96-4705. Testing Requirements for Ocean Dumping  

  • [Federal Register Volume 61, Number 41 (Thursday, February 29, 1996)]
    [Proposed Rules]
    [Pages 7765-7770]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-4705]
    
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    40 CFR Parts 220 and 227
    
    [FRL-5432-2]
    RIN 2040-AC81
    
    
    Testing Requirements for Ocean Dumping
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Proposed rule.
    
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    SUMMARY: EPA today is issuing a proposed rule that would clarify 
    certain provisions of the Agency's ocean dumping regulations relating 
    to requirements for bioassay testing. The purpose of today's proposal 
    is to clarify regulatory language that was interpreted by the U.S. 
    Court of Appeals for the Third Circuit in a different manner than EPA 
    intended. Today's proposal would confirm the validity of existing 
    testing practices, and would not change them.
    
    DATES: Written comments on this proposed rule will be accepted until 
    April 1, 1996. All comments must be postmarked or delivered by hand to 
    the address below by this date.
    
    ADDRESSES: Send written comments on this proposed rule to the Ocean 
    Dumping Proposed Rule Comment Clerk, Water Docket, MC-4101, 
    Environmental Protection Agency, 401 M Street, SW, Washington, DC 
    20460. Commenters should submit any references cited in their comments. 
    Commenters are requested to submit an original and three copies of 
    their written comments and any enclosures. Commenters who want receipt 
    of their comments acknowledged should include a self-addressed, stamped 
    envelope. No facsimile or electronic mail transmissions (faxes or e-
    mail) will be accepted.
        A copy of the supporting documents for this proposed rule are 
    available for review at EPA's Water Docket, Room L-102, 401 M Street, 
    SW, Washington, DC 20460. For access to the docket materials, call 202/
    260-3027 between 9:00 a.m. and 3:30 p.m., for an appointment.
    
    FOR FURTHER INFORMATION, CONTACT: John Lishman, Chief, Marine Pollution 
    
    
    [[Page 7766]]
    Control Branch, Oceans and Coastal Protection Division (4504F), 
    Environmental Protection Agency, 401 M Street, SW, Washington, DC 
    20460, telephone 202/260-8448.
    
    SUPPLEMENTARY INFORMATION:
    
