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SECTION 2 OSHA REGULATIONS

1. REVISED GLOBAL HAZARD COMMUNICATION REGULATION

2. OCCUPATIONAL EXPOSURE LAW

3. BLOODBORNE PATHOGEN LAW

&

SAFETY NEEDLE LAW


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What is OSHA?

OSHA is the Occupational Safety and Health Administration. The purpose of OSHA is "to assure as far as possible every working man and woman in the Nation a safe and healthful working conditions and to preserve our human resources." To accomplish tbis - OSHA has divided the United States into 10 territories with local regional offices. A lis ting of these regional offices follows this page.

OSHA purpose is to encourage employers and employees to reduce work place hazard s. Each employer "mus t furnis h a place of employm ent which is free from recognized haza rds that cause or are likely to cause death or se1ious physica l harm to employees". T his is also known as the "general duty clause".

Will OSHA inspect our facility ?

OSHA may conduct work place inspections. An OSHA inspector must show credentials upon entering any work place. Most inspectio ns are co nducted without advance notice. In most cases such ins pections are due to OSHA's receiving a complain t. Complaints may be formal (person sign s complaint) or informal (anonymo us) . Some compla in ts may be hand led by letter. Ins pections will include a review of safety policies, employee interviews, vis ual inspection and review of records. Depending on the findings of the inspection, OSHA may issue citatio ns, penaltie s or fines .

Where can I get copies of the standards?

Copies of three standards are found in this chapter. An "easy to read" version and the Federal Register for each standard. To get additional standards or informatio n booklet s you can call your local OSHA office or access the OSHA web site: hhtp:// www.osha .gov. or caJ1 OSHA P ubl icatio ns jn Washin gton, D.C. #(202) 693-1999. T he tuberculo s is chapter conta ins the CDC gu.ide lines for infection control since OSHA never finalized a TB standard. The ergonomic chapter contains OSHA' s guid eli ne for ergonomic safety.

Posting o f OSHA docum ents :

The OSHA "Job Safety and Health - It's Lhe Law" poster found in the front cover of this mru1Ual must be po sted in an area where all employees will see -it.


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OSHA INSPECTIONS


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INSPECTIONS:

lnspections are us uall y cond uc ted without advance notice. T he re are, how ever, special circumstances under which OSHA may give advance notice, though it will normally be less than 24 ho urs. Special circumstances include:

,,/ Inspections that must take place after regular business hours or that require s pecial preparation.

.I Cases where notice is required to assure that the employer and employee representativeor other nece ss ar y personnel will be present.

.I Cases where an inspec tion must be delayed for more than five working days when there is good cause.

Employers who receive advance no tice of an ins pection m us t inform their employee safety officer to be available. OSHA may not conduct warrant Jess i nspections without valid conse nt. The agency does have power to acquire a judicially authorized search warrant based upon evidence of a violation. OSHA would prefer that problems be resolved inte rnall y. A form to file a safety concern or complaint with an em ployer (not OSHA ) can be found in chapter 12 - OSHA Updates.

INSPECTION PRIORITIES:

OSHA obviously cannot inspect all work places. Priority is given to complaints tha t indicate the possibility of imminent danger. The act gi ves eac h employee the right to request an OSHA inspection when he or s he belie ves immine nt danger exists from a hazard or violatio n of an OSHA standard that threatens physical harm. OSHA maintains confidentiali ty if req ues ted.OSHA would prefer that problems be resolved internally when po ssible.

INSPECTOR'S PREPARATION:

Prior to visiting the work place the inspec tor reviews the complai nt and becomes familiar with as many relevant facts as possible about the workplace, including the i nspect io n his tory, the natur e of the busine ss and the particular laws that might apply.


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INSPECTION:

Upon arrival theinspector will present official credentials and ask to meettheemployerorsafety representative , explain the purpose of the visit, the scope of the inspection and the standards that apply. The employer will be given a copy of the complaint (without the name if the person has reques ted anonymity). The employer or the safety representative will accompany the OSHA officer dming the inspection. The route and duration of the inspection are determined by the inspector. The inspector will make every effort to minimize int erruptions lo work routines. T he inspector will observe safety and health conditions; examine records; s ur vey engineering controls; consult with employees private ly, if necessary; take photos; take instrume nt readings (i.e. hood function readings); collect air sa mple s (if fume exposure is the reported problem); and monitor employee safety practices. Each employee observed or ques tioned by the OSHA inspector is protected under the act from disc rimi nation for exercising his or her safety and health rights. OSHA will place special importance on safety information (pol ic y manual), posting of OSHA documents, safety data sheets (SDS), label s andsigns and employee record keepi ng (safety training, job exposure classificatio n, Hepatiti s B vaccine information etc.).

During the i nspection , the inspector will point out any unsafe or unhealthful working condition observed, and discuss possible action to correct problems. 1f a problem can be corrected on the spot, the inspection record will note the employers ''good faith" in compliance, howev er, the problem will still be noted in the citation.

INSPECTION RESULTS:

After the inspection, a closing conference is held with the inspector , e mployer and safety officer. It is a time for frank disc uss ion of problems, needs , ques tions and answers. The employe r will receive a formaJ list of citations and not ices of proposed penalties by certified mail. The employer must post a copy of the citation at or near the place cited for violation for 3 days o r until the violation is con-ected. There are different penalties for different types of violations.

A foUow-up inspec tion may be conducted after an initial OSHA ins pectio n to verify that the proble ms previously cited have been corrected


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All areas cited must be corrected as soon as possible or by date stated in the citatio n. If problem s cannot be corrected by th.is da te, the employer ca n file for a new date for con-ection based on a good faith effort to comply. If the citation s are being appealed. a new date for con-ec tio n may be issued.

APPEALS PROCESS:

If the emp loyerdisagrees with the findings of the inspec tion , the employer has 15 working days from the receipt of the citation to reques t an informal meeting and review of the citations. The reques t mus t be s ubmitted to OSHA in writing. If an employee who in itfated an inspection by complai nt disagrees with the decision not to issue the emplo yer a citation. he or she may reques t an info rma l meet ing to review rhe dec isio n.

CONCLUSION:

Being in complian ce with OS H A regu la tions at all times is the law! Address all OSHA regulations that apply to the work place. Keep safety policje s up to date, implement work place policies, maintain accurate safety records and provide safety training. Rememb er, employee com plaim is the mo s t co mmon reaso n for a medical facility to be inspected . Problems should be addressed and resol ved in a reasonable time frame. Employees may not be discriminated against if a complaint is made. Ins pectio ns due to complai nt are more frequent than most employers rea lize . Don't overlook safety! Inspect ion day is not the time to realize you are not prepared!

References:

Job and Safety Quarterly/Spring 1995, by Helen Hoban Rogers

"OSHA in s pectio ns" written by OSHA and the U.S. Department of Labor.


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OSHAFactShat

Hazard Communication Standard Final Rule

New changes to the Occupational Safety and Health Administration's (OSHA) Hazard Communication Standard are bringing the United States Into alignment with the Globally Harmonized Syst.em of Classificationand Labeling of Chemicals (GHS), further Improving safety and health protections for America's workers. Building on the success of OSHA's current Hazard Communication Standard, the GHS is expected to prevent Injuries and Illnesses, save !Ives and improve trade conditions for chemical manufacturers.The Hazard Communlcatlon Standard in 1983 gave the workers the 'right to know,' but thenew Globally Harmonized System gives workers the'right to understand.'

The new hazardcommunicationstandard still requires chemical manufacturers andImporters to evaluate the chemicals they produce or import and provide hazard information to employers and workers by putting labels on containers and preparing safety data sheets. However, the old standard allowed chemical manufacturers and Importersto convey hazard Information on labels and material safety data sheets In whatever format they chose. The modified standard provides a single set of harmonized criteria for dassifying chemicals according to their healthand physical hazards andspecifies hazard communication elements for labeling and safety data sheets.

Benefits: The new standard covers over 43 million workers who produce or handle hazardouschemicals Inmore than flYe milllon workplace.s across the country. The

modification is expected to prevent over 500 workplace Injuries and illnesses and 43 fatalities annually. Once fully implemented it wlll also:


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• Enhance worker comprehension of hazards, especially for low and limited-literacy workers, reduce confusion in the workplace, facilitate safety training, and result In safer handling anduse of chemicals;

• Provide workers quicker and more efficient access to information on the safety data sheets;

• Result in cost savings to American businesses of more than $475 million in productivity improvements, fewer safety data sheet and label updates and simpler new hazard communication training; and

• Reduce trade barriers by harmonizingwith systems around the world.

R ulemaldng bilckground : OSHA published a Notice of Proposed Rulemaking to update the Hazard Communication Standard in September 2009 and held public hearings In March 2010.

Major changes tX> the Ha:tard Comm un ication Standard:

Hazard dassificatlon: Chemlcal manufacturers andImporters are required to determine the hazards of the chemicals they produce or Impor.t Hazard dassificatlon under the new, updated standard provides specific criteria to address health andphysical hazards as well as das.slfica on of chemical mixtures.

Labels: Chemical manufacturers and importers must provide a label that Includes a signal word, pictogram, hazard statement, and precautionary statement for each hazard class and category.

Safety Data Sheets:The new format requires 16 specific sections, ensuring consistency In presentation of important protection lnfurmatlon.

Information and tra ining : To facilitate understanding of the new system, the new standard requires that workers be trained by December 1, 2013 on the new label elements and safety data sheet format, In addition to the current training requriements.

C h a ng e s from the Propose d to the Fina ! Rule : OSHA reviewed the record andrevised the Anal Rule Inresponse to the comments submitted.Major changes include:

• Maintaining the disclosure of exposure limits (Threshold Limit Values [fLVs]) established by the American Conference of Governmental Industrial Hygienists (ACG!H) andcarcinogen status from nationally and lntemationany recogplzed fists of carcinogens onthe safety data sheets;

• Clarification that the borders of plctograms must be red on the label;

• Flexibility regarding the required precautionary and hazard statements to allow label preparers to consolidate and/or eliminate inappropriate or redundant statements; and

• Longer deadllnes fur full Implementationof the standard (see the chart below).

What you need to do and when:

Chemical users: Continue to update safety data sheets when new ones become available, f)(OYide training on the new label elements and update hazard communication programs if new hazards are identified.

Chemical Producers: Review hazard informatlon for all chemicals produced or imported, classify chemci als according to the new classificationcriteria, and update labels and safety data sheets.


Effective

Completion Date


Requ i rement(s)


Who


-'-'--------'- ----

-D-e-cember-I, -20-13-·' Train employees on the new label elements and SOS format.

June I, 201s• Comply with all modified provisions of this final rule, except:


-·i·Employers


----

_J'


j Ol emlcal manufacturers, importers,

http://www.osha.gov/dsg/hazcom/HCSFactsheet.html 6/17/2013


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< < Back to Hazard Communicaitons

Hazard Communication Pictogram s ••

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The followingpictogram files can be downloaded. The size of each pictogram can be adjusted and wUI remain proportional.

EPS is a standard format (vector image) for prinUng materials professionally or for producing materials for large projects (e.g., labels for signs, tanks, vessels).

NOTE: Appendix c, Section C.2.3.1of 29 CFR 1910.1200 states the fohowing: Pictograms shall be In the shape of a square set at a point and shaU lndude a black hazard

symbol on a white background with a red frame sufficiently wide to be clearly visible. A square red frame set at a point without a hazard symbol lsnot a pictogram and is not

permitted on the label.

Flame Over Circle Flame Exploding Bomb Skull and Crossbones Corrosion

EPS JPG PNG EPS JPG PNG EPS JPG PNG EPS JPG PNG EPS JPG PNG

Dimensions: 1017(w ) x 1 017(h ) Dimensions: !017(w)x 1017(h) o;menslons: 1011(w) x 1017(h)D i mensions: 1017(w) x 1017(h) Olmeru1Jons: 1017(w) X 1017(h)

Resolullon: 300 dpl Resolution: 300 dpi Resolution: 300dpl Resolution: 300 dpl Resoludon: 300 dpi

Gas Cylinder Health Hazard Environment Exdamatlon Mark

EPS JPG PNG EPS JPG PNG EPS JPG PNG EPS JPG PNG

Dimensions: 1017(w) x !017(h) Dimensions: 1017{w) x !Ol7(h) Dimensions: 1017(w) x 1017(h) Dimensions: l 017(W} x !017(h)

Raoludon: 300 dpi Resoludon: 300dpi Resolutlon : 300 dpl Resotutio<1: 300 <!pl

Freedom of Information Act f Privacy & Security Statement I Disclaimers I Important WebSite Notices I In rna tio na l I Contact Us

U.S. Department of Labor I Oo:upatlonal Safety & Health Administration I 200 Constitution Ave., NW, Washington, OC 20210 Telephone: 800-321-0SHA (6742) ( TTY: an -889-5627

www.OSHA.gov

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Thls section provides recommendations ror fighting a fire caused by the chemical. The required Informationconsists of:

• Recommendations of suitable extinguishing equipment, and Information about extinguishing equipment that Is not appropriate for a particular situation.

• Advice onspecific hazards that develop from the chemical during the fire, such as any hazardous combustion products created when the

chemleal bums..

• Recommendationson special protective equipment or precautions for firefighters.

Sect io n 6 : Accidental Release Measures

Text Box: Section 4: First-Aid Measur es

Text Box: Thissection describes the Initial care that should be given by untrained responders to an Individual who has been e)q)()Sed to the chemical. The
required Information consists of:

•	Necessary first-aid Instructions by relevant routes of exposure (inhalation, skin and eye contact. andIngestion).
•	Description of the most Important symptoms or effects, and any symptomS that are acute or delayed.
•	Recommendations for Immediate medical care and special treatment needed, when necessary.

Text Box: S ec tion  5: F i re- Fighting Measures


Text Box: This section provides guidance on the safe handling practices and conditions for safe storage of chemicals. The required information consists of:

•	Precautions for sate handling, indudlng recommendations for handling Incompatible chemicals, minimizing the release of the chemical Into the environment, and providing advice on general hygiene practices (e.g., eating, drlnklng, and smoking in work areas Is prohibited).
•	Recommendationson the conditions for safe storage, indudlng any incompatibilities. Provide advice on spedfc storage requirements (e.g.,
ventilation requirements)


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Text Box: Section 11:  Toxicological Information

Text Box: This section Identifies toxlex>logical and health ffects lnfonnation or Indicates that such data are not available.The required lnformatiOn consists of:

•	Information on the likely routes or exposure (inhalation, Ingestion, skin and eye contact). The SOS should Indicate If the lnformabon Is
unknown.
•	Description of the delayed, immediate, or chronic effects from short• and long-term exposure.
•	The nOOlelicaf measures of toxicity (e.g., acute toxk:ity estimates such as the LD50 (median lethaldose)) • the estimated amount [of a subs13nce] expected to klU 50% of test animals In a single dose.
•	Descriptoi n of the symptoms. This desaiptlon Includes the symptoms assoctated with exposure to the chemical lndudlng symptoms from the lowest to the most severe exposure.
•	Indication of whether the chemical iS llsted In the National ToxicoJooy Program (NTP) Report on O!rdnogens (latest edition) or has been found to be a potential carcinogen In the lntemational N)er,cy for Research on cancer (!ARC) Monographs (latest editions) or found to be a potential carcinogen by OSHA

Text Box: Section 12:  Ecological Information (non-mandator)y

Text Box: This section provides information to evaluate the environmental impact of the chemlcal(s) if It were released to the environment. The Information may include:

•	Data from toxicity tests performed on aquatic and/or terrestrial organisms, where available (e.g., acute or chronic aquatic toxicity data for
fish, algae, crustaceans, and other plants; toxicity dala on birds, bees, plants).
•	Whether there Is a potential for the chemical to persist and degrade In the environment either through blodegradatJon or other processes,
such as oxldatlon or hydrolysls.
•	Results of  tests of bloacairnutationpotential, making reference to the octanol-wa partition coeffideflt (Kow) and the bloconcentratlon
factor (l!Cf), where available.
•	The potential for a substance to move from the soil to the groundwater (Indicate results from adsorption studies or leaching studies).
•	Other adverse effect5 (e.g., environmental fate, ozone layer depletion potential, photochemical ozone creation potential, endocrine disrupting potential, and/or global warming potentJaQ.


Text Box: This se<;tion provides guidance on dass,fic:atlon information for shipping and transporting of hazardous chemical(s) by road, air, rail, or sea. The
Information may include:

•	UN number (i.e., four•figure Identificationnumber of the substance)' .
•	UNproper shipping nam;e ,
•	Transport hazard dass(es)l..
•	Packing group number, if applicable, based on the degree orhazar .
•	Environmental hazards (e.g., Identify If It isa marine pollutant according to the lntematlonal Maritime Dangerous Goods Code (IMDG
Code)),
•	Guidan<:I! on transport in bulk (aa:ordlng to AMex II of MARPOl 73/78 and the International Code for the Constructlon andEquipment of Ships carrying Da rous Chemicals In Bulk (International Bulk Chemlcal Code (IBCCode)).
•	Any speclal precautions which an employee should be aware of or needs to comply with, in connectionwith transport or conveyance either within or outslcle their premises (Indicate when Information is not available).

Section 15: Regulato ry I n form ation (non-mandatory)

.

This section identifies the safety, health, and environmental regulations specific for the product that Is not indicated anywhere else on the SOS.

The information may include:

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Side-by-Side Comparison of OSHA ' s Existing Hazard Communication Standard (HCS 1994) vs. the Revised Hazard Communication Stand a rd (HCS 2012)

This document provides a compar.ison of thechanges from the existing Hazard Communication Standard (the current Hazard Communci ation Standard, 1910.1200, as published in th e Code of Federal Regulations (CFR) on Mardi 11, 1994; herein referred to asHCS 1994) and the final rule revising theHazard Communication Standard to be ronsistent with the United Nations Globally Harmonii:ed System of aasslflcatlon and Labelling of Chemicals (herein referred to as the HCS 2012).

The HCS 1994 is a performance-oriented standard that provides guidance for defining hazards and for performing hazard determinations. However, thecurrent standard does not specify an approach or format to follow. The Globally Harmonized System of aassification and Labelling of Chemicals (GHS) has certain aspects that are perfomiance-oriented, but the key provisions are a unifonnitt· orfentedapproach for the classiflcatlonand presentation, through labellng and safety data sheets, of hazard Information.

The HCS 2012 ls written as a modification to the existing standard, and those parts of the standard that do not relate to the GHS, or are already consistent with It remani u nchanged. Additionally, some minor changes to terminology have been made in order to align this rule with language used In the GHS. For example, the term "hazard determination"has been dianged to "hazard dasslficatlon• and "material safety data sheet" has been changed to· safety data shee·t.

The followingSlde-by·side comparison shows the changes made to the HCS 1994 as stricken text in the le ·hand column. Additions or changes made to the ex i sting HCS (1994) to create the revised HCS (aligning the HCS with the GHS, and effective 2012) are shown as underllned text in the right-hand column.

Purpose.

The Hazard Communication Standard (HCS) 1994 includes a paragraph that describes the purpose of the HCS, and addresses preemption of state and local laws. The Hazard Communication Standard (HCS 2012) includes essentially the same paragraph as the HCS 1994. The primary modification to this paragraph Is to state affirmatively that part of the purpose is to harmonize with international requirements. OSHA also darified the standard's preemptive affect on State laws. Other than terminology, no additional substantive changes have been made In this paragraph of the HCS.


HCS 1994

(a) Purpose.

(a)(l ) The purpose of this section Is to ensure that the hazards of all chemicals produced or imported are e-reltieted, and that Information roncemlng their hazards is transmitted to employers and employees. lhi3 transmittal of Information Is to be accomplished by meansof comprehensive hazard communicationprograms, whld1are tn lndude container labeling and other forms of warning, materiel-safety data sheets and employee training.

(aX2) This occupational safety and health standard IsIntended to address comprehensively the issue of ewtlt,et!ng the potential hazards of chemkals, and communicating Information concerning hazards and appropriate protective measures to employees, and to preernptany legal ieq11ire1ne11t5 of a state, or political subdivision of a state, pertaining to this subject. Ernltlllting the potential hazards of chemicals, and communicatingInformationCXlncernlng hazards and appropriate protective measures to employees, may lndude, for example, but Is not limited to, provisions for: develoipngand maintaining a written hazard communication program for the wori<place, including lists of hazardous chemicals present; labeling of containers of chemicals In the worlcplace, as well as of cxmtalners of chemicals being shipped to other workplaces; preparation and distribution of meterief safety data sheets to

employees and downstream employers; anddevelopment and Implementation of employee training programsregardinghazards of chemicals and protective measures. Under section 18 of the Act, no state or polltJca1subdivision of a state may adopt or enforce, tt110 1:19h en, comt o, age11c, , any requirement relating to the Issue addressed by this Federal standard, except pursuant to a Federally-approved state plan.


HCS2012

(a) Purpose .

(a)(l) The purpose of this section Is to ensure thatthe hazards of all chemicals producedor imported are and that information roncernlng the

hazardsIs transmitted to employers and employees.

requirements of this section are I n tended to be consistent with the prov isions of the United NationsGlbbally Harmonized System of aassification and L.abellM of Chemica ls{GHSl. Revlsjon 3. transmittal of information Is to be accomplished by means of comprehensive hazard communication programs,

which are to include container labeling and other forms of warning, safety data sheets andemployee training.

(aX2) This occupational safety and health standard is Intended to address comprehenslvely the Issue of the potentialhazards of chemicals, and communicatingInformation roncernlng hazards and appropriate protective

measures to employees, and to preempt any legislativeor regulatory enactments of a state, or political subdivision of a state, pertaining to this subject. Qam!.09 the potential hazards of chemicals and communicating

Information concerning hazards and appropriate protective measures to employees, may include, for example, but is not llmlted to, provisions for: developing and maintaininga written hazard communication program for the workplace, Including lists of hazardous chemicals present; labelingof

or

CXln tainersof chemicals In the workplace, as well as of containers of chemicals being shipped to other wori<pla ; preparation anddistribution safety data

sheets to employees and downstream employers; and development and Implementationof employee training programsregarding hazards of chemicals and protective measures. Under section 18 of the Act, no state Of political subdivision of a state may adopt or enforce any requirementrelating to the Issue addressed by this Federal standard, except pursuant to a Federally· approved state plan.


Sccpe and Applk:ation.

In this paragraph, OSHA has removed reference to Appendi x E, which previously provided employers with guidance info rmation regarding the determinatlonof their compliance obligations.Rather than include thisInformation in the Appendix, OSHA will provide separate guidance documents to employers.Additionally, this paragraph in the HCS 2012 will continue to address the many practical aCCXlmmodatlons OSHA has made regarding application of the HCS to different types ofworkplaces, as welt as deal with the interface of the HCS to other Federal laws that address similar areas. No changes In these rules are necessary to

I I

.I incorporatethe GHS; therefore, only terminology changes have been made In thisparagraph of the HCS.

