Tuesday, December 30, 2008

Definition of Solid Waste Rule - Recycling of Hazardous Wastes

The US EPA "Definition of Solid Waste" rule goes into effect on December 29, 2008. The rule is a hazardous waste regulatory exclusion, intended to streamline the requirements for recycling certain materials, such as sludges, by-products and spent materials. EPA estimates that 1.5 million tons of hazardous secondary materials will be exempted from regulation as hazardous wastes each year under this rule. By removing unnecessary regulatory controls, EPA expects to make it easier and more cost-effective to safely recycle hazardous secondary material.

The rule provides conditional exemptions for:

  • materials that are generated and legitimately reclaimed under the control of the generator;
  • materials that are generated and transferred to another company for legitimate reclamation under specific conditions; and
  • materials that EPA or an authorized state determines to be non-wastes through a case-by-case petition process.

This rule also includes a provision to help determine which recycling activities are legitimate under the new exclusions and non-waste determinations.

It is important to note that in some States, revisions to State Rules may be necessary before waste generators can take advantage of these changes. States can decide whether or not to fold the new Federal rules into State rules.

Caltha LLP provides technical support to waste generators on waste management regulations, waste minimization and pollution prevention.

For further information contact Caltha LLP at
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Monday, December 29, 2008

Court Restores Clean Air Interstate Rule (CAIR)

On December 23, 2008, the US Court of Appeals for the District of Columbia Circuit reversed its vacatur of the US EPA Clean Air Interstate Rule (CAIR). CAIR was intended to regulate interstate emissions of nitrogen oxides (NOx) and sulfur dioxide (SO2) contributing to nonattainment areas for fine particulate and ozone. The Court had vacated CAIR in July 2008, citing significant flaws in EPA’s regulations.

The recent ruling means that CAIR, as previously promulgated by EPA, will remain in place until such time as the EPA revises the rule, as per the instructions of the Court’s order in July.


For further information contact Caltha LLP at
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Wednesday, December 24, 2008

Proposed Rules on Ammonium Nitrate Handling - DHS Security Requirements

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 facility...to prevent the misappropriation or use of ammonium nitrate in an act of terrorism.''

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

Ammonium nitrate is also regulated as a Section 313 Water Priority Chemical, and may have additional control and security requirements under the Clean Water Act [Read more about requirements for Section 313 chemicals]


Caltha LLP provides technical support to facilities required to meet hazardous material storage and reporting requirements.


For further information contact Caltha LLP at
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Tuesday, December 23, 2008

New York (NYDEC) Plastic Bag and Film Recycling Rules- Effective January 2009

On December 13, 2008, Governor Patterson signed New York State's Plastic Bag Reduction, Reuse, and Recycling Act. This law requires larger retail and chain stores to accept clean plastic bags for recycling starting January 2009.

Under the new law, retail establishments with more than 10,000 square feet of retail space, or those that are part of a chain with more than five stores (each with more than 5,000 square feet of retail space), must provide bins for the collection of used plastic carryout bags, recycle the returned bags and keep records for three years describing the amount of plastic bags collected and recycled.

The new state law will pre-empt local governments from adopting their own plastic bag recycling laws. However, it is expected that additional legislation will be enacted to amend the bill signed by the governor to allow New York City to retain an effective and popular local law that established a citywide recycling program for plastic carryout bags and film plastics. Another expected amendment will require the recycling of film plastics as part of the statewide program.


For further information contact Caltha LLP at
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Monday, December 22, 2008

Washington WEEE Recycling Law - E-Cycle Washington

Beginning January 1, 2009, the E-Cycle Washington program kicks-off and provides no cost recycling of many waste electronic and electrical equipment (WEEE). The program is available to households, small businesses, schools & school districts, small governments, special purpose districts, and nonprofits & charities who can recycle electronic products free of charge.

E-Cycle Washington is one outcome of the Washington Electronic Product Recycling Law and Department of Ecology rules passed in 2007. These rules include:

  • Manufacturer requirements
  • Transporter requirements
  • Recycler requirements
  • Retailer requirements
  • Reporting requirements
  • Education and outreach

Caltha LLP assists manufacturers in meeting their internal product stewardship goals and regulatory requirements.


For further information contact Caltha LLP at
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Friday, December 19, 2008

Federal Lead Standards - Companies Agree To Early Restrictions

A number of toy manufacturers have agreed to adopt the new federal standards immediately, ahead of a new federal law ratcheting down standards for lead in toys that won't go into effect until Feb. 10, 2009. By this agreement to settle a law suit with the State of California, the companies agreed not to sell any toys they know contain lead above the soon-to-be Federal standard of 90 parts per million (ppm), The companies will also pay over $0.5 million for lead testing and improved consumer notification.

