[Federal Register Volume 59, Number 200 (Tuesday, October 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25744]


[[Page Unknown]]

[Federal Register: October 18, 1994]


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Part VIII





Environmental Protection Agency





_______________________________________________________________________



40 CFR Part 227




Clarification of Suspended Particulate Phase Bioaccumulation Testing 
Requirements for Material Dumped in Ocean Waters; Final Rule
ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 227

[FRL-5091-6]

 
Clarification of Suspended Particulate Phase Bioaccumulation 
Testing Requirements for Material Dumped in Ocean Waters

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA today is issuing a final rule clarifying that the ocean 
dumping regulations do not require bioaccumulation testing of the 
suspended particulate phase of materials to be dumped at sea. This 
clarification applies to the suspended particulate phase only, and does 
not affect any other testing requirements contained in the regulations. 
EPA believes that bioaccumulation testing of the suspended particulate 
phase is unnecessary and inappropriate. The Agency has never previously 
interpreted or applied its regulations to require such testing. Thus, 
EPA is issuing this final rule to remove any possible ambiguity over 
the testing requirement. This rule supersedes an interim final rule 
which also clarified that bioaccumulation testing of the suspended 
particulate phase is not required. The interpretive footnotes added to 
the ocean dumping regulations by the interim final rule are being 
deleted in favor of today's rule.

EFFECTIVE DATE: This rule shall be effective November 17, 1994.
ADDRESSES: Copies of comments submitted and the docket for this 
rulemaking 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 a.m. and 3:30 p.m. on weekdays 
for an appointment.

FOR FURTHER INFORMATION CONTACT: John Lishman, Chief, Marine Pollution 
Control Branch, Oceans and Coastal Protection Division (4504F), U. S. 
Environmental Protection Agency, 401 M Street, SW, Washington, DC 
20460; telephone 202/260-8448.

SUPPLEMENTARY INFORMATION:

A. Discussion

1. The Interim Final and Proposed Rulemaking

    On May 20, 1994, EPA published an interim final rule in the Federal 
Register interpreting and clarifying the ocean dumping regulations. 59 
FR 26,566. The interim final rule, which was immediately effective, 
made clear that the regulations do not require bioaccumulation testing 
of the suspended particulate phase of material to be dumped at sea. It 
accomplished this by adding footnotes at the end of 40 CFR 227.6(c)(2) 
and 227.27(b) that read:

    This provision shall not be interpreted as requiring 
bioaccumulation testing of the suspended particulate phase of dumped 
materials.

    EPA issued the interim final rule without advance notice or 
opportunity for public comment, relying on the ``interpretive rule'' 
and ``good cause'' exceptions to the notice and comment requirements of 
the Administrative Procedure Act (APA). 5 U.S.C. 553(b)(3)(A) and (B). 
For additional information regarding the interim final rule, the basis 
for the rule and the factors supporting its issuance without prior 
notice and comment, see 59 FR 26,566 (May 20, 1994).
    In a separate Federal Register notice published on May 20, 1994, 
EPA sought comment on a proposed rule that also would clarify that 
bioaccumulation testing of the suspended particulate phase is not 
required. 59 FR 26573 (May 20, 1994). The proposal included two options 
to effect this clarification:
    (1) Reaffirm the footnotes added to 40 CFR 227.6(c)(2) and 
227.27(c) by the interim final rule; and
    (2) Amend the first sentence of 40 CFR 227.6(c)(2) by deleting the 
words ``including bioaccumulation;'' amend the third sentence of 40 CFR 
227.6(c)(2) by deleting the words ``either,'' and ``or to 
bioaccumulation;'' and amend 40 CFR 227.27(b) by inserting the 
following additional sentence between the first and second sentence:

    Suspended particulate phase bioaccumulation testing is not 
required.