    A. Statutory and Regulatory Background, and Summary of Previous 
    Litigation
    
        The Ocean Dumping Regulations, which govern the evaluation and 
    permitting of material to be ocean dumped, were promulgated by EPA on 
    January 11, 1977, under Title I of the Marine Protection, Research, and 
    Sanctuaries Act of 1972, as amended, 33 U.S.C. 1401 et seq. 
    (hereinafter ``the Act'' or ``the MPRSA''). These regulations are 
    contained in 40 CFR Parts 220-229.
        The MPRSA prohibits the transportation of material from the United 
    States for the purpose of ocean dumping without a permit, and prohibits 
    U.S. instrumentalities and U.S. registered or flagged vessels from 
    transporting materials from any location for the purpose of ocean 
    dumping without a permit. The Act also prohibits the unpermitted 
    dumping of material transported from a location outside the United 
    States into the Territorial Sea or the Contiguous Zone, if the dumping 
    affects the Territorial Sea or U.S. territory.
        Under Section 102(a) of the Act (33 U.S.C. 1412(a)), EPA has 
    responsibility for issuing permits for the ocean dumping of all 
    materials other than dredged material. Under Section 103(a) of the Act 
    (33 U.S.C. 1413(a)), the Secretary of the Army has responsibility for 
    issuing permits for the ocean dumping of dredged material. This 
    permitting authority has been delegated to the Corps of Engineers 
    (``the Corps''). The Corps applies EPA ocean dumping regulations in 
    making its permit decisions. EPA's role pertaining to the Corps' 
    issuance of dredged material disposal permits is one of review and 
    concurrence. Although the Corps is the permitting authority for dredged 
    material, Section 103 of the Act establishes a substantial role for EPA 
    with regard to the evaluation of the impacts of the ocean disposal of 
    dredged material.
        On June 1, 1993, Clean Ocean Action, an organization concerned with 
    issues affecting water quality, as well as other groups (``the 
    plaintiffs''), filed a complaint and a request for injunctive relief in 
    the United States District Court, District of New Jersey, against the 
    Corps, EPA, and the Port Authority of New York and New Jersey (``the 
    Port Authority''), challenging an ocean dumping permit issued to the 
    Port Authority by the Corps. Clean Ocean Action v. York, Civil No. 93-
    2402 (DRD) (D.N.J.). The permit authorized the Port Authority to 
    perform maintenance dredging from two Port Authority facilities in 
    Newark Bay, and to dispose of the dredged material in the Atlantic 
    Ocean at the New York Bight Dredged Material Disposal Site (also known 
    as the Mud Dump Site).
        In a decision dated June 7, 1993, the District Court denied the 
    plaintiffs' request for a preliminary injunction to halt the disposal 
    of the dredged material at the Mud Dump Site. After additional briefing 
    and other proceedings, the District Court issued a formal opinion on 
    June 28, 1994, again denying the requested injunctive relief. In its 
    opinion, the District Court also concluded that the bioassay tests 
    performed on the dredged material met the requirements of the ocean 
    dumping regulations. 861 F. Supp. 1203 (D.N.J. 1994).
        On June 12, 1995, the United States Court of Appeals for the Third 
    Circuit affirmed the District Court's denial of a preliminary 
    injunction. Clean Ocean Action v. York, 57 F.3d 328 (3d Cir. 1995). The 
    Third Circuit also stated, however, that the District Court had erred 
    in its conclusion that the bioassays performed on the dredged material 
    in issue met the requirements of the ocean dumping regulations.
        As a result of the opinion of the Third Circuit, a degree of 
