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Legislation Ministers fudge emission ceilings EU environment ministers have signiÆcantly watered down a directive setting emission ceilings for four key air pollutants from 2010. Under the national emissions ceilings (NECs) directive EU countries will drastically reduce output of sulfur dioxide nitrogen oxides volatile organic compounds and ammonia over 1990 levels within a decade. However the European Commission said that the targets agreed did not go nearly far enough to address key environmental problems. Under its original proposal the Commission had aimed to halve overall EU acidiÆcation cut population ozone exposure by 75% and vegetation ozone exposure by two-thirds as well as a onethird reduction in the area of soils subject to eutrophication.A Commission analysis shows that the present agreement leaves a large deÆcit compared to these original targets. The decision will provoke further tension with the European Parliament which had already approved the Commission's original proposals. MEPs had also demanded that emissions from aircraft and shipping be included in the proposal an element which ministers left out. In a related move the environment ministers also reached agreement on a long-delayed directive to cut pollution from large combustion plants such as power stations and industrial boilers. Under the agreement combustion plants licensed after the directive enters into force will have to comply with emission limits roughly half those of current levels for sulfur dioxide nitrogen oxides and dust.The sticking point had been for plants licensed between 1987 and that date for which a set of intermediate limits has now ben agreed. EU Council of Ministers www.consilium.eu.int House reins in EPA The House of Representatives has approved signiÆcant cuts to core environmental protection and public health programmes being implemented or This journal is # The Royal Society of Chemistry 2000 proposed by the EPA. The move amounts to a 10% cut in basic programmes which the Agency said would severely impair its work in key areas. The main casualty will be measures designed to meet objectives under the Clean Water Act at a time when around 40% of waterways fail quality standards (see separate item this issue).Clean-up of PCB-contaminated sediments in rivers lakes and streams is likely to be delayed. The cuts will also prevent the Agency from fulÆlling its responsibility under the Clean Water Act to work with states to develop speciÆc clean-up plans for 20,000 polluted water bodies [see JEM 1999 1 87N JEM 2000 2 45N]. In addition EPA has been forced to drop plans to reduce arsenic in drinking water. Other programmes cutback by the House include Superfund clean-ups for contaminated sites an environmental protection programme for the Great Lakes the Climate Change Technology Initiative and a national public information system on air quality. Ozone controls Ænally in place After long-drawn out negotiations the European Parliament and EU governments have Ænally agreed a formula to control hydrochloroØuorocarbons (HCFCs) one of the main culprits in ozone depletion.The contentious issue centred on whether HCFCs should be phased out altogether and over what time period. Having previously resisted an outright ban ministers have now accepted a phase out by 2015 rather than the 2007 deadline demanded by MEPs. Use of virgin HCFCs in maintenance of existing refrigeration and air conditioning equipment will be banned from 2010 and use of HCFCs in new equipment will be outlawed from 1st July 2002. Use of recycled HCFCs will continue to be permitted between 2010 and 2015 but the Commission is to review the availability of alternatives by the end of 2008 potentially opening the way to an earlier ban on recycled HCFCs.Other elements of the new regulation include a timetable for banning the agricultural pesticide methyl bromide an immediate ban on the ozone depleter News bromochloromethane and new controls on the sale and use of CFCs halons carbon tetrachloride 1,1,1-trichloroethane and hydrobromoØuorocarbons. The agreement came shortly after the European Commission had released a new study emphasising the link between ozone-depleting chemicals and greenhouse gases. The report by the Dutch consultancy Ecofys says that emissions of hydroØuorocarbons (HFCS) which are used as replacements for HCFCs are one of three potential greenhouse gases for which emissions are rising quickly.The others are perØuorocarbons (PFCs) and sulfur hexaØuoride (SF6). Measured in terms of CO2 equivalents emissions of the three gases stood at 55 million tonnes (Mt) in 1990 67 Mt in 1995 and will rise to 188 Mt by 2010 if unchecked. ``Banked'' emissions locked up in products such as refrigerators could mean total releases will rise steadily past 2010. However the study notes that the cost of reduction measures is relatively low. Around one third of the total releases 40 Mt could be avoided at a cost of just 5 per tonne compared to 58 per tonne generally required for CO2 abatement. Prevention measures include reducing leaks and use of alternative blowing agents for polyurethane and polystyrene foams.European Commission Ozone Directive www.europa.eu.int/comm/environment/ ozone/index.htm; ``Economic Evaluation of Emission Reductions of HFCs PFCs and SF6 in Europe'' www.europa.eu.int/ comm/environment/enveco/studies2.htm Canada targets PM-10s Fine particulate matter is one of the main pollutants targeted under a smog reduction programme announced by Environment Canada. Launching the new programme Environment Minister David Andersen said that PM-10s would be one of the pollutants identiÆed for speciÆc emission reduction targets across a number of key industrial sectors as part of measures to cut ground-level ozone. The move followed receipt of a new scientiÆc report which 57N J. Environ. Monit. 2000 2 News recommended declaring particulate matter smaller than 10 mm as toxic.The programme includes launch of a process to examine measures to reduce emissions from vehicles and in fuels and an upgrading of Canada's National Air Pollution Surveillance Network. The government aims to mirror new US standards which are to be phased in over the period 2004±2009. The net result should be to reduce ozone-related emissions from new passenger vehicles by 77% and from light duty trucks by 95%. These domestic measures complement the bilateral negotiations underway with the United States under the 1991 Canada±US Air Quality Agreement to reduce transboundary pollution of ozone precursors such as nitrogen oxides and VOCs. Environment Canada www.ec.gc.ca Environmental quality EU struggles with Kyoto targets The European Union is struggling to meet its commitments under the Kyoto protocol to reduce greenhouse gases according to recent reports.Both ofÆcial Ægures and a study by a US research institute show that most EU countries except the UK are likely to miss their Kyoto targets. The latest ofÆcial Ægures from the European Environment Agency show an overall fall of 2% between 1990 and 1998 in emissions of six gases speciÆed under the Kyoto protocol. Total CO2 emissions have been increasing since 1994 and but for relatively large falls in the early 1990s overall emissions would have been higher than 1990 levels. Most of the emission cut was achieved by Germany and the UK with levels in other countries increasing.A sustained 16% drop in methane emissions also contributed to the overall reduction. This picture is conÆrmed in a study by the US-based Pew Centre which analyses progress towards the Kyoto 2008±2012 reduction targets in the UK Germany Austria the Netherlands and Spain. Only the UK is on track the study says and of the others only Germany is even close. Even in the UK and Germany the reductions are spinoffs from other events–the switch from coal to gas power generation and 58N J. Environ. Monit. 