Vital Signs

American Industry is faced with some regulatory hurdles coming across the Atlantic from the European Union. These are the new REACH and E-PRTR laws. REACH became effective on June 1, 2007, whereas companies operating in Europe must start tracking their chemical usages from January, 2007 and beyond, to report toxic releases just as American companies are accountable for Toxic Release Inventory.

There will be many influences on how American companies export to Europe, whether they actually have to file reports on these laws or not. Purchasing and inventory control, not to mention accurate disclosure of product contents, will all be a part of the EU’s conformance and compliance equation.

Here are synopses on these two laws. For information on these, or other laws impacting exporting to Europe and EU operations among the 27 member nations, contact one of the Vanguard representatives above.

Very few of the chemicals used in Industry every day have ever been tested adequately for health and environmental safety. In many cases, no one knows which chemicals pose the most or least dangers to workers, consumers and the natural environment. REACH is the European Union’s (EU) response to an overwhelming problem. With the EU’s adoption of this revolutionary law on December 18, 2006 under Regulation 2006/1907, REACH came into force on June 1, 2007. From that time forward, Industry must register and test all chemicals in use (manufactured in Europe OR imported into the EU) in the EU in quantities greater than one ton per year (an annual usage threshold). REACH is the most important EU legislation in the last two decades. It is the strictest law to date regulating chemicals and will impact industries throughout the world.

Companies must register their chemicals with the new central European authority – the European Chemicals Agency (ECA) located in Helsinki, Finland. REACH will benefit companies by allowing a pre-registration period of June 1, 2008 through December 1, 2008. This will allow companies adequate time before they must test and fully register their chemicals.

It’s obvious that this annual usage threshold-qualifier is extremely low. The premise in business is to generate large volumes of products purchased and reordered by customers. It is not at all difficult for a company to produce just 2,000 lbs. of a given chemical for use in commerce over the course of an entire year. [Allowing for a typical company that would turn its product inventory over about once a month, or 12 X’s per year, REACH would require accountability and tracking for all companies that inventory and/or use any listed chemically-oriented product in excess of 133 lbs, based on one 8-hour shift per day.] More than one shift per day will drive such inventory numbers downward.

In 1981, when Europe adopted its regulation for new chemicals, some 100,000 chemicals were listed as already in use and therefore grandfathered. 25 years later, the chemicals that were on the market in 1981 still account for virtually all of the volume of industrial chemical use. Thus, grandfathering the pre-1981 chemicals meant that the new chemical testing standards were largely ineffective. A patchwork of other European regulations called for testing and regulation of selected chemicals that were identified as potential hazards. But at the glacial pace of progress under these regulations, it would have taken literally thousands of years to complete the testing of the chemicals already on the market in Europe. REACH, first proposed in 2001, will eliminate the grandfathering of chemicals and continue to require testing of new chemicals. The program will mandate that both new and old chemicals be tested under a schedule that starts with the substances known to be dangerous, and the largest volume chemicals. The initial proposal would have subjected all chemicals to roughly the new chemical standards. But after several years of amendments, the current form of REACH represents a dramatic strengthening of standards for the pre-1981 chemicals that still dominate the market, but a less stringent standard for low-volume new chemicals.

Roughly 30,000 grandfathered chemicals are thought to remain in use in annual usage volumes of 1 ton or more, making them subject to REACH. The great majority of chemicals are expected to pass the tests and be approved for use. When potential hazards are identified, chemicals will be subject to authorization, i.e., approved only for narrowly defined and carefully regulated uses where hazards can be minimized. In extreme cases, chemicals can be restricted (banned) altogether. If there is disagreement about these judgments, an appeals procedure explicitly allows weighing the economic and other effects of authorization or restriction against the health and environmental impacts.

Some categories of chemicals are exempt from REACH because they are covered by other European regulations. In some cases, industry has succeeded in amending the REACH proposal to exclude particular categories.) Pharmaceuticals, pesticides, fuels, and nuclear materials are all handled under other regulations. REACH fundamentally covers industrial chemicals, and the numerous specialty chemicals that are not in the exempted categories. The chemical inputs used to make pharmaceuticals and pesticides are subject to REACH, even though the final products are not. Likewise, REACH does not cover plastic polymers such as PVC (plastic applications, such as pipe), but does cover the monomers, such as vinyl chloride, which are used to make plastics. As in the case of vinyl chloride and PVC, the monomers are often more directly hazardous than the polymers.

