In contrast to the USEPA's assertions regarding the comparability of EQ sewage sludge and commercial fertilizers, CFBF notes that for bulk use, the nutrient content of commercial fertilizers, as opposed to sewage sludge, is more constant and less subject to the inherent variability resulting from differences in treatment facility processing. As the USEPA states: "[ t] he chemical composition of sewage sludge may vary greatly between wastewater treatment works and also over time at a single plant." The National Academy of Sciences describes the problem: USEPA, 2003d 126 From the farmer's perspective, other factors limit agriculture use of sewage sludge. Sewage sludge is inherently more difficult to use than chemical fertilizers. In part, this is because the composition of plant nutrients and trace elements vary due to differences among types of sludges ( e. g., different water contents or treatment processes) and differences among municipalities and their industrial contributors. The composition of commercial fertilizers are formulated to meet crop requirements.

More troubling is that the USEPA believes EQ sewage sludge:

[ C] an even be applied to sites where sewage sludge that is non EQ for pollutants has been applied ( even if the site has reached its maximum cumulative pollutant loading rate [ CPLR]) without having to document compliance with any management practices. EQ sewage sludge can be transported to and applied in States other than where it was prepared without any notification requirements."

Yet there is very little difference between Class A EQ sewage sludge and non EQ sewage sludge. EQ and non EQ sewage sludges are subject to the same instantaneous ceiling concentration limits for heavy metals. The only difference between EQ and non EQ sewage sludges are that, when calculated on a monthly average basis, the heavy metals content of EQ sewage sludges are limited to between one third to one half of the heavy metals concentrations allowed in non EQ sewage sludges. One exception is Nickel, for which EQ and non EQ sewage sludges have the identical pollutant limits. An obvious concern with relying on self determined, infrequently calculated averages is that some loads of EQ sewage sludge produced during a particular month may contain heavy metals that exceed the average, and may reach levels equivalent to non EQ sewage sludge.

Further, the same heavy metals are present in EQ and non EQ sewage sludges and these metals will build up in the soil with continued applications regardless of the sewage sludge classification. For this reason it makes no sense to allow EQ sewage sludge to be applied at sites where non EQ sewage sludge already has contaminated the property. Since one of the basic premises of the USEPA's Part 503 regulations is that sewage sludge applications eventually may lead to harmful levels of heavy metals concentrations in soil, and as the same metals are present in EQ as in non EQ sewage sludges, CFBF finds no rationale for waiving any regulatory and administrative controls imposed on non EQ sewage sludge for EQ sewage sludge. The bottom line is that when the when the NRC revisited this issue in its updated 2002 study, it specifically found that "[ e] xemptions from nutrient management and site restrictions for land application of bulk EQ biosolids should be eliminated."

CFBF believes the facts justify the finding that the unregulated use of EQ sewage sludge for bulk land application purposes reasonably will result in adverse health effects and so EQ sewage sludge should not be exempt from regulation.

Conclusion The lack of necessary data, combined with the USEPA's acknowledgment of unknown long term effects demonstrates that more conservative regulations are necessary in order to protect the USEPA, 2003d 127 health and safety of those persons most directly effected by the land application of sewage sludge. This requires the re evaluation of the USEPA's Part 503 analyses, assumptions and policy choices and unbiased research and examination of whether more protective policies should be adopted for land applications in rural areas on agricultural lands.

Response With respect to the commenter's assertion that the Part 503 Standards may not protect rural/ farm areas where vast amounts of sewage sludge are transported from cites to be land applied to farms: The Part 503 Standards are based on modeling and protecting with an adequate margin of safety, the most highly exposed segments of the U. S. population, farm families that use sewage sludge on their farm land. With respect to the other issues raised in these comments, please see the response to comments in this section from David Carpenter in Comment Log No. 43.

EPA Log # 50: Water Environment Federation ( WEF)

Comment G. Regulatory Activities The NRC recommended that EPA revise or develop regulatory criteria for biosolids in a timely fashion and identify additional regulatory mechanisms to better protect human health and the environment from exposure to land applied biosolids. A number of associated recommendations were included, such as the development of molybdenum standards. Several additional risk management practices were also recommended.

WEF supports the following positions and initiatives outlined by EPA:

° EPA will review the molybdenum standard ( to be completed in 2003), ° EPA will evaluate whether to amend Part 503 to eliminate the non EQ Table 4 alternative for selling and distributing biosolids products that are sold or given away in bags or containers weighing less than one metric ton, ° EPA believes the current operational standards are appropriate for achieving environmental performance while encouraging efficient, cost effective, and innovative systems approaches, ° EPA indicates that the additional practices recommended by the NRC are linked to site specific or local level conditions ( topography, soil characteristics etc.) and that State and local jurisdictions will have better knowledge and are better positioned to establish additional management practices.

Response EPA appreciates and agrees with these comments.

PA Log # 46: Association of Metropolitan Sewerage Agencies ( AMSA)

Comment Regulatory Activities AMSA 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. USEPA, 2003d 128 AMSA understands that the NRC is recommending that all biosolids products sold or given away in bags or other containers should be exceptional quality ( EQ). AMSA also understands that by eliminating the non EQ Table 4 alternative, EPA would essentially prohibit 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, AMSA 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.

Some AMSA members have expressed concern about the NRC's recommendation that the nutrient management exemption be eliminated. EPA never expressly addresses this recommendation in its response. Some AMSA members currently use this exemption and AMSA recommends that the Agency thoroughly research and document the need for any regulatory decision it might make on this issue. AMSA agrees with EPA that states and local jurisdictions 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.

AMSA 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 Please refer to the Summary Response in this section of this document and the EPA response to comments received in the Pathogens Section of this document. Please refer to previous responses on the issues contained in these comments ( e. g. Log Comment No. 43 David Carpenter with respect to the issue of the use of sewage sludge on lawns and home gardens).

States EPA Log # 52: Washington State Department of Ecology Comment Regulatory Activities. In its summary EPA notes that the NRC recommended that all biosolids sold should be EQ products and that bulk EQ products should not be exempt from nutrient management and site restrictions. This is a significant recommendation to which EPA did not respond directly. I am uncertain as to merit of the proposal. In Washington Class B biosolids have been purchased for nominal amounts in recognition of their fertilizer value. Likewise it may not be prudent to prohibit the use of EQ products ( compost for example) in certain sensitive areas. On the other hand there is no good justification for not requiring by rule ( but not strictly by permit) that bulk EQ products be applied at agronomic rates and follow other appropriate management practices. Since this recommendation represents a fairly significant departure from common management concepts it warrants further consideration by EPA. USEPA, 2003d 129 The NRC recommended the revision of the 503 rules to eliminate Table 4 for annual pollutant loading rates. EPA notes that virtually no material is sold which exceeds the Table 3 pollutant concentration limits. As a consequence EPA seems to question the strict necessity of removing the table and says it will evaluate data during the coming year to make a determination in this matter.

The presence of this table in the rule is at best a nuisance. Less now than before, but we still find ourselves having to explain the basis for Table 4 ( that it is not really a broadly applicable annual pollutant loading rate limit); and then having to defend the rule for having what frankly seems to be a pretty useless standards. It just adds to the burden of public skepticism. Nobody in their right mind would attempt to market a product with the caveat, " But it's got a lot of pollutant X in it, so only put on this amount and you'll be okay." In my opinion, forget the further evaluation step and propose to remove Table 4. I would not propose an unreasoned expenditure of resources for this singular purpose, but surely we can take the simplest and most expedient route to eliminating Table 4 without further debating the point.

Response Please see the EPA response to Comment Log No. 43 David Carpenter in this section of this document.

EPA Log # 45: Florida Department of Environmental Protection Comment Regulatory Activities  Site Restrictions: While it may be more appropriate for state and local entities to adopt more stringent site management restrictions as indicated in the EPA response, Part 503 is expected to contain adequate, minimum standards for site restrictions. EPA made site management restrictions an integral part of the strategy in Part 503 to ensure the safety of Class B land application. Thus, after ten years of implementation experience with Part 503, it is recommended that EPA review the adequacy of current site restrictions as well as consider the recommendations by the NRC to evaluate potential new restrictions for various site related factors such as site slope and depth to ground water.

Furthermore, existing site restrictions and any potential future ones should be reviewed by EPA with regard to the ability to reasonably enforce the restrictions, especially given the limited resources of the EPA and state biosolids staffs.

Regulatory Activities   Other Countries Regulations: In addition to the NRC's recommendation to review other countries' regulations, it is recommended that EPA review various state regulations as well as other federal agency regulations and programs for different viewpoints, perspectives, and regulatory strategies.

Comments on Pollutant Identification/ Regulation The EPA Office of Water should consider reviewing the Soil Screening Guidance developed by the Office of Solid Waste and Emergency Response under the Superfund program for inconsistencies with the biosolids program ( i. e. different standards for the same pollutant or USEPA, 2003d 130 where the soil screening guidance calls for a very restrictive limit for a pollutant not currently regulated by Part 503). Any inconsistencies should be documented and resolved.

Response Please see the Summary Response to this section and EPA's response to Comment Log No. 8 with respect to site restrictions based on local conditions. Please see EPA's response to comments on standards from other countries ( Comment Log No. 25). With respect to new pollutants considered for regulation under Part 503, please see the EPA response to Comment Log Nos 36 and 43 David Carpenter.

EPA Log # 48 and 39 ( duplicates): Wisconsin Department of Natural Resources Comment 18. Section VIII. G. Regulatory Activities  New Standards  If EPA will complete its review of molybdenum data in 2003, will a proposed amendment to 40 CFR part 503 follow? It is not clear from this notice. Also, it is agreed that few if any instances exist where non EQ biosolids are sold or given away in less than one metric ton containers. That does not preclude the need to eliminate the option and the use of Table 4 in those instances. EPA should be able to articulate a policy decision in this regard and should do so.

19. Section VIII. G. Regulatory Activities  Standardized Management Practices  The NAS report and we agree with EPA that performance based technical and operational standards are appropriate for pathogen and vector control. That is not an issue. However, a major component of the operational standard is the assumptions of natural attenuation in soil after application. This must be verified and it is still not clear whether that is part of EPA's plan. It should be specifically delineated ( see comment 8 above). It is stated that the establishment of national design criteria may not result in the most efficient site specific practices for protecting public health. In the same paragraph it is stated that the additional management practices recommended by the NRC are linked to site specific or local level conditions. It appears that EPA has confused two distinctly different recommendations. The report recommendation for standard treatment plant design would establish appropriate detention times, temperatures, aeration, mixing, feed and withdraw regimes etc. based upon pathogen destruction across the process. There would be no local variation to this other than energy requirements, etc. The study proposed in the Exposure section should examine pathogens in raw sludge, treated biosolids and make a correlation of destruction based on engineering principles. Whether this will be done and the scope of the study should be better delineated. The report recommendation that EPA further consider management practices at land application sites would include slope restrictions, setbacks to homes, surface water, and public and private water supply's, soil type and characteristics, etc. These likewise do not need to be set locally. If there are no residences or surface waters nearby a flat field, then separation distances will not be a problem. If they are required in the rule as a minimum they will employ best management practices to minimize runoff potential, groundwater impacts, and public nuisance issues. As EPA considers these site requirements they should consider that experience shows that in states that impose such restrictions, public complaints are minimized. EPA should give serious consideration to this recommendation and clarify its intent. USEPA, 2003d 131 20. Section VIII. G. Planned Regulatory Activities  Studies  It is stated that EPA is planning to evaluate certain Class B disinfection processes including anaerobic digestion and lime addition, as well as the natural attenuation processes which form the basis of the Class B management component. Again, detail and specific studies should be cited. Aerobic digestion and other processes should also be included. Again as stated in comment 8 above and elsewhere, this is critical work and should be done on a large enough and comprehensive enough scale to draw meaningful conclusions, as recommended in the report.

