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2014 PMA Annual Meeting, Supplier Showcase & Processing Techniques Seminar (PTS) Environmental Health and Safety Regulatory Update Donald P. Gallo and Mike Kocak Tuesday, May 13, 2014

Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

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Page 1: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

2014 PMA Annual Meeting, Supplier Showcase & Processing Techniques Seminar (PTS)

Environmental Health and Safety Regulatory Update

Donald P. Gallo and Mike Kocak Tuesday, May 13, 2014

Page 2: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

OECD - MOCA

•  The Organisation for Economic Co-operation and Development (OECD): –  "promote[s] policies that will improve the economic and social

well-being of people around the world" –  "provides a forum in which governments can work together to

share experiences and seek solutions to common problems" –  "work[s] with governments to understand what drives economic,

social and environmental change" –  "measure[s] productivity and global flows of trade and investment" –  "analyse[s] and compare[s] data to predict future trends" –  "set[s] international standards on a wide range of things, from

agriculture and tax to the safety of chemicals." http://www.oecd.org/about/.

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 3: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

OECD - MOCA

•  September 18, 2013 – Representatives of PMA and the American Chemical Council (ACC) met in Washington, DC to discuss OECD's MOCA international hazard assessment and to submit documents, studies, and reports on MOCA health effects for inclusion in the Cooperative Chemical Assessment Meeting (CoCAM) and the screening initial data set (SIDS). –  ACC was a party to the CoCAM meeting as the United States

Chemical Industry representative to the Business Industry and Advocacy Counsel (BIAC).

–  Japan sponsored MOCA and prepared the initial submission to the CoCAM meeting.

•  October 14, 2013 – Representatives of PMA, Omni Specialty, and Ihera American/K-I Chemical U.S.A., Inc. met with the Japanese delegation prior to the CoCAM hearing.

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 4: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

OECD - MOCA •  October 15-17, 2013 – OECD conducted an international hazard

assessment of MOCA at the CoCAM-5 meeting in Washington DC. –  Member countries commented on the MOCA submission and

proposed hazard assessment during the SIDS Initial Assessment hearing. –  Japan's representatives prepared a response to these comments. –  The Danish representative and representatives of PMA negotiated

alternative language regarding MOCA exposure from articles. –  Japan's representatives were directed to complete the hazard

assessment within the next 6 months (when OECD will meet again to approve the final version).

•  The final language of the MOCA hazard assessment will be negotiated between the Japanese government representatives, the Danish government representative.

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 5: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

OSHA's National Emphasis Program (NEP) for Occupational Exposure to Isocyanates

•  Isocyanates = all chemicals with two or more isocyanate groups –  Polyisocyanates and Diisocyanates (most common:

methylenebis(phenyl isocyanate) (MDI) and toluene diisocyanate (TDI))

•  Isocyanates react with compounds containing alcohol groups to produce polyurethane polymers that are components of flexible and rigid foams, fibers, surface coatings, elastomers, insulation, auto industry products, foam mattresses, packaging materials, polyurethane rubber, adhesives, building insulation materials, and other products.

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 6: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

OSHA Isocyanates NEP (cont'd)

•  According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a critical step in eliminating the health hazard. Engineering controls such as closed systems and ventilation should be the principal method for minimizing isocyanate exposure in the workplace. Other controls, such as worker isolation and personal protective clothing and equipment are also recommended. Early recognition of sensitization and prompt and strict elimination of exposures is essential to reduce the risk of long-term or permanent respiratory problems for workers who have become sensitized."

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 7: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

OSHA Isocyanates NEP (cont'd)

•  OSHA's National Emphasis Program - Occupational Exposure to Isocyanates (Directive Number CPL 03-00-017) took effect June 20, 2013. The three year program will end June 20, 2016. –  Goal: protect workers from the serious health effects caused

by occupational exposure to isocyanates.

©2014 All Rightseserved Reinhart Boerner Van Deuren s.c.

