United States: International Environmental Monitor: July 2004

Carcinogenic, Mutagenic and Toxic to Reproduction Substances in Products
By Koen Van Maldegem

On May 25, 2004, the SCCNFP (Scientific Committee on Cosmetic Products and Non- Food Products intended for consumers) adopted an opinion which confirmed its previous opinion of September 2001 on "Chemicals ingredients in cosmetic products classified as carcinogenic, mutagenic or toxic to reproduction (CMR) according to

Directive 67/548/EEC" on dangerous substances. According to this opinion, the use in cosmetic products of category 1, 2 and 3 CMRs must be prohibited. A substance classified in category 3 may however be used in cosmetics if it has been evaluated by the SCCNFP and was found acceptable for use in cosmetic products.

Following the September 2001 opinion, the European Parliament and Council adopted a Directive amending for the seventh time Directive 76/768/EEC on cosmetic products, in which they confirmed the SCCNFP opinion. In the framework of this Directive, the Commission is now in the process of adopting an implementing measure that will ban the use of category 1 and 2 CMRs in cosmetic products and will ban the use of category 3 CMRs for which there is no positive risk assessment or for which no mandate for risk assessment was submitted. The Commission Directive should be adopted in September 2004. The current draft requires Member States to adopt implementing measures by September 11, 2004, which is a very short implementation period.

On July 15, 2004, the European Environment Agency published, alongside the Commission, a report on the latest data available concerning greenhouse gas emissions. According to this report, emissions of the 6 gases monitored under the Kyoto Protocol dropped by 0.5% in 2002 in EU-15. On July 7, the Commission also issued a Communication (Ref.: COM(2004)500) by which it approved 8 national CO2 allocation plans (Danish, Irish, Dutch, Slovenian, Swedish, Austrian, German and British plans). The national plans have to outline the number of emission allowances that Member States intend to allocate to their industries for the 2005-07 trading period and how much each participating plant will receive. When the Commission has assessed a plan unconditionally, the Member State can take a final allocation decision. Three of these plans however are accepted on the condition that some technical changes are made by September. (The Commission requested changes if the volume of allowances for the 2005-07 period does not allow the Member State to meet its Kyoto targets during the first commitment period 2008-12 or if a Member State intends to redistribute allowances among the participating companies during the 2005-07 period, so-called "ex-post adjustments").

Several other national plans have been received recently and should be assessed by September. Two Member States of EU-15, Greece and Italy, still fail to communicate their national plans. The Commission has sent them a letter of formal notice (first stage of the infringement proceeding). Furthermore, only 4 (Austria, Germany, France and Sweden) out of the 15 Member States adopted the necessary measures to implement the emission trading Directive (Ref.: Directive 2003/87/EC). The compliance date was December 31, 2003. The Commission accordingly sent reasoned opinions to the 11 Member States which failed to comply with the Directive. The new Member States which joined the EU on May 1, 2004, were supposed to adopt their national plans and national measures transposing Directive 2003/87/EC by the accession date. The Commission granted them several additional weeks of grace.

On July 19, 2004, the Commission authorized the import, feed use and industrial processing of Monsanto NK603 maize under Directive 2001/18/EC. This authorization is valid for ten years. The Commission adopted this Decision after the Council failed to reach a qualified majority on the issue within three months from the Commission’s proposal (Ref.: COM(2004)193 of March 26, 2004). On the same day, the Agriculture Council could not reach a qualified majority on a Commission proposal to authorize NK6023 maize for human use as a novel food under Regulation 258/97. If the Council still fails to reach a qualified majority or to adopt or reject the proposal before September 24, the Commission will adopt this Decision itself. (Ref.: COM (2004)439 of June 24, 2004). A third application has been filed by Monsanto for the cultivation of NK603 in EU. The European Food Safety Authority (EFSA) has issued a positive opinion, stating that "the herbicide-tolerant GM maize NK603 is as safe as conventional maize."

(Ref.: http://www.efsa.eu.int/pdf/pressrel_gmo_0203_final_en.pdf)

Environmental Council

On July 16-18, 2004, the Environment Ministers gathered in Maastricht for an informal Environment Council. The main themes developed were the Dutch Presidency’s proposal for a "clear, clever and competitive Europe" and the Commission’s Communication on flood risk management. The Council wishes to strengthen EU competitiveness by further applying eco-efficient innovations and reinforcing the recognition of the Lisbon Strategy ambition to become the most ecoefficient economy by 2010. It called for the development of national and EU instruments to give eco-efficient innovations a fair and competitive market perspective, and notably for the implementation of the Commission’s ETAP program presented as a practical tool that shows that the environment is not a burden but a factor for industry competitiveness. (Ref.: COM(2004)38 of January 28, 2004)

On July 19, 2004, the European Commission approved the import, processing and use of Monsanto’s Roundup Ready Corn in animal feed throughout the European Union. This approval is conditional on approval under the European Union Novel Foods Regulation. At that time, the Council of Agricultire Ministers did not reach a qualified majority on the use of Roundup Ready Corn and its processed products as food and food ingredients under this regulation. The decision will continue in the regulatory process. The approval does not include approval for use of the product for cultivation which is the subject of a separate submission. Monsanto views this approval as progress toward completing all the necessary regulatory approvals for Roundup Ready Corn in the EU and toward an end to the EU moratorium on biotech approvals. In the weeks before the EU approval, Argentina approved this product for planting, and Japan approved Monsanto’s YieldGard Plus stacked corn trait for importation.

