Cenogenics Corporation 

100 Route 520 • Drawer 308 

Morganville, New Jersey 07751 

Telephone (732) 536-6457 • (800) 747-9457 

Fax (732) 972-8527 • e-mail: cenogenics@verizon.net 

In the Matter of 

Cenogenics Corporation 

FAA Docket No. CP10EA0007 

FDMSNo. FAA-2010-0786 

CERTIFICATE OF SERVICE 

I hereby certify that the Answer following has been sent this date by Federal Express addressed 

as follows: 

Original and One Copy 

The Honorable Ronnie A. Yoder, Chief Administrative Law Judge 

U.S. Department of Transportation 

Office of Hearings, M-20, Room El 2-320 

1200 New Jersey Avenue, S.E. 

Washington, DC 20590 

Hearing Docket Clerk, AGC-430 

Federal Aviation Administration 

Wilbur Wright Building - Suite 2W 1000 

800 Independence Avenue, S.W. 

Washington, DC 20591 

Jeanine C. Gotimer, Complainant's Council 

Attorney, Office of the Regional Council, EAL-7 

Eastern Region 

Federal Aviation Administration 

1 Aviation Plaza 

Jamaica, NY 11434 

i j j 

XI 

CO 

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CO 

Respectfully submitted, 

Cenogenics Corporation 

100 Route 520,Drawer 308y / ^ 

MorganvilteC^077^ Z ' /-^""^y 

Bvj^^/^<i%^^<^^- ^ ' A ^ 

Michael Katz ~) 

President 

Date: August 26, 2010 

Certified To ISO 9001 and ISO 13485 
Cenogenics Corporation 

100 Route 520 • Drawer 308 

Morganville, New Jersey 07751 

Telephone (732) 536-6457 • (800) 747-9457 

Fax (732) 972-8527 • e-mail: cenogenics@verizon.net 

August 25, 2010 

U.S. Department of Transportation 

Office of Hearings, M-20, Room El 2-320 

120 New Jersey Avenue, S.E. 

Washington, DC 20590 

To: The Honorable Ronnie A. Yoder, Chief Administrative Law Judge 

Re: In the Matter of Cenogenics Corporation 

FAA Docket Number: CP10EA0007 

Answer 

Cenogenics Corporation, the respondent, hereby files its Answer to the complaint filed August 4, 

2010 as shown in the above stated docket number. 

Cenogenics takes the position that the allegations in the above complaint are without merit and 

request a re-consideration of the civil penalty. We present the following in support of our 

position (please note the complaint numbers referenced below are those cited in the letter dated 

August 4, 2010): 

Reference Complaint Number 2: related to 49 C.F.R. 172.704, Training 

We disagree with the allegation that Cenogenics Corporation has not trained its hazmat 

employees in accordance with C.F.R. 172.704 and would like to present the following evidence 

in support of our position. Cenogenics has in place and has had in place training procedures 

and records to satisfy the requirements of the above code of federal regulation. 

• Cenogenics has in place, and has had in place, since the onset of our shipping the 

hazardous material in question a procedure for packaging the product for shipment. See 

attached Standard Operating Procedure (S.O.P.), PG-0573-05 (Attachment 1). Please 

note that this procedure has been revised 5 times (evidenced by the generation number, 

the last two digits of the S.O.P. number), as required by regulatory changes over the 

years. Only one employee has responsibility for the packaging of the product, Bert 

Valville, the production technician. Prior to packaging and shipping the product in 

question, the new employee, Bertrand Valville, who manufactured and packaged the 

product received "function-specific" training ( as required by 172.704(1) and (2)) and was 

supervised by myself, Nitza Katz. Bert Valville was tested by demonstrating his ability to 

perform the task correctly under my supervision. We consider correct work performance 

is the best and most "appropriate means" of testing (172.702 (d) states "...employer 

shall ensure that each of its hazmat employees is tested by appropriate means...."). 

Attached (Attachment 2) is Bert Valvule's training record (S.O.P. OP-00111-04) for all of 

Certified To ISO 9001 and ISO 13485 
the Organization's Standard Operating Procedures (an FDA/ISO requirement). The 

employee and instructor signatures are record of training. Evidence of proper work 

performance (test) is recorded by my signature under "Training Effective Date". Please 

refer to the S.O.P. titled "Packaging Developer for Austria", S.O.P. PG-0573-05. I have 

highlighted the relevant reference for your review. 

Safety training (as required under 172.704 (3)) as well as PPE (Personal Protective 

Equipment as required by 172.704 (3) (ii)) is provided to each employee that handles 

hazardous materials, as required by OSHA and also within the scope of 172.704, within 

days after the start of employment. Please reference attached Chemical Hygiene Plan, 

S.O.P. SF-0025-02 (Attachment 3), Bloodborne Pathogen Exposure Control Plan, 

S.O.P. SF-0023-02 (Attachment 4) and Chemical Hazard Communication Plan, S.O.P. 

SF-0098-01 (Attachment 5). I have also attached, as evidence of training, the signed 

training records for these procedures for our newest employee, Bertrand Valville 

(Attachments 6-8). Please note the starting date of his employment was 2/17/09 and the 

training was conducted from 2/18/09 through 3/16/09. 

Emergency response and security awareness training ( 172.704 (3)(i), (4) and (5) are 

provided in the Occupant Emergency Response Plan, S.O.P. SF-00153-03. The 

procedure (Attachment 9), and a signed training record (Attachment 10) are attached for 

your review. Please note that though the references cited for this procedure are CFR 

121.12 and CFR 73.12 (USDA and CDC), CFR 172.704, under (5) (b) allows that 

training " required by other Federal or international agencies, may be used to satisfy 

the training requirements in paragraph (a) ". 

In addition to the above safety documents used for hazardous materials safety training, 

each of our manufacturing instruction procedures is preceded by a section titled 

"Caution" in which the safety precautions for the specific chemicals and/or biological 

materials used in that procedure are detailed. All of our manufacturing procedures 

require verification by a "checker" for each critical step of the process. This is an FDA 

requirement. In essence, each operator is being tested each time he/she uses a 

hazardous material in the manufacture of a product. 

Subsequent to the inspection by Special Agent Charies Odum and at his suggestion, I 

registered for an online Dangerous Goods training with DGI and completed certification. 

Attached is a copy of my DG certificate (Attachment 11). 

Our method for testing has been for the employee to show his/her ability to perform the 

work correctly. We consider this the most "appropriate means". The works is inspected 

by a Supervisor in-house and by our freight fonwarder (see response to Numbers 3, 4 

and 5). However, at the suggestion of the inspector, following my certification, I added 

an additional test. I prepared written function-specific tests for the two employees 

involved in aspects of the DG shipping. Attached are copies of the tests (Attachments 12 

and 13). 

Reference Complaint Numbers 3 and 4 and 5, Shipper's Declaration for Dangerous 

Goods Training for Eileen Kerster 

• Eileen Kerster is the Organization's export secretary and customer service 

representative. She does not handle hazardous materials. Her function with respect tp 

hazardous material shipping is to complete all of the documentation required for the 

Organization's shipments. Eileen Kerster has been made aware of the nature of our 

product that is considered dangerous goods and has had training in the completion of 

the Shipper's Declaration of Dangerous Goods. Her "function-specific" training and 

£3-
testing, as well as mine and Mr. Katz's, has been provided by our freight fonwarder, Air 

Sea International Forwarding, Inc. as permitted under 49 C.F.R. 172.702(c), "Training 

may be provided by the hazmat employer or other public or private sources.". She 

prepares the declaration under the direct supervision of Ray Tobia, president of Air Sea, 

who is certified by DGI Training Center to ship dangerous goods and renews his 

certification every two years. Mr. Tobia reviews the DG Declaration for each shipment 

and inspects the cargo for proper packaging and labeling. Therefore, Eileen Kerster is, in 

effect, being tested each time a shipment is prepared. Additionally, the cargo and 

documentation is inspected by the airiine's hazardous material specialist prior to 

shipping. We consider this an "appropriate means" of testing since there can be no 

better test than correct work performance. I have attached for your review a copy of Ray 

Tobia's DG certificate (Attachment 14) and a letter from Ray Tobia (Attachment 15) 

describing the procedure we have had in place for the past 14 years for the direction, 

supervision and review of the DG shipment and documentation. 

Further to the evidence presented above, I find the allegation that Eileen Kerster had not 

received function-specific training illogical. As described above, her function within the 

organization with respect to DG is to complete the documentation. If Eileen Kerster had 

not had awareness training, how is it that she knew that the Declaration For Dangerous 

Goods was a regulatory requirement? Had she not been properiy trained, how is it that 

she knew how to correctly fill out the Declaration? 

Reference Complaint Number 6, General Training 

• Only two employees have responsibility for DG shipments that are sent by air, the 

technician that manufactures and packages the product and the export secretary that 

prepares the documentation. Both of these individuals have had function specific training 

and performed their tasks under the direct supervision of an immediate supervisor or a 

DG certified individual. Please reference my responses above. 

Reference Complaint Number 7, Emergency Telephone Number 

• Cenogenics has provided two telephone numbers on the Shipper's Declaration For 

Dangerous Goods where either Michael Katz or myself can be reached at all times when 

shipping DG. One number is the business number and the second number is our home 

number. Since my husband and I have overiapping work hours, one or the other can be 

reached at all times during the shipping of DG. Attached are copies of the DG 

Declaration for the two shipments in question (Attachments 16 and 17). Please note at 

the bottom right of each form that there are two telephone numbers listed next to the line 

"24 hr. Emergency contact Tel. No.". 

Reference Complaint Numbers 8 and 9, UN1170 Ethanol Solution 

» We disagree with the allegation that we used the incorrect description for the DG in 

question for the following reason. The shipment in question under your number 8 and 9 

is the VDRL Antigen, a diagnostic reagent for the detection of syphilis infections. The 

product consists of a solution of ethanol, cardiolipin, cholesterol and lecithin. Only the 

t,i 
ethanol solution is listed as dangerous goods. Therefore, the proper shipping name as 

shown in both of the DGR tables, CFR172.101 and the lATA table 4.2 is ethanol solution 

and the UN number shown in both tables is UN1170. 1 have attached copies of the 

relevant pages of both tables for your review (Attachments 18 and 19). The lATA 

regulation 4.1.2.1(c) states that the generic description (in this case, as you stated, 

"Flammable Liquids") is to be used only when "an article or substance is not listed by 

name in the List of Dangerous Goods". Please reference attached photocopy from the 

lATA Dangerous Goods Regulations (Attachment 20). In this case, since the proper 

name of the hazardous material was listed (ethanol solution) in both the DGR and the 

lATA tables, it is required in the description. For this reason we used "ethanol solution" 

with its corresponding UN number as the description. Also, please note that for both the 

generic and the proper name, the hazardous class and the packing group are the same. 

Reference Complaint Number 10, Shipment UN1986 

• For this product also, we would like to offer reasons for our description use. The product 

solution in this shipment consists of specially denatured ethyl alcohol with toluene, 

hydrogen peroxide and water. The toluene is not a separate component that is added to 

the formulation; it is the denaturing agent of the raw material ethyl alcohol. The toluene 

is also classified as a flammable and is the same class and packaging group as the 

alcohol. The second component most contributing to the hazard of the mixture is 

hydrogen peroxide. However, the final concentration of the hydrogen peroxide in the 

mixture is much less than 8%. The 172.101 table of hazardous substances only 

describes hazardous conditions of hydrogen peroxide solutions at a concentration of at 

least 8% (Attachment 21). Additionally, the lATA List of Dangerous Goods, table 4.2 

(Attachment 22), describes hydrogen peroxide solutions of less than 8% as "not 

restricted". It is therefore, not a requirement to provide the name of this component in the 

description since the concentration in the product is less than 8% and therefore, not 

considered a hazardous material. 

I have attached oUr manufacturing protocol, S.O.P. MP-0531-04, and testing data for this 

product as record of verification of the concentration of the hydrogen peroxide in our 

reagent solution (Attachment 23). 

In addition, I would like to state that Cenogenics Corporation, as a medical device manufacturer, 

is regulated by numerous government agencies. We are a small company of only nine 

employees. In our twenty-eight year history, we have never attempted to defy, circumvent or 

ignore regulations. We are legally registered and regulariy inspected by the FDA, USDA, CDC 

and OSHA. Additionally, we are registered to ISO 9001 and ISO 13485 (a voluntary 

International Standard Organization). They, too, audit our Organization annually for compliance 

to the ISO Standard as well as compliance to international regulation that apply to our industry. I 

am proud to report that we have an excellent track record. At no time during our history has any 

agency found that we were in defiance of regulatory requirements. We certainly made no 

attempt to avoid DG regulations as is evidenced by our completion of the Declaration of 

Dangerous Goods and the numerous procedures we have in place. Furthermore, we were 

forthright with information requested by the FAA agents. We were also happy and quick to 

comply with the suggestions made by the agent and viewed these as improvements to our 

already existing procedures. I offer this information as evidence that Cenogenics is and always 

has been aware of and made every effort to comply with any and all applicable regulatory 
requirements. We, therefore, feel that the facts and circumstances, as demonstrated, do not 

warrant the proposed civil penalty. Thank you for your consideration. 

Further to our Answer, we would appreciate an opportunity to present financial statements 

showing we have suffered significant financial loses making it a severe hardship to pay the fine 

as proposed. We would also appreciate knowing the financial reporting format and 

documentation required for your court's examination. In addition, we believe our responses 

showing that we take the shipment of hazardous materials seriously, work hard to be in 

compliance and immediately undertake suggestions for improvement can provide a basis for 

settlement. 

Your kind consideration in allowing the hearing in this matter be held in Newark, New Jersey 

would be appreciated. 

Respectfully submitted. 

Nitza Katz 

Vice President and Quality Manager 

Enclosures: 

Attachments Nos.1 - 23 and Certificate of Service 
ATTACHMENT 1 

CENOGENICS CORPORATION 

PACKAGING PROCEDURE 

STOOL BLOOD TEST DEVELOPING SOLUTION FOR DIPRO 

Procedure prepared by: Michael Locke Date: 2/1/08 S.O.P. PG-0573-05 

Procedure approved by: Nitza Katz Date: 2/1/08 Supersedes: PG-0573-04 

CONTAINER 

NOTE: The S.B. Developing Solution is filtered directly into the shipping container. 

SPECIFICATIONS: 

15 gallon Delex plastic drum, tighthead ST15G TH PL DRUM, 0203-white UN CODE 

1H1/Y1.8/100 

Maximum fill allowed in drum is 60 liters. 

VENDOR: 

National Packaging 

65 Railroad Avenue ^ ^ %-^^ 

Ridgefield, New Jersey 07657 

FAX: (201)941-8777 

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„ X'-^ 

FOR PICK UP: 

60 North Union 

Hillside, New Jersey 

(908) 688-4299 

LABELS: 

1. CUSTOMER ADDRESS LABEL 

2. DEVELOPER REAGENT 

LOT NUMBER 

EXPIRATION DATE 

VOLUME 

CONTAINER NUMBER (1 of 2, 2 of 2, etc.) 

# 

^ \ ^ 
STOOL BLOOD TEST DEVELOPING SOLUTION FOR DIPRO S.O.P. PG-0573-04 PAGE 2 of 2 

3. ALCOHOLS, FLAMMABLE, TOXIC, N.O.S. 

UN NO. 1986 

CLASS/DIVISION 3 

PACKING INST. 307 

(ETHYL ALCOHOL) 

PACKING GROUP II 

PLEASE KEEP DRUM UPRIGHT 

4. FLAMMABLE LABEL (see attached sample) 

5. CARGO ONLY LABEL (see attached sample) 

actual wording is DANGER DO NOT LOAD IN PASSENGER AIRCRAFT 

6. TOXIC 6 LABEL (see attached sample) 

7. ARROW LABEL (see attached sample) 

NOTE: DO NOT USE OXIDIZER LABEL. 

