The Other Clean Air Rule

This time EPA fails to protect public health

Friday, August 1, 1997

The Other Clean Air Rule

This time EPA fails to protect public health

EPA's supplemental notice (1996) and draft Final Rule reflect major concessions made to the industry. The chief consultant for the American Hospital Association (AHA) has referred to the EPA proposal as "painless," acknowledging a reversal in EPA's direction on the rule.

At the same time, America's doctors and nurses have taken bold steps in an effort to uphold their commitment to keep people healthy. It's time EPA sought the advice of these health professionals, rather than the lobbyists.

August 1, 1997


The Environmental Protection Agency (EPA) is on the verge of approving yet another set of important and controversial Clean Air Act regulations. But in contrast to the agency's decision just weeks ago to tighten restrictions on fine particle pollution and ground level ozone, hailed by environmentalists as a major victory for public health, the forthcoming standards for Maximum Achievable Control Technology (MACT) for medical waste incinerators represent a major setback to a decade-long effort to prevent contamination of the environment and the food supply from two highly toxic by-products of medical waste incineration: dioxin and mercury.

The little noticed rule, which EPA was forced to promulgate under a lawsuit environmentalists won three years ago, will permit hundreds of health care facilities to continue using outdated pollution control devices, and in some cases no pollution control devices at all.

EPA scientists have identified medical waste incinerators as among the top sources of environmental contamination by both mercury and dioxin. Both toxins find their way to people after their release from incinerators. According to the agency, dairy and meat products are the main exposure routes for dioxin, and fish consumption is the major source of mercury. According to one EPA official, this rule is moving forward based on an EPA estimate that medical waste incinerators are a relatively minor source of dioxin, even though the Agency's Dioxin Reassessment states that MWI's are a major source of dioxin.

EPA's weak medical waste incinerator regulations will dramatically reduce pressure on hospitals and other health care institutions to adopt cost-effective approaches to waste management, including an array of waste reduction practices and alternative sterilization techniques. Hundreds of medical incinerators will simply continue to burn unsorted waste containing high quantities of dioxin-forming plastics, mercury, cadmium, lead and other problem materials, using inadequate pollution control equipment.

As described in a March, 1997 EWG report (First, Do No Harm), in 1995 EPA initially proposed more stringent rules in response to the lawsuit. But after heavy lobbying by the American Hospital Association, a trade group, EPA substantially weakened the proposed rules in June, 1996 (EPA 1996). The agency's final proposal, now under White House review, included very few of the strengthening provisions recommended by public health groups, physicians, environmentalists and community groups. Health Care Without Harm, a coalition of dozens of such organizations, plus religious, labor, nursing and other interests, has protested the EPA proposal and appealed to the White House to revise the regulations in order to protect the public health.

The draft final rule, which is required to be based on the best technologies that currently exist, will, as currently drafted, allow medical facilities to use inferior technologies, and as a result, they will continue to release high levels of two of the most toxic chemicals known to science, dioxin and mercury. According to EPA estimates, 80,000 to 85,000 pregnant women - a 28 percent increase from the previous year - are exposed to mercury levels high enough to pose risks to their children. In 1996, mercury was responsible for over 1,600 fish advisories across the country which warn the public to limit consumption of various species of fish due to high levels of contamination (EPA 1997b).

Peer-reviewed research has determined that dioxin causes cancer, affects the immune system, causes birth defects - including fetal death - decreases fertility, causes female and male reproductive dysfunction, and adversely affects a variety of hormonal processes involving insulin, thyroid hormones and steroid hormones. Few chemicals cause such a wide variety of effects and none exhibit dioxin's astonishing ability to cause damage at doses almost too low to measure. While consumers are not advised of dioxin in beef and dairy products, which are the primary sources of human exposure, EPA acknowledges that through our diets, we are exposed to 3 to 6 pg (picograms) dioxin each day. EPA's safe level is only 0.01 pg/day (EPA 1997, DiVito et al. 1995) which means that the average person consumes 300 to 600 times the safe amount every day. Moreover, nursing infants take in 50 times the amount that adults consume daily (EPA 1997).

EWG's analysis of the final MACT rule finds it to be inadequately protective of the public health. The Health Care Without Harm Coalition's outstanding concerns with the rule include the excessive emissions limits, the weak pollution prevention mandate, the exemption for some facilities from air pollution control technology, and weak inspection and monitoring programs.

Excessive Emissions Limits

The Clean Air Act requires the EPA to encourage upgrades in pollution control technology through the designation of Maximum Achievable Control Technology, or MACT. Unfortunately, the MACT rules are not directly based on human health. If they were, the standards for many pollutants would be zero. However, the rules have to be at least as stringent as the emissions achieved by the performance of the best 12% of similar facilities. This reliance on a technology standard to indirectly protect public health underscores the importance of setting the strongest MACT dictated by existing technology.

