[Federal Register Volume 67, Number 195 (Tuesday, October 8, 2002)]
[Proposed Rules]
[Pages 62659-62667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25586]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 228

[FRL-7392-2]


Historic Area Remediation Site (HARS)-Specific Polychlorinated 
Biphenyl Worm Tissue Criterion

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing today 
to modify the designation of the Historic Area Remediation Site (HARS) 
to establish a HARS-specific worm tissue polychlorinated biphenyl (PCB) 
criterion of 113 parts per billion (ppb) for use in determining the 
suitability of proposed dredged material for use as Remediation 
Material. This amendment to the HARS designation would

[[Page 62660]]

establish a pass/fail criterion for evaluating PCBs in worm tissue from 
bioaccumulation tests performed on dredged material proposed for use at 
the HARS as Remediation Material. This value would remain in effect 
until after EPA and the U.S. Army Corps of Engineers (USACE) complete 
their review of the 2002 HARS human health scientific peer review 
comments, conduct and respond to the comments on the scientific peer 
review on the ecological proposal, and revise, as necessary, the 
process used to evaluate the suitability of dredged material proposed 
for use as Remediation Material at the HARS for all contaminants of 
concern in accordance with the September 27, 2000 Memorandum of 
Agreement between EPA and the USACE.
    Among other things, the September 27, 2000 MOA established an 
interim guidance value of 113 ppb for PCBs in the tissues of bioassayed 
worms, to be considered when determining whether proposed dredged 
material from the New York/New Jersey Harbor is acceptable for 
placement at the HARS. At the time of the MOA, the agencies agreed 
that, while the peer review was not complete, the science review 
warranted the implementation of this interim change. The September 2000 
MOA selected PCBs from the other contaminants because PCBs were 
specifically mentioned in the HARS designation. This interim change is 
designed to keep remediation of the HARS current with the latest 
scientific information concerning PCBs.
    Upon signing the MOA, EPA withdrew its concurrence (given prior to 
the MOA) for the U.S. Gypsum Corporation to place dredged material at 
the HARS as Remediation Material. U.S. Gypsum brought suit against the 
USACE and EPA, and in a July 10, 2002 decision, Judge Jed Rakoff of the 
U.S. District Court, Southern District of New York, held that the 
announcement of the 113 ppb interim value in the MOA was de facto 
rulemaking that should have been the subject of public notice and 
comment. This rulemaking is intended to address the court's concerns.

DATES: Comments: Comments must be received by November 7, 2002.
    Public Hearings: The public hearing dates are as follows:
    1. October 28, 2002, at 7:00 P.M., Monmouth Beach, New Jersey.
    2. October 29, 2002, at 2:00 PM., New York, New York.

ADDRESSES: Comments: Comments may be submitted by mail or 
electronically as follows: 1. By mail: Submit written comments on this 
notice to: Mr. Douglas Pabst, Team Leader, Dredged Material Management 
Team, U.S. Environmental Protection Agency Region 2, 290 Broadway, New 
York, NY 10007-1866 (E-mail [email protected]) To ensure proper 
identification of your comments, include in the subject line the name, 
date and Federal Register citation of this notice.
    2. Electronically: Submit your comments electronically to: 
[email protected] Electronic comments must be submitted as an ASCII 
or WordPerfect file avoiding the use of special characters and any form 
of encryption. Comments will also be accepted on disks in WordPerfect 
or ASCII file format sent or delivered to the addresses above. All 
comments and data in electronic form must be identified by the name, 
date and Federal Register citation of this notice. No confidential 
business information should be sent via e-mail.
    Public Hearings: The public hearing locations are:
    1. Monmouth Beach, New Jersey: Monmouth Beach Municipal Auditorium, 
22 Beach Road, Monmouth Beach, New Jersey, 07750.
    2. New York City, New York: Room 27D, EPA Region 2, 290 Broadway 
New York, New York 10007-1866.

FOR FURTHER INFORMATION CONTACT: Mr. Douglas Pabst, Team Leader, 
Dredged Material Management Team, U.S. Environmental Protection Agency 
Region 2, 290 Broadway, New York, NY 10007-1866 (E-mail 
[email protected]) (212) 637-3797.

SUPPLEMENTARY INFORMATION:

General Information

I. Regulated Entities

    Entities potentially affected by this action include those who 
might have sought or will seek permits to place dredged material into 
ocean waters at the HARS for purpose of remediation, under the Marine 
Protection, Research, and Sanctuaries Act, 33 U.S.C. 1401 et seq. 
(hereinafter referred to as the MPRSA). The rule would primarily be of 
relevance to entities in the New York-New Jersey Harbor and surrounding 
area seeking permits from the USACE to place Remediation Material at 
the HARS, as well as the USACE itself. Potentially affected categories 
and entities seeking to use the HARS include:

