Occupational Safety and Health Administration and National Institute for Occupational Safety and Health
An estimated 60,000 deaths every year in the United States are related to occupational diseases and injuries. In 1994, occupational injuries alone were responsible for an estimated $120 billion in lost wages, lost productivity, administrative expenses, health care, and other costs, although the annual occupational fatality rate has been reduced from 18 per 100,000 workers in 1970 to 8 per 100,000 in 1993.
The purpose of the Occupational Safety and Health Act of 1970 is "to assure so far as possible every working man and woman in the nation safe and healthful working conditions." That is to be accomplished by supporting reseach in the field of occupational safety and health, providing medical criteria which "assure insofar as practicable that no employee will suffer diminished health, functional capacity, or life expectancy as a result of his work experience," and developing and promulgating occupational safety and health standards. Two agencies were established to accomplish the purposes of the act: the Occupational Safety and Health Administration (OSHA) in the Department of Labor and the National Institute for Occupational Safety and Health (NIOSH) in the Department of Health, Education and Welfare (now the Department of Health and Human Services).
OSHA is mandated, among other things, to establish and enforce workplace standards to effect the purposes of the act. Standards promulgated under the act are required to be based on the latest available scientific data in the field, the feasibility of the standards, and experience gained under this and other health and safety laws. This language and judicial interpretations require that OSHA standards must be both economically and technologically feasible and also have demonstrable benefits.
NIOSH is the only federal entity charged with conducting research in ocupational safety and health; developing innovative methods, techniques, and approaches for addressing problems in occupational safety and health; discovering latent diseases and establishing causal connections between diseases and work; responding to employer and worker requests to evaluate possibly unsafe or unhealthy working conditions; exploring new problems in occupational safety and health, including those created by new technology; and training a workforce of professionals in occupational research, demonstrations, and experiments to effect the purposes of the act.
Assessing OSHA's Regulatory Effectiveness
Finding
Although the nation’s recordkeeping system for job-related injuries is widely accepted, underre-porting is considered substantial. Furthermore, estimates of the incidence or prevalence of fatal and nonfatal work-related illnesses are very imprecise, partly because there is no adequate national surveillance system and partly because of complexities associated with discerning cause and effect. The economic burden of occupational injuries amounts to almost half the total cost of all injuries in the United States. The cost of occupational illnesses is believed to exceed that attributable to injuries; for example, the annual costs of occupational skin diseases alone including lost work days and reduced productivity might reach $1 billion. The impact of occupational injuries, disabilities, and diseases spreads in ripples beyond the affected worker and employer to families and society at large in ways that are not easily measured or expressed in monetary terms. The effectiveness of OSHA’s regulatory activities directed towards reducing chronic occupational risks cannot be assessed in the absence of adequate national surveillance data.
Recommendation
Congress should direct OSHA, NIOSH, and the Bureau of Labor Statistics to strengthen their surveillance and intervention-effectiveness research and evaluations. Congress should direct OSHA and NIOSH to increase the efforts they devote to quantifying risks, costs, and benefits; these activities, which will require additional resources, should help assess the effects of OSHA’s regulations on workplace health and safety and to guide NIOSH research and OSHA regulatory priorities.
A substantial proportion of the estimated 60,000 worker fatalities each year is believed to result from occupational diseases associated with exposures to toxic substances and harmful physical and infectious agents. Many cases of fatal, chronic, and disabling occupational diseases develop over 10-30 years and are poorly counted by employer reporting or worker-compensation systems. For the cases that are reported, the attributable costs underestimate costs due to lost productivity and reduced earning potential; such human values as reduced quality of life are not considered. The lost work day is an inadequate measure of the impact of chronic diseases. Without accurate information on the incidence and prevalence of occupational illnesses, the effect of a regulation on incidence or prevalence cannot be assessed. Without information on the effect of regulations, it is difficult to target research and regulatory priorities toward the exposures and illnesses of greatest concern.
Over the last two years, a comparative risk analysis for priority-setting has been conducted by OSHA with strong participation from NIOSH and many stakeholders. The product of that effort, OSHA’s priority-planning process, is the identification of 18 emerging or persistent occupational safety and occupational health issues most in need of agency action, both regulatory and nonregulatory. The results were unveiled in December 1995; work has begun on their implementation. The agenda outlines regulatory priorities based on objective data, subjective judgment, and expert knowledge. Whether workplace interventions based on the identified priorities will have the desired effect on occupational illnesses needs to be assessed and, hopefully, verified through an effective surveillance program.
In a similar process in 1995-1996, NIOSH led 500 federal agencies, industries, associations, labor unions, academics, and private citizens in the development of its National Occupational Research Agenda. The agenda from this stakeholder process outlines priorities for the nation’s public and private research in occupational safety and health. It is intended to increase the efficiency and effectiveness of such research by focusing efforts on the most important current and emerging scientific needs for improving the safety and health of workers. It is also an important step in efforts by NIOSH to engage in and promote extensive research coordination and collaboration among organizations and scientists throughout the public and private sectors. Testimony from the stakeholders identified risk assessment methods as a research need of such importance that it was included in the final list of 21 priority research areas.
In both the OSHA and NIOSH priority-setting projects, information on the incidence and prevalence of occupational injuries and illnesses was used to the extent available. However, both OSHA and NIOSH drew heavily on the expert judgment and experience of the stakeholders who participated in the open and iterative processes by which the final products were developed.
OSHA has dedicated a major effort to stimulating state-level and private-sector voluntary initiatives. Priorities and data should assist such devolution and delegation of responsibility.
