OSHA’s Silica Proposal Up Close - khlaw.com Proposal Slides 10.10.13.pdf · The Good, The Bad and...

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David [email protected]

Lawrence [email protected]

Manesh [email protected]

MJ [email protected]

OSHA’s Silica Proposal Up Close:The Good, The Bad and The Ugly

Presented by:

│ www.khlaw.com │ KELLER AND HECKMAN LLP2 Copyright © 2013

David G. Sarvadi

Mr. Sarvadi practices in the areas of occupational health and safety, toxicsubstance management, pesticide regulation, and product safety.

Mr. Sarvadi represents clients before a variety of federal and stateenforcement agencies in legal proceedings involving OSHA citations,EPA Notice of Violations, TSCA consent orders, CPSC Notices, FIFRAStop Sale Use and Removal Orders, and EEOC Charges ofDiscrimination. He works with clients in developing, reviewing, andauditing compliance programs in all of these areas, and in obtainingagency rulings on proposed or novel activities and questions, seekinginterpretations of regulations as they apply to specific sets of facts. Hehas been counsel to the National Coalition on Ergonomics from itsinception.

He has a background in occupational safety and health, having workedas an industrial hygienist for more than 15 years and became a CertifiedIndustrial Hygienist in 1978, a designation he held until he voluntarilyrelinquished it in 2010. Prior to becoming an attorney, he managed acorporate industrial hygiene program for a Fortune 500 company. Mr.Sarvadi was selected by the National Academy of Sciences to participatein a panel of the Institute of Medicine that was asked to review a NIOSHstudy on the use of respirators. He was asked to participate because ofhis expertise in law and industrial hygiene.

David SarvadiPartner

[email protected]


Lawrence P. Halprin

Lawrence Halprin is a partner in Keller and Heckman’s workplacesafety and health, chemical regulation and litigation practicegroups. He is nationally recognized for his work in workplacesafety and chemical regulation. His workplace safety and healthpractice covers all aspects of legal advocacy, including:representing clients in OSHA and MSHA investigations andenforcement actions; providing compliance counseling andtraining; conducting incident investigations, compliance audits andprogram reviews; participation in federal (OSHA, MSHA andNIOSH) and state rulemakings and stakeholders processes;bringing and intervening in pre-enforcement challenges to finalagency rules; advising on legislative reform and oversight; andparticipation in the development of national consensus standardsunder the ANSI process, and TLVs under the ACGIH process.

Mr. Halprin's engineering and financial background and extensiveknowledge of OSHA rulemakings have greatly enhanced hisability to: provide compliance counseling and represent clients inenforcement actions; and evaluate and critique rulemakingproposals and suggest alternative approaches. On behalf of oneor more clients, Mr. Halprin has participated in almost every majorOSHA rulemaking over the past 25 years as well as numerousCal-OSHA rulemakings.

Lawrence HalprinPartner

[email protected]


Manesh K. Rath

Manesh Rath is a partner in Keller and Heckman’s litigation andOSHA practice groups. He has been the lead amicus counsel onseveral cases before the U.S. Supreme Court including Staub v.Proctor Hospital and Vance v. Ball State University.

Mr. Rath is a co-author of three books in the fields of wage/hour law,labor and employment law, and OSHA law. On developing legalissues, he has been quoted or interviewed in The Wall StreetJournal, Bloomberg, Smart Money magazine, Entrepreneurmagazine, on "PBS's Nightly Business Report," WAVY-TV and C-SPAN. He was listed in Smart CEO Magazine's Readers' Choice Listof Legal Elite.

Mr. Rath has extensive experience representing industry in OSHArulemakings. He has successfully represented employers—includingsome of the largest in the country—in OSHA citations andinvestigations before federal OSHA in regions across the countryand in state plan states.

Mr. Rath currently serves on the Board of Advisors for the NationalFederation of Independent Business (NFIB) Small Business LegalCenter. He served on the Society For Human Resources (SHRM)Special Expertise Panel for Safety and Health law for several years.He is the editor and co-author of the OSHA chapter of theEmployment and Labor Law Audit (9th and 10th Editions) and a co-author of the book Occupational Safety and Health Law Handbook(2001).

