94-5298. Lead Fishing Sinkers; Response to Citizens' Petition and Proposed Ban; Proposed Rule -  

  • [Federal Register Volume 59, Number 46 (Wednesday, March 9, 1994)]
    [Unknown Section]
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    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 94-5298]
    
    
    [[Page Unknown]]
    
    [Federal Register: March 9, 1994]
    
    
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    Part III
    
    
    
    
    
    Environmental Protection Agency
    
    
    
    
    
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    40 CFR Part 745
    
    
    
    
    Lead Fishing Sinkers; Response to Citizens' Petition and Proposed Ban; 
    Proposed Rule
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    ENVIRONMENTAL PROTECTION AGENCY
    40 CFR Part 745
    [OPPTS-62134; FRL-4643-3]
    RIN 2070-AC21
     
    Lead Fishing Sinkers; Response to Citizens' Petition and Proposed 
    Ban
    
    AGENCY: Environmental Protection Agency (EPA).
    ACTION: Proposed rule.
    
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    SUMMARY: On October 20, 1992, the Environmental Defense Fund (EDF), 
    Federation of Fly Fishers, Trumpeter Swan Society, and North American 
    Loon Fund petitioned EPA under section 21 of the Toxic Substances 
    Control Act (TSCA), and the Administrative Procedure Act (APA), to 
    initiate rulemaking proceedings under section 6 of TSCA to require that 
    the sale of lead fishing sinkers be accompanied by an appropriate label 
    or notice warning that such products are toxic to wildlife. EPA granted 
    the petition; however, the Agency believes that a labeling provision 
    would not adequately address the risk of injury to waterfowl and other 
    birds (waterbirds), from ingestion of lead fishing sinkers. In 
    addition, EPA also believes that zinc fishing sinkers adversely affect 
    waterbirds, and can cause mortality. Therefore, EPA is proposing this 
    rule under section 6(a) of TSCA to prohibit the manufacturing, 
    processing, and distribution in commerce in the United States, of 
    certain smaller size fishing sinkers containing lead and zinc, and 
    mixed with other substances, including those made of brass. The Agency 
    also requests that persons with information relevant to the issues 
    outlined in this document submit that information to EPA.
    DATES: Written comments in response to this proposed rule must be 
    received by May 9, 1994. If persons request time for oral comment, EPA 
    will hold an informal hearing in Washington, DC. The exact date, time, 
    and location of the hearing, if held, will be announced in the Federal 
    Register. For further information regarding the hearing, see Unit XV. 
    of this preamble.
    ADDRESSES: Comments should be submitted in triplicate to: TSCA Docket 
    Receipt (7407), Office of Pollution Prevention and Toxics, 
    Environmental Protection Agency, Rm. E-G99, 401 M St., SW., Washington, 
    DC 20460, Attention: Docket No. 62134. For information regarding the 
    submission of comments containing information claimed as confidential 
    business information (CBI), see Unit XIV. of this preamble.
    
    FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, 
    Environmental Assistance Division (7408), Office of Pollution 
    Prevention and Toxics, Rm. E-545, 401 M St., SW., Washington, DC 20460, 
    Telephone: (202) 554-1404, TDD: 202-554-0551.
    
    SUPPLEMENTARY INFORMATION:
    