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Page 8: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

OSHA Isocyanates NEP (cont'd)

•  Where potential exposures to isocyanates exist, OSHA will: –  evaluate engineering, administrative, and work practice

controls –  review the Personal Protective Equipment (PPE) hazard

assessment and evaluate the use of appropriate equipment (eye/face/respiratory protection and chemical-resistant gloves)

–  collect personal air samples –  check for visible surface contamination –  determine surface, dermal, and PPE contamination by wipe

sampling of tools, drinking fountains, lockers, inside PPE, etc.

©2014 All Rights Reserved

Reinhart Boerner Van Deuren s.c.

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Page 9: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

OSHA Isocyanates NEP (cont'd) •  Citations – OSHA:

–  may issue citations under its PPE or housekeeping standards if wipe samples reveal surface contamination or dermal exposure

–  may issue a General Duty clause citation or Hazard Alert Letter even if no overexposures are documented but illnesses/health effects are reported

•  If OSHA does not issue a citation, it can issue and follow up on a Hazard Alert Letter.

•  OSHA will conduct follow up inspections to determine whether employers have eliminated hazards or reduced exposures.

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 10: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

OSHA Isocyanates NEP (cont'd)

•  NEP's first six months (June 2013 -January 2014) –  OSHA performed approximately 110 inspections

•  43 inspections involved violations •  181 violations were cited overall

–  Most frequently cited OSHA standards •  respiratory protection (29 CFR § 1910.134) •  hazard communication (29 CFR § 1910.1200) •  spray finishing (29 CFR § 1910.107) •  flammable liquids (29 CFR § 1910.106) •  personal protective equipment (29 CFR § 1910.132) •  In addition to preparing for an Isocyanates NEP inspection,

employers should assess their overall OSHA compliance status.

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 11: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

OSHA Isocyanates NEP – Case Study •  September 9, 2013 – The Iowa Work Force Development inspected Thrombert, Inc.

pursuant to OSHA's Isocyanates NEP. Thrombert was the first company in Iowa to be randomly selected for an inspection under this NEP. The inspector: –  asked to see Thrombert's:

•  hazard communication program •  chemical lists •  OSHA 300A forms for the last 5 years •  isocyanates monitoring records •  safety training plans (HAZWOPER, chemical spills, isocyanates, etc.) •  PPE assessments •  safety data sheets •  fire-exit diagrams

–  interviewed all employees who work in the molding area. –  returned two weeks later to perform air sampling.

•  Thrombert supplied documentation of its Isocyanates NEP project plan.

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 12: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

OSHA Isocyanates NEP – Case Study •  The inspector expressed surprise when Thrombert's Manufacturing

Manager supplied him with all the requested documentation. •  The inspection resulted in no adverse findings. •  Thrombert believes that its excellent outcome can be attributed to:

–  studying the Isocyanates NEP –  being prepared for an inspection –  training employees for awareness and understanding –  performing routine air monitoring and striving for all non-detectable

readings.

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 13: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a
Page 14: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

Thank you

Questions?

Next Mike will report on GHS

Page 15: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

PMA EHS / Regulatory Committee Phoenix – May 2014

The Global Harmonized System-What you must

do.

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Page 16: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

OSHA REVISES the HAZARD COMMUNICATION STANDARD.

OSHA has revised Haz.Comm. to align the classification of hazardous chemicals and the communication of chemical hazards with the

United Nation’s Globally Harmonized System of Classification and Labeling of

Chemicals (GHS).

Page 17: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

OSHA REVISES the HAZARD COMMUNICATION STANDARD.

Major changes to the Hazard Communication Standard (HCS), found at

29 CFR 1910.1200, include: Revised criteria for classification of

chemical hazards; Revised labeling provisions that include

requirements for use of standardized signal words, pictograms, hazard statements, and

precautionary statements;

Page 18: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

OSHA REVISES the HAZARD COMMUNICATION STANDARD.

A specified 16-section format for safety data sheets (no longer called MSDSs); and Related revisions to definitions and

requirements for employee training on labels and safety data sheets.

Page 19: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

OSHA REVISES the HAZARD COMMUNICATION STANDARD.

