EPA Log # 37: David A. Burrows Comment EPA's short term goal is grossly insufficient as a response to the NRC's overarching recommendation ( NRC Report page 6) that " EPA promote and support response investigations, targeted exposure surveillance studies, and a few well designed epidemiological investigations of exposed populations."

On page 17390 of the Federal Register the EPA shows how it will delay doing the NRC tracking of incident where human illness may be related to the spreading of sewage sludge and will ignore the NRC recommendation to conduct " a few well designed epidemiological investigations of exposed populations."

On page 17390 of the Federal Register EPA states " The Agency is investigating the possibility of developing a process for timely notifications, recording, and tracking incident reports in collaboration with the Center for Disease Control and Prevention ( CDC)." The Agency has initiated preliminary discussion with CDC to discuss possible mechanisms for recording and tracking biosolids related disease incidents." This is bureaucratic footdragging and reflects poorly on EPA.

Response Please see the Summary Response to this section and EPA response to Log No. 8.

EPA Log # 40: Thomas F. Albert Comment Comment # 4: On page I7384 EPR's principal health related short term goal ( goal # 7) is listed last. Why is the only clearly health related short term goal listed LAST? When discussing its overarching recommendations the NRC report ( page 5) calls clear attention to the need for EPA to CONDUCT health related studies. To be specific regarding its overarching recommendations the NRC report on page 5 states " Because of the anecdotal reports of adverse health effects, the public concerns, and the lack of epidemiological investigation, the committee concluded that EPA should conduct studies that examine exposure and potential health risks to worker and residential populations."

Comment # 5: On page 17384 EPA's short term goal # 7 is health related and specifically Mentions " tracking incident reports and investigating whether adverse human health outcomes can be associated with biosolids exposure. " This is exactly the type of health related research that sludge impacted people are calling for. Why is this listed as the last of EPA's short term goals? Why isn't this the FIRST of the short term goals? Unfortunately, EPA not only lists this LAST among its short term goals, but EPA also puts 2 " weasel words" into goal # 7 that clearly show its low priority and show that nothing will be done soon. By " weasel words" I mean that EPA says that it will " conduct a dialogue" with other health based Federal agencies. Why " conduct a dialogue"? Why not just go and do it? Another example of " weasel wording" in goal # 7 is that USEPA, 2003d 87 the " dialogue" will be concerned with the " possibility of cooperating tracking incident reports." Why only " dialogue" about the " possibility" of cooperative tracking? The way that short term goal # 7 is stated it seems clear that EPA gives a VERY LOW PRIORITY to tracking down sludge related health complaints.

Comment # 6: EPA's last listed short term goal ( goal # 7) is so " weasel worded" that it seems clear that EPA has no intention of addressing the NRC report's primary Health Finding ( page 6 NRC report) and the related NRC report recommendation ( NRC report Page 6). The NRC report's first Health Finding ( listed on page 6 of NRC report) s quite clear " There is a lack of exposure and health information on populations exposed to biosolids." What can be clearer than this? The NRC finding further states " EPA needs to study more rigorously the exposure and health risks, or lack thereof, in worker and community populations exposed to biosolids." ( NRC report page 6). The NRC report recommendation that follows this Health Finding is also very direct " the committee recommends that EPA promote and support response investigations, targeted exposure surveillance studies, and a few well designed epidemiological investigations of exposed populations." How can EPA's short term goals pretend to respond to the NRC report's overarching health related recommendation?

Comment # 7: EPA's 7 short term goals ( page 17384) DO NOT COME CLOSE TO RESPONDING TO THE NRC REPORT'S HEALTH RELATED OVERARCHING RECOMMENDATION. Why do EPA's short term goals not properly address the human health issue? If Class B sewage sludge applied to land posed no human health threat, why wouldn't EPA quickly design and conduct the studies to document " no effect"? The obvious reluctance by EPA to promptly conduct suitable health related studies should make a reasonable person even more concerned about the health effects of land applied Class B sewage sludge. Are the thousands of sludge impacted people lying? Are their health related fears groundless? Why does EPA not want to conduct proper health related studies as called for by the NRC report ( such as on NRC report pages 4 6)?

Comment # 8: The last sentence in the " Major Short Term Goals and Priority Actions During FY03 and FY04 section is MISLEADING. The sentence ( page 17384) states " these activities would be aimed at implementing NRC recommendations for reducing the potential for public health impact and updating the scientific basis of Part 503." Unfortunately, it is not clear whether this apparent " bottom line" type statement pertains only to short term goal # 7 or to all of the short term goals. The statement is misleading because the short term goals, even as a group, do not reasonably respond to the NRC report's primary health related recommendation ( NRC report page 6). That NRC recommendation urges that " EPA promote and support response investigations, targeted exposure surveillance studies, and a few well designed epidemiological investigations of exposed populations." The NRC report continues by stating " This recommendation is intended to provide a means of documenting whether health effects exist that can be linked to biosolids exposure." None of the short term goals directly state that EPA will support response investigations or targeted surveillance studies or epidemiological studies. EPA knows that thousands of sludge impacted people, just like the NRC report, are calling for such studies. Why aren't such specific efforts part of EPA's short term goals? USEPA, 2003d 88 Comment # 9: On page 17384 EPA lists 4 " Major Longer Term Goals and Future Priorities ( FY05 and Beyond)." The second sentence is MISLEADING. The misleading sentence states " The following priority areas are aimed at implementing recommendations for reducing the potential for public health impact." How can such a statement be true when none of the longer term goals specially address the primary health effects recommendation as stated on page 6 of the NRC report? That primary health effects recommendation of the NRC report urges EPA to " promote and support response investigations, targeted exposure surveillance studies, and a few well designed epidemiological investigations of exposed populations." Not one of the EPA's long term goals specifically responds to this NRC recommendation. Why does EPA seem to avoid responding to this NRC recommendation? If EPA was truly responding to the NRC report's primary health effects recommendation ( as stated on page 6 of NRC report), the EPA goals ( short term and long term) would specifically call for such health related studies.

Comment # 30: On page 17390 is the VERY BRIEF section " F. Human Health Studies." Why is the human health study section so brief? Why isn't this section FIRST? In EPA's comments it divides its responses to the NRC recommendations into 8 categories ( these are categories A H). Of the 8 categories of EPA responses, only one category is shorter than the Human Health Studies section. In responding to the NRC recommendations; 1) why does EPA list the Human Health Studies category near the end of its listing ( it is # 6 of 8 categories), and 2) why does EPA devote so little space to the Human Health Studies category ( only one of the 8 categories is shorter in length)?

Comment # 31: As noted above EPA's Human Health Studies section is very brief and appears on page 17390. As earlier noted EPA has its Human Health Studies section " near the end of its list", that is, this category appears as the sixth category of EPA's 8 categories of responses to the NRC recommendations. One should ask, why aren't Human Health Studies listed as EPA's # 1 category when responding to the NRC report's recommendations? Regarding human health matters in relation to sewage sludge, it is instructive to see how the Summary section of the NRC report handles this matter. In the NRC report Summary, just after the Overarching Recommendations, is the Health Effects section and in that section the very first recommendation calls upon EPA to conduct health studies ( see page 6 of NRC report). One can reasonably ask, since the NRC report's Summary has its Health Effects section first after the Overarching Recommendations, why then does EPA place Human Health Studies as category # 6 of its 8 categories of response to the NRC recommendations? This question seems even more appropriate when one recognizes that in the NRC report Summary's Health Effects section the first recommendation is a call for health studies. That recommendation on page 6 of the NRC report is very clear and explicit " the committee recommends that EPA promote and support response investigations, targeted exposure surveillance studies, and a few well designed epidemiological investigations of exposed populations." The NRC committee further stated," This recommendation is intended to provide a means of documenting whether health effects exist that can be linked to biosolids exposure." Again, WHY does EPA have this health studies section so far down its " list"?

Comment # 32: On page 173190 EPA devotes very little space ( 43 lines) as to how EPA plans to address NRC human health studies recommendations. This very brief " plan" proposed by EPA is USEPA, 2003d 89 INADEQUATE and nearly useless. It does show 2 things reasonably clearly; 1) EPA plans to IGNORE the NRC recommendation to conduct epidemiological studies, and 2) EPA goes to some length to show how it will DELAY even doing the NRC recommended tracking of incidents where human illness may be related to spreading sewage sludge. Of the brief " plan" by EPA to address the NRC human health studies recommendations it is interesting to see that it is rather neatly divided into 3 parts. Part # 1 ( 16 lines) gives WEAK EXCUSES as to why EPA will IGNORE THE NRC RECOMMENDATION to conduct " a few well designed epidemiological investigations of exposed populations." Part # 2 of the EPA plan ( 15 lines) does Not say that EPA will do the NRC recommended health incident tracking type studies. Rather, in Part # 2 of its plan, EPA gets very vague as it will " investigate the possibility", and it has " initiated preliminary discussions with CDC", and it will apparently discuss " possible mechanisms for recording and tracking biosolids related disease incidents." ( Why all the use of " investigate", " possibility", " initiate", " preliminary", and " possible"? Doesn't this sound like delay, delay, delay? Part # 3 of the EPA plan ( 12 lines) just extolls the virtues of a University of Arizona study and how it may interact with often mentioned ( and over rated) cooperative sludge study in Pennsylvania conducted by EPA/ USDA/ PA DEP.

Comment # 33: As noted, EPA plans to devote very little effort to addressing NRC human health studies recommendations ( see the 43 lines on page 17390). EPA plans to IGNORE the NRC recommendation to conduct " a few well designed epidemiological investigations of exposed populations." As noted earlier the NRC recommendation is part of the NRC committee's very first recommendation regarding Health Effects ( see page 6 of NRC report). If EPA plans to ignore this NRC recommendation, EPA should provide better reasoning rather than the WEAK EXCUSE ( 16 lines) it presents on page 173190. To the thousands of sludge impacted people who call for health related studies, this EPA decision reinforces the opinion of many that EPA is AFRAID of what such studies will show. If this is not the case, then EPA should provide concerned citizens with a well reasoned argument ( not a 16 line excuse) as to why the NRC recommendation should be ignored.

Comment # 34: As mentioned before the NRC report summary, as the first recommendation regarding Health Effects, calls upon EPA to conduct health studies. On page 6 of the NRC report " the committee recommends that EPA promote and support response investigations, targeted exposure surveillance studies, and a few well designed epidemiological investigations of expose populations.'' On page 17390 EPA in its " Targeted Human Health Investigations" section ( all of 14 lines) more or less " beats around ' the bush" regarding this issue. In the brief section EPA DOES NOT commit to doing such studies. Let me repeat here the vague, tentative wording that EPA uses, " The Agency is investigating the possibility of developing a process for timely notification, recording, and tracking incident reports in collaboration with the Centers for Disease Control and Prevention ( CDC)." " The Agency has initiated preliminary discussion with CDC to discuss possible mechanisms for recording and tracking biosolids related disease incidents." On looking at these 2 quoted sentences, does it look like EPA is moving ahead to address the NRC recommendation or does it look like EPA is DELAYING? Why " investigating the possibility", why not just do it? Why " preliminary discussion", why not real discussion? Conducting health incident investigations is NOT Rocket SCIENCE. EPA presents a clear picture of not wanting to USEPA, 2003d 90 move ahead with rather simple, straight forward incident investigations. This timid," foot dragging" type behavior reflects very poorly upon the agency and helps reinforce the suspicions of many sludge impacted people that EPA doesn't really want to know the results of such studies. If EPA persists in avoiding and/ or delaying such NRC recommended health studies it should provide a reasoned argument ( not 14 lines) as to why.

Response Please see the Summary Response to this section for a description of specific activities EPA will undertake to track reported health incidents and develop exposure measurement tools to investigate reports of adverse human health effects from land application of sewage sludge. On the conduct of epidemiological studies, please see response to comment EPA Log No. 8.

EPA Log # 25: Northumberland Association for Progressive Stewardship ( NAPS) Sewage Sludge Study Group Comment F. Human Health Studies Lines 959 990. We further question EPA's resolve in gathering scientific data when it says," At this time ( funding again), the Agency does not plan to conduct an epidemiological study, as discussed in the NRC report." We firmly believe that without epidemiological studies, we cannot determine the true effect of sludge carrying pollutants on human health. Relying on only a limited number of targeted human health investigations from the field will not, in our opinion, help in resolving this issue.

