OSHA Inspection: SHARA LABORATORIES INC.

Issued

Apr 11, 1991

Abate by

May 15, 1992

Penalty

Initial $500 · Current $300 Reduced

Hazardous substances P308B106T208

General-duty citation text

SECTION 5(A)(1) OF THE OCCUPATIONAL SAFETY AND HEALTH ACT OF 1970: THE
EMPLOYER DID NOT FURNISH EMPLOYMENT AND A PLACE OF EMPLOYMENT WHICH WERE
FREE FROM RECOGNIZED HAZARDS THAT WERE CAUSING OR LIKELY TO CAUSE DEATH
OR SERIOUS PHYSICAL HARM TO EMPLOYEES IN THAT EMPLOYEES WERE EXPOSED TO
THE HAZARD OF EXCESSIVE AIRBORNE CONCENTRATIONS OF ENZYME DUSTS WHICH
CAN CAUSE OCCUPATIONAL ASTHMA AND HYPERSENSITIVITY:
A) A TABLET PRESS OPERATOR WAS EXPOSED TO A TOTAL ENZYME DUST
CONCENTRATION OF 537.2 UG/M3 DURING AIR SAMPLING ON 10/24/90. THIS
EXPOSURE TO ENZYME THAT DUST INCLUDED:
BROMELAIN 66.0 1G/M3
PANCREATIN 152.1 UG/M3
TRYPSIN    319.1 UG/M3
B) A GRANULATOR WAS EXPOSED TO A TOTAL ENZYME DUST CONCENTRATION OF
59.6 UG/ME DURING AIR SAMPLING ON 10/24/90. THIS EXPOSURE TO ENZYME
DUST INCLUDED:
BROMELAIN  4.5 UG/M3
PANCREATIN 26.3 UG/M3
TRYPIN     28.8 UG/M3
AN EFFECTIVE ABATEMENT INCLUDES REDUCTION OF EXPOSURE TO ENZYME DUSTS,
THROUGH ENGINEERING AND WORK PRACTIC CONTROLS, TO LEVELS THAT ELIMINATE
EMPLOYEE SENSITIZATION REACTIONS AS INDICATED BY AN EFFECTIVE MEDICAL
SURVEILLANCE PROGRAM.
*ENGINEERING AND WORK PRACTICE CONTROLS THAT CAN REDUCE LEVELS OF DUST
INCLUDE BUT ARE NOT LIMITED TO:
-ESTABLISH A REGULATED AREA TO LIMIT EXPOSURE POTENTIAL. LIMIT ACCESS
TO PERSONS TRAINED AND PROTECTED FROM THE HAZARDS OF ENZYME DUST.
REGULATED AREAS SHOULD BE COMPLETELY SEALED, AND SEPARATED FROM OTHER
WORK AREAS WITH A NONRECIRCULATING VENTILATION SYSTEM.
-ENCLOSE WEIGHT SCALE OR OTHER MEASURING DEVICES IN A LAB TYPE HOOD.
-USE A SLOTTED, PUSH PULL TYPE HOLDER FOR CONTAINERS BEING MEASURED OR
FILLED WITH VARIOUS ENZYME DUSTS.
-INCORPORATE A CLOSED-SYSTEMS, VACCUM FEED SYSTEM FOR TRANSFER OF BULK
ENZYME POWDERS, MEASURING OPERATIONS AND/OR LOADING FEED HOPPERS OR
PRESSES.
-FIT CHUTES, DRUMS AND BLENDERS WITH CLOSELY FITTED COVERS ATTACHED TO
LOCAL VENTILATION TO REDUCE ENZYME DUST FROM ESCAPING WORK OPERATIONS.
-INCORPORATE LOCAL VENTILATION COLLECTION HOODS ADJACENT TO AND
SURROUNDING DUST GENERATION SITES ON THE TABLET PRESS. FOLLOW THE SAME
PROCEDURE FOR OTHER PROCESS EQUIPMENT USED IN PRODUCING ENZYME
PRODUCTS (E.G, TABLET DUSTER MACHINE).
-ENCLOSE ENTIRE OPERATION AREA OF ENZYME PRODUCTS PROCESS EQUIPMENT
IN GLOVEBOX TYPE ENCLOSURE (E.G., LUCITE BOX WITH ATTACHED GLOVES FOR
OPERATOR ACCESS). SMALLER VERSION SHOULD BE FITTED TO THE SIEVE AND
COLLECTION BARREL FOR REWORK OPERATIONS.
-PROVIDE CLOSED/COVERED WORK CART FOR TRANSPORT OF EXPOSED ENZYME
POWDER AND/OR TABLETS TO OVENS OR OTHER PROTECTION AREAS NOT PART
OF THE REGULATED WORK AREA.
-CLEAN OUT EMPTIED ENZYME DUST CONTAINERS IN THE REGULATED WORK AREA.
ESTABLISH WORK PROCEDURES TO RINSE EXCESS DUST FROM BARREL WITH WATER,
USING WET VACCUM TO LIMIT SPREAD OF DUST TO AIR AND PREVENT DIRECT
EMPLOYEE CONTACT WITH DUST WHEN REACHING INTO BARRELS TO HAND WIPE
CLEAN.
-INVESTIGATE USE OF HEPA FILTER TYPE VACUUM TO REDUCE SMALL PARTICULATE
CONTAMINATION OF WORK AREA.
-ESTABLISH REGULAR WASTE DISPOSAL PROCEDURES FOR WASTE ENZYME PRODUCTS.
PROVIDE CONTAINERS SUITABLE TO PREVENT BREAKAGE DURING STORAGE AND