The final rule became effective in May of 2012. However, OSHA has provided the following extended compliance dates to

meet the new requirements:

Page 20: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

OSHA REVISES the HAZARD COMMUNICATION STANDARD.

December 1, 2013 — Employers must train employees on the new label elements and

SDS format. June 1, 2015 — Compliance with all

modified provisions of the final rule for chemical mfgs, importers, distributors, and

employers. The only exception is for distributors as follows:

Page 21: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

OSHA REVISES the HAZARD COMMUNICATION STANDARD.

December 1, 2015 — Distributors shall not ship containers labeled by the chemical mfg.

or importer unless it is a GHS label. June 1, 2016 — Employers must update

alternative workplace labeling and their haz. comm. program as necessary, and provide

additional employee training for newly identified physical or health hazards.

Page 22: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

December 1, 2013 Training

•  The first compliance date of the revised Hazard Communication Standard was Dec. 1, 2013. By that time employers must have trained their workers on the new label elements and the SDS format.

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Page 23: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

If you need more information on required topics for this training refer to the OSHA Fact Sheet: “December 1st, 2013 Training Requirements for the Revised Hazard Communication Standard”

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Page 24: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

•  Some of the types of information you’ll see on the new labels include

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Page 25: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

•  Signal word: used to indicate the relative level of severity of hazard and alert the reader to a potential hazard on the label. There are only two signal words, “Danger” and “Warning.” Within a specific hazard class.

•  The word “Caution” is not used.

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Page 26: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

•  Pictogram: OSHA’s required pictograms must be in the shape of a square set at a point and include a black hazard symbol on a white background with a red frame sufficiently wide enough to be clearly visible.

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Page 27: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

•  Hazard statement(s): describe the nature of the hazard(s) of a chemical, including, where appropriate, the degree of hazard. For example: “Causes damage to kidneys through prolonged or repeated exposure when absorbed through the skin.”

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Page 28: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

•  Precautionary statements are phrases that describe recommended measures that should be taken to minimize or prevent adverse effects resulting from exposure to a hazardous chemical or improper storage or handling.

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Page 29: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

•  The MSDS now becomes an SDS •  This has a standardized 16-section

format. • We are in the process of revising

the current PMA MSDS for cast urethane articles to meet the new requirements

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Page 30: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

The best help is free

• OSHA’s Hazard Communication website (http://www.osha.gov/dsg/hazcom/index.html) has QuickCards and OSHA Briefs to assist employers with the required training.

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Page 31: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

•  Thank you

•  ARE THERE ANY QUESTIONS???

•  Back to Don for Emergency Planning

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Page 32: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

Emergency Planning and Community Right-to-Know Act (EPCRA) - SARA Title III

•  Section 302 -- Emergency Planning and Notification –  extremely hazardous substances ("EHS")

•  Section 304 -- Emergency Release Reporting –  release > CERCLA hazardous substance RQ or EPCRA EHS

•  Sections 311-312 -- Hazardous Chemical Notification and Inventory Reporting –  Facilities with chemicals in quantities that equal or exceed thresholds

•  EHS – lower of 500 pounds or Threshold Planning Quantity (TPQ) •  other hazardous chemicals -- 10,000 pounds •  [gasoline and diesel fuel have separate thresholds]

–  § 311 -- submit MSDSs or list of chemicals to SERC, LEPC, and local fire department

–  § 312 -- submit annual inventory report for chemicals to SERC, LEPC and local fire department by March 1

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 33: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

EPCRA - SARA Title III

•  Section 313 -- Toxic Chemical Release Inventory Reporting –  Reporting criteria

•  specified industry sectors •  10 or more employees •  in given year:

–  manufacture or process > 25,000 lbs of listed chemical –  otherwise uses > 10,000 lbs of listed chemical

–  Report quantity released to environment and/or managed through recycling, energy recovery and treatment •  release = emitted to air or water; placed in land disposal

–  Submit Form R to EPA and state by July 1 •  EPCRA TRI reporting overlaps with CAA RMP requirements: "Approximately 2,400

facilities were RMP registered and also reported to TRI in 2009. That is, 20% of about 12,000 RMP-registered facilities reported to TRI and 11% of about 21,000 TRI filers also were RMP-registered facilities in RY2009." July 24, 2012, U.S. EPA, Factors to Consider When Using Toxics Release Inventory Data, http://www2.epa.gov/sites/production/files/2013-09/documents/tri_factors_to_consider_2013.pdf.

