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* Risk Assessment, a Community Perspective Jay Feldman National Coalition Against the Misuse of Pesticides, Washington, DC - Environ Health Perspect 103(Suppl 6):153-158 (1995) Key words: pesticides, risk assessment, food safety, alternatives to pesticides The deficiencies associated with current risk assessment and negligible risk method- ologies used to protect public health and the environment during the current epi- demic of environmentally induced diseases serve as the imperative for moving ahead with a program to phase out hazardous pesticides and to implement alternatives. With the release of the National Academy of Sciences June 1993 report, Pesticides in the Diets of Infants and Children, the pub- lic once again is reminded of the failure of the U.S. government to adequately protect the population from potentially harmful pesticides. Methods of generating exposure data and testing for pesticide toxicity are found to provide inadequate protection for those who fall outside the averages, includ- ing children. The analysis supports the retention and expansion of the prevention- oriented Delaney Clause of the Federal Food, Drug, and Cosmetic Act as an approach that removes pesticides shown to cause serious adverse effects and promotes alternatives. With the release of the National Academy of Sciences (NAS) June 1993 report, Pesticides in the Diets of Infants and Children, the public once again is reminded of the failure of the U.S. govern- ment to adequately protect the population from potentially harmful exposure to pesti- cides. While the report focuses on inade- quate protection of children from pesticides, the central conclusion is applicable across the general population-current methods of generating exposure data and testing for pes- ticide toxicity do not adequately protect This commentary was presented at the Symposium on Preventing Child Exposures to Environmental Hazards: Research and Policy Issues held 18-19 March 1994 in Washington DC. Manuscript received: December 5, 1994; accepted: May 15, 1995. Address correspondence to Jay Feldman, Executive Director, National Coalition Against the Misuse of Pesticides, 701 E Street, SE, Washington, DC 20003. Telephone (202) 543-5450. Fax (202) 543- 4791. those who fall outside the average. In the case of children, this means that exposure data do not take into account their diet, which is disproportionately composed of particular commodities (1) and virtually ignore the limitations of and the impact of pesticides on developing organ systems (2). In addition, while the NAS report focuses on food exposure, the authors note that pesticides are not simply a food safety problem (3). Safety concerns must take into account the toxicity of all pesticides in the aggregate, with an evaluation of all routes of exposure. The NAS report raises serious questions about the government's ability to develop meaningful risk assessment models to cal- culate with any kind of certainty the real risks that pesticides present. In fact, the report indicates that the U. S. Environ- mental Protection Agency (U.S. EPA) has very limited ability to ensure the public that there can be adequate public health protection without major changes in the way the agency conducts its program. In testimony outlining an intent to propose pesticide legislation in the 103rd Congress, Clinton Administration officials acknowl- edge the inadequacies of the current regu- latory system and NAS findings of the need to overhaul the regulatory require- ments. Administration officials said in con- gressional testimony, "As acknowledged by the NAS study, full information on con- sumption habits for infants and children is not up-to-date" (4). Lynn Goldman, Assistant Administrator for Prevention, Pesticides and Toxic Substances, said, The report made a variety of recom- mendations concerning how EPA evaluates pesticide toxicity, residue levels, and food consumption, and how this information is used in risk assessments. The Academy's recom- mendations, taken as a whole, pre- sent a great challenge in terms of higher standards for the quality, quantity, sensitivity, and scope of the data the Agency uses in evaluat- ing risks from pesticides. This is a formidable challenge, but one we are prepared to meet (5). The NAS report is just one of many reports that raise serious questions about our knowledge of pesticides and their effect on people (6). From these reports, we should draw the conclusion that we cur- rently have insufficient information to safely calculate the real risks of pesticides. This situation exists against a backdrop of adverse human health and environmen- tal effects that in many cases are reaching crisis proportions. * The rates of illness and mortality asso- ciated with cancer are rising. Devra Lee Davis, formerly with the NAS Board on Toxicology and now a senior sci- entific advisor to the Secretary of Health at the Department of Health and Human Services (DHHS), said in her Oct. 21, 1993 congressional testimony, "We found that industrial countries' rates of cancer mortality increased from 1968 to 1986 for a number of sites, including melanoma, prostate, non- Hodgkins lymphoma, multiple myeloma, breast, brain and kidney can- cer" (7). The NRC found that all forms of cancer except lung and stomach cancer are increasing in people over 54-and that this is not attributable to increased detection capabilities (8). * Dramatic worldwide declines in male sperm counts have been found over the last 50 years (9). * There are reproductive failures in wildlife species ranging from alligators in Florida to polar bears in Alaska (10). * Elevated rates of childhood brain can- cer (11) and childhood leukemia (12) are associated with homes where pesti- cides are used. National Cancer Institute epidemiological data from 1991 showed that the rate of childhood malignancies climbed almost 11% from Environmental Health Perspectives 153