------------------------------------------------------------------------
                                        Examples of potentially affected
               Category                             entities
------------------------------------------------------------------------
Industry.............................  Ports in NY/NJ Harbor and
                                        surrounding areas seeking MPRSA
                                        permits for dredged material to
                                        be placed at the HARS.
                                       Marinas in the NY/NJ Harbor and
                                        surrounding areas seeking MPRSA
                                        permits for dredged material to
                                        be placed at the HARS.
                                       Shipyards in the NY/NJ Harbor and
                                        surrounding areas seeking MPRSA
                                        permits for dredged material to
                                        be placed at the HARS.
                                       Berth owners in the NY/NJ Harbor
                                        and surrounding area seeking
                                        MPRSA permits for dredged
                                        material to be placed at the
                                        HARS.
State/local/tribal governments.......  Local governments owning ports or
                                        berths in the NY/NJ Harbor and
                                        surrounding area seeking MPRSA
                                        permits for dredged material to
                                        be placed at the HARS.
Federal..............................  US Army Corps of Engineers for
                                        its proposed dredging projects
                                        in NY/NJ Harbor and surrounding
                                        areas to be placed at the HARS.
                                       Federal agencies seeking MPRSA
                                        permits for dredged material
                                        from NY/NJ Harbor and
                                        surrounding areas to be placed
                                        at the HARS.
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a 
guide for readers regarding entities likely to be affected by this 
action. This table lists the types of entities that EPA is now aware 
could potentially be affected by this action. Other types of entities 
not listed in the table could also be affected. To determine whether 
your organization is affected by this action, you should carefully 
consider whether your organization is subject to the requirement to 
obtain an MPRSA permit in accordance with the Purpose and Scope 
provisions of 40 CFR 220.1, and you wish to use the site subject to 
today's proposal. If you have any questions regarding applicability of 
this action to a particular entity, please consult the person listed in 
the

[[Page 62661]]

preceding FOR FURTHER INFORMATION CONTACT section.
    Other entities potentially affected by today's proposal would 
include commercial and recreational fishing interests using New York 
Bight Apex fishing and shellfish grounds. However, by establishing a 
pass/fail interim PCB tissue criterion that is approximately 75 percent 
lower than the previously established 400 ppb worm tissue guideline for 
remediation of areas adversely impacted by historic disposal activities 
(see discussion below), any effects of today's proposal on fishery and 
shellfish resources would be expected to be positive.

II. Background

    In 1972, the Congress of the United States enacted the MPRSA to 
address and control the dumping of materials into ocean waters. Title I 
of MPRSA authorized EPA (and the USACE in the case of dredged material) 
to regulate dumping in ocean waters. Since the MPRSA was enacted, and 
through its subsequent amendments (including the Ocean Dumping Ban Act 
of 1988, which prohibited ocean dumping of sewage sludge and industrial 
waste), dumping in the New York Bight has been dramatically reduced.
    Regulations implementing the MPRSA are set forth at 40 CFR Parts 
220 through 229. With few exceptions, the MPRSA prohibits the 
transportation of material from the United States for the purpose of 
ocean dumping except as may be authorized by a permit issued under the 
MPRSA. The MPRSA divides permitting responsibility between EPA and the 
USACE. Under Section 102 of the MPRSA, EPA has responsibility for 
issuing permits for all materials other than dredged material (e.g., 
fish wastes, burial at sea). Under Section 103 of the MPRSA, the 
Secretary of the Army has the responsibility for issuing permits for 
the ocean dumping of dredged material. This permitting authority has 
been delegated to the USACE. Determinations to issue Section 103 MPRSA 
permits for dredged material are subject to EPA review and concurrence.
    Section 102(c) of the MPRSA also provides that EPA shall designate 
recommended times and sites for ocean dumping, and Section 103(b) 
further provides that the USACE shall use such EPA designated sites to 
the maximum extent feasible. EPA's ocean dumping regulations provide 
that EPA's designation of an ocean dumping site is accomplished by 
promulgation of a site designation in 40 CFR Part 228 specifying the 
site. On October 1, 1986, the Administrator delegated the authority to 
designate/de-designate ocean dumping sites for dredged material to the 
Regional Administrator of the Region in which the site is located. In 
accordance with that authority, EPA Region 2 designated the HARS in 
September 1997 for placement of dredged material suitable for use as 
Material for Remediation (40 CFR 228.15(d)(6) (62 FR 46142)). Pursuant 
to that designation, dredged material proposed for use at the HARS must 
be determined to be suitable for use as Remediation Material. 
Remediation Material is defined as uncontaminated dredged material 
(i.e., dredged material that meets current Category I standards and 
will not cause significant undesirable effects including through 
bioaccumulation).
    The designation ensured that material be selected so that it will 
not cause significant undesirable effects including through 
bioaccumulation or unacceptable toxicity in accordance with 40 CFR 
227.6. The HARS was designated for continuing use until EPA determines 
that the PRA (Primary Remediation Area: a nine square nautical mile 
area to be remediated) has been sufficiently capped with at least 1 
meter of the Material for Remediation.
    The HARS is being managed to reduce impacts of historical disposal 
activities at the site to acceptable levels (in accordance with 40 CFR 
228.11 (c)). The HARS is being remediated with uncontaminated dredged 
material (i.e., dredged material that meets current Category I 
standards and will not cause significant undesirable effects including 
through bioaccumulation) (hereinafter referred to as ``the Material for 
Remediation'' or ``Remediation Material'').
    On September 27, 2000, EPA and the U.S. Army Corps of Engineers 
(USACE) entered into a Memorandum Of Agreement (MOA) that announced a 
schedule and a process by which EPA and USACE would review the science 
and the guidelines used in the evaluation of dredged material proposed 
for placement as Remediation Material at the HARS. Specifically, the 
Agencies committed to the shared objective of completing the scientific 
peer review process, initiated by EPA, and responding to the input from 
peer review and the public.
    EPA is proposing today to modify the HARS designation (40 CFR 
228.15(d)(6)) to establish a HARS-specific worm tissue PCB criterion of 
113 ppb for dredged material proposed for use as Remediation Material, 
pursuant to 40 CFR 228.10 and 228.11(c). It should be noted that MPRSA 
site designation does not constitute or imply EPA's approval of actual 
placement of material at the site. Before placement of the Material for 
Remediation at the HARS may commence, the USACE must evaluate permit 
applications according to EPA's Ocean Dumping Regulations and obtain 
EPA's concurrence.