Response As stated in EPA response to Log No. 8, EPA does not believe that epidemiological studies are the best use of EPA resources to characterize potential health risks from the land application of sewage sludge.

Environmental Groups EPA Log # 7: Sierra Club Comment EPA ignored recommendations from Georgia's EPD in 1998 to immediately shut down Augusta's sewage sludge land application program. Now, EPA's Office of Research & Development is analyzing data indicating that hay fertilized with Augusta sludge may be causing infections and liver damage in workers using it for erosion control along state roads and Interstate highways.

Across the country, hundreds of people have reported that their health and quality of life have been severely impacted by land application of sewage sludge. Sewage sludges are mostly disposed of in areas where residents lack the economic and political means to protect their communities. The practice, therefore, disproportionally impacts poor and minority communities. Some residents have filed lawsuits, seeking damages from municipalities and private companies producing and applying sewage sludges. Many local governments have restricted or banned land application. USEPA, 2003d 91 Anecdotal evidence that links sludge spreading to illnesses, live stock damage, and groundwater contamination is mounting. The Cornell Waste Management Institute has been documenting cases of adverse reactions reported by people exposed to land applied sewage sludges. The NRC recommended that EPA address the growing number of reports of health related incidents and study land application sites generating these complaints.

Concurrent with the publication of this NRC recommendation, researchers at the University of Georgia linked illnesses and deaths among residents living within approximately 1 km of land application sites to exposure to certain Class A and Class B sludges, especially lime stabilized materials. Individuals using private wells located near land application sites report chronic diarrhea and vomiting from recurring gastrointestinal infections involving rotavirus and other enteric pathogens. Most complains, however, are attributed to irritant dusts blowing from dry, sludged fields. Symptoms include skin rashes, burning eyes, burning throat, burning lungs, persistent cough, and difficulty breathing. These symptoms are often followed by opportunistic infections in irritated tissue ( e. g., sinus and throat infections, boils, pneumonia), which may be life threatening. Health related complaints were reported even when the applications appeared to comply with EPA guidelines in 40CFR Part 503. The NRC panel warned that effects of mixtures of chemical and pathogens in sludge on human health have been overlooked and should be addressed. Nevertheless, when private citizens complain of adverse health effects, they are often threatened with litigation by the leading U. S. corporation profiting from land application. Instead, EPA should be aggressively investigating these complaints.

According to a recent Inspector General audit, EPA and most states have no reliable system for reporting, tracking, and investigating adverse health incidents associated with land application of sewage sludge. Responding to the NRC's recommendation that report s of adverse effects be investigated, EPA is only planning to " investigate the possibility of developing a process for timely notification, recording, and tracking incident reports in collaboration with the Centers of Disease Control & Prevention ( CDC) ( 19: p. 17390)" and " exploring a plan to conduct a molecular pathogen exposure study" involving people living near land application sites who develop infections ( 19: p. 17387).

The Sierra Club recommends that EPA take a much more active role in alleviating situations where people living near land application sites are negatively impacted. Simply " investigating the possibility" of tracking adverse health effects and " exploring a plan" to track sources of infections in people coping with overwhelming odors and sewage sludge dusts in their homes is unacceptable.

Response Please see the Summary Response to this section. EPA recognizes the value of the work of Cornell Waste Management Institute ( CWMI) in analyzing and synthesizing the reporting of health incidents from land application of sewage sludge. However, CWMI also recognizes that it has not been confirmed that the illnesses recorded were due to land application of sewage sludge. As to the Georgia case, EPA has gathered information on this case. EPA has found no evidence that exposure to land applied sewage sludge was the cause of any of the allegations of animal or human deaths cited. USEPA, 2003d 92 EPA Log # 43: Natural Resources Defense Council ( NRDC)

Comment HUMAN HEALTH STUDIES NRC recommends a systematic epidemiological approach to evaluating the human health effects of biosolids exposure under current regulations. NRC recommends studies in response to unusual occurrences of disease and unusual exposures, preplanned exposure assessment studies, and complete epidemiological studies that can address serious or widespread problems. EPA rejects the NRC approach in favor of more limited human health studies, but it fails to identify any particular " targeted " studies that it actually plants to undertake. EPA claims that it has completed and continues to conduct studies on exposure and disease occurrence, which it claims are described in the Risk Assessment and Human Health sections of the comment. Although those sections discuss a generalized intent to conduct such studies in the future and make reference to the EPA/ USDA/ PA site specific project, there is no evidence of a completed or ongoing study evaluating the occurrence of disease or other human health effects from biosolids. If such studies exist, they need to be explicitly noted and made available to the public.

EPA's stated commitment to targeted human health studies also appears disingenuous. In contrast to NRC ' s recommendation that EPA study the actual human effects of biosolids exposure by establishing a framework to investigate and document claims of disease following exposure, the Agency states that its " primary objective " is to merely characterize the presence of pollutants in biosolids and the pathways by which human exposure may occur. EPA acknowledges NRC's belief that there is an " immediate need for a systematic approach for investigating claims of disease." Unfortunately, EPA does not commit to meeting that need. Instead, EPA says that it plans to investigate " the possibility of developing a process for timely notification, recording, and tracking." However, even this extremely tentative effort seems unlikely in light of a recent statement by EPA officials that " investigating health impacts from biosolids is not an EPA responsibility," but rather one that belongs to the National Institute of Occupational Safety and Health and the Centers four Disease Control. EPA's statutory responsibilities to protect public health require that it ensure adequate human health studies are being conducted. If NIOSH and the CDC possess superior expertise in this field, then EPA should ensure that the President directs those agencies to implement the NRC's recommendations. There are numerous sludge sites across this country that have been identified by people who have become sick as the likely cause of their illnesses. EPA owes it to these people to figure out whether sludge is making them sick. If EPA cannot devote the resources to doing so or arrange for CDC or NIOSH or another public health agency to do so, it must ban land application of sludge because EPA cannot make a finding that the regulations are " adequate to protect public health and the environment from any reasonably anticipated adverse effects." 33 U. S. C. 1345( d)( 2) & ( 3).

Response Please see the Summary Response to this section. As stated before in the response to EPA Log No. 8 in this section, EPA does not believe that epidemiological studies are the best use of EPA resources to characterize potential health risks from the land application of sewage sludge. USEPA, 2003d 93 Municipal Wastewater Treatment Plants EPA Log # 24: Hampton Roads Sanitation District ( HRSD)

Comment Response Team for Biosolids Health Report HRSD strongly recommends the inclusion of Centers for Disease Control and Prevention for investigating all claims of disease or illness following biosolids exposure. It is critical that a third party with no allegiance to biosolids fully investigate any claims of illness to provide a level of confidence to the public that the investigation is unbiased. In Virginia, citizens have criticized the state regulators for announcing their support of biosolids land application. Consequently, these citizens are quick to discredit any complaint investigations conducted by the regulators; especially when the citizens disagree with the conclusions of the investigations.

A tracking system to document the details of each investigation would be very effective to ensure that the information is accurately distributed to all interested parties. Relying on word of mouth or newsletter summaries tends to distort the findings of the investigations.

Response EPA agrees with this comment on the inclusion of CDC in this issue. Please see the summary Response of this section. As stated before, EPA will consider and evaluate all information reported from stakeholders as long as this information can be verified and meet the standards of EPA's Data Quality Guidelines.

EPA Log # 47: Miami Dade County Water and Sewer Depatment ( MDWASD)

Comment EPA's plan to investigate the possiblity of developing a process for timely notification, recording, and tracking incident reports in collaboration with other health based Federal agencies, such as the Centers for Disease Control and Prevention.

In order to scientifically determine if there are any adverse health effects from the land application of biosolids, there must be a way for rapid communication between health organizations, regulatory agencies, and potentially affected members of the public. MDWASD encourages the EPA to investigate the feasibility of such a communication method, such as developing a real time web site that various agencies could share as a research and tracking tool. Working with such health based organizations such as the Center for Disease Control and Prevention is an essential component to filling the data gaps of biosolid use and health effects.

Response EPA agrees with these comments.

Land Application Company EPA Log # 26: Synagro Technologies, Inc.

Comment DEVELOP A METHOD TO INVESTIGATE AND TRACK COMPLAINTS INVOLVING HUMAN HEALTH EFFECTS FROM NEARBY LAND APPLICATION SITES. USEPA, 2003d 94 Small scale, geographic based health investigations have always been hampered because residential populations, like those around biosolids land application sites, are too small to yield the statistical power necessary to exhibit robust correlations. Additionally, the case is that such populations are too epidemiologically diverse to conduct a reliable study of health effects.

A number of complications make it difficult, if not impossible, to single out treated biosolids as a causative agent. For example, the expert panel points out that there is no currently existing reliable exposure metric because biosolids are not unique materials. All of the microorganisms and chemicals found in biosolids are found elsewhere, often in higher concentrations. Thus, it is difficult to link the presence of a particular chemical or microorganism found in a receptor with the occurrence of that organism or chemical in biosolids without ruling out all possible confounders.

EPA should not allocate resources in an attempt to develop a new model to investigate and track complaints of human health effects from nearby biosolids land application sites.

° To date there is no reliable evidence of a causal relationship between biosolids exposure and human health effects ( Report conclusions)

° Local health authorities, under existing public health programs, best investigate claims of illness associated with biosolids exposure. Since most of the health effect s claims are for common ailments ( gastrointestinal upset, upper respiratory symptoms), it is important that any investigations of health effects be conducted using rigorous principles of disease causation. A physician referral should be the initial point of entry into these programs.

° The Centers for Disease Control and Prevention ( CDC) already compile data on infectious diseases including many of the gastrointestinal problems that have been alleged to be associated with biosolids in the past. It is likely that CDC or state health department data may be able to be used to perform incidence and prevalence studies without gathering additional information. Recent investigations made available to the popular press do not accurately or appropriately generate useful statistics on adverse end points such as gastroenteritis ( and other infirmities) because they seldom calculate relative risk comparisons that are essential to epidemiological analyses.

° POTWs, biosolids management organizations, and farmers already monitor the health of workers exposed to biosolids. These existing data may be used to evaluate not only health effects associated with workers, but also alleged effects in the less exposed general population.

The NAS/ NRC report called for response incident investigations, targeted exposure surveillance, and well designed epidemiological studies. EPA has proposed developing a tracking mechanism with CDC and collaborative exposure assessment work with USDA, State of PA, and the NSF WQC at the University of Arizona. It is important to note the following:

° No documented cases of human illness to date. USEPA, 2003d 95 ° Meaningful epidemiological studies probably can't be done because of confounding, lack of exposure metric, small populations, etc.

° Physicians and local health departments should be first point of contact, screen out unjustified complaints. Work with state environmental agencies.

° CDC could keep national database of justified complaints, documented illnesses.

° Any health studies should be conducted using good practice and standard protocols.

° Epidemiological definitions of causation should be standard for linking complaint to biosolids.

Until there is evidence that biosolids recycling has caused health problems, EPA should not consider any studies that would waste valuable taxpayer's dollars. EPA should not waste taxpayers' money on frivolous studies suggested by a small vocal minority of self interested researchers. These are actions that make Congressional Oversight hearings so difficult for EPA.

Furthermore, the burden of proof should be on those making allegations of deaths and serious illnesses ( the so called " sludge victims"). All that is available is anecdotal information that documents nothing. The only epidemiological study done with biosolids was the Ohio Farm Study in 1985 that showed no problems with families living near sites where biosolids were land applied compared to families living on farms where no biosolids were used. If EPA wants t o spend any money in this area, it should be to fully investigate some of the claims of the so called " sludge victims" with an independent and credible third party, such as the CDC.

Response Please see Summary Response to this section for EPA plans to track reported health incidents and the development of exposure measurement tools to investigate reports of adverse human health effects from exposure to sewage sludge. EPA agrees with the comment that, to date, there is no reliable evidence of a causal relationship between biosolids exposure and adverse human health effects.