In 2008, Congress passed a consumer product safety legislation, the Consumer Product Safety Improvement Act, which:

  • Lowers the standard for lead in paint and surface coatings from 600 parts per million currently to 90 parts per million after Aug. 14, 2009,
  • Establishes tighter restrictions for lead in other materials used in toys, such as plastics, metals and fabrics.

Under the terms of the settlement agreement in California, the companies will:

  • Implement the federal lead standards on Dec. 1, 2008, instead of Feb. 10, 2009,
  • Meet the 90 ppm lead in paint standard by Dec. 1, 2008, instead of by Aug. 14, 2009,
  • Meet the 300 ppm standard for lead in plastics, metals, and fabrics by Dec. 1, 2008.

If the companies find toys in excess of the lead standard, they will stop selling and distributing those toys, regardless of when the toy was made. If the companies violate the lead standard in the future, the California Attorney General can obtain penalties through an expedited enforcement process.

Caltha LLP assists manufacturers, importers and exporters in evaluating and meeting product stewardship requirements.


For further information contact Caltha LLP at
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Thursday, December 18, 2008

State Antidegradation Policy - Significance to Wastewater and Stormwater Dischargers

Over recent years, much attention has been placed on State policies and procedures regarding impaired waters, 303d listing, and TMDLs. However, State Antidegradation Policies can be as significant, and in many cases can affect a greater number of dischargers.

In essence, the two regulatory programs address two subsets of "waters of the State" 1) those that currently do not meet their water quality standards, and 2) those that do currently meet standards.

Impaired Waters Programs address waters that do not meet their respective water quality standards. Studies and implementation plans ("TMDLs) are required to move these impaired waters back into compliance.

In contrast, Antidegradation policies or programs address waters that current meet their respective standards. In this case, policies or rules are in place to assure that NEW or EXPANDED discharges to these waters do not result in an unacceptable degradation in water quality (even if still below water quality standards). Antidegradation policies will generally set thresholds for new or expanded discharges above which Antidegradation Reviews may need to be conducted before the discharge is permitted.

One of the complicating factors in antidegradation policies is the application to stormwater discharges which require an NPDES permit. Typically the antidegradation policy thresholds are not expressed in units that are easily applied to stormwater discharges. For example, an existing industrial facility which has a permit to discharge stormwater expands its truck parking area, which technically increases flow. Depending on the specific requirements of the State's antidegradation policy, this increase may require an antidegradation review.

Caltha LLP provides technical support to wastewater and stormwater permittees nationwide to address antidegradation requirements.


For further information contact Caltha LLP at
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Wednesday, December 17, 2008

Missouri (MDNR) Nutrient Water Quality Criteria For Streams

The Missouri Department of Natural Resources (MDNR) has begun the formal process of setting nutrient water quality criteria for streams and rivers in the State, as required under section 304(a) of the Clean Water Act. This is the second phase of a process approved by US EPA in 2005 to set water quality standards for specific nutrients in waters of the State. This process was detailed in the document "Nutrient Criteria Plan".

Nutrient criteria for lakes and reservoirs have already been drafted and are scheduled for submission into the rulemaking process as a part of revision to Water Quality Standards.

Beginning in February 2009, MDNR will be conducted public meetings to solicit input into the development of nutrient criteria for streams and rivers.

Caltha LLP assists clients nationwide in assessing and addressing water quality standards.


For further information contact Caltha LLP at
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Monday, December 15, 2008

TALU - MPCA Considers Major Revison To Water Quality Standards

Minnesota is working to revise its Water Quality Standards to incorporate a tiered aquatic life use framework for rivers and streams in the state. The Tiered Aquatic Life Use (TALU) framework represents a significant revision to the Water Quality Standards of the State’s aquatic life use classification.

MPCA will be conducting public meetings to discuss the approach during January 2009. Rulemaking to incorporate TALU into State Water Quality Standards would not occur until 2010-2011.

The TALU approach utilizes biological assessments of water bodies to identify “stressed” aquatic communities. This assessment would be separate from, and in addition to, traditional current chemical monitoring of lakes and streams to determine if they meet State Water Quality Standards. TALU also provides a mechanism to determine impairments of “modified or limited water resources”, which may include channelized streams and agricultural ditches.

