                           VPP Stake Holder Meeting
                                  Attendance
                                August 28, 2017
                            New Orleans, Louisiana

                                     Name
                                    Company
                                     Email
Gregory D. Smith
PSGC
<EMAIL_ADDRESS>C. Gary Lopez
AJG
<EMAIL_ADDRESS>Brenda Kay Zylstra
ASSE
<EMAIL_ADDRESS>Richard Brown
DOL/OSHA Region II
<EMAIL_ADDRESS>Michael Levy
DOL/OSHA Region II
<EMAIL_ADDRESS>MaryAnn Garrahan
DOL/OSHA
<EMAIL_ADDRESS>Peter Wilsey
DOL/OSHA Region IX
<EMAIL_ADDRESS>Paul Lavage
DoD VPPCX
<EMAIL_ADDRESS>Stephen Gauthier
Gauthier Consulting
<EMAIL_ADDRESS>Tim Irving
DOL/OSHA Region I
<EMAIL_ADDRESS>Allen Stump
MOSH
<EMAIL_ADDRESS>Milford Stern
VOSH
<EMAIL_ADDRESS>Jerry Waibel
Army
<EMAIL_ADDRESS>Terry Penn
DOL/ODHA Region III
<EMAIL_ADDRESS>Kodjo S. Knox-Limbacker
OSD
<EMAIL_ADDRESS>Jeffrey Stolz
Raytheon Company
<EMAIL_ADDRESS>Carol Henson
Delta Airlines
<EMAIL_ADDRESS>Heath Bittel
Marathon Petroleum
<EMAIL_ADDRESS>Brent McCarty
Marathon Petroleum
<EMAIL_ADDRESS>Deborah Krajicek
Marathon Petroleum
<EMAIL_ADDRESS>Nancy Mugavaro
DOL/OSHA Region V
<EMAIL_ADDRESS>Tina Kennedy
VPPPA Region V Board
<EMAIL_ADDRESS>Lee Jordan
Tüv Süd America
<EMAIL_ADDRESS>Alexis Ageves
AECOM Hunt
<EMAIL_ADDRESS>Dan Lazorcak
Honeywell Intl.
<EMAIL_ADDRESS>Iraj Pourmehraban
CalOSHA-VPP
<EMAIL_ADDRESS>Jimmy Jacquez
Morton Salt Inc.
<EMAIL_ADDRESS>Bill Linneweh
Hendrickson
<EMAIL_ADDRESS>Sawn French
Eli Lilly & Company
<EMAIL_ADDRESS>John Seibert
DoD
<EMAIL_ADDRESS>Jerry Aslinger
OSD P&R
<EMAIL_ADDRESS>Karen Nelson
OSD P&R
<EMAIL_ADDRESS>Anna Lyons
DLA
<EMAIL_ADDRESS>Robert Barniko
SMCX
<EMAIL_ADDRESS>Courtney Malveaux
VPPPA
<EMAIL_ADDRESS>Bill Lapprandf
DoD SMCX
<EMAIL_ADDRESS>Christopher Chaffin
DoD SMCX (CTC)
<EMAIL_ADDRESS>Mike Maddox
VPPPA
<EMAIL_ADDRESS>
                                     Name
                                    Company
                                     Email
Dan DeHart
DOL/OSHA Region IV
<EMAIL_ADDRESS>Janet Nixon
CTC\SMCX
<EMAIL_ADDRESS>Ivory G. Williams
DOL/OSHA Region IV
<EMAIL_ADDRESS>Troy Armstead
HQ US Air Force
Troy.Armstead@US .AF.mil
Sharon Dumit
SC OSHA
<EMAIL_ADDRESS>Kenny Fernandez
SC OSHA
<EMAIL_ADDRESS>Joe Bergan
Huber Engineered Woods
<EMAIL_ADDRESS>Sheldon Primus
OSHA Compliance Help
<EMAIL_ADDRESS>Jonathan Briley
Pfizer Inc.
<EMAIL_ADDRESS>Brian Whitehead
Pfizer Inc.
<EMAIL_ADDRESS>Lesley Morrison
Pfizer Inc.
<EMAIL_ADDRESS>Christopher Briwder
Pfizer Inc.
<EMAIL_ADDRESS>Poshan W. Rabade
FPL
<EMAIL_ADDRESS>Maria E. Cardenas
Florida Power & Light (FPL)
<EMAIL_ADDRESS>Casey Logue
Timberlake Construction Co.
<EMAIL_ADDRESS>Brandy Stackhouse
Harris Rebar
<EMAIL_ADDRESS>J.J. DeGiovanni
United Airlines
<EMAIL_ADDRESS>Mitchell Jacobs
United Airlines
<EMAIL_ADDRESS>Michael Courouleau
GE
<EMAIL_ADDRESS>Dennis Blowers
ARLANXEO
<EMAIL_ADDRESS>Mark Hall
Cintas
<EMAIL_ADDRESS>Brye Sargent
Sysco Corp.
<EMAIL_ADDRESS>Mike Jennings
Sherwin Williams
<EMAIL_ADDRESS>Cliff Butler
Sherwin Williams
<EMAIL_ADDRESS>Martin Gaspard
Clean Harbors
<EMAIL_ADDRESS>Scott Sylvester
Clean Harbors
<EMAIL_ADDRESS>Nabor Leiga
NuStar Energy
<EMAIL_ADDRESS>William  Klingbeil
DOL/OSHA Region VI
<EMAIL_ADDRESS>Josh Flesher
DOL/OSHA Region VI
<EMAIL_ADDRESS>James Taylor
Total Safety
<EMAIL_ADDRESS>Andy Youpel
Brandenburg
<EMAIL_ADDRESS>Travis L. Williams
Kiowa Power Partners LLC
<EMAIL_ADDRESS>Leigh Jackson
DOL/OSHA Region IV
<EMAIL_ADDRESS>David Whitley
Dougkas J. Wooliver & Sons Inc.
<EMAIL_ADDRESS>


[Federal Register Volume 76, Number 76 (Wednesday, April 20, 2011)]
[Notices]
[Page 22094]
[FR Doc No: 2011-9519]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Effectiveness of Exempt Wholesale Generator Status

------------------------------------------------------------------------
                                                            Docket Nos.
------------------------------------------------------------------------
LSP Energy, Inc.........................................     EG11-43-000
Milford Wind Corridor Phase II, LLC.....................     EG11-44-000
Elk Wind Energy LLC.....................................     EG11-45-000
Grande Prairie Generation, Inc..........................     EG11-46-000
Mountain View Power Partner IV, LLC.....................     EG11-47-000
Cedar Point Wind, LLC...................................     EG11-48-000
Gratiot County Wind LLC.................................     EG11-49-000
Cambria CoGen Company...................................     EG11-50-000
CPV Batesville, LLC.....................................     EG11-51-000
Mount Miller Wind Energy Limited Partner................      FC11-3-000
Grande Prairie Generation, Inc..........................      FC11-4-000
------------------------------------------------------------------------

    Take notice that during the month of March 2011, the status of the
above-captioned entities as Exempt Wholesale Generators or Foreign
Utility Companies became effective by operation of the Commission's
regulations. 18 CFR 366.7(a).

    Dated: April 13, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-9519 Filed 4-19-11; 8:45 am]
BILLING CODE 6717-01-P


HAZARD RANKING SYSTEM DOCUMENTATION PACKAGE QUANTA RESOURCES EDGEWATER, BERGEN COUNTY, NEW JERSEY CERCLIS ID No.: NJD000606442 VOLUME 1 of 1 EPA C o n t r a c t N o . : 68 W7 0026 Work Assignment N o . : 053 HRHR 02ZZ Work Order No.: ' 20064 053 100 2022 December 2000 P r e p a r e d f o r :

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY R e g i o n I1 2 9 0 B r o a d w a y , 1 8 t h F l o o r New York, NY 1 0 0 0 7 P r e p a z e d by:

Roy F. Weston, Inc E d i s o n , NJ 08837 SITE SUMMARY The Quanta Resources s i t e is l o c a t e d a t 163 River Road i n Edgewater, Bergen County, New Jersey. The s i t e covers' approximately 8 acres. The Quanta property i s bordered t o t h e north by t h e C e l o t e x I n d u s t r i a l P a r k , t o t h e s o u t h by the former Spencer Kellogg I n d u s t r i a l P a r k , t o t h e w e s t b y R i v e r Road, and t o t h e e a s t by the Hudson River. From approximately 1930 t o 1981 t h e s i t e had been used a s an o i l and t a r s t o r a g e and r e c l a m a t i o n f a c i l i t y .

