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2  Policy Context for Regulating Live Organisms in  Ballast Discharge  The policy context around regulation of ballast water discharge is important to understanding the potential for a numeric standard on living organisms in ballast to reduce the risk of invasions. Two independent agencies, the U.S. En- vironmental Protection Agency (EPA) and the U.S. Coast Guard (USCG), have authority to directly regulate ballast water discharges to waters of the United States. How their programs developed, overlap, and complement one another is the subject of this chapter.  STATUTORY BACKGROUND OF BALLAST MANAGEMENT The first United States law with regulatory jurisdiction over live organisms in ballast water discharge was, by a 2005 U.S. District court decision, the Clean Water Act Amendments of 1972 (Clean Water Act, 33 U.S.C. §§ 1251–1387, 2006). The Act and its subsequent amendments (hereafter referred to as the CWA) impose progressively more stringent requirements on point sources of pollutants via the National Pollution Discharge Elimination System (NPDES). In 1973 when the EPA promulgated regulations implementing the NPDES, there was little or no attention from Congress or the environmental community to the specific problem of live organisms in discharges from vessels. In fact, EPA’s regulations specifically exempted “discharge incidental to the normal operation of a vessel” (40 C.F.R. § 122.3(a) (2008)). This regulatory exemption, which greatly expanded a statutory exemption of “discharges incidental to nor- mal operations of vessels of the Armed Forces” (emphasis added) (33 U.S.C. § 1362(6)), was considered unremarkable for over two decades. Environmental groups finally petitioned EPA to vacate the exemption in 1999. The agency denied the petition, and the groups filed suit. In March 2005, the U.S. District Court for the Northern District of California in San Francisco ruled that the EPA must begin regulating ballast water discharges through the CWA NPDES pro- gram (Northwest Envtl Advocates et al. vs. United States EPA, No. C 03– 05760–SI, 2005). EPA issued its first Vessel General Permit (VGP) in 2008,   35 

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36    Propagule Pressure and Invasion Risk in Ballast Water    and subsequent versions are anticipated that include water quality standards for ballast water. Ballast introductions of aquatic invasive species did become salient in Con- gress in the late-1980s when massive infestations of the ship-mediated zebra mussel (Dreissena polymorpha) and Eurasian ruffe (Gymnocephalus cernua) burgeoned in the Great Lakes. Industrial and municipal raw water users and fisheries interests raised frantic appeals for federal action (Cangelosi, 2003). However, at that time, Congress and its constituents, including some in the envi- ronmental community, regarded most aquatic invasive species impacts to be economic rather than environmental. That is, even in the immediate wake of these dramatic infestations, there were few if any calls for the issue to be ad- dressed under the CWA. Consequently, Congress sought in 1990 to fill an ap- parent regulatory vacuum with the Nonindigenous Aquatic Nuisance Prevention and Control Act of 1990, also known as NANPCA (P.L. 101-646; 16 U.S.C. 4701 et seq.,), which ordered the USCG to regulate ballast operations of ships. NANPCA was the first federal law globally with the explicit purpose of re- gulating ballast discharges of aquatic invasive species. NANPCA required the USCG to issue voluntary guidelines within six months and regulations within two years of enactment to prevent new introductions of aquatic nonindigenous species by ships entering the Great Lakes. Modeled after a voluntary Canadian program, the new U.S. regulatory program required all ships entering the Great Lakes and northern sections of the Hudson River, after operating outside the Exclusive Economic Zone (EEZ) of the United States and Canada of 200 nauti- cal miles from shore, to undertake ballast management operations prior to dis- charging ballast water in a U.S. Great Lakes port, or face criminal and civil pe- nalties. Because all vessels entering the Great Lakes via the St. Lawrence River pass through U.S. territorial water, this regulation effectively covered all bal- lasted transoceanic vessels entering the Great Lakes system irrespective of whether their destination port was in the U.S. or Canada. Specifically, NANPCA required ships to undertake open-ocean ballast wa- ter exchange, the only available approach at the time to reduce the risk of ship- mediated introductions of invasive species, or an alternative environmentally sound treatment method approved by the USCG as being at least as protective as ballast water exchange. NANPCA required that after a voluntary period of two years the program must become mandatory. It also set up an Aquatic Nuisance Species Task Force and regional panels for coordinating action to control aqua- tic invasive species infestations. In 1996, Congress enacted the National Invasive Species Act of 1996 [NI- SA, Pub. L. No. 104-332, 110 Stat. 4073 (codified as amended 16 U.S.C.)] to reauthorize and expand the NANPCA program. The provisions of NISA reflect the extent to which the geographic scope of concern over ship-mediated intro- ductions of invasive species had increased in just a half decade. NISA charged the USCG with promulgating a national ballast management program to com- plement the Great Lakes regional program. The law stipulated that the national program must be made mandatory within three years of its initiation if voluntary