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 34: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

Spill Prevention Control and Countermeasure ("SPCC") Plans

•  Specified facilities must prepare, amend, and implement SPCC Plans: -  non-transportation related facilities -  above-ground oil storage capacity > 1,320 gallons or

completely buried oil storage capacity > 42,000 gallons -  could reasonably be expected to discharge oil to navigable

waters or adjoining shorelines in quantities that may be harmful

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 35: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

SPCC Plans

•  August 28, 2013 EPA Guidance (has since been revised 6 times) –  provides uniform inspection guidelines for the ten EPA

regions –  assists regional EPA inspectors in implementing the SPCC

program and clarifies their role in reviewing compliance –  provides owners/operators with SPCC rule requirements and

information for developing, designing, and implementing SPCC plans

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 36: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

SPCC Plans

•  Tier I Qualified Facilities –  40 CFR § 112.3(g) – "The owner or operator of a qualified

facility as defined in this subparagraph may self-certify his facility's Plan.

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 37: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

Hazardous Waste Management •  Hazardous waste = liquid, solid, contained gas, or sludge wastes that contain

properties that are dangerous or potentially harmful to human health or the environment. http://www.epa.gov/epawaste/index.htm.

•  Hazardous waste types: –  Listed

•  F -- wastes from common manufacturing and industrial processes •  K -- wastes from specific industries •  P and U -- wastes from commercial chemical products

–  Characteristic •  Ignitability •  Corrosivity •  Reactivity •  Toxicity

–  Universal (i.e., batteries, pesticides, mercury-containing equipment, lamps)

–  Mixed (contains radioactive and hazardous waste components)

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 38: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

Exceptions to Federal Hazardous Waste Treatment Requirements -- Generator On-Site

Treatment

•  Addressing residuals that remain in equipment and tanks after processing chemicals and/or raw materials could be considered generation of hazardous waste and trigger significant regulatory compliance obligations and costs.

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 39: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

Solvent-Contaminated Wipes 2013 EPA Final Rule

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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•  "In 2013, EPA issued a final rule that modifies the hazardous waste management regulations for solvent-contaminated wipes under the Resource Conservation and Recovery Act (RCRA). Specifically, this rule revises the definition of solid waste to conditionally exclude solvent-contaminated wipes that are cleaned and reused and revises the definition of hazardous waste to conditionally exclude disposable solvent-contaminated wipes. The purpose of this final rule is to provide a consistent regulatory framework for solvent-contaminated wipes that is appropriate to the level of risk posed by these wipes in a way that maintains protection of human health and the environment, while reducing overall compliance costs for industry, many of which are small businesses." http://www.epa.gov/epawaste/hazard/wastetypes/wasteid/solvents/wipes.htm.

•  State regulations may differ from the federal program.

Page 40: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

Toxic Substances Control Act (TSCA) Reform

•  The Chemical Safety Improvement Act (CSIA), S. 1009, was introduced on May 22, 2013 by (the late) Senator Frank Lautenberg (D-NJ) and Senator David Vitter (R-LA) and multiple co-sponsors to reform and modernize TSCA. –  EPA must establish a risk-based screening process and

perform safety evaluations to prioritize all active chemicals.

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 41: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

TSCA Reform

•  A draft of the Chemicals in Commerce Act (CCA) was released on February 27, 2014 by Rep. John Shimkus (R-Ill). The act would: –  Equip EPA to sort existing chemicals in commerce into high

and low priority categories based on exposures and hazards –  Subject high priority chemicals to rigorous scientific

examination (including requiring manufacturers and processors to produce information and test chemicals for risks so that EPA can determine whether chemicals will result in unreasonable risk of harm for their intended use) and a rule restricting their use or other requirements

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 42: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

TSCA Reform

•  Rep. Shimkus' April 22, 2014 revised draft of the CCA. •  On April 29, 2104, the House Energy and Commerce

Subcommittee on Environment and the Economy held a hearing on the draft.

