Health and Safety Programs

The university’s animal care and use program and its animal facilities are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). AAALAC-I is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs.

Both research and non-research animals have the potential to cause injury, transmit zoonotic disease, and/or cause allergic reactions to those who have contact. This can be either direct contact from handling an animal or just from being in close proximity, i.e., working or passing through an animal housing room. The program applies to personnel (staff members or qualified students) who in the conduct of their work in research, testing and teaching have direct contact with vertebrate animals including their tissues, body fluids, wastes and/or indirect animal aerosol exposure. Personnel who have these types of exposures need to be provided with the appropriate awareness training. Understanding routes of disease transmission, disease or allergy signs and symptoms, personal protective equipment, waste handling, and emergency contact information is very important.

In many cases a preventative annual physical examination is necessary for animal handling personnel. To accomplish this Purdue University has the Animal Exposure Occupational Health Program. Environmental Health & Safety (EHS) will be administrating this program. The first step is to re-enroll individuals into this program. Purdue University staff and students listed on the Purdue Animal Care and Use Committee (PACUC) protocols will have an opportunity to complete an Animal Exposure Risk Assessment and if circumstances warrant, a physical examination by an occupational health provider. Because this program is not mandatory, individuals have the option of declining this service. Completion and submission of the Animal Exposure Risk Assessment is required before an employee can opt out of the program. Contact PFW EHS to begin the process if you are on a PACUC protocol.

Occupational Animal Exposure

• Both research and non-research animals have the potential to cause injury, transmit zoonotic disease, and/or cause allergic reaction to those who have contact.
• These animal hazards can occur by either direct contact from handling an animal or just by being in close proximity, i.e., working or passing through an animal housing room.

Animal Exposure

• Staff members who have indirect but close proximity exposure to animals need to be provided with the appropriate awareness training. Employees who have potential for animal exposure are those that maintain equipment and building services staff assigned to animal housing buildings.
• Understanding routes of disease transmission, disease or allergy signs and symptoms, personal protective equipment (PPE), waste handling, and emergency contacts is very important. Your job tasks will determine your potential exposure, i.e., working on a ventilation system will have a greater exposure potential then emptying the trash. EHS can provide you with a risk assessment before your exposure to the potential hazard.

Animal Allergies

• An allergen is a substance, usually a protein that can cause your immune system to react as if you are being infected with a cold virus. Cats, rabbits, mice, rats, birds, and guinea pigs are the most frequently implicated allergy causing species.
• Exposure to animal related allergens (fur, saliva, hair, dander, and protein from urine) may occur by inhaling contaminates or by direct contact.
• Allergies develop after you have been exposed to foreign proteins. Example: after being exposed to an animal protein found in rat urine you can become sensitized (your body is ready to fight this reoccurring foreign protein). Scenario: you enter a room housing rats just like you have done many, many times before but this time your immune system recognizes the rat urine protein as an invader and is prepared for battle. Special cells called “mast cells” release chemical defense agents that have been stored up just for this occasion (notably histamine). This release of defense chemicals is what causes the hives, sneezing, nasal drainage, and shortness of breath. All people are capable of having an allergic reaction, some more so than others.

Allergy Signs and Symptoms

• Allergy symptoms include rhinitis (runny nose and sneezing similar to hay fever), conjunctivitis (irritation and tearing of the eyes), asthma, and/or dermatitis (skin reactions).
• Some people react quickly and begin having temporary symptoms within 10–15 minutes after exposure. Others can have a delayed reaction starting several hours after exposure. There are some people, due to their genetic composition, who react by developing more severe allergy related diseases like asthma or dermatitis. Allergic reactions are implicated if symptoms are reduced or stop after leaving the workplace.

Personal Protective Equipment

• Minimize the risk of development of animal allergies or zoonotic disease by working in well-ventilated areas, using good hygiene practices (proper hand washing technique), using personal protective equipment (PPE) such as gloves, wearing N-95 rated dust masks and laboratory coats or coveralls.
• PPE is the last barrier between you and the hazard. Make sure your selection fits properly and is appropriate for the job task. A typical selection of PPE includes outerwear, latex or nitrile gloves, closed-toe shoes, and perhaps a N-95 dust and vapor mask.
• EHS can recommend specific types of PPE.

Zoonotic Diseases

• Many diseases can be transmitted between animals and people. These are called zoonoses. Pregnant workers can be at very high risk for certain animal diseases. Awareness, common sense, PPE, and avoidance will protect against and prevent most of these diseases.
• Rabies: a fatal central nervous system attaching virus transmitted from infected mammal saliva.
• Toxoplasmosis: a protozoan infection causing mono like symptoms in adults and horrible birth defects in the fetus.
• Leptosprirosis: a bacterial infection caused from contact with infected animal urine that causes sudden onset of headache, chills, and other flu like symptoms.
• Ascariasis: round worm infection, can cause serious problems for internal organs.
• Psitticosis: an acute chlamydial (intracellular bacteria) disease that causes fever, headache, myalgia, and pneumonia-like respiratory illness. Associated with inhaling feather dust and dried bird droppings.
• Q Fever: an airborne rickettsial (organisms smaller than bacteria) that causes chills and fever in adults and horrible birth defects for the fetus. Associated with sheep.
• In many labs research animals are infected with biohazardous agents. Does this mean you will be infected by entering a research facility? No, especially if you follow simple precautions.