EPER is the European Pollutant Emission Register, the first European-wide register of industrial emissions into air and water, which was established by a Commission Decision of July 17, 2000. According to the EPER Decision, Member States have been mandated to produce a triennial report, which covers the emissions of 50 pollutants to be included if the threshold values indicated in Annex A1 of the EPER Decision are exceeded.

The first reporting year was 2001 (although Member States also had the option of providing data for 2000 and 2002); this information was reported, in June, 2003 and published on the Internet, http://eper.ec.europa.eu, in February, 2004. The website, which is hosted by the European Environment Agency (EEA) gives access to information on the annual emissions of approx. 9,200 industrial facilities in the 15 old Member States of the EU as well as of Hungary and Norway.

The second reporting year was 2004 and includes data from the new Member States. Those data were published in late autumn, 2006 and comprise data of emissions from approximately 12,000 industrial facilities.

The information on the website is easily accessible and can be obtained by pollutant, activity (sector), air and water (direct or via a sewerage system) or by EU/country. It is also possible to see detailed data on individual facilities and rank them by the size of their pollutant emissions. You can search by name, address or by clicking on a map. Alternatively, sources of a particular pollutant can be researched. With the 'Time Series,' functionality data from reporting years 2001 and 2004 can be compared.

The data of both reporting years and the reporting process itself were evaluated according to specific criteria; the results were published on the website under EPER Review.

E-PRTR is the European Pollutant Release and Transfer Register, which succeeds the EPER. It is intended to fully implement the obligations of the UN-ECE PRTR Protocol, which was signed in May, 2003 by 36 countries and the European Community.

The obligations under the E-PRTR Regulation extend beyond the scope of EPER mainly in terms of more facilities included, more substances to report, additional coverage of releases to land, off-site transfers of waste and releases from diffuse sources, public participation and annual instead of triennial reporting.

The first reporting year under the E-PRTR will be the year 2007 and respective information will have to be reported by Member States in June, 2009. The Commission will publish the data in Autumn, 2009.

To contribute to the prevention and reduction of industrial pollution, and to improve public access to information on the environment, the European Union (EU) has established the European Pollutant Release and Transfer Register (EPRTR).

E-PRTR ACT	Regulation (EC) No 166/2006 of the European Parliament and of the Council of January 18, 2006 concerning the establishment of a European Pollutant Release and Transfer Register and amending Council Directives 91/689/EEC and 96/61/EC.
SUMMARY	This Regulation mandates Pollutant Release and Transfer Register (PRTR) at European Union (EU) level in the form of a publicly accessible electronic database. This database will meet the requirements of the United Nations Economic Commission for Europe (UN-ECE) Protocol on Pollutant Release and Transfer Registers, signed by the Community in May 2003.

The public will be able to access this register free of charge on the Internet and will be able to find information using various search criteria (type of pollutant, geographical location, affected environment, source facility, etc.)

The register will contain information on releases of pollutants to air, water and land, as well as transfers of waste and pollutants, where emissions exceed specified threshold values and result from specific activities. The register will also cover releases of pollutants from diffuse sources (such as transportation).

The activities concerned are specified in the so-called Annex I, and include in particular those covered by Directive 96/61/EC (the Integrated Pollution Prevention and Control (IPPC) Directive). They include those associated with thermal power stations, mining, quarrying and metalworking industries, chemical plants, paper and timber industries and also waste and waste-water treatment plants.

Annex II of the EPRTR lists the waste and pollutants covered by the register, which include greenhouse gases, acid rain pollutants, ozone-depleting substances, heavy metals and certain carcinogens such as dioxins.

Information gathered at the national level by Member States and reported to the Commission will be fed into the database on a regular basis. First of all, operators carrying out one or more of the activities listed in Annex I will submit information to the competent national authority if their activities involve releases or transfers of pollutants exceeding the threshold values assigned to the specific, listed chemicals under this regulation.

