HHS General Administration Manual Part 30 Environmental Protection

The National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321-4370d, establishes policy and requirements governing all Federal Departments and agencies with respect to protecting the environment. This chapter supplements specific requirements established by NEPA and by the associated implementing regulations promulgated by the Council on Environmental Quality (CEQ) (40 CFR 1500-1508). This chapter also establishes Department policy and procedures with respect to the implementation of NEPA and provides guidance to HHS Staff Divisions (STAFFDIVs) and Operating Divisions (OPDIVs) in establishing additional regulations for implementing NEPA that are unique to each OPDIV/STAFFDIV.

NEPA requires all Federal Departments and agencies to assess, as an integral part of their decision making process, the potential environmental impacts of their actions prior to initiation of those actions. NEPA establishes environmental policy, sets goals (Section 101), and provides procedures (Section 102) for carrying out the policy. Specifically, Section 102(2)(C) of NEPA requires all agencies of the Federal Government to include an environmental statement "in every recommendation or report on proposals for legislation and other major Federal actions significantly affecting the quality of the human environment..." The purpose of this and other requirements is to ensure that environmental information is available to public officials and citizens before Federal agencies make decisions to take actions which could significantly affect the quality of the human environment.

1. CEQ Regulations Definitions. Definitions that apply to the terms used in this chapter are set forth in the CEQ regulations under 40 CFR Part 1508. The terms and the sections of 40 CFR Part 1508 in which they are defined follow:

Categorical Exclusion (40 CFR 1508.4)
Cooperating Agency (40 CFR 1508.5)
Cumulative Impact (40 CFR 1508.7)
Effects (40 CFR 1508.8)
Environmental Assessment (EA) (40 CFR 1508.9)
Environmental Document (40 CFR 1508.10)
Environmental Impact Statement (EIS) (40 CFR 1508.11)
Federal Agency (40 CFR 1508.12)
Finding of No Significant Impact (FONSI) (40 CFR 1508.13)
Human Environment (40 CFR 1508.14)
Jurisdiction by Law (40 CFR 1508.15)
Lead Agency (40 CFR 1508.16)
Legislation (40 CFR 1508.17)
Major Federal Action (40 CFR 1508.18)
Mitigation (40 CFR 1508.20)
NEPA Process (40 CFR 1508.21)
Notice of Intent (40 CFR 1508.22)
Proposal (40 CFR 1508.23)
Scope (40 CFR 1508.25)
Significantly (40 CFR 1508.27)


2. Chapter 30-50 Definitions. The following terms are defined solely for the purpose of implementing the supplemental procedures provided by this chapter and are not necessarily applicable to any other statutory or regulatory requirements. To the extent that a definition of one of these terms should conflict with a definition in an applicable statute, regulation or Executive Order, that statute, regulation or Executive Order definition shall supersede the GAM definition.

   "Department" means the U.S. Department of Health and Human Services (HHS)

   "Pollution Prevention" includes, but is not limited to, reducing or eliminating hazardous or other polluting inputs, which can contribute to both point and non-point source pollution; modifying manufacturing, maintenance, or other industrial practices; modifying product designs; recycling (especially in-process, closed loop recycling); preventing the disposal and transfer of pollution from one media to another; and increasing energy efficiency and conservation. Pollution prevention can be implemented at any stage -- input, use or generation, and treatment -- and may involve any technique -- process modification, waste stream segregation, inventory control, good housekeeping or best management practices, employee training, recycling, and substitution. Any reasonable mechanism which successfully avoids, prevents, or reduces pollutant discharges or emissions other than by the traditional method of treating pollution at the discharge end of a pipe or stack should, for purposes of this chapter, be considered pollution prevention. (This definition of "pollution prevention" has been adopted by CEQ. See Council on Environmental Quality, "Memorandum to Heads of Federal Departments and Agencies Regarding Pollution Prevention and the National Environmental Policy Act," 58 FR 6478 (1993).)

   Note: A definition of "pollution prevention" that has been developed by the U.S. Environmental Protection Agency is used in Chapters 30-60 through 30-90.