III. Need To Establish a HARS-Specific Tissue PCB Criterion

    The need for remediating the HARS is described in detail in the 
HARS SEIS (EPA 1997a), associated proposed (62 FR 26267) and final (62 
FR 46142) rulemaking, and the Response to Comments on the proposed rule 
(EPA, 1997b). In summary, the proposal to terminate and de-designate 
the MDS, and simultaneously redesignate the site and surrounding 
degraded areas as the HARS, is amply supported by the presence of toxic 
effects in the HARS (a Category III sediment characteristic), dioxin 
bioaccumulation exceeding Category I levels in worm tissue collected 
from the HARS (a Category II sediment characteristic), National Oceanic 
and Atmospheric Administration (NOAA) ER-L/ER-M exceedances in some 
HARS sediments, and PCB/TCDD contamination in area lobster stocks. 
While it is impossible to quantify how much of New York Bight Apex 
contamination is the direct result of past dredged material disposal, 
other ocean dumping activities (e.g., former sewage sludge disposal at 
the 12-Mile Site), or other sources (e.g., via Hudson River plume or 
atmospheric deposition), the presence of these degraded sediments in 
the Apex is cause for concern.
    Organisms living in or near these degraded surface sediments in 
near shore waters will be continually exposed to contaminants until the 
contaminants are buried by natural sedimentation, placement of 
Remediation Material, or otherwise isolated or removed. Exposed 
sediments can directly and indirectly impact benthic and pelagic 
organisms. Impacts to terrestrial organisms (including human beings) 
are also possible if the contaminants were to undergo trophic transfer.
    NOAA tissue data from lobsters that were harvested in the New York 
Bight Apex in 1994 revealed that PCB concentrations in the hepatic 
tissue (tomalley) of the lobsters were above U.S. Food and Drug 
Administration consumption guidelines. It must be kept in mind that the 
lobsters analyzed in the NOAA study were harvested from wild stocks in 
the Apex, whose populations migrate seasonally through the region, 
including the HARS. Contamination of these animals cannot be 
definitively linked to specific areas of dredged

[[Page 62662]]

material disposal, to other past dumping activities, or to other 
pollution sources. Nor does the study indicate that human consumption 
of lobster muscle tissue (meat) presents health risks. However, the 
lobster study data do show that contaminants are being accumulated, and 
that concern about potential human-health risks is warranted. This 
contaminant data set complements other evidence of benthic 
contamination in the New York Bight Apex region.
    The evaluative framework used to determine suitability of dredged 
material for use as Remediation Material at the HARS was developed in 
1996 for the MDS and revised in 1998 for the HARS. It is a framework 
for assessing the potential for human health and ecological effects by 
comparing bioaccumulation test results to guidance values. These 
guidance values were derived from researching the best available 
literature at the time. The 1996 framework continued the use of a PCB 
guidance value of 400 ppb for worm tissue based on the Matrix approach 
defined in the 1981 USACE guidance: Final Interpretive Guidance for 
Bioaccumulation of Petroleum Hydrocarbon, DDT, Cadmium, and Mercury in 
the New York Bight.
    In 1998, EPA began the peer review process specified in the New 
York/New Jersey Harbor Estuary Program (HEP) Comprehensive Conservation 
and Management Plan (CCMP). A panel of 11 scientific peer reviewers 
submitted comments pertaining to the HARS evaluative framework and 
guidance values. For PCBs and the other matrix values, peer reviewers 
expressed concerns regarding the relevance of the Matrix approach 
developed in 1981, and recommended evaluating PCBs and the other matrix 
values, using human health and ecological risk assessment procedures 
(USEPA, 2000).
    On September 27, 2000, EPA and the U.S. Army Corps of Engineers 
(USACE) entered into a Memorandum Of Agreement (MOA) that announced a 
schedule and a process by which EPA and USACE would review the science 
and the guidelines used in the evaluation of dredged material proposed 
for placement as Remediation Material at the HARS. Specifically, the 
Agencies committed to the shared objective of completing the scientific 
peer review process, initiated by EPA, and responding to the input from 
peer review and the public.
    In addition, the MOA established an interim guidance value of 113 
ppb for PCBs in the tissues of bioassayed worms, to be considered when 
determining whether proposed dredged material from the New York/New 
Jersey Harbor is acceptable for placement at the HARS. At the time of 
the MOA, the agencies agreed that, while the peer review was not 
complete, the science review warranted the implementation of the 113 
ppb value on an interim basis. The September 2000 MOA addressed PCBs 
and not the other contaminants because PCBs were specifically mentioned 
in the HARS designation. In addition, experience in evaluating NY/NJ 
Harbor dredged material indicated that the PCB levels were often 
significant to the determination. This interim use of the 113 ppb value 
was intended to keep remediation of the HARS current with the latest 
scientific information concerning PCBs. The MOA states, ``This change 
[PCBs] reflects current scientific developments and ensures that the 
agencies' approach remains consistent with the remedial objectives of 
the HARS designation. Notably, this change will result in improvements 
in the quality of HARS Remediation Material with respect to numerous 
parameters other than PCBs, because elevated PCB levels frequently are 
associated with elevated levels of other chemicals of concern.'' The 
113 ppb HARS-specific PCB value will improve the quality of HARS 
Remediation Material to reflect current scientific standards, and to 
provide for the continued management of the HARS to reduce impacts 
within the PRA to acceptable levels in accordance with 40 CFR 
228.11(c), as required in 40 CFR 228.15(6)(A). The 113 ppb figure was 
understood to be an interim value, since the scientific processes and 
benchmark measures used to determine whether or not dredged material 
meets the remediation goals of the HARS were still under review. The 
review of the guidelines for the HARS has taken longer than anticipated 
in the MOA and is still underway.
    Upon signing the MOA, EPA withdrew its concurrence (given prior to 
the MOA) for the U.S. Gypsum Corporation to place dredged material at 
the HARS as Remediation Material. U.S. Gypsum brought suit against the 
USACE and EPA, and in a July 10, 2002 decision, Judge Jed Rakoff of the 
U.S. District Court, Southern District of New York, held that the 
announcement of the 113 ppb interim value in the MOA was de facto 
rulemaking that should have been the subject of public notice and 
comment. This rulemaking is intended to address the court's concerns 
while allowing for the use of 113 ppb value as a binding criteria 
applicable to dredged materials to be placed at the HARS. The need for 
establishing a HARS-specific tissue PCB criterion: (1) Reflects EPA 
Region 2's interpretation and ongoing review of the science associated 
with responding to the 1998 peer review comments (USEPA, 2000a); (2) is 
in response to the high degree of public controversy over the question 
of suitability of HARS Remediation Material; (3) is appropriate as an 
interim protective step in light of the remediation goals of the HARS, 
in particular the specific mention of PCBs in the need for remediating 
the HARS; (4) represents an interim measure to incorporate recent 
science (as opposed to 1981 science) as EPA and the USACE develop a new 
HARS-specific evaluation process by evaluating and responding to the 
2002 peer review comments on the human health proposal, conducting the 
scientific peer review on the ecological proposal, and responding to 
comments on the ecological proposal; and (5) addresses the court's 
procedural concerns.
    This proposed HARS-specific worm tissue PCB value would remain in 
effect until EPA and the USACE develop a new HARS-specific evaluation 
process by evaluating and responding to the 2002 peer review comments 
on the human health proposal, conducting the scientific peer review on 
the ecological proposal, and responding to comments on the ecological 
proposal. In total, this effort may take up to 2 years to fully address 
and implement for all contaminants of concern.