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Policy Context for Regulating Live Organisms in Ballast Discharge  37    implementation was not adequate. To assure informed agency follow-through, Congress required vessels to report on ballast management activities carried out pursuant to the law from the time of enactment, and the USCG to periodically assess compliance based on these reports. In every region except the Great Lakes, where ballast management was al- ready mandatory, the maritime industry failed to report, much less implement, ballast management measures. In 2001, the USCG reported to Congress that the proportion of vessels that provided information on ballast water management was around 25 percent, too low for a positive assessment of compliance with the voluntary guidelines, making a transition to a regulatory program of ballast management nationally a foregone conclusion (USCG, 2001). The USCG ful- filled its statutory obligation to make the guidelines mandatory three years later, in July 2004. Era of Ballast Water Exchange Invasions by aquatic nonindigenous species discovered subsequent to bal- last water exchange requirements on ships entering the Great Lakes, such as by the fishhook water flea Cercopagis pengoi in Lake Ontario in 1998, suggested that the shipping vector was still transmitting nonindigenous aquatic species into the Great Lakes. One major cause of continued problems was likely incomplete application of ballast water exchange. In the late 1980s, while policy was still being developed to address ship-mediated invasions, it was common for ships to enter the Great Lakes entirely loaded with ballast water, discharge the water in the upper lakes, and depart the lakes entirely loaded in cargo (grain). But by the mid-1990s, concurrent with, but not a consequence of, the advent of the first ballast water exchange regulatory program, a large percentage of vessels entered the St. Lawrence Seaway laden at least partially with cargo (e.g., steel) (Cange- losi and Mays, 2006), such that most vessels had less than 10 percent of their tanks loaded with declarable (i.e., pumpable) water (Colautti et al., 2003). Ballast water exchange at that time was considered safe and practicable on- ly on fully ballasted tanks. Thus, the USCG exempted ships that were carrying cargo rather than ballast from ballast water exchange. Ships had the option of declaring their condition as “No Ballast On Board” (NOBOB) and those that did were not subject to any further scrutiny. How little ballast constituted eligibility for the NOBOB exemption was not clearly defined, monitored, or documented. As a consequence, it is possible that some ships laden mostly with cargo but with a full unexchanged ballast tank or two declared NOBOB in good faith and proceeded to discharge their unexchanged ballast at ports of call in the Great Lakes in the 1990s and the first half of the following decade. A bi-national monitoring program was finally initiated by the U.S. and Canada to check 100 percent of ballast tanks for these vessels on the Great Lakes in 2006. In addition to the problems attendant to unexchanged ballast water from this minority of full tanks discharged into the lakes, subsequent studies revealed that

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38    Propagule Pressure and Invasion Risk in Ballast Water    even the so-called “empty” tanks, carrying only unpumpable water, entrained a diverse but varied flora and fauna, and themselves could be a potentially impor- tant vector for new invasive species introductions to the Great Lakes. These ballast residuals were suspected as posing a risk owing to their predominance within the foreign trade, the live biota they contained, and the abundance of via- ble resting stages contained in residual sediments (e.g., Bailey et al., 2003; Reid et al., 2007). The Shipping Federation of Canada, whose member companies transmit 95 percent of trade in Eastern Canada, agreed to (among other things) more rigor- ous ballast water management practices that subject residual ballast water to similar flushing practices as filled tanks, to purge and kill live freshwater organ- isms, and to minimize sediment accumulation. This was codified in the Sep- tember 2000 Code of Best Practices for Ballast Water Management for vessels entering the Great Lakes. In 2002, the twin Seaway authorities—the St. Law- rence Seaway Development Corporation (USA) and the St. Lawrence Seaway Management Corporation (Canada)—required all foreign flagged vessels to comply with these best management practices. Transport Canada and the USCG later reinforced these regional requirements. However, despite advancements in scope and accountability, the shipping industry generally complained that ballast water exchange was difficult to im- plement and costly in terms of fuel and carbon emissions; federal officials found ballast water exchange difficult to enforce; and scientists expressed concern that it was not adequate to abate continued invasions. Congress (P.L. 104-332), the International Maritime Organization (IMO), the USCG, and the National Re- search Council (NRC, 1996) began commending ballast water treatment in lieu of ballast water exchange as the best long-term solution to ballast-mediated aq- uatic species invasions. Concurrently, early treatment performance demonstra- tions suggested that mechanical operation of ballast treatment on ships could be feasible and biologically effective (Cangelosi, 1997; Parsons and Harkins, 2002; Rigby et al., 1997). With the acceptance of a future transition to routine ballast water treatment, interest in a performance standard that would be applicable to ballast water advanced, and a protracted exploration of options for setting mea- surable performance standards for ballast water management pursuant to NANPCA and NISA began. STANDARD-SETTING PROCESSES OF THE TWO STATUTES The authorities of EPA and USCG to regulate ballast water have not been formally coordinated, although Congress made an effort to do so in 1996 when it enacted NISA. It is therefore in the hands of the implementing agencies to ef- fect that coordination for the benefit of the regulated community. To this end, EPA’s Office of Wastewater Management and the USCG are working jointly to derive numeric limits for living organisms in ballast water for the next CWA Vessel General Permit and for regulatory programs of the USCG to prevent the

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Policy Context for Regulating Live Organisms in Ballast Discharge  39    establishment of new aquatic nonindigenous species through the discharge of ships’ ballast water. All actions pursuant to the Clean Water Act must support this statute’s overall goal to “eliminate discharge of pollutants” into navigable waters; its inte- rim goal to achieve, where attainable, “water quality which provides for the pro- tection and propagation of fish, shellfish, and wildlife and provides for recreation in and on the water”; and its stated objective to “restore and maintain the chemical, physical, and biological integrity of the Nation’s waters.” Finally, the CWA contains a narrative standard, prohibiting the discharge of “toxic pol- lutants in toxic amounts.” The CWA defines “pollutant” to include “biological materials” (33 U.S.C. 1362(6)) and toxic pollutants as “those pollutants, or combinations of pollutants, including disease-causing agents4, which after dis- charge and upon exposure, ingestion, inhalation or assimilation into any organ- ism, either directly from the environment or indirectly by ingestion through food chains, will, on the basis of information available to the Administrator, cause death, disease, behavioral abnormalities, cancer, genetic mutations, physiologi- cal malfunctions (including malfunctions in reproduction) or physical deforma- tions, in such organisms or their offspring” (33 U.S.C. 1362(13)). Thus, these narrative standards also are applicable to organisms and human and wildlife disease agents that may be entrained in ballast discharge. To make these goals and objectives operational, EPA and the states have developed water quality standards that address the pollutant limits needed to protect the natural resources of concern. These criteria reflect the latest scientif- ic knowledge on “the kind and extent of all identifiable effects on health and welfare including, but not limited to, plankton, fish, shellfish, wildlife, plant life, shore lines, beaches, aesthetics, and recreation which may be expected from the presence of pollutants…”; “the concentration and dispersal of pollutants, … through biological, physical, and chemical processes”; and “the effects of pollu- tants on biological community diversity, productivity, and stability...for varying types of receiving waters” [33 U.S.C. 1314]. All of the above considerations are potentially relevant to biological constituents in ballast discharge. NPDES permits are written to prevent point source discharges from violat- ing water quality standards, using two basic types of effluent limits. In the case of ship discharges (and many other point sources), EPA has relied on technolo- gy-based standards based on the best available technology economically achiev- able (BAT) [33 U.S.C. 1311(a)]. Although technological, operational, and eco- nomic feasibility are considerations in the agency’s decision-making, the guid- ing principle is that the BAT must result in “reasonable further progress toward the national goal of eliminating the discharge of all pollutants” [33 U.S.C. 4   Case  law  supports  an  interpretation  of  “disease‐causing  agents”  that  includes  bacteria  and  virus‐ es.   See  APWU  v.  Potter,  343  F.3d  619  (2d  Cir.  2003)  (in  a  case  involving  CERCLA,  which  defines  the  term  “pollutant  or  contaminant”  to  include  “disease‐causing  agents,”  the  court  identified  anthrax,  a  bacterium,  as  a  “pollutant  or  contaminant”);  U.S.  v.  City  of  North  Adams,  Mass.,  777  F.Supp.  61,  81 n.22 (D. Mass. 1991) (in a case involving the Safe Drinking Water Act, the court identified bacte‐ ria and fungi as “disease causing agents”). 