Improved Cooperation Between OSHA and NIOSH
Finding
The Occupational Safety and Health Act institutionalized the clear separation of health research (NIOSH) and science-based policy decisions (OSHA). Although it is important that OSHA and NIOSH have distinct responsibilities, it is also critical that these interdependent organizations work closely together. For example, OSHA and NIOSH have recently coordinated their regulatory and research agendas through the OSHA Priority Planning Process and the NIOSH National Occupational Research Agenda.
Recommendation
OSHA and NIOSH should continue to facilitate effective collaboration so that OSHA’s regulatory needs guide NIOSH’s research efforts and NIOSH’s contributions to OSHA are well targeted toward OSHA’s regulatory and science policy needs, as well as towards serving private-sector worker protection programs. Conversely, NIOSH research findings and risk assessments should be a strong influence on OSHA priority-setting for regulatory and other interventions to address workplace safety and health.
As the 1994 National Research Council report Science and Judgment in Risk Assessment emphasized, science policy judgments made in the course of risk assessment would be improved if they were more clearly informed by a regulatory agency’s priorities and goals in risk management. Protecting the integrity of risk assessment and building more productive linkages to risk management were both considered essential. OSHA and NIOSH are clearly interdependent: NIOSH identifies health-based exposure limits and provides OSHA with scientific criteria and recommendations in support of OSHA’s mandate to set health and safety standards, OSHA uses this information to develop occupational standards that reflect feasibility considerations.
The risk assessment and risk management responsibilities of OSHA and NIOSH are closely linked, so it is important that they ensure an effective interaction. The interagency task force formed to conduct the priority-planning process and the exchange of senior staff, who serve as full-time liaisons within the agencies’ directors’ offices, are good steps.
Guidelines for Risk Assessment
Finding
OSHA seems to have relied upon a case-by-case approach for performing risk assessment and risk characterization in support of risk management policy decisions. Its 1980 "cancer policy" is rarely used and was written before the many scientific advances of the 1980s and 1990s. Its risk management targets—for example, reducing cancer risk to less than one case per 1,000 workers exposed—reflect the difficulty of demonstrating technical or economic feasibility at lower risk levels.
Recommendation
OSHA should publish, after appropriate public involvement and review, one or more sets of guidelines that lay out its scientific and policy defaults. At a minimum, the guidelines should cover an explicit rationale for choosing the defaults and an explicit standard for how and when to modify them; methods for assessing risk for noncancer health effects of concern in occupational settings; methods for quantifying and expressing uncertainty and individual variability in risk; and a statement of the magnitude of individual risk that it considers negligible for the various adverse health effects. The guidelines should help OSHA decide how extensive a risk assessment is needed in different situations. Finally, OSHA should explain and justify its actions when it evaluates or regulates a substance differently than other federal agencies that regulate the same substance.
Risk assessment guidelines have served EPA well over the years, with guidelines evolving as knowledge is gained (see, for example, the 1996 Proposed Guidelines for Carcinogen Risk Assessment). OSHA has similar needs but its analyses are too different to adopt EPA’s guidelines or the recommendations of Science and Judgment in Risk Assessment (NRC 1994a). In their testimony before the Commission, Adam Finkel, director of OSHA’s Directorate of Health Standards Programs, and Frank White, vice president of Organization Resources Counselors, Inc., agreed that articulated risk assessment guidance is urgently needed. They also agreed with the testimony of Frank Mirer, director of the Health and Safety Department of the International Union of United Auto Workers, that OSHA’s risk assessment procedures should not be uniform but consistent with the magnitude of effect or controversy that a particular standard is likely to generate. To be useful, OSHA’s guidelines must recognize that OSHA cannot treat each risk assessment with the same degree of rigor and detail, particularly as it seeks to make up the ground lost in a 1992 court decision vacating more than 400 permissible exposure limits (PELs). Because of the large number of PEL risk assessments that are needed and the fact that substances regulated via PELs will not be subject to the numerous ancillary provisions of OSHA’s substance-specific rule-makings (such as medical surveillance and worker training), OSHA should outline a less exhaustive risk assessment template for this category of analysis.
Updating Workplace Permissible Exposure Limits for Air Contaminants
Finding
OSHA’s limits for chemical exposures (permissible exposure limits, PELs) are out-of-date, not readily updated, and not sufficiently protective of worker health for millions of American workers. The OSHA PEL update process has been slowed to a crawl by a series of legal challenges. A chemical-by-chemical PEL-setting process, based on intensive assessments of toxicity, exposure, risk, and feasibility, has proved impractical for any but the highest use chemicals. A more constructive and streamlined process is needed for regulating workplace exposures to a large number of air contaminants.
Recommendation
Labor, industry, and OSHA should develop a science-based stakeholder process for updating workplace PELs and for developing new PELs for air contaminants. The process should begin by bringing the PELs up to date with the changes that have been made over the last 30 years in consensus standards. Then, a longer phase of selecting high-priority substances for more thorough analysis, using analytical methods chosen in consultation with stakeholders, could begin. Congress should provide authorizing language required to give standing to the process and the PELs so chosen.
When the Occupational Safety and Health Act was enacted in 1970, the new Occupational Safety and Health Administration promptly adopted existing workplace threshold limit values (TLVs) as permissible exposure limits (PELs). Those TLVs had been established by the non-government organization known as the American Conference of Governmental Industrial Hygienists (ACGIH) in 1968, based on then-available scientific information and best professional judgment. The ACGIH TLV Committee periodically re-evaluates and updates the TLVs, based on professional judgment and new information, but uses no explicit risk-based or feasibility-based methodology.