IV. Proposed Action

    In an effort to continuously incorporate and utilize the best 
available science to reduce adverse impacts that have occurred within 
the HARS (see, 40 CFR 228.11), EPA is proposing today to modify the 
designation of the HARS (40 CFR 228.15(d)(6)) to establish a HARS-
specific worm tissue PCB criterion of 113 ppb for dredged material 
proposed for use as Remediation Material. As discussed in detail in 
Section III, implementation of the HARS-specific tissue PCB criterion 
of 113 ppb for dredged material proposed for use as Remediation 
Material will provide for continued remediation in accordance with 40 
CFR 228.10 and 228.11(c).

V. Derivation of HARS-Specific 113 ppb PCB Criterion

    This revision of the worm PCB Matrix value reflects EPA Region 2's 
interpretation and ongoing review of the science associated with 
responding to the 1998 peer review comments. This risk-based value was 
calculated using exposure assumptions chosen to represent specific 
conditions associated with consuming fish from the HARS. As

[[Page 62663]]

such, we believe it is the best delineation of a level for PCBs at 
which remediation of the HARS can be assured, based on our current 
assessment of available knowledge about PCBs, bioaccumulation, and the 
area of the HARS. The 113 ppb value for PCBs in worm tissue is based on 
an assessment of human noncancer health hazard risk. It is the lowest 
of three (cancer, noncancer, and ecological values) PCB risk- or 
effects-based values derived by EPA Region 2, in consultation with 
USACE, based in part on the recommendation of 1998 scientific peer 
reviewers. The general risk assessment basis for this HARS-Specific 
value is described below; for further details pertaining to the 
specific derivation of the tissue level used as the HARS-specific 
value, see USEPA 2000b.

1. Human Health Risk

    Uptake of HARS contaminants by marine organisms was assumed to 
occur through direct exposure to the sediments and/or through uptake 
from eating contaminated prey. For assessing ecological and human 
health risks, a simplified description of the food web was used to 
describe feeding relationships between species at the HARS. The New 
York Bight food web used in modeling transfer of contaminants was 
described by a simplified food chain consisting of three representative 
levels. These trophic levels were: bottom dwelling organisms, 
predators, and upper level predators.
    For the purpose of evaluating risks to humans, it was assumed that 
fish consumption is the pathway of concern for humans to be exposed to 
contaminants in dredged material proposed for use as Remediation 
Material at the HARS, and that the fish consumed would be exposed 
through trophic transfer of contaminants from invertebrate prey. 
Because the HARS is located offshore and in open water, and because 
data shows that suspended and dissolved constituents of dredged 
material do not persist in the water column following release from the 
barge, pathways of human exposure other than consumption of seafood 
(e.g., inhalation, or direct exposure through bathing) were not 
emphasized in the evaluation process.
    To determine whether a tested sediment would result in 
bioaccumulation that would cause significant undesirable effects with 
regard to human health, standard human health risk calculations were 
used to develop tissue values associated with specified levels of 
protection (cancer risk of 1x10-4, hazard index of 1). The 
basic risk assessment equations underlying the calculations used to 
develop the HARS tissues values are as follows:
[GRAPHIC] [TIFF OMITTED] TP08OC02.075

[GRAPHIC] [TIFF OMITTED] TP08OC02.076

Where:

MV--Measured tissue value (mg/kg)
CPF--Cancer potency factor (Kg-day/mg)
FIR--Fish Ingestion Rate (g/day)
CF--Conversion factor (kg/g)
EF--Exposure frequency (365 days/year)
ED--Exposure duration (70 years)
TTF--Trophic transfer factor (unitless)
BW--Body weight (70 Kg)
AT--Averaging time (25,550 days)
BFR--Whole body to fillet ratio (unitless)
RfD--Reference dose (mg/Kg-day).

