Document MJkaKyKK4Ey4JqYYQjpMJvdRk
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Legal Issues Concerning Regulation of Crystalline Silica
Adele L. Abrams, Esq., CMSP, REA Beltsville, MD, USA
IOHA Sixth International Scientific Conference September 2005
Overview: Crystalline Silica
o Crystalline silica is the chemical compound silicon dioxide (SiO2) - commonly known as quartz - it is the second most common mineral in the earth's crust.
o Crystalline refers to fact that oxygen and silicon atoms are arranged in three-dimensional repeating pattern
Amorphous silica molecules are linked randomly. o Crystalline silica over-exposure in occupations such as
mining, construction, sandblasting, concrete demolition, foundries etc. is a documented health hazard. o Other sources include: agricultural tilling, paved and unpaved road, household products (cleansers, cosmetics, wallboard, paint, talc powder), unwashed vegetables
Silica Health Issues
o In the United States, 3 million workers are exposed to respirable silica dust (particles less than 10 pm in diameter) -1.7 million are still overexposed.
o Workers or other individuals with high rates of crystalline silica exposure -acute or chronic- may develop silicosis and/or lung cancer.
o Crystalline silica classified as "Group One" human carcinogen by IARC. Considered carcinogenic by NTP and ACGIH.
o New research indicates links between silica exposure and pulmonary tuberculosis, emphysema, scleroderma -- as well as auto-immune diseases (e.g., lupus, nephropathy, scleroderma, and rheumatoid arthritis).
Silica Health Issues
o Silicosis is the oldest known, well-documented, occupational lung disease (Hippocrates, Pliny)
o US Public Health Service first warned of disease in foundry workers and sandblasters in 1917
o Data available in US linking silicosis to granite mining in 1920s
o OSHA, MSHA adopted regulatory schemes in 1970s to restrict occupational silica exposure to 100 ug/m3 (0.10 mg/m3).
o OSHA, MSHA adopted hazard communication standards - require employers to train workers on hazards, offer PPE, label products and maintain current MSDSs. Despite this, deaths still occur . . . Why is this disease not better controlled in the U.S. worker population?
U.S. Regulation of Silica
o OSHA regulates silica exposure at 29 CFR 1910.1000"Z" tables.
o Newrulemaking in progress, but process stalled due to political factors.
o NIOSH REL and ACGIH TLV are 0.05 mg/m3 and this information must be included per Hazard Communication Standards
29 CFR 1910.1200 (OSHA);
30 CFR Part 47 (MSHA).
o MSHA regulates silica exposure in underground and surface coal, metal and non-metal mines (includes sand pits and cement plants) under general air contaminant standards.
o Current rules incorporate outdated ACGIH TLV (1972Coal, 1973-metal/nonmetal).
o Current OSHA and MSHA PEL formula for quartz is:
10/(% quartz + 2) mg/m3 This equates to 10 ug/m3
(0.10 mg/m3).
The PEL for respirable cristobaliteandtridymite is one-half the value for quartz
Proposed U.S. Silica Rule
o October 2003 - Department of Labor circulates draft proposal for comprehensive standard, which includes: Revised PEL (three alternative PELs under consideration: 50, 75, and 100 pg/m3, as 8-hour TWA), Exposure assessment requirements, Medical surveillance, Employee training, Hygiene facilities, and Respirator use (only to supplement engineering controls and work practices after all feasible engineering and work practice controls have been implemented). Also would require that employer use engineering controls and work practices to maintain exposures at or below the PEL, unless such controls are not feasible or employees are exposed above the PEL for fewer than 30 days per year.