OFFICE 

A Shipper's Declaration and an R/A form must be completed. The JR 

include "UN 1986" in UN or I.D. No. field. ^ ^ 1>-

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CENOGENICS CORPORATION ATTACHMENT 3 

GENERAL OPERATIONS 

• ^ 

CHEMICAL HYGIENE PLAN FOR LABORATORY DIAGNOSTICS/CENOGENICS 

Procedure Prepared by ^^^^^yy^^^ l Date y^^/< ^ ^ SOP: SF-0025-02 

Procedure Approved h\i y^^-^^t^^u^f-^y^^yy^^ Date ///^Ap . Supersedes: SF-0025-01 

Introduction: 

The purpose of this Chemical Hygiene Plan is to provide employees who have 

occupational exposure to laboratory chemicals with procedures and practices that will 

protect them from health hazards presented by laborator^^micals in the workplace. 

The procedures and practices herein will meet thejie^S^m'ents set forth in 29 CFR 

Part 1910.1450. .^^® ^ G 

Exposure Determination: ^^ ^ 

At this facility only some of the employees have AG)mi|B|tnJ>n£il exposure to laboratory 

chemicals. The following job classifications and ta^lgp^re as follows: 

1. Production Manager and Laboratory Technicians: Direct hands-on-contact with 

a variety of laboratory chemicals. 

2. Shipping Clerk: Responsible for receiving laboratory chemicals into the 

warehouse and transporting them to the laboratory. 

Implementation Schedule and Methods: 

Engineering and work practice controls will be utilized to reduce or eliminate the 

exposure to laboratory chemicals. The procedures and practices herein fall under the 

following headings: 

1. General Principles for Work with Laboratory Chemicals 

2. Labels and Symbols 

3. Hazard Identification 

4. A Complete List of all Laboratory Chemicals 

5. Personal Protective Equipment (PPE) 

6. Additional Protective Equipment 

7. Usage of Respirators 

8. Designated Workspace 

9. Receiving and Storage of Laboratory Chemicals 

10. Hazardous Waste Disposal 

11. Housekeeping 

12. Spills and Accidents 

13. First Aid Training 

14. Fire Plan/Emergency Contacts 

15. Medical Plan 

16. Information and Training 
CHEMICAL HYGIENE PLAN FOR S.O.P. SF-0025-02 PAGE 2 

LABORATORY DIAGNOSTICS/CENOGENICS 

1. Reneral Prinriples for wor k wit h i ahoratnry Chemicals 

The following should be used for all laboratory work with laboratory chemicals: 

a. Read all "Cautions" on Master Production Records (MRP). 

b. Become knowledgeable of the Material Safety Data Sheet (MSDfi£^V4l*chemical 

before using it in a procedure. Be aware of all health hazar^^^d precautions 

outlined in the MSDS. 

c. Be able to identify all Hazard Symbols and National Fire Protection Association 

(NFPA) Waming Diamonds on all laboratory chemicals. (See Appendix A). 

d. Do not smell or taste chemicals. 

e. Avoid eating, drinking, smoking, gum chewing or applying cosmetics in areas 

where laboratory chemicals are present. 

f. Do not use damaged glassware. 

g. Use labware only for its intended use. 

h. Wash hands before leaving the laboratory. 

i. Avoid practical jokes that will startle another worker. 

j . Do not mouth suction for pipetting or starting a siphon. 

k. Confine long hair and loose clothing. Do not wear sandals, perforated shoes or 

open toed shoes. 

I. Always use personal protective equipment (PPE), such as, gloves, labcoats, 

faceshields or goggles when stated in an MSDS or the "Cautions" sections of an 

S.O.P.. 

m. Use appropriate respirator protection when stated in an MSDS or the "Cautions" 

sections of an S.O.P.. 

n. Avoid use of contact lenses in the laboratory. If contact lenses are necessary, 

inform a supervisor so special precautions can be taken, 

o. Use the hood in the Bacti-lab for procedures involving the release of toxic chemical 

vapors or dust, 

p. Always work in a well ventilated area when using laboratory chemicals that release 

hazardous vapors. Use ceiling ventilation fans where available, 

q. Never leave a procedure in process unattended. 

r. Never work alone in the building if the procedures being conducted are hazardous, 

s. Report all spills and accidents immediately to a Supervisor, 

t. Be alert to unsafe conditions and report them to a Supervisor, 

u. Never discharge to the sewer acids and bases or any other laboratory chemical that 

can cause a fire, explosion or structural damage. 

V. Deposit Hazardous Waste in its appropriately marked container. 
CHEMICAL HYGIENE PLAN FOR S.O.P. SF-0025-02 PAGE 3 

LABORATORY DIAGNOSTICS/CENOGENICS 

2. I ahels and Symhok - C Jf^ 

Many labels and symbols are present throughout the laborav^^i n warehouse waming 

employees with occupational exposure to special hazard: All empM^m^with 

occupational exposure must be knowledgeable of the following: C^TV^ 

a. Hazard Symbols: These are symbols found posted on all l^b^pi^grsr chemicals. 

They describe laboratory chemicals as poisonous, corrosiver^im^ng, harmful and 

irritating, flammable, oxidizing or radioactive (See AppendMiA). Posters can be 

found in all rooms equipped for handling laboratory chemicals. 

b. National Fire Protection Association (NFPA): The NFPA Diamond is found posted 

on all laboratory chemicals. It rates laboratory chemicals based on their degree of 

Flammability, Reactivity, Health Hazards and Special Wamings (See Appendix B). 

Posters can be found in all rooms equipped for handling laboratory chemicals. 

c. Biohazard Label: The Biohazard label is posted on all refrigerators and freezers 

where food and beverage storage is not permitted. 

3. Hayarri Iriantifination: 

With respect to labels, symbols and MSDS's: 

a. Employer shall ensure all labels on incoming hazardous chemicals are not removed 

or defaced. 

b. All MSDS's that are received with incoming hazardous chemicals are to be filed in a 

know location and available to all employees with occupational exposure. 

4. Complete Li.<;t of Laboratory Chpmirais 

At this facility all the chemicals used in any S.O.P. have been compiled into a list showing 

their chemical description, hazards that apply, inventory ranges and storage and location 

codes that apply (Appendix C). Each chemical listed is supported with an MSDS filed in 

the Bacti Lab. All employees must review this list with their supervisor. When new 

chemicals are introduced into procedures, they will be added to this list. 

5. Personal Prntertive Fqiiipment (PPF) 

Employees having occupational exposure to laboratory chemicals are required to wear PPE 

when handling hazardous chemicals. At this facility the following items are available: 

a. Lab Coats 

b. Disposable Latex Gloves 

c. Face Shields, Face Masks and Goggles 

Employees having occupational exposure must obsenAe the following precautions for using 

PPE: 

a. Always remove PPE before leaving this facility. Never bring home PPE that has 

been wom in the course of the day. 

b. Remove laboratory costs immediately upon significant contamination with a 

hazardous chemical. 
CHEMICAL HYGIENE PLAN FOR S.O.P. SF-0025-02 PAGE 4 

LABORATORY DIAGNOSTICS/CENOGENICS 

c. Inspect disposable latex gloves for tears or weak spots. 

d. Inspect face shields, face masks and goggles for cracks, punctures or other 

physical defects. 

e. Wash hands after wearing protective gloves. 

6. Additional Protective Equipment: 

At this facility Additional Protective Equipment is defined as: ^ 

a. Laboratory Hoods 

b. Ceiling Ventilation Fans 

^ 

^ • ^ 

c. Fire Extinguishers i^ ^ 

d. "Survivair" Full-face Respirator and "Flexi-Star" Hga^JLe Respiratory \ 

e. Eyewash/Shower o A^"" 

f. Overhead Sprinkler System vCw) ^ 

The laboratory hood in the Bacti-Lab should be used for ariy^procedure inVpr* utilizing a volatile 

chemical which releases toxic vapors. In order to increase the performance of the hood, 

the sash should be down at all times providing a shield between the employee and 

hazardous chemicals. 

The ceiling ventilation fan in the Bacti-Lab must be operating when an MSDS or 

"Cautions" section of an S.O.P. calls for adequate ventilation. 

The windows in Lab 3 must be open when an MSDS or a "Cautions" section in an S.O.P. 

calls for adequate ventilation. 

Fire extinguishers are located in the hallway bordering all laboratory rooms. Employees 

with occupational exposure should be knowledgeable of how to operate a fire 

extinguisher. 

The "Survivair" Respirator or "Flexl-Star" Respirator must be worn when handling 

hazardous organic chemicals. The MSDS of such a chemical will state under the 

Precautions section to use a respirator of this type. 

The Eyewash/Shower must be used when an employee has been splashed with a 

hazardous chemical in the eyes or skin. 

7. Usage of Respirator 

At this facility there are two types of respirators: 

a. "Survivair" Full-face respirator 

b. "Flexi-Star Half-face respirator 

Employees using either of these respirators for the first time, should have a 

supervisor show them the proper way to fit the respirator. The manufacturer's 
CHEMICAL HYGIENE PLAN FOR S.O.P. SF-0025-02 PAGE 5 

LABORATORY DIAGNOSTICS/CENOGENICS 

instruction manuals for both respirators are kept in the Equipment file under 

Respirators. The instruction manuals should be reviewed with the employee before 

using the respirators, 

c. Each time an employee uses either of the respirators, he/she must sign off on the 

Respirator Log Sheet (Appendix D1 and D2). These log sheets are attached to the 

side of the boxes in which the respirators are stored. 

8. Designated Workspace: 

Employees with occupational exposure may only handling labqr^|SF^''^emicals in the 

following locations: 

a. Bacti-lab 

b. Lab 2 

c. Lab 3 

Only the Bacti-lab and Lab 3 can be used when handling hazardous chemicals that 

release toxic vapors. These are the only two laboratories equipped with adequate 

ventilation. 

9. Receiving and Storage 

At this facility, the Shipping Clerk must know the Hazard Symbols and NFPA Warning 

Diamonds printed on incoming laboratory chemicals. When appropriate, PPE must be 

worn when handling hazardous chemicals. 

The storage of a chemical is dependent on its handling and storage instructions stated on 

the MSDS. The MSDS will outline the appropriate environment, compatible chemicals and 

incompatible chemicals with which a laboratory chemical may or may not be stored. 

Before a laboratory chemical can be stored in an area, the following guidelines should be 

observed: 

a. Have full knowledge of a laboratory chemical's storage conditions as stated in the 

MSDS. 

b. Inspect the potential storage area for any chemical and physical incompatibilities. 

(EX.) Isopropyl alcohol can not be stored near an open flame. 

c. Remove any chemical or physical incompatible substances from the potential 

storage site. 

10. Hazardous Waste Disposal: 

The only type of hazardous waste generated at this facility is a chloroform raffinate. 

To insure minimal harm to employees with occupational exposure and to the 

environment, the following guidelines must be observed when handling chloroform 

raffinate: 

a. Always wear adequate and appropriate PPE as stated in the MSDS (e.g. latex 

gloves, lab coat, respirator) 
CHEMICAL HYGIENE PLAN FOR S.O.P. SF-0025-02 PAGE 6 

LABORATORY DIAGNOSTICS/CENOGENICS 

b. Never pour the chloroform raffinate down the drain. 

c. Always remove the chloroform raffinate immediately from the workspace to a 

designated area. At this facility, the designated area is located outside the 

Machine Room. A fifty-five gallon steel drum has been designated for 

chloroform raffinate disposal. It is cleariy marked with an orange and white 

"Hazardous Waste" sign. 

d. Contact a Supervisor when the steel drum is half full so that the hazardous 

waste cartage company (Marisol Inc.) can be notified of a pick-up. 

i 

The level of chloroform raffinate in the steel drum can not exceed "^SB gallons. A 

wooden dipstick has been calibrated to 25 gallons and must bj^ii||ra when determining 

the amount of hazardous waste presently in the steel d^ffif.^pne calibrated wooden 

dipstick is marked as "Chloroform Raffinate Dipstick" ai^^fored behind the Machine 

Room entrance. 

11. Housekeeping o y 

This facility will be maintained in such a way as to provide a>Bleiin and safe workplace. 

The following shall be instituted: 

a. Regular floor cleanings 

b. Regular removal of trash 

c. Informal inspections of the facility 

d. Calibration/maintenance schedule - all safety equipment will be calibrated 

and/or inspected. Documentation will be kept in the Calibration Scheduling File 

and the Equipment File for each piece of safety equipment. 

i. Eye wash/Shower - inspections according to the manufacturers 

instructions, 

ii. Respirators - Inspections according to the manufacturers instructions, 

iii. Laboratory hoods - Annual inspections/calibrations by Medical Repair 

Laboratories, 

iv. Fire Extinguishers - Annual inspections performed by the Mariboro 

Township Fire Department. 

V. Ventilation Fan - Periodically inspected to check efficiency of air 

draw. 

e. Clear passageways through hallways shall be maintained. Hallways are not be 

used as storage areas. 

12. Spills and Accidents 

If a spill or accident does occur, the following steps must be taken: 

a. Contact a supervisor immediately. 

b. Refer to the specific MSDS for the proper clean-up, disposal and medical 

procedures. All MSDS's will have a section outlining emergency procedures; 

however, in general the following should be exercised: 
• ^ 

CHEMICAL HYGIENE PLAN FOR S.O.P. SF-0025-02 PAGE 7 

LABORATORY DIAGNOSTICS/CENOGENICS 

i. Eye Contact - Promptly flush eyes with water for a prolonged period 

of time and seek medical attention, 

ii. Ingestion - Encourage the victim to drink large amounts of water, 

iii. Skin Contact - Promptly flush the affected area with water and 

remove any contaminated clothing, 

iv. Clean-Up - Promptly clean up spills using appropriate PPE and 

disposal means. 

^^W^^-'" 

13. Fire Plan/Emergency Contact jem?^^^ ' 

Throughout the laboratory and warehouse are Fire Evacuatio^^q^^F^l^ns in each of the 

rooms. The Fire Evacuation Route Plan is specific for eadSr^iln, outlining the safest 

route for that location (Appendix E1 and E2). " . \ 

All exits are cleariy marked with red and white "Exit" signs. r\V\V v ^ -

All doorways that do not lead to an exit are cleariy marked with'^i^ed and white "No Exit" 

signs. 

At each telephone. Emergency numbers are clearly marked with orange and white 

"Police, Fire, Ambulance" labels. 

All employees at this facility will be trained in the usage of the fire extinguishers by 

Jersey Coast Fire Company. New employees will be trained by their supervisor. Their 

training will be documented on the In-House Fire Extinguisher Training Document 

(Appendix G). 

14. Medical Plan 

At this facility, whenever an employee with occupational exposure develops signs or 

symptoms associated with a hazardous chemical, that employee will be provided with 

the opportunity to receive medical attention. 

Ail medical examinations and follow-up consultations shall be performed by a licensed 

physician at no cost to the employee, without loss of pay and at a reasonable time and 

place. 

The employer must record an employee's work related accident on the OSHA 200 Form 

and keep the form filed until February 1, when it then is posted in a public area until 

March 1 (Appendix F). 

The following information must be provided to the physician by a supervisor: 

a. identity of the hazardous chemical(s) to which the employee may have been 

exposed. 
CHEMICAL HYGIENE PLAN FOR S.O.P. SF-0025-02 PAGE 8 

N LABORATORY DIAGNOSTICS/CENOGENICS 

b. A description of the conditions which the exposure occu 

c. A description of any signs or symptoms. | 

The employer shall obtain a written opinion from the examiningQJ|)y^ian which shall 

include the following: 

a. Any recommendation for further medical follow-up. 

b. The result of the medical examination and any associated tests. 

c. Any medical condition which may be revealed in the examination which may 

place the employee at risk as a result of exposure to a hazardous workplace. 

d. A statement that the employee has been informed by the physician of the 

results of the consultation or medical examination and any medical condition 

that may require further examination or treatment. 

e. The written opinion shall not reveal specific findings of diagnoses unrelated to 

occupational exposure. 

15, Information and Training 

At this facility all employees with occupational exposure will be adequately informed 

about the work in the laboratory, its risks and what to do if an accident occurs. 

Such information shall be provided at the time of an employee's initial assignment to a 

work area where hazardous chemicals are present and prior to assignments involving 

new exposure situations. 

The employees shall be informed of: 

a. The contents of 29 CFP Part 1910.1450. 

b. The contents of this Chemical Hygiene Plan. 

c. All MSDS's associated with hazardous chemicals. This will include the 

following information: 

i. Permissible exposure limits for OSHA. 

ii. Signs and symptoms associated with exposure to hazardous 

chemicals, 

iii. Methods and observations that are used to detect the presence or 

release of a hazardous chemical, 

iv. The physical and health hazards of a hazardous chemical. 

