Friday, November 28, 2008

EPCRA 311 - 312 Reports - Amendments to Reporting Requirements

On November 3, 2008, US EPA published a revision to rules under the Emergency Planning and Community Right-to-Know Act (EPCRA) Sections 311 and 312.

The key revisions included the following:

  • Clarification on acceptable calculation methods for mixtures containing EPCRA chemicals to determine if reporting thresholds are exceeded;
  • Defining the time allowed to report changes at the facility relevant to EPCRA chemicals to appropriate agencies. This includes notifying that the facility is no longer in operation, then new extremely hazardous substances (EHSs) are present at the facility, if EHSs are moved to a different location at the facility, if EHSs are no longer present at the facility, and other changes relevant to emergency planning.

For more information, refer to:

Regulatory Briefing - Revision to EPCRA Reporting Requirements

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Wednesday, November 26, 2008

Mercury Air Emissions - Petition to Control Air Emmisions to Reduce Mercury in Water

The New England Interstate Water Pollution Control Commission has petitioned that EPA regarding Section 319(g) of the Clean Water Act, which requires controls on air emissions of mercury. EPA is being asked to bring together a management conference with eleven States that contribute much of the mercury emissions that end up in water bodies in the Northeast.

The EPA approved a Northeastern regional mercury TMDL last year that the States beleive can only can be achieved through stricter federal air emission controls on mercury. Under Section 319(g) of the Clean Water Act, States can petition the EPA to bring together "a management conference of all states which contribute significant pollution resulting from nonpoint sources,".

The petition prepared by the New England Interstate Water Pollution Control Commission says that Pennsylvania, Virginia, New Jersey, Ohio, West Virginia, Maryland, Michigan, Indiana, Kentucky, North Carolina and Illinois each contribute significant nonpoint source mercury pollution that prevent them from meeting their goals.

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Monday, November 24, 2008

EU REACH Directive - Chemical Users Responsibilities

Although the burden of risk evaluation and control is placed on the manufacturers and importers, REACH does include requirements that apply to USERS of regulated materials. The risk assessment process used to register materials is based on specific uses and mitigations. Therefore, the User requirements assure that mitigation measures are actually used, and that any new uses of materials, which were not included in the risk assessment, are evaluated.

To accomplish this, Users are required to

  • Use materials only for labeled uses
  • Understand and use all risk mitigation measures incorporated into the manufacturers risk analysis

If Users of materials wish to have new uses, they have two options available:

  1. They can inform their manufacturer or supplier of the new uses and request that the new uses be added to the list of recognized uses (which may require further risk assessment)
  2. They can perform and submit their own risk assessment on the new use

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EU REACH Directive - Basic Requirements

REACH is an acronym that stands for “Registration, Evaluation and Authorisation of Chemicals”. REACH replaces about 40 different EU regulations and provides a uniform approach to evaluating, approving, and if necessary, restricting the manufacture, import and uses of chemicals within EU Member States.

Because REACH also addresses the uses of chemicals, this directive can have a direct impact on a wide range of organizations. This article provides a summary of some of the key elements and concepts of the REACH Directive.

The basic format for the REACH directive is:

  • All chemicals manufactured and/or imported to the EU in volumes more than 1 ton per year are required to be registered
  • All registered chemicals must identify uses
  • Manufacturers and importers must assess the risks associated with the manufacture and uses of chemicals, and then report findings to a central agency, the European Chemicals Agency.
  • The European Chemicals Agency will be responsible for reviewing and evaluating chemical information and determining if any further actions to control risks are appropriate.

If chemicals or mixtures contain chemicals of very high concern (carcinogens, mutagens, etc.), then specific authorizations and/or restrictions on the manufacture, import, and/or uses of the materials may be required.

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Environmental Management Systems - Cornerstones to Sustainable Systems

Whether immediately evident or not, management systems are imbedded in most operations. This is true not only of the environmental and safety aspects of an operation, but most other segments of the business, from product development and accounting, to filling customer orders. Systems audits consider the effectiveness of the systems built to accomplish a specific objective.

The underlying goal in developing a management system is to prepare a sustainable system – one that is adequately robust that it can still operate effectively even if changes occur within the operation. One common change that could impact systems is staffing changes, as key individuals transition to other positions or other companies. A SUSTAINABLE management system will be able to accommodate changes, so that the objective (e.g., regulatory compliance, accurately filling orders, etc.) is continuously met.