   "Responsible official" means the Secretary, the Departmental decision-maker designated by the Secretary of Health and Human Services or the Secretary's designated representative, or the Head of an OPDIV/STAFF, or an official designated by the Head of an OPDIV/STAFFDIV, or the Federal agency official who makes the decision to irreversibly and irretrievably commit the agency's resources to execute the proposed action.

3. Acronyms. The following acronyms are used in this chapter:

CEQB -- Council on Environmental Quality
CFRB -- Code of Federal Regulations
EA -- Environmental Assessment
EISB -- Environmental Impact Statement
EPA -- Environmental Protection Agency
FONSIB -- Finding of No Significant Impact
HHS -- U.S. Department of Health and Human Services
NEPA -- National Environmental Policy Act of 1969
NOIB -- Notice of Intent
OPDIV -- HHS Operating Division
ROD -- Record of Decision
STAFFDIV -- HHS Staff Division
U.S.C. -- United States Code

This chapter applies to all organizational elements of HHS. This chapter applies to any HHS action affecting the quality of the environment of the United States, its territories, or possessions. HHS actions having environmental effects outside of the United States, its territories or possessions are subject to the provisions of Executive Order 12114, Environmental Effects Abroad of Major Federal Actions, 44 FR 1957 (1979), 42 U.S.C. ' 4321 note. HHS guidelines implementing Executive Order 12114 are located at Section 30-50-75.

All HHS policies and programs will be planned, developed, and implemented so as to achieve the policies declared by NEPA and required by the CEQ regulations to ensure responsible stewardship of the environment for present and future generations.

Environmental impact consideration is an integral part of HHS's planning and decision-making process. For actions initiated by the Department or one of its OPDIVs/STAFFDIVs, the process begins when an issue is identified that requires action under the statutes it administers. The identifying organization also may issue a public call for environmental data or otherwise consult with affected individuals or groups when a contemplated action in which it is or may be involved poses potentially significant environmental impacts.

Assessment of environmental factors continues throughout planning and is integrated with other program planning at the earliest possible time. Assessment of environmental factors includes the identification of the parts of the environment that may be affected by the action, the evaluation of pertinent environmental data, and the consideration of alternatives consistent with 40 CFR 1502.14.

NEPA and the CEQ regulations establish a mechanism for building environmental considerations into federal agency decision-making. This mechanism will be used to incorporate pollution prevention into the early planning stages of a proposal.

OPDIVs/STAFFDIVs shall determine, utilizing the procedures in the CEQ regulations and this chapter, whether any HHS proposal:

1. Is categorically excluded from preparation of an EIS or an EA (30-50-25; 30-20-40);

2. Requires preparation of an EA (30-50-30);

3. Requires preparation of an EIS (30-50-35).

OPDIVs/STAFFDIVs may choose to prepare a NEPA document for any HHS action at any time to further the purposes of NEPA.

OPDIVs/STAFFDIVs shall determine for each major federal action (hereinafter "action") not categorically excluded, the data needed for an environmental assessment and a system for acquiring such data. OPDIVs/STAFFDIVs shall prepare an environmental assessment for each proposed action not categorically excluded and, as a result of its findings prepare a Finding of No Significant Impact (FONSI) or an Environmental Impact Statement (EIS).

Sections 30-50-40 through 30-50-65 describe the environmental documents that may be required during the process of considering the environmental aspects of an action.

These sections describe the various types of NEPA documents including their purposes and contents. OPDIVs/STAFFDIVs may publish in the Federal Register additional requirements for the preparation of environmental documents under their responsibility.

Data and information that are protected from disclosure by 18 U.S.C. ' 1905 or 21 U.S.C. '' 331(j) or 360j(c) or other applicable laws shall not be included in environmental documents prepared under this chapter. When such data and information are pertinent to the environmental review of a proposed action, an applicant or petitioner shall submit such data and information separately as a confidential section of the application or petition, but shall summarize the confidential data and information in the environmental document to the extent possible.