Beginning i n t h e e a r l y 1930s, AlliedChemical Corporation Asphalt Division ( now Allied Signal) operated a t a r p r o c e s s i n g p l a n t a t t h e site. In 1974, Allied Chemical s o l d t h e p r o p e r t y t o t h e e s t a t e of M r . James Frola and M r . Albert Von Dohln. In 1977, M r . Frola and Mr. Van Dohln l e a s e d t h e p r o p e r t y t o E. R. P. Corporation for the storage and recycling of o i l . S h o r t l y t h e r e a f t e r , E. R. P. assigned i t s l e a s e t o Edgewater Terminals, Incorporated. Quanta Resources Corporation obtained usage of the property through transfer of t h e l e a s e from Edgewater Terminals. The s i t e had 61 above ground storage tanks ( ASTs) with a t o t a l c a p a c i t y of over 9 million gallons, along with an unknown number of underground storage tanks ( USTs) and numerous underground pipes. These tanks were used t o s t o r e c o a l t a r , o i l , t a r , a s p h a l t , s l u d g e , p r o c e s s w a t e r and other unknown liquids.

On July 2, 1981, t h e New Jersey Department of Environmental Protection ( NJDEP) forced the c l o s i n g o f t h e Q u a n t a R e s o u r c e s f a c i l i t y when it was discovered that the storage tanks contained large quantities of oil with polychlorinated biphenyl ( PCB) concentrations as h i g h a s 260 p a r t s p e r m i l l i o n fppm) .

' Between 1984 and 1988, removal a c t i o n a c t i v i t i e s were conducted a t t h e QRC s i t e . These actions were supervised by the U. S. Environmental Protection Agency ( EPA) and focused on the cleaning and decommissioning of the ASTs and USTs. I n a d d i t i o n , some underground piping and s h a l l o w s o i l s c o n t a i n i n g c o a l t a r were removed from t h e s i t e . I n 1992, EPA conducted an assessment of the previous removal actions, which included the collection of s o i l , ground water, and sediment samples. Analytical results from these sampling a c t i v i t i e s i n d i c a t e d t h a t CERCLA hazardous substances were s t i l l present on s i t e . From 1992 t o p r e s e n t , t h e EPA Removal Program has conducted several sampling events which included the collection of surface and subsurface soil samples, and surface water and sediment samples collected from the Hudson River i n a r e a s where a sheen was observed a d j a c e n t o t h e Q u a n t a R e s o u r c e s i t e . A n a l y t i c a l d a t a from these sampling events indicated the presence of elevated levels of polynuclear aromatic hydrocarbons ( PAHs) and metals.

Under an Administrative Consent Order with EPA, Allied Signal contracted GeoSyntec Consultants t o conduct a Removal S i t e I n v e s t i g a t i o n { RSI) a t t h e QRC s i t e . This investigation was conducted i n 1998 and 1999 and included the collection of surface and s u b s u r f a c e s o i l s a m p l e s c o l l e c t e d from Quanta Resources property as w e l l as from p r o p e r t i e s i n t h e v i c i n i t y of the Quanta Resources property, ground water samples collected from monitoring wells, and sediment samples collected from the Hudson River. Based on the results of a c t i v i t i e s conducted during the RSI, heavy end product was estimated to extend from the area west of where River Road exists to approximately 750 f e e t i n t o t h e Hudson River.

An observed release to surface water by direct observation i s documented through the d i r e c t d e p o s i t i o n of heavy end coal t a r p r o d u c t t o h e Hudson River. Level I1 concentrations of PAHs ( including benzo ( a) anthracene, benzo ( a) pyrene, benzo ( g, h, i) perylene, , benzo ( k ) fluoroanthene, and dibenzo( a, h) anthracene) are documented t o t h e Hudson River, which i s a fishery and a sensitive environment ( i  e . , s t a t e  designated water body f o r t h e maintenance of aquatic l i f e ) . Name of Site:

Contact Persons Site Investigation:

Documentation Record: HRS DOCUMENTATION RECORD REVIEW COVER SHEET Quanta Resources Mr. Robert Montgomery ( 732) 906 6934 U. S. Environmental Protection Agency Edison, NJ Ben Conetta ( 212) 637 4435 U . S . Environmental Protection Agency New York, NY Dennis J. Foerter ( 732) 417 5877 Roy F. Weston, Inc. Edison, NJ Pathwavs, Components, or Threats Not Scored The Ground Water, Soil Exposure, and Air Pathways were not scored because the site score would not be significantly impacted by those pathways. In addition, the Drinking Water Threat of. the Surface Water Pathway was not scored because it would not have an impact on the pathway score. EELS DOCUMENTATION RECORD Name of Site: Quanta Resources EPA ID No.: NJD000606442 EPA Region: 2 S t r e e t Address of S i t e : 163 River Road, Edgewater County and State: Bergen, N J General Location i n t h e S t a t e : n o r t h e r n N J Topographic Map: Central Park, N . Y .  N . J .

Latitude : 40" 4 8 ' 15.5" North Date Prepared: November 2000 Longitude: 73" 59' 21.0'' West ( Ref. 3)

Scores Ground Water Pathway Not Scored Surface Water Pathway 1 0 0 . 0 0 Soil Exposure Pathway Not Scored A i r Pathway Not Scored HRS SITE SCORE 50.00 4 WORKSHEET FOR COMPUTING HRS SITE SCORE 1.

2a.

2b.

2c.

3.

4 .

5.

6. Ground Water Migration Pathway Score ( S,,) ( from Table 3 1, l i n e 13) S SZ Not Scored Surface Water Overland/ Flood Migration Component 1 0 0 . 0 0 1 0 , 0 0 0 ( from Table 4 1, l i n e 30)

Ground Water t o Surface Water Migration Component Not Scored ( from Table 4 25, l i n e 28)

Surface Water Migration Pathway Score ( SSJ 1 0 0 . 0 0 1 0 , 0 0 0 E n t e r t h e l a r g e r of l i n e s 2a and 2b a s t h e pathway score.

S o i l Exposure Pathway Score ( S,) ( from Table 5 1,. l i n e 22)

A i r Migration Pathway Score ( Sa) ( from Table 6 1, l i n e 1 2 ) Not Scored Not Scored Total of sq; + s,, Z + s,~ + saz 10,000 HRS Site Score Divide the value on l i n e 5 by 4 and t a k e t h e s q u a r e r o o t 50.00 5 SURFACE WATER OVERLAND/ FLOOD MIGRATION COMPONENT SCORESHEET Factor Cateqories and Factors Maximum Value Value Assiqned DRINKING WATER THREAT Likelihood of Release 1.

Observed 2. Potential to Release by Overland Flow 2a. 10 Containment 2b. 25 Runoff

2c. Distance to Surface Water 2d. Potential to Release by Overland Flow ( lines 2a x [ 2b + 2cl) 500

3. Potential to Release by Flood Waste Characteristics 1 550 6. Toxicity/ Persistence a 10,000 I I 7. Hazardous Waste Quantity a 100 8. Waste Characteristics 100 32 Tarqets 9. Nearest Intake I 50 0.00 10. Population 10a ., b Level I Concentrations lob. b Level I1 Concentrations 6 0.00 0.00 L,*. ,

SURFACE WATER OVERLAND/ FLOOD MIGWTION COMPONENT SCORESHEET 1oc. P o t e n t i a l C o n t a m i n a t i o n 0 . 0 0 b F a c t o r C a t e u o r i e s a n d F a c t o r s DRINKING WATER . THREAT ( Concluded) Value Assiuned Maximum Value 10d. P o p u l a t i o n ( l i n e s 1 0 a + 10b + 1Oc) 0  00 b 11. Resources 0 . 0 0 b 1 2 . Targets ( l i n e s 9 + 10d. + 11) 0.00 5 Drinkinu Water T h r e a t S c o r e 13. Drinking Water T h r e a t S c o r e I I ( [ l i n e s 5 x 8 x 12]/ 82,500, s u b j e c t t o a maximum o f 100) 1 0 0 0.00 HUMAN FOOD CHAIN THREAT Likelihood o f Release 1 4 . Likelihood of Release ( same v a l u e as l i n e 5) 550 550 Waste Characteristics 18.

4 5 7 SURFACE WATER OVERLAND/ FLOOD MIGRATION COMPONENT SCORESHEET ~~~ ~~ ~~ ~ ~ ~ _ _ _ _ _

Human Food Chain Threat S c o r e 2 1 . Human Food Chain Threat S c o r e ( [ l i n e s 14 x 1 7 x 2 0 1 / 8 2 , 5 0 0 , s u b j e c t t o a maximum of 100) 96.06 100 8 C % laxi SURFACE WATER OVERLAND/ FLOOD MIGRATION COMPONENT SCORESHEET Factor Cateqories and Factors Maximum Value Value Assiqned ENVIRONMENTAL THREAT Likelihood of Release 22. Likelihood of Release (

same 5)

550 550 Waste Characteristics 23. Ecosystem Toxicity/ Persistence/ Bioaccumulation a 500,000,000 24. Hazardous Waste Quantity a 100 25. Waste Characteris. tics 1,000 320 Tarqets 26. Sensitive Environments 26b.

26c.