In 1986 OSHA mounted a PEL update project, with considerable industry support for the adoption of consensus exposure limits, again largely based on TLVs, for over 400 industrial chemicals. The extent of the scientific evidence supporting the TLVs was highly variable, however, and no uniform criteria for choosing them could be cited. Many academic and labor occupational health specialists criticized the TLVs for permitting too much exposure. When the PELs were proposed in 1989, litigation was filed by several industry groups and by labor. A court ruled in 1992 that this rulemaking was flawed and unacceptable, due to inconsistent and unclear determinations of risk and insufficiently elaborate assessments of feasibility. However, stringent requirements for detailed toxicologic, epidemiologic, exposure, cost, and feasibility information to support many specific rulemakings would far exceed available budgetary and staff resources of OSHA and of NIOSH.
In 1996, OSHA identified a subset of about 20 substances for the first phase of a new PEL update and held a public meeting for comment. Industry criticized this renewed effort, preferring a labor/management/OSHA advisory process and offering to provide exposure data as part of such a process. Labor has been skeptical about such an arrangement, fearing industry domination.
The Commission believes that the tension between the amount of scientific, engineering, and economic analysis required and the need for timely updates and new standards could be resolved in two phases.
Phase I would consist of updating the original OSHA PELs (based on the TLVs of 1968) with current TLVs established by the ACGIH. To do so may require legislation to overcome the criticisms of the court about the previous PEL update. Presumably there could be a rebuttable presumption that the current TLVs are not unduly stringent and have been judged to be technologically and economically feasible.
Phase II would consist of selective attention to those substances, in groups of 10 to 30 chemicals, where estimated risks, known exposure levels, widespread use, or other considerations justify a high priority for further exposure reduction. This process is similar to OSHA’s recent effort with the set of 20 chemicals and would allow labor, industry, OSHA, and NIOSH to have an opportunity to agree on the criteria for nomination and selection of chemicals and on a template for risk and feasibility analysis. OSHA and its stakeholders should seek agreement on a template for analysis. Perhaps OMB and the Small Business Administration could assist with guidance on how best to meet their criteria for reviews under Executive Order 12866 and under the Small Business Regulatory Enforcement Fairness Act of 1996, respectively.
This two-phase process should begin by trying to generate consensus about phase I and exploring the need for legislation authorizing the adoption of current TLVs. Similarly, recommendations to Congress might emerge for the phase II process to facilitate negotiated rulemaking and the necessary reviews.
We believe Congress would prefer that such stakeholder consensus emerge before Congress moves into what have been minefields. The precedents include the process that led to modification of the pesticide residue provisions of the Delaney clause in the Food Quality Protection Act of 1996. We have made a similar recommendation for a stakeholder process to define desired legislative action for updating the Toxic Substances Control Act.
It should be noted that PELs are distinct from OSHA’s comprehensive health standards, such as those for asbestos, benzene, and recently proposed for methylene chloride. The comprehensive standards include a PEL but may also include implementation requirements such as monitoring, training, and use of protective equipment. About 25 chemicals have been regulated by OSHA with comprehensive standards. Candidates for comprehensive standards have been chosen primarily as a result of petitions from stakeholders and also on the basis of considerations of toxicity, exposure, and number of workers exposed.
The Food and Drug Administration (FDA) promotes and protects the public health by regulating a wide variety of consumer and medical care products. FDA is responsible for ensuring that human food, animal feed, and cosmetics are safe and truthfully labeled; that human and animal drugs, medical devices, and biologics are safe, effective, and truthfully labeled; and that radiation from x-ray equipment and electronic products (such as television receivers and microwave ovens) does not exceed acceptable limits. FDA is now exercising its responsibility to protect minors from chemicals in cigarettes. Thus, a wide array of safety issues is considered, with a broad spectrum of benefits. FDA also conducts research on risk assessment methods and mechanisms of adverse health effects. In this section, the Commission offers recommendations about food safety, drug approval, and dietary supplements.
The Delaney Clause
Finding
The Delaney clause of the Federal Food, Drug, and Cosmetic Act prohibits FDA approval of food additives (section 409) and color additives (section 721) that have been shown in appropriate studies to cause cancer in laboratory animals (or humans). Exactly what is covered by the Delaney clause is very complicated. Pesticide residues that are considered food additives were recently exempted from the Delaney Clause by the 1996 Food Quality Protection Act (see EPA Office of Prevention, Pesticides and Toxic Substances on page 124). Prohibition was an appropriate precautionary response to unknowns about cancer-causing chemicals when FFDCA was enacted in 1958, but it is inconsistent with modern analytic detection methods and current scientific knowledge. The Delaney Clause illustrates what can happen when Congress legislates scientific judgments, however well intentioned, in a manner that cannot evolve with advances in scientific knowledge.
Recommendation
The language of the Delaney clause should be modified to permit consideration of the quantitative risk that a covered food additive or color additive might pose, specifying that direct or indirect addition of carcinogens to foods should be prohibited to the extent needed to provide reasonable certainty of no harm, in keeping with well-established FDA statutory language.