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Selected International OELs
Country Australia Austria Belgium France (mining)
Greece Italy
OEL Name National Exposure Standard Worksafe
MaximalenArbeitsplatz Koncentrat ion
Ministere de l'Emploi et du Travail
Empoussierage de reference
Quartz Limit 0.2 mg/m3
0.15 mg/m3
0.1 mg/m3
5 mg/m3(dust < 5% Q) or 25 mg/m3/%Q (dust > 5% Q)
Legislation for mining act ivities
Threshold Limit Value
0.1 mg/m3 0.05 mg/m3
Netherlands United Kingdom
Maximaal Aanvarde Concentrate
Maximum Exposure Limit
0.075 mg/m 0.3 mg/m3
OSHA and MSHA Sampling
o US regulations promulgated by OSHA and MSHA require monitoring the presence of silica forms in the workplace atmospheres and marketed products.
o OSHA samples relatively few worksites ... MSHA inspects each mine at least twice/yr. and performs health sampling at least annually. Agency can issue citation based on a single sample during a single shift.
o All sampling results and citations for overexposure are posted on government
website (identifying company involved). This
creates historical record of overexposures that can be used in tort litigation.
OSHA Risk Assessment
o OSHA's risk assessment estimates a lifetime mortality risk of 12.6 per thousand for workers exposed at 100 micrograms per cubic meter of air (100 ug/m3 is equivalent to the current PEL of 0.10 mg/m3) for a 45-year work- life.
o The lung cancer risk model predicts a lifetime mortality risk of 27.2 per thousand for workers exposed at 100 ug/m3 for a 45-year work- life.
o For exposed workers, this means 12.6 per thousand are projected to die sometime from silicosis and 27.2 per thousand are projected to die sometime from lung cancer at current permissible exposure limits.
> OSHA estimates that at construction and manufacturing work sites surveyed from 1979 to 1999, silica dust exceeded the recommended maximum more than half the time.
Role of ASTM E1132
o ASTM International is updating its voluntary
consensus standard E1132, which establishes standard practices for health requirements relating to occupational exposure to respirable crystalline silica.
o Under Technology Transfer Act of 1995,
and OMB Circular A-119, US agencies must consider any relevant voluntary consensus standards before developing a new rule.
OSHA and MSHA must consider the viability of ASTM E1132.
ASTM El 132
o ASTM E11 32 does no. set exposure limits, nor specify any particular sampling and analytical method - although ASTM is considering
development of selected OFIsin the future.
o It addresses respiratory
medical surveillance, medical protection, worker training and education, warning labels and signs, and laboratory analysis.
o ASTM F1132 also establishes a hierarchy of engineering controls, administrative controls, respiratory protection, and
work practices.
o ASTM F1132 encourages employers to sample and maintain records of occupational exposures, to
use supplied air respirators or ventilated enclosures, and to establish Exposure Control Plans.
o It provides sampling technique information for qualitative assessment.
ASTM E1132
o ASTM E1132 could form the basis for a comprehensive crystalline silica health standard if adopted by OSHA/MSHA upon completion.
o However, labor unions claim that ASTM E34 committee (developing E1132) is industrydominated and that existing standard is being weakened.
o ASTM 1132 (and other non-governmental standards such as ACGIH TLVs) can establish "industry consensus" on best practices and or imputed knowledge that can be used to establish liability in tort litigation!
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ACGIH Silica Activity
o ACGIH sought to modify silica TLV (lower to
0.025 mg/m3 - which is 25 percent of mandatory US government exposure limit)
o Proposal was tabled proposal in 1/05 after
litigation brought against ACGIH (and co defendants US Dep't of Labor) claiming unlawful federal advisory committee and product defamation.
Now, ACGIH claims "lack of sufficient data" to lower silica TLV.
NIOSH say sampling technology limitations preclude use of 0.025 mg/m3TLv.
Silica Litigation in U.S.
o Silica-related litigation is exploding -- often initiated by lawyers/plaintiffs who are veterans of asbestos litigation.
o Same "experts" used in asbestos cases and silicosis liability cases (e.g., X-ray readers and physicians).
o Silicosis claim filings up 900% in recent years (one US mining company has 24,000 claims pending).
o Insurance policies now include silica exclusions - as yet judicially untested.