V. Appropriate PPE. 

vi. Appropriate work practices, 

vii. Emergency procedures. 

d. Measures that are taken for medical examinations and consultations. 

The employees shall be trained in: 

a. The proper use of the fire extinguishers, "Survivair" and "Flexi-Star" respirators 

and First Aid. Training records will be documented and kept on file under this 

Chemical Hygiene Plan. 
CHEMICAL HYGIENE PLAN FOR S.O.P. SF-0025-02 PAGE 9 

LABORATORY DIAGNOSTICS/CENOGENICS 

b. Reading and understanding an MSDS. 

c. Hazard Labels and NFPA identification. 

d. Recognizing the release of hazardous chemicals in the workplace. 

e. Recognizing signs and symptoms associated with a hazardous chemical 

exposure. 

f. Hazardous Waste disposal. 

g. Escape routes during a fire evacuation. ; y > 

The individual conducting the training shall be knowled^i^ble of iJis^^ytmot matter. 

Employees must sign a Training Document stating thS^Tn^ie received training in this 

Chemical Hygiene Plan and understand how it pertains to their work environment 

(Appendix H). 
CHEMICAL HYGIENE PLAN FOR S.O.P. SF-0025-02 PAGE 10 

LABORATORY DIAGNOSTICS/CENOGENICS 

^3'"" % 

References 

"Exposure to Hazardous Chemical in Laboratories", U.S. Dept. gf^f ^ &'t)ccupational 

Safety and Health Administration, OSHA 3119, 1989, pp. 

"Hazard Communication : A Compliance Kit"", McLaughlin, Ann (U.€r?yp^t.^vrLabor) 

and Pendergrass, John A. (Occupational Safety and Healtf>0«a(^imstration), OSHA 

3104, 1988, pp. A1 - J5. V) ^ 

Standard title: Occupation Exposure to Hazardous Chemical in Laboratories. 

Standard number: 1910.1450 

Standard title: National Research Council Recommendations Concerning Chemical 

Hygiene in Laboratories (non-Mandatory). 

Standard number: 1910-1450 App A. 
ATTACHMENT 4 

CENOGENICS CORPORATION 

GENERAL OPERATIONS # ^ ' 

^ 

BLOODBORNE PATHOGENS EXPOSURE CONTROL PLAN *"- ^^^ ^ 

Procedure Prepared by y.-1^^AfJ:/7^.,^sA^-'''^^^ Date_^jw^^SOP : SF-0023-02 

Procedure Approved by /%:,<y4j ^ fyi^& " DaXe^JJll^^Z^ Supersedes: SF-0023-01 

A. Introduction 

The OSHA Bloodborne Pathogens Standard, 29 CFR 1910.1030, details the proper 

procedures that must be practiced at facilities that handle potentially infectious materials. 

At this facility, potentially infectious materials are defined as any whole blood, plasma, or 

serum of human origin. 

Before any potentially infectious materials can be accepted at this facility, an 

HIV/HBV/HCV certification must be received. All potentially infectious materials are 

tested for HIV/HBV/HCV by FDA approved methods and guaranteed by licensed brokers 

to be negative for these bloodborne diseases. Nevertheless, the general precautions 

outlined in this Exposure Control Plan must be followed when handling potentially 

infectious materials. 

B. Purpose 

The purpose of this plan is to: 

1. Eliminate or minimize the potential hazard from exposure to potentially infectious 

materials. 

2. Comply with the OSHA Bloodborne Pathogens Standard, 29 CFR 1910.1030. 

C. Exposure Determination 

At this facility only some of the employees have occupational exposure. The following 

job classifications and tasks are listed: 

1. Production Supervisor and Laboratory Technicians: Direct hands-on- contact with 

a variety of human sera, either normal or positive for specific analytes. 

2. Packaging Crew: Dispensing a variety of control sera into reagent bottles. 
BLOODBORNE PATHOGENS S.O.P. SF-0023-02 PAGE 2 

^ EXPOSURE CONTROL PLAN 

3. Laboratory Assistant: Washing decontaminated glassware^<N^I||^i^e"labware, and 

other labware apparatus. ^' \'N!'C V^ ^ 

D. Implementation Schedule and Methodology ^ ' ;^-'^ \?i 

Engineering and work practice controls will be utilized to eliminatengr minimize exposure 

of employees at this facility. The following controls will be utilized: 

1. General Principles for Working with Potentially Infectious Materials in the 

Laboratory 

2. Available Personal Protective Equipment (PPE) 

3. Additional Protection (ie. Hood, UV Light, Disinfectants) 

4. Laundering of PPE 

5. Housekeeping 

6. Regulated Waste 

7. Blood Drawing Needle Disposal 

8. Labeling 

9. Hepatitis B Vaccination 

10. Exposure Incident 

11. Information and Training 

1. General Principles for Handling Potentially Infectious Materials in the Laboratory 

The following general guidelines should be observed when handling potentially infectious 

materials: 

a. Never touch your face or mouth in the laboratory. 

b. Always use personal protective equipment when handling potentially infectious 

materials. 

c. Always wash hands thoroughly with a germicidal soap after each procedure, 

especially before using the restrooms or eating. Germicidal soaps are found in both 

^ restrooms, the Bacti-Lab and Lab 3. 
BLOODBORNE PATHOGENS S.O.P. SF-0023-02 PAGE 3 

EXPOSURE CONTROL PLAN 

d. Eating, drinking, gum chewing or applying cosmetics in the labora^ol^^^pltthibited. 

Smoking is prohibited in all areas of the laboratory, front offiq^lXVi^\Jt^irehouse. 

e. Confine long hair and loose clothing. \J ^ g 

f. Contact lenses cannot be worn when handling potentiall^|^|^^08'm«erials. If 

contact lenses are necessary, goggles must be worn. | | ^ - ' 

g. Do not wear sandals, perforated shoes or open-toed shoes in the laboratory. Never 

walk barefooted in the laboratory. 

h. Never mouth pipet potentially infectious materials. 

i. Any misconduct that will startle another employee, resulting in spilling a potentially 

infectious material is prohibited. 

j . Never use damaged glassware. 

k. Always report spills and accidents to a supervisor immediately. 

2. Personal Protective Eguipment (PPE) 

Employees having occupational exposure are required to use PPE when handling 

potentially infectious materials. At this facility the following items are available: 

a. Launderable lab coats, gowns, and smocks. 

b. Disposable and sterile wrapped gloves. 

c. Face shields, face masks, goggles. 

Employees having occupational exposure must observe the following precautions for 

using PPE: 

a. Always remove PPE before leaving this facility. Never bring home PPE that has 

been worn in the course of the day. 

b. Place PPE in appropriately designated areas after usage. 

i.) Lab Coats, gowns, and smocks are to be hung on the coat rack outside 

the entrance to the laboratory. Personal clothing cannot be hung on the 

same coat rack. Personal clothing will be hung in the front office closet. If 

lab coats, gowns, or smocks have come in contact with potentially 

infectious materials (i.e. spills, splashes), they must be treated as in 

Section D, No. 4, Laundering. 
BLOODBORNE PATHOGENS S.O.P. SF-0023-02 \ \ PAGE 4 

EXPOSURE CONTROL PLAN \ ^ ' 

"•'""•• .' ' V 'v'^s-^' 

*• •••, :. •-•,-* . ^ • 

ii.) Goggles, face shields, and face masks are kept Ui 1[be, l^acti Room and 

Loading Room. If the goggles or face sl^ ^ ""i&bme in contact with 

potentially infectious materials (ie. spills, splashes), they should be wiped 

clean with an appropriate disinfectant (Section D, No. 5, Housekeeping) or 

exposed to UV light overnight. If the face masks should come in contact 

with potentially infectious materials, they should be immediately removed 

and placed in a "Biohazard" bag. 

iii.) Never wash or decontaminate disposable gloves for reuse. After usage, 

place in "Biohazard" bags and autoclave for 30 minutes at 121° C. 

iv.) Utility gloves and dishwashing gloves may be decontaminated for reuse if 

the integrity of the glove has not been changed in any way. Discard if 

cracking, peeling, tearing, or puncturing is present. 

V.) Always wash hands when gloves are removed and before entering the 

bathrooms or lunchroom. 

3. Additional Protection 

Employees having occupational exposure must limit their work with potentially infectious 

materials to those rooms equipped with Additional Protection. Additional protection is 

defined for this facility as having one or all of the following: 

a. Rooms equipped with UV lights. 

b. Rooms equipped with biological hoods. 

c. Rooms equipped with a full bottle of an appropriate disinfectant (Section D, No. 5, 

Housekeeping). 

The only rooms in this facility that can be used for handling potentially infectious materials 

are: 

a. Bacti Room 

b. Lab 2 

c. Lab 3 

d. Loading Room 

4. Laundering of PPE 
BLOODBORNE PATHOGENS S.O.P. SF-0023-02 PAGE 5 

EXPOSURE CONTROL PLAN 

Employees with occupational exposure cannot remove their labcoats,r^dy^i^sX^r smocks 

from this facility to take home and launder. v^^-^A)*^^ 

Weekly laundering of lab coats, gowns, and smocks will take place at no^^^cg^.^ the 

employees with occupational exposure. Every Friday lab coats, gg^^ ^ liti^^a^i will 

be placed in the "Biohazard" bin in the Furnace Room and will be il^d^^iiu^he employees 

by the following Monday. Newly laundered PPE will be stored on the shelf above the coat 

rack outside the laboratory entrance. If the lab coats and gowns are not ready for the 

employees on the following Monday, then these items will be provided by the employer at 

no cost to the employee. 

If an accident occurs (ie. spill, splash) where a lab coat, gown, or smock is penetrated by 

a potentially infectious material, then the garment must be removed immediately and 

placed in the "Biohazard" bin. A replacement lab coat or gown will be provided for the 

employee. 

5. Housekeeping 

Available to the employees with occupational exposure are disinfectants with germicidal, 

fungicidal, and virucidal properties. These include 2% Lysol, 70% Isopropyl alcohol, and 

1 % Sodium hypochlorite solutions ( household bleach diluted 1:5). These disinfectants 

must be used to clean items that have had contact with potentially infectious materials. 

At this facility, PPE must be worn while cleaning with one of the above mentioned 

disinfectants in the following situations: 

a. All equipment and work surfaces that have come in contact with potentially 

infectious materials must be soaked or wiped down. This includes all glassware, 

pipets, Nalgene brand labware, countertops, biological hood benches, and floors (if 

spills occur). 

b. Protective coverings such as parafilm, autoclave paper, or aluminum foil should be 

placed in an autoclavable "Biohazard" bag. The bag should be placed under UV 

light overnight or autoclaved for 30 minutes at 121° C. The counter top below the 

protective coverings should be wiped down and replaced with a new covering. 

c. Ail materials used in cleaning a spill (i.e. rags, towels, sponges) must be thoroughly 

soaked, exposed to UV light overnight, or immediately placed in an autoclavable 

"Biohazard" bag and autoclaved for 30 minutes at 121° C. 

d. All glassware, Nalgene brand labware, and filter press apparatus, must be filled, 

sprayed, or flushed and placed in an autoclavable basin before bringing to the sink. 

e. Reusable receptacles, such as, basins, pails, or cans that have come in contact with 

potentially infectious materials must be wiped down after each use. 
BLOODBORNE PATHOGENS S.O.P. SF-0023-02 PAGE 6 

EXPOSURE CONTROL PLAN 

.c\\^\^ 

f. Broken glass should be sprayed and picked up with tongs, forcep^i<^%.brush and 

dustpan. The broken glass will be placed in an "Biohazai^SMj^^i^^tddlaved for 

30 minutes at 121° C. The items used to pick up the bi^^^l^ s will be sprayed 

or washed down and placed under UV light overnight. 

g. All filter presses, Cornwall syringes, loading hoses, and glass connector tubes must 

be flushed and soaked with an approved disinfectant before they can be brought to 

the sink. 

h. Glass or plastic slides must be soaked before they can be brought to the sink. A 

slide bucket with an approved disinfectant should be prepared ahead of time when 

anticipating the use of glass slides with potentially infectious materials. 

6. Regulated Waste 

Located in the Bacti-Lab, Lab 2, and Lab 3 there is an 8 1/2" x 11 " autoclavable 

"Biohazard" bag basket. These autoclavable "Biohazard" bag baskets are to be used for 

the disposal of pipet tips, dispenstirs, wooden mixing sticks, and culture tubes that have 

had contact with potentially infectious materials. 

Also available are 12" x 24" and 24" x 36" autoclavable "Biohazard" bags that should be 

used for larger volumes of waste that have come in contact with potentially infectious 

materials. 

Items that must be autoclaved will follow these guidelines: 

a. Only the above mentioned autoclavable "Biohazard" marked bags can be used. 

b. Autoclavable "Biohazard" bags must be securely closed with autoclavable tape; 

however, a vented opening must be allowed. 

c. All autoclavable "Biohazard" bags must be placed in an autoclavable basin to avoid 

leakage. 

d. Once the autoclavable "Biohazard" bags have been autoclaved for 30 minutes at 

121° C, then they may be placed in the regular trash. 

e. If waste material has been exposed to UV light overnight, it may be placed in the 

regular trash if disposable, or brought to the sink if washable. 
BLOODBORNE PATHOGENS S.O.P. SF-0023-02 

EXPOSURE CONTROL PLAN 

7. Blood Drawing Needle Disposal ri^"^ 

WW A'' • 

Disposable needles shall be discarded immediately or as soon as possible in a red 

"Biohazard" container that has a one-way lock-tight lid, is puncture-resistant plastic, and 

has leak proof seams. This container will be maintained upright and not allowed to 

overflow. Full containers will be autoclaved for 30 minutes at 121° C and discarded in 

the regular trash. 

The red "Biohazard" container shall be easily accessible to employees with occupational 

exposure and located only in Lab 3, where blood drawing occurs. 

8. Labeling 

Fluorescent orange or orange-red "Biohazard" labels will be affixed to all refrigerators and 

freezers containing potentially infectious materials. These labels will warn all employees ( 

including those employees with no occupational exposure) that food and drinks cannot be 

stored in the "Biohazard" labeled refrigerators or freezers. The same "Biohazard" labels 

will also be affixed to the laundry bin and to disposable needle container. 

9. Hepatitis B Vaccine 

This facility will make available the Hepatitis B vaccine to the employees with 

occupational exposure. The Hepatitis B vaccination series will be: 

a. Made available at no cost to the employee. 

b. Made available to the employee at a reasonable time and place. 

c. Performed by a licensed physician. 

d. Provided according to the recommendations of the U.S. Public Health Service. 

e. Offered after the employee has received incident exposure training. 

Documentation of the Hepatitis B vaccination series will be maintained for all employees 

with occupational exposure. 

if an employee with occupational exposure declines the Hepatitis B vaccination series 

offered, then he or she must sign the OSHA required waiver indicating their refusal (See 

Appendix A). However, if the employee at a later date decides to accept the vaccination, 

the vaccination shall then be made available. Documentation of the vaccination waivers 

will be maintained for all employees with occupational exposure. 
BLOODBORNE PATHOGENS S.O.P. SF-0023-02 PAGE 8 

EXPOSURE CONTROL PLAN 

10. Exposure Incidents -' 

l # ^ 

An exposure incident is defined as: •**>• M •^^i ^ 

An accident resulting in a potentially infectious material entering an employee's eyes, 

nose, mouth, or open wound in the skin via splashing, spilling, being cut by broken 

glass, or being stuck with a needle. 

If an exposure incident does occur, the employee will be offered a confidential medical 

examination and a post exposure follow-up at no cost to the employee. These are the 

steps that must be taken if the employee consents to medical care: 

a. A copy of The Bloodborne Pathogens Standard, 29CFR 1910.1030, and an 

Exposure Incident Report (See Appendix B) must be completed by a supervisor 

and given to the attending licensed physician. 

b. Blood testing to determine HBV, HCV or HIV infectivity only if the employee 

consents. 

c. The supervisor shall obtain and provide the employee with a copy of the 

evaluating physician's written opinion within 15 days of the completion of the 

evaluation. The written opinion of the physician may only contain the following 

information: 

i.) A statement that the employee has been informed of the results. 

ii.) A statement that the employee has been told about any medical 

conditions which require further evaluation or treatment resulting from 

the exposure to potentially infectious materials. 

d. All documentation pertaining to an exposure incident will be maintained in both 

the OSHA and Employee Files. 