HANDLING. LABEL AND IDENTIFY HAZARDS OF ENZYME DUST ON WASTE BAGS TO
ASSIST RECOGNITION BY WASTE HANDLERS.
*A MEDICAL SURVEILLANCE PROGRAM THAT CAN VERIFY THE EFFECTIVENESS
OF ENGINEERING AND WORK PRACTIVE CONTROLS, INCLUDES BUT IS NOT
LIMITED TO THE FOLLOWING:
-IDENTIFY THE ELEMENTS OF AN APPROPRIATE MEDICAL PROGRAM FOR THE
SPECIFIC ENZYMES AND EMPLOYEES WHO ARE EXPOSED TO THEM. SOME TESTS
THAT CAN BE USED TO EVALUATE EMPLOYEE SENSITIZATION TO ENZYME DUSTS
INCLUDE:
--HEALTH HISTORY AND QUESTIONNAIRE
--PULMONARY FUNCTION TESTS
--PHYSICAL ASSESSMENT
--SKIN PRICK TESTING
--PERIODIC CHEST X-RAY
--METHACHOLINE TESTS
--SEROLOGIC TESTS MEASURING SPECIFIC IGE AND LGG ANTIBODIES
-IMPLEMENT THE HEALTH PROGRAM THROUGH MANAGEMENT DIRECTIVES AND WORK
RULES.
-CONDUCT ONGOING EVALUATIONS OF THE HEALTH PROGRAM TO ENSURE ITS
EFFECTIVENESS.
-PROVIDE TRAINING TO EMPLOYEES IN THE PURPOSE AND CONTENTS OF THE
HEALTH PROGRAM.
F) DETERMINE THAT THE FURNACE IS OPERATING AT RATED POWER CONSISTENT
WITH THE GAS/AIR FLOW AND RELATED CONTROL SETTINGS, IF UNSTABLE
OPERATION IS ENCOUNTERED, OR IF THE PERFORMANCE IS DEVIATED BY MORE
THAN PRESCRIBED VALUES, TAKE THE SPECIFIED ACTIONS.
AFTER DEVELOPING THE FURNACE OPERATING PROCESS (A) THROUGH (F), REVIEW
IT WITH THE FURANCE AND CONTROL SYSTEM INSTALLERS AND/OR MANUFACTURERS
DOCUMENT THE REVIEW AND RESPONSES. MAKE APPROPRIATE CHANGES TO THE
START-UP PROCEDURE.
2) REDUCE THE START-UP PROCEDURE TO A SERIES OF CLEAR-INSTRUCTIONS AND
POST THEM IN THE IMMEDIATE AREA BESIDE ALL AFFECTED FURNACES. TRAIN
TRAIN RESPONSIBLE EMPLOYEES, INCLUDING MAINTENANCE, OPERATING CREWS,
AND THEIR MANAGERS IN THE WRITTEN FURNACE START-UP PROCEDURE.
DOCUMENT THE TRAINING.
3) PERIODICALLY, EVALUATE THE FURACE START-UP AND OPERATING PROCEDURE
THROUGH A PROCESS OF INSPECTIONS AND RETRAINING AS NECESSARY.
RETRAINING SHALL BE NOT LESS THAN ONCE EVERY TWELVE MONTHS AND
DOCUMENTS SHALL INDICATE THE SPECIFICS OF THE TRAINING, DATES(S),
AND EACH PERSON WHO WAS TRAINED.
4) PROVIDE MEASURES TO ENSURE THE STRICT ENFORCEMENT OF THE FURNACE
START-UP AND OPERATING PROCEDURE.
5) ESTABLISH A NORMAL AND AN EMERGENCY FURNACE SHUTDOWN PROCEDURE FOR
THE FURNACE AND ITS CONTROL SYSTEM BASED UPON THE INSTRUTIONS OF THE
INSTALLER(S) AND/OR THE MANUFACTURER(S)-THAT IS PARALLEL WITH AND
CONSISTENT WITH STEPS (1) THROUGH (4) ABOVE. THE SHUTDOWN PROCEDURE
SHALL INCLUDE CLEAR INSTRUCTIONS ON THE SWITCH, VALVE, AND CONTROL
SETTINGS THAT THE FURNACE SHALL BE LEFT IN. IF FOR NAY REASON
PRESCRIBED SETTINGS ARE NOT MET, DESIGNATED MANAGERS SHALL BE
INFORMED. A CLEAR WRITTEN REPORT OF ANY DEVIATIONS OF THE FURNACE
IN ITS OPERATION AND SHUTDOWN STATUS SHALL BE KEPT AT A DESIGNATED
LOCATION BESIDE THE FURNACE, AND A DUPLICATE COPY SHALL BE KEPT AT
THE RESPONSIBLE MANAGER'S OFFICE. THE SEPERATE COPY MUST NOT BE
RETAINED IN THE IMMEDIATE AREA BESIDE THE FURNACE.

Issued

Apr 11, 1991

Abate by

May 15, 1991

Penalty

Initial $400 · Current $250 Reduced

Hazardous substances P308B106T2081560

Issued

Jan 16, 1991

Abate by

Jan 19, 1991

Penalty

Initial $280 · Current $145 Reduced

Issued

Jan 16, 1991

Abate by

Jan 22, 1991

Penalty

Initial $280 · Current $145 Reduced

Hazardous substances 1560P159

Issued

Jan 16, 1991

Abate by

Feb 19, 1991

Penalty

Initial $420 · Current $210 Reduced