    uncertainty now exists regarding certain of the ocean dumping 
    regulatory testing requirements. Today's proposed rulemaking would 
    clarify those regulatory requirements in a manner that is consistent 
    with existing testing practices.
        In particular, the Third Circuit examined the language of 40 CFR 
    227.6(c). That section currently provides that the potential for 
    significant undesirable effects due to the presence of constituents 
    listed at 40 CFR 227.6(a) ``shall be determined by application of 
    results of bioassays on liquid, suspended particulate, and solid phases 
    of wastes according to procedures acceptable to EPA, and for dredged 
    material, acceptable to EPA and the Corps of Engineers.'' EPA and the 
    Corps had argued, and the District Court had found, that Sec. 227.6(c) 
    reserves discretion in the agencies not to require bioaccumulation 
    bioassay tests in the suspended phase if acceptable procedures for such 
    tests are not available and approved for use. The Third Circuit, 
    however, concluded that Sec. 227.6(c) requires suspended phase 
    bioaccumulation bioassays even where neither EPA nor the Corps of 
    Engineers has identified acceptable procedures. The Court read that 
    section as reserving discretion in the agencies to determine how, but 
    not whether, to conduct the tests. 57 F.3d at 332.
        As described more fully in Part B of today's preamble, today's 
    proposal would amend Secs. 220.2, 227.6, and 227.27 to more clearly 
    reserve discretion regarding when bioassays are to be conducted. This 
    would be done by clarifying that bioassays are not required if there 
    are no Agency-approved procedures, as will be explained in more detail 
    below. (EPA has previously amended Secs. 227.6(c)(2) and 227.27(b) of 
    the ocean dumping regulations to clarify specifically that 
    bioaccumulation tests are not required in the suspended phase. See 59 
    FR 26566 (May 20, 1994) (Interim Final Rule); 59 FR 52650 (October 18, 
    1994) (Final Rule)).
        The Third Circuit opinion also addressed Sec. 227.27(d). That 
    section provides that ``appropriate sensitive benthic organisms,'' 
    which are to be used in solid phase testing under Sec. 227.6(c)(2), 
    means ``at least one species each representing filter-feeding, deposit-
    feeding, and burrowing species chosen from among the most sensitive 
    species accepted by EPA as being reliable test organisms to determine 
    the anticipated impact on the site * * *'' There are some marine 
    species that exhibit more than one of the filter-feeding, deposit-
    feeding, and burrowing characteristics. Current Agency guidance 
    specifies that when bioaccumulation and toxicity testing is performed 
    on the solid phase, two species may be used for each of these two sets 
    of tests, so long as the two species together exhibit all of the three 
    species characteristics. The Third Circuit opinion, however, could be 
    construed to indicate that three different test species should be 
    required for solid phase bioassay tests. See 57 F.3d at 332, 333 n.2. 
    (In the case before the Third Circuit, only one benthic organism was 
    tested for bioaccumulation of dioxin in the solid phase before the 
    District Court required additional testing. 861 F. Supp. at 1210.)
        EPA is proposing to amend the definition of the ``appropriate 
    sensitive benthic organisms'' used in benthic bioassay tests to mean at 
    least two species that together exhibit filter-feeding, deposit-
    feeding, and burrowing characteristics. Consistent with current Agency 
    guidance, the proposed language would clarify that the use of two such 
    species is sufficient. In addition, today's proposal would amend the 
    definition of ``appropriate sensitive 
    