The Delaney clause, inserted in 1958 into section 409 of the FFDCA specifies that "no [food] additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal"; equivalent language in section 721 specifies that "a color additive shall be deemed unsafe . . ." In fact, definitions of food additives are extremely complicated. Excluded from the category of food additives under the Delaney clause are uses of substances generally recognized as safe (GRAS), ingredients sanctioned before 1958 (such as sodium nitrite and BHA in some uses), and pesticide residues on raw agricultural commodities. All intentionally added substances and uses not excluded are covered, such as artificial sweeteners and pesticides that concentrate in processed food. Pesticides occuring in raw or processed foods have now been exempted by the 1996 Food Quality Protection Act. Color additives, covered separately from food additives, may be added to foods, drugs, cosmetics, and even devices. Indirect additions to the food supply are covered by the Delaney clause, including chemicals that migrate into foods from packaging or other food contact surfaces. Although FDA has been a leader in developing methods for quantitative risk assessment of carcinogens, under the prohibition of the Delaney clause the methods cannot be used.
In 1962, Congress enacted an amendment to the Delaney clause known as the diethylstilbestrol (DES) proviso. This amendment permitted the use of carcinogenic compounds as animal feed additives and veterinary drugs so long as "no residue of the additive shall be found by methods approved by the Secretary by regulation in any edible portion of the animals after slaughter or in any food such as milk or eggs yielded by or derived from living animals." To define no residue, FDA developed a quantitative, negligible risk standard known as the sensitivity-of-method standard. The FDA commissioner is authorized to specify which analytic detection method should be used to characterize concentrations of additives. The methods chosen typically have a sensitivity corresponding to detection of a concentration associated with an upper-bound lifetime incremental cancer risk of one in a million (10-6).
The Delaney clause does not define what is found to induce cancer and therefore does not invite exceptions for substances that induce tumors in rodents by mechanisms that are not relevant to human cancer risk (see Using Rodent Tests to Predict Human Cancer Risk on page 64). Even in 1958, however, Delaney required the FDA to determine whether evidence of carcinogenicity in animals had been obtained in "appropriate studies," with emphasis on feeding studies for obvious reasons of relevance. Because the clause focuses on the potentially carcinogenic properties of additives, it does not consider risks of other adverse health effects that can far outweigh risks of cancer—such as risks of developmental or neurologic toxicity—although those risks do get full attention from FDA under other authorities. Nevertheless, the requirement under the Delaney clause to reach a decision on animal carcinogenicity and appropriateness of studies makes a disproportionate claim on agency and petitioner resources, which might better be spread over investigations and reviews of all serious health effects and over decisions of whether any proposed uses of an additive would be deemed safe. Quantitative risk assessment methods are applied routinely to determine acceptable concentrations of natural, unavoidable food contaminants (such as aflatoxin in peanuts and corn, or mercury in swordfish) or of trace contaminants of food and color additives, and to determine the urgency of regulatory actions.
To its credit, adoption of the Delaney clause called attention to substances that might cause cancer and to the importance of caution when knowledge is limited. The Commission has concluded from various testimony, however, that the direct impact of the Delaney clause on reducing cancer risks for the public has not been large, partly because most food protection decisions are governed by other strong provisions of the food safety laws and partly because the clause has been invoked decisively only a few times. Furthermore, FDA’s efforts to regulate sodium nitrite in 1979 (under multiple provisions of FFDCA) highlighted the need to balance risks and benefits at different concentrations when a chemical has major health benefits (in this case, prevention of potentially lethal botulism from stored meats).
Debate about the role of food additives and pesticide residues in relation to the role of other dietary factors that increase or decrease cancer risk led to the National Research Council report Carcinogens and Anticarcinogens in the Human Diet (NRC 1996b). That report concluded that calories, fat, and fiber are more important for overall cancer risk than individual food constituents, whether synthetic or naturally occurring.
Rate of Drug Approval
Finding
Despite acceleration of the drug approval process, especially for HIV-AIDS and cancer treatment agents, and despite providing guidance to pharmaceutical and biotechnology firms during various stages of drug development, FDA is often criticized by patient groups eager for access to new agents or agents approved in other countries. At the same time, FDA bears a heavy responsibility to assure the public that the risks of serious adverse effects have been fully investigated, properly evaluated by disinterested experts, and weighed against the benefits of the drug.
Recommendation
FDA should sustain its efforts to provide early guidance on appropriate studies and to complete reviews and necessary inspections expeditiously. Accelerated reviews and approvals should be linked to rigorous postmarketing surveillance. In keeping with its counterpart agencies in other countries, FDA should update criteria for toxicity testing and clinical trial protocols so that properly documented studies meeting those criteria in other countries can be used as evidence for FDA review. Also, FDA should continue to work with other countries to harmonize procedural and paperwork requirements, as well as the protocols. Such efforts should include all classes of therapies.
An inevitable tension exists between careful premarketing assessment before regulatory approval of drugs, vaccines, and other medical products and the desire to make important advances in patient care available to patients. The Commission supports FDA efforts to accelerate the review process, use fee-based enhancement of FDA staff resources, and give guidance to firms and their clinical and biostatistical investigators. Moving towards accelerated approvals must be accompanied by requirements for effective postmarketing surveillance, perhaps including restriction of early prescribing rights to qualified and certified specialists who must closely study their patients’ side effects and report them promptly.
In this global economy, FDA is building on many years of public and private international partnerships seeking harmonization of testing protocols and risk assessment methods to make appropriate use of studies and documentation from other nations that meet mutually agreed-on regulatory standards. Nevertheless, approvals in other countries with different benefit and risk criteria and with different degrees of reliance on postmarketing surveillance cannot automatically lead to approval by FDA. More attention in this country to off-label use and postmarketing surveillance of both benefits and risks would be desirable.