HCS1994

(b) Scope andappliaJtion .

_r • -


HCS2012

(b) Scope and application. I



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AdministrationAct (27U.S.C. 201et seq.) and regulations issued under that Act, when subject to the labeling reQUirements or that At:.t and labeling regulations issued under that Act by the Bureau or AlCXlhol, Tobacco, !Ind Fireorms ;

(b)(S)( v) Alty consumer product or hazardous substance as those terms are

definedIn theConsumer Product Safety At:.t(15 U.S.C. 2051 et seq.) and Federal Hazardous Substa. Act {15 u.s.c. 1261etseq.) respectively, when

subject to a const.mer product safety standard or labelingrequirement of those

Acts, Of regulations Issued under those Ac.ts by the Const.mer Product Safety

Commission; and,

(b)(S)(vi) Agricultural or vegetable seed treated with pesticides and labeled In accordance with the Federal Seed Act (7 U.S.C. 15S1 etseq.) and the labeling regulations issued under that Act by the Department of Agrlcvlture.

(b)(6) This section does not apply to:

(b)(6)(1) Any hazardous waste as such term ls defined by the Solid Waste

Oi$pOSill Act, as amended by the Resource Conservation and Rea>very fv:l of 1976, as amended (42 u.s.c. 6901 et seq.) , when subject to reoutatlons Issued under that Act by the Environmental Protection Agency;

(b)(6)(ii) Any hazardous substance as such termIs defined by the Comprehensive Environmental Response, c.ompensaUon and Liability Af:f (CERQA) (42U.S.C. 9601 et seq .) when the hazardous substance Is the foals or remedial or removal action being conducted under CERCl.A In accordance with the Environmental Protection Agency regulations.

(b)(6)(1d) Tobacco or tobacco products;

(b)(6)(1v) Woodor wood products, Including lumber which wfli not be processed, where the chemci al manufacturer or Importer can establish that the only hazard they pose to emplo'(ees ls the potential for Rammabllity or combustibility (wood or wood products which have been treated with a hazardous dlemical covened by this standard, and wood which may be subsequently sawed or cut, generating dust, are not exempted);

(b)(6)(v) Articles, (as that term is defined in paragraph (c) of this section);

(b)(6){vi) Food or alcohofic beverages which are sold, used, or prepared in a reta0 establishment (such asa grocery store, restaurant, or drinking place), and foods Intended for personal consumptlon by employees white In the

workplace;

(b)(6)(vil) Any drug, as that term is defined In the Federal Food, Drug, and

Cosmetic Act (21 u.s.c. 301 et seq.), when It IsIn solld, final form ror direct

administration to the patient (e.g., tablets or pills;) drugs which are pad(aged by the chemical manufacturer for sale to consumers Ina retailestablishment (e.g., over-the-<:ounter drugs); and drugs intended for personal oonsumption by employees while In the workplace (e.g., first aidsupplies);

(b)(6)(vill) Cosmetics which are packaged for sale to consumers In a retail establishment, and cosmetics intended for personal consumption by employees whilt In the woncplace ;

(b)(6)(1x) Any consumer product or hazardous substance, as those terms are defined In theConsumer ProductSafety Act (15 U.S.C. 2051 etseq.) and Federal Hazardous Substances Act (15 U.S.C. 1261et seq.) respecttvely, where the employer can show that it is used In the workplace for the purpose intended by the chemical manufclcturer or importer of the product, and the use resultsIna duration and frequency of eicposure which Isnot greater than the

range of exposures that could reasonably be experienced by consumers when used for the purpose Intended;

(b)(6)(x) Nuisance particulates where thechemical manufacturer or mporter can establlSh that they do not pose any physical or heallh halard covered under thissection;

(b)(6)(xi) Iona.Ing and nonlonizlng radiation; and.

(b)(6)(xii) Biologlcal halards.


(b)(S)(v) Any consumer product or haiardous substance as those terms are defined In the Consumer Product Safety Act (15 U.S.C. 2051 etseq.) and Federal Haiardous Substances Act (15 U.S.C. 1261et seq.) respectively, when subject to a consumer product safety standard or labeling requirement of those Acts, or regulations Issued under those Acts by the COnsumer Product Safety

Commission; and,

(b){5)(111) Agricultural or vegetable seed tteated With pestJddes and labeled in

accordance with the Federal Seed Act (7 u.s.c. 1551 et seq.)and the labeling regulations Issued under that Act by the Department or Agriculture.

(b)(6) This section does not apply to:

(b)(6)(l) Any halardous waste as such term is defined by theSolid Waste Disposal Act, as amended by the Resoura! Conservation andRecovery Act or 1976, as amended (42 u.s.c.6901 et seq.), when subject to regulations Issued under that Act by the Environmental Protection Agency;

(b)(6)(11) Any haiardous substance as such term ls defined by the

Comprehensive EnvlrorvnentalResponse, Compensation andUablllty (CERCLA) ( 42 u.s.c.9601 et seq.) when the hazardous substance ls the focus

of remedial or removal action beingconducted under CEROA In accordance

withEnvirorvnental Protection Agency regulatiOns.

(b)(6)(1i1) Tobacco or tobacco products;

(b)(6)(tv) Woodor wood products, indudlng lumber which willnot be processed, where the chemical manufacturer or importer can establish that the only hazard they pose to employees Is the potential for flammabifity Of oombustlbHlty (wood or wood products which have been tteated with a hazardous chemical covered by this standard, and wood which may be subsequently sawed or cut, geoerating dust, are not exempted);

(b)(6)(v) Articles (as that term isdefined In paragraph (c) of this section);

(b)(6)(vi) Food or alcohollc beverages which are sold, used, or prepared Ina retail establishment (such asa grocery store, restaurant, or drinking place), and foods Intendedfor personal consumption by employees while In the workplace;

(b)(6)(vll) Any drug, as that term is defined In the Federal Food, Drug, and Cosmetlc Act (21 U.S,C. 301et seq.), when it IsInsolid, final form for direct administrationto the patient (e.g., tablets or pills); drugs which are packaged by the chemical manufacturer for sale to const.mer.; Ina retail establisMlent (e.g., over-the-counter drugs); and drugs Intended for personal consumption by employees while Inlhe workplace(e.g., first aid supplies);

(b)(6)(111ll) Cosmetics which are packaged for sale IX> consumers in a retail establishment, and cosmetics Intended frx personal consumption by employees while in the woriqllace;

(b)(6)(1x) Ariy consumer product or hazardous substance, as those terms are defined in the Consumer Product Safety Act (15 us.c. 2051 etseq.) and Federal Hazardous Substances Act (15 U.S.C. 1261 et seq.) respectively, where

the employer canshow that It Is used In the worlq>lace for the purpose Intended by the chemical manufacturer or Importerof the product, and the use results In a duration and frequency of exposure whichls not greaterthan the

range of exposures that could reasonably be experienced by consumers when

used for the purpose Intended;

(b)(6)(x) Nuisanceparticulates where the chemical manufacturer or importer can establish that they do not pose any physical or health hazard covered under tllis section;

(b)(6)(xl) Ionizing and nonionizing radiation; and, (b)(6)(xli)Blologlcal hazards.


Definitio ns.

Several key changes have been made to update the definitions section. This final rule provides more detailedphysical and health hazard criteria. However, this

lnfonnation has now been moved from this section Into Appendices A and B.

J AdditionaPy, in order to be consistent with the GHS, OSHA has added, deleted, and modified a number or the definitions. The following changes were made to

....

delinltlons in the HCS 2012:

the following

tatement, !Abel ele

Added definitions: Oasslfication, Hazard category, Hazard dass, Hazard not otherwise dasslfled, Hazard s ments, Pictogram,

•• .. •

I • 1 • _J


l - - - - 1 Q /7 /')()1'J



"Emplayee• means a worker who may be exposed to hazardous chemicals under normal operating conditions or in foreseeable emergencies. Workers such asoffice workers or bank tellers who encounter hazardous chemicals only In non-routine, isolated instances are not covered.

"Employer" meansa person engaged In a business where chemicals are either used, distributed, or are produced for use or distribution, lndudfng a contractor or subcontractor.

"&i,kl,ite" mee11s II chtn,icel th11t ceuse,e sud«n, 11111,o,t instimtllneous 1ele11,e of p,e:,sc,e, 911,, 011d he11t ,,hen subjected to 511dden shock, p,essti,c, o, high ten ,perotu,c.

"Exposure or exposed" means that an employee is subjected in the course of employment toa chemical that Is a physical or health hazard, and includes potential (e.g. accidental or possible) exposure. "Subjected" In termsof health hazards lndudes any route of entry (e.g. Inhalation, ingestion, skin contact or absoll)tion.)

•n ann1111ble"11,ce11, 11 ctic111icel th11t fell! Into 011e of the folkloil,g cetego, ics.

(il "Ae,o, ol, R11mn,oble" 111e11,15 en ee,o,ol tl,at; 11hen tested b1 the method de:,e,ibed In 16 CFR 1508.45, ,ield5 tl f10111e p,ojectlon exceeding 10 l11dles et full ,ohe ope111i1g, 01 o floshbed< to flente exte11dh,g back to th,e 111,c) 11t en,

de g,ee of ,11i'tc o pe11i119,

(R) "Ges, fie,11rnable" 11,ce,"· (") .-. gas thllt; at ambient ten,pe,atwe end p,esstue, fonm e fle11n11eble 111i:.ctu1e oith oir tlt a conee11t1etio11of thhteen

(13) pe1ee11t b, ,01t1me or Jes,, or

(0) A gas that, et an,bie11t tcmpe111tu,e 111,<J p,usurc, fo.111,., 111ngc of fllln,111t1b! c111b<tu1e, nlth 11!1 11ide1 then h,ct.c (12) pe,cent bt volume,

,ege,dlus of the k, .. e, limit,

(ni) "tl(luid, fle111111oble11111eon, en, liquid he,ing e fle:s.'ipoi11t below 100 deg. F

(37.0 deg. C), e:.cccpt 0111 mixture ho,h,g C0111po11e11t, with fl11s hp,oht, of 100 deg. F (37.8 deg. C) or higl ,e,, the totlll of nhlch make up99 peree11t 01 more

of the totlll ,olu11te of the nrixh!re.

(h) ''Solid, flemn,ablc" 111ee11s e 301id, othe, than o blasting 11ge11t 01 explo5ivc 11, deA11ed in 1918.109( 11), that Is liable to ce foe through frictlon, ab!o1ptlon of Inoi,tu,c, 3p011te11eous chemiceI cl'J1111gc, or .ctelncd heet on, 11111 11ufectu1it,g 01 p,occ,sing, 01 nhictJ ce11 be Ignite,d e&dilt end t1hc11 ig11ited buiiis30 1igo1ousfy e1,d pci,istc11 , e, to oeete e ,c1ious h1m11d. .-. ehen,ieel

,t,el l be co,15ide,ed to bee fle11111111ble 30lld if, wher, tested br the method desc,lbed it, 16 CfR 1598.+4, it Ignites111,d bm,as .. Ith II self sustlli11cd fle11,c et e ,ete greate, the11 011c te11tli of1111 Ii id1 pe, seco,d elo119 1131111rjo1 axis.

' Rest.point• means the minin,um ten,pe,otu,c et 11hich II liquid gives off e

,apo, i11sufficient conee11t1ation to i911itc "hw tested'" folio.,, .

{fl Tegliebue Clo,cd Te:stc, (See A111e1icen N11tio1111I Stllnd111d l1cti'lod of Test

fol Flesh Point by Tag Clo,cd Tcste,, 211.24 1979 (,IGl11 B 56 79)) fo1 liquids

.. Ith o ,iscosit') of les, th1111 45 Se 1 boltUni'te1,el Seconds (SUS) et 108 deg. F (37.0 deg. C), ttlet do not co11tllh, 5tJ!pC11ded !SOiids 1111d do not hll,e e te11dcnc, to fo1n1 e 3u,feee Rim u11de, test, or

(ii) Penski P1ertens Oosed 'fester (sec Nnelice11 Plationel Stllndard Method of fest fo, Fiest. Poi11t bt Pens!<, l!e1tc11, Clo,cd 'fa,te , 211.7 1979 (A$TH B 93 79)) fo, liquid, 11ith a viscosity equel to 01 91eate, 1h11,, 15SUS111188 deg. F (37.0 deg, C}, or thel'co,•tain sdspended ,olids, or thet he,e e ttr,denc, to fo1111 ., surface Rl111di.de, test, or

(iii) Setoflesh Oet!ed Telter (se e ,to1tet ice11 lletio1111I Stlmdard I1ethod of Test for Flesh Poi11t by Setefl11sh Closed Testc, (.tcST?1 B 32i'O 7e)).

Organic pe1o xides, nhieh undergo out:oeeeelc,atir,g tt.e1n1al decomposition, ere

occlude d f.0111 011, of the flashpol11t detc11nine on methods speclncd abo, c.

"foreseeable emergency" means any potential occurrence such as, but not limited to, equipment failure, rupture of containers, or fallure of control equipment which could result in an uncontrolled release of a hazardous chemical Into the workplace.

"ll!l%e1dous chC1T1icel" mc1111, e11, cf,e111ic11I o hlcl'J iJ a ph1sieel h11re1d or 11

heelt!, illffl!1d.

''ilaterd 0'1!1ning" meens en, t1ords, picture,, ,-,n,bols, o, eo111binetio11 thereof appee,ing 01111 l!lbel 01 other epp,oprietc fon11 of we111h,9 which eo11vc1 t!,e

L specinc ph1 sieel e11d l,eeith l,112:a,d(,), ind1:1ding tll1get 01gen effect,, of the

c!ten ,icel(s) In the container(,). (See the deRni on, for 'phf!lcel hererd'' end

" health l ,eta1d" to detc1111hte the hez:erd5 .. hich must be eo,ered.)


employment to a chemical that is a physical or health hazard, and lndudes potential (e.g. accidental or poSSible) exposure. ''Subjected" in terms of health hazards Includes any route of entry (e.g. inhalatlon, Ingestion, skin contact or absorption.)

I I

"Foreseeable emergency" means any potential occurrence such as, but not limited to, equipment failure, rupture of containers, or failure of control equipment which could result in an uncontrolled release of a hazardous chemical Into the workplace.

"Hazard category• means the dMs;on of criteria within each hazard class. e.g .• gral acute toxicity and flammable llauids Include four hazard categorjes. Thesecategories compare hazard severity within a hazard dassandshould not be taken asacomparison of ha7.ard categories more qenera!ly.

"Hazard class" means the nature of the ohvsical or health ha zards. e,q.• flammable solid. carcinogen. oral acute toxicity.

" Ha,ard not otherwise classified (HNOCl" means an adverse physical or health effect identified through evaluation of scientific eyjde nce during the classlflc.ation process that does oot meet the sPecified criteria tor111e physicaland health tw.ard classes addressed in this section. This does not extend coverage to adverse physical and health effects fur which there ls a ha!<!rd class addressed fn thissection. but the effect either falls below tbe cut·off value/concentration limit of the hazard class or is under a GHS hazard category that has not been adopted by OSHA /e.g ., acute toxicity Category Sl.

"Hs@rd statement" meansa statement assig ned to a hazard dass and category that describes the nature of the hazard/sl of a chemical lnduding, where approprtate, the degree of hazard.

"Hazardous chemical" means any chemical which 1s dasslfied asa physical hazard or a health hazard. a simple asohvxiant, combustibledust. pyroohoric gas. or hai.ard not otherwise ctasslfied.

"Health hazard" means a chemical which Is dassified as posing oneof the foilowjna hazardous effects: acute toxicity /any route of exposure}: skin mrrosion or irritlltton: serious eye damage oreye irritation: respiratory or skln sensjtilatlon: germ cell mutaoenldty: carcinogenicity: reproductive toxicity;

specific target organ toxicity /single or reoeated exoosure l; or aspiration hazard. The criteria tor determining whether a chemical 1s classified as a health hazard are detailed In Appendix A to §1910.1200 Health Hazard

"Immediate use" means that the hazardous chemical will be under the control of and used only by the person who transfers It from a labeledcontainer and only within the work shift In which it is transferred.

"Importer" means the.first business with employees within the Customs Territory of the United States which receives hazardous chemlcais produc.ed In other countries for the purpose of supplying them to distributors or employers within the UnitedStates.

'Label" meansan appropriate group of written, printed or graphic information elements concernloq a hazardous chemical that is affixed to. printed on. orattached tothe Immediate container of a hazardous chemical, or to the outside pad<aalng.

"Label elements" means the specified pJctogram. hazard state ment. signal

word and precautlonart starement for each hazard class and category .

"Mixture· meansa combination or a solution composed of two or more substances In which they do not react,

'Physical hazard" means a chemical that Is classified as oosiog one of the following hazardous effects: explosive: flammable (ga§s , aerosols, liquids, orscllds): oxidizer (liquid, solld or gas): self·reactlye: pyrophorlc (liquid orsclld):self-heating: organic peroxide: corrosive to metal; oos under pressure; or iocontact with water emitsflammable gas. See Appendix o to §1910.1200 - Physical Hazard Criteria.

"Pictogram· meansa comoosJtlon that may include a symbol plusother graphic etements. sud) as a border. background pattern, or co!o , r th atis Intended to convey specific information about the hazards of a chemical. Eight plctogramsare designated under this standard for application to a hazard category.

"Precautionary statemenr means a ph rase that describes recommended measures thatshould be taken to minimize or prevent adverse effects resultlna from exposure to a hazardous chemical. or Improper storage or handltng.

"Product identifier" means the name or number used for a haza rdous chemical on a label or In the sos. 1t provides a un!aue means by whicn the user can Identify the chemical. The product Identifier used shall permit cross- references



rl'. •


0 /"T /"\('\ 1"


rage:; t u1 L.V

'Workplace" means an establishment, job site, or project, at one geographical location containing one or more work areas.

Hazard classification.

The hazard classification approach In the GHS is quite different from the performance-oriented approach in the HCS 1994. The GHS has specific Criteria for eac:n health and physical hazard, along with detailed instructions for hazard evaluation and detennlnations as to whethermixtures of thesubstance are covered.

OSHA has lnduded the general provisions for hazard dassiflcatlon In paragraph (d) of the revised rule, and aClded extensive appendlxes that address the criteria for each health or physical effect. Mandatory Appendices A and B provide classification guidance for Health Hazards and Physical Hazards, respectively. The hazard dassificatlon criteria contained in the HCS 2012 is test method- utral. That Is, the person dasslfytng a chemical or substance should use available data andno additional testing Is required to classify a chemlcal.

Please refer to the Summary and Explanation of the Final Rule to gain a better understandlng of the changes.


HCS1994

(d) Hazardtkt .nTJ'ntition.

(d)(l) Olemical manufacturers and importers sha ll ev aluate chemicals produced in their woncplaces or imported by them to dete111111 ,e if the7 ere h!mlrdcu,. Employers are not required to e't'9luate chemicals unless they choose not to rely on the perfonned by the chemical manufacturer 0t importer for the chemical to satisfy this requirement.

(d)(2} Chemical manufacturers, Importers or employers eveftfflting chemicals shall identify and consider the available scientific evidence concerning !tlCh hazards. Fo, l,eell:h hMe1d, , e, idenoc ,which i! ! te ti!tieell1 ! igniAeent end

..hich Is be!ed on et leest one po e st11d1 condtJCted in ecco,dence iiith

e:s!eb ti !l ,ed !cientific principles i! co,l!idered to be s11fficie,,t to esteb li!h 11 hMOrdot1! effect if the , e!t1lt! of the !hld1 meet the definltlo,e of heelth hot1116! in !hi! section. Appendlx A shall be consulted for the !COpe of hee!tn hazards co¥efCd, and Appendix B shall be consulted for the o itc,18 IC be follonecl n iti'l1e:spectto the cempletcue!! of the e,el t111tlon, end the dete to be

reported:

(d)(3) 'fhe chemieel ,11ern.te ctu1e., in,po1tc1 o, w ,plo,1e e, elueting chen,ieels shelf beet the follon ing !OtllCC! IIS estebli!hl ng lhetthe chemieeb llsted h, them e1e hM111dot1S.

(d)())(I) 29 €FR pe1t t9tB, st1bp811: Z:, 'foldc end I lezerdot1s Su b! te11ce, , Ocet1petiont1I Sefetr end Ileolth Admi11i,t.etion (OSili'.), 01,

(d)(J)(ii) "Tlue! hold Limit 1Jelue! for Ehemieel Substencc, end f'hysieel i'.9e111:3 111 the Ylo,k Em i101u11e11t, 1 Mne.iee11 Confe,ence of Go,e11wnenl:l!I JudustJial

Ilygle11lsl:! {,f,€611I) (letest editio11). The d'le,11ieelme1111filctu1e,, ln,porte,,or employer Is !till 1e:sponsible fo, e, elt1etlng the heze1d, es,ocleted oith tl',e cl ,emieels It, the,e!Ot1,cc liffl ht ecco,de11a oltl, tl.e 1eq11heme11b of thl!

stendefd,

(<!)(4) Che111ieel iiillnufectu1e1! , lntpo1t e, ! 1md e,11plo,ei, e, elt1etl11g c he111ieeb shell beet the follo.. lngsouice:s es el:l!blls!,i119 thet e chemfeel i! 11 ee1dnoge11 01 pote11tiel ee1ci nogen fo, hm:e,d comn111uieetion pu,po:scs.

(d)(4)(i) Pl11ti01111IToxioolog1 Pi091em (ln=P), 'i'<,u 111111 Report on Cerd nogens'' (lete,t edition),

(d)(4)(ii) I,,te,,.elio11el !,gen for Rue:e,ch on Ce,.ce, (1,t<R€)

"flo 11og1e phs'1 (letest editio11s) , o ,

(d)(4)(iii)29 CfR p111t 1918, s11bpe,t Z, Toxic en d I lm:e,dom Subste11ces, OcCt1p11tio1111f Sefet't end Ileelth Ad,ni11i!t1e on.

llcte. The •Regi! tr'J ofTo,cie Effects of Chen,leel SUb!tllnca • published b1 the tletio11el J,etitute fut OCCtJpetlor.elSefet)' e11d Ileelth indieete! 11hcther e cheiiii cel hllS been found b1 IITP o, h'IRC to be e pote11tlel ee1ci11oge11.

(d)(S) The chemlcel me1111fectu1er, lmpo,te, or t iiiplo1er shell determine the i'.eze1ds of mb<'tt1re, of cheiiiiCOb IIS foHo,,s.

