PERMIT RATIONALE FOR REISSUANCE
Baxter Healthcare Corporation
Bolivar County
Cleveland, Mississippi
Water NPDES No. MS0000833
January 2021

I.	FACILITY INFORMATION

Facility Name:  		Baxter Healthcare Corporation
Facility Address:  	911 North Davis Avenue 
	Cleveland, MS  38732    
Cleveland, 
Permit No.:  		MS0000833
SIC:  			2834
Permit Writer:  		Samar Patel
EPD Branch:  		Water I Branch

II.	NATURE OF BUSINESS
Baxter Healthcare Corporation (Baxter) manufactures intravenous/irrigation solutions and medical devices used in the healthcare industry.  Baxter extrudes molds, sterilizes, and fills plastic bottles with solutions made at their Cleveland facility.  

III.	EFFLUENT AND RECEIVING STREAM FLOW DATA

External Outfall 001: discharges a long term average flow of 1.13 MGD and a daily maximum flow of 2.79 MGD into a drainage ditch (7Q10=0) then into Lead Bayou. Discharge consists of internal Outfall 101 wastewater, 0.040 MGD of non-contact cooling water, and 0.082 GD of storm water. 

Internal Outfall 101: discharges a long-term average flow of 1.06 MGD and a maximum daily flow of 2.69 MGD into the Clearwater Pond. Discharge consists of the following waste streams: 

•	Boiler blowdown (60,000 gpd)
•	Air compressor cooling (40,000 gpd)
•	Solution filling/packing/mix (196,000 gpd) 
•	Sanitary (10,000 gpd)
•	Steam sterilization (215,000 gpd)
•	Reverse osmosis (789,000 gpd) 
•	Reverse osmosis softening (15,000 gpd)
•	Still blowdown and drains (30,000 gpd)
•	Miscellaneous (~23,500)

IV.	TOTAL MAXIMUM DAILY LOAD (TMDL) AND 303(d) ISSUES

Lead Bayou is not listed on the 2018 303(d) list of Impaired Water Bodies

This permit complies with the following applicable TMDLs:

Organic enrichment/low DO for the Lead Bayou TMDL was finalized September 2013.  The TMDL specifically addressed the discharge from Baxter, assigning average limits of 10 mg/L for CBOD5, 2 mg/L for NH3 (as nitrogen), and 6 mg/L minimum DO.  

Organic enrichment/low DO, nutrients and sediment/siltation for the Big Sunflower River TMDL finalized June 30, 2003, determined that the NPDES point sources did not contribute significant amounts of sediment and did not assign specific limits to Baxter. 

The monitoring for total nitrogen (TN) and total phosphorous (TP) are based upon the Yazoo River Basin TMDL for nutrients for selected Large Rivers in the Delta. The TMDL was completed in June of 2008. Although this site is not listed as one of the point source in the 2008 TMDL, the draft permit carries forward the quarterly monitoring for TN and TP to be consistent with the recommended quarterly monitoring for nutrients as specified in the nutrient TMDL

V.	TYPE OF WASTEWATER TREATMENT:

External Outfall 001:  sedimentation and dechlorination

Internal Outfall 101:  neutralization, activated sludge and chlorination prior to discharge from the Clearwater Pond.

VI.	DATA FROM APPLICATION FORM 2C

           	  External Outfall 001
Parameter	Maximum Daily Value	
Biochemical Oxygen Demand, 5-Day (BOD5)	ND	
Chemical Oxygen Demand (COD)	19.5 mg/L	
Total Organ Carbon (TOC)	5.22 mg/L	
Total Suspended Solids (TSS)	31 mg/L	
Flow	2.79 MGD	
Temperature (max)	31.1oC	
pH	8.38-8.94 SU	
Bromide	0.431 mg/L	
Chlorine, Total Residual	0.419 mg/L	
Ammonia (as N)	0.657 mg/L	
Fluoride	0.203 mg/L	
Nitrate-nitrite	0.457 mg/L	
Nitrogen-total organic (as N)	ND	
Oil and grease	ND	
Phosphorus	0.712 mg/L	
Sulfate	40.8 mg/L	
Surfactants	0.133 mg/L	
Barium	0.010 mg/L	
Boron	0.308 mg/L	
Magnesium	0.818 mg/L	
Molybdenum	0.004 mg/L	
Antimony	0.00228 mg/L	
Arsenic	0.00126 mg/L	
Copper	0.026 mg/L	
Mercury	1.46 ng/l	
Zinc	0.026 mg/L	
            