    EPA also solicited comment on other rulemaking options that would 
clarify that bioaccumulation testing of the suspended particulate phase 
is not required. For further information, see 59 FR 26573 (May 20, 
1994).
    EPA published the interim final rule and the proposed rule in 
response to a preliminary opinion of the United States District Court, 
District of New Jersey, dated July 6, 1993. In the preliminary opinion, 
the Court said that bioaccumulation testing of the suspended 
particulate phase should have been conducted before the U.S. Army Corps 
of Engineers granted a permit to the Port Authority of New York and New 
Jersey to dispose of dredged material from Newark Bay. Clean Ocean 
Action, et al. v. York, et al., Civil No. 93-2402 (DRD)   (D. N.J.) 
(``Clean Ocean Action I''). As a result of the preliminary opinion, 
there was uncertainty as to whether the ocean dumping regulations 
required permit applicants to perform bioaccumulation testing of the 
suspended particulate phase. The interim final rule and the 
accompanying proposal were intended to eliminate any uncertainty that 
bioaccumulation testing of the suspended particulate phase is not 
required. For further information on Clean Ocean Action I, see the May 
20, 1994, Federal Register notices accompanying the interim final rule 
and the proposed rule.
    On June 1, 1994, Clean Ocean Action and others filed a second 
lawsuit against EPA challenging the interim final rule, and 
specifically the clarification provided with respect to 40 CFR 
227.6(c)(2). (The plaintiffs did not challenge the clarification to 40 
CFR 227.27(b)). Clean Ocean Action, et al. v. Browner, et al., Civil 
No. 94-2614 (DRD)(D. N.J.)(``Clean Ocean Action II''). The plaintiffs 
alleged, among other things, that the interim final rule was not 
eligible for the interpretive rule or ``good cause'' exceptions to the 
notice and comment requirements of the APA. Upon the plaintiffs' 
request, the Court ordered the Agency to show cause why a preliminary 
injunction should not be issued preventing EPA from ``taking any 
actions authorized by'' the interim final rule.
    On June 24, 1994, the Court issued orders denying all injunctive 
relief that the plaintiffs had requested in both Clean Ocean Action I 
and Clean Ocean Action II. Among other things, the Court ruled that 
even before EPA issued the interim final rule, the ocean dumping 
regulations did not require bioaccumulation testing of the suspended 
particulate phase. The June 24, 1994, opinions reversed the July 6, 
1993, preliminary opinion on that point. The Court found that the 
interim final rule was a valid interpretive rule and that EPA had 
complied with the APA in issuing it without advance notice and 
opportunity for public comment. The plaintiffs have appealed both 
orders to the United States Court of Appeals for the Third Circuit.