Regulating Dietary Supplements
Finding
The Nutrition Labeling and Education Act of 1990 set up a framework for justifying health claims on food labels, including those for dietary supplements. This framework requires significant scientific agreement and review and approval by FDA. FDA published the mandated regulations in January 1993 and approved several health claims. Soon thereafter, however, the Dietary Supplement Health and Education Act of 1994 (DSHEA) changed FDA’s authority to regulate the safety and labeling of dietary supplements. The agency now has the burden of proving that a dietary supplement is adulterated before it can act to protect public health. DSHEA also created a presidential commission that was directed to reconsider what evidence would be necessary to make health claims for vitamins and other dietary supplements. Today, dietary supplements can carry FDA-approved health claims. DSHEA also permits manufacturers to make statements of nutritional support without prior approval from FDA. A Keystone Center dialogue report (1996) on health claims for foods and dietary supplements supported the 1990 act and the 1993 FDA regulations and made additional suggestions.
Recent evidence of hazards from herbal supplements promoted among young people for a "natural high" illustrates the consequences of allowing biologically active substances on the market without adequate evidence of safety. Also, evidence from clinical trials indicating probable harm from beta-carotene supplements in smokers at high risk of lung cancer and heart disease without any corresponding benefit illustrates the importance of assuring that health claims are supported by sound science before they are used to promote the sale of products.
Recommendation
FDA’s authority to require scientific evidence to justify manufacturers’ claims of safety of and health benefits from nutritional supplements should be reaffirmed and strengthened.
Vitamin supplements, herbs, and "natural" foods are increasingly marketed with claims of health benefits, reflecting preliminary data from epidemiologic analyses or medical testimonials. Evidence from clinical trials is rarely available. Since 1994, overwhelming evidence has been published that one of the most popular and most promising supplements, beta-carotene, previously considered anticarcinogenic, does not reduce risks of lung cancer and heart disease; instead, beta-carotene is associated with increases in those risks in people at high risk (ATBC 1994, Omenn et al. 1996). In light of the public’s and scientists’ desire to prevent cancer, heart disease, and other major diseases, we should strengthen the scientific basis of public health advice, regulatory approval, and product marketing.
The U.S. Department of Agriculture (USDA) Office of Risk Assessment and Cost-Benefit Analysis (ORACBA) was established by the Federal Crop Insurance Reform and Department of Agriculture Reorganization Act of 1994. The office’s primary role is to ensure that major human health, safety, and environmental regulations proposed by USDA are based on sound scientific and economic analysis. A major regulation is one that is projected to have an incremental economic cost of at least $100 million per year. The office is responsible for providing technical assistance, for coordinating risk-analysis activities across USDA, and ensuring that the statutory requirements of the act are met. Risk analysis activities take place in many USDA agencies, including the Food Safety and Inspection Service, the Animal and Plant Health Inspection Service, the Agricultural Research Service, and the Economic Research Service. This section offers several recommendations that should be considered as the office’s activities take shape.
Development of Regulations
Finding
ORACBA has the statutory authority to review a major regulation before it is submitted to the Secretary of Agriculture.
Recommendation
ORACBA should become involved in the regulatory development process as soon as the impetus for a regulation is identified.
It does not make sense to wait until a regulation has been under development for a year or more and is virtually complete to determine whether it meets risk and cost criteria. Considerations of context, as well as risk and cost, should be included in the regulation development process from the start and, to the extent that they are consistent with statute, should help guide it. Risk and cost evaluations performed only when a regulation is almost complete are unlikely to be useful because too much time and too many resources will already have been invested in the outcome.
Peer Review
Finding
USDA has no formal procedure for external peer review of its risk assessments or economic analyses.
Recommendation
ORACBA should establish formal guidelines for peer review of the procedures, practices, and products of risk assessment and economic analysis at USDA.
As noted in Section 6 of this report, peer review is an essential part of the regulatory process. Peer review should encompass review of the raw technical data that underlie a risk assessment or benefit-cost analysis, the models and assumptions used and their interpretation, and how those data were cited in regulatory decisions. Involving independent peer reviewers in the regulatory process can help to clarify the objectives and scope of rulemaking and verify the quality of the technical information considered. It can also ensure that the information evaluated at the start of the process has been used in a technically defensible manner. More detailed recommendations about the role of peer review panels in regulatory decision-making are in section 6. When USDA’s regulatory actions involve some types of pesticide or food safety issues, it might be appropriate to coordinate their peer review with EPA or FDA.
Microbial Risk Assessment
Finding
In January 1993, pathogenic E. coli caused at least four deaths, dozens of cases of kidney failure in children, and over 600 illnesses in one outbreak linked to undercooked, contaminated ground beef. This toll would have been far greater had an excellent public health science base and surveillance and investigation activity not been in place at the local and state health departments and at the University of Washington’s School of Public Health, which relied on modern genetic techniques for detecting and tracing contamination. Salmonella or Campylobacter contamination of chickens or eggs has also led to fatal illnesses. Those and similar incidents focused public attention on the protection of our food supply from microbial contamination. However, the methods currently used by USDA and the food industry to assess microbial risks for the purpose of evaluating and regulating food safety are rudimentary, conflicting, and based on inadequate data.
Recommendation
USDA should develop and improve methods for assessing microbial risks for food safety evaluation. It should also develop information and data reporting requirements to gather data to support those risk assessments.