    Evaluating human risks associated with contaminants in dredged 
material proposed for use at the HARS assumes that recreational anglers 
represent a reasonably maximally exposed (RME) population for assessing 
risks to humans. More explicitly stated, EPA Region 2 assumed that 
there is a subpopulation of anglers that fishes exclusively at the HARS 
and that all recreationally-caught fish reportedly consumed by this 
subpopulation of anglers are obtained by angling at the HARS. The 
assessment assumed that fish are filleted prior to being eaten. In 
addition, the assessment assumed that the consumed of fish did not use 
the HARS 100 percent of the time.
    The following specific guideline measures and assumptions were 
applied to all human health risk/effects evaluations to estimate human 
exposure to HARS contaminants.

Cancer Potency Factor (CPF)/Reference Dose (RD)--Available cancer 
potency factors (2 per mg/kg-day) and chronic reference doses for oral 
exposure of PCBs (0.02 [mu]g/kg-day) were obtained from the EPA 
Integrated Risk Information System (IRIS).
Seafood consumption (FIR)--A factor of 7.2 grams per day (g/day) was 
used as a site-specific estimate of daily fish consumption by high 
consumers (i.e., New Jersey recreational anglers) in the vicinity of 
the HARS (USEPA, 2000b).
Exposure Duration (ED): EPA Region 2 assumed a default lifetime 
exposure of 70 years for its assessment of human health risks (USEPA, 
2000b).
Site Use Factor--A factor to express the proportion of time that fish 
predators may be exposed to contaminated benthic prey residing at the 
HARS. A factor of 0.777 (i.e., 77.7 percent HARS-area foraging), was 
derived to estimate site use for a ``generic'' fish in the diet of the 
target sub-population (i.e., New Jersey recreational fishers) (USEPA, 
2000b).
Whole-body to fillet factor (BFR)--In assessing risks due to PCBs, EPA 
Region 2/CENAN employ a whole-body to fillet correction factor of 1.35 
to estimate the concentration of contaminant in the whole body of the 
fish that is associated with the concentration in the edible (fillet) 
portion of the fish (USEPA, 2000b).
Trophic Transfer Factor (TTF)--Trophic transfer of contaminants from 
benthic prey to fish predators was estimated by applying a discrete 
factor that expresses the ratio of the residue concentration in 
predator as a function of the residue concentration in prey. A trophic 
transfer factor of 3 was applied based on the predictions of a widely 
applied food web model (Gobas, 1993).

    The regulations at 40 CFR 227.6 require that there be reasonable 
assurance that no significant undesirable effects will occur. The 
regulations further provide that such reasonable assurance be based on 
consideration of statistical significance of effects at the 95 percent 
confidence

[[Page 62664]]

level. In our current and proposed processes, standard statistical 
tests are in fact used throughout the process of evaluating dredged 
material for suitability for placement at the HARS. Statistics are used 
to ensure confidence in the determination whether bioaccumulation 
measured in test organisms exceeds that in reference organisms. Given 
the methodology and assumptions used to calculate the value of 113 ppb, 
we believe that use of the number directly, compared to the arithmetic 
mean of bioassayed tissues using the material proposed to be placed at 
the HARS, provides the reasonable assurance required by the 
regulations. The additional use of statistical confidence limits, in 
this situation, does not increase confidence in the determination.
    Accordingly, for the purposes of this rule, to promote clarity and 
to address concerns that have been frequently and vigorously expressed 
by elected officials and members of the public, the 113 ppb PCB value 
would be applied directly to the arithmetic mean of the worm 
bioaccumulation tissue test results, as a pass/fail standard. In light 
of the unique nature of the HARS as a site with the purpose of 
remediating the area designated, this approach provides further 
assurance that no significant undesirable effects will occur, in 
accordance with 40 CFR 227.6 and will reduce impacts to acceptable 
levels in accordance with 40 CFR 228.11(c). As such, projects having 
arithmetic means of PCB worm concentrations above 113 ppb and whose 
bioaccumulation has been shown with 95% confidence to be statistically 
significant (as compared to accumulations in reference exposures) would 
be considered to be unsuitable for placement at the HARS as they would 
exceed the HARS-specific PCB tissue criterion necessary to achieve the 
remedial goal of the HARS.
    As part of our overall review of the matrix values, including the 
ongoing peer review process, we are considering, among other things, 
whether and how statistical confidence limits should continue to be 
applied in evaluating bioaccumulation test results. This decision 
should not be understood as an indication that EPA will not continue to 
rely on statistical confidence limits in the future, for PCBs as well 
as for other contaminants of concern, after our ongoing scientific peer 
review of the HARS TEF is completed.

VI. Supporting Documents

    1. USEPA. 1997a. Supplement to the Environmental Impact Statement 
on the New York Dredged Material Disposal Site Designation for the 
Designation of the Historic Area Remediation Site (HARS) in the New 
York Bight Apex. May 1997.
    2. USEPA. 1997b. Response to Comments on the May 13, 1997, Proposed 
Rule for the Simultaneous De-Designation and Termination of the Mud 
Dump Site (MDS) and Designation of the Historic Area Remediation Site 
(HARS). August 1997.
    3. USEPA. 2000. Memorandum of Agreement: among the Department of 
the Army, the Environmental Protection Agency, and the U.S. Army Corps 
of Engineers. To Strengthen Environmental Protection of the Ocean 
Environment and to Promote Economic Progress in the Port of New York 
and New Jersey. September 27, 2000.
    4. USEPA. 2000a. Proposed Changes to the Bioaccumulation Testing 
Evaluation Framework and Response to Scientific Peer Reviewers Comments 
on the Framework for Determining the Suitability of Dredged Material to 
be Placed at the Historic Area Remediation (HARS). October 19, 2000.
    5. USEPA. 2000b. Memorandum to the File from Douglas Pabst. 
Subject: Modification of the Matrix Value for PCB in Worm Tissue. 
September 27, 2000.