Association EPA Log # 30: Tri TAC Comment Additional Research Needed The first two objectives above relate directly to the issue of additional research   both new studies designed to address priority areas in the Part 503 regulations and existing projects within and outside EPA. Tri TAC believes that EPA's first priority for conducting research to update the scientific basis of Part 503 must be a series of exposure assessment studies to directly assess potential health impacts and to obtain additional data on exposure to biosolids and other organic residuals. USEPA, 2003d 96 Exposure Assessment Studies to Compile Additional Human Health Data Communities across the U. S., and especially in California, which are considering, or have established, bans or restrictions on the land application of biosolids, cite the lack of information on the human health effects of exposure to biosolids. This is where EPA can have the most impact on preserving the safe practice of land application as a long term, sustainable management alternative for biosolids. The NRC Report makes a number of recommendations regarding this issue, foremost of which is the need to conduct exposure assessment studies to characterize the exposures of workers and the general public who come into contact with biosolids either directly or indirectly. The studies " would require identification of microorganisms and chemicals to be measured, selection of measurement methods for field samples, and collection of adequate samples in appropriate scenarios" ( NRC Report, p. 6). These studies would determine the makeup of emissions ( e. g., odors, bio aerosols, volatiles) from biosolids land application sites, measure the exposure potential for workers, such as appliers and farmers, as well as nearby communities, and assess the potential nexus to human health impacts. Should the results of these exposure assessment studies suggest a negative impact on human health, additional resources could be committed to conducting a complete epidemiological study of biosolids use to provide evidence of " a causal association, or lack thereof, between biosolids exposure and adverse human health effects" ( NRC Report, p. 6).

Tri TAC is aware of a number of research efforts, either currently underway or being considered by organizations such as the Water Environment Research Foundation and the University of Arizona, which could provide critical information for such exposure assessment studies. In addition, as with previous EPA efforts, Tri TAC's public agency members would be willing to work with the EPA on its ongoing biosolids research efforts. EPA should make every attempt to use studies conducted by other organizations and use the resources of the biosolids program stakeholders, including citizens and interested activist groups, to maximize its own limited resources.

Response Team for Biosolids Health Reports Alleged or unsubstantiated claims of adverse health effects are more damaging to local biosolids programs than any other issue and it is here that public relations and responsive investigation must meet. Without the proper response and investigation by a credible authority, citizens have no choice but to believe the limited evidence, based more on fear than fact, which is presented to them. The logistics of an incident response team capable of investigating past and future claims of health impacts is complicated. There must be a method for timely notification and a process for tracking and recording incidents. EPA's involvement is key, as many of the questions regarding biosolids management are national in scope, but the process must also acknowledge that land application decisions are local. EPA Headquarters and Regional offices, states, and local governments should all have a role in investigating such health claims, and the additional expertise of the Centers for Disease Control and Prevention ( CDC) may also be necessary. Finally, an accessible national tracking system to document the details of each investigation would be vital to ensure biosolids managers, local, state and federal regulators, and the public have the information they need to make educated decisions concerning the land application of biosolids. USEPA, 2003d 97 Response Please see the Summary Response to this section for EPA plans to track reported health incidents and to develop exposure measurement tools to investigate reports of adverse human health effects from exposure to sewage sludge. EPA intends to build on research being conducted by organizations outside of EPA and welcomes Tri TAC's offer to participate in this effort.

EPA Log # 50: Water Environment Federation ( WEF)

Comment Responsiveness   EPA notes that they are investigating cooperative efforts with health agencies such as the Centers for Disease Control ( CDC) to respond to and investigate complaints of health effects related to biosolids use. WEF strongly encourages the development of dialogue between EPA, CDC, and other relevant agencies on cooperatively tracking incident reports and investigating whether adverse human health outcomes can be associated with biosolids exposure. The development of this type of response team is critical and should be a top priority; especially since human health complaints have mostly been related to pathogens and odors ( see Focus on Priorities above). Considering the complexity of the issue and resource limitations, EPA has made a good effort to respond to complaints, however, WEF recommends that another agency like CDC play a significant role, and even take the lead in this effort because of current perceptions regarding EPA responsiveness on health complaints.

F. Human Health Studies The NRC recommended that EPA conduct a variety of investigations including epidemiological studies of exposed populations. In its response, EPA indicated that the Agency does not plan to conduct epidemiological studies because they are complex, time consuming, and require substantial funding. It is unfortunate, though understandable, that a comprehensive epidemiological study along the lines of the 1985 EPA study cannot be performed. Depending upon how they are developed, targeted human health investigations, which may provide the basis for future epidemiological studies, should help address public concerns.

In developing the approach to any human health studies, continued work with CDC is recommended and, if possible, it may be preferable for the CDC to take the lead in this effort. This recommendation stems from the perception that EPA has not adequately addressed previous health complaints, and that the Agency is vested in the beneficial use of biosolids and thus cannot provide objective insight. Regardless of who leads such efforts, timely, methodical and thorough responses to complaints regarding biosolids will be critical to gaining public confidence.

EPA also indicates that it is investigating the possibility of developing a process for timely notification, recording, and tracking of incident reports in collaboration with the CDC. As stated before, WEF strongly supports EPA's efforts to work with CDC to identify mechanisms for recording and tracking biosolids related incidents.

Response EPA agrees with these comments .

EPA Log # 46: Association of Metropolitan Sewerage Agencies ( AMSA) USEPA, 2003d 98 Comment Additional Research Needed The first two objectives above relate directly to the issue of additional research   both new studies designed to address priority areas in the Part 503 regulations and existing projects within and outside the Agency. AMSA believes that EPA's first priority for conducting research to update the scientific basis of Part 503 must be a series of exposure assessment studies to directly assess potential health impacts, especially those associated with pathogens, and to amass additional data on exposure. AMSA also encourages the Agency to support research on odor associated with biosolids management and ways to mitigate those odors during processing and land application.

Exposure Assessment Studies to Compile Additional Human Health Data Communities across the U. S. that are considering, or have established, bans or restrictions on the land application of biosolids consistently cite the lack of information on the human health effects of exposure to biosolids. This is where EPA can have the most impact on preserving land application as a long term, sustainable management alternative for biosolids. The NRC Report makes a number of recommendations regarding this issue, foremost of which is the need to conduct exposure assessment studies to characterize the exposures of workers and the general public who come into contact with biosolids either directly or indirectly. The studies " would require identification of microorganisms and chemicals to be measured, selection of measurement methods for field samples, and collection of adequate samples in appropriate scenarios" ( NRC Report, p. 6). These studies would determine the makeup of emissions ( e. g., odors, bio aerosols, volatiles) from biosolids land application sites, measure the exposure potential for workers, such as appliers and farmers, as well as nearby communities, and assess the potential nexus to human health impacts. Should the results of these exposure assessment studies suggest a negative impact on human health, additional resources could be committed to conducting a complete epidemiological study of biosolids use to provide evidence of " a causal association, or lack thereof, between biosolids exposure and adverse human health effects" ( NRC Report, p. 6).

AMSA is aware of a number of research efforts, either currently underway or being considered by organizations such as the Water Environment Research Foundation, which could provide critical information for such exposure assessment studies. In addition, as with previous EPA efforts, AMSA's public agency members would be willing to work with the Agency on its ongoing biosolids research efforts.

Response Team for Biosolids Health Reports Alleged or unsubstantiated claims of adverse health effects are more damaging to local biosolids programs than any other issue and it is here that public relations and responsive investigation must meet. Without the proper response and investigation by a credible authority, citizens have no choice but to believe accounts, based more on fear than fact, that is presented to them regarding potential health effects from land applied biosolids. The logistics of an incident response team capable of investigating past and future claims of health impacts are complicated. There must be a method for timely notification and a process for tracking and recording incidents. Federal involvement is key, as many of the questions regarding biosolids management are national in scope, but the process must also acknowledge that land application decisions are local. EPA USEPA, 2003d 99 Headquarters and Regional offices, states, and local governments should all have a role in investigating such health claims.

AMSA encourages EPA to develop a process for timely notification, recording, and tracking incident reports in collaboration with other federal agencies. Given their expertise in such matters, AMSA believes that the Centers for Disease Control and Prevention ( CDC) may need to play an integral role, if not the lead role, in any type of incident reporting process. Ultimately, a national tracking system to document the details of each investigation would be vital to ensure biosolids managers, local, state and federal regulators, and the public have the information they need to make educated decisions concerning the land application of biosolids.

Response Project 4 Field Studies of Application of Treated Sewage Sludge in today's FR notice responds to the first paragraph of the comments. With respect to the call for exposure studies, please see the EPA response to comment Log No. 30 of this section. EPA appreciates AMSA's offer to participate in the Agency's research effort.

Counties EPA Log # 28: Solano County Department of Environmental Management Comment4. Human health surveys for potential health effects from land applied biosolids. A) Epidemiological Studies Solano County DEM strongly suggests that the USEPA reevaluate its response to the NRC's Human Health recommendations. While large scale epidemiological studies may be difficult, Solano County DEM highly recommends that the USEPA, in coordination with the Center for Disease Control and state and local health agencies, undertake at least one study that includes multiple locations and conduct an epidemiological study that focuses on biosolids land application and potential impacts on a community and rural residences adjacent to land application sites.

B) Training, notification, and reporting In its response to the NRC report, the USEPA states that it is " investigating the possibility of developing a process for timely notification, recording, and tracking incident reports in collaboration with" the CDC. Solano County DEM believes that this is extremely important and should be given high priority by the USEPA. In addition, the USEPA, in coordination with CDC, should develop a program and support training to inform and educate State and local health care providers and regulatory agencies of possible symptoms or effects from exposure to biosolids, methods to establish an integrated routine notification and reporting process, and processes for rapid response by multiple agencies and health care providers so that health complaints can be properly investigated for potential correlation to biosolids land application activities.

Response With respect to comment A and as stated in the response to Log No. 8 in this section, EPA does not believe that epidemiological studies are the best use of EPA resources to characterize potential health risks from the land application of sewage sludge. EPA agrees with comments B and believe that the activities described in the Summary Response to this section USEPA, 2003d 100 will lead to proper investigation of health complaints by State, local health providers and regulatory agencies.

States EPA Log # 52: Washington State Department of Ecology Comment EPA's plan to investigate the possibility of developing a process for timely notification, recording, and tracking incident reports in collaboration with other health based Federal agencies, such as the Centers for Disease Control and Prevention.

In reviewing EPA's response I did not note much of anything in the way of an actual plan. As an idea, however, I strongly support this initiative. There are a number of high profile cases around the country which have detracted from the national biosolids program and called into question both science and policies. The national program is knit of common fabric, and what ill befalls one state or agency, also befalls others. If arguments of critics in these cases are correct, then we need to make changes. If they are not correct, we need to know why. Attempts have been made at various times by various persons and groups to investigate these cases and provide summaries. The lack of ready resources and a consistent approach to investigation, response, and documentation is a clear detriment to national program implementation. I feel compelled to once again observe that the best plan possible will be of little value if staff do not have resources and ability to respond and follow the established standard procedures for investigation and documentation. Further, if related short ( and long) term goals for improving program knowledge are not realized, then investigations will be based on data and methodologies that will continue to be subject to criticism by the people they are most needed to respond to.

One additional suggestion I can offer here is that EPA should set the bar for what must occur in order for an incident to warrant a response. If thorough responses to the most critical incidents are carried out they will likely be fairly resource consumptive.

Response Please see the Summary Response to this section: EPA has now provided more details on its actual plan. EPA has the proper resources to carry out these activities which will be complemented by research carried out outside the Agency.

EPA Log # 45: Florida Department of Environmental Protection Comment Comments on the Program for Incident Management We strongly encourage the EPA to pursue cooperation with the CDC in developing and implementing an approach and procedures for investigating and documenting alleged illnesses and incidents.

The EPA is encouraged to stay informed of homeland security efforts by other federal agencies and states in areas such as chemical and biological agent detection and health incident reporting. It USEPA, 2003d 101 may be that some technologies or programs developed for homeland security could be adapted to improve the biosolids program.

Response EPA agrees with these comments.