2000 2 Danes warned not to get carried away Denmark's environmental record has been praised by the Organisation for Economic Co-operation and Development (OECD).But in the latest of a series of reviews on national environmental policies OECD urges the Danish government to ensure that improvements are achieved in the most effective way. The OECD is particularly concerned over some aspects of economic instruments in areas such as water charges carbon emissions wind turbines transport and waste management. A recently published list of priority chemicals shows that Denmark remains in the vanguard of European industrial decline in East Germany respectively. In an attempt to Ænd a more innovative approach the European Commission earlier this year proposed an EU-wide permit trading system. Two economic studies behind these proposals have now been released. According to the studies an EU-wide emission trading market including all industrial sectors would save 34% of the total costs of complying with Kyoto.Under this scenario the annual cost in 2010 is estimated at 6bn compared to 9bn if no trading takes place. European Environment Agency www.eea.eu.int; European Commission CO2 Trading Studies www.europa.eu.int/ comm/environment/enveco/studies2.htm; Pew Centre www.pewclimate.org US data conÆrms water pollution New data from the EPA show more than 40% of the US waterways surveyed are too polluted for Æshing or swimming. The Ægures which relate to 1998 are generally consistent with other Ændings over the last decade. Runoff from agricultural and urban areas remains the primary source of the leading pollutants namely siltation bacteria the nutrients phosphorous and nitrogen and heavy metals.Around one-third of US waterways are environmental policy. The list of ``undesirable'' substances has already provided an impetus for voluntary action by industry. The government says the updating of the list is a vindication of its approach of promoting soft regulation of the chemicals sector without the need for legislative restrictions. New chemicals added to the list include the fuel additive MTBE the Ærst European country to target it [see JEM 2000 2 30N JEM 2000 2 48N]. Others are chlorinated substances borax and several oil distillates. Denmark is also pressing ahead with plans to curtail the use of lead and the detergent LAS (see separate items in this issue).Danish EPA www.mst.dk; OECD www.oecd.org covered by the assessment which is based on returns from individual states. Among the study's Ændings over 290,000 miles of the 840,000 miles of assessed rivers and streams do not meet water quality standards. Nearly half of all lakes reservoirs and ponds assessed were also found to be polluted. And in the Great Lakes 96% of the shoreline miles indicated pollution exceeding water quality standards. On ground water the states found that quality generally remains good and resources are sufÆcient to support many different uses. EPA OfÆce of Water Quality ``National Water Quality Inventory 1998 Report to Congress'' available at www.epa.gov/ow Manufacturers Øout detergent agreement European detergent manufacturers are failing to meet targets agreed under a voluntary agreement two years ago according to the European Commission.Under the 1998 deal the manufacturers committed to reduce per capita consumption of detergents by 10% from 1996 levels by 2002. The agreement also included cuts in packaging and energy use per wash cycle. A progress review has shown that detergent consumption actually increased by 2% in 1998 the latest year for which Ægures are available. The Commission blamed the increase on the reluctance of manufacturers to promote concentrated detergent products which can reduce consumption by over 50%. Products with greater bulk might appear better value for money and so manufacturers are reluctant to promote concentrate products.The review came as market leader Proctor & Gamble clashed with the Danish authorities over the proposed ban on linear alkyl benzene sulfonate (LAS) a key component of many detergents [see JEM 1999 1 114N]. P&G claimed that LAS poses no threat to the environment and that LAS-free powders were less effective. The Danish EPA said that its own tests refuted both P&G's environmental and consumer claims and that it would press ahead with its proposal to include the chemical on its ``undesirable'' list. Danish EPA www.mst.dk; Proctor & Gamble www.pg.com EU bathing water improves Water quality at ofÆcial coastal and freshwater bathing sites in the EU increased marginally last year according to the latest annual report by the European Commission.Reporting on the implementation of the 1976 Bathing Chemical hazards EPA ignites dioxin debate Dioxins are Ærmly back on the political agenda following the publication of a major report by the EPA which estimates that public health risks are much higher than previously thought. Reporting on an exhaustive reassessment of the environmental and health risks from dioxins begun in 1991 the EPA has released two draft chapters of its report for public comment. The report Ænds that dioxin levels in the environment have declined substantially over the last twenty years as a result of which actual exposures among the general population seem to be declining.However based on a more complete understanding of dioxin toxicity the draft Ænds that health risks may be higher than previously believed. The chances of producing cancers for example are put at 10-fold higher levels than before. Dioxins can also produce Water Directive the Commission says that for the Ærst time overall compliance with mandatory values now exceeds 90% for both types of waters. Under the directive EU member states must sample bathing waters for two types of faecal pollution and three types of chemical pollution. In 1999 95.6% of EU coastal waters conformed to the mandatory values a 1% increase from last year. Compliance for freshwater stood at 90.2% up from 86.5%. The Commission will propose a revision to the directive early next year primarily to reØect new pollution monitoring guidelines being produced by the World Health Organisation.European Commission www.europa.eu.int/water/water-bathing/ index_en.html Lead petrol ban pays off An EU-wide ban on the use of lead as a fuel additive agreed under the 1998 fuel quality directive is already reaping beneÆts in terms of air quality. Reporting monitoring results from January and February of this year immediately after the ban came into effect the French Ministry of Environment said that levels of lead in air in urban areas had decreased by an average of 42%. This is the Ærst many other effects on cells and some of these ``may be occurring at or within one order of magnitude of average background ºintake or body burden levels'' the report says.For certain effects including subtle behavioural impacts EPA asserts that ``a no-effect level has yet to be established''. The report follows an EU review of dioxin health risks published last December [see JEM 2000 2 11N] and an earlier report from the UNEP emphasising the paucity of data on exposure risks in most Western countries [see JEM 1999 1 62N]. The draft assessment and associated documents are available at the NCEA website. EPA is due to publish the Ænal report and a dioxin reduction strategy in the autumn. EPA National Center for Environmental Assessment www.epa.gov/ncea/dioxin.htm News indication of immediate environmental beneÆts from prohibition.The measure came into force on 1st January this year in all EU countries except Italy and Spain which don't have to comply for another two years. French Ministry of Environment www.environnement.gouv.fr Patchy progress on Baltic plan A regional plan to achieve environmental improvements across the 11 countries bordering the Baltic Sea is making hesitant progress a recent report concludes. Most countries in the region have succeeded in cutting acidiÆcation the report says but combined emissions of greenhouse gases are relatively unchanged from 1990 levels–the baseline for measuring progress towards Kyoto targets. The Baltic 21 initiative was launched in 1996 and is being closely watched as the Ærst co-ordinated attempt to promote sustainable development at a regional level.A revised work programme has been launched focusing on capacity building structural changes demonstration programmes and exchange of know-how. Baltic 21 www.ee/baltic21 EU chemicals strategy delayed Controversial plans to overhaul the EU chemicals regulation regime have been delayed until the autumn. Led by the European Commission's Enterprise and Environment Directorates the exercise involves a wide-ranging review of the EU's strategy for chemicals management. The Commission is understood to favour shifting the onus of risk assessment from member states to chemicals producers and users. Currently it is up to member states to prove that a chemical is dangerous before risk reduction measures can be proposed.The strategy is likely to propose reversing the burden of proof so that manufacturers will have to prove products are safe before they go on the market. Discussions on the nature of this ``proof'' seem to be the main cause of the delay. Other areas being targeted are a 59N J. Environ. Monit. 