    I. Authority
    
        If EPA determines that there is a reasonable basis to conclude that 
    the manufacture, processing, distribution in commerce, use, or disposal 
    of a chemical substance or mixture of chemical substances, or that any 
    combination of such activities, presents or will present an 
    unreasonable risk of injury to human health or the environment, section 
    6(a) of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2605(a), 
    authorizes EPA to apply one or more of the following requirements to 
    such substance or mixture to the extent necessary to protect against 
    the risk: (1) Prohibit or limit the amount of a chemical substance or 
    mixture manufactured, processed, or distributed in commerce; (2) 
    prohibit or limit the amount of chemical substance or mixture 
    manufactured, processed, or distributed in commerce for particular uses 
    or at particular concentration levels; (3) require labeling or warning 
    rules; (4) require manufacturers and processors to make and retain 
    records of the process used to manufacture or process a chemical 
    substance or mixture, and to conduct tests to monitor compliance with 
    regulatory requirements; (5) prohibit or otherwise regulate any manner 
    or method of commercial use; (6) prohibit or otherwise regulate any 
    manner or method of disposal of such substance or mixture or articles 
    containing such substance or mixture; (7) require that manufacturers 
    notify the public of unreasonable risk associated with a chemical 
    substance or mixture, and to replace or repurchase the product. Section 
    6 of TSCA requires EPA to apply the least burdensome requirements to 
    protect adequately against the risk. Section 6(a)(2)(A) of TSCA, 
    prohibiting the manufacturing, processing, or distribution in commerce 
    of a chemical substance or mixture for a particular use or at a 
    particular concentration level, provides EPA the authority to issue 
    this proposed rule. Section 8(a)(1) of TSCA gives EPA authority to 
    require persons who manufacture or process chemical substances and 
    mixtures to maintain records for manufacturing purposes, including 
    records necessary for effective enforcement of TSCA requirements.
        Section 12(a) of TSCA exempts from regulation under the Act any 
    chemical substance, mixture, or article containing a chemical substance 
    or mixture that is manufactured, processed, or distributed in commerce 
    solely for export and bears or is enclosed in a container bearing a 
    stamp or label stating that is intended for export. However, this 
    exemption does not apply to any of the situations enumerated in TSCA 
    section 12(b), nor to any recordkeeping requirements promulgated 
    pursuant to TSCA section 8.
        Section 12(b) of TSCA requires that any person who exports or 
    intends to export a chemical substance or mixture for which a rule has 
    been proposed or promulgated under section 6 must notify EPA of such 
    exportation or intent to export.
    
    II. Background
    
    A. TSCA Section 21
    
        Any person may petition EPA under section 21(a) of TSCA to initiate 
    proceedings for the issuance, amendment, or repeal of a rule or order 
    under section 4, 5, 6, or 8 of TSCA. As required by section 21(b), the 
    petition must set forth the facts which the petitioner claims establish 
    that it is necessary for the Agency to issue, amend, or repeal a rule 
    or order under those sections of TSCA. Section 21(b) also directs EPA 
    to decide either to grant or deny the petition within 90 days after a 
    petition is filed. If EPA denies a petition, the Agency must publish 
    the reasons for the denial in the Federal Register. If the Agency 
    grants the petition, EPA must promptly commence an appropriate 
    proceeding in accordance with section 4, 5, 6, or 8 of TSCA.
    
    B. Petition Claims and Request
    
        EPA received a petition under TSCA section 21 and the APA on 
    October 20, 1992, from the EDF, Federation of Fly Fishers, Trumpeter 
    Swan Society, and North American Loon Fund requesting EPA to initiate 
    rulemaking proceedings under section 6 of TSCA to require that the sale 
    of lead fishing sinkers be accompanied by an appropriate label or 
    notice warning that such products are toxic to wildlife (Ref. 5). The 
    petition claims that trumpeter swans and common loons are dying from 
    ingestion of lead fishing sinkers. The petition did not specify the 
    particular type, shape, or size of lead fishing sinkers that are the 
    source of the problem, therefore requiring a label or warning notice. 
    The petitioners also submitted a letter to the Agency on December 10, 
    1992, which reported that a Mississippi Sandhill Crane was discovered 
    dead on the Mississippi Sandhill Crane National Wildlife Refuge in 
    1992, and a flat, well-worn object was recovered from its gizzard (Ref. 
    6). The letter also stated that a necropsy of the bird revealed a lead 
    concentration of 69 parts per million (ppm) (wet weight) in the liver, 
    and in response to an inquiry to the Fish and Wildlife Service (FWS) 
    about the nature of that object, EDF was advised that it was a lead 
    fishing sinker (Ref. 6).
    