TALU presents a few issues related to integration into existing regulatory programs and requirements, including:

  • How will assessments made using TALU relate to determination of impairment, and the State list of Impaired Waters (“303d List”)?
  • If listed on 303d List, how would a TMDL be implemented?
  • How would permitted discharges be controlled if discharging to a “stressed” water body?
  • How would it be determined that a discharge “causes or contributes to” an impairment if discharging to a “stressed” water body?
  • How would TALU be used for “development and modification of water quality standards to produce improved standards”?

Caltha LLP provides technical support to wastewater dischargers needing to evaluate and address their State's water quality standards.


For further information contact Caltha LLP at
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Thursday, December 11, 2008

Environmental Due Diligence Checklist - Role of Regulatory Compliance

Environmental compliance issues can have a significant financial impact and should be incorporated into the scope of environmental due diligence. A formal compliance audit may be considered, and may have some additional benefits in reducing future liabilities. [read more about recent changes to EPA Audit Policy as it applies to new owners] However, given time and access constraints, a formal audit may not always be feasible during due diligence. In this case, four key areas related to environmental compliance are of high importance.

Non-compliance Issues that Could Result in Capital Improvements. Correcting some non-compliance issues can cost significant amounts of money. For example, tanks without the required secondary containment are expensive to retrofit. Upgrades to pollution control equipment, such as wastewater treatment or air emission control can also be expensive. It is important to understand industrial site operations, so those compliance items which typically involve capital improvements can be highlighted.

Asbestos. The management of asbestos-containing materials is regulated under OSHA, and often is not considered under “environmental compliance”. Management of asbestos in-place requires an Asbestos Management Plan, specialized training and employee notification. Ultimately, if areas with asbestos are disturbed, added costs for handling and disposal of the asbestos material will be realized. Understanding whether asbestos occurs and how it being managed is important to factoring in these future costs.

Missing Permits or Approvals. Changes made at a facility overtime can require new permits, revision to existing permits or pre-approvals for agencies. Understanding what permits and approvals are required is sometimes a complicated task; the result is that upon reviewing the operations, missing permits or approvals can be discovered. “After-the-fact” permitting is often a difficult and expensive process. Capital improvements may be required to comply with the permits, once obtained. The affected processes might need to be shut down until proper permits are obtained. All of these consequences can have a significant financial impact, which should be addressed during the due diligence process.

Upcoming Regulations. The fourth area is upcoming regulations. Although a facility may be in compliance with current requirements, these requirements can change. Impending regulations should be considered to assess any additional costs that will be incurred for the operation. Imminent regulations could, for example, could involve changes to air rules which may require upgrades to pollution control equipment. International regulations on products may also apply; for example, the Waste Electrical & Electronic Equipment (WEEE) and Restriction of Hazardous Substances (RoHS) rules in Europe, which could impact US-based manufacturers.


Caltha LLP provides environmental due diligence services nationwide, specializing in Food, Manufacturing and Electric Utility sectors.


For further information contact Caltha LLP at
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Wednesday, December 10, 2008

TSCA Amendment – Mercury Export Ban Act of 2008

In October 2008, the Mercury Export Ban Act of 2008 was signed into law. The Act amendments the existing Toxic Substances Control Act (TSCA). The Act, sponsored by Senator Barack Obama, places controls on the use, export and storage of elemental mercury. Key elements of the Act are:

PROHIBITION ON SALE, DISTRIBUTION, OR TRANSFER OF ELEMENTAL MERCURY BY FEDERAL AGENCIES. Beginning in October 2008, no Federal agency can convey, sell, or distribute to any other Federal, State or local government agency, or any private individual or entity any elemental mercury.

PROHIBITION ON EXPORT OF ELEMENTAL MERCURY. Effective in 2013, the export of elemental mercury will be banned. This part also requires that a report be made to Congress by October 2009 that summarizes the current and projected production, uses and export of mercury from the US. This part also offers case-by-case exemptions for "essential uses" of mercury for which suitable alternatives are not available.

LONG-TERM STORAGE. The Mercury Export Ban Act also requires that the Federal government create by 2013 storage facilities for mercury wastes generated in the US.

Caltha LLP provides technical support to companies nationwide to maintain compliance with TSCA and other regualtory programs.


For further information contact Caltha LLP at
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Tuesday, December 9, 2008

Minnesota OSHA AWAIR Program Revision – New NAICS Requirements

In November 2008, the Minnesota OSHA adopted the new NAICS classification to determine if employers are required to comply with A Workplace Accident and Injury Reduction (AWAIR) Program. Employers that fall within the listed NAICS codes are required to prepare and maintain a written AWAIR program.