2000 2 News tightening of the authorisation procedures for carcinogenic and mutagenic substances and revisions to the liability of chemical producers. Meanwhile chemical risk assessments under the EU's present legislative framework continue at a snail's pace. Five further assessments were adopted by an EU scientiÆc committee in May bringing to nine the number of risk assessments completed under the 1993 Existing Substances Directive.A further 40 to 50 risk assessments are expected to be forwarded to the EU's scientiÆc committee for review later this year. The assessments relate to the thousands of ``existing'' substances which were on the market before EU product approval rules were introduced in 1981. In June a further 30 chemicals were put on a priority list for detailed risk assessments taking the total of substances currently under investigation to 140. CSTEE Chemical Risk Assessments www.europa.eu.int/comm.dg24/health/sc/ sct/outcome_en.html Experts reject lead ban Denmark's plans to introduce a wideranging ban on lead for health reasons are scientiÆcally unjustiÆed according to an EU scientiÆc committee.A recent report into the proposed restrictions by the EU's ScientiÆc Committee on Toxicology Ecotoxicology and Environment (CSTEE) supports objections raised previously by the European Commission and other member states. In its opinion the committee said that ``The Danish authorities have not provided sound scientiÆc evidence to demonstrate that the introduction of a general ban on use of lead products would result in a signiÆcant additional reduction in the body burdens of lead of the general population''. Danish claims that maximum lead intake levels for children are being exceeded are ``probably not correct'' CSTEE said. However it did agree that current maximum permissible levels set by the WHO may be too high.Responding to the report Environment Minister Svend Auken said the Danish government would be pressing ahead with the proposals with draft legislation due later this year. ``Proactive general measures'' were needed he said even though historical sources such as fuel additives had now been eliminated. 60N J. Environ. Monit. 2000 2 Denmark announced plans to ban the import manufacture and sale of lead and leaded products in late 1998 [see JEM 1999 1 40N]. The Ærst measures were due to come into force last November but under pressure from the European Commission were suspended pending delivering of the CSTEE's opinion. Danish EPA www.mst.dk; CSTEE www.europa.eu.int/comm/dg24/health/sc/ out63_en.pdf Fertility study sparks EDC fears The Worldwide Fund for Nature (WWF) has published evidence of alarmingly low sperm counts in what it claims is the Ærst study involving a random sample of men.Looking at Danish soldiers researchers at Copenhagen's Rigshospitalet found that 43% had sperm counts at levels which WWF said would lead to decreased fertility. WWF said the results emphasised the renewed urgency in EU efforts to tackle endocrine-disrupting chemicals (EDCs). ``Similar Ændings in the past have been criticised for being unrepresentative,'' said WWF spokesperson Elizabeth Salter. ``This study proves that reduced sperm production is real and common''. Although the study made no investigation of causes WWF believes that exposure to known EDCs such as tributyl tin and bisphenol-A are mainly to blame.Meanwhile WWF's UK branch has issued a separate report on bisphenol-A linking it to various fertility effects including reduced sperm production increased prostate weight and endometriosis a condition in which uterine tissue is found outside the uterus. WWF said that children were at the highest risk from EDCs and called on the UK government to phase out or ban their production and use. Industry reacted angrily to the report claiming that the low-dose theory under which even very small exposure to chemicals might have signiÆcant biological effects was ``scientiÆcally highly questionable''. In a statement CEFIC the European chemical industry association said that the ``weight of scientiÆc evidence ºdemonstrates that bisphenol-A does not pose a meaningful risk to the environment''.Danish study ``High frequency of suboptimal semen quality in an unselected population of young men'' Human Reproduction vol.15 no.2 366±372; WWF-UK www.wwf-uk.org/news/pdfs/ BPA.pdf; CEFIC www.ceÆc.org; Bisphenol-A study www.bisphenol-a.org WTO rules against white asbestos The World Trade Organisation has upheld France's ban on imports of Canadian white asbestos (chrysotile). Canada which is the world's largest exporter of white asbestos started formal WTO complaint proceedings in 1998 following a ban by France on the basis of cancer risks. An EU-wide ban on the material has since been agreed due to take effect in 2005 [see JEM 1999 1 62N].ScientiÆc experts consulted by the WTO unanimously agreed that white asbestos was carcinogenic. France's ban is therefore legitimate since under WTO rules countries can restrict trade where necessary to protect human health or the environment. WTO www.wto.org Biochemical pesticide registered EPA has registered a new biochemical pesticide as an alternative to conventional synthetic pesticides such as methyl bromide. The Harpin protein (trade name Messenger) is registered to control a wide variety of fungal bacteria and viral pathogens as well as several insect pests. Methyl bromide is a broad spectrum pesticide that protects against nematodes and fungal diseases but is believed to contribute to ozone depletion and to have adverse health effects.Unlike most pesticides the Harpin protein does not act directly on the target pest. Instead it activates a natural defence mechanism in the host plant called systematic acquired resistance that makes the plant resistant to a wide range of fungal bacterial and viral diseases. Because the product is applied at low rates and degrades rapidly in the Æeld no residues are expected on treated crops and studies demonstrate no adverse effects on humans or wildlife. EPA OfÆce of Pesticides www.epa.gov/ pesticides/biopesticides Household pesticide banned EPA has effectively eliminated household use of the pesticide chlorpyrifos following one of the most exhaustive scientiÆc evaluations ever conducted on pesticide health hazards.Also known under the trade name Dursban chlorpyrifos is used in a variety of household pest controls including against bedbugs cockroaches Øeas and wasps. Commenting on the decision EPA Administrator Carol Browner said that chlorpyrifos was one of a class of older riskier pesticides for which exposure was known to cause neurological effects. ``It is clear that the time has come to take action to protect our children from exposure to this chemical'' she said. Public and occupational health HEI probes PM±mortality link As regulatory agencies in the US the EU and elsewhere review air quality legislation scientists funded by the US-based Health Effects Institute have made substantial contributions to understanding the associations between particulate matter (PM) and mortality.While various studies have suggested public health effects of PMs scientists have pointed out uncertainties about interpretation of the data. For instance it is unclear whether any observed associations might be accounted for by other pollutants; whether bias in exposure measurements leads to the association; or whether the effect might be explained by mortality displacement. In an effort to address these uncertainties and to determine the effects of other pollutants in mortality HEI launched the National Morbidity Mortality and Air Pollution Study (NMMAPS). Dr Jonathan Samet and his colleagues at John Hopkins University in collaboration with investigators at Harvard University conducted this time-series study in large US cities representing various levels of PM-10s and gaseous pollutants.New analytical methods had to be developed to address issues of exposure measurement error and mortality displacement. In analyses for both the 20 and 90 largest US cities NMMAPS found overall mortality increased by an average of 0.5% for every 10 mg m23 increase in PM-10 measured the day before death. This effect was slightly greater for deaths due to heart and lung disease than for total deaths. The morbidity analysis showed an approximate 1% increase in admissions for cardiovascular disease 3M opts for voluntary phase out In a surprise move chemical giant 3M has announced a worldwide phase-out of all products based on perØuorooctanyl chemistry.This is one of a family of chemicals the perØuoroalkyls (PFAs) used in a wide range of consumer household and industrial products. The main chemical concerned perØuoro-octanyl sulfonate (PFOS) was developed by 3M in the 1950s and has been used in products such as specialist and about a 2% increase in admissions for pneumonia and chronic obstructive pulmonary disease for each 10 mg m23 increase in PM-10. Further analyses are being undertaken on regional differences mortality±morbidity effects and concentration±response relationships. Health Effects Institute ``The National Morbidity Mortality and Air Pollution Study Part I Methods and Methodological Issues; Part II Morbidity and Mortality from Air Pollution in the United States HEI Research Report 94'' available at www.healtheffects.org Mobiles linked to chemicals Following hard on the heals of concerns about microwave exposure [see JEM 2000 2 23N] Swedish researchers claim that mobile phones may also emit hazardous chemicals during use.This may explain symptoms such as headaches experienced by some phone users. Bo Bo» rstell and colleagues at IMTEC a contract testing laboratory in Malmo» warmed mobile phones to body heat as they could be when pressed against the ear. A range of chemicals were found to be emitted including phenol cresol and biphenyls.