Response Please see the Summary Response to this section of this document with respect to molybdenum standards. Please see the EPA response to Comment Log Nos. 8 and 25 with respect to the last two paragraphs of these comments ( site specific conditions as a consideration in developing protective standards and " National Design Criteria").

TOPIC H. BIOSOLIDS MANAGEMENT Summary Response: EPA considered this comment category to include Part 503 Standards program implementation. Relevant activities in this category include EPA's Program for permits, oversight, compliance assistance, and enforcement of the Part 503 Standards. EPA also considered the voluntary Environmental Management Systems ( EMSs) being developed by the National Biosolids Partnership ( NBP) of which EPA is a member organization to play an integral role in Biosolids Management. The following describes EPA and NBP commitments efforts in this area. The reader is referred to Project No. 2, Objective B and Project No. 14 in Section VII B of today's Federal Register Notice for a detailed discussion of EPA's and the NBP's programs for Biosolids Management, respectively. For convenience, these sections of today's Notice are extracted and given below.

All other comments under this topic, not germane to EPA's definition of Biosolids Management, have been responded to in other comment categories in other sections of this document.

Project 2: Compliance Assistance and Enforcement Actions As indicated in the Agency's preliminary strategy of April 9, 2003 ( see 69 FR 17391) and this final action plan, EPA will continue to provide compliance assistance to individuals, municipalities, or other entities on matters pertaining to sewage sludge use and disposal and will take enforcement actions, as appropriate. This project relates to Category H, Biosolids Management Activities, in the April 9, 2003 notice. See 68 FR 17391.

EPA has maintained an active presence in biosolids compliance and enforcement activities. EPA's enforcement and compliance activities are tracked in the Integrated Compliance Information System ( ICIS) and Permit Compliance System ( PCS) databases. Specifically, the ICIS database documents the following Federal enforcement actions taken to address biosolids: 391 administrative orders for FY 1995  2002, 119 administrative penalty orders for FY 1995 USEPA, 2003d 132 2002, and one civil judicial action in FY 1997. The PCS database documents 382 regional and state biosolids inspections for FY 2000  2002.

Furthermore, EPA Regions and States have the responsibility to address situations where compliance assistance and enforcement actions to address biosolids are appropriate and necessary. Regional responsibilities for the biosolids program include actively following up on phone calls and complaints received from the public, and, where appropriate as demonstrated by the data, initiating Agency enforcement actions. EPA has taken enforcement actions and/ or appropriate administrative remedies to address biosolids violations of 40 CFR part 503 and will continue to take such actions, including instances where biosolids pose an imminent and substantial endangerment to human health or the environment.

To assist the States and Regions in their oversight of the biosolids program, EPA has, either in place or in development, tools to assist and promote compliance with biosolids regulatory requirements. The National Pollutant Discharge Elimination System ( NPDES) Compliance Inspection Manual, which is used by EPA and State inspectors to perform inspections in the field, includes a " Sludge ( Biosolids)" chapter. EPA is currently revising and updating the manual, which is expected to be complete in 2004. The Clean Water Act/ NPDES Computer Based Inspector Training CD ROM, including a module specific to biosolids inspections, was finalized in August 2003. EPA plans to make both of these tools available on the EPA website.

Additionally, there are two compliance assistance web sites, which are available for biosolids compliance studies, information and tools, and for links to other sites with pertinent biosolids compliance information. One is the National Environmental Compliance Assistance Clearinghouse at: http:// cfpub. epa. gov/ clearinghouse/. This site is a searchable clearinghouse of compliance assistance materials. The second website is the Local Government Environmental Assistance Network ( LGEAN) at http:// www. lgean. net. This on line compliance assistance center, which focuses on local government environmental requirements, is operated by the International City/ County Management Association ( ICMA), and has six other partners representing local government.

EPA is also working to improve its data reporting and management system that supports compliance oversight. EPA is continuing to work with States as it modernizes the Permit Compliance System ( PCS) to allow for more effective program oversight. As part of the PCS modernization, a separate workgroup ( including States and EPA) was devoted to the data needed to manage the biosolids program. Based upon the recommendations of this workgroup, the PCS Executive Council decided to add data elements to PCS to improve tracking and oversight of the biosolids program, and the draft detailed design was distributed for review. The detailed design document was finalized in September 2003, which served as the basis for the software development. The anticipated implementation date for the modernized PCS is December 2005, provided adequate funding is committed to this project.

The land application of sewage sludge in compliance with EPA's regulations is an appropriate choice for communities. The NRC concluded that " There is no documented scientific USEPA, 2003d 133 evidence that the Part 503 rule has failed to protect human health. However, additional scientific work is needed to reduce persistent uncertainty about the potential for adverse human health effects from exposure to biosolids." Thus, EPA has directed its water enforcement and compliance resources to focus on risks posed by wet weather issues and untreated pollutants, including raw sewage and wastes associated with storm water, sanitary sewer overflows, combined sewer overflows, and concentrated animal feeding operations. Both agriculture and urban runoff/ storm sewers are listed in the top four sources of impaired river miles in the 2000 National Water Quality Inventory Report to Congress ( section 305( b) report). Given the complexity and magnitude of addressing potential human exposures to pathogens and chemicals from untreated human and animal wastes from wet weather and the present scientific knowledge of the relative risks associated with biosolids, there is an appropriate level of resources allocated to biosolids compliance and enforcement activities.

Project 14: Improve Stakeholder Involvement and Risk Communication The NRC recommended that stakeholders should be involved in the risk assessment process and to examine biosolids management practices to ensure that the underlying risk assessment principles are effectively translated into practice. As stated in its preliminary strategy in the April 9, 2003 notice, the Agency's policy is to involve stakeholders at various stages of policy development. The Agency intends to consider how consultation with stakeholders should be included in developing future sewage sludge risk assessments. See 68 FR 17386. EPA received many comments on its preliminary strategy of April 9, 2003, urging the Agency to involve stakeholders more widely in the many aspects of the sewage sludge program.

EPA is committed to working with stakeholders who are concerned with the application or disposal of sewage sludge ( the general public, State and local agencies, and private groups). In addition, the Agency will consider how it can implement the NRC's recommendations to involve stakeholders in updating and strengthening the scientific credibility of the sewage sludge regulations.

The Agency's risk communication programs are aimed at improving public awareness of the issues and achieving pollutant exposure reductions. Embodied in all of the projects is not only a need to foster public awareness of the issues surrounding sewage sludge use and exposure, but also a recognition of the advances in problem solving that can be achieved through collaboration and cooperation.

Through the activities and organizations described in this project, EPA will participate in improving the effectiveness of risk communication methods at national, regional, and local levels. States have their own oversight programs, some of which are quite comprehensive. There is a total of about 150 full time equivalent State employees assigned to their respective biosolids programs. Five States have been authorized by EPA to administer the Part 503 program, and 15 additional States are at various stages in the authorization process. National coordination of State, regional and Headquarters biosolids programs are achieved via an annual State and Regional biosolids coordinators meeting. EPA plans to continue to work closely with State and USEPA, 2003d 134 Regional biosolids coordinators and plans to support the annual workshop for sharing the latest information about biosolids management and oversight. Other organizations and activities that are designed to promote stakeholder involvement include the following:

An Information Sharing Group ( ISG) has been established based upon the concepts developed in WERF studies concerning joint fact finding research. The ISG includes concerned citizens, health scientists, municipal operators, farmer representation, biosolids managers, and input from State and Federal regulatory agencies. The ISG has been established to work jointly with about 25 scientific experts in a large cooperative study of odor, particulates, pathogens, and endotoxins in the air around biosolids and animal manure land application sites. WERF has efforts underway to expand the use of such information sharing in various research projects.

The National Biosolids Partnership ( NBP) is an alliance formed in 1997 with the Association of Metropolitan Sewerage Agencies ( AMSA), the Water Environment Federation ( WEF), and EPA. The goal of the NBP is to advance environmentally sound and accepted sewage sludge management practices through partnerships with producers, service contractors, users, regulatory agencies, universities, the farming community, and environmental organizations.

The NBP is developing a voluntary Environmental Management System ( EMS) for sewage sludge to help wastewater agencies improve their sewage sludge management programs beyond the regulatory minimums. The EMS involves environmental improvement, public involvement, and independent third party review of the facility applying for EMS status. Fiftythree wastewater agencies in the U. S. are participating in this voluntary program. Several of these municipalities are ready or will be ready for third party audit of their EMS programs in 2004. Participating municipalities report benefits, such as more efficient operation, reduced odors in sewage sludge, less intrusive transport of the sewage sludge to land application sites, better communication, and meaningful involvement by the public.

In order for a wastewater facility to be admitted and certified to the Partnership EMS program, it must meet five requirements established by the NBP:

1. document responsibility for the Biosolids Value Chain pretreatment, treatment, and all biosolids management practices; 2. commit to 10 principles in the NBP's Code of Good Practice; 3. meet all NBP requirements; 4. complete a fully independent third party audit of its EMS that has been verified by a NBP's accredited audit company; and 5. demonstrate their commitment to continual improvements in their EMS for environmental performance, regulatory compliance, public participation, and quality biosolids management practices.

Recently, the NBP recognized the Orange County Sanitation District ( OCSD) in Fountain Valley, California, as the first wastewater agency in the Nation to be admitted to the Partnership EMS for biosolids programs. The EMS certification signifies that OCSD meets the NBP's USEPA, 2003d 135 requirements for the EMS program and that it supports excellence in sewage sludge management practices, exceeds regulatory compliance obligations, and provides meaningful opportunities for public participation.

The NBP recognized the City of Los Angeles Department of Public Works as the second wastewater agency in the Nation to be admitted to the Partnership EMS for sewage sludge program. A third party audit of the City's Biosolids EMS program led to certification on September 4, 2003. EPA continues to support the development of EMS programs for wastewater agencies and the goals of improved communication and addressing public concerns in a more timely manner.

The NBP also announced release of its 2003 Environmental Management System for Biosolids " Self Help" Training Program intended to help wastewater agencies that are interested in starting their own EMS. The Agency plans to continue supporting NBP activities and to work with municipalities to expand their use of EMS and other programs in biosolids management. Two NBP websites present relevant sewage sludge information: www. biosolids. org and http:// biosolids. policy. net/ emsguide/ manual/ goodpractmanual. vtml .

Academia EPA Log # 51: Ellen Z. Harrison Comment EPA is not proposing additional management practice requirements, like setbacks from homes. NRC recommends these be considered. Application of Class B sludges containing pathogens up to property lines and thus proximate to places where children play and people spend time in their yards is poor policy. Having witnessed a child playing on a swing set behind their trailer, just feet from the edge of a field to which sludge was being applied, can anyone doubt that there is the potential for that child to be exposed to the pathogens in the applied sludge? EPA needs to commit to establishing setbacks.

EPA is not proposing to require nutrient management or site restrictions for bulk applications of EQ sludges as recommended by NRC. In fact I find no mention of this issue in the EPA response. Since nutrient contamination of waterways and groundwater is a concern, and since nutrient levels in Class A EQ sludges may be the same as in Class B, it makes no sense to exempt them from such considerations.