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Page 1: Risk Assessment,a Community Perspective Jay Feldman · RiskAssessment,a CommunityPerspective JayFeldman National Coalition Againstthe MisuseofPesticides,Washington, DC-Environ Health

*

Risk Assessment, a Community PerspectiveJay FeldmanNational Coalition Against the Misuse of Pesticides, Washington, DC

- Environ Health Perspect 103(Suppl 6):153-158 (1995)

Key words: pesticides, risk assessment, food safety, alternatives to pesticides

The deficiencies associated with currentrisk assessment and negligible risk method-ologies used to protect public health andthe environment during the current epi-demic of environmentally induced diseasesserve as the imperative for moving aheadwith a program to phase out hazardouspesticides and to implement alternatives.With the release of the National Academyof Sciences June 1993 report, Pesticides inthe Diets of Infants and Children, the pub-lic once again is reminded of the failure ofthe U.S. government to adequately protectthe population from potentially harmfulpesticides. Methods of generating exposuredata and testing for pesticide toxicity arefound to provide inadequate protection forthose who fall outside the averages, includ-ing children. The analysis supports theretention and expansion of the prevention-oriented Delaney Clause of the FederalFood, Drug, and Cosmetic Act as anapproach that removes pesticides shown tocause serious adverse effects and promotesalternatives.

With the release of the NationalAcademy of Sciences (NAS) June 1993report, Pesticides in the Diets of Infantsand Children, the public once again isreminded of the failure of the U.S. govern-ment to adequately protect the populationfrom potentially harmful exposure to pesti-cides. While the report focuses on inade-quate protection of children from pesticides,the central conclusion is applicable acrossthe general population-current methods ofgenerating exposure data and testing for pes-ticide toxicity do not adequately protect

This commentary was presented at the Symposiumon Preventing Child Exposures to EnvironmentalHazards: Research and Policy Issues held 18-19March 1994 in Washington DC. Manuscript received:December 5, 1994; accepted: May 15, 1995.

Address correspondence to Jay Feldman,Executive Director, National Coalition Against theMisuse of Pesticides, 701 E Street, SE, Washington,DC 20003. Telephone (202) 543-5450. Fax (202) 543-4791.

those who fall outside the average. In thecase of children, this means that exposuredata do not take into account their diet,which is disproportionately composed ofparticular commodities (1) and virtuallyignore the limitations of and the impact ofpesticides on developing organ systems (2).In addition, while the NAS report focuseson food exposure, the authors note thatpesticides are not simply a food safetyproblem (3). Safety concerns must takeinto account the toxicity of all pesticides inthe aggregate, with an evaluation of allroutes of exposure.

The NAS report raises serious questionsabout the government's ability to developmeaningful risk assessment models to cal-culate with any kind of certainty the realrisks that pesticides present. In fact, thereport indicates that the U. S. Environ-mental Protection Agency (U.S. EPA) hasvery limited ability to ensure the publicthat there can be adequate public healthprotection without major changes in theway the agency conducts its program. Intestimony outlining an intent to proposepesticide legislation in the 103rd Congress,Clinton Administration officials acknowl-edge the inadequacies of the current regu-latory system and NAS findings of theneed to overhaul the regulatory require-ments. Administration officials said in con-gressional testimony, "As acknowledged bythe NAS study, full information on con-sumption habits for infants and children isnot up-to-date" (4).