Manesh RathPartner

[email protected]


MJ Marshall

MJ serves as a Vice President in Grayling's Energy, Environment andSustainability Practice where she helps manage a variety of corporate andassociation clients and conducts energy and environment policy and industryresearch.MJ's three decades of Washington experience includes work as a SeniorLegislative Assistant to former U.S. Senator Malcolm Wallop (WY), ProfessionalStaff Member of the Senate Energy Committee and Legislative Director to aMember of Congress. MJ has also represented diverse industries such asenergy, mining, environment, construction and chemicals, including those usedin the manufacture of flavors, fragrances and colors. As the Director ofGovernment Relations for the Mason Contractors Association of America(MCAA), Marshall led a broader coalition effort in 2003 to coordinate thedevelopment and submission of comprehensive comments on OSHA's draftsilica proposal and pursue an alternative regulatory approach with OSHA andNIOSH that ultimately culminated in the adoption of the ASTM standard coveringcrystalline silica in construction. MJ is also actively engaged in nanotechnologyissues, focusing particularly on the manufacturing side.A native of Virginia, Marshall graduated from Catawba College with a degree inFrench and Psychology and holds a Paralegal Certificate from GeorgetownUniversity.

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I.Overview of Proposed Silica Rule


OSHA Proposed Rule

Published In Federal Register onSeptember 12, 2013

Establishes comprehensive standards in

• General industry

• Maritime

• Construction

Would regulate exposure to respirablecrystalline silica (RCS)


Who is Affected?

Construction• Abrasive blasting – paint removal, rust removal• Rock drilling,• Road work, tunneling, pouring concrete• Groundbreaking, excavation, jackhammering• Maintenance of structures• Cutting and drilling into structures to install equipment

Shipyards – cleaning, cutting, paint and coatings Manufacturing

• Brick and other masonry• Foundries• Tools and dies• Steel• Molds, jewelry, dental implants, glass, china, ceramics• Household abrasives, adhesives, paints, soap, glass

Mineral extraction – e.g., hydraulic fracturing Mining – separate MSHA proceeding


Comprehensive Standard

Permissible exposure limit (PEL) and action level (AL) Exposure monitoring that determines other requirements Exposure control measures

• Engineering controls• Work practices• PPE

Regulated area or Access Control Plan Protective equipment Hygiene areas and practices Housekeeping Medical surveillance Hazard communication


Permissible Exposure Level

Airborne concentration of RCS of 50 μg/m³ (1/2 the current PEL)

Calculated over 8 hour time weighted average(TWA)

Triggers all requirements of standard

• Medical monitoring if over 30 days per year


Action Level

Airborne concentration of RCS of 25μg/m³

Calculated over 8 hour time weightedaverage (TWA)

Thus, at half of the Permissible ExposureLevel (PEL)

Triggers:

• Periodic exposure monitoring


Monitoring

Initial Monitoring

Periodic Exposure Assessment• If initial monitoring indicates levels at or above

Action Level

• Fixed Schedule

– If at or below PEL, at least every 6 mos.,

– If above PEL, at least every 3 mos.

• Performance-based requirement

– For each employee

– Based on combination of air monitoring orobjective data sufficient to be accurate


Compliance Methods

include:• Engineering controls

– In construction, may comply with Table 1• Work practice controls

–Job Rotation not permissible to achieve PEL–Limiting exposure time is bona fide work

practice control–When these are not feasible, must still use

them to bring exposure to lowest feasiblelevel, and then supplement them withrespiratory protection

• Respiratory Protection


Medical Surveillance

includes:• Make this available for each employee exposed

above the PEL for 30 days/year or more at no costto employee

• Initial baseline exam within 30 days of initialassignment

• At least every three years, or more asrecommended by health care provider

• Physical exam, chest x-rays, pulmonary functiontest, testing for latent TB, any other test deemedappropriate by health care provider.