(dl{S)ti) !Fe 11,ixtu,e hes bee11 tested ese .. hole to dctc,ntine It! heze1ds, tl.e

,csuil:5 of such testing!hell be used to detc1mit,e lfhetl,e, the iiilxtu,e il

hMerdo-,

(d)(S)(ll) If II iiiixtme ha,uot bee11 tested e, e ., hole to detc1mi11e nhethe1 the n1b<tt11e is e heolth hoze,d, t!,e 111ixtt11e s i,e ll be 11ss11111td to p1csent the sen,e heelth hezerd! e! do the component, tthid, oomprile one peicent (b1 .. eight

01 ,011111.e) 01 g,eotc, of tl,e111brtt11e, except thet 11.e liiixtute she ll be o!St1111ed

to p.e:sc11t e ce1ci11ogc11ic lumud if It co11te i11s e COiiipot.ent ii, 0011cc11t111tlo1eof

0.1 pe,am 01 91eetc1 .. l,id t is co11sidt1td IC bee ce1ci.t09t 11 o ndct pe

(dj( ) of t!ds !ectiOt ,,


HCS2012

(d} Hazard dassification.

(dXl) Chemical manufacturers and Importers shall evaluate chemicals

produced in their workplaces or Imported by them to classify the chemicals jn

accordance with ttils section. For each chemical. the chemical m anufacturer or Importer shall determine the hazard dasses. and where appropriate. the

category of each dass that apply to ttie chemical belno class lft ed . Employers are not required to chemicals unless they choose not t.o rely on the dassificatlon performed by the chemical manufacturer or importer for the chemical to satisfy this requirement.

(dX2) Chemical manufacturers, importers or employe rs chemicals shall Iden tifyand consider the of available scientificliterature and QlDfil evidence concerning the potential hazards. There js no requirement to test the chemlc:al to detennloe how to dassifvItshazards. Appendix AJl!

§1910.1200 shall be cxinsulted for classification o f health hazards, and Appendix B to§1910.1200 shall be consulted for the dassificatjon of physjgl

Cdl{3l Mjxtures .

MlQllll Chemlcal manufacturers, importers, or employers evaluating chemicals

shall follow the procedures described In Appendices A and B to §1910.1200 to the hazards of the chemicals. includ ing determlnatjons regarding when

rotxtvres ofthe dassifled c:hemlca l s are covered by this section .

{d}{3){ii) When classifying mixtures they produce or Import. chemica l manufacturers and Importers of miXtures may rely on the Information providedon the current safety data sheetsof tbe Individual lngredlents exceot where ttJe

chemica l manufacturer or importer knows. or in the exercise of reasona ble

dlllgence should know, that the safety data sheet misstates o r omit;; Information required by this sect.ion.


(d)(S)(liij If o mbrtare has110t b«:11 tested es e .. t.ole to dete.iiih,e .. t.cthe1 the n,ixta,e 1, e ph7sicel hezerd, the chcmicel n.e11 11Fectt1,c,, b11po,te,, o,

• •


i)}Ut:-oy-i)lUt: \...,UlllJJi:1.l'l:SUll .cxi:suug H\..,.:) 1 ::1::t"t v:s. Ilv.:> ..:.v1..:.

Under this revised paragraph; chemical manufacturers and importers must provide a label that indudes: the product Identifier, supplier information whichIs to Include name, address and phone number of manufacturer, importer or distributor; and the signal word, pictogram, and hazard statement for each hazard class and category. Precautionary statements must also be provided. The HCS 1994 does not require the use of plctograms,Sl)edflc signal words, or precautionary

statements.


HCS1994

(f) Labelsand otherformsof waming.

(f)(l)The chemical manufacturer, importer, or distributor shall ensure that each container of hazardous chemicals leaving the wof1<place is la beled, tagged or marked with tt,e follo..1119 i 11fo1111etto11.

( f)(l )(i) lde11tit, of the ltem,dous die111icel(s), (f)(l Xii),tq)p10pdetx: ltem,d .. emings, end

(f)(l Xiii) Name end address of the chemical manufacturer, Importer, or other responsible party.

(f)ti!)(i) For solid=tal (such asa steel beam or a metal casting), solld wood, or plastic items that are not exempted as articles due to their downstream use, or shipments of whole grain, the required label may be transmitted to the customer at the time of the initial shipment, and need not be included with subsequent shipments to the same employer unless the Information on the labelchanges;

( ii) The label may be transmitted with the initial shipment itself, or with the tTlllteriekafety data sheet that Is to be provided prior to or at the time of the first shipment; and,

(f)ti!)(iii) This excepiton to requiring labels on every container or hazardous chemicals is only for the solid material itself, and does not apply to hazardous chemicals usedIn conJunctlonwith, or known to be present with, the material and to which employees handling the items in transit may be exposed (for example, cutting fluids or pesticides In grains.)

·.

(flt3:) Chemical manufacture11>,Impo rters, or distributors shall ensure that each container of hazardous chemicals leaving the workplace ls labeled, tagged, or marked In accordance with this section In a manner which does not conflict with the requirements of the Hazardous Materials Transportation Act (49 U.S.C. 1801et seq.) and regulations Issued under that Actby the Department of Transportation.

,,i!h

ff)(4} If the h!ltl! r dou, cl'te111ICt!I ls ieatileted b, OSI IA In 11 ;,t1i,,tenee ,pedf ic heelth 3tepdp1d, tt:,e ch!!f]1icel 111e11gfeetu,e,. iqmortt,, dl3ttibgtoi 21 C\IIP1o1e1 moll c11,u1e thnt t!Jc lobe!, o, other fQijje of ooP•og v,ed ere in oeco1da11ce

the , eottla:,nenb of thet !l:tli,derd.

(f)fflExcept as provided in paragraphs (1')(6}and (f)fflofthis section, the employer shall ensure that each container of hazardous chemicals in the workpal ce is labeled, tagged or marked with the follo1ri11g i11fo1111etion.

(f)(5-)(I) Identity of the heze1dot1, ehcmlet!I(,) eontei11ed t!mein, eJtd,

(f)(5-)(ii) Apptop tie te l'lem,d ne111i11g,, o, elte1ueth el1, words, pictures, symbols, or combination thereof, which provide at least general Information regardlng the hazards of the chemicals, and which,In conjunction with the other Information immediately available to employees under the hazard commuincationprogram, wiO provide employees with the speciRc lnformatJon regarding the physical and health hazards of the haiardous chemical.

(1)(6) The employer may use signs, placards, process sheets, batcll tickets, operating procedures, or other such written materiais In lieu of affocing labels to individual stationary process containe11>, as long asthe alternative method Identifies the containers to which It is applicable and conveys the information required by paragraph (f)fflofthis section to be on a label. The written

materials readily accessible to the employees in their work area

throughout each workshi

(f)ft}The employer ls not required to label portable containers into which hazardous chemicals are transferred from labeled containe11>, and which are Intendedonly for the immediate use of the employee who performs the transfer. For purposes of this section, drugs which are dispensed by a phannacy to a health care provider for direct administration to a patient are exempted from labeling.

( The employer shall not remove or deface existing labels onincoming containers or hazardous chemicals, unless the container is Immediately marked with tt,e required information.

(1)(9) The employer shall ensure that labels or other forms of warning are legible, InEnglish,and prominently displayed on the container, or readily available in the work area throughout each work shift. Employers having


HCS2012

(f) Labelsandotherfonns of waming.

(f)(1)1.J!bels on shipped contaJners. The chemical manufacturer, Importer, or distributor shall ensure that each container of hazardous chemicals leaving the workplace Is labeled, tagged or marked. fjazards not otherwise classified donot have to be addressed on the container. Where the chemical manufacturer

or importer ;s reaulred to label, tag or mark the following in formation shall be

(f)(1}(i) Product identifier. (f)(1Xi i \ Signal word: (f)(l}(iii\ Hazard statementCs>: (f)(l)(iv) Pictogram{sl:

(f)(l)(vl Precautionary statement/sl; and.

(f)(l)(vi) Name, address, and telephone number of the chemical manufacturer, importe,r or other responsible party.

(1)(2\ The chemical manufacturer, Importer, or distributor shall ensure that the lnfon:nation provided under paragraphs (Q(t)m through M of this section is in accordance with Appendix cto §1910.1200. for each haiard dass andassociated hazard category for the haz.ardous chemical. prominently displayed, and in EnaUsh (other languages may also beinduded if appropriate).

mmcm

(Q{3) The chemjcal manufacturer, Importer, or distributor shall ensure that the information provided under parag@phs through Civlof this section Is located together on the tag, label or mark.

(f)(4\ Solid materials

(f)ill(l) For solid metal (such as a steel beam or a metal casting), solid wood, or plastic Items that are not exempted as artides due to their downstream use, or shipments of whole grain, the requiredlabel may be transmitted to the customer at the time of the initi al shipment, and need not be lnduded with subsequent shipments to the same employer unless the Information on the label changes;

(f)ill(II) Toe label may be transmitted with the Initial shipment Itself, or with the safety data sheet thatIs to be providedprior to or at the time of the first shipment; and,

(f)ill(lii) This exception to requiring labels on every container of hazardous chemicals Is only for the solid material Itself, and does not apply to hazardous chemicals used in conjunction with, or known to be present with, the material and to which employees handling the items In transit may be exposed (for example, cutting fluids or pesticides In grains).

(f)illOlemical manufacture11>,Importers, or distributors shall ensure that each container of hazardous chemicals leaving the workplaceis labeled, tagged, or marked In accordance with this section In a manner which does not conflict with the requirements of the Hazardous Materials TransportationAct (49 U.S.C. 1801 et seq.) and regulations Issued under that Act by the Department of Transportation.

(f}(6l Workplace labeling. Except as provided in paragraphs (f)illand(f)(fil of this section, the employer shall ensure that each container of hazardous chemicals in the workplace ls labeled, tagged or markedwith

(Q(6l{I) The Jnfo,matlon specified under paragraphs comm through {y) of this

section for labels on shipped containers, o r.

(Q(6l{iil Product Identifier and words, pictUres, symbols, or combination thereof, which provide at least general informatlon regarding the haiards of the chemicals, and which, in conjunction withthe other information immediatelyavailable to employees under the hazard communication program, will provide employees with the speciflC infonnatlon regarding the physical and health hazards of the hazardous chemical.

(f)ill The employer may use signs, placards, process shee ts , batch tickets, ope.rating procedures, or other such writtenmaterials in lieu of affaxing labels to indivlduai statlonary process containers, as long as the alternative method Identifies the containers to which It is applicable and conveys the infonnation


• • •

• 1 1 • - 1 Q ,...,/")()1')


.-::,1ae-oy-.:,1ae t...ompansont XJsn ng ttc 1 "f vs. ttU:iLU 1L t'age 11 or LU


HCS1994

(g) Hl!tt!rm( safety data sheets.

(g)(l) Chemical manufacturers and importers shall obtain or develop a meteMt

safety data sheet for each hazardous chemical they produce or import. Employers shall have a meteriel safety data sheet In the workplace for each hazaroous chemical which they use.


HCS 2012

--

{g) Safety data sheets.

(g)(l) Chemical manufacturers and Importers shall obtain or develop a safety data sheet for each hazardous chemic.al they produce or import. Employers shall have a safety data sheet in the workplace for each hazardous chemical which they use.


.i.,..

{g)(2) Cech me riel safety data sheet shall be in EngllSh (although the employer may maintain copies in other languages as well), and 1ell..e.o.""1.1..t.e.i,-1 .e. t leest the follo.,ing iofo1n1etlon:

fg)(2}fl) The ideo titp U!ed 011 th e le I, end, =pt es p,,o ided fo, ii1 pe1eg1eph fl, of this seetloo on trede seo ets.

(g)(2)(1X.-.) IF the hMe1dous chemiceI is II single substence, its cl.e1oicel end

COfiiiiiOM ne11.e(s),

(g)(2)(i)(B) Jf the liMa1dou, chemica,l i a mixt0te v, ,l ld t hes bce11 tested os a


(gJ(2) The chemical manufacturer or Importer preparing thesafety data sheet shall ensure that itis In English (although the employer may maintain copies in other languages as well}, andincludes at least the following section numbersand headings. andassociated Information under each heading. in t he order listed (See Appendix D to §1910.1200;:Safety Data S!)eets. for the specific content of each section of the safety data sheetl:

(I) Section 1, Identification;

/Ill Section 2. Hazard<s) ldentlflcatlon ;


I I I


11hole to dete1111h1e its liM111d,, the chemical eod co.11111on 1111me ( s ) of the llill Section 3. Composition/Information on ingredients; i.19, ed ienc, >1hich co ntribute to the!e k11on,1 heauds, arid the co.1.11011 nen,e

(s) of the mixtu1e itself, 01, {ivl Section 4, Flrst·ald measures;


(g)t2) (i)(C) lfthe l,aa,1dous c:hen,iai l is e 111ixtu1e nhich hes not bee11te,

es e .,t,ole.

(g)(2WXC)(l) The c:hen1ical end common 11e.ne(s) of ell ii,g1ed ie11ts flhlch he,e been de rmined to be l.eelth lum11d,, eiid 1thid1con1p1ise 1% 01 g1eete, of tl1e composition, e,ccept 11,et ci',e111lcels ide11tif.ed e, ai1d11oge,e uoder

pe1ag 1aph (d) of this seetio" shell be listed if the amce11t,etlons a,e 8.1% or 91eate,, end,

(g)(2)(i)(C)(2) The ct,emical e1td C01rn11on nerne(s) of11II i1191edi e11ts flh lch hll,e bee11 deten11l11ed to be heettl. heze,ds, end which compli,e less t!.a11 1% (8.1% fo, ca1cir,oge1t!) of the mixtu,e, if the,e is e,ideuoe tl111tthe in, g edlent

(s) eottld be .eleesed from the n1b<tu.e iu cvnce11b e tions which i,ould exceed e11estebllshed os11.-. pe1111issibk e,qx,suie lii11it 01 >cCGJII Th1eshold Limit

'ie lue,'" could p,esent II heelth ii,k to e,,1plo7ees , 11,td,

(g)f2)(Q(CXJ) The che111icnl &lid con1n,on 111111.e(s) of ell i1191edle11U nhlci'l he, e bee11 dete1111i11ed to p1esc 11t11 ph7si cnl hazetd nhe11 p1esent 111 the

(g)(2)(ii) P,h7 lcal a, tel chemical cha,acte1lstics of the heza1dous ehe111lcal (such

es ,r,po1 P•CSSUIe, flesti pol11t) ,

(g)(2)(iii) 'The ph,sical heze,cb of the haai,dous chenlical, l11d udi11g the po ntiel for fi.e, explosion, en,d eectl, it, ,

(g)(2)(1, ) The l1eelt h haze,d, of the heierdous che111lcal , ioeludi11g slg11s end

5fh1pto111, ofexposu,e, e,td e111 medical oonditloos ohich 11.e ge11e1ell,

.eo:,g11b:ed 11, bei11g egg1 11,11ted br exposdre to the chemical ,

(9)(2)(,) The p,ime,, ,oute(s) of cob r,

(g)(2)(,i) The 051IA permissible expostlre limit; ACGII I Th,esheld limit Vt!luc, e nd eo, 0t!,e1 exposu,e limit used 01 1ecommended b7 tl1e d'lemfclll rne11dfecto1e1, importe,, 01 e11,plo,e, p.epe,h19 the m11te.iaf se fet) dete sheet;

"he.e e,eileble,

tg)(2)(,ii) Whethe1 tl'Je het111dous ehe111ical Is listed In the !4etlonel Toxlco l09', P,og,em (NTP) Al111uel Repo1t on Ce1d11oge,e (ieteJt edltio11) o, hes " feund te be II potential ce,einegen 111 tlle lnternetionel Agenc:-, for Reseerd'l on

Ceiice, ( Cl r100091eph, (lete.st editions), 01 bt 051 IA,

(9)(2)(, iii) .-.11, ge11e1!11l1 applleable p,eaibtions fo. we ha r.dllog end use w hich e.e kl.ow.11 to the d ,enilcal 111e11ufectu1e1, i111porter or e111p10,er

p reperir,g tt,e rneteiiel sefer, dete sheet, induding epp,opilete h1gienlc

p1aetlces, p1oteeti,e n sd1esddring iepeh e,td meh1te11enoe of c:o11te n!l"eted equip111e11t, a11d prooedu1es fo, eleen tip of splfls e11d lee ks,

(g)(2)fbc) .-.Nf ge11crall7 epplicable cu11t1ol n1eesu1es nh ich e,e kl,0.,11 to the chemical 11m11ufeetu1e1, irnpo1te 1 01 emplo,er p1epe.i 11g the 111ete liel sefetr

detl l s heet; sud , es epp,oplie e11gh,ee.iog coobols, wo rk p1act iees , 01 pe1sonel p1otecti, e eq ulpme,11t

(g)(2)(x) Eme19CiiC'f end first eld p,ooedures,

: (9)(2)(xi) The dete of p1e pe1etion of ti1e 11etc,iel sefet 7 date sheet 01 the lest d 1e11ge to it, end,

e!IS a11d

(9)(2)(.,il) The neme, edd, telephone 11dmbe1 of the chemical


{v) Section s. Fire-fighting measures ;

{vi}Section 6. Accidental release measures ;

{viii Section Z, Hand ling and storage ;

{yiii} Section a. Exoosure con tro l s/ pe rsonal protection :

/Ix} Section 9. Physical and chemical properties :

<x) Section 10.Stability and rea ctMtv: (xll Section 11. Toxic:ologlcal Information.

(xii} Section 12, Ecological information:

lxililSection 13, Disoosal considerations :

lxly) section 14, T ra nsport Information ;

{xv} Sect:100 1s. Regulatorv 1nformatlon; and

{xv i } Section 16, Other Information, including dateof preparation or las t

Note 1 to paragraph (g}(2l; To be consistent with the GHS. an sos must a lso Include the headings In paragraphs (gl(2}Cxij} lflrouoh{g}/2}XYJ In order ,

1s.

Note 2 to paraaraph /ql<2}; OSHA will not be enforcing information requirements in sections 12 through as these areas are n ot 11nder its

Jllrisdiction .

(g)(3) If no relevant information Is found for any sub-heading wlthin a section on the safety data sheet, the chemical manufacturer, Importer or employer preparing the safety data sheet shall marlc it to indicate that no applicable information was found.

(g)(4) Where complex mixtures have similar hazards and contents (i.e. the chemical ingredients are essent ially the same, but the specific composition varies from mixture to mixture), the chemical manufacturer, importer or employer may prepare one safety data sheet to apply tD all of these similar mixtures,

(g)(S) The chemical manufacturer, importer or employer preparing the safety data sheet shall ensure that the Information l1!9Y!ded accurately reflects the scientific evldence used In making the hazard classlfiC;'!tion. If the chemical manufacturer, importer or employer preparing the safety data sheet becomes newly aware of any significant information regarding the hazards of a chemical, or w s to protect against the hazards, this new information shall be added to the safety data sheet within three months. If the chemical is not currently being produced or imported the chemical manufacturer or importer shall add the Information to the safety data sheet before the chemical is introduced into the workplace again.

(g)(6)(i) Chemical manufacturers or importers shall ensure that distributors and employers are provided an appropriate safety data sheet with their Initial shipment, and with the first shipment after a safety data sheet Is updated;


• • ..


n 1 -r l"'f\ 1f"\


Mae-oy-;)1ae compansont XIst mg ttc::s 1 N vs. ttc ::s L UL l rage u or LU


,,---



maintaining paper copies of the ffll!teriel-safety data sheets are permitted as long as no barriers to immediate employee access in each workplace are created by such options.)

(g)(9) Where employees must travel between workplaces during a workshift, I.e., their work is carried out at more than one geographical location, the meteriaf safety data sheets may be kept at the primary workplace facility. In this situation, the employer shall ensure that employees can immediately obtain the required Information In an emergency.

(g)(lO) Mllteriel safety data sheets may be keptin any form, induding operating procedures, and may be designed to cover groups of hazardous chemicalS In a work area where it may be more appropriate to address the

hazards of a process rather than indMdual hazardous chemicals. However, the employer shall ensure that In all cases the required Information ls provided for each hazardous chemical, andIs readily accessible during each work shl to

employees when they are in In-their work area(s).

(g)(11) Meteriel safety data sheets shall also be made readily available, upon request, to designated representatives encl-to the Assistant Secretary, in accordance with the requirements of 29 CFR 1910.1020(e). Bil e c!lc, ! hell ebo be 9i,e11ecce!! to meteriel sefet, det:8 sheets i11the serne111a1111e,.

Training and I nfonnlltl on .

The provisions in paragraph (h) indicate that the new label, safety data sheet formats and presentation of information must be discussed In training. All employers will be required to conduct additional training to ensure that their employees are familiar with the new standardized labels and safety data sheets. Otherwise, the training provisions remain the same as the HCS 1994.


HCS1994

(h) Employee lnfofT11ildon andtraining.

(h)(l) Employers shall provide employees with effectlve inrormation and trainingon hazardous chemicals In their work area at the time of their Initial assignment, andwhenever a nen ph,sical 01 heel tll hez!l1 d the employees have not previously been trained abo\Jt Is introduced Into their work area.

Inf-ormation and trainingmay be designed to cover categories of hazards (e.g., flammability, carcinogenicity) or specific chemicals. Chemical-specific information must always be available through labels and meteriei safety data

sheets.

(h)(2) Information. Employees shall be lnrormed or: (h)(2XI) The requirements of this section;

(h)(2)(ii) Any operations in their work area where hazardous chemicals are present; and,

(h)(2)(iil) The location and availability of the written hazard communication program, Including the required llst(s) of hazardous chemicals, and material safety data sheets required by this section.

(h)(3) Training. Employee training shall include at least:

(h)(3Xi) Methods and observations that may be used to detect the presence or release of a hazardous chemical In the work area (such as monitoring conducted by the employer, continuous monitoring devices, visual appearance or odor of hazardous chemicals when being released, etc . );

(h){3)(11) The physical and-health h!mlrd5 of the chemicals in the work area;

(h)(3)(ili) The measures employees can take to protect themselves from these hazards, Including specific procedures the employer has implemented to protect employees from exposureto hazardous chemicals, such as appropriate work practices, emergency procedures, andpersonal protective equipment to be used; and,

(h)(3)(iv) The details of the hazard communication program developed by the employer, including an explanatiOn of the labeling system end the rntl'tffllll safety data sheet, and how employees can obtainanduse the appropriate hazard information.


HCS2012

(h) Employee lnfofT11ilticn andtraining .