Environmental Threat Score 28. Environmental Threat Score ([ lines 2 2 x 25 x 271/ 82,500, subject to a maximum of 60) 60 10.67 SURFACE WATER OVERLAND/ FLOOD MIGRATION COMPONENT SCORE FOR A WATERSHED 29. Watershed Score" ( lines 13 + 21 + 28,

subject to of 100) 100 100.00 SURFACE WATER OVERLAND/ FLOOD MIGRATION COMPONENT SCORE 30. Component Score ( Sof) c, ( highest score from line 29 for all watersheds evaluated, subject to a maximum 100) 100 100 . oo ~ m = value applies to waste characteristics category. " Maximum value not applicable. ' Do not round t o n e a r e s t i n t e g e r .

9 REFERENCES Reference Number 1.

2.

3.

4 .

5 .

6.

7.

8 .

9.

10.

11.

12.

13.

14.

15. Description of the Reference U. S. Environmental Protection Agency ( USEPA), Revised Hazard Rankinq Svstem, Final Rule, 55 ER 51532, December 14, 1990, ( also contained in 40 CFR, Appendix A of the National Contingency Plan, 2000). [ 135 pp.]

U. S. EPA, Superfund Chemical Data Matrix, SCDM Data Version: m 9 6 . [ 5 pp. 1 Foerter, D., Roy F. Weston, Inc. ( WESTON), Proiect Note to Quanta Resources File, Subject: Latitude and Lonqitude Calculations, September 8, 2000. [ 3 PP. I WESTON  Region I1 Superfund Technical Assessment and Response ( START) Team, Samplinq OA/ OC Work Plan, Ouanta 2 Site, Edaewater, Beraen Countv, NJ, DNC # START 02 F 01527 ( excludinq attachments), December 18, 1997. [ 13 ' PP. 1 Olinger, K., START Site Lead, WESTON  Region I1 START, Letter to Bob Montqomerv, On Scene Coordinator ( OSCI , EPA, Subiect: Quanta Resources Site PRP Summarv Report ( includinq PRP Summarv report), December 23, 1998. [ 24 . PP. 1 Foerter, D., WESTON, Proiect Note to Quanta Resources File, Subject: Fisheries  Ouanta Resources Meetinq, September 8, 2000. [ 73 pp.]

Presworsky, I., Project Manager, WESTON  Region I1 START, Letter to Bob Montqomerv, On Scene Coordinator ( OSC) , EPA, Subiect: Samplinq Trip Report, Quanta Edqewater Site ( includinq Samplinq Trip Report minus fiqures and attachments), April 2, 1998. 17 pp. 1 Rosenberg, D., Data Reviewer, WESTON  Region I1 START, Transmittal Memo to Bob Montqomerv, OSC, EPA, Subject: Ouanta Edqewater Site, Edqewater, Berqen County, New Jersey, Data Validation Assessment, ( including final data assessment narrative and analvtical data packacre), June 11, 1998. [ 274 PP 1 Foerter, D., WESTON, Proiect Note to Ouanta Resources File, Subiect: Fisheries  Quanta Resources Site, September 8, 2000. [ 4 pp.]

Foerter, D., WESTON, Proiect Note to Quanta Resources File, Subiect: Sensitive Environments  Ouanta Resources Site, September 8, 2000. [ 5 pp.]

Dorneman, K., WESTON, Proiect Note to Quanta Resources File, Subject: Hazardous Waste Ouantity, September 8, 2000. [ 3 pp.]

Foerter, D., WESTON, Proiect Note to Ouanta Resources File. Subiect: Heavv End Coal Tar Product  Ouanta Resources Site, September 8, 2000. [ 5 pp.]

Foerter, D., Roy F. Weston, Inc., Telecon Note with Ilene Presworskv, Environmental Scientist, Excel Environmental, Subject: Quanta Resources, 13 September 2000. [ l p.]

U. S. Geological Survey, Water Resources Division, Water Resources Data, New York, Water Year 1996, Volume 1. Eastern New York excludinq Lonq Island, U. S. Geoloqical Survev Water Data Report NY 96 1, 1997. [ 4 pp.]

Foerter, D., WESTON, Proiect Note to Ouanta Resources File, Subiect: Analytical Data  Sample Ouantitation Limits, September 15, 2000. [ lo pp.]

10 SD Characterization and Containment Source No.: 1 SOURCE DESCRIPTION 2.2 Source Characterization Number of the source:  1  Name and description of the source: Heavy end product discharge Source type: Other Source 1 consists of heavy end coal tar product. During the RSI conducted by GeoSyntec Consultants, cone penetrometer testing ( CPT) was conducted utilizing a Rapid Optical Screening ToolTM ( ROSTTM) . T h i s a c t i v i t y was conducted i n an e f f o r t t o d e l i n e a t e t h e l a t e r a l e x t e n t of heavy end product both on the Quanta Resources property and within the Hudson River. Heavy end product i s composed o f c o a l t a r , c r e o s o t e and other hydrocarbons. Based on t h e r e s u l t s of t h i s t e s t i n g , heavy end product was estimated to extend from the area west of where the new River Road exists to approximately 750 f e e t i n t o t h e Hudson R i v e r . I n u p l a n d a r e a s , t h e p r o d u c t c o n s i s t o f h a r d s o l i d c o a l t a r p i t c h , s t i c k y c o a l t a r r o o f i n g p i t c h and v i s c o u s o i l  l i k e t a r . The product present in Hudson River sediments consisted of lenses of oil like product and roofing pitch within the river s i l t . ( Ref. 6, pp. 1, 4 ) . The t o t a l a r e a of the heavy end product discharge i s e s t i m a t e d t o be 848,225 square feet ( Ref. 11, pp. 1 3).

I t is a l l e g e d t h a t p r o d u c t was d i s c h a r g e d t o t h ? Hudson River via improperly closed underground piping which e x i s t s on the Quanta Resources property ( Ref. 13). During the RSI investigation, one pipe was believed t o extend from a former oil/ water separator to t h e Hudson River ( Ref. 12, p. 2 ) . i n a d d i t i o n , s e v e r a l t e s t t r e n c h e s were excavated during the RSI i n an e f f o r t t o l o c a t e d b u r i e d p i p e s . These a c t i v i t i e s r e s u l t e d i n t h e identification of several underground pipes and conduits. Some of these pipes contained c o a l t a r p r o d u c t ( R e f . 12, pp. 3 7) .

The heavy end product discharge i s not excluded as a source due t o t h e p r e s e n c e o f c o a l t a r ( Ref. 5, pp. 11, 13). in addition, contaminants not associated with petroleum p r o d u c t s ( e . g . , 1,1,2,2 tetrachloroethane, styrene) were d e t e c t e d i n a waste sample collected from a t e s t p i t where product was present ( Ref. 8, pp. 44, 1 0 9 ; 13, p. 1).

Location of the source, with reference to a map o f t h e s i t e :

The heavy end coal t a r product discharge extends southeast from an area west of the new River Road location to approximately 750 f e e t i n t o t h e Hudson River. ( Ref. 6, p. 4 ) .

Containment Release via overland migration and/ or flood:

There are no containment structures ( i. e., engineered cover, run on control system, runoff management system, l i n e r s ) a s s o c i a t e d w i t h s o u r c e 1. Based on an evaluation of these conditions, a containment factor of 10 i s assigned for source 1 ( Ref. 1, p. 51609).

11 1 h I SD Hazardous Substances Source No.: 1 2 . 4 . 1 Hazardous Substances Hazardous substance+

Benzo ( a) anthracene ( max. = 520 mg/ kg 98315 01)

Benzo ( a) pyrene ( max. = 370 mg/ kg 98315 01)

Benzo fg, h, i) perylene { max. = 2003 mg/ kg 98315 01)

Benzo ( k ) fluoranthene ( max. = 180 mg/ kg 98315 01)

Dibenzo ( a, h) anthracene ( max.= 52 mg/ kg 98315 01) Evidence RSI Sampling Event ( 1998 1999)

98315 01*, 98315 02*, 98317 06 ( Sed 4A) **

98315 01*, 98315 02*, 98317 06 ( Sed 4A) **

98315 01*, 98315 02*, 98317 06 ( Sed 4A) **

98315 01*, 98315 02*, 98317 06 ( Sed 4A) **

98315 01*, 98315 02*, 98317 06 ( Sed 4A) ** Reference Notes :

" J" = estimated concentration  Although the concentration i s q u a l i f i e d a s e s t i m a t e d , the estimated value documents t h a t t h e s e s u b s t a n c e s a r e s t i l l present.

mg/ kg = milligrams per kilogram * Samples 98315 01 and 98315 02 were s o i l s a m p l e s c o l l e c t e d d u r i n g t h e i n s t a l l a t i o n o f monitoring well MW 103. Sample 98315 01 was c o l l e c t e d a t an interval of 0 t o 1 foot below ground surface ( bgs) and sample 98315 02 was c o l l e c t e d a t a d e p t h i n t e r v a l of 3 t o 4 f e e t bgs). These samples were r e p o r t e d t o have flame ionization detector readings of 50 t o 300 units above background. Both samples consisted of wood brick and t a r ( Ref. 5, p. 13).