Communication

Employers must include RCS in hazardcommunication standard program

In labels, SDS, inventory, and training.

Among hazards that must be included:

• Cancer, lung effects, immune system effects, andkidney effects

• Identify affected operations and protectiveprocedures, including PPE and medicalsurveillance program.

Employer must ensure that employee candemonstrate knowledge of these elements


Recordkeeping

Keep records of:• Air monitoring

–Testing procedure and results

–Identity of lab that performed analysis

–Process or operation being performed

–Identity of all employees represented bythe monitoring and actually monitored

–The material containing RCS

• Objective data of representative exposure

• Medical monitoring

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II.Significant Risk and

The OSHA Risk Assessment


Significant Risk

OSH Act § 3(8) defines “occupational safety and healthstandard” to mean a set of workplace measures“reasonably necessary or appropriate to provide safe orhealthful employment and places of employment.“

Benzene

• § 3(8) requires a threshold finding that the

toxic substance in question poses a significanthealth risk in the workplace, and that a new, lowerstandard is therefore "reasonably necessary orappropriate to provide safe or healthful employmentand places of employment."


Significant Risk

OSH Act § 6(b)(5): standards for toxic materials

• Congress provided qualitative definition ofsignificant risk

• DOL/OSHA must set the standard which mostadequately assures, to the extent feasible, onthe basis of the best available evidence, thatno employee will suffer material impairmentof health or functional capacity even if suchemployee has regular exposure to the hazarddealt with by such standard for the period ofhis working life.


Significant Risk

Benzene• “Significant risk” not a mathematical

straightjacket, but a DOL/OSHA policydetermination subject to judicial review. Neednot be calculated with scientific certainty

– If… the odds are one in a billion that a person will diefrom cancer … , the risk clearly could not beconsidered significant. On the other hand, if the oddsare one in a thousand that regular inhalation of …vapors … will be fatal, a reasonable person mightwell consider the risk significant ….

– OSHA: 1/1000 from exposure over working lifetime of45 years (8hr/day x 5 days/wk x 50 wks/yr x 45 yr)


History of OSHA PELs

Table VII-4: Selected OSHA Risk Estimates for Prior and Current PELs (Excess Cancersper 1000 Workers) [modified]

Standard Risk at Prior PELRisk at Current

PELFederal RegisterDate – Final Rule

Ethylene Oxide 63-109 per 1000 1.2-2.3 per 1000 June 22, 1984Asbestos 64 per 1000 6.7 per 1000 June 20, 1986Benzene 95 per 1000 10 per 1000 September 11, 1987Formaldehyde 0.4-6.2 per 1000 0.0056 per 1000 December 4, 1987Methylenedianiline *6-30 per 1000 0.8 per 1000 August 10, 1992Cadmium 58-157per1000 3-15per1000 September 14, 19921,3-Butadiene 11.2-59.4 per 1000 1.3-8.1 per 1000 November 4, 1996Methylene Chloride 126 per 1000 3.6 per 1000 January 10, 1997Chromium VI 101-351 per 1000 10-45 per 1000 February 28, 2006

Estimated Risk atCurrent PEL

Estimated Risk atProposed PEL

Crystalline SilicaGeneral Industry PEL 13-60 per 1000 6-26 per 1000 N/AConstruction/Shipyard PEL 27-653 per 1000 6-26 per 1000

* no prior standard; reported risk is based on estimated exposures at the time of the rulemaking


OSHA Estimate of Excess/PrematureDeaths from Silica Exposure

Table VII-2: [OSHA Estimate of] Expected ExcessDeaths per 1,000 Workers [over 85 year lifetime]

Fatal Health Outcome CurrentGeneral

Industry PEL(0.1 mg/m3)

CurrentConstruction/Shipyard PEL

(0.25-0.5mg/m3)

ProposedPEL

(0.05 mg/m3)

Lung Cancer:

10-cohort pooled analysis 22-29 27-38 18-26

Single cohort study-lowest estimate 13 37-95 6

Single cohort study-highest estimate 60 250-653 25

Silicosis 11 17-22 7

Non-Malignant Respiratory Disease(including silicosis) 83 188-321 43

Renal Disease 39 52-63 32


OSHA Estimated Impact of Standard

Number of affected employees

• Construction: 1.8 million

• General Industry and Maritime: 0.3 million

OSHA Estimate of Annual Benefits of ProposedStandard: Number of Cases Prevented

• Is this double counting?

