[Federal Register Volume 61, Number 190 (Monday, September 30, 1996)]
[Rules and Regulations]
[Pages 51196-51203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24995]
[[Page 51195]]
_______________________________________________________________________
Part VII
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 227
Ocean Dumping Testing Requirements; Final Rule
Federal Register / Vol. 61, No. 190 / Monday, September 30, 1996 /
Rules and Regulations
[[Page 51196]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 227
[FRL-5617-6]
RIN 2040-AC81
Testing Requirements for Ocean Dumping
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA today is issuing a final rule clarifying portions of the
Agency's ocean dumping regulations regarding the number of species to
be used in bioassay testing of the solid phase (that part of the
material that would settle rapidly to the bottom after dumping). The
purpose of today's rule 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 rule confirms the validity
of existing solid phase testing practices under which the use of two
species is permissible, provided the two species tested together
represent the three categories of organisms specified in the
regulations, and will maintain current safeguards for protection of the
marine environment. The proposed rulemaking (February 29, 1996)
included proposed changes that would have addressed liquid and
suspended particulate phase test species, as well as other aspects of
the testing requirements. The Agency has limited the scope of today's
final rule to clarify only the number of species to be used in solid
phase bioassay tests, in a manner consistent with current testing
practices and scientific guidance. The Agency has determined that this
final rule will provide protection of our ocean waters, without
requiring unnecessary tests.
EFFECTIVE DATE: This final regulation becomes effective on September
30, 1996.
ADDRESSES: A copy of the supporting documents for this rule are
available for review at EPA's Water Docket, Room 2616, 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
Control Branch, Oceans and Coastal Protection Division (4504F),
Environmental Protection Agency, 401 M Street, SW, Washington, DC
20460, Telephone 202/260-1952.
SUPPLEMENTARY INFORMATION:
A. Regulated Entities
Entities potentially regulated by this action are persons or
entities seeking permits to dump material into ocean waters under the
Marine Protection, Research, and Sanctuaries Act, 33 U.S.C. 1401 et
seq. That statute currently bans the ocean dumping of industrial wastes
(with the exception of waste from tuna cannery operations in American
Samoa or Puerto Rico) and also bans ocean dumping of sewage sludge. As
a result, the rule would primarily be of relevance to parties seeking
permits from the U.S. Army Corps of Engineers for the ocean dumping of
dredged material as well as the U.S. Army Corps of Engineers itself.
Potentially regulated categories and entities include:
------------------------------------------------------------------------
Examples of potentially regulated
Category entities
------------------------------------------------------------------------
Industry.......................... * Ports seeking dredged material
ocean dumping permits.
* Marinas seeking dredged material
ocean dumping permits.
* Shipyards seeking dredged material
ocean dumping permits.
* Berth owners seeking dredged
material ocean dumping permits.
* Tuna canneries in American Samoa
seeking fish waste ocean dumping
permits.
State/local/tribal governments.... * Local governments owning ports or
berths seeking dredged material
ocean dumping permits.
Federal Government................ * US Army Corps of Engineers.
* Federal agencies seeking dredged
material ocean dumping permits.
------------------------------------------------------------------------
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by the
action. This table lists types of entities that EPA is now aware could
potentially be regulated by this action. Other types of entities not
listed in this table could also be regulated. To determine whether your
organization is potentially regulated by this action, you should
carefully consider whether your organization is subject to the
requirement to obtain an ocean dumping permit in accordance with the
Purpose and Scope provisions of Section 220.1 of Title 40 of the Code
of Federal Regulations. If you have questions regarding the
applicability of this action to a particular entity, consult the person
listed in the preceding FOR FURTHER INFORMATION, CONTACT section.
B. Background
On February 29, 1996, the Agency issued a proposal in the Federal
Register to clarify certain provisions of the Agency's ocean dumping
regulations relating to bioassay testing requirements (61 FR 7765)
under the Marine Protection, Research, and Sanctuaries Act (33 U.S.C.
1401 et seq.) (hereinafter ``the Act'' or ``the MPRSA''). The original
deadline for receipt of comments on the proposed rule was April 1,
1996; however, in response to requests from the public for extension of
the comment period, the Agency extended the comment period an
additional 30 days, resulting in a final deadline for receipt of
comments of May 1, 1996 (61 FR 13794, March 28, 1996).
The purpose of the proposal was to clarify regulatory language that
was interpreted by the United States Court of Appeals for the Third
Circuit in a different manner than EPA intended. See, Clean Ocean
Action v. York, 57 F.3d 328 (3d Cir. 1995). That opinion raised a
degree of uncertainty about the number of species that had been used in
the tests conducted on the solid phase of the material in issue before
the court, and the degree to which the Agency retained flexibility to
determine when laboratory bioassay testing is required. The proposed
rule addressed both the number of test species to be used under the
regulations and issues related to when bioassay testing is required. It
was not intended to change the evaluative procedures currently used and
set out in program guidance, or the substantive criteria used to
evaluate ocean dumping permit applications. The proposal was intended
to clarify the regulations in a manner consistent with the Agency's
longstanding interpretation of the regulations and existing testing
practices. For further information on the statutory and regulatory
background of the proposal, the reader is referred to the preamble at
61 FR 7766-7767.
The Agency received a number of comments on the proposed rule, some
of which expressed support for the proposal and some of which expressed
opposition. A summary of all comments received and the Agency's
response is
[[Page 51197]]
set out in Section D below. The complete text of all comments received
and the Agency's response may be found in ``Response to Individual
Comments Received on the Proposed Rulemaking on Testing Requirements
for Ocean Dumping.'' This document is included as part of the
rulemaking record, and can be inspected at the Agency's Water Docket,
the location of which is in the ADDRESSES section above.
