. Design system 2. Equipment delivery 3. Install
F.N.Sublette/ G.B.H.Speed
COST $ 10,000
New (Fetterolf) Spray Rinse Valve 1. Evaluate new type valves
currently being tested 2. Prepare cost estimate 5 CE
to replace existing Phaudler spray rinse valves 3. Equipment delivery 4. Install
F.N.Sublette/ G.B.H.Speed
$ 50,000
New VCl Recovery System 1. Design 2. Equipment delivery 3. Installation
Increase Total Ventilation Through Reactor Building 1. Design system 2. Prepare cost estimate CE 3. Equipment delivery 4. Install
D.L.Walker/ G.B.H.Speed
W.E.Dunning/ G.B.H.Speed
$653,000 $120,000
Low Temperature VCl Recovery System 1. Design system 2. Prepare cost estimate CE 3. Equipment delivery 4. Install
High Pressure Water Cleaning System for Reactors 1. Determine system to use 2. Prepare cost estimate CE 3. Install
W.E.Dunning/
J.T.Barr/ W.E.Dunning/ G.B.H.Speed
$500,000 $ 10,000
CE NO. Maintenance Maintenance
VFCE #450
AP00001285
PROJECT NUMBER III-O
III-P
SUMMARY
VC1 IMPROVEMENT PROJECT
PROCESS MODIFICATIONS FOR TOE CONTAINMENT OR REMOVAL OF VC1
PROJECT
PERSON RESPONSIBLE
COST
Chemical Cleaning of Reactors 1. Determine system to be used 2. Design system 3. Prepare cost estimate 5 CE 4. Equipment delivery 5. Install
Pensacola/ W.E.Dunning/ G.B.H.Speed
$750,000
Redesign all monomer handling piping
1. From the P I flow sheets prepared under Project II-C-1, review all monomer
piping to determine if modification can be made to
reduce number of flanges 6 polymer buildup 2. Redesign if required
3. Prepare cost estimate CE 4. Equipment delivery 5. Install
F.N.Sublette/ G.B.H.Speed
$ 50,000
CE NO.
APOObOl286
SIM4ABY VC1 IMPROVEMENT PROJECT REDUCTION OF PVC PARTICULATES
PROJECT NUMBER IV-A
IV-B
PROJECT
Replace Product Collectors with Cyclones 1. Design system 2. Prepare cost estimate CE 3. Equipment delivery 4. Install
Complete upgrading of Bulk Handling, Loading Bagging 1. Review of existing system 2. Design revised system 3. Determine cost prepare CE 4. Equipment delivery 5. Install
PERSON RESPONSIBLE D.L.Walker/
W.E.Dunning/ G.B.H.Speed
COST $150,000
CE NO. Maintenance
$750,000 EST
APOOOOI287
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V-C
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SUMMARY VC1 IMPROVEMENT PROJECT
REDUCE LOST BATCHES
PROJECT
Chemical Charge System 1. Review charging procedures
to eliminate errors 2. Review charging system
Reevaluate all recipes catalyst levels
New IK water system 1. Design system 2. Prepare cost estimate CE 3. Equipment delivery 4. Install
Add additional refrigeration $ cooling tower water supply 1. Design system 2. Prepare cost estimate CE 3. Equipment delivery 4. Install
PERSON RESPONSIBLE F.L.Riddle
F.L.Riddle D .L .Walker
W.E.Dunning/ 6.B.H.Speed
i
COST
CE NO.
$227,000
VFCE #430
$750,000 EST
APOOOOt 288
SUM1ARY VC1 IMPROVBENT. PROJECT
OPERATOR TRAINING
PROJECT NUMBER
VI-A
PROJECT Update operating manuals
PERSON RESPONSIBLE
J.P.Parker
VI-B
Group individual training sessions
J.P.Parker
COST
CE NO.
AP00001289
06Z10000dV
VINYL CHLORIDE REDUCTION PROFIT IMPROVEMENT PROJECTS
NO. I IMPROVE AREA MONITORING FOR VC1 LEAKS
A. INITIATE FORMAL LEAK PATROL 1. Set up procedures and record keeping 2. Select maintenance man for job 3. Instruct man in need for job and sample procedures 4. Start patrols
B. REVIEW SAMPLE POINT LOCATIONS 1. Relocate to reflect two systems a. Personnel operating area b. Process control area
C. ADD ALARM LIGHT AND HORN (INCLUDES NO. 2 BENDIX) 1. Design system, prepare cost estimate and CE 2. Order equipment 3. Install system
D. ADD SECOND BENDIX CHROMATOGRAPH 1. Prepare CE 2. Order equipment 3. Install
E. REVIEW NEED FOR ALARM LICHTS AND HORN CN BECKMAN ANALYZER USED IN FINISHING, BAGGING AND COMPOUNDING
F. COLLECT CHROMATOGRAPH DATA CN COMPUTER (INCLUDE BOIH BENDIX 5 BECKMAN) 1. Design system, prepare cost estimate and CE 2. Order equipment
. 3. Install system
AP00001291
prLOriT IMPROVEMENT PROJECT
Department
Project No.
Date________
PVC I-A 8 July 1974
Capital Investment $ 80,000/yr.
Annual Benefits Person Responsible W.D.DRAFFEN
"TJTHTFTTSPEED
DESCRIPTION: (Include plan of action and timetable) __ INITIATE FORMAL LEAK PATROL
The purpose of this project is to detect and stop VC1 leaks as soon as possible. It is proposed to add one additional maintenance man per shift (total 4) with the primary responsibility of patroling the polymerization building with a Century Analyzer. Upon detecting a leak, he will, if possible, make the necessary repairs on the spot, or connect an exhaust hose to the leak, and report the leak to insure repairs are made. A separate log will be maintained by the patrol personnel. He will work closely with process personnel for ' effective reduction in monomer leaks.
This project is divided into'the following steps:
1. Set up procedures and record keeping 2. Select maintenance man for job 3. Instruct nan in need for job and sample procedures 4. Start patrol. .
TIMING: SEE MASTER TIME TABLE
AP00001292
Department
Project No. <
Date________
t Iv'.Ol-TT IMPROVEMENT PROJECT
PVC I-B 8 July 1973
Capital Investment 2,000
Annual Benefits _____ N/A Person Responsible G.B.H .SPEED
DESCRIPTION: (include plan of action and timetable)
REVIEW SAMPLE POINT 'LOCATIONS
The plant currently has one 10 point Bendix Chromatograph monitoring.the
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polymerization building. An additional 10 point Bendix will be added under
project I-D. It is felt that some of the existing $anple locations do not
reflect the actual operating areas. This project will review the existing locations and considering the additional 10 points to be added, will propose a
new layout with the purpose of not only covering the operating areas but areas not normally used but where VC1 can escape.
The two areas will be divided into:
____a_)__P__e_r_s_o__n_n_e__l _o__p_e__r_a_tin% g areab) Process control area
TIMING: SEE MASTER TIME TABLE
i
AP00001293
P.7.0JIT improvement project
Department Project No,
PVC
, Capital Investment $
Annual Benefits
^/A
Date "
8 July 1974 !
Person Responsible L.R.THCMPSON G.B .H. SPEED
DESCRIPTION: (include plan of action and timetable) ADD ALARM LIOTTS AND HORN TO BENDIX CHRCMATOGRARt
,The purpose of this porject is to provide means by which the operating personnel will know when the VC1 exposure in a particular area is above' the proposed limit. It is proposed to install a flashing red light at each sample point location and a horn on each floor. If the VC1 concentration exceeds the limit the light will start flashing at the point of high concentration and the horn will sound indicating that a sample point on that level is beyond the limits. Thus the operators will know that a fresh air mask is required in the area and that maintenance is required to stop the leak:.
This project is divided into the following steps:
1. Design system, prepare cost estimate and CE
2. Order equipment 5. Install system
TIMING: SEE MASTER TIME TABLE
AP00001294
rr.OFIT IMPROVEMENT PROJECT
Department
P'VE
Capital Investment $ 50.000
Project No.
_________
Annual Benefits
Date_____________ 8 July 1974
Person Responsible L.R.THOMPSON G.B.H.SPEED
DESCRIPTION: (include plan of action and timetable)
ADD SECOND BENDIX CHROMATOGRAHi
rJhe purpose of this project is to provide additional VC1 monitoring in the polymerization building. After installing the original 10 point Bendix it was found that the 10 points do not provide adequate coverage of the area.
Also during calibration-or other outages of the existing chromatograph, there is no record of the building.exposure. With the second chromatograph. additional coverage of the building will be obtained and the second 10
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points will be dispersed with the first 10 points to provide some record during outage of either unit.