•  Rep. Shimkus may revise the draft legislation again before introducing it for markup.

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 43: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

EPA Enforcement and Penalties •  Field citations -- $5,000/violation/day •  Civil penalties -- $37,500/violation/day (no maximum) •  Administrative enforcement actions -- $200,000 maximum penalty •  Criminal penalties and imprisonment

–  company –  manager/supervisor –  responsible corporate officer doctrine –  scienter /knowing –  negligence – Clean Water Act

•  Whistleblower provision – EPA can pay up to $10,000 for information that leads to a civil penalty or criminal enforcement

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 44: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

EPA Enforcement and Penalties •  Incentives for Self-Policing: Discovery, Disclosure, Correction and Prevention of

Violations (the "EPA Audit Policy") -  Incentive for Self-Policing

•  Eliminating/reducing (75%) gravity-based penalties •  No recommendations for criminal prosecution •  No routine requests for audit reports

-  Conditions •  Systematic discovery of violation (environmental audit or compliance

management system) •  Voluntary discovery (not through required procedure) •  Prompt disclosure (in writing within 21 days) •  Discovery and disclosure (independent of government or third party plaintiff) •  Correction and remediation •  Prevent recurrence •  No repeat violations •  Other violations excluded •  Cooperation

©2014 All Rights Reserved Reinhart Boerner Van Deuren s.c.

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Page 45: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

Thank you

Questions?

Next Mike will report on REACH and the global situation

Page 46: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

PMA EHS / Regulatory Committee Phoenix May 2014

An overview of Global Chemical

Initiatives 45

Page 47: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

PMA EHS / Regulatory Committee

International, national, regional and local

governments are making efforts to shift to a more

comprehensive approach to managing industrial

chemicals. 46

Page 48: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

PMA EHS / Regulatory Committee

Each year we see many more laws and regulations to control

chemicals around the world. This review is intended to provide a small glimpse of portions of the world wide chemical regulatory

situation.

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Page 49: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

PMA EHS / Regulatory Committee

The European Union’s REACH Program

In 2007, the European Union’s regulation on chemicals and their

safe use, the Registration, Evaluation, Authorisation and

Restriction of Chemical substances (REACH) entered into force.

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Page 50: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

REACH • There is a three step process to make

the use of a chemical subject to Authorisation.

• Step one has been completed: • On 12/19/2011, MOCA became one of

151 chemicals that have been included in the Candidate List of

Substances of Very High Concern for Authorisation

•  Therefore, MOCA is an “SVHC” chemical.  49

Page 51: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

REACH

• Step 2-

On Jan. 17th, 2013, EChA recommended that MOCA be

included in Annex XIV, the List of Substances subject to

Authorization.

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Page 52: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

STEP 2-

• This occurred in the “Fourth recommendation for inclusion in the

authorisation list”.

• The REACH Regulation requires that ECHA recommends from the "Candidate

List" priority substances for inclusion in Annex XIV of REACH (the "Authorisation

List”)at least every two years. 51

Page 53: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

STEP 2

• and for these substances proposes Annex XIV entries to the European

Commission, taking into account the opinion of the Member State

Committee. The European Commission finally decides, by "committee

procedure”, which substances will be included in Annex XIV and with which

entries.

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Page 54: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

REACH

• Therefore, MOCA is now an “SVHC chemical that has been Recommended for

Authorization”

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Page 55: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

REACH

• Step 3 HAS NOT yet been completed-

This final step will be the inclusion of MOCA into Annex XIV, the List of Substances Subject to

Authorization

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Page 56: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

REACH

When (if?) this happens a 39 month clock starts. You have 21

months to apply for Authorisation. 18 months after this is the sunset date in which MOCA will not be able to be used in the EU unless authorization is received for a

specific use.