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    marine organisms,'' which are to be used in suspended phase tests under 
    Sec. 227.6(c)(3), to mean at least two species that together are 
    representative of the following types of organisms: phytoplankton or 
    zooplankton, crustacean or mollusk, and fish. The proposed language 
    would clarify, consistent with current agency guidance, that the use of 
    two such species is sufficient.
        The purpose of today's proposal is to clarify the regulatory 
    language that was interpreted by the Third Circuit in a different 
    manner than EPA intended. The Agency is not changing the evaluative 
    procedures that are currently used and set out in program guidance and 
    thus is not changing the level of environmental protection of the ocean 
    dumping program. EPA is allowing for a thirty day period for comment on 
    this proposal. The Agency believes a thirty day comment period is 
    adequate because the proposal would clarify the regulations in a manner 
    consistent with existing practices. The Agency also is working on more 
    comprehensive amendments to the ocean dumping regulations in order to 
    further update them and improve their clarity. The Agency anticipates 
    issuance of a proposal later this year.
    
    B. Discussion
    
    (1) Bioassay provisions
    
        The mere presence of contaminants or pollutants in material 
    proposed for disposal does not in itself reveal the potential for 
    adverse effects on marine life, or whether pollutants are even present 
    in forms that are bioavailable (Reference 1 and 2). Because of this, 
    exposure of organisms to material proposed for dumping in laboratory 
    tests or other biological effects-based assessments are conducted to 
    determine the potential for adverse biological effects resulting from 
    contaminants that may be present in the material (Reference 3). The 
    determination of both when and how to perform such evaluations often 
    involves complicated scientific and technical judgment. The Agency, as 
    described below, has provided technical guidance to identify acceptable 
    procedures for evaluating the potential biological effects of material 
    proposed for dumping.
        In 1977, EPA and the Corps provided national technical guidance on 
    procedures for performing biological evaluations of dredged material in 
    the manual entitled ``Ecological Evaluation of Proposed Discharge of 
    Dredged Material into Ocean Waters'' (``the Green Book'')(Reference 4). 
    EPA provided national technical guidance for other material in the 
    manual entitled ``Bioassay Procedures for the Ocean Disposal Permit 
    Program(``the Blue Book'') in 1977 (Reference 5); the Green Book was 
    revised in 1991 (Reference 6). The guidance describes scientifically 
    and technically appropriate testing and evaluations to assess the 
    potential biological effects of material proposed for ocean dumping. 
    Because such guidance has been issued, today's proposal would update 
    the regulations to delete provisions in Sec. 227.6(e) referring to such 
    guidance as being under development and providing interim criteria, as 
    well as similar language from Sec. 227.27(b) and (d).
        As previously discussed, the existing regulations provide that 
    bioassays shall be run ``in accordance with'' approved Agency 
    procedures. This language was intended to reserve Agency technical 
    discretion on when and how to perform such bioassays. However, the 
    Third Circuit opinion has cast some doubt on this issue. To better 
    clarify that the Agency has reserved its discretion in establishing 
    procedures for when and how to perform bioassays, today's proposal 
    would add a new definition of ``bioassay'' in proposed Sec. 220.2(j) to 
    make clear that references in the regulations to ``bioassays'' means 
    only those that have been approved for use by EPA, or in the case of 
    dredged material, approved by EPA and the Corps. The intent is to make 
    clear that in the absence of approved procedures, bioassays are not 
    required by the regulations. As a conforming matter, today's proposal 
    would also delete language in existing Secs. 227.6(c), (c)(2), c(3), 
    and 227.27(a)(2) and (b) referring to bioassay procedures approved by 
    the Agency. The language that is proposed to be deleted becomes 
    redundant or unnecessary in light of the proposed definition of 
    ``bioassay.''
        The proposed definition of bioassay further makes clear that the 
    Agency has reserved its discretion on the evaluative procedures to be 
    used by employing the term ``effects-based evaluations.'' This would be 
    done to avoid any implication that the regulations intend to mandate 
    only the exposure of organisms to materials or contaminants in 
    laboratory tests. While such tests provide one way to evaluate the 
    toxicity and bioaccumulation potential of contaminants from a material 
    proposed for ocean disposal, they are not the only way to make such 
    assessments. Improvements in the sciences of toxicology and risk 
    assessment allow conclusions to be made about the potential 
    environmental impacts of ocean disposal of a material without actually 
    running such laboratory tests in all cases. As a result, an adequate 
    evaluation of material proposed for ocean dumping does not always 
    require the performance of specific laboratory biological tests for 
    each material or contaminant evaluated. In general, as will be 
    explained below, the following biological effects-based approaches can 
    be used or combined to evaluate material proposed for ocean disposal: 
    (1) Laboratory tests of organisms exposed to the material or results of 
    such tests run on similar material; (2) toxicological and/or risk 
    assessment models; or (3) screening evaluations that use highly 
    protective estimates of exposure and effects assumptions.
        As stated above, exposure of organisms to materials or contaminants 
    in laboratory experiments provide one way to measure the potential 
    effects of dumping the material. Results of such tests on similar 
    material may also be adequate for determining the potential effects 
    depending on a number of factors, including, but not limited to, the 
    following: (1) Whether the methods used are consistent with currently 
    approved test procedures; (2) whether organisms tested include those 
    identified in 40 CFR 227.27 (c) and (d), as appropriate; and (3) 
    whether the characteristics of the material tested are sufficiently 
    similar to the material to be dumped so that one can reasonably predict 
    the potential for environmental effects from dumping of the latter 
    material by extrapolating from the results of testing on the former 
    material.
        The bioavailability of many contaminants in the environment also 
    can be predicted through the use of toxicological and/or risk 
    assessment models. For example, the equilibrium partitioning model is 
    one approach that can be used to predict the bioavailable fraction of a 
    contaminant in an aquatic sediment (Reference 2). A variation of this 
    model, called the Theoretical Bioaccumulation Potential (TBP) model, 
    has been used to screen dredged material for further bioaccumulation 
    testing (Reference 6). A review of the use of the TBP model in dredged 
    material evaluations indicates that it is highly protective because of 
    the use of conservative assumptions in the model (Reference 7). In the 
    future, incorporation of additional laboratory bioassay and field-
    generated information into the TBP model will improve its accuracy and 
    reliability. In the meantime, however, its conservatism ensures that 
    using it is an environmentally protective approach (Reference 7).
        Finally, conservative assumptions also can be used to predict the 
    ``upper bound'' of potential environmental 
    