C. Description of Final Rule
The Agency has elected to limit the scope of today's final rule to
only the issue of the number of species to be used in solid phase
tests. Today's rule does not take final action on the parts of the
proposal that addressed other testing issues. Although a number of
commenters supported proceeding with the entire scope of the proposed
rule, as is discussed further below, a number of other commenters were
concerned about the potential implications of the other aspects of the
proposal. EPA will be investing at least nine months in a process for
all affected groups to help the Agency review the ocean disposal
testing requirements and ensure that any further revision reflects both
sound policy and science.
Accordingly, today's final rule is limited to amending
Sec. 227.27(d) of the regulations, which addresses the number of test
species to be used in solid phase testing by defining ``appropriate
sensitive benthic marine organisms'' for use in solid phase laboratory
bioassay tests. The organisms to be used are defined in existing
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....'' By describing a range of characteristics that the test
species must represent for different exposure pathways, the regulations
protect the marine environment by considering the different
sensitivities to environmental contaminants exhibited by marine
organisms with these different characteristics [Reference 1].
The Agency's approved testing procedures provide for the use of no
fewer than two different species that together cover the three
characteristics specified in 40 CFR 227.27(d). For example, the marine
worm, Nephtys incisa, is both a deposit-feeder and a burrower
[Reference 2], and the amphipod crustacean, Ampelisca abdita, is both a
filter-feeder and a deposit-feeder [Reference 3]. Because 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), the proposal would have
amended 40 CFR 227.27(d) to reflect more clearly EPA's longstanding
interpretation of that provision, i.e., that at least two species may
be used in solid phase bioassay testing, provided that together they
are representative of the three categories of organisms specified in
the regulations. The proposal would have done this by removing the
words ``one species each'' from Section 227.27(d) where they modified
the three groups of characteristics, and replaced them with ``at least
two.'' The proposal would not have changed the requirement that the
test species be ``chosen from among the most sensitive species''
accepted as reliable test organisms.
In addition, although the issue of the number of test species that
may be used was addressed by the Third Circuit in the context of the
solid phase testing provisions of Sec. 227.27(d), the proposed rule
would have made similar changes in 40 CFR 227.27(c) with regard to
liquid and suspended particulate phase testing. This was because
Sec. 227.27(c) similarly defines ``appropriate sensitive marine
organisms'' to be used in such testing 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 * * *.''
As is discussed below, some commenters preferred the use of three
species, and expressed concern that allowing the use of multi-
characteristic organisms might result in under-estimation of the
potential effects of material proposed for disposal. As explained in
the discussion of comments below, however, EPA has determined that for
the solid phase, the use of two appropriately sensitive species that
together are representative of the three categories of organisms
specified in the regulations is technically appropriate for use in the
ocean dumping regulatory program, and that the regulations should
unambiguously allow for such a solid phase testing approach. At the
same time, the regulations do not restrict the Corps' and EPA's ability
to require testing of more than two species where appropriate.
However, because as described below, the current testing guidance
calls for the use of three species for liquid and suspended particulate
phase testing, and in light of the concerns expressed over the proposed
rule, the Agency has elected not to include changes to Sec. 227.27(c)
as part of today's final rule. That section of the regulations was not
specifically at issue before the Third Circuit or addressed in its
opinion. The Agency continues to stand by its longstanding
interpretation of the existing regulatory language. However, given that
the existing practice and guidance for liquid and suspended phase
testing currently employ three species testing, that Sec. 227.27(c) was
not addressed in the Third Circuit opinion, and the overall concerns
expressed by some commenters on the proposed rule, the Agency does not
believe it is necessary to include clarifying changes to Sec. 227.27(c)
in today's final rule. The remainder of the test species discussion in
today's preamble thus focuses on solid phase issues.
While the ocean dumping regulations provide for a comprehensive
assessment of the potential environmental impacts of disposal,
evaluation of the material to be disposed plays an important role in
environmental assessments. The use of laboratory tests forms a major
part of the regulatory evaluations of the potential impacts of
discharges of material into the aquatic environment [Reference 1]. It
is generally recognized that there is no one ``white rat'' that can
predict the potential impact of the disposal of all material on all
organisms in all marine ecosystems. This difficulty can be addressed by
conducting multiple laboratory tests. However, simply conducting more
tests may provide redundant data and may waste resources [Reference 4].
Decisions regarding how many and what kinds of organisms to test are a
matter of complex scientific judgment. Experience gained from
conducting multiple laboratory tests with a large number of species can
be used to determine the relative sensitivity of testing organisms
[Reference 5]. In addition, species sensitivity must be understood
within the context of the exposure of the organism to the material
during the test [Reference 5]. With information about the relative
sensitivity of a large number of organisms for different exposures to a
material, an optimum suite of testing organisms can be identified.