``This may explain why frequent users of mobile phones complain over constant headaches and dizziness'' Mr Bo» rstell said. Both IMTEC and phone manufacturers such as Ericsson are now undertaking further work to ascertain where the chemicals originate from. ``They may come from details on the phones made from phenolic plastic'' said Mr Bo» rstell. ``Another source may News Ære-Æghting foams and oil and greaseresistant coasting for paper packaging and textiles. Although there is no evidence of PFOS causing harm like other PFAs it is known to be persistent and bioaccumulative. New analytical techniques indicate it is present in human and animal tissues at levels of parts per billion. 3M's unilateral move was welcomed by environmental agencies in the US and Canada and is likely to increase pressure for a broader international phase-out of similar chemicals.be liquids used to facilitate the release of the phone shell from plastic presses at the factory. Circuit cards may also be the villains.'' Smoking and drinking ``known carcinogens'' Tobacco smoke and drinking alcohol have been ofÆcially listed as known causes of cancer for the Ærst time. They are two of 20 new or reclassiÆed substances in the US National Institute of Environmental Health Science's (NIEHS) Ninth Report on Carcinogens. As well as ``consumption of alcoholic beverages'' and ``tobacco smoking'' (i.e. direct inhalation of tobacco smoke) the report also lists ``environmental tobacco smoke'' (passive smoking) and ``smokeless tobacco'' (chewing tobacco and snuff) as ``known human carcinogens''–the report's highest category.Another ten chemicals or activities have also been upgraded or added to this category including solar UV radiation and exposure to sunlamps and sunbeds; crystalline silica; cadmium and cadmium compounds; ethylene oxide; 1,3-butadiene; and the drug tamoxifen. Substances added in the ``reasonably anticipated to be human carcinogens'' category are diesel exhaust particulates; isoprene; chloroprene; phenolphthalein; tetraØuoroethylene; and trichloroethylene. Saccharin and ethyl acrylate a substance used in making latex paints and textiles were delisted on the basis of improved scientiÆc evidence on health effects.The carcinogens report is a scientiÆc and public health document Ærst ordered by Congress in 1978 to educate both the public and health 61N J. Environ. Monit. 2000 2 News professionals to recognise cancer risks. Conclusions regarding carcinogenicity in humans or experimental animals are based on Research activities DOE launches Æeld centre The US Department of Energy (DOE) has announced its Oak Ridge National Laboratory in Tennessee as the site for a major new research facility on bioremediation. The Æeld centre to be located adjacent to ORNL will be a Æeld centre for the study of biological geological and chemical processes in bioremediation of groundwater.Teams of researchers from universities and DOE laboratories including ORNL will be involved. The centre includes a 243 acre contaminated site and a 404 acre uncontaminated background area which will be used for comparison and control studies. The presence of different mixtures of pollutants across the site make it ideally suited to this type of investigation. The work will focus initially on better characterisation of both the contaminated and background areas using techniques such as hydraulic testing tracer testing and groundwater and sediment sampling. This information will help scientists identify speciÆc plots for Æeld studies over the next 5 to 10 years. Publications Thyroid pathology report EPA's National Center for Environmental Assessment (NCEA) has published a study of the effects of ammonium perchlorate on the thyroid.The review was concerned with harmonising data from previous studies undertaken using differing methodologies into thyroid histopathology in rats. The work is part of on-going efforts to inform assessment of risk due to perchlorate environmental contamination. NCEA ``The Effects of Ammonium Perchlorate on Thyroids Pathology 62N J. Environ. Monit. 2000 2 expert scientiÆc judgement with consideration given to all relevant information. The report is published every two years. Swedes bridge the gap A major conference to be held in Sweden next year aims to improve communication between the environmental research community and policy-makers.Entitled Bridging the Gap the conference will take place in Stockholm during Sweden's presidency of the EUin the Ærst half of 2001. One of the conference's main aims is to ensure that the latest Ændings from environmental research are fed through into EU policies on sustainable development and the implementation of the EU's sixth Environmental Action Programme. It should also inform the EU's future plans for environmental R&D. ``The idea is to lessen the gap between those who discover knowledge and those who transform it into practical environmental management'' said Erik Fellenius Head of Research at the Swedish EPA. ``It is also a question of how we convey knowledge in an effective way.We hope to be able to increase the understanding between researchers and decision-makers concerning goal conØicts and the special concerns that decision-makers need to consider''. Swedish EPA www.bridging.environ.se Working Group Report'' available at www.epa.gov/ncea/perch.htm Remediation technology case studies Nearly 80 new case studies of novel remediation technologies are now available covering a wide variety of approaches for the remediation of soil and groundwater. Published by the Federal Remediation Technologies Roundtable the case studies are part of a series of over 200 which are intended to aid the selection and use of more cost- NIEHS www.niehs.nih.gov/oc/news/ 9thROC.htm Dendrimers as Øuorescent sensors With analysts needing to detect trace chemicals at ever lower levels instrument makers invest signiÆcant amounts in developing highly sensitive sensors.Anew approach using highly branched molecules known as dendrimers could help with this quest. Dendrimers are widely seen as promising vehicles for drug delivery pollution control and more selective chemical catalysis. Writing in the journal Chemical Communications researchers from Bologna and Bonn universities report that dendrimers can selectively bind with tiny amounts of cobalt ions in solution. The resulting compound produces an ampliÆed signal that can be registered by ordinary Øuorescence detectors. According to the researchers the technique is capable of detecting cobalt at concentrations of 25 mg l21 a level some 3 to 5 times that considered safe for human ingestion. Tailoring of the molecular properties of the molecules should enable the sensitivity to be increased as well as allowing the detection of other heavy metal species. V. Balzani and F. Vo»gtle ``Dendrimers as Øuorescent sensors with signal ampliÆcation'' in Chem. Commun. 2000 853±854 effective remediation strategies. Each case study documents results from a reallife application either at full or demonstration scale. The new additions include processes for phytoremediation and bioremediation; treatment of dense nonaqueous phase liquids; a variety of in-situ processes including electrokinetics and permeable reactive walls; and technologies for the separation and stabilization of radioactive contaminated soils and debris. Federal Remediation Technologies Roundtable www.frtr.gov

ISSN:0960-7919    

DOI:10.1039/b005334l

出版商:RSC    

年代:2000

数据来源: RSC

摘要:

Pesticides in Perspective Introduction When agrochemical companies assess the possible development of a new pesticide a key consideration is which regions of the world have a potential market. Armed with this information companies can predict likely sales of the product and of course global registration is the ultimate goal. Very often the most important market is the USA purely due to the size of the market and the inØuence on Canada and South America. As a consequence gaining market entry into the USA is of paramount importance. However due to the introduction of FQPA (Food Quality Protection Act) registration in the USA is now a lengthy business. Gaining a quick review in the USA is thus key in any strategy concerning registration of a new product and this article reviews Expedited registration review in the USA the EPA's reduced risk program{ Executive summary The rapid approval of new pesticides is critically important from a business perspective.One way to ensure relatively timely review of registration applications in the United States is for the US Environmental Protection Agency (EPA or the Agency) to designate a pesticide as a reduced risk pesticide. EPA's reduced risk program has been operational since 1993. The passage of the Food Quality Protection Act (FQPA) in 1996 placed increased emphasis on this program; mandating that the Agency issue guidelines for the program and expedite the review of reduced risk compounds. The program applies to conventional pesticides; it does not include biological pesticides or antimicrobials.Statutory criteria for reduced risk include reduced risk to {The opinions expressed in the following article are entirely those of the authors and do not necessarily represent the views of either The Royal Society of Chemistry the Editor of the Editorial Board of JEM Zeneca Agrochemicals or those of the Column Editor. DOI 10.1039/b005460g This journal is # The Royal Society of Chemistry 2000 what is currently required under the EPA (Environmental Protection Agency) Reduced Risk Program to gain an expedited review. If successful this will lead to a company being able to sale a product considerably earlier. The author of this article is Rick Tinsworth who studied biology at Providence College Rhode Island and who up until 1990 had 22 years experience of working for the US government (FDA Food and Drug Administration Consumer Product Safety Commission and EPA).During this time he had a range of responsibilities serving as Deputy Director and Director in various Departments including the OfÆce of Toxic Substances and the Registration and Special Review and Reregistration Divisions of the OfÆce of Pesticide human health non-target organisms and the environment. In 1997 EPA published guidance for its reduced risk program. The guidance identiÆed reasons why the Agency had accepted or rejected reduced risk submissions and discussed information and data required to be addressed in reduced risk submissions.Reasons for acceptance included low mammalian toxicity low avian toxicity low potential to contaminate groundwater and low pest resistance potential. Reasons for rejection included inadequate comparative analysis weak risk reduction case and lack of efÆcacy data. The Agency guidance emphasized the need to provide a thorough comparative analysis of the reduced risk compound and current alternatives on the market. This includes a review of toxicity exposure and risk information a discussion of comparative product performance and a description of price sales and marketing information. The Agency does in fact expedite the review process for reduced risk compounds. The time for review and Pesticides Programs.In 1990 Rick joined Jellinek Schwartz and Connolly (JSC) and is currently a Vice President with responsibility for co-managing JSC's extensive pesticide regulatory practice which provides clients with strategic policy and regulatory advice. Rick has worked with many clients on the development of reduced risk documents for many compounds. Consequently outside of the EPA Rick probably has a unique overview experience of the EPA's reduced risk program. For anyone involved in the pesticide registration arena this article is well worth reading. Dr Terry Clark Column Editor Zeneca Agrochemicals UK E-mail Terry.Clark@aguk.zeneca.com approval is substantially faster for reduced risk pesticides compared to nonreduced risk products.While EPA's reduced risk program is generally considered to function well there is some concern that the Agency sometimes makes decisions based on political or public relations reasons rather than being based on science. Introduction From a business perspective the rapid registration of a new pesticide is critically important. This is particularly true for agricultural use pesticides; getting on the market in time for the next growing season can make a dramatic difference in the Ænancial bottom line of a new pesticide product. For this reason pesticide companies devote considerable resources not only to develop the data needed to support the registration of new products but also to develop and implement strategic efforts designed to improve the chances for rapid registration.At the same time the number type and complexity of studies designed to 63N J. Environ. Monit. 2000 2 Pesticides support registration have changed substantially and will continue to do so. In addition pressure from environmental groups to cancel pesticides perceived to be unsafe and to register only those that have been thoroughly evaluated and determined to be safe from the perspective of the environmental groups has led the US Environmental Protection Agency (EPA or the Agency) to proceed very cautiously in the registration review process. Finally limits on the availability of resources for reviewing studies supporting new registrations and for making regulatory decisions concerning new chemicals have caused EPA to set priorities on which new pesticides will be evaluated by the Agency.One way to ensure relatively rapid data review and registration decisions is for EPA to grant ``reduced risk'' status to a new pesticide. Having a new pesticide designated as a reduced risk pesticide for priority review can lead to both a pesticide company and EPA meeting their objectives; that is rapid registration of a pesticide (company objective) deemed safer than alternative products currently on the market (EPA objective). This paper describes EPA's reduced risk program critiques both the Agency's and the industry's performance under this program and offers recommendations for improvements in the program which will continue to be used as a priority setting mechanism by EPA for the foreseeable future.Background In order to sell or distribute a pesticide in the United States there must be a registration (license) for that pesticide. To obtain the registration pesticide registrants must submit studies needed for EPA to make decisions concerning the potential risks that may occur as the result of the use of the pesticide. In addition to registering new pesticides and new uses for already registered pesticides EPA conducts two other major programs. The Agency's reregistration/tolerance reassessment program focuses on requiring the development of data designed to upgrade the scientiÆc databases supporting pesticides previously registered by the Agency to meet modern science standards and on the use of those upgraded data to make decisions concerning the safety of those pesticides.The second program called the special 64N J. Environ. Monit. 