             Internal Outfall 101 
Parameter	Maximum Daily Value	
Biochemical Oxygen Demand, 5-Day (BOD5)	9.3 mg/L	
Chemical Oxygen Demand (COD)	48 mg/L	
Total Organ Carbon (TOC)	4.03 mg/L	
Total Suspended Solids (TSS)	26.0 mg/L	
Ammonia (as N)	2.0 mg/L	
Flow	2.69 MGD	
Temp. (max)	32oC	
pH	7.77-8.98 SU	
Bromide	0.567 mg/L	
Chlorine, Total Residual	ND	
Fecal Coliform	280 col/100 mL	
Oil and grease	ND	
Phosphorus	ND 	
Sulfate	51.1 mg/L	
Barium	0.019 mg/L	
Boron	0.442 mg/L	
Magnesium	1.07 mg/L	
Molybdenum	0.007 mg/L	
Antimony	0.00154 mg/L	
Arsenic	0.00092 mg/L	
Lead	0.00091 mg/L	
Copper	0.0245 mg/L	
Mercury	4.38 ng/l	
Nickel	0.00097 mg/L	
Zinc	0.026 mg/L	

VII. 	WATER QUALITY LIMITATIONS BASED ON WASTELOAD ALLOCATION 

Wasteload Allocation (WLA) received October 5, 2020 (See Appendix I).  The following limits are consistent with the TMDL for Lead Bayou and shall be applied at the internal Outfall 101.

Parameter	Average	
Flow	Report (MGD)	
Carbonaceous Biochemical Oxygen Demand, 5-Day (CBOD5)	10 mg/L	
Total Ammonia Nitrogen (NH3-N)	2.0 mg/L	
Minimum Dissolved Oxygen (Min. DO)	6.0 mg/L	
E. coli (replacing Fecal Coliform)	126 col/100mL	
Total Residual Chlorine (TRC)	0.011 mg/L	
Total Nitrogen (TN)	Report lb/day	
Total Phosphorus (TP)	Report lb/day	
pH	6.0 SU - 9.0 SU	

VIII.	EPA APPLICABLE CATEGORICAL GUIDELINES AND LIMITATIONS

40 CFR Part 439, Subpart D, the Mixing/Compounding and Formulation Subcategory of the Pharmaceutical Manufacturing Category. Applicable to the wastewater generated from solution filling/packing/mix operations discharged from internal Outfall 101.  

Parameter	Maximum Monthly Average	Daily Maximum	
BOD5	Mass loading limit based on 45 mg/L = 397.8 lb/day	N/A	
TSS	Mass loading limit based on 1.7 x BOD5 limit = 676.3 lb/day	N/A	
COD	86 mg/L	228 mg/L	
	439.42 (BPT) and 439.43 (BCT) limit BOD5 and TSS and 439.44 (BAT) limits COD.
	Loads in lb/day = (flow MGD) x (concentration in mg/L) x (8.34)
	The long term average flow of 1.06 MGD used to calculate loads.
	BOD5 = (1.06 MGD) x (45 mg/L) x (8.34) = 397.8 lb/day
	TSS = (BOD5 lb/day limit) x (1.7) = 676.3 lb/day

IX.	TOXICITY SCREENING

The copper criteria were previously adjusted based upon hardness of less than 25 mg/L and a Water Effect Ratio (fWER) of 15. 

A previously authorized fWER must be re-evaluated during the 5th year of the current permit and a fWER of 15 or greater must be achieved to retain the initial fWER. The permittee conducted a single sampling WER study in July 2019 and a fWER result of 41.2 was achieved; therefore, the initial WER has been retained. 

The adjusted copper criteria utilizing fWER of 15:
Chronic (monthly average) criterion = 0.00274 * 15 = 0.0411 mg/l
Acute (daily maximum) criterion = 0.00364 * 15 = 0.0546 mg/l

QW	=	max. 30-day avg. wastewater flow
Qr	=	receiving stream flow (7Q10 flow used for acute and chronic screening and Mean Annual Flow (MAF) used for Human Health screening). 7Q10 and MAF=0
Xr	=	receiving stream concentration
XW	=	historical effluent data (use max. concentration for acute screening and LTA concentration for chronic and human health screening); Cu DMR data August 2019 – July 2020; Zn DMR data June 2017 – June 2020.
XWa 	=	permit limits from previous permit or from effluent guidelines
Xta	=	the calculated instream concentration based on existing permit limits or the              			calculated limit based on current effluent guidelines
Xt	=	the calculated instream concentration based on historical effluent data 
IWC 	=	Instream Wastewater Concentration