In comments on the rule, filed in August of 1996, the Natural Resources Defense Council (NRDC, 1996) alerted EPA to flaws in its calculations. According to NRDC, the agency did not consider the actual performance of facilities, but rather made assumptions about their performance based on what facility permits allow. Since many of the permits were written years before this MACT rule, they allow a large amount of toxic releases which the current rulemaking was intended to reduce. The 1990 Clean Air Act Amendments could not have anticipated that MACT would be based on permit limits developed, in many cases, prior to the passage of the Amendments themselves since the construction of the rule anticipates the generation and implementation of new technology. Clearly, the limits indicated in permits reflect the minimum requirements applicable at the time of the permit issuance, whereas the MACT rule for medical waste incineration was intended to go beyond previous requirements in order to reduce toxic releases.

EPA data demonstrate that many facilities currently exceed the MACT levels proposed in EPA's draft final rule. EPA's assumption that the performance of facilities is equal to permit limits incorrectly overestimates emissions and as a result, EPA's MACT does not represent the maximum achievable control technology in principal or practice.

According to NRDC, which supplemented EPA's data with some data from other incinerators, the dioxin standard should be 0.012 rather than 2.3 ng/dscm TEQ (nanograms per dry standard cubic meter toxic equivalents), nearly 200 times lower (See table) (NRDC 1996). This is the level proposed for large and medium MWI's. Some small facilities, however, would be allowed to release as much as 15 ng/dscm.

For mercury, NRDC found a similar discrepancy. The EPA standard would be 550 to 7500 ug/dscm while NRDC's calculation suggests it should be as low as 3.3 ug/dscm (See table) (NRDC 1996). There is no facility in the database that releases as much as 7500 ug/dscm mercury. If this database is representative of the universe of MWI's it is difficult to imagine how these new rules could have any effect whatsoever.

While NRDC supplemented the EPA database with data from other operating incinerators, there is no reason to exclude any data point that NRDC used. However, even if EPA used only its own data, the top 12% of the facilities in the database would still achieve emissions far lower than EPA's standard. For dioxin, EPA's data would predict MACT of 0.03 ng/dscm TEQ and for mercury, 7.0 ug/dscm (See Table).

The Clean Air Act also requires EPA to develop MACT rules for other sources of dioxin including municipal waste (trash) incinerators, and hazardous waste incinerators. Hazardous waste incinerators are required to reduce dioxin to levels one tenth of what the draft final rule would allow for even the best medical waste incinerators. This lenient requirement for medical waste incinerators is based on the pretense that medical waste incinerators are unable to burn more cleanly. To the contrary, EPA's own emissions data show that some medical waste incinerators could already achieve emissions standards even lower than the hazardous waste incinerator standards. EPA's MACT for medical waste incinerators ignores these better facilities, and does little to encourage improvements in medical waste incineration, or in waste management practices at the majority of medical facilities that do not currently employ the best technologies.

Waste Reduction Programs are Extremely Weak

Currently, many medical facilities burn all of their waste, even though 85% of it is non-infectious, and resembles waste from any other business. Waste reduction programs can eliminate a large fraction of the waste, leaving less in need of treatment. Facilities such as Beth Israel in New York, Dartmouth Hitchcock Medical Center in New Hampshire, and Fletcher-Allen Health Care in Vermont have found that switching from incineration to alternatives such as autoclaving, combined with a well-managed waste reduction program can save hospitals significant sums of money. For example, Beth Israel Medical Center saved $600,000 in the first year alone (EWG 1997).

EPA's MACT rule for medical waste incinerators diverges from the technology-only approach in its use of so-called "Good Combustion Practices." These practices rely on human behavior in a manner similar to that of a waste reduction program. However, the waste reduction plans discussed in the draft final rule are not considered part of the Good Combustion Practices.

While EPA requires that facilities develop waste reduction plans it makes implementation of the plan voluntary. Therefore, there is no guarantee that the plans will actually be carried out. More disturbing, however is EPA's allowance that the plans "may require no waste reduction activities for certain areas or departments, or, if warranted, the entire facility." This language undercuts the already weak planning provision by allowing facilities to avoid addressing the problem.