Lynn Goldman, Assistant Administratorfor Prevention, Pesticides and ToxicSubstances, said,

The report made a variety of recom-mendations concerning how EPAevaluates pesticide toxicity, residuelevels, and food consumption, andhow this information is used in riskassessments. The Academy's recom-mendations, taken as a whole, pre-sent a great challenge in terms ofhigher standards for the quality,

quantity, sensitivity, and scope ofthe data the Agency uses in evaluat-ing risks from pesticides. This is aformidable challenge, but one weare prepared to meet (5).The NAS report is just one of many

reports that raise serious questions aboutour knowledge of pesticides and their effecton people (6). From these reports, weshould draw the conclusion that we cur-rently have insufficient information tosafely calculate the real risks of pesticides.

This situation exists against a backdropof adverse human health and environmen-tal effects that in many cases are reachingcrisis proportions.* The rates of illness and mortality asso-

ciated with cancer are rising. Devra LeeDavis, formerly with the NAS Boardon Toxicology and now a senior sci-entific advisor to the Secretary of Healthat the Department of Health andHuman Services (DHHS), said in herOct. 21, 1993 congressional testimony,"We found that industrial countries'rates of cancer mortality increased from1968 to 1986 for a number of sites,including melanoma, prostate, non-Hodgkins lymphoma, multiplemyeloma, breast, brain and kidney can-cer" (7). The NRC found that all formsof cancer except lung and stomachcancer are increasing in people over54-and that this is not attributable toincreased detection capabilities (8).

* Dramatic worldwide declines in malesperm counts have been found over thelast 50 years (9).

* There are reproductive failures inwildlife species ranging from alligatorsin Florida to polar bears in Alaska (10).

* Elevated rates of childhood brain can-cer (11) and childhood leukemia (12)are associated with homes where pesti-cides are used. National CancerInstitute epidemiological data from1991 showed that the rate of childhoodmalignancies climbed almost 11% from

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J. FELDMAN

1973 to 1988, and did not appear to bea function of better reporting (13).Our country needs a national frame-

work for recording and evaluating overallchemical use. We live in an age where toxicsubstances have become a basic ingredientin our food production system and otheraspects of pest management. Instead ofregulating these materials out of food, weare debating appropriate ways of rationaliz-ing acceptable levels of toxic materials.This process goes on even when there doexist alternative, nontoxic, or less toxicfood production systems that compete inproductivity and profitability.

At the community level, where pesti-cide and pest management decisions aremade-about such things as schools, parks,and rights-of-way-the question is whetherpeople want to institutionalize a certainlevel of toxic material or whether they wantto phase out the use of toxic and hazardousmaterials and force a shift to alternativemethods of control.

Central to the discussion on commu-nity decisions are questions of risk assess-ment. Community people are told that thechemicals in wide use are tested and foundto represent an acceptable or "negligiblerisk." Generally, people are told that thepublic is exposed to trivial or traceamounts of chemicals or, for example, thattheir risk from exposure to a carcinogen isone in a million. What drives these con-clusions is a process of decision makingcommonly referred to as risk assessment.While risk assessment has attached to it ascientific mystique, the methodologybrings with it some commonplace assump-tions about exposure and toxicity that theNAS report has challenged. In fact, whatemerges from any investigation of riskassessment is uncertainty. Much has beenwritten about the uncertainties associatedwith risk assessment. The NAS report RiskAssessment in the Federal Government:Managing the Process (1983) concluded,

[D]ata may be incomplete, andthere is often great uncertainty inestimates of the types, probability,and magnitude of health effectsassociated with a chemical agent, ofthe economic effects of a proposedregulatory action, and of the extentof current and possible futurehuman exposures. These problemshave no immediate solutions, giventhe many gaps in our understandingof the causal mechanisms of car-cinogenesis and other health effectsand in our ability to ascertain the

nature or extent of the effects asso-ciated with specific exposures (14).The president of the American

Chemical Society said, "...risk assessmentrequires inferences drawn from limited sci-entific data" (15). A physician working inoccupational and environmental medicine,Grace Ziem, writing about multiplechemical sensitivity (MCS), said,"Although initially skeptical that such ill-ness reactions could occur following low-level chemical exposure, I became awarethat existing chemical exposure limits werescientifically faulty and that no-effect levelsextrapolated from chronic animal studieswere often orders of magnitude below cur-rent legal exposure limits" (16-19).