These factors were all thoroughly evaluated by the Agency during the
development of the current guidance for testing, and the species
recommended for use by that guidance reflects this analysis.
The current recommendations of EPA and the U. S. Army Corps of
Engineers for testing organisms are contained in the guidance manual
entitled, Evaluation of Dredged Material Proposed for Ocean Disposal--
Testing
[[Page 51198]]
Manual [Reference 6], commonly known as the ``Green Book.'' To assess
the potential water column impacts associated with the liquid and
suspended particulate phase, the Green Book recommends that toxicity
tests be conducted on three appropriately sensitive water column
species representing phytoplankton or zooplankton, crustacean or
mollusk, and fish [Reference 6]. To assess benthic impacts (impacts to
organisms that live on the sea bottom), the Green Book recommends that
a 10-day acute toxicity test and a 28-day bioaccumulation test be
conducted on the solid phase with at least two ``appropriately
sensitive marine benthic species'' for the type of test conducted
(i.e., two acute toxicity organisms for acute toxicity tests and two
bioaccumulation organisms for bioaccumulation tests). Thus, current
guidance recommends that a total of three species be tested for water
column effects, and at least two ``appropriate sensitive marine benthic
species'' be tested for both bioaccumulation and toxicity in the solid
phase of the dumped material. Thus, more than two species are tested in
the solid phase, and all three species characteristics identified in
the regulations are represented in each of the two types of solid phase
testing. All three water column species characteristics (phytoplankton
or zooplankton, crustacean or mollusk, and fish) and all three solid
phase species characteristics (filter-feeding, deposit-feeding, and
burrowing) are therefore represented in these tests. The species used
are all selected from among the most sensitive and reliable for the
type of test in which they are used (acute toxicity or
bioaccumulation).
For a particular type of test (e.g., acute toxicity or
bioaccumulation tests), the scientific community has generally arrived
at a consensus on the most appropriate organisms for testing
[References 2, 3, 7, and 8]. For solid phase acute toxicity tests, the
amphipods Ampelisca abdita, Eohaustorius estuarius, Leptocheirus
plumulosus, and Rhepoxynius abronius are documented in the scientific
literature as being reliable and sensitive test organisms, and are
currently the only organisms subject to an EPA standard method for
sediment acute toxicity tests [Reference 3]. Standard methods are
desirable because they promote consistency among the different
laboratories running the tests. These organisms have been used
extensively in the study of aquatic sediment contamination, and have
been shown to be good indicators of adverse ecological effects to
benthic communities [References 9-17]. All four of these amphipods
share similar sensitivity to contaminants [Reference 3]. However, all
four amphipods are not equally appropriate for all sediments; each
organism has particular tolerances for sediment grain size, salinity,
and other natural characteristics of sediment [Reference 3]. The Agency
is not currently aware of reliable infaunal organisms (i.e., organisms
living in the sediment and thus in direct contact with sediment
contaminants) that are more sensitive than these amphipods for solid
phase acute toxicity testing. Nevertheless, the Agency currently
recommends that, in addition to the testing of at least one amphipod,
at least one additional appropriate sensitive benthic marine organisms
(e.g., a mysid shrimp, or a marine polychaete) be tested in the solid
phase [Reference 6]. The Green Book has made this recommendation to
provide additional assurance that potential interspecies variability is
addressed, and also to ensure that the three characteristics listed in
Section 227.27(d) are covered. The Agency is not aware of any
information to suggest that the regulations need to mandate testing on
a third organism to provide adequate information on the potential acute
toxicity of organisms exposed to the solid phase of the material.
Where two species are used in acute toxicity testing of the solid
phase, two species are used in bioaccumulation testing of the solid
phase, and the results of these tests are assessed collectively with
other tests and assessments, there is ample information to ensure
environmental protection, and the requirements of the Act are fully
met. This is particularly true because the number of species used in
biological tests is only one of several criteria used to satisfy the
ocean dumping regulations before material may be disposed of in marine
waters.
The regulations address the protection of marine ecosystems not
only through permitting criteria contained in 40 CFR Part 227, but also
by selecting disposal sites so as to minimize the effects of disposal
activities on the marine environment (See 40 CFR Part 228). The Part
227 criteria include the testing provision being clarified in today's
rule, which is used in assessing whether the material is suitable for
ocean disposal and will not cause significant undesirable effects on
the environment. Direct measurement of the effects of pollution on
complex ecosystems is very difficult. While laboratory testing of the
potential effects of pollutants on marine organisms does not directly
provide information about ecosystem responses, it can integrate the
additive and interactive effects of complex mixtures of chemicals, and
examine a variety of endpoints over different exposure periods to
predict potential impact at several levels of biological organization
for sensitive surrogate species [Reference 9]. Moreover, the species
used in testing under the current guidance (e.g., amphipods and
polychaetes) play significant roles in the food chain and are
ecologically important.