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    impacts. For example, evaluations can be based on the assumption that 
    100 percent of a contaminant in a material proposed for ocean disposal 
    will be bioavailable. This approach can be used for screening chemicals 
    that might require further evaluation to determine compliance with 
    water quality criteria by assuming all of the contaminants in the 
    material are dissolved into the water column during dumping. (Reference 
    6.) The use of TBP, as discussed above, integrates the use of 
    toxicological models with conservative assumptions in determining the 
    bioavailability of contaminants in the material that settles to the 
    bottom after dumping.
        The reference to ``effects-based evaluations'' in proposed 
    Sec. 220.2(j) is intended to make clear that, as provided for in 
    approved Agency procedures, the approaches described above can be used 
    to evaluate the potential environmental effects of material proposed 
    for ocean dumping, either as a screening device in lieu of actual 
    laboratory testing, or in combination with the results of such tests. 
    At the same time, the language is intended to provide flexibility for 
    the future in order to assure that as science and technology improve 
    and other effects-based evaluations are approved for use, they may be 
    used as well.
        In addition, the current ocean dumping regulations provide that 
    bioassays are to be conducted ``in accordance with'' procedures 
    approved by EPA and the Corps. In certain cases, there are no approved 
    laboratory testing protocols available, or as described above, other 
    evaluative tools provide effects-based information comparable to that 
    which might be obtained from running a laboratory bioassay. The Third 
    Circuit opinion, however, could be read as suggesting that even though 
    Agency-approved bioassay test procedures are not specified, the 
    regulation still requires laboratory bioassays to be run. Although the 
    proposed definition of bioassay described above is intended to resolve 
    this point, in order to further remove any possible ambiguity, today's 
    proposal would make a change in regulatory language in Sec. 227.6(c). 
    The proposed change would replace a reference to performing bioassays 
    ``in accordance with'' approved Agency procedures, to performing 
    bioassays ``when bioassay procedures have been approved.''
        Finally today's proposal would also amend Secs. 227.6(c)(2) and 
    (3), 227.27(b), and 227.27(c), which currently provide that bioassays 
    ``shall be conducted'' using approved organisms and procedures. To 
    avoid any possible ambiguity that this might mandate only the use of 
    laboratory tests on organisms exposed to the material proposed for 
    dumping, today's proposal would make changes in those sections to 
    clarify that ``if'' such laboratory testing is conducted it shall use 
    approved organisms and procedures.
        In summary, today's proposal is intended to confirm that the Agency 
    has reserved discretion on how to evaluate material proposed for 
    dumping. This has been done, as described above, in three principal 
    ways: (1) by adding a definition of ``bioassay'' that makes clear that 
    this term means an effects-based evaluation which is to be conducted 
    only if approved procedures exist for such evaluations; (2) by revising 
    language to be clear that the Agency has reserved discretion to 
    identify what, when, and how evaluation processes will be used; and (3) 
    by clarifying that laboratory tests are not required in all cases. 
    These changes make clear that the Agency has reserved its discretion in 
    this complex technical area.
        Approved Agency evaluation procedures can be found in the Blue 
    Book, the Green Book, and Regional implementation manuals, or parties 
    seeking to use other procedures may seek their approval from EPA, or in 
    the case of dredged material, from EPA and the Corps. EPA does not 
    intend to require evaluations that have not been approved, or that are 
    not useful in a regulatory context. The determination as to the types 
    of evaluations necessary to assess potential biological effects of 
    material proposed for ocean dumping involves highly complex technical 
    issues, and is impacted by evolving changes in the science and methods 
    underlying such assessments. Today's action by the Agency is intended 
    to preserve EPA's discretion in this complex technical area to ensure 
    that the appropriate and up-to-date evaluations as approved by the 
    Agency are conducted.
    
    (2) Number and types of organisms to be tested
    
        The current ocean dumping regulations define ``appropriate 
    sensitive marine organisms'' and ``appropriate sensitive benthic marine 
    organisms'' for use in laboratory tests. The type of organisms used can 
    impact on the sensitivity of the tests in determining toxicity, and the 
    existing regulations provide that the organisms to be used represent 
    three categories of organisms. For the liquid and suspended phases the 
    organisms to be used are defined in Sec. 227.27(c) ``as at least one 
    species each representative of phytoplankton or zooplankton, crustacean 
    or mollusk, and fish species chosen from among the most sensitive 
    species documented in the scientific literature or accepted by EPA as 
    being reliable test organisms* * *'' For the solid phase, these are 
    defined in Sec. 227.27(d) as ``at least one species each representing 
    filter-feeding, deposit-feeding, and burrowing species chosen from 
    among the most sensitive species accepted by EPA as being reliable test 
    organisms* * *''
        As discussed above, EPA has described a range of characteristics 
    that the test species need to represent. The Agency believes this 
    approach is protective of the marine environment because different 
    marine organisms are known to exhibit different sensitivities to 
    environmental contaminants (Reference 8). The Agency's approved testing 
    allows the use of two different species that together cover the three 
    species characteristics in 40 CFR 227.27(c) and (d). For example, the 
    marine worm, Nephtys incisa, is both a deposit-feeder and burrower 
    (Reference 9), and the amphipod crustacean, Ampelisca abdita, is both a 
    filter-feeder and deposit-feeder (Reference 10).
        The Third Circuit opinion, however, could be construed to indicate 
    that 40 CFR 227.27(d) requires the use of three different test species 
    for the solid phase. See, 57 F. 3d 328, 333 n. 2. EPA is proposing 
    today to remove any ambiguity about the number and type of organisms 
    specified by Secs. 227.27(c) and (d). This would be done by removing 
    the words ``one species each,'' and clarifying that what is meant is at 
    least two species that together are representative of the three 
    categories of organisms. The change makes clear that the use of two 
    species representing the three characteristics specified in the 
    regulations, is acceptable.
    