* * Sample 98317 06 ( Sed 4A) was collected from a sediment sample location ( i. e., Sed 4A) within the Hudson River. This sample was c o l l e c t e d a t a d e p t h o f 4.9 t o 5.9 f e e t and was , d e s c r i b e d t o have a black, oily, visible product present. The sample was also reported t o have a s t r o n g c o a l t a r o d o r ( R e f . 5, p. 11).

+ Due t o t h e f a c t h a t h e s e s u b s t a n c e s a r e n o t u b i q u i t o u s i n t h e n v i r o n m e n t , no background samples are required for comparison.

12 SD Hazardous Substances Source No.: 1 2.4.1 Razardous Substances ( cont'd)

On March 25, 1998, a waste sample ( TP 01 02) was collected from a test pit by EPA ( Ref. ,

8, pp. 44). Analytical results from this sample indicated the presence of the following PAHs :

Hazardous substance Concentration ( uu/ kq)

Benzo ( a) anthracene 11,000,000 J Benzo ( a) pyrene 12,000,000, J Benzo ( g, h, f) perylene 5,000,000 J Benzo ( k) f luoranthene 3,800,000 J Dibenzo ( a, h) anthracene 19,000,000 J 1,1,2,2 tetrachloro 55,000 ethane Styrene 28,000 J = estimated concentration" ug/ kg = micrograms per kilogram Reference 8, pp. 44, 182 8, pp. 44, 182 8, pp. 44, 182 8 , pp. 44, 182 8, pp. 44, 182 8, pp. 44, 109 8, pp. 44, 109 * Although these values are qualified, the results of these samples document that these substances are present at estimated concentrations significantly above the method detection limit of 1,200 ug/ kg ( Ref. 8, p. 27) . /

13 SD Hazardous C o n s t i t u e n t Q u a n t i t y Source N o . : 1 2.4.2 Hazardous Waste Ouantity 2 . 4 . 2 . 1 . 1 H a z a r d o u s C o n s t i t u e n t Q u a n t i t y The i n f o r m a t i o n a v a i l a b l e i s n o t s u f f i c i e n t t o evaluate Tier A s o u r c e h a z a r d o u s c o n s t i t u e n t q u a n t i t y .

H a z a r d o u s C o n s t i t u e n t Q u a n t i t y V a l u e ( S): N/ A 14 I, 1 SD Hazardous Wastestream Quantity Source No.: 1 <IP_ADDRESS>.2 Hazardous Wastestream Ouantity The information available is not sufficient to evaluate Tier B source hazardous wastestream quantity.

Hazardous Wastestream Quantity ( W): N/ A Hazardous Wastestream Quantity Assigned Value: N/ A 15 SD Volume Source No. : 1 <IP_ADDRESS>.3 Volume Based on a n a l y t i c a l r e s u l t s of sampling a c t i v i t i e s conducted during the RSI i n 1988 1999, it i s a p p a r e n t t h a t t h e heavy end product i s p r e s e n t a t d e p t h ; however, t h e e x a c t volume i s unknown ( Ref. 6, p. 4 ) . A source volume of > O w i l l therefore be assigned.

Dimension of source ( yd3) : > O Reference( s) : 1, p. 51591 Volume Assigned Value: > O 1 6 SD Area Source No.: 1 <IP_ADDRESS>.4 Area Since the volume of the waste source has been determined, a value of 0 is given for area measurement. It should be noted that an evaluation of the extent of the heavy end product discharge indicates that the estimated area of waste source No. 1 is 848,225 square feet ( Ref.. 11, pp. 1 3).

Area of source ( ft') : Not evaluated Reference( s) : 1, p. 51591 Area Assigned Value: 0 17 ,. <_

SD Source Hazardous Waste Quantity Value Source NO.: 1 <IP_ADDRESS>.5 Source Hazardous Waste Ouantitv Value Based on a n a l y t i c a l r e s u l t s of sampling a c t i v i t i e s conducted during the RSI i n 1988 1999, it is a p p a r e n t t h a t t h e heavy end proauct i s p r e s e n t a t d e p t h ; however, t h e e x a c t volume i s unknown ( Ref. 6, p . 4 ) . A source waste quantity of > O w i l l therefore be assigned.

Source Hazardous Waste Quantity Value: > O 18 SD Characterization and Containment Source No. : 2 SOURCE DESCRIPTION 2.2 Source Characterization Number of the source:  2  Name and description of the source: Contaminated Soil Source Type: Contaminated Soil Source 2 consists of contaminated s o i l . During the RSI conducted by GeoSyntec Consultants i n 1998 1999, surface and subsurface soil samples, were collected on the Quanta Resources property. Analytical results indicated the presence of PAHs and m e t a l s i n s o i l s a t l e v e l s s i g n i f i c a n t l y g r e a t e r t h a n l e v e l s d e t e c t e d i n s o i l samples collected from areas which do n o t a p p e a r t o have been impacted from a c t i v i t i e s a t t h e Q u a n t a R e s o u r c e s s i t e . Contaminants detected i n s o i l a t c o n c e n t r a t i o n s s i g n i f i c a n t l y above background include arsenic, benzo ( a) anthracene, benzo ( a) pyrene, benzo ( g, h, i) perylene, benzo ( k) fluoranthene, and dibenzo ( a, h) anthracene. Samples which represent background s o i l c o n d i t i o n s were collected from properties located northwest of the Quanta Resources site. These samples include samples collected from sample locations HF 2, HF 3, HF 4, and HF 5 ( Ref. 6, pp. 5, 8, 1 0 , 34 4 0 ) .

The contaminated s o i l is n o t e x c l u d e d a s a , s o u r c e a t t h e s i t e due t o t h e f a c t t h a t contaminants not associated with petroleumproducts ( e. g., arsenic) were d e t e c t e d i n s i t e s o i l s ( Ref. 6 , pp. 5, 8 ) . I t i s r e p o r t e d t h a t a r s e n i c was d e t e c t e d i n s o i l samples, c o l l e c t e d i n t h e n o r t h w e s t c o r n e r of the Quanta Resources property, i n c o n c e n t r a t i o n s greater than 30,000 ppm. These samples were collected between t h e o f f i c e t r a i l e r s and the sheet metal building ( Ref. 6, p. 2 ) .

Location of the source, with reference to a map of t h e s i t e :

Areas of contaminated s o i l a r e d e f i n e 8 by S I s o i l sample locations T 1, T 8, MW 105, QR 02, and QR 03. These samples were c o l l e c t e d d u r i n g t h e RSI investigation ( Ref. 6, pp. 5, 8, 1 0 , 4 0 ) .

Containment Release via overland migration and/ or flood:

There a r e no containment struCtures ( i . e . , engineered cover, run on control system, runoff . management system, l i n e r s ) a s s o c i a t e d w i t h s o u r c e 1. Eased on an evaluation of these conditions, a containment factor of 10 i s assigned for source 1 ( Ref. 1, p. 51609). '

1 9 2 . 4 . 1 Hazardous Substances Hazardous substance Arsenic max. = 6 7 . 2 mg/ kg, 98315 03)

Benzo ( a) anthracene ( rnax. = 1 , 9 0 0 mg/ kg 98313 04)

Benzo ( a) pyrene ( rnax. = 2 , 5 0 0 mg/ kg 98313 041 benzo ( g , h, i) perylene ( max. = 1 , 4 0 0 mg/ kg 98313 04)

Benzo ( k) f luoranthene ( max. = 1 , 1 0 0 mg/ kg 98313 04) Evidence RSI Soil samples ( 1998 1999) :

98313 02, 98313 03, 98313 04, 9 8 3 1 5  0 3 , 9 8 3 1 5  0 5 98313 02, 98313 03, 98313 04, 98326 01, 99169 01, QR 02 SD Hazardous Substances Source No.: 2 Reference 6, PP 5 , 8 6, pp 5, 8 , 10, 40 98313 02, 98313 03, 98313 04, 6, PP 5, 8, 10, 98326 01, 99169 01, QR 02 40 98313 02, 98313 03, 98313 04, 98326 01, 99169 01, QR 02 98313 02, 98313 03, 98313 04, 98326 01, 99169 01, QR 02 , Dibenzo ( a, h) anthracene 98313 02, 98313 03, 98313 04, ( rnax. = 390 mg/ kg 98326 01, 99169 01, QR 02 98313 04)

mg/ kg  milligrams per kilogram 6, pp. 5, 8 , 10, 40 Duringthe RSI i n v e s t i g a t i o n , s o i l samples which represent background soil conditions were collected from properties located northwest of the Quanta Resources site. These lacations do not appear t o have been impacted by previous activities conducted a t t h e Q u a n t a Resources ' site. These samples include samples collected from sample locations HF 2, HF 3, HF 4, and HF 5 ( Ref. 6, pp. 5 , 3 4 ) . The highest concentrations of the above contamznants d e t e c t e d i n t h e s e background s o i l samples include:

Arsenic 1 0 . 7 mg/ kg Benzo ( a) anthracene 0.0035 mg/ kg Benzo ( a) pyrene 0.0036 mg/ kg Benzo ( g , h, i) perylene 0 . 0 0 1 0 mg/ kg Benzo ( k) fluoranthene 0.0022 mg/ kg Dibenzo ( a, h) anthracene 0.00037 mg/ kg Ref. 6, pp. 5 , 3 4 20 SD Hazardous C o n s t i t u e n t Q u a n t i t y Source No. : 2 2.4.2 Hazardous Waste Ouantity 2 . 4 . 2 . 1 . 1 H a z a r d o u s C o n s t i t u e n t Q u a n t i t v The i n f o r m a t i o n a v a i l a b l e i s n o t s u f f i c i e n t t o e v a l u a t e Tier A s o u r c e h a z a r d o u s c o n s t i t u e n t q u a n t i t y .