The EPA Office of the Inspector General first ( OIG) twice investigated the EPA sludge program ( USEPA, 2002; USEPA, 2000). The first report documents insufficient oversight of the sludge program by EPA. The agency clearly did not respond positively to that report, since EPA staffing levels declined dramatically in the sludge program during the 2 years between the first and second reports. There is clearly no EPA presence in most areas that would ensure that even the inadequate 503 rules are being complied with. EPA proposes to " continue" program implementation   which is not responsive to the recommendation to enhance EPA oversight and USEPA, 2003d 136 enforcement. The fact that sludges are being spread close to where families live and on lands on which we grow our food makes such a stance indefensible. A credible enforcement and compliance assurance presence is essential. Voluntary programs which EPA supports such as the EMS system is not a replacement for oversight.

Response Please see the Summary Response to this section.

Citizens EPA Log # 8: David A. Burrows Comment On page 17392 of the Federal Register it states: " Regions and States have the flexibility and responsibility to address situations where compliance assistance and enforcement actions to address biosolids are appropriate and necessary." Local governments are virtually powerless to do so in Pennsylvania and the Pennsylvania Department of Environmental Protection clearly seems industry oriented and responds poorly to citizens complaints.

Response Please see the Summary Response to this section.

EPA Log # 29: Henry J. Staudinger Comment H. EPA's Biosolids Management Strategy is Not Adequate.

NRC recommends that EPA increase the resources devoted to its biosolids program; expand its biosolids management activities and develop a procedural framework to implement human health investigations.

EPA points to the existence of an enforcement or compliance presence in each of the EPA Regional Offices, when EPA knows that those offices fail to respond when complaints are made. EPA's response provides little assurance that better biosolids management will occur.

IV. Comments on Issues Specially Identified by EPA 1. EPA's preliminary strategy for responding to the NRC Recommendations given that the Agency's biosolids program does not have sufficient resources to implement all of the recommendations.

Unless and until EPA allocates sufficient resources and determines under what conditions biosolids are truly safe, it must take other steps to afford minimum protection to those who are forcibly exposed to biosolids, including by way of example:

a. Prohibit land application of biosolids where the immune compromised and other sensitive individuals may be exposed. USEPA, 2003d 137 b. Prohibit land application of biosolids at pollution sensitive sites and during pollution sensitive conditions.

c. Prohibit further land application of biosolids that elicit credible health complaints.

d. Require full disclosure of constituents in biosolids that elicit credible health complaints.

e. Impose substantial penalties when land applied biosolids fail to meet Part 503 requirements. ( This would not only reduce public health and environmental risks, but could serve as a funding source for needed studies.)

f. Require that all land applications be limited to the agronomic rates for all nutrients. This will not only reduce public health risks, it will also reduce phosphorous and nitrogen pollution following biosolids applications. ( This is especially important in areas such as the Chesapeake Bay Watershed where EPA has long been active in attempting to reduce phosphorous and nitrogen pollution.)

g. Impose land application fees and use the funds collected to better monitor, test and enforce applicable regulations as well as to fund independent studies.

h. Assure independent studies to address public health and environmental concerns. ( Industry funded studies that are not totally independent will have the same lack of credibility as the studies once funded by the tobacco industry when that industry argued that tobacco products were safe.)

Response Please see the Summary Response to this section. EPA has committed the appropriate amount of personnel ( FTEs) and extramural dollars to implement the sewage sludge program described in today's Federal Register Notice.

EPA Log # 49: The Resource Institute for Low Entropy Systems Comment The EPA should stop using federal money to support the promotion of sewage sludge as a soil amendment. The EPA has given millions of dollars to the sludge industry's trade association, the Water Environment Federation, and the sludge industry's Water Environment Research Foundation. This funding should stop and be redirected to institutions, organizations, and individuals with no financial stake in the production, disposal, or use of sewage sludge. If the majority of an organization's membership has a financial stake in sludge management, they should be disqualified from federal funding on issues related to sludge research.

Response EPA no longer " promotes" the land application of sewage sludge. Rather it is EPA's position that the choice of a use or disposal practice for sewage sludge management is the responsibility of local communities that generate sewage sludge as long as the chosen practice meets all of the appropriate requirements of the Part 503 Standards and complimentary State standards for the chosen sewage sludge management practice. USEPA, 2003d 138 EPA Log # 40: Thomas F. Albert Comment Comment # 37: On page 17391 begins section " H. Biosolids Management" in the EPA comments. This section starts off with a great summary of NRC recommendations regarding biosolids management activities. These include; ( 1) strengthen oversight program, ( 2) track suspected instances of health impacts, ( 3 ) determine whether or not Part 503 management practices are working,, ( 4) implement health investigations, ( 5) determine whether treatment technologies for pathogen control are effective, and ( 6) determine whether chemical standards are met.

Comment # 38: On pages 17391 17393 EPA indicates how it will address NRC biosolids management recommendations. This by far the longest discussion by EPA as to how it plans to address certain NRC recommendations. Unfortunely, even though this section is quite long ( compared to the others) it leaves much to be desired. Listed below as items A H are specific comments pertaining to some points in the section.

A: EPA notes that it has " an enforcement or compliance presence in each of the EPA Regional Offices for following up on phone calls and complaints received from the public," EPA should explain what is meant by " presence", how many people would be more helpful.

B: EPA notes that " States have their own oversight programs, some of which are quite comprehensive." Judging from the number of complaints that I have heard from other sludge impacted people, most state offices devoted to sludge matters are primarily devoted to " getting the sludge on the ground." My own experience with PA Dept. of Environmental Protection is that they have very little interest in helping sludge impacted people, rather their primary interest seems to be " getting the sludge on the ground." If EPA has information that state sludge offices do more than " get the sludge on the ground", it would be very helpful for EPA to include that in its final version of the comments.

C: EPA makes another SELF SERVING and MISLEADING statement " EPA continues to meet its statutory obligations under the Clean Water Act ( CWA) pertaining to sewage sludge." If EPA is doing such a great job; 1) why does the NRC report contain 345 pages and 57 recommendations, 2) why did EPA's Office of Inspector General conclude " EPA does not have an effective program for ensuring compliance with the land application requirements of Part 503" ( see NRC report page 26), and 3) why do thousands of sludge impacted people complain so loudly ( see NRC report page 25)?

D: When discussing EPA resources devoted to biosolids and health impacts EPA notes " EPA will reconsider resources devoted to biosolids if additional research and science demonstrate greater risk." Why does EPA use the word " reconsider"? It seems clear that even if studies show a greater health risk due to sludge, EPA will only RECONSIDER increasing resources to reduce that risk. Such a statement only serves to show that health issues related to sludge are LOW PRIORITY for EPA. If this is not the case then EPA should present a reasoned argument to the contrary. USEPA, 2003d 139 E: EPA refers to a study supported by the Water Environment Research Foundation ( WERF) that " included a survey on public perceptions and what people know about biosolids, what their concerns are and whether their concerns are being addressed adequately." EPA surely knows ( or should know) that the thousands of people fighting against Class B sludge are not " happy" with Class B sludge. The NRC report ( page 25) briefly presents the basic concerns of most sludge impacted people; odors, various illnesses ( headache, respiratory and digestive disturbances, eye irritation, etc.), reduced property values, flies, etc. EPA should also recognize that; 1) nearly all people that live near a sludge field do not want it near them, 2) people who " push sludge" ( regulators, industry personnel) do not live near a sludge field, 3) there are numerous NGOs whose members do not want sludge near them, and 4) to my knowledge there are no groups of people ( such as neighborhoods) that are actively seeking to have Class B sewage sludge placed on fields next to their homes or their children's school. Does EPA know of families that are actively seeking to have Class B sewage sludge placed on neighboring lands that are adjacent to their homes or their children's school?

F: In the Science and Public Outreach subsection EPA notes " a need to foster public awareness of the issues surrounding biosolids use and exposure." EPA further notes that it " is committed to improving the effectiveness of risk communication methods at national, regional, and local levels." What are " risk communication methods"? Sludge impacted people surely want to know more about the sludge near them and the likely health risk. Ask sludge impacted people, most will likely state that they have great difficulty in getting reliable information from regulators or industry personnel. Just try to get information on bioaerosols or indicators of well contamination due to sludge. Why doesn't EPA start helping people get this information? Why is it that people who " push sludge" ( regulators, industry personnel, etc.) do not have their families living next to a sludge field?

G: In the Science and Public Outreach subscription there is what seems to be yet another mention of the cooperative sludge study ( EPA/ USDA/ PA DEP) in Pennsylvania. If this study is to be mentioned so often, WHY aren't its severe LIMITATIONS also mentioned?

H: The last part of the " how EPA will address NRC biosolids management recommendations" section is a subsection " Planned Biosolids Management Activities." This planned activities subsection is " extra brief," only 11 lines. It is VERY DISAPPOINTING as it just more or less says that EPA will try to achieve the goals ( short term and long term) stated on page 17384. No specifics are given. Unfortunately, there are no specifics as to how EPA plans to address the 6 points ( briefly stated NRC recommendations) listed above in Comment # 37 and listed in the 3 paragraphs of the section " Summary of Biosolids Management NRC Recommendations." Where are the SPECIFICS as to how EPA will address the NRC recommendations?

Comment # 39: In my opinion there is a MAJOR DEFICIENCY in the 2 sections that pertain to; 1) how EPA plans to address NRC Regulatory Recommendations, and 2 ) how EPA plans to address NRC Biosolids Management Recommendations. In neither of these sections, and nowhere in the EPA comments, is there a clear plan to determine the effectiveness of SITE USEPA, 2003d 140 RESTRICTIONS in relation to Class B sewage sludge. EPA apparently IGNORES the 2 NRC recommendations listed below regarding Class B site restrictions.

NRC recommendation: " Studies should be conducted to determine whether the site restrictions specified for Class B biosolids in the Part 503 rule actually achieve their intended effect with regard to pathogen levels" ( page 305 NRC report).

NRC recommendation: " Site restrictions, buffer zones, and holding periods for land applied Class B biosolids should consider geographic and site specific conditions that affect pathogen fate and transport" ( page 304 NRC report).

When considering Class 6 sewage sludge applied to land, the NRC committee " found that some potential exposure pathways were not sufficiently considered when the use restrictions were developed. For example, potential off site inhalation of dust and aerosols does not appear to have been considered" ( page 304 NRC report). The NRC committee also noted " EPA also did not address sufficiently the potential for surface water contamination by runoff, ground water contamination, and secondary transmission of disease" ( page 14 NRC report). The NRC committee also noted " No risk assessments were conducted to establish the 1993 pathogen standards" for Class B sludge ( NRC report page 13). EPA knows that most citizen sludge related complaints concern Class B sewage sludge. People near Class B sludge fields worry about health concerns, foul odors, airborne spread of germs, contaminated runoff onto adjacent properties, drinking water ( wells) contamination, flies, declining property values, etc. Why doesn't EPA propose a vigorous study program to determine whether or not Class B sludge site restrictions are protective?

Response Please see EPA's response through the Summary Response of this section of this document.

EPA Log # 25: Northumberland Association for Progressive Stewardship ( NAPS) Sewage Sludge Study Group Comment In your docket paper you ask for clear descriptions of our concerns and alternatives. As you will see, all we ask for here is that you implement the NRC recommendations. The answers we have received to date from our state and now from your response paper, indicate that the main issue is the lack of state and federal funding available for much needed research and risk assessment strategies. It is the people living in rural areas that suffer the consequences. It seems to us that the cost of necessary research should be a cost of doing business and should be shared by the main beneficiaries: municipalities generating sludge, the sludge disposal industry and the farmers having the sludge land applied ( a solid minority of farmers and acreage, at least in Northumberland County). State and federal taxpayers living in rural communities should not have their taxes used for this purpose, since we already shoulder the financial burden of establishing and maintaining private septic sewage systems. When allocated to customers of the municipal sewage disposal systems, we suggest that the annual cost per customer would be relatively low. USEPA, 2003d 141 And so, assuming that EPA cannot dedicate sufficient monies from your own budgets, we recommend that a pool of funds from these sources be the major source of funding.