    C. References
    
        1. ``Effects-based testing and sediment quality criteria for 
    dredged material'', T.D. Wright, R.M. Engler, and J.A. Miller, in Water 
    Quality Standards for the Twenty-First Century, EPA-823-R-92-009, 
    December 1992, pp. 207-218.
        2. ``Technical basis for deriving sediment quality criteria for 
    nonionic organic contaminants for the protection of benthic organisms 
    by using equilibrium partitioning,'' U.S. Environmental Protection 
    Agency, EPA-822-R-93-011, Washington, DC, September 1993.
        3. ``The use of bioassays as part of a comprehensive approach to 
    marine pollution assessment,'' Mar. Pollut. Bull. 14:81-84. 1983.
        4. ``Ecological evaluation of proposed discharge of dredged 
    material into ocean 
    
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    waters,'' U.S. Environmental Protection Agency and U.S. Army Corps of 
    Engineers, Second Printing, April 1978.
        5. ``Bioassay procedures for the ocean disposal permit program,'' 
    U.S. Environmental Protection Agency, Office of Research and 
    Development, March 1978.
        6. ``Evaluation of dredged material proposed for ocean disposal--
    testing manual,'' U.S. Environmental Protection Agency and U.S. Army 
    Corps of Engineers, April 1991.
        7. ``TBP revisited: a ten year perspective on a screening test for 
    dredged sediment bioaccumulation potential,'' V.A. McFarland and P.W. 
    Ferguson, in Dredging `94 Proceedings of the Second International 
    Conference on Dredging and Dredged Material Placement, E.C. McNair, 
    Ed., American Society of Civil Engineers, 1994.
        8. ``Problems associated with selecting the most sensitive species 
    for toxicity testing,'' J. Cairns, Jr. and B.R. Niederlechner, `` 
    Hydrobiologia 153: 87-94 (1987).
        9. ``Guidance manual: bedded sediment bioaccumulation tests,'' U.S. 
    Environmental Protection Agency, Office of Research and Development, 
    ERL-N Contribution No. N111, September 1989.
        10. ``Methods for assessing the toxicity of sediment-associated 
    contaminants with estuarine and marine amphipods,'' U.S. Environmental 
    Protection Agency, EPA/600/R-94/025, June 1994.
    
    Compliance With Other Laws and Executive Orders
    
    A. Regulatory Flexibility Act
    
        Under the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., 
    EPA must prepare a Regulatory Flexibility Analysis for regulations 
    having a significant impact on a substantial number of small entities. 
    The RFA recognizes three kinds of small entities, and defines them as 
    follows:
    
        (1) Small governmental jurisdictions: any government of a 
    district with a population of less than 50,000.
        (2) Small business: any business which is independently owned 
    and operated and not dominant in its field, as defined by the Small 
    Business Administration regulations under the Small Business Act.
        (3) Small organization: any not for profit enterprise that is 
    independently owned and operated and not dominant in its field.
        As discussed below in the discussion of Executive Order 12866, 
    today's proposed rule does not impose economic burdens. Accordingly, 
    EPA has determined that today's proposed rule would not have a 
    significant impact on a substantial number of small entities, and that 
    a Regulatory Flexibility Analysis therefore is unnecessary.
    
    B. Paperwork Reduction Act
    
        The Paperwork Reduction Act, 44 U.S.C. 3501 et seq., is intended to 
    minimize the reporting and record keeping burden on the regulated 
    community, as well as to minimize the cost of Federal information 
    collection and dissemination. In general, the Act requires that 
    information requests and record keeping requirements affecting ten or 
    more non-Federal respondents be approved by the Office of Management 
    and Budget. Since today's proposed rule would not establish or modify 
    any information or record keeping requirements, it is not subject to 
    the requirements of the Paperwork Reduction Act.
    
