[Federal Register Volume 68, Number 51 (Monday, March 17, 2003)]
[Rules and Regulations]
[Pages 12592-12602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6302]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 228

[FRL-7467-6]


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

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) today modifies 
the designation of the Historic Area Remediation Site (hereinafter 
referred to as HARS) by establishing 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 
establishes 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. The PCB criterion will remain 
in effect until after EPA and the U.S. Army Corps of Engineers (USACE) 
complete their review of the 2002 scientific peer review comments on 
the HARS testing evaluation process used for bioaccumulation data from 
dredged material proposed for use at the HARS as Remediation Material 
for human health effects, conduct and respond to the comments on the 
future scientific peer review on the HARS testing evaluation process 
used for bioaccumulation data from dredged material proposed for use at 
the HARS as Remediation Material for ecological effects, and revise, as 
necessary, the HARS testing evaluation process used for bioaccumulation 
data from 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 (MOA) (USEPA, 2000a) 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 implementation of 
this interim change was warranted based upon existing information. This

[[Page 12593]]

change is designed to ensure that the remedial goals of the HARS will 
be met.
    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, 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: This final regulation is effective on April 16, 2003.

ADDRESSES: 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 
Home page at: http://www.epa.gov/region02/water/dredge.
    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 a.m. 
and 3:30 p.m. Monday through Friday, excluding legal holidays, for an 
appointment. The record is also available for viewing at EPA Region 2's 
Edison, NJ 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 a.m. 
and 3:30 p.m. 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.

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:

I. Regulated Entities

    Entities potentially affected by this action include those who 
might have sought or will seek permits or authorizations 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/facilities 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 areas 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 areas seeking MPRSA
                                     permits for dredged material to be
                                     placed at the HARS.
Federal Agencies..................  U.S. Army Corps of Engineers for its
                                     proposed dredging projects in NY/NJ
                                     Harbor and surrounding areas to be
                                     placed at the HARS.
                                    Other Federal agencies (e.g. U.S.
                                     Navy) 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 required to obtain a MPRSA permit 
(See 40 CFR 220.1), and you wish to use the HARS. If you have any 
questions regarding applicability of this action to a particular 
entity, please consult the person listed in the preceding FOR FURTHER 
INFORMATION CONTACT section.
    Other entities potentially affected by today's final rule would 
include commercial and recreational fishing interests using New York 
Bight Apex fishing and shellfishing 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 final rule on fishery 
and shellfish resources would be expected to be positive.

II. Background

    On October 8, 2002 EPA proposed modifying the designation of the 
HARS by establishing a HARS-specific worm tissue PCB criterion of 113 
ppb for use in determining the suitability of proposed dredged material 
for use as Remediation Material. (67 FR 62659).
    The MPRSA was enacted in 1972 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.
    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

[[Page 12594]]

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 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. Regulations implementing these and other 
provisions of MPRSA are set forth at 40 CFR parts 220 through 229. 
Forty CFR part 228 provides that EPA's designation of an ocean dumping 
site is accomplished by promulgation of a site designation 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 (August 29, 
1997). Pursuant to that designation, use of the HARS is restricted to 
dredged material determined to be suitable for use as Material for 
Remediation.
    Material for Remediation, or Remediation Material, is defined in 40 
CFR 228.15(d)(6)(A) as material ``selected so as to ensure 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. This Remediation Material is, 
``uncontaminated dredged material (i.e., dredged material that meets 
current Category I standards and will not cause significant undesirable 
effects including through bioaccumulation)'' (Preamble to HARS 
designation Final Rule 62 FR 46142). 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).
    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 input from both 
the peer review and the public.
    EPA is today modifying the HARS designation (40 CFR 228.15(d)(6)) 
by establishing a HARS-specific worm tissue PCB criterion of 113 ppb 
for dredged material proposed for use as Material for Remediation, 
pursuant to 40 CFR 228.10 and 228.11(c). This value will remain in 
effect until after EPA and the U.S. Army Corps of Engineers (USACE) 
complete their review of the 2002 scientific peer review comments on 
the HARS testing evaluation process used for bioaccumulation data from 
dredged material proposed for use at the HARS as Remediation Material 
for human health effects, conduct and respond to the comments on the 
future scientific peer review on the HARS testing evaluation process 
used for bioaccumulation data from dredged material proposed for use at 
the HARS as Remediation Material for ecological effects, and revise, as 
necessary, the HARS testing evaluation process used for bioaccumulation 
data from dredged material proposed for use as Remediation Material at 
the HARS for all contaminants of concern in accordance with the 
September 27, 2000 MOA between EPA and the USACE. It should be noted 
that MPRSA site designation does not constitute or imply EPA's approval 
of the placement of particular 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. Public Comments

    In the preamble to the proposed rule, EPA requested public comment 
by November 8, 2002, and held two public hearings (attended by an 
estimated total of 120 people) as follows:

October 28, 2002, at 7 PM: Monmouth Beach Municipal Auditorium, 22 
Beach Road, Monmouth Beach, New Jersey, 07750 (16 individuals presented 
testimony).
October 29, 2002, at 2 PM: EPA Region 2 NYC Office, Conference Room 
27A, 290 Broadway, NY, NY 10007-1866 (five individuals presented 
testimony).