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40    Propagule Pressure and Invasion Risk in Ballast Water    1311(b)(2)(A)]. The BAT should evolve with technological and commercial advancement of systems, but this reality is dependent upon agency follow- through. When application of the EPA-designated BAT is not sufficient to meet wa- ter quality standards, the EPA must issue water quality-based effluent limita- tions, which consider site-specific evaluation of the discharge and its effect on a receiving system [see: http://www.epa.gov/npdes/pubs/chapt_06.pdf), 33 U.S.C. 1311(b)(1)(C)]. States may add conditions to NPDES permits if such conditions are necessary to assure that discharges will meet state water quality standards [33 U.S.C. 1341(d)]. Any ship that discharges in violation of an NPDES permit is subject to enforcement or suit by EPA, a state, or a citizen. In comparison, NANPCA and NISA also speak to both environmental pro- tection and feasible and available methods for achieving this goal, but the rela- tionship is less structured than for the CWA. The narrative statutory goal of the Great Lakes-specific NANPCA program is “to prevent unintentional introduc- tion and dispersal of nonindigenous species into waters of the United States through ballast water management and other requirements.” The NANPCA definition of nonindigenous species, which subsumes both live organisms and pathogens, is “any species or other viable biological material that enters an eco- system beyond its historic range, including any such organism transferred from one country into another.” NANPCA authorized the Secretary of the Depart- ment of Transportation (acting through the USCG) to issue regulations specifi- cally “to prevent the introduction and spread of aquatic nuisance species into the Great Lakes through the ballast water of vessels.” “Aquatic nuisance species” are defined as “a nonindigenous species that threatens the diversity or abun- dance of native species or the ecological stability of infested waters, or commer- cial, agricultural, aquacultural, or recreational activities dependent on such wa- ters.” The voluntary national ballast management program created by NISA contained a similarly stated purpose: “to prevent the introduction and spread of nonindigenous species in waters of the United States by ballast water operations and other operations of vessels equipped with ballast water tanks.” In contrast to the CWA, NANPCA and NISA do not require development of discharge standards. They instead require that ships undertake specific ship operations, namely ballast water exchange consistent with USCG requirements or environmentally sound ballast water treatment that the USCG approves as being at least as effective as ballast water exchange, among others options. Thus, the statutes essentially set a “management standard” (ballast water ex- change) as a performance floor. However, the USCG must infer a risk-reduction level associated with that management standard to determine an allowable bal- last water treatment; the laws state an overall objective “to prevent introduction and spread” of aquatic invasive species and require the USCG to approve treat- ments based on their being “at least as effective” as exchange. When the USCG began promulgating operational guidelines for “effective” ballast water exchange for the Great Lakes and national programs, it soon be- came clear that a metric of effectiveness based on some limit on numbers of near

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Policy Context for Regulating Live Organisms in Ballast Discharge  41    coastal organisms entrained in discharge, was all but impossible to construct and enforce. The ability of ballast water exchange to reduce numbers of potentially harmful organisms in ballast discharge is not a single value, but varies across ships, voyages, and even tanks within a ship. As discussed in Chapter 1, ex- change dilutes and reduces initial densities of high-risk near-coastal organisms but not organisms generally, since open-ocean organisms (of lower risk) are taken up in the exchange as the near-coastal water is purged. The USCG ulti- mately imposed an indirect but measurable performance metric for ballast water exchange in its Great Lakes regulations of a necessary post-exchange ballast water salinity exceeding 30 parts per thousand (ppt), based on the assumption that highly saline water was indicative of effective open-ocean ballast water exchange. Unfortunately, this indirect approach is less reliable when applied to marine system voyages, due to high near-shore salinities at many harbors. Waite and Kazumi (2001) noted that a purge of 95 percent of the near-coastal water during ballast water exchange was close to optimal from a physical stand- point, offering an alternative indirect metric that would be applicable to all voyages. Methods for requiring and enforcing a 95 percent purge were incorpo- rated into proposed reauthorization language for NISA as a national ballast wa- ter exchange performance metric and into the IMO D-2 standards (see later dis- cussion). For reasons of technical complexity, the USCG did not propose numeric metrics for allowable live organisms in exchanged ballast water for over two decades after the first law’s enactment. However, such standards are now ne- cessary in order to operationalize the NANPCA and NISA requirements that ships be allowed to substitute environmentally sound ballast water treatment “at least as effective as ballast water exchange” at preventing introduction and spread of aquatic invasive species by ships. CURRENT INTERNATIONAL, FEDERAL, AND STATE STANDARDS The USCG’s first exploration of standards for ballast water treatment oc- curred in the context of discussions at the International Maritime Organization (IMO). Ballast water management came to the attention of the IMO as early as 1988, largely as a result of the Canadian government and the International Joint Commission/Great Lakes Fishery Commission report (IJC, 1990). In 1993, the IMO requested that all member nations implement voluntary guidelines based on the Canadian ballast management guidelines. In 1997, the Marine Environ- mental Protection Committee (MEPC) guidelines were reviewed, revised, and adopted as Assembly Resolution A 868(20). The resolution also requested the MEPC to work towards completion of a legally binding Convention, together with guidelines for uniform implementation. For five years a U.S. interagency working group including both USCG and EPA participated in the MEPC’s Ballast Water Working Group to develop the IMO’s International Convention for the Control and Management of Ships’ Bal-