H a z a r d o u s C o n s t i t u e n t Q u a n t i t y V a l u e ( S I : N/ A 21 SD Hazardous Wastestream Quantity Source No.: 2 <IP_ADDRESS>.2 Hazardous Wastestream Ouantity The information available is not sufficient to evaluate Tier B source hazardous wastestream quantity.

Hazardous Wastestream Quantity (' 8): N/ A Hazardous Wastestream Quantity Assigned Value: N/ A 22 SD Volume Source No.: 2 <IP_ADDRESS>.3 Volume Based on a n a l y t i c a l r e s u l t s of s o i l samples col1, ected during the RSI i n 1988 1999, it is apparent'that some amount of contamination i s present at depth; however, the exact volume i s unknown ( Ref. 6, pp; 5 , 8, 1 0 , 4 0 ) . A source volume of > O ' w i l l therefore be assigned.

Dimension of source ( yd3) : > O Reference( s) : 1, p. 51591 Volume Assigned Value: N/ A 23 SD Area Source No.: 2 <IP_ADDRESS>.4 Area Since the volume of the waste source has been determined, a value of 0 is given for area measurement.

Area of source ( ft') : Not evaluated Reference( s) : 1, p. 51591 Area Assigned Value: 0 24 SD Source Hazardous Waste Quantity Value Source No. : 2 <IP_ADDRESS>.5 Source Hazardous Waste Ouantitv Value Based on a n a l y t i c a l r e s u l t s of s o i l samples collected during the RSI i n 1998 1999, it i s a p p a r e n t t h a t some amount of contamination i s p r e s e n t a t de, pth; however, t h e e x a c t volume i s unknown ( Ref. 6, pp. 5 , 8, 10, 4 0 ) . A source waste quantity of > O w i l l therefore be assigned.

Source Hazardous Waste Quantity Value: > o 25 SD Summary SITE SUMMARY OF SOURCE DESCRIPTIONS Containment Source Hazardous Source No.

Value Water

1 2 > O > O NE 10 NE NE NE 10 NE NE NE = Not Evaluated 2 6 SWOF Surface Water Overland Flow/ Flood Migration Pathway 4.1 O V E W / F L O O D MIGRATION COMPONENT <IP_ADDRESS> DEFINITION OF HAZARDOUS SUBSTANCE MIGRATION PATH FOR OVERLAND/ FLOOD COMPONENT The s i t e i s located on the banks of the Hudson River ( Ref. 6, p. 3). Overland flow from t h e s i t e d r a i n s t o t h e e a s t toward the Hudson River ( Ref. 13).

Available information indicates that an observed release to the Hudson River has occurred by d i r e c t o b s e r v a t i o n t h r o u g h t h e d i r e c t d e p o s i t i o n of hazardous substances. During the RSI conducted by GeoSyntec Consultants, cone penetrometer testing ( CPT) was conducted u t i l i z i n g a Rapid Optical Screening ToolTM ( ROSTm). T h i s a c t i v i t y was conducted i n an e f f o r t t o d e l i n e a t e t h e l a t e r a l e x t e n t o f heavy end product both on the Quanta Resources property and within the Hudson River. Heavy end product i s composed of c o a l t a r , c r e o s o t e and other hydrocarbons. Based on t h e r e s u l t s of t h i s t e s t i n g , heavy end product was estimated to extend from the area west of where the new River Road e x i s t s t o approximately 750 f e e t i n t o t h e Hudson River. In upland areas, the product consisted of hard solid coal t a r p i t c h , s t i c k y c o a l t a r r o o f i n g p i t c h and v i s c o u s o i l  l i k e t a r . The product present i n Hudson River sediments consisted of lenses of oil like product and roofing pitch within t h e r i v e r s i l t . ( Ref. 6 , p. 1) . The t o t a l a r e a of the heavy end product discharge i s e s t i m a t e d t o b e 848,225 square feet ( Ref. 11, pp. 1 3).

I t i s a l l e g e d t h a t p r o d u c t was discharged t o t h e Hudson River via improperly closed underground piping which exists on the Quanta Resources property. During the RSI investigation, one pipe was believed to extend from a former oil/ water separator to the Hudson River ( Ref. 1 2 , p. 2 ) . In a d d i t i o n , s e v e r a l t e s t t r e n c h e s were excavated during the RSI i n a n e f f o r t t o l o c a t e d b u r i e d p i p e s . These a c t i v i t i e s r e s u l t e d i n t h e identification of several underground pipes and c o n d u i t s t o t h e Hudson River. Some of these pipes were r e p o r t e d t o c o n t a i n c o a l t a r p r o d u c t ( R e f . 12, pp. 3 7) . During EPA Removal a c t i v i t i e s conducted i n 1998, sheens were observed t o be emanating from the Hudson River mud f l a t s a d j a c e n t t o t h e Q u a n t a R e s o u r c e s s i t e . T h i s was especially evident during low t i d e ( Ref. 13) . An absorbent boom has been u t i l i z e d t o c o n t a i n t h e c o n t a m i n a t e d product ( Ref. 6, p. 3) . Cross sections A A', B B', and D D', generated during the RSI, i n d i c a t e t h a t t h e heavy end, coal tar product i s continuous on the Quanta Resources property below t h e s o i l and i n t o t h e Hudson River. Cross section C C', also generated during the RSI, i l l u s t r a t e s t h a t t h e heavy end coal t a r product i s located primarily on or adjacent to the Quanta Resources property ( Ref. 12, pp. 10 14).

During the RSI, a sample was collected from sediment location sed 4A, l o c a t e d i n t h e Hudson River adjacent to the Quanta property. This sample was described as being black and o i l y w i t h v i s i b l e p r o d u c t and a s t r o n g c o a l t a r odor ( Ref. 5, p. 11) . Analytical r e s u l t s from t h i s sample indicated the presence of several PAHs including benzo( a) pyrene, b e n z o ( a ) a n t h r a c e n e , b e n z o ( 9, h , i ) p e r y l e n e , b e n z o ( k) f l u o r o a n t h e n e , a n d dibenzo ( a, h) anthracene ( Ref. 6, pp. 6, 51) .

The observed release indicated by the direct deposition of hazardous substances to surface water constitutes Level I1 contamination of the Hudson River. The Hudson River i s a f i s h e r y i n t h e v i c i n i t y of t h e s i t e ; a g i i l n e t t e r f i s h e s t h i s a r e a f o r American shad. Other species fished for human consumption, from t h e a r e a o f t h e Hudson River adjacent to the Quanta Resources site, include striped bass, white perch, white catfish, blue crab, tomcod, American e e l , and winter flounder ( Ref. 9, pp. 1, 2 ) . The annual production of f i s h t a k e n from t h i s p o r t i o n of t h e r i v e r i s unknown but i s e s t i m a t e d t o be greater than 0 . Hudson River i s classified by the NJDEP a s a Class SE2 s u r f a c e w a t e r i n t h e v i c i n i t y of t h e s i t e ; t h i s s t a t e  d e s i g n a t i o n c o n n o t e s a n a r e a f o r t h e p r o t e c t i o n and maintenance o f a q u a t i c l i f e ( R e f . 1 0 , pp. 1  5 ) .

27 SWOF Observed Release <IP_ADDRESS> LIKELIHOOD OF RELEASE <IP_ADDRESS>.1 Observed Release Direct Observation bv Direct Deposition Basis for D i r e c t O b s e r v a t i o n Background i n f o r m a t i o n i n d i c a t e s t h a t A l l i e d Chemical Corporation Asphalt Division ( now Allied Signal) operated a c o a l t a r p r o c e s s i n g p l a n t a t t h e site. The site was a l s o used f o r t h e s t o r a g e and recycling of o i l . The s i t e had 6 1 above ground storage tanks ( ASTs) , along with an unknown number of underground storage tanks ( USTs) and numerous underground pipes. These tanks were used t o s t o r e o i l ( i n c l u d i n g PCB contaminated o i l ) , tar, asphalt, sludge, process water and other unknown liquids ( Ref. 4 , p. 4 ) .