In addition to the testimony and comments provided at the hearings, EPA 
also received 220 sets of written comments on the proposed action.
    Dredging and remediation of the HARS has proven to be a 
controversial and complex issue in recent years. As would be expected 
in light of such controversy, EPA received both supportive and non-
supportive comments. In developing the final rule, EPA reviewed and 
considered all the written comments as well as those received verbally 
at the two public hearings. Most of the comments received were e-mails 
from elected officials, local governments, citizens and environmental/
public interest groups that expressed, to varying degrees, support for 
the 113 ppb HARS-specific worm tissue PCB criterion. Many of these 
comments requested that the proposed rule be adopted without change. 
Thus, the 113 ppb HARS-specific PCB worm tissue criterion appears to be 
acceptable to the majority of those who provided comments. 
Approximately 40 commenters requested an end to ocean dumping and 
placement of dredged material at the HARS; for these commenters, the 
113 ppb HARS-specific PCB worm tissue criterion appears not to have 
been sufficiently conservative. Approximately 20 comment letters were 
critical and non-supportive. Although in the minority based upon number 
of comments received, they presented the majority of issues raised. 
These non-supportive comment letters were from the USACE, New York 
Shipping Association, New York City Economic Development Corporation, 
private marina owners, ferry operators, dredging applicants, and other 
business groups. These comment letters requested that EPA not finalize 
the proposed rule until completion of the human health and ecological 
scientific peer review process. (That process commenced in 1998, and is 
expected to be completed in four to five more years.) The non-
supportive comments had similar criticism of the proposed rule. Most 
expressed reservations concerning the scientific basis and economic 
consequences for the HARS-specific worm tissue PCB criterion of 113 ppb 
and offered alternative ideas for estimating a HARS-specific PCB worm 
tissue criterion. Following are summaries of the most significant among 
these comments:

Definition of PCBs

    A few comments requested that EPA include a definition of PCBs in 
the final rule. For purposes of this rule total PCBs are defined in the 
EPA Region 2/USACE

[[Page 12595]]

New York District guidance document entitled, Guidance for Performing 
Tests on Dredged Material Proposed for Ocean Disposal or the Regional 
Testing Manual (RTM) (EPA Region 2/USACE-NYD, 1992). Applicants are 
instructed to analyze the following 22 PCB congeners: PCB 8, 18, 28, 
44, 49, 52, 66, 87, 101, 105, 118, 128, 138, 153, 170, 180, 183, 184, 
187, 195, 206, and 209.
    The recommended method for estimating total PCB concentrations 
referenced in the RTM was changed on February 14, 1996 (EPA, 1996). The 
change was based on a review of various data sets that measured an 
extended list of PCB congeners (106 or more). The data indicated that 
total PCB tissue residue could be more reliably estimated by doubling 
the subtotal of the 22 PCB congeners listed above. The rationale and 
data sets supporting this change are described in the human health 
scientific peer review charge for the scientific peer review (EPA, 
2001). After doubling the dredging project 28-day worm tissue 
bioaccumulation results of the 22 PCB congeners to obtain a total PCB 
tissue residue value for dredged material, the resulting total PCB 
tissue residue value is adjusted to reflect equilibrium conditions 
(steady state) by multiplying by 2. The resulting total PCB tissue 
residue value for dredged material will be compared to the 113 ppb 
HARS-specific PCB worm tissue criterion, for each dredging project.