Therefore, a number of requirementsare central to risk discussions at the com-munity level. These requirements, whichshould be thought of as principles for com-munity decision making, are* To ensure that all pesticides proposed

for use are fully tested, with specificfocus on vulnerable or sensitive popula-tion groups;

* To provide full disclosure of pesticidetest data, all pesticide product ingredi-ents, pesticide ingredients in all endproducts, and possible health and envi-ronmental effects, as well as to postingand to inform of proposed pesticide use;

* To contribute to the prevention ofadverse health and environmentaleffects; and,

* To reduce and, where possible, elimi-nate unnecessary use of pesticides. Whileuse reduction decisions must targethigh-risk chemicals, an overall strategyto reduce pesticide use should not belimited by deficiencies and limitationsin our ability to define risk accurately.

Testing of Pesticides forHealth and EnvironmentalEffectsAn April 1993 report issued by the U.S.General Accounting Office (GAO) offers avery distressing update on the status ofU.S. EPA's efforts at reregistration underthe 1988 amendments to the FederalInsecticide, Fungicide and Rodenticide Act(FIFRA). The report issues findings thatindict U.S. EPA's program in two areas: a)failure to meet statutorily imposed dead-lines; and, b) a reduction in data require-ments as part of an effort to speed up thepesticide reregistration process. (GAO, inits report, cites U.S. EPA concurrence withthe facts presented.) (20)

To evaluate U.S. EPA's reregistrationefforts, we must review their evaluation in atleast three areas of data. GAO has describedthese areas as follows: a) toxicity data, gener-ally from laboratory studies, to identify pos-sible adverse health effects; b) environmentalfate and ecological effects data, which iden-tify the fate of a chemical in the environ-ment after application and its possibleeffects on nontarget species; c) exposuredata, which assess the frequency, extent, androutes of exposure for people, includingsubpopulations such as children (21).GAO found the following:

U.S. EPA is Behind Schedule onReregistraionsAccording to GAO (22),

U.S. EPA continues to fall behindits schedule to reregister the 18major lawn care pesticides. In themeantime, the pesticides continueto be applied in large amounts with-out complete knowledge of theirsafety. Since March 1991, U.S.EPA's scheduled study completiondates for many of the 18 major lawncare pesticides have slippedsignificantly, some by as much as 4years. The following factors con-tributed to delays, according toGAO: the need for higher level stud-ies; repetition of rejected studies;time extensions; and concern aboutpesticide derivatives. Much of thedelay seems to be a function of theregistrant failing to adequately per-form a study and registrant delaysresulting in time extensions. Somedelays are generated by U.S. EPA.The same can be said for food use pesti-

cides, most of which are also used in lawncare. According to GAO testimony deliv-ered to Congress in 1992,

Enactment of FIFRA '88 wasintended to address such concerns[about the safety of many existingtolerances] by accelerating the rereg-istration of about 23,000 older pes-ticide products. However, thereregistration task has proven moreformidable than anticipated, and theU.S. EPA will not meet the 1997reregistration time frame establishedby FIFRA '88. In the interim, previ-ously registered pesticide productsmay be used on food under theirexisting registration and tolerances,despite the U.S. EPA's incompleteknowledge of their human healthand environmental effects (23).

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U.S. EPA Has Changed the Basis ofMakinZ Reregistration Decisions from"Fully' Complete to a "SubstantialiyComplete Database.Because of this change, it appears U.S.EPA has been able to accelerate its timeschedule. In the case of 2,4-D, U.S. EPAeliminated the need for a crop residuestudy to makes its reregistration decision,saving 21 months. With Isofenphos, theregistrant made up 24 months in slippagewhen, "EPA determined that it did notneed spray drift studies due in 1995,"according to GAO. "Two other pesticides,Pendimethalin and Glyphosate, improvedby 28 and 12 months, respectively, sinceJune 1992, for similar reasons" (24). U.S.EPA says it will be using data on similarpesticides when it drops a data requirementor proceeds with reregistration even thoughthe study has not been received. Accordingto GAO,

One of the 18 pesticidesGlyphosate-is currently inReregistration Eligibility Document(RED) preparation. Although EPAhad earlier rejected a number of theregistrant's environmental fate stud-ies, it determined that the databasefor Glyphosate was sufficientlycomplete with the studies. EPAofficials told us that they may notrequire the registrants to repeat therejected studies (25).U.S. EPA told GAO that it might make

registration decisions without waiting for a1996 groundwater study on diazinon or acancer study on an atrazine metabolite.