(h)(l) Employers shall provide employeeswith erfectlve lnf-ormation and training onhazardous chemicals In their work area at the time of their Initial assignment, andwhenevera new chemical hazard the employees have not previously been trained about IsIntroduced into their work area. lnformatlon and training may be designed to cover categories of hazards (e.g., flammablllty, carcinogenicity) or spedf;c chemicals. Chemical-specific information must always be available through labels and safety data sheets.

(h)(2) Information. Employees shall be informed of: (h)(2)(i) The requirements of this section;

(h)(2)(ii)Any operations in their work area where hazardous chemicals are present; and,

(h)(2)(iii) The location and availability of the written hazard communication program, induding the required llst(s) of hazardous chemicals, and safety data sheets required bv this section.

(h)(3) Training. Employee training shall includeat ieast:

(h)(J)(I) Methods and observations that may be used to detect the presence or release of a haiardous chemical In the work area (such as monl!Drlng conducted by the employer, continuous monitoring devices, visual appearance or odor of hazardous chemicals when being released, etc . );

(h)(3)(1i) The physical,health. simple asphyxiation, combustible dust andoyrophoric gas hazards, as well ashazards not otherwise dassified , of the chemicals in the work area;

(hX3Xlii) The measures employees can take to protect themselves from these hazards, includlng specific procedures the employer has implemented to protect employees from exposure to hazardous chemicals, sud!asappropriate work practices, emergency procedures, and personal protective equipment to be used; and,

(h){3)(iv) The details of the hazard communication program developed by the employer, Including an explanation of the labels received on shipped containers and the workolace labeling systemused by their emotover; the safety data sheet. including the order of information and how employe5 can obtain and use the appropriate hazard Information.


T r a de seCTY!ts.

Toe trade secret provisions or the GHSare consistent with the HCS 199'1 and therefore only a few changes were made to this section. TI,e GHS, unlike the current HCS, requires disclosure of the percentage compoSltion of mixtures on the SOS. This final rule adopts this requirement, but allows the manufacturer to claim trade secret protection for this requirement. ThJs Is the only substantive change to the existing standard's irade secret protections.


HCS 1994 HCS2012

S1de-by-S1de Comparison ..Existing HCS 1994 vs. HCS 2012 Page 15 of20


,,.--


services of the health professional (I.e. downstream employer, labor organization, or individual employee), employee, or designated representative, agree In a written confidentiality agreement that the health professional, employee, or designated representative, will not use the trade seaet Information for any purpose other than the health need(s) asserted and agree not to release the information under any circumstances other than to OSHA, as provided Inparagraph (i)(6) of this section, except as authorized by the terms of the agreement or by the chemieal manufacturer, lmp<>rter, or employer.

(1)(4) The confidentialityagreement authorized by paragraph (i)(3)(iv) of this section:


mainta in the confidentiality of the disclosed Information;and,

(l)(3)(iil)(v) The health professional, and the employer or contractor of the services of the health professional (i.e. downstream employer, labor organization, or individual employee), employee, or designated representative, agree in a written confidentiality agreement that the health professional, employee, or designated representative, will not use the trade secret Information for any purpose other than the health need(s) asserted and a9ree not to release the Information under any circumstances othe r than to OSHA, as

provided in paragraph ( i)(6) of this section, except asauthorized by the terms

of the agreement or by the chemical manufacturer, importe,ror employer.


(1)(4){i) May restrict the use of the infonnationto the health purposes indicated (1)( 4) The confidentilaity agreement authorized by paragraph (i)(3)( iv) of this in the written statement of need; section:

(I){4){fi) May provide for appropriate legal remedies in the event of a breach of (i){4)(i) May restrict the use of the information to the health purposes Indicated

the agreement, Including stipulation of a reasonable pre-estimate of likely in the written statement of need; damages; and,


0)(4)01i) May notlnduderequirements for the posting of a penalty bond.

(i)(S) Nothing in this standard is meant to preclude the parties from pu ing non-contractual remediesto the extent permitted by law.

(1)(6) If the health professi onal, employee, or designatedrepresentative receiving the trade secret informationdecides that there Is a need to disclose lt to OSHA, the chemicalmanufacturer, importer, or employer who provided the Information shall be Informedby the health professional, employee, or designated representative prior to, or at the same time as, suchdisclosure.

(1)(7) If the chemical manufacturer, importer, or employer denies a written request for disclosure of a specific chemical identity, the denial must:

(1)( 7)(1) Be provided to the health professiona,l employee, or designated representative, within thirty days of the request;

(i)(7)(U)Be In writing;

(1)(7)(iii)Include evidence to support the daim that the specific chemical Identityls a trade secret;

(IX7)(iv) State the specific reasons why the request is being denied;and,

,e,,

(i)(7)(v) Eleplain in detail how alternative Information may satiSfy the specific medical or occupational health need without revealing the ,pedf\c cl lice! Identity.

(1)(8) The health professional, employee, or designated representative whose request for information is denied under paragraph (1)(3) of this section may refer the request and the written denial of the request to OSHA fo r consideration.

{IX9) When a health professional, employee, or designated representative refers the denial to OSHA under paragraph (1)(8) of this section, OSHA shall conskler the evidence to determine If:

(I)(9)(i} The chemical manufacture,r Importer, or employer has supported the claim that the specific chemical i dentity is a trade secret;

{1)(9)(11) The health professional, employee, or designatedrepresentativehas supported the daim that there is a medical or occupational health need for the lnformatioo; and,

(I)(9)(iil) The health professional, employee or designated representativehas demonstrated adequate means to protect the confldentiality.

(i)(lO)(i) If OSHA determines that the specific chemicalIdentity requested under paragraph

(1)(3) ol this section is not a "bona fide" trade secr et, or that it isa trade secret, but the requesting health professional, employee, or designated representative has a legitimate medical or OCC\Jpatlonal health need for the

-

information, has executed a written confidentlaitly agreement and has shown adequate means to protect the confidentialityof the information, the chemical manufacture,r Importe,r or employer will be subject to citation by OSHA.

(1)(10)(11) If a chemical manufacture,r importer, or employer demonstrates to OSHA that the execution of a confidentiality agreement would not provide sufficient protection against the potential harm from the unauthorized disclosure of a trade secre, t pedfic ehenlieel ide11tit1, the .Asslstant secretary may issue such orders or impose such additional limitations or conditions upon the disclosure of the requested chemical information as may be appropriate to assure that the oa:upational health services are provided without an undue risk


(1)(4)(11) May provide for appropriate legal remediesin the event of a breach of the agreement, including stipulation of a reasonable pre-estimate of likely damages; and,

(i)( 4)(iii) May not include requirements for the posting of a penalty bond.

(1)(5) Nothing in this standard ismeant to preclude the parties from pursuing non-contractual remedies to the extent permitted by law.

(1)(6) If the health professional, employee, or designated representative receiving the trade secret information decides that there ls a need to disdose it to OSHA, the chemical manufacturer, Importer, or employer who provided the information shall be informed by the health professional, employee, or designated representativeprior to, or at the same time as, such disclosure.

(1)(7) If the chemical manufacturer, Importer, or employer denies a written request for disclosure of a specific chemcial ldentitv or percentage composition, the denial must:

(1)(7)(1) Be provided to the health professlonal, employee, or designated representative,within thirty days of the request;

(1)(7){1i) Be In writing;

(i)(7)(1i1) lndude evidence to support the dalm that the specific chemical Identity or percent of comoosltlonls a trade secret;

(1)(7)(1v) State the specific reasons why the request is beingdenied; and,

(1)(7){v) Explain In detail how alternative information may satisfy the specific medical or occupational health need wi thout revealing the trade secret.

(i)(8) The health professional, employee, o, designated representative whose request for information is denied under paragraph (i)(3) of this section may refer the request and the written denial of the request to OSHA for consideration.

(i)(9) When a health professiona,l employee, or designated representative refers the denial to OSHA under paragraph (1)(8) of thissection, OSHA shall consider the evidence to determineif:

(1)(9)(1) The chemical manufacture,r Importer, or employer has supported the dalm that the specific chemical identity or pe<centage composition ls a trade secret;

{1){9)(ii) The health profe.ssional, employee, or designatedrepresentativehas supported the daim that there is a medical or occupational health need for the lnfomiation; and,

(i)(9Xiil) The health professional, employee or designated representative has demonstrated adequate means to protect the confidentiality.

(I)(lO)(i) If OSHA de terminesthat the specific chemical l dentitv or percentage composition requested under paragraph (i)(3) of this section is not a "bona fide" trade secret. or that it is a trade secret but the requesting health professional, employee, or designated representativehas a legitimate medci al or occupational health need for the infonN tion, has executed a written confidentialityagreement, and has shown adequate means to protect the confidentialityof the information, the chemical manufacturer, importer, or employerwlll be subject to citation byOSHA.

(i){lO)(ii ) If a chemical manufacturer, Importer, or employe; demonstrates to OSHA that the execution of a confidentiality agreement would not provide sufficient protection against the potential harm from the unauthorized disclosure of a trade seaet, the Assistant Secretary may issue such orders or

I


:S1cte-b y-:S1deComparisonHxi stmg HC:S 1994 vs. HC:S :w 12 .Page 1 7 ot 20


Physic.al hazards (o ){2)i(ll)

'1 · Health hazards (g Xl )(lv)

).


2. Hazard ( s} I d entificatio n

(a) Classificationof the chemical In accordance wittl paragraph (d) of •

§1910.1200;


(b) Signal word, hazard statement(s), symbol(s) and precautionary statement

(s) In accordance with paragraph (f) of §1910.1200. (Ha2ard symbols may be provided as graphical reproductions ln blade and white or the name of the symbol, e.g., flame, skull and crossbones);

(c) Describe any hazards not otherwise dassifled that have been Identified

during the classificationprocess;

(d) Where an Ingredientwith unknown acute toxicity Is used in a mixture at a concentration 1% and the mixture is not dassifted based on testing of the mixture as a whole, a statement that X% of the mixture consists of ingredient

(s) of unknown acute toxicity is required.

Section 3 . Composition/Informationon Ingredien ts. lhls section contains no new requirements other than fonnat


HCS 1994

  • Chemical and common name of ingredients contributing to known haiards

(g){l)(l)(A), ( B )

· For untested mixtures, the chemical and common name of ingredients at 1% or more thatpresent a health hazard and those that present a physical hazard in the mixture (g X2)( 1)(C)(1), (3)

Ingredients at 0.1% or greater, if listed cardnogens{g)(2)(1)(C)(2)



HCS2012

3. Composition/Information on Ingred ients

Except asprovided for in paragraph (i) of §1910.1200 on trade secrets:

For substances

(a} Chemical name;

{b) Common name and synonyms;

(c) CAS number andother unique identifiers;

(d) Impurities and stabilizing additives which are themselves dassifled and which contribute to the classificationof the substance.

For M ixtures

In addition to the informationrequired for substances:

(a) The chemical name andconcentration (exact percentage} or concentration ranges of all Ingredients which are classified as health haiards In accordance with paragraph (d} of §1910.1200 and

(1} are present above their cut-off/concentrationlimits; or

(2) present a health rlSk below the cut-off/concentrationlimits.

(b} Toe concentration (exact percentage) shall be specified unless a trade secret claim iS made In accordance with§1910.1200(i}, when there is batch·tD­ bab:h variability in the production of a mixture, or for a group of substantially similar mixtures A.0.5.1.2) with similar chemical composition. In these cases, concentration ranges may be used.

For All Chemicals Where a Trade secret I s Claimed

Where a trade secret Is claimed In accordance with paragraph (i) of

§1910.1200, a statement that the specific chemieal identity and/or exact percentage of composition {concentration} has been withheldasa trade secret is required.


Section 4. F i rst-aid measures . lhis section contains no new requirements other than format.


HCS 1994

4. First-aid mosures

  • Emergency and first-aid procedures (g)(l)(x)

Signs and symptoms of exposure (gXl )(l v)


HCS 2012

(a} Description of necessary measures, subdMded according to the different routes of exposure, i.e., Inhalation, skin and eye comact, andIngestion;

{b) Most important symptoms/effects, acute and delayed.

(c) lndicatlon of immediatemedical attention andspecial treatment needed, if necessary.


Section s. Fire-fighting measures. ThlS section contains no new requirements other than format


HCS1994

· Physical hazards (potential for fire, explosion}(g )( l ) ( III)


HCS2012

S. Fi re- fighti ng m ea sures


• • ,I'


• • •••• :....·


S ide- by-Side Comparison Existing HCS 1994 vs. HCS 2012 Page 19 of 20

( r ) V ISCOStty.

Section 10. stabili ty a nd reactivity. Although the information on conditions to avoid and hazardous decomposition products iS new to HCS, it has been required

In the ANSI 2400.1 standard for a number of years. I '


HCS1994

  • Physical hazards (potential for fire, explosion, reactivity)(g) ( 2)( 111 )

HCS 2012

10. Stability and reactivity


• Organic peroxldes, pyrophoric, unstable(reactive), or water-reactivehazards (a) ReactMty;

(g) ( 2)( 111), definitions In (c)

(b) Chemical stability;

(c) Possibility of hazardous reactions;

(d) Conditions to avodi (e.g., static discharge, shock, or vibration);

(e) Incompatible materials;

(f) Hazardous decomposition products.

Section 11. ToxlcologicalInformation. This section contains no new requirements other than format.


HCS 1994

• Health hazards, induding signs and symptoms of exposure, and any medical conditions which are generally recogni zed as being aggravatedby exposure tu the chemical (g ){ 2)(lv)

• Primary routes of entry (g)(2)(1v)

• Whether the hazardous chemical Is listed in the National Toxicology Program (NTP) Report on carcinogens(latest edition) or has been found to be a potential carcinogen in the lntemational Agency for Research on Cancer (IARC)

Monographs (latest edltlons), or by OSHA (g )(2) ( Yi)


HCS 2012

11. Toxicological Information

Descriptionof the various toxicological (health) effects and the available data

used ro identify those effects, indudlng:

{a) In formation on the likely routes of exposure (Inhala tion, ingestion, skin and eye contact);

(b) Symptoms related to the physical, chemical and toxicological

characteristics;

(c) Delayed and immediate effects and also chronic effects from short- and long-term exposure;

(d) Numerical measures of toxicity (such asacute toxidty estimates).

(e) Whether the hazardous chemical is listed In the NationalToxlco!ogy Program (NTP) Report on carcinogens (latest edltlon) or has been found to be a potential carcinogen in the International AgeOCf for Research on cancer (IARC) Monographs (latest editions), or by OSHA.


Section 12. Ecological information(Noo-mandarory. )To be GHS-compliant the requirements for this section are provided.


HCS1994

• No present requirements


HCS 2012

12. Ecological Information (Non-mandatory)

(a) Ecoroxldty (aquatic and terrestrial, where available);

(b) Persistenceand degradablllty;

(c) 8loaccumulativepotential;

(d) Mobility in soil;


section 13 . Disposal considerations(Non-mandatory). To be GHS-compliant the requirements for this section are provided, but OSHA w111not enforce. However, OSHA may enforce provisions associated with safe handling and use, indud lng appropriate hyglenlc practices. See Section 7 above.


HCS1994

• See Section 7

Section 14. Transport Information (Non-mandatory). To be GHS-compliant the requirements for this section are provided, but OSHA will not enforce.

No present requirements

HCS 1994


HCS2012

13. DiSposaJ considerations(Non-mandatory)

Descrlptlon of waste residues and information on their safe handling and methods of disposal, Including the disposal of any contaminatedpackaging.

HCS2012

  • No present requirements 14. Transport information {Non-mandatory)

• I • •


(a) UN number;

• •

•- .. --.·r­


} \


Exposure to Hazardous Chemicals

in Laboratories

U.S. Depar1men1 or Labor Elizabelll Dole, Secretary

Occur,a1ional S.:ilety aml Healtll Administration Gerard F. Sc.:innoll, Assistant Secre1ary

1989

OSHA 3119

MaIerial conlained in thi s publ ication is in the public domain and may be reproduced, full y or panially, without

:,errnissionof the Federal Government Sourc e credit is requestedbut

not required.

T!1c inform ation contained in this publication is not considered a substitute for any provisionsor the standard.

(:I

( )


B ac kground

Laboratory workers .:ire rouIi 11c ly cxposccl to ll,12.iruous chemicals such .:is acetone, carb on monoxide, fo1111;1ldohyde, l1yclrogen sulfide, mercury, nrtric nc,d and xylene. Many accidonl s .ind injuries occur annuolly in lat,n r. 1Io ries. resulting in cll emical-re falocl illnesses ranging frorn skin and eye irritation to l..llal pulmonary edcnin.

Traditionally, OSHA's npproach to contr olli n g occurational exposures to l1.:izarcfo 11s chemicals ll as be en l11rougl1 Ill e development of subsIr1nce -specific s tandards (e {I. ber)Z0ne) . Where sul>slance-specific standards do nol exist, comph;111ce willl OSHA permissil>lc exposure l1111i1s (PELs), in the Z Tables of Tille 2!>, Coc/c of Fee/oral Regulations (CFR),

19 1o. 1000 is r equired.

OSHA has lo11nd th;,I JI11s npp r o acl1 works well in an inclustrial so1tIng wl1cr e workf!fS may receive exposure s over prolonged peri ocls to lc1rge quantilics of sever:1I I I.-irn rd ou s cll e111ica l s . I n l;.11)01;.i1orics. llw u s e or sucll cl1e111icals ,s generally limiled 10 small q11anIiIies. on a sllo11-1crm basis, in

operation s where clw111ic;1ls ;:incl pr oced ures clwnge lrcquonll y. Conscq11er11ly, l;1horc1Imy workers ,ire cxpo sccJ 10 many dill crcn 1 cllemic:-ils hut ucnernlly 10 !i111allcr quanlilics

fo r shorter periocls o f 11111e Il1c111 workers in general Inclus1ry. Accordingly, OSIIA ,ecoonizcs 1110 need for a rogulc1tio11 lll at focu ses on II1c unique I1aIure of lohornto ry work c1ncl IJelieves tliat its new sIanclc1,cl for lc1horn 1nries acfchosses l11is n eed.

The s1andc1rd omphasiLCS Ille use of v,ork practices ancl ellec1i•1cworker pro1e cIion appropriate to tile unique nc1Iurc or tile labora0I 1y. This pelforrnancc-orienl cd rule Is inlonclcd 10 provide employers willl til e llcx11Jilily ol impl emcnling s.:ifc work prac1iccs and procedures specific 10 1I,eir workplace wllile al 1110 sa111c li rne 1cac11ino1I,e importa,11 goa l or

reduci r)g worker inju,ies ;:incl lnesses. Tl111s, wilh Il1is

stan,d.ird, OSHA t1i111s 10 rt:tluce siunific.int 11sl-. 10 employees in a rnanner tllat is cost-elleclive lor approx,matcly 934,000 exposed c111ployecs in some 3-1,2 f 4 l;1boraIori e s inclucf1110 incJus1rial, clinrc .:1I<1nd scll ool l,1ll oratorics


) ) )


The location ancl availability ol the employer's Chemical Hygiene Plan.

Permissible exposure limits lor regulated substances and recommended exposure limits for other hazardous chemicals where no OSHA standard applies.

• Signs and symptoms c1ssociated with exposures to hazardous chemicals.

• Location and availability or known reference materials, including Material Safety Data Sheets (MSDSs) on tile

hazards, sale handling, storage, and disposal or hazardous chemicals in the workplace.

Training . The employee training plan must consist of the following elements:

• The components of the Chemical Hygiene Plan and how it is implemented in the workplace.

• The hazards of the chemicals in the work area and the protective measures employees can take.

• Specific procedures put into eflect by the employer to provide protection. including engineering controls, work practices, personal protective equipment.

• Methods and observations--e.g., continuous monitoring procedures, visual appearance or

smell--that workers can use to detect the presence of hazardous chemicals.

Medical Examina tions and Consulta tion

The laboratory standard does not mandate medical surveillance lor all laboratory workers. There are, however, certain circumstances where employers must provide any employee who works with llaz'ardous cl1emicals an opportunity lor medical attention.

Specifically, medical a11en1ion, including any lollow-up examination and treatment recommended by the examining physician, must be ottered 10 the lollowing:

• Any employee who exhibits signs or experiences symptoms associated with exposure to a hazardous chemical used in the laboratory.

• 4


• Any employee wl10 is exposecl routinely al)ove the action level or, in ll1e absence or an action level,

;-ibovc the PEL lor an OSHA reoulaled substance for wllicll t11ere are exposure monitoring or medical surveillance requirements.

A medical consultation conducted 10 cln termine til e need for a me(licnl examination must be ollerccl to any· employee who is present in the work area when a spill, leak. explosion or other accident occurs 111a1 results in a po tential significant exposure 10 a tiazardous cl1emical.

The employer is required 10 give the physician specilic inlormation on the identity of til e 11azardous cl1emicai, concJ,tions under which tile exposure occurred. and a description or 111e signs c1ncl symptoms experienced by the worker. The employer also must obtain lrom the physician an , wri1ten opinion lor a recornrnenclecl follo w-up examination, medicc1I exam ;ind tlie cJltendant tnsl results: any dc1ec1cd medical c.ond 11ion s ol lhe employee thnt rnigl11 pose

increased risk; an<l a slcltement that the employee was informed ol tile medical examination/consultation results.

Methods of Control and Personal Protective Equipment

As part or t11e Chcrnjcal Hygiene Plan, employers must clevelop criteria for c.JC?tcrminino antJ implc,ncnting control measures 10 reduce employee exposure to hazardous cl1erniccJIS in th e laborato ry. TracJitfonnlly, t11ese rnec1sures have included en0ineering controls, work prac1ice controls, ancJ personal protective equipment. E119ineering co ntrols include general ventilation, fum e hoo cls , glove boxes, and other exhaust systems. Work practice r.ontrols may cover

items such as restricting eating and d1inking areas, ,,

prollilJiting moutll pipelting, and perlorming work in such a

manner as to minimize exposures to h azardous cl1emicals ancl lo maximize the eHectivcness of tile engineering controls.

OSHA policy cltctatcs !11:11 engineering anti work practices controls be 11snd 10 reduce emr,loyce nxposure below the PEL. Rc:spiratory protection is to !Jc used only as an interim me;,surc or when en0ineenng or work practice controls ;ire infe asible. Use 01 respiratory equipment rn11s1 comply wil11

5


.,..

'


) l ).



and local government) sectors. Two stales. Connecticut and New York, cover the public sector only.

States administering their own OSHA-approved occupc1tional safety and hGalth plans must adopt standards identical to; or

• at least as effective as, the Federal standards. Until a Stale

standard is promulgated, OSHA will provide interim

enforcement assistance, as appropriate. in these States.


Related OSHA Publication s

A single free copy of the following materi;il s may be obtained from OSHA liclct offices or the OSHA Publications Office, 200 Constitulion Avenue, N.W., Room N3101. Washington, O.C.