11. Information and Training 

Employees with occupational exposure will receive information and training on the 

following: 

a. A copy of this Exposure Control Plan and the OSHA Bloodborne Pathogens 

Standard, 29 CFR 1910.1030. 

b. An explanation of the tasks that may involve exposure. 
BLOODBORNE PATHOGENS S.O.P. SF-0023-02 PAGE 9 

EXPOSURE CONTROL PLAN 

-\n 

c. An explanation on how to reduce exposure by usingrPP^) "T t ^' ' 

d. A demonstration on how to use PPE correctly. ,., ;^J;C 

e. Hand-outs that discuss epidemiology and modes of tr^p;i»mh^\)f bloodborne 

pathogens (Appendix E). 

f. Hand-outs that detail information on the Hepatitis B vaccination series regarding 

its purpose, benefits, side effects, number of vaccinations (Appendix D), and 

declination statement (Appendix A). 

g. A discussion of the procedures to follow if an exposure incident occurs. 

The individual conducting the training shall be knowledgeable of the subject matter. 

Employees must sign a Training Document stating they have received training in this 

Exposure Control Plan and its Appendices, and understand how it pertains to their work 

environment (Appendix C). 
BLOODBORNE PATHOGENS S.O.P. SF-0023-02 PAGE 10 

EXPOSURE CONTROL PLAN 

References 

^vS ' 1. "Draft Sample Written: Bloodborne Pathogen Exposure Control ^^ro#^6lnpliance with 

OSHA Standard 29 CFR 1910.1030", Wl Dept. of Health and Social Services (Section of 

Occupational Health), 1992, pp.1-17. 

2. "Hepatitis B Vaccine (Vaccines, Viral)", Facts and Comparisons, November 1989, pp. 

467a-468. 

3. "Hepatitis B, A Disease in Need of Prevention," Merck and Co., 1991, pp. 1-12. 

4. Occupational Exposure to Bloodborne Pathogens; Final Rule (29 CFR Part 1910.1030). 

Federal Register. Vol. 58, No. 235, Dec. 6, 1991, pp.64175-64182. 

5. "Occupational Exposure to Bloodborne Pathogens", U.S. Dept. of Labor and Occupational 

Safety and Health Administration, OSHA 3127, 1992, pp. 1-22. 
BLOODBORNE PATHOGENS S.O.P. SF-0023-02 PAGE 11 

EXPOSURE CONTROL PLAN 

APPENDIX A 

HEPATITIS B VACCINATION DECLINATION STATEIVttN 

...... i:J \XVi -l 

''•':.'* ' y 0 

I understand that due to my occupational exposure to blood or other potentially infectious 

materials I may be at risk of acquiring hepatitis B virus (HBV) infection. I have been given the 

opportunity to be vaccinated with the hepatitis B vaccine, at no charge to myself. However, 

I may decline hepatitis B vaccination at this time. I understand that by declining this vaccine 

I continue to be at risk of acquiring hepatitis B, a serious disease. If in the future i continue 

to have occupational exposure to blood or other potentially infectious materials and I want to 

be vaccinated with the hepatitis B vaccine, I can receive the vaccination series at any time 

and at no charge to me. 

Employee signature Date 

Supervisor signature Date 
^ 

BLOODBORNE PATHOGENS S.O.P. SF-0023-02 PAGE 12 

EXPOSURE CONTROL PLAN 

APPENDIX B 

, -•(=:' • • 

•\ f^. \ r 

EXPOSURE INCIDENT REPORT o(^V^' \ 

p\ y, 

Date of exposure incident:. 

Name of employee: 

Name of supervisor it was reported to: 

Employee's duties at the time of the exposure incident: 

Route of exposure: 

Action Taken: 

Has the employee received the Hepatitis vaccination series? 

Yes No 

A medical examination and post-exposure follow-up examination has been offered to me as a 

result of an exposure incident in which I was involved. 

I have accepted I have declined ail medical 

consultations offered to me by Laboratory Diagnostics/Cenogenics. 

Employee signature Date_ 

Supervisor Approval Date 
^ 

BLOODBORNE PATHOGENS S.O.P. SF-0023-02 PAGE 13 

EXPOSURE CONTROL PLAN 

APPENDIX C 

TRAINING DOCUMENT 

I have received the Information and Training on the Bloodborne Pathogen Exposure Control 

Plan for Laboratory Diagnostics/Cenogenics. I received the following information and 

training in the session: 

1. A copy of this Exposure Control Plan and the Bloodborne Pathogens Standard, 29 

CFR 1910.1030. 

2. An explanation of the tasks that may involve exposure to potentially infectious 

materials. 

3. An explanation on how to reduce exposure by wearing PPE. 

4. A demonstration on how to use PPE correctly. 

5. A discussion taken from Appendix C on the epidemiology and modes of 

transmission of bloodborne pathogens. 

6. A discussion taken from Appendix D on the Hepatitis B vaccination series 

regarding its purpose, benefits, side effects, number of vaccinations and 

declination statement. 

7. A discussion on the procedures to follow in case an exposure incident occurs. 

As an Employee with occupational exposure I am aware of and understand the safety 

measure I should execute when handling potentially infectious materials. I have read and 

understand the Exposure Control Plan for this facility. I have had an opportunity to ask 

questions and have them answered. I also understand, that I may at any time, ask 

questions of my immediate supervisor pertaining to proper safety procedures or any other 

topic discussed in the training. 

Employee signature Date 

Supervisor approval Date 
BLOODBORNE PATHOGENS S.O.P. SF-0023-02 PAGE 14 

EXPOSURE CONTROL PLAN 

APPENDIX D fO^ k 

HEPATITIS B VACCINATION _ ^w. %'^V 

Introduction 

The Hepatitis B vaccination series offered by Laboratory Diagnostics/Cenogenics will 

be administered by a licensed physician at a local medical facility. The vaccination 

series is provided to employees with occupational exposure at no cost and at a 

convenient time and place. The employee has the right to decline the vaccination 

series, however, the employee may opt at a later date to have the vaccination series 

administered at no cost and at a convenient time at insta-Care. 

Background 

There are two varieties of the Hepatitis B vaccine. Both types of this vaccine have 

been shown to induce protective antibodies against Hepatitis B infection in individuals 

who have received the three-shot vaccination. Both types of the Hepatitis B vaccine 

have been proven to last for at least five years in individuals receiving the three-shot 

vaccination. Finally, data has also shown that the transmission of AID by the 

Hepatitis B vaccination does not exist for either vaccine type. 

Administration of the Hepatitis B Vaccine 

The Hepatitis B vaccine consists of a series of three injections. These injections are 

given in the deltoid muscle of the upper arm. The vaccination schedule consists of an 

initial injection, another injection one month later, and a final injection six months from 

the initial injection. All three injections must be administered for this vaccination to be 

effective. A schedule of the employee's injections will be maintained by the medical 

care facility and also in our Employee Files. 

Benefits of the Hepatitis B Vaccine 

The Hepatitis B vaccination series provides active immunity against Hepatitis B for 

employees with occupational exposure to potentially infectious materials. Employees 

having occupational exposure have a greater risk of contracting Hepatitis B because of 

the frequent handling of blood and blood products of human origin. Although all 

potentially infectious materials used at Laboratory Diagnostics/Cenogenics are certified 

by licensed brokers to be HBV, HCV/HIV negative, there does exist the potential risk 

of exposure. The Hepatitis B vaccination series reduces that risk of exposure by 

providing immunization against this bloodborne disease. 
BLOODBORNE PATHOGENS S.O.P. SF-0023-02 PAGE 15 

EXPOSURE CONTROL PLAN 

Adverse Reactions 

As with any vaccination, there exists the potential for adverse reactions to occur in 

certain individuals. It is possible that none of the adverse reactionsyW^^ will be 

experienced by an employee receiving the Hepatitis B vaccipalitf^ruH^ these 

adverse reactions have been reported in studies and shoul^l^\maae apparent to the 

employee. The following adverse reactions may occur: 

1. Injection site - local soreness and swelling of the upper^rm5%^ I 

2. Gl tract - nausea, vomiting, diminished appetite, diarrhea. 

3. Central Nervous System - headache, lightheadedness, dizziness, irritability, 

disturbed sleep. 

4. Respiratory - cough, flu-like conditions. 

5. Body as a whole - fatigue, fever > 100°F, sweating, chills, flushing. 

Conclusion 

Based on the above information, employees with occupational exposure can personally 

decide if they want to accept the Hepatitis B vaccination series. If an employee 

chooses the Hepatitis B vaccination series, an appointment at a local medical care 

facility will be scheduled at a convenient time for the employee to begin the 

vaccination series. All subsequent appointment will also be scheduled at a convenient 

time for the employee. If an employee chooses to decline the Hepatitis B vaccination, 

they must complete a Declination Statement (Appendix A of this S.O.P). In either 

circumstance, documentation of the employee's decision will be maintained in the 

OSHA and Employee Files. 
BLOODBORNE PATHOGENS S.O.P. SF-0023-02 PAGE 16 

EXPOSURE CONTROL PLAN 

APPENDIX E ^0\S0 

TRANSMISSION OF BLOODBORNE PATHOGENS 

Bloodborne Pathogens are defined as pathogenic microorganisms that are present in human 

blood and capable of causing disease if transmitted to others. This group of 

microorganisms includes those responsible for the transmission of Hepatitis B (HBV), 

Hepatitis C (HCV) and HIV infection. 

Hepatitis B virus may be found in blood and other body fluids, such as urine, tears, semen, 

vaginal secretions and breast milk. Hepatitis is usually spread by contact with infected 

blood or blood products. Transmission of Hepatitis can occur by blood transfusions 

involving infected blood, close personal contact (ie. sexual contact, sharing of razors, 

sharing of toothbrushes) and using infected needles. 

HIV has only been shown to exist in blood and blood products. As of date, HIV has only 

been shown to be transmitted by illicit injectable drug use, sexual contact and blood 

transfusions with infected blood. 

Persons at increased risk of contracting these bloodborne diseases are those who 

frequently handle infected blood and other body fluids in the course of their work, those 

who live in crowded conditions (HBV), those with poor hygiene (HBV) and those who have 

many sexual contacts. 
ATTACHMENT 5 

LABORATORY DIAGNOSTICS CO., INu. 

GENERAL OPERATIONS <\^ \ 

CHEMICAL HAZARD COMMUNICATION PLAN 

Procedure Prepared bY..,-^?^'-;.L- ;.c. /:.• L /"'} ^' ^ V'>^..->^. •- Date^'v'^; ''^^'- SOP: SF-0098-01 

-- /-" 

Procedure Approved \i>i_.^'--^U^Ti''2'L^^^^^ Date ' y ^/f P Supersedes: none 

INTRODUCTION 

The OSHA Chemical Hazard Communication Standard, 29 CFR 1910.1200, ensures that all 

employers receive the necessary information needed to properly Inform and train their 

employees and to put |n place employee protection programs. The plan also provides 

necessary information to employees so they can participate in, and support, the protective 

measures in place at their workplace. 

NOTE: A copy of this standard is on file in the Regulatory File cabinet for review. All 

questions and/or concerns may be brought to the attention of the Production 

Supervisor. 

PURPOSE 

The purpose of this plan is to inform you that our company is in compliance with this OSHA 

standard by: 

1. compiling a list of hazardous chemicals, 

2. using MSDS's (Material Safety Data Sheets), 

3. ensuring containers are properiy labeled and Identified, and 

4. providing all affected employees with training. 

LIST OF HAZARDOUS CHEMICALS 

A. DEFINITIONS 

1. "Hazardous chemical" means any chemical which is a physical hazard or a health 

hazard. 

2. "Hazard warning" means any words, pictures, symbols, or combination thereof 

appearing on a label or other appropriate form of warning which convey the specific 

physical and health hazard(s), including target organ effects, of the chemical(s) in the 

container(s). (See the definitions for "physical hazard" and "health hazard" to 

determine the hazards which must be covered.) 

3. "Health hazard" means a chemical for which there is statistically significant evidence 

based on at least one study conducted in accordance with established scientific 
CHEMICAL HAZARD COMMUNICATION PLAN S.O.P. SF-0098-01 ^v^ \ PAGE 2 

principles that acute or chronic health effects maYJwkcur in exposed ^ployees . The 

term "health hazard" includes chemicals which are carcinoger\j^|^^itifl or highly toxic 

agents, reproductive toxins, irritants, corrosive|g^^^i^ers , hepatotoxins, 

nephrotoxins, neurotoxins, agents which act on t ^ JiCTratopoietic system, and 

agents which damage the lungs, skin, eyes, or mucous membranes. 

4. "Physical hazard" means a chemical for which there is scientifically valid evidence 

that it is a combustible liquid, a compressed gas, explosive, flammable, an organic 

peroxide, an oxidizer, pyrophoric, unstable (reactive) or water-reactive. 

5. "Identity" means any chemical or common name which is indicated on the material 

safety data sheet (MSDS) for the chemical. The identity used shall permit crossreferences to be made among the required list of hazardous chemicals, the label and 

the MSDS. 

B. LISTING 

Refer to Appendix A and B for complete listing of chemicals. 

II. LABELING AND OTHER FORMS OF WARNING 

A. DEFINITION 

"Label" means any written, printed, or graphic material displayed on or affixed to containers 

of hazardous chemicals. 

B. Each container of hazardous chemicals must be marked with the following information: 

1. Identity of the hazardous chemical, 

2. Appropriate hazard warnings, and 

3. Name and address of the chemical manufacturer, importer or other responsible party. 

C. Chemical manufacturers, importers, distributors, or employers who become newly aware of 

any significant information regarding the hazards of a chemical shall revise the labels for the 

chemical within three months of becoming aware of the new information. Labels on 

containers of hazardous chemicals shipped after that time shall contain the new information. 

If the chemical is not currently produced or Imported, the chemical manufacturers, 

importers, distributor, or employer shall add the information to the label before the chemical 

is shipped or introduced into the workplace again. 
CHEMICAL HAZARD COMMUNICATION PLAN S.O.P. SF-0098-01 . ; PAGE 3 

3 ^ 

,..v'V';.-

(II. MATERIAL SAFETY DATA SHEETS (MSDS's) 

A. DEFINITION <;"*; ' - ' 

"Material safety data sheet (MSDS)" means written or printed material concerning a 

hazardous chemical which is prepared in according with paragraph (g) of the 1910.1200 

OSHA regulation. The Material Safety Data Sheet (MSDS) is a detailed information bulletin 

prepared by the manufacturer or importer of a chemical that describes the physical and 

chemical properties, physical and health hazards, routes of exposure, precautions for safe 

handling and use, emergency and first-aid procedures, and control measures. Information 

on an MSDS aids in the selection of safe products and helps prepare employers and 

employees to respond effectively to daily exposure situations as well as to emergency 

situations. 

B. LOCATION 

Copies of all MSDS's for all chemicals in use are kept in the Laboratory Raw Materials File 

Cabinet and are readily available to all employees during each work shift. 

The Laboratory personnel is responsible for acquiring MSDS's. The vendor will be 

contacted if an MSDS is not supplied with an Initial shipment (S.O.P. RM-0020). 

IV. TRAINING 

A. Employees who work with or who are potentially exposed to hazardous chemicals will 

receive Initial training on the Hazard Communication Standard and the safe use of those 

hazardous chemicals. Whenever a new hazard is introduced, additional training will be 

provided. Supervisors will be trained regarding hazards and appropriate protective 

measures so they will be available to answer questions from employees and provide 

monitoring of safe work practices. 

The training plan will emphasize these items: 

• Summary of the OSHA standard and this written procedure. 

• Chemical and physical properties of hazardous materials (e.g., flash point, reactivity) 

and methods that can be used to detect the presence or release of chemicals. 

• Physical hazards of chemicals (e.g., potential for fire, explosion, etc.). 

• Health hazards, including signs and symptoms of exposure, associated with exposure 

to chemicals and any medical condition known to be aggravated by exposure to the 

chemical. 
CHEMICAL HAZARD COMMUNICATION PLAN S.O.P. SF-0098-01 \ PAGE 4 

• Procedures to protect against hazards (e.g., oefe^^ r protective equipment required, 

proper use, and maintenance; work practl<?e^^ metho^^^ssUr e proper use and 

handling of chemicals; and procedures for em^rgerj^|^i^p|^^e). 