U.S. EPA Does Not Have AdequateExposure Data to Make SafetyDecisionsIn its 1992 testimony, GAO indicated thatU.S. EPA did not have reliable data on thequantity of pesticides used on food crops.The statement went even further to saythat inadequate knowledge supports riskestimates. According to GAO, "[W]efound that EPA's estimate of potentialhuman exposure to pesticide residues infood is uncertain because these [USDANationwide Food Consumption] surveysare flawed" (26).

Similarly, with nondietary exposure,U.S. EPA has poor exposure data to use forpurposes of reregistration because theagency simply assumed that significantexposure was unlikely. "...EPA is workingon better testing and assessment guidelinesfor all types of residential exposure to tox-ics," says GAO (27). It appears unlikely

that U.S. EPA will have guidelines devel-oped before fiscal year 1997 and then onlyif funding becomes available.

Farmworker protection remains inade-quate under new worker protection regula-tions that do not ensure that all workershave full information, training, and med-ical monitoring provided all other workersprotected under the Occupational Safetyand Health Act. Our country's "harvest ofshame" must be addressed within the con-text of reregistration to ensure the well-being of those who harvest the nation'sfood. According to the GAO,

Hired farmworkers are not ade-quately protected by federal laws,regulations, and programs; there-fore, their health and well-being areat risk. Hired farmworkers go intofields sprayed with pesticides, butmany have no knowledge of thespecific chemicals they are exposedto or the potential health effects.Field sanitation on many smallfarms may be inadequate, constitut-ing a serious health hazard to hiredfarmworkers on those farms. Youngchildren . . . may be more suscepti-ble than adults to the harmfuleffects of pesticides" (28).

Integrity ofTest Data is Still an IssueIn 1991 the U.S. EPA Inspector General(IG) reported to the agency inadequateauditing of testing laboratories used bychemical companies that generate studiesused for reregistration. In the wake of majorpesticide testing scandals involving falsifiedpesticide health and safety data, U.S. EPA'sOffice of the IG has revealed serious gaps inthe agency's good laboratory practices(GLP) inspection program. According tothe IG, U.S. EPA might not recognize a badstudy when it came across one because, "theAgency does not have standards to deter-mine if a specific GLP deficiency wouldcompromise the validity of a study."According to the IG, "of the 220,000 stud-ies completed under FIFRA, only 2268 haveever been audited-just under one percent"(KA Kouz, personal communication).

The cost of dependency on pesticidesmust be calculated more broadly. There isincreased general understanding that pesti-cide use has secondary environmental andeconomic impacts, which some researchershave totaled at $8 billion annually (29).

Defining Acceptable RiskIn the year since the Ninth Circuit Courtdecision upholding the Delaney Clause of

the Federal Food, Drug, and Cosmetic Act(30), the provision has been called out-dated and anachronistic by politicians andindustry interests. However, the law isbased on the scientific understanding thatwe cannot prove the level at which a cancer-causing substance initiates a cancer effect,although we can determine that a chemicalis a carcinogen. This distinction stemsfrom the fact that high dose animal experi-mentation can tell us that a chemicalcauses cancer, but it does not tell us thelow dose point at which the chemical hasno effect. Given that carcinogens havedelayed or long-term effects, animal experi-ments have never been able to replicate thetime period and low dose. For all the criti-cism, the high dose method has yieldedimpressive results, proving accurate in thevast majority of cases in which chemicalsare known through epidemiological studiesto cause cancer in humans (31). There isno scientific basis for suggesting that anycarcinogenic exposure represents a trivial ornegligible risk. The Delaney Clause errs onthe side of public health protection, andrightly so.

Those arguing the Delaney Clause'sdemise would have it replaced with a negli-gible risk standard, as proposed by RHLehman and TJ Bliley in H.R. 1627 (32).The negligible risk standard is steeped inrisk assessment methods filled with uncer-tainties and miscalculations as to sensitivepopulation groups, such as children andelderly, average body weight, consumptionpatterns, and other exposures affecting thetotal toxic load that any one individualalready carries.

RiskAssumptions Belie RealityThe risk assessment strategies proposed toreplace Delaney ignore multiple chemicalexposures (33). For example, 11 of U.S.EPA's 32 carcinogenic pesticides are regis-tered for use on apples and 10 for use ongrapes. Assessing the risk from a piece offruit, a plate of food, and three meals a dayis beyond the grasp of the proposal. Worseyet, there is no attempt to aggregate therisk of nonfood exposure to the very samepesticides, which are widely used on lawnsand in parks and school yards, or the riskto those at highest risk.