I
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This project is divided into the following steps:
1. Prepare CE
2. Order equipment 3. Install
TIMING: 'SEE MASTER TIME TABLE
APOOOOf295
P ROFIT IMPROVEMENT PROJECT
DepartmentFVC Project No,
I *cE
Date
^ July 1974
. Capital Investment $ 2S,000 EST
Annual Benefits
N/A
Person Responsible G,B,H,SPEED
DESCRIPTION: (include plan of action and timetable) REVIEW NEED FOR ALARM LIGHTS AND HORN CN BECKMAN CHRCMATOGRAfH
,,A 10 point Beclanan Chromatograph is currently in use analyzing the operation area of the PVC finishing building, bagging area, warehouse and compounding plant. Based on preliminary data the VC1 concentrations in these areas have been below 10 ppm. Additional data will be analyzed as obtained to determine if excursions above 10 ppm do exist. Depending on the number of excursions and locations the need for alarm lights and horns will be made.
TIMING: SEE MASTER TIME TABLE
AP00001296
PROFIT IMPROVEMENT PROJECT
Department Project No.
PVC I-F
Capital Investment $10Q>000 OST
Annual Benefits
^/A
Date________
8 July 1974
Person Responsible L.R.THOMPSON G.B.H.SPEED
DESCRIPTION: (Include plan of action and timetable) COLLECT CHROMATOGRAPH DATA CN COMPUTER
^Currently the chromatograph charts from both the Bendix and Beckman Analyzers are being manually read and the data recorded. The same will be done when the second Bendix is added. . The manual reading is 'time consuming and expensive. It is proposed to install a computer that vd.ll automatically collect the individual reading from each point and every 24 hours produce a record of the reading along with an average for each point and for the total area. These records.are required by law.
This project is divided into the following steps:
1. Design system, prepare cost estimate and CE 2. Order equipment 3. Install'system
TIMING: SEE MASTER TIME TABLE
APOOOOf297
86ZL0000dV
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VINYL CHLORIDE REDUCTION
PROFIT IMPROVEMENT PROJECTS
NO. II
PROJECTS TO REMOVE OPERATOR FRCM EXPOSURE
A. TIME AND MOTION STUDIES
1. Top Floor Operator a. Charging Nos. 16, 17 or 18 reactors b. Charging Nos. 1, 2 or 3 reactors c. Charging No. 19 reactor d. Making up solution
2. Stripper Operator a. Homopolymer batch b. Copolymer batch c. 400 batch d. 19th reactor
3. Bottom Floor Operator 4. Finishing Operator
B. COMMUNICATIONS
1. Determine system, prepare cost estimate and CE 2. Equipment delivery 3. Install equipment
C. AUTOMATION OF PROCESS
1. Prepare P I flow sheets a. Monomer charging b. IM water charge c. Solution charge d. VAc charge e. Propylene charge f. Drop header g. North recovery h. Center recovery i. South recovery j. Air k. Refrigerated water
2. Automation, or remote control of process a. From C-l above, determine amount of automation or remote control required b. Design system, prepare cost estimate
3. Television monitoring of equipment a. From C-l above and survey of equipment determine number and location of television cameras b. Design system and prepare cost estimate
APOOOOf299
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PROFIT IMPROVEMENT PROJECT
Department
' PVC
Capital Investment $ 200000 ^
Project No. Date_______
II-D 8 July 1974
Annual Benefits ______________
Person Responsible D.L.WALKER G.B.H.SPEED
DESCRIPTION: (include plan of action and timetable) BREATHING AIR SYSTEM
As proposed in the tentative regulations, a fresh air breathing system must be provided for operators in case the VC1 level exceeds the limit. The project
proposes a conplete and separate fresh air system with filter beds for the removal of 00. A temporary system is currently in use utilizing the
instrument air system.
This project is divided into the following steps':
1. Revise existing temporary system ior adequacy and. modiiy if necessary 2. Install fresh air breathing station at T/C Unloading__________ ._________ 3. Install permanent breathing air system
a. Prepare cost estimate and CE___________________________________________
b.. Equipment delivery c. 1) Installation of filter and .connections
2) Installation ot compressor and ctryer
TIMING: SEE MASTER TIME TABLE
AP00001301
VINYL CHLORIDE REDUCTION PROFIT IMPROVEMENT PROJECTS
NO. II PROJECTS TO REMOVE OPERATOR FROM EXPOSURE C. AUTOMATION OF PROCESS (continued) 4. Enclosed control room a. Determine location b. Determine cost of relocating equipment if required c. Design control room including control panel, etc. and prepare cost estimate 5. Prepare total cost package for items C-Z, 3 and 4 and prepare CE 6. Equipment delivery 7. Install D. BREATHING AIR SYSTEM 1. Revise existing temporary system for adequacy and modify if necessary 2. Install fresh air breathing station at T/C Unloading 3. Install permanent breathing air system a. Prepare cost estimate and CE b. Equipment delivery c. 1) Installation of filter and connections 2) Installation of conpressor and dryer
APOOOOf302
Department Project No. Date________
PROFIT IMPROVEMENT PROJECT
PVC II-A
8 July 1974
, Capital Investment $ ^/A
Annual Benefits
^/A
Person Responsible F.L.RIDDLE
DESCRIPTION: (include plan of action and timetable)________________________
TIME AND MOTION STUDIES
Time and motion studies are planned for each operating job in the polymer
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building and for.various phases of some of the jobs. The purpose of these
studies is to determine where an operator spends most of his time so these
areas can be adequately monitored and more emphasis can be put on making these
areas clean. The studies will also be used to determine what valves or
equipment can be operated automatically or remotely. The various jobs or
job phase? to be studied are as follows:
1. Top Floor Operator a. Charging Nos. 16, 17 or 18 reactors
" o. uiargmg iV33. 1, Z"or* T TeaCTOTH " " c*. Charging No. 19 reactor
d. Making up solution 2. ' Stripper Operator
a. komopoiymer batch . b. Copolymer batch
c. 466 batch d. 19th reactor 3. bottom hioor OperatoT"" 4. Finishing Operator
TIMING: SEE MASTER TIME TABLE
AP00001303
Pr.OFIT IMPROVEMENT PROJECT
Department
^Project No.
Date________
' PVC II-B 8 July 1974
Capital Investment _$ 75,000 EST
Annual Benefits
N/A
Person Responsible J.D.PEARSON
DESCRIPTION: (include plan of action and timetable) COMMUNICATIONS
In the operations of the PVC Plant, operators need to be in constant communication with each other for the correct timing of charging, dropping and stripping of
reactors. The operators are separated on different floors by concrete. Due to the above normal noise level, it is very difficult to communicate by voice
alone. In the case of an emergency or VC1 leak, notification of all affected personnel is slow. By means of a walkie talkie type communication system, all operators,can be notified of emergency or leaks at once. It is the purpose of this project to supply such a system.
The project is divided into the following steps: 1: Determine system, prepare cost estimate and CE 2. Equipment delivery 3. Install equipment
TIMING: SEE MASTER TIME TABLE
AP00001304
P?:CT1T improvement project
Department Project No.
II-C
Capital Investment $ 2,000,000 EST Annual Benefits ____________
Date
8 July 1974
------------------------- :
L
Person Responsible W.E.DUNNING GIF.HTSVbbU""
F.L.RIDDLE
DESCRIPTION: (include plan of action and timetable)
AUTOMATION OF PROCESS
Tfte purpose of this project is to eliminate the exposure of the operator to VG1 by removing the operator from the operating area through the use of automatically or remotely controlled valves and/or equipment. From the time and motion studies
and update P 8 I flow sheets, the entent of automation will be determined. The use of television cameras will also be evaluated. In the scope of this project is an enclosed VC1 free control room in which the major operations will be
conducted, from.