    C. Summary of Studies Cited in Petition
    
        The petition cited a number of studies which reported mortality in 
    trumpeter swans, mute swans, and common loons due to ingestion of lead 
    fishing sinkers. The petitioners also cited a recent bulletin from the 
    FWS reporting that an immature Mississippi sandhill crane died from 
    lead poisoning (Ref. 19).
        1. Common loons (Gavia immer). A 2.5 year study of mortalities of 
    common loons in New England found that lead toxicity from ingested 
    fishing sinkers was the most common cause of death in adult breeding 
    birds (Ref. 13). The study reported that 64 percent of adult common 
    loons (Gavia immer) received for analysis from New Hampshire, and 44 
    percent of adults received from Maine, had ingested fishing sinkers. 
    Thirty-one adults were examined, and of these, 16 (52 percent) were 
    shown to have died from lead poisoning. The authors of the study 
    concluded that due to adverse effects on breeding adults, lead 
    poisoning may be an important factor in limiting loon populations in 
    some areas.
        Levels of lead found in the blood of loons that had ingested 
    sinkers averaged 1.4 ppm. The study indicated that scientists consider 
    0.35 to 0.60 ppm lead in the blood to be indicative of lead poisoning 
    in many species. Levels of lead in the livers of 4 loons that had lead 
    sinkers in their gizzards ranged from 5.03 to 18.0 ppm, while levels in 
    10 loons that did not have fishing sinkers in their gizzards ranged 
    from <0.05 to="" 0.11="" ppm.="" the="" study="" also="" states="" that="" 5="" or="" 6="" ppm="" in="" the="" liver="" is="" considered="" a="" toxic="" level="" in="" waterbirds.="" toxic="" effects="" of="" lead="" to="" loons="" were="" found="" to="" be="" similar="" to="" those="" seen="" in="" other="" waterbirds.="" lead="" poisoning="" was="" diagnosed="" as="" the="" cause="" of="" death="" in="" 7.3="" percent="" of="" common="" loons="" necropsied="" (total="" of="" 7="" adult="" loons)="" in="" a="" minnesota="" study="" (ref.="" 4).="" five="" of="" the="" seven="" lead="" poisoned="" birds="" contained="" lead="" sinkers.="" lead="" concentrations="" in="" the="" liver="" of="" the="" loons="" ranged="" from="" 7.12="" to="" 35="" ppm,="" wet="" weight.="" although="" the="" incidence="" of="" lead="" sinkers="" was="" low="" in="" all="" necropsied="" birds,="" it="" is="" relatively="" high="" in="" relation="" to="" those="" birds="" found="" to="" have="" died="" from="" lead="" poisoning.="" in="" addition,="" only="" those="" birds="" whose="" body="" condition="" during="" necropsy="" indicated="" potential="" lead="" poisoning="" were="" actually="" analyzed="" for="" lead.="" therefore,="" the="" incidence="" of="" lead="" poisoning="" in="" the="" study="" could="" be="" an="" underestimate="" of="" the="" actual="" number="" of="" loons="" exposed="" to="" lead="" sinkers="" and="" suffering="" from="" lead="" poisoning="" in="" minnesota.="" the="" petitioners="" also="" cited="" a="" case="" report="" involving="" three="" common="" loons="" found="" dead="" in="" new="" hampshire,="" wisconsin,="" and="" maine="" that="" were="" submitted="" to="" a="" wildlife="" health="" laboratory="" for="" necropsy="" (ref.="" 12).="" two="" adult="" loons="" died="" of="" lead="" poisoning="" (lead="" liver="" levels="" were="" 20.6="" ppm="" and="" 46.1="" ppm),="" and="" a="" lead="" fishing="" sinker="" was="" found="" in="" each="" bird.="" one="" of="" these="" loons="" had="" ingested="" an="" oval="" shaped="" lead="" fishing="" sinker="" which="" measured="" 5="" mm="" by="" 4="" mm="" (or="" roughly="" 1/5="" inch)="" in="" size.="" the="" third="" loon="" had="" a="" lead="" liver="" level="" of="" 38.52="" ppm="" and="" three="" fragments="" of="" a="" fishing="" line="" were="" found="" in="" the="" loon's="" stomach.