20210, (202) 523-!J667. Please send a self-addressed label

with tl1c request.

Air Contaminanls--Permissible Exposure

Limits · OSHA 3 1 1 2

All Abou t OSHA · OSHA 2056

Chemical Hazard Communic ation . OSHA 3084

Haznrd Communicalion--A Compliance Kit - OSHA 3104

(fhis may be ordered from lf1e Superintenuent of Documents, Government Prinlin!J Olfice. Washin91on. O.C. 20402 for $18.00 ($22.50 for forci911 acldresscs). Specify OSHA Pul)lication 3104, GPO Order Number 929 -0 22 - 00000-9. Tlie kit can be ordered from GPO by phone using VISA or MasterCard: call (202) 703 -3230 .)

H az a rd Co mmunic atio n Guidelines

tor Compliance - OSHA 311 1

How to Prepare for Workplace Emergencies • OSHA 3088

Job Hazard Analysis · OSHA 3071

OSHA Computerized Information System - OSHA 3085 (Contains Glie mi cnl information Ille of sampling and analytic melf1ods analyses for more than 750 workplace chemicals)

OSHA Inspec tions - OSHA 2098


Personal Protective Equipment · OSHA 3077

• Respiratory Protection - OSHA 3079

• Training Requir emen ts in OSHA Standards and •

Training Guidelines · OSHA 2254

8 9


COPY OF REGULATIO NS

THE STANDARD FOR THE OCCUPATIONAL EXPOSURE TO HAZARDOUS CHEMICALS IN LABORATORIES

SUBSECTION 2A

OCCUPATIONAL EXPOSURE TO HAZARDO US CHEMICALS IN LABORATORIES, FINA L RULE •

Federal R eg is ter

Wed nes da y, January 31, 1990 Part II

Department of Labor

Occupational Safety and He a lth Administration

29 CFR Part 1910


' - -''


PART 1910-OCCUPATIONAL SAF ET Y AND HEALTH STANDARDS

1. The authorily cit.at.ion for part 1910, subpart Z is amended by adding lhe following citation at lhe end. (Citation which precedes aslerisk indicates general rulemaking aulhority.)

Aulhority: Secs. 6 and 8. Occupational Safety and Heallh Acl, 29 U.S.C. 655, 657; Secretary of Labor's Orders Nos. 12-71 (36 FR 8754). 8-76 (41 FR 25059), or 9-83 (FR 35736), as applicable; and 29 CFR pan 1911.

Section 1910.1450 is also issued under sec. 6(b), 8(c), and 8(g)(2), Pub. L. 91-596, 84 Stat. 1593, 1599. 1600; 29

u.s.c. 655, 657.

2. Section 1910.1450 is added lO subpart Z, part 1910 lO read as follows:

191.1450 Occupational exp osu r es to hazardous chemicals in la bora tor ies.

(a) Scope and application. (I) This section shall apply lo all employers engaged in lhe laboratory use of

hazardous chemicals as defined below.

(2) Where lhis section applies, it shall supersede, for laboraLOries, lhe requiremenlS of all olher OSHA health standarGS in 29 CFR part 1910, subpart. Z, except as follows:

(i) For any OSHA hcallh standard, only the requirement to limit employee exposure lo Lhe specific pennissible exposure limil shall apply for laboraLOries, unless that part.icular standard stat.es olherwise or unless the conditions of

paragraph (a)(2)(iii) of lhis section apply.

(ii) Prohibition of eye and skin cont.act where specified by any OSHA health standard shall be observed..

(iii) Where the action level (or in lhe absence of an action level, the permissible exposure limit) is routinely exceeded for an OSHA regulated substance with exposure monitoring and medical surveillance requiremenL , paragraphs (d) and (g)(l)(ii) of Lh.is section shall apply.

(3) This section shall not apply to:

(i) Uses of hazardous chemicals which do not meet lhe definition of laboratory use, and in such cases, lhe employer shall comply with the relevant standard in 29 CFR part 1910, subpart Z even if such use occurs in a

laboratory.


• • - •r

"Flashpoin1" means the minimum temperature at which a liquid gives off a vapor in sufficienl concentration to ignite when tested as follows:

(i) Tagliabue Closed Tester (See American National Standard Mel.hod of Test for Flash Point by Tag Closed

Tester, Zl 1.24-1979 (ASTM D 56-79)-for liquids which a viscosity of less than 45 Saybolt Universal Seconds (SUS) al l00°F (37.8°C), that do not comain suspended solids and do not have a tendency to form a surface film under teSt; or

(ii) Pensky-Martens Closed Tester (see American National Standard Method of Test for Flash Point by Pensky­

Manens Closed Tester, Z l1.7-1979 (ASTM D 93-79))-for liquids with a viscosity equal lo or greater than 45 SUS al IOO"F (37.8°C), or that contain suspended solids, or that have a tendency tO form a surface film under teSt.; or

(ili) Setaflash Closed Tester (see American National Standard Method of Test for Flash Point by Seta.flash Closed Tester (ASTM D 3278-78)].

Organic peroxides, which undergo autoaccelerating thermal decomposition. are excluded from any of the flashpoint

determination methods specified above.

"Hazardous chemical" means a chemical for which there is statistically significant evidence based on al least one study conducted in accordance with established scientific principals that acute or chronic health effects may occur in exposed employees. The term "health hazard" includes chemicals which are carcinogens. toxic or highly toxic agents, reproductive toxins, irritants, corrosives, sensitizers, hepalotoxins, nephrotoxins, neurot0xins. agents which act on the hematopoietic systems. and agents which damage the lungs. skin eyes, or mucous membranes.

Appendices A and B of the Hazard Communication SU1I1dard (29 CFR 1910.1200) provide further guidance in

defining the scope of health hazards and determining whethe r or not a chemical is to be considered hazardous for

purposes of th.is standard.

"Laborcuory" means a facility where the "laboratory use of hazardous chemicals" occurs. It is a workplace where

relatively small quantities of hazardous chemicals are used on a non-production basis.

"Laboratory scale" means work with substances in which the containers used for reactions, transfers, and other handling of substances are designed to be easily and safely manipulated by one person. "Laboratory scale" excludes those workplaces whose function is to produce commercial quanti ties of materials.

"Laboratory-type hood" means a device located in a laboratory, enclosure on five sides with a moveable sash or fixed partial enclosed on the remaining side; constructed and m<tini.ained to draw air from the laboratory; and allows chemical manipulations lo be conducted in the enclosure without insertion of any portion of the employee's body

o!her than hands and arms. ,

Walk-in hoods with adjustable sashes meet the above definition provided that the sashes are adjusted during use so that the airflow and the exhaust of air contaminants are not compromised and employees do not work inside the enclosure during the release of airborne hazardous chemicals.

"Laboraiory use of hazardous chemicals" means handling or use of such chemicals in which all of the following

conditions are met

(i) Chemical manipulations are carried out on a "laboratory scale;"

(ii) Multiple chemical procedures or chemicals are used;

(iii) The procedures involved are not part of a production process, nor in any way simulate a production process;

(iv) "Protective laboratory practices and equipment" are available and in common use to minimize the potential for employee exposure to hazardous chemicals.

"Medical co11Sultation" means a consu ltation which takes place between an employee and a licensed physician

for the purpose of determining what medical examinations or procedures, if any, are appropriate in cases where a significant exposure to a hazardous chemical may have taken place.

"Organic peroxide" means an organic compound that contains the bivalent --0 --0 -- structure and which may be

considered to be a structural derivative of hydrogen peroxide where one or both of the hydrogen atoms has been replaced by an organic radical.

"Oxi dizer " means a chemical other than a blasting agent or explosive as defined in § 1910.109 (a). that initiates

or promotes combustion in other materials. thereby causing fire either of itself of through the release of oxygen or other gases.

"Physical hazard'' means a chemical for which there is scientifically valid evidence that it is a combustible

liquid, a compressed gas, explosive, nammable, an organic peroxide. an oxidizer, pyrophoric, unstable (reactive) or

watet-reactive.

"Protective laboratory practices and equipment" means those laboratory procedures, practices and equipment accepted by laboratory health and safety experts as effective, or that the employer can show lo be cffccl.ive, in

minimizing the potential for employee exposure to hazardous chemicals.


(vii) Designation of personnel responsible for implement.at.ion of the Chemical Hygiene Plan including the assignment of a Chemical Hygiene officer and , if appropriate, establishment of a Chemical Hygiene Committee; ard


.,.--.


(viii) Provisions for additional employee protection for work with particularly hazardous substances. 1llese include "select carcinogens," reproductive toxins and substances which have a high degree of acu1e toxicity. Specific consideration shall be given to !lie following provisions which shall be included where appropriate:

(A) Establishment of a designa1ed area;

(B) Use of containment devices such as fume hoods or glove boxes;

(C) Procedures for safe removal of contaminated waste; and

(D} Decontamination procedures.

(4) The employer shall review and e valuate !he effectiveness of the Chemical Hygiene Pl.an a1 least annually and update it as necessary.

(f) Employee information and rraining.

(1) The employer shall provide employees with infom1a1ionand training to ensure ll1a1111ey are apprised of me haz.ards of chemicals present in their work area.

(2) Such information shall be provided at the time of an employee's inilial assignment to a work area where haz.ardous chemicals are present and prior to assignments involving new exposure situations. The frequency of refresher infom1ation and training shall be determined by lhe employer.

(3) Information. Employees shall be informed of:

(i) The contents of this standard and iLS appendices which shall be made available to employees;

(ii) The location and availability of me employer's Chemical Hygiene Plan:

(iii} The permissible exposure limits for OSHA regulated substances or recommended exposure limits for omer hazardous chemicals where !here is no applicable OSHA standard;

(iv) Signs and symptoms associated with exposures to hazardous chemicals used in me laboratory: and

(v) The location and availability of known reference ma1crial on the hazards, safe handling, storage and disposal of hazardous chemicals found in the laboraiory including, but not limited to, Material Safety Data Sheets received from the chemical supplier.

(4) Training. (i) Employee training shall include:

(A) Methods and observations mat may be used to detect the presence or release of a hazardous chemical (such as monitoring conducted by the employer, continuous monitoring devices, visual appearance or odor of hazardous chemicals when being released, etc.);

(B) The physical and health hazards of chemicals in the work area; and

(C) The measures employees can take to protect themselves from these hazards, including specific procedures the employer has implemented to proiect employees from exposure to hazardous chemicals, such as appropriate work practices, emergency procedures, and personal protective equipment to be used.

(ii) The employee shall be trained on me applicable details of the employer's written Chemical Hygiene Plan.

(g) Medical consultation and medical examinarions. (I) The employer shall provide all employees who work with hazardous chemicals an opportunity to receive medical attention, including any follow-up examinations which the examining physician determines t0 be necessary, under the following circumstances:

(i) Whenever an employee develops signs of symptoms associated with a hazardous chemical to which the employee may have been exposed ,n the laboraLOry, the employee shall be provided an opportunity to receive an appropriate medical examination.

(ii) Where exposure monitoring reveals an exposure level routinely above the action level (or in the absence of an action level, the PEL) for an OSHA regulated substance for which !here arc exposure monitoring and medical surveillance requirements, medical surveillance shall be established for the affecled employee as prescribed by the particular standard.

(iii) Whenever an event takes place in the work area such as a spill, leak, explosion or other occurrence resulting in the Ukelihood of a hazardous exposure, the affected employee shall be provided an opportunity for a medical consultation. Such consultation shall be the purpose of determining the need for a medical cxaminalion.

(2) All medical examinations and consultations shall be perfom1ed by or under the direct supervision of a licensed physician and shall be provided without cost 10 the employee, withou t loss of pay and at a reasonable lime and place.

(3) Infonnat.io n provided to the physician. The employer shall provide the following info nnation to the physician:

(i) The identity of the hazardous che mic al(s) 10 which me employee may have been exposed;

(ii) A description of !he conditions under w11ich the exposure occurred including quantitative exposure data, if available; and

(iii} A description of the signs and symptoms of e xposure that the employee is experiencing, if any.


• •


8. Responsibilities

1. Chief Executive officer

2. Supervisor or Administrative Unit

3. Chemical Hygiene officer

4. Laboratory Supervisor

5. Project Direcwr

6. Laboratory Worker

C. The Laboratory Faciliry

1. Design

2. Maintenance

3. Usage

4. Ventilation

D. Components of the Chemical Hygiene Plan

1. Basic Rules and Procedures

2. Chemical Procurement. Dislribution. and Storage

3. Environmental Monitoring

4. Housekeeping, Maintenance and Inspections

5. Medical Program

6. PersonaJ Protective Apparel and equipment

7. Records

8. Signs and Labels

9. Spills and Accidents

10. Training and Information

11. Waste Disposal

E. General Procedures for Working With Chemicals

1. GeneraJ Rules for all Laboratory Work with Chemicals

2. Allergens and Embryotoxins

3. Chemicals of Moderate Chronic or High Acute Toxicity

4. Chemicals of High Chronic Toxicity

5. Animal Work with Chemicals of High Chronic Toxiclly

F. Safery Recommendations

G. Macerial SaferyDaca Sheets Fore-.vord

As guidance for each employer's development of an appropriate laboralOry Chemical Hygiene Plan, lhe following non-mandatory recommendations are provided. They were extracled from "Prudent Practices for Handling Hazardous Chemicals in Laboratories" (referred to below as "Prudent Practices"), which was publi shed in 1981 by the National Research Council and is available from the National Academy Press. 2101 Constitution Ave.. NW .• Washington D.C. 20418.


,,,--- .


"Prudent Practices" is cited because of ilS wide clisuibuLion and accept.a.nee and because of its preparation by members of the laboratory community through the sponsorship o f the National Research Council. However. none of the recommendations given here will modify any requirements of the laborawry standard. This Appendix merely presents pertinent recommendations from "Prudent Practices'', organized into a form convenient for quick reference during operation of a laboratory facility and during development and application of a Chemical Hygiene Plan. Users of lhis appendu should consult "Prudent Practices" for a more extended presentation and justification for each recommendation.


• • • • •


2. Avoid underestimation of risk. Even for substances of no known significant hazard, exposure should be minimized; for work wilh substances which present special hazards, special precautions should be taken (10. 37, 38). One should assume tha1 any mixture will bemore toxic lhan its mos1 toxic component (30, 103) and that all substances of unknown ioxicity arc ioxic (3, 34).

3. Provide adequate ventilation. The bes! way 10 prevent exposure IO airborne subsi.ances is to prevent lheir escape inio the working atmosphere by use of hoods and Olher venlilalion devices (32 , 198).

4. Institute a chemical hygiene program . A mandatory chemical hygiene program designed IO minimize exposures is needed; ic should be a regular, continuing effort, not merely a standby or shon-tenn activity (6. 11). Its recommendations should be followed in academic teaching laboratories as well as by full -time laboratory workers (13).

5. Observe the PELs. TLVs. The Pennissible Exposure Limits of OSHA and the Threshold Limit Values of lhe American Conference of Governmental Industrial Hygienists should not be exceeded (13).

B. Chemical Hygiene Responsibilities

Responsibility for chemical hygiene rests a1 all levels (6, 11, 21) including the:

l. Chief execurive officer, who has ultimate responsibili ty for chemical hygiene within the institution and must, with other administrators, provide continuing support for insti tution al chemical hygiene (7, 11).

2. Supervisor of the department or other administrative unit, who is responsible for chemical hygiene in I.hat unit (7).

3. Chemical hygiene officer(s). whose appointment is essential (7) and who must:

(a) Work with administrators and other employees 10 develop and implement appropriate chemical hygiene policies and practices (7);

(b) Moniior procuremeni, use, and disposal of chemicals used in lhe lab (8);

(c) See that appropriate audits are maintained (8):

(d) Help project direciors develop precautions and adequate facilities (10);

(e) Know lhe current legal requirements concerning regulated subsi.ances (50); and

(f) Seek ways co improve the chemical hygiene program (8, 11).

4. Laboratory supervisor, who has overall responsibility for chemical hygiene in the laboratory (21) including rcsponsibilily 10:

(a) Ensure lha1 workers know and follow I.he chemical hygi<':1e rules, !hat protective equipment is available and

in working order, and lhat appropriate training has been provided (21, 22);

(b) Provide regular, formal chemical hygiene and housekeeping inspections of emergency equipment (21, 171);

(c) Know lhe current legalrequirements concerning regulated substances (50, 231);

(d) Determine lhe required levels of protective apparel and equipment ( 156, 160, 162); and

(e) Ensure !hat facilities and training for use of any material being ordered arc adequate (2 1 5).

5. Project director or director of other specific opera1ion, who has primary responsibility for chemical hygiene procedures for lhat operation (7).

6. Laboratory worker, who is responsible for.

(a) Planning and conducting each operation in accord.lncc with I.he institutional chemical hygiene procedures (7,

21, 22, 230): and

(b) Developing good personal chemical hygiene habits (22).

• • • • ..


{d) Laboratory storage. Amounts permitted should be as small as practical. Storage on bench tops and in hcxxls is inadvisable. Exposure to heal or direct sunlight should be avoided. Periodic inventories should be conduc ted, with unneeded it ems being discarded or reu1rned 10 the storeroom/stockroom (225-6, 229).

3. Environmenl.a.l Monitoring

Regular instrumental monitoring of airborne concentrations is not usually j usti fied or practical in laboratories but may be appropriate when testing or redesigning hoods or other venLilal.ion devi ces (12) or when a highly toxic substance is stored or used regularl y (e.g. 3 Limes/week) (13).

4. Housekeeping, Maintenance, and Inspections

(a) C leaning. Floors should be cleaned regularly (24).

(b) Inspections. Formal housekeeping and chemical hygiene inspections should be held al least quan erl y (6, 2 l) for W1ilS which have frequent personnel changes and semiannually for others; informal inspections should be continual ( 21).

(c) Maintenance. Eye wash fountains should be inspected al int erv als of not less than 3 months (6).

Respira tor s for routine use should be inspected periodically by the l aboratory supervisor (169). Safety showers should be tested routinely (169). Other safety equipment should be inspected regularly. (e.g. every 3-6 months) (6, 24, 171). Procedures to prevent restarting of out-of-service equipment should be establ ished (25).

(d) Passageways. Stairways, and hallways should nol be used as siorage areas (24). Access to exits, emergency equipment.. and utility controls should never be blocked (24).

5. Medical Program

(a) Compliance with regulations. Regular medical surveillance should be established to the extent required by regulation ( 12).

(b) Routine surveillance. Anyone whose work involves regular and frequent handling of 1oxicologicall y

significant quantities of a chemical should consult a qualified physician LO determine on an individual basis whethera regular schedule of medical surveillance is desirable ( 11, 50).

(c) First aid. Personnel trained in first aid should be available during working hours and an emergency room

with medical personnel should be nearby ( 173). See pp. 176- 178 for description of some emergency first aid

procedures.

6. Protective Apparel and Equipment


an:1


These should include for each laboratory:

(a) Protective apparel compatible with the required degree of protective for substances being handled ( 158-161);

(b) An easily accessible drench-type safely shower (162, 169);

(c) An eyewash fountain (162);

(d) A fire extinguisher (162-164);

(e) Respiratory protection (164-9), fire alarm and telephone for emergency use (162) should be available nearby;

(f) Other items designated by the laboratory supervisor (156, 160).


7. Records

(a) Accident records should be wriuen and retained (174).

(b) Chemical Hygiene Plan record s should document 1hat the faciliucs and precautions were compatible with

current knowledge and regulations (7).

(c) Inventory and usage records for high-risk subsurnces should be kepi as specified in section E3e below.

(d) Medical records should be retained by the insti1u1ion in accordance with the requirements of stale and federal regulations ( 12).

8. Signs and Labels

Prominent signs and labels of the following 1ypcs should be posted:

(a) Emergency telephone numbers of emergency personnel/facilities, supervisors, and laboratory workers (26):


The Chemical Hygiene Plan should require mat laboratory workers know and follow its rules and procedures. in addition tO the procedures of the sub programs mentioned above, these should include the rules listed below.

I . General Rules •

The foUowing should be used for essentially all laboratory work with chemicals:

(a) Acciderus and spills- Eye contact

Prompl.ly Oush eyes with water for a prolonged period (15 minutes) and seek medical attention (33, 172). Ingest.ion : Encourage the victim Lo drink large amounts or water (178).

Skin Contact: Promptly flush the affected area with water (33, l 72, 178) and remove any contaminated clothing ( 172, l 78). If symptoms persist after washing, seek medical au.ention (33).

Clean-up. Promptly clean up spills, using appropriate protective apparel and equipment and proper disposal (24. 33). See pp. 233-237 for specific clean-up recommendations.

(b) Avoidance of "rou,ine" exposure: Develop and encourage safe habits (23): avoid unnecessary exposure to chemicals by any route (23);

Do not smell or taste chemicals (32). Vent apparatus which may discharge toxic chemicals (vacuum pumps, distillation columns, etc.) ontO local exhaust devices(199).

Inspect gloves ( 157) and Lest glove boxes (208) before use.

Do not allow release of lOxic substances in cold rooms and warm rooms, since these have contained recirculated at.mospheres (209).

(c) Choice of chemicals: Use only those chemicals for which the quality of the available ventilation system is

appropriate ( I 3).

(d) Eating, smoking. ere. : Avoid eating, drinking. smoking, gum chewing, or application of cosmetics in areas where laboratory chemicals arc present (22, 24, 32. 40); wash hands before conducting these activities (23, 24). Avoid st0rage, handling or consumption of food or beverages in storage areas. refrigerators, glassware or utensils which arc also used for laboratory operation (23, 24, 226).

(e) Equipment and glassware: Handle and store laboratory glassware with care lO avoid damage: do not use

damaged glassware (25). Use extra care with Dewar flasks and other evacuated glass apparatus: shield or wrap them to contain chemicals and fragments should implosion occur (25). Use equipment only for its designed purpose (23, 26).

([) Exi,ing: Wash areas of exposed skin well before leaving the laboratory (23).

(g) Ho rseplay: Avoid practical jokes or other behavior which might confuse, st.a.rtle or distract another worker (23).

(h) Mouth suction: Do not use mouth suction for pipetling or starting a siphon (23, 32).

(i) Personal apparel: Confine long hair and loose clothing (23. 158). Wear shoes at all times in the laboratory but do not wear sandals, perforated shoes, or sneakers (158).

U) Personal housekeeping: Keep the work area clean and unclutlered, with chemicals and equipment being

properly labeled and stored; clean up the work area on completion of an operation or at lhe end of each day (24).

(k) Personal protection: Assure that appropriate eye protection ( 154-156) is worn by all persons, including visitors. where chemicals are stored or handled (22, 23, 33, 154).