Because the shift to the NAICS system may make some employers subject to AWAIR that previously were not subject, a “grace period” have been established for companies to develop and implement their written programs. All companies subject to AWAIR must have their program established no later than May 3, 2009.

[read more about differences between SIC code and NAICS systems]


For further information contact Caltha LLP at
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Monday, December 8, 2008

Iowa DNR Antidegradation Policy – IDNR Accepting Comments on Draft Policy

The Iowa Department of Natural Resources (IDNR) is proposing changes to its “Antidegradation Policy”. The changes can impact any wastewater discharger in Iowa, but especially new permittees or existing permittees that may wish to increase their discharge in the future. The changes being proposed include:

  • Incorporate by reference the document entitled “Iowa Antidegradation Implementation
    Procedure,” which proposes an approach to assessing and minimizing degradation of Iowa’s surface waters,
  • Update antidegradation policy language with four tier approach,
  • Remove High Quality (Class HQ) and High Quality Resource (Class HQR) designated uses and add several waters to the newly proposed Outstanding Iowa Water (OIW) category.


The purpose of the antidegradation policy is to set minimum requirements to conserve, maintain, and protect existing uses and water quality for water bodies that currently meet their water quality standards. The department is required by Clean Water Act to develop and adopt a statewide antidegradation policy and to identify procedures for implementing the policy. Comments on the draft policy are being accepted through January 29, 2009.


For further information contact Caltha LLP at
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Sunday, December 7, 2008

Auxiliary Facilities – TRI Reporting Requirements Under New NAICS System

In 2007, EPA issued a final rule requiring that facilities reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), commonly called the toxics release inventory (TRI), identify the nature of their business by using North American Industry Classification System (NAICS) codes. Beginning with reports submitted 2007, NAICS codes replaced Standard Industrial Classification (SIC) codes that have been in use since TRI was initiated in 1987.

Both the SIC and NAICS systems were developed to organize and track information the US economy. The basic difference in approach to the two systems is that the SIC system classifies establishments based on their economic output (i.e, what they produce or provide), and the NAICS classifies establishments according to the processes used to produce goods and services (i.e., what they do). With one exception, the switch to NAICS did not affect facilities already required to report under TRI. No industry groups were added to or deleted from the list as a result of the change.

The exception involves businesses classified as "auxiliary facilities" which, under SIC, are those facilities that provide support functions for a manufacturing activity. For example, a distribution center operated by a paper products manufacturer was assigned the same SIC code as the manufacturing operation it supported. Under NAICS, the same distribution center would be assigned a code reflecting the warehousing and logistics operations.

Auxiliary facilities traditionally reported to TRI using the SIC code of the establishment they supported. NAICS did not adopt the SIC concept of auxiliary establishments. Under NAICS, these facilities now report their TRI according to their own activities.


For further information contact Caltha LLP at
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Friday, December 5, 2008

Mercury Source Reduction Sectors - Draft GLRC Priority Sectors

In 2008, the Great Lakes Regional Collaboration (GLRC) Executive Committee directed that a Great Lakes Mercury Emission Reduction Strategy be developed with a goal of producing institutionalized activities to sustain mercury emission reductions from unregulated sources, and regulated sources with potential for additional reduction. The strategy would produce recommendations or options for state action. A workgroup was formed in April 2008 to develop the Strategy.

In November 2008, the work group released several draft documents which will be part of the overall Draft Mercury Emission Reduction Strategy Report. These documents have been made available for public comment until December 17, 2008.

A key document out for review is the draft listing of priority source sectors to be addressed. These sectors were selected based on a set of criteria (which are also being published for public comment) and using existing information of mercury sources. The priority source sectors are:

  • Utility boilers
  • Metals production
  • Waste incineration
  • Cement production
  • Non-utility fuel combustion
  • Mercury cell chlor-alkali plants
  • Mercury emission related to product use and disposal


For further information contact Caltha LLP at
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Wednesday, December 3, 2008

Proposed Revision to South Dakota (DENR) Water Quality Standards

The South Dakota Department of Environment & Natural Resources (DENR) has proposed revisions to the State water quality standards.

Link to proposed SDDENR water standards

Many of the revisions being propsed relate to the application of dissolved oxygen (DO) standards to lakes and rivers.