Animal Exposure Do’s and Don’ts

• Do: Get permission to enter a research area from the principal investigator or lab personnel. Respect warning signs like biohazard and radiation stickers.
• Don’t: Touch research animals. Some of the research animals are very expensive.
• Do: Utilize the appropriate PPE. If you do not know what type of PPE to use, contact EHS.
• Don’t: Handle animal waste or bedding without the appropriate PPE.
• Do: Discard used PPE properly and wash your hands properly. Hand washing is a very simple step that is extremely important in preventing disease transmission.
• Don’t: Take animal soiled PPE or work clothes home. You don't want to exposure your family to animal allergens or biohazards.
• Do: Leave everything in a research area as you found it (lights, locks, temperature, etc.).
• Don‘t: Enter animal areas where you are not authorized to go. Having a master key does not authorize you to go into certain animal housing areas. Always check with lab staff first.

Reporting
Report suspect allergic reactions or zoonotic illness to your Supervisor and to EHS (Biosafety Officer). If you have signs and symptoms of an animal exposure related allergy let us know and we will send you a risk assessment form to complete.

What is Q Fever?
Ruminants such as sheep, goats, and cattle can present a significant risk to animal handlers for exposure to a highly transmittable disease causing organism known as Coxiella burnetii. In pregnant ruminants, Coxiella burnetii builds up to enormous numbers in certain tissues and fluids, i.e., the uterus or womb, the placenta, the mammary glands or udders, birth fluids, and milk. This rickettsial organism is extremely resistant to drying and can survive many months in the environment. As few as ten Coxiella burnetii microbes can cause an acute infection called Q Fever. Individuals acquire this infection by inhaling aerosols and contaminated dusts generated by animals or animal products. Animal handlers, farm workers, students, and visitors must be made aware of the potential disease development that could result from exposure to the placenta, amniotic fluids, milk, and feces from birthing ruminants. 

Signs and Symptoms of Q Fever
Individuals can be infected with Q Fever unknowingly, or mistake their symptoms for the flu. Often, it is impossible to diagnose without laboratory tests. Q Fever strikes as a sudden illness, affecting a large number of people in the same workplace. Common signs and symptoms include:

• sudden onset of high fever
• headache
• malaise and fatigue
• nausea and/or vomiting
• chills and sweating
• general feeling of sickness and loss of appetite

More serious complications can affect the immune-compromised, individuals with heart abnormalities, and pregnant human females, i.e., endocarditis and miscarriage or premature birth. Person to person transmission occurs rarely, but contaminated clothing can transmit the organism. Individuals should notify their physician or their occupational health provider if signs and symptoms of Q Fever arise.

Q Fever Prevention
Personal Protective Equipment such as OB Sleeved gloves, nitrile gloves, N-95 dust mask, and protective outerwear should be available for individuals exposed to ruminants, especially during birthing procedures. Hands should always be washed with a disinfectant soap immediately after contact with the animals, tissues, or wastes.

Surfaces contaminated by ruminant birthing fluids and tissues can be decontaminated with a 1 to 10 bleach and water solution. Contaminated bedding can be composted and tissues can be incinerated or buried. Take care not to produce dust when cleaning and/or decontaminating. If dust production in unavoidable, the use of a properly fitting N-95 dust mask is suggested.

Be aware of the sources of Q Fever; especially fluids and tissues from pregnant ruminants. Only allow authorized individuals who have been made aware of the potential biohazards to enter the ruminant housing and birthing area.

Animal Exposure Occupational Health Program
Both research and non-research animals have the potential to cause injury, transmit zoonotic disease like Q Fever, and/or cause allergic reaction to those who have contact. This can be either direct contact from handling an animal or just from being in close proximity, i.e., working or passing through an animal housing room. In many cases a preventative annual physical examination is necessary for animal handling personnel. 

Learn More

Ruminant Standard Operation Procedure

• In the laboratory setting, handlers of female ruminants should work under BSL2 conditions.
• Q Fever awareness training for staff, students, and visitors who have contact with ruminants, especially potentially pregnant human females and individuals with heart conditions.
  CDC Q Fever
  LAP Zoonotic Disease Information
• Personal Protective Equipment should be available for individuals exposed to ruminants, especially during birthing procedures, i.e., OB Sleeved gloves, nitrile gloves, protective outerwear.
• Hands should always be washed with disinfectant soap immediately after contact with the animals, tissues, or wastes.
• Dust reduction methods for cleaning should be utilized.
• Surfaces that come in contact with amniotic fluids can be decontaminated with a 1 to 10 ratio of household bleach with water.
• Placental tissue and contaminated bedding should be appropriately disposed so that it does not present a hazard or releasing Coxiella organisms into the environment, i.e., incineration, burying, or composting.
• Only authorized individuals should be allowed in the animal housing and birthing area.
  Individuals should notify their physician or their occupational health provider if signs and symptoms of Q Fever arise.
• Animal handling staff should participate in the Animal Exposure Occupational Health Program.

Bites and Scratches
An animal bite or exposure is defined as having one's skin pierced or abraded by animal teeth or claws, or by coming in contact with animal saliva or tissue on abraded skin, eyes, or mucus membranes. Bites and scratches are potentially dangerous not only from the physical damage but also for the potential of contracting zoonotic disease or allergic reactions.

To protect from animal bites and scratches, employees should utilize sedation, anesthesia or a restraining device when possible. They should also use the proper animal handling procedures for the species. Also, be aware of the animals comfort zone and how far it can reach out to bite or scratch.

Since animals can bite through latex gloves, employees should use a thicker over-gloves when appropriate. Employees should also consider using a two-person team for complex procedures.