Silica-Related Mortality 688

Fatal Lung Cancers (midpoint estimate) 162

Fatal Silicosis & other Non-Malignant Respiratory

Diseases (emphysema, bronchitis)

375

Fatal Renal Disease 151

Silicosis Morbidity 1,585


NIOSH Data on Silicosis Mortality

Figure I-1. Number of silicosis deaths andage-adjusted mortality rate, U.S. residentsage 15 years and older, 1968-2005


Issues to Consider in EvaluatingOSHA Risk Assessment

How to proceed with critique• Underlying original studies and meta-studies

– Were original studies and meta-studies designed andconducted according to established scientific principles,and did they report statistically significant conclusions?

• OSHA health effects analysis (HEA)– Did OSHA include all relevant studies, and properly

analyze and critique entire data base?

• OSHA preliminary risk assessment (PRA)– No studies evaluating risk at proposed PEL, but only at

much higher exposure levels. Significance?

– Reliance on mathematical modeling and extrapolation

– HEA and PRA underwent peer review


Issues to Consider in EvaluatingOSHA Risk Assessment

Overwhelming task for most affectedemployers to conduct such a review.

Quality of exposure data

• Did studies relied upon by OSHA provide adequateexposure data?

• Was conversion from particle count data to massdata accurate?

• OSHA PRA: says ERG contractor performedvariability analysis based on potential errors in dataused and found would not make a significantdifference. Was this analysis done properly?


Threshold Effect Level

OSHA: “a threshold exposure level might liewithin the range of the proposed action level,and thus add uncertainty to the estimatedrisks associated with exposure to the actionlevel, available information cannot firmlyestablish a threshold exposure for silica-related effects.”

Resolution of this issue could be critical• In responding to any effort to seek a lower PEL• In connection with potential tort liability• If employees exposed below the PEL request

respirators

Technical Feasibility,OSHA Rulemaking on

Silica, Time forIndustry Action

MJ MarshallVice President

Grayling202-479-7187

[email protected]

LowestAchievablePermissible

Exposure Limit

OSHA’s analysis: lowest achievable PEL is 50micrograms per cubic meter

108 operations examined in general industry,maritime and construction

To evaluate exposures OSHA reviewed:–published literature–SEP reports–NIOSH reports/Health Hazard Evaluations–ERG and OSHA site visit reports–Samples representative of industries with

exposure readings ranging from 25 to 250micrograms per cubic meter for selectedoperations, some readings much higher

OSHA also reviewed:

– (1) extent to which engineering controls can reduce and

maintain exposures

– (2) capability of sampling and analytical methods to

measure exposure

OSHA found:

– (1) In 21 percent of industry operations, PEL of 50 not

feasible with engineering and work practice controls

– (2) At concentrations below 50/at or above 25, errors

increase in data, but accurate enough to trigger

compliance needs

X-Ray Diffraction most reliable analytical method, but also

most expensive

PEL –RepresentativeSampling Data

Front-end loaders – 50% exposed to silica levels of 35 ug/m3,

but below PEL of 50, recommend enclosed cab retrofits, LEV to

maintain low levels

Maintenance workers/Ready Mix Concrete, results ranged from

11-58 ug/m3, additional controls such as wet methods or dust

suppression and HEPA filtered vacuums recommended

Material handlers – 29% of workers exposed below PEL of 50;

based on 7 sample results and OSHA data; additional controls:

LEV, HEPA-filtered vacuums

Abrasive blasters – 27 samples; in uncontrolled circumstances,

exposures ranged from 12ug/m3 to 29,040; with wet methods,

exposures ranged from 36 to 407 ug/m3

Proposed ActionLevel (AL) of

25ug/m3

In Technical Feasibility Study, OSHA found that PEL/AL of 25 onlyachieved in industries where small amounts of silica used, suchas dental labs, paint and coatings, and mineral processing

In ferrous foundry industry, 25 could not be achieved withoutrespirators

OSHA rule proposes requirement of initial exposure analysis toensure exposures below AL of 25; periodic monitoring requiredto maintain exposures below PEL of 50

If above the AL, but below PEL, monitoring every 6 months

If above the PEL, monitoring every 3 months

Additional monitoring required when change in productionprocess, control equipment, personnel or work practicesresulting in additional exposures

AL creates confusion and greater potential for liability

ConstructionIndustry

PEL of 50 achievable in 10 of 12 activities (abrasiveblasting and tuckpointing not feasible); OSHA looking foradditional data to identify more activities to be coveredunder rule

Most activities in construction below PEL; however,duration of tasks and exposure monitoring varies

Construction sites constantly changing

If, as OSHA concludes, that 241,269 workers inconstruction need respirators in cases where PEL notachievable with engineering and work practice controls,why not SECAL

SECAL: Special Engineering Control Air Limit

SECAL set for cadmium when specified processes andworkplaces found not to meet PEL

Construction-Methods ofCompliance

Consider the following scenario on a construction site:– One person mixing mortar; dumping bag, dust

everywhere– One person cutting brick using dry methods– One person cutting block using wet methods– One person tuckpointing (removing old mortar between

bricks)– One front-end loader operator moving brick and block– One maintenance worker– Wind gusting at outdoor site; normal conditions

previous day– New employee on site to perform new task (abrasive

blasting)

How can employer ensure compliance with proposedstandard?

Proposed rule in this scenario would require employer todo the following:

– Set up regulated areas or establish access controlpoints for dry cutting, mortar mixing, tuckpointing

– Provide employees in regulated areas with protectiveclothing and respirators

– Perform exposure monitoring due to change in weatherconditions and personnel

Very complicated

Industry can and should provide data and justification forSECAL and other methods of compliance

Unions trying to force changes in technology

Alternatives to silica limited, expensive and health effectsuncertain

Must ensure standard is feasible and cost-effective


Grayling202-479-7187

[email protected]

www.khlaw.com


IV.Economic Feasibility Issues


Economic Feasibility/Regulatory Flexibility

Required by Presidential Orders• Assess all benefits and costs

• Select regulatory approaches to maximize netbenefits

Preamble VIII• Summary of the Preliminary Economic Analysis

• Initial Regulatory Flexibility Analysis

• 99 pages

Preliminary Economic Analysis• 1401 pages!


Overview

Annualized costs, all industries• $658 MM

• 0.2% annual revenues

• 0.5% annual profits

Benefits• Avoided fatalities

– 162 cancers

– 375 silicosis

– 151 renal disease

• Avoided illnesses– 1585 silicosis cases


Industries Affected

Asphalt Paving Products

Asphalt Roofing Materials

Industries with Captive Foundries

Concrete Products

Cut Stone

Dental Equipment and Supplies

Dental Laboratories

Flat Glass

Iron Foundries

Jewelry

Mineral Processing

Mineral Wool

Nonferrous Sand Casting Foundries

Non-Sand Casting Foundries

Other Ferrous Sand Casting Foundries

Other Glass Products

Paint and Coatings

Porcelain Enameling

Pottery

Railroads

Ready-Mix Concrete

Refractories

Refractory Repair

Shipyards

Structural Clay

24 General Industry/ Maritime Sectors1 Huge Generic Industry


Industries Affected

Construction Industry Sectors2361 Residential Building Construction2362 Nonresidential Building Construction2371 Utility System Construction2372 Land Subdivision2373 Highway, Street, and Bridge Construction2379 Other Heavy and Civil Engineering Construction2381 Foundation, Structure, and Building ExteriorContractors2382 Building Equipment Contractors2383 Building Finishing Contractors2389 Other Specialty Trade Contractors