During the RSI conducted by GeoSyntec Consultants, cone penetrometer testing ( CPT) was conducted u t i l i z i n g a Rapid Optical Screening ToolTM ( ROSTm) . T h i s a c t i v i t y was conducted i n an e f f o r t t o d e l i n e a t e t h e l a t e r a l e x t e n t o f heavy end product both on the Quanta , Resources property and within the Hudson River. Heavy end product i s composed of coal tar, creosote and other hydrocarbons. Based on t h e r e s u l t s o f t h i s t e s t i n g , heavy end product was estimated to extend from t h e a r e a west of where the new River Road e x i s t s t o approximately 750 f e e t i n t o t h e Hudson River ( Ref  6 , pp. 1, 4) . I n u p l a n d a r e a s , t h e p r o d u c t c o n s i s t e d o f h a r d s o l i d c o a l t a r p i t c h , s t i c k y c o a l t a r r o o f i n g p i t c h a n d v i s c o u s o i l  l i k e t a r . The p r o d u c t p r e s e n t i n Hudson River sediments consisted of lenses of o i l  l i k e product and roofing pitch within the river silt. ( Ref. 6, p. 1). The t o t a l a r e a of t h e heavy end product discharge is e s t i m a t e d t o be 848,225 square f e e t ( R e f . 11,' pp. 1 3).

I t i s a l l e g e d t h a t p r o d u c t was d i s c h a r g e d t o t h e Hudson River via improperly closed underground piping which e x i s t s on the Quanta Resources property ( Ref. 13). During the RSI investigation, one pipe was believed t o extend from a former oil/ water separator to the Hudson River ( Ref. 1 2 , p. 2 ) . I n a d d i t i o n , s e v e r a l t e s t t r e n c h e s were excavated during the RSI i n an e f f o r t t o l o c a t e d b u r i e d p i p e s . These a c t i v i t i e s r e s u l t e d i n t h e identification of several underground. pipes and conduits. Some o f t h e s e p i p e s were r e p o r t e d t o c o n t a i n c o a l t a r p r o d u c t ( R e f . 12, pp. 3  7 ) . During EPA Removal a c t i v i t i e s conducted i n 1998, sheens were observed t o be emanating from the Hudson River mud f l a t s a d j a c e n t t o t h e Q u a n t a R e s o u r c e s s i t e . T h i s was especially evident during low t i d e ( R e f . 1 3 ) . An absorbent boom h a s b e e n u t i l i z e d t o c o n t a i n t h e c o n t a m i n a t e d p r o d u c t ( R e f . 6, p . 3) . cross^ sections A A' , B B', and D D' , generated during the RSI, i n d i c a t e t h a t t h e heavy end c o a l t a r p r o d u c t i s continuous on the Quanta Resources property below the s o i l and i n t o t h e Hudson River. Cross section C C` , also generated during the RSI, i l l u s t r a t e s t h a t t h e heavy end coal t a r p r o d u c t i s located primarily on o r a d j a c e n t t o t h e Q u a n t a Resources property ( Ref. 12, pp. 1 0  1 4 ) .

28 SWOF Observed Release Hazardous Substances i n the Release Benzo ( a) pyrene, benzo ( a) anthracene, benzo ( g, h, i) perylene, benzo ( k) fluoroanthene, and dibenzo( a, h) anthracene were d e t e c t e d i n samples collected from the Hudson River adjaceht ,

to the Quanta Resources shoreline.

Sample I D Samplinq Location Depth*

Date Reference

98317 06 RSI location Sed 4A 4 . 9 11/ 13/ 98 6, PP 6, 51 ( Sed 4A)

SED 5 Hudson River * * surface 3/ 10/ 98 71 p. 6; 8 , PP 42, 131 SED 8 Hudson River** surface 3/ 27/ 98 7 , P . 6, 8, PP. 451 176 *  denotes feet below ground~ surface **  Samples collected from Hudson River adjacent to the Quanta property where oily sheens were observed ( Ref. 1 3 ) .

Sample I D Hazardous Substance Concentration Reference 98317 06 benzo ( a) anthracene 470,000 mg/ kg ( Sed 4A) 6, p. 51 benzo ( a) pyrene 310,000 mg/ kg 6, p. 51 benzo ( k ) fluoroanthene 160,000 mg/ kg 6, p. 51 dibenzo ( a, h) anthracene 40,000 mg/ kg 6. P. 5 1 SED 5 benzo (

a)

anthracene 1 2 , 0 0 0 ug/ kg benzo (

a)

pyrene 8,000 ug/ kg benzo ( g, h, i) perylene 2,200 ug/ kg benzo ( k ) fluoroanthene 8 , 7 0 0 ug/ kg dibenzo ( a, h) anthracene 910 ug/ kg 8, p. 131 8, p. 131 8, p. 131 8, p. 131 8: P. 131 SED 8. benzo ( a) anthracene benzo ( a) pyrene 8 , 1 0 0 ug/ kg 8, p. 1 7 6 5,700 ug/ kg 8, p. 1 7 6 mg/ kg: milligrams per kilogram ug/ kg: micrograms per kilogram Notes: Sample Quantitation L i m i t s ( SQLs) were n o t r e p o r t e d f o r Sample 98317 06 ( Sed 4A). The SQLs for observed release contaminants detected in sample SED 5 i s 4,300 ug/ kg. The SQLs for observed release contaminants detected in sample SED 8 i s 4,900 ug/ kg ( Ref. 15) .

Hazardous Substances Released:

benzo ( a) anthracene benzo ( a) pyrene benzo ( g, h, i) perylene benzo ( k ) fluoranthene dibenzo ( a, h) anthracene Observed Release Factor Value: 550 29 SWOF/ Food Chain Toxicity/ Persistence/ Bioaccumulation 4 . 1 . 3 . 2 WASTE CHARACTERISTICS <IP_ADDRESS>.1 Toxieity/ Persistence/ Bioaccumulation Hazardous Source Substance Arsenic Benzo ( a) 1, 2 anthracene Benzo ( a)  1, 2 pyrene Benzo( g, h, i) 1, 2 perylene Benzo ( k) 1, 2 f luoranthene Dibenzo( a, h) 1, 2 anthracene 1,1,2,2 tetra 1 chloroethane Styrene 1 *

* * Toxicity Factor ,

Value 10,000 1,000 10,000 ...

100 10,000 10 10 Persistence Factor Value*

1 1 1 0.

0.4 Bioaccu mulation Value**

500 50,000 50,000 50,000 50,000 50,000 5 50 Toxicity/ Persistence/ Bioaccumulation Factor Value ( Table 4 16) .  Ref.

5 x 106 2, p. B 2 5 x lo7 2, p. B 2 5 x 108 2, p. B 2 ... 2,

p.

B

3 5 x l o 6 2, p. B 3 5 x 10' 2, p. B 7 2 2,

p.

B

18 20 2 ,

p.

B

18 The closest upstream gaging station that records discharge data on the Hudson River is located at Green Island, NY. This station reported a mean annual discharge of 13,800 feet per second ( Ref. 14) . According to Table 4 13 of the HRS, this would qualify the Hudson River in the vicinity of the site as a Large River ( Ref. 1, p. 51613) . Therefore, values for " River" were assigned for persistence.

Due to the fact that the Hudson River is brackish in the vicinity of the Quanta Resources site, the higher of the fresh water and salt water values was evaluated for bioaccumulation ( Ref. 9, p. 2).

Ben'zo( a) pyrene has a Toxicity/ Persistence/ Bioaccumulation values of 5 x 10'; therefore, a value of 5 x 10' is assigned for Toxicity/ Persistence/ Bioaccumulation Factor Value.

Ecosystem Toxicity/ Persistence/ Bioaccmulation Fadtor Valuer 5 x 108 30 SWOF/ Food Chain Hazardous Waste Quantity <IP_ADDRESS>.2 Hazardous Waste Quantity Source Hazardous Waste Quantity Source Number Value ( Section <IP_ADDRESS>.5.1 1 2 > O > O Is source hazardous constituent quantity data complete? ( ves/ no)

no no ! Sum of Values: > O The sum corresponds to a hazardous waste quantity factor value of 1 in Table 2 6 of the HRS rule ( Ref. 1, p. 51591). However, since surface water targets are subject to Level I1 contamination, then either the value of Table 2 6 or a value of 100 is assigned, whichever is greater ( Ref. 1, p. 51592) . Therefore, a hazardous waste quantity factor  value of 100 is assigned.

<IP_ADDRESS>.3 Waste Characteristics Factor Category Value Toxicity/ persistence factor value X hazardous waste quantity factor value 10,000 x 100 = 1 x lo6 ( Toxicity/ persistence X hazardous waste quantity) X bioaccumulation potential factor value ( 1 x lo6) . x 50,000 = 5 x 10''

The corresponding waste characteristics factor category value from Table 2 7 of the HRS rule is 320 ( Ref. 1, p. 51592).