Our second major alternative, in the absence of sufficient research and risk assessment monies, is to have all of the sewage sludge disposed of in state approved landfills. We are told that about 40% of the sewage disposed of in Virginia goes to landfills and incinerators. The local municipal sewage disposal interests say that the landfills are filling up, and the sludge operators say it would be too expensive. We say they need to dig some new land fills and, once again, pass on the cost to the main beneficiaries: the municipal treatment plants, the sewage disposal companies and the farmers. It would cost citizens of municipalities less than $ 1.00 per year each if all sludge is land filled.

Our third alternative, in the absence of research funds, is to establish safety buffers and other protections that will satisfy our concerns and most of our allies in opposition to current land application practices. EPA must ensure that unless and until needed research is completed, that the immune compromised not be exposed to sewage sludge. Instead of 100 and 200 feet for buffers, for example, require that the edges of land applied fields be at least one mile from homes, shallow wells, schools, churches, hospitals, etc. This would then restrict land application to fields well away from residential homes and infrastructure.

Here are some specific comments about the drafl EPA responses:

VII: EPA's Strategy for Responding to the NRC Recommendations? Lines 470 472. In the discussion of current and future EPA resources, no mention is made of determining and requesting additional resources, or re prioritizing resources to implement the NRC's recommendations. This is an early indication that EPA is satisfied with the status quo. EPA must be prepared to identify and apply additional resources if it is to comply with the Clean Water Act. Buried back on Lines 1110 1111 is the statement, " EPA will reconsider resources devoted to biosolids if additional research and science demonstrate greater risk." But if EPA resources are not to be allocated up front for improved science and risk assessment, how will you determine if there is greater risk?

H. Biosolids Management Lines 1088 1375. The State of Virginia, a major importer of sewage sludge, and a Dillon Rule State, has two people on staff at the Virginia Health Department, to enforce regulations and monitor sludge land application throughout the State. This situation will be improved somewhat with the local government monitors authorized by new law passed last year. But the monitors win be very limited in the aspects they will be allowed to test and control. For example, because notification of local residents is not specifically authorized by Department of Health regulation, the cost of mailing out notifications to the local residents will not be reimbursable by the State imposed user fee just being implemented. EPA regulations must address this issue of restrictions imposed on localities in Dillon Rule states as stated on lines 1105 1107, " Regions and States have the flexibility and responsibility to address situations where compliance assistance and enforcement actions to address biosolids are appropriate and necessary." USEPA, 2003d 142 Lines 1252 1375. Reference is made to the 411 pollutants included in EPA's 1988 1989 analyses. How many hundreds of chemicals, pathogens, viruses, pharmaceuticals and other harmful pollutants have been identified as going through the human waste stream since then? How many new chemicals are going into the sewers? How may combinations of all of the above? The land application of sewage sludge represents a vector of water contamination, especially for relatively insoluble substances. The EPA has not adequately addressed this vector. This issue is essential to the protection of human health and the environment.

Response Please see EPA's response in the Summary Response to this section of this document.

Environmental Groups EPA Log # 7: Sierra Club Comment The NRC panel concluded that sludge is such a complex and unpredictable mixture and land application wrought with so many variables and uncertainties, that no reliable risk assessment is possible for this activity ( 8) The Sierra Club therefore recommends that EPA switch from risk assessment methodologies ( 19: 17387 et passim) to precautionary management strategies based on facts, not formulas.

EPA's reluctance to place additional restrictions on public exposure to sewage sludges appears to be primarily, if not solely, based on an assurance that there are no documented cases of illnesses when sludge is applied according to the 503 Rule. This assurance, however, is meaningless given the fact that no system is in place for tracking and investigating such cases. It is also misleading, since numerous cases linked to sludge applied under the 503 Rule were documented in the peer reviewed medical and scientific literature a few days before the NRC report was published ( 6, 7).

EPA plans to strengthen the oversight role of its Pathogens Equivalency Committee ( PEC), which evaluates and approves the efficacy of methods used in disinfecting sewage sludges ( 19 ). The PEC, has recently begun requiring companies seeking approval for new treatment technologies to more fully demonstrate the efficacy of those technologies for reducing pathogens. Municipalities and private industry, however, are still free to use any of the old technologies that were approved without such testing.

The end result is that companies using the current, untested technologies that gave rise to widespread adverse health complaints are given economic advantages over competitors wanting to market safer technologies. In short, the public must wait for the results of research conducted under programs designed to promote current technologies as being safe before EPA will consider whether it will require any improvements in currently approved technologies. Companies offering new, safer alternatives, on the other hand, must meet strict efficacy requirements to gain PEC approval. This policy clearly serves the interests of the major players within private industry with which EPA has developed a close working relationship, but does not in any way serve the public interest. USEPA, 2003d 143 EPA's position should be that exposing populations near land application sites to noxious air contaminants and allowing drinking water sources to become contaminated with sewage sludge is simply unacceptable. The Agency must take immediate steps to remedy situations where this has occurred and prevent similar problems from developing in other areas. Promulgating more protective sludge management measures should not be left to local communities ( 19: p. 17391) but must be incorporated into the federal rules. Especially since a number of communities whohave tried to put in place more protective ordinances, have been sued or threatened with lawsuits for doing so.( 23). A number of common sense precautionary management strategies that have been developed by the Sierra Club ( 10) and the Cornell Waste Management Institute should be implemented immediately, even before they are incorporated in future legislation.

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

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

Comment REGULATORY AND MANAGEMENT ACTIVITIES NRC makes numerous recommendations categorized by EPA as regulatory and management activities. These include that EPA: review the literature pertaining to biosolids from other nations; establish new molybdenum standards; adopt national standard treatment design criteria; develop a quantitative microbial risk assessment to establish regulatory criteria for pathogens; require that all biosolids sold should be exceptional quality (" EQ "); and eliminate exemptions for nutrient management and site restrictions for land applied EQ biosolids.

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.

Research alone is not enough. NRDC urges EPA to take action to improve the safety of land applied sludge. That is the key to improving public acceptance of sludge spreading, which is frequently identified by both EPA and the sludge industry as a goal. NRDC urges EPA to take the NRC recommendations to heart and improve required management practices for Class B sludge or ban it altogether, enforce currently required management practices, ban sale or distribution of non EQ sludge for public or home use ( e. g., playgrounds, schoolyards, parks), and ban application of sludge on land used to grow food for human consumption either directly or indirectly ( from animals raised on crops grown on sludge). In addition, the NRC identified several exposure pathways that may not be adequately protected under current use restrictions: groundwater contamination, off site inhalation of dust and aerosols, and surface water contaminated by runoff. Addressing these potential exposure pathways should be a top priority for EPA. USEPA, 2003d 144 Of additional concern is the fact that EPA's biosolids research continues to lack any overarching evaluative framework within which such activities can be planned and reviewed. Simply leaving states and local authorities with the responsibility of establishing additional management practices is likely to lead to non protective results in some states. Allowing those with local knowledge the latitude to develop more effective management practices to supplement federal baseline standards could be beneficial, but without any national strategy to evaluate the results, many of these efforts may have very limited effect.

NRDC commends EPA's commitment to review the biosolids protocols of other nations but urges EPA not to discount or dismiss this information merely because it emanates from countries employing different approaches and legal frameworks. Genuinely considering different approaches to common problems would allow EPA officials to effectively think outside the box while re evaluating familiar policies, procedures, and research methods.

EPA declines to follow NRC's recommendation to require that biosolids sold be EQ, basing its decision on unspecified information that " virtually no biosolids products are sold or given away in bags or other containers " that do not comply with EQ. If EPA were correct, then the biosolids industry should have no objection to a ban which would protect the public from home use and exposure to toxins and pathogens in sludge.

EPA also rejects NRC's recommendation for the adoption of national standard design criteria, reasoning that " the establishment of [ such ] criteria may not application of the most efficient site specific practices for protecting public health." While additional tailoring of management practices in accordance with local climate, geography or other factors in order to enhance protections of public health may also be helpful, baseline federal standards must first be set that are protective of public health and the environment.

One of the broadest criticisms offered by NRC ( as well as by the EPA's own is that EPA provides insufficient support and oversight to the program. In response, EPA contends that it continues to meet its statutory obligations under the CWA pertaining to sewage sludge and that its allocation of resources is proportional to its assessment of the risks posed to public health and the environment by biosolids. Such conclusory assertions beg the question: how can EPA make this claim when it is relying on outdated research and regulatory mechanisms and continuing its lax enforcement of this program?

EPA needs to take an organizational step back from the handful of individual research projects it is currently pursuing and develop a broad systematic framework for ensuring that its biosolids program meets statutory requirements. Such a framework should incorporate many of the individual recommendations contained in the NRC Report into future EPA supported biosolids projects in a cost effective way. Standardization of research criteria and validation of methods, management, and treatment techniques would amplify the value of each individual project. Unrealized synergies would result from such a coordinated approach, enabling EPA to develop state of the science regulations that would assuage public concerns about biosolids exposure and ensure that public health and the environment are fully protected. USEPA, 2003d 145 Response With respect to the last paragraph of these comments, EPA believes that the final action plan of research and the results of the Section 405( d)( 2) C) screening project announced in today's Federal Register Notice can be characterized as a broad systematic framework for ensuring the safety of the land application of sewage sludge and that the Part 503 Standards are meeting Clean Water Act mandates, respectively.

Comments of Dr. Peter L. deFur Research, Monitoring and Management The NRC noted that the EPA 503 program needs to incorporate monitoring and research into the current program mix. EPA should conduct monitoring for chemical constituents, both inorganic and organic, to provide an enhanced database on which to manage sewage sludge. Nationally, there is no mechanism or program in place to gather new data, and EPA should remedy this problem.

The EPA list of chemicals in sludge, and the list compiled by Harrison ( 2003) both include a number of chemicals for which there are no or insufficient data on toxicity. This paucity of specific data was one of EPA's reasons that chemicals were excluded from further consideration in the original 503 rule. This problem exists in other regulatory areas for EPA  risk assessments are not completed in the absence of toxicology data and with absolutely no exposure data ( though this omission is more often overcome by modeling on the basis of physico chemical properties of chemicals).

EPA can take several steps to remedy the paucity of toxicological data: 1) require the data of the manufacturers under federal law; 2) initiate a research effort to obtain some of the more critical data; 3) change the regulatory approach to increase incentives for providing the data and at the same time provide disincentives to the regulated community to continue with the present lack of data; 4) initiate a regulatory approach that makes default assumptions about unknown chemicals to allow positive management pending the completion of data acquisition.

The present 503 Rule deals with human health, leaving ecological risks to other efforts. Serious problems exist with POTW discharges, as indicated by the numerous scientific papers on the developmental problems in fish caused by sewage outfalls ( Jobling et al., 1998). The problem extends to other sorts of chemical contaminations that cause other problems, including salmon migration ( Fairchild et al., 1999). Furthermore, the total amount of estrogenically active chemicals must be assessed, as this activity can alter biological function ( Schultz et al., 2003), such as male reproduction.

Response ( to all of the comments for Comment Log No. 43) Please refer to the Summary Response of this section of this document. With respect to comments in the last paragraph, Part 503 Standards extend only to the sewage sludge generated in wastewater treatment plants and not to effluent discharges from these facilities.