EPA has determined that the variety of appropriately sensitive test
organisms used to determine suitability of material proposed for ocean
dumping, through water column and solid phase tests that evaluate acute
toxicity and potential bioaccumulation, provide sufficient information
to determine whether the material proposed for dumping meets the
statutory standard of no unreasonable degradation of human health or
the marine environment. The final evaluation is a conservative
integration of the results from all these tests. In order for a
material to be found suitable for dumping, all of the tests performed
must indicate that the criteria are met. For instance, if only one of
the species used is determined to fail acute toxicity testing, the
material is deemed unsuitable for ocean dumping. Given the total
testing and site selection process, the use of two appropriately
sensitive species for solid phase testing will generally be more than
sufficient to protect the environment.
However, given the concern expressed by several commenters, today's
final rule is further clarified in two aspects, while still allowing
for the use of two species. The first sentence in proposed
Sec. 227.27(d) has been revised to delete the phrase ``at least two''
species, and instead to substitute the phrase ``two or more'' species.
This change is made to make it perfectly clear that the regulations are
not intended to limit testing to only two species, and that the Agency
retains the authority to require the use of more than two species. In
addition, the second sentence of proposed Sec. 227.27(d) is revised
from the proposal by adding language to clarify that the species are to
be ``chosen from among the species that are most sensitive for each
type they represent * * *.'' This change is made in response to
concerns expressed by some commenters that some multi-characteristic
organisms might not be sensitive for each characteristic they
represent. These commenters expressed concern that an organism that was
both a filter-feeder and a deposit-feeder might not be among the most
sensitive
[[Page 51199]]
filter-feeders and among the most sensitive deposit-feeders. As is
discussed below, the multi-characteristic organisms identified in the
current testing guidance, such as the amphipod, are among the most
sensitive and reliable organisms for all the feeding types they are
used to represent, and fully comport with this revised provision.
D. Summary of Comments and Agency Response
The comments on the proposed rule generally fell into four broad
categories. These categories and the Agency responses are set out
below.
(1) Comment period deadline: A number of commenters requested
additional time to consider the proposal, and submitted requests to
extend the public comment period by a certain number of days, or
requests that the Agency indefinitely suspend work on the rule. Other
commenters took a different view and requested that the Agency not
extend the comment period at all, urging the Agency to act
expeditiously to complete the rulemaking.
As explained in the preamble to the proposed rule, the Agency
originally believed that a 30-day comment period was appropriate
because the proposed rulemaking was intended to clarify, not
substantively change, the Agency's longstanding interpretation and
implementation of the ocean dumping regulations. After carefully
considering the comments received prior to the close of the original
30-day comment period, the Agency acted to extend the comment period
for an additional 30 days (61 FR 13794). The Agency believes that
allowing a 60-day comment period is reasonable and appropriate, since
the proposal was intended to clarify the regulations in a manner
consistent with the Agency's longstanding interpretation and its
current testing manuals. The Agency has further responded to the
concern expressed by some commenters regarding the need for additional
time by limiting the scope of today's final rule to the number of
species to be used in solid phase bioassay testing. The Agency intends
to invest at least nine months in a process for all affected groups--
industry, labor, and environmental groups--to help the Agency review
the ocean disposal testing requirements and ensure that any further
revision reflects both sound policy and science. See, letters of July
24, 1996, from EPA Administrator Browner, Transportation Secretary
Pena, and Army Secretary West, to Congressmen Frank Pallone, Robert
Menendez, and Robert Torricelli, which are included in the rulemaking
record. EPA believes that such an approach, under which issues related
to the number of solid phase test species to be used are expeditiously
resolved, while remaining issues are included in a review of ocean
disposal testing requirements that will involve further discussion
among stakeholders, appropriately addresses the range of comments
received related to the deadline for public comments. EPA expects that
the issues to be addressed in this review, as well as their relative
priority, will be identified as part of the definition of this process.
(2) Effect of proposed rule on environmental protection of the
oceans: A number of commenters expressed concern that the proposed rule
would result in a weakening of the existing regulations' protection of
the oceans. Other commenters disagreed with this view, agreeing with
EPA's position that the proposal was a clarification of the regulations
in a manner consistent with Agency practice. Unlike the proposal,
today's final rule is limited to the issue of the number of solid phase
test species to be used. Thus, those concerns unrelated to the number
of species used are not at issue in today's final rule.
To the extent that some commenters raised general concerns about
reduced protection of the oceans resulting from the use of two rather
than three species in bioassay tests, the Agency notes that the use of
two species for solid phase testing does not reflect a change from
existing practice, and is fully consistent with the most recent testing
manual, the Green Book [Reference 6]. In addition, as is explained
elsewhere in this preamble, the Agency has determined that allowing the
use of two appropriately sensitive species that together represent the
three categories of organisms specified by the regulations, permits a
sufficient evaluation of the solid phase of the material proposed for
disposal, and is fully protective of the marine environment.
Furthermore, under the regulations, the Agency retains the authority to
require solid phase testing on more than two species, whenever it
believes two species would not provide for an adequate evaluation of
the potential impacts to the marine environment. Finally, to the extent
these commenters were concerned about the number of species used in
liquid or suspended particulate phase testing, as previously discussed,
the Agency does in fact include three species for such tests in the
national guidance, and today's final rule makes no changes to the
relevant regulatory provision.