• Work procedures to follow to assure protection when cleaning hazardous chemical 

spills and leaks. 

• Where MSDS's are located, how to read and Interpret the Information on both labels 

and MSDS's, and how employees may obtain additional hazard information. 

Retraining is required when the hazard changes or when a new hazard is introduced into 

the workplace, but It will be company policy to provide training regularly. 

B. NON-ROUTINE TASKS 

Periodically, employees are required to perform hazardous non-routine tasks. Some 

examples of non-routine tasks are: confined space entry, tank cleaning, and painting 

reactor vessels. Prior to starting work on such projects, each affected employee will be 

given information by the Supervisor about the hazardous chemicals he or she may 

encounter during such activity. This information will include specific chemical hazards, 

protective and safety measures the employee can use, and steps the company is using 

to reduce the hazards, including ventilation, respirators, presence of another employee 

and emergency procedures. 

C. Upon completion of training, refer to Appendix C. 

V. CONTRACTOR EMPLOYERS 

Upon notification the supervisor will advise outside contractors in person of any chemical 

hazards that may be encountered in the normal course of their work on the premises, the 

labeling system in use, the protective measures to be taken, and the safe handling 

procedures to be used. In addition these individuals will be informed of the location and 

availability of MSDS's. Each contractor bringing chemicals on-site must provide us with the 

appropriate hazard information on these substances, including the labels used and the 

precautionary measures to be take in working the these chemicals. 
CHEMICAL HAZARD COMMUNICATION PLAN S.O.P. SF-0098-01 PAGE 5 

APPENDIX A 

NOTE: This listing contains all known chemicals which may or may not currently be in use or in 

stock in either location. Although the chemicals listed are classified as hazardous as 

stated In their respective MSDS, the quantities housed in both locations do not meet 

DEP hazard threshold as defined by the Community Right to Knoi^vy-purvey. 

sopropyl alcohol (for cleaning) \ j .Tsaft*^"^*-!^ 

Warehouse Location oCv*?^^ :'?;^. 

Specially Denatured Alcohol (SDA) 12A-3, Anhydrous, 200 Proof ;fl0%i;t^Jcp6^) 

Ethyl Alcohol, Anhydrous, 200 Proof (VDRL Antigen) ^S # 

Phenol, 1.0% solution in suspension (Febrile Antigens) 

Formaldehyde, 1.0% solution in suspension (Febrile Antigens) 

Hydrogen peroxide (Developer) 

Sodium azide, as a preservative in solution (0.1%) 

Thlmerosal, as a preservative in solution (0.02%) 

Gum Gualac Powder 

Methyl Ethyl ketone 

Sodium hypochlorite (bleach) 

Crodaseal (Ammonium hydroxide, 0.8%) 

Crystal violet, powdered dye 

Brilliant green, powdered dye 

Proflavine hemisulfate, powdered dye 

Laboratory Location 

Isopropyl alcohol 

Specially Denatured Alcohol (SDA), 12A-3, Anhydrous, 200 Proof 

Ethyl Alcohol, 3A, Anhydrous, 200 Proof 

Ammonium hydroxide 

Barium chloride 

Boric acid 

Brilliant green, dye 

Carbon tetrachloride 

Chloroform 

Citric acid 

Coverage Plus (disinfectant) 

Crystal violet, dye 

Formaldehyde, 37 % 

Glacial Acetic Acid 

Glutaraldehyde, 25% aqueous 

Gum gualac powder 
CHEMICAL HAZARD COMMUNICATION PLAN S.O.P. SF-0098-01 PAGE 6 

Hydrochloric Acid 

Hydrogen peroxide 

Lactic acid, 85 % 

Phenol 

Propane fuel, mini tanks 

Phosphoric acid, 85 % 

Potassium hydroxide 

Potassium permanganate 

Sodium azide ^ 

Sodium borate (Borax) decahydrate cC^^ 

Sodium borohydride \ 

Sodium hydroxide 

Sodium hypochlorite (Bleach) , "* 

Sodium oxalate 

Sodium phosphate, dibasic, heptahydrate 

Sodium phosphate, monobasic, dihydrate 

Sulfuric acid 

Thermometers (mercury) 

Thlmerosal 

Triton X-100 

APPENDIX B 

NOTE: This listing contains chemicals classified as hazardous as stated in their respective 

MSDS's. V These chemicals may or may not be currently in stock or in use and are 

located in the laboratory only for R&D. 

R&D CHEMICALS (LABORATORY LOCATION ONLY) 

Acetone 

Ammonium oxalate, monohydrate 

Ammonium thiocyanate 

Arsenic Trioxide 

Barium oxide, anhydrous 

Barium dioxide 

Brucine 

Cadmium chloride, 2.5-Hydrate 

Calcium chloride, dihydrate 

Calcium hydroxide 

Calcium oxide 

Chloroacetic acid 

Chlortetracycllne hydrochloride 
CHEMICAL HAZARD COMMUNICATION PLAN S.O.P. SF-0098-01 PAGE 7 

Cobalt oxide 

Copper (II) oxide 

Cupric acetate, monohydrate 

N, N-Dlethyl - 1,4 - Phenylenedlamine, 97 % 

N, N-Dlmethylformamide 

3, 3' - Dlmethoxybenzidlne, 97 % 

Dimethyl Sulfoxide 

m-Dinltrobenzene 

Ethylenediamlnetetraacetlc acid (EDTA) 

Ether, anhydrous 

Ferric sulfate, n-Hydrate 

Hydrazine sulfate 

Iodine 

Lauryl Sulfate (Sodium Dodecyl Sulfate (SDS) 

Lead sub-acetate 

Lead (II) sulfide, -200 mesh 

Lithium nitrate 

Magnesium 

Magnesium nitrate 

Magnesium perchlorate (anhydrone) 

Manganese Dioxide 

Mercuric Acetate 

Mercuric Chloride 

Mercuric Iodide, Red 

Mercuric Nitrate, Monohydrate 

Molybdenum Trioxide 

p-Nltroaniline 

Oakite 32 

4-PhenylazoanlHne hydrochloride, 97 % 

Phenylmethylsulfonyl fluoride 

Phosphorus Oxychloride 

Potassium chromate 

Potassium cyanide 

Potassium dlchromate 

Potassium nitrate 

Silver carbonate, 99 % 

Sodium arsenate, dibasic, 7-hydrate 

Sodium arsenlte 

Sodium Bisulfite 

Sodium Cyanide 

Sodium fluoride 

Sodium nitrate 

Sodium nitrite 

Sodium phosphate, Tribaslc, 12-Hydrate 
CHEMICAL HAZARD COMMUNICATION PLAN S.O.P. SF-0098-01 PAGE 

tert-Butyl alcohol 

Toluene sulfonic acid 

o-Toluldlne 

Trichloroacetic acid, solid 

Tris (hydroxymethyl) amlnomethane hydrochloride 

Vanadyl sulfate 

Zinc acetate, dihydrate 

'•••> M 
CHEMICAL HAZARD COMMUNICATION PLAN S.O.P. SF-0098-01 PAGE 9 

APPENDIX C 

TRAINING DOCUMENT 

I have received the following Information and Training Sernlrlfe^n "the Chemical Hazard 

Communication Plan for Laboratory Diagnostics/Cenogenics: 

a. A copy of this Chemical Hazard Communication Plan and an explanation of the standard 

upon which it is based. 

b. Understanding the hazard warnings, labels and the NFPA (National Fire Protection 

Association) symbols on chemical containers. 

c. Understanding a Material Safety Data Sheet (MSDS) and where they may be located. 

d. Knowing when Personal Protective Equipment (PPE) is appropriate. 

e. Recognizing the signs and symptoms associated with exposure to hazardous chemicals. 

As an employee with a potential for occupational exposure, I am aware of and understand the 

safety measures I should execute when handling hazardous laboratory chemicals. I have read and 

understand the Chemical Hazard Communication Plan for this facility. I have had an opportunity to 

ask questions and have them answered. I also understand that I may at any time, ask questions 

of my immediate supervisor pertaining to proper safety procedures or any other topic discussed in 

the training seminar. 

Employee's signature: Date: 

Training Supervisor: Date: 
ATTACHMENT 6 

CHEMICAL HYGIENE PLAN FOR 

LABORATORY DIAGNOSTICS/CENOGENICS 

S.O.P. SF-0025-02 PAGE 12 

Appendix H 

TRAINING DOCUMENT 

I have received the Information and Training Seminar on 

Laboratory Diagnostics/Cenogenics. I received the followi 

session: 

ical Tlygiene Plan for 

formation and training in this 

a. A copy of this Chemical Hygiene Plan and an exj^a^i^^Mfri^ 

upon. 

jKme standard it is based 

b. Understanding a Material Safety Data Sheet and knowing where they are filed. 

c. Understanding the Hazard Labels and the NFPA symbols. 

d. Knowing when PPE is appropriate. 

e. Recognizing the signs and symptoms associated with exposure to hazardous 

chemicals. 

f. Knowing the proper disposal of hazardous waste. 

g. Training in how to use fire extinguishers, respirators and First Aid. 

h. Know the fire evacuation plan for the laboratory and warehouse. 

As an employee with occupational exposure, I am aware of and understand the safety 

measures I should execute when handling hazardous laboratory chemicals. I have read 

and understand the Chemical Hygiene Plan for this facility. I have had an opportunity to 

ask questions and have them answered. I also understand that I may at any time, ask 

questions of my immediate supervisor pertaining to proper safety procedures or any other 

topic discussed in the training seminar. 

Employee's signature: 

Approved by: 

6..^l/M Da.e: S/^/° 1 

Date 

. <P/y^/o^ 
ATTACHMENT 7 

BLOODBORNE PATHOGENS S.O.P. SF-0023-02 PAGE 13 

EXPOSURE CONTROL PLAN 

APPENDIX C 

TRAINING DOCUMENT 

I have received the Information and Training on the Bloodborne Pathogen Exposure Control 

Plan for Laboratory Diagnostics/Cenogenics. i received the following information and 

training in the session: 

1. A copy of this Exposure Control Plan and the Bloodborne Pathogens Standard, 29 

CFR 1910.1030. 

2. An explanation of the tasks that may involve exposure to potentially infectious 

materials. 

3. An explanation on how to reduce exposure by wearing PPE. 

4 . A demonstration on how to use PPE correctly. 

5. A discussion taken from Appendix C on the epidemiology and modes of 

transmission of bloodborne pathogens. 

6. A discussion taken from Appendix D on the Hepatitis B vaccination series 

regarding its purpose, benefits, side effects, number of vaccinations and 

declination statement. 

7. A discussion on the procedures to follow in case an exposure incident occurs. 

As an Employee with occupational exposure I am aware of and understand the safety 

measure I should execute when handling potentially infectious materials. I have read and 

understand the Exposure Control Plan for this facility. I have had an opportunity to ask 

questions and have them answered. I also understand, that I may at any time, ask 

questions of my immediate supervisor pertaining to proper safety procedures or any other 

topic discussed in the training. ^ ^ ,^ r 

Employee signature /^-^M^ ^ ' ^ / •"' Date '__ 

Supervisor approval / '^''^>-%-^<^<^<T[ Date ^'^y<yj:-
ATTACHMENT 8 

CHEMICAL HAZARD COMMUNICATION PLAN S.O.P. SF-0098-01 PAGE 9 

APPENDIX C 

TRAINING DOCUMENT 

I have received the following information and Training Seminar on the Chemical Hazard 

Communication Plan for Laboratory Diagnostics/Cenogenics: 

a. A copy of this Chemical Hazard Communication Plan and an explanation of the standard 

upon which it is based. 

b. Understanding the hazard warnings, labels and the NFPA (Mi^^i f F^lre Protection 

Association) symbols on chemical containers. "**' ^ ^ 

c. Understanding a Material Safety Data Sheet (MSDS) and where they may be 

d. Knowing when Personal Protective Equipment (PPE) is appropriate.\ xjN V' " 

e. Recognizing the signs and symptoms associated with exposure to hazardous chemicals. 

As an employee with a potential for occupational exposure, I am aware of and understand the 

safety measures I should execute when handling hazardous laboratory chemicals. I have read and 

understand the Chemical Hazard Communication Plan for this facility. I have had an opportunity to 

ask questions and have them answered. I also understand that i may at any time, ask questions 

of my immediate supervisor pertaining to proper safety procedures or any other topic discussed in 

the training seminar. 

Employee's signature: l\iA^~k^\/iJ^'^ ^ Date:__^2___ _ 

Training Supervisor: /^^InS^-^A^^O^ Date: <^/yjyiPp 
ATTACHMENT 9 

CENOGENICS CORPORATION 

GENERAL OPERATIONS 

OCCUPANT EMERGENCY RESPONSE PLAN 

Procedure prepared by: Nitza Katz Date: 7/1/05 S.O.P. SF-00153-03 

Procedure approved by: Michael Katz Date: 7/1/05 Supercedes: SF-00153-02 

PURPOSE: The purpose of this procedure is to define the action plan required in the 

case of an emergency. 

REFERENCE: 9 CFR 121.12 and 42 CFR 73.12 

CENOGENICS LOCATIONS 

1. Laboratory and office: 100 Route 520 

Morganville, NJ 07751 

732-536-6457 tel. 

732-972-8527 fax 

inguirv(S)cenogenics.com 

2. Warehouse and packaging: 712 Ginesi Drive 

Morganville, NJ 07751 

732-972-2145 

3. Exits are marked on the floor plans for each building. Floor plans are posted in each 

building. It is required that the area around each exit remains clear and free of any 

obstacle that could hinder access to the door. 

4. All exits are cleariy marked with "EXIT" signs. All exists are equipped with emergency 

exit lights. The exits lights are tested monthly to assure that they are In working order 

as described In S.O.P. SF-0054 (Emergency Light Inspection Procedure). 

COMPANY CONTACTS 

For questions pertaining to the Occupant Emergency Response Plan, contact: 

Michael Katz, President 

Nitza Katz, Vice President 

609-259-0010 (home tel.) 

EMERGENCY NUMBERS 

1. Cenogenics maintains a list of contact names and numbers for emergency situations. 

Refer to attachment "Emergency Telephone Number". 

2. The list of emergency numbers is posted by each telephone. 
Oocupant Emergency Plan S.O.P. SF-00153-03 Page 2 of 5 

EVACUATION 

For any of the emergency described below, when you are instructed to leave the building 

and report to your supervisor: 

1. Employees working in the laboratory building located at 100 Rt. 520, report to the 

supervisor at the warehouse building located at 712 Ginesi Drive. 

2. Employees working in the warehouse building located at 712 Ginesi Drive report to 

the supervisor at the laboratory building located at 100 Rt. 520. 

It is the responsibility of the supervisor to account for the safety of all employees before 

they are dismissed. 

FIRE EMERGENCY 

1. Fire extinguishers are located throughout the building at each location. The fire 

extinguishers are serviced annually. Each employee is trained on the use of the fire 

extinguisher at the time of employment (reference Chemical Hygiene Plan, S.O.P. SF0025). .. f 

The "Machine Room" in the laboratory building is equipped with^|^iyi<fad automatic 

sprinklers. 

3. Both locations are equipped with smoke detectors. 

4. The laboratory building's security system has smoke, heat ancTnoo^dfectors and is 

connected to a central station. In case of a fire, the alarm will Mun d and the fire and 

police department will automatically be notified. 

5. In case of fire, go to the nearest phone away from the fire area and dial 911. If it is not 

possible to safely call from inside of the building, leave the building IMMEDIATELY by 

way of the nearest exit. DO NOT stop to collect personal items. Once safely outside of 

the building, use a cell phone to call 911. Once safely outside of the building, report 

to your supervisor. 

6. In case of an emergency where it is necessary to evacuate the building, it is the 

responsibility of the supervisor to account for the each member of the staff. If an 

individual is missing, it must be reported to the emergency response unit (fire dept., 

police, etc.). 

7. The emergency response unit will determine when and if it is safe to re-enter the 

building. Your supervisor will let you know whether to return to the building or go 

home and wait for further instruction. 