="" results="" from="" necropsies="" conducted="" on="" 222="" common="" loon="" carcasses="" from="" 18="" states="" submitted="" to="" the="" national="" wildlife="" health="" research="" center="" from="" 1975="" through="" 1991="" were="" also="" cited="" in="" the="" petition="" received="" by="" epa="" (ref.="" 10).="" lead="" poisoning="" was="" responsible="" for="" 14="" (6="" percent)="" common="" loon="" deaths.="" eleven="" of="" these="" birds="" had="" fishing="" sinkers="" in="" their="" gizzards="" (ref.="" 17).="" post="" mortem="" examinations,="" or="" necropsies="" performed="" on="" the="" loons="" that="" died="" from="" lead="" poisoning="" indicated="" that="" although="" the="" lead="" sinkers="" differed="" in="" shape="" and="" length,="" the="" largest="" reported="" diameter="" was="" 7="" mm,="" or="" approximately="" 1/4="" inch="" (ref.="" 17).="" these="" data="" also="" revealed="" that="" two="" common="" loons="" ingested="" what="" appeared="" to="" be="" lead="" jigs="" (weighted="" hooks="" used="" for="" fishing).="" while="" not="" listed="" as="" a="" threatened="" or="" endangered="" species="" under="" the="" federal="" endangered="" species="" act="" (esa),="" 16="" u.s.c.="" 1531,="" common="" loons="" are="" listed="" as="" an="" endangered="" or="" threatened="" species="" in="" some="" new="" england="" states="" (ref.="" 5).="" 2.="" trumpeter="" swans="" (cygnus="" buccinator).="" mortality="" due="" to="" lead="" poisoning="" was="" investigated="" for="" 72="" trumpeter="" swans="" found="" dead="" in="" 7="" western="" states="" (ref.="" 2).="" ingestion="" of="" lead="" pellets="" or="" fishing="" sinkers="" accounted="" for="" approximately="" 20="" percent="" of="" the="" known="" deaths="" in="" idaho,="" montana,="" and="" wyoming,="" and="" nearly="" 50="" percent="" in="" western="" washington.="" the="" maximum="" lead="" concentration="" in="" livers="" of="" swans="" found="" dead="" was="" 37="" ppm="" (wet="" weight).="" concentrations="" of="" 3="" to="" 4="" ppm="" expressed="" as="" wet="" weight="" in="" livers="" was="" considered="" by="" various="" researchers="" to="" be="" toxic="" to="" birds.="" four="" swans="" were="" diagnosed="" to="" have="" signs="" of="" lead="" poisoning="" due="" to="" ingestion="" of="" fishing="" weights.="" the="" four="" birds="" ingested="" a="" total="" of="" eight="" lead="" fishing="" sinkers.="" the="" study="" postulated="" that="" trumpeter="" swans="" are="" particularly="" susceptible="" to="" lead="" poisoning="" because="" they="" feed="" by="" digging="" up="" large="" amounts="" of="" bottom="" sediments="" of="" streams="" and="" lakes,="" and="" ingesting="" large="" amounts="" of="" plant="" material="" in="" this="" manner.="" 3.="" mute="" swans="" (cygnus="" olor).="" two="" studies="" were="" cited="" that="" examine="" mortality="" in="" mute="" swans,="" a="" species="" introduced="" into="" the="" unites="" states="" that="" is="" similar="" to="" trumpeter="" swans.="" in="" the="" first="" study,="" lead="" fishing="" weights="" were="" found="" (an="" average="" of="" 11="" per="" bird,="" one="" bird="" contained="" 43)="" in="" the="" gizzards="" of="" 16="" out="" of="" 18="" (88="" percent)="" mute="" swans="" found="" dead="" or="" dying="" along="" the="" trent="" river="" in="" england="" (ref.="" 16).="" the="" mean="" concentration="" of="" lead="" in="" the="" kidney="" of="" these="" swans="" was="" 1,734="" ppm="" dry="" weight.="" the="" area="" along="" the="" river="" where="" they="" fed="" was="" heavily="" contaminated="" with="" lead="" fishing="" split="" shot.="" mute="" swans="" were="" also="" examined="" along="" the="" thames="" river="" in="" another="" study="" (ref.="" 1).="" out="" of="" 94="" dead="" swans="" examined,="" 57="" percent,="" or="" 53="" were="" shown="" to="" have="" died="" from="" ingesting="" fishing="" weights.="" the="" average="" number="" of="" lead="" sinkers="" found="" in="" the="" gizzards="" of="" these="" swans="" was="" seven.="" the="" median="" lead="" level="" in="" the="" liver="" of="" these="" swans="" was="" 105="" ppm="" dry="" weight="" and="" 908="" ppm="" dry="" weight="" in="" the="" kidney.