This project is divided into the following steps:
1. Pjrepare P 8 I flow sheets a. Monomer charging`
b. DM water charge c. Solution charge
__________________________________ _______________
d. VAc charge e. Propylene charge
f. Drop header, g. North recovery
h. Center recovery i. South recovery *_______________ 1
j. Air
"
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k. Refrigerated water_____________
2. Automation, or remote control of process
a. From C-l above, determine amount of automation or remote control required
b. Design system, prepare cost estimate
3. Television monitoring of equipment
a.-i-rom l-i aDove and survey 6f equipment cteCfcfHIinS
AM lC'diltlOh ------
of television cameras
b. Design system and prepare cost estimate
APOOOOI305
PROJECT NO, I I I
90lOOOOdV
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VINYL CHLORIDE REDUCTION
PROFIT IMPROVEMENT PROJECTS
NO. Ill
PROCESS MODIFICATIONS FOR THE CONTAINMENT OR REMOVAL OF VCI
A. THIRD STEAM JET 1. Design system 2. Determine cost 3. Install
B. CHARGE POT DRAIN SYSTEM 1. Design system 2. Determine cost and prepare CE 3. Install
C. SWECO SCREEN EXHAUST FAN 1. Design system 2. Determine cost and prepare CE 3. Install
D. REACTOR AND THIRD FLOOR EXHAUST SYSTEM 1. Design system 2. Determine cost and prepare CE 3. Install
E. FIRST AND SECOND FLOOR EXHAUST SYSTEM
1. Design system 2. Determine cost and prepare CE 3. Install
F. NEW STRIPPER TRANSFER PUMPS 1. Design system 2. Determine cost and prepare CE 3. Install
G. IMPROVE VENTILATION PATTERN
1. Redesign blower discharge nozzles 2. Conduct air flow studies with smoRe H. MONOMER RECOVERY DRAIN SYSTEM 1. Revise existing drain system and equipment 2. Modify or add drain as required 3. Equipment delivery as required 4. Install additional instruments as required
APOOOOf307
VINYL CHLORIDE REDUCTION
PROFIT IMPROVEMENT PROJECTS
NO. Ill
PROCESS MODIFICATIONS FOR TOE CONTAINMENT OR REMOVAL OF VC1
I. ' CHARGE POT RUPTURE DISC VENT LINES
1. Design system 2. Equipment Delivery 3. Install
J. NEW (FETTEROLF) SPRAY RINSE VALVE
1. Evaluate new type valves currently being tested 2. Prepare cost estimate and CE to replace existing Phaudler
spray rinse valves 3. Equipment delivery 4. Install
K. NEW VC1 RECOVERY SYSTEM
1. Design 2. Equipment delivery 3. Installation
L. INCREASE TOTAL VENTILATION THROUGH REACTOR BUILDING
1. Design system 2. Prepare cost estimate and CE 3. Equipment delivery 4. Install
M. LOW TEMPERATURE VC1 RECOVERY SYSTEM
1. Design system 2. Prepare cost estimate and CE 3. Equipment delivery 4. Install
N. HIGH PRESSURE WATER CLEANING SYSTEM FOR REACTORS
1. Determine system to use 2. Prepare cost estimate and CE 3. Install
O. CHEMICAL CLEANING OF REACTORS
1. Determine system to be used 2. Design system 3. Prepare cost estimate and CE 4. Equipment delivery 5. Install
AP00001308
VINYL CHLORIDE REDUCTION PROFIT IMPROVEMENT PROJECTS
NO. Ill PROCESS MODIFICATIONS FOR THE CONTAINMENT OR REMOVAL OF VC1 P. ' REDESIGN ALL MONCMER HANDLING PIPING 1. From the P I flow sheets prepared under project II-C-1, review all monomer piping to determine if modification can be made to reduce number of flanges and polymer buildup. 2. Redesign if required 3. Prepare cost estimate and CE 4. Equipment delivery 5. Install
AP00001309
PROFIT IMPROVEMENT PROJECT
Department .Project No. Date________
PVC III-B 8 July 1974
Capital Investment $ 10000 EST
Annual Benefits _________________ Person Responsible FN.SUBLETTE
G.B.H.SPEED
DESCRIPTION: (include plan of action and timetable) CHARGE POT DRAIN SYSTEM
When a reactor is charged, monomer vapors are left in the catalyst charge pot.
- ______ _________ _____
_____
As a safety precaution, the pot is drained of any liquid and pressure bled-off
in case any catalyst is left in the pot. The drain currently vents into the reactor building. This project will connect all drains to a central drain
system outside the building.
This project is divided into the following steps: 1. Design system 2. Determine cost and prepare CE___________________
3. Install
TIMING: SEE MASTER TIME TABUS
AP00001310
PROFIT IMPROVEMENT PROJECT
Department
PVC
Capital Investment $ 10 >000 ^
Project No. Date________
III-C 8 July 1974
Annual Benefits ________________ Person Responsible F,N,SUBLETTE
G.B.H.SPEED
DESCRIPTION: (Include plan of action and timetable)
SWECO SCREEN EXHAUST FAN '
Stripped resin is pumped from the strippers to Sweco Screens to remove large xi------------------------------------------------------------------------------------------------------------- ------- . ...............
particles. These screens located just outside the building allow residual
monomer to escape and drift into the operating area.' A temporary exhaust system was installed inside the reactor building and has drastically improved
the operation. This project proposes the installation of a permanent exhaust fan outside the reactor building.
This project is divided into the following steps:
1. Design system 2. Determine cost and prepare CE___________________
3. Install
TIMING: SEE MASTER TIME TABLE
AP00001311
< PROFIT IMPROVEMENT PROJECT
Department
^Project No.
Date _____
PVC III-E 8 July 1974
Capital Investment $ 140,000 * Includes III-D
Annual Benefits
,, ,, ' .. Person Responsible
D.L.WALKER G.B.H.SPEED
DESCRIPTION: (include plan of action and timetable) FIRST AND SECOND FLOOR EXHAUST SYSTEM
Currently any leaks that develop on the first or second floor of the reactor
i.O i.
- - '
-- ----
building must be cleared through the use of wall fans. With the cross
ventilation in the building a leak on the opposite wall must go completely
across the building before being exhausted. This project proposes a large
exhaust fan. with multiple flexible connections that can be connected to a leak source until repairs can be made.
This project is divided into the foilwing steps: 1. Design system 2. Determine cost and prepare CE
3. Install
TIMING: SEE MASTER TIME TABLE
AP00001312
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PROFIT IMPROVEMENT PROJECT
Department ^Project No. Date________
JVC III-E 8 July 1974
Capital Investment $ 140,000 Includes III-D
Annual Benefite__________
Person Responsible D.L.WALKER r. r h spppn
DESCRIPTION: (include plan of action and timetable) FIRST AND SECOND FLOOR EXHAUST SYSTEM
Currently any leaks that develop on the first or second floor of the reactor
...Ci -...........
.............
i. 11 ......................... ........--
----..
....
building must be. cleared through the use of wall fans. With the cross
ventilation in the building a leak on the opposite wall must go conpletely
across the building before being exhausted. This project proposes a large exhaust fan. with multiple flexible connections that can be connected to a leak source until repairs can be made.
This project is divided into the following steps: 1. Design system 2. Determine cost and prepare CE
3. Install
TIMING: SEE MASTER TIME TABLE
AP00001313
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. .. Department
^Project No.
Date
.. 0,
DESCRIPTION:
PVC III-G
. Capital Investment $ 25,000
. . ..
Annual Benefits
8 July 1974
Person Responsible R^-McGINNIS G.B.H.SPEED
(include plan of action and timetable) improve Ventilation pattern
Cn the third floor of the reactor building, the fresh air blower exhaust
i HI ----'ll
I III
----------
is located about.12 feet above the floor. As a result, the fresh air does not
reach the operators level until it is half way across the building.
This project will investigate means for discharging the fresh air along the wall to provide a complete sweep of the building.
This project is divided into the following steps:
1. Redesign blower discharge nozzles 2. Conduct air flow studies with smoke
TIMING: SEE MASTER TIME TABLE
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>RGFIT IMPROVEMENT PROJECT
Department
PVC
' . Capital Inveetment $25000 EST
Project No.
' Annual Benefits _________________
Date
.
July 1974 '
Person Responsible F-N.SUBLETTE G.B.H.SPEED
DESCRIPTION: (include plan of action and timetable) . MCNCMER RECOVERY DRAIN SYSTEM-
In the operation of the monomer recovery system, water condenses out of the
. ---------------------------- :------------------;------------------------------------------------------------------------------
monomer as pressure is increased. In addition, water is used in the Nash
system to compress the gases. . As such, these systems include gas/liquid separators which must be drained of excess liquid. In tlie present system,
these separators drain into the reactor building, releasing any dissolved
monomer and on occasions monomer vapor.
This projfeet proposes installing level control equipment as the separator
and a closed central drain system discharging outside the building.
This "project is divided into `the following steps: 1. Revise existing drain system and equipment 2. Modify or add drain as required 3. Equipment delivery as required. 4. Install additional instruments as required
L .----------- :-- TIMING: SEE MASTER TIME TABLE
I. ..---------------- :-------------- --
!.._____________________________ ___
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AP00001316
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PROFIT IMPROVEMENT PROJECT
department
PVC
Capital Investment $ 653.^00 ^
Project No.
III-K
Annual Benefits
Date
8 July 1974
Person Responsible D.k.WALKGR G.B.H.SPEED
DESCRIPTION: (include plan of action and timetable) NEW VC1 RECOVERY. SYSTEM
The present VC1 recovery system is spread over the entire inside of the
_<2.------------------------------------------------------------------------- -------------------- ----- ---------------
building and includes old equipment both Nash type and reciprocating type
compressors. The control of the equipment is essentially manual. The
obsolescent, poor layout and lack of instrumentation has.resulted in poor VC1 efficiencies and frequent plugging of equipment and lines which results
in the escape of VC1. It is proposed to locate all VC1 recovery equipment outside the building in one location. The equipment is to be instrumented to provide minimum operator attention.
This project is divided into the following steps:
1. Design 2. Equipment Delivery________________________________ 3. Installation
TIMING: SEE MASTER TIME TABLE
T
AP0000I3f9
PROFIT IMPROVEMENT PROJECT
Department
^Project No.