Determination of "Silicosis"
o 'B" Readers using ILO criteria have provided "diagnostic" data relied upon by courts- a 1/0 reading also forms basis for recordable silicosis under OSHA and MSHA rules
o NIOSH announced in July 2005 that it intends to clarify its role in certifying B-readers after US District Court found thousands of silicosis diagnoses faulty based on misread chest x-rays.
NIOSH best practices suggest B-readers should be "blind" to subject's exposure history
Even credentialed radiologists disagree on interpretations 20 - 30 % of time - a single X-ray is meaningless in litigation context.
There are suggestions of audit program for B-readers to preserve integrity of system
Demo project by Institute for Legal Reform tracking screening abuse patterns. First results due 9/05
New York considering criminal prosecution of doctors and screeners who engage in fraudulent silicosis diagnoses
Legal Exposures - Mining Companies
o Worker's compensation liability o Third party liability o Product liability o Corporate image damage o Harm to employee morale o Union concerns o Financial exposure of individual officers/bankruptcy o Exposure under Sarbanes-Oxley Act (shareholder
liability) o Governmental action (civil & criminal) based on
OSHA/MSHA violations or under conspiracy theories o Impact on growth and corporate development
Silica Litigation
o Silica-related claims allow reparations from parties responsible for silica dust exposure.
o May include "mixed dust" exposures.
o Payments may include:
medical bills,
lost wages, punitive damages,
non-economic damages endured by the victim and family
o Courts rarely look at quantifying exposure.
o Litigation often focuses on inadequacy of
warnings:
MSDSs and product labels ... but long latency period (1 5- 40 years) means exposures predate warnings.
"Sophisticated user" defense being questioned by courts.
Silica Litigation
o Targets are an array of companies,
including: Metal/nonmetal mines, industrial sand processors and users railroads foundries construction companies plant and refinery operators safety-equipment manufacturers Premises liability theories also advanced as well as industry-wide `'conspiracy''to conceal dangers of silica-containing products.
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Silica Litigation
O "Sophisticated user" defense rejected by the Supreme Court of Minnesota in a personal injury/products liability action brought by a foundry worker with silicosis. Gray v. Badger Mining Corp. (March 2004). Held supplier had duty to warn employer if it possessed special knowledge regarding product hazards that were not also known to
employer OR the end user (employees of customer) O Tompkins v. U.S. Silica Company-jury awarded $7.6
Million in wrongful death case due to respiratory failure from emphysema and silicosis. The decedent's exposure period was from 1968 to 1977 as a sandblaster. Plaintiff prevails on "failure to warn" theory.
O Humble Sand & Gravel v. Gomez (Texas, 9/04) supplier of bagged sand has no duty to warn its direct customers of hazards but MIGHT have duty to warn customer employees by placing warning on bagged product. Suit only ended because Gomez died during litigation (car accident)
Silica Litigation in U.S.
Federal contract workers also engaged in
litigation: o Griegov. BechtelCorp., Nev. Dist. Ct. A481996 (March
2004) - class action lawsuit alleges that more than 1,200 workers at the U.S. Department of Energy's Nevada Yucca Mountain site were "knowingly exposed" to toxic dust and gases . . . and that the contractors and subcontractors on the project "schemed to conceal the dangers."
o Plaintiffs seek damages, a finding that the work was an "abnormally dangerous activity" involving strict liability, and also a finding that the defendants' actions were so egregious as to constitute intentional misconduct and gross negligence.
o Defendants' April 2005 motion to dismiss claiming worker's compensation barred the claims was denied.
Defense Strategies
O Learned intermediary; O Sophisticated user;
O Sophisticated intermediary; o Bulk supplier; and O Raw material or component part
supplier defenses.
BUT . . . Restatement (Second) of Torts 388: if third party is known to be careless, supplier of hazardous products will have reason to believe warnings will not be adequately communicated to exposed workers. Analysis is comparing magnitude of risk v. burden of warning.
Silica and Asbestos Claims
O Insurers estimate that suits have been filed on behalf of 70,000 plaintiffs against more than 400 defendants.