How Can You Get Additional Information or Copies of Support Documents?

    1. Electronically. You may obtain electronic copies of this 
document and various support documents from the EPA home page at the 
Federal Register http://www.epa.gov/fedrgstr/, or on EPA Region 2's 
homepage at: http://www.epa.gov/region02/water/dredge/113rule.
    2. In person. The complete administrative record for this action 
has been established and includes supporting documentation as well as 
printed, paper versions of electronic comments. Copies of information 
in the record are available upon request. The official record of this 
rulemaking is available for inspection at the EPA Region 2 Library, 
16th Floor, 290 Broadway, New York, NY 10007-1866. For access to the 
docket materials, call Rebecca Garvin at (212) 637-3185 between 9 am 
and 3:30 pm Monday through Friday, excluding legal holidays, for an 
appointment. The record is also available for viewing at EPA's Region 2 
Field Office Library, 2890 Woodbridge Avenue, Building 209, MS-245, 
Edison, New Jersey 08837. For access to the docket materials at this 
facility, call Ms. Margaret Esser (732) 321-6762 between 9 am and 3:30 
pm Monday through Friday, excluding legal holidays, for an appointment. 
The EPA public information regulation (40 CFR part 2) provides that a 
reasonable fee may be charged for copying.

VII. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    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 result in 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 entitlement, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.'' It has been determined that this rule is not a 
``significant regulatory action'' under the terms of the Executive 
Order 12866 and is therefore not subject to OMB review.

B. Regulatory Flexibility Act (RFA), as Amended by the Small Business 
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et 
seq.

    The RFA generally requires an agency to prepare a regulatory 
flexibility analysis of any rule subject to notice and comment 
rulemaking requirements under the Administrative Procedure Act or any 
other statute unless the agency certifies that the rule will not have a 
significant economic impact on a substantial number of small entities. 
Small entities include small businesses, small organizations, and small 
governmental jurisdictions.
    After considering the economic impact of today's proposed rule on 
small entities, the Agency certifies that this action will not have a 
significant economic impact on a substantial number of small entities 
for reasons explained below.
    For the purposes of assessing the impacts of today's rule on small 
entities,

[[Page 62665]]

small entity is defined as: (1) A small business based on the Small 
Business Administration's (SBA) size standards; (2) a small 
governmental jurisdiction that is a government of a city, county, town, 
school district or special district with a population of less than 
50,000; and (3) a small organization that is any not-for-profit 
enterprise which is independently owned and operated and is not 
dominant in its field. The SBA thresholds define minimum employment, 
sales revenue, or other factors than may qualify an industry segment as 
small. The thresholds used in this analysis are firm level four digit 
Standard Industrial Classification (SIC) codes. Exhibit 1 presents the 
SBA size standards used in this analysis.
    EPA used current information concerning the potential universe of 
small entities that could be affected by the rule by obtaining 
information about all permits issued and any current permit 
applications. Since the HARS was first designated in 1997, the U.S. 
Army Corps of Engineers has received 17 permit applications for HARS 
placement, of which 14 permits were issued (Federal authorizations were 
not included in this analysis as the USACE is not a small entity), and 
there are currently 3 permit applications pending. As the HARS is 
anticipated to exist for a limited time, until the PRA has been 
remediated with at least one meter of Remediation Material, EPA 
believes it is reasonable to estimate that this universe of current and 
pending applications constitute the reasonable universe of entities 
affected by the proposed rule. Of the 17 permit applications, 4 (Castle 
Astoria Terminals, Inc., Port Imperial Marina, New York WaterWays, and 
International Matex Tank Terminals) are small entities, which is not a 
substantial number of small entities. Of the 4, 3 (Castle Astoria 
Terminals, Inc., Port Imperial Marina, and New York WaterWays) would 
have been affected by today's proposal, based upon past permitting 
information. Castle Astoria Terminals, Inc. has had a permit for HARS 
placement since 1999, but has not dredged to date. Port Imperial 
Marina, recently received a permit for HARS placement, but dredges very 
infrequently. New York WaterWays does not currently have a HARS 
placement permit, and has not dredged for many years. Further, these 
small entities are only a very small percentage of their SIC code.
    In summary, based on past permit information, there would have been 
a small absolute number of small entities affected by the proposed 
rule, with very low impacts. As such, EPA concludes that the proposed 
rule will not have a significant impact on a substantial number of 
small entities.

C. Paperwork Reduction Act

    This proposed rule would not impose an information collection 
burden under the provisions of the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501, et seq.) because it would not require persons to obtain, 
maintain, retain, report, or publicly disclose information to or for a 
Federal agency.

D. The Unfunded Mandates Reform Act and Executive Order 12875

    Title II of the Unfunded Mandates Reform Act (UMRA), Public Law 
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 of 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 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.
    EPA has determined that this proposed rule does not contain a 
Federal mandate that may result in expenditures of $100 million or more 
for State, local, and tribal governments, in the aggregate, or the 
private sector in any one year. EPA estimated total annualized (post-
tax) costs of compliance for the proposed rule to be $13.5 million. Of 
this total $13.5 million would be incurred by the private sector and $0 
would be incurred by State and Local governments. Thus, this proposed 
rule is not subject to the requirements of Sections 202 and 205 of 
UMRA.
    EPA also has determined that this proposed rule contains no 
regulatory requirements that might significantly or uniquely affect 
small governments. This proposed rule would apply equally to all 
dredged material to be placed at the HARS, thus there would be no 
unique effect of the rule on small governments. This rule is not 
anticipated to result in significant expenditures for small governments 
based on the universe of permit holders and applicants for the HARS. 
Thus, the requirements of Section 203 of UMRA also do not apply to this 
rule.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 
10, 1999), requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''
    This proposed rule does not have federalism implications. It will 
not have substantial direct effects on the States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government, 
as specified in Executive Order 13132. Thus Executive Order 13132 does 
not apply to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination 
with Indian Tribal Governments'' (65 FR 67249, November 6, 2000), 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by Tribal officials in the development of regulatory 
policies that have Tribal implications.'' ``Policies that have Tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian Tribes, on 
the relationship between the Federal