The proposed final rule stops short of requiring facilities to fashion meaningful waste management programs, doing a major disservice to the regulated community and the public. Based on the case studies mentioned above, a better defined requirement for such a program would significantly reduce the cost of the rule, regardless of what MACT limits are chosen. As was shown in First, Do No Harm, switching to waste reduction programs saves facilities considerable amounts of money. Requiring such a program as part of enforceable "Good Combustion Practices," with descriptive language regarding the types of activities that should be included in the plan would go a long way toward reducing waste, and minimizing the amount of dioxin, mercury, and other contaminants released into communities, while minimizing the cost to the regulated community.

Exclusion of Rural Facilities

While EPA's draft final rule is considerably more restrictive in its definition of "rural" facilities than the earlier proposal, the rule's exemption of many such facilities from the requirement for state-of-the-art pollution control technologies remains unnecessary and reckless. Since many facilities employ waste management programs, the performance of such programs should be considered in the setting of MACT for small rural facilities. At the very least, waste reduction and segregation plans should be mandatory and facilities should be held to the same emissions limits as larger facilities. Alternatives such as autoclaves and microwave systems, when combined with waste reduction programs can achieve lower emissions and are not confined to urban areas. These options would allow rural facilities to meet or exceed the dioxin and mercury emissions limits comparable to the emissions limits of urban facilities with scrubber technology.

EPA's suggestion that "small HMIWI [hospital/medical/infectious waste incinerators] operating with good combustion alone are also required to reduce Hg emissions through pollution prevention" provides little solace for two reasons. First, these facilities are held to a much more lenient mercury limit than the larger facilities (7,500 vs. 550 ug/dscm), thus removing the driving force for mercury segregation. And second, the term "pollution prevention" remains undefined in the draft final rule, which does not state the exact requirements that would be expected of such facilities in order to alleviate excessive mercury releases.

Inspection and Monitoring Programs are Unsatisfactory.

Each facility is subject to initial equipment inspection under the state plans. The draft final rule provides the criteria for these inspections but does not require that the inspection be done by a third party, rather it is to be conducted by the owner or operator.

For small rural facilities, which don't have pollution control devices, the EPA argues that the cost of continuous emissions monitoring is too high. Instead of continuous monitoring, EPA requires only that these facilities measure the actual pollutants once, and then set operating parameters based on that test. From then on the facilities will test only the operating parameters, and a few indicator pollutants, but, they will not be required to test for dioxin, mercury or any other metals or organic products of incomplete combustion.

While EPA suggests that the costs of continuous monitoring are disproportionately high, the Agency demonstrates that continuous emissions monitors would cost these facilities about one third of what actual pollution control devices would have cost. Therefore, the monitoring costs are a fraction of what these facilities would have been required to spend, were it not for their remote locations. Since rural facilities have been afforded considerable savings in the devices, and it stands to reason that their emissions may be higher as a result, this cost is not unreasonable. Continuous monitoring should not be less feasible due to their remote location.


Cleverly, D. H. 1996. Estimation of Environmental Releases of Dioxin-Like Compounds in the United States: 1987 and 1995. Presentation by Mr. Cleverly, U.S. EPA at the EPA Dioxin Formation/Sources Workshop, Chevy Chase Maryland. November, 1996.

DiVito, M.J., L.S. Birnbaum, W. H. Farland, and T.A. Gasiewicz. 1995. Comparisons of Estimated Human Body Burdens of Dioxinlike Chemicals and TCDD Body Burdens in Experimentally Exposed Animals. Environmental Health Perspectives. 103:820-831.

Environmental Working Group. 1997. First, Do No Harm: Reducing the Medical Waste Threat to Public Health and the Environment.

Natural Resources Defense Council. 1996. Comments of the Natural Resources Defense Council, Inc. on EPA's Proposed Standards for Medical Waste Incinerators. 61 F.R. 31736. August 8, 1996. Prepared by James S. Pew and Marjorie Clarke.

U.S. EPA. 1994a. Estimating Exposure to Dioxin-Like Compounds, Vol. I: Executive Summary. External Review Draft. U.S. EPA, Office of Research and Development. EPA/600/6-88/005Ca, June 1994.

U.S. EPA. 1994. Estimating Exposure to Dioxin-Like Compounds, Vol. II: Properties, Sources, Occurrence and Background Exposures. Review Draft. U.S. EPA, Office of Research and Development. EPA/600/6-88/005Cb, June 1994.

U.S. EPA. 1996. Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources: Medical Waste Incinerators. Federal Register Vol. 61, No. 120. PP. 31736-31779. June 20, 1996.

U.S. EPA. 1997. Draft Discussion Documents for the Current Dioxin Reassessment Draft.

U.S. EPA. 1997b. Update: Listing of Fish and Wildlife Advisories. EPA Fact Sheet. EPA-823-97-007. Office of Water. June 1997.

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