Categorical Exclusions. Actions within a class that individually or cumulatively have been determined under Section 30-20-40 not to significantly affect the quality of the human environment ordinarily are excluded from the preparation of an EA or EIS. To find that a proposed action is categorically excluded, OPDIVs/STAFFDIVs shall determine if:

1. The proposal fits within a class of actions described in 30-20-40 or a categorical exclusion developed by the OPDIV/STAFFDIV in accordance with 30-20-30; and

2. No extraordinary circumstances are related to the proposed action that may affect the significance of the environmental effects of the proposal.

Any proposed action of a type specified in this section ordinarily requires the preparation of an EA, unless it qualifies for exclusion under Section 30-20-40. Such actions include:

1. Major recommendations or reports made to Congress on proposals for legislation in instances where the Department or OPDIV/STAFFDIV has primary responsibility for the subject matter involved; and

2. Actions Involving Extraordinary Circumstances. As provided by 40 CFR ' 1508.4, an EA or an EIS will be required for any specific action that ordinarily is excluded if the OPDIV/ STAFFDIV has sufficient evidence to establish that the specific proposed action may significantly affect the quality of the human environment. OPDIVs/STAFFDIVs shall prepare an EA when there are extraordinary circumstances in which a normally excluded action may have a significant environmental effect. Extraordinary circumstances include the following:

1. Unique situations presented by specific proposals, such as scientific controversy about the environmental effects of the proposal;

2. Uncertain effects or effects involving unique or unknown risks; or

3. Unresolved conflicts concerning alternate uses of available resources within the meaning of Section 102(2)(E) of NEPA.

3. Actions Involving Cumulative Impacts. The CEQ regulations require consideration of three types of actions when determining the scope of environmental impact statements. These actions are: (1) connected actions; (2) cumulative actions; and (3) similar actions. An action may have three types of impacts: (1) direct; (2) indirect; or (3) cumulative. A determination that an action is categorically excluded will be precluded if the action is connected to another action that may require an environmental impact statement or when viewed with other proposed actions may have cumulatively significant impacts. CEQ defines "connected actions" and "cumulative actions", at 40 CFR ' 1508.25, as follows:

1. Connected Actions. "Connected" actions means actions that are closely related and therefore should be discussed in the same impact statement. Actions are connected if they:

   1. Automatically trigger other actions which may require environmental impact statements;

   2. Cannot or will not proceed unless other actions are taken previously or simultaneously; or

   3. Are interdependent parts of a larger action and depend on the larger action for their justification.

2. Cumulative Actions. "Cumulative actions" are actions which, when viewed with other proposed actions, have cumulatively significant impacts and should therefore be discussed in the same impact statement.

EIS's are prepared for HHS organization actions when:

1. Evaluation of data in an Environmental Assessment (EA) leads to a finding by the responsible official that a proposed action may significantly affect the quality of the human environment under the criteria in 40 CFR 1508.14 and 1508.27; or

2. Initial evaluation by the responsible official of any action, including any action for which an EA would otherwise be required, establishes that significant environmental effects may be associated with one or more of the probable courses of action being considered.

1. Purpose. As defined by CEQ in 40 CFR ' 1508.9, an Environmental Assessment (EA) is the public document in which environmental and other pertinent information on a proposed action are presented, providing a basis for a determination whether to prepare an Environmental Impact Statement (EIS) or a Finding of No Significant Impact (FONSI).

   An EA shall be prepared for each action not excluded pursuant to Section 30-20-40. The EA shall be a complete, objective, and well-balanced document that allows the public to understand the HHS organization's decision.

2. Contents. The EA shall:

1. Briefly provide sufficient evidence and analysis for determining whether to prepare an EIS or FONSI;

2. Briefly discuss the need for the proposed action;

3. Describe the potential environmental impacts of the proposed action;

4. Describe measures, including suitable pollution prevention techniques, which would be taken to avoid or mitigate potential environmental impacts associated with the proposed action;

5. Describe in detail the environmental impact of reasonable alternatives to the proposed action (including no action), particularly those that will enhance the quality of the environment and avoid some or all of the adverse environmental effects of the proposed action;

6. Include a comparative analysis of environmental benefits and risks of the proposed action and alternatives, identifying the preferred action based on environmental factors;

7. Include, if appropriate, a floodplain/wetlands assessment prepared under Sections 30-40-40 or 30-40-70 and analyses needed for other environmental determinations;

8. List those persons preparing the assessment and their areas of expertise and persons and agencies consulted; and

9. List complete citations for all referenced documents and include copies of referenced articles that are not generally available.