Date _____
PVC III-L 8 July 1974
Capital Investment $ 120,000
Annual Benefits
Person Responsible D-L.WALKER G.B.H.SPEED
DESCRIPTION: (include plan of action and timetable) INCREASE TOTAL VENTILATION THROUGH REACTOR BUILDING
_^he reactor building currently has ventilation capacity to provide a_______ normal air change of 12 per hour and emergency of 24 per hour. If through other process modifications tAe VC1 exposure level cannot be maintained below the limit, additional ventilation will be considered.
This project is divided into-the following steps:
1. Design system 2. Prepare cost estimate and CE____________________
3. Equipment delivery 4. Install
TIMING: SEE MASTER TIME TABLE
AP00001320
PROSIT IMPROVEMENT PROJECT
Department
'
Project No.III-M
TM_
'
.. Capital lavtmant $ 500 000 251
Annual Benefits
Date
** "
Person Responsible W.E.PUNNING G.B.H.SPEED
DESCRIPTION: (include plan of action and timetable) . LCW TEMPERATURE VC1 RECOVERY SYSTEM
The majority of the problems associated with monomer recovery resulting in
..... ...
i
..............................................
'
-
--1
'
fouling and monomer release occurs in the compression of the vapor from the
discharge of the vacuum pump, to the condensers.
This project proposes the use of low temperature C20-25F) recovery system which' would eliminate the need for compression. The monomer would condense at the vacuum pump discharge pressure.
This project is divided into the following steps:
1. Design system 2. Prepare cost estimate and CE 3. _ Equipment delivery 4. `install
TIMING: SEE MASTER TIME TABLE
AP00001321
PROFIT IMPROVEMENT PROJECT
Department
PVC
. Capital Investment $ 100,000 EST
Project No.
Date
DESCRIPTION:
III-N
Annual Benefits
8 July 1974
Person Responsible
(include plan of action and timetable)
J.T.BARR
W.E.DUNNING G.B.H.SPEED
. HIGH PRESSURE WATER CLEANING SYSTEM FOR REACTORS
Currently all reactors are opened and manually hosed down between charges
................ ---- .......... ' '.I----.. -- .......... .
i
I- | ,,
and entered and manually cleaned every three to five charges. The opening
of reactors results in the release of monomer to the operating area. This project proposes the use of a high pressure water cleaning system
that is more effective than manual hosing. It is hoped that the
effectiveness will be improved to allow discontinuing the between batch hosing and less frequent manual cleaning.
This project is divided into the following steps:
1. .Determine system to use 2. Prepare cost estimate and CE
_______________
.3. Install
TIMING: SEE MASTER TIME TABLE
AP00001322
PROFIT IMPHOYSMENT PROJECT
Department Project No. Date________
PVC_________ III-0 8 July 1974
Capital Investment _$ 750,000
Annual Benefits _____ Person Responsible _ W.E.DUNNING
G.B.H.SPEED
DESCRIPTION: (includo plan of action and timetable) .CHEMICAL CLEANING OF REACTORS
A? Calvert City only one reactor. No. 19 stainless steel, is currently being
. -- -
-- --
.......................................................-- -----------, i
chemically cleaned with EMF. The other 18 reactors are manually cleaned. No
man has ever entered No. 19 for cleaning. Chemical'cleaning with DMF results in a far superior job than manual cleaning. With a properly designed chemical
cleaning system the use of operator to clean reactors can be eliminated.
If entry for mechanical reasons are required, the reactor can be scrupulously cleaned with EMF before entering.
The purpose of this project is to eliminate the need to enter reactors for cleaning through the use of a chemical cleaning system.
This project is divided into the following steps: 1. Determine system to be used 2. Design system
3. Prepare cost estimate and CE 4. Equipment delivery
5. Install
TIMING: SEE MASTER TIME TABLE
AP00001323
r PROFIT IMPROVEMENT PROJECT
r Department
. Capital Investment $ 50,000
c Project No. Date _____
r
III-P
8 July 1974 ----------------------------------
Annual BenefitB
Person Responsible F-N.SUBLETTE G.B.H.SPEED
DESCRIPTION: (include plan of action and timetable)
r REDESIGN ALL MONCMER HANDLING PIPING
c Due to the addition of monomer recovery equipment to the facility through the years, monomer recovery equipment is located throughout the polymer
c building. Many lines traverse the building several times from beginning
to end. It is the purpose of this study to review all the monomer piping
c and redesign and relocate in a more direct route with less flanges, dead
c spots, etc. can be made.
c This project is divided into the following steps: 1. From the P 6 I flow sheets prepared under project II-C-1, review all monomer piping to determine if modification can be made to reduce
[ number of flanges and polymer buildup. 2.' Redesien if reauired . 3. Prepare cost estimate and CE
i; 4. Equipment delivery 5. Install
i;
TIMING: SEE MASTER TIME TABLE
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AP00001324
SZlOOOOdV
VINYL CHLORIDE REDUCTION PROFIT IMPROVEMENT PROJECTS
NO. IV REDUCTION OF PVC PARTICULATES
A. REPLACE PRODUCT COLLECTORS WITH CYCLONES
1. Design system 2. Prepare cost estimate and CE 3. Equipment delivery 3. Install
t
B. COMPLETE UPGRADING OF BULK HANDLING, LOADING AND BAGGING
1. Review of existing system 2. Design revised system 3. Determine cost and prepare CE 4. Equipment delivery 5. Install
AP00001326
PUC/EIT IMPROVEMENT PROJECT
Department
PVC
. Capital Investment $ 750,000
.Project No.l'V-'B
Annual Benefits ________________
Date
8 July 1974
Person Responsible _W*E.DUNNING G.B.H.SPEED
DESCRIPTION: (include plan of action and timetable) , . COMPLETE UPGRADING OF BULK HANDLING. LOADING AND BAGGING
The existing bulk handling, loading and bagging system at Calvert City are
r*.________________________________________
________ _ __________
obsolete, under capacity and lack any instrumentation. As a resuit during
any resin transfer operation leaks develop, equipment breaks down, dust flies everywhere and even silos are overfilled.
The purpose of this project is to completely overhaul the transfer system to eliminate the sources of leaks, provide exhaust system with collectors to keep the bagging area dust free and automate the system to prevent overfilling
of silos and bulk containers.
This project is divided into "the following steps:
1. Review of existing system 2. Design revised system 3. Determine cost and prepare CE 4. Equipment delivery________________________________
5. Install
TIMING: SEE MASTER TIME TABLE
AP00001327
I PROFIT IMPROVEMENT PROJECT
Department
PVC
. Capital Investment $ 150,000
Project No.
if.
Date
IV-A 8 July 1974
Annual Benefits
Person Responsible D.L.WALKER _ G.B.H.SPEED
DESCRIPTION: (include olan of action and timetable) . REPLACEMENT OF PRODUCT COLLECTORS WITH CYCLCNES
The existing bag house product collectors are original equipment and are in a poor condition requiring constant maintenance. In addition, the bags break frequently allowing resin to escape.
This project will replace the existing product collectors with cyclones. By their design, cyclones have no moving parts or bags to break. Being stainless steel, corrosion will be eliminated.
This project is divided into the following steps: 1. Design system 2. Prepare cost estimate and CE 3. ^Equipment delivery 4. "install
[
TIMING: SEE MASTER TIME TABLE
i; -----------------------'------------- r--
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AP00001328
6Z1000QdV
VINYL CHLORIDE REDUCTION PROFIT IMPROVEMENT PROJECTS
NO. V REDUCE LOST BATCHES A. CHEMICAL CHARGE SYSTEM 1. Review charging procedures to eliminate errors 2. Review charging system B. REEVALUATE ALL RECIPES AND CATALYST LEVELS C. NEW DM WATER SYSTEM 1. Design system 2. Prepare cost estimate and CE 3. Equipment delivery 4. Install D. ADD ADDITIONAL REFRIGERATION AND COOLING TOWER WATER SUPPLY 1. Design system 2. Prepare cost estimate and CE 3. Equipment delivery 4. Install
APOOOOf 330
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P.ICEIT IMPROVEMENT PROJECT
DepartmentPV___________________
project No.
V-B
Date
^ *^u^y
.. Capital Investment $ Annual Benefits Person Responsible F.L.RIDDLE
DESCRIPTION: (include plan of action and timetable) REEVALUATE ALL RECIPES AND CATALYST LEVELS
^possible reason for losing a batch either through emergency venting or as BB's may be that the recipe does not contain the most desirable or correct level of suspending agent, buffer, etc. Also, the catalyst level may be tod high for the cooling.capacity of the plant on a 24 hour'basis.
This project will review the recipes and recommend changes where need to insure that optimum ingredient level is used.
TIMING: SEE MASTER: TIME TABLE
APOOOOf 332
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PROFIT IMPROVEMENT PROJECT
Department (
Project No.
t
Date
PVC V-C 8 July 1974
. Capital Investment $ 227,000
Annual Benefits ______
Person Responsible
D%L.WALKER G.B.H.SPEED
DESCRIPTION: (include plan of action and timetable) NEW DEMINERALIZED WATER SYSTEM
Poor water quality has been found to result in an unstable suspension system resulting in the need for discharging a batch of resin. The poor quality water problems experienced at Calvert City are attributed to the old and undersize DM unit currently in service. It is planned, to replace the present unit with a larger more reliable type system.