2000 2 review program considers whether the registration of certain pesticides should be cancelled because these pesticides presented an unreasonable risk. The registration reregistration and special review programs have been in operation for years in the EPA and there has always been stiff competition for technical and regulatory resources between the programs. The passage of the Food Quality Protection Act (FQPA) increased the competition for resources placed increased emphasis on evaluating and canceling currently registered pesticides and limited the Agency's incentive to register new pesticides to those registrations that fell into certain categories such as reduced risk pesticides.Food Quality Protection Act Prior to the passage of the FQPA in August 1996 the basic standard for registration was whether or not a pesticide and a particular use presented a reasonable or unreasonable risk. An unreasonable risk existed when the potential risk outweighed the perceived beneÆts of use. In the case of a reasonable risk the beneÆts exceed the risk. EPA still uses this standard when considering worker ecological and environmental risks. For dietary risks the FQPA required the adoption of a new standard.That is the use must be ``safe'' which means that the Administrator of EPA must determine that there is a reasonable certainty that no harm will result from dietary and other routes of exposure to the pesticide. The FQPA safety standard requires that EPA consider not only exposure from foods but the Agency must also consider exposure from drinking water and other possible sources of exposure (e.g. homes schools parks). In addition EPA is required to consider whether a particular pesticide shares a common mechanism of toxicity with other chemicals. Finally an additional FQPA safety factor must be used in evaluating risk to infants and children if there are concerns for these population subgroups or if there is insufÆcient data to make such a determination.The FQPA also requires the Agency to reassess all existing tolerances (food use limits) within ten years of passage of the statute establishes new registration timelines for antimicrobial pesticides and requires EPA to expedite the registration of reduced risk pesticides. As a result of the FQPA EPA's pesticide program is focusing almost entirely on the tolerance reassessment effort and on other FQPA mandates such as the reduced risk program. Registration of non-reduced risk pesticides is not a priority with few exceptions; such registrations are taking many months longer than prior to the FQPA. The clear incentive for industry is to attempt to package each registration action as a reduced risk initiative.EPA priority system and organophosphate replacements In April 1997 in an effort to establish schedules for the review of new chemicals new uses experimental use permits and registration amendments requiring the review of scientiÆc data EPA established a priority system for application reviews. Registrants were requested to rank order their submissions and to explain how their priorities were consistent with EPA's registration goals. The Agency stated that its rank order for priority reviews were . Methyl bromide alternatives; . Reduced risk candidates; . US Department of Agriculture-EPA identiÆed potentially vulnerable crops (limited pesticides available to handle an important pest); .Minor use priorities (with limited Ænancial incentive to develop pesticides to deal with pests); . Non-minor use priorities; and . Pesticides that addressed trade irritants. In September 1998 the Agency modiÆed this priority list by inserting signiÆcant organophosphate (OP) replacements that pass the reduced risk review as the second priority after methyl bromide replacements. EPA also stated that OP replacements that were not granted reduced risk status but were recommended by EPA's Reduced Risk Committee for expedited review would be ranked just below non-OP reduced risk candidates. The reason for this special emphasis on OP replacements is because of EPA's concerns about the risks presented by OP products currently on the market; both for individual OP compounds and as a class of chemistry that may have a common mechanism of toxicity.Again the incentive for industry is to seek expedited review of an application by seeking reduced risk status; if a company can also convince EPA that the compound is an OP replacement so much the better. Reduced risk program EPA had considered various options for conducting a reduced risk program for a number of years and such a program was Ærst established in July 1993 well before the passage of the FQPA. The FQPA mandated that procedures and guidelines for the program be established (again much of which was done prior to the FQPA) and speciÆed that reduced risk applications must receive expedited review; thus re-emphasizing the signiÆcance of the program both for the Agency and for the industry.What pesticides are covered by the program EPA's reduced risk program is limited to conventional pesticides. While the major focus of the program is on new active ingredients the program also covers new uses of currently registered pesticides and also new formulations of products for currently registered uses. The EPA reduced risk program does not include biochemicals microbial pesticides or transgenic plant pesticides. It also does not include antimicrobial pesticides. In the fall of 1994 the Agency had established a separate division the Biopesticides and Pollution Prevention Division (BPPD) within the OfÆce of Pesticide Programs to handle the data review and regulatory decision making for biological pesticides.Biological pesticides were and are considered to present less risk than conventional pesticides and EPA established BPPD to expedite the registration of such pesticides. Thus the Agency was already focusing priority attention on these types of pesticides well before passage of the FQPA. In the case of antimicrobial pesticides the FQPA required the Agency to conduct an evaluation of its program to register these types of pesticides and develop regulations to improve the review and registration of these products. In addition the statute speciÆed timeframes for the review of different types of antimicrobial registration applications. Following the passage of the FQPA the Agency established a new division to handle these products.The remaining pesticide registration applications are handled in EPA's OfÆce of Pesticide Programs' Registration Division. This division is charged with the responsibility for conducting the reduced risk program for conventional chemical pesticides. Statutory Criteria The FQPA requires the Agency to expedite the review of applications for registration of pesticides that may reasonably be expected to . Reduce the risks of pesticides to human health; . Reduce the risks of pesticides to nontarget organisms; . Reduce the potential for contamination of groundwater surface water or other valued environmental resources; and/or .Broaden the adoption of integrated pest management strategies or make such strategies more available or more effective. Each reduced risk submission must meet one or more of the above criteria; ideally from a registrant chance of success perspective the submission will meet all four criteria. EPA Guidance Reasons for acceptance and rejection. EPA's basic guidance to pesticide companies for developing reduced risk submissions is contained in Pesticide Registration (PR) Notice 97-3 entitled ``Guidelines for Expedited Review of Conventional Pesticides under the Reduced-Risk Initiative and for Biological Pesticides''. This PR Notice was published in September 1997. By the time PR Notice 97-3 was published EPA had reviewed 39 reduced risk submissions.Twenty-two were accepted; sixteen were rejected (a Ænal decision on the thirty-ninth submission apparently had not been made by the Agency). Based on a review of a subset of the accepted and rejected submissions EPA provided guidance concerning factors contributing to the Agency's decisions in these cases. Factors considered signiÆcant by the Agency for accepted reduced risk submissions in descending order of importance were . Human health effects . Very low mammalian toxicity . Toxicity generally lower than alternatives (10-100-fold difference) . Displaces chemicals that pose potential human health concerns (e.g. OPs B2 carcinogens (i.e. probable human carcinogens )) . Reduces exposure to mixers Pesticides loaders applicators and re-entry workers .Non-target organism effects (birds and insects) . Very low toxicity to birds . Very low toxicity to honeybees . SigniÆcantly less toxicity/risk to birds than alternatives . Not harmful to beneÆcial insects highly selective pest impacts . Non-target organism effects (Æsh) . Very low toxicity to Æsh . Less toxicity/risk to Æsh . Potential toxicity/risk to Æsh mitigatable . Similar toxicity to Æsh as alternatives but signiÆcantly less exposure . Groundwater and surface water . Low potential for groundwater contamination . Low drift runoff potential . Runoff mitigatable . Lower use rates than alternatives fewer applications . Low pest resistance potential (i.e.new mode of action) . Highly compatible with IPM (i.e. integrated pest management) . EfÆcacy Factors considered signiÆcant for rejected reduced risk decisions in descending order of importance were . Human health effects . Inadequate/inappropriate comparisons with alternatives . Inadequate documentation of effects . Human health risk reduction case weak . Risk reduction case inadequate when compared to alternatives . Non-target organism effects (birds and Æsh) . Toxic to birds . Toxic to Æsh . Risk reduction case inadequate when compared to alternatives . Potential groundwater problems . Unlikely to replace higher risk alternatives 65N J. Environ. Monit. 