A key responsibility of USDA is protecting the nation’s food supply from microbial contaminants, together with FDA. USDA’s meat and poultry inspection program and FDA’s food inspection program were not designed to prevent food safety problems, however. Inspections involve visual reviews of operating procedures, with little knowledge of conditions prior to the inspection or ability to predict future conditions. Agencies and industries have been expanding their use of the concept of hazard analysis and critical control points (HACCP). Pathways for contamination are identified, controls are designed and installed, monitoring is supposed to be performed, and records are made available for audits. Problems are expected to stimulate a feedback to critical control points and control measures. This program is a counterpart to manufacturing aspects of Responsible Care in the chemical industry; combining this preventive approach with an effective public health surveillance scheme could raise public confidence in the safety of our food supply domestically and help set an international standard for safe food. For example, beginning in 1995 all seafood exported to the European Community had to be produced under standards certified by the exporting country and accepted by the EC as equivalent to their HACCP standards. At the state level, HACCP plans are being used to update and unify ordinances regarding retail food handling and sanitation, together with such industry groups as the National Fisheries Institute, the National Food Processors Association, public health agencies, and consumer groups. As emphasized by Michael Taylor, formerly of FDA and now at USDA, the key elements of prevention are anticipation of the problems and design of appropriate preventive methods. These require a useful knowledge base and continuous scientific progress from research on such topics as growing microorganisms that have not yet been cultured, biofilms that harbor microorganisms shielded from sanitizing techniques, emerging foodborne pathogens, and conditions that affect the virulence (hazard) of potentially pathogenic microorganisms. Also, there is need for more information about food processing, packaging, and distribution techniques.
Risk assessment should play a key role in this activity, but methods of evaluating risks associated with microbial contaminants are in their developmental stages and require more rigorous application and evaluation. Many microbial risk problems require the development of new methods and models, particularly for early stages of food production where pathogen prevention might occur. In addition, there are no databases on microbial diseases and risks comparable with those on chemical hazards. More detailed recommendations on the development of microbial risk assessment methods are found in Risks From Microorganisms on page 84. Collaboration with the EPA Office of Water, whose Information Collection Rule establishing monitoring and data reporting requirements for public water supply systems might be a good model for a similar USDA rule, would be appropriate (see page 130).
The Food Safety and Inspection Service of the USDA has recently developed the Public Health and Science Program, which includes a quantitative risk assessment capability and has made significant progress in this area. One of the goals of that program is to aggressively develop data to be used in microbial risk assessments and models for performing those assessments. The National Microbiological Baseline Data Collection Programs were begun in 1992 to collect data on microbiological profiles of inspected carcasses and ground product. Baseline data have been collected for steers and heifers, cows and bulls, broiler chickens, market hogs, ground poultry, ground turkey, and ground beef. Those data have been used to establish performance criteria and standards for raw products in the HAACP final regulations. The Public Health and Science Program has also initiated, in collaboration with the Centers for Disease Control and FDA, the Sentinel Site Surveillance Program. That program is tracking foodborne diseases of public health significance in five states. It is expected to provide, for the first time, a good estimate of the incidence of sporadic foodborne illness due to the major enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, E. coli 0157:H7, and possibly Vibrio). The Public Health and Science Program has also begun to develop refined models for quantitative risk assessments and is presently working in collaboration with others inside and outside USDA to develop a dynamic fault tree model for the risk presented by E. coli 0157:H7 in ground beef.
President Clinton has highlighted in public pronouncements the need for more vigilant food protection and use of modern scientific methods. His concern resulted in increased fiscal year 1997 funding of the Sentinal Sites Surveillance Program and other FDA and USDA hazard identification and risk assessment research programs.
Evaluating the Benefits of Conservation Practices
Finding
There is no formal plan to monitor and evaluate the benefits of all the conservation practices managed or encouraged within USDA, whether on public or private lands.
Recommendation
USDA should develop and implement methods for monitoring and evaluating benefits of all conservation practices managed under the auspices of USDA. These include programs managed by the Forest Service as well as the Natural Resources Conservation Service and Farm Services Agency.
A key responsibility of USDA is assuring natural resources are conserved through a variety of programs. This includes assuring that:
• The natural resources necessary for food and fiber production are conserved in a way that farming can continue indefinitely into the future.
• The effects of farming do not degrade the natural resources which we all share and need in our daily lives, nor do they threaten the public health.
• The use and management of the national forests and forest lands do not jeopardize the other resources or the future health of the forests and lands.
Assessing whether these programs are achieving their goals is essential to USDA’s accountability and to ensuring the wise use of scarce resources. As discussed in Section 2 of this report, the Commission’s Risk Management Framework emphasizes the importance of the Evaluating Results stage of risk management. Plans for evaluation should be built into every program’s overall implementation plan to specify when evaluation will be conducted, who will conduct it, and what will be evaluated. Without evaluation, the success or failure of a program cannot be determined, its cost-effectiveness cannot be assessed, and future programs cannot benefit from lessons learned.
The Department of Energy (DOE) manages one of the largest environmental programs in the world, including 130 sites and facilities in over 30 states and territories, the legacies of World War II and the Cold War. The purpose of environmental management at DOE is to reduce health, safety, and ecological risks associated with radioactive and hazardous waste and contamination resulting from the production, development, and testing of nuclear weapons. Risk assessment for radiation sources has been a tool developed and effectively used by DOE, the Nuclear Regulatory Commission, and their predecessor agencies for many decades (see Risks From Radiation Hazards on page 82). This section offers recommendations on the use of comparative risk for prioritysetting and budgeting.