Hazardous Waste Quantity Factor Value: 100 Waste Characteristics Factor Category Value: 320 31 SWOF/ Food Chain Targets <IP_ADDRESS> HUMAN FOOD CHAIN THREAT  TARGETS Actual Human Food Chain Contamination The HRS states that a fishery ( or portion of a fishery) within the target distance limit of the watershed subject to actual contamination can be considered if hazardous substances have bioaccumulation potential factor values of 500 or greater and are present in the observed release by direct observation to the watershed ( Ref. 1, p. 51620). Samples with hazardous substances which meet this criteria are listed below:

Sample ID 98317 06 ( Sed 4A)

SED 5 SED 8 Hazardous Substance Benzo ( a) anthracene Benzo ( a) pyrene Benzo( g, h, i) perylene Benzo ( k) fluoranthene Dibenzo ( a, h) anthracene Benzo ( a) anthracene Benzo ( a) pyrene Benzo ( g, h, i) perylene Benzo ( k ) f luoranthene Dibenzo ( a, h) anthracene Benzo ( a) anthracene Benzo ( a) pyrene Benzo ( g, h, i) perylene Benzo ( k) f luoranthene Dibenzo ( a, h) anthracene C l o s e d F i s h e r i e s Identitv of Fisherv Hazardous Substance N/ A Sample ID N / A B e n t h i c T i s s u e Sample ID N/ A Distance from Probable Point of Entry Distance from Probable Point of Entry Bioaccumulation Potential Factor Value 50,000 50,000 50,000 50,000 50,000 50,000 50,000 50,000 50,000 50,000 50,000 50,000 50,000 50,000 50,000 Hazardous Substance Orcranism 32 SWOF/ Food Chain Targets Level I Concentrations N/ A Sample ID: N/ A Sample Medium: N/ A Location: N/ A Reference: N/ A Hazardous Substance Benchmark Hazardous Substance Concentration Concentration Benchmark N / A Reference for Benchmark: N/ A Most Distant Level I Sample Sample ID: N/ A Distance from the probable point of entry: N/ A Reference: N/ A Level I Fisheries Identitv of Fisherv ( Relative to Probable Point of Entrv) Extent of the Level I Fishery N/ A Most Distant Level I1 Sample Sample ID: 98317 06 ( Sed$ A) Distance from the probable point of entry: 0.0 mi Reference: 6, pp. 6, 51 Distance from Sample ID Probable Point of Entrv Hazardous Substance Factor Value Bioaccumulation 98317 06 0.0 ( Sed 4A)

SED 5 0.0 SED 8 Benzo ( a) anthracene 50,000 Benzo (

a)

pyrene 50,000 Benzo ( g, h, i) perylene 50,000 Benzo ( k) fluoranthene 50,000 Dibenzo ( a, h) anthracene 50,000 Benzo ( a) anthracene 50,000 Benzo (

a)

pyrene 50,000 Benzo ( 9, h, i) perylene 50,000 Benzo ( k) fluoranthene 50,000 Dibenzo ( a, h) anthracene 50,000 Benzo ( a) anthracene 50,000 Benzo (

a)

pyrene 50,000 Benzo ( g, h, i) perylene 50,000 Benzo ( k) fluoranthene 50,000 Dibenzo ( a, h) anthracene 50,000 33 SWOF/ Food Chain Targets Level I1 Fisheries Extent of Level I1 Fishery I d e n t i t y o f F i s h e r v ( R e l a t i v e t o P r o b a b l e P o i n t of Entrv)

Hudson River* 0 . 0 mile**

* The Hudson River i s a f i s h e r y i n t h e v i c i n i t y of the site; a g i l l n e t t e r f i s h e s t h i s a r e a f o r American shad. Other species fished for human food chain consumption, from the area of the Hudson River adjacent to the Quanta Resources site, include striped bass, white perch, white catfish, blue crab, tomcod, American e e l , and winter flounder ( Ref. 9, pp. 1, 2 ) . The annual production of f i s h t a k e n from t h i s p o r t i o n o f t h e r i v e r i s unknown but is e s t i m a t e d t o be g r e a t e r t h a n 0 .

** Although samples were c o l l e c t e d a t t h e p r o b a b l e p o i n t s o f e n t r y t o s u r f a c e w a t e r ( i . e . , 0.0 mile), the extent of heavy end coal tar product appears to extend approximately 750 f e e t i n t o and approximately 0 . 1 m i l e along the shoreline of the Hudson River ( Ref. 6, p. 4 ) .

34 SWOF/ Food Chsin Food Chain Individual <IP_ADDRESS>.1 Food Chain Individual Sample I D : 98317 06 ( Sed@) Hazardous Substance: Benzo( a) pyrene Bioaccumulation Potential: 50,000 Note: Refer t o t h e p r e v i o u s s e c t i o n 4 . 1 . 3 . 3 f o r more details regarding the samples and hazardous substances associated with the observed release.

Type of Surface Identitv of Fisherv Water Bodv Reference Dilution Weiqht Hudson River Large River 1, p. 51613; N/ A 1 4 Based on t h e f a c t t h a t t h e Hudson River is a fishery subject to Level I1 concentrations, a value of 45 i s assigned for food chain individual factor value ( Ref. 1, P. 51620).

Food Chain Individual Factor Value: 4 5 35 SWOF/ Food Chain Level I Concentrations <IP_ADDRESS>.2 Population <IP_ADDRESS>.2.1 Level I Concentrations I d e n t i t y of Annual Production Fishery N/ A Human Food Chain Population Value Sum of Human Food Chain Population Values: N/ A Level I Concentrations Factor Value: 0 36 SWOF/ Food Chain Level I1 Concentrations <IP_ADDRESS>.2.2 Level I1 Concentrations Identity of Annual Production Fishery ( pounds) Hudson River > O Reference 1, p  51621; 9, pp. 1 3 Human Food Chain Population Value 0.03 Level I1 Concentrations Factor Value: 0.03 31 SWOF/ Food Chain Potential Human Food Chain Contamination <IP_ADDRESS>.2.3 Potential Human Food Chain Contamination Type of Identity Annual Surface Average Fishery, ( pounds) Bodv Flow Ref. Value ( P,) Weisht ( DL p i s i of Production Water Annual Population Dilution Because a maximum score of 100.00 was achieved for the surface water migration pathway without considering potential fishery production within the 15 mile TDL, Potential Human Food Chain Contamination was not scored ( NS).

Sum of PixDi: NS ( Sum of PixDi) / lo: NS Potential Human Food Chain Contamination Factor Value: NS 38 SWOF/ Environment Toxicity/ Persistence/ Bioaccumulation <IP_ADDRESS> WASTE CHARACTERISTICS <IP_ADDRESS>.1 Ecosystem Toxicity/ Persistence/ Bioaccumulation Hazardous Substance Arsenic Benzo ( a) anthracene Benzo ( a)  pyrene Benzo ( g, h, i) perylene Benzo ( k ) fluoranthene Dibenzo ( a, h) anthracene 1,1,2,2 tetra chloroethane Styrene *

* * Ecosystem Toxicity Factor Value*

100 10,000 10,000 ... ... ...

1 0 0 100 Persistence Factor Value * *

1 1 1 1 '

1 1 0.4 0 . 4 Ecosystem Toxicity/ Persistence' Factor Value ( Table 4 20)  Ref.

1 0 0 2,

p.

B 2 1 0 , 0 0 0 2, p. B 2 1 0 , 0 0 0 2, p. B 2 ... 2, p. B 3 ... 2, p. B 3 *.. 2 , p. B I 40 2, p. B 18 40 2, p. B 18 Due t o t h e f a c t t h a t t h e Hudson River i s b r a c k i s h i n t h e v i c i n i t y of the Quanta Resources s i t e ; t h e h i g h e r o f t h e f r e s h w a t e r a n d s a l t water values was evaluated for ecotoxicity ( Ref. 9, p. 2 ) .

The c l o s e s t u p s t r e a m g a g i n g s t a t i o n t h a t r e c o r d s d i s c h a r g e d a t a on the Hudson River i s l o c a t e d a t Green Island, NY. T h i s s t a t i o n reported a mean annual discharge of 13,800 feet per second ( Ref. 1 4 ) . According t o Table 4 13 of the HRS, t h i s would q u a l i f y t h e Hudson R i v e r i n t h e v i c i n i t y of t h e s i t e a s a Large River ( Ref. 1, p. 51613). Therefore, values for " River" were a s s i g n e d f o r p e r s i s t e n c e .

39 Hazardous Substance Arsenic Benzo ( a) anthracene Benzo ( a) pyrene Benzo ( g, h, i) perylene Benzo ( k) f luoranthene Dibenzo ( a, h) anthracene 1,1,2,2 tetra chloroethane Styrene * Ecosystem Toxicity/ Persistence Factor Value 100 10,000 10,000 ... ... ...

40 40 Ecosystem Toxicity/

Bioaccumulation Persistence/

Factor Value Bioaccumulation (

Section Ref.

Factor Value <IP_ADDRESS>.1.2)" No. 2, P . ( Table 4 21L 500 50,000 50,000 50,000 B 2 5 X 104 B 2 5 x 10'

B 2 5 x 10' B 3 ...

50,000 B 3 ...

50,000 E I ."

5 B 18 200 50 B 18 2 X 103 Due to the fact that the Hudson River is brackish in the vicinity of the Quanta Resources site, the higher of the fresh water and salt water values was evaluated for bioaccumulation ( Ref. 9, p. 2).