2. Summary of Comments Received and Agency Response

    EPA received eleven letters commenting on the proposal and the 
interim final rule. These comments and the Agency's responses are 
summarized in the following section. Detailed responses to the comments 
are set out in the ``Response to Individual Comments Received on the 
Interim Final and Proposed Rulemaking on Suspended Particulate Phase 
Bioaccumulation Testing Requirements.'' This document is available in 
the rulemaking record, and can be inspected at EPA's Water Docket, the 
location of which is stated above. The response to comments document 
also can be obtained from the Agency at the address specified above in 
the section headed, FOR FURTHER INFORMATION CONTACT.
    Of the eight letters commenting on the interim final rule, three 
(from the Port Authority of New York and New Jersey, BP Oil Company, 
and the Port of Portland, Oregon) agreed with EPA that suspended 
particulate phase bioaccumulation testing was not required by the 
existing ocean dumping regulations, was unnecessary and should not be 
required. Five comments (from Clean Ocean Action and nine supporting 
organizations, the Conservation Law Foundation, Coastal Advocates, the 
St. Simons Island Save the Beach Association, and the Natural Heritage 
Institute) were critical of the interim final rule. These commenters, 
except the Natural Heritage Institute, adopted Clean Ocean Action's 
comment letter. All three comments received by the Agency on the 
proposed rule (from the BP Oil Company, the Port Authority of New York 
and New Jersey, and the Massachusetts Port Authority) supported EPA's 
view that bioaccumulation testing of the suspended particulate phase 
was not required by the existing ocean dumping regulations and should 
not be required. The Agency considered all comments prior to taking 
today's final action.
    The individual comments fell into three broad categories:
    (a) The need for bioaccumulation testing of the suspended 
particulate phase.
    The comments from the environmental advocacy groups adopted Clean 
Ocean Action's view that the existing regulations require 
bioaccumulation testing of the suspended particulate phase, that there 
is a need for bioaccumulation testing of the suspended particulate 
phase, and that this requirement should not be altered. The main 
argument advanced in support of the position that bioaccumulation 
testing of the suspended particulate phase should be required was that 
adverse sublethal effects to pelagic species from the suspended 
particulate phase can not be evaluated without performing 
bioaccumulation testing of the suspended particulate phase itself. None 
of these commenters submitted data, scientific studies, or factual 
information of any other nature supporting this view or refuting the 
technical or scientific basis for EPA's conclusion that bioaccumulation 
testing of the suspended particulate phase is not necessary. However, 
other commenters, such as the Port Authorities, provided specific 
technical arguments supporting the view that suspended particulate 
phase bioaccumulation tests are unnecessary and should not be required.
    After considering all comments on this issue, EPA continues to 
believe that suspended particulate phase bioaccumulation testing should 
not be required. As EPA explained at length in the two rulemaking 
notices published on May 20, 1994, the Agency believes this is the case 
for three principal reasons: (1) Exposure to the suspended particulate 
phase in the environment does not provide sufficient time for 
bioaccumulation to occur; (2) bioaccumulation testing of marine 
organisms in the solid phase provides a worst case indication of 
bioaccumulation potential, so that separate suspended particulate phase 
testing is unnecessary in any event; and (3) no reliable laboratory 
tests are available for bioaccumulation in the suspended particulate 
phase.
    Further, the commenters are incorrect that bioaccumulation testing 
of the suspended particulate phase is necessary to determine whether 
significant adverse sublethal effects result from the suspended 
particulate phase. The potential for such effects from the suspended 
particulate phase of dredged material is determined by application of 
the results of bioaccumulation bioassays on the solid phase according 
to procedures acceptable to EPA and the Corps of Engineers. These 
assist in determining the biological availability of contaminants and 
the potential for those contaminants to cause sublethal or chronic 
effects. The factors listed in the 1977 and 1991 Green Books for 
interpreting solid phase bioaccumulation testing results are relevant 
to determining the potential for sublethal effects on pelagic 
organisms. Specifically, the potential for contaminants to biomagnify 
within aquatic food chains is addressed. Toxicologic importance of 
contaminants to all species (including pelagic organisms) also is 
addressed. 1991 Green Book at 6-6; see also 1977 Green Book at G15. 
Moreover, as noted above and as explained in the preamble to the May 
20, 1994, Interim Final Rule (59 FR 26,566), bioaccumulation testing of 
the solid phase provides a worst case indication of bioaccumulation 
potential of the suspended particulate phase.
    The potential for significant adverse sublethal effects from the 
suspended particulate phase is also determined by application of the 
results of acute toxicity bioassays on the suspended particulate phase 
according to procedures acceptable to EPA and the Corps of Engineers. 
Under those approved procedures, a safety factor is applied to the 
acutely toxic concentration to assure protection from chronic sublethal 
effects. 1991 Green Book at 6-2; see also 1977 Green Book at D19. The 
safety factor used typically is 1% of the acutely toxic concentration, 
although the factor can be adjusted, either upwards or downwards, on 
the basis of the scientific evidence applicable to a particular 
material to be dumped. See 40 CFR 227.27(a)(3). This product of the 
safety factor times the acutely toxic concentration is used to 
establish the limiting permissible concentration (``LPC'') (see 40 CFR 
227.27). The LPC is compared to the predicted concentration of 
suspended material after consideration of initial mixing. 40 CFR 
227.29. Exceedence of the LPC by the dumped material suspended in the 
water column would mean the regulatory criteria are not met. See 40 CFR 
227.13(c)(3). Thus, the procedures and tests do in fact consider the 
potential for chronic sublethal effects. The 1% safety factor was 
developed by the National Academy of Sciences in a voluminous study 
entitled ``Water Quality Criteria: 1972.'' This safety factor has been 
used for over 20 years to estimate safe chronic values from acute 
concentration values.
    Given the absence of scientific arguments to the contrary, and for 
all of the foregoing reasons, EPA is taking final action clarifying 
that the ocean dumping regulations do not require bioaccumulation 
testing of the suspended particulate phase.
    (b) Lack of notice and comment on the interim final rule.
    The environmental advocacy groups argued that the interim final 
rule should not have been issued without advance notice and opportunity 
for comment because it was ineligible for the interpretive rule and 
good cause exemptions to the APA. These comments are directed at the 
procedural validity of the interim final rule, not the appropriateness 
of today's rule. In any event, as noted above, the United States 
District Court for the District of New Jersey has issued an opinion on 
Clean Ocean Action's motion for a preliminary injunction in Clean Ocean 
Action II denying injunctive relief on the grounds that the interim 
final rule was a valid interpretive rule, as EPA had argued.
    (c) Regulatory revisions are required to address several issues 
unrelated to requirements for bioaccumulation testing of the suspended 
particulate phase.
    EPA received several comments from the regulated community 
advocating a variety of amendments to the ocean dumping regulations. 
Some of the issues raised by those commenters were requests for: (1) 
Specific deadlines for EPA/Corps review of permit applications; (2) 
revised definitions in the regulations that would expand the present 
language for such terms as ``trace contaminant,'' ``benthic 
organisms,'' ``bioassay,'' and ``bioaccumulation;'' (3) use of a single 
benthic species for solid phase bioaccumulation tests; (4) development 
of specific regulatory provisions to address capping of dredged 
material; and (5) revisions to regional guidance manuals, to include 
specific information on such factors as appropriate test temperatures, 
and sediment renewal rates.
    These comments raise issues that are beyond the scope of today's 
rulemaking. The Agency is currently preparing a proposal that will 
include more comprehensive revisions to the ocean dumping regulations, 
particularly with respect to the disposal of dredged material. The 
Agency will consider the suggestions while preparing that proposal.
    For detailed responses to the full comments as submitted, see the 
response to comments document in the rulemaking record.