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Page 57: Environmental Health and Safety Regulatory Update · • According to the National Institute for Occupational Safety and Health (NIOSH), "[p]reventing exposure to isocyanates is a

REACH

• Applying for authorisation is very expensive.

• We think it’s unlikely that authorizations for MOCA would

be granted, effectively stopping MOCA from use in polyurethane parts sold in

Europe 56

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REACH Current Obligations under REACH

Manufacturers or importers of articles containing more than 0.1%

by weight of an SVHC must provide their customers, and consumers on request, with

adequate information on the safe use and disposal of the article,

minimally the name of the SVHC.] 57

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REACH

Current Obligations under REACH

If the 0.1% level is exceeded AND the total is >1 ton per year

you also have to notify the European Chemicals Agency

of the quantities of SVHCs used in their articles.

58

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It’s not just Europe

59

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GLOBAL CHEMICAL INITIATIVES

China REACH In June of 2010, China

adopted the Provisions on Environmental Regulations of New Chemical Substances. The regulations are similar to

the EU’s REACH and are known as China REACH.

60

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GLOBAL CHEMICAL INITIATIVES

Canada’s Domestic Substances List

The Canadian Environmental Protection Act, adopted in

1999, requires the government to categorize all existing

chemicals in Canada and catalog them into an inventory,

the Domestic Substances List.

61

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CANADA

Chemicals on the list would then be assessed for their

potential to be toxic to either human health or the

environment. This led to formation of the Chemical

Management Plan. 62

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CANADA Part of the current 2nd phase of the CMP consists of the assessment and potential management of 9 groups of substances, including the “MDI

and diamines” group: 4,4-MDI; 2,2-MDI; 2,4-MDI; MDI mixed

isomers/generic (CAS 26447-40-5) [all

EC Cat 3 carcinogens]; polymeric MDI, and 4,4-MDA[EC Cat 2 carcinogen, Cat 3 Genotoxin,

IARC 2B possible human carcinogen]. 63

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CANADA

It is anticipated that the draft screening assessment will be

released soon. A 60 day public comment period will then commence.

64

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GLOBAL CHEMICAL INITIATIVES

Bottom line: Based on the results of the

assessment, risk management controls may

be required.

65

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GLOBAL CHEMICAL INITIATIVES

Other countries, including less developed countries, are

getting active as shown by the following examples

66

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GLOBAL CHEMICAL INITIATIVES

INDIA In March 2012, India announced a

draft REACH-like National Chemical Policy.

SERBIA In May of 2012, their List of

Substances of Very High Concern was increased from 6 to 14

67

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GLOBAL CHEMICAL INITIATIVES

AUSTRALIA Will complete review of 3000 Stage

One chemicals by 2016 to determine which require risk

mitigation to ensure safe use. This includes TDI, MDI and MOCA due to being a REACH SVHC, having a

USEPA Action Plan or being classified as carcinogenic.

68

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GLOBAL CHEMICAL INITIATIVES MEXICO published a new National

Chemical Inventory.

Turkey and JAPAN has their version of REACH.

SWITZERLAND has adopted REACH.

TAIWAN is actively developing a more complete chemical control system,

targeting toxic chemicals.

69

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GLOBAL CHEMICAL INITIATIVES

well I think you get the idea.

It’s not getting any easier.

70

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GLOBAL CHEMICAL INITIATIVES

Let’s not ignore the U.S.

71

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GLOBAL CHEMICAL INITIATIVES State Efforts: Maine, Washington, Calif.

Many states are considering legislation focused on toxic

chemicals . Maine, Washington and California

have passed comprehensive chemicals policy bills; Maine and

Washington’s bills cover chemicals of concern specifically in children’s

products. 72

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GLOBAL CHEMICAL INITIATIVES

State Efforts: New York and Delaware. New York and Delaware have

introduced bills on Priority Chemicals lists emphasizing risk to pregnant women and children. New York’s

has a Jan 1, 2018 ban on identified chemicals use in children’s

products.