Below are four characteristics of sustainable management systems:

Commitment of Staff. One of the common perceptions of the “systems” approach is that it takes the burden off individuals to accomplish the objective. Although somewhat true, it is important to recognize that the burden often shifts to many individuals, each of which has a specific task to complete.

The commitment of all staff who assume a role within the system is critical to sustainability. If any one individual fails to fulfill their role, the system will begin to fail. Over the short-term, others may compensate for the lack of commitment by taking on more roles, but ultimately the system will fall apart because it is not operating as it was designed.

Effective Training. Sustainable management systems will assure that training is not only given as scheduled, but will also assure that the training is effective – ineffective training is the root cause of many, if not most, system failures.

We train and train, but they just don’t get it”. If this is the case, it is time to consider the root cause – the problem is more likely with the training, rather than with the trainees.

In sustainable management systems, training is not limited to the classroom. “On the job” training is just as important and often is more effective. However, it requires the commitment of managers and supervisors who can provide it.

Frequent Feedback. Systems often fail because no one recognized a system breakdown was occurring until it was too late. Sustainable systems are not perfect systems – but, they are developed to assure that systemic problems are identified and corrected early. By self-correcting, the overall system not only improves and becomes more robust, it also adapts to the changes within the organization.

Management Commitment. No system can be sustained without clear management support, which is connected to the top levels of the organization. Local management support is important, but without top management endorsement, systems tend to become “pet projects”, ending with any changes to management staffing or structure.

Developing sustainable management systems takes careful consideration and planning. Referring to the four areas described above will enhance the sustainability of the system and will improve the ability of the system to evolve as the organization changes.

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Saturday, November 22, 2008

Globally Harmonized Standard (GHS) - Relationship to Other Regulatory Programs

Implementation of the Globally Harmonized Standard (GHS) in the US will indirectly affect other regulatory compliance programs. The communication of hazards is required by OSHA, however certain aspects are also regulated by other agencies. The USEPA regulates labeling and hazard communication for pesticides; the US DOT regulates the labeling and placarding of hazardous materials while in transport. These agencies will also be responding to the GHS.

Although required by OSHA, the information contained in an MSDS will be used by other regulatory programs. For example, many facilities that have an air emission permit and must prepare an annual air emission inventory (AEI) will utilize the information contained in their raw material MSDSs to determine their facility emissions. Facilities may also use the MSDS data to determine if wastes contain chemicals that are used to identify “hazardous wastes”. Previously, information on other regulations that may apply to a chemical has not been required to be included in an MSDS. This is primarily due to the fact that OSHA, the agency requiring the MSDS, did not have authority in these other areas. In many cases, companies preparing MSDSs have included information on other regulatory programs. For example, an MSDS will often list the Reportable Quantity (RQ) under CERCLA in the event of spills. Under the GHS, information on other regulations that apply to the substance is required on the MSDS. One of the challenges chemical manufacturers and distributors will have is to determine what regulations apply – especially considering that this is an “international” system, and therefore would not be limited to the regulations of one country, such as the US.

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Changes To Hazard Communication Requirements Under Globally Harmonized Standard (GHS)

In 1992, the United Nations Conference on the Environment and Development (UNCED) adopted a mandate that a standardized system be developed to classify, label and communicate the hazard of materials. Several countries, including the US and Canada, had developed their own systems; however, inconsistencies between the individual requirements of these countries made international trade more challenging. While similar, the regulations of each country are different enough to require multiple labels and safety data sheets for the same product in international trade. A multinational work group, including representatives from U.S. Occupational Safety & Health Administration (OSHA), began developing the standard, now termed the Globally Harmonized System (GHS).

The GHS was adopted by the United Nations (UN) in 2003 and there is an international goal for as many countries as possible to implement the GHS by 2008. OSHA intends to revise the Hazard Communication Standard to align with the GHS and published an Advanced Notice of Proposed Rulemaking in 2006. The current Hazard Communication Standard affects many, if not most, industrial and commercial employers in the US. Most will have developed Hazard Communication programs to meet the current OSHA requirements. Changes to the requirements will impact most of these companies.

The revision to the Hazard Communication Standard will also directly affect manufacturers and distributors of chemicals. These companies may need to review and revise existing Material Safety Data Sheets (MSDS) to meet new requirements.