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42    Propagule Pressure and Invasion Risk in Ballast Water    last Water and Sediments. The Convention was adopted at the International Conference on Ballast Water Management for Ships in February 2004. Though the U.S. has not signed the agreement (Canada has), many convention provi- sions, including the standards, reflect critical input from both USCG and EPA during the deliberative process. The Convention identifies two key standards, IMO D-1 and D-2, which vary with respect to minimum requirements, date of implementation, and appli- cation by size and date of build for different vessels (see Tables 2-1 and 2-2). D-1 is a ballast water exchange standard, requiring at least 95 percent volume- tric exchange for empty-refill-style exchange, and three times the tank volume for vessels that conduct flow-through exchange. The D-2 standard sets maxi- mum permissible limits on live organisms in ballast effluent, based on the size or taxonomic category of organisms (Table 2-2). It states that ships conducting ballast water management shall discharge:  “Less than 10 viable organisms per m3, for greater than or equal to 50 μm in minimum dimension;  Less than 10 viable organisms per ml, for less than 50 μm in min- imum dimension and greater than or equal to 10 μm in minimum dimen- sion; and  Discharge of the indicator microbes shall not exceed the specified concentrations. The indicator microbes, as a human health standard, in- clude, but are not be limited to: o Toxicogenic Vibrio cholerae (O1 and O139) with less than 1 colony forming unit (CFU) per 100 ml or less than 1 CFU per 1 gram (wet weight) zooplankton samples; o Escherichia coli with less than 250 CFU per 100 ml; o Intestinal enterococci with less than 100 CFU per 100 ml.” The size classes contained in the IMO standard very roughly coincide with taxonomic groups of plankton (i.e., zooplankton and phytoplankton for the larg- er and smaller class sizes, respectively) in marine systems, but also with pro- jected mechanical capacity to filter ballast water in a full-scale treatment process. The fecal indicator bacteria identified and the levels set for them re- flected accepted human contact standards (EPA, 1986). The V. cholerae (sero- types O1 and O139) levels in the standard, a facet of the standard particularly hard to assess in treatment performance evaluations in the real world, were called out largely in response to concerns from Brazil that pathogens in ballast water pose a serious threat to receiving ports (MEPC 47/2/11, Brazil, 2003). The United States delegation, along with some others, argued for a more stringent standard during IMO deliberations (BWM/CONF/14, 2004), but this position did not prevail. The U.S. delegation, backed by direct input from Unit- ed States Senators (in a letter to Admiral Thomas H. Collins, dated January 22, 2004), did secure a provision in the convention that makes explicit an assump- tion that member states can unilaterally implement standards more stringent than

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Policy Context for Regulating Live Organisms in Ballast Discharge  43      TABLE 2‐1  IMO D‐1 and D‐2 Ballast Water Performance Standards  Standard  Exchange Type  Viable Organism Density  Empty‐ ≥ 95%  Refill  exchange  D‐1  N.A.  Flow‐ 3x tank  through  volume  Organism  Concentration  <10 m‐3  ≥50 μm MD  <10 ml‐1  ≥10 μm MD and <50  μm MD  <1 CFU 100 ml‐1 or   D‐2  N.A.  <1 g‐1 zooplankton wet  Vibrio cholera  weight   <250 CFU 100 ml‐1  Escherichia coli  <100 CFU 100 ml‐1  Intestinal enterococci  N.A. = Not Applicable. MD = minimum dimension.  CFU = colony forming unit.  Vibrio cholerae refers to toxic strains O1 and O139.  TABLE 2‐2  Timeline for implementation of IMO Ballast Water Management Regulations  Note:  Built  refers  to  vessel  build  date.  D1  refers  to  the  need  for  vessels  to  conduct  bal‐ last  water  management  that  at  least  meets  the ballast  water  exchange  standards,  while  D2  refers  to  ballast  water  management  that  at  least  meets  the  ballast  water  perfor‐ mance  standard.   SOURCE:  Reprinted,  with  permission,  from  David  and  Gollasch  (2008).  © 2008 by Stephan Gollasch.      

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44    Propagule Pressure and Invasion Risk in Ballast Water    IMO’s. Canada ratified the Convention on April 9, 2010, while the United States, as yet, has not. The IMO Convention, which will come into force one year after not less than 30 States representing 35 percent of the world’s mer- chant tonnage have ratified without reservation5, nonetheless provides a com- mon basis for the EPA and USCG to pursue domestic standards. NISA-Related Requirements In 2009, five years after the IMO Convention was agreed upon, the USCG issued a notice of proposed rulemaking citing its authority through NISA, which contained an interim and final numeric standard for live organisms in ballast discharge (Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009). This action reflected demands derived in part from concerns that allowable levels of discharges of organisms within the IMO standard are not sufficiently different from taking no action. For example, the IMO discharge limit for protists of 10 live cells/ml does not significantly differ from even worse case uptake condi- tions. Indeed, an Australian study showed that a typical Alexandrium toxic plankton bloom may reach cell densities in ballast water of just one order of magnitude more than the IMO discharge limit, at 102 cells/ml (Hallegraeff, 2001). Others expressed concern that while the IMO standard will eliminate discharge of extremely dense concentrations of organisms, ballast discharge meeting the IMO discharge standard from a single ship could still represent a sizable inoculation when compounded over the numerous tons of ballast water a ship may load and subsequently discharge. Indeed, Bailey et al. (2009) post- ulated that the IMO D-2 standard (< 10 individuals m-3) would result in a 0.27 probability of establishment for some zooplankton, like the parthenogenetic wa- ter flea Daphnia retrocurva, which because of its life history could colonize at very low inoculum densities; other zooplankton had lower or negligible invasion probabilities. The proposed 2-phase USCG rule is shown in Table 2-3. The standard takes the potential for technological advancement into account by proposing an interim and final numeric standard which combine considerations of environ- mental protectiveness and technological feasibility. The proposed rule installs the IMO D-2 standard as an interim standard for ballast discharge, and a more stringent Phase 2 standard that ships must meet over time as technology be- comes available. Phase 1 would come into effect immediately for new vessels constructed on or after January 1, 2012; for existing vessels constructed before January 1, 2012, the standard would come into effect in 2014 and 2016, depend- ing on vessel ballast water capacity. Phase 2 would come into effect for all ves- sels on January 1, 2016, although existing vessels would have until their first 5  Currently 28 countries representing over 28% tonnage have ratified the Convention. 