For further information contact Caltha LLP at
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Tuesday, December 2, 2008

Audit Policy - EPA Policy Changes Regarding New Owners

Since 2000, US EPA has offered reduced enforcement for self-disclosure of environmental compliance violations. EPA’s policy document, “Incentives for Self-Policing: Discovery, Disclosure, Correction, and Prevention of Violations” is commonly known as the “Audit Policy”. On August 1, 2008, the EPA published an interim approach to applying the Audit Policy to new owners that allows new owners to make a fresh start with the EPA.

With the interim approach, the EPA recognizes that a new owner should not be penalized for the economic benefit component relating to violations that arose before a facility was under its control, as long as the new owner is willing to correct issues promptly and institute preventive measures.

Some key elements of the interim approach include:

  • Defining a “new owner” to ensure that the violations disclosed originated with the prior owner, and that the new owner was not responsible for the non-compliance disclosed;
  • Extending the time for reporting for up to nine months after closing the transaction;
  • Relief from the economic benefit component of the penalty for new owners; and
  • Applying five of the nine qualifying conditions differently to the new owner.

One of the important aspects of this policy is that non-compliance at the Seller’s facility can be reported to regulatory agencies before or soon after property transfer. In making the disclosure, the new owner can make the previous owner responsible for penalties, etc., especially associated with economic benefit component, related to the non-compliance.


For further information contact Caltha LLP at
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Demolition Wastes - Proposed MPCA Rule

The Minnesota Pollution Control Agency (MPCA) has published draft rules relating to assessment and removal of certain items and materials prior to the renovation and/or demolition of structures.

For the purposes of the draft rule, renovation/demolition is defined as “physical alteration of the interior or exterior of a structure for the purpose of renovating or removing the structure, and includes alteration or removal of walls, ceilings, floors, or roofs or associated structural components”. Structures subject to the draft rule include residential, recreational, governmental, agricultural, commercial, or industrial and other buildings.


The draft rule lists specific items and materials that must be characterized, tested, managed, and disposed of, reused or recycled before renovation and demolition:

  • items that would normally be disposed of as mixed municipal solid waste ;
  • household hazardous waste;
  • industrial solid waste or hazardous waste;
  • waste tires;
  • major appliances;
  • items that may contain elemental mercury;
  • items that may contain PCBs;
  • items that may contain CFCs;
  • oils;
  • lead-containing items;
  • electronic products containing a cathode ray tube;
  • electronic products containing a circuit board;
  • asbestos;
  • material trapped in sumps and traps;
  • radioactive waste; and
  • other materials or items that are prohibited at the demolition waste facility.

Some exemptions are included in the draft rule, such as when the structure is unsafe to enter as determined by a local government authority.


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Environmental Compliance Audits - Role in Environmental Due Diligence

"Should I include a compliance audit as part of my environmental due diligence?”
This question arises frequently during environmental due diligence for mergers and acquisitions. The answer is actually relevant to many types of transactions, whether a business is being acquired, or if “assets only” are being purchased.

Compliance with applicable regulations can have a significant financial impact on a business transaction; however, separating and focusing on key issues will reduce the level of effort required and eliminate spending time and resources collecting information that has very little impact on the transaction.

Many of the “best-in-class” companies conduct routine environmental compliance audits of their operations. The important point is that even the best run companies will find compliance issues at their facilities and will routinely be in corrective action to improve their operations and address any deficiencies. Often, these non-compliance issues are administrative, such as maintaining required documentation, or training-related. Once the deficiency is identified, it can be quickly remedied at little or no cost.

While considering using a formal Environmental Compliance Audit during due diligence, it should acknowledged that most audits will identify some areas of improvement within the organization. Given this, careful consideration should be given to how this information will be used in the due diligence effort. Given the time frame typically allowed for due diligence, it is often difficult to conduct a formal compliance audit. Beyond the time constraints, confidentially concerns may limit access to facility staff who would typically be an integral part of the audit process. And in the end, the the most important consideration will be whether or not the information gathered will be useful to business decisions regarding the transaction.

In many cases, a COMPLIANCE ASSESSMENT is more useful that a COMPLIANCE AUDIT. For more information:

Article comparing Environmental Compliance Assessments to Compliance Audits


For further information contact Caltha LLP at
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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


For further information contact Caltha LLP at
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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.


For further information contact Caltha LLP at
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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


For further information contact Caltha LLP at
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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.


For further information contact Caltha LLP at
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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.


For further information contact Caltha LLP at
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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.


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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.


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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.


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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 facility...to prevent the misappropriation or use of ammonium nitrate in an act of terrorism.''

For further information go to: http://edocket.access.gpo.gov/2008/E8-25821.htm

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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