This project is divided into the following steps:
1. Design system 2. Prepare cost estimate and CE
3. Equipment delivery 4. Install
TIMING: SEE MASTER TIME TABLE
AP00001333
r
r PROFIT IMPROVEMENT PROJECT
r Department
PVC
, Capital Investment $ 750000
Project No.
Annual Benefita __________________
r Date8 July 1974
Pereon Responsible W.B.DUNNING
, ' G.B.H.SPEED
r DESCRIPTION: (include plan of action and timetable)
r ' ADD ADDITIONAL REFRIGERATION AND COOLING TOWER WATER SIFPLY Approximately five batches a month are lost due to inadequate refrigerated water
<U supply. It is planned to install an additional refrigeration machine, surge
tankage and additional cooling tower water facilities-to maintain adequate
control over the polymerization process.
This project, is divided into the following steps:
1. Design system 2. Prepare- cost estimate and CE
3. Equipment delivery 4. Install
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r. Department Project No,
PVC' : VI-A
Capital Inveatment $ ~~~ .
* t. .
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. Annual Benefits
r * Date8 July 1974
Pereon Responsible J.P-PARKER . F.L.RIDDLE
r DESCRIPTION: (include Plan of action and timetable) UPDATE OPERATING MANUALS '
i i - Due to the many changes and additions in the process such as catalyst'
[ charges, 19th reactor, effluent reclaim, etc. many of the operating
procedures have not been updated, or have been issued as a separate
sheet. With the new P .I flow sheets being prepared in II-C, the
operating manual will be revised to incorporate all new procedures and
equipment.
.
TIMING: SEE MASTER TIME TABLE
55.
AP00001337
PROFIT IMPROVEMENT PROJECT
Department
Project No.
4- *
Date
PVC VI-B 8 July 1974
. Capital Investment $
Annual Benefits P_erson --Responsib*le J * P PARKER
DESCRIPTION: (include plan of action and<tlmetable) 'GROUP .AND INDIVIDUAL TRAINING SESSIONS
Gypup and individual training sessions will bp hptrt to ar-nua-int thp_______ operators with new procedures and insure understanding of old procedures. The sessions will also be used to keep the operators aware of the VC1 exposure problem and progress made.
TIMING: SEE MASTER TIME TABLE
AP00001338
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APRIL 30, 1974 MIDDLESEX MEETING
VCM REDUCTION IN COMPOUNDING PLANT
I. BASIS FOR VCM REDUCTION PROGRAM A. Legal' Aspects - Govt. Regulatory Actions on VCM Levels 1. PVC Used in C.C. Compounding 2. PVC Used by Customers 3. Compound VCM Levels B. Experimental Programs 1. Modification of Present Compound Line 2. New Compounding Line
II. COMPOUND ANALYSIS FOR VCM LEVEL - CURRENT STATUS A. VCM Extraction from PVC Liquor Bottles 1. Total VCM Vs. Extractable VCM 2. Early Work Comparing Plant and Special Middlesex Compounds B. Latest "Round-Robin" Study
III. CONCLUSIONS
APOOOOf 358
MANUFACTURING CHEMISTS ASSOCIATION
1825 CONNECTICUT AVENUE, N. W.
WASHINGTON. O. C. 20009
-- FOR RELEASE-------------------------------------------------------------------------------
CONTACT:
For Immediate) Rolcase
Richard F. Blowitt
(202) 433-6126, ext. 282
WASHINGTON, D, C., April 16 -- The Manufacturing Chemists
Association (MCA) announced today preliminary indications that
vinyl chloride exposure has produced angiosarcoma -- a liver
cancer -- in mice at several exposure levels.
*"
Industrial Bio-Test Laboratories, Inc., who are conducting
the ilCA-administcrcd vinyl chloride animal exposure study,
informed MCA that their work -- although very preliminary at
this point -- tends to coufivm the findings of Professor Cesare
Malloni, an Italian scientist who found that vinj'l chloride
4
exposure in rats caused cancer.
MCA immediately notified the Occupational Safety and Health
i
Administration, the National Institute for Occupational Safety
and Health and the Environmental Protection Agency of the preliminary test results.
In the MCA-administercd study, rats, hamsters and mice
are being exposed seven hours a day, five days a week, to 2500 parts per million (ppm), 200 ppm and 50 ppm. After seven months ol exposure, angiosarcoma 1 as been observed in mice at all levels, but not in rats or hams Levs.
(more)
APOOOOf359
Page 2 of 2 Professor Maltoni reported at the 0S1IA hearings on vinyl chloride February 15 that he had obi served the liver cancer in rats exposed four hours a day, five cays a week, tc> 250 ppm for up to 12 months. However, he did not find the cancer in testing at the 50 ppm level. The animal exposure study is continuing. Another MCAadministered study on the chemical, documenting the health experience of present and former emijloyeos who have worked with the material, the results of which also will be released, is expected to be completed in the near future. Further vinyl chloride testing is under consideration.
# ff MCA-3S39
AP00001360
PROPOSED RULES
1121.1
(b) Technical services.
used since that lime. Only certain for ous drug- fluids after they have been in
(1) The builder-developer proposing mulations of PVC, however, arc prior- contact with devices composed in whole
fl new subdivision which will have 10 sanctioncd for use in food packaging and or in part of polyvinyl chloride.
or more dwelling sites will secure the therefore arc exempt from classification (0) Tho effect on blood and tissues
services of a site planner, architect, ns food additives and may be used with of vinyl chloride extracted from devices
landscape architect, or engineer, reg out pre-marketing clearance by the Food composed in whole or in part of polyvinyl
istered or otherwise certified as qualified and Drug Administration.
chlorido inserted or Implanted in the
in the state in which the subdivision Early in 1973, the Pood and Drug Ad body.
is to be constructed, to provide complete ministration began receiving reports of All persons In possession of such data
planning, drawings, specifications, and passible migration problems of ingredi arc urgently requested to submit It to the
supervision on land, street, utility and ents of PVC bottles then being test mar Food and Drug Administration in writing
grading development.
keted for distilled spirits, As a result of (preferably in quintupllcate). if at nil
12) Complete technical services will further analytical testing, the Commis possible on or before June 21, 1974. Tills
be obtained end paid tor by the builder- sioner published the May 17, 1973 pro data should be sent to the Hearing Clerk,
developer with liis own funds.
posal wherein he concluded that the use Food and Drug Administration. Room
(3) At completion of construction (or of PVC for the packaging of alcoholic C-0C, 5900 Fishers Lane, Rockville, MD
when construction will be accomplished foods may cause such foods to be adulter 20352. Received data, may be seen hi the
in phases, at the end of each phase), the ated. No PVC bottles have been used for above office during working hours. Mon
person who is qualified and resist crcd or such purposes since then. After the pub day through Friday.
certified in the state in which the sub lication of the proposal, the Commis The Commissioner recently received a
division is to bo constructed and' is pro- sioner began investigating scientific re petition from the Health Research
vidine supervisory services during the ports regarding the possible migration of Group, 2000 P Street NW., Washington.
period of work shall notify the FKA PVC container ingredients to nonalco D.C. 2G036, proposing to prohibit immedi
County Office in writing that all work has holic foods os well. Agency action on tills ately the continued use of vinyl chloride
been completed in substantial conform matter and on the earlier proposal is ex as a constituent or propellant of cosmetic
ance with the approved plans and speci pected to be published shortly In the aerosol products and of polyvinyl chlo
fications. .
* *
2. Amend i 1004.61 as follows:
Federal Register. The Commissioner is ride os a container material for any cos also considering the applicability of this metic product which can lench out de information to various drug products tectable amounts of vinyl" chloride from packaged In PVC, and to various devices the polyvinyl cliloride container mate
1C01.67 Streets.
composed in whole or in part of PVC rial, Tlis petitioner contends that there
(a) New subdivisions and expansion of
existing subdivisions. (1) Streets must conform to master
street plans, design standards and con
duction specifications of the applicable public body, city, town, county or state and the requirements of the FIIA. De
velopments with more than 20 sites Ehall have two accesses available, unless an exception is granted by the State
Director. *
which may come in contact with drug fluids, or which may be inserted or im
planted in the human body. Because of the broad interest in the
subject of vinyl cliloride by both the pub lic and the scientific community because of its potential as a serious threat to the public health, tha Commissioner has un dertaken an agency-wide effort to explore the problem in connection with these products within the jurisdiction of the Food and Drug Administration and to fashion the appropriate regulatory ac
is substantial evidence that vinyl chlo
ride monomer is carcinogenic. A copy of the petition and letter of
transmittal to the Commissioner arc on
file in the Office of the Hearing Clerk. The Commissioner has reviewed all
cosmetic product Ingredient statements on flic with the agency, representing ap proximately 50 percent of current market formulations, as of February 1.1674, and has ascertained that no Information ex ists in these flies indicating use of vinyl chloride in cosmetic aerosol products.