Full Disclosure Is CriticalThose who currently use and are exposedto pesticides are being denied informationregarding the identity and toxicity of thetrade secret inert ingredients. The terminert, by which trade secret pesticide

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formulation ingredients are commonlyknown, is an extremely deceptive mis-nomer since the great majority of thesematerials are quite chemically and biologi-cally active. Furthermore, U.S. EPA hasconsistently failed to give adequate atten-tion to the toxicological review of the atleast 1100 trade secret ingredients, openlyadmitting that it has so little informationon 71% (800) of them that it cannot evenrate their potential toxicity.

Among the more notable types of mate-rials of concern are those that are registeredas active ingredients in other formula-tions-solvents with considerable biologi-cal activity and surfactants that facilitatepassage of other chemicals through biologi-cal membranes including human skin,insect integument, and plant cell walls.

In general, trade secret ingredientscomprise from 25 to 99% of a formula-tion. This implies that very large quantitiesof these materials are being dispersed intothe environment. Given that many of thesesecret ingredients are known to have ormay have serious toxicological effects, itseems clear that the secret ingredients maybe posing as significant a threat to humanhealth and the environment as are theactive ingredients themselves.

Given that secret ingredients compriselarge portions of formulations, are biologi-cally active, and may pose serious toxicolog-ical and environmental concern, U.S. EPAhas a clear responsibility to perform full andadequate assessments of risks posed by thesematerials, based upon adequate data thatmust be required of manufacturers. U.S.EPA has shown no indication that it plansto commit any resources to the review ofthe over 800 secret ingredients of unknowntoxicological concern.

Despite large potential exposure andknown and unknown potential for serioushuman health and environmental harm,these materials are allowed trade secret sta-tus. People have no opportunity to makeinformed decisions in purchasing and usingpesticidal products since they do not knowall the ingredients. Furthermore, federal,state, and local agencies can provide no realassurance to the public that the pesticides inuse do not pose a serious risk because theycannot know what materials comprise asignificant portion of the formulations.

Preventing the Poisoning in alime of National Health CrisisIt must be recognized that the negligiblerisk standard-central to H.R. 1627 andother legislative proposals-is based on

extremely imperfect methods of predictingrisk, collectively known as risk assessment.It is the inadequacies of these predictivetools that require our critical examinationto determine the validity of the concept asa whole.

An evaluation of cancer is instructive indetermining the application of risk assess-ment. One operating premise is that dra-matic steps must be taken to preventavoidable exposure to carcinogenic materialsat a time when cancer plagues our nation.Cancer is a killing and disabling disease ofepidemic proportions and now strikes onein three persons and kills one in four (34).Scientific consensus contends that cancer ismainly caused by exposure to causativeagents in the environment and chemicallyinduced cancer has been well demonstrated.We are exposed to a wide range of carcino-gens in our environment, some of whichoccur naturally, but many are a direct resultof an industrialized society.

Attempts at managing risks under anegligible risk policy ignore the fact thatthe last 3 decades have confirmed the sci-entific basis of the Delaney Clause and ourinability to quantitatively define carcino-genic risk.

The Delaney Principle Is Still the BestScientific Standard for Cancer ControlCancer mechanisms are not completelyunderstood, but all scientifically acceptabletheories preclude measuring or predicting asafe level of exposure to any carcinogenbelow which no individual or populationgroup will develop cancer. Recognition ofthis forms the basis of the Delaney Clausestandard of no additional cancer or "noinduction of cancer."

As a substitute for the Delaney Clause,H.R. 1627 proposes to establish a negligiblerisk standard, tied to an acceptable inci-dence of cancer. Ratification of this newstandard, already adopted by the U.S. EPAin an interpretive rule in October 1988 (53FR 411050) and successfully challenged incourt, undermines long-term public healthand safety.

Negligible Risk s Too Crulde a MeasureA negligible risk formulation relies on riskassessment modeling, a crude tool contain-ing numerous uncertainties that make itinadequate for predicting potential hazardsto people ingesting carcinogens. Depend-ing on the assumptions and models used,calculated risks can vary by orders of mag-nitude. Risk assessment cannot accuratelyyield thresholds for cancer effects in

humans. At best, it can give us indicationsof relative risks.