EPA Log # 48 and 39 ( duplicates): Wisconsin Department of Natural Resources Comment 17. Section VIII. F. Human Health Studies  Planned Human Health Activities  It is stated that the Agency's primary objective is to characterize pollutants and microbial agents in biosolids, but no plan to fulfill that characterization is presented here. Is it intended that the characterization is limited to that described in parts A. Survey and B. Exposure of this section? There is no provision to monitor microbial agents other than fecal coliform in Part A and it is unclear what all will be examined under Part B. More specific detail of what will be monitored should be provided and whether and what type of study will actually be performed. It is also noted that the Agency is investigating the possibility of developing a notification and tracking system for health complaints. No mention is made of actually conducting investigations into the validity of adverse health allegations or who would conduct them. It is critical that investigations be done quickly and effectively and the results of those investigations be tracked and available to regulators and the public. EPA should comment further and provide specific plans to address this report recommendation.

III. The following comment is in response to EPA's plan to develop a process to investigate and track incidents of alleged adverse health effects.

1. This is a major area of action recommended in the NRC report and only briefly discussed under the response plan as addressed above. It is critical that state and local health representatives work with EPA and perhaps CDC to investigate all alleged incidents in a timely and efficient manner. It is likewise imperative that the investigations be tracked and reported whether they confirm or dispel the alleged affect. This process needs to be further defined and articulated by the Agency.

Response EPA has developed in today's FR notice, a more detailed description of its work plan which we believe responds to the commenters questions and comments: Project 4 ( Field Studies of Application of Treated Sewage Sludge) will investigate pollutants emitted from land application sites; Project 5 ( Targeted National Survey of Pollutants in Sewage Sludge) will characterize the occurrence of certain chemicals in sewage sludge; finally, the Summary Response to this section describes Project 6 and 7 related to the investigation of alleged incidents from exposure to sewage sludge. EPA intends to work with all stakeholders, especially our State regulatory partners and CDC in accomplishing the activities described in the Summary Response to this section.

Municipalities EPA Log # 55: City of Rio Vista, California USEPA, 2003d 102 Comment EPA ' s response also largely ignores NRC ' s specific recommendations to do response incident investigation, targeted exposure surveillance and well designed epidemiological investigations of exposed populations. For example, even with regard to gathering data on incidents, the plan takes a wait and see attitude:"[ t ] he Agency is investigating the possibility of developing a process for timely notification, recording and tracking incident reports  ." Epidemiological studies are deemed too costly to perform and will not be done.

Response Please see the Summary Response to this section. As stated before, EPA does not believe that epidemiological studies are the best use of EPA resources to characterize potential health risks from the land application of sewage sludge.

TOPIC G. REGULATORY ACTIVITIES Summary Response As discussed below and in today's Federal Register notice, EPA will be evaluating whether to propose a new pollutant concentration limit and cumulative pollutant loading rate for molybdenum in land applied sewage sludge. In addition, possible regulatory changes may be forthcoming pending the results of the studies and refined risk assessment outlined in the FR Notice. At this time, EPA is committing to take only one short term action on Part 503 revisions. Project 13 in Section VII B in today's Federal Register Notice commits to a review of molybdenum numerical standards for land applied sewage sludge under the Part 503 Rule. A full set of numerical standards for molybdenum in land applied sewage sludge was included in the Round One Part 503 Rule when it was published in February, 1993. Based on a judicial challenge to this part of the Part 503 Standards, EPA withdrew all molybdenum numerical standards with the exception of the " maximum" numerical standard from the Part 503 Rule. EPA, in the1994 Federal Register notice that announced the withdrawal, indicated that at a future date, EPA would reevaluate the information that it had on molybdenum and re propose the three numerical standards that had been withdrawn. The project described below fulfills that commitment.

Project 13: Review Criteria for Molybdenum in Land applied Treated Sewage Sludge One of the NRC's recommendations was that EPA should propose molybdenum standards to replace those that EPA rescinded following a legal challenge to numerical limitations promulgated in the Round One rule. Also, some commenters believe that EPA should reassess the molybdenum standard. The preliminary strategy in the April 9, 2003 notice indicated that EPA would determine the applicability of new information as the basis for re proposing molybdenum standards for land applied sewage sludge. See 68 FR 17391. This activity is included in the Agency's final action plan, as stated below.

In 2000, EPA held a workshop to update toxicity and environmental properties for molybdenum in sewage sludge. Based on that workshop, EPA intends to assess the need and appropriate level for a numerical standard for molybdenum in sewage sludge using a summary of USEPA, 2003d 103 workshop results and conclusions, supplemented with additional data developed since 2000. EPA expects to complete this assessment in 2005.

In the long term, EPA commits to evaluate all of the information that is generated from today's Federal Register Notice's action plan of research. Based on this information, EPA commits to revisit all of the Part 503 Standards and propose amendments to these Standards if, based on this information, EPA determines that Part 503 amendments are necessary to enhance public health and environmental protection from chemical pollutants and pathogens in landapplied sewage sludge. Based on the schedule for potentially proposing numerical standards for pollutants identified in the screening exercise under the Section 405( d)( 2)( C) Clean Water Act requirement described in Section IX of today's Federal Register Notice, EPA will first design and conduct a targeted national survey of pollutants in sewage sludge in 2005 through 2007. The results of the survey will provide pollutant concentration values that EPA will then use in a more refined risk assessment and risk characterization. Based on the results of these refined analyses, EPA will propose as soon as practicable new regulations under Section 405( d) for any pollutants which it determines may be present in sewage sludge in concentrations which may adversely affect public health or the environment.

Academia EPA Log # 51: Ellen Z. Harrison Comment In response to a request from a municipality, I developed a draft municipal ordinance that addresses many of the concerns posed by the land application of sewage sludges ( Harrison, 2003). I believe that EPA should enact these provisions nationally as a means to be reasonably protective of public health and the environment.

Response EPA has reviewed this information and thanks the commenter for submitting it. See the Summary Response to this section of the document. It is possible that some of provisions in this draft ordinance could eventually be incorporated into the Part 503 Standards based on the process described in the Summary Response.

Citizens EPA Log # 8: David A. Burrows Comment The regulation of molybdenum in biosolids needs to be reassessed as recommend by the NRC. ( Federal Register p. 17382)

The NRC recommendation that " the elimination of exemptions for nutrient management and site restrictions for land applied EQ biosolids" ( Federal Register p. 17390) is necessary to protect both the environment and human health. USEPA, 2003d 104 You state ( Federal Register p. 17391): " States and local jurisdictions will have better knowledge of local conditions, and are in better position to establish additional management practices to augment the protectiveness of the part 503 standards." Many states, Pennsylvania included, do not allow local governments ( counties, townships) to adopt strict regulations with regards to biosdids. In fact, local jurisdictions are virtually powerless. This emphasizes the need for the EPA to adopt strict regulations that are truly protective of both human health and the environment. EPA's mandate is to protect the citizens of this country, not the sludge industry.

On page17391 of the Federal Register it states that " part 503 numerical standards are based on a conservative set of exposure pathway and risk assessment assumptions." Research is needed to support these assumptions.

Also on page 17391 of the Federal Register it states that " EPA is planning to evaluate certain Class B disinfection processes including the natural attenuation of pathogens that occurs while sludge is on or in the soil." There is an absolute need for accurate data regarding Class B " disinfection" to protect human and environmental health. There is also the need for strict monitoring system so that " disinfection" is done correctly every time. With regard to the natural attenuation of pathogens while sludge is in or on the soil, the period of study should be at least one year to check for the regeneration of pathogens.

Response See the Summary Response in this section of the document. EPA does recognize the importance of site specific conditions in establishing protective sewage sludge standards. The Part 503 Standards are designed to be conservative. As such, EPA believes that they are generally protective throughout the United States. However, the Part 503 Standards have a provision that allows EPA Permitting Authorities to add requirements to the base Part 503 Standards and/ or modify the Part 503 Standards to effect a more protective set of standards based on local conditions to enhance protection of public health and the environment. States through their own sewage sludge standards can ( and almost all do) have additional and/ or more stringent sewage sludge standards that recognize local site specific conditions.

EPA Log # 29: Henry J. Staudinger Comment G. EPA's Regulatory Activities Strategy is Not Adequate. NRC Recommends national standard criteria, the development of regulatory criteria for biosolids in a timely fashion and the identification of additional regulatory mechanisms to better protect public health and the environment, development of a quantitative microbial risk assessment to establish regulatory criteria for pathogens, studies to determine if Part 503 achieves its intended effect and the elimination of exemptions for nutrient management site restrictions.

EPA objects to national standard criteria on the basis of its unsupported assertion that Part 503' s numerical criteria for pollutants in biosolids together with operational standards for pathogen and vector attraction reduction are appropriate to protect public health when complied with. It also cites the difficulties in applying national standard criteria to local pollution sensitive circumstances cited by NRC. USEPA, 2003d 105 Instead of rejecting a national criterion because of local pollution sensitive circumstances, EPA should recognize the need to develop national standards, to be supplemented to reflect local conditions. Although EPA says that it plans to evaluate such practices to determine if additional requirement are warranted, based on past experience there is little expectation that EPA will do so.

EPA's refusal to address local pollution sensitive conditions in the past as well as its failure to admit that it has long been aware of the need to modify the regulations in to bring those situations within the parameters of the risk assessment it relies on, provide little comfort that EPA will implement this part of its strategy.

There must be a clear regulatory directive that local public health and environmental issues be addressed before biosolids can be land applied. To this end, input from localities regarding local pollution sensitive conditions is essential.

Response Please see the EPA response to Comment Log No. 8 of this section of this document.

EPA Log # 49: The Resource Institute for Low Entropy Systems Comment Congress should amend the Clean Water Act to eliminate language about the " beneficial use" of sewage sludge. There is no beneficial use for this toxic waste product. Research and action should be focused on how to produce less of it and how to safely dispose of it so that it causes no public health or environmental harm.

Response EPA disagrees with this comment. As long as land application projects comply with Part 503 and complimentary State Standards, EPA believes that land application is an appropriate choice for the management of sewage sludge. Sewage sludge when applied under these conditions is considered a beneficial practice since the sewage sludge acts as a crop nutrient source and as a soil amendment.

EPA Log # 36: Lynton S. Land Comment EPA has established a list of toxic chemicals as part of the Toxic Release Inventory. Irrespective of the rate at which that list is updated, the number of chemicals of environmental concern almost certainly grows larger each year and the amounts released to POTWs increase most years. It is certain that the numbers reported annually in the TRI are low, not only because new chemicals are generated each year making the list continually out of date, but because there are many loopholes in the reporting process, leniency in who must report, and opportunities for failing to comply with applicable laws because of lack of rigorous oversight. What matters is not what substances are released to POTWs, but what substances are released into contact with the public.

In the case of soluble substances, EPA relies on dilution to reduce the concentration of the toxic substances to a low enough level that it is impossible to " prove" that the public is being harmed. USEPA, 2003d 106 EPA's philosophy is based on economics, where human heath issues are balanced against the purported economic needs of industry.

In the case of insoluble substances, I can find no evidence that EPA seriously considers the concentration of the toxic substances released to the environment in the effluent from POTWs, namely in the sludge. This is despite a 1979 study ( EPA 4401 79  300 " Fate of Priority Pollutants in Publicly Owned Treatment Works: Pilot Study") that clearly demonstrated that some toxic substances are concentrated in the sludge, and some POTWs are worse than others. Attached is correspondence with Mr. Hanlon in this regard. It is obvious from his reply that EPA has no intention of trying to identify those POTWs that are the worst offenders, and has no mechanism to routinely determine the concentration of toxic substances in sludge.

EPA is responsible for protecting the environment. Once a substance is declared toxic, it is EPA's responsibility to determine the extent to which the substance is released to the environment in the air, water or sludge. Once the release rate is known, then and only then can decisions be made ( not necessarily by EPA) as to whether the current practice is " safe," or whether remedial action is necessary. Obviously the best practice, which has been reasonably successful in the case of heavy metals in sludge, is to turn off the tap. EPA's current policy serves the interest of those who release the toxic chemicals into public facilities, not the interest of the public who are then in a position to be affected by the chemicals.