California’s Electronic Waste Recycling Act, enacted as Senate Bill 20 in 2003, will establish a series of requirements over the next four years for manufacturers, retailers and consumers of electronic products that contain cathode ray tubes (CRTs) and Liquid Crystal Display (LCD) panels. Key provisions of the Electronic Waste Recycling Act are in effect now. Others are being implemented on a prescribed timetable, and others are being reconsidered and revised. When all of these requirements are in place, California will have a comprehensive recycling and disposal program for CRT and LCD products and will impose European standards that ban the sale of CRT and LCD products that contain prohibited chemicals. As each provision of this state law is implemented, it will have effects on manufacturers around the world.

April 1, 2004 – Notification by Manufacturers to Retailers. By this date, every "manufacturer" who sells a "covered electronic device" to retailers of those devices in California was required to identify for every "retailer" each device that is subject to the Act. The term "manufacturer" includes a person who manufactures a covered device that is sold in California and a person who sells a covered device under that person’s brand name. A "covered electronic device" is a video display device with a screen size greater than four inches in size, measured diagonally. A "retailer" is a person who sells, leases or transfers a covered electronic device to a consumer in California.

November 1, 2004 – Recycling Fees. On or after this date, a recycling fee will be collected by retailers on the first sale in California of a covered electronic device from a retailer to a California consumer. On this date, it will become unlawful for a manufacturer to sell a covered electronic device in California that is not in compliance with this law. (This requirement originally was to be imposed on July 1, 2004. Emergency legislation (Senate Bill 901) extended the implementation date for this requirement to November 1, 2004 but left all other implementation dates intact.)

January 1, 2005 – Labeling Requirements. On or after this date, it will be unlawful for any person to sell in California a covered electronic device that is not clearly labeled with the name of the manufacturer or the manufacturer’s brand label.

July 1, 2005 – Reporting Requirements. On or before this date and annually thereafter, each manufacturer that sells a covered electronic device in California will be required to file a report that identifies the number of covered electronic devices it sold in California during the preceding year and a set of "baselines" identifying (1) the amounts of certain designated chemicals in those devices in that year and the reduction of those chemicals from the previous year, (2) the total estimated amount of recycled materials in those devices and the increase in recycled materials from the previous year, and (3) any efforts to design such devices for recycling and plans for further efforts in the future.

July 1, 2005 – Recycling Requirements. On or before this date and perpetually thereafter, each manufacturer subject to the law will be required to make information available to consumers that describes where and how to return, recycle, and dispose of covered electronic devices. (This "requirement" presumes that manufacturers and retailers, in conjunction with state authorities, have put in place a system for recycling and disposing of covered electronic devices, with "collectors" and "recyclers" of covered electronic devices to receive payments from an Electronic Waste Recovery and Recycling account, funded by the recycling fees discussed above.)

January 1, 2007 – Prohibition on Sale of Covered Electronic Devices That Do Not Conform to European Standards. On this date or the date on which EU Directive 2002/95/EC becomes effective in Europe, whichever is later, it shall be unlawful for any person to sell in California any covered electronic device manufactured after that date that does not comply with the Directive. The Directive, when effective, will prohibit the sale of devices that contain the following chemicals: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBBs) or polybrominated diphenyl ethers (PBDEs).

The law has three penal provisions. It allows for "civil liability" of up to $2,500 per offense to be imposed administratively by the state’s Integrated Waste Management Board (IWMB) for each sale of a covered electronic device for which a recycling fee has not been paid. The law also allows for a "civil penalty" of up to $5,000 for each offense, to be imposed by a superior court, for each such sale. The law further allows for "civil liability" of up to $25,000, to be imposed administratively by the IWMB, "against any manufacturer for failure to comply" with the law, except for penalties imposed under the provisions above.

The Boards of Supervisors in California counties Humboldt, Marin, Butte and San Luis Obispo agreed to include initiatives on the November election ballot that introduce a ban on the growth of biotech crops in these counties. While USDA, FDA and EPA regulate the production and use of biotech crops, state counties are increasingly influenced by those that argue federal oversight of biotech crops is insufficient. Several anti-GMO activist groups have merged together to form one organization focused on obtaining bans on biotech products in California counties. Mendocino county has already passed a measure that bans the growth of such crops, though no genetically modified crops or animals were previously raised in this county before the ban. Organizers in several additional California counties, as well as counties in Hawaii and Vermont, are collecting signatures and urging politicians to pass similar legislation in their counties.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), § 307, added § 801(m) to the Federal Food, Drug, and Cosmetic Act (the Act) to require that FDA receive prior notice for food imported or offered for import into the United States. To help companies in complying with the myriad of requirements under the prior notice requirement, the FDA and the U.S. Customs and Border Protection Directorate (CBP) have recently released a revised Compliance Policy Guide on prior notice requirements for imported food shipments. The Compliance Policy Guide contains detailed charts for use by FDA and CBP in determining whether to refuse a shipment of food. The Guide also provides information on categories of violations and actions in response to violations. A wide range of options are presented through these and other items. FDA and CBP may undertake the listed actions or may take different or additional actions if they believe particular circumstances warrant them.

FDA Finalizes Rule on Administrative Detention of Food Items
By Brian Finch 

The FDA recently released the final rule to establish administrative procedures for detaining food items under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). This detention authority applies to food for which FDA has credible evidence or information that it presents a threat of serious adverse health consequences or death to humans or animals. The final rule allows FDA to detain a food item based upon credible evidence or information gathered from an inspection, examination or investigation. A detention order must be approved by a FDA District Director or higher official. Copies of the detention order will be given to the owner, operator or agent in charge of the facility where the detained item is located, or if it is in a vehicle to the shipper or the owner of the food item. The detained items must be placed in a secure location and cannot be detained for more than 30 days. The rule applies to domestic and imported food, although it is most likely to be used on domestic food items.

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