GAS EMERGENCY 

1. In the case of a natural gas leak, phone NJ Natural Gas (800) 222-1222 IMMEDIATELY. 

2. Evacuate the building to a safe location outside the building and report to your 

supervisor. Before leaving the building. It is the responsibility of each supervisor to 

assure that any potential hazard such as open flames are turned off. 
Occupant Emergency Plan S.O.P. SF-00153-03 Page 3 of 5 

3. It is the responsibility of the supervisor to account for each member of the staff. If an 

individual is missing, it must be reported to the emergency response unit (fire dept, 

police, etc.). 

4. NJ Natural Gas will determine when and if it is safe to re-enter to the building. Your 

supervisor will let you know whether to return to the building or go home and wait for 

further instruction. 

WEATHER EMERGENCY 

1. In case of a weather emergency, it is the discretion of the company management 

whether it is necessary to close the company. 

2. In case of inclement weather prior to reporting to work, please contact the company 

management (reference Emergency Telephone Numbers) for company closing. 

CHEMICAL HAZARD INFORMATION AND EMERGENCY 

1. Reference Chemical Hygiene Plan, S.O.P. SF-0025 and Chemical Hazard 

Communication Plan, SF-0098. 

2. Reference the "CAUTION" section of each standing operating procedure for the 

proper use, handling and emergency action for any potentially hazardous chemical. 

BIOLOGICAL HAZARD INFORMATION AND EMERGENCY ^^s?W 

1. Reference Blood Borne Pathogen Exposure Control Plan, S.O.P. SF« 

2. Reference the "CAUTION" section of each standing operal^ttf^procedure for the 

proper use, handling and emergency action for any potentially hazardous blolo|pical 

material. '^" ^^0^^ 

SELECT AGENT INFORMATION AND EMERGENCY ^ 

1. Cenogenics possess the following select agents: 

a. Brucella melitensis, strain Rev. 1 

Brucella melitensis culture is used in the preparation of Brucella melitensis 

antigen, a diagnostic reagent used to detect the presence of B. melitensis 

antibodies in serum. 

b. Brucella abortus, strain 1119-3 

Brucella abortus is used in the preparation of Brucella abortus antigen and Rose 

Bengal Brucella abortus antigen, diagnostic reagents used to detect the presence 

of B. abortus antibodies in serum. 

2. In the case of broken contaminated glass, do not pick up by hand. Use a brush and 

dustpan and place the broken glass in a sharps container for proper disposal. 

Decontaminate the lab bench or the floor with a disinfectant solution. The brush and 

the dustpan must be autoclaved in a sealed autoclave bag before washing. 

3. In the case of an accident that may have caused exposure to the select agent (i.e. 

puncture from contaminated needle, etc.), report to the RO Immediately and seek 

medical attention. Refer to the Emergency Phone Number List posted by each phone 
Occupant Emergency Plan S.O.P. SF-00153-03 Page 4 of 5 

for the name and telephone number of the doctor and/or hospital. Report potential 

exposure to the doctor. 

4. Should an individual with access to the select agent suspect that he/she has been 

exposed to the select agent and is exhibiting symptoms of infection (i.e. fever, 

headache, flu-like symptoms), report to the RO immediately and seek medical 

attention. Refer to the Emergency Phone Number List posted at each phone for the 

name and number of the doctor and/or hospital. Report potential exposure to the 

doctor. 

5. Loss of keys to any of the following is considered a compromise to the security of the 

select agents: 

a. key to refrigerator where cultures are stored, ^awt. ^ 

b. key to the freezer where the select agents are stored, .^f^^ $ 

c. key to the bacteriology laboratory, ^ '" 

d. key to the bacteriology incubator, 

e. key to the manufacturing filing cabinets, 

f. key to the laboratory building. 

tOH^WtHl\^\-

In case of loss, report to the RO immediately. It is the responsibility of the RO to 

investigate and assure that all sensitive records pertaining to the select agent are in 

place. The RO must account for the select agent inventory. If everything is in order, 

the lock must be replaced. Record of replacement and key assignment must be 

maintained. 

6. If it is determined that sensitive records are missing or the select agent inventory 

cannot be reconciled or appears to have been altered, the proper authorities must be 

notified immediately. The management official must immediately notify APHIS orally 

and then the appropriate Federal, State and local law enforcement agencies (refer to 

Emergency Phone Number List posted by each phone). The oral report must be 

followed within seven days by a written report, APHIS Form 2043 (see attached). 

7. It is the responsibility of the management to notify the authorities of an unauthorized 

request to transfer, an unauthorized release, loss and/or theft of the select agents. 

The management official must immediately notify APHIS orally and then the 

appropriate Federal, State and local law enforcement agencies (refer to Emergency 

Phone Number List posted by each phone). The oral report must be followed within 

seven days by a written report, APHIS Form 2043 (see attached). 

SUSPICIOUS OBJECT OR SUSPICIOUS PERSONS 

1. If at any time you receive a letter, envelope or parcel and for whatever reason you 

suspect that it could be dangerous, bring it to the attention of your supervisor 

IMMEDIATELY. If the supervisor is unable to properly identify the object or the source 

of the object and also determines it to be of a suspicious nature, the local police 

should be notified IMMEDIATELY and given a full description of the object in 

question. DO NOT open. 

2. Unauthorized entry into Cenogenics buildings is PROHIBITED. If an unauthorized 

individual wishes to enter the building and cannot adequately explain the reason or 

can not show adequate credential, refuse entry. Note that all regulatory agents (FDA, 

USDA, Police, etc.) are required by law to show proper identification. You must ask to 
Occupant Emergency Plan S.O.P. SF-00153-03 Pages of 5 

see identification and notify your supervisor before allowing admittance to the 

building. 

The laboratory building does not permit unescorted visitors. All visitors must sign in 

and out in the visitors log at the front office (reference S.O.P. Bio-Safety and Security 

Plan, S.O.P. SF-00125). 

3. If an individual who is refused entry, becomes persistent and refuses to leave or 

enters the building, DO NOT become confrontational. Go to the nearest safe 

telephone and call the police (911). 

4. If you notice a suspicious person or vehicle lurking outside of the building, DO NOT 

APPROACH. Notify the police (911). 

^^^• . ^ 

BOMB THREAT .^^^ ^ ^ 

1. In the case of a bomb threat, phone the local emergency police^i^j^^^^ATELY . 

2. Evacuate the building to a safe location outside the buildin^ind report Jo 

supervisor. m% 

3. It Is the responsibility of the supervisor to account for the each member of the staff. If 

an individual is missing, it must be reported to the emergency response unit (fire 

dept., police, etc.). 

4. The emergency response unit will determine when and if it is safe to re-enter to the 

building. Your supervisor will let you know whether to return to the building or go 

home and wait for further instruction. 

TRAINING AND RECORDS 

1. All Cenogenics' employees shall be trained by the company management in the 

Occupant Emergency Response Plan. 

2. All trained personnel must sign the "OCCUPANT EMERGENCY PLAN TRAINING 

RECORD" stating that they have received training in the Occupant Emergency Plan, 

understand all aspects of the Plan and have had an opportunity to ask questions (see 

attached). 

RECORD 

1. "OCCUPANT EMERGENCY PLAN TRAINING RECORD" will be maintained in the 

regulatory file located in the laboratory building. 

2. The organization will maintain a record of an emergency response in the regulatory 

file. The record should identify the incident, the emergency responder, describe 

response action taken and evaluate the effectiveness of the response. 

REVIEW 

This plan will be reviewed by the RO annually and updated as deemed necessary by 

changes in the company, government regulations and/or as a corrective action to an 

ineffective incident response. 
ATTACHMENT 10 

CENOGENICS CORPROATATION 

OCCUPANT EMERGENCY PLAN TRAINING RECORD 

I have received training on the Occupant Emergency Plan describing the safety and 

security measures I should employ in the case of any of the emergency situations 

described in the Plan. Additionally, I have received information related to the select 

agents possessed by Cenogenics, Brucella abortus and Brucella mQlite^isis. I 

received the following instructional material: =*-^. v'^ ^ 

a. A copy of the Occupant Emergency Plan *-vK'^\V\V' 

b. A copy of the Select Agent Risk Assessment oCXX'^Y y^ '^ 

c. A copy of the Brucella Material Safety Data Sheet 

As an employee of Cenogenics Corporation, I am aware of and understand the 

safety and security measures I should execute in case of an emergency that could 

threaten my safety, the safety of my fellow employees and the security of the select 

agents possessed by the Organization. I have read and understand the Occupant 

Emergency Plan. I have had an opportunity to ask questions and have them 

answered. I also understand that I may, at any time, ask questions of the RO 

(Responsible Official), Nitza Katz, pertaining to proper safety and security 

procedures or any other topic discussed during the training session. 

[i^(^xf-A.d VA^-'H ^ Employee name: 

Employee signature: ^-^--''^^^'^ " Date: ^' ^ ^ ^ 

RO Signature: 

SF-00153-03 

'yJoAMJA.-- Date ^^ ^ 
ATTACHMENT 11 

r'^*rrsrr*r—jk:-'jtr~:t^--.^-rj»rr'Ar':i^ rT:d^rr^rr:^r^:jkrTJ^rrjir'':*Lrr'jtr~'jkr^ 

Certificate of Completion 

ONUNE lATA DANGEROUS GOODS TRAINING 

This is to certify that 

Nitza Katz C O 

has been successfully trained and tested in the transportation of Dangerous Goods in accordance with 

the requirements of the International Civil Aviation Organization (ICAO), lATA DG Regulations 

and the U.S. DOT, Title 49CFR, Subpart H. 

Additional Function Specific training may be required if you ship or accept Radioactive Materials. 

This certificate is valid for 24 months from the date of completion. 

Troinlng 

Center 

To verify training itxords and materials contact; 

DGI Training Center 

1060 b'l Camrno Real, Sui(c# B. Redwood City CA 94063 

Telephone-. 800-338-2291 

www.dgitn)ining.com 

Seminar Completion Date: July 08, 2009 

Test Score: 80 % 

Type of Training: Online - lATA 

Program Director; Candif, £, C«cA 

Li.'V'.-i^'V'.ii.^r^-.'^.-^'V'^-;.:^:.^ r^iiir^^^r;i^iw^ 
ATTACHMENT 12 

CENOGENICS CORPORATION 

DANGEROUS GOODS DOCUMENTATION FUNCTION-SPECIFIC TEST 

Test prepared by: Nitza Katz Date; 7/14/09 S.O.P SF-00158-01 

Name d ((:<:• y- J AC L O-^TC 

Position ^ ( lO fo-lcl- O-yui U.c J^'YAC V '•^'•C-'UM ( CJ 

Date test taken ^^^.c U L / 5 J^DO f 

QUESTIONS tf^^iW^ ^ 

Fill in appropriate answers in the space provided. 

1. List the Cenogenics' products that contain dangerous goods. 

2. What documentation is required for shipping the dangerous goods? 

3. Where are the required forms kept? 

4. Where can you purchase forms, if required? 
Dangerous Goods Documentation Function Specific Test Page 2 of 2 

5. For each of the products listed in question 1, list the following information: 

Product 1 Product 2 

Cenogenics' product 

^^-j^'i-i: A;^c/vt- £.^ 1-. Uf^- ^ 

UN or ID No. CVV /9fi'C--

Proper Shipping Name 

a OMu^LOduheriK, 

Class or Division 

(subsidiary risk) 3i(^d 

Packing Group TT / / 

6. Which of the Cenogenics' product may be transported as "Cargo Aircraft 

Only"? 

-^I'^C'C/Mc^^l ^ £b-n,L^X^LyQ fc%S ' f 

if ' ^ 

U 

What is the Cenogenics' procedure to be followed after completion of the 

Dangerous Goods Documentation? 

L Qjaki^ LruOOifuL ^yi ji^^^K-•td CMid /Ux^ OX . 

8. How often should you check for changes to the DG regulations? 

;>v . 

If you have questions regarding the documentation of DG, to whom should 

you direct your questions? 

^7w M 

Employee: Passed test ^ /y ^ 

Test graded by /.-'/^.^t ^ 

Failed test 

Date 7A-A, 
ATTACHMENT 13 

CENOGENICS CORPORATION 

DANGEROUS GOODS PACKAGING FUNCTION-SPECIFIC TEST 

Test prepared by: Nitza Katz Date: 7/14/09 S.O.P 8F-00159-01 

Name So^TdAt J I/AIU-l U 

Position P^JJULV^^QA TeCpl 

Date test taken CToLV I<D ZOO' i 

QUESTIONS 

„ % ..0 •:• 

1. Name the Cenogenics' product that you manufacture or package for 

shipping that contains dangerous goods. 

STOO L fe^ocO '^^ ^ T>gv/fctY.:-^<s -^olu-ncv-l 

2. What chemical is contained in the above product that requires classification 

as a dangerous good? 

3. Where can you find the specifications for packaging the product? 

^AcKAG^(y 3^^ ^ g^[Qo4 T^ T (D€U6d.^.kr -^QUT>'0 ^ ^ O^ t eG-0^7S-<^ 

4. How often should you verify that the procedure for packaging the DG is 

current with the required regulations? 

5. What DG labels are currently required? 

3 ) TOT^'C^^ , ^ (jf^GKX I'^W^tvli, 
Dangerous Goods Packaging Function Specific Test S.O.P. SF-00159-01 Page 2 of 2 

6. Where are the DG labels kept? 

7. Where you can you purchase DG labels, if required? 

8. In addition to the DG labels, what other labeling is required? 

9. What container is used to package the product? 

10. If you have questions regarding the documentation of DG, to whom should 

you direct your questions? 

C 

Employee: Passed test '•'^ /^^<-^ Failed test 

Tes %j^^-/^M Date 7/^^'^ / t graded by U-jf^j^^t'^A. Date 

ATTACHMENT 15 

Air Sea International Forwarding, Inc. 

August 24, 2010 

1405 Route 18, Sntte 206 

Old Bridee, New Jenc? 08857 

Teleibone 732-607-0600 

OP"' Cenogenics Corporation ^ ^ 

Route 520 \^ J 

Morganville, NJ ^" ^ 

Attn: Mrs.Nitza Katz 

Subject: (Hazardous Material Shipments 

We as your freight forwarder, for that past 14 years, have handled your shipments, both non 

hazardous and hazardous 

We provkled general awareness training and function specific training to your hazmat employees 

responsible for shipping hazardous materials in accordance with 172.704. In addition, I examine 

the company's documents for proper procedure and cargo for proper packaging and labeling as a 

means of testing. 

Regarxting your hazardous shipments, we have always had a procedure in place where as your 

office will fax us a copy of the completed shippers declaration for hazardous materials, I being 

certified to handle hazaixlous materials by air, personally review your documents, and then 

confimn with your office if they are correct or any changes need to be made. 

In addition, all cargo is inspected, again by me per^nally, to ensure proper packing is used. 

Further, when we tender the cargo to any airiine, the entire shipment is again inspected by that 

particular airtines hazardous material specialist. If there is something we may have missed or 

overtooked, or a mistake that was made the airiine will reject it. 

All shipments are inspected by us using the lATA Dangerous Goods By Air regulations. 

Further, I have attached my current certificate which shows that we am property trained to handle 

hazardous materials by air. 

Shoukl you have any questions, or require any further infonnation, please feel free to contact me 

at any time. 

Sincere 

Air 
SHIPPER'S DECLARATION FOR DANGEROUS GOODS 

Shiplper 

CENOGENICS CORPORATION 

100 ROUTE 520 - DRAWER 308 

MORGANVILLE, NEW JERSEY 07751 U.S.A. 

Air Waybill No. 

ATTACHMENT 16 

Page 1 of Pages 

Shipper's Reference Number 

(optional) 

Consignee 

GRUPO MEXLAB 

SUSANA GOMEZ PALAFOX #5486 

ZAPOPAN, JALISCO 

MEXICO, 

Two completed and signed copies of this Declaration must 

be handed to the operator. 

SI 

0^\\-

WARNING 

TRANSPORT DETAILS 

This shipment is within the 

limitations prescribed for: 

(delete non-applicable)^ 

PASSENGER 

AND CARGO 

AIRCRAFT 

XXX. xxjoa 

:J5NLXXXXX 

Airport of Destination: 

Airport of Departure: 

GUADALAJARA AIRPORT 

Failure to comply in all res|ftcta wTm the applicable 

Dangerous Goods Regulatiorrc^ay be In breach of 

the applicable law, subject to legal penalties. 