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Policy Context for Regulating Live Organisms in Ballast Discharge  45    TABLE 2‐3  Phase 1 and Phase 2 Proposed USCG Ballast Discharge Standards  Microbial (≤ 10 μm)  10 μm to  Phase  > 50 μm         50 μm  Total  V. cholerae*  E. coli  enterococci  < 10/ m3    1  < 10/ml   NA  <1 CFU   <250 CFU  <100 CFU  /100 ml  /100 ml  /100 ml  < 1/100m3     < 1/100 ml  2  < 1,000  <1 CFU   <126 CFU  <33 CFU  bacterial  /100 ml  /100 ml  /100 ml  cells AND  <10,000  viruses  per 100  ml  *Toxicogenic V. cholerae O1 and O139  regularly scheduled dry dock after that date to install treatment technology. A final rule-making is pending. As discussed in Box 2-1, the virus standard (which is not part of the IMO D-2 standard) has been the subject of much con- troversy. The USCG derived its proposed numeric limits for living organisms using the Population Viability Analysis approach (see Chapter 4). This model relates initial population size with extinction probability, which is known to be regu- lated by decreases in population size, low rates of population increase, and high variance in population size. The USCG concluded from this analysis (USCG DPEIS, 2008) that  smaller inoculation density will yield less risk of establishment,  treated discharge meeting the IMO standard will yield at least as much and usually more risk reduction than ballast water exchange, and  risk reduction below that provided by the IMO D-2 standard is im- portant enough to justify a second phase standard three orders of magnitude stricter than the IMO. EPA Vessel General Permit As noted above, the EPA has not yet developed numeric water quality crite- ria or identified best available technology economically achievable for live or- ganisms in ballast water discharge.6 The EPA’s Vessel General Permit issued in 6   While  the  federal  component  of  the  VGP  contained  no  numeric  limits  on  living  organisms  in  bal‐ last  discharge,  the  state  component  of  the  process,  the  CWA  section  401  certifications,  resulted  in  several ballast water discharge standards added to the permit (see discussion below). 

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46    Propagule Pressure and Invasion Risk in Ballast Water      BOX 2‐1  Viruses in the Context of Invasion Risk from Ballast Water    Aquatic  viruses  are  very,  very  small;  most  range  between  20  and  200  nanometers  (1  nm  =  10‐9  meter).   They  also  are  very,  very  abundant;  even  in  pristine  coastal  waters,  their  concentrations  routinely  range  from  1010  to  1012  per  liter.   Suttle  (2005)  estimated  the  world  ocean  contains  on  the  order  of  1030  viruses.    It  is  important  to  understand,  however,  that  despite  their  enormous  numbers,  nearly  every  one  of  these  viruses  is  of  no  consequence  for  human  health.    Overwhelmingly  so,  the  host  cells  in  which  they  propagate  their  genetic  material  are  the  myriad  species  of  co‐occurring  bacterioplank‐ ton,  phytoplankton,  and  heterotrophic  protists  found  in  fresh,  brackish,  and  marine  waters.    In  general,  viruses  are  considered  to  be  very  host‐specific,  sometimes  to  the  subspecies  level  (Lawrence,  2008).    While  there  is  potential  for  viruses  pathogenic  to  humans  to  be  released  through  ballasting  operations,  that  possibility  is  less  relevant  than the potential introduction of viruses that infect fish, shellfish, and other ecological‐ ly or economically important aquatic species.    When  dealing  with  environmental  samples,  there  are  a  host  of  difficulties  asso‐ ciated  with  sampling  and  concentrating  viruses  pathogenic  to  humans,  then  subse‐ quently identifying them using cell‐culture methods or reverse‐transcriptase polymerase  chair  reaction  (PCR).   Enumeration  of  aquatic  viruses  is  not  straightforward.   Even  with  transmission‐electron  microscopy  (TEM),  a  technique  that  allows  their  direct  visualiza‐ tion,  there  are  problems  attendant  with  recognizing  some  of  their  less  distinctive  mor‐ photypes.  A more commonly used method to enumerate aquatic viruses (more proper‐ ly,  “virus‐like  particles”)  involves  staining  their  nucleic  acids  with  a  fluorochrome  and  counting  pinpoints  of  light  using  epifluorescence  microscopy  (Patel  et  al.,  2007).    Nei‐ ther  staining  nor  TEM,  however,  can  indicate  whether  the  virus  is  infective  or  inacti‐ vated.    Furthermore,  visualization  of  viruses  in  seawater  samples  may  overlook  those  already  infecting  host  species  and  whose  ballast  water  transport,  therefore,  would  be  tied to transport of the host bacterium, protist, fish, or shellfish.    As is the case with some free‐living bacteria and protists, evidence is emerging con‐ sistent  with  the  proposal  that  viruses  have  a  biogeography.   That  is,  not  all  viruses  are  distributed everywhere.  Both metagenomic and observational studies have shown geo‐ graphic  constraints  in  the global‐scale  distribution  of  some  viruses  (studies  cited  in  Law‐ rence et al., 2008).  Compared  to  other  microorganisms,  therefore,  and  certainly  in  contrast  to  meta‐ zoans,  much  has  yet  to  be  articulated  about  the  biology  and  biogeography  of  aquatic  viruses.   There  are  a  number  of  technical  challenges  that  impede  our  improved  under‐ standing of them.    