(3) Comments unrelated to the number of test species to be used: A
number of specific comments were received on testing issues unrelated
to the number of test species, including concerns about the use of
models, the use of alternatives to laboratory bioassays, and concerns
that the proposal gave the Agency too much discretion with regard to
what tests to require. Today's final rule addresses only the number of
test species to be used in the solid phase. As stated above, the Agency
will be investing at least nine months in a process with affected
stakeholders to review the ocean dumping testing requirements. To the
extent such issues are raised in that process, EPA will carefully
consider those comments.
(4) Comments on number of species to be used: One of the comments
on the number of species to be used pointed to language in Sec. 102(a)
of the Marine Protection, Research, and Sanctuaries Act (MPRSA)
addressing the effect of dumping on plankton, shellfish, and wildlife;
another comment pointed to similar language addressing the effect of
dumping on marine ecosystems. These commenters suggested that the use
of two species would be contrary to the specified statutory provisions.
The Agency does not agree with this comment. MPRSA Sec. 102(a) does not
require that tests be conducted on each of the organisms enumerated, or
on marine ecosystems as part of the permitting process, but rather
requires that the potential effects of dumping are factors to be
considered by EPA in developing the ocean dumping criteria. The Agency
has considered the Sec. 102(a) requirements in developing the ocean
dumping regulations. For example, 40 CFR Sec. 227.27(a) requires the
use of marine water quality criteria in evaluating the suitability of
material for dumping. Those criteria were developed after examination
of contaminant effects on a wide range of organisms, including fish,
shellfish, and plankton [Reference 20]. In addition, testing manuals
developed for the ocean dumping regulations identify a range of species
for testing, including fish, shellfish, zooplankton, crustaceans and
worms [Reference 6]. Finally, the regulations address not only the
evaluation of material proposed for disposal as part of the permitting
process, but also the selection of ocean disposal sites. The site
selection criteria contain provisions protective of marine ecosystems
that seek to localize potential impacts, and to avoid locating disposal
sites in sensitive areas of the marine
[[Page 51200]]
environment. 40 CFR Sections 228.5 and 228.6.
Other commenters questioned whether two species alone were
representative of complex marine ecosystems. These commenters did not
specifically assert that three species would be fully representative of
entire marine ecosystems; however, the commenters appeared to believe
that the more species tested, the better the representation of entire
marine ecosystems. Depending upon the sensitivity and types of
organisms chosen, the Agency agrees with the principle that the greater
the diversity of species tested, the more likely they are to be
representative of complete ecosystems. The reason so much emphasis is
placed on selecting organisms for testing from among the most
sensitive, is that in so doing one is assured of protecting the
majority of species in the ecosystem. Although the two species may not
react to contaminants the same way as all the species in a marine
ecosystem, if they are selected from among the most sensitive species
they will represent the potential impacts to the marine ecosystem.
Furthermore, in implementing a nationwide regulatory program, the
Agency also must take into account the difficulty and expense of
performing bioassay tests, potential variability in results if non-
standardized test species are used, and the large number of tests that
may need to be run for large volumes of spatially heterogenous
material, such as dredged material. As explained elsewhere in this
preamble, the Agency has determined that for the solid phase, the use
of two appropriately sensitive organisms representing three
characteristics specified in the regulations normally is sufficient to
determine the potential for a dumped material to unreasonably degrade
the marine environment, or to endanger human health. Moreover, the
regulations do not limit the authority to require testing of additional
species when warranted.
The Agency's ocean dumping regulations address the protection of
marine ecosystems both through permitting criteria contained in 40 CFR
Part 227, and site selection criteria contained in 40 CFR Part 228, and
not solely through the number of species to be tested. These criteria
provide for a thorough assessment of the physical and chemical
characteristics of the material, and a thorough evaluation of the
suitability of placing that material at a specific location, which is
selected after careful assessment of the surrounding environment. In
addition, the testing regulations themselves require the selection of
appropriately sensitive and reliable test organisms to predict
potential impacts at the disposal site. By requiring that appropriately
sensitive organisms are used, the regulations assure that species used
in tests will detect potential effects of dumped material on marine
life. The organisms recommended for use are identified in the testing
manual that implements the regulations [Reference 6]. The organisms
recommended are among the most sensitive suitable for use in a
regulatory testing program; these organisms include amphipods, shrimp,
marine polychaetes, and molluscs. These animals are recognized in the
scientific literature as being sensitive predictors of impacts
[References 2, 3, 6, and 8]. Using these organisms further protects the
ecosystem because these organisms are ecologically important, based on
abundance in the environment and their role in the structure of the
marine community.
Some commenters supporting the use of three species pointed to
EPA's Technical Support Document for Water Quality-based Toxics Control
[Reference 21] (hereafter referred to as ``the TSD''), which addresses
bioassay testing in the Clean Water Act's (CWA) Section 402 point
source discharge permitting program. These commenters believe that the
TSD called for the use of at least three species in bioassay testing.
However, although that manual does generally recommend the use of three
species, it also specifically recognizes that the optimum number of
species may be fewer, and the relevant CWA regulations (40 CFR
Sec. 136.3) do not specify a particular number of species to be used.