Animal Bite Related Diseases

• Pasteurellosis: The most common bite-associated infection is caused by a bacterium called Pasteurella. Most cats and dogs, even healthy ones, naturally carry this organism in their mouths. When an animal bites a person, these bacteria can enter the wound and start an infection. The first signs of pasteurellosis usually occur within 2 to 12 hours of the bite and include pain, reddening, and swelling of the area around the site of the bite. Pasteurellosis can progress quickly, spreading through the body from the bitten area. Untreated, this infection can lead to severe complications. Bites to the hand need special attention; if pasteurellosis develops in the tissues of the hand, the bacteria can infect tendons or even bones and sometimes cause permanent damage if appropriate medical care is not administered promptly.
• Rat-Bite Fever: Rat-bite fever is caused by Streptobacillus monilformis or Spirillum mino; these organisms are in the respiratory tracts and mouths of rodents, especially rats. Most human infections are the result of a bite wound. Symptoms include chills, fever, malaise, headache and muscle pain. A rash can develop along with painful joints, abscesses, endocarditis, pneumonia, hepatitis pyelonephritis, and enteritis.
• Rabies: Rabies is a preventable viral disease of mammals most often transmitted through the bite of a rabid animal. The vast majority of rabies cases reported to the Centers for Disease Control and Prevention (CDC) each year occur in wild animals like raccoons, skunks, bats, and foxes. Domestic animals account for less than 10% of the reported rabies cases, with cats, cattle, and dogs most often reported rabid.

Animal Bite Monitorying
Potential exposure to serious zoonotic diseases, such as rabies, is monitored by the Indiana State Department of Health, and by the Purdue Animal Exposure Occupational Health Program (AEOHP). Animal bites are a state reportable health event. The Indiana State Department of Health “Animal Bite Report - Report of Rabies Prophylaxis” form must be completed by the health care provider. You must also complete an Injury Report form.

Bite Prevention (Laboratory)

• Species specific animal handling techniques are taught by the Laboratory Animal Program veterinary staff and the animal facility management staff.
• Rabies prevention post bite steps do not apply to laboratory rodents, i.e., rats, mice, rabbits, or hamsters.
• If possible, direct handling of wild animals or any animals suspected of being infected should be avoided by using tongs, bite gloves, squeeze cages, shields, or other protective equipment.
• Animals known to be aggressive should always be handled by a minimum of two people.

Bite Prevention (Nonlabratory)

• Do not approach or try to pet or handle strange dogs, cats, squirrels, raccoons, possums, bats, or other wild animals.
• Avoid injured animals or animals that are behaving oddly, (staggering or nocturnal animal sighted during the day).
• Report animals that are demonstrating odd behavior to the local animal control officer.

Post-Bite Procedures

• Bite incidents may require that the animal be quarantined, especially if the animal's vaccination history is unknown. If possible, confine the animal to prevent any further injuries and to allow quarantine or immediate rabies testing. It is important to have the name and address of the animal's owner so that EHS can conduct follow-up procedures. If ownership is unknown, record the address where the bite occurred so the local animal control officer can begin a search.
• If the bite breaks the skin, treat it as a minor wound. Wash the area thoroughly with soap and water, apply an antibiotic cream, and cover it with a clean bandage. If the bite creates a deep puncture or the skin is badly torn and bleeding, apply pressure to stop the bleeding.
• Seek medical attention right away for any animal bite or injury. Based on the information gathered, a post exposure prophylaxis recommendation will be developed by the health care provider.
• Immediately report the incident to the facility animal care supervisor, Laboratory Animal Program, EHS, and the principal investigator.

Animal Exposure Occupational Health Program

This program ensures that individuals exposed to potential biohazards are aware of transmission routes, signs and symptoms of exposure, precautions needed to prevent disease, and waste handling procedures. Biohazards include any infectious micro-organisms or toxic by-products, which are capable of producing adverse health effects in humans, animals, and plants.

This program is for employees with the potential for exposure to human blood or blood products and ensures that they are aware of the risks associated with bloodborne pathogens (organisms that cause disease in humans). EHS provides training for decontamination and waste handling procedures and carries out blood product exposure investigations.

Blood-borne Pathogens Exposure Control

The DEA controlled substances procedure is in place to ensure that the university is in compliance with both state and federal regulations concerning the use and handling of controlled substances. This procedure applies to Purdue University staff who utilize controlled substances while teaching or conducting research. Compliance will be accomplished by proper licensing with the State and the U.S. Department of Justice Drug Enforcement Administration (DEA), record keeping, inventory, and handling by University research staff.

Monitoring and Inspection
Environmental Health and Safety (EHS) is responsible for monitoring the record keeping, inventory, security, and disposal of controlled substances. Inspections will be conducted on an annual basis to assist you with controlled substances handling procedures and to assure University compliance with DEA regulations. If you have questions concerning controlled substances either contact EHS or the Regional DEA Office located in Merrillville, IN, at 219-681-7000.

How to Register
Individuals must first notify EHS of their intentions and then register with the state of Indiana for the use of controlled substances prior to registering with the DEA.

Indiana Controlled Substances Registration 

DEA Controlled Substances Registration

Registration Tips

• Ensure the information that you are providing is legible. We suggest that you complete the DEA registration online and then print your submission copy. (This site is listed on our DEA Controlled Substances web page)
• Obtain your Indiana Controlled Substance Registration (CSR) first. Make sure you remind the Indiana State Board of Pharmacy inspector to include your name on the CSR. This inspector will make a site visit to your lab prior to issuing the State CSR.
  Note: The State does not inform the DEA Office when you are registered. You must attach a copy your State CSR card with the DEA registration form.
• Make sure you have the proper controlled substance schedule listed for the drug(s) you will be using. Also make sure you have listed the proper drug codes. They must coincide with the schedules requested.

Caution: The Indiana controlled substance schedules are the reverse of the Federal schedules! The drug schedule license you apply for on the Federal application must correspond to the drug schedule you are licensed for in Indiana (e.g., if your Indiana license shows you are licensed for Schedule 2N you would request a Schedule 2 license on the Federal application).