Wear appropriate gloves when the potential for contact with ioxic materials exists (l 57); inspect me gloves before each use, wash !hem before removal, and replace them periodically (157). (A table of resistance lO chemicals of common glove materials is given p. 159).

Use appropriate ( I 64-166) respiratory equiprnent when air contaminant concentrations arc not sufficiently restricted by engineering controls (164-5). inspecting me respirator before use (169) .

Use any other proteetive and emergency apparel and equipment as appropriate (22, 157-I 62).

Avoid use of contact lenses in the laboratory unless necessary, if they are used, inform supervisor so special precautions can be taken (155).

Remove laboratory coats imm ediately on significant contamination (161).

(1) Planning: Seek information and advice about hazards (7), plan appropriate protective procedures, and plan positioning of equipment before beginning any new operation (22, 23).

(m) Una11ended operarions: Leave li ghts on.place an appropriate sign on !he door, and provide for containment

of toxic substances in lhe event of failure of a utility service (such as cooling water) to an unanendcd operation (27, 128).


,--- (g) Waste: Thoroughly decontaminat.e or incinerate contaminated clothing or shoes (41 ). lf possible, chemically decontaminate by chemical conversion (40).

Store contaminated wast.e in closed. suitably labeled, impervious containers (for liquids. in glass or plastic boules half-filled with vermiculite) (40).

4. Work with Chemicals of High Chronic Toxicity

Examples: dimethylmercury and nickel carbonyl (48), benzo-a-pyrene (51), N-ni1rosodiethylamine (54), other human carcinogens or substances with high carcinogenic potency in animals (38).J

Further supplemental rules to be followed. in addition to all these mentioned above, for work with subsmnces of known high chronic toxicity (in quantities above a few milligrams to a few grams. depending on the subst.ance) (47). (Procedure A of "Prudent Practices" pp. 47-50).

(a) Access : Conduct all transfers and work with these substanecs in a "cont.r0lled area": a restricted access hood. a glove box, or portion of a lab, designated for use of highly toxic substances, for which all people with access are aware of the substances being used and necessary precaution (48).

(b) Approvals: Prepare a plan for use and disposal of these materials and obtain the approval of the laboratory supervisor (48).

(c) Non-contamination/Decontamination: Protect vacuum pumps against contaminalion by scrubbers or HEPA filters and vent them into the hood (49). Decontaminate vacuum pumps or other contaminated equipment, including glassware, in the hood before removing them from the controlled area (49, 50).

Decontaminate the cont.r0lled area before normal work is resumed there (50).

(d) £:citing: On leaving a controlled area, remove any protective apparel (placing it in an appropriate, labeled container) and thoroughly wash hands. forearms, fnce, and neck (49).

(e) Housekeeping: Use a wet mop or a vacuum cleaner equipped with a HEPA filter instead of dry sweeping if the toxic subst.ance was a dry powder (50).

(f) Medical surveillance: If using toxicologicall y significant quantities of such a substance on a regular basis (e.g., 3 times per week). consult a qualified physician concerning desirability of regular medical surveillance (50).

(g) Records: Keep accurate records of I.he amounts of these substances stored (229) and used. the dates of use,

. ,,,....... and names of users (48).

(h) Signs and labels: Assure I.hat the controlled area is conspicuously marked wilh warning and restricted access signs (49) and that all containers of these substances are appropriately labeled with identity and warning labels (48).

(i) Spills: Assure that contingency plans. equipment, and materials to minimize exposures of people and propeny in case of accident are available (233).

U) Storage: Store containers of these chemicals only in a ventil ated, limit.cd access (48, 227. 229). area in

appropriat.ely labeled, unbreakable, chemic all y resistant, secondary containers (48, 229).

(k) Glove bo.:ces: For a negative pressure glove box, ventilation rate must be at least 2 volume changes/hour and pressure at least 0.5 inches of water (48). For a positive pressure glove box, thoroughly check for leaks before each use (49). In either case, trap the exit gases or filter them through a HEPA filter and then retease them into the hood (49).

(I) Waste: Use chemical decontamination whenever possible; ensure that containers of contaminat.cd waste (including washings from contaminated nasks) are transferred from the controlled area in a secondary container under the supervision of authorized personnel (49, 50, 233).

5. Animal Work with Chemicals of High Chronic Toxicity

(a) Access: For large scale studies, special facilities with restricted access arc preferable (56).

(b) Administration of the toxic substance: When possible. administer the substance by injection or gavage inst.cad of in the dieL If administration is in the diet, use a caging system under negative pressure or under laminar air flow directed toward HEPA filters (56).

(c) Aerosol suppression: Devise procedures which minimize formation and dispersal of contaminated aerosols. including those from food, urine, and feces (e.g., use HEPA filtered vacuum equipment for cleaning, moisten contaminated bedding before removal from the cage. mix diets in closed containers in a hood) (55, 56).

{d) Personal protection: When working in I.he animal room. wear plastic or rubber gloves. fully buttoned

laboratory coat or jumpsuit and. if needed because of incomplete suppression of aerosols, other apparel and equipment (shoe and head coverings.respirator) (56) .

(e) Waste disposal: Dispose of contaminated animal tissues and excreta by incineration if the available incinerator can conven the contaminant to non-toxic products (238): otherwise, package I.he waste appropriately for burial in an EPA-approved si1e ( 239).

..-


N- nitrosod.iethylamine (54)

. ,-.. Peracetic acid (141) Phenol (142)

Phosgene (I 43)

Pyridine ( 144)

Sodium azide (145)

Sodium cyanide (147)

Sulfur dioxide (101)

Trichloroethylene (149)

Vinyl chloride (1.50)

Appendix B to§ 1910.1450-References (Non-Mandat.Or)')

The following references are provided lO assist the employer in the development of a Chemical Hygiene Plan.

The materials listed below are offered as non-mandat0ry guidance. References listed here do not imply specific endorsement of a oook, opinion, technique, policy or a specific solution for a safety or health problem. Other references not listed here may better meet the needs of a specific laboralOry. (a) Materials for the development of the

Chemical Hygiene Plan:

1. American Chemical Society, Safety in Academic Chemistry Laboratories, 4th edil.ion, 1985.

2. Fawcett, H.H. and W.S. Wood, Safety and Accident Prevention in Chemical Operal.ions, 2nd edition, Wiley­ lnterscience, New York., 1982.

3. Flury, Patricia A., Environmental Health and Safety in the Hospital Laboratory, Charles C. Thomas

Publisher, Springfield IL, 1978.

4. Green, Michael E. and Turk, Amos. Safety in Working with Chemi ca·Js. Macmillan Publishing Co., NY,

1978.

5. Kaufman, James A., Laboratory Safety Guidelines, Dow Chemical Co.. Box 1713, Midland, MI 48640,

1977.

6. National Institutes of Health, NTH Guidelines for the Laboratory use of Chemical Carcinogens, NTH Pub.

No. 81-2385, GPO, Washington, OC 20402,1981.


;- ·


7. National Research Council. Prudent Practices for Disposal of Chemicals from Laboratories, National Academy Press, Washington, DC. 1983.

8. National Research Council, Prudent Practices for Handling Hazadous Chemicals in Laboratories, National

Academy Press. Washington, DC, 1981.

9. Renfrew, Malcolm, Ed., Safety in the Chemical Laboratory, Vol. IV, J. Chem. Ed,. American Chemical

Society, Easton, PA, 1981.

10. Steere, Norman V., Ed., Safety in the Chemical Laboratory, J. Chem. Ed. American Chemical Society,

Easton, PA, 18042, Vol. I, 1967, Vol. II, 1971, Vol. III 1974.

11. Steere, Norman V., Handoook of Laboratory Safety, the Chemical Rubber Company Cleveland, OH, 1971.

12. Young, Jay A., Ed., Improving Safety in the Chemical Laboratory, John Wiley & Sons, Inc. New York, 1987.

(b) Hazardous SubsLanCes Infonnation:

1. American Conference of Governmental Industrial Hygienists, Threshold Limit Values for Chemical Substances and Physical Agents in the Workroom Environment wit.h Intended Changes, P.O. Box 1937 Cincinnati,

OH 45201 (latest edition).

2. Annual Repori on Carcinogens, National Toxicology Program U.S. Department of Health and Human Services, Public Health Service, U.S. Government Printing office, Washington D.C. (latest edition).

3. Best Company, &st Safety Directory, Vols. I and II, Oldwick, NJ., 1981.

4. Bretherick, L., Handbook of Reactive Chemical Haz.ards, 2nd edition, Bunerworths, London, 1979.

5. Bretherick, L., Hazards in the Chemical Laboratory. 3rd edition. Royal Society of Chemistry, London, 1986.

6. Code of Federal Regulations, 29 CFR part 1910 subpart Z. U.S. GovL Printing office, Washington, OC

20402 (latest edition).

7. IARC Monographs on the Evaluation oft.he Carcinogenic Risk of Chemicals t0 Man, World Health Organization Publications Ce nt.er, 49 Sheridan Avenue, Albany, New Yorlc 12210 (latest edi tion) .

8. NIOSH/OSHA Pocket Guide to Chemical Hazards. N1OSH Pub. No 85-114, U.S. Government Printjng

office, Washington DC. 1985 (or latest edition).

9. Occupational Health Guidelines, N1OSHIOSHA NIOSH Pub. No. 81-123 U.S. Government Printing office.

Washington, DC, 1981.


• • • •



l

Occupational E xposure to Bloodborn e Pathoge n s

U.S. Department of Labor Roben B. Reich. Secretary

Occupa1ional Sa fety and Health Administration Joseph A. Dear, Assistant Secretary

OSHA 3127

1996 (Revised) This informational booklet is intended to provide a generic, non­ exhaustive overview of a panicular standards-related topic. This publication does _not itself alter or determine compliance responsibili­ ties, which are set forth in OSHA standards themselves and the Occupational Safety and Health Act. Moreover, because inierpretations and enforcement policy may change over time, for additional guidance on OSHA compliance requirements. the reader should consult current administrative interpretations and decisions by the Occupational Safety and Health Review Commission and the couns.

Material contained in this publica­ tion is in the public domain and may be reproduced, fully or panially, without permission of the Federal Government. Source credit is requested but not required.

This information will be made

•• available 10 sensory impaired

individuals upon request

Voice phone: (202) 219-86 I5; Telecommunications Device for the Deaf (TDD) message referral phone: 1-800-326-2577.


) )

Introduction

Acqui re d Immunodeficiency Syndrome (AIDS) and Hepatitis B merit serious concern for workers occupationally exposed to blood, other potentially infectious materials, and certain other body fluids that contain bloodbome pathogens such as the human immunodeficiency virus (HIV), and the Hepatit is B virus (HBV). According to Occupational Safety and Heulth Administration's (OSHA) cstima1cs. more than 5.6 million workers in health care and public safety occupations could be potentially exposed to these viruses.*

These workers include. but arc not limi1cd 10, physi<:ians. dcn1is1s. dental employees, phlcbotomists, nurses, monicians. paramedics. medical examiners, laboratory and blood bank technologists and technicians, housekeeping personnel. laundry workers, employees in long-tern, care facilities. and home care workers. Other workers who may be occupa­ tionally exposed to blood or other potentially infectious materials. depending on thei r work assignments. include research laboratory workers. and public safety personnel (fire. police, rescue. corrccti..rnal officers, c1c.).

Exposure to bloodbome pathogens may occur in many ways. Although nccdlcstick injuries arc the most common means of'exposure for health care workers. bloodbome pathogens also can be transmitted through contact with the mucous membranes and non-intact skin of workers.

OSHA recognizes the need for a regulatio n that prescribes safeguards to protect workers against the health hazards related to bloodbomc pathogens. Thus. with the full implementation of i1s standard, OSHA aims to reduce the risk of occupational exposure to bloodborne diseases.

This standard, Part 1910.1030 of Title 29 of the Code of Federal Regulations. was published in the Federa/ Register on December 6, 1991. (29 CFR 1910.1030) and became effective on March 6. 1992.

Federal OSHA authority extends lo all private sector employers with one or more employees, as well as federal civilian employers. States administering their own occupational safety and health programs through plans approved under section I8(b) of the Occupational Safery and Health (OSH) Act of 1970 must adopt standards and enforce requirements that are at least as effective as federal requirements. Of the 25 current state plan states and territories, 23 cover the private and public (i.e.. state and local governments) sectors, and 2 cover the public sector only (sec listing at the end of this booklet).


  • OSHA. Ortice or Regulatory Analysis, 1991.

' I



)

• Way,. ... which


bloodborne pathogens arc transmitted:


The hepatitis B vaccine and v:icc111auon series must be offered \j 1


Explanation o f the exposure control plan and how 10 obtain a copy: Information on how 10 recognize tasks that might result in occupa­ tional exposure;

"'

Explanation of the use and limitations of work practice and engineer­

ing controls. and personal protective equipment;

• Infom1ation on the types. selection, proper use. location, removal. handling. decontamination. and disposal of personal protective equipment;

Information on hepa titis B vaccination such as safety. benefits.

efficacy. methods of administration. and availability;

• Information on who to contact and what to do in an emergency;

Information on how to report an exposure incident and on the post­ exposure evaluation and followup;

Information on warning labels. and signs . where applicable. and

color-coding; and

Question and answer session on any aspect of the training.

Additional training in standard mic robiolog ical practices and tech­ niques. practices, and operations specific to the facility, and the proper handling of human pathogens or tissue cultures is required for employees who work in HIV and HB V laboratories and production facilities. This additional training must be given before beginning initial work assign­ ments.

P r e ventive Measures

Hepat itis B Vaccination

,\

1,

..

The employer mus t make the hepatitis B vaccine and vaccination series available to all employees who have occupational exposure as well as provide a post-exposureevaluation and followup to all employees who experience an exposure incident. The vaccine and vaccinations, as well as all medical evaluations and followup must be made available at no cost to the employee, provided at a reasonable time and place. and perfonned by or under the supervision of a licensed physician or another licensed health care professional whose scope of practice allows him or her to independently perfonn activities required by paragraph (f) of the standard (such as a nurse practitioner). Vaccinations also must be administered according to current recommendations of the U.S. Public Health Service. Employees who decline the vaccination mus t sign a declination form (sec Appendix A). The employee may request and obtain the vaccination at a later date and at no cost, if he/she con tinues to be exposed.

IO working days of initial assignment to employees who have occul-'..- tional exposure 10 blood or other potentially in fec tious materials unless

(I) the employee has previously received the complete hepatitis 13 vaccination series. (2) antibody testing reveals that the employee is immune. or (3) medical reasons prevent taking the vaccin ations. Prescreening is not required before receiving the hepatitis B vaccination series.

The employer must obtain and provide the employee with a copy of the health care profcssional's writ1en opinion stating whether a hepatitis B vaccination is indicated for the employee and whether the employee has received such vaccination.

Any booster doses of tl1c hepatitis B vaccine recommended by the U.S. Public Health Service also must be provided.

Universa l Preca utions

Universal precautions must be observed. This method of infection co ntrol requires the employer and e mployee to assume that all human

blood and specified human body nuids arc infectious for HIV, Hl3V, and mher bloodbome pathogens. Where differentiation of types of hrnly

nuids is diffic ult or impossible. a ll body tluids :.ire to be considered as potentially infec tious.

Methods of Co nt rol

Engineering and Work Pract ice Controls

Engineering and work practice controls arc the primary methods used to prevent occupa tional transmission of HBV and HlV. Personal protec­ tive clothing and equipment also arc necessary when occupational exposure to bloodbomc pathogens remains even after instituting these cont rols.

Engin ee rin g co ntrol s reduce employee exposure in the workplace by eitJ1er removing or isolating the hazard or isolating the worker from exposure. Self-sheathing needles. puncture-resistant disposal containers for contaminated sharps instruments, resuscitation bags. and ventilation devices arc examples of e ngineering controls. Engineering controls must be examined and maintained or replaced on a scheduled basis.

Proper work practice contro ls alter the manner in which a task is perfonncd. In work areas where a reasonable likelihood of occupational exposure exists, work practice controls include restricting eating. drink­ ing , smoki ng. applying cosmetics or lip balm. and handli ng contact lenses; prohibiting mouth pipetting: preventing the storage of food ancl/or


4 5

I


) ) )


• Decontaminate work surfaces with an appropriate disinfectant, after completion of procedures. immediately when ovenly contaminated. after any spill of blood or other potentially infectious materials. and at the end of the work shift when surfaces have become conta minated since the last cleaning.

• Remove and replace protective coverings such as plastic wrap and

aluminum foil when contaminated.

• Inspect and decontaminate, on a regular basis. reusable receptacles such as bins. pails. and cans that have a likeliho()(l for hemming contamina ted. When contamination is visible. dean and dewnwmi­ nate reccpcaclcs immediately. or as soon as feasible.

Always use mechanical means such as tongs. forceps. or a brush and a dust pan to pick up contaminated broken glassware; never pick up

with hands even if gloves arc worn.

• • Swre or process reusable sharps in a way that ensures safe handling. Place other regulated waste* in closable nnd labeled nr color coded containers. When storing. handling. transporting or shipping. place other regulated waste in containers that arc constructed to prevent leakage.

When discarding contaminated sharps. place them in containers that

are closable, puncture-resistant, appropriately labeled or color-coded. and lcakproof on the sides and bonom.

• Ensure that sharps containers arc easily accessible to personnel and

located as close as is feasible to the immediate area where sharps arc used or can be reasonably anticipated to be found. Sharps comainers also must be kept upright throughout use. replaced routinely, closed when moved. and not allowed 10 overfill.

• Never manually open. empty. or clean reusable contaminated sharps

disposal contai ncrs.

Discard all regulated waste according 10 federal. state, and local regulations.

Handle contamina ted laundry as linlc as possible and with a mini­

mum of agitation.

Use appropriate personal protective equipment when handling contaminated laundry.

Place wet contaminated laundry in leak-proof. labele d or colo r-coded

containers before transponing.

Bag contaminated laundry at its locatton of use.

Never son or rinse contaminated laundry in areas of its use.

'Liquid or scmi-ltqu1d blood or other potentially infectious materials: items coniaminatcd

• with blood or other potentially infectious materials that would release these substances in a liquid or semi-liquid state if compressed; items caked with dried blood or other potentially infectious materials and arc capable of rclc3sing these materials during handling; con1am1- nated sharps; and pathological and microbiological wastes containing blood or other potentially infec11ous materials.


Labeling

The standard requires that nuorcscent orange or orange-red warning. labels be attached to containers of regulated waste, to refrigerators and freezers containing blood and other potentially infectious materials . and to other containers used to store. transpon, or ship blood or other pmcn­ tially infectious materials (sec Table I). These labels arc not required when (I) red bags or red containers arc used, (2) containers of blood. blood components. or blood products arc labeled as to their contents and have been rclca-;cd for transfusion or other dinical use, and (3) individual containers of blood or other pote ntially infectious materials arc pl:iccd in a labeled container during storage, transport, shipment or disposal. The warning label must be fluorescent orange or orange-red, contain the biohazard symbo l and the word BIOHAZARD (sec Figure I ), in a contrasting color, and be anuchcd IO cat'h object by string, wire. adhesive. or another method to prevent loss or unintentional removal of the label.

As already indicated, the above preventive 111ca urcs arc inte ndcu to eliminate or minimize the risks of occupational exposure. In the event that an exposure occurs. however. certam prnccdun:s arc required.

Wha t lo Do if an Expos ur e I ncident Occurs

·n,e stand ard requires that the post-exposure medical evaluation and followup be made available immediately for employees who have had an exposure incident. At a minimum, the evaluation and followup must . at least. include the following element s:

• Document the routes of exposure and how exposure occurred.

• Identify and document the source individual. unless the employer can establish that identification is infeasible or prohibited by state or local law.

• Obtain consent* and tes t source individual's blood as soon as possible to determine HIV and HBV infcctivity and document the source's blood test res ults.

• If the source individual is known 10 be infected with either HIV or HBV. testing need not be repeated to determine the known infectiv­ ity.

• Provide the exposed employee with the source individual's test results and information about applicable disclosure laws and regula­ tions concerning the source identity and infectious status.

• After obtaining consent, collect exposed employee's blood as soon as feasible after the exposure incident and test blood for HB V and HIV serological status.


8 9


\

resulting from the exposure incident that may require further evaluation or treatment. All other diagnoses must remain confidential and not be included in the written report.

The requirements for the medical and training records arc disc usse d in Lhe next section on recordkecping.

Rccor dl<eep in g

Employers also must preserve and maintain for each employee an accurate record of occupational exposure according to OSHA 's rule governing access 10 employ ee exposure and medical records, Title 29Code of Federal R egularions. Pan 1910.20.

Under the bloodbornc pathogens standard. however, medical records also must include the following infonnation:

• Employee·s name and social security number:

Employee' s hepatitis B vaccination status including vaccination dates and any medical records related 10 the employee's ability to receive vaccinations;

Results of examinations. medical testing, and post-exposure evalua­ tion and followup procedures:

• Health care profcssional's wriuen opinion; and

• A copy of the information provided to the health care professional.

Medical records must be kept confidential and maintained for at least the duration of employment plus 30 years.

The bloodbome pathogens standard also requires employers 10 main­ tain and 10 keep accurate training records for 3 years and 10 include the following:

• Training dates.

• Conte nt or a summary of the trainin g.

• Names and qualifications of tramer(s), and

• Names and job titles of trainees .

Upon request, bolh medical and training records must be made avail­ able 10 the Director of the National Institute for Occupational Safety and Health (NIOSH) and to the Assistant Secretary of Labor for Occupa tion al Safety and Heallh. Training records must be available 10 employees or employee representatives upon request. An employee's medical records can be obtained by that employee or anyone having that employee's wnnen consen1. Also, if Lhc e mployer ceases to do business. medical and training records must be transferred 10 the successor employer. If there is

12


·. no successor employer. the employer must notify the Director. Nlt.,.,d'.

Department of Health and Human Services, for specific tlirec.:tions

regarding disposition of Lhe records at least 3 months prior 10 in1endcd disposal.

II

I

HIV and HBV Research Labora to ries and P ro duction Faciliti es

In adtlttion to other requirements of the standard. employer, 1n rc,e an:h laboratories and production facilities engaged in the culture. production. conccntr:nion. experimentation. and manipulation of HIV and H B V 1• must ensure the following:

• Provide HIV and HBV resea rch la borator ies wi1h a facility for hand-and-eyewashing and an autoclave for dccontamina1ing regulated waste.