I therefore formally request that EPA address the role of sewage sludge in releasing toxic chemicals ( as defined by EPA) to the environment. At an absolute minimum EPA should tabulate the kinds and amounts of substances on the TRT list received by each POTW that receives toxic chemicals. EPA should further require that all sewage sludge destined for land application, from POTWs that receive toxic influent, be analyzed for all substances the POTW receives. The results should all be readily available to all potential recipients of the sludge and routinely provided to the state agencies responsible for land application practices. The public deserves to know which POTWs receive toxic substances in their influent stream, the amounts of the substances involved, and the concentration of the substances in the sludge.

Response EPA has developed the Part 503 Standards based on two National Sewage Sludge surveys designed to identify relevant pollutants in the Nation's sewage sludge. EPA will be designing and executing a third pollutant analytical survey starting in FY 2005. EPA believes that the information produced in these three surveys is the appropriate information to base Part 503 rulemaking on. See the comments and responses on the survey at the beginning of this document.

EPA Log # 40: Thomas F. Albert Comment Comment # 35: On page 17391 EPA devotes a few paragraphs as to how EPA plans to address NRC regulatory recommendations. This section, like most others in the EPA comments, is disappointing. EPA states " Part 503 is designed to protect public health through compliance not onlywith numerical criteria for pollutants found in biosolids, but also with operational standards for pathogen and vector attraction reduction." Why doesn't EPA admit USEPA, 2003d 107 here that, if the Part 503 is working so well why is the NRC report 345 pages in length and contain 57 recommendations? Obviously there is much need for improvement, why doesn't EPA admit it? EPA, in the " Standardized Management Practices" section, states " These operational standards are performance based, based on operational goals for specified reduction, to enable elimination of pathogens   " This is MISLEADING since most sludge is no better than Class B and Class B is not known to have all of its pathogens eliminated. In the same section EPA notes, " EPA believes that such means are appropriate for achieving environmental performance while encouraging efficient, cost effective, and innovative systems and approaches." If these methods are so good; 1) why does the NRC report contain so many findings and recommendations regarding the need to determine whether or not the chemical and pathogen standards are protective, and 2) why do so many thousands of people living near sludge fields complain about odor, illness, water contamination, etc.? In the same section ( Standardized Management Practices) EPA says " States and local jurisdictions will have better knowledge of local conditions, and are in a better position to establish additional management practices to augment the protectiveness of the part 503 Standards." This is SELF SERVING AND MISLEADING. EPA is trying to excuse its way out of making better regulations. EPA also knows full well that controlling sludge at the local level is not very successful as local jurisdictions usually have little or no authority to regulate such material. EPA also notes regarding pollutants ( presumably just chemicals) in sludge that " the Part 503 Standards consist of numerical limits with adequate margins of safety to protect public health and the environment." If this is true, why does the NRC report as its first overarching recommendation include the wording "( 1) new risk assessments should be conducted to update the scientific basis of the chemical limits" '( page 4 of NRC report)? If the chemical standards are so protective, why does the NRC report ( page 12) present a chemical standards Finding as " The committee found the technical basis of the 1993 chemical standards for biosolids to be outdated"?

Comment # 36: In the very brief " Studies" section ( 10 lines) of the discussion as to how EPA plans to address NRC regulatory recommendations ( page 17391) EPA notes a proposed study regarding Class B sludge. EPA states that it " is planning to evaluate certain Class 5 disinfection processes including the natural attenuation of pathogens that occurs while the sludge is on or in the soil for the site restriction periods stated in current regulations." This is one of the very few mentions of Class B sludge in the EPA comments. In view of the tremendous number of complaints generated regarding Class B sludge, it is good to see that EPA is actually going to do a study. It is interesting to note that in mentioning this study, EPA does not use " delay words" such as possibly or preliminary, or consider or may.

Response Please see the Summary Response to this section of this document.

EPA Log # 25: Northumberland Association for Progressive Stewardship ( NAPS) Sewage Sludge Study Group Comment G. Regulatory Activities Lines 1040 1068. The State of Virginia is awaiting changes in federal regulations in order to update its ordinances and regulations, as provided for in recently passed state law. It appears that EPA, in this section, is planning to avoid the establishment of national standard treatment design USEPA, 2003d 108 criteria. Leaving this important element to the discretion of the states will not, in our judgment, resolve the issue. This is especially true in Virginia, where we import many tons of sludge from out of state, yet have no quality control over sludge being sent across our border and land applied. We do not know, for example, the concentration of any of the toxic chemicals in EPA's Toxic Release Inventory in sewage sludge imported in our state, nor the concentrations of these chemicals released to specific POTWs that supply the sludge.

Lines 1043 1059. As for regulations from other nations, we are of the opinion that they definitely should be reviewed by EPA, as we are told that they are ahead of this Country in this field of expertise and regulation and may be very useful. In Europe, for example, contrary to the " honey buckets" I experienced in Germany during the early sixties, aggressive action is being taken in several countries in the interest of public health, by banning land application. ( See http:// www. members. aol. com/ wwanglia/ framesf. htm on NATS website www. LouounNATS. org.

Response Please see the Summary Response to this section and response to EPA log # 8 of the document that refers to local conditions. As stated in the proposed action plan in the April 9, 2003 Federal Register Notice, EPA believes that " National Design Criteria" are not the most effective method for environmental and public health protection. Please refer to this April 9, 2003 for a detailed discussion on EPA's position on this issue. EPA as stated in the April 9, 2003 Notice is aware of other countries sewage sludge standards. For the reasons outlined in the April 9, 2003 Notice, EPA believes that the Part 503 Standards are as equally protective of public health and the environment and are based on conservative risk assessment and technology concepts. Other country's standards are based on other philosophies ( such as the so called " Precautionary Principle") that do not reflect Clean Water Act mandates.

Environmental Groups EPA Log # 43: Natural Resources Defense Council ( NRDC)

Comment EPA'S PROPOSED DECISION NOT TO REGULATE ADDITIONAL TOXIC POLLUTANTS EPA is required to review the part 503 sewage sludge regulations at least every two years for the purpose of identifying additional toxic pollutants and promulgating regulations for such pollutants. According to EPA's preliminary review of existing sewage sludge regulations, " EPA has not identified any additional toxic pollutants that warrant regulation in sewage sludge." Instead, EPA plans to " conduct a screening analysis of those chemicals for which adequate data and analytical methods are available and for which there is evidence that they may occur in sewage sludge. "

NRDC calls on EPA to regulate additional toxic pollutants. In particular, NRDC urges EPA to sample sewage sludge for toxic pollutants and to regulate all of those that are found to be present in sewage sludge in concentrations which may adversely affect public health or the environment. According to the attached comment by Dr. David 0. Carpenter, " at the very least all persistent and highly toxic substances should be regulated." Furthermore, the criteria upon which EPA has based USEPA, 2003d 109 its preliminary review is " no longer valid" according to the attached comment by Dr. Peter L. deFur. Dr. deFur recommends that EPA consider regulation of a number of classes of pesticides, metals, organic compounds, pharmaceuticals, and industrial compounds. Based on these attached comments and the literature they reference, NRDC urges EPA to reconsider its preliminary review of the sewage sludge regulations and to move forward regulation for all those additional toxic pollutants in sewage sludge that may be present in sewage sludge in concentrations which may adversely affect public health or the environment.

EPA does not commit to implement any of these recommendations. It does indicate that it plans to make a determination in the next year whether to re regulate molybdenum and whether to ban sale of non EQ sludge, but it does not actually commit to setting any new standards, to improving any management practices, to setting any new national treatment design criteria, or changing any other aspect of current sludge regulation or practice. Indeed, under the heading " Planned Regulatory Activities," EPA's Response identifies only " Studies " that it plans to pursue.

Response Today's Federal Register Notice announces the results of the screening analysis performed under Section 405( d)( 2)( C) of the Clean Water Act. Thus, EPA has fulfilled its statutory mandate.

Comments of Dr. David O. Carpenter The current EPA regulations of biosolids ( sewage sludge) f ail to protect the public health, and are much less stringent than comparable regulations in other developed countries. The EPA has no regulation of chromium or of any organic pollutant, including persistent and highly toxic substances such as dioxins/ furans, PCBs, pesticides and other persistent organics. Furthermore, there is no regulation of any contaminant that is present in less than 5% of the biosolids analyzed in the National Sewage Sludge Survey, which means that a local industry that produces a toxic substance riot commonly found in biosolids may contaminate locally produced biosolids with impunity. At the very least all persistent and highly toxic substances should be regulated. The practice of exempting from regulation all substances that are not present in at least 5% of biosolids should be abandoned in favor of standards more protective of the public health.

Do EPA's regulations adequately protect public health from contaminants in biosolids? Biosolids contain a number of toxic and substances potentially dangerous to human health. These include metals, organic pollutants, pharmaceuticals, and microbial and parasitic organisms. The present paper will not further consider pharmaceutical, microbial or parasitic contamination, although these are obviously of importance.

There are a number of considerations when attempting to determine to what degree the chemical contaminants constitute a danger to human health. These include concentration, persistence, likelihood of human contact by ingestion, inhalation or dermal absorption and degree of toxicity. While recycling of the nutrients and organic matter contained in biosolids is an excellent strategy in theory, the benefits of such re use must be balanced by concern that the practice of recycling may harm the health of people, wildlife and the ecosystem because of the fact that many toxic substances are concentrated in the sludge. Moreover, application of biosolids to some sites may USEPA, 2003d 110 pose significantly greater danger of human exposure, either directly or indirectly through animal or food contamination which is then consumed by people, whereas application to other sites may pose significantly less danger of human exposure. Current regulations do not distinguish residential lawn or garden application from application to corn or soy bean fields or pastures.

Of the various considerations listed above, persistence of the contaminant is an important factor. Metals, being natural elements, are never going to go away, and therefore it is appropriate that application of metals to topsoil of any type be regulated carefully. Our knowledge of the long term dangers of metals is best typified by the legacy of lead paint and leaded gasoline, which have contaminated soils around the outsides of old houses painted with leaded white paint as well as the soils around major highways and streets that carried traffic burning leaded gasoline for many years ( Mielke, 1999). It must be expected that this contamination will continue to pose a health hazard for the foreseeable future. The toxicity of other metals is also well documented ( Lawrence and McCabe, 1995; Carpenter, 2001), and as for lead the health hazards include both cancer and non cancer effects ( Ostrowski et al., 1999). Thus, it is appropriate for EPA to establish limits on levels of metals in biosolids. While there may be some debate as to the specific levels established for the nine metals currently regulated ( McBride, 1998), this issue is beyond the scope of this report.

Of those substances not currently regulated by 40 CFR Part 503, the greatest concern, in the judgment of the author, is for those organic substances that persist in the environment and in the bodies of animals and humans. This includes particularly dioxins/ furans, PCBs and chlorinated pesticides, and newly recognized substances such as polybrominated diphenyl ethers and perfluorooctyl sulfonates. These substances are known carcinogens, immune system suppressors, endocrine disruptors and neurobehavioral toxicants. The fact that they persist in the environment makes them particularly dangerous.

While a number of other organic substances have significant toxicity ( polyaromatic hydrocarbons, phthalates, pesticides other than organochlorines, detergents and other volatile organics and solvents), most of these substances are somewhat less persistent. However, all have significant toxicity. For example, polyaromatic hydrocarbons are known carcinogens ( Mastrangelo et al., 1996). Gray et al. ( 1999) have demonstrated that antiaindrogenic pesticides and phthalates alter male rat reproductive function, while Colon et d.( 2000) have reported that phthalate esters in the serum of young girls is associated with premature breast development. Christiansen el: al.( 1998) have found nonylphenol to be estrogenic in male fish, altering testicular function. Thus, even though these compounds are less persistent, they are toxic to humans.

In at least two regards, the EPA decisions on how to regulate contaminants in biosolids do not protect the health of the public. There are a multitude of other industrial products which will be present in biosolids resulting from local industry. Some of these may be persistent, highly toxic and at high concentrations in locally produced biosolids. If, however, these particular contaminants were not found to be present in 10% of all biosolids sampled, they were declared exempt from regulation. This is not justifiable. Since the identify of releases from various industries is pretty well known on the basis of approvals granted through the Toxic Release USEPA, 2003d 111 Inventory or waste water discharge permits, there should be no great difficulty in identifying substances that should be biosolids collected from the vicinity of such industries. NAS ( 2002) clearly states that the EPA's decision not to regulate any chemical that was detected in less than 5% of samples in the Nation Sewage Sludge Survey is not justified, and I strongly concur with this conclusion.