2000 2 Pesticides . Lack of efÆcacy data .Phytotoxicity A more detailed discussion of Agency decision making behavior is provided later in this paper. For now note that the factors listed above are to a large extent toxicity oriented rather than risk based. In addition note that the Agency considers efÆcacy and makes judgements concerning the potential for a new pesticide to actually replace alternatives currently on the market when deciding whether a new pesticide will reduce risk. Topics to be discussed in reduced risk submissions. PR Notice 97-3 requires that pesticide registrants address speciÆc topics in their reduced risk submissions. These subject areas are designed to provide the Agency with the basic information needed to make decisions without requiring extensive review and analysis by EPA staff.The Agency requires that reduced risk applicants discuss data on the reduced risk candidate and to utilize publicly available data on the alternatives being addressed for comparative purposes. EPA does not expect pesticide companies to conduct additional studies to develop data to support the reduced risk rationale. EPA requires that the following areas be discussed in reduced risk submissions. Executive summary. An executive summary must identify the chemical by name structure and class of chemistry. The summary must discuss the mode of action of the pesticide. It must cover the proposed use pattern for the pesticide and identify all major alternatives currently in use including conventional chemicals biological pesticides and mechanical and cultural use practices.The executive summary must provide a brief overview of human health ecological and environmental fate effects of the reduced risk candidate. Finally the summary must identify which of the four FQPA reduced risk criteria mentioned above are met by the reduced risk submission and must provide a brief rationale supporting that conclusion. Human health discussion. PR Notice 97-3 requires that each reduced risk submission provide a thorough overview of the toxicology database for the active ingredient. This overview must address acute mutagenic subchronic chronic oncogenic developmental reproductive and neurotoxic effects. The discussion 66N J.Environ. Monit. 2000 2 must identify studies specify dose levels discuss no observed effect levels (NOELs) and lowest observed effect levels (LOELs). Effects observed must be described qualitatively and quantitatively. The toxicity of animal and plant metabolites must be addressed. The human health discussion needs to address toxicology exposure and risk. Worker consumer and dietary (both food and water) risk must be addressed. An FQPA analysis that addresses key subjects must be provided including a discussion of aggregate risk possible common mechanism of toxicity and endocrine disruption issues and the need for additional safety factors to protect infants and children. Ecological effects and environmental fate.Each reduced risk submission must also provide information concerning the ecological effects and environmental fate database for the reduced risk candidate. Studies must be summarized. Again toxicology exposure and risk must be discussed. Generally modeling work is done to characterize exposure to provide a basis for conducting risk assessments. Such assessments must address possible risk to non-target organisms including mammals birds Æsh aquatic invertebrates marine and estuarine organisms and plants. Environmental persistence mobility in soil and water transport in air (spray drift and volatility) and bioaccumulation must be addressed. Other hazards. In this section of the reduced risk submission the Agency requires a brief discussion of three topics related to the pesticide – potential to deplete stratospheric ozone; potential to present a hazard through storage transportation use or disposal; and potential to impact endangered species.The endangered species discussion relates back to the earlier analysis of environmental and ecological effects. Reduced risk discussion. This section of the reduced risk submission must provide a qualitative and quantitative comparison of the reduced risk candidate compound and the major alternative pest control practices. Again the comparison must address conventional chemical pesticides biological pesticides and mechanical and cultural use practices. The comparison needs to address toxicity exposure and risk to the extent possible based on data and information available to the reduced risk applicant.This topic is the crux of the reduced risk submission. Narrative tables graphs charts and pictures can be used to make the reduced risk argument. EPA expects to see a comparison of NOEL and LOEL levels for the alternative pesticides a discussion of the severity of toxicological effects modeling work and other assessments to characterize various routes of exposure for people and nontarget organisms and comparative risk assessments that address both acute and chronic risks. Registrants generally also include a discussion of the potential for a reduced risk pesticide to reduce environmental burden. Newer products often require lower application rates than older pesticides.As a new product achieves market share and displaces older compounds it is often possible to show substantial reductions in the pounds of active ingredients that are used. Based on the information in this area the EPA Reduced Risk Committeemakes decisions concerning the potential for a new pesticide to reduced risk. However there are several other topics the Agency considers to decide whether a candidate compound will actually reduce risk. Pest resistance and management. EPA requires that registrants address the potential for a new pesticide to develop resistance problems. If resistance problems are considered likely the Agency may be concerned that a reduced risk candidate will not achieve a signiÆcant market share; thus adversely impacting the displacement of riskier alternatives currently in use.The Agency also requires a brief discussion of the potential for a new pesticide to Æt into IPM programs. EPA is particularly interested in this area since IPM and related programs are considered important in efforts to reduce the environmental burden of pesticide use. Comparative performance data. EPA requires that pesticide registrants develop and maintain data to support the efÆcacy of registered products. These data do not need to be submitted to the Agency to support applications for registration unless public health pests are involved. However EPA requires a discussion of efÆcacy data and in particular the Agency is interested in a comparison of the effectiveness of the new pesticide and major current alternatives for reduced risk purposes.Stronger performance of the reduced risk candidate improves the chances that the compound will achieve the market share needed to actually reduce risk. In contrast comparable or inferior efÆcacy may adversely impact the ability of the new compound to effectively penetrate the market. The Agency wants to see statistical analysis of the comparative data and requires a full discussion of experimental methodologies application rates application intervals weather conditions and other related topics. Negative data must be included. Market plan information. PR Notice 97-3 does not require that registrant marketing plans for a new pesticide be addressed but based on feedback to registrants from the EPA Reduced Risk Committee this is clearly an important area that applicants must address.This subject area requires that registrants discuss comparative price information plans for marketing and advertising new products and estimatedmarket share that companies expect over time. Generally the Agency expects to see a Æve year plan and analysis that shows the impact of the new pesticide relative to the products currently on the market. As in the case of efÆcacy EPA uses this information to decide whether new compounds will in fact achieve the market share needed to actually reduce risk. Other information.The Ænal two pieces of information that the Agency requires are a label for the new pesticide and a data matrix that identiÆes all the studies that support the reduced risk submission and registration application. Reduced risk documents The Agency prefers that reduced risk submissions be as short as possible. At the same time registrants must provide the information and analysis needed to make their case. Reduced risk documents are generally several hundred pages long