Sites, Employers and Employees Affected

Total entities, sites, and employees inaffected industries

• 1,025,888 Entities

• 1,041,291 Establishments

• 17,508,728 Employees

Affected entities, sites, employees

• 532,866 Entities

• 533,597 Establishments

• 2,144,061 Employees


Affected Employees

2,144,061 Total

• Half above the proposed action level

• 26% above the current PEL

• 23% between the proposed and current PEL


Why Is The Standard Necessary

Private Market Forces Inadequate Causes of Market Failure

• Imperfect information– Both employees and employers– Inability to process risk information

• Externalities– Injury/illness costs not borne by employers and workers compensation– Most costs borne by government (!)– =>Inefficiently high risk

• Imperfect competition– Captive labor pools– Inability/reluctance to relocate– =>lower wages than risk would command

The market will not provide the level of protection afforded bythe proposed standard.


Are There Inadequate Data?

Are exposure estimates based on samplesizes that are too small?

• Asphalt paving – 5 samples

• Asphalt roofing materials – 12 samples

• Abrasive blasting operators – 7 samples

• Dental supplies – 3 samples

Are industry characteristics accurate?

• Engineered stone

– OSHA PEA – 1 entity?


Is OSHA’s Methodology Appropriate?

Control costs on a per-employees basis• Related to the estimates of overexposed

employees

• Multiplied estimated control cost by thenumber of overexposed

– At proposed PEL 50 μg/m3

– At alternative PEL 100 μg/m3 ,

Is this circular?• Should control costs be estimated per

establishment? Per task?


Costs Not Considered

General Industry

• Substitution of low or non-silica materials

– Not considered by ERG

– Inferior performance?

– Lower productivity?

• Some controls methods where other controlsdeemed to reduce exposure sufficiently


Exposure Assessment Costs

Based on per breathing zone sample

• Direct costs

– IH fees, laboratory, and shipping

• Productivity loss

• Recordkeeping

Results

• Total per sample

– $412.44 GI/M

– $415.48 Construction



OSHA did well• Included productivity loss

• Used professional time estimates

• Adjusted fees based on establishment size

OSHA did not so well• IH cost estimate is too low - $500/day

– Current fees exceed $100 per hour

– Likely does not include travel time or reportpreparation time



Is the assumption that exposureassessment only requires collection of asample?

• Did OSHA include cost of assessingworkplace for most exposure, representativeemployee?

• Assumed 4 workers per area?


Medical Costs

On-site vs Travel to a medical facility• Current employees

– Assumed on-site for 100% of employers with >500employees, 75% for 20-499 employees and 20% for<20.

• New-hires– Assumed on-site for 90% of employers with >500

employees, 50% for 20-499 employees and 10% for<20

• My estimates: 20% of employers with >500employees, 5% for 100-499 employees and 0%for <100


Issues

Did OSHA’s contractor identify all affectedindustries?

Are the numbers of employees affectedaccurate?

Are the methods used appropriate?

Are the assumptions rationally related toactual practice?


What To Do

Review PEA and underlying documents for yourindustry• PEA – 1400 pages• OSHA-2010-0034-1365 – 622 pages• OSHA-2010-0034-1709 updated construction

industry draft – 134 pages• 1700 documents!

– Many not available online – copyright

Survey your members, plants, operations• Get real data• Summarize and submit

– Use trade associations to maintain confidentiality– Account for ALL costs

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V.The Substantial Evidence Requirement


Industrial Union Department, AFL-CIO v. AmericanPetroleum Institute (the Benzene Case)

• U.S. Supreme Court, 1980

• Exposure to benzene may lead to blooddisorders et al

• 1974: NIOSH reviewed cases,recommended 10 ppm/8 hr TWA (the then-current ANSI level)

• 1974-1976: NIOSH acknowledged no studyprovided dose–response data at 10ppm

• 1976: NIOSH memo to OSHA = 1 ppm


The Benzene Case, cont’d

cont’d….