This article highlights some of the key changes reflected in the GHS compared to the current OSHA Hazard Communication Standard.

Labeling requirements. The GHS will expand the information required for labeling. Under the current OSHA requirements, labels need to identify: 1) chemical or common name, and 2) nature of hazard.

Hazard Classification. One of the most significant changes compared to the current OSHA requirement is the classification of hazards. Although the current standard does include a system of hazard classification, the GHS revises this classification system and the criteria used to assign hazards to chemicals. The GHS also incorporates a standard list of potential health effects to be considered.

Training. The training requirements under the GHS are less prescriptive compared the current OSHA Hazard Communication Standard.

Material Safety Data Sheets. The basic information required in an MSDS will be similar to what is currently familiar to most employees and employers. However, several sections will become mandatory; these include Ecological Information, Transportation Information, Disposal Information & Regulatory Information. Although these sections are often voluntarily included in MSDS, the GHS will require they be included in all MSDSs.

Transportation Placarding. The GHS provides for standard pictograms to be used to mark dangerous goods in transport.

For further information contact Caltha LLP at
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Thursday, November 20, 2008

Manufacturer Requirements under EU REACH Directive

Much of the REACH Directive details requirements placed on manufacturers and importers of chemicals. In summary, unlike past regulations, REACH places the burden of proof regarding potential risks of chemicals on the manufacturers and importers.

For all regulated materials, manufacturers/importers will be required to prepare an assessment of risks to human health and the environment associated with the identified uses of the subject material. Therefore, to accomplish this, manufacturers/importers will first need to identify the uses of the material. Then, based on the recognized uses, exposure scenarios and risk assessment can be completed. At this point, manufacturers can recommend procedures for use, pollution prevention practices, personal protective measures, or other measures to mitigate the risks associated with the recognized uses.

The European Chemicals Agency will review the risk information submitted. The agency will determine if further mitigations are required, or if more broad restrictions need to be developed.

For further information contact Caltha LLP at
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Sunday, November 16, 2008

TSCA Compliance - Factors Which Complicate Compliance with Inventory Update Rule (IUR)

Every five years, companies that either manufacture or import chemicals or mixtures of chemicals on the “TSCA List” must report their activities. The latest reporting year was 2005; therefore, reporting will not be required again until 2010.

The reporting requirement, referred to as the “Inventory Update Rule”, or IUR, is only one of several requirements in the Toxic Substances Control Act (TSCA) enacted in 1985. The IUR requirements are the most broadly applicable of all the TSCA requirements.

Historically, compliance with TSCA and the IUR requirements has been a continuing challenge for facilities. Compliance audits will commonly identify findings related to TSCA, and TSCA is one the most prevalent areas for enforcement action, fines & penalties.

It is somewhat speculation to project why on-going TSCA compliance tends to be more difficult; however, there are some factors which may be an influence UIR compliance:

IUR reporting is required infrequently. IUR reporting has been required every five years. Without some type of “institutionalized” compliance system, staff changes, etc. can result in loss of the institutional knowledge on reporting requirements.

There is no State equivalent to TSCA. Many facilities rely on State or local agencies for compliance updates and information. Because TSCA is not delegated to States, as are many other programs, it tends to become less visible.

Importers of chemicals are equivalent to manufacturers of chemicals. Companies that manufacture chemicals tend to be well versed in TSCA compliance. However, companies that import chemicals have the same reporting requirements. Since suppliers can change, companies can become importers, and potentially subject to IUR, very easily.

Effect of centralized/decentralized purchasing. For companies that utilize a centralized purchasing system for multiple sites, the centralized purchasing site becomes the “reporting site”. Even if the amount of TSCA chemicals shipped to individual sites are all well below the reporting threshold, the total amount imported by the central purchasing site becomes the basis for determining if an IUR report is required.

For further information contact Caltha LLP at
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Saturday, November 15, 2008

Environmental Management System Audits Compared to Compliance Audits

Recently, there has been an increased interest in conducting “Systems Audits” especially within businesses or agencies already familiar with “Compliance Audits”. In this article, we compare Systems Auditing to traditional Compliance Auditing.

Compliance auditing tends to be a straight-forward process. Objective evidence is collected to determine the status of compliance relative to specific requirements. Often these will be regulatory requirements, but compliance audits can be conducted relative to company or agency policies or procedures. To conduct a compliance audit, the auditor needs to know what the specific requirements are. Based on documentation review and observations made by the auditor, compliance with these requirements is evaluated.

