[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]
_______________________________________________________________________
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.
-----------------------------------------------------------------------
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]
BILLING CODE 6560-50-P