[[Page 62666]]

government and the Indian Tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian Tribes.''
    This proposed rule does not have Tribal implications. It would not 
have substantial direct effects on Tribal governments, on the 
relationship between the Federal government and Indian Tribes, or on 
the distribution of power and responsibilities between the Federal 
government and Indian Tribes, as specified in Executive Order 13175. 
EPA does not have information indicating that any Tribe would incur 
costs because of this rule. Thus, Executive Order 13175 does not apply 
to this rule.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any 
rule that (1) is determined to be ``economically significant'' as 
defined under Executive Order 12866, and (2) concerns an environmental 
health or safety risk that EPA has reason to believe might have a 
disproportionate effect on children. If the regulatory action meets 
both criteria, the Agency must evaluate the environmental health and 
safety effects of the planned rule on children, and explain why the 
planned regulation is preferable to other potentially effective and 
reasonably feasible alternatives considered by the Agency. This 
proposed rule is not an economically significant rule as defined under 
Executive Order 12866 and does not concern an environmental health or 
safety risk that EPA has reason to believe may have a disproportionate 
effect on children. Therefore, it is not subject to Executive Order 
13045.

H. Executive Order 13211: Energy Effects

    This proposed rule is not subject to Executive Order 13211, 
``Actions Concerning Regulations That Significantly Affect Energy 
Supply, Distribution, or Use'' (66 FR 28355 (May 22, 1001)) because it 
is not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer Advancement Act 
of 1995 (``NTTAA''), Public Law 104-113, Section 12(d) (15 U.S.C. 272 
note) directs EPA to use voluntary consensus standards in its 
regulatory activities unless to do so would be inconsistent with 
applicable law or otherwise impractical. Voluntary consensus standards 
are technical standards (e.g., materials specifications, test methods, 
sampling procedures, and business practices) that are developed or 
adopted by voluntary consensus standards bodies. The NTTAA directs EPA 
to provide Congress, through OMB, explanations when the Agency decides 
not to use available and applicable voluntary consensus standards. This 
proposed rule does not involve technical standards. Therefore, EPA did 
not consider the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 requires that, to the greatest extent 
practicable and permitted by law, each Federal agency must make 
achieving environmental justice part of its mission. Executive Order 
12898 provides that each Federal agency must conduct its programs, 
policies, and activities that substantially affect human health or the 
environment in a manner that ensures that such programs, policies, and 
activities do not have the effect of excluding persons (including 
populations) from participation in, denying persons (including 
populations) the benefits of, or subjecting persons (including 
populations) to discrimination under such programs, policies, and 
activities because of their race, color, or national origin.
    No action from this proposed rule will have a disproportionately 
high and adverse human health and environmental effect on any segment 
of the population. In addition, this rule does not impose substantial 
direct compliance costs on those communities. Accordingly, the 
requirements of Executive Order 12898 do not apply.

K. National Environmental Policy Act of 1969

    Section 102(c) of the National Environmental Policy Act of 1969, 
Section 4321 et seq, (NEPA) requires Federal agencies to prepare 
environmental impact statements (EIS) for major Federal actions 
significantly affecting the quality of the human environment. The 
object of NEPA is to build into the Agency decision making process 
careful consideration of all environmental aspects of proposed actions. 
Although EPA ocean dumping program activities have been determined to 
be ``functionally equivalent'' to NEPA, EPA has voluntarily undertaken 
to follow NEPA procedures when designating ocean dumping sites. See, 63 
FR 58045 (Oct. 29, 1998) .
    In August 1982, EPA published a final EIS designation of the New 
York Dredged Material Disposal Site (Mud Dump Site).'' The EIS assessed 
the environmental impacts of establishing an ocean disposal site for 
100 million cubic yards (mcy) of dredged materials generated within the 
Port of New York and New Jersey. After completion of the EIS, EPA 
designated the Mud Dump Site as an Impact Category I disposal site 
(see, 40 CFR 228.10(c)) with a capacity of 100 mcy (see, 40 CFR 
228.15(d)(6)). Approximately 68 mcy of dredged material was disposed of 
at the Mud Dump Site. In 1997, EPA prepared a Supplemental EIS, for the 
Designation of the Historic Area Remediation Site (HARS) in the New 
York Bight Apex. That document addressed the environmental 
considerations relevant to the HARS, and identified the Priority 
Remediation Area (PRA) within the HARS. At the time of the rule 
designating the HARS, the PCB matrix value for disposal at the site was 
400 ppb. The establishment of the new PCB matrix value of 113 ppb is a 
refinement based on new information since the designation of the HARS, 
which will have positive impacts on the marine environment. EPA does 
not consider this refinement as a substantial change in the designation 
of the HARS. Consequently, no additional NEPA review is required.