="" 4.="" mississippi="" sandhill="" crane="" (grus="" canadensis="" pulla).="" the="" petitioners="" also="" submitted="" a="" fws="" technical="" bulletin="" which="" reported="" that="" a="" mississippi="" sandhill="" crane,="" a="" federally="" endangered="" species,="" was="" found="" dead="" on="" the="" mississippi="" sandhill="" crane="" national="" wildlife="" refuge="" in="" 1992="" due="" to="" lead="" poisoning="" (ref.="" 19).="" the="" lead="" concentration="" in="" the="" crane's="" liver="" was="" 69.41="" ppm="" wet="" weight="" (ref.="" 18).="" the="" object="" found="" in="" the="" gizzard="" resembled="" lead,="" was="" triangular="" in="" shape="" although="" flattened,="" and="" approximately="" 8="" by="" 10="" mm,="" or="" approximately="" 1/2="" inch="" in="" size="" (ref.="" 18).="" although="" a="" definitive="" identification="" of="" the="" object="" was="" not="" made,="" based="" on="" the="" size="" and="" shape="" of="" the="" object,="" the="" bird="" may="" have="" ingested="" a="" lead="" fishing="" sinker.="" d.="" summary="" of="" epa="" response="" to="" petition="" and="" edf="" lawsuit="" epa="" granted="" the="" petition="" on="" january="" 14,="" 1993="" (ref.="" 22).="" after="" reviewing="" the="" petition,="" the="" accompanying="" studies,="" and="" other="" information="" gathered="" by="" epa,="" the="" agency="" preliminarily="" determined="" that="" certain="" lead="" fishing="" sinkers="" present="" an="" unreasonable="" risk="" of="" injury="" to="" waterbirds,="" and="" that="" rulemaking="" under="" section="" 6(a)="" of="" tsca="" to="" ban="" the="" manufacture,="" processing,="" and="" distribution="" in="" commerce="" of="" certain="" lead="" sinkers="" would="" be="" necessary="" to="" protect="" against="" that="" risk.="" epa="" informed="" edf="" by="" letter="" on="" march="" 11,="" 1993,="" that="" it="" was="" planning="" to="" issue="" a="" proposed="" rule="" to="" address="" these="" concerns="" (ref.="" 23).="" despite="" epa's="" expressed="" intent="" to="" issue="" a="" proposed="" rule="" to="" address="" the="" risks="" posed="" by="" certain="" lead="" fishing="" sinkers,="" including="" regulatory="" options="" more="" stringent="" than="" the="" labeling="" requested="" in="" the="" petition,="" edf="" sued="" epa="" on="" march="" 15,="" 1993,="" in="" the="" u.s.="" district="" court="" for="" the="" district="" of="" columbia,="" alleging="" epa's="" failure="" to="" promptly="" publish="" a="" notice="" of="" proposed="" rulemaking="" under="" section="" 6="" of="" tsca="" (ref.="" 8).="" epa="" subsequently="" informed="" edf="" that,="" as="" an="" outgrowth="" of="" developing="" the="" proposed="" rule,="" epa's="" preliminary="" analysis="" indicated="" that="" not="" only="" were="" lead="" fishing="" sinkers="" toxic="" to="" waterbirds,="" but="" that="" sinkers="" made="" of="" some="" other="" materials="" likely="" to="" be="" used="" as="" substitutes="" for="" lead="" in="" sinkers="" might="" also="" present="" unreasonable="" risks="" to="" waterbirds="" (ref.="" 24).="" epa="" also="" indicated="" that="" to="" analyze="" these="" other="" risks="" adequately,="" the="" schedule="" for="" proposal="" would="" be="" delayed="" until="" january="" 1994.="" based="" on="" epa's="" commitment="" to="" utilize="" its="" best="" efforts="" to="" issue="" a="" proposed="" rule="" by="" january="" 14,="" 1994,="" to="" ban="" lead="" in="" certain="" fishing="" sinkers,="" epa="" and="" edf="" filed="" a="" joint="" motion="" for="" continuance="" with="" the="" u.s.="" district="" court,="" requesting="" suspension="" of="" all="" legal="" proceedings="" until="" late="" january="" 1994="" (ref.="" 9).="" the="" court="" granted="" this="" motion="" and="" ordered="" the="" parties="" to="" submit="" a="" joint="" status="" report="" to="" the="" court="" by="" january="" 21,="" 1994="" (ref.="" 20).