Municipal Wastewater Treatment Plants USEPA, 2003d 146 EPA Log # 14: Metro Wastewater Reclamation District Comment The NRC report recommended that the EPA consider funding, supporting, and officially sanctioning the Pathogen Equivalency Committee ( PEC) as part of the program. The Metro District does not object to this recommendation; however, if implemented by EPA, the District recommends that membership on the PEC be opened to include qualified scientists employed by private biosolids contractors and wastewater treatment plants. As currently structured, the PEC includes only employees from EPA and the Centers for Disease Control. Because of this limitation, the PEC has not benefitted from the expertise that scientists from the regulated community could bring to the debate concerning wastewater solids treatment processes and pathogen equivalency issues.

The Metro District supports EPA's strategy of continued funding of relevant scientific research concerning the impact of biosolids on human health and the environment. As part of this effort, the District recommends that EPA consider funding studies conducted by private biosolids applicators or wastewater treatment agencies. These entities may be able to develop data useful to EPA's long term goals of understanding the benefits and potential consequences of biosolids land application and determining whether existing Part 503 site management restrictions are effective.

The NRC report recommended that EPA devote additional human resources to management and oversight of the federal biosolids program.. EPA's response to this recommendation was to indicate that additional staff has been assigned to the federal program.. EPA also noted that individual states have staff assigned to the management of approved programs. The Metro District believes that, whenever feasible, state oversight of individual biosolids programs is the best regulatory option. The District recommends that, in addition to devoting additional staff to the federal program, EPA consider contributing additional funding to states to implement their own programs. EPA should take steps to remove roadblocks that hinder or prevent states from receiving approval authority to administer such programs. State run biosolids programs can improve biosolids management practices by providing more local technical support and reducing compliance activities associated with multiple permitting and regulatory requirements. For example, the District  as a biosolids producer and land applier in a non delegated state  must comply with the requirements of: ( 1) the federal 503 regulations, ( 2) the Colorado Biosolids Regulation ( 5 CCR 1002 64), ( 3) the District's discharge permit ( which includes specific biosolids management requirements), ( 4) the EPA Region Vlll Biosolids General Permit, and ( 5) various local government regulations.

In addition, states with approved and funded biosolids programs likely would be in a better position to address other management issues raised by the NRC report, such as expanding and strengthening oversight programs, tracking allegations of possible exposure related health effects, and conducting studies to determine how well the management practices specified in 40 CFR Part 503 achieve their intended goals. The Metro District supports such expanded roles for state run programs. USEPA, 2003d 147 Response EPA generally agrees with these comments.

EPA Log # 19: Metropolitan Water Reclamation District of Greater Chicago Comment We have several research projects that are under development, undergoing start up, in progress, or that are recently completed that will generate, are generating, or have generated scientific data and information that the EPA may find useful over the next few years as they reevaluate exposure and risk assessment. These projects are:

a. The Trace Element Toxicity Study in which phytotoxic thresholds were determined for nickel and zinc for various turf grasses and crops. b. The USX South Works Slag Reclamation Project in which the leaching of metals, and inorganics and organic priority pollutants from biosolids has been studied under worst case conditions. c. The molybdenum leaching study which is being designed and will be contracted out shortly. d. Pathogen exposure assessment at land application sites.

Response EPA appreciates the offer to share this data. As stated previously, a key feature of EPA's sewage sludge program is an active outreach and cooperative effort with all sewage sludge Stakeholders.

EPA Log # 24: Hampton Roads Sanitation District ( HRSD)

Comment As a generator of biosolids, HRSD appreciates the undue pressure that has been placed on EPA with regards to biosolids land application. We have experienced firsthand the public resentment to an ecologically appropriate program. Additional biosolids regulations have been promulgated in our State in response to public emotion rather than the introduction of new scientific information. HRSD believes this to be a disturbing precedent and would like to see EPA take the lead in stopping this trend. It can only be accomplished by EPA actively seeking quality data and initiating valid exposure assessment studies. Exhibiting a strong presence in the oversight of biosolids management will go a long way in restoring public confidence. Any new regulations should be the result of peer reviewed information and not an attempt to quiet false claims of public endangerment.

Response EPA appreciates and agrees with these comments. Today's Federal Register Notice demonstrates that EPA will continue to lead the National effort in the maintenance and improvement of an environmentally sound and cost effective sewage sludge management program.

Unknown EPA Log # 34: Anonymous USEPA, 2003d 148 Comment Also at issue is the EPA's extreme limitations placed on the NRC in terms of the scope of allowable recommendations. Many elements of biosolids management were outside of the NRC scope, fortunately the NRC presented the concerns it the report . It appears that the EPA is using the NRC's scope of study as a basis to avoid a wide number of recommendations. Some specific examples are : " EPA would be well advised to include more specific site requirements in its biosolids regulations, including minimum depth to groundwater, controls on winter application, and setback distances from residences" ( p. 89) and " the major problem discussed at the work shop was the Class A process criteria that do not take into account potentials for regrowth" ( p. 79). " EPA has not acted to revise the molybdenum standard" ( p. 50) and " radioactive contaminants were not included in the committee's assessment, even though the committee is aware that radioactive compounds may be present in biosolids" ( p. 28).

Another major issue is that the EPA response is only focused on human health. Noting page 28 of the NRC report the EPA issued the requirement: " the committee was asked to focus its evaluation on human health risks and not on plant, animal or ecological risks" This is despite the mandate by the CWA to set standards " adequate to protect public health and the environment from reasonably anticipated adverse effect of each pollutant" ( emphasis added). Issues raised in the NRC report pertaining to lack of enforcement, review, and impacts to surface water and ground water are not addressed by the EPA in the response.

Response EPA has considered all of the NRC recommendations. The final action plan described in today's Federal Register Notice responds to the most critical recommendations of the NRC and is designed to augment protection of public health from the land application of sewage sludge in an expeditious manner. Radioactive contamination as well as ecological effects from sewage sludge land application were not addressed by NRC although NRC was not constrained from considering and providing recommendations on the former. The issue of radionuclides in sewage sludge and their potential threat to human health is being addressed by a separate Inter Agency effort. A Federal Register Notice announcing this will be published by the end of Calendar 2003.

EPA did perform a screening ecological risk analysis ( SERA) on dioxins in sewage sludge ( Federal Register Notice of October 24, 2003). The results of this activity indicated that the presence of dioxins, which are highly toxic, environmentally persistent and bioaccumulative in land applied sewage sludge, did not result in a significant threat to ecological species. In addition, EPA applied the same ecological screening, which was applied to dioxins, to the chemicals which were screened, as described in today's notice. In the future, when a more robust ecological risk assessment methodology for land application of pollutants is available, EPA would expect to consider ecological impacts from these other pollutants in land applied sewage sludge in future Part 503 Rule amendments.

Land Application Company EPA Log # 26: Synagro Technologies, Inc. USEPA, 2003d 149 Comment The NAS/ NRC report made specific recommendations regarding EPA's management of biosolids programs. EPA has responded to these recommendations in a positive manner.

° Significance of NBP and other consensus organizations needs to be maintained. ° State and local regulatory and public health agencies should remain first points of contact and regulation for biosolids.

Response EPA agrees with these comments.

Associations EPA Log # 30: Tri TAC Comment EPA's Response to the NRC Report makes it clear that the NRC's overall finding that " there is no documented scientific evidence to indicate that the part 503 rule has failed to protect human health," but that additional scientific work is needed to reduce persistent " uncertainty" about the potential for adverse human health effects from exposure to biosolids, will be a guiding principle for EPA as its plans the future of its biosolids regulatory program. Acknowledging the limits of EPA's finite budget, and given the numerous recommendations made by the NRC, Tri TAC recommends that the EPA maximize its limited resources by targeting those areas that will directly address the public's persistent uncertainty and improve public confidence in the practice of land applying biosolids.

Tri TAC supports the EPA's initial strategy for responding to the NRC's recommendations. EPA has outlined three main objectives for attaining a better understanding of biosolids reuse and reducing the potential for, and uncertainty related to, human health impacts:

° Update the scientific basis of Part 503 by conducting research in priority areas; ° strengthen the biosolids program by evaluating results of completed, ongoing, or planned studies both within and outside EPA; and ° to continue ongoing activities for enhancing communication with outside associations and with the public.

These objectives largely mirror what Tri TAC contends that must be the EPA's priorities for strengthening its regulatory program for biosolids management.

Enhanced Communication EPA's third objective, to continue ongoing activities for enhancing communication with outside associations and the public, is by far the most critical for enhancing the broad understanding and public acceptance of the biosolids program. EPA's continued support of the National Biosolids Partnership's voluntary Environmental Management System program is certainly a key component of this enhanced communication, but the EPA's efforts must go further to ensure the public has confidence in the practice of land application. USEPA, 2003d 150 Ensuring Public Awareness of EPA's Regulatory Program It has grown increasingly clear to Tri TAC that the public, especially in California, as well as local elected and appointed officials, are not sufficiently aware of EPA's comprehensive regulations regarding the land application of biosolids and, as such, are more susceptible to determining that biosolids are not beneficial. Local hearings in California and in Arizona on whether to prohibit the land application of biosolids have increased and it is critical that these local decision makers hear from EPA that the Part 503 biosolids regulatory program ensures that land application is performed soundly and safely. Tri TAC recommends that EPA designate a specific staff position to voice EPA's perspective at such hearings and, more generally, to ensure that the Part 503 program's safeguards are broadly understood. This is a task that simply cannot be performed by other stakeholders and would go far toward guaranteeing that decisions regarding the land application of biosolids are made not on the basis of emotional and potentially misleading accounts, but on a full understanding of the safeguards currently in place. Should EPA not have the resources to hire someone new for such a position, EPA should make every effort to use its current staff at both Headquarters and/ or in the Regions to testify at these hearings and ensure that the EPA's perspective is voiced.

Biosolids Management The NRC Report recommended that EPA devote additional human resources to management and oversight of the federal biosolids program. Tri TAC understands that EPA bases its allocation of resources to its biosolids compliance and enforcement program on its assessment of the risks to public health and the environment posed by biosolids and understands that, given the low assessed risk, the biosolids program has not been identified as a high priority area for Agency resources. Nevertheless, as mentioned above in the General Comments section of this letter, Tri TAC believes that some additional funding for staff at the national level is warranted to improve communication with the public on the Part 503 program and the safeguards it provides.

As EPA collects new information with regard to implementing the NRC's recommendations, EPA should continue to evaluate whether the resources currently committed to the biosolids program are adequate. Tri TAC's welcomes any increase in resources, at the federal or state level, deemed necessary by the NRC or EPA to strengthen this critical program.

Tri TAC does not believe that the responsibility for making additional resource commitments rests solely with EPA. States, including California, also need to make commitments, especially in the areas of compliance assistance and enforcement. These types of investments will no doubt be challenging given the current economic condition of many state budgets, but such resource commitments will prove to be more than cost effective in the future. EPA should consider contributing additional funding to states to implement their own programs and take steps to remove roadblocks that hinder or prevent states from receiving approval authority to administer such programs. State run biosolids programs can improve biosolids management practices by providing more local technical support and reducing compliance activities associated with multiple permitting and regulatory requirements. USEPA, 2003d 151 Response EPA is in general agreement with these comments as reflected in the final action plan described in today's Federal Notice.

EPA Log # 27: California Farm Bureau Federation Comment The ISG's supposed " large cooperative study" is limited and does not respond to the NRC's recommendations.

The notice, at 68 FR 17392, refers to an Information Sharing Group ( ISG), established to " work jointly with about 25 scientific experts in a large cooperative study of odor, particulates, pathogens and endotoxins in the air around biosolids and animal manure land application sites." In reality, the study is limited to five very small application sites with:

Scarce or nonexistent historical records or data as to the constituents that are in the biosolids and whether they have ever elicited health effects. Not all chemicals are being analyzed in emissions, and therefore all chemicals that could potentially be emitted during land application will not be known. Furthermore, these are case studies and may have limited value for predicting outcomes related to emissions, exposure, odor and irritation at other sites that utilize biosolids.