Wait for Completion of the 2002 Scientific Peer Review Prior to 
Promulgating the 113 ppb HARS-Specific PCB Worm Tissue Criterion

    A number of those who commented on the proposed rule suggested that 
EPA should wait for completion of the scientific peer review prior to 
promulgating any revision to the old 400 ppb matrix value for PCBs. EPA 
categorically rejects this view. The 400 ppb worm tissue matrix value, 
established as guidance in 1981, was based entirely on a non-
degradation policy, and was not based on any kind of risk assessment. 
There is broad scientific consensus that the 400 ppb guidance value is 
not adequately protective of human health and the environment. Failure 
to revise the matrix value could result in propagating adverse impacts 
at the HARS that EPA is endeavoring to remediate.
    In contrast, the 113 ppb worm tissue value is a rational, risk-
based value, protective of human health and the environment, based upon 
available scientific information pending completion of the current 
scientific peer review and evaluation process. There is, moreover, 
solid evidence that further protective measures are needed. For 
example, for a number of years, the States of New York and New Jersey 
have had advisories for ``limited consumption'' of several species of 
fish (striped bass and bluefish) and lobster tomalley caught in the 
waters of the New York/New Jersey Harbor and Bight area, and have, in 
some cases, prohibited the sale, consumption, and/or harvesting of 
fish, crustacea, and shellfish due to toxic contamination, especially 
of PCBs and dioxins.
    The HARS designation Supplemental Environmental Impact Statement 
(SEIS) (USEPA, 1997a), among other documents, contains significant 
evidence that dredged material disposal has contributed contaminants to 
the area, and therefore has likely contributed to the present 
conditions observed in the New York Bight Apex. Organisms living in or 
near these degraded surface sediments in nearshore 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. Those conditions are 
cause for concern. In particular, contaminant bioaccumulation by 
infaunal organisms presents the potential for food chain/trophic 
transfer, potentially posing a risk not only to aquatic animals but 
also to seafood consumers. For example, elevated levels of PCBs and 
dioxin/furan compounds were found in the tissues of infaunal species 
and the hepatopancreas of lobsters collected from the vicinity of the 
former Mud Dump Site (MDS). The total PCB and 2,3,7,8-TCDD (dioxin) 
levels in lobster hepatic tissue sampled in the Bight Apex exceeded 
Food and Drug Administration (FDA) consumption guidance that, in most 
cases, recommends no consumption, or at least limited consumption, at 
those levels. (See SEIS Chapter 3.5.1.1.) (USEPA, 1997a).
    The 113 ppb criterion appropriately furthers the remediation goals 
of the HARS. The need for remediating the HARS is extensively 
documented in the HARS designation rulemaking record, including the 
Federal Register notices (62 FR 26275 and 62 FR 46142), HARS Response 
to Comments Document (EPA, 1997b) and the HARS SEIS (EPA, 1997a). 
Bioaccumulation in organisms collected within the HARS was one of the 
factors leading to the selection of the Remediation Alternative in the 
HARS SEIS. It is EPA's conclusion that continued use of dredged 
material that bioaccumulates above 113 ppb in worm tissue would not 
advance, but would rather hinder, the goals of the HARS remediation and 
could result in increased tissue levels for organisms living within the 
site. EPA also concludes that continued ocean placement of dredged 
material that results in total PCB bioaccumulation above 113 ppb in 
worm tissue could contribute to human health effects.
    EPA strongly disagrees with those comments that suggest that the 
current peer review process should be completed before any action is 
taken to update the old 1981 matrix value of 400 ppb. EPA believes that 
it is entirely inappropriate to perpetuate an outdated and non-
protective criterion simply because scientific consideration of the 
matter is ongoing. Indeed, science is by definition always ongoing, and 
in this context scientific developments will continue long after the 
current peer review of the HARS criteria is completed. Completion of 
the peer review process will certainly be an important milestone, and 
EPA anticipates that at that time, the criteria for many contaminants 
of concern will be revised. It is possible, perhaps even likely, that 
further revisions of the value for PCBs will also be made at that time. 
But it is unreasonable to suggest that EPA should not act today, based 
on the best scientific information available at present, to replace a 
demonstrably unprotective value with a protective one, simply because 
better information may be available several years from now.
    The scientific peer review process was initiated in 1998, continues 
today, and more time will be necessary to complete it. EPA believes 
that the interim PCB criterion is reasonable, based on the currently 
available scientific information, and is appropriately conservative to 
provide for the continued management of the HARS to reduce impacts 
within the Primary Remediation Area (PRA) to acceptable levels in 
accordance with 40 CFR 228.11(c), as required in 40 CFR 228.15(6)(A). 
It is important to implement a more appropriately conservative PCB 
criterion now, rather than to continue using guidelines that could 
potentially perpetuate benthic conditions that would need further 
remediation.
    It is also important to note that the human health portion of the 
2002 scientific peer review has been completed. The consensus opinions 
of