5|ftcta wTm 

orrc^av b 

Shipment type: (delete non-applicable) 

NON-RADIOACTIVE fXXaOQQCXiXtOf 

NATURE AND QUANTITY OF DANGEROUS GOODS 

Dangerous Goods Identification 

UN 

or 

ID 

No. 

Proper Shipping Name 

Class 

or Division 

(Subsidiary 

Risk) 

Packing 

Group 

Quantity and 

type of packing 

Packing 

Inst. 

Authorization 

UN1170 ETHANOL SOLUTION 1 FIBERBOARD 

BOX X 2 LITER 

305 

Additional Handling Information 

24 hr. Emergency Contact Tel. No. (732) 536-6457/(609) 259-0010 

I hereby declare that the contents of this consignment are fully and 

accurately described above by the proper shipping name, and are 

classified, packaged, marked and labelled/placarded, and are in all 

respects in proper condition for transport according to applicable 

international and national governmental regulations. I declare that all 

of the applicable air transport requirements have been met. 

Name/Title of Signatory 

EILEEN KERSTER - SECRETARY 

Place and Date 

MORGANVILLE, NJ 10/27/08 

Sic jure 

'^arrfryg above) >dhzu 

STYLE* F07LC LABELI*IASTER ® (800) 621-5808 www.labelmaster.com 
SHIPPER'S DECLARATION FOR DANGEROUS GOODS 

G'^Q^INIC S CORPORATION 

100 ROUTE 520 - DRAWER 308 

IVIORGANViLLE, NEW JERSEY 07751 U.S.A. 

Air Waybill No. ATTACHMENTS 

Page of Pages 

Shipper's Reference Number 

(optional) 

i 

I Consignee 

SCHENKER STINNNES LOGISTICS - IMPORT 

AIRPORT VIENNA 

A-1300 VIENNA, AUSTRIA 

FOR: DIPROME D A-2484 WEIGELSDOR F 

Two completed and signed copies of this Declaration must t# 

be handed to the operator. 

TRANSPORT DETAILS 

This shipment is within the 

limitations prescribed for: 

Airport of Departure: 

Airport of Destination: 

VIENNA, AUSTRIA 

WARNING 

Failure to comply in all respe^jA^Tmr the applicable 

Dangerous Goods Regulations^^ y be in breach of 

the applicable law, subject to legal penalties. 

Shipment type: (delete non-applicable) 

I NON-RADIOACTIVE yKxaoKxarxxao;: 

NATURE AND QUANTITY OF DANGEROUS GOODS 

Dangerous Goods Identification 

UN 

or 

ID 

No. 

Proper Shipping Name 

Class 

or Division 

(Subsidiary 

Risk) 

Packing 

Group 

Quantity and 

type of packing 

Packing 

Inst. 

Authorization 

UN1986 ALCOHOLS, FLAMMABLE, 

TOXIC, N.O.S. 

(ETHYL ALCOHOL) 

3(6.1) 4 PLASTIC DRUMS X 

57.75 LITERS 

1 PLASTIC DRUM X 

44 LITERS 

307 

307 

Additional Handling Information 

iCAO/IATA 

24 hr. Emergency Contact Tel. No. 

(732) 536-6457/(609) 259-0010 

I hereby declare that the contents of this consignment are fully and 

accurately described above by the proper shipping name, and are 

classified, packaged, marked and labelled/placarded, and are in all 

respects in proper condition for transport according to applicable 

international and national governmental regulations. I declare that all 

of the applicable air transport requirements have been met. 

Name/Title of Signatory 

EILEEN KERSTER - SECRETARY 

Place and Date 

MORGANVILLE, NJ 03/20/09 

SignsHtlre 

(sBeyt^M above) „y ^ y 

STYLE* F07LC LABELt*lASTER ® (800) 621-5808 www.labelmaster.com 
lATA Dangerous Goods Regulations ATTACHMENT 18 

• 

A 

A 

A 

D 

D 

D 

A 

UN/ 

ID no. 

A 

3166 

3166 

3082 

3077 

2558 

2023 

2752 

3272 

1035 

1961 

1170 

2491 

2491 

3475 

3475 

3475 

1170 

Proper Shipping 

Name/Description 

B 

Engines, Internal combustion, flammable gas powered 

Engines, Internal combustion, flammable liquid 

powered 

Engines, rocltet, see Rocliet motors t (UN 0186), Rocltet 

motors with hypergolic liquids t (UN 0250), Rocliet 

motors t (UN 0280), Rocket motors t (UN 0281), 

Rocl(et motors with hypergolic liquids t (UN 0322), 

Rocl(et motors, liquid fuelled t (UN 0395), Rocicet 

motors, liquid fuelled t (UN 0396) 

Environmentally hazardous substance, liquid, n.o.s. -k 

Environmentally hazardous substance, solid, n.o.s, it 

EiTibromohydrin 

Epichlorohydrin 

1,2-Epoxybutane, stabilized, see 1,2-Butylene oxide, 

stabilized (UN 3022) 

Epoxyethane, see Ethylene oxide (UN 1040) 

1,2-Epoxy-3-ethoxypropane 

2,3-Epoxy-1-propanal, see Glycidaldehyde (UN 2622) 

2,3-Epoxypropyl ethyl ether, see 

1,2-Epoxy-3-ethoxypropane (UN 2752) 

Esters, n.o.s. * 

Ethane 

Ethane, refrigerated liquid 

Ethanethiol, see Ethyl mereaptan (UN 2363) 

Ethanol 

Ethanolamine 

Ethanol amine dinitrate 

Ethanolamine solution 

Ethanol and gasoline mbcture 

with more than 10% ethanol 

Ethanol and motor spirit mixture 

with more than 10% ethanoi 

Ethanol and petrol mixture 

with more than 10% ethanoi 

Ethanoi aqueous solutions containing 24% or less alcohol 

by volume 

Ethanol solution 

Ether, see Diethyl ether (UN 1155) 

Class 

or 

Oiv. 

(Sub 

Risk) 

C 

9 

9 

9 

9 

6.1 (3) 

6.1 (3) 

3 

3 

2.1 

2.1 

3 

8 

8 

3 

3 

3 

3 

Hazard 

l.abel(5) 

D 

Miscellaneous 

Miscellaneous 

Miscellaneous 

Miscellaneous 

Toxic S Ramm. 

liquid 

Ramm. liquid 

Flamm, liquid 

Flamm. gas 

Flamm. liquid 

Corrosive 

Corrosive 

Flamm. liquid 

Flamm. liquid 

Flamm. liquid 

Flamm. liquid 

PG 

E 

III 

III 

II 

III 

II 

III 

II 

III 

III 

III 

II 

II 

II 

II 

III 

EQ 

see 

2.7 

F 

EO 

EO 

E1 

El 

E4 

E1 

E2 

E1 

EO 

E2 

El 

E1 

El 

E2 

E2 

E2 

E2 

El 

Passenger and 

Carao Aircraft 

Ltd Qty 

Pkg 

Inst 

G 

Y914 

Y911 

-

Y609 

Y309 

Y305 

Y309 

-

-

Y3Q5 

Y309 

Y818 

YB18 

Y305 

Y305 

Y305 

Y305 

Y309 

Max Net 

Qty/Pkg 

H 

30kgG 

30l(gG 

-

1L 

10L 

1L 

10 L 

~ 

-

1L 

10 L 

1L 

1L 

1L 

1L 

1L 

1L 

10 L 

Pkg 

Inst 

1 

Max Net 

CMy/Pkg 

J 

Forbidden 

900 

914 

911 

No limit 

450 L 

400 kg 

1 

Forbidden 

609 

309 

305 

309 

5L 

60 L . 

5L 

60 L 

1 

Forbidden 

1 1 

Forbidden 

305 

309 

818 

Fori 

818 

305 

305 

305 

NotR 

305 

309 

5L 

50 L 

5L 

idden 

5L 

5L 

5L 

5L 

sstricted 

5L 

60 L 

Cargo 

Aircraft Onlu 

Pkg 

Inst 

K 

900 

900 

914 

911 

Max Net 

Qty/Pkg 

_L_ j 

No limit 

No limit 

450 L 

400 kg 

Forbidden 

611 

310 

307 

310 

200 

Fort 

307 

310 

820 

Fori 

820 

307 

307 

307 

NotR 

307 

310 

60 L 

220 L 

60 L 

220 L 

150 kg 

Idden 

60 L 

220 L 

60 L 

idden 

60 L 

60 L 

60 L 

60 L 

jstricted 

60 L 

220 L 

~^ 

,-3 

si 

4,i 

J 

AB 

A7 

M 

A13 

A7Q 

m 

A1J 

-.li 

> 

A 9 ^ 

A15«^ 

mi 

A156; 

•V* 

Alii 

A3: 

A1 . 

; 

A3i 

Afaa= 

A3 

A3: 

A1S6 

A156 

A166 

A3 

A58 

194 

SOth EDITION, 1 JANUA B 

FOR EXPIJ^NATION OF THE ABBREVIATIONS AND REFERENCE MARKS, SEE APPEN 
->\wii'iir hj i,iirjwirj, i.( !_• 

ATTACHMENT 19 

r^ttbt 

fp^ -

G 

G 

- J 

* • 

D 

Dynamite, see Explosive, blasting, type A. 

Efectmlyte (sad or alkali) for 

batteries, see Battery fluid, 

acid or Battery fluid, alkali. 

Elevated temperature liquid, 

flamrtiable, n.o.s., with flash 

point aeore 37.8 C, at or 

above its flash point. 

Elevated temperature liquid, 

n.o.s., at or above 100 C and 

below its flash point (including 

molten metals, molten salts. 

etcj. 

Elevated temperature solid, 

n.o.s., at or above 240 C, see 

§U3.24T(hl(4). 

Engines, internal combustion. 

ffammable gas povmrad. 

Engines, internal combustion. 

flammable liquid powered. 

Environmentally hazardous substances, liquid, n.o.s. 

Environmentally hazardous substances, solid, n.o.s. 

Epictilorotiydrin 

1,2-EpoKy-3-ettioxypropane 

Esters, n.o.s 

Etching acid, liquid, n.o.s., see 

Hydrofluoric acid, solution etc. 

Ethane 

Ettiane-Propane mixture, refrigerated linuld. 

Ettiane refrigerated liquid 

ethanolamine dinitrate 

Etiionol or Ethyl alcohol or Ethanol solutions or Ethyl alcohol 

solutionsEthanolamine or Ethanolamine 

solutions. 

Ether, see Diethyl ether 

Ethers, n.o.s 

3 

9 

9 

9 

9 

9 

9 

6.1 

6.1 

3 

3 

2.1 

2.1 

2 1 

Forbidden 

3 

8 

3 

UN3256 

UN3257 

UN3268 

UN3ie6 

UN3186 

UN3082 

UN3077 

UN2023 

UN2752 

UN3272 

UN1035 

1^1961 

UN1961 

UN1170 

UN2491 

UN3271 

ill 

ill 

ill 

III 

III 

1 

11 

III 

II 

III 

II 

III 

III 

11 

3 

9 

9 

9 

9 

9 

9 

6.1.3 

6.1,3 

3 

3 

3 

2.1 

2.1 

2.1 

3 

3 

B 

3 

I81,T3, TP3, 

TP29 

IB1,T3, TP3, 

TP29 

135 

8, 146, IB3, T4, 

TP1,TP29 

8, 146, B54, (B8, 

N20 

T14, TP2, TP13 

1B2, T7, TP2, 

TP13 

B3, T2, TP1 

IB2, T7, TP1, 

TPB, TP28 

IB3, T4, TP1, 

TP29 

B1, 

B1 

T75, TP5 

T75, TP5 

24, IB2, T4, TP1 

24, B1, IB3, T2, 

TP1 

IB3, T4, TP1 

IB2, T7, TP1, 

TPB, TP28 

None .... 

None .... 

247(h) 

(4). 

220 

220 

155 

155 

None ... 

None .... 

150 

150 

150 

306 

None .... 

None .... 

150 

150 

154 

150 

None .... 

None .... 

None .... 

220 

220 

203 

213 

201 

202 

203 

202 

203 

304 

316 

None .... 

202 

203 

203 

202 

247 

247 

247 

220 

220 

241 

240 

243 

243 

242 

242 

242 

302 

314, 

315. 

315 

242 

242 

241 

242 

Forbidden 

Forbidden 

No limit 

No limit 

No limit 

Forbidden 

5 L 

60 L 

5 L 

Forbidden 

FortJidden 

Forbidden 

5 L 

60 L 

5 L 

No limit 

No limit 

No limit 

No limit 

Forbidden 

60 L 

220 L 

60 L 

150 kg 

Forbidden 

Forbidden 

80 L 

220 L 

60 L 

40 

40 

TO 

(B 

t/) 

m 

D) 

o 

01 

a 

in 

T) 

(B 

0 

O 

CQ 

3 

> a 

3 

p 

o 

40 

40 

" J 

ro 
lATA Dangerous Goods Regulations ATTACHMENT 20 

II 

4.1 

Refrigerant gas, n.o.s. UN 1078 

Selenium compound, solid, n.o.s. UN 3283 

(d) General n.o.s. entries covering a group of substances or articles meeting the criteria of one or more 

classes or divisions, for example 

UN 1759 

UN 2810 

Corrosive solid, n.o.s. 

Toxic liquid, organic, n.o.s. 

4.1.0.3 Self-reactive substances of Division 4.1 must be 

assigned to one of the generic entries listed in 

Appendix C.1 in accordance with the classification principles described in 2.4.2.3.3 of the UN Recommendations. 

4.1.0.4 Organic peroxides of Division 5.2 must be assigned to one of the generic entries listed in Appendix C.2 

in accordance with the classification principles described 

in 2.5.3.3 of the UN Recommendations. 

4.1.1 Items Listed By Name 

4.1.1.1 If the name is known, go directly to the List of 

Dangerous Goods (Subsection 4.2). 

4.1.1.2 If the UN or ID number is known, go to the 

Numerical/Cross-reference Index (Subsection 4.3) to find 

the List of Dangerous Goods. 

4.1.2 Items Not Listed by Name 

4.1.2.1 When an article or substance is not listed by 

name in the List of Dangerous Goods, the shipper must: 

(a) determine that the article or substance is not 

forbidden by referring to the characteristics in Subsection 2.1 and the classification criteria described in 

Section 3; 

(b) if the item is not forbidden, classify it by comparing its 

properties with the classification criteria described in 

Section 3. If the item has more than one hazard, the 

shipper must refer to Subsection 3.10 to determine 

the primary hazard; 

(c) use the generic or n.o.s. proper shipping name which 

most accurately describes the article or substance. 

Proper shipping names must be determined in the 

order shown in 4.1.0.2. 

This means that a substance is only assigned to an 

entry of type 4.1.0.2 (c) if it cannot be assigned to an 

entry of type 4.1.0.2 (b) and to an entry of type 

4.1.0.2 (d) if it cannot be assigned to an entry of 

4.1.0.2(b) or 4.1.0.2(c). 

Example 1: Methyl-n-amyl carbinol, an alcohol with 

a flash point of 54°C (130°F), is not listed by name 

so it must be declared under the most accurately 

descriptive name which is Alcohol, n.o.s. 

(Methyl-n-amyl carbinol) rather than Flammable 

liquid, n.o.s.-k. 

Example 2: Ethyl cyclohexane, a hydrocarbon with 

a flash point of 35°C (95°F) is not listed by name so it 

must be declared under the most accurately descriptive name which is Hydrocarbons, liquid, n.o.s. 

rather than Flammable liquid, n.o.s.-k. 

(d) Generic or n.o.s. proper shipping names, i| 

by the inclusion of the "*" symbol in Colunin| 

List of Dangerous Goods must be suppletnert 

the technical or chemical group names in bra. 

immediately following the proper shipping naW 

requirement does not apply to controlled su^ 

when their disclosure is prohibited by nationj 

international convention. For explosives of i 

the dangerous goods description may 

plemented by additional descriptive text toj 

commercial or military names. The technic 

must be a recognized chemical or oth6 

currently used in scientific and technical hai\ 

texts and journals. Trade names must not 

For a pesticide, only the ISO common nan 

other name(s) listed in the World Health i 

(WHO) Recommended Classification of Pes6 

Hazard and Guidelines to Classification,^ 

name(s) of the active substance(s) must be u| 

Example 3: The proper shipping name 

ture of Freon® 14 and Freon® 23 is R 

gas, n.o.s. (Tetrafluoromethane, Trifluoron 

Freon® 14 and Freon® 23 are not ac 

because they are trade names. 