including appendices. Marketing sales and pricing information is usually provided in a conÆdential appendix. Reduced Risk Committee The Reduced Risk Committee consists of representatives from various Divisions in EPA's OfÆce of Pesticide Programs. Representatives from the following Divisions are members of the committee Registration Division; Special Review and Reregistration Division; Biopesticides and Pollution Prevention Division; Health Effects Division; Environmental Fate and Effects Division; and Biological and Economic Analysis Division.Reduced risk procedures To be considered for reduced risk status a registrant submits a document covering the topics discussed above to the Reduced Risk Committee. Generally the Agency wants the application for registration of the subject pesticide to be submitted before or at the same time as the submission of the reduced risk document. EPA generally schedules a committee meeting about thirty days after the submission of the reduced risk document.These meetings usually last for several hours. The applicant is permitted tomake a short presentation outlining the reduced risk argument. The committee members than ask any questions they may have about the submission. The applicant then leaves the meeting and the committee begins its deliberations concerning the submission. Usually the committee makes a decision at that time and the registrant is invited back into the meeting so that the committee can provide feedback to the applicant. If the committee decision is negative registrants are given a chance to Æle a rebuttal argument to address issues and concerns raised by the committee. EPA requires that the rebuttals be submitted within about thirty days of the committee meeting.There are also some cases in which decisions are not made by the committee until additional information and analyses are provided by applicants. Once a pesticide is granted reduced risk status the Agency schedules the compound for expedited review. The data review process in terms of thoroughness and procedures followed is the same for both reduced risk and nonreduced risk chemicals. What works well Expedited review EPA's reduced risk program has been operational since for seven years. During that time the average time to register non-reduced risk conventional pesticides has ranged from 28 to 38 months. Time to register covers the time from submission to a registration decision. These averages range from 28 Pesticides months for registration decisions made in Æscal year (FY) 1997 and 2000 to date to 38 months in FY 1995 and FY 1996 prior to the passage of the FQPA.In contrast during those same seven years the average review time for reduced risk pesticides has ranged from 14 to 25 months. The average was 14 months in FY 1995 and 1996 prior to the FQPA to 25 months in the year 2000 to date. Clearly the Agency does in fact expedite the review and approval of reduced risk compounds. This actual expedited review process beneÆts the Agency which considers the reduced risk program important from a public policy perspective and it also beneÆts registrants who can bring products to market more rapidly. Adding new uses to a reduced risk compound's registration is even more rapid.The current average review time for these submissions according to EPA staff is 15 months. EPA staff also report that the average time for non-reduced risk new uses has ranged from 31 to 47 months during the last few years. Success rate of submissions EPA staff report that in excess of 100 reduced risk submissions have been made by registrants and the success rate each year ranges between 70 and 80 percent. This success rate indicates that the Agency guidance concerning what is needed in a submission and the industry's response to that guidance is positive. Positive impact on public health and the environment The Agency has not published an evaluation that demonstrates that reduced risk pesticides have in fact replaced or reduced the use of riskier pesticides.However if one assumes that the arguments presented in reduced risk submissions are reasonably accurate then the reduced risk program has been successful in responding to dietary worker ecological and environmental risk concerns and will continue to do so as newly registered compounds achieve greater market share in the future. Concerns about the reduced risk process Quality and timeliness of agency decision making In general relatively few complaints have been raised about the decisions made by EPA's Reduced Risk 67N J. Environ. Monit. 2000 2 Pesticides Committee. The committee receives relatively high marks for the quality and timeliness of its work.Complaints that do arise include a belief that some decisions seem to be based on how the decisions will make the Agency look from a public relations or political perspective rather than being based on science. In a few cases registrants have complained that committee members have not devoted the time and effort needed to conduct a thorough review of reduced risk submissions. Finally the timeliness of agency registration actions for reduced risk compounds has increased substantially since the passage of the FQPA. In the Ærst case it is clear that the Agency views the reduced risk program as important from a public policy perspective and certainly EPA uses the success of the reduced risk program in its public relations and political activities.Many believe that this factor inØuences how the committee makes decisions; that is the committee does not want to make a decision that might be criticized by environmental groups. Factors that appear to almost guarantee a negative reduced risk decision include the possible need for an extra FQPA safety factor to protect infants and children and neurotoxicity or oncogenicity toxicity issues. This seems to be true even if it is clear that there is no real risk concern and even if the new pesticide appears to clearly be less risky than compounds already on the market. 68N J. Environ. Monit. 2000 2 As far as the thoroughness of the committee review process is concerned it is clear that Reduced Risk Committee members do not believe they should take the time to delve into complex toxicity or risk issues.The committee members believe that it is the registrant's responsibility to clearly and simply make the reduced risk argument. If the committee believes that more than a relatively few hours of work are needed to properly evaluate an issue the committee will reject the submission and argue that complex science questions must be evaluated as part of the normal Agency review process. Finally it is worth noting that prior to the passage of the FQPA EPA was registering reduced risk compounds in about 14 months. In FY 2000 the average time is 25 months compared to an average time of 28 months for nonreduced risk compounds. While FQPA certainly requires additional analysis to make decisions it is a concern that it is taking more than two years to make registration decisions for new pesticides; particularly for pesticides that EPA considers to be priority actions. Quality of industry submissions On the industry side of the ledger there are several issues. One is that registrants are attempting to make as many submissions as possible reduced risk candidates in order to get EPA expedited review or registration applications. In some cases this may have led to submissions that were marginal reduced risk cases at best. An additional issue is that in some cases reduced risk submissions have been rejected because the committee deemed the registrant's submission inadequate. In some cases the problem has been with the comparative risk analysis. In others applicant's have not fully developed and presented the comparative efÆcacy case and the marketing information needed to strongly support their submission. Conclusions EPA's reduced risk program is considered a great success by the Agency. The program will continue to receive emphasis in the coming years. The Agency needs to ensure that the additional work required to make decisions under the FQPA does not unduly slow down the review process for reduced risk compounds. Industry will continue to attempt to develop reduced risk arguments for its new products and uses because that is the best way to get relatively rapid review by EPA. Registrants need to submit rationales that make reduced risk arguments as simply and as thoroughly as possible. This includes comparative risk comparative product performance and marketing information. Rick Tinsworth Jellinek Schwartz and Connolly

ISSN:0960-7919    

DOI:10.1039/b005460g

出版商:RSC    

年代:2000

数据来源: RSC