[[Page 12596]]

the scientific peer review panel are reported in the June 20, 2002 
report entitled Interim Consensus Report of the HARS Scientific Peer 
Review. Phase 1: Human Health Evaluation (USEPA, 2002a). EPA intends to 
resume Remediation Material Workgroup (RMW) meetings with the focus on 
the HARS testing evaluation process used for bioaccumulation data from 
dredged material proposed for use at the HARS as Remediation Material, 
before responding to the peer reviewers' consensus report and 
finalizing the human health and ecological effects testing evaluation 
framework (TEF).
    One of the central consensus opinions of the 2002 scientific peer 
review panel is that improvement of estimates of key exposure 
parameters requires that site-specific studies be conducted to obtain 
updated or better information. The USACE and EPA have developed several 
scopes of work for studies to obtain this information. It is clear, 
however, that many of these necessary studies will require substantial 
time to complete. The interim PCB tissue criterion would ensure that 
material that is placed at the HARS attains a level of protection 
consistent with the current best estimates of exposure and with the 
remedial intent of the HARS.
    The PCB criterion will remain in effect until after EPA and the 
USACE complete their review of the 2002 scientific peer review comments 
on the HARS testing evaluation process used for bioaccumulation data 
from dredged material proposed for use at the HARS as Remediation 
Material for human health effects, conduct and respond to the comments 
on the future scientific peer review on the HARS testing evaluation 
process used for bioaccumulation data from dredged material proposed 
for use at the HARS as Remediation Material for ecological effects, and 
revise, as necessary, the HARS testing evaluation process used for 
bioaccumulation data from dredged material proposed for use as 
Remediation Material at the HARS for all contaminants of concern in 
accordance with the September 27, 2000 MOA between EPA and the USACE. 
When the above steps are completed, any further changes to the HARS 
testing evaluation process used to evaluate PCBs, or other contaminants 
of concern, will be the subject of further rulemaking, as necessary. 
EPA estimates that it will take four to five years to fully complete 
this process, including additional rulemaking, as necessary.

Exposure Assumptions Are Too Conservative

    A frequent observation made in the negative comments on the 
proposed rule is that the site-specific exposure assumptions used by 
EPA in calculating the 113 ppb HARS-specific PCB worm tissue criterion 
are ``overly conservative'' or ``unrealistic.'' EPA rejects this 
assertion. The 113 ppb HARS-specific PCB worm tissue criterion is 
designed to be appropriately conservative to protect human health and 
the marine environment. The value was calculated using a non-cancer 
Hazard Quotient of 1, the level recommended by EPA Superfund guidance 
for remediation of sites with hazardous substance contamination; and a 
cancer risk factor of 10-4, the minimum level recommended by 
EPA Superfund guidance.
    Where EPA was conservative in calculating the PCB criterion, this 
conservative approach was appropriate given the relative paucity of 
data from which to derive alternative, site-specific exposure figures. 
However, the conservativism of individual exposure assumptions made in 
the calculation is balanced by EPA's use of a less conservative cancer 
risk level of 1 x 10-4. Had EPA chosen a more protective 
cancer risk level of 1 x 10-5 or 1 x 10-6, as is 
typical when selecting goals for site remediation, the calculated HARS-
specific PCB worm tissue criterion would have been one or two orders of 
magnitude lower. Thus, EPA believes that the use of what some comments 
contend is an unrealistically conservative set of exposure assumptions 
(selected because of the absence of data on which to base arguably more 
realistic assumptions) is more than offset by EPA's use of a cancer 
risk level which is at the very low end of what is considered 
acceptable under EPA's other hazardous site remediation programs. If 
reliable, site-specific exposure data were available, EPA would use 
them in its calculations. In finalizing the review of the HARS testing 
evaluation process, EPA will also evaluate the use of a cancer risk 
level that is more protective and more consistent with what is 
typically used in Superfund site remediation. If EPA were to select a 
more protective cancer risk level, even with different exposure data, 
the net result might well be a calculated PCB value no higher than, and 
almost certainly lower than, 113 ppb.
    The comments that criticized EPA's conservative exposure 
assumptions also failed to note the ultimate intent of the proposed 
rule, which is to further the remediation of the HARS. The need for and 
intent of such remediation was clearly established in the HARS 
designation in 1997 (62 FR 46142).