Consistent with 40 CFR 1500.4(j) and 1502.21, EAs may incorporate by reference information presented in other documents that are reasonably available to HHS and to the public within the time to comment.

OPDIVs/STAFFDIVs may specify formats and additional content of EAs that are required to be prepared for proposed actions within their responsibility. A notice of the availability of OPDIV/STAFFDIV formats and instructions for preparation of environmental assessments shall be published in the Federal Register.

3. Criteria. In determining whether a proposed action will or will not "significantly affect the quality of the human environment," OPDIVs/STAFFDIVs should evaluate the expected environmental consequences of a proposed action by means of the following steps, utilizing the guidance provided in 40 CFR 1508.27:

   Step One -- Identify those things that will happen as a result of the proposed action. An action normally produces a number of consequences. For example, a grant to construct a hospital may terminate human services; will involve destruction and construction; will provide a service. Actions may be connected, cumulative, or similar (see 40 CFR 1508.25(a)).

   Step Two -- Identify the "human environments" that the proposed action will affect. In accordance with 40 CFR 1508.27, the significance of an action must be analyzed in several contexts, such as society as a whole (human, national), the affected region, the affected interests, and the locality. The significance of an action will vary with the setting of the proposed action. Environments may include terrestrial, aquatic, subterranean, and aerial environments, such as islands, cities, rivers or parts thereof.

   Step Three -- Identify the kinds of effects that the proposed action will cause on these "human environments." A change occurs when a proposed action causes the "human environment" to be different in the future than it would have been, absent the proposed action. These changes involve the introduction of various "resources" (including those often characterized as waste).

   Example: A decrease in the amount of soil entering a stream; the introduction of a new chemical compound to natural environments.

   In addition to organisms, substances, and compounds, the term "resources" include energy (in various forms), elements, structures, and systems (such as a trash collection service in a city). Present environmental impacts and reasonably foreseeable future environmental impacts must be considered.

   In identifying changes caused by the proposed action, OPDIVs/STAFFDIVs should identify the magnitude of the changes likely to be caused within smaller and larger "human environments" affected (e.g., part of a city, the whole city, the metropolitan area).

   The impacts resulting from the proposed action may be direct, indirect, or cumulative (see 40 CFR 1508.25(c)).

   Step Four -- Identify whether these changes are significant. The following points should be considered in conjunction with 40 CFR 1508.8 (effects), 40 CFR 1508.14 (human environment), and 40 CFR 1508.27 ("significantly") in making a decision concerning significance:

• A change in the characterization of an environment is significant (e.g., from terrestrial to aquatic);

• The establishment of a species in or removal of a species from an environment may be significant;

• The more dependent an environment becomes on external resources, the larger the magnitude of change (and the more likely it is to be significant);

• The larger the environment under consideration, the lower the amount of change needed before the change may be significant.

The CEQ regulations in 40 CFR 1508.27 describe a number of factors that should be considered in evaluating severity (intensity) of an impact. OPDIVs/STAFFDIVs should consider the cumulative effect of the proposed action. An action may be individually insignificant but cumulatively significant when the action is related to other actions. Significance exists if it is reasonable to anticipate a cumulatively significant impact on the environment. Significance cannot be avoided by terming an action temporary or by breaking it down into small component parts.

Step Five -- Consider alternatives to the proposed action. Alternatives to the proposed action include:

• No action alternative;

• Other reasonable courses of action; and

• Mitigation measures.

1. Purpose. A Finding of No Significant Impact (FONSI) is a document prepared by an OPDIV/STAFF that briefly presents the reasons why an action, not otherwise excluded (see 30-20-40), will not have a significant effect on the human environment and for which, therefore, an EIS will not be prepared (40 CFR '1508.13).