(42 U.S.C. HSO'v: delegation of authority by 6C0. of Agri., 38 FR 14S44, 14018, 1 CFB 2.23: delegation of autlioritv by the Am. See. for
Rural Development, 38 KR 14044, 14032, 7 CFR 2.70).
tions that should be taken to assure full
protection of the public health. Repre sentatives of tills agency are also mem bers of a Federal inter-agency task force formed to gather data on the overall ef
Furthermore, the Cosmetic, Toiletry and Fragrance Association. Inc. (CTFA), lias
Informed the Food and Drug Adminis tration that the results of a recent tele
phone poll, covering 25 companies in
Dated: April i5, 1074.
fect of vinyl chloride on the total cn- cluding the major aerosol hair spre;.
.' Frank B. eiliott, Administrator.
Fanners Home Administration.
|FD Doe.74-0152 Filed 4-19-74;8:45 am)
. vironment and to initiate coordinated ac tion to minimize this Impact.
In connection with this search for in formation, the Commissioner is particu
larly interested in receiving data in re
manufacturers, show that no cm.s;
contacted lias manufactured km... containing vinyl chloride sin.c 1973. In 1973. according to this iu:i. :::atlon, two companies produced vinyl chlo
sponse to the following points relating to ride-containing products with a total
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
the use of polyvinyl chloride in contain volume of approximately 1.625,000 units.
ers lor food and cosmetics, and in de The CTFA estimates that the percentage
vices:
of hair spray cans manufactured in 1073
Food end Drug Administration I 21 CFR Parts 310 and 700 ]
(1) The extent of usage of polyvinyl which contained vinyl chloride is less
chloride by type of container or container than 0.4 percent. A copy of tho Infor
liner and type of product.
mation received from the CTFA is on
VINYL CHLORIDE AS AN INGREDIENT OF (2) The vinyl chloride content in poly file in the Office of the Hearing Clerk.
DRUG AND COSMETIC AEROSOL PROD vinyl chloride used to manufacture or There is no known past or present
UCTS
line various food and cosmetic contain usage of vinyl chloride as a propellant
Notice of Proposed Rule Making
' In (ho Fcdcru, Rucister of May 17, 1073 (38 FR 12031), (he Commissioner of
ers. including description of the methods and extraction systems used to determine this content.
(3) The rote and level of vinyl chloride
in food aerosol products. Any such use
without a food additive regulation would be a violation of the Federal Food, Drug, and Cosmetic Act.
Food and Drugs published a notice of extraction from the aforementioned con With regard to drug products, the Food proposed rulemaking lor prior-sanc tainers or their liners by various foods nnd Drug Administration lias recently tioncd polyvinyl cliloride (PVC) resin. and cosmetics, including data derived reviewed its flics and conducted f, sur
Polyvinyl chloride is a polymeric resin after periods of storage.
vey of nil known drug manufacturers oi
produced by polymerization of vinyl (4) Tlie rate and level of percutaneous aerosol products to determine the extent chloride v.-hich was used as a component absorption of vinyl chloride from cos to which vinyl chloride is used as a com of food packaging materials prior to the metics and devices when in contact with . ponent, including propellant, in such
passago of the Food Additive Amend the skin or mucous membrane.
products. The only known use of vinyl
ments of 1058 and which has been widely (5) The vinyl chloride content of vari chloride in drug products has been as a
FEDERAL REGISTER, VOl. 39, NO. 7*--MONDAY, APRIL 22, 1974
APOOOOf361
MU LG
propose:) ruus
propellant In aerosol preparations. While made of any additional such manufac vidual maj" bo exposed eoiJd bo signifi
all the Information ruquabtvd in the turers if and as they arc located.
cantly la excess of the safe level estab
.survey was not supplied by roanuir.c- Two cosmetic aerosol hair spray manu lished la connection with occupational
'turers, the review of the agency files and facturers commenced such recalls ns of exposure. Evidence Indicates that vinyl
preliminary results of the survey Indi April 2, 1974 and a drug and cosmetic chloride inhalation can result in acute
cate that vinyl clilorlde Is not currently manufacturer, identified after a file toxicity manifested by dizziness, fci-ad-
being used in aerosol drug products. search, began recall of seven drug and nche, disorientation, and unconscious
There are no approved new drug appli threo cosmetic aerosol products as of ness where Inhaled at high concentra
cations for vinyl chloride as a component April 8, 1074, following mi April 4, 1974 tions. Studios also demonstrate carcino
of any dm. There Is evidence, however, request.
genic effects in animals as a result cl
that manufacturers of some over-the- Therefore, pursuant to provisions of Inhalation exposure to vinyl chloride.
counter drug products used vinyl chlo the Federal Food, Drug, end Cormctic Furthermore, vinyl chloride has recently
ride as a propellant until 1073.
Act (secs. 502, 505, coi(a>. 701(a); 52 been linked to liver disease, Including
To determine the full extent that vinyl Stat. 1050-1055, os amended; 21 UB.C. liver cancer, in workers engaged in the
chloride Is used in dm products end to 352, 355, 361(a), 371(a)) and under au polymerization of vinyl chloride. It is tho
determine if any additional action is thority delegated to the Commissioner view of the Commissioner that vinyl
needed to protect the public, there Is of Food and Drugs (21 CPU 2.1201, It is chloride is a deleterious substance which
published elsewhere in this issue of the proposed tliat Parts 310 and 703 be may render any cosmetic aerosol prod
Kedsrai. Registe:i, a notice, pursuant to amended os follows:
uct that contains it as an ingredient
$ 132.7(a)(4) (21 CFIt 132.7(a)(4)), of 1. By adding a new i 310.506 to,Sub- injurious to users. Accordingly, any cos
the regulations under the Drug Listing part 2 of Part 310 to read as follows: metic aerosol product containing vinyl
Act of 1972, requiring all registrants to submit a list of all drug products mar keted containing the Ingredient vinyl chloride or packaged in containers com
posed of or lined with polyvinyl chloride. The Commissioner has determined
310.505 Use or vinyl chloride as an ingredient. Including propellant, of aerosol drag products.
(a) Vinyl chloride has been used os a propellant In aerosol drug preparations.
chlorido as an ingredient is deemed to to adulterated under section GOKa) of tbs Federal Food, Drug, and Cosmetic Act.
(b) Any cosmetic aerosol product con taining vinyl chloride as an ingredient shipped within the jurisdiction of the act
that there ere sufficient scientific data on which to base a decision Hurt: (1) vinyl chloride presents an unnecessary hazard to the public health when it is used as
an ingredient In cosmetic aercsol prod ucts and that such use should be banned, and (2) vinyljchlorlde, when used as an ingredient in drug aerosol products. Is not generally recognised ns safe and ef fective, Is a new drug within the meaning of section 201 (p) of the Federal Food, Drug and Cosmetic Act. end requires an
approved new drug application as a con
Evidence indicates that vinyl chloride inhalation can result in acute toxicity manifested by dizziness, headache, dis orientation, and unconsciousness where
inhaled at high concentrations. Cardiae effects, bone changes, and degenerative changes in the brain, liver, and kidneys
have been reported in animals. Studies also demonstrate carcinogenic effects In nnimals as a result of Inhalation, expo sure to vinyl chloride. Recently, vinyl
chloride has been linked to liver disease. Including liver cancer, in worker* en
is subject to regulatory action.
Interested persons may, on or before May 22,1974, file with the Hearing Clerk, Food and Drug Administration, room G-CO, SC00 Fishers Lane, Rockville,'MD 20852, written comments (preferably in quintupilcate) regarding this proposal. Comments may be accompanied by a memorandum or brief in support thereof. Received comments may be seen la the above office during working hours. Monday through Friday.
dition of marketing.
gaged in. the polymerization of vinyl Dated: April 1C, 1374.
There Is ample evidence that vinyl chloride. chloride inhalation can result in acute (b> The Commissioner finds that there toxicity manifested by an array of cyn'.p- is a lack of general recognition by quali
A. M. Sciimtst, Commissioner oj Food a.id Drags.
toms. Including unconsciousness as a re fied experts of the safety or effectiveness (Pit Doc.74-9233 Piled 4-I9-74;8:45 am]
sult of high concentration of inhalation. of aerosol drug preparations containing
Cardiac effects, bone changes, and de vinyl chloride as an ingredient, includ generative changes in the brain, liver, ing propellant. Therefore, any such prod and kidneys have also teen reported in uct containing vinyl chloride is a new
DEPARTMENT CF TRANSPORTATION
animals. Reported studies also demon drug and a new drug application ap
COAST GUARD
strate carcinogenic effects In animals as proved under section 505 of the Federal a result of Inhalation exposure to vinyl Food, Drug, and Cosmetic Act is re
33 CFR Pert 117 ]
chloride. Of most significance, however, quired for marketing.