="" in="" accordance="" with="" epa's="" regulations="" for="" issuing="" a="" regulation="" under="" section="" 6="" of="" tsca,="" 40="" cfr="" part="" 750,="" epa="" is="" now="" proposing="" this="" rule="" under="" section="" 6(a)="" of="" tsca="" to="" address="" unreasonable="" risk="" of="" injury="" to="" waterbirds="" (such="" as="" the="" trumpeter="" swan,="" common="" loon,="" and="" sandhill="" crane).="" this="" rule="" as="" proposed="" would="" prohibit="" the="" manufacture="" (including="" import),="" processing,="" and="" distribution="" in="" commerce="" of="" certain="" size="" lead-="" and="" zinc-containing="" fishing="" sinkers="" for="" use="" in="" the="" united="" states.="" the="" manufacture,="" processing,="" and="" distribution="" in="" commerce="" of="" these="" lead-="" and="" zinc-containing="" fishing="" sinkers="" solely="" for="" export="" would="" not="" be="" prohibited.="" in="" granting="" the="" petition,="" epa="" agreed="" to="" examine="" the="" appropriateness="" and="" feasibility="" of="" a="" tsca="" section="" 6(a)(3)="" labeling="" requirement="" requested="" by="" the="" petitioners.="" however,="" epa="" believes="" that="" a="" labeling="" provision="" would="" not="" adequately="" reduce="" the="" unreasonable="" risk="" of="" injury="" from="" lead-="" and="" zinc-containing="" fishing="" sinkers="" to="" waterbirds.="" epa="" believes="" that="" a="" label="" would="" not="" result="" in="" a="" sufficient="" decline="" in="" consumer="" purchases="" of="" lead-="" or="" zinc-containing="" fishing="" sinkers="" such="" that="" waterbirds="" would="" be="" adequately="" protected.="" epa="" also="" believes="" that="" since="" fishing="" sinkers="" typically="" become="" deposited="" in="" the="" environment="" accidentally,="" (i.e.,="" even="" when="" carefully="" handling="" or="" using="" fishing="" sinkers,="" they="" may="" be="" accidentally="" lost="" or="" discarded="" into="" the="" environment),="" labels="" would="" have="" little="" affect="" on="" how="" sinkers="" are="" used="" in="" practice="" and="" would="" not="" significantly="" affect="" the="" environmental="" risks="" of="" using="" sinkers.="" epa="" also="" considered="" a="" number="" of="" other="" regulatory="" options,="" however,="" the="" agency="" does="" not="" believe="" those="" options="" would="" adequately="" reduce="" the="" unreasonable="" risk="" of="" injury="" to="" waterbirds.="" a="" further="" discussion="" of="" all="" options="" considered,="" including="" epa's="" determination="" why="" labeling="" would="" be="" minimally="" effective="" in="" this="" case,="" can="" be="" found="" in="" unit="" vi.="" of="" this="" preamble.="" if="" epa="" finds="" that="" a="" final="" tsca="" section="" 6="" rule="" is="" warranted="" after="" evaluation="" of="" the="" public="" comments="" received,="" the="" agency="" will="" use="" its="" best="" effort="" to="" promulgate="" such="" a="" regulation="" within="" 3="" years="" of="" this="" proposed="" rule.="" e.="" summary="" of="" epa's="" analysis="" and="" proposed="" rule="" epa="" based="" this="" proposed="" regulatory="" action="" on="" a="" number="" of="" factors="" such="" as="" the="" scientific="" evidence="" regarding="" the="" toxicity="" of="" lead="" and="" zinc,="" exposure="" to="" fishing="" sinkers,="" the="" economic="" consequences="" of="" the="" rule="" as="" proposed,="" and="" availability="" of="" substitutes.="" these="" factors="" are="" discussed="" further="" in="" units="" iii.,="" iv.,="" and="" v.="" of="" this="" preamble.="" extremely="" low="" amounts="" of="" lead="" and="" zinc="" adversely="" affect="" waterbirds.="" lead="" causes="" damage="" to="" the="" liver,="" kidney="" and="" central="" nervous="" system,="" and="" adversely="" affects="" reproduction="" and="" growth="" in="" waterbirds.="" zinc="" is="" also="" toxic="" to="" waterbirds="" and="" can="" damage="" the="" central="" nervous="" system.="" studies="" have="" shown="" that="" exposure="" to="" both="" lead="" and="" zinc="" can="" cause="" death="" in="" waterbirds.="" ingestion="" of="" a="" small="" sinker="" can="" result="" in="" the="" death="" of="" a="" waterbird.