Moreover, this study is not a health effects study and thus " does not address those NRC recommendations." Therefore, the USEPA should not rely on the ISG and the referenced study for conclusive health effects data or as a valid response to NRC concerns.

Further research must be conducted by neutral entities with no economic interest in the results.

The public is skeptical of research activities that are funded and/ or performed by entities that have a vested interest, primarily economic, in the continuation and expansion of biosolids land applications and that, at the same time, oppose any limitations to their activities. It is not apparent that completely unbiased research can ever be conducted by such entities, due to their inherent conflicts of interest. In order to restore public faith in the investigatory and regulatory duties of the USEPA, the USEPA must not play the role of both regulator and promoter of biosolids. USEPA biosolids research funds should be directed to neutral research bodies that have no predetermined expectations or economic interests in the results. Only in this fashion will the public gain confidence in the USEPA's processes and better accept the associated risk assessments and regulations governing biosolids use in this country.

Response See the Summary Response in this section of this document. EPA in previous sections of this document has responded to the issue of " tainting of information" received from stakeholders associated with the wastewater treatment industry. All data from all stakeholders will be considered and evaluated by EPA against the standards of EPA's Data Quality Guidelines. As stated before, EPA no longer " promotes" the land application of sewage sludge. Rather it is EPA's position that the choice of a use or disposal practice for sewage sludge management is the responsibility of local communities that generate sewage sludge as long as the chosen practice USEPA, 2003d 152 meets all of the appropriate requirements of the Part 503 Standards and complimentary State standards for the chosen sewage sludge management practice.

EPA Log # 50: Water Environment Federation ( WEF)

Comment Cooperation, Collaboration and Inclusion   The proposed strategy emphasizes teaming with other agencies, which should improve perceived credibility and optimize the use of USEPA resources, and the inclusion of stakeholders. The Pennsylvania study, which was referenced several times in the report, is a model of this cooperative, inclusive approach and should serve as a model for other initiatives noted in this strategy.

The strategy identifies proposed short term and long term priority actions. Under item 4 of the long term goals, EPA indicates that its approach includes " promoting policy and procedural guidance for ensuring and maximizing the quality of information disseminated". WEF recommends that this be included as a short term goal to make sure that information disseminated by EPA adheres to a basic standard of quality. EPA also included " review available data, track ongoing studies by researchers outside of EPA, and identify information" as short term actions. WEF is available as an information resource to assist EPA in this task and is willing to provide any applicable WEF data or information.

In the case of biosolids, EPA has not been effective in coordinating and reviewing the data that is routinely submitted by Publicly Owned Treatment Works ( POTWs) and other affected parties to the regions. WEF believes that this data needs to be coordinated better by EPA in order to base any of its enforcement actions and priorities. EPA should allow electronic submission of biosolids quality data from POTWs and other affected parties. Electronic submission of biosolids data would alleviate the need for regional staff to reenter this data, maintain accuracy by the submitter, and allow EPA to compile, analyze, and document this information in a timely fashion. Electronic submission of data would also facilitate continued and increased usage of an existing data management tool, the Biosolids Data Management System ( BDMS), and help make it into a more complete database.

H. Biosolids Management WEF supports the use of multiple approaches and groups proposed by EPA to insure that POTWs have the tools available to promote and go beyond compliance with biosolids regulations. WEF also agrees with the NRC recommendation that EPA increase its resources devoted to the biosolids program and expand biosolids program activities.

The commitment to improved risk communication as EPA embarks on the ambitious program set forth in this strategy is also encouraged, since a lack of understanding regarding the actual risks associated with biosolids use remains a key obstacle to its acceptance. EPA must improve its ability to communicate with the general public, elected officials, and other key groups. WEF believes that these groups must be better informed about improved biosolids quality and know where and how biosolids are being recycled and overseen. EPA needs to inform stakeholders of the real causes of alleged problems from the use of biosolids and to inform these groups of the USEPA, 2003d 153 benefits of recycling biosolids and other by products, especially in relation to manures and chemical fertilizers, both of which are used in far greater quantities than biosolids.

EPA should continue its support for the Environmental Management System for biosolids under development by the National Biosolids Partnership. The NBP has been aggressively promoting excellence in biosolids management practices from within the biosolids community through the development of the EMS. The EMS is a creative and progressive program intended to help assure compliance and go beyond regulatory compliance, serve as a tool to enhance facility performance, and address concerns in local communities such as odors and noise. WEF believes that the NBP's EMS program will also allow regulatory agencies to better target their enforcement and compliance efforts.

Response EPA is in general agreement with these comments.

EPA Log # 46: Association of Metropolitan Sewerage Agencies ( AMSA)

Comment Enhanced Communication EPA's third objective, to continue ongoing activities for enhancing communication with outside associations and the public, is by far the most critical for enhancing the broad understanding and acceptance of the biosolids program. EPA's continued support of the National Biosolids Partnership's Environmental Management System program is certainly a key component of this enhanced communication, but the Agency's efforts must go further to ensure the public has confidence in the Part 503 program and the practice of land application.

Ensuring Public Awareness of EPA's Regulatory Program It has grown increasingly clear to AMSA that the public, both at the local and national levels, as well as local elected and appointed officials, are not sufficiently aware of EPA's comprehensive regulations regarding the land application of biosolids and, as such, are more susceptible to determining that biosolids are not beneficial. Local hearings around the country on whether to prohibit the land application of biosolids have increased and it is critical that these local decision makers hear from EPA that the Part 503 biosolids regulatory program ensures that land application is performed soundly and safely. AMSA recommends that EPA designate a specific staff position to voice EPA's perspective at such hearings and, more generally, to ensure that the Part 503 program's safeguards are broadly understood. This is a task that simply cannot be performed by other stakeholders and would go far toward guaranteeing that decisions regarding the land application of biosolids are made not on the basis of emotional and potentially misleading accounts, but on a full understanding of the safeguards currently in place. Should EPA not have the resources to hire someone new for such a position, the Agency should make every effort to use its current staff at both Headquarters and/ or in the Regions to testify at these hearings and ensure that the Agency's perspective is voiced.

Biosolids Management The NRC Report recommended that EPA devote additional human resources to management and oversight of the federal biosolids program. AMSA understands that EPA bases its allocation of USEPA, 2003d 154 resources to its biosolids compliance and enforcement program on its assessment of the risks to public health and the environment posed by biosolids and understands that, given the low assessed risk, the biosolids program has not been identified as a high priority area for Agency resources. Nevertheless, as mentioned above in the General Comments section, AMSA believes that some additional funding for staff at the national level is warranted to improve communication with the public on the Part 503 program and the safeguards it provides.

As EPA collects new information with regard to implementing the NRC's recommendations, the Agency should continue to evaluate whether the resources currently committed to the biosolids program are adequate. As stated in our January 30, 2003 letter, AMSA's members are top performers in the industry and would welcome any increase in resources, at the federal or state level, deemed necessary by the NRC or EPA to strengthen this critical program.

AMSA does not believe that the responsibility for making additional resource commitments rests solely with EPA. States also need to make commitments, especially in the areas of compliance assistance and enforcement. These types of investments will no doubt be challenging given the current economic condition of many state budgets, but such resource commitments will prove to be more than cost effective in the future. EPA should consider contributing additional funding to states to implement their own programs and take steps to remove roadblocks that hinder or prevent states from receiving approval authority to administer such programs. State run biosolids programs can improve biosolids management practices by providing more local technical support and reducing compliance activities associated with multiple permitting and regulatory requirements.

Response EPA is in general agreement with these comments. EPA appreciates the comments speaking to resources available to EPA and EPA's decision to allocate these resources to issues and activities that can be the most effective in enhancing public health.

Counties EPA Log # 28: Solano County Department of Environmental Management Comment 5. Biosolids Management In its response, the USEPA states that it is " committed to improving the effectiveness of risk communication at national, regional, and local levels". In addition, the USEPA discusses an Information Sharing Group ( ISG) which has representatives from Federal and State regulatory agencies. Solano County DEM recommends that input from local regulatory agencies be sought as well. Nationally, most of the compliance monitoring of the existing Part 503 regulations is either done through self regulation by the biosolids applicator or through very limited monitoring by Federal and State agencies, and actually falls to local jurisdictions. In the State of California, few local agencies choose to continue to allow the land application of biosolids because concerns over long term impacts. Solano County and the Department of Environmental Management, as a local government agency responsible for regulation of the land application of biosolids, welcomes USEPA, 2003d 155 USEPA's efforts to improve risk communication and looks forward to any opportunity to be an active stakeholder and provide input into the biosolids program.

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

States EPA Log # 52: Washington State Department of Ecology Comment As the primary state lead witnessing the near devolution of the federal program over the past several years I find myself somewhat in disagreement even with the basic way EPA describes its own program. EPA notes for example that there are enforcement and compliance staff in each regional office and that EPA continues to meet its statutory obligations. In these regards I can only conclude that EPA is somehow viewing the national program from an almost diametrically opposite position. Having staff for compliance and enforcement activities under the CWA is not the same thing as doing something with regard to biosolids program implementation. I have seen EPA's own data belying this argument. I do not know what is strictly meant by EPA's statement that it continues to meet CWA obligations for the program. Reports by the OIG in recent years have clearly described the opposite circumstances of an adequately funded and well implemented program. EPA even backpedaled so far in its interpretation of statutory obligation as to assert that the national program is self implementing and no permits are required, yet it is clear from reading of the CWA that that standards for biosolids are to be implemented in a permit program. Indeed, if this is not the case then why does EPA not dispense with the majority of the review process for proposed delegation to states and simply turn the federal program over?

I know many states and persons will recall clearly a time in the not too distant past when EPA went on record as disinvesting in the national biosolids program. Resources were of course a factor and will likely always be a factor, but a common thread throughout this process and one clearly reflected in EPA's present response to the NRC report is the persistent belief that biosolids pose a low risk to public health and the environment and therefore warrant a low priority in terms of resource allocation. EPA says in fact in its response that it has based allocation of resources on its assessment of relative risks to public health and the environment from biosolids. Respectfully, this thinking is in error.

Properly managed and with proper oversight, biosolids do not pose a significant risk to public health and the environment. It is more than evident, however, that many members of the public and even some agency staff at both federal and state levels do not share this belief. Concerns are only exacerbated by the common knowledge that EPA is not adequately implementing this program. In the business of risk management EPA should remember that perception = reality. Further, the capital and operating costs associated with the production, treatment and management of biosolids from treatment works are a significant portion of total costs, ranging to 30 40% by some accounts. While I do not question that clean water should be a higher priority for national and state environmental programs, EPA's attention to the second major effluent stream produced by treatment works has been disproportionate as compared to the resources USEPA, 2003d 156 invested by treatment works and overall has simply been inadequate. Assumptions that public concerns are somehow mollified by assurances of low risk do not hold up under even the most casual scrutiny where there are conflicts around alleged impacts to public health. Further assumptions that the national program can remain viable on a diet of assurances are ill advised at the very best. Not to diminish at all the hard work of many operators, consulting professionals, scholars, and trade organizations across the country, it is a simple fact that the viability of the national biosolids program has been largely sustained for several years by a relative handful of extraordinarily dedicated staff at the federal and state levels. I do not believe EPA as an institution has fully appreciated the level of effort and sacrifice that has been required of some of these people. Recognizing that some prioritization will occur and expecting that perhaps not all resources necessary can be allocated toward meeting the NRC recommendations, EPA must cease the caveats, pull back from ideas borne of program disinvestment philosophy, and look within itself to reprioritize the funds necessary to adequately address the majority of the critical issues identified in the NRC report.