Studies existed with evidence of effects atexposures well above 10 ppm

but did not provide support that limitshould be 1 ppm

OSHA: it is impossible to develop a dose-response curve in time for a standard dueto the latency of illnesses derived fromexposure



S. Ct.: OSHA made no finding that theprovisions of the standard werereasonably necessary or appropriate toprovide a safe or healthful workplace

6(b)(5) of Act: OSHA must set a standardon the best available evidence

A standard must be reasonably necessaryto remedy a significant risk



Court: OSHA must show, on the basis ofsubstantial evidence, that it’s more likelythan not that long term exposure to10 ppm = significant risk or material harm


Cotton Dust

OSHA set standard at 200 μg/m³ / 8 hr TWA

Industry members conceded that there existssubstantial evidence that cotton dust is linkedto byssinosis

Petitioners challenged whether the standardwas “reasonably necessary or appropriate” atthe proposed PEL

Petitioners argued that OSHA lackedsubstantial evidence that the standard wastechnologically or economically feasible


Cotton Dust (cont’d)

S.Ct.: Substantial evidence of feasibility

OSHA not expected to do cost-benefitanalysis, since Congress has already donethat.


AFL-CIO v. OSHA (The PELs Case)

§ 3(8) Definitions under the Act: A standard is something that requires a

condition or practice that is “reasonablynecessary or appropriate” to provide safe orhealthful employment

11th Cir. held that OSHA had not sufficientlydemonstrated that the new PELs werereasonably necessary (or feasible)

OSHA does not have to calculate the exactprobability of harm to show that significant riskexists, but it does have to estimate the actualrisk and not rely on conventions for assessingrisk


Back to Silica:On Basis of Substantial Evidence

Must OSHA meet the substantial evidencerequirement for each element of the standard?

Does OSHA provide substantial evidence that:

Respirators are less reliable than work practices

25 μg/m³ is a level below which no exposuremonitoring necessary

30 days above PEL necessitates medicalmonitoring rather than, e.g., 45, 60, 90?

The studies cited can also be inferred to applyto all operations in all industries covered underthe proposed standard?


Elements of the proposed rule

Has OSHA set forth the evidence in support of:

50 μg/m³ PEL?

Its scheme for exposure monitoring?

The threshold for medical monitoring?

Hierarchy of controls?

• Use engineering controls even when they won’tachieve reduction to below PEL?


Preamble

OSHA has “preliminarily determined” thatthere is a significant risk remaining at theproposed PEL, but that 50 μg/m³ is thelowest feasible level


Health Effects

Are the studies the latest available, or arethey dated?

NIOSH Work-Related Lung DiseaseSurveillance System

Are all NIOSH data based on all affectedindustries?

• Do all forms of crystalline silica has sameeffects.

1968 – 2002, silicosis related deaths (2008)decreased by 93% in overall mortality rate

Constant since late 1990’s

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VI.The Comment Period


Schedule

Comments due December 11, 2013

Notice to Participate In Hearings dueNovember 12, 2013


Some IssuesRaised By Proposed Rule:

Adequacy of comment period Feasibility of PEL Justification for lowered PEL Validity of cost estimates Alleged causal connection between chronic

exposure and specific and non-specificdiseases of the lung, kidney, and immunesystem

The assumption of a linear correlationbetween risk and exposure level with nothreshold level


Issues Include (cont’d):

Premise that engineering and workpractice controls are superior torespiratory protection

Prohibition on dry sweeping

Distinction between general industry andconstruction activities

Monitoring of co-located activities

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THANK YOU !

David SarvadiPartner

Keller and Heckman LLP

1001 G Street NWSuite 500 West

Washington, DC 20001(202)434-4249

[email protected]

Lawrence HalprinPartner



Washington, DC 20001(202)434-4177

[email protected]

Manesh RathPartner



Washington, DC 20001(202)434-4182

[email protected]


Grayling(202)479-7187

[email protected]

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