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Policy Context for Regulating Live Organisms in Ballast Discharge  47    2008 contained only ballast water management and exchange requirements that largely mirrored the existing USCG regulatory program. However, a recent court settlement requires the agency to produce numeric criteria in draft by No- vember 2011 in the next version of the VGP. The current VGP includes some requirements not contained in the USCG program. For example, it disallows “discharges which violate water quality standards from vessels which are equipped with ballast tanks,” referring to state and pending federal standards developed pursuant to the CWA. The VGP also specifies additional management requirements on vessels (unless the vessel meets one of the exemptions in Part 2.2.3.11 of the VGP)7 engaged in Pacific nearshore voyages between Captain of the Port Zones, and on vessels with emp- ty/unpumpable ballast residuals engaged in transoceanic or Pacific nearshore voyages. In these cases, various versions of salt-water flushing operations are required. Finally, the VGP stipulates that vessels may not discharge unexc- hanged or untreated ballast water or sediment into U.S. waters that are federally protected wholly or in part for conservation purposes. Comparison of Regulatory Programs in EPA and USCG Some features of the current EPA and USCG regulatory programs over live organisms in ballast discharge are inherently similar to each other. For example, both programs apply to ships equipped with ballast tanks, discharges of ballast water into “waters of the United States”, and virtually any taxonomic category of organism in discharge, including viruses. Other features of the EPA and USCG existing programs are substantively different. The USCG program cov- ers all aspects of the ship vector, including hull fouling and other sub-vectors, while the EPA program is focused on ballast discharges. The VGP applies to all vessels operating in a capacity as a means of transportation, except recreational vessels (as defined in CWA §502(25)) equal to or greater than 300 gross tons or with capacity to hold or discharge more than 8 cubic meters of ballast. This broad categorization of vessels includes some number of fishing vessels not in- cluded in the USCG program based on NISA. Alaska is not covered by the USCG, but it is covered by EPA. Under the VGP, dischargers are responsible to conduct self-inspections and monitoring, and report on them annually, though the VGP does not designate a recipient for the reports. There is currently no inspection program associated with the VGP. Meanwhile, the USCG program includes mandatory reporting 7   Exemptions  (in  Part  2.2.3.11  of  the  VGP)  apply:  Vessels  may  not  conduct  exchange/flushing  for  safety  reasons,  if  an  alternative,  environmentally  sound  method  of  ballast  water  management  approved  by  the  USCG  has  been  used  prior  to  discharge,  the  vessel  is  in  the  Coast  Guard  STEP  pro‐ gram,  all  ballast  water  is  retained  onboard  (there  is  no  discharge),  the  vessel  does  not  traverse  more  than  one  COTP  zone,  and  for  Pacific  nearshore  voyages,  the  vessel  is  exempt  if  ballast  water  consists  of  water  drawn  from  treated  municipal  water  supplies,  as  long  that  ballast  water  is  not  mixed with any ballast water/sediments from other sources. 

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48    Propagule Pressure and Invasion Risk in Ballast Water    and a healthy system for receiving and archiving report information, and inspec- tions to corroborate report claims. Statutory exemptions for the purposes of maintaining ship safety are similar for the two regulations, except that no ex- emptions are allowed for ships on the Great Lakes as required under NANPCA. The statutory features of agencies’ standards are different in that EPA requires distinct water quality criteria and technology standards, and it sets, reviews, and revises its standards. The USCG technology standard is defined in the statute and requires risk reduction. Finally, there are also relevant issues which neither the EPA or USCG bal- last discharge regulatory program actively covers. One example involves oil tankers into Alaska, which are exempted by statute from requirements under NISA and also currently escape reporting to EPA because there is no inspection program associated with the VGP. (However, this latter exemption is not based on the statute and could be rectified with regulatory revision.) State Standards for Ballast Discharges of Live Organisms A number of U.S. states have implemented their own ballast water require- ments via CWA Section 401 certification (see Table 2-4). These requirements emerged out of frustration with the perceived slow pace of federal develop- ments; most states have indicated that they will relax or eliminate their programs should an effective federal program materialize. On the Great Lakes, states with ballast water permitting policies include Michigan, Minnesota, New York, and Wisconsin. Michigan passed legislation in 2005 that requires all ocean-going vessels to obtain a permit from the Michi- gan Department of Environmental Quality before entering a port in state waters beginning January 2007. Permits for ballast water discharge are provided only for four state-approved ballast treatment technologies: sodium hypochlorite, chlorine dioxide, ultraviolet light, and deoxygenation. However, due to trade patterns, ocean-going vessels do not discharge ballast water in Michigan waters, only cargo. Consequently, no ship has been outfitted with treatment in response to this law. In 2008, Minnesota passed legislation that required vessels to seek approval from the Minnesota Pollution Control Agency prior to discharging ballast water, and requiring existing vessels to treat to the IMO D-2 performance standards by 2016. Wisconsin began regulating discharges of ballast water by ocean-going vessels in February 2010, requiring 100 times the IMO D-2 performance stan- dards for existing vessels by 2014. A subsequent technology availability review led the State to roll the requirement back to IMO D-2 performance standards provided they are undertaken in combination with ballast water exchange in the open ocean (see http://dnr.wi.gov/news/mediakits/mk_ballast.asp). Also in 2010, New York promulgated requirements that existing and new ships treat ballast to 100 and 1000 times, respectively, the IMO D-2 performance, even if they are simply passing through New York waters without discharging ballast