Risk-Based Nuclear Weapons Site Cleanup
Finding
The massive program of cleanup of nuclear weapons production and waste sites has historically lacked a risk-based approach. Since late 1993, DOE has established a process that is committed to relating risks and risk reduction to budget and programmatic priorities. DOE’s Environmental Management Program (DOE/EM) established six strategic goals: to address truly urgent risks, to ensure worker safety, to assume managerial and financial control, to become outcome oriented, to focus on technology development, and to become more customer and stakeholder oriented. The effort is experimental and is a highly desirable input to the annual budget request and appropriation.
Recommendation
The 3 1/2-year initiative of DOE/EM, stimulated by Congress, to learn to assess and manage the entire environmental program from a risk perspective should be continued and should be examined as a model for the EPA Superfund program. Stakeholder related efforts, such as DOE’s site-specific advisory boards, require long-term budgetary support.
The DOE sites are large, numerous, and complex; they include radioactive wastes, diverse chemical wastes, mixed radioactive and chemical wastes, and contaminated and dilapidated facilities, and they have special nuclear materials that need to be decommissioned. The program is one of the largest "discretionary" federal budget items, having grown from $2.3 billion in FY 1990 to $6.5 billion in FY 1994 before "downsizing" to $5.7 billion for FY 1997. It is complicated by signed agreements with numerous states and EPA (tri-party agreements) and signed agreements with American Indian nations that have treaty rights to large areas of particular sites. Those agreements, a legacy of the Bush Administration, used technical expertise of the time and empowered the states to make potent claims on federal responsibility. All parties acknowledge that there remain major uncertainties about the nature, extent, and remediability of major components of those sites, let alone a final selection of a permanent nuclear waste repository site.
DOE Secretary Hazel O’Leary, at Hanford Summit I in September 1993, committed the department to complying with occupational and environmental requirements of sister federal agencies (OSHA and EPA) and to taking dramatic steps to override the 50-year history of secretive operation of the nuclear weapons program. She and Assistant Secretary Thomas Grumbly called on the scientific community to join the effort with fresh ideas and capabilities. Grumbly reiterated that request at a National Research Council workshop commissioned by DOE to determine whether they needed to identify new institutional mechanisms to develop "objective, neutral, systematic, and iterative risk-based analysis" for their sites. Within 60 days, a National Research Council committee issued Building Consensus Through Risk Assessment, supporting the DOE plan (NRC 1994b). The report highlighted the inclusion of cultural, socioeconomic, historical, and religious values in a new risk-based approach that incorporated public involvement at each step. Eventually, DOE funded the Consortium for Risk Evaluation With Stakeholder Participation (CRESP) and several smaller academic groups and consulting firms to work with all stakeholders, including DOE. Commissioners Goldstein and Omenn are among the founders and leaders of the consortium.
At the same time that this long-term institution-building was occurring, the conference report of the Energy and Water Development Appropriations Subcommittee for FY 1994 stated that DOE "needs to develop a mechanism for establishing priorities among competing clean-up requirements" and submit a report to Congress by June 30, 1995. DOE mobilized a major effort to describe and characterize its major activities on risk data sheets and submitted its summary of the results in Risks and the Risk Debate: Searching for Common Ground, The First Step (DOE 1995) in timely fashion. The DOE Environmental Management Advisory Board endorsed this draft risk report as an important first step in linking risk data with compliance considerations for use in budget decisions; it also recommended improvements in data quality, review, public involvement, and consistent interpretation of data in light of future land-use planning and long-term cost projections.
DOE/EM followed up in late 1995 and early 1996 by substantially reworking its risk data sheet approach and then integrating it with the EM 1998 budget process. Risk data sheets rank the significance of each DOE activity in terms of seven considerations, of which the first three are specific risk factors: public safety and health; site personnel safety and health, environmental protection; compliance with applicable laws and regulations; mission impact; reduction of the "mortgage"of remaining cleanup obligations; and social, economic, and cultural impacts. For every activity, each of the seven considerations is ranked high, medium, or low; definitions of those evaluations are somewhat uncomfortable and cumbersome. DOE regional and site managers developed the rankings and data to support the 1400 risk data sheets, but substantial efforts to involve stakeholders in both criteria definition and risk data sheet quality assurance are evolving. The entire risk-ranking process is being reviewed externally and internally at DOE. Congress, this Commission, and most others regard this unprecedented process as a worthy start. DOE should balance the need to formalize the process quickly with the need to keep it fluid until its elements became coherent. Many suggestions for improvement are being assessed for incorporation. A sustained evolutionary effort is needed.
Worker Safety at DOE Sites
Finding
DOE sites represent an important opportunity to evaluate potential risks to workers from remediation activities. Worker safety is an important responsibility of DOE and its contractors.
Recommendation
DOE should actively develop means to integrate and evaluate worker risk into their decision-making process concerning the choice and timing of remediation options.
Historically, DOE’s approach to managing worker health and safety risks has suffered from problems of fragmentation. Work planning had typically been a sequential process involving many levels of review and delays. Safety and health professionals were simply one of many inputs to the reviews, which often produced conflicting comments or work plans that were disconnected from actual conditions. Workers were rarely involved in either preparation or review of work plans, so problems that could have been averted because of the workers’ extensive experience and unique knowledge of work conditions were not discovered and corrected until after a plan was released. As a result, most workplace deaths and serious injuries at DOE sites over the past five years can be attributed to inadequate hazard identification and control within the work planning process.