    C. Executive Order 12866
    
        Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
    Agency must determine whether the regulatory action is ``significant,'' 
    and therefore subject to OMB review and the requirements of the 
    Executive Order. The Order defines ``significant regulatory action'' as 
    one that is likely to lead to a rule that may:
    
        (1) Have an annual effect on the economy of $100 million or 
    more, or adversely and materially affecting a sector of the economy, 
    productivity, competition, jobs, the environment, public health or 
    safety, or State, local, or tribal governments or communities;
        (2) Create a serious inconsistency or otherwise interfere with 
    an action taken or planned by another agency;
        (3) Materially alter the budgetary impact of entitlements, 
    grants, user fees, or loan programs, or the rights and obligations, 
    of recipients thereof; or
        (4) Raise novel legal or policy issues arising out of legal 
    mandates, the President's priorities, or the principles set forth in 
    the Executive Order.
    
        It has been determined that this proposed rule is not a 
    ``significant regulatory action'' under the terms of Executive Order 
    12866, and is therefore not subject to OMB review.
    
    D. The Unfunded Mandates Reform Act, and Executive Order 12875
    
        Under the Unfunded Mandates Reform Act (UMRA) of 1995, signed into 
    law on March 22, 1995, EPA must prepare a written statement to 
    accompany any rule where the estimated costs to State, local, or tribal 
    governments in the aggregate, or to the private sector, will be $100 
    million or more in any year. The UMRA defines a ``private sector 
    mandate'' for regulatory purposes as one that, among other things, 
    ``would impose an enforceable duty upon the private sector.'' EPA has 
    determined that today's proposed regulation does not impose any 
    enforceable duties upon the private sector. Therefore, this proposed 
    rulemaking is not a ``private sector mandate,'' and is not subject to 
    the requirements of the UMRA.
        Further, EPA has determined that today's action does not include a 
    Federal mandate that may result in estimated costs of $100 million or 
    more to either State, local, or tribal governments in the aggregate, or 
    to the private sector. This proposed rulemaking should have minimal 
    impact on the regulatory burden imposed on permittees, because the 
    proposed rulemaking merely clarifies ocean dumping testing 
    requirements. Thus, EPA has determined that an unfunded mandates 
    statement is unnecessary.
        Executive Order 12875 requires that, to the extent feasible and 
    permitted by law, no Federal agency shall promulgate any regulation 
    that is not required by statute and that creates a mandate upon a 
    State, local, or tribal government, unless funds necessary to pay the 
    direct costs incurred by the State, local, or tribal government in 
    complying with the mandate are provided by the Federal government. EPA 
    has determined that the requirements of Executive Order 12875 do not 
    apply to today's proposed rulemaking, since no mandate is created by 
    this action.
    
    List of Subjects
    
    40 CFR Part 220
    
        Environmental protection, Engineer Corps, Water pollution control.
    
    40 CFR Part 227
    
        Environmental impact statements, Water pollution control.
    
        Date: February 23, 1996.
    Carol M. Browner,
    Administrator.
        For the reasons set out in this preamble, Parts 220 and 227 of 
    Title 40 of the Code of Federal Regulations are proposed to be amended 
    as follows:
    
    PART 220--[AMENDED]
    
        1. The authority citation for Part 220 continues to read as 
    follows:
    
        Authority: 33 U.S.C. 1412 and 1418.
    
        2. Section 220.2 is amended by adding paragraph (j) to read as 
    follows:
    
    
    Sec. 220.2  Definitions.
    
    * * * * *
        (j) Bioassay means such effects-based evaluations as may be 
    approved by EPA, 
    
    [[Page 7770]]
    or in the case of dredged material, by EPA and the Corps of Engineers, 
    for use in evaluating whether material has the potential to cause 
    acute, chronic, or other sublethal effects following dumping.
    
    PART 227--[AMENDED]
    
        3. The authority citation for 40 CFR Part 227 continues to read as 
    follows:
        Authority: 33 U.S.C. 1412 and 1418.
    
        4. Section 227.6 is amended:
        a. In paragraph (a) introductory text by removing the words ``(f), 
    (g), and (h)'', and adding, in their place, the words ``(e), (f), and 
    (g)''.
        b. In paragraph (c) introductory text, by removing from the first 
    sentence the words ``according to procedures acceptable to EPA, and for 
    dredged material acceptable to'', and adding, in their place, the words 
    ``when bioassay procedures have been approved by EPA, or for dredged 
    material, approved by'';
        c. By removing the second and third sentences of paragraph (c)(2) 
    and of paragraph (c)(3) and by adding a new sentence in their place in 
    each paragraph, to read as follows:
    
    
    Sec. 227.6  Constituents prohibited as other than trace contaminants.
    