Implementation of the 113 ppb HARS-Specific PCB Worm Tissue Criterion 
Will Have Significant Negative Economic Consequences

    Some comments have made dire predictions about economic 
dislocations if EPA proceeds with the proposed promulgation of the 113 
ppb HARS-specific PCB worm tissue criterion. EPA does not believe that 
this will be a likely outcome. On the contrary, dredging activity, and 
placement of dredged material at the HARS, has continued apace in the 
more than two years since the September 2000 MOA, when EPA and USACE 
first started using the PCB value of 113 ppb. Undoubtedly, some 
dredgers who would wish to use the HARS will be unable to do so because 
their material does not satisfy the 113 ppb criterion; and it may cost 
more for these individual dredgers to dispose of the material 
elsewhere. However, EPA disagrees that widespread, adverse economic 
consequences are to be expected from this rulemaking. Specifically, 
there has been more dredged material placed at the HARS since the 113 
ppb PCB value was announced under the September 2000 MOA (approximately 
11 million cubic yards, based on scow volume, of maintenance and 
deepening dredged material), than was placed in previous years 
(approximately 4 million cubic yards, based on scow volume, of 
maintenance and deepening) (USACE, 2002). A PCB criterion of 113 ppb 
would render only approximately 300,000 cubic yards of maintenance 
dredged material from 3 past projects, since the September 2000 MOA 
(U.S. Gypsum, Port Imperial, and a portion of Naval Weapons Station 
Earle), unsuitable for placement at the HARS at an estimated cost of 
$14.1 million. A PCB criterion of 113 ppb would render approximately 
1.2 million cubic yards (including the 300,000 mentioned earlier) of 
maintenance dredged material from 8 past projects (including the three 
discussed above) since the HARS was designated (Buttermilk Channel, 
Raritan River, Raritan Cutoff, Refined Sugars [now American Sugars], 
and Castle Astoria) unsuitable for placement at the HARS, which 
represents an average of 240,000 cubic yards per year (over a 5 year 
period). EPA estimated a worst case scenario of 1.33 million cubic 
yards in any given year would be unsuitable for the HARS based upon 
todays rule, at a cost of $62.5 million. See response to comment 7-2 in 
the Response to

[[Page 12597]]

Comments Document (USEPA, 2003a). Approximately 15 million cubic yards 
of Remediation Material has been placed at the HARS since it was 
designated in 1997. No deepening material (below 45 feet Mean Low 
Water) is expected to be affected by today's rule.
    Nevertheless, MPRSA section 103(b) expressly provides an 
opportunity for the USACE to select a disposal site meeting the 
criteria of 40 CFR part 228, should use of an EPA-designated site prove 
not to be feasible. Existence of an EPA-designated disposal site thus 
is not a prerequisite for ocean disposal, nor does it bar use of other 
sites selected in accordance with section 103(b).
    Further, MPRSA section 103(b) states that in considering permit 
applications, the Secretary's determination as to the need for the 
dumping is to be ``[b]ased upon an evaluation of the potential effect 
of a permit denial on navigation, economic and industrial development, 
and foreign and domestic commerce of the United States * * *'' And, in 
the highly unlikely event that there was to be no economically feasible 
alternative to ocean disposal, MPRSA section 103(d) provides the 
opportunity for the Secretary of the Army to seek a waiver of the 
environmental criteria. EPA's rulemaking in no way affects that 
authority.

Existing Permits/Authorizations Should Be ``Grandfathered''

    One comment requested that EPA ``grandfather'' existing dredging 
projects that have an approved Testing Evaluation Memo (signed by EPA 
and the USACE), but do not have a USACE permit or authorization. EPA 
considered this comment and has determined that the 113 ppb HARS-
specific PCB worm tissue criterion will be applied to all USACE permit 
and authorization requests pending as of the effective date of the 
final rule and all permit and authorization requests filed thereafter.
    EPA carefully considered and responded to each comment received. A 
complete Response to Comments Document has been prepared which contains 
all the comments received and EPA's responses to each of these 
comments. That document is available for viewing at the location 
specified in the section titled, ``How Can You Get Additional 
Information or Copies of Support Documents'' below.