It also should be noted that the TSD addresses water column bioassays,
that the Green Book for the ocean dumping program also recommends the
use of three water column species for such tests, and that today's
final rule does not address water column testing. Finally, the Agency
also notes that for the solid phase of the dumped material, the Green
Book recommends use of both a 10-day acute toxicity test and 28-day
bioaccumulation test [Reference 6, p. 3-12]. Each of these two tests is
conducted with at least two ``appropriate sensitive marine benthic
species'' for the type of test conducted [Reference 6, pp. 11-10 and
12-2]. Thus, more than two species are tested in the solid phase, and
all three species characteristics identified in the regulations are
represented in each of the two types of solid phase testing.
Other commenters raised concerns that allowing one of the species
used to represent two of the three characteristics specified in the
regulations might result in under-estimation of potential effects.
These commenters indicated that organisms that are both filter- and
deposit-feeders would not represent how organisms that are primarily
filter-feeders would respond. The Agency agrees with the commenter that
organisms can alter their behavior in response to environmental
conditions, including food availability; this point is supported in the
literature [Reference 22]. The bioavailability, and ultimately the
toxicity, of a contaminant in a sediment may depend upon factors
related to how closely an organism is in contact with the sediment,
e.g., whether it ingests sediment, or whether it is in contact with the
sediment or interstitial water [Reference 18, p. 120]. Behavior that
minimizes contact by the organism with the sediment, such as filtering
overlying water, will significantly reduce an organism's exposure to
contaminants, and will significantly minimize the potential for
observing an effect in the organism due to contaminants in the sediment
[References 18 and 19]. The Green Book emphasizes that organisms tested
in solid phase bioassays should be in intimate contact with the
sediment or should ingest sediment [Reference 6, pp. 11-10 and 12-2].
Because an exclusively filter-feeding organism need not be in intimate
contact with the sediments, and would have to be fed during the test
since there would be nothing to filter (decreasing sediment exposure
due to ingestion), the Agency has determined that solid phase testing
of such organisms would not yield significant additional results.
The Agency is not aware of, nor do the commenters offer,
documentation to explain their belief that true filter-feeders may be
more sensitive than species that represent both filter-feeding and
deposit-feeding modes. Moreover, based on over twenty years of
experience using toxicity tests in the ocean dumping program, the Green
Book strongly recommends use of infaunal amphipods as appropriate
sensitive benthic marine organisms [Reference 6, p. 11-10]. These
organisms represent both filter-feeding and deposit-feeding modes, and
are extensively used in the scientific community to study the effects
of sediment contamination. They are also among the most sensitive
species documented in the scientific literature as being reliable test
organisms [References 9-17]. Because of widespread use within the
scientific community, a number of standardized protocols have been
developed for the amphipod toxicity test [References 3, 7,
[[Page 51201]]
8, and 23], and EPA recognizes amphipods as a recommended species for
solid phase acute toxicity testing in the Green Book [Reference 6, p.
11-10].
In summary, EPA has determined that the variety of appropriately
sensitive test organisms used to determine suitability through water
column and solid phase tests that evaluate acute toxicity and potential
bioaccumulation provide an adequate basis to determine if a material
proposed for dumping will unreasonably degrade the marine environment
or endanger human health. The final evaluation is a conservative
integration of the results from all these tests. In order for a dredged
material to be found suitable for dumping, all of the tests performed
must indicate that the criteria are met. For instance, if one of the
species used is determined to fail acute toxicity testing, the material
is deemed unsuitable for ocean dumping. Given the overall testing and
site selection process, the use of two appropriately sensitive species
for solid phase testing will generally be more than sufficient to
protect the environment.
E. References
1. Cairns J. and B.R. Niederlehner, ``Problems associated with
selecting the most sensitive species for toxicity testing,''
Hydrobiologia, 153:87-94, 1987.
2. ``Guidance manual: Bedded sediment bioaccumulation tests'',
U.S. Environmental Protection Agency, Office of Research and
Development, ERL-N Contribution No. N-111, September 1989.
3. ``Methods for assessing the toxicity of sediment-associated
contaminants with estuarine and marine amphipods,'' Office of
Research and Development, U.S. Environmental Protection Agency,
Washington, DC, EPA/600/R-94/025, June 1994.
4. Burton, G. A. and K.J. Scott, ``Sediment Toxicity
Evaluations--Their Niche in Ecological Assessments,'' Environ. Sci.
Technol., 26(11):2068-2075, 1992.
5. Mount, D.I., ``Scientific Problems in Using Multispecies
Toxicity Tests for Regulatory Purposes,'' in J. Cairns, Jr. (Ed),
Multispecies Toxicity Testing, Pergamon Press, NY, 1985, pp. 13-18.
6. ``Evaluation of dredged material proposed for ocean
disposal--Testing manual,'' U.S. Environmental Protection Agency and
U.S. Army Corps of Engineers, February 1991. EPA-503/8-91/001
(commonly known as the ``Green Book'').
7. SETAC, ``Guidance Document on Sediment Toxicity Tests and
Bioassays for Freshwater and Marine Environments'', eds. I.R. Hill,
P. Matthiessen, and F. Heimbach, Society of Environmental Toxicology
and Chemistry--Europe, 1993.