Provide HIV and HBV production facilities with work ureas separaled from unrestricted areas (corridors or olhcr con1iguous areas') within the building by two sets of self-closing access doors: with a ducted exhaust-air ventila1ion system: an autoclave near the work area for decontamination; a sink for hand washing that ,s foot. elbow. or automatically operated and is near the exit door; eye wash facility; and water-rcsistanl. scalable surfaces of walls. floors. and

ceiling.

• Decontaminate. autoclave. or incinerate all regulated waste before disposal.

• Keep doors closed when work involves HIV and HBV.

• Place co ntaminated materials in durable, leak-proof. appropri:uely labeled or color-coded. closed containers before removing them from the work area.

• Pennit only authorized personnel in work areas and in animal rooms.

• Place proper hazard warning signs, incorporating the biohazard symbol, on access doors when potentially infectious materials or infected animals arc present in the work areas (sec Figure 2).

• Do not work with potentially infectious materials on an open bench. Use biological safety cabinets or other physical-containment devices.

• Install on ly certified biological safe ty cabinets and certify them annually Lhereafter or when moving them 10 another location within the facility.

• Wear appropriate personal protective equipmcnl such as coats. gowns, smocks, and unifon11S only in work areas and in animal rooms when handling other potentially infeclious materials: and decontaminate clo1hing before laundering.


•This does not apply to clinical or diagnostic labora1ories.


13


) \

The guidelines recommend specific actions under each of these general clements 10 achieve an effective safety and health program. A single free copy of lhe guidelines can be obtained from the U.S. Depanment of Labor. OSHA Public ations, P.O. Box 37535, Wash ington. DC 200137535, by sendi ng a self-addressed mail label with your requesl.

Cons ult a tion Programs

Cons ultation assistance is available to employers who want help in

• establishing and maintaining a safe and hcah.hful orkplacc. Largely funded by OSHA. !.he se rvice is provided at no cost to 1he emp loyer.

Primarily developed for smaller employers with more hazardous opera­ tions, t.hc consultationservice is delivered by state government agencies

I or universities e mploying profession al safety consu ltants and health

consultants. Comprehensive assistance includes an appraisal of all mechanical, physical work practice, and environmen tal hazardsof the

workplace and all aspects of lhe employer's present job safety and health program. No penalties are proposed or cita tions issued for hazards identified by the consultan t.

For more mfonnation concerning consultation assistance. sec the list of consultation projects listed at the end of this booklet (sec Appendix B).

S t a te P rog r a m s

The Occupario11al Safery and Health Act of 1970 encourages states to develop and o perate their own job safety and health plans. Sta tes with plans approved under section I 8(b) of the Act mm,t adopt standards and enforce requirements that arc at least as effective as federal requirements. There are currently 25 s1a1cplan states and territories: 23 covering bmh private and public (state and local government) employees and 2 covering publ ic sector employees only. Plan states must adopt standards <.:ompa­ rable (but not necessarily identical) to the federal within 6 months of a federal standard's promulgation. Until a sta te standard is promulgated, OSHA provides interim enforcement assis tance. as appropriate, in these states. A listing of approved state plans appears at the end of this publication .

Volu n tary Pr ot ection Programs

• Voluntary protection programs (VPP) and ()nsile consultation crviccs.

when coupled with an effective enforcement program. expand worker protec1ion to help meet the goals of the OSH Act. The three VPPs-Star. Meri!, and Demonstration- are designed to recognize outs tandin g achievement by companies that have successfully incorporated compre­ hensive safety and health programs into their tornl management system.

••

16


TI1ey motivate others to achieve excellent safety and health results in uu.: same ou1s1and ing way and they establish a cooperative relationsh ip among employers, employees. and OSHA.

For additional infom1ation on VPPs and how 10 apply, contact the OSHA nation al, regional. or area offices listed at the end of this booklet.

T ra in ing and Education

OSHA's Training lns1i1u te in Des Plaines. IL, provides basic and advanced courses in safety and health for federal and state compl!ance officers, stale consultants, federal agency personnel, and private sector employers, employees, and their representatives.

OSHA also provides funds to nonprofit organizations . through grants. 10 conduct workplace train ing and education in subjects where OSHA believes !.here is a lack of workplace training. Curren t grant subjects include agricultural safety and health. hazard communication programs. and HIV and HBV. Gran1s a.re awarded annually, with a I-yea r renewal possible. Grant recipients are expected to contribute 20 pcr<.'.ent of the

to tal g rant cost.

For mo re infom1ation o n grants. and training and education. coniact the OSHA Training Institute, Office of Training and Educmion, 1555 Times Drive. Des Pla ines. IL 600 I R, (8 47) 297-48 JO.

Finally, OSHA's area officesoffer a variety of infom1atio nal services. such as publica1ions, audiovisual aids. technical advice, and speakers for special engagements. Each regional office has a bloodbornc pathogens coordinator to assist employers.

Electron ic In for ma tion

La bor News Bulletin Board - OSHA news releases. recent Federal Regis ter no tices. fact shee ts, and other infom1a1ion arc available by modem by dialing (202) 219-4784. Callers should set the modem at 300, 1,200, 2,400, 9,600, or 14,400 BAUD; Parity: None: Data Bits=8: Sto p

Bit- I. Voice phone (202) 219-8831.

In ter net - OSHA standards, interpretation . directives. and addi1ional infonnatio n arc now on the World Wide Web athllp://www.osha.gov/ and hnp://www.osha-slc.gov/.

C D-ROM - A wide variety of OSHA ma1crials including standards. interpretations, dire ctives, and more can be purchased on CD-ROM from the Government Printing Office. To order, write 10 Superinicndcnt elf

I

Documents, P.O. Box 37 1954, Pi1tsburgh. PA 15250-7954. Specify ,,

OSHA Regulations, Documents and Technical Infonnation on CD-ROM.

(ORDT). SIN 729-031-000005. The price is 588 per year (S 110.00

Foreign): single copy $30.00 ($37.50 foreign ).

17


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·....

Standard Number 1910.1030 - COMPLETE Bloodborne pathogens.

Authority: Secs. 6"and 8, Occupational Safety and Health Act , 29 U.S.C. 655,657, Secretary of Labor's Orders Nos. •

12-71 (36 FR 8754), 8-76 (41 FR 25059), or 9-83 (48 FR 35736), as applicable; and 29 CFR Part 1911.

(a) Scope and Application . This section applies to all occupational exposure to blood or other potentially infectious materials as defined by paragraph (b) of this section.


I... ,.I


(b)


Definitions. For purposes of this section, the following shall apply: "Assistant Secretary" means the Assistant Secretary of Labor for Occupational Safety and Health, or designated representative. "Blood" means human blood, human blood components, and products made from human blood. "Bloodbome Pathogens" means pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV) and human immunodeficiency virus (HIV). "C linica l Laboratory" means a workplace where diagnostic or other screening procedures are performed on blood or other potentially infectious materials . "Contaminated" means the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface. "Contaminated Laundry" means laundry which has been soiled with blood or other potentially infectious materials or may contain sharps. "Contaminated Sharps" means any contaminated object that can penetrate the skin including, but not limited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires. "Decontamination" means the use of physical or chemical means to remove, inactivate, or destroy bloodbome pathogens on a surface or item to the point where they are no longer capable of transmitt ing infectious particles and 1he surface or item is rendered safe for handling, use, or disposal. "Director" means the Director of the Nalional Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designated representative. "Engineering Controls" means controls (e.g., sharps disposal containers, self-s heathing needles) that isolate or remove 1he bloodbomc pathogens hazard from the workp lace. "Exposure Incident" means a specific eye, mouth , other mucous membrane. non-intact skin, or parentera l contact with blood or other potentially infectious materials that results from the performance of an employee's duties. "Handwashing Facilities" means a facility providing an adequate supply of running potable water, soap and single use towels or hot air drying machines. "Licensed Healthcare Professional" is a person whose legally pem1itted scope of practice allows him or her to independently perform 1he activities required by paragraph (f). Hepatitis B Vaccination and Post-exposure Evaluation and Follow-up. ''HBV" means hepatitis B virus. "HIV" means human immunodeficiency virus. "Occupational Exposure" means reasonably anticipated skin, eye, mucous memb rane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties. "Other Potentially Infectious Materials" means

(I) The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardia! fluid , peritoneal fluid, amniotic fluid, saliva in dental procedures , any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids:

(2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and

(3) HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containingculture mediw11 or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV. "Parenteral" means piercing mucous membranes or the skin barrie r through such events as needlesticks, human bites, cuts, and abrasions. "Personal Protective Equipment" is specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts or blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment. "Production Facility" means a facility engaged

in industrial-scale, large-volume or high concentration production of HIV or HBV. "Regulated •

Waste" means liquid or semi-liquid blood or other potentially infectious materials: contaminated

items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials


I

• I • • • • • • I• •


(d) Methods of Compliance.

(I) General. Universal precautions shall be observed to prevent contact with blood or other potentially infectious materials. Under circumstances in which differentiation between body fluid types is difficult or impossible, all body fluids shall be considered potentially infectious materials.

(2) Engineering and Work Practice Contro ls.

(i) Engineering and work practice controls shall be used to eliminate or minimize employee exposure. Where occupational exposure remains after institl1tion of these controls, personal protective equipment shall also be used.

(ii) Engineering controls shall be examined and maintained or replaced on a regular schedule

to ensure their effectiveness.

(iii) Employers shall provide handwashing facilities which are readily accessible to employees.

(iv) When provision of handwashing facilities is not feasible, the employer shall provide either an appropriate antiseptic hand cleanser in conjunction with clean cloth/paper towels or antiseptic towelettes. When antiseptic hand cleanser.; or towelettes are used, hands shall be washed with soap and running water as soon as feasible.

(v) Employers shall ensure that employees wash their hands immediately or as soon as feasible after removal of gloves or other personal protective equipment.

(vi) Employers shall ensure that employees wash hands and any other skin with soap and water, or flush mucous membranes with water immediately or as soon as feasible following contact of such body areas with blood or other potentially infectious materials.


(vii)


r-


Contaminated needles and other contaminated sharps shall not be bent, recapped, or removed except as noted in paragraphs (d)(2)(vii)(A) and (d)(2)(vii)(B) below. Shearing or breaking of con ta minated needles is prohibited.

(A) Comaminated needles and other contam inated sharps shall not be "' be nt,

recapped or removed unless the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical or dental procedure.


(B) Such bending, recapping or needle removal must be accomplished through the use of a mechanical device or a one-handed technique.

(viii) Immediately or as soon as possible after use, contaminated reusable sharps shall be placed in appropriate containers until properly reprocessed. These containers shall be:

(A) puncture resistant;

(B) labeled or color-coded in accordance with this standard;

(C) leakproof on the sides and bonom; and

(D) in accordance wit!, the requirements set forth in paragraph (d)(4)(ii)(E) for reusable sharps.

(ix) Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses

are prohibited in work areas where there is a reasonable likelihood of occupational

exposure.

(x) Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present.

(xi) All procedures involving blood or other potentially infectious materials shall be perfom1ed in such a manner as to minimize splashing, spraying, s pa ttering, and generation of droplets of these substances.

(xii) Mouth pipetting/suctioning of blood or other potentially infectious materials is prohibited.

(xiii) Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or

shipping.

{A) The containe r for storage, transport, or shipping shall be labeled or color-coded according to paragraph (g)( I )(i) and closed prior to being stored, transpo rted, or

• •


(vi) If a gannent(s) is penetrated by blood or other potentia lly infectious materials, the garment(s) shall be removed immediately or as soo n as feasible.

(vii) All personal protective equipment shall be removed prior to leaving the work area.

(viii) When personal protective equipment is removed it shall be placed in an appropriately designated area or container for storage, washing, decontamination or disposal.

(ix) Gloves. Gloves shall be worn when it can be reasonably antic ipated that the employee may have hand contact with blood , ot her potentially infectious materials, mucous membranes, and non- intact skin; when perforn1ing vascular access procedures except as specified in paragraph {d)(3)(ix)(D); and when handling or touching contaminated items or surfaces.

(A) Disposable (single use) gloves such as surgical o r examinati on g lo ves, shall be replaced as soon a practical when contaminated or as soon as feasible if they are tom, punctured, or when their ability to function as a barrier is compromised.

(B) Disposable (single use) g loves shall not be washed or deconta minat ed for re-use.

(C) Utility gloves may be decontaminated for re-use if the integrity of the glove is not compromised. Howeve r, they must be discarded if they are cracked, peeling. torn, punctured, or exhibit o the r sig ns of deterioratio n or when their ability to function as a barrier is compromised.

(D) If an employer in a volunteer blood donation center judges tha t routine gloving for all phlcbotomies is not necessary then the employe r shall:

{I} Periodica lly reevaluate this policy ;

{2} Make g loves availa ble to all employees who wish to use the m for phlebotomy;

{3) Not discourage the use of gloves for phlebotomy; and

{4} Require that g lo ves be used for phlebotomy in the following c ircumstances:

{i} When the employee has cuts, scratches, or othe r breaks in his or her skin;

{ii} When the employee judges that hand contamination with blood may occur, for example, when performing phlebotomy on an uncooperative source individua l; and

{iii} When tht: employee is receiving training in phlebotomy.

(x) Masks, Eye Protec tion, and Face Shields. Masks in combination with eye protection devices, such as goggles or glasses with solid side shields. or chin-length face shields. shall be worn whenever splashes, spray, spatter. or droplets of blood or other potenually infectio us materia ls· may be generated and eye, nose, or mouth con tamina tion can be reasonably antic ipat ed.

(xi) Gowns, Aprons, and Other Protective Body C loth ing. Appropria te protectiveclothing such as, but not limited to, gowns, aprons, lab coats, clinic jackets, or similar outer gam1ents shall be worn in occ upational e xposure situations. The type and characteristics will depend upon the tas k and degree of exposure antic ip ated.

(xii) Surgical caps or hoods and/or shoe covers or boots shall be worn in instances when gross contamination can reasonably be anticipate d (e.g., autopsies, orthopaedic surgery).

(4) Housekeep ing.

(i) General. Emplo yers shall ensure that the worksite is maintained in a clean and sanita ry condition. The e mploye r shall determine and implement an appropriate written schedule for cleaning and method of decontamination based upon the location within the facility, type of surface to be clean ed, type of soil present, and tasks or procedures being perfonned in the area.

(ii) All equipment and environmental and working s urfaces sha ll be cleaned a nd

•• •


{ l } Regulated waste shall be placed in containers which arc:

[;i] Closa ble:

[b] Constructed to contain all contents and prevent leakage of fluids during handl ing, storage, transport or s hipping;

[c] Labeled or color-coded in accordan ce with paragraph (g)(I )( i)

thi s s tandard ; and

[d] Closed prior to removal to prevent spillage or protnision of contents during handling, storage, transpor1, or shipping.


{2}


If outside contamination of the regula ted waste container occurs, it s ha ll be placed in a second container . The second container shall be:

(a) Closable;

[b) Constructed to contain all contents and prevent leakage of fluids during handling, storage, transport or s hipping:


[c)

[d]


Labeled or color-coded in accordance with paragraph (g)(I )( i) of thi s stan dard; and

Closed prior 10 removal to prevent spillage or protrusion of contents during handling, s torage, transport, or shipping.


(C) Disposal of all regulated waste shall be in accordance with appli ca ble re g ulations of the United States, S tates and Territories, and political subdivisions of States and Territories.


(iv)

-


Laundry.

(A) Contaminat ed laundry s hall be handJed as little as possible with a minimum of agitation.

{ I } Co ntaminated laundry shall be bagged or containeri ze d al the location where ii was used and shall not be soned or rinsed in the locat io n of use.

{2} Con tam inated laundry s hall be placed and transported in bags or


containers lab e led or color-coded in accordance with paragraph (g)( I)(i) of this standard. When a facility utilizes Universal P recautions in the handling of all so ile d laundry, alternat ive labeling or co lor- coding is s ufficient if it permits a ll employees to recognize the containers as requiring compliance with Unive rsal Precautions.

{3} Whenever contaminated laund ry is wet and presents a reasonable like lihoo d of soak-through of or leakage from the bag or container, the laundry shall be place d and transpo rted in bags or containers whic h prevent soak-through and/or leakage of fluids to the ex terior.

(B) The employer shall ensure that e mployees who have contact with contaminated laundry wear protec tive gloves and other appropriate personal protective equipment.

(C) When a fac ili ty ships contaminated laund ry off-site to a second facilit y which docs not utilize Universal Precautions in the handling of all laund ry, the facility generating the contaminated lau ndry must place such laun dry in bags or conta iners which are labeled or color-coded in accordance with paragraph (g)( I )(i).

(e) HIV and HBV Research Labo ratories and Production Facilities.


(I)

(2)


This paragraph applies to research laboratories and production facilities engaged in the culture, production. concentration, experimentat ion, and manipulation of HlV and HBV. It does not a pply to clinical or diagnostic laboratories engaged sole ly in the analysis of blood, tissues, or organs. These requirements apply in addition to the other requirements of the s tandard .

Research laboratories and production faci lities shall meet the following criteria:

(i) Standard Microbiological Practices. All regulated waste shall either be incinerated or decontaminated by a method such as autoc laving known to e ffectively destroy bloodbome pathogens.


• •• •


• •

centrifuge rotors, and containment caging for animals, shall be used for all activities with other potentially infectious materials that pose a threat of exposure to droplets, splashes , spi lls, or aerosols.

(B) Biological safety cabinets shall be certified when installed, whenever they are moved and at least annu ally.

(3) HIV and HBV research laboratories shall meet the following c riteria:

(i) Each laboratory shall contain a facility for hand washing and an eye wash facility which is readily available within the work area.

(ii) An autoclave for decontamination of regulated waste shall be available.

(4) HfV and HBV production facilities shall meet the following criteria:

{i) The work areas shall be separated from areas that are open to unrestricted traffic flow within the building. Passage through two sets of doors shall be the basic requirement for entry into the work area from access corridors or other contiguous areas. Physical sepa ration of the high-containment work area from access corridors or other areas or activities may also be provided by a double-doored clothes-ch ange room (showers may be included), airlock, or other access facility that requires passing through two sets of doors before entering the work area.

(ii) The surfaces of doors, walls, floors and ceilings in the work area shall be water resistant so that they can be easily cleaned. Penetrations in these surfaces shall be scaled or capable of being sealed to facilitate decontamination .

(iii) Each work area shall contain a sink for washing hands and a readily available eye wash facility. The sink shall be foot, elbow, or automatically operated and shall be located near the exit door of the work area.

(iv) Access doors to the work area or containment module shall be self-closing.

(v) An autoclave for decontamination of regulated waste shall be availab le within or as near as possible to the work area.

(vi) A ducted exhaust-air ventilation system shall be provided. This system shall create

directional airflow that draws air into the work area through the entry area. The exhaust air shall not be recirculated to any other area of the building, s hall be discharged to the outside. and shall be dispersed away from occupied areas and air intakes. The proper direction of the airflow shall be verified (i.e., into the work area).

(5) Training Requirements. Additional training requirements for employees in HIV and HBV research laboratories and HIV and HBV production facilities are specified in paragraph (g)(2)(ix).

(f) Hepatitis 13 Vaccination and Post-exposure Evaluation and Follow-up.

(I) General.

(i) The employer shall make available the hepatitis B vaccine and vaccination series to all employees who have occupational exposure, and post-exposure evaluation and follow-up to all employees who have had an exposure incident.

(ii) The employer shall ensure that all medical evaluations and procedures including the hepatitis B vaccine and vaccination series and post-exposure evaluation and follow-up, including prophylaxis, are:

(A) Made available at no cost to the employee:

(8) Made available to the employee at a reasonable time and place;

(C) Performed by or under the supervision of a licensed physician or by or under the supervision of another licensed healthcare professional; and

(D) Provided according to recommendations of the U.S. Public Health Service current at the time these evaluations and procedures take place, except as specified by this paragraph (f).

(iii) The employer shall ensure that all laboratory tests are conducted by an accredited laboratory at no cost to the employee.

-

(2) Hepatitis B Vaccination.

{i) Hepatitis 8 vaccination shall be made available af1er the employee has received the training required in paragraph (g)(2)(vii)(l) and within IO working days of initial assignment to all employees who have occupational exposure unles s the employee has

•• ... .. rt


(D) Results of the sou rce individual's blood testing, if available; and

(E) All medical records relevant to the appropriate treatment of the employee including vaccination status which are the employer's responsibility to maintain .

(5) Healthcare Profoss iona l' s Writlcn Opinion. The employer shall obtain and provide the employee with a copy of the evaluating healthcare professional's written o pinion within 15 days of the completion of the evaluation .

(i) The health care profcssional's written opinion for Hepatiti s B vaccination s hall be limited to whether Hepatitis B vaccination is indicated for an employee, and if the employee has received such vaccination.

(ii) The healthcare professional 's written opinion for post-exposure evaluation and follow-up shall be limited to the following information:

(A) That the employee has been informed of the results of the evaluation ; and

(B) That the employee has been told about any medi ca l conditions resulting from exposure to blood or other potentinlly infectious materials which require forther evaluation or treatment.

(iii) All other findings or diagnoses shall remain confidential and shall not be included in the written re port.

(6) Medical Recordkeeping. Medical records required by this standard shall be maintained in accordance with paragraph (h)(I) of this sec tion.


,,.-.


(g) Co mmunica tion of Hazards to Employees.

(I) Labels and Signs.

(i) Labels.

(A) Warning labels s hall be affixed to containers of regulated waste, refrigerators and freezers contain ing blood or other potentially infectiou s material; and other containers used to store, transport or s hip blood or other potentially infectious materials, except as provided in paragraph (g)( I )(i)(E), (F) and (G).


(B)

(C)

(D)

(E)

(F)

(G)

(H)


(I)

(ii) ) Signs. (A)


Labels required by this section shall include the following legen d: (For

<Illus tration >, of Biohaza rd symbol, Press F9) BIOHAZARD

These labels s hall be fluorescent orange or orange-red or * predominantly so. with lettering and symbols in a contra sting color.

Labels s hall be affixed as close as feasible to the container by strin g, wire, adhesive, or other method that preve nts their loss or unintentional removal.

Red bags or red contain e rs may be s ubstituted for labels .

Containers of blood, blood components, or blood products that are labeled as to their contents and have bee n released for trans fusion or other clinical use are exempted from the labeling requirements of paragraph (g).

Individual cont ainers of blood or other potentially infectiou s materials that are placed in a labe led containe r during storage, transport, sh ipment or disposal are exem pted from the labeling requirement.

Labels required for contaminated equi pment shall be in accordance with this paragraph and shall also state which portion s of the equipment remain contaminated.

Regulated waste that has been decontaminated need not be labeled or color-coded.