• When completing the DEA registration form, make sure the name and address are identical to those on the Indiana State license.
• Schedule 1 Controlled Substances registrations require specific application instructions: Contact Robert Golden at 41496 for instructions.
• Complete the “Fee Exemption” Section (section 10) on the DEA 225 form. Exemption from payment of application fee is limited to federal, state or local government operated hospitals, institutions and officials. The applicant’s superior (i.e., your department head) or agency officer must certify exempt status. The signature, authority title, and telephone number of the certifying official (other than the applicant) must be provided.
• FAX 62572 or send your DEA application form to Josh Brown EHS/CIVL. After EHS has reviewed the DEA 225 form, the registrant will send the application form to:
  
  Drug Enforcement Administration
  United States Department of Justice
  Central Station
  P.O. Box 28083
  Washington, D.C. 20038-8083
  
  Note: Every package sent to the DEA Washington location, especially bulky application packets, is subjected to a hazard analysis scan process. This Department of Justice security measure can add up to six weeks to your approval time frame. Send only the printed application; do not include other required information (see section 8 below) at this time.
   
• Once your application request has been entered into the DEA database, an agent from the Merrillville Regional DEA Office will contact you to request that you mail or fax to them the additional required documentation that will include:
  • Controlled Substance Authorized User Signature List listing all staff who will have access to controlled substances
  • Copy of your research protocol and/or a completed DEA research protocol information sheet
  • Curriculum vitae
  • Narrative covering how you will secure the controlled substances and how you will conduct inventories
• Send all forms and documentation by registered mail. Keep a copy for your records.

DEA License Scope
Practitioner means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other institution or individual licensed, registered, or otherwise permitted to distribute, dispense, conduct research with respect to, or administer a controlled substance in the course of professional practice or research in Indiana.

A non-practitioner, in Indiana, would be anyone that performs research and does not have a practitioner's license. A researcher is classified as a non-practitioner and can only be registered as such. A non-practitioner cannot dispense or write prescriptions with a researcher registration but can purchase and/or administer controlled substances. A researcher works under a protocol, which directs the specific actions and the specific drugs that may be used in the research protocol.

Agents are authorized employees or lab staff who act on behalf of the registrant. The requirement of registration is waived for any agent or employee of a person who is registered to engage in any group of independent activities, if such agent or employee is acting in the usual course of his/her business or employment.

Power of attorney; any purchaser may authorize one or more individuals, whether or not located at the registered location of the purchaser, to obtain and execute order forms on his/her behalf by executing a power of attorney for each such individual. The authorization forms and further information can be found in Title 21Code of federal Regulations Section 1305.07 (21 CFR 1305.07).

Controlled Substances
Controlled substances are designated as Schedule I–V (C-I, C-II, C-III, C-IV and C-V) according to their medical use, potential for abuse, and safety or dependence liability. Each controlled substance, or basic class thereof, has been assigned an “Administration Controlled Substances Code Number” for purposes of identification of the substances or class on certain Certificates of Registration issued by the administration pursuant to 21 CFR 1301.35 and on certain order forms issued by the administration pursuant to 21 CFR 1305.05. Refer to 21 CFR 1308 for the schedules of controlled substances.

Schedule I
The Indiana State Board of Pharmacy shall recommend placement of a substances in Schedule I if it finds that:

1. The substance has high potential for abuse; and
2. The substance has no accepted medical use in treatment in the United States or lacks accepted safety for use in treatment under medical supervision.

Examples of Schedule I substances include heroin, lysergic acid diethylamide (LSD), marijuana, and methaqualone.

The board may recommend placement of a substance in schedule I under this chapter if it finds that the substance is classified as a controlled substance in schedule I under federal law.

Schedule I Controlled Substances can be found in 21 CFR 1308.11. See Indiana Code 35-48-2-4 (IC 35-48-2-4) for the Indiana list of Schedule I Controlled Substances.

Schedule II
The Indiana State Board of Pharmacy shall recommend placement of a substance in Schedule II if it finds that:

1. The substance has high potential for abuse;
2. The substance has currently accepted medical use in treatment in the United States, or currently accepted medical use with severe restrictions; and
3. The abuse of the substance may lead to severe psychological or physical dependence.

Examples of Schedule II substances include morphine, phencyclidine (PCP), cocaine, methadone, and methamphetamine.

The board may recommend placement of a substance in Schedule II under this chapter if it finds that the substance is classified as a controlled substance in Schedule II under federal law.

Schedule II Controlled Substances can be found in 21 CFR 1308.12. See IC 35-48-2-6 for the Indiana list of Schedule II Controlled Substances.

Schedule III
The Indiana State Board of Pharmacy shall recommend placement of a substance in Schedule III if it finds that:

1. The substance has a potential for abuse less than the substances listed in schedule I and II under this chapter;
2. The substance has currently accepted medical use in treatment in the United States; and
3. Abuse of the substance may lead to moderate or low physical dependence or high psychological dependence.

Anabolic steroids, codeine and hydrocodone with aspirin or Tylenol®, and some barbiturates are examples of Schedule III substances.

The board may recommend placement of a substance in schedule III under this chapter if it finds that the substance is classified as a controlled substance in schedule III under federal law.

Schedule III Controlled Substances can be found in 21 CFR 1308.13. See IC 35-48-2-8 for the Indiana list of Schedule III Controlled Substances.

Schedule IV
The Indiana State Board of Pharmacy shall recommend placement of a substance in Schedule IV if it finds that:

1. The substance has a low potential for abuse relative to substances in Schedule III under this chapter;
2. The substance has currently accepted medical use in treatment in the United States; and
3. Abuse of the substance may lead to limited physical dependence or psychological dependence relative to the substances in schedule III under this chapter.

Examples of drugs included in Schedule IV are Darvon®, Talwin®, Equanil®, Valium®, and Xanax®.