It has become accepted practice to useanimal cancer bioassays in which animalsare exposed at doses that approximate theanimal's maximum tolerated dose. This isdone to maximize the likelihood of a posi-tive effect, using experimental animalgroup sizes that are manageable logisticallyand economically. Central to predictingthe toxic effects of a substance is theprocess of generating a graphical dose-response curve. The shape of such a curvemay vary from chemical to chemical, andeven for a single chemical it is not likely tobe linear over its entire range. However,scientists plotting tumor incidence againstdose of the putative carcinogen are plottingdata points relevant to the high end of thecurve where doses are large. In fact, thevalidity of extrapolation down to low dosesis not easily verifiable and may not accu-rately predict the shape of the curve at thatend of the scale.

The One-Hit model used by U.S. EPA,widely considered our most conservativemodel, assumes that tumor yield graphedagainst dose will be linear in the low-doserange (based on mathematical proof).However, a review indicates that it is lessconservative as popularly assumed (35).Using data from 1212 bioassays on 308chemicals tested by the NationalToxicology Program, it was found that in asmall percentage of cases the mathemati-cally generated curve may deviatesignificantly from the actual animal bioas-say results. This occurs more frequentlythan expected by chance, resulting insignificant underestimation of risk by whatis characterized as an extremely conservativetechnique.

ions Exi EstiCarcinogen PotencyAn essential element in cancer risk calcula-tion, carcinogenic potency, is derived bycalculating the slope of the curve graphedby plotting tumor yield against dose in ani-mal bioassays. These slopes, which U.S.EPA calls Q*-values, may be derived froma series of carcinogenicity bioassays andaveraged to get an overall potency figure.The artificiality of this process is especiallytroublesome when experimental data donot correspond well to linear dose-responsemodels, for example, with many Class C(possible human) carcinogens. Also,potency is alterable by a host of externalfactors. As Maugh (36) stated in a 1987review,

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Significant differences in theobserved potency of carcinogens inlaboratory animals can be obtained,for example, by exposing the ani-mals to chemical agents that stimu-late or depress drug-metabolizingenzyme systems; by modification ofthe animals' diet; by changing thehormonal balance of the animals;and by stressing the animals in vari-ous ways, such as by increasing thenumber in a cage.Most important, the influence of multi-

ple chemical exposures is an importantissue that current mathematical models aretoo crude to assess, yet it is a reality ofhuman exposure.

Limitations Exist in EstimatingExposureExposure calculations are combined withcarcinogenic potency values to obtain acancer risk estimate. Just as artificial as car-cinogenic potency estimates, exposure esti-mates can be derived in several ways,depending on the quality of the pesticideresidue database. Dietary exposure esti-mates tend to generalize risk over an aver-age situation or population, away from theconsideration of particular situations andindividual sensitivities. This oversimplifi-cation is dangerous, since the simple inclu-sion of exposure figures for sensitivesubpopulations within the overall averageexposure calculation does not in factaddress the particular hazard that a sub-population might face. Rather, it obliter-ates it from conscious consideration. Asstated by Hattis (37), "Should the analysttake pains to uncover and disclose the dis-tribution of the risk among the popula-tion? A 10-6 risk of death from a specifichazard for an aggregated group mighttranslate into 10- for a particularly at-risksubset. Holdren cites possible differences inthe distribution of risk between rich andpoor, the medically susceptible and thepopulation as a whole, and between thosewho have a voice in the acceptance of riskand those who do not" (38).

In addition to the problems mentionedabove, risk assessments are limited to theeffects of exposure to a single toxic agent.They do not consider "plate-of-food" risksand thereby underestimate the additive riskfrom ingesting multiple carcinogens.

Negligible Risk Standard IsUnacceptable to the PublicPeople have made it clear that they do notwant to eat, or do they want their children

to eat, carcinogenic pesticides. Growersand consumers agree that the food supplymust be safe. The negligible risk standardof safety is not an adequate predictor ofsafety. The public does not want to belulled into a false sense of security. Forthese reasons, we support the establishmentof a standard by which society prohibitsthe purposeful introduction of cancer-caus-ing agents into the food supply and rejectsthe unproven assumption that these poi-sons are necessary to a food production sys-tem yielding affordable food prices.