2. Responsibilities. The responsible official will evaluate the information contained in the EA to determine whether it is accurate and objective, whether the proposed action may significantly affect the quality of the human environment, and whether an EIS will be prepared. The responsible official will examine the environmental effects of the proposed action and the alternative courses of action, select a course of action, and ensure that any necessary mitigating measures are implemented as a condition for approving the selected course of action. When the responsible official has determined that the proposed action will not have a significant effect on the human environment, the responsible official will sign the FONSI, thereby establishing that the official approves the conclusion not to prepare an EIS for the action under consideration.

   A FONSI shall be prepared only if the related EA supports the finding that the proposed action will not have a significant effect on the quality of the human environment. The environmental assessment (or a summary of the EA) shall be included as a part of the FONSI.

   If significant effects requiring the preparation of an EIS are identified, a Notice of Intent (NOI) to prepare an EIS will be published in the Federal Register in accordance with ' 30-50-55. If an EA does not support a FONSI, an EIS shall be prepared and a Record of Decision (ROD) issued before action is taken on the proposal addressed by the EA, except as permitted under 40 CFR 1506.1.

3. Contents. The FONSI shall include the following:

1. The supporting EA or a summary of it (including a brief description of the proposed action and alternatives considered in the EA, environmental factors considered, projected impacts);

2. References to any other related environmental documents (40 CFR ' 1501.7(a)(5));

3. Any mitigation measures that will render the impacts of the proposed action not significant;

4. Any findings required by Sections 30-40-40 or 30-40-70 in connection with floodplain or wetlands environmental reviews;

5. The date of issuance; and

6. The signature of the approving official.

If the assessment is included, the FONSI need not repeat any of the discussion in the assessment but may incorporate it by reference.

4. Proposed Action. An OPDIV/STAFFDIV may proceed with the proposed action after the FONSI is issued, subject to any mitigation measures identified in the FONSI that are essential to render the impacts of the proposed action not significant.

1. Public Availability of FONSI and EA. OPDIVs/STAFFDIVs shall make a FONSI and its related EA available to the public as provided in the CEQ regulations at 40 CFR '' 1500.6, 1501.4(e)(1) and 1506.6, including making copies available for inspection in public reading rooms or other appropriate locations for a reasonable time.

2. Public Availability of FONSI. For a limited number of actions, the proposed FONSI and its related EA will be made available for public review (including review by state and area-wide information clearinghouses) for 30 days before a final determination is made whether to prepare an EIS and before the action may begin. This procedure will be followed when the proposed action is, or is closely similar to, one that normally requires an EIS or when the proposed action is one without precedent (40 CFR ' 1501.4(e)). OPDIVs/STAFFDIVs may issue a proposed FONSI for public review and comment in other situations as well.

3. Revised FONSI. If a FONSI is revised, it is subject to the public availability requirements of this section.

1. Purpose. The Notice of Intent (NOI) notifies the public that an EIS will be prepared and considered (40 CFR ' 1508.22). This determination may be based on information contained in an EA or on other available information which indicates that potentially significant effects may be associated with a proposed action.

2. Responsibilities. When an environmental assessment indicates that a significant environmental impact may occur and significant adverse impacts can not be eliminated by making changes in the project, an NOI shall be published in the Federal Register as soon as practicable after the responsible official has made a decision to prepare an EIS and before the scoping process. When the responsible official finds that there will be a lengthy period between the decision to prepare an EIS and the time of actual preparation, the NOI may be published at a reasonable time in advance of preparation of the draft EIS.

3. Contents. As required by 40 CFR ' 1508.22, the NOI will:

1. Describe the proposed action and possible alternatives;

2. Describe the proposed scoping process, which may include a request for information or suggestions regarding the scope of the EIS;

3. State whether a public scoping meeting will be held, and the location, date, and time of such meeting; and

4. State the identification of persons within the HHS organization to contact for information about the proposed action and the EIS

4. Scoping. Publication of the NOI in the Federal Register begins the scoping process. Scoping is an early and open process for determining the scope of issues to be addressed and for identifying the significant issues related to a proposed action (40 CFR 1501.7). The scoping process for an EIS shall be undertaken in accordance with the procedures in 40 CFR 1501.7. An NOI shall be made available to the public in accordance with 40 CFR 1500.6 and 1506.6. OPDIVs/STAFFDIVs shall allow a minimum of 30 days for the receipt of public comments during the scoping process.