The board may recommend placement of a substance in schedule IV under this chapter if it finds that the substance is classified as a controlled substance in schedule IV under federal law.

Schedule IV Controlled Substances can be found in 21 CFR 1308.14. See IC 35-48-2-10 for the Indiana list of Schedule IV Controlled Substances.

Schedule V
The Indiana State Board of Pharmacy shall recommend placement of a substance in Schedule V if it finds that:

1. The substance has low potential for abuse relative to the controlled substances listed in schedule IV under this chapter;
2. The substance has currently accepted medical use in treatment in the United States; and
3. The substance has limited physical dependence or psychological dependence liability relative to the controlled substances listed in schedule IV under this chapter.

Cough medicines with codeine are examples of Schedule V drugs.

The board may recommend placement of a substance in schedule V under this chapter if it finds that the substance is classified as a controlled substance in schedule V under federal law.

Schedule V Controlled Substances can be found in 21 CFR 1308.15. See IC 35-48-2-12 for the Indiana list of Schedule V Controlled Substances.

Records of Registrants
Every registrant shall maintain records and inventories and shall file reports required by 21 CFR 1304.03. A registered individual practitioner is required to keep records of controlled substances in Schedules II, III, IV, and V which are administered in the lawful course of professional practice if they regularly engage in dispensing or administering.

All records required shall be maintained for at least two years from the date of such inventory or records, for inspection and copying by authorized employees of the DEA. Retaining records for five years is advisable due to the statute of limitations. These records must be in conformance with the record keeping and inventory requirements of federal law. This includes all purchasing records, all administering and dispensing records, all Controlled Substance Ordering Forms (DEA Form 222), and all physical inventories. Schedules I and II must be maintained separately from all other records of the registrant, and Schedule III, IV, and V must be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant. The phrase “readily retrievable” means they can be separated out from other records in a reasonable time.

Note: Records must be made available within five (5) working days after a request by the Indiana Board of Pharmacy for such records or information on controlled substances transactions.

Purchasing Records
Purchasing records can be one or more of the following:

• A copy of the invoice
• A copy of the shipping document
• A copy of the packing slip

Purchasing records must contain the following information:

• Name, address, and DEA number of the company from which the controlled substance was purchased
• Name of the controlled substance purchased
• Size and strength of the controlled substance purchased
• Amount purchased (which should match the amount received)

The purchasing record (invoice, shipping document, or packing slip) must be annotated with the handwritten date of receipt. The date written on this document must match the date entered in the Date Received column on your Record of Controlled Substance Purchases (REMCS Form 2).

Administering and Dispensing Records
Administering records must contain the following information:

• Your DEA number, name, and address
• The recipient’s DEA number, name, and address
• A complete description of the product and the quantity distributed
• The date of distribution by the selling registrant
• The handwritten date received by the receiving registrant

Dispensing records must contain the following information:

• Name and address of person (research subject) to whom administered/dispensed
• Date administered/dispensed
• Initials of person administering or dispensing on behalf of registrant
• Name of the controlled substance
• Strength and size of the controlled substance
• Amount administered/dispensed (number of units or volume)

Use the Record of Controlled Substance Administered/Dispensed (REMCS Form 3).

Inventory Records
Controlled substance inventory is one of the most important aspects of the DEA program. Inventory maintenance is the key to the loss detection, theft, and the diversion of controlled substances. The Controlled Substance Physical Inventory (REMCS Form 1) meets the DEA requirements for a Controlled Substance inventory record. Read the complete inventory requirements from the DEA.

Security and Employee Authorization Documentation
Security depends greatly on the type, quantity, and form of controlled substances being used in the research project. Schedule I, II, III, IV, and V controlled substances must be stored in a locked steel cabinet or a locked substantially constructed cabinet. Controlled substances should not be located near a glass panel where they can be visible from the outside.

Researchers must provide effective controls to guard against theft of controlled substances. This includes limiting the number of keys and the number of employees who will have access to these keys. Developing a key accountability standard operating procedure is recommended. Only authorized personnel should be allowed in the laboratory where controlled substances are used or stored. Authorized users’ names must be documented on the Controlled Substance Authorized Users List (REMCS Form 5) which is copied and forwarded to EHS, along with a completed and signed Controlled Substance Program Social Security Release (REMCS Form 6) for each individual listed on the Form 5. Keep ONLY a copy of the REMCS Form 5 with the controlled substance inventory.

Note: Always ask visitors or individuals entering these areas for identification and why they are there. When maintenance work is done in the controlled substance storage area the research staff must maintain adequate observation.

DEA Ordering Forms
To order a controlled substance you must first have a DEA license. The Controlled Substance Ordering Form (DEA Form 222) is a paper-based form used to order controlled substances. It is requisitioned directly from the DEA and is required to be filled out in triplicate. The DEA Form 222 also allows the exchange of controlled substances from the registrant to another party registered with the DEA (typically used when a controlled substance is sent to a reverse distributor for credit or disposal).

Schedule I or II registrants can request official DEA Form 222. 

You will receive the maximum number of order form books allowed for your business activity.

Schedule III, IV, and V drug orders do not require a DEA Form 222. These drugs can be ordered directly from the manufacturer. However, you may be asked to provide a copy of your DEA Registration before your order will be prepared and shipped.

Use the Record of DEA Form 222 Use (REMCS Form 4) to maintain accountability of all DEA Form 222's.

Note: If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes his name or address as shown on his registration) or is suspended or revoked as to all controlled substances listed in Schedules I and II for which he/she is registered shall relinquish all unused controlled substances and order forms for such substance to the university police.

