Risk Assessment in the Federal Government Managing the Process Working Papers (1983) / Chapter Skim
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Federal Risk Assessments for Potential Carcinogens: An Empirical Review
Federal Risk Assessments for Potential Carcinogens: An Empirical Review
Pages 103-124
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From page 103... ...
Me purpose of thin paper is to summarize available empirical information on the nature of the policy problem of chemical carcinogenicity and the federal regulatory response. In general, the results are somewhat disappointing: ~ detailed empirical documentation of risk assessment practices in federal agencies would be a massive undertaking, which perhaps helps to explain why none has yet appeared.
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From page 104... ...
Current scientific understanding of cancer incidence leads to a conclusion that a large faction of these cases could have been prevented if the causative agent could have been identified and public exposures reduced or eliminated. The actual proportion of preventable cancers is still being discussed, with figures as high as 90: suggested; the UOSo Government' s Second Annual Report on Carcinogens more cautiously states that "many scientists now believe that about one-third to two-~hirds of al 1 cancers are agents contained in the air, water, food, or soil'' (NTP9 198L)
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From page 105... ...
However, epidemiological studies of cancer are expensive, time-consuming, and fraught with difficulties -- not the least of which is the problem of establishing the actual existence and level of past human exposures to any particular suspect chemical. As a result, direct human evidence is available for only a few cne~cal~; in fact, the International Agency for Research on Cancer lists fewer than 60 chemicals as having been adequately evaluated as cancer hazards in humans (IARC, 1980~.
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From page 106... ...
Me remaining 62 include industrial chemicals, miscellaneous chemicals and analogs, industrial processes, and incus t rial byproduc t s . The Regulatory Response Authority to restrict public exposures to toxic substances is distributed among 24 statutes that are administered by regulatory agencies (Toxic Substances Strategy Committee, 19801.
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From page 107... ...
I t reveals two dominant trends in the distribution of federal efforts: I EPA has had the widest experience, FDA and OSHA somewhat less, and CPSC the least: 55 were addressed under the clean water program at EPA 29 were addressed under the clean air program at EPA tS were addressed under the pesticides program at EPA 2 were addressed under the drinking water program an EPA 24 -were addressed under the food program at FDA 18 were addressed by OSHA - 5 were addres sed by CPSC 2.
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From page 108... ...
',~ L D~ L E;r~ £t~ - e ~t~e 1 ~t~ on~ fDsC~o.2 f9eC v~o' - ao. t Fo~.O - ~ S;~~ n acmo ~1 Source: Assessment of Technologies f or Determining Cancer Risks f rom the Environment, OTA, June 1981.
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From page 109... ...
109 TABLE ~ - Continued , £~ - see ~ act " , ·~stJ~e# R—Math ~ ~c~no~ane Under Various ~ (Cygnus - 1 ewe Eva C" ~ ail SOWN Flaw OS" aim.
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From page 110... ...
For arsenic, there were 16 reports, of which 12 analyzed exposure and seven health and environmental ef fee ts . If the EPA experience is typical, federal risk assessment activity is neither uniformly rigorous or uniformly cursory.
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From page 111... ...
Similarly, EPA pesticides program has long had lists of "suspect" pesticide ingredients, and it has had to decide which ones to formally consider for cancellation or for new controls. Other programs, most prominently those that must in effect grant official licenses for the production or use of new products or substances, are forced to categorize relative risk on a case-by case basis so they can decide which new applications to concentrate on.
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From page 112... ...
Case 3: Airborne Carcinogens: Screening Based on Quantitative Data In some cases, agencies have fairly extensive quantitative data for a list of chemicals ~ but limitations on agency resources preclude regulating the entire liste Setting regulatory priors Sties may require a cl~emical-by-chemical quantitative comparison of the health risk. EPA's Carcinogen Assessment Group (CAG)
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From page 113... ...
Examp les o f expl ic i t ba lane ing provisions are found in the pesticide law and the safe drinking water law, while examples of implicit balanc ing are found in the toxic substances law. (Details of these and other examples can be fount in Table 2.
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From page 114... ...
114 TABLE 2 Wok ~ - mono tat ~ - uIstb~ ot ~p~ to C~l~e 0_~ ~_~.n~ __ ~~ —ma_ —~ ~ _ _*
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From page 115... ...
115 TABLE 2 - Continued We Len ~~r9 ton ~ 8088 - ~ ~~ t.
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From page 116... ...
The implication is that formal risk assessments could find practical use -- either more or les ~ his ibly -- in al ~ programs O There is also a practical difference between use of risk assessment in programs that involve pre-maricet approval of substances and in programs thee operate through other post-hoc mechanisms, such as environmental emission limits. A study of federal risk assessment practices prepared by Clement Associates found that this distinction was the greatest single statutory determinant of the way in which risk assessments were conducted (Cleancut Associates, 1981~.
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From page 117... ...
The influence of procedural fac~cors on the time involved in issuing a final rule is illustrated by Table 3. All of the actions listed included hearings The total length of the proceedings from initial action to final standard ranges up to seven years, but the average is in the range of five.
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From page 118... ...
118 TABLE 3 so o d o o is_ 1 111 1 'C ~ O · la _ e, O a O C o C ~ O— d a; me S o 1: O d ~ d _ Cal l_ ~ 0 0 t_ _ V O ~ O
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From page 119... ...
119 TABLE 3 - Continued to I, o o c o 1 1 .
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From page 120... ...
120 FIGS 1 WEEK O - ~ Administrator Approves Dc~lopma~t and W - ring Group Formation 44 ~ 45 Steering Commin" Clearance ~ Begin Interagency Review 50~ ~ Begin OMB Coordination 53 - End OM8 Ccord;~tion 59 ~ ~ Propose in Federal Register 65 ~ a , ~ End Public Comment Period 91 -a S - Bring Commin" Clearance 94 - - Begin Interagency Review 98 ~ - Begin OM8 Coordination 101 - - End OM8 Coordination 108 4 Proton Promulgate in Federal Register J ~ _~—' ' Rules Final ' Rules Source: Decision Making in the En~rironmes~tal Protection Agency 9 Vol O IT 9 ARC 9 1977 .
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From page 121... ...
A final example is the control of toxic substances at EPA, where an increasing number of statutory mandates enacted over the past decade have explicitly called for a balancing of risks ant benefits in a way that previous enactments have not. Among these are FIFRA, passed in 1972, and TSCA, passed in 1976.
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From page 122... ...
The major aspects of quantitative risk assessment are fairly well standardized, but numerous differences do exist. The IRLG guidelines are reported to be given uneven use, and noncarcinogenic risks tend to be more variable in their assessments than carcinogenic ones.
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From page 123... ...
"Cancer ant Industrial Chemical Production. " Science, Vol.
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From page 124... ...
S77 f f . Toxic Substances Strategy Committee.
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