Over the last two years, DOE has launched an enhanced work planning initiative that brings together all the personnel who need to provide input to the work planning process as an integrated, multidisciplinary team to develop, review, and approve the work plan in one step. Health and safety considerations are identified by professionals such as health physicists, industrial hygienists, safety engineers, and occupational medicine specialists, who participate in the team along with managers, planners, and maintenance and operations supervisors. Workers also participate as members of the team, ensuring timely input and the benefit of their hands-on experience. Demonstration pilots of the enhanced work planning initiative have shown exceptional results: increased productivity, greater awareness of health and safety, decreases in safety and health incidents (e.g., a 61% drop in recordable incidents at Hanford Tank Farm), and cost savings (e.g., a greater than 25:1 dollar savings per dollar spent at Fernald). Backlogs, planning time, and working time have been reduced substantially as well. These savings have resulted from the exchange of expertise, improved communication, and increased up front health and safety professional and worker involvement. Nevertheless, extensive efforts are still needed to build an informative database on all workers, including subcontractor employees, and to link job hazard analyses, industrial hygiene, radioactivity monitoring, health surveillance, and occupational medical services for worker protection and program evaluation.
Integrating community and remediation worker risks provides challenges. For example, the risk to those who remove hazardous chemicals and radioactive wastes occurs only between the time that the work begins and the end of their lifetimes, while the risk to community members extends into future generations if remediation does not occur or is ineffective or insufficient. In addition, much worker risk is due to injuries and occurs in early adulthood, while much of the risk of mortality in the community is due to cancer or other diseases occurring late in life. Integrating analyses of worker and community health risks thus presents the challenges of accounting for different health and safety effects, different periods of exposure occurring at different times in a lifetime, and different perceptions about the risks and benefits of remediation options and cleanup standards.
The Defense Environmental Restoration Program was established by Congress in 1984 to evaluate and remediate sites that were contaminated as a result of Department of Defense (DOD) activities. The Commission received testimony from the office of the Deputy Under Secretary of Defense (Environmental Security) about DOD’s strategy for implementing a relative risk-based sequencing procedure for setting priorities among the sites that were to be addressed. This section discusses very briefly DOD’s efforts to establish remediation priorities among its contaminated sites.
Risk-Based Priority-Setting at DOD Sites
Finding
Not all of the contaminated sites that DOD is required to clean up pose major risks to health or the environment. DOD has developed a relative risk ranking procedure to facilitate the process of priority-setting among contaminated sites.
Recommendation
DOD should continue its efforts to establish risk-based remediation priorities among its contaminated sites in collaboration with community advisory groups and state and federal regulatory authorities.
Listing procedures for the Superfund National Priority List establish entire DOD installations as single sites for the purpose of listing. DOD installations are generally large and varied, however, with locations of potentially high risk and locations of potentially low risk within a single installation. Since 1984, DOD has identified almost 20,000 potentially contaminated sites on some 1,700 current installations and about 8,000 potentially contaminated sites at formerly used installations in the United States. Given the large number and diversity of contaminated sites, DOD needed a means to focus remedial activity that is consistent with relative risks to health and the environment. Although cleanup of contaminated sites on closing bases is important, the total number of contaminated sites is so large that there is a need for setting cleanup priorities.
DOD is promoting the use of a risk management concept to evaluate the sequence of work at the environmental restoration program sites in conjunction with the regulatory agreement status of each site. The scheme was subjected to review by the National Research Council and was compared with other hazard ranking schemes. The relative risk site evaluation framework is a qualitative method used by all DOD components to evaluate the relative risk posed by a site in relation to other sites. It should not be equated with more formal risk assessments conducted to assess baseline risks. Relative risk site evaluations are required for all sites at active military installations, base realignment and closure installations, and formerly used defense properties that have future funding requirements that are not classified as:
• Having all remedies in place
• Response complete
• Lacking sufficient information
• Abandoned ornance
DOD and DOD components are using the relative risk site evaluation framework as a tool to help sequence work at sites and as a headquarters program management tool. As a program management tool, the framework is being used to periodically identify the distribution of sites in each of three relative risk categories—high, medium, and low. A series of discrete relative risk site evaluations provides headquarters program managers with a macro-level view of changes in relative risk distributions within DOD over time. The relative risk site evaluation framework and resulting data also provide DOD with a basis for establishing goals and performance measures for the environmental restoration program.
The relative risk site evaluation concept categorizes sites as high, medium, or low risk on the basis of three factors: hazard (a ratio of contaminant concentrations in an environmental medium to comparison values or standards), migration pathway (a measure of movement or potential movement of contaminants away from the original source), and receptor (an indication of the potential for human or ecological contact with site contamination). A site’s category can change because of new or additional information or as a result of cleanup activities.
As in the Commission’s Risk Management Framework, the rankings are performed in collaboration with community advisory groups at the sites. In practice, decisions about which sites should be addressed first include considerations in addition to the rankings, such as the statutory and regulatory status of a particular installation or site, public concerns, program execution considerations, and economic factors. Cleanup practices and community involvement are given special priority at sites on the base closure list.
DOD’s ranking procedure does not involve actual assessments of health risks, nor does it address the decision of whether work is necessary at a site. The procedure only provides relative risk information for use in determining the sequence in which sites will be addressed. A risk assessment is performed as an integral part of site characterization, however. In addition to human exposure assessments, biological and ecological impacts must be considered in the risk assessment. The information developed in the risk assessment provides the basis for developing and evaluating remedial action alternatives, focusing on specific contamination problems at the site, and refining the relative risk evaluation.
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