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Policy Context for Regulating Live Organisms in Ballast Discharge  49    water. New York recently issued a new deadline for compliance of 2013 (see http://www.dec.ny.gov/docs/water_pdf/vesselgpletter.pdf). Requirements on new ships are on a tighter time-line in all cases. Other Great Lakes states (e.g., Indiana, Illinois, Pennsylvania, Ohio) have less specific regulations, requiring a permit prior to ballast discharge by ocean-going vessels, and unspecified ballast management (Great Lakes Commission, 2008). Some Great Lakes’ states in- clude ‘lakers’ in their ballast water policies (Table 2-4). The Rhode Island State Legislature charged the state’s Department of Envi- ronmental Management with gathering information on international, federal, and state ballast water management policies and making recommendations for the establishment of a state ballast water management program. Other states such as Maryland and Virginia have laws requiring vessels to report their ballast opera- tions. Oregon also has reporting requirements and requires vessels arriving from overseas to conduct ballast water exchange. California has a mandatory state ballast water management program that is supported by fees charged to vessel operators, and Washington State’s program requires ballast water reporting and monitoring and establishes standards for ballast water treatment systems. Other Countries Transport Canada in the late 2000s amended the Canada Shipping Act to mandate ballast water exchange, treatment, and discharge to a reception facility, or retention on board for most foreign vessels arriving to Canada.8 NOBOB vessels arriving from outside the Exclusive Economic Zone (> 200 nautical miles offshore in water ≥ 200m depth) are required to flush mid-ocean water through their tanks, treat ballast water to the IMO’s D-2 performance standard, comply with the aforementioned best management practices, or demonstrate that proper ballast water exchange has previously been conducted to the IMO D-1 standard. The Australian Quarantine and Inspection Service (AQIS) is designated as the lead agency for the management of ballast water risks in Australia. In 1990, AQIS introduced voluntary ballast water guidelines. The guidelines were refined and became mandatory on July 1, 2001. The requirements have legisla- tive backing and are enforced under the Quarantine Act of 1908 (Common- wealth of Australia Quarantine Act 1908, as amended by Act No. 17 of 2002, http://www.opbw.org/nat_imp/leg_reg/aus/qar.pdf). There are no ballast water discharge standards distinct from the IMO standards associated with this Aus- tralian program. 8   Excepting  coastal  vessels  arriving  from  north  of  Cape  Blanco  (Oregon)  or  Cape  Cod  (Massachu‐ setts),  ballast  water  from  these  northern  U.S.  sources  can  be  discharged  only  into  receiving  Cana‐ dian waters of the same biogeographic region (i.e., not into the Great Lakes). 

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  TABLE 2‐4  Summary of State Ballast Water Treatment Permit Requirements and U.S. Clean Water Act Certification Conditions as of  50    January 2011 Propagule Pressure and Invasion Risk in Ballast Water 

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Policy Context for Regulating Live Organisms in Ballast Discharge  51   

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52    Propagule Pressure and Invasion Risk in Ballast Water    In New Zealand, voluntary controls were placed on the discharge of ballast water in March 1992 by the then Ministry of Agriculture and Fisheries. The controls sought to ensure that vessels refrain from discharging ballast water while in New Zealand waters. New Zealand introduced mandatory controls on ballast water discharges in 1998, under the Biosecurity Act 1993 (New Zealand Biosecurity Act 1993, Public Act 1993 No 95, http://www.legislation.govt.nz/ act/public/1993/0095/latest/DLM314623.html). CONCLUSIONS The Clean Water Act and over 20 years of subsequent federal and state leg- islative activity explicitly addressing the problem of ship mediated introductions of invasive species have generated a complex domestic network of regulatory arrangements around ballast water discharge. Internationally, the regulatory arrangement is simpler, largely reflecting the IMO agreement terms, but imple- mentation intensity is highly variable across member nations. This interagency, interjurisdictional regulatory mass is the starting point for deriving a numeric ballast discharge standard. Fortunately, there are few relevant issues that the EPA and USCG regulato- ry programs, in combination, cannot actively cover. That is, though the current regulatory programs implementing the statutes have inadequacies, and future regulatory renditions may also fall short, the statutes themselves appear to provide the essential considerations and scope to successfully implement scientifically based numeric standards, given sources of variation (de- scribed in Chapter 3). For example, the CWA is capable of addressing place- specific issues, such as characteristics of the receiving system, through the State certification process and can even begin to address cumulative loading through the Total Maximum Daily Load (TMDL) program. Meanwhile, the NISA pro- gram is comprehensive with respect to the ship-related modes of introduction. Both statutes allow the implementing agency to be sensitive to critical risk fac- tors such as voyage patterns and frequencies through variable enforcement in- tensity, and these considerations can be integrated into the EPA’s water quality criteria development process. Both statutes can be complemented with other environmental laws to prevent problems with residual toxicity of treated dis- charge. The success of these programs will be contingent upon the willingness and ability of EPA and USCG to implement their regulatory programs to yield comprehensive coverage of risk factors in a manner that can be complied with by the regulated community. Both EPA and USCG programs authorize rigorous enforcement of reporting and implementation actions by industry, a feature that will greatly facilitate data gathering on living organisms density and diversity that can support better un- derstanding of the relationship between propagule pressure (in terms of inocu- lum density) and the probability of invasion (see Chapter 4). Specifically, the USCG regulations are likely to require ship owners to equip ships with sampling