The second decision which fails to protect the human health of the public is the exclusion from regulation of all substances no longer manufactured in the United States. This results in exemption of PCBs and chlorinated pesticides, substances known to be present in some biosolids at high concentrations and substances with well documented human toxicity. The NAS ( 2002) states the EPA should not exclude chemicals from regulatory consideration based solely on whether or not those chemicals have been banned from manufacture in the United States ( e. g., PCBs) since they are still found in sewage sludge from many wastewater treatment plants, and I completely agree with this conclusion.

Regulations for Contaminants in Biosolids in Europe: While the regulations for contaminants in biosolids varies among the various countries in Europe, in general the concentration limits are much lower than in the US, and more substances are regulated ( NAS, 2002). Chromium is regulated in most European countries. Dioxins/ furans, PCBs, the sum of organohalogenated compounds, nonylphenyls, di( 2 ethylhexyl) phthalate, linear alkyl benzene sulfonates, and polyaromatic hydrocarbons are all regulated in at least some European countries.

Substances Which Should Be Regulated under Part 503: Chromium: While EPA originally included chromium in the list of regulated metals, this was dropped at a later date. Chromium, especially in the hexavalent form, is a known human carcinogen, causes liver and kidney damage and gastrointestinal irritation, and even the less toxic Cr( lll) is a mutagen ( Pellerin and Booker, 2000). As indicated above chromium in biosolids is regulated in almost every European country. While chromium may not be present in most biosolids, it is known to be at high levels in the vicinities of certain industries. Because it is a very dangerous metal there is no question that it should be regulated in biosolids.

Dioxins/ furans and coplanar PCBs: Dioxins are classified as known human carcinogens. Dioxins and furans are a mixture of 75 individual congeners, depending upon the number and positions of chlorines around the rings. Those which certain position, especially in the 2,3,7,8 positions, are potent in binding to the aryl hydrocarbon ( Ah) receptor. The Ah receptor, for which the endogenous ligand is not known, is one of the classes of cytosolic receptors which when activated triggers gene induction and alterations in protein synthesis ( Okey et al., 1994). Certain of the 209 PCB congeners, those that assume a coplanar position on the basis of not having chlorines in the ortho position, also activate the Ah receptor, albeit not with as high an affinity as the most toxic dioxin congener. However, because the concentrations of PCBs in the environment are usually much higher than those of dioxin, the coplanar PCBs may dominate , in induction of dioxin like responses. Because of the variety of substances and congeners of USEPA, 2003d 112 substances that activate the Ah receptor, activities of mixtures are usually expressed as toxic equivalents ( TEQs) ( Safe, 1990).

Dioxin like compounds cause a large variety of human diseases in addition to cancer, such as heart disease, hypertension and diabetes ( Pesatori et al., 1998; Vena et al., 1998). Dioxins are immunosuppressive agents, and endocrine disruptors of both thyroid and sex steroid function ( Birnbaum, 1995; NAS 2003). Risk for some of these diseases appears to be elevated at concentrations in humans that are not much greater than ambient background in the population, which is evidence that it is extremely important to reduce human exposure ( NAS 2003).

At present, sewage sludge that is land applied is the second greatest contributor to release of dioxin and dioxin like compounds to the environment in the United States ( Dwain Winter, USEPA, presentation to the NAS Committee on Dioxin and Dioxin like Compounds in the Food Supply: Strategies to Decrease Exposure, 2 April 2002). With the major reduction in releases of dioxin from incineration, thanks to the Clean Air Act, only backyard burn barrels release a greater amount of dioxin like compounds, as indicated by g TEQdfwho98/ year. This report indicates that total dioxin TEQ sources were 1,106g, and that sewage sludge contributed 76.6 g or 6.9% of the total dioxins. In addition sewage sludge incineration contributes14.8 g TEQdfwho98/ year to the air, which is 1.3% of total emissions. There are multiple sources of dioxin like compounds that get into biosolids, ranging from industrial discharges to waste water from washing machines and even showers, reflecting dioxins in clothing ( Horstmann and McLachlan, 1995). Application of biosolids to agricultural fields has been demonstrated to cause accumulation of dioxin like compounds in both soils and in the milk from cows grazing on the fields ( McLachlan et al., 1994). In a later study McLachlan et al.( 1996) found that dioxins and furans persisted in soils, such that over 50% of the dioxins and furans applied to) a field as sewage sludge in 1972 were still present in 1990.

Because of the significant toxicity to humans of dioxin like compounds, and the fact that land application of sewage sludge is the second largest source of environmental contamination with dioxins, it is of urgent importance that it be regulated.

PCBs: Unlike dioxins and furans, which are primarily products of combustion, PCBs were manufactured from the late 1920s until the mid 1970s, and had a variety of valuable uses as hydraulic fluids, in transformers, paints, floor and ceiling tiles and many other uses. Their manufacture and use was banned in 1977 because of evidence that they were persistent in the environment, wildlife and humans. There are 209 PCB congeners, depending upon the number and position of chlorines around the biphenyl ring.

While the coplanar PCBs are dioxin like, and are activators of the Ah receptor, most of the 209 PCB congeners do not significantly bind to the Ah receptor. Yet these non  dioxin like PCBs have significant toxic actions mediated via different mechanisms. As with lead, PCBs cause decrements in IQ and neurobehavioral changes, such as shortened attention span and reduced ability to deal with frustration. Non dioxin PCBs also cause thyroid and sex steroid endocrine disruption, cancer and immune system suppression by different mechanisms than those of the USEPA, 2003d 113 coplanar congeners ( Carpenter, 1998). ATSDR reports that the average serum PCB levels in persons without unusual sources of exposure are 0.9 1.5 ppb. As mentioned above the studies of Schell et al. ( 2002) document physiological effects of concentrations of PCBs in this range. As with dioxin like substances, this fact makes it extremely important that exposure to PCBs be reduced. While manufacture of PCBs in the United States and most other countries ceased in the mid 1970s, these are very persistent compounds both in the environment and in the human body. While levels in the population are declining slowly over time, our understanding of how toxic these substances are has been increasing, such that in many regards they are more clearly a public health hazard today than was realized 30 years ago. Any increment of exposure should be avoided.

There is one prior study that demonstrates elevated PCB exposure in biosolid users. Baker et 231.( 1980) reported that after application of biosolids to domestic gardens, serum PCB levels were positively associated with garden care and negatively associated with wearing gloves while gardening.

It is likely that the primary exposure pathway of dioxins and PCBs to humans from surface application of biosolids is the adherence of the biosolids to forage or pasture crops which are then eaten by animals used for human consumption ( Chaney et al., 1996; NRS 2003). However, another important pathway is unintentional direct ingestion of contaminated biosolids by children ( Stanek and Calabrese, 1995).

In the National Sewage Sludge Survey, EPA ( 1995) reports no detectable levels of PCB congeners 1016, 1221, 1232 or 1242 were found in any of the 198 tested samples. The remaining congeners  PCB 1248, 1254, and 12610  were found to be above the minimum detectible level in about 10 percent of the biosolids samples. This statement reflects an inexcusable ignorance of what PCBs are. The numbers listed are not congeners, but Aroclor mixtures, each of which contains many different PCB congeners. In addition Aroclor analysis is inaccurate and usually has a very poor detection level. Since the different PCB congeners cause very different health outcomes, it is totally inappropriate for the risk assessment to be based only on Aroclor patterns.

Other halogenated compounds: Pesticides, and particularly chlorinated pesticides, are also contaminants of concern. Like dioxins and PCBs, these substances are persistent and lipophilic. The organochlorine pesticides have not been manufactured in recent years, but they are still found in significant concentrations in many media, including sewage sludge. Most of pesticides manufactured today in the US are not as persistent, but like the organochlorine pesticides exposure elevates risk for immune suppression, birth defects, cancer, reproductive abnormalities and other diseases ( Dich et al., 1997; Sharp et al., 1986). In addition considerable attention is now being given to polybrominated diphenyl ethers, used as flame retardards, as these compounds are structurally similar to PCBs and have similar toxicities. They are persistent, lipophilic and they bioaccumulate. The European practice of setting limits on biosolid concentrations of all halogenated compounds is a good way in which to prevent exposure to a variety of persistent compounds of varying degree of toxicity, and is recommended for use by EPA. USEPA, 2003d 114 Other organic substances: Several European countries have established standards for other specific organics contaminants. The most stringent standards are in Denmark. Denmark has a standard of 50 mg/ kg dry weight for di( 2 ethylhexyl) phthalate. Phthalates are plasticizers and are known endocrine disruptors. They currently have a standard of 10 mg/ kg dry weight for nonylphenol and nonylphenolethoxylates, another class of endocrine disruptors used as surfactants. Austria, Denmark, France and Sweden regulate polyaromatic hydrocarbons ( PAHs) as a general class, or in some cases regulate specific PAHs such as fluoranathene, benzo( b) fluoranthene and benzo( a) pyrene. It is particularly interesting that France specifically regulates PAHs only when applied directly to pasture land.

While these are certainly toxic substances with human health effects ( especially endocrine disruption, and in the case of PAHs, cancer), in the author's opinion biosolids constitute such a minor portion of exposure that regulation in this medium, while desirable, is much less of a priority than for the substances listed above. It has been reported, for example, that the major route of exposure of humans to PAHs is through the diet, and that cereals and vegetables, rather than meats, are the major source. The transport to the cereals and grains is primarily via air ( Phillips, 1999). This indicates that contaminated biosolids pose a likely route of exposure, but one that is much less than that from other combustion sources. These compounds have moderate persistence, but are not nearly as persistent as metals or chlorinated compounds. Importance of use of the precautionary principle: The precautionary principle is very applicable to the question of what contaminants should be regulated in biosolids. If a substance is toxic, persistent and bioaccumulates, and if there is a possibility that it will get into humans either via the food chain or particularly into children who have direct contact with it, steps should be taken to prevent this exposure from occurring.

There are several important actions that can be taken to reduce human exposure to contaminants in biosolids. The most obvious is regulations to prevent surface soil application of any biosolid that contains excessive amounts of persistent and toxic substances. Those substances that are not persistent are of concern as well, but the duration of time over which human contact should be limited is much less when the toxic substances degrade into non toxic compounds relatively rapidly in the environment. In the author's judgment, this consideration requires additional regulation of chromium and the general category of persistent organic pollutants ( POPS) as defined by the Stockholm treaty. The exemption of substances no longer manufactured in the US should be eliminated, since these compounds, especially the persistent chlorinated compounds, remain a major public health hazard.

There should also be regulation as to the use of land on which biosolids are placed. One major concern is biosolid application to land used either for pasture or growth of forage food for livestock that will be consumed by humans. Contaminates from the biosolids pill deposit on leaves of plants, and if these are consumed by animals the contaminants will be passed into the human food chain. Grazing livestock also ingest significant amounts of soils. Application on to fields on which corn or soy beans are grown poses much less danger of accumulation, since the grains are enclosed in a covering that is removed at harvest. USEPA, 2003d 115 The use of biosolids on lawns and gardens should be immediately stopped. These are the sites where exposure to children is not only possible, but indeed likely. It is amazing to the author that the 1995 EPA Guide to the Biosolids Risk Assessments for the EPA Part 503 Rule shows photos of lawns before and after application of biosolids, basically recommending such use. It is true that biosolids contain nutrients for lawns and gardens, but there are many other sources of these nutrients that avoid any possibility of exposure of children, household pets and even the adults to contaminants. Use on lawns and gardens will also result in immediate exposure to substances that may not be as persistent but still are toxic. Therefore, application of biosolids onto lawns and gardens is unwise even in the absence of the more persistent contaminants.

It is certainly true that the alternatives to land application of biosolids are not without potential hazards as well. EPA's data shows dioxin production from biosolid incineration. Landfills have the potential to leach and allow contaminates to migrate. There is certainly benefit in recycling organic materials that provide nutrients to plants. However, priority must be to protect human health.