73

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GLOBAL CHEMICAL INITIATIVES California’s draft Consumer Product

Regulations cover all consumer products, and will require companies to assess safer

alternatives if their product is identified as containing a chemical of concern. California’s regulations

identify workers as a potential population of concern for exposure

when considering alternatives. 74

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GLOBAL CHEMICAL INITIATIVES

75

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GLOBAL CHEMICAL INITIATIVES

Like I said before,

It’s not getting any easier.

76

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EHS-Regulatory meeting- 2014

Thank you

The end

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• CARMA meeting- 2014 next

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CARMA meeting- 2014

•  1.    Introduc-on:  What  is  the  CARMA  group?  It’s  the  Chemical  And  Raw  Material  Ac-on  Group.  It  is  dedicated  to  defending  chemicals  and  raw  materials  that  are  most  important  and    especially  those  unique  to  our  industry

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CARMA meeting- 2014

• 2. Scope and Membership. It is functioning as part of PMA like old Suppliers Committee. Although it is expected that core membership will be suppliers, membership is open to any PMA members. The goal is for it to be self-funding although PMA has covered start-up costs to date.

2.    Scope  and  Membership.  It  is  func-oning  as  part  of  PMA  like  old  Suppliers  CommiIee.  Although  it  is  expected  that  core  membership  will  be  suppliers,  membership  is  open  to  any  PMA  members.  The  goal  is  for  it  to  be  self-­‐funding  although  PMA  has  covered  start-­‐up  costs  to  date.

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CARMA meeting- 2014

• Current activities: • 3. (Mike) A plan is in place to update

the PMA’s model MSDS in light of GHS requirements. Chem Advisors Co. in Pittsburgh is reviewing our existing MSDS to determine what needs to be changed to meet GHS SDS requirements.

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CARMA meeting- 2014 • 4. (Mike) Status of Human Relevancy

Framework- IARC’s has classified MbOCA as a known human carcinogen. The PMA Board commissioned a Human Relevance Framework study on the carcinogenicity of MbOCA. Hopefully it will show that MOCA is not a human carcinogen and eventually overturn IARC’s classification. –  Ted Hogan will be PMA liaison

– Dr. Gollapudi of Exponent in Chicago will perform study. Finalizing contract.

– Need to start fundraising.

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CARMA meeting- 2014

• 5. Steve Seneker from Anderson Development will now present and update of their test data on the amount of unreacted MbOCA left in cured parts. (Steve Seneker)

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CARMA meeting- 2014

• 6. ACC/CPI and Don’s report on the OECD meeting (Don)

• OECD/CoCAP MOCA hazard assessment initial screening (SIDS) dossier. Attempting to get Japanese (sponsors) to add in importance of Stoichiometry.

• Use them for our lobbying needs? next slide

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CARMA meeting- 2014 • Do we need to do our own lobbying? At

last meeting There was also broad support to start a program to meet with appropriate EPA/OSHA representatives in There was also broad support to start a program to meet with appropriate EPA/OSHA representatives in Washington D.C. on a regular basis. Also engage in communication with US/International regulatory/advisory bodies-ASTDR, IARC, EChA

•   

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CARMA meeting- 2014 • 7. (Mike) REACH- MOCA situation, on

the road to authorization being required. • Current REACH requirements concerning

MbOCA • DOE on residual MOCA vs. processing vs.

systems- still needed? Or does eventual authorization make it unneeded since none is allowed (no de minimus value)?    

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CARMA meeting- 2014

• Suggested at previous CARMA meeting: Communicate with BRMA, Aussies, Europe, BAM(Brazil, Argentina, Mexico) and international suppliers to see what they have done / will do regarding MOCA and REACH and their preparations for Authorization.

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CARMA meeting- 2014

•  8.    MDI  regula-ons  including  Canadian  Chemical  Management  Plan  (CMP).  •  9.    ACGIH  lowering  of  TDI  exposure  limits.  •  10.    Form  a  steering  CommiIee.  Directly  encourage  large  suppliers  directly  to  have  EHS  Depts.  Help  CARMA  and  the  PMA  EHSReg.  Div.  •  11.  Funding