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Policy Context for Regulating Live Organisms in Ballast Discharge  53    ports that will deliver representative samples of discharged ballast water (USCG Research and Development Center, 2008). Indeed, many of the few ships sub- ject to treatment trials already have such sampling ports. The Great Ships Initia- tive is currently installing and trialing sample ports consistent with these guide- lines in up to 12 Great Lakes-relevant ships. Once the sampling hardware is in place, and sampling protocols are agreed to, a major obstacle to generating high- quality and generalizable data for populating risk–release models will have been eliminated. REFERENCES Bailey, S. A., I. C. Duggan, C. D. A. van Overdijk, P. Jenkins and H. J. MacIsaac. 2003. Viability of invertebrate diapausing eggs collected from residual ballast sediment. Limnology and Oceanography 48:1701–1710. Brazil. 2003. Ballast Water ANVISA. GGPAF Projects 2002. Pp. 3–4. Brazilia, Feb- ruary 2003. Available online at: http://www.anvisa.gov.br/eng/pab/ballast_wa- ter3.pdf. Last accessed on May 30, 2011. BWM/CONF/14. 2004. Considerations of the Draft International Convention for the Control and Management of Ships’ Ballast Water and Sediments: Ballast Water Discharge Standards, Regulation D-2. Cangelosi, A., and N. Mays. 2006. Great Ships for the Great Lakes? Commercial Ves- sels Free of Invasive Species in the Great Lakes-St. Lawrence Seaway System. A Scoping Report for the Great Ships Initiative. Available online at: http://www.nemw.org/scopingreport.pdf. Last accessed June 1, 2011. Cangelosi, A. 2003. Blocking Invasive Aquatic Species. Issues in Science and Tech- nology, The National Academies, The University of Texas at Dallas, Winter 2002- 03. Available online at: http://issues.org. Last accessed May 30, 2011. Cangelosi, A. 1997. The Algonorth experiment. Seaway Review 25(3): January–March 1997. Colautti, R. I., A. J. Niimi, C. D. A. van Overdijk, E. L. Mills, K. Holeck, and H. J. Ma- cIsaac. 2003. Spatial and temporal analysis of transoceanic shipping vectors to the Great Lakes. Pp. 227–246 In: Invasive Species: Vectors and Management Strate- gies. G. M. Ruiz and J. T. Carlton, editors. Washington, DC: Island Press. David, M., and S. Gollasch. 2008. EU shipping in the dawn of managing the ballast water issue. Marine Pollution Bulletin 56:1966–1972. EPA. 1986. Bacteriological ambient water quality criteria for marine and fresh recrea- tional waters. EPA 440/5-84-002. Cincinnati, OH: EPA Office of Research and Development. Glassner-Shwayder, K., and T. Eder. 2010. Summary of Key Elements of Great Lakes State and Provincial Ballast Water Treatment Permit Requirements & U.S. Clean Water Act Sec. 401 Certification Conditions. Ann Arbor, MI: Great Lakes Com- mission. Great Lakes Commission. 2008. Summary of Great Lakes State Ballast Water Legisla- tion. Ann Arbor, MI: Great Lakes Commission. Hallegraeff, G. M. 2001. Is a 99% Effective Ballast Water Treatment Sufficient? In: 1st International Ballast Water Treatment Standards Workshop Report. GloBallast Pro- gramme, 2001. Australia: University of Tasmania.

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54    Propagule Pressure and Invasion Risk in Ballast Water    International Joint Commission. 1990. Exotic Species and the Shipping Industry: The Great Lakes/St. Lawrence Ecosystem at Risk: a special report to the governments of the United States and Canada by the International Joint Commission and the Great Lakes Fishery Commission. Lawrence, J. E. 2008. Furtive foes: algal viruses as potential invaders. ICES J. Mar. Sci. 65:716–722. Marine Environment Protection Committee (MEPC). 2001. 47/2/11. Harmful Aquatic Organisms in Ballast Water. Investigation carried out in selected ports in Brazil to identify and characterize pathogens in ballast water. Available online at: https://www.ccaimo.mar.mil.br/sites/default/files/MEPC_47-2-11.pdf. Last accessed June 2, 2011. NRC (National Research Council). 1996. Stemming the Tide: Controlling Introductions of Nonindigenous Species by Ships’ Ballast Water. Washington, DC: National Academy Press. Parsons, M. G., and R. W. Harkins. 2000. The Great Lakes ballast technology demon- stration project filtration mechanical test program. Marine Technology and SNAME News 37:129–140. Parsons, M. G., and R. W. Harkins. 2002. Full-scale Particle Removal Performance of Three Types of Mechanical Separation Devices for the Primary Treatment of Ballast Water. Marine Technology 39(4):211–222. Patel, A., R. T. Noble, J. A. Steele, M. S. Schwalbach, I. Hewson, and J. A. Fuhrman. 2007. Virus and prokaryote enumeration from planktonic aquatic environments by epifluorescence microscopy with SYBR Green I. Nature Protocols 2:269–276. Reid, D. F., T. H. Johengen, H. MacIsaac, F. Dobbs, M. Doblin, L. Drake, G. Ruiz, and P. Jenkins. 2007. Identifying, verifying, and establishing options for best manage- ment practices for NOBOB vessels. Report to the Great Lakes Protection Fund. Availble online at: http://www.glerl.noaa.gov/res/Task_rpts/2004/aisreid04-1.html. Last accessed June 2, 2011. Rigby, G., G. Hallegraeff, and C. Sutton. 1997. Ballast Water Heating and Sampling Trials on the BHP Ship MV Iron Whyalla in Port Kembla and en-route to Port Headland. Herausgeber AQIS. Archiv UTas eCite RODA Server (University of Tasmania Research Output Digital Asset Repository). Available online at: http://ecite.utas.edu.au/10654. Last accessed June 1, 2011. Suttle, C.A. 2005. Viruses in the sea. Nature 437:356–361. USCG (U.S. Coast Guard). 2001. Report to Congress on the Voluntary National Guide- lines for Ballast Water Management, November 2001. USCG. 2008. Ballast Water Discharge Standard. Draft Programmatic Environmental Impact Statement. April 2008. USCG Research and Development Center. 2008. Analysis of Ballast Water Sampling Port Designs Using Computational Fluid Dynamics. CG-D01-08. Waite, T., and J. Kazumi. 2001. Possible Ballast Water Treatment Standards: An Engi- neering Perspective. In: 1st International Ballast Water Treatment Standards Work- shop Report. GloBallast Programme, 2001. Available online at: http://globallast. imo.org/monograph%204%20standards%20workshop.pdf. Last accessed June 2, 2011.