IV. Supporting Documents

1. USACE. 1981. Final Interpretive Guidance for Bioaccumulation of 
Petroleum Hydrocarbon, DDT, Cadmium, and Mercury in the New York Bight. 
Memorandum from North Atlantic Division Corps of Engineers to G.R. 
Tobertson, Deputy Director of Civil Works, Dept. of Army.
2. EPA/USACE. 1991. Evaluation of Dredged Material Proposed for Ocean 
Disposal-Testing Manual. Environmental Protection Agency, Washington, 
DC, and U.S. Army Corps of Engineers, Washington, DC. EPA-503/8-91/001. 
February 1991.
3. EPA Region 2/USACE-NYD (New York District). 1992. Guidance for 
Performing Tests on Dredged Material Proposed for Ocean Disposal. U.S. 
Army Corps of Engineers New York District and Environmental Protection 
Agency Region, New York, NY. Draft Release. December 1992.
4. EPA. 1996. Letter dated February 14, 1996 from Mario Del Vicario, 
U.S. Environmental Protection Agency, region 2, to John Tavolaro, U.S. 
Army Corps of Engineers New York District. Subject PCB Quantification. 
February 1996.
5. NY/NJ HEP (New York/New Jersey Harbor Estuary Program). 1996. 
Comprehensive Conservation and Management Plan for the Harbor Estuary 
Program, including the Bight Restoration Program. Final Report. March 
1996.
6. 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.
7. 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.
8. USEPA. 1997c. Biological Assessment for the Closure of the Mud Dump 
Site and Designation of the Historic Area Remediation Site in the New 
York Bight Apex. May 1997.
9. USEPA. 2000a. 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.
10. USEPA. 2000b. 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.
11. USEPA. 2000c. Memorandum to the File from Douglas Pabst. Subject: 
Modification of the Matrix Value for PCB in Worm Tissue. September 27, 
2000.
12. USEPA. 2001. Scientific Peer Review Package and Charge, Proposed 
Bioaccumulation Testing Evaluation Framework for Assessing the 
Suitability of Dredged Material to be Placed at the Historic Area 
Remediation Site (HARS). USEPA, Region 2. New York, NY. December 21, 
2001.
13. USACE. 2002. Email from Stephen Knowles to EPA Region 2. Subject: 
Ocean Placement Summary Table. December 12, 2002.
14. USEPA. 2002a. Interim Consensus Report of the HARS Specific Peer 
Review. Phase 1: Human Health Evaluation. July 20, 2002.
15. USEPA. 2002b. Memorandum to the File from Douglas Pabst. Subject: 
Private Permits Placing Dredged Material at the Historic Area 
Remediation Site. October 1, 2002.
16. USEPA. 2002c. Memorandum to the File from Douglas Pabst. Subject: 
Small Businesses Applications to Place Dredged Material at the Historic 
Area Remediation Site. October 1, 2002.
17. USEPA. 2002d. Dun & Bradstreet Reports for Castle Astoria 
Terminals, American Sugars, Port Imperial Marina, International Matex 
Tank Chemicals, and New York Waterways. September 20, 2002.
18. USEPA. 2003a. Response to Comments on the October 8, 2002 Proposed 
Rule for the Establishment of a Historic Area Remediation Site (HARS)-
Specific Polychlorinated Biphenyl Worm Tissue Criterion. March 7, 2003.
19. USEPA. 2003b. Memorandum to the File from Douglas Pabst. Subject: 
Private Permits for Navigational Dredging with Placement of Dredged 
Material at the Historic Area Remediation Site. March 6, 2003.
20. USEPA. 2003c. Email from Robert Hargrove to Douglas Pabst. Subject: 
Coastal Zone Consistency Review for the Proposed PCB 113 Guideline for 
the HARS. March 5, 2003.
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

[[Page 12598]]

Region 2's Home page at: http://www.epa.gov/region02/water/dredge.
    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 a.m. 
and 3:30 p.m. Monday through Friday, excluding legal holidays, for an 
appointment. The record is also available for viewing at EPA Region 2's 
Edison NJ 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 a.m. and 
3:30 p.m. 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.

V. 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.''
    Today's action, which establishes a HARS-specific PCB worm tissue 
criterion of 113 ppb, is not a significant regulatory action under E.O. 
12866. In particular, as explained in the Response to Comments Document 
included in the record for this rule, even if one assumes a worst case 
scenario of 4 million cubic yards of maintenance dredged material from 
New York/New Jersey Harbor for one year, the projected worst-case 
economic impact could be approximately $62.5 million or as low as $14.1 
million per year depending upon the dredging volume determined to be 
unsuitable for the HARS (See Response to Comment 7-2 in the Response to 
Comments Document (USEPA, 2003a)). Furthermore, the 113 ppb PCB value 
has been in use since the September 2000 MOA. Since that time there has 
been only one HARS application where the dredged material was 
determined unsuitable for the HARS (U.S. Gypsum) on the basis of the 
113 ppb PCB value. Two additional HARS applications (Port Imperial 
Corporation and Naval Weapons Station Earle) would have been rejected 
under the proposed rule. As such, given that only two businesses (the 
U.S. Navy is not a maritime business) would have been affected, EPA has 
seen no material economic impact on maritime businesses in NY/NJ Harbor 
since the 113-ppb value was announced in the September 2000 MOA (USEPA 
2000a). Since the signing of the MOA in September 2000, there has been 
more dredging and even deepening of NY/NJ Harbor than since the HARS 
was designated (USACE, 2002). From the time the HARS was designated in 
1997 through when the September 2000 MOA was announced, two additional 
businesses (Castle Astoria and Refined Sugars [now American Sugars]) 
would have been impacted by today's rule. A total of four businesses 
would have been impacted by today's rule, since the HARS was designated 
to present. Given that each business represents a different industry, 
EPA concludes that this rule does not represent a material impact on 
any one business in New York/New Jersey Harbor. Therefore, today's rule 
will not 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. 
It thus 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. Paperwork Reduction Act

    This final 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.