Reduce Pesticide DependencyThere are a number of systems in placepertaining to pest control for farms, struc-tures, and landscapes. In agriculture, thereare a number of sustainable agriculturalsystems that reduce pesticide dependency(39). Organic agriculture has shown itselfto be profitable and productive. Soybeangrowers in Practical Farmers of Iowa havereplaced the cancer-causing herbicidealachlor with tillage systems and plantingtechniques to shade out weeds. They elimi-nated one of the 32 carcinogenic pesticidesannounced by U.S. EPA while maintainingproductivity and profitability-at yieldshigher than the state average and an aver-age savings of at least $11 an acre (40). Inschools, parks, along rights-of way, and inforestry, alternatives to pesticides haveproved successful. The GovernmentServices Administration, in its pest controlprogram for 30 million square feet of fed-eral office building space, has reduced pes-ticide use by 98% through the use ofintegrated pest management (41).

Our pest management systems must bereoriented toward pest prevention bydesigning out vulnerabilities and stress inthe agricultural environment and practicesin the urban environment that invite pestproblems. Until we are able to do this, wewill maintain our current crisis orientationtoward pest management with an exagger-ated need for pesticide use and pressure toaccept higher and higher risks because ofescalating pest problems (42).

ConclusionWe have an opportunity to change the reg-ulation of pesticides and still meet the foodproduction and nutritional needs of thepublic and the productivity and profitabil-ity needs of those who grow and marketfood commodities. The National CoalitionAgainst the Misuse of Pesticides (NCAMP)has proposed a federal pest managementact, which takes a holistic look at pest

management and the social and healthcosts of pesticide dependency. It is anapproach quite different from FIFRA andH.R. 1627. It is the purpose of the federalpest management act to provide for theprotection of public health and the envi-ronment from unwise or inappropriate pestmanagement practices. It is founded on thenotion that the environment and naturalresources of the country are a heritagewhich is held in trust for the benefit of suc-ceeding generations and that the publichealth is a paramount concern, not subjector subordinate to economic considerations.The approach is founded on the belief thata just and effective regulatory scheme can-not be devised, established, or administeredwithout public understanding and involve-ment.

In keeping with the purpose, the acthas the following goals:* To adopt and implement a national

and international policy for the promo-tion of integrated pest managementand sustainable natural resource man-agement;To recognize that pesticides are toxicsubstances and that they must be regu-lated as part of a cradle-to-grave toxi-cant control policy;

* To govern pest management practicesby a regulatory scheme that embodiesopen decision making and public par-ticipation at every stage and at all levels;

* To govern pest management practicesby a regulatory scheme that is health-based and designed to protect all sus-ceptible populations; and

* To ensure that environmental qualitymust not be degraded and shall be pro-tected by the promotion of safe pestmanagement practices and by elimina-tion of dependency on chemical pestmanagement and agricultural methods.Legislation now before Congress,

including H.R. 1627, embraces the busi-ness-as-usual approach to pesticide law andasks us to take a narrow look at pesticideuse, while lowering standards of protectionby calling the risks negligible. Rather thanbring the public into the decision-makingprocess, H.R. 1627 in particular would dis-empower people and state governments bypreempting the authority of states to adoptmore protective standards than the federalgovernment.

Pesticide policy reform must move usahead, not backward because of anunfounded fear that we cannot achieve ourpest management and productivity goals. Itis difficult to find a person who does not

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want to achieve the goal of public healthand environmental protection while meet-ing needs for food production. The ques-tion is whether we, as a nation, can affordto maintain a course of dependency onhighly toxic pesticides with policies thattinker with flawed risk assessment calcula-tions. We may feel good about what we

have accomplished in the short run, but wewill have failed our children, future genera-tions, and the sustainability of our planet.

The emphasis must now shift to a mas-sive reorientation away from pesticides,with regulatory and user incentives for theadoption of alternatives, disincentives, andpenalties for those who maintain pesticide

dependency, and research, technical, andfinancial support to facilitate the transitionto nonchemical pest management systems.We can no longer simply talk about substi-tuting toxic chemicals with chemicals oflower toxicity. We must talk about replac-ing toxic materials with pest managementapproaches that are not reliant on poisons.

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