Example 4: A solid pesticide product 

Carbofuran. It will be declared as Carbamai 

aide, solid, toxic (Carbofuran), UN 2757. 

Example 5: A mixture consisting of xyti 

acetone, exhibiting a flash point of 24°C (7^ 

an Initial boiling point above 35°C (95°F), 

classified using a proper shipping name 

rately represents its hazard and its appllcatii 

in a form that is to be used as a paint femo| 

a generic entry. Paint related material, UK 

appropriate. On the other hand, if it does 

such a function, but is used (for example, 

intermediate in a manufacturing process, 

simple n.o.s. proper shipping name may 

Flammable liquid, n.o.s.-k 

(e) Where there is any doubt as to whether a 

article or substance is permitted for transppfl 

or under what conditions, the shipper and/orf 

must consult an appropriate national authorit) 

(f) Hydrates may be included under the properi 

name for the anhydrous substance. 

4.1.2.2 Table 4.1.A lists all the n.o.s. entries j 

main generic entries, grouped by hazard class or| 

Within each hazard class or division the 

placed into three groups, where appropriate, as I 

(a) specific entries covering a group of substi 

articles of a particular chemical or technical i 

(b) pesticide entries, for Class 3 and Division 6.1 

(c) general entries covering a group of subsU 

articles having one or more general 

properties. 

Generic or n.o.s. proper shipping names follow 

"*" symbol must be supplemented with the tec 

chemical group name, see 4.1.2.1(d). The most| 

proper shipping name must always be used. 

122 SOtti EDITION, 1 JANU I 
ATTACHMENT 21 

•>\UnJ'Uf hj l.)i73*irB, M f 

W 

Hydrogen, compressed 

Hydrogen cyanide, solution in alcohol with not morg than 45 

percent hydrogen cyanide. 

Hydrogen cyanide, stabilized 

whb less than 3 percent water. 

Hydrogen cyanide, stabilized, 

with fess than 3 percent water 

and absorbed in a porous 

Inert material. 

Hydrogen fluoride, anhydrous .... 

Hydrogen iodide, anhydrous 

Hydrogen iodide solution, see 

Hydriodic acid, solution. 

Hydrogen peroxide and peroxyacetic acid mixtures, stabilized 

with acids, water and not 

more than 5 percent pemxyacatic acidHydrogen peroxide, aqueous solutions wHh more than 40 percent but not more than 60 

percent hydrogen peroxide 

(stabilized as necessary). 

Hydrogen peroxide, aqueous solutions with not less than 20 

percent but not more than 40 

percent hydrogen peroxide 

(stabilized as necessary). 

Hydrogen peroxide, aqueous solutions, with not less than 8 

percent but less than 20 percent hydrogen peroxide, (stabilized as necessary). 

Hydrogen parcent stabilized or 

Hydrogen peroxide aqueous 

solutions, stabilized with mom 

than 60 percent hydrogen paroxide. 

Hydrogen, refrigerated liquid 

(cryogenic liquid). 

Hydrogen selenlde, anhydmus .. 

Hydrogen sulfate, see Sulfuric 

acid. 

UN1049 

UN3294 

UN1051 

UN1614 

UN1052 

UN2197 

UN3149 

UN2014 

UN2014 

UN2984 

UN2015 

UN1966 

UN2202 

1 

1 

1 

1 

II 

II 

11 

III 

1 

2.1 

6.1,3 

6.1,3 

6.1 

8,6.1 

2.3 

5.1, 8 

5.1,8 

5.1.8 

5.1 

5.1.8 

2.1 

2.3, 

2.1. 

2, B9, B14, B32, 

B74, T20, TP2, 

TP13, TP38, 

TP45 

1,835,861 , 

B65, B77, B82 

5 

3, B7, B45, B71, 

B77, T10, TP2 

3,814 

145, A2, A3, A6, 

B53, IB2, IPS, 

T7, TP2, TPB, 

TP24 

12, A3, A6, B53, 

BBO, BB1, BBS, 

IB2, IPS, T7, 

TP2, TPS, TP24, 

TP37 

A2, A3, A6, 853, 

IB2, IPS, T7, 

TP2, TP6, TP24, 

TP37 

A 1, IB2, IPS, T4, 

TP1,TP6, TP24, 

TP37 

12, A3, A6, B53, 

BBO, 881, 885, 

T10, TP2, TPB, 

TP24, TP37 

T75, TPS 

1 

306 

None .... 

None .... 

None .... 

None .... 

None .... 

None .... 

None .... 

None .... 

152 

None .... 

None .... 

None .... 

302 

227 

195 

195 

163 

304 

202 

202 

202 

203 

201 

316 

192 

302, 

314. 

244 

244 

None .... 

243 

314, 

315. 

243 

243 

243 

241 

243 

318, 

319. 

245 

Forbidden 

Forbidden 

Forbidden 

FortJidden 

Forbidden 

Forbidden 

FortJidden 

Forbidden 

150 kg 

Forbidden 

Forbidden 

Forbidden 

Forbidden 

Forbidden 

Forbidden 

Forbidden 

Forbidden 

Forbidden 

40,57 

40 

40 

25,40 

40 

40 

25, 66, 

75, 106 

25, 66, 

7S, 106 

25, 66, 

75, 106 

25, 75, 

106 

25, 66, 

75, 106 

40 

40 

70 

(B 

tn 

(D 

0) 

O 

3 -

01 

3 

a 

in 

•V 

m 

n 

D> 

7 

0 

(O 

b> 

3 

Crt 

> 

a 3 

3 

* 

o O 

ur> 

^ 

ro 

~A 

o 
ATTACHMENT 22 

Identification 

^r-—"'' ^ 

£'.••• i 

& Proper Shipping 

^ S ' Name/Description 

fELge n bromide solution, see Hydrobromic acid 

^roge n cliloride, anhydrous 

Lj^ge n cliloride, refrigerated liquid 

w 

^drogen, compressed M^jfoaen cyanide, aqueous solution 

Wbrnimore than 20% hydrogen cyanide 

iuflraoen cyanide, solution in alcohol 

p h not more than 45% hydrogen cyanide 

i^foae n cyanide, stabilized 

gi^alning less than 3% water 

ivdragen cyanide, stabilized 

lontaining less than 3% water and absorbed in a porous 

•iSert material 

jiydragen cyanide, unstabilized 

^rogendifiuorides, solid, n.o.s. 

Hydrogendifluorldes, solution, n.o.s. 

Hydrogen fluoride, anhydrous 

Hydrogen fluoride solution, see Hydrofluoric acid 

(UN 1790) 

Hydrogen In metal hydride storage system 

HydrAgen in a metal hydride storage system contained 

In equipment 

Hydrogen in a metal hydride storage system packed 

with equipment 

Hydrogen iodide, anhydrous 

Hydrogen iodide solution, see Hydriodic acid (UN 1787) 

iiydrogen, liquid, see Hydrogen, refrigerated liquid 

Hydrogen peroxide and peroxyacetic acid mixture 

stabilized 

with acid(s), water and nol more than 5% peroxyacetic acid 

"yj">98n peroxide, aqueous solution 

Wrth 20% or more but 40% or less hydrogen peroxide 

(stabilized as necessary) 

JStJ^Sen peroxide, aqueous solution 

• TM B/. or more but less than 20% hydrogen peroxide 

(stabilized as necessary) 

Hydrogen peroxide, aqueous solution 

win more than 40% but 60% or less hydrogen peroxide 

tstabihzed as necessary) 

Hydrogen peroxide, aqueous solution, stabilized 

« w more than 60% hydrogen peroxide 

ydrogen peroxide, aqueous solution with less than 8% 

"yorogen peroxide (stabilized as necessary) 

Hydrogen peroxide, stabilized 

Class 

or 

Div. 

(Sub 

Risk) 

C 

2.3(8) 

2.3 (8) 

2.1 

6.1 

6.1(3) 

6.1 (3) 

6 1 

8 

8(6.1) 

8(6.1) 

2.1 

2.1 

2.1 

2.3 (8) 

5 1(8) 

5.1 (8) 

5.1 

5.1 (8) 

5.1 (8) 

5 1(8) 

Hazard 

Label(s) 

D 

Flamm. gas 

Corrosive 

Corrosive & Toxic 

Flamm. gas 

Flamm. gas 

Flamm. gas 

Oxidizer & 

Corrosive 

Oxidizer & 

Corrosive 

Oxidizer 

PG 

E 

II 

III 

II 

III 

II 

II 

III 

EQ 

see 

2.7 

F 

EO 

E2 

El 

E2 

El 

EO 

EO 

EO 

E2 

E2 

E1 

Passenger and 

Cargo Aircraft 

Ltd Qtv 

Pkg 

Inst 

G 

-

-

-

-

-

-

-

-

Y815 

Y825 

Y809 

Y819 

-

-

-

-

-

Y501 

Y501 

Y514 

-

-

-

-

Max Net 

Qty/Pkg 

H 

-

-

-

-

-

-

-

5 kg 

5 kg 

0.5 L 

1L 

-

_ 

0.5 L 

0.5 L 

1 L 

-

-

-

-

Pkg 

Inst 

1 

Max Net 

Qty/Pkg 

J 

Forbidden 

1 

t 

Forbidden 

1 1 

Forbidden 1 

Forbidden 

1 

1 

Forbidden 

1 

1 

Forbidden 

1 

1 

Forbidden 

1 

1 

Forbidden 

815 

825 

809 

819 

15 kg 

25 kg 

1 L 

5 L 

Forbidden 

Forbidden 

1 

Forbidden 

1 

1 

FortJidden 

1 

1 

Forbidden 

501 

501 

514 

1L 

1 L 

2.5 L 

Forbidden 

Fort)idden 

1 

1 

Not Restricted 

1 

1 

Forbidden 

1 

Cargo 

Aircraft Only 

Pkg 

Inst 

K 

Max Net 

Qty/Pkg 

L 

Forbidden 1 

1 

Forbidden 

1 

200 150 kg 

Forbidden 

1 

I 

Forbidden 

1 

1 

Forbidden 

1 

i 

Forbidden 

1 

1 

Forbidden 

817 

826 

813 

821 

50 kg 

100 kg 

30 L 

60 L 

Forbidden 

214 

214 

214 

Fort 

506 

506 

515 

100 kg 

G 

100 kg 

G 

100 kg 

G 

jidden 

5L 

5L 

30 L 

1 

Forbidden 

1 

1 

Forbidden 

1 

1 

Not Restncted 

1 

1 

Forbidden 

1 

S.P. 

see 

4.4 

M 

A2 

A1 

A3 

A2 

A1 

A143 

A1 

A143 

A1 

A143 

A2 

A96 

A2 

A75 

ERG 

Code 

N 

2CP 

2CP 

10L 

6L 

6F 

6H 

6L 

eL 

8L 

SP 

8P 

8P 

10L 

10L 

10L 

2CP 

5C 

5C 

5i. 

5C 

5C 

5C 

i|vp'°'^' ' JANUARY 2009 

LANATION OF THE ABBREVIATIONS AND REFERENCE MARKS, SEE APPENDIX B. 211 
CENOGENICS CORPORATION 

MASTER PRODUCTION RECORD 

ATTACHMENT 23 

DEVELOPING SOLUTION FOFLSTOOL BLOOD TEST 

- ^ ^ - ' 

Procedure prepared by NIT5 

Procedure approved by 

LOT NUMBER 

0531-04 

MP-0531-03 

Assign lot number as per S.O.P. OP-0024. 

BATCH VOLUME ADJUSTED BATCH VOLUME 

NOTE: The usual batch volume for routine production is 193.9 liters. However, the 

developing solution may be prepared in smaller or larger batches as required (ie. 

special request by customer). The volume of required ingredients must be adjusted 

proportionately. Record all calculations on the back of this sheet. 

FORMULA: 

INGFIEDIENTS 

Deionized water 

H2O2, 30% Stabilized 

Alcohol, denatured 

anhydrous, SDA-12A 

LOT/MFR. QUANTITY 

REQUIRED PER 

193.9 L 

19.05 L 

17.25 L 

157.6 L 

QUANTITY 

ADDED 

OPERATOR CHECKER DATE 

NOTE: INGREDIENTS REQUIRED FOR TESTING 

2N Sulfuric acid 

Standardized potassium permanganate (KMnOJ, 0.1 N 

Deionized water 

CAUTIONS 

1. Follow all safety precautions outlined in Chemical Hygiene Plan, S.O.P. SF-0025. 

2. Hydrogen peroxide will irritate the skin on contact. Wear rubber gloves, and face shield or 

goggles to protect skin and eyes. 

3. Solution may only be prepared in a vented room. Use exhaust fan and respirator mask. 

4. Protect solution from heat and light. 

5. Do not use open flames in work area. 

6. Cover mixing tank after mixing. Keep tank covered at all times to reduce fumes and fire 

hazard. 

7. Follow cautions for potassium permanganate outlined in S.O.P. SD-0535. 
DEVELOPING SOLUTION FOR STOOL BLOOD TEST 

LOT NUMBER 

S.O.P. MP-0531-04 PAGE 2 

.fP^ i 

J \* 

INSTRUCTIONS <m "h. 

% 

HECK. DATE 

Wash mixing tank with denatured anhydrous alcohol and allow to air dry. 

Add deionized water to tank. 

Add hydrogen peroxide to tank. 

Add alcohol to tank. 

Mix with electric stirrer for a minimum of 20 - 30 minutes. 

Obtain a sample of approximately 20 ml from both the bottom of the tank 

and the top. Perform potassium permanganate titration procedure as 

describe under "TESTING" to determine the hydrogen peroxide 

concentration. Titration should be performed at least twice on each sample. 

If results are not within specifications, mix again and repeat testing before 

making any adjustments. 

If repeated testing confirms that the product is not within specifications, 

make necessary adjustments and repeat mixing. 

H,0: VOL. 

H,0,: VOL. LOT/MFR. 

ALCOHOL: VOL. LOT/MFR. 

Perform potassium permanganate titration on adjusted batch. 

10. Filter solution through 0.8 micron membrane and store in tightly sealed (DOT 

approved) plastic drums. Store at room temperature protected from heat and 

light. 

1 1 . Submit a sample (±2 0 ml) to Quality Control for product release testing. 

Give this procedure to a Supervisor for review and approval. 

TESTING INSTRUCTIONS 

NOTE: Testing performed as per USP XX, NF XV, page 381 . 

1. Add 20 ml of deionized water to a 250 ml flask. 

2. Using a 2 ml pipet, deliver 2 ml of the developing solution to be tested to the flask. 

3. Add 20 ml of 2N sulfuric acid to the flask. 

4. Fill buret with standardized potassium permanganate. Record starting volume in chart below. 

5. Place a magnet In the flask and produce a vortex with a magnetic stirrer. 

6. Titrate each sample to end point: release potassium permanganate into the flask dropwise until a faint pink 

color appears and persists for at least 15 seconds. Read color against a white background. Record ending 

volume of potassium permanganate in chart below 
DEVELOPING SOLUTION FOR STOOL BLOOD TEST S.O.P. MP-0531-04 

LOT NUMBER 

7. Calculate the H2O2 concentration. Each ml of 0.1N potassium pernahg 

PAGE 3 

s equivaienWo 1.701 mg of 

H2O2: 

VxN f X 1.701 X 100 or V x Nf x 1.701 

2 mix 1000 (mg) 20 

Take the average of at least two trials from both the top and the bottom samples tested for the final result. 

The difference between the two results, however, may not differ more than 5%. 

HYDROGEN PEROXIDE SPECIFICATION: 3.63% - 4.02% 

SAMPLE (TOP/BOTTOM) 

TRIAL NUMBER 

KMnO^ BEGINNING VOL. 

ENDING VOL. 

V = ml USED 

HYDROGEN PEROXIDE % 

AVERAGE 

Sulfuric acid, 2N : LOT/EXP 

KMnO^: LOT/EXP Normality factor (Nf) 

Reviewed and approved by Date