Where applicable, Member States will also be required to gather information on releases from diffuse sources. Member States must then report the information they have collected to the Commission by the stipulated deadline (within 15 months of the end of 2007 (which is April 1, 2009) for data relating to 2007, and subsequently within 12 months of the end of each reporting year). Member States are permitted to keep certain information confidential. If they do, they must notify the Commission of the type of the information that is being withheld and the grounds for withholding it.

The Commission, with the cooperation of the European Environment Agency (EEA), will provide the public with access to the information contained in the database by ensuring it is available on the Internet by the stipulated deadline (within 21 months of the end of 2007 for data relating to 2007, and subsequently within 16 months of the end of each reporting year).

Title VI of the Clean Air Act (CAA) directed the Environmental Protection Agency (EPA) to protect the ozone layer through several regulatory and voluntary programs. Sections within Title VI cover production of Ozone-Depleting Substances (ODS) (40 CFR 82 Subpart A), the recycling and handling of ODS (40 CFR 82 Subpart F), the evaluation of substitutes under the SNAP program (40 CFR 82 Subpart G), and efforts to educate the public.

ODS are compounds that contribute to stratospheric ozone depletion. ODS are generally very stable in the upper atmosphere and only degrade under intense ultraviolet light in the stratosphere. When they break down, they release chlorine or bromine atoms, which then deplete ozone. All ODS have been identified and determined to be severe (Class I) or less severe (Class II) based on their ozone-depleting potential and global warming potential. Class I chemical production and import have ceased and have been replaced by Class II chemicals in almost all applications. Examples of Class II chemicals currently in use for refrigeration and foam blowing activities are R-22 and 142b. By March 2008, these Hydrochlorofluorocarbons (HCFC) must be replaced by Hydrofluorocarbons (HFC), such as 134a, in foam blowing activities. By 2010, all HCFC production and import will cease. By 2020, all activities using HFC must find a lower ozone-depleting substitute or switch to a non-ODS.

In refrigeration, chilling and dehumidifying applications, the HCFC are grandfathered for reuse and recycling in existing units through the year 2015. However, there are a number of reporting requirements for operators of this equipment that have more than fifty pounds (50 lbs.) in any one unit. Calculations of Annual Leakage Rates must be performed between repairs for each unit. There are limits on how often repairs can be performed on the same component and how long before the repair must be completed. Verification tests must be conducted on repaired equipment and reports must be submitted to Regional EPA offices if repairs are found to be ineffective. Only EPA certified technicians can perform recharging and verification testing on these units. The EPA audits usage records of certified recycling and reuse Heating, Ventilating and Air-Conditioning (HVAC) companies. These audits are often used to target firms for inspection.

Avian Influenza, or “Bird Flu”, refers to a large group of different flu viruses that primarily affect birds. This flu virus is extremely lethal to infected birds, killing as many as 90%, depending upon the strain of virus. On rare occasions, these bird viruses can infect other species, including pigs, cats, dogs and humans. The vast majority of these influenza viruses do not infect humans, but one particular strain, avian H5N1, has pandemic potential, or the potential to spread around the world through humans. This would require the virus to mutate, or adapt, into a strain that is not only contagious among humans but which could be spread through the air as other influenza strains do. It is important to note that all flu pandemics are caused by new influenza viruses that have adapted to humans.

The H5N1 strain first infected humans in Hong Kong in 1997, causing 18 human cases and six deaths. Since then, over 328 human cases have been confirmed in 12 countries; Azerbaijan, Cambodia, China, Djibouti, Egypt, Indonesia, Iraq, Lao Peoples Democratic Republic, Nigeria, Thailand, Turkey and Viet Nam. These cases have resulted in 200 deaths. Most of these infections were seen in people who handled poultry or who lived in close proximity to poultry or other infected birds, such as waterfowl. To date, Indonesia and Viet Nam have been the most severely affected countries, with 106 and 100 cases reported, respectively.

The World Health Organization (WHO) and the Occupational Safety and Health Administration (OSHA) suggest the following if you need to travel to a country with known avian influenza in its poultry population:

The following web sites have a great deal of information on the subject of Avian Influenza:

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