B. Conclusion

    Several commenters who supported the Agency's clarification of the 
regulations urged the Agency not to take final action adding the 
footnotes to 40 CFR 227.6(c) and 40 CFR 227.27(b) as proposed. Even 
though EPA believes the addition of the footnotes would adequately 
clarify that bioaccumulation testing of the suspended particulate phase 
is not required, the Agency agrees that the second option described in 
the May 20, 1994, proposal (the deletion of language from 40 CFR 
227.6(c)(2), and the addition of language to 40 CFR 227.27(b), as 
proposed) would result in greater clarity and ensure that there is no 
ambiguity on this issue. Accordingly, the Agency has taken final action 
implementing the second option proposed and deleting the footnotes that 
were added to 40 CFR 227.6(c) and 40 CFR 227.27(b) by the interim final 
rule.

Supporting Documentation

A. 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 review by the Office of Management and Budget 
(OMB) 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;
    (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.
    This Rule clarifies the Agency's long-standing interpretation of 
the regulations and does not change existing practice or impose 
economic burdens. Thus, it has been determined that this rule is not a 
``significant regulatory action'' under the terms of Executive Order 
12866, and therefore is not subject to OMB review.

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 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. 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 above in the discussion of Executive Order 12866, 
today's final rule is not a significant regulatory action. Accordingly, 
EPA has determined that today's rule would not have a significant 
impact on a substantial number of small entities, and that a Regulatory 
Flexibility Analysis therefore is unnecessary.

List of Subjects in 40 CFR Part 227

    Environmental protection, Dredged material, Ocean dumping, Testing 
requirements, Water pollution control.

    Dated: October 11, 1994.
Carol M. Browner,
Administrator.

    For the reasons set out in this preamble, part 227 of title 40 of 
the Code of Federal Regulations is amended as follows:

PART 227--[AMENDED]

    1. The authority citation for part 227 continues to read as 
follows:

    Authority: 33 U.S.C. 1412 and 1418.


Sec. 227.6  [Amended]

    2. Section 227.6(c)(2) is amended by removing from the first 
sentence the words ``including bioaccumulation'' removing from the 
third sentence the words ``either'' and ``or to bioaccumulation'', and 
by removing Footnote 1 at the end thereof.


Sec. 227.27  [Amended]

    3. Section 227.27(b) is amended by adding between the first and 
second sentence thereof the following additional sentence: ``Suspended 
particulate phase bioaccumulation testing is not required'', and by 
removing Footnote 2 at the end thereof.

[FR Doc. 94-25744 Filed 10-17-94; 8:45 am]
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