Eenzo ( a) pyrene has an Ecotoxicity/ Persistence/ Bioaccumulation values of 5 x 10'; therefore, a value of 5 x 10' is assigned for Ecosystem Toxicity/ Persistence/ Bioaccumulation.

"_""""""""""""""""""""""""""""""""~~"""""""

Ecosystem Toxicity/ Persistence/ Bioaccumulation Factor Value: 5 x l@

40 SWOF/ Environment Hazardous Waste Quantity 4 . 1 . 4 . 2 . 2 Hazardous Waste Quantity Source Hazardous ' Waste Quantity Source Number Value ( Section <IP_ADDRESS>.5.

1 2 > O > O Is source hazardous constituent quantity data complete? ( ves/ no)

no no Sum of Values:  > O The sum corresponds to a hazardous waste quantity factor value of 1 in Table 2 6 of the HRS rule ( Ref. 1, p. 51591). However, since surface water targets are subject to Level I1 contamination, then either the value of Table 2 6 or a value of 100 is assigned, whichever is greater ( Ref. 1, p. 51592). Therefore, a hazardous waste quantity factor value of 100 is assigned.

4 . 1 . 4 . 2 . 3 Waste Characteristics Factor Category Value Ecosystem toxicity/ persistence factor value X hazardous waste quantity factor value 10,000 x 100 = 1 x l o 6 ( subject to a maximum value of 1 x 10')

( Ecosystem toxicity/ persistence X hazardous waste quantity) X bioaccumulation potential factor value ( 1 x IO6) x 50,000 = 5 x 10" ( subject to a maximum value of 1 x The value exceeds the maximum of 1 x 10" for the waste characteristics product. The corresponding waste characteristics factor category value from Table 2 7 of the HRS rule is 320 ( Ref. 1, p. 51592).

Hazardous Waste Quantity Factor Value: 100 Waste Characteristics Factor Category" Va1ue: 320 41 SWOF/ Environment Targets <IP_ADDRESS> ENVIRONMENTAL THREAT  TARGETS Level I Concentrations N/ A Sample ID: Sample Medium: Location: Reference:

Hazardous Substance N/ A N/ A N/ A N/ A N/ A Reference for Benchmark: Hazardous Substance Benchma'rk Concentration Concentration Benchmark N/ A Most Distant Level I1 Sample Sample ID: N/ A Distance from the probable point of entry: Reference: N/ A Hazardous Substance N/ A Hazardous Substance Concentration N/ A 42 SWOF/ Environment Level I Concentrations <IP_ADDRESS>.1 Sensitive Environments <IP_ADDRESS>.1.1 Level I Concentrations Sensitive Environments Distance from Probable Point of Entry to Nearest ? oint of Sensitive Sensitive Environment Environment Reference Sensitive Environment Value ( s )

N/ A Sum of Sensitive Environments Value: 0 Wetlands Wetland N / A Wetland Frontaqe Reference Total Wetland Frontage: N/ A Wetland Value: 0 Sum of Sensitive Environments Value + Wetland Value: 0 Ref. N/ A Level I Concentrations Factor Value: 0 43 SWOF/ Environment Level I1 Concentrations <IP_ADDRESS>.1.2 Level I1 Concentrations Sensitive Environments Distance from Probable Point of Entry to Nearest Sensitive Point of Sensitive Sensitive Environment Environment Reference ( s ) Environment Hudson 0.0 ( State designated area for protection or maintenance of aquatic life) 10, pp. 1 5 5 Sum of Sensitive Environments Value: 5 Wetlands Wetland N/ A Wetland Frontase Reference Wetland Value: 0 Sum of Sensitive Environments Value + Wetland Value: 0 Ref. N/ A Level I1 Concentrations Factor Value: 5 44 i <IP_ADDRESS>.1.3 Potential Contamination SWOF/ Environment Potential Contamination "+  ' '

Because a maximum score of 100.00 was achieved for the surface water migration pathway, potential contamination was not evaluated.

Sensitive Environments Type of Surface Water Bodv N/ A Wetlands Type of Surface Water Bodv N / A Type of Surface Water Bodv N/ A Sensitive Environment Reference ( s ) Sensitive Environment Value ( s )

Wetlands Wetlands Frontaqe Reference ( SI of Surface Water Bodv Sum of Sensitive Wetland Environment Frontaqe Dilution Values CSjl Value ( Wjl Weiqht ( Djl Dj ( Wi + S j )

Sum of Dj ( Wj + Sj) : N/ A ( Sum Of Dj ( Wj + S j ) ) / IO: N/ A Ref. N/ A Potential Contamination Factor Value: 0 45


[Federal Register: October 10, 2008 (Volume 73, Number 198)]
[Notices]
[Page 60299-60300]
[DOCID:fr10oc08-82]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

Cardiovascular and Renal Drugs Advisory Committee; Notice of
Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Cardiovascular and Renal Drugs Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on December 10, 2008, from
8 a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, Maryland Ballroom,
8727 Colesville Rd., Silver Spring, MD. The hotel phone number is 301-
589-5200.
    Contact Person: Elaine Ferguson, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery 5630 Fishers Lane, rm.1093), Rockville, MD 20857, 301-
827-7001, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>or
FDA Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER>
in the Washington, DC area), code<PHONE_NUMBER>. Please call the
Information Line for up-to-date information on this meeting. A notice
in the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: The committee will discuss new drug application (NDA) 22-
349, IMAGIFY (perflubutane polymer microspheres) injectable suspension,
Acusphere Inc., proposed for use as an ultrasound imaging agent
indicated for patients with stable chest pain being evaluated for
inducible ischemia for the detection of coronary artery disease based
on assessment of myocardial perfusion and wall motion.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting.

If FDA is unable to post the background material on its Web site prior
to the meeting, the background material will be made publicly available
at the location of the advisory committee meeting, and the background
material will be posted on FDA's Web site after the meeting. Background
material is available at http://www.fda.gov/ohrms/dockets/ac/
acmenu.htm, click on the year 2008 and scroll down to the appropriate
advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
December 3, 2008. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those desiring to make formal
oral presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before November 21, 2008. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by November
25, 2008.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Elaine Ferguson at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: October 8, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-24199 Filed 10-9-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 84, Number 27 (Friday, February 8, 2019)]
[Notices]
[Pages 2876-2877]
[FR Doc No: 2019-01603]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-3548]

Public Warning and Notification of Recalls; Guidance for Industry
and FDA Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a final guidance for industry and FDA staff entitled
``Public Warning and Notification of Recalls.'' The guidance
establishes guidance for industry and FDA staff regarding the use,
content, and circumstances for issuance of public warnings and public
notification of recalls under federal regulations. The intent of the
guidance is to increase and expedite the appropriate and accurate use
of public warnings and public notification and to increase public
health protection by better informing the public about violative
products being recalled. The guidance clarifies and supplements
existing policy for industry and FDA staff regarding the use of public
warnings and public notification.

DATES: The announcement of the guidance is published in the Federal
Register on February 8, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or

confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your comments,
that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-3548 for ``Public Warning and Notification of Recalls ''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on this guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Strategic Planning and Operational Policy, Office of
Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr.,
Element Building, Rockville, MD 20857. Send one self-addressed adhesive
label to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.

FOR FURTHER INFORMATION CONTACT: For questions or information regarding
this document, contact Chris Henderson, Office of Regulatory Affairs,
Office of Strategic Planning and Operational Policy, Human and Animal
Food Policy Branch, Food and Drug Administration, 12420 Parklawn Dr.,
Rockville, MD 20857,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry and
FDA staff entitled ``Public Warning and Notification of Recalls under
21 CFR part 7, subpart C.'' We are issuing this guidance consistent
with our good guidance practices regulation (21 CFR 10.115). The
guidance represents the current thinking of FDA on this topic. It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.
    In the Federal Register of January 19, 2018 (83 FR 2758), we made
available a draft guidance for industry and FDA Staff entitled ``Public
Warning and Notification of Recalls under 21 CFR part 7, subpart C,
Draft Guidance for Industry and FDA staff'' and gave interested parties
an opportunity to submit comments by March 20, 2018, for us to consider
before beginning work on the final version of the guidance. We received
comments on the draft guidance. We considered every comment and made
changes, where appropriate. The guidance announced in this notice
finalizes the draft guidance dated January 17, 2018.
    The guidance establishes official guidance for industry and FDA
staff regarding the use, content, and circumstances for issuance of
public warnings and public notification of recalls under 21 CFR part 7,
subpart C. The intent of the guidance is to increase and expedite the
appropriate and accurate use of public warnings and public notification
and to increase public health protection by better informing the public
about violative products being recalled. The guidance clarifies and
supplements existing policy for industry and FDA staff regarding the
use of public warnings and public notification.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). Any collection of information, such as a firm's public warning
(21 CFR 7.42(b)(2)), has been approved under OMB control number 0910-
0249.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Safety/Recalls/default.htm or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.

    Dated: January 16, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-01603 Filed 2-7-19; 8:45 am]
 BILLING CODE 4164-01-P