Disposal and Loss Records
To minimize waste, DEA registrants should only purchase quantities they intend to use. Damaged, expired, unwanted, unusable, or non-returnable Controlled Substances must be accounted for, retained, and disposed of in accordance with applicable State and Federal regulations.

A Registrant Record of Controlled Substances Destroyed (DEA Form 41) must be completed prior to disposing of any DEA controlled substance. Two (2) copies of the form must be sent to the local Indiana DEA branch and one (1) copy should be retained by the registrant for at least two years.

Disposal records must contain the following information:

• Your DEA number, name, and address
• The reverse distributor’s DEA number, name, and address
• The number of units (in finished forms and/or commercial containers) disposed of in any manner, including the manner of disposal

The disposal record must be dated to reflect when the products were sent for destruction and left your inventory.

EHS should be contacted to help determine the correct disposal method.

Contact the Supplier Method
Some suppliers will take back pharmaceuticals for credit. If possible, this is the best means of controlled substance disposal.

On-site Disposal Method
Small quantities (less than 1 pound) can be disposed onsite by the DEA registrant using the following six-step controlled substance disposal procedure:

• Contact EHS with a controlled substance disposal request.
• Complete the Registrant Record of Controlled Substances Destroyed (DEA Form 41) prior to disposal.
  Inform EHS when the DEA Form 41 has been completed and is ready for review.
• EHS will forward this form to the DEA with a projected two-week disposal date.
• At the end of the waiting period arrangements will be made for a Purdue Police Officer and EHS representative to be present as witnesses to the disposal, verify the DEA Form 41 and inventory records.
• EHS will forward two copies of the DEA Form 41 to the Agent in Charge of Indiana DEA, and provide one copy for the researcher's inventory records.

Reverse Distribution Method
For large quantities (greater than one pound), contact a reverse distributor. This option transfers ownership of the controlled substance to a DEA-approved Pharmaceutical Returns Processor for reuse, resale or destruction at a hazardous waste incinerator. This process may involve the completion of DEA Form 222 or DEA Form 41. The following are three commonly used reverse distributors:

• MedTurn: 317-867-2552
• National Notification Center: 800-636-9826
• Guaranteed Returns: 800-729-3279

Spills
Breakage, spills, or other witnessed controlled substance losses do not need to be reported as lost. This type of loss must be documented by the registrant and witness on the inventory record. Controlled substances that can be recovered after a spill, but cannot be used because of contamination (tablets), must be placed in the disposal/destruction waste stream. If the spilled controlled substance is not recoverable (liquids); the registrant must document the circumstances in their inventory records and the witnesses must sign.

Theft of or Missing Controlled Substance Reporting
The DEA license holder must have complete accountability of all controlled substances stored or used in their area. This makes keeping good records essential so that any shortages or missing controlled substances will not go unnoticed. Theft or misuse of a controlled substance is a criminal act that must be reported to the following agencies:

• Indiana State Board of Pharmacy: 317-234-2067
• Nearest DEA office:
  • Merrillville Resident Office
    1571 East 85th Avenue
    Suite 200
    Merrillville, IN 46410
    219-681-7000
    219-681-7024 (fax)
• PFW University Police: 260-481-6827
• Josh Brown, Purdue Biosafety Officer: 765-494-1496

In addition to the immediate phone reporting, a Report of Theft or Loss of Controlled Substances (DEA Form 106) must be completed and submitted to the Indiana DEA office.

Reporting is also necessary if small quantities of controlled substances become unaccounted for on a re-occurring basis. Keep copies of DEA Form 106 in your inventory records.

Other Pertinent Record Information

• Maintain current, complete and accurate records to reflect substances:
  • Received (Purchased)
  • Sold (Administered and dispensed)
  • Delivered to another registrant
  • Otherwise disposed of
  • Theft or loss
• Separate records are required for each location
• Separate records are required for each independent activity for which he/she is registered.

When recording dates of receipt, importation, distribution, exportation, or other transfers, the date on which the controlled substances are actually received, imported, distributed, exported, or otherwise transferred shall be used as the date of receipt or distribution on any documents of transfer (e.g., invoices or packing slips).

EHS conducts testing to ensure that water inside buildings is safe for human consumption and investigates quality issues such as taste and odor.

1. Wash your hands before handling food items and after handling raw food items.
2. Do not participate in the carry-in if you or other family members have been ill with gastroenteritis or diarrhea symptoms within the last two weeks.
3. Clean food preparation surfaces before and in between using raw items.
4. Use utensils instead of hands during food preparation.
5. Keep food ingredients from being contaminated:
   1. Keep pets away from the preparation area.
   2. Don’t let fans blow onto food.
   3. Keep raw food away from cooked food and ingredients.
   4. Protect food with a solid lid, plastic wrap, or foil (no towels).
6. Refrigerate food items and keep cold until ready to serve. Do not leave cooked food items at room temperature.
7. Do not bring home-canned items.

Departments hiring caterers need to ensure that the caterer is permitted in their home county and should check the caterers last two health inspection reports. Proper procedures for food handling must be followed at all times. 

Personnel

• Hair restraints should be used by all individuals involved with food preparation, serving, or food handling. Beards should also be restrained.
• Hands should be washed before starting food preparation and at any other time the hands are contaminated.
• Clean clothes should be worn by all food handling employees.
• Individuals with any of the following: infected cuts or sores, colds, diarrhea, boils, communicable disease, etc., should not prepare or serve foods.

Storage
All food items and/or food contact utensils (such as single service plates, cups, or silverware) should be stored six inches above the ground or floor.