Qr = 0 MGD (7Q10); 0 MGD (Mean Annual Flow) 

IWC = 100 * QW / (Qr + QW) 
Since Qr = 0, IWC = 100%

Xt = (Qr*Xr) + (Qw*XW) / (Qr + QW)
When Xr = 0 then Xt = Xw * IWC/100
Since IWC = 100%; Xt = Xw
Toxicity Screening Summary

Parameter	Max. Xt
(mg/L)	AWQC (mg/L)	Pass/
Fail	Avg. Xt
(mg/L)	CWQC (mg/L)	Pass/
Fail	Avg. Xt
(mg/L)	HHC (mg/L)	Pass/
Fail	
Arsenic, Total	0.0126	0.340	Pass	0.0126	0.150	Pass	0.0126	0.024	Pass	
Copper, Total	0.045 	0.05462	Pass	0.0255 	0.04112	Pass	0.0255 	1	Pass	
Mercury, Total	0.0000146	0.0018	Pass	0.0000146	0.00094	Pass	0.0000146	0.000153	Pass	
Zinc, Total	0.040	0.065	Pass	0.040	0.065	Pass	0.040	26	Pass	
1Mississippi default freshwater aluminum criteria values.  
2Adjusted criteria based on WER study.
 AWQC = Acute Water Quality Criteria; CWQC = Chronic Water Quality Criteria; HHC = Human Health
 Criteria

X.	PROPOSED FINAL LIMITATIONS 

1.	External Outfall 001

Average
Parameter	Categorical Limit (CAT)	Water Quality Limit (WQL)	Current Permit Limit (CPL)	Proposed Permit Limit	Sampling Frequency	Basis	
Flow	N/A	N/A	Report MGD	Report MGD	Continuous	CPL	
Alkalinity1	N/A	N/A	Report mg/L	Report mg/L	Quarterly	WER	
pH	6.0 SU (min)	6.0 SU (min)	6.0 SU (min)	6.0 SU (min)	Twice/Month	CAT	
Chlorine, total residual (TRC)	N/A	0.011 mg/L	0.011 mg/L	0.011 mg/L	Twice/Month	MSWQS
WLA	
Hardness1	N/A	N/A	Report mg/L	Report mg/L	Quarterly	WER 	
Total Nitrogen (TN)	N/A	Report lb/day	Report lb/day	Report lb/day	Quarterly	TMDL	
Total Phosphorus (TP)	N/A	Report lb/day	Report lb/day	Report lb/day	Quarterly	TMDL	
TOC1	N/A	N/A	Report mg/L	Report mg/L	Quarterly	WER	
Copper	N/A	N/A	0.0411 mg/L	0.0411 mg/L	Quarterly	WER 	
Zinc	N/A	0.065 mg/L	0.065 mg/L	0.065 mg/L	Quarterly	MSWQS 	

	Maximum
Parameter	Categorical Limit (CAT)	Water Quality Limit (WQL)	Current Permit Limit (CPL)	Proposed Permit Limit	Sampling Frequency	Basis	
Flow	N/A	N/A	Report MGD	Report MGD	Continuous	CPL	
Alkalinity1	N/A	N/A	Report mg/L	Report mg/L	Quarterly	WER	
pH	9.0 SU (max)	9.0 SU (max)	9.0 SU (max)	9.0 SU (max)	Twice/Month	CAT	
Chlorine, Total Residual (TRC)	N/A	N/A	0.019 mg/L	0.019 mg/L	Twice/Month	MSWQS
CPL	
Hardness1	N/A	N/A	Report mg/L	Report mg/L	Quarterly	WER 	
Total Nitrogen (TN)	N/A	Report lb/day	Report lb/day	Report lb/day	Quarterly	TMDL	
Total Phosphorus (TP)	N/A	Report lb/day	Report lb/day	Report lb/day	Quarterly	TMDL	
Temperature	N/A	90oF	90oF	90oF	Twice/Month	MSWQS	
TOC1	N/A	N/A	Report mg/L	Report mg/L	Quarterly	WER	
Copper	N/A	N/A	0.0546 mg/L	0.0546 mg/L	Quarterly	WER 	
Zinc	N/A	0.065 mg/L	0.065 mg/L	0.065 mg/L	Quarterly	MSWQS 	