The employe r shall post s igns at the entrance to work areas specified in paragraph (e), HIV and HBV Research Laboratory and Production Faciliti es, which shall bear the following legend:

BIOHAZARD

(Name of the Infec tious Agent) (Special requirements for entering the area)



(viii) The person conducting the training shall be knowledgeable in the s ubject matter covered by the elements contained in the training program as it relates to the workplace that the training will address.

(ix) Additional lnitial Training for Employees in HIV iind HilV Laboratories and Production f aci lit ies . Employees in HTV or HBV research la boratories and HIV or HBV productio n facilities shall receive the following initial training in addition 10 the above training require ments.

(A) The employe r shall ass ure that emplo yees demonstrate pro ficiency in standard microbiological practices and techniques and in the practices and operations specific to the facility before being allowed to work with HIV or HB V.

(B) The employer s hall assure that emp loyees have prior experience in the handl ing of human pathogens or tissue cu ltures before working with HIV or 1-IBV.

(C) The employer shall provide a tra ining program to employees who have no prior experience in handling human pathoge ns. Initia l work activities shall not include the handling of infectious agents. A progression of work activit ies s hall be assigned as techniques are lea rned and proficiency is developed. The employer shall assu re that employees participate in work activities involving infectious agen ts on ly after proficie ncy has been demonstrated.

(h) Recordkeeping .

(I) ) Medical Records.

(i) The employe r shall establi s h and maintain an accurate record for each employ ee with occupationa l exposure, in accordance with 29 CFR 1910.20.

(ii) T his record shall include:

(A) The name and social sec urity number of the employee;

(B) A copy of the employee's hepatitis B vacc inati on status including the dates of all the hepatitis B vaccinations and any medical records relative to the employee ' s abili ty 10 receive vaccination as required by paragraph (f)(2);

(C) A copy of all results of examinations, medical test ing, and follow-up procedures as required by paragraph (f)(3);

(D) The employer's copy of the healthcare professional 's written opinion as required by paragrnph (t)(5); and

(E) A copy of the information provided to the healthcare professional as requi n::d by paragraphs (f)(4)(ii)(B)(C) and (D).

(iii) Confidentia lity. The employer shall ensure that emp loyee medical records required by paragraph (h}( I) are:

(A) Ke pt confidential; and •

(B) Not disclosed or reported withou t Lhe e mp loyee's express written consent to any person within or outsi de the workplace except as required by Lhis section or as may be required by law.

(iv) The employe r shall maintain the records required by paragraph (h) for at least Lhc duration of employment plus 30 years in accordance with 29 CFR 19 10.20.

(2) Training Records.

(i) Training records shall include the following in formation:

(A) The dates of the training sessions;

(8) The contents or a summary of the training sessions;

(C) The names and qualifications of persons conducting the training; and

(D) The names and job titles of all persons attending the training sessio ns.

(ii) Training records shall be maintained for 3 years from the date on which the training occu rred.

(3) Availabi lity.

(i) The employer shall ens ure that all records required to be maintained by this section shall be made available upon request to the Assistant Secretary and the Director for examinati on and copy ing.

.. • ••••


Thursday, January 18, 2001


Part IX

Department of Labor


Occupational Safety and Health Administration

29 CFR Part 1910

Occupational Exposure to Bloodborne

P at h o ge n s; Needlesticks and Other Sharps Injuries; Final Rule

• • .. r • - a.


Federal Re g i s ter / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations 5319


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ill . Summary and Explana tion The revisions to OSHA's DDP

standard required under tho Neecllestick Safety and Prevention Act can be broadly categorized into four areas: modification of definitions relating to engineering controls; revision and updating of tho Exposure Control Plan; solicitation of employee input; and recordkeeping.

The revised standard adds two additional terms to the definition section found in paragraph (b) and alters the definition of one other term. It adds "Sharps with Engineered Sharps Injury Protections" and defines this term as "a nonneedle sharp or a needle device

used for withdrawing body fluids, accessing a vein or artery, or administering medications or other flu ids, with a built-in safety feature or

mechanism that effectively reduces the risk of an exposure incident." This term encompasses a broad array of devices that make injury involving a contaminated sharp less likely, and includes, but is not limited to, syringes

with a sliding sheath that shields the


such as sharps with engineered sharps injury protections and needleless systems." This change clarifies that safer medical devices are considered lo be engineering controls under the standard. The term "Enginee ring Controls" includes all control measures that isolate or remove a hazard from the workplace, encompassing not only sharps with engineered sharps injury protections and needloless systems but also other medical devices designed to reduce the risk of percutaneous exposure to bloodborne pathogens.

Examples include blunt suture needles and plastic or mylar-wrapped glass capillary tubes, as well as controls that are not medical devices, such as sharps disposal containe rs and biosafcty cabinets.

The expanded definitions reflect the

intent of Congress to have OSHA amend the BBP standard to clarify

• • tho direction already provided by OSHA in its Compliance Directive; nnmcly, that employers who have employees with occupational exposure to bloodbome pathogens must consider and, whcro


adoption; the method or methods used to evaluate devices and the results of evaluations; and justification for

selection decisions. This information must be updated al least annually.

The revised Exposure Control Plan requirements make clear that employers

must implomcnl the safer medical devices that are appropriate, commercially available, and effective. No one medical device is app ropriate in all circumstances of use. For purposes of this standard, an "appropriate" safer medical device includes only devices whose use, based on reasonable judgment in individual cases, will not jeopardize patient or employee safety or be medically contraindicated. Although new devices arc being continually introduced, OSHA recognizes that a safer device may not be available for every situation. If a safer device is not available in the marketplace, tho employer is not required to develop any such device. Furthermore, tho revised requirements are limited to tho safer medical devices that are considered to be "effective.'' For purposes of this


-

attached needle after use; needles that retract into a syringe after use; shielded or retracting catheters used to access the bloodstream for intravenous administration of medication or fluids; and intravenous medication delivery systems that administer medication or fluids through a catheter port or connector site using a needle that is house d in a protective covering.

Tho revised s tandard also adds tho

term "Needleless Systems," which is defined as "a device that docs not use needles for: (A) The collection of bodily Ouids or wilhdrowal of body fluids after initial venous or arterial access is established; (B) tho admin istration of medication or Ouids; or (C) any other procedure involving the potential for occupational exposure to bloodborne pathogens duo to percutaneous injuries from contaminated sharps." "Needleless Systems" provide an alternative to needles for the specified procedures, thereby reducing the risk of percutaneous injury involving contaminated sharps. Examples of needleless systems include, but are not limited to, intravenous medication delivery systems that administer medication or fluids through a catheter port or connector site using a blunt cannula or other non-needle connection, and jct injection systems that deliver subcutaneous or intramuscu lar injections of liquid medication through tho skin without use of a needle.

Tho definition of "Engineering

' Controls" has been modified lo include as examples "safer medical devices,


appropriate. use effective engineering

controls, including safer medical devices, in order to reduce the risk of injury from needlcsticks and from other sharp medical instrwnents • • • (Ex. 5-3).

Thus, the revised definitions do not reflect any new requirements being placed on employers with regard to protecting workers from sharps injuries, but are meant only to clarify the original standard, and to reflect the development of new snfer medical devices since that time.

Paragraph (c)(l)(iv) of the standard is

revised to add new requirements lo the annual review and update of the Exposure Control Plan. Tho review and update of the plan is now required lo "(A) reflect changes in technology that eliminate or reduce exposure to bloodborno pathogens; and (B) document annually consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure." Thus, the additional provisions require that employers, in their written Exposure Control Plans, account for innovations in procedure and technological developments that reduce the risk of exposure incidents. This would include, but would not be limited to, newly available medical devices designed to reduce the risk of percutaneous exposure to bloodborne pathogens. Consideration and implementation of safor medical devices could be documented in the Exposure Control Plan by describing the safer devices identified as candidates for


standard, an ''e ffective" safer medical device is a device U1al, based on reasonable judgment, will make an exposure incident involving a contaminated sharp less likely to occur il1 the application in which it is used.

-

Paragraph (c)(l)(v) of the revised standard now requires that "An employer, who is required to establish an Exposure Control Plan shall solicit input from non-managerial employees responsib le for direct patient care who aro potentially exposed to injuries from contaminated sharps in the identification, evaluation, and selection of effective engineering and work practice conlrols and shall document tho solicitation in the Exposure Control Plan." This change represents a new requirement, which is performance­ oriented. No specific procedures for obtaining employee input arc prescribed. This provides the employer with flexibility to solicit employee input in any manner appropriate to the circumstances of the workplace. A dental office om ploying two hygienists, for example, may choose to conduct periodic conversations to discuss identification, evaluation, and selection of controls. A large hospital, on the other hand, would likely find that an effective process for soliciting employee input requires tJlC implementation of more formal procedures. The solicitation of input required by the standard requires employers to take reasonab le stops to obtain employee input in the identification, evaluation, and selection of controls. Methods for soliciting employee input may include


• • •


• ..-·.



Fe d e r a l R e g i ster /Vol. 66, No. 12 /Thursday, January 18, 2001/Rules and Regulations 5321


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the procedure being performed, the body part affected, objects or substances involved and how they were involved) so that the intended evaluation of risk and device effectiveness can be accomplished.

Information in the sharps injury log

must be recorded and maintained in a manner that protects the privacy ofthc injured employee. If data from the log arc made available to other parties, any information that directly identifies an employee (e.g., name, address, social security number, payroll number) or information that could reasonably be used to identify indirectly a specific employee (e.g., exact age, date of initial employment) must be withheld.

The format of tbe sharps injury log is not specified. The employer is permitted to determine the format in which the log is maintained (e.g., paper or electronic), and may include information in addition to that required by the standard, so long as the privacy of injured workers is protected. The Agency recognizes that many employers already compile reports of percutaneous exposure incidents in a variety of ways. Existing mechanisms for collecting these reports will be considered sufficient to meet the requirements of the standard for maintaining a sharps

injury log, provided that the information gatJ10red meets the minimum requirements specified in the standard, and the confidentiality of the injured employee is protected.

Under newly published revisions to OSHA's Recordkeeping rule (29 CFR 1904). employers are required to record sharps injuries involving contaminated objects on the OSHA 300 Log of Work­ Related Injuries and Ulnesses and the OSHA 301 Injury and 11lness Incident Report (the new forms replace the current 200 and 101 forms). When the revisions become effective, employers may elect to use the OSHA 300 and 301 forms to meet the sharps injury log requirements, provided two conditions are met. First, the employer must enter the type and brand of the device on either the 300 or 301 form. Second, tJ10 employer must maintain the records in a way that segregates sharps injuries

from other types of work-related injuries and illnesses, or allows sharps injuries to be easily separated. For example, if OSHA 300 and 301 records are maintained on a computer, the

employer must ensure that the computer is able to produce a record of sharps injuries that does not include other


types of work-related injuries and illnesses (i.e., through using a program that allows for sorting of entries by injury type). If records are kept on paper forms, the employer would need to use a separate page of the 300 Log for sharps injuries.

The revisions to the Record.keeping

rule will not become effective un til January 1, 2002, at the earliest, and until then many sharps injuries involving contaminated objects will not be recordable on the OSHA Jog. Therefore, employers must keep a separate sharps log from the effective date of this rule until the revised Reco rdkeeping rule becomes effective.

These revisions lo the BBP standard

become effective April 18, 2001. Exposure Control Plans that are reviewed and updated on or after this effective date must reflect the requirements of the revised standard. Percutaneous exposure incidents that occur on or after this effective date must be recorded on the sharps injury log.

OSHA's BBP standard, including tho

amendments herein promulgated, is applicable to general industry and shipyard employment (as referenced in 29 CFR 1915.1030).

IV. . Econ omic Analysis

Incremental Costs of the Mandated Revisions lo the Standard

OSHA has determined that the total cost of this action is $33,814,991 per year, and thus, that it is not an economically significant regulatory action within the meaning of Executive Order 12866. However, the rule is defined as a significant rule under the Executive Order, and has been reviewed by the Office of Management and Budget. This amendment to tl1e final standard does not involve any new engineering requirements to protect workers from sharps injuries, but it does include two new record.keeping requirements: First, the amended

standard requires employers to "establish and maintain a sharps injury log for the recording of percutaneous injuries* • *" However, for rer:ordable neodlestick incidents, OSHA already requires employers to collect much of the information needed for developing such a log under other rules, the Recordi ng and Reporting Occupational

Injuries and Illnesses regulation (29 CFR 1904) in particular. Moreover, OSHA has recently published revisions to 29 CFR 1904 that would cover the remaining, previously nonrecordable


needlestick injuries. Second, the current action requires any employer "who is required to establish an Exposure Control Plan" to "solicit input from

non-manageria'l employees responsible for direct patient care who are potentially exposed to injuries from contaminated sharps in the identification, evaluation, and selection of effective engineering and work practice controls and shall document the solicitation in the Exposure Control Plan." The methodology OSHA has used for computing costs for each requirement of the amended standard is presented in the next two sections.

Cost of Establishing and Maintaining a Sharps Injury Log

The rule requires employers to maintain a log for all needlostick and sharps injuries. At a minimum, the sharps injury log must contain: "(A) The typo and brand of device involved in the incident, (B) the department or work area where the exposure incident occurred, and (C) an explanation of how the incident occurred." The costs attributable to the log correspond directly to the number of needlestick and sharps injuries. The International Health Care Worker Safety Center (]HCWSC) provides the best available estimate of the number of need lestick injuries (Ex. 3-172V). IHCWSC has computed that 590,164 needlestick and sharps injuries occur annually.

Needlestick and sharps injury cases will require an effort pertaining to collection of data on the type and brand of device, the department or work area where the incident occurred. and an explanation of how the incident occurred. Because the amount of information required to be collected is limited, OSHA estimates that it will require an average of five minutes per case (0.08 hours) to collect the data a.nd enter it onto the separate log. Assuming that the task of collecting information related to the incident and entry onto the log will be conducted by an individual with the skill level of a Personnel Training and Labor Rela tions Specialist, an hourly wage of $26.32 is used to compute cost. (The hourly wage for Personnel Training and Labor Relations Specialist as reported in the Bureau of Labor Statistics Occupational Employment Statistics Survey is $19.03; benefits are computed at 38.3 percent of the hourly wage.) Thus, the incremental annual cost of the separate sharps injury lug is:



(590,164 cases) x (0.08 hours/case) x ($26.32/hour) = $1,294,352.


Federa l Register /Vol. 66, No. 12 /Thursday, January 18, 2001/Rules and Regulations 5323


federal mandate that may result in increased expenditures by state, local, or tribal governments in the aggregate of more than $100 mrnion, or increased expenditures by the private sector of more than $100 million. Moreover, the Agency has determined that for purposes of section 203 of the Act, this rule does not significantly or uniquely affect these entities.

Background

The Unfunded Mandates Reform Act was enacted in 1995. While much of the Act is designed to assist the Congress in determining whether its actions will impose costly new mandates on state, local. and tribal governments, the Act also includes requirements lo assist federal agencies to make this same determination with respect to regulatory actions.

Analysis

As discussed in Section IV, Economic Analysis, this rule will have incremental costs of $34 million per year, all of which aro associated with maintaining the sharps injury log and soliciting and documenting employee information. These total costs represent an average cost of $67 per year per affected establishment. OSHA does not anticipate any disproportionate budgetary effects upon any particular region of tho nation, or particular state, local or tribal governments. or urban or rural communities.

VI. Environmental Imp acts

The National Environmental Policy Act requires that "major Pederal actions significantly affecting the quality of the human environment" be accompanied by a statement addressing the environmental impact of the proposed action. (42 U.S.C. 4332(C)) Department of Labor regulations establish a criteria for determining when an environmental impact statement is required in a rulemaking proceeding:

Preparation of an environmental impact statement will always bo required for proposals for promulgation. modification or revocation of health standards which will significantly affect air, water or soil quality, plant or animal life, the use of land or other aspects of the human environment.

29 CFR 11.10 (a)(3)

OSHA has concluded that no significant environmental impacts would result from this rulemaking. This final standard expands the universe of engineering controls permissible for reducing occupational exposure to bloodborne pathogens. It also widens the scope of Exposuru Control Plan review, requires maintenance of a sharps injury log. and mandates the


solicitation of input from employees on the identification , eval uation, and selection of effective engineering and work practice controls. The Agency has not identified any impacts of these requirements on tho environment.

VII. F e d era lism

This standard has been reviewed in accordance with the Executive Order on Federalism (Executive Order 13132, 64

FR 43255, Aug. 10, 1999). The order requires that agencies, to tho extent possible, refrain from limiting state policy options; consult with states prior to taking actions that would restrict state policy options; and take such action only when there is clear constitutional authority and the presence of a problem of national scope. Executive Order 13132 also provides that agencies shall not promulgate regulations that have significant Federalism implications and impose substantial direct compliance costs on state or local governments, unless the agency consults with state and local officials early in the process of developing the proposed regulation and provides a summary Federalism impact statement in the preamble of the final rule. Finally, the Order provides for preemption of state law only if there is

a clear Congressional intent for the agency to do so, and provides that any such preemption is to be limited to tho extent possible.

Under Section 6(b) of the Executive

Order, an agency is exempt from state consultation requirements if it is promulgating a regula tion that is required by statute. The amendments to OSHA's BBP standard codified in this rule were explicitly written by Congress and enacted as Public Law 106--430.

Moreover , Congress clearly intended the revised BBP standard lo have thosame legal effect as other standards issued under 6(b) of the Occupational Safety and Health Act of 1970. Nonethe less, OSHA has consulted extensively with those 25 States and territories that operate OSHA-approved State plans with regard to OSHA policy on safe needle devices and the requirements of the subject legislation.

Section 18 of the OSH Act expresses Congress' intent to preempt state laws relating to issues on which Pederal OSHA has promulgated occupational safety and health standards. Under the OSH Act, a state can avoid proomption only if it submi ts, and receives Federal approval for, a Stale plan for the development and enforcement of

sta ndards. OSHA-approved Slate plans operate under authority of State law and must adopt occupational safety and health standards which. among other


things, must be at least as effective in providing safe and healthful employment and places of employment as Federal standards.

In Gade v. National Solid Wastes

Management Assoc., the U.S. Supreme Court reaffirmed the view that Section 18 of the OSH Act effectively preempts slates without approved plans from adopting or enforcing any laws that directly, substantially, and specifically regulate occupational safety and health. 505 U.S. 88, 107 (1992). However,

needlestick laws in states without an OSHA-approved State plan would not be affected to tho extent to which they regulate the occupational safety and health conditions of state or local government employees (soc Section 3(5) of the OSH Act ).

VIIl . S ta t e Plan S lat es

The 23 states and 2 territories that operate their own federaJly approved occupational safety and health plans must adopt a comparable amended standard within six months of the publication date of a final PederaJ OSHA standard. Tho Stales and territories with this obligation include: Alaska, Arizona, California, Connecticut (for Sta te and local government employees only). Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan.

Minnesota, Nevada, New Mexico, New

York (for State and local government employees only), North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Virgin Islands, Washington, and Wyoming. Until such timo as state and territorial standards are amended, Federal OSHA will provide interim enforcement assistance, as appropriate.

IX. Pap erw ork Redu c tion Ac t

This final rule contains new collection of information (paperwork) requirements in revisions to l1,e Bloodborne Pathogen Standard (1910.1030 and 1915.1030) made as a result of the Ncedlestick Safety and Prevention Act (Pub. L. 106-430). Those new paperwork requiremen ts are subject to review by tho Office of Management and Iludget (0MB) under the Paperwork Reduction Act of1995 (PRA 95), 44

U.S.C. 3501 et seq., and its regulation at 5 CFR Part 1320. OSHA solicits public comments concerning its estimate of the burden hours and costs for the revised paperwork requirements. The Agency will summarize the comments received and include a summary of them in its request lo 0MB to approve the information collection requirements; they will also become a matter of public record. OSHA seeks this information as part of its continuing effort to reduce




F e d er al Re g i s t e r I Vol. 66, No. 12 /Tbursday, January 18, 2001 / Rules and Regulations 5325


Section 1910.1030 is also issued under Pub. L. 106--430, 114 Stal 1901.

* * *

2. Section 1910.1030 is amended as follows:

A. In§ 1910.1030, paragraph (bl. the definition for "Engineering Controls" is revised and definitions are added in alphabetical order lo read as set forth below:

8. Paragraph (c)(l)(iv) is revised to read as set forth below:

C. Paragraph (c)(l)(v} is redesignatcd paragraph (c)(l)(vi), and a new paragraph (c}(l}(v) is added to read as set forth below:

D. A new paragraph (h)(S} is added to read as set forth below:

..

§ 1910.1030 Bloodborne pathoge ns.

" • *

(b) * * •

Engineering controls means controls (e.g., sharps disposal containers, self­ sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems} that isolate or remove the bloodborne pathogens hazard from the workplace.

*

Needle/ess systems means a device that docs not uso needles for:

(1) The collection of bodily fluids or


(3) Any other procedure involving the potential for occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps.

Sharps with engineered sharps injury pro t ections means a nonneedle sharp or a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids, with a built-in safety feature or mechanism that effectively reduces the risk of an oxposure incident.

.. * ,.. * ..

(c) • * *

(1) • * •

(iv) Tho Exposure Control Plan shall be reviewed and updated at least annually and whenever necessary to reflect new or modified tasks and procedures which affect occupational exposure and to reflect new or revised employee positions with occupationa l exposure. The review and update of such plans shall also:

(A) Reflect changes in technology that

eliminate or reduce exposure to bloodborne pathogens; and

(B) Document annually consideration and implementation of appropriate

commercia lly available and effective safer medical devices designed to eliminate or minimize occupational


care who are potentially exposed to injuries from contaminated sharps in the identification, evaluation, and selection of effective engineering and work practice controls and shall document the solicitation in the Exposure Control Plan.

*

(h). * ..

(5) Sharps injury log. (i) The employer shall establish and maintain a s harps injury log for the recording of percutaneous injuries from contaminated sharps. The information in the sharps injury log shall be recorded and maintained in such manner as to protect the confidentiality of tho i njured employee. The sharps injury log shall contain, at a minimum:

(A) The type and brand of device involved in the incident,

(B) The department or work area whore the exposure incident occurred, and

(C) An explanation of how the facident occurred.

(ii) The requirement to establish and maintain a sharps injury log shall apply to any employer who is required to maintain a log of occupational injuries and illnesses under 29 CFR 1904.

(iii) The sharps injury log shall be maintained for tho period required by


withdrawal of body fluids after initial


exposure.

(v) An employer,


who is required to


29 CFR 1904.6.


venous or arterial access is established; (2} The administration of medication

or fluids; or


establish an Exposure Control Plan shall solicit input from non-managerial employees responsible for direct patient


* *

[FR Doc. 01-1207 Filed 1-17-01: 8:45 am)

BILLING CODE 4510-26-P


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