(COD 74115]
is the fact that vinyl chloride has been (c) A completed and signed "Notice linked to liver disease, including liver of Claimed Investigational Exemption
NEW RIVER SOUND AND STR&KAHAN RIVER, FLA.
cancer, in workers engaged in the poly for a New Drug" (Form FD-1571). as set merization of vinyl chloride to PVC. The forth in 1 312.1 of this chapter. Is re scientific articles providing this evidence quired to cover clinical Investigations
Proposed Drsv/brldgo Operation Regulations
are on file in the Oilce of the Hearing designed to obtain evidence that such At the request of the Florida Yacht
Clerk. In view of this evidence, the Com preparations arc safe and effective for Club Council, tire Coast Guard is con
missioner concludes that the banning of tho purposes Intended.
sidering revoking the regulations for the
vinyl chloride as an Ingredient In drug (d) Any such drug within the Juris Bast Las Olas Boulevard drawbridge
and cosmetic aerosol products is re diction of the set which is not in accord across the Atlantic Intraroastal Water
quired. These products are often used with this regulation is subject to regula way in Fort Lauderdale. Florida, to re
in the confines of a small room where tory action. .
quire that tho draw open on signal. Pres
the levol of vinyl chloride to which the Individual may bo exposed, although usually only for a short time, could bo
2. By adding a new ( 700.14 to Subpart B of Fart 700 to read as follows:
ent regulations allow closed periods from November 15 through May 13 from 7 a.m. to C pus. during which tho draw need
significantly In excess of the safe level S 703.11 Use of vinyl chloride at an la* only open on the hour and half hour. Tr.U
established in connection -with occupa
grcdlcnt, Including propellant of cos* change Is being considered for the fol
tional exposure.
malic aerosol products.
lowing reasons:
As a corollary to this conclusion, the (a) Vinyl chloride has been used as an (a) The regulations presently in fcrco
Commissioner has requested all known Ingredient in cosmetic aerosol products were issued on March 15, 1533 (15 Kfl
manufacturers of such products with including hair sprays. Where such aero 14(11), and were amended on July 2, Iff3
supplies still on tho market to recall sol products arc used In the confines of 08 FR S7S2), October 23. 1D55 (22 Fit
theso supplies from the market to tile rs- a small room, as is often the caso, tho 2113), and October 20,1953 (21FF. SCC-I).
tail level, and similar requests will bo level of vinyl chloride to wliich the indi These regulations were issued to osse vs-
fEDEEAl REGISTER, VOL J9, MO. 71---MONDAY, A7RIL 21, 1974
AP00001362
112I5S
NOTICES
the denial order Issued asninst tlic re dressed to: Central Reference and Rec halation can result in acute toxicity
spondent on Februtin- 28, 1972 <37 FTt ords Inspection Facility, U.S. Depart ninnlfcxtcd by an array of symptoms in
530G).
ment of Commerce, Washington, D.C. cluding unconsciousness rs a result of
Dated: April J2,197G. Riper II. Meyer.
20230. Dated: April 17.1971,
high concentration inhalation. Cardiac cITccts. bona changes, and degenerative changes In the brain, liver, and kidneys
Director,
Rauch II. Meyer,
have also been reported in animals, in
Office 0/ Export Administration.
Director, Office o) Export Ad addition, there ore studies demonstrat
IFit Doe.74-0080 Filed 4-10-71:8:45 am]
ministration, Bureau oj Easi- ing tiic carcinogenic effects in animals West Trade, Department of as a result of inludalien exposure to t in;.-;
. Commerce.
chloride, and it has been linked to liver
COMPUTER SYSTEMS TECHNICAL ADVISORY COMMITTEE
ira Dnc.74-0039 Filed 4-19-74:8:45 am]
disease, Including liver cancer. In work ers engaged in tiic polymerization of the
Notice of Medina
Pursuant to the provisions of the Fed_ eral Advisory Committee Act (Public
Law 92-iC3). notice is hereby given tliat a meeting of the Licensing Procedures Subgroup of the Computer systems Technical Advisory- Committee will be held Monday, April 29, 1974. at 1:30 p.m. in Conference Room A, Main Com merce Building. H:h and Constitution Avenue, Washington, "D.C.
Members r.dvisc the Office of Export Administration, Burcr.u of East-West Trade, with respect to ciucstions involv ing technical matters, worldwide avail ability and actual utilization of produc tion and technology, and liecnang pro cedures which may affect the level of export controls applicable to computer
systems, including technical data re lated thereto, and including those whore export is subject to luultiUiieral (COCOM) controls.
Agenda items are as follows-.
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
Feed and Drug Administration
fNADA No. 48-23GV|
AGRITRONICS COR?.
Ar.ritrorues Swine Premix T-S; Withdrawel Cf Approval of New Animal Drug Application
Pursuant to provisions of the Federal Food. Drug, and Cosmetic Act (see. 512, 82 Stat. 343-351; 21 U.S.C. 3G0b) and under authority delegated to the Com missioner of Food and Drugs (21 CFIt 2.120), the following notice is issued:
Agrilronics Corp., 811 2-lth St, Dcs Mol::os, IA 50311, has requested that Its NADA (new animal drug application) No. 48-2S6V be withdrawn is accordance with i 135.25(d) (21 CFR. 135.2C(d>) on the grounds (hat the drug is not being marketed. Notice is given that npprov.d cf NADA No., 48-236V for Agiltronie* Swine Promlx T-3. which contains ty-
monomer to polyvinyl cliloritio. Polyvinyl chloride, a polymeric rcxhi
produced by polymerization of vinyl chloride, is used in drug packaging
materials. There is evidence of vinyl chloride migration when polyvinyl chlo
ride is used in packaging material for products containing alcohol. There- have
also been reports of the possible migra tion of polyvinyl chloride eoiitcinar ingredients l non-alcoholic products as well. Because cf this it is necessary to give special study lo such packaging material to determine if it is safe for its intended use.
For these Reasons it Is c-scntlM that the Commissioner have, knowledge of
every drug product currently maikc-tod in the United States that contains vinyl
chloride ns an ingredient, and informa tion regarding every marketed drug product packaged in a polyvinyl chloride container or in a container lined with
polyvinyl chloride. Such iniormation is necessary for determining i! there is ade
1. Opening remarks by the Chxtnur.n. losin and sulfamethazine, is hereby quate evidence whether drugs containing
Computer Systems Technical Advisory Committee.
3. Appointment of sWorroup cbr.irmr.n. 3. Presentation of papers or comments by
.the public. 4 Discussion of export licensin'; proce dures relating to computer systems.
5. Executive Session: Continuation of dis cussion' oi export licensing procedures.
The public will be permitted to attend the discussion of agenda items 1-4, and a limited number of scats trill be avail able to the public for these agenda items. To the extent time permits, members of the public may present oral statements to the subgroup. Interested persons tire also invited to file written statements with the subgroup.
With respect to agendo Item 5, "Exec utive Session," tlie Assistant Secretary of Coimncrce lor Administration, on De cember 20, 1973, determined, pursuant to section 10(d) of Public Law 92-4G3, that tills agenda item should be exempt from tiic provisions of sections 10 (a) (1) and (a)(3). relating to open meetings and public participation therein, because the meeting will be concerned with mat
ters listed in 5 U.S.C. 552(b) (1). Further information may be obtained
from John L. Collins, Chairman, Com
puter Systems Technical Advisory Com
witlidrawn.
Effective date. This notice shall be ef fective April 22,1D74.
Dated: April 15,1974.
' Sam D. Fixe. Associate Commissioner
hr Compliance.
|V'B Doc.74-01 IV Filed 4-19--74;8:45 am|
HUMAN' DRUGS CONTAINING VINYL CHLORIDE OR PACKAGED IN POLY VINYL CHLORIDE CONTAINERS
Notice to Drug Manufacturers, Packer*, and Distributors
Elsewhere in this Issue of the Fecesal Register (39 FR 14215) the Commis sioner of Food and Drugs has proposed tliat all aerosol drug products containing vinyl chloride as a component, including propellant, are new drugs and subject to regulatory proceedings "unless the prod ucts arc the subject of new drug appli cations approved pursuant to section 505 of the Federal Food, Drug, and Cosme tic Act. That proposal is based on scien tific data demonstrating that vinyl chlo ride la not generally recognized ns safe and effective as a component, including propellant, of a drug product.
vinyl chloride or pocketed In containers composed of, or lined with, polyvinyl chloride are safe and effective for their intended purposes and wliat action. It any, is required to protect 'the public health.
Section 510(j)(3> of the act, as added by the Drug Listing Act of 1572, author izes the Commissioner to require each registrant under section 510 of the act
to submit a list of each drug product which the registrant is manufacturing, preparing, propagating, compounding, or
processing for commercial distribution and which contains a particular ingredi ent. when the Commissioner has r.vude
a finding that the submission of such it list is necessary to cany out the pur poses of the act For live reasons stated
above the Commissioner so finds wilh regard to drugs containing vinyl chlo ride. As packaging materials are an integral part of the drug product, the Commissioner also so finds with regard
to drug products packaged in polyvinyl chloride containers or in containers with polyvinyl chloride liners.