L. The Endangered Species Act

    Under Section 7(a)(2) of the Endangered Species Act, 16 U.S.C. 
1536(a)(2), federal agencies are required to ``insure that any action 
authorized, funded, or carried on by such agency * * * is not likely to 
jeopardize the continued existence of any endangered or threatened 
species or result in the destruction or adverse modification of habitat 
of such species * * *.'' Under regulations implementing the Endangered 
Species Act, a federal agency is required to consult with either the 
U.S. Fish and Wildlife Service or the National Marine Fisheries Service 
(depending on the species involved) if the agency's action ``may 
effect'' endangered or threatened species or their critical habitat. 
See, 50 CFR 402.14(a).
    EPA initiated its consultation process with the U.S. Fish and 
Wildlife Service (USFWS) on April 6, 1995 for what was then the Mud 
Dump Site and surrounding areas. The consultation process was concluded 
with them on July 28, 1995, with the USFWS's concurrence that EPA's 
action was not likely to adversely affect federally listed

[[Page 62667]]

species under its jurisdiction. The action covered by this proposed 
rule is more protective of the marine environment. Accordingly, the 
conclusions of our earlier consultation with the USFWS for the 
designation of the HARS is still valid.
    EPA initiated threatened and endangered species consultation with 
the National Marine Fisheries Service (NMFS) on April 4, 1996. As 
directed by the NMFS, EPA prepared a Biological Assessment (BA) to 
assess the impacts of the designation of the HARS on the Kemp's ridley 
and loggerhead sea turtles, and the humpback and fin whales. In May 
1997, EPA sent the NMFS a copy of the BA, which concluded that the 
designation of the HARS is not likely to adversely affect the species 
in question; NMFS concurred with this conclusion. Since the BA utilized 
a PCB worm tissue matrix value of 400 ppb and this action proposes 113 
ppb, any impacts to endangered or threatened species, or their critical 
habitats resulting from this action will be positive; the conclusion of 
the earlier consultation with NMFS is still valid.

M. Magnuson-Stevens Fishery Conservation and Management Act

    The 1996 Sustainable Fisheries Act amendments to the Magnuson-
Stevens Fishery Conservation and Management Act (MSFCMA) require the 
designation of essential fish habitat (EFH) for federally managed 
species of fish and shellfish. Pursuant to section 305(b)(2) of the 
MSFCMA, federal agencies are required to consult with the National 
Marine Fisheries Service (NMFS) regarding any action they authorize, 
fund, or undertake that may adversely affect EFH. An adverse effect has 
been defined by the Act as follows: ``Any impact which reduces the 
quality and/or quantity of EFH. Adverse effects may include direct 
(e.g., contamination or physical disruption), indirect (e.g., loss of 
prey, reduction in species' fecundity), site-specific or habitat-wide 
impacts, including individual, cumulative, or synergistic consequences 
of actions.'' EFH became effective after the HARS was designated. 
However, prior to September 2000 all USACE permits and authorizations 
were subject to EFH review utilizing a PCB matrix value of 400 ppb and 
were found acceptable. Since September 2000, all USACE permits and 
authorizations have been subject to EFH review utilizing a PCB matrix 
value of 113 ppb and have been found acceptable. Since this action 
proposes 113 ppb, any impacts to EFH species, or their critical 
habitats predicted from this action would be expected to be the same, 
as such, the consultation requirements of Section 305(b)(2) of the 
MSFCMA do not apply to this rule.

N. Plain Language Directive

    Executive Order 12866 requires each agency to write all rules in 
plain language. EPA has written this proposed rule in plain language to 
make this proposed rule easier to understand.

O. Executive Order 13158: Marine Protected Areas

    Executive Order 13158 (65 FR 34909, May 31, 2000) requires EPA to 
``expeditiously propose new science-based regulations, as necessary, to 
ensure appropriate levels of protection for the marine environment.'' 
EPA may take action to enhance or expand protection of existing marine 
protected areas and to establish or recommend, as appropriate, new 
marine protected areas. The purpose of the Executive Order is to 
protect the significant natural and cultural resources within the 
marine environment, which means ``those areas of coastal and ocean 
waters, the Great Lakes and their connecting waters, and submerged 
lands thereunder, over which the United States exercises jurisdiction, 
consistent with international law.''
    Today's proposed rule implements Section 103 of the MPRSA which 
requires that permits for dredged material are subject to EPA review 
and concurrence. The proposed rule would amend 40 CFR 228.15(d)(6) by 
establishing a HARS-specific tissue PCB criterion of 113 ppb for 
dredged material proposed for use as Remediation Material.
    As the HARS-specific PCB criterion of 113 ppb represents the lower 
of the non-cancer, cancer, and ecological PCB values, EPA expects that 
this proposed rule would afford additional protection of aquatic 
organisms at individual, population, community, or ecosystem levels of 
ecological structures, especially since the previous matrix value was 
400 ppb. Therefore, EPA expects today's proposed rule would advance the 
objective of the Executive Order to protect marine areas.

List of Subjects in 40 CFR Part 228

    Environmental protection, Water pollution control.

    Dated: October 1, 2002.
Jane M. Kenny,
Regional Administrator, EPA Region 2.

    In consideration of the foregoing, EPA is proposing to amend part 
228 of chapter I, title 40 of the Code of federal Regulations is 
amended as follows:

PART 228--CRITERIA FOR THE MANAGEMENT OF DISPOSAL SITES FOR OCEAN 
DUMPING

    1. The authority citation for part 228 continues to read as 
follows:

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

    2. Section 228.15 is amended by adding paragraph (d)(6)(v) (E) to 
read as follows:


Sec.  228.15  Dumping sites designated on a final basis.

* * * * *
    (d) * * *
    (6) * * *
    (v) * * *
    (E) HARS-specific Polychlorinated Biphenyl (PCB) Tissue Criterion:
    PCB bioaccumulation worm test results for dredged material approved 
for use at the HARS as Remediation Material shall not exceed the HARS-
specific PCB tissue criterion of 113 ppb. This HARS-specific PCB tissue 
criterion will be applied to the arithmetic mean concentration reported 
for the analyses of the worm tissue replicates exposed to the tested 
sediments, without the use of statistical confidence limits.
* * * * *
[FR Doc. 02-25586 Filed 10-7-02; 8:45 am]
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