Compliance auditing tends to develop a “snap-shot” of compliance on the day the audit was conducted. The important point is whether or not the auditee is in compliance, and not how compliance is attained.

Systems audits extend beyond strict compliance on the day of the audit. Although compliance with requirements is an important factor in a systems audit, providing an indication of system effectiveness, auditing the process leading to compliance is just as important.

For systems audits, the auditor needs to not only understand the specific compliance requirements, but also needs to understand the system the auditee uses to attain compliance. To pass a systems audit, the auditee must be in compliance with requirements and must demonstrate that an effective system is in place and being implemented to continuously be in compliance.

Systems audits will assess the compliance assurance system, and not simply assess the status of compliance on the day of the audit. Because a systems audit requires more intimate knowledge of the systems being used by the auditee, typically a systems auditor will request more information prior to the audit, including documents such as written plans and procedures, training requirements, etc. Often, systems audits will focus on specific areas, rather than being a site-wide assessment.

As an example, we will consider how a systems audit would address a specific compliance issue –proper labeling of drums in a hazardous waste storage area. In this case, drums of hazardous waste must be properly labeled; this is very straight forward for a compliance auditing process. The specific requirements for labeling are well documented and apply to all facilities that store hazardous waste. The auditor simply reviews the labeling documentation and determines if it meets these requirements.

Auditing the proper labeling of the hazardous waste drums with a systems auditing approach will require that the auditor understand the process the facility uses to assure that drums are properly labeled. While the requirements for labeling are generic and apply to all facilities that store hazardous waste, the system to assure proper labeling will be unique to each facility.

The compliance audit reviewed one type of document –the drum label –to determine compliance. The systems audit may review a broad range of documents related to the facility’s compliance system; for example,

  • Internal checklists/blank label forms
  • Written procedures
  • Training requirements and training records

A systems auditor may also conduct interviews with key staff to assure they have been trained and understand the procedures they need to follow.

Systems audits offer a clear advantage beyond compliance audits – they address the underlying processes in place to assure on-going compliance. Systems audits also require a higher level of effort by the auditor and involve a broader range of personnel at a facility.

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Amendments to Hazardous Material Transportation Rules

The U.S. Department of Transportation – Pipeline & Hazardous Materials Safety Administration (PHMSA) published amendments to its rules in early 2008. The amendments will took effect on October 1, 2008. Some amendments which may require upgrades to transportation equipment will be phased in over two years. These rules apply to anyone transporting hazardous materials or offering hazardous materials for shipment.

This section highlights some of the key changes reflected in the PHMSA amendments.

Requirements for Fuels Containing Ethanol. Over recent years, fuels containing ethanol have become much more prevalent in the market. These fuels are often transported along with traditional fuels, such as gasoline or diesel. However, the emergency response procedures for spills involving ethanol-gasoline mixtures are different compared to traditional fuels. For example, these mixtures are more soluble in water and foam materials typically used to control fuel spills are not effective.
Therefore, PHMSA has amended their rules to more specifically address the labeling and placarding of shipments containing ethanol mixtures. This is primarily being done to alert emergency responders, so they can use appropriate response measures. These requirements will take effect over a two-year period to allow upgrades to tankers, etc, used to transport these materials.

Requirements for Shipments Containing “Marine Pollutants”. Marine pollutants are a group of materials which represent special hazards if released into aquatic environments. Bulk shipments of these materials have special handling, labeling, etc. requirements. The issue that PHMSA addressed was that shippers typically prepared shipping paperwork based on initial mode of transportation. Some shipments that include some form of marine transportation might begin with truck or rail transport. The current amendments clarify that shippers are obligated to conform to requirements for marine pollutants if any portion of the route is by vessel.

Requirements for Shipments Containing “Hazardous Substances”. Some hazardous materials shipped may include chemicals that are also regulated as “hazardous substances” under CERCLA. These chemicals have Reportable Quantities (RQ) established. If a release occurs that exceeds the RQ, it must be reported to appropriate agencies.
The amendments require that limited quantity, non-bulk packages that contain hazardous substances be labeled with the letters “RQ”.