="" various="" species="" have="" died="" from="" ingestion="" of="" lead="" fishing="" sinkers="" such="" as="" sandhill="" cranes,="" trumpeter,="" mute,="" and="" tundra="" swans,="" and="" common="" loons="" found="" in="" different="" areas="" of="" the="" united="" states.="" waterbirds="" may="" ingest="" fishing="" sinkers="" for="" a="" number="" of="" reasons.="" small="" sinkers="" (1="" inch="" and="" under)="" may="" appear="" most="" like="" pieces="" of="" grit="" necessary="" to="" break="" down="" food,="" or="" as="" food="" items="" such="" as="" seeds="" which="" waterbirds="" ingest.="" waterbirds="" such="" as="" swans="" may="" ingest="" sinkers="" as="" they="" sift="" through="" sediments,="" and="" loons="" may="" ingest="" sinkers="" when="" eating="" fish="" with="" attached="" fishing="" tackle,="" or="" pick="" up="" sinkers="" from="" the="" bottom="" of="" waterbodies.="" lead="" fishing="" sinkers="" up="" to="" and="" including="" 1="" inch="" have="" been="" found="" in="" the="" gizzards,="" or="" digestive="" tracts="" of="" waterbirds.="" studies="" have="" reported="" cases="" of="" sinkers="" ingestion="" in="" birds="" found="" in="" different="" parts="" of="" the="" united="" states.="" epa="" does="" not="" believe="" that="" the="" use="" of="" lead-="" and="" zinc-containing="" sinkers="" is="" essential.="" several="" available="" or="" commercially="" viable="" substitutes="" for="" lead="" and="" zinc="" sinkers="" exist="" which="" are="" less="" toxic="" to="" waterbirds="" (e.g.,="" bismuth,="" tin,="" antimony,="" steel,="" and="" tungsten).="" the="" economic="" impact="" (purchase="" price="" of="" sinkers)="" of="" the="" proposed="" regulation="" on="" consumers="" is="" estimated="" to="" be="" less="" than="" $4.00="" for="" the="" average="" angler="" per="" year.="" this="" is="" minimal="" in="" comparison="" to="" other="" fishing="" expenditures="" such="" as="" rods,="" reels,="" licenses,="" etc.="" the="" benefit="" of="" the="" proposed="" rule="" is="" measured="" in="" terms="" of="" number="" of="" sinkers="" removed="" from="" the="" market="" or="" reduced="" for="" exposure="" to="" waterbirds.="" each="" sinker="" which="" does="" not="" enter="" the="" environment="" reduces="" the="" number="" of="" sinkers="" available="" for="" ingestion="" and="" potential="" waterbird="" mortality="" or="" death.="" the="" rule="" as="" proposed="" would="" prevent="" an="" estimated="" 450="" million="" lead-="" and="" zinc-containing="" fishing="" sinkers="" from="" being="" produced="" each="" year,="" and="" potentially="" from="" entering="" the="" environment.="" not="" only="" would="" the="" proposed="" rule="" serve="" to="" reduce="" risks="" posed="" to="" waterbirds,="" but="" it="" would="" also="" assist="" in="" reducing="" human="" health="" risk="" to="" home="" manufacturers="" of="" lead="" fishing="" sinkers.="" while="" epa="" has="" not="" analyzed="" the="" risks="" to="" human="" health="" due="" to="" the="" manufacture="" of="" lead="" fishing="" sinkers="" at="" home,="" the="" health="" effects="" of="" lead="" are="" well="" documented.="" lead="" can="" cause="" learning="" disabilities="" in="" children,="" miscarriages,="" and="" may="" contribute="" to="" hypertension="" or="" high="" blood="" pressure.="" persons="" who="" make="" lead="" sinkers="" at="" home="" may="" receive="" harmful="" exposures="" during="" the="" melting="" and="" pouring="" of="" lead="" through="" the="" inhalation="" of="" dust="" or="" vapors.="" iii.="" regulatory="" assessment="" a.="" lead="" lead="" is="" a="" soft,="" bluish="" metallic="" element="" mined="" from="" rock="" and="" found="" naturally="" all="" over="" the="" world.="" its="" malleability,="" low="" melting="" point,="" ease="" of="" processing,="" abundance,="" low="" cost,="" density,="" and="" durability="" give="" lead="" good="" functional="" value.="" accordingly,="" it="" has="" been="" used="" to="" manufacture,="" or="" as="" an="" ingredient="" in="" many="" different="" products="" including="" paint,="" gasoline,="" batteries,="" solder,="" and="" radiation="" shielding.