5. Public Scoping Meetings. A public scoping meeting normally will be conducted whenever an NOI has been published, except that a public scoping process is optional for supplemental EISs (40 CFR 1502.9(c)(4)). Public scoping meetings shall not be held until at least 15 days after public notification. 40 CFR 1506.6(c)(2).

6. Scoping Issues. Pollution prevention should be considered an issue in the scoping process because it will encourage those outside the HHS organization to provide insights into pollution prevention technologies that might be available for use in connection with the proposal or its possible alternatives.

1. Public Notice. The public has the opportunity to offer comments and otherwise participate in the NEPA process as set forth in 40 CFR ' 1506.6 from the time the decision is made to prepare an EIS. A Notice of Intent (30-50-55) to prepare an EIS is published in the Federal Register and serves as the first public notification that an EIS will be prepared. The scoping process (30-50-55), as announced in the Notice of Intent, allows the public, Indian tribes, Federal agencies, States, and local governments to participate in determining the issues to be considered in the EIS.

   OPDIVs/STAFFDIVs shall make diligent efforts to involve the public in the environmental review process by providing public notice of NEPA-related hearings, public meetings, and the availability of environmental documents so as to inform those persons and agencies who may be interested or affected. The responsible official shall ensure that public notice is provided for in accordance with 40 CFR '' 1500.6 and1506.6(b). Notice shall be made through direct mail, the Federal Register, local media, or other means appropriate to the scope, issues, and extent of public concern. In all cases, notice shall be given to those who have requested it on an individual action. Public notice shall include the name and location of a contact official through whom additional material may be obtained. EPA will publish in the Federal Register a Notice of Availability of HHS draft and final ElSs

   OPDIVs/STAFFDIVs must give public notice in the following instances:

1. Prior to preparing a draft statement in order to solicit public participation; and

2. Prior to any public hearings.

2. Public Hearings. OPDIVs/STAFFDIVs shall hold public hearings as part of the NEPA environmental review process when hearings will assist substantially in forming environmental judgments. The hearings shall be conducted in a manner that is consistent with OPDIV/STAFFDIV program requirements. The responsible official shall conduct a public hearing on a draft EIS and shall ensure that the draft EIS is made available to the public and the hearing announced at least 15 days in advance of the hearing. The announcement shall identify the subject of the draft EIS and include the location, date, and time of the public hearing.

3. Availability of Draft EIS. Draft EISs will be prepared, forwarded to EPA for filing, and made available to the public early enough in the consideration of the proposed action to permit meaningful review of the environmental issues involved. A draft EIS will be sent to any party having an interest in the document, and will be available to the public upon request for the purpose of receiving substantive comment, corrections, and additional information on the issues covered by the statement. Copies of draft statements shall be provided to:

1. U. S. Environmental Protection Agency;

2. Council on Environmental Quality;

3. Other Federal agencies having related special expertise or jurisdiction by law;

4. Appropriate local and national organizations;

5. Appropriate State and local agencies, including those authorized to develop and enforce environmental standards;

6. Indian tribes, as appropriate, and

7. Others requesting a copy of the draft statement.

4. Comments on Draft EIS. After preparing a draft EIS and before preparing a final EIS, the responsible official shall obtain the comments of Federal agencies,

   Indian tribes, State and local government agencies, and the public in accordance with 40 CFR ' 1503.1. The responsible official shall respond to comments in the final EIS in accordance with 40 CFR ' 1503.4. There shall be a 45-day minimum comment period for a draft EIS after EPA publishes a Notice of Availability of the document in the Federal Register (40 CFR ' 1506.10(c)). Procedures for the preparation and circulation of a supplemental statement are contained in 30-50-65G.