Regarding certain specific elements of the short and long term strategies

Major Short Term Goal # 1. Continue program implementation ( regulatory, compliance, and enforcement). If EPA is sincere in its statement of intent in this case then here is an example which rather well defines the contrasting viewpoints on federal performance. The Office of Inspector General has criticized EPA's implementation of the national biosolids program in two consecutive reports. Implementation of the federal program is virtually non existent in some respects. States have consistently criticized EPA or begged for action as regards certain aspects of program implementation. EPA has responded either with disinvestment philosophy or with a " biosolids is a low priority" mantra. The recommendation of this very first major short term goal reads essentially, continue the status quo.

The recommendation should read, " Objectively assess the status of national biosolids program implementation including the findings of the Office of Inspector General and propose and implement the best improvements that can be managed over the next two fiscal years." I believe there would be support for such a goal statement. Continuing to do what has largely been deemed inadequate seems neither laudable nor advisable.

Other Major Short Term Goals. The remaining six major short term goals can be dissected to varying degrees but generally are acceptable as goal statements, except for the question of prioritization. I see many of these goals as interdependent. One may not be fully accomplished without the input of another, or the benefit of one cannot be recognized without the accomplishment of another. For example, if EPA accomplishes the first six goals for the short term, and yet makes no progress on the seventh  a standardized incident response approach  then much of the merit of what is accomplished with the preceding goals will not be applied to critical case situations. Rather than look at these short term goals in strict order of priority, I encourage EPA to think in terms of concurrent implementation with optimum progress measured for each goal by the way it serves to answer the needs of the others. Hopefully some of the new USEPA, 2003d 157 staff in the Office of Water ( mentioned later in EPA's response) can assist in carrying out the necessary work to accomplish all of these goals.

Long Term Major Goal# 1: Continue program implementation ( regulatory, compliance, and enforcement). Regarding program implementation, please refer to the previous discussion above regarding funding and allocation of resources.

Other Major Long Term Goals. Generally the goals of updating and strengthening the national program by conducting appropriate research and incorporating new information speaks to an evolving and improving program ( assuming adequate resources). Such goals are very supportable. I also support goal four in particular, regarding partnerships. While I will not be hesitant to criticize EPA for its implementation shortcomings, one area where the agency has made some good choices is in partnering. I see the time as ripe for expanding partnerships, strengthening connections to research institutions and tapping the expertise and support of other agencies such as USDA and CDC. Continued good partnering, however, requires a more realistic discussion of EPA's commitment to program implementation and an appropriate shift of resources to support necessary changes and accomplishments.

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

EPA Log # 53: Michigan Department of Environmental Quality Comment Major Short Term Goal # 1. Continue program implementation ( regulatory, compliance, and enforcement). Continuation of the Biosolids program as is currently practiced is not acceptable. A Wastewater Treatment Plant produces two major effluent streams, the treated water and the biosolids. The water discharge has long been addressed by EPA and has gotten the major amount of attention and funding. The biosolids produced were treated as an afterthought. In many plans they are addressed as an arrow off the page; " Biosolids to Disposal." Inadequate biosolids planning has caused ongoing operational headaches for a significant number of wastewater treatment plants and those plants turn to the states and EPA for guidance. In many cases the biosolids support staff needed have simply not been present. Continuing in the status quo is unacceptable. The Agency must commit to an increased program in both resources and staffing.

Response Please see the Summary Response to this section of this document. EPA believes that the action plan announced in today's Federal Register Notice " reinvigorates" and improves EPA sewage sludge program and subsequently enhances the visibility of environmentally appropriate sewage sludge management practices at the local level.

EPA Log # 45: Florida Department of Environmental Protection Comment Biosolids Management   Regional Office Resources: The subject of resources for oversight by the regional offices, particularly field staff, are not adequately addressed by this response. USEPA, 2003d 158 The current levels of staffing and enforcement by both EPA and states were known by the NRC panel during their study. Also, past EPA reports and documents that were available to the NRC panel would have indicated to the panel the general EPA position of basing funding for the biosolids program on the assessment of relative risks. However, it was after reviewing this information that the NRC panel came to the conclusion that increased resources were needed and thus, made the recommendation that EPA increase oversight resources.

We recommend EPA consider increasing regional office resources as recommended by the NRC report.

Biosolids Management   State Funding: As mentioned above, despite knowing the current extent of state programs, the NRC panel recommended the EPA provide funding to state programs to help them provide additional, sufficient levels of oversight. While it is recognized that many of the EPA sponsored activities such as the annual EPA funded state regulators meeting, the National Biosolids Partnership, the Biosolids Data Management System, and other activities are very beneficial to states and are vital to continue, additional funding would help states maintain and increase biosolids staffing levels.

Since statements in other parts of the EPA draft response indicate that EPA is relying on states for enforcement of biosolids activities, it is recommended that the EPA reconsider the NRC recommendation of providing funding to states to support the biosolids program.

Biosolids Management   PEC: The NRC called for the Pathogen Equivalency Committee ( PEC) to be formally funded, supported, and officially sanctioned as an integral part of the federal biosolids program. However, it appears that the EPA response only commits to continuing to operate the PEC as it does now, without formally allocating staff time, funding, or providing recognition in agency mission statements.

We support the NRC recommendations regarding the PEC and it is recommended the EPA response be revised to commit to this recommendation.

Response See the Summary Response to this section of this document.

EPA Log # 48 and 39 ( duplicates): Wisconsin Department of Natural Resources Comment Several key areas should be given special consideration by the Agency as the evaluation of the biosolids program continues and future policy decisions are made. These issues are of national importance and include:

1. The viability of a national biosolids program which includes responsible biosolids recycling will be in question without a firm commitment of resources. Those resources need to be in both staffing levels and dollars. EPA should: provide access to expert technical support to states and maintain a national technical support program to include the Pathogen Equivalency Committee USEPA, 2003d 159 ( PEC), provide general program oversight, coordinate and implement research and a research plan, and provide permitting activities in non delegated states. The Agency should encourage and facilitate state delegationthrough the transfer of funds from Congress.

2. Program priority should not be based on risk alone, but rather on the necessary level of program support and research to maintain its viability. Local restrictive bans on land application are often in response to a real or perceived lack of oversight in a particular locale and result from a lack of public confidence in program integrity. Public confidence in program oversight, regulatory adequacy, and long term viability of Agency objectives should be considered when assessing priority.

3. The issuance of permits to sludge generators/ biosolids recyclers is critical to demonstrate effective oversight and ensure compliance. A commitment is mandatory to achieve this either through the NPDES program, RCRA, the Safe Drinking Water Act, or the Clean Air Act. The permit issuance serves as the link between the regulator and the regulated entity. Once permits are issued, a standard protocol for compliance assistance and enforcement can and should be developed and implemented.

Many of the stated objectives and responses are laudable. However, funding and resources for any of them is uncertain at best and unlikely at worst unless EPA as an Agency and Congress specifically commit them. The federal government has contributed some 25 billion dollars in grants and another 7 billion dollars in low interest loans to allow for capital expenditures to provide adequate sludge treatment in this nation between 1972 and 1999. This is a tremendous investment that must be secured through adequately protective regulations and effective implementation of those regulations. Moreover, the recycling of biosolids is a program which demands public support for long term viability, and that support comes from confidence in the scientific basis for regulations, adequacy of research initiatives, and regulatory oversight of the program. While most of the nation still enjoys strong support for this important recycling program, there are pockets of vocal opposition which result in restrictive ordinances or bans and these are generally in areas where there is the real or perceived belief that program oversight is inadequate. We have clear knowledge borne from experience that what occurs in one state impacts other states and thus this is truly a national issue which must be supported at the federal level. Wisconsin has a long standing model biosolids program in which more than 98% of biosolids generators ultimately recycle biosolids. Without an effective national program, if recycling does not remain a viable option, the capital cost for converting from land application to disposal in licensed landfills in Wisconsin alone, would exceed 315 million dollars in capital expenditures and more than 40 million dollars in increased annual operating costs. However, perhaps the most significant cost would be the abandonment of a successful program due to the shortsighted insistence that it is a low risk program and equating that with a low priority. Priority should not be based on risk alone, but rather on the necessary level of program support and research needs to maintain its viability.

The following comments are in reaction to the Agency's preliminary strategy for responding to the NRC report recommendations. USEPA, 2003d 160 1. Section VII short term goals FY 03 04 and long term goals FY 05 and beyond  Goals to be "  subject to available resources ". It is recognized that these are austere budgetary times and that priorities must be set to maximize the benefits of expenditures. However, a policy decision is needed at the Agency and in Congress regarding support for this program. The recommendations in the NAS report were made in the context that recycling biosolids was conceptually good public policy but which needed work done to ensure its safety and resources to ensure its implementation. Either Congress and EPA agree with this or they do not. A commitment of resources to support the beneficial use program is required now or a commitment of resources to expand landfills or construct incinerators will become necessary in the immediate future. States fully support the former. The Agency should state its position and financial commitment in either case. See comment 2.

2. Section VII. Short term and long term goals 1. States as its goal: Continue program implementation ( regulatory, compliance, and enforcement). Less than one tenth of one percent of the Agency's budget is devoted to the biosolids program ( NAS 2002, pg. 54 55). In recent years five letters have been written by WDNR to EPA on behalf of all states seeking increased federal support for the program. The EPA Inspector General has listed biosolids as one of the Agency's ten most deficient programs. Clearly continuing in the status quo is unacceptable. The Agency must commit to an increased program in both resources and staffing. In addition, EPA should advocate further partnering with states through facilitation of the delegation process and make funds available for states to implement their own program.

3. Section VII. Last paragraph assumes the same level of funding in future years as is currently allocated. If this is true, then virtually none of the proposed response objectives will be able to be completed. EPA should be specific regarding the funding levels and what can and can't realistically be accomplished. Consideration should be given to promoting research at Universities through existing grant programs.

21. Section VIII. H. Biosolids Management  Biosolids Management Activities  It is claimed that the number of regulatory staff in the Office of Water ( OW) at EPA Headquarters has recently been increased. If this is the case, specific details should be provided. Within OW, the Office of Wastewater Management, which includes the Permits Branch and the Municipal Technology Branch have not had any staff increases of which we are aware. Even the NAS report acknowledged that Regional offices will take enforcement action if necessary but there is a complete lack of national direction in assuring compliance and how to take enforcement action. EPA claims to meet its statutory requirement under the Clean Water Act pertaining to sewage sludge. However, there continues to be a complete absence of involvement by the Permits branch in the biosolids program which is in stark contrast to 33 USCS s 1345 ( f). This section states that any permit issued under section 402 of this act which is the NPDES program, to a POTW treating sewage sludge shall include requirements for the use and disposal of sludge unless they are covered under a permit issued under RCRA, the Safe Drinking Water Act, or the Clean Air Act. While 40 CFR part 503 is enforceable even without a permit, it appears that it is EPA's position that they are therefore exempt from permitting requirements. States disagree vehemently and believe, as stated in the report, that POTWs serve two equally important functions: to clean water USEPA, 2003d 161 for discharge back to surface and groundwater and to effectively treat sludge such that it can be safely recycled to the environment or otherwise disposed. Both are outfalls that should be regulated through the NPDES program. In Wisconsin, this has been done since the mid 1970s and has resulted in strong public support for biosolids recycling and more than 98% of facilities recycling. As stated previously, priority should not be based on risk alone but should consider what is necessary for program viability. EPA should take and articulate a firm position in this matter including permit activities.