In addition to the required list of containing vinyl chloride ar.d a required list oi drug products packaged In poly
vinyl chloride containers or in containers with polyvinyl chloride linrrs, the Com
mittee, 111'..: World Trade Corporation, The Food and Dm;: Administration Ls missioner Is requesting, but not xuquSr--
1C01 K Street NW.. Washington, D.C. 2000G (A/C 202-833-CbflO).
aware that vinyl chloride has been used as a pvopcilant in aerosol drug prepara
ing, that certain oilier information be submit'e-d. The Commissioner acknowl
Minutes of those portions of the meet tions. but has no information that vinyl edges that some of the information being
ing which arc open to the public will chloride is currently being used in the requested has also been requested In the
be nvai'.r.blo 30 days irom the date of manufacture oi ding products, There it regulations Implement-!.g tko Drug List
the meeting upon written request ad-. ample cvidonco that vinyl chloride in ing Act of 1972. and will be available
FEDERAL REGISTER, VOL 39, NO. 78--MONDAY, AFRU 33, 1974
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from that source. However, It will Greatly
simplify the compilation of this Infor mation if it is included in this sub
mission. Therefore, pursuant to the provisions
of the Federal Food. Drue, r.nd Cosmetic Act (secs. 201. 510. 701(a), 52 Elat. 10-101013, ns amended, 1053, ns amended,
1055, as amended; 21 U.s.c. 321, 300,
371(a); 42 U.S.C. 2G2) aud under au thority delegated to the Commissioner (21 CI-Tt 2.120). each rcr.istrant under section 510 of the act Is required to sub mit to the Food and Dm; Administra
tion ft list of-all hitman drugs which arc being manufactured, prepared, propa gated, compounded, or processed for commercial distribution and which con tain vinyl chloride whether or not the vinyl chloride is an active or inactive in gredient ar.d a list o' all human drug products packaged in polyvinyl chloride containers or in containers with poly
vinyl chloride liners as follows:
1. neportiug firm name, address, and registration number.
2. List of drugs containing vinyl rlilorido (by trada namo, It any, and established
name, if any) and a list of drug products for which polyvinyl chloride is used as a con tainer or a container liner (by trade namo, if any, and established name, if any).
It is requested but not required that the following Information also be sub
mitted:
3. National Drug Code (NDC) if one has
been assigned. 4. A statement wheir.er the drug Is mar
keted over the counter or limited to pre scription distribution.
5. Home of aciib lit1st ration. B. Amount of vinyl chloride In average daily dore, 7. Quantity of drug distributed (number
of do.utgo units) during previous 12 months. 8. A copy of Uio label aud labeling.
In addition to the information requested in items X through 8 (excluding item 6) for drug products packaged in polyvinyl chloride containers or iu containers witli polyvinyl chloride liner* it i* requested, but not required, that the following in formation be submitted.
0. A statement of the vinyl chloride con tent in polyvinyl chloride used for the manu facture of the drug container or container lining. Include description of the methods and extraction systems used to determine this content. If this lnformstion is not known, provide the mime and address of tlie drug container or container liner supplier and/or manufacturer.
10. The rate and level of extraction of vinyl chloride from Ute polyvinyl chloride containers or container liners by the particu lar drug or by any othor extraction or rolvcut systems. Including data derived after periods of storafo. Where such information ix not known, but Is or may bo available from the supplier or manufacturer of the con:sincr
or liner, provido the name and address of such supplier or manufacturer.
11. The rato and level of ntaorptfon of rinyi chloride as an Ingredient or of vinyl chloride extructod from a polyvinyl chlorldo container or liner by tlie drug contained on an average dally doas. Where such Informa tion is not known, but Is or may be available from the supplier or manufacturer of tlie
container or liner, provide the namo and address of such supplier or mttnuCucturcr.
12. Knine and iwtilms of tho manufacturer of Uio polyvinyl chloride resin, where ouch information la known.
Till; information shall bo submitted to: Department of Health, Education, and Wet-
I:.ro Food and Drug Administration Bureau of Drupe, Drug Listing Staff (lirD-7) 5C00 Fishers Lr.no Rockville, MO 20353
by May 22,1074.
Dated: April 15, 1074.
A. M. Scitmor, Commissioner o/ Food and Drugs. [FR Doe.74-0231 Filed 4-10-7*;8: anil
ADVISORY COMMITTEES
Notice of Meeting*
Pursuant to the Federal Advisory Com mittee Act of October 0, 1072 (Public Law 92-463. 80 Stat. 770-775: 5 U.S.C. App.), the Food and Drug Administra tion announces Ute following public ad visory committco meetings anti other re quired information in accordance with provisions set forth in section 10(a) CX) aud (2) of the act:
Committee nuiuo
Pol?, time, place
Typed meeting find
eemtua person
1. m May $ cmJ 9,9 Op.'n May S. 0 vm.
u.m.. CciiftT- ter 10 tt.in., clnw'd
* cues Room C, May v. uRer IU
Amit'-hle
VlUWtuAil
U.m.. ek'v'ii Muy 9.
Inclinling liMe...v;o
!>*( CMt-mr.r.
ltO.M11 IvUHJi,
Uruis.
liftckvill*. Md.
U'ljj Vi<!-.ir.< l.vie. ItiiekviKe, MU. 90*31,3JI-41349CQ.
Purpose. Reviews and evaluates avail able information concerning safety and effectiveness of active ingredients of cur rently marketed non-prescription drug products containing internal analgcsio
agents. Agenda. Open session: Comments and
presentations by interested persons. Closed session: Continuing review of nonprescription Internal analgesic drugs
under investigation.
CORsUiUW nt.mc
Dai*, thr*, pUca
Typo of meeting
mil . coutact paHon
2 Tfincl w Jtuvk'Ur of frrfl.o* p.tslic IVvi.'c*
May U*9 fi.tn., jf'itri VUi
JU./tur iMt LuUt CUy, X.'tah.
Or<n 9 a.ci. t*10
11.1)1., c'.uH'U e.f: r JOa.m. J-tir.r* K. Vfjln (JII M-ly0)#
Fisher* TauOi Ituckvilte, MU. Su&tt, aoMtt-JSM.
Purpose. Reviews and evaluates avail able data concerning safety, effective ness, and reliability of orthopaedic de
vices currently in use. Agenda. Open session: Comments and
presentations by interested persons. Closed session: Continuation of review of previous classification results and Iden
tification of specific areas for standards
for tlio.'S devices classified as requiring standards.
CotmniU^ name
DfiU\ plu.~
Typo of meutii * i.n<i
1. ri.tirl nn Ilivler ci 1M1 J
Davkuv
May ?3 nnl ?C, 9 mi:., Amir*
Irsti
A*.-*<ohttl a JUtl.;.. CI.1feigo, 11L
Orn M.y 12. ? 1 ,U. lo U)
n.m..r!r*sfU M..y i#. i. Kfuirljf, (JITM-luH S >0 na..r Luu\
MU. Itov'J, Sol--5 li-lTiTC.
Purpose. Reviews and evaluates avail able data concerning the safely, effec
tiveness. and reliability of dental devices currently in use.
Agenda. Open session: Comments and presentations by interested persons: de vice classification; and device legisla tion. Closed session: Continuir.3 review and classification of cental devices.
Agerfda items are subject to change as priorities- dictate.
During the open sessions shown above, interested persons may present relevant information or views orally to any com mittee for Us consideration. Information or views submitted to any committee in writing before or during a meeting shall also be considered by Uic committee.
A list of committee members end sum mary minutes of meetings may be ob tained from the contact person for the commStlee both for meetings open to the public and those meetings closed to the public in accordance with section
10(d) of tlie Federal Advisory Commit tee Act.
Most Food and Drug Administration advisory committees are created to ad vise the Commissioner of Food and Dress on pending regulatory mat'.ci-s. Recommendations made by the commit tees on these matters are intended to result in action under the Federal Food, Drug, and Cosmetic Act. and these committees thus necessarily participate with the Commissioner in exercising his law enforcement responsibilities.
Tlie Freedom of Information Act rec ognized that the premature disclosure of regulatory plans, or indeed internal discussions of alternative regulatory ap proaches to a specific problem, could have adverse effects upon both public and private interests. Congress recog nized that such plans, ever, when final ized. may not be made fully available in advance of the effective dale without damage to such interests, and therefore provided for this type of discussion to remain confidential. Thus, law enforce ment activities have long been recog nized c.s a legitimate subject for confi dential consideration.
These committees often must coniWer trade secrets ar.d otl-.tr confidential in
formation submitted by particular man
ufacturers which the Food ar.d Drug
Administration by law may not disclose,
and which Congress has included willtin
tlie exemption.'; from tlie Freedom of
Information Act. Such information in
cludes safety and effectiveness informa
tion. product formulation, and manu
facturing methods and procedures, all
FEDERAL REGISTER, VOL. 39, NO. 78--MONDAY, APRIL 22, 1974
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