O Plaintiff attorneys modeling litigation after asbestos claims - focus on trades involving creation of smallparticle silica dust such as sandblasting and foundries but success will depend on facts of each individual case.
O Comparison of asbestos/silica cases: Both involve injuries to industrial workers arising from dust inhalation, with similar classes of plaintiffs (e.g., shipyard and construction workers) Theories of liability are the same (product defect, failure to warn) Claims appear amenable to mass screenings, mass consolidations, forum shopping (but silica exposure has no signature disease) BUT . . . Recent decisions severely restrict mass consolidation and require plaintiffs to plead specific facts regarding time period and
circumstances of exposure. See, e.g., Janssen Pharmaceutica Inc. v.
Armond 866 So.2d 1092 (Miss. 2004).
Backlash Against Plaintiffs
O Multi-District Tort Litigation- In re Silica Prods. Uab. Litig., 280 F. Supp. 2d 1381 (2003) - $1 BILLION demand for settlement.
O Many (65%) of the 10,515 plaintiffs were "asbestos case re-treads" -used same MDs and B-readers from asbestos cases. Their silicosis diagnoses came from only 12 doctors!
O In 249-page ruling (June 2005), US Dist. Ct. Judge J.G. Jack sanctioned (fined) plaintiffs' attorneys and agreed that plaintiffs' "evidence" did not qualify as a diagnosis of silicosis. She found one radiologist made 3,617 'diagnoses" in this case in 1/ mo. period. Several of plaintiff medical "experts' recanted testimony under questioning. Attorneys had placed ads to recruit clients for mass tort action, claiming any"signs" of lung disease could be eligible for compensation. 90% of cases were kicked out of federal court- remanded for consideration by state courts. Judge found attorneys manufactured "phantom epidemic"
Tort Reform Efforts in U.S.
o Asbestos litigation has bankrupted more than 60 companies and may cost insurers more than $200 BILLION ($70B paid)
o Asbestos tort reform legislation may also include silica claims, but difficult to get bipartisan support (much union opposition) Issues surround differing compensation schemes for malignant versus non-malignant illnesses
o U.S. Congress also conducting inquiry concerning fraudulent silicosis diagnoses based on Texas federal case multi-district case. Also looking at whether physicians changed prior diagnoses of asbestosis to silicosis to secure higher compensation in light of pending changes to current tort system for asbestos claims. Hearings may be set in Sept/Oct. 2005 on issue in House Energy & Commerce Committee.
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Conclusion
o Litigation involving injuries related to inhalation
of silica dust has been around since the 1940s, but it is becoming "next asbestos" (subject to judicial backlash)
o Recent rejection of the "sophisticated user"
doctrine by courts, and evolving trend to link silicosis to lung cancer and other diseases, will spark even more litigation.
o Accuracy of sampling/analysis is critical to
determining actual exposure levels in workplace situations - which methods are reliable to 0.05 or 0.025 mg/m3?
o Manufacturers of silica-containing products
must be diligent about updating warnings and recommending use of respiratory protection.
Conclusion
o Employers remain in best position to protect workers from hazards ofrespirable crystalline silica - through engineering controls, PPE, and safe work practices.
o New OSHA/MSHA standards lowering PEL and documenting overexposures based on findings of possible "carcinogenicity" will establish liability that may again spur lawsuits - this time focusing on cancers instead of silicosis.
o Plaintiffs will increasingly access OSHA/MSHA public data on sampling results and citations to support litigation.
o Consensus standards (e.g. ASTM E1132) will be used by attorneys to show industry "standards of care."
Conclusion
o Employers must sample for silica and implement preventative measures NOW to protect workers and third parties from adverse effects of possible overexposures and to document compliance with mandatory OELs.
o A proactive approach to silica risk reduction is key to protecting workers and fending off frivolous lawsuits.
QUESTIONS?
Adele L. Abrams, Esq., CMSP, REA Law Office of Adele L. Abrams P.C.
U.S. - 301-595-3520 safetvlawver@aol.com http://www.safety- law.com
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