C. 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 final rule on 
small entities, the Agency certifies that this action will not have a 
significant economic impact on a substantial number of small entities 
as explained below.
    For the purposes of assessing the impacts of today's rule on small 
entities, a 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. Size standards have been established for types of economic 
activity, or industry, generally under the North American Industry 
Classification System (NAICS) defined at 13 CFR 121.201. Table 1 lists 
the SBA size standards and NAICS codes for businesses potentially 
applicable to today's rule.
    Table 1. Small Business Size Standards matched to North American 
Industry Classification System (NAICS). The NAICS codes in this table 
include modifications made to NAICS by the Office of Management and 
Budget effective January 1, 2002. Referred to as NAICS 2002. These size 
standards are based on NAICS 2002. They are effective October 1, 2002.

[[Page 12599]]



----------------------------------------------------------------------------------------------------------------
                                                                                       Size            Size
                                                                                   standards  in   standards  in
              NAICS codes                       NAICS U.S. industry title          millions  of     number  of
                                                                                      dollars        employees
----------------------------------------------------------------------------------------------------------------
221210................................  Natural Gas Distribution................  ..............             500
Except................................  Dredging and Surface Cleanup Activities        \1\ $17.0  ..............
                                         \1\.
311312................................  Cane Sugar Refining.....................  ..............             750
311313................................  Beet Sugar Manufacturing................  ..............             750
322130................................  Paperboard Mills........................  ..............             750
324110................................  Petroleum Refineries \2\................  ..............       \2\ 1,500
327420................................  Gypsum Product Manufacturing............  ..............           1,000
336611................................  Ship Building and Repairing.............  ..............           1,000
336612................................  Boat Building...........................  ..............             500
483111................................  Deep Sea Freight Transportation.........  ..............             500
4831123...............................  Deep Sea Passenger Transportation.......  ..............             500
483113................................  Coastal and Great Lakes Freight           ..............             500
                                         Transportation.
483114................................  Coastal and Great Lakes Passenger         ..............             500
                                         Transportation.
483211................................  Inland Water Freight Transportation.....  ..............             500
483212................................  Inland Water Passenger Transportation...  ..............             500
488310................................  Port and Harbor Operations..............            21.6  ..............
488320................................  Marine Cargo Handling...................            21.5  ..............
488330................................  Navigational Services to Shipping.......             6.0  ..............
493110................................  General Warehousing and Storage.........            21.5  ..............
493120................................  Refrigerated Warehousing and Storage....            21.5  ..............
493130................................  Farm Product Warehousing and Storage....            21.5  ..............
493190................................  Other Warehousing and Storage...........            21.5  ..............
----------------------------------------------------------------------------------------------------------------
1 NAICS code 237990--Dredging: To be considered small for purposes of Government procurement, a firm must
  perform at least 40 percent of the volume dredged with its own equipment or equipment owned by another small
  dredging concern.
2 NAICS code 324110--For purposes of Government procurement, the firm may not have more than 1,500 employees or
  more than 75,000 barrels per day capacity of petroleum-based inputs, including crude oil or bona fide
  feedstocks. Capacity includes owned or leased facilities as well as facilities under a processing agreement or
  an arrangement such as an exchange agreement or a throughput. The total product to be delivered under the
  contract must be at least 90 percent refined by the successful bidder from either crude oil or bona fide
  feedstocks.

    EPA obtained information about all permits issued and any current 
permit applications in order to assess the potential universe of small 
entities that could be affected by today's rule. Since the HARS was 
first designated in 1997, the U.S. Army Corps of Engineers has received 
19 private permit application for HARS placement (USEPA, 2003b), of 
which 15 permits were issued (Federal authorizations were not included 
in this analysis as the USACE is not a small entity), and there are 
currently 2 active permit applications pending (New York Waterways and 
Naval Weapons Station Earle Pier 3). The remaining permit applications 
(New York State Thruway and Department of Army, Op Sail) are no longer 
active. As the HARS is expected 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 assume that the universe of 
current and pending applications (based upon over 5 years of 
application history) constitutes the reasonable universe of entities 
affected by the todays' rule. Of the 19 permit applications, only 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 four, three 
(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, which expired in January 2003, 
but they never dredged. 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. This analysis was included in the 
preamble to the proposed rule (67 FR 62659) and no additional small 
businesses were identified during the comment period.
    In summary, based on past permit information, there would have been 
only a few small entities affected by the final rule, with low impacts. 
As such, EPA concludes that the final rule will not have a significant 
impact on a substantial number of small entities. Therefore, for the 
reasons explained above, the Regional Administrator certifies, pursuant 
to section 605(b) of the RFA, that the final rule will not have a 
significant economic impact on a substantial number of small entities.