="" lead="" affects="" nearly="" every="" system="" of="" the="" human="" body.="" while="" it="" is="" harmful="" to="" individuals="" of="" all="" ages,="" lead="" exposure="" is="" especially="" detrimental="" to="" children,="" fetuses,="" and="" women="" of="" childbearing="" age.="" lead="" enters="" the="" bloodstream="" and="" may="" cause="" lead="" poisoning,="" a="" disease="" which="" can="" cause="" learning="" disabilities,="" interfere="" with="" growth,="" cause="" permanent="" hearing="" and="" visual="" impairment,="" and="" cause="" other="" damage="" to="" the="" brain="" and="" nervous="" system="" in="" children.="" in="" large="" doses,="" lead="" can="" cause="" blindness,="" brain="" damage,="" convulsions,="" and="" even="" death.="" lead="" exposure="" before="" or="" during="" pregnancy="" can="" affect="" fetal="" development="" and="" can="" cause="" miscarriages.="" in="" adult="" males,="" lead="" exposure="" may="" contribute="" to="" hypertension="" and="" infertility.="" both="" adults="" and="" children="" can="" receive="" harmful="" exposures="" to="" lead="" by="" inhaling="" the="" fine="" dust="" or="" vapors="" produced="" when="" sinkers="" are="" made="" at="" home.="" as="" indicated="" in="" unit="" ii.="" of="" this="" preamble,="" lead="" exposure="" may="" produce="" harmful="" effects="" and="" even="" death="" in="" wildlife="" as="" well.="" lead="" adversely="" affects="" the="" function="" and="" structure="" of="" the="" kidney,="" central="" nervous="" system,="" bones,="" and="" production="" and="" development="" of="" blood="" cells="" in="" waterbirds.="" exposure="" to="" lead="" can="" cause="" lead="" poisoning="" in="" waterbirds,="" producing="" convulsions,="" coma,="" and="" death.="" waterbirds="" may="" be="" directly="" exposed="" to="" lead="" through="" ingestion="" of="" lead="" fishing="" sinkers.="" b.="" use,="" production,="" and="" distribution="" of="" lead="" sinkers="" lead="" is="" also="" used="" to="" manufacture="" fishing="" sinkers.="" sinkers="" are="" used="" to="" assist="" in="" casting,="" and="" to="" carry="" the="" fishing="" line="" with="" attached="" lures="" and="" hooks="" to="" a="" certain="" depth="" in="" the="" water.="" there="" are="" no="" universal="" sizes="" or="" shapes="" of="" lead="" fishing="" sinkers="" due="" to="" differences="" in="" the="" type="" of="" fish="" being="" sought,="" the="" equipment="" being="" used,="" and="" the="" environmental="" conditions.="" however,="" all="" sinkers="" are="" attached="" in="" some="" manner="" to="" the="" fishing="" line,="" and="" provide="" weight="" so="" that="" the="" hook,="" bait,="" or="" lure="" is="" below="" the="" surface="" of="" the="" water.="" the="" sinkers="" which="" may="" be="" lost="" or="" discarded="" in="" aquatic="" (freshwater)="" or="" terrestrial="" habitats="" vary="" in="" shape="" and="" range="" in="" weight="" from="" 1/100="" of="" an="" ounce,="" to="" 8="" ounces,="" and="" in="" size="" from="" under="" 1/16="" inch="" up="" to="" 3="" inches.="" they="" may="" be="" round="" split="" shot,="" or="" triangular,="" egg,="" cone,="" tear-drop,="" or="" elongated="" oval="" shapes.="" the="" agency's="" examination="" focused="" on="" the="" types="" of="" sinkers="" used="" for="" freshwater="" fishing,="" which="" include:="" (1)="" split="" shot,="" (2)="" worm="" weights,="" (3)="" egg="" sinkers,="" (4)="" bass="" casting,="" (5)="" pyramid="" sinkers,="" (6)="" rubber="" core,="" (7)="" pinch="" grip,="" and="" (8)="" slip="" shot.="" epa's="" evaluation="" also="" focused="" on="" sinkers="" under="" 2="" inches="" in="" length="" or="" width="" regardless="" of="" weight.="" this="" size="" was="" chosen="" because="" the="" agency="" believes="" this="" size="" sinker="" would="" be="" the="" largest="" readily="" ingested="" by="" waterbirds,="" and="" commonly="" available="" in="" the="" environment.="" it="" is="" estimated="" that="" approximately="" 2