22. Section VIII. H. Biosolids Management  Biosolids Management Activities  It is stated that EPA has revised Chapter 10 of its NPDES inspection manual, which covers sludge treatment and biosolids use. However, since there is no involvement from the permits branch of OW and since sludge outfalls are seldom if ever included in effluent NPDES permits, there is no compelling reason for inspectors to include biosolids in their inspection. This must be mandated as a necessary component of inspections and has not been done to date. EPA should clearly state its position on this matter and articulate it for the record.

23. Section VIII. H. Biosolids Management  Biosolids Management Activities  It is stated that PCS is being modernized and the recommendations of a biosolids workgroup, on which I served, was endorsed by the PCS Executive Council. How firm a commitment will EPA make on the record to include all the data elements the workgroup recommended? It is feared that since so little reporting is required by regulation that many of the recommendations will be cut if the budget becomes tight. Even though many of the elements are not mandated by regulation it is believed that they are mandatory for effective oversight and program assessment. The Agency should commit for the record to include all recommended data elements. The Agency should likewise articulate their plans for the existing Biosolids Data Management System ( BDMS) and both systems potential to link to state databases.

24. Section VIII. H. Biosolids Management  Biosolids Management Activities  It is stated that EPA " will continue to support and evaluate the activities of the PEC." As stated previously above, there is currently woefully inadequate support of both resources and staff time dedicated to the PEC, and thus " continued" support is an unacceptable response. Please see comment 14 above.

25. Section VIII. H. Biosolids Management  Biosolids Management Activities  State Regulations  It is stated that 40 CFR part 503 is enforceable without a permit. Even if this is true, the permit ( under NPDES or other programs) is the necessary mechanism for tracking compliance and serves as the link between the regulating authority and the regulated entity. This link does not currently exist at an adequate federal level and is variable at the state level. Federal dollars should be made available for states to implement this program, as it is for the NPDES effluent program, and delegation should be facilitated. As stated above in comment 21, enforcement activity is defined and initiated through the permit process. EPA should clearly state its position on permitting, enforcement, and state delegation.

26. Section VIII. H. Biosolids Management  Planned Biosolids Management Activities  It is stated that EPA will set biosolids priorities based upon results of objectives presented in this USEPA, 2003d 162 response and an evaluation in the broader context of other agency priorities. EPA should consider in this evaluation not only risk but also what base line support is necessary to maintain a viable recycling program and the costs of allowing that program to fail. This intent and details to implement it should be clearly stated and provided in the final plan.

27. Section VIII. H. Biosolids Management  Planned Biosolids Management Activities  There is a small but growing movement in the nation to consider banning the land application of Class B biosolids and require treatment to meet Class A pathogen control. This alone will not eliminate odors, and will in fact enhance them in some cases. Nor will it eliminate all other management or pathogen issues and therefore individuals may be misguided in the belief that this is a panacea. Effective treatment at the Class B level along with effective site management and regulatory oversight is critical for program success. The Agency should reaffirm this and provide the mechanisms necessary to ensure its implementation.

Response Please see the Summary Response to this section of this document. As stated before, today's action plan and its implementation includes an appropriate level of EPA resource commitment both in terms of EPA personnel and extramural funds.

PA Log # 38: New England Interstate Water Pollution Control Commission ( NEIWPCC)

Comment Foremost among our concerns is the continued relative low priority in terms of oversight and resources that EPA has assigned to biosolids management. The National Research Councils findings, as described in their June 2002 report  Biosolids Applied to Land ( NRC Report), clearly states: `` EPA provides insufficient support and oversight to the biosolids program. EPA gives low priority to its biosolids program, because it contends the risk from exposure to chemical and pathogens are low and that land application programs generally function as intended and in compliance with the regulations. This contention should be better substantiated."

The NRC Report goes on to specifically recommend the following:

EPA should strengthen its biosolids oversight program by increasing the amount of funding and staff ( technica1and administrative) devoted to it.

EPA should provide additional funds ( not diverted funds) to states to implement biosolids programs and facilitate delegation of authority to states to administer the federal biosolids regulations.

EPA's response to the Biosolids Management findings and recommendations does not appear to adequately address the resource issues raised in the NRC Report. EPA's response to the findings and recommendation contained in the NRC Report appear to have been developed solely within the Office of Water without the support or " buy in" from policy makers within the Agency who have the authority to allocate resources. Virtually every effort outlined in the response is predicated by the repeated phrase " subject to available resources ". USEPA, 2003d 163 One particular statement in EPA's response to the Biosolids Management category that the majority of the NEIWPCC Residuals Workgroup members do not agree with is contained on page 17391 of the Federal Register notice, which states " There is also an enforcement or compliance presence in each of the EPA Regional Offices for following up on phone calls and complaints received from the public, and initiating Agency enforcement actions, as appropriate." The NEIWPCC Residuals Workgroup is of the majority opinion that there is an imbalance between EPA Regional Offices in terms of biosolids program enforcement and compliance. In some EPA regions, federal biosolids management enforcement or compliance activities are virtually nonexistent.

While the NEIWPCC Residuals Workgroup agrees with the concept that biosolids management when done in compliance with the regulations poses a low risk, two indisputable facts of biosolids management are that: 1) the pathogen concerns associated with biosolids management have the potential to pose significant risk in substandard management scenarios, and 2) there remains a significant degree of public skepticism and dispute as to the adequacy of the federal regulations and federal oversight that ensure that these activities are conducted in a manner which poses an acceptable level of risk. For the benefit of states seeking delegation and in order to allow ERA to better focus its limited biosolids management resources, the majority of NEIWPCC Residuals Workgroup members encourage EPA to facilitate the processing and granting of state requests for delegation of their biosolids program.

The majority of NEIWPCC Residuals Workgroup members believe that the NRC Report recomendations, if implemented, will provide the knowledge necessary to either validate the regulation as it currently stands, or to revise the regulation should such an action be warranted. Validation and/ or revision of the regulation, when coupled with an elevated commitment on the part of EPA to provide federal oversight, guidance, and compliance/ enforcement efforts, can only serve to increase both the effectiveness of regulatory programs at the state level as well as public acceptance of biosolids management practices at the local level.

These points having been made, we are in concurrence with the actions outlined in the Agency's response but strongly urge the Agency to revisit the overarching policy that denies the program sufficient funding to successfully carry out this agenda.

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

EPA Log # 59: New Jersey Department of Environmental Protection Comment There are many worthy short and long term goals identified ( Section VII). The EPA needs to identify program staff whose responsibility it will be to ensure implementation of the goals. Within the next year, there are at least two major Research Symposiums which should help to establish a prioritized research agenda. Without appropriate coordination and staff resources at the federal level, any research effort will not be optimally effective towards achieving the stated goals. USEPA, 2003d 164 With respect to a prioritized agenda, the Department believes that high priority should be given to conducting field studies and surveys to validate that Class A and Class B treatment processes for pathogens perform as currently believed. In addition, to improve the rules for the use or disposal of biosolids, the EPA should consider the NRC recommendation to investigate additional indicator organisms ( such as Clostridium perfringens) for potential use.

The Department believes that it should be EPA's priority to facilitate the delegation of the biosolids program to qualified state agencies by reducing the resource burden required to obtain delegation. Specifically, there are many states that maintain superior biosolids programs. Nevertheless, the delegation application process results in undue paperwork and administrative burdens. The delegation process can and should be greatly simplified to two elements by allowing states ( 1) through their Attorneys General to certify the State's statutory and regulatory authorities, and ( 2) via letter from the Governor of the state to request program approval to reaffirm the State's commitment to carry out delegation. Equally important, the facilitation of state delegation should be encouraged by providing federal funds for states to implement the program.

Upon delegation, the state programs can relieve EPA of much of the work involved in continuing to implement the program ( regulatory, compliance, and enforcement). This would allow EPA to shift resources to address the other NRC recommendations and to provide needed expertise and technical support to the states. Nevertheless, a commitment of resources at the federal level is absolutely essential to implement these recommendations. At a minimum, the EPA should fully fund at least one position in each of the EPA regions to serve as biosolids coordinator. In addition, adequate staff positions must be specifically earmarked for the biosolids program to maintain a national technical support program, general program oversight, research and research coordination, incident response and human health investigations, and permitting activities in states that do not maintain an active biosolids program.

Response Please see the Summary Response to this section of this document. EPA has continued to pursue State delegation of the Part 503 Standards. Many states have good sewage sludge programs. However, it is true that only five state programs have been approved for administering the Part 503 sewage sludge program ( Utah, Oklahoma, Texas, South Dakota, and Wisconsin). Fifteen more states have indicated some interest in obtaining program approval, but there are issues that need resolving, such as self audit restrictions, insufficient public notification, and lack of state funding.

TOPIC I. GENERAL OR OVERARCHING Summary Response: The NRC panel provided several overarching recommendations to EPA in the Summary section of their report to stress their importance. The NRC Panel also elaborated on the overarching recommendations by placing detailed discussions of these in approximately 60 specific recommendations which make up the bulk of the NRC Report. Sections A H of this document have responded in detail, by Comment Topic Category, to all comments related to USEPA, 2003d 165 NRC specific recommendations. Therefore, in this section of this document, EPA is responding specifically to those comments that were not addressed in Sections A H of this document.

Academia EPA Log # 51: Ellen Z. Harrison Comment General comments Thank you for this opportunity to comment on EPA's proposed response to the National Research Council ( NRC) recommendations. As a member of the NRC Biosolids committee, I am intimately familiar with the report and its recommendations. Since reports can end up sitting on a shelf, it is helpful to have this public airing of the ways in which EPA plans to respond to the recommendations. The involvement of the EPA Office of Research and Development in the response is a positive step.

In general the proposed EPA response is disappointing. The NRC report raised many concerns and detailed many recommendations. However, EPA seems to be basically endorsing the status quo and proposing little that is new or responsive.

These are the most glaring failures to address the NRC recommendations:

1. Human Health: Failure to commit to studies of health at sites where people reporting illness. Failure to commit to health surveillance at land application sites.

2. Failure to recognize the serious limitations of the NSSS regarding limits of detection so that when " failure to detect" is used to eliminate chemicals from consideration, chemicals may be eliminated due to the flawed survey rather than due to absence of the chemical in sludges.

3. Failure to commit to engaging stakeholders in risk assessment and research.

4. Failure to commit to revising risk assessment to include multi pathway aggregate risks; risks to sensitive populations; risks to children and fetuses; interactions between contaminants and pathogens.

5. Failure to require bulk EQ sludges to meet nutrient and site restrictions 6. Failure to commit to establishing regulations protective under reasonably anticipated high risk conditions.

7. Failure to suggest increased emphasis on/ resources for the sludge program.

One aspect of concern in addressing any recommendations is that EPA continues to use the same staff in the Office of Water who have been involved in the development and defense of the current sludge rules and program. I recognize that these are the people in the agency with relevant USEPA, 2003d 166 knowledge, but it is not surprising that a fresh and objective view is unrealistic to expect of people with such a long and vested interest in the status quo.

In responding to the NRC recommendations regarding updating the risk assessment, ORD and not OW should be engaged. This would both help to involve people with a fresh perspective, but would also involve people with greater expertise in risk assessment. It would also promote more consistent risk assessment between the sludge program and other EPA programs.

EPA mentions an incident investigation team that would respond to reports of problems at land application sites. Unfortunately, they appear to be using these same staff for that team. The investigative reports by EPA of incidents to date have not given the people claiming harm from sludge applications confidence in the EPA's objectivity. The incident reports are viewed as " white washes." That makes it highly unlikely that complainants will cooperate with EPA in the future. There needs to be an independent group established to investigate complaints, one not comprised of government agencies or professional associations at the federal, state or local level that have a stake in the regulation of sludges. There are many qualified people who would likely serve on such a body. I, for one, would be willing to serve on and help to organize such a group.