Food Preparation

• Food items should only be prepared in an approved food preparation area that can be inspected by a health agency. This includes:
  • University dormitory kitchens
  • Fraternities/Sororities
  • Cooperatives
  • Schools
  • Commercial Food Preparation Areas
• Potentially hazardous foods are prohibited. These include food items such as egg salads, ham salads, cream pies, custards, meat pies, and meringues.
• Keep all food items in storage, preparation, and on display covered with a non-porous material such as plastic wrap, foil, waxed paper, or lids.
• Proper facilities should be provided for maintaining foods at correct temperatures: below 41° F for cold food and above 140° F for hot food.
• Hot plates, ice tables, thermoses, coolers, and crock pots may be used if they are properly constructed and maintained.

Miscellaneous

• Items that the patron must handle should be individually wrapped and arranged so that contamination from mishandling does not occur.
• Straws, coffee stirrers, toothpicks, and condiments should be individually wrapped when placed on display unless served by a food handler.
• Locations for the temporary food service should have the facilities to meet the following criteria:  handwashing facilities, floors, ceilings (tents for outside events), insect and rodent free, and clean surroundings.
• Proper trash disposal should be provided.
• The menu and site location will be reviewed by the department of Environmental Health and Safety (EHS) for approval.
• Any other requirement deemed necessary by the EHS department to protect public health shall be initiated by the temporary food service establishment.
• Requirements are found in the Indiana State Department of Health Regulation 410 IAC 7-24.

Purdue Fort Wayne has a detailed catering policy for private rentals and external clients.

Catering Policy

What is asbestos?
Asbestos is a fibrous mineral that was used in various building materials and industrial products.

Where might I encounter asbestos-containing materials while working at PFW?
Asbestos is found in a number of building materials, including: sprayed-on insulation, trowled-on insulation, acoustical plaster, pipe insulation, boiler insulation, duct insulation, floor tile, transit cement board, vinyl flooring, wire insulation, and ceiling tiles. It is also used as thermal insulation in some devices and in friction products such as brake shoes.

Why should I be concerned about asbestos?

Overexposure to asbestos has been shown to cause two types of lung disease (asbestosis and mesothelioma), as well as cancers of the lung and peritoneum. Diseases associated with asbestos exposure were caused by high, long-term exposure and, much less often, by very high short-term exposure.

Will having asbestos-containing materials in my work area hurt me?
No. Asbestos must be airborne and inhaled in order to be harmful, and asbestos-containing materials must be disturbed to become airborne.

What should I do if I have to work with or on a material that I suspect may contain asbestos?
Contact your foreman or supervisor. They will contact EHS personnel and request a sample of the material be analyzed for asbestos.

What should I do if my intended work operation is going to disturb asbestos-containing material?
Contact your foreman or supervisor. They will contact EHS, who will have asbestos-containing materials removed in a safe manner using properly trained and certified personnel.

What types of work practices might cause me to be overexposed to asbestos?
Sweeping asbestos-containing debris, improperly removing asbestos-containing materials, disturbing asbestos-containing materials (sawing, drilling, sanding, or otherwise).

Who can I call regarding questions about asbestos?
Contact Environmental Health and Safety at [email protected] or 260-481-4193.

Occupational Safety and Health Administration (OSHA) requires “employers engaged in the laboratory use of hazardous chemicals” write a Chemical Hygiene Plan (CHP) that meets their regulations.

Purdue University provides a Chemical Hygiene Plan Manual that covers most of the requirements for most laboratory areas. It must be customized for those areas where it does not cover all the requirements. Guidance for how this is to be done is included in the manual. It is essential that this be done by someone who is completely familiar with the work and work area covered, and who has read and understood the CHP Manual and the requirements. Assistance is always available from EHS.

The administrative unit to which a laboratory work group belongs is responsible, for all laboratory groups in that unit, for:

• Seeing that this customization gets done, if necessary, and
• Ensuring that a printed copy of the CHP is present in each group, and
• Making sure that affected staff are given the required training and information.

The CHP covers many or most of the OSHA requirements for most labs, but it must be customized for your work area and must address all chemical safety issues in your work area.

Recommended Reading
Glove Guide (from UC Berkeley)

There are numerous confined spaces (pits, manholes, tanks, etc.) on our campus—many are added during new construction and renovations. If your job requires you to enter a confined space, you must follow certain procedures to ensure your safety. The policy, guidelines and procedures can be found in the Purdue University Confined Space Program.

Exposure monitoring is used to measure and assess employees’ exposure to chemicals. We make appropriate recommendations to exposure within applicable limits.

The university has an Active Hazard Communication program that uses a “train the trainer” approach to meet compliance requirements. The program covers all employees of the university including full-time, part-time, temporary, and student employees that are not engaged in the laboratory use of chemicals.

EHS conducts the training for work area trainers. These trainers are known as designated trained individuals or DTIs. DTIs serve as the work area coordinators for HazCom including initial implementation and continued maintenance of the program in their work areas. Individuals that are to be the DTIs must attend a training/orientation session. The DTI training is a 30–45 minute course that covers the requirements of the law, requirements of the university’s program, an abbreviated review of Industrial Hygiene concepts, and a short example of how to establish the program in their work area. Hands-on class exercises may also be used to demonstrate program requirements and concepts.

Indoor air quality, IAQ, covers a broad range of issues. Some of the items that fall into IAQ may be temperature extremes, elevated relative humidity, stuffy air, odors, sleepiness, headaches, and sinus congestion. Any of these issues should persist for two or more weeks and affect 25% of the occupants before being considered to be related to the building. Individual sensitivities will cause each person to react differently.

The presence of transient odors does not necessarily constitute poor indoor air quality. Transient odors may include smells pulled in on the outside air such as vehicle exhaust or roofing repair work and paint or construction odors within a building. This is not to say that some transient odors will not cause short term headaches or mucous membrane irritation. Generally these odors are short-lived and do not present a long-term health hazard.