Summary and Conclusions: There are a number of serious deficiencies in the current EPA regulations regarding biosolids application and their whole risk assessment process. These are:

1. Current regulations for nine metals are less stringent than those in other developed countries and do not adequately protect public health.

2. The current regulation which accepts substances no longer manufactured in the US from regulation should be eliminated. No regulation is currently in place for several persistent toxic chemicals, including chromium, dioxins/ furans, PCBs and other halogenated persistent pollutants. These are compounds of great toxicity and are present in biosolids, with consequent threats to human health. Such regulation should be implemented.

3. The rule that only those contaminates present in greater than 5 or 10% of biosolids should be considered for regulation is not protective of human health, and should be changed to allow for regulation of persistent and toxic substances that may be present in biosolids on a very local level because of a particular industry.

4. Restrictions should be placed on lands on which biosolid application is appropriate. EPA should cease to allow and even to support application of biosolids of any form onto lawns and gardens and onto farm lands used for pasture and/ or forage crop production for animals used for human food.

5. The use of reference doses and the assumption of there being a threshold for non  cancer outcomes is not justified and results in and underestimation of the importance of various non cancer endpoints especially neurobehavioral and endocirine disruption effects. In the author's estimation the risk assessment process would be more protective of human health using USEPA, 2003d 116 something comparable to cancer slope factors and assuming no threshold for perturbation of physiologic function.

Response With respect to sewage sludge standards of other countries, please see the EPA response to Comment Log No. 25 in this section. The issue of dioxin and dioxin like compounds in sewage sludge has been addressed by EPA's recent decision that numerical standards for these compounds in land applied sewage sludge are not warranted ( Federal Register Notice dated October 24, 2003). All other portions of these comments are addressed by referring to the Summary Response of this section and by the previous EPA responses in the Survey, Exposure, and Risk Assessment sections of this document. Note: Chromium was originally regulated as part of the Round One Standards when they were published in 1993. Based on a judicial challenge in 1994 in which the Plaintiffs successfully argued that chromium posed an insignificant risk to public health from its presence in land applied sewage sludge, all chromium numerical standards were deleted from the Part 503 Standards for land applied sewage sludge.

With respect to the use of sewage sludge on lawns or home gardens, EPA is considering amending the Part 503 Standards in the future to require that sewage sludge used in this manner be in conformance to the pollutant concentration standards ( Table 3 of Subpart B of the Part 503 Standards). This amendment, when enacted, will require sewage sludge used on lawns and home gardens to be of the highest quality under the Part 503 Standards. In the mean time, the current numerical standards that are in place for such sewage sludge used in this manner are judged to be protective of human health.

Comments of Dr. Peter L. deFur The 503 rule sets numerical regulatory standards for only 10 of more than 200 chemicals, not considering the remaining chemicals due to low detection frequency, low concentration in the sludge, or insufficient data on toxicity or fate and transfer in the environment ( according to the 503 rule). These criteria are no longer valid, as concluded by NRC ( 2002) and literature publications. Furthermore, the original 1989 survey is no longer sufficiently current to use as a basis for this important regulation. Finally, the risk assessment procedures used in 1989 are no longer up to date. The rule needs to protect fetuses from multiple chemical exposures that are present during development and then in childhood from other sources. The evaluation of chemicals should be based on the combined exposure to the full range of chemicals and pathogens in sewage sludge.

Response Please see the response to David Carpenter in this set of comments. Also, please see the EPA response to Comment Log No. 36 in this section.

Municipal Wastewater Treatment Plants EPA Log # 14: Metro Wastewater Reclamation District Comment The Metro District agrees with EPA's approach for addressing regulatory activities issues raised by the NRC report. Specifically, the District agrees with EPA that revised standards USEPA, 2003d 117 for molybdenum should be considered; however, any proposed standards should be based upon the most up to date scientific information and a newly conducted risk assessment.

EPA should assess whether or not it is necessary to restrict the sale or distribution of Class A biosolids in amounts less than one metric ton unless the biosolids meet the exceptional quality criteria. If distribution of Class A biosolids that do not meet the exceptional quality requirements in amounts less than one metric ton is not a common practice, promulgation of new requirements to address this limited practice may not be needed.

The Metro District agrees with EPA's assessment of the need to address the NRC report's recommendations related to " Standard Management Practices." Biosolids production and land application operations vary significantly around the country. The District believes that attempting to codify practices beyond those already set forth in 40 CFR Part 503 is not only unnecessary but also unwise. The variety of options that would have to be included in a revised regulation would be so numerous it would be nearly impossible for the average biosolids producer or land application manager to identify which practices to utilize. Enforcement also would be virtually unworkable. Allowable biosolids production methods and land application practices should be approved based on sound science and land management principles that have been proven over time.

Response Please see the Summary Response to this section of this document. Also please see the EPA response to Comment Log Nos. 43 ( David Carpenter) and 25.

EPA Log # 19: Metropolitan Water Reclamation District of Greater Chicago Comment On page 17390 in Section VIII. G. l., the notice cites an NRC recommendation for the " elimination of exemptions for nutrient management and site restrictions for land applied EQ biosolids." This recommendation was not addressed by EPA in their response on page 17391. If the nutrient management exemption is eliminated for EQ biosolids, it can have an impact on our biosolids management program and perhaps the biosolids management programs of other POTWs. Currently under Part 503, the Metropolitan Water Reclamation District of Greater Chicago ( Chicago) is exempt from applying EQ biosolids to land at N based agronomic rates. This enables Chicago to apply biosolids at reclamation rates at the Fulton County, Illinois site and at soil conditioning rates in the Controlled Solids Distribution Program. These practices comply with the Part 503 regulations and are also permitted by the Illinois Environmental Protection Agency ( IEPA). This practice has been explained to EPA Region V in every annual biosolids report since the first report in February 1994. This explanation is found in Appendix I  Biosolids Management Programs of the Metropolitan Water Reclamation District of Greater Chicago Under 40 CFR Part 503 ( January 28,1994 letter to Michael J. Mikulka of USEPA Region V).

Technically, if this exemption is eliminated, Chicago would need to obtain case by case approval for greater than agronomic loading rates from the permitting authority, which is currently EPA Region V, since the IEPA has not been delegated for Part 503 authority. Elimination of this exemption may not be difficult for our Fulton County program because it has biosolids USEPA, 2003d 118 continuously applied in agricultural utilization and it is a managed site. However, for the Controlled Solids Distribution Program, we may be faced with obtaining site specific loading rates from EPA Region V for each project site, which would slow our response time to customer requests for biosolids utilization in the metropolitan area on numerous sites. It is likely that EPA Region V does not have the resources to be responsive to such a demand.

Response Please see the Summary Response to this section of this document.

Unknown EPA Log # 34: Anonymous Comment Alternative to be considered Two changes to the existing program that would begin a process to improve the science and public perception would include : 1) A pre application permitting program on a site specific basis. 2) A volume based fee remittance program that would provide the funding to be used to offset the permitting program and to be designated toward research and analytical methods development.

The concept of obtaining a permit prior to performing an activity is a standard practice for the EPA. In fact the two other sewage sludge management methods ( incineration and land filling) both require permits prior to the construction. Land application is an activity which involves environmental risk. The public deserves be aware of the activity PRIOR to the activity taking place. Public comment should be allowed on a case by case basis. Public review and comment in the present situation is not possible or limited at best. The elements of a permitting program would include : 1) An application submission from the source of the sewage sludge. 2) Federal or State program review and a preliminary determination ( or rejection of the application if it is incomplete). 3) Draft permit terms and conditions, and a definite term to the duration of the land application activity. 4) The public notice of the availability of the preliminary determination, and the draft terms and conditions. 5) An opportunity to submit comments to the permit authorities. 6) State or Federal review to the of the comments, and the requirement of a public hearing if significant issues are identified during the public comment period. 7) Addressing of the public comments and the final decision of the permissibility of proposed application. 8) Issuing a final permit with terms and conditions. 9) Federal or State conducted inspections. 10) Prompt review and enforcement of any inspection violations or public complaints.

The permit application would include: 1) A detailed description of the properties that will or may receive the land application of sewage sludge. 2) The source and volume of the sewage sludge to be applied. 3) The concentrations of toxic pollutants, and pathogens known to be present in the sewage sludge. 4) Proposed and maximum Agronomic application rate. 5) Temporary storage sites during floods, frozen soil, snow covered soil conditions or other events that prevent the immediate application of the sewage sludge. 6) Management methods proposed to prevent public access restriction requirements required for class B application of material. 7) Other information necessary to demonstrate to the public that the project will not endanger the public or environment. USEPA, 2003d 119 Response Please see the Summary Response in this section of this document and the EPA response to Comment Log Nos. 8 and 25 with respect to the issue of consideration of local sitespecific conditions in the design of protective standards and National Design Standards, respectively. For EPA's position and responses to Part 503 Program implementation vis a vis permit issuance, oversite, compliance and enforcement, please refer to today's Federal Register Notice that addresses this issue in Section VII B, project No. 1. and the EPA responses in the section on Biosolids Management in this document.

Land Application Company EPA Log # 26: Synagro Technologies, Inc.

Comment The NAS/ NRC report recommended that EPA revise its regulatory approach by considering biosolids protocols used by other nations, adoption of national standard treatment design criteria, refinement of stabilization controls using metabolic techniques, develop molybdenum standards, develop a QMRA and further regulate Class A biosolids. EPA has responded to each of these recommendations in a positive fashion.

° Current regulatory framework is effective to protect human health and the environment. No need for major changes.

° Any regulatory changes should be based either on known technologies or results of a risk assessment.

° All regulatory changes should go through appropriate rulemaking procedures.

Response EPA generally agrees with these comments. In response to the first bullet above, see the Summary Response to this section of this document.

Association EPA Log # 30: Tri TAC Comment Regulatory Activities Tri TAC agrees with EPA's approach for addressing the regulatory issues raised by the NRC Report. Specifically, Tri TAC agrees with EPA that revised standards for molybdenum should be considered. However, any proposed standards should be based on the most up to date scientific information and a newly conducted risk assessment.

Tri TAC understands that the NRC is recommending that all biosolids products sold or given away in bags or other containers should be exceptional quality ( EQ). Tri TAC also understands that by eliminating the non EQ Table 4 alternative, EPA would essentially be prohibiting selling or giving away biosolids products in bags or other containers weighing less than one metric ton unless those products met the EQ standard. Before making any final regulatory decision, Tri TAC USEPA, 2003d 120 encourages EPA to confirm whether there are any biosolids products being sold that conform to the Table 4 alternative and to document their justification for removing the alternative.

Tri TAC agrees with EPA that states have a better understanding of local conditions and, therefore, are in the best position to establish additional management practices to enhance the protectiveness of the Part 503 standards as needed.

Tri TAC endorses the NRC Report's recommendation to study the correlation between pathogen destruction and indicator organism levels in biosolids from various treatment processes, such as anaerobic and aerobic digestion, and lime stabilization. Studies of this type will provide data that will either substantiate the protective nature of the Class A and Class B pathogen destruction criteria, or show there is a need to revise them.

Response EPA generally agrees with these comments. See EPA's response to Comment Log No. 8 in this section of this document. EPA refers the reader to EPA's response to David Carpenter with respect to the molybdenum issue ( Comment Log No. 43 in this section).

EPA Log # 27: California Farm Bureau Federation Comment The relevant focus for protecting persons from health risks associated with the use of biosolids must be the rural communities and environment where the biosolids are applied, not the urban " public at large," which generates but largely does not land apply biosolids.

The USEPA's Part 503 regulations ostensibly are designed to protect the " public at large" from the health risks and effects of the land application of sewage sludge. However, as the California State Water Resources Control Board ( CSWRCB) noted in its 2001 environmental impact report ( EIR) in support of its proposed statewide minimum standards for the land application of sewage sludge ( currently under review pursuant to a court order), the Part 503 regulations were based, in part, on a " willingness to accept some health risk to support the reuse of sewage sludge." Yet the generally urban " public at large" is not at any risk from the land application of sewage sludge since the vast majority of sewage sludge, and all risks attendant to it, although generated by urban communities, is shipped to and disposed in rural, agricultural communities.