5. Proposed Rulemaking. If the subject of a draft EIS is also the subject of a notice of proposed rulemaking, the Federal Register notice of proposed rulemaking will state that the draft EIS is available upon request, and will solicit comments from all interested persons.

6. Final EIS. Copies of final statements shall be provided in accordance with the list in subsection C and to all agencies, persons, or organizations who submitted comments regarding the draft statement. Copies of each final EIS will be available upon request, and the responsible HHS organization will make copies of the final statement available for public inspection in public reading room(s).

7. Record of Decision. The responsible official shall publish the ROD in the Federal Register and disseminate the ROD to the public as provided in 40 CFR ' 1506.6, except as provided in 40 CFR ' 1507.3(c).

HHS has a responsibility under Section 102(2)C of NEPA to review and comment on draft ElSs developed by other Federal agencies. In accordance with 40 CFR ' 1503.2, HHS must comment on each EIS on issues for which it has "jurisdiction by law or special expertise."

1. Jurisdiction by Law. An OPDIV/STAFFDIV reviewing a draft EIS should review each alternative action discussed in an EIS in terms of the Departments statutory responsibilities. For example, the reviewer should examine:

1. Potential effects on the delivery or quality of health, social, or welfare services;

2. Potential effects associated with the manufacture, transportation, use, storage, and disposal of chemicals or other hazardous or radioactive materials;

3. Potential changes in plant or animal populations (This includes examination of the potential effects the proposed action may have on human health. Changes in natural predator populations may upset the ecological balance to the extent that an increased incidence of morbidity or mortality will occur unless offsetting safeguards are instituted); and

4. Potential changes in the physical environment that could affect human health or welfare (e.g., air pollution, change in land use). (This shall also include an examination of the availability and quality of water, sewage, and solid waste disposal facilities.)

2. Jurisdiction by Special Expertise. Individuals reviewing EISs may comment, in addition, in areas beyond their immediate job responsibilities when they have special expertise which may be appropriate. For example, a veterinarian employed in a disease prevention program can comment on an EIS discussion about the effects of a forestry project on animal populations.

3. Types of Comments. Comments on an EIS or on a proposed action shall be as specific as possible and may address either the adequacy of the statement or the merits of the alternatives discussed or both. A reviewer's comment on an external EIS can address one or more of the following:

1. That data are missing or inaccurate;

2. That the organization of the EIS precludes a valid review;

3. That the projections or descriptions of effects are not complete or are inaccurate;

4. That the reviewer does not concur with the projections (stating reasons);

5. That certain safeguards will lessen the extent of an effect or the magnitude of an impact;

6. A preference for an action alternative (or no action); or

7. An objection to a federal agency's preferred alternative (if one is identified in the draft EIS) and recommend adoption of new or existing alternatives.

Objections to a federal agency's alternative should be lodged on the basis of the direct or indirect effects on HHS programs or mission. When an objection or reservation about the proposal is made on grounds of environmental impacts, an OPDIV/ STAFFDIV shall specify the mitigation measures it considers necessary to allow it to grant or approve applicable permit, license, or related requirements or concurrences (40 CFR 1503.3).

If a lead federal agency's predictive methodology is criticized, the OPDIV/STAFFDIV should describe the alternative methodology which it prefers and the rationale for its preference. An OPDIV/STAFFDIV shall specify in its comments whether it needs additional information to fulfill other applicable environmental reviews or consultation requirements and what information it needs. In particular, an OPDIV/STAFFDIV shall specify any additional information it needs to comment adequately on the draft statements analysis of significant site-specific effects associated with the granting or approving of necessary Federal permits, licenses, or entitlements.

4. Resolution of Comments. If an OPDIV/STAFFDIV objects to all or part of a Federal agency's proposed action and, after consultation with the agency, is unable to resolve its differences, it shall determine if the proposed action meets the criteria for referral in 40 CFR ' 1504.2. If the criteria are met, the OPDIV/STAFFDIV head shall refer the objection to CEQ within 25 days of the date that the final EIS is made available to EPA in accordance with 40 CFR '1504.3.