Indoor air complaints are investigated by EHS. Investigations may include temperature, relative humidity, carbon dioxide, and mold and bacteria concentrations. Additional parameters may be checked depending on the specific complaint. Repair, equipment modifications, and evaluations are conducted by Operations and Maintenance. Special room cleaning and disinfection may be conducted by Building Services when necessary.

For questions, or to report an indoor air problem, contact EHS at [email protected] or 260-481-4193.

EHS conducts noise measurements to evaluate noise hazards and also recommends controls and employee monitoring where applicable.

The OSHA Occupational Noise Exposure Standard and Hearing Conservation Amendment (29 CFR 1910.95) is designed to protect employees from hearing damage that may occur from exposure to excessive sound pressure levels. The Occupational Noise Standard establishes exposure levels at which certain actions must be taken. In environments where sound pressure levels may equal or exceed an 8-hour time weighted average (TWA) of 85 dBA, an audiometric testing and monitoring program is made available to employees and the wearing of hearing protection is suggested.  In environments with exposure levels equal to or greater than a 90 dBA TWA, the use of hearing protection is required. At no time should an employee be exposed to impulsive or impact noise exceeding 140 dB peak sound pressure level.

Purdue University Hearing Conservation Program

EHS provides training in the selection and proper use of respiratory protection. We also conduct fit testing prior to respiratory use.

Under 29 CFR 1910.134 an employee may be required to wear respiratory protection while working. The Purdue University Respiratory Protection Program provides an overview of the policies, guidelines and procedures that must be followed to ensure your safety. If you have any questions about inhalation exposure(s) or situations that can create a potential for an inhalation exposure, contact EHS at [email protected] or 260-481-4193.

Trained individuals regularly inspect university buildings and grounds for fire and safety code compliance.

Ergonomics is the study of people’s efficiency and comfort in their workplace. Its purpose is to study people in their work environment and make determinations of whether the worker is using their workspace in the most efficient manner without risk of injury. EHS is currently concentrating on office ergonomics but is available to do ergonomics in work areas other than offices.

Injuries that can be attributed to poor office ergonomic setup can range from simple discomfort to disabling ailments that have to be remedied by a physician and/or surgery. Some symptoms/discomfort associated with workspace setup include the following:

• Headache
• Eye Strain
• Neck Pain
• Shoulder Pain
• Back Pain
• Arm Pain
• Wrist Pain
• Numbing of the Hands and Fingers
• Leg Discomfort

Maintaining Posture

• The Chair: It should be at a height that allows the feet to be placed flat on the floor with the thighs level or slightly pointed down. There should be no pressure on the back of the thigh. Sit up straight allowing the natural curve of the spine to contour to the lumbar support of the chair. This posture will put the user at the proper sitting height to use the computer.
• Keyboard Height: Let the arms hang naturally at the sides and bring the forearms up until they are parallel with the floor. With the hands extending naturally from the wrists, move up to the keyboard, the hands should lay naturally on the keys. This is the proper keying height. The wrists should not bend in, out, up, or down, but should maintain a straight line from the top of the forearm across the back of the hand. Do not rest the wrists on the sharp edge of the workstation surface while keying.
• Computer Monitor Distance and Height: Sitting in the keying position, set the distance to the monitor screen at arm's length (this can vary depending on the user's visual acuity). The height of the monitor should be where the eyes look naturally at the top third of the screen when the head is held level. If the user wears bi or trifocals, the monitor will usually be positioned at a lower level, so the user does not have to tilt the head up to view the screen.

With these simple postures in mind, many people can solve their own ergonomic problems when working at a computer workstation.

Contact us for an ergonomic evaluation.

Fall protection training is required for anyone working four feet or more above the next walking/working surface or any height above dangerous equipment or machinery.

• Training is required for each individual situation.
• Documentation is required for certification of hazard assessment (see Personal Protective Equipment section) and individual training.

EHS provides safety consultation for faculty and staff and investigate accidents that occur on university property. We review employee injury and illness records (OSHA 300 log) to identify potential hazards, and provide this information to responsible departments and safety committees.

Review the following reference material on control of hazardous energy:

• Purdue University Control of Hazardous Energy Program (Lockout/Tagout)
• Lockout/Tagout tutorial from OSHA
• OSHA rule at 29 CFR 1910.147 

EHS provides assistance with program set-up, required training, and auditing for OSHA compliance.

The US Department of Labor Occupational Safety & Health Administration (OSHA) Personal Protective Equipment Standard (29 CFR 1910 Subpart I) led to the implementation of the following policy and forms to ensure compliance with the standard:

• Personal Protective Equipment Policy
• Certification of Hazard Assessment Form (Single Task)
• Certification of Hazard Assessment Form (Position/Title)
• Certification of Hazard Assessment Form (Location)
• Personal Protective Equipment Certification of Training Form
   

All Hazard Assessment Forms

EHS performs periodic surveys of areas where radioactive materials are used to ensure that regulatory requirements are met. EHS also calibrates survey instruments, provides personnel dosimetry and bioassays, and responds to laboratory spills of radioactive material.

EHS maintains records of procurement, use authorization, and disposal of radioactive materials. EHS also assists with procurement, receiving, and disposal of radioactive materials.

EHS serves as a liaison to governmental agencies for use of radioactive materials and radiation-producing devices. This ensures that radioactive materials and radiation-producing devices are used in a safe manner, consistent with state and federal regulations.

EHS provides training programs for individuals who use radioactive materials or radiation-producing devices, individuals who transport radioactive materials, and individuals using lasers.

• Animal Exposure Awareness
• Asbestos Awareness
• Biological Safety
• Hazard Communication Plan
• Hot Work Program
• Lab Safety Awareness
• Personal Protective Equipment (PPE) Policy
• Radiation Safety
• Stormwater Pollution Prevention