Hence, the acceptance of " some health risk" by the USEPA on behalf of the general public comes almost exclusively at the expense of farmers and their communities where the sewage sludge is applied. As the NRC recently confirmed:

To date, epidemiological studies have not been conducted on exposed populations such as biosolids appliers, farmers who use biosolids on their fields, and communities near land application sites.

There is significant disagreement in the scientific community over the validity and completeness of the USEPA's current risk assessment, particularly its incomplete analyses of long term effects on soils and crops. Much of the disagreement arises from recognized deficiencies in the USEPA's USEPA, 2003d 121 analyses, mostly due to the lack of necessary information, but also the result of policy decisions that follow a less, not more conservative approach to regulation. Under this approach, looser regulations are adopted, even though it is acknowledged that long term consequences are unknown, with vague assurances that controls can be increased in the future when better data is collected.

Unfortunately, more stringent controls will come too late for the people exposed to those consequences: the farmers and their communities. The USEPA's policies and assumptions underlying its risk assessment and regulations must be reexamined to properly reflect the risks faced by the much smaller, rural populations where the majority of urban generated sewage sludge is transported and land applied.

The USEPA has acknowledged that it lacked sufficient data to develop conservative regulatory standards to protect exposed individuals and the environment.

The USEPA's approach to sewage sludge regulation " entails developing maximum permissible pollutant loading limits and/ or maximum permissible pollutant concentration for the soil. It necessitates a more complete understanding of pollutant chemistry, health hazards, pathways to exposure, and sophisticated modeling techniques." Unfortunately, the USEPA was unable either to adequately model these issues or to find sufficient data upon which to develop maximum permissible loading limits.

First, the USEPA recognized it did not have sufficient information to set standards for all pollutants in sewage sludge, meaning that some pollutants which could pose public health and environmental risks would go unregulated.

The scope of the Part 503 standards is necessarily constrained by the adequacy of information on sewage sludge pollutants and means of use or disposal . . .

Today's rule establishes standards for these pollutants and sludge use or disposal methods for which the Agency had sufficient information to establish protective numerical limits, management practices, and other requirements. The Agency recognizes that today's rule may not regulate all pollutants in sewage sludge that may be present in concentrations that may adversely affect public health and the environment.

Rather than waiting for more complete information, however, the USEPA promulgated standards only " for those pollutants and use or disposal practices for which sufficient information exists." Yet, little information was available even for this constrained review. In fact, the USEPA acknowledged that it could not find any studies that investigated the effects of heavy metals in sewage sludge on plants.

The USEPA, therefore, was forced to use short term experimental studies analyzing specific metals effects on a limited number of crops. Most of the available data was for corn, which is not very sensitive to metals concentrations in soil. Data on more sensitive crops was scarce. As a USEPA, 2003d 122 result, the USEPA used data for just a few crops to extrapolate phytotoxicity effects for all crops. This, even though the USEPA knew of the significant uncertainties in trying to develop such relationships:

The phytotoxicity assessment was based on the relationships between sludge application rate and tissue residue, between tissue residues and reduction in growth and reduction in yield. The relationship between reduction in growth and reduction in yield is particularly uncertain. The uncertainties will vary with chemical, crop species, and toxic endpoint; the best data were available for zinc, corn, and growth reduction.

Regardless, the USEPA proceeded ahead using two different approaches to determine limits for metals known to cause phytotoxicity and extrapolating those results to all crops. The first approach was to use data on corn, which is classified as a crop that is " very tolerant" of heavy metals in the soil. The USEPA selected a 50% yield reduction as the threshold for presuming phytotoxicity had occurred. The USEPA acknowledged, however, that a 50% yield reduction assumption was subjective, and said that ideally, such thresholds should be determined from long term field studies in which reduction in yield was assessed subsequent to the application of sewage sludge. The USEPA obviously failed to consult with farmers who gladly would have told the USEPA that even a 10% reduction in the crop yield is unacceptable.

The second approach tried by the USEPA was to review the available literature for information on plant tissue concentrations associated with potential phytotoxicity in sensitive crops ( leafy vegetables). However, little information was available. For example, no data on chromium effects on sensitive crops was available, so the first approach, using the relatively metal tolerant corn data, was used. For copper, the USEPA relied on data for bush beans and snap beans, which similarly are not the most sensitive species of crops.

For both its approaches, however, the USEPA did not have data on long term studies. Rather, "[ s] hort term experiments were used to develop a plant concentration of pollutant associated with phytotoxicity . . . ".

The bottom line is that the USEPA regulations cover only a small number of pollutants in sewage sludge and the concentration limits for those few pollutants are based on extrapolations of limited data with no knowledge of the long term consequences. Not surprisingly, the USEPA's recommendations have caused the relevant scientific community to voice their concerns. As the Cornell Waste Management Institute discussed:

Excessive accumulation of certain metals, such as copper, zinc and nickel reduces crop yields. We need to assess not only short term benefits, but long term risks of yield reduction due to accumulation of contaminants over time. This pathway ( Pathway 8, Table 3) was evaluated by USEPA in the risk assessment and has also been considered by agronomists at the land grant universities in the northeast ( Pennsylvania State University, 1985). The cumulative limits for copper, nickel and zinc in the Part 503 regulations are approximately 10 times those recommended by the northeast soil scientists. USEPA, 2003d 123 Further, the subsequent investigation and collection of data to verify the USEPA's assumptions have demonstrated their fallacy. For example, in its risk assessment, the USEPA based its 300 ppm concentration limit for lead in sewage sludge on the assumption ( challenged at the time by parties commenting on the risk assessment), that a safe threshold for lead concentrations in children did exist. The USEPA more recently has determined, however, that:

[ L] ead and lead compounds are highly persistent and highly bioaccumulative. The persistence of lead in the environment is not in question since, as a metal, lead cannot be destroyed in the environment. With respect to whether lead or lead compounds released to the environment will result in lead that is bioavailable, the data indicate that under many environmental conditions lead does become available.

As a result, the USEPA now concludes that:

[ L] ead and lead compounds have been shown to cause adverse effects at concentrations far less than the de minimis levels. For example, EPA has stated that it appears that some of the health effects of lead, particularly changes in the levels of certain blood enzymes and in aspects of children's neurobehavioral development, may occur at blood lead levels so low as to be essentially without a threshold.

Based on this new information, the USEPA's 300 ppm lead concentration limit for sewage sludge is excessive and poses significant risks to the children of the farmers, workers and nearby communities where sewage sludge is applied. As the USEPA itself acknowledged in its Part 503 risk assessment, " because childhood ingestion of dirt is so widespread, and the potential consequences so severe, a highly conservative limit is warranted, especially in the context of regulatory decisions that authorize a threshold pollutant such as lead to be added to the environment." Further, the exposure of this erroneous assumption in the USEPA's risk assessment demonstrates why a thorough reevaluation of the entire risk assessment process and adoption of more conservative regulations for all regulated metals ( and additional pollutants that a properly prepared risk assessment might identify and regulate) is warranted.

The potential for adverse long term impacts is the real danger from sewage sludge use on agricultural properties.

The USEPA must acknowledge and deal with the very real scientific dispute regarding the safety of sewage sludge use on agricultural lands, in particular, for long term effects. The main problem is the lack of sufficient information about long term consequences of sewage sludge use. As previously discussed, the USEPA has acknowledged that it did not have data on long term impacts of sewage sludge on crops:

There are uncertainties concerning the long term behavior of metals in sludge. The sludge experts that EPA relied on conclude, based on field studies, that iron oxides and manganese oxides found in sludge as a result of wastewater treatment and metal oxides naturally found in soils may form complexes with the metals and significantly reduce their bioavailability. Documentation to support USEPA, 2003d 124 these conclusions is limited. At a minimum, when the organic component of the sludge breaks down, it is possible that average concentrations of pollutants may increase or they may become more bioavailable.

This concern is echoed by Dr. McBride ( Cornell University), in his article entitled " Toxic Metal Accumulation from Agricultural Use of Sludge: Are USEPA Regulations Protective?", wherein he concurred that: " The long term consequences of the application of metal laden sewage sludges at the loadings permitted by the USEPA 503 regulations are still unknown."

Dr. McBride goes on to make the following recommendation:

Most of the agriculturally productive soils in this country are presently in use; food production cannot simply be relocated if existing farm land is degraded. Our best agricultural soils need to have their productivity and crop quality protected, not for 10, 20 or even 100 yrs, but in perpetuity. To this end, a cautious approach to the application of toxic metals in sludges to agricultural soils would be prudent.

Other scientific studies demonstrate that long term effects of sewage sludge use pursuant to Part 503 regulations are unknown, and that the synergistic effect of multiple metals together in the soil has not been considered by the USEPA, yet could be a significant problem. Even the NRC acknowledged that:

Following organic matter decomposition, trace elements from wastewater and sludge are released and form sparingly soluble reaction products. . . . Because of there sparingly soluble nature and their limited uptake by plants, they tend to accumulate in the surface soil and become part of the soil matrix. With repeated applications of wastewater, and particularly sludges, these elements could accumulate to levels toxic to plants and soil organisms. They could also accumulate in crops where they could, in turn, build up to potentially harmful levels in humans, domestic animals, and wildlife that consume the crops. . . .

Concerns have been expressed about what may happen once a site has reached its cumulative limit for metals and sludge application stops. The chemical properties of the soil will likely change over time. The availability of certain trace elements may increase and potentially cause phytotoxicity problems and/ or cause greater bioaccumulation of trace elements in crops. While there is little published information on this long term problem, the City of Chicago has accumulated soils and crop data . . . . Additional research is needed in this area, but these preliminary results indicate that trace elements are not necessarily more available for periods of up to 10 years following cessation of sludge applications.

Finally, the USEPA has been criticized for its policy decision to lower the health risk standard for sewage sludge from the originally proposed limit of 1 in 1,000,000 to 1 in 10,000, a hundred fold decrease in the safety factor. The USEPA did not provide evidence to support this policy change, except for the bare assertion that a lower safety factor was sufficient because so few people nationally are at risk ( although 100% of persons living and working on sludge amended USEPA, 2003d 125 properties, as well as their rural communities are at risk) and because the higher standard might prevent some POTWs from land applying their sewage sludges ( certainly not a safety consideration). For a number of the contaminants the USEPA evaluated, however, cancer risk was determined to be the most significant risk from the use of sewage sludge. Therefore, it was this change alone that resulted in the USEPA adopting higher permissible levels of contaminants in sewage sludge. As the Cornell Waste Management Institute notes, a much stricter cancer risk value than 1 in 10,000 is typically used in setting regulations and in many regulatory contexts ( e. g., drinking water regulation), a risk of one excess cancer in 1 million people exposed is used to establish the standards.

The bottom line is that USEPA may be committing an egregious error in stating that its assumptions and risk analysis are " conservative." Not until the USEPA properly and sufficiently resolves the following concerns can the Part 503 regulations be considered sufficiently " conservative" and protective of the public health: ( 1) additional contaminants and pollutants should be regulated and, in particular, the absence of data must necessitate the setting of protective standards until more data can be collected, not ignoring the risk entirely; ( 2) the risk assessment should be revised to include the use of higher cancer risk standards that are the basis of existing air and water quality standards; and ( 3) additional safety factors and further studies are needed considering the scarcity of knowledge about the long term effects of using use of sewage sludge on agricultural lands.

There is no factual support or policy justification for exempting any Class A Exceptional Quality ( EQ) sewage sludge from regulation.

The wide spread availability of sewage sludge for land application purposes did not begin until the USEPA issued its Part 503 regulations in 1993. The classification of Class A EQ sewage sludge was not even defined in the Part 503 regulations, but appeared later, in subsequently published guidance documents. The USEPA provided very little evidence to support its determination that Class A EQ sewage sludge should be exempt from most of the administrative requirements and application limitations imposed on non EQ sewage sludge. The USEPA simply asserts that " EQ sewage sludge is considered to be comparable to other common fertilizer products." 34 CFBF disagrees with this conclusion.

First, there is a difference between EQ sewage sludge sold in small quantities in bags for home and landscaping use and the bulk application of sewage sludge on farmland at rates of 20 40 tons/ acre. CFBF takes no position at this time on the regulation of EQ sewage sold in bags. Bulk use, however, raises significant concerns.