Shippers Responsibly to Confirm Transporter Has Required Permit. The transportation of some types of hazardous materials requires that the transporter apply for and obtain a “safety permit” from the Federal Motor Carrier Safety Administration (FMCSA). To be issued a safety permit, carriers must meet FMCSA requirements and have a satisfactory safety rating.
The current amendment extends the requirements that carriers have the required safety permit to companies making the shipment. Therefore, companies wishing to ship materials requiring a transporter to have a safety permit must confirm that their transporter(s) have a valid permit.

Placement of Labels. The current requirements specify that at least two sides of a package must be labeled in accordance with labeling standards. The amendment clarifies that intermediate bulk containers (IBC) must also be labeled on at least two sides.
Other amendments were made which have more limited application within the regulated community. These include requirements related to:
  • Standards for shipment of bulk chlorine
  • Standards for shipment of compressed gas cylinders
  • Standards for shipment of dry ice (or packages containing dry ice)
  • Standards for transportation of certain explosives
  • Requirements for transportation of household hazardous wastes
  • Standards for material segregation
  • Design requirements for portable tanks

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Impending Regulation of Ammonium Nitrate Handling by DHS

The Department of Homeland Security (DHS) has published an Advance Notice of Proposed Rulemaking (ANPRM) seeking comments on a recent amendment to the Homeland Security Act entitled "Secure Handling of Ammonium Nitrate". The amendment requires the DHS to ''regulate the sale and transfer of ammonium nitrate by an ammonium nitrate prevent the misappropriation or use of ammonium nitrate in an act of terrorism.''

For further information go to:

Written comments must be submitted on or before December 29, 2008

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REACH Directive - Assessing Existing Chemicals Under REACH

Unlike the previous regulations, REACH applies to ALL chemicals currently used or sold in the EU. Existing chemicals, as of 1981, were exempted from the previous regulations; since then only new chemicals were required to have risk evaluations conducted.

All existing chemicals, previously exempted, will now have to go through the same risk evaluation. During the next several years, risk evaluations will be required from manufacturers and/or importers on a phased-in basis.

The REACH Directive does offer partial or full exemptions for certain materials:

R&D Uses. To prevent the Directive from unnecessarily hampering R&D developments, substances used in product- or process-development do not need to be registered for up to 5-years

Special Uses. Some special use chemicals, especially related to Food and Medical Products Sectors, have different requirements

Currently, about 30,000 chemicals are thought to be used in the EU at volumes greater than 1 ton/year. About 16% of these have come into the market since 1981 and have been regulated as “new” chemicals and were evaluated using the previous regulatory framework. Therefore, about 84% of the materials currently being used in the EU will require assessment for chemical risks.

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Toxic Release Inventory Reporting - Changes to TRI Requirements in Minnesota

In May 2008, the State of Minnesota passed a State law that effectively reversed recent Federal actions relaxing Toxic Release Inventory (TRI) reporting requirements as they apply to Minnesota TRI reporting sites.

As background, in December 2006 U.S. EPA revised the reporting requirements for releases of listed chemicals (commonly known as 313 chemicals) required under Section 313 of the Emergency Planning & Community Right-to-Know Act (EPCRA). The revision allowed some facilities to use a streamlined reporting process; chemicals reported using the streamlined process would not be included in facility TRI reports released to the public.

In response, twelve States, including Minnesota, filed a law suit against U.S. EPA in November 2007. The suit claims that the revision prevented citizens and communities from having access to the critical information required under EPCRA.

The State Law only affects how TRI data are reported; it does not change the thresholds used to determine if a TRI report is required. This change only applies to TRI reporters located in Minnesota and only applies for those sites with total releases less than 5,000 lbs/year. No revisions were made by U.S. EPA for reporting 313 chemicals that have releases greater than 5,000 lbs/year.

The revisions made by U.S. EPA in 2006 related to the Forms used to report 313 chemical releases. Form R is typically used to report releases, and data submitted on Form R is released to the public. Form A is a streamlined reporting process, used for 313 chemicals released in smaller quantities. Data submitted on Form A is not released to the public. The revision made by U.S. EPA changed the thresholds for when Form A could be used. Form R could always be used to report data, even for small quantities.
Minnesota State Law now requires that Form A can only be used to report Non Persistent, Bioaccumulative or Toxic (PBT) Chemicals if the annual release is less than 500 lbs. Form A can not be used for any Persistent, Bioaccumulative or Toxic (PBT) Chemicals regardless of the quantity released.

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