2.	Internal Outfall 101

      Average
Parameter	Categorical Limit (CAT)	Water Quality Limit (WQL)	Current Permit Limit (CPL)	Proposed Permit Limit	Sampling Frequency	Basis	
Flow	N/A	N/A	Report MGD	Report MGD	Continuous	CPL	
pH	6.0(min)	6.0(min)	6.0(min)	6.0(min)	Twice/month	MSWQS	
NH3-N	N/A	2.0 mg/L	2.0 mg/L	2.0 mg/L	Weekly	WLA
TMDL	
e. coli
	N/A	126 col/100mL	N/A	126 col/100mL	Twice/Month	MSWQS
WLA	
BOD5	397.8 lb/day
45 mg/L	10 mg/L	107 lb/day
(10 mg/L)	107 lb/day 
(10 mg/L)	Weekly	WLA
TMDL	
COD	86 mg/L	N/A	427 lb/day
(40 mg/L)	427 lb/day
40 mg/L	Weekly	CPL	
Min. DO	N/A	6.0 mg/L	6.0 mg/L	6.0 mg/L	Weekly	WLA
TMDL	
TSS	676.3 lb/day
(76.5 mg/L)	N/A	181 lb/day
(17 mg/L)	181 lb/day
(17 mg/L)	Weekly	CPL	

	      Maximum 
Parameter	Categorical Limit (CAT)	Water Quality Limit (WQL)	Current Permit Limit (CPL)	Proposed Permit Limit	Sampling Frequency	Basis	
Flow	N/A	N/A	Report MGD	Report MGD	Continuous	CPL	
pH	9.0(max)	9.0(max)	9.0(max)	9.0(max)	Twice/month	MSWQS	
NH3-N	N/A	N/A	3.0 mg/L	3.0 mg/L	Weekly	CPL	
e. coli	N/A	410 col/100mL	NA	410 col/100mL	Twice/Month	MSWQS
WLA	
BOD5	N/A	N/A	214 lb/day
(20 mg/L)	214 lb/day
(20 mg/L)	Weekly	CPL	
COD	228 mg/L	N/A	854 lb/day
(80 mg/L)	854 lb/day
(80 mg/L)	Weekly	CPL	
TSS	N/A	N/A	363 lb/day
(34 mg/L)	363 lb/day
(34 mg/L)	Weekly	CPL	

* ENG = Engineering Judgment, WER = Water Effect Ratio Study, TMDL = Total Maximum Daily Load, MSWQS = MS Water Quality Standards, CAT=Categorical Limit, CPL= Current Permit Limit; WLA = Wasteload Allocation

Water quality-based limitations, existing permit-based limitations, and categorical limitations were evaluated as shown in the table above to determine the proposed limits, with the most stringent of all three limits proposed since it will be most protective of water quality. Even though the categorical limitations were found to be higher than the present permit limitations, the applicant has demonstrated the ability and technology, to meet the current more stringent limits. Therefore, the limits originally set in the permit will not be changed during this renewal for the aforementioned parameters based on the Anti-Backsliding provisions of 11 Miss. Admin. Code Pt. 6, Ch. 1, Subch. 1 of Wastewater Regulations for NPDES Permits. 

1	The monitoring for hardness, alkalinity, and TOC in the previous permit were based on EPA’s Interim Guidance on Determination and Use of Water Effect Ratios for Metals (the Guidance) dated February 1994. Based on our review of historical DMR data and the application submitted June 13, 2019, these constituents are present in effluent wastewater. Water quality standards do not limit these constituents in the effluent. Based on our engineering judgment and anti-backsliding provisions, monitoring for these constituents will be retained in the proposed draft permit. The DMR data showed that the values reported for these constituents are consistent with the values reported in the 2019 WER study.

Effluent Monitoring Requirements:

The Outfall 001 flow shall be measured continuously utilizing a continuous recorder. TRC, pH,  e. coli, and dissolved oxygen shall be measured via grab samples. Temperature shall be measured instantaneously. All other parameters shall be measured with 24 hr. composite samples.

Whole Effluent Toxicity (WET): 
The chronic WET tests conducted using Pimephales promelas (Fathead minnow) and Ceriodaphnia dubia in July 2019 and November 2019 have IC25 of greater than 100% IWC for chronic toxicity so no additional effluent characterization testing is required in the permit.
 
However, in accordance with the State of Mississippi, Wastewater Regulations, 11 Miss. Admin. Code Pt. 6, Ch.1 and TSD guidance document, the permittee is required to retest the effluent discharge for chronic toxicity during the last year of this permit term and submit these results with the application for the next permit reissuance. The sampling frequency during effluent characterization shall be at least twice per year and sampling shall be timed to cover the seasonal extremes of the year such as hot-dry or cold-wet.

APPENDIX I

WASTELOAD ALLOCATION 
OCTOBER 5, 2020