8. ASTM, ``Standard Guide for Conducting 10-day Static Sediment
Toxicity Tests with Marine and Estuarine Amphipods,'' Designation: E
1367-90, American Society of Testing Materials, Philadelphia, PA,
1990.
9. Lamberson, J.O., T.H. DeWitt, and R.C. Swartz, ``Assessment
of Sediment Toxicity to Marine Benthos,'' in Sediment Toxicity
Assessment, ed. Allen G. Burton. Lewis Publishers: Boca Raton, FL,
1992; pp. 183-211.
10. Redmond, M.S., P.A. Crocker, K.M. McKenna, E.A. Petocelli,
K.J. Scott and C.R. Demas, ``Sediment Toxicity Testing with the
Amphipod Ampelisca abdita in Calcasieu Estuary, Louisiana,'' Arch.
Environ. Contam. Toxicol. 30:53-61, 1996.
11. Schlekat, C.E., K.J. Scott, R.C. Swartz, B. Albrecht, L.
Antrim, K. Doe, S. Douglas, J.A. Ferretti, D.J. Hansen, D.W. Moore,
C. Mueller and A. Tang, ``Interlaboratory Comparison of a 10-day
Sediment Toxicity Test Method Using Ampelisca abdita, Eohaustorius
estuarius and Leptocheirus plumulosus,'' Environ. Toxicol. Chem.,
14(12):2163-2174, 1995.
12. Long, E.R., M.R. Buchman, S.M. Bay, R.J. Breteler, R.S.
Carr, P.M. Chapman, J.E. Hose, A.L. Lissner, K.J. Scott and D.A.
Wolfe, ``Comparative Evaluation of Five Toxicity Tests with Sediment
from San Francisco Bay and Tomales Bay, California,'' Environ.
Toxicol. Chem., 9:1193-1214, 1990.
13. DeWitt, T.H., R.C. Swartz, and J.O. Lamberson, ``Measuring
the Acute Toxicity of Estuarine Sediments,'' Environ. Toxicol.
Chem., 8:1035-1048, 1989.
14. Swartz, R.C., W.A. DeBen, K.A. Sercu and J.O. Lamberson,
``Sediment Toxicity and the Distribution of Amphipods in
Commencement Bay, Washington, USA,'' Marine Poll. Bull., 13(10):
359-364, 1982.
15. Swartz, R.C., D.W. Schults, G.R. Ditsworth, W.W. DeBen, and
F.A. Cole, ``Sediment Toxicity, Contamination, and Macrobenthic
Communities near a Large Sewage Outfall,'' Special Technical
Publication 865, ASTM, 1985; pp. 152-175.
16. Swartz, R.C., F.A. Cole, D.W. Schults, and W.A. DeBen,
``Ecological Changes in the Southern California Bight near a Large
Sewage Outfall: Benthic Conditions in 1980 and 1983,'' Marine
Ecology--Progress Series, 31:1-13, 1986.
17. Swartz, R.C., F.A. Cole, J.O. Lamberson, S.P. Ferraro, D.
Schultz, W.A. DeBen, H. Lee II, and R. Ozretich, ``Sediment
Toxicity, Contamination and Amphipod Abundance at a DDT- and
Dieldrin-Contaminated Site in San Francisco Bay,'' Environ. Toxicol.
Chem., 13(6):1-14, 1994.
18. Meador, J.P., E. Casillas, C.A. Sloan and U. Varanasi,
``Comparative Bioaccumulation of Polycyclic Aromatic Hydrocarbons
from Sediment by Two Infaunal Invertebrates,'' Mar. Ecol. Prog.
Ser., 123:107-124, 1995.
19. Whiteman, F.W., G.T. Ankley, M.D. Kahl, D.M. Rau, and M.D.
Balcer, ``Evaluation of Interstitial Water as a Route of Exposure
for Ammonia in Sediment Tests with Benthic Macroinvertebrates,''
Environ. Toxicol. Chem., 15:794-801, 1996.
20. Stephan, C.E., D. I. Mount, et al., ``Guidelines for
Deriving Numerical National Water Quality Criteria for the
Protection of Aquatic Organisms and Their Uses'', U.S. EPA, ORD. 103
pp. NTIS PB85-227049.
21. ``Technical Support Document for Water Quality-Based Toxics
Control,'' U.S. Environmental Protection Agency, EPA 505/2-90-001,
March 1991.
22. Wang, W.X., N.S. Fisher, and S.N. Luoma, ``Assimilation of
Trace Elements Ingested by the Mussell Mytilus edulis: Effects of
Algal Food Abundance,'' Mar. Ecol. Prog. Ser., 129:165-176, 1995.
23. Swartz, R.C., W.A. deBen, J.P. Jones, J.O. Lamberson, and
F.A. Cole, ``Phoxocephalid Amphipod Bioassay for Marine Sediment
Toxicity,'' In: R.D. Cardwell, R. Purdy, and R.C. Bahner (Eds.),
Aquatic Toxicology and Hazard Assessment, Seventh Symposium, ASTM
Special Technical Publication 854, 1984, pp. 284-307.
Compliance With Other Laws and Executive Orders
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 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 affect in a material way the economy, 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.
This rulemaking should have minimal impact on permittees. The
rulemaking merely clarifies ocean dumping testing requirements in a
manner consistent with current testing practices, under which the use
of two solid phase test species is permissible, provided that the two
species together represent the three categories of organisms specified
in the regulation. It thus has been determined that this rule is not a
``significant regulatory action'' under the terms of Executive Order
12866, and is therefore not subject to OMB review.
B. Regulatory Flexibility Act, as amended by the Small Business
Regulatory Enforcement Fairness Act of 1996
The Regulatory Flexibility Act (RFA) provides that, whenever an
agency promulgates a final rule under 5 U.S.C. Sec. 553, an agency must
prepare a regulatory flexibility analysis (RFA)
[[Page 51202]]
unless the head of the agency certifies that the proposed rule will not
have a significant economic impact on a substantial number of small
entities. 5 U.S.C. Secs. 604 & 605. EPA has determined that today's
rule will not have a significant economic impact on small entities
because the rule does not change current procedures for testing dredged
material in order to evaluate its suitability for ocean dumping. The
rule merely clarifies these testing requirements in a manner consistent
with the Agency's longstanding interpretation of its own regulations.
Consequently, EPA's action will not impose any additional economic
burden on small entities such as small private dredging operations that
seek authorization for the dumping of dredged materials. In fact, to
the extent that it relieves small entities of any potential for testing
more species than required by Agency practice, the rule reduces any
potential economic impact on small private dredgers. For this reason,
the Administrator certifies, pursuant to section 605(b) of the
Regulatory Flexibility Act, that the rule will not have a significant
economic impact on a substantial number of small entities.
C. 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.
D. The Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), P.L.
104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
Today's rule contains no Federal mandates (under the regulatory
provisions of Title II of the UMRA) for State, local, or tribal
governments or sections 202 and 205 of the UMRA. As is explained
elsewhere in this preamble, the rule does not change current procedures
for testing dredged material in order to evaluate its suitability for
ocean dumping. The rule merely clarifies these testing requirements in
a manner consistent with the Agency's longstanding interpretation of
its own regulations. Accordingly, it imposes no new enforceable duty on
any State, local or tribal governments or the private sector. Even if
today's rule did contain a Federal mandate, this rule will not result
in annual expenditures of $100 million or more for State, local, and
tribal governments in the aggregate, or the private sector. Thus
today's rule is not subject to the requirements of sections 202 and 205
of the UMRA.
For the foregoing reasons, EPA also has determined that this rule
contains no regulatory requirements that might significantly or
uniquely affect small governments. Thus the requirements of Section 203
of UMRA do not apply to today's rule.
E. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, EPA submitted a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives and the Comptroller General of the
General Accounting Office prior to publication of the rule in today's
Federal Register. This rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
F. Administrative Procedure Act
The Administrative Procedure Act (APA), 5 U.S.C. 551 et seq.,
generally requires that substantive rules be published 30 days prior to
their effective date except:
``(1) A substantive rule which grants or recognizes an exemption or
relieves a restriction; * * *
or (3) as otherwise provided by the agency for good cause found and
published with the rule.'' 5 U.S.C. 553(d).
EPA is issuing today's final rule as immediately effective under
the provisions of 5 U.S.C. 553(d). As is explained elsewhere in this
preamble, today's final rule is intended to clarify the ocean dumping
regulations' testing requirements in a manner consistent with the
Agency's longstanding interpretation, existing testing guidance, and
current program practice. In the absence of an effective rule
clarifying the number of species to be used in ocean dumping testing,
Federal projects and permit applicants affected by the Third Circuit
opinion in Clean Ocean Action v. York, supra, will face uncertainties
in developing their future testing plans, and projects for which
testing has been completed will remain clouded by the uncertainties
stemming from the Third Circuit opinion. Because today's rule is
intended to confirm, not alter, the status quo, the Agency believes
that there is ``good cause'' under 5 U.S.C. 553(d)(3) to issue today's
rule as immediately effective. Moreover, today's rule confirms that the
ocean dumping regulations in fact allow the use of two species, not
three, in solid phase bioassay testing. The effect of today's rule is
to resolve uncertainties resulting from the opinion of the Third
Circuit in a manner that avoids unnecessary testing; thus, the
immediate effectiveness of today's rule also is warranted under 5
U.S.C. 553(d)(1).
List of Subjects in 40 CFR Part 227
Environmental impact statements, Environmental protection, Water
pollution control.
[[Page 51203]]
Dated: September 23, 1996.
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. 227.27 [Amended]
2. Section 227.27 is amended in paragraph (d) by removing the words
``at least one species each representing'' and adding, in their place,
the words ``two or more species that together represent'' and by
removing the words ``species chosen from among the most sensitive
species'' and adding, in their place, the words ``characteristics.
These organisms shall be chosen from among the species that are most
sensitive for each type they represent, and that are documented in the
scientific literature and''.
[FR Doc. 96-24995 Filed 9-26-96; 11:20 am]
BILLING CODE 6560-50-P
