[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