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

[[Page 12600]]

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 final 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 final rule to be between $14.1 million and $62.5 
million (worst case scenario). See response to comment 7-2 in the 
Response to Comments Document (USEPA, 2003a). Of this total cost, $14.1 
million to $62.5 million would be incurred by the private sector and 
none would be incurred by State and Local governments. Thus, this final 
rule is not subject to the requirements of sections 202 and 205 of 
UMRA.
    EPA also has determined that this final rule contains no regulatory 
requirements that might significantly or uniquely affect small 
governments. This final 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 final 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 government and the Indian Tribes, 
or on the distribution of power and responsibilities between the 
Federal government and Indian Tribes.''
    This final 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 final 
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: Actions That Significantly Affect Energy 
Supply, Distribution, or Use

    This final rule is not subject to Executive Order 13211, ``Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use'' (66 FR 28355 (May 22, 2001)) because it is not a 
significant regulatory action under Executive Order 12866.

I. National Technology Transfer 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 
final 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 final 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

[[Page 12601]]

compliance costs on those communities. Accordingly, the requirements of 
Executive Order 12898 do not apply.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit 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 United States prior 
to publication of the rule in the Federal Register. A ``major rule'' 
cannot take effect until 60 days after it is published in the Federal 
Register. This action is not a ``major rule'' as defined by 5 U.S.C. 
804(2). This rule will be effective on April 16, 2003.

L. 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 (October 29, 1998).
    In August 1982, EPA published a final EIS for the 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 (USEPA, 1997a). 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 promulgation of the 113 ppb HARS-specific PCB 
worm tissue criterion 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, and no additional 
NEPA review is required.
    However, EPA received comments on the proposed rule questioning 
EPA's determination that no further NEPA evaluation is required to 
establish the 113 ppb HARS-specific PCB worm tissue criterion. 
Specifically, these comments questioned whether EPA was remiss in not 
evaluating the need for, and impacts associated with the use of, other 
disposal methods in light of the new PCB criterion. In point of fact, 
EPA does not evaluate such issues when designating ocean disposal sites 
because permission to use an ocean site for the disposal of dredged 
material can be granted only after a determination has been made that 
no alternative disposal options exist. Evaluations of alternative 
disposal options are more properly performed in the review process for 
individual ocean dumping permit applications. As such, EPA again 
concludes that no further NEPA documentation is needed to establish a 
113 ppb HARS-specific PCB worm tissue criterion.

M. 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 species 
under its jurisdiction. The action covered by this final rule is more 
protective of the marine environment. Accordingly, the conclusions of 
our earlier consultation with the USFWS for the designation of the HARS 
are 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) (USEPA, 
1997c) 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 final rule 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.

N. 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

[[Page 12602]]

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.

O. Plain Language Directive

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

P. 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.''
    The HARS-specific PCB worm tissue criterion of 113 ppb is the non-
cancer (hazard quotient of 1), and is the lower of the 282 ppb cancer 
(1 x 10-4), and 329 ppb ecological PCB values (USEPA, 
2000c). EPA expects that this proposed rule would afford additional 
protection of aquatic organisms at individual, population, community, 
or ecosystem levels of ecological structures, because the previous 
matrix value was 400 ppb. Additionally the 113 ppb HARS-specific PCB 
worm tissue criterion is roughly one-third lower than the 329 ppb PCB 
value for the protection of ecological health. EPA is promulgating the 
113 ppb HARS-specific PCB worm tissue criterion as it is the lower of 
the human health (cancer and non-cancer) and ecological protection 
values. Therefore, EPA expects today's final 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: March 10, 2003.
Jane M. Kenny,
Regional Administrator, Region 2.

    In consideration of the foregoing, EPA is amending part 228, 
Chapter I of title 40 of the Code of Federal Regulations 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: 
Total PCB bioaccumulation worm test results for dredged material 
approved for placement at the HARS as Material for Remediation 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. 03-6302 Filed 3-14-03; 8:45 am]
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