    * * * * *
        (c) * * *
        (2) * * * If these bioassays involve laboratory testing of 
    organisms, they shall be conducted with appropriate sensitive marine 
    organisms as defined in Sec. 227.27(c), and the procedures used will 
    require exposure of organisms for a sufficient period of time and under 
    appropriate conditions to provide reasonable assurance, based on 
    consideration of the statistical significance of effects at the 95 
    percent confidence level, that, when the materials are dumped, no 
    significant undesirable effects will occur due to chronic toxicity of 
    the constituents listed in paragraph (a) of this section; and
        (3) * * * If these bioassays involve laboratory testing of 
    organisms, they shall be conducted with appropriate sensitive benthic 
    marine organisms, and the procedures used will require exposure of 
    organisms for a sufficient period of time to provide reasonable 
    assurance, based on considerations of statistical significance of 
    effects at the 95 percent confidence level, that, when the materials 
    are dumped, no significant undesirable effects will occur due either to 
    chronic toxicity or to bioaccumulation of the constituents listed in 
    paragraph (a) of this section; and
    * * * * *
        e. By removing paragraph (e) and redesignating paragraphs (f) 
    through (h) as paragraph (e) through (g).
        5. Section 227.27 is amended:
        a. In paragraph (a)(2), by removing the words ``in a bioassay 
    carried out in accordance with approved EPA procedures'';
        b. In the first sentence of paragraph (b), by removing the words 
    ``using appropriate sensitive marine organisms in the case of the 
    suspended particulate phase, or appropriate sensitive benthic marine 
    organisms in the case of the solid phase;'';
        c. In paragraph (b), by removing footnote 1 and by revising the 
    last sentence to read as set forth below.
        d. By revising paragraphs (c) and (d) to read as follows:
    
    
    Sec. 227.27  Limiting Permissable Concentration (LPC).
    
    * * * * *
        (b) * * * If these bioassays involve laboratory testing of 
    organisms, they shall be conducted with appropriate sensitive marine 
    organisms in the case of the suspended particulate phase, or 
    appropriate sensitive benthic marine organisms in the case of the solid 
    phase.
        (c) Appropriate sensitive marine organisms means at least two 
    species that together are representative of the following types of 
    organisms: phytoplankton or zooplankton, crustacean or mollusk, and 
    fish. These organisms shall be chosen from among the most sensitive 
    species documented in the scientific literature or accepted by EPA as 
    being reliable test organisms to determine the anticipated impact of 
    the wastes on the ecosystem at the disposal site. If the bioassays 
    involve laboratory testing of these organisms, they shall be run for a 
    minimum of 96 hours under temperature, salinity, and dissolved oxygen 
    conditions representing the extremes of environmental stress at the 
    disposal site, except that phytoplankton or zooplankton may be run for 
    shorter periods of time as appropriate for the organisms tested at the 
    discretion of EPA, or EPA and the Corps of Engineers, as the case may 
    be.
        (d) Appropriate sensitive benthic marine organisms means at least 
    two species that together exhibit filter-feeding, deposit-feeding, and 
    burrowing characteristics. These organisms shall be chosen from among 
    the most sensitive species accepted by EPA as being reliable test 
    organisms to determine the anticipated impact on the site.
    
    [FR Doc. 96-4705 Filed 2-27-96; 11:06 am]
    BILLING CODE 6560-50-P
    
    

Document Information

Published:
02/29/1996
Department:
Environmental Protection Agency
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
96-4705
Dates:
Written comments on this proposed rule will be accepted until April 1, 1996. All comments must be postmarked or delivered by hand to
Pages:
7765-7770 (6 pages)
Docket Numbers:
FRL-5432-2
RINs:
2040-AC81: Ocean Dumping Testing Requirements Clarification
RIN Links:
https://www.federalregister.gov/regulations/2040-AC81/ocean-dumping-testing-requirements-clarification
PDF File:
96-4705.pdf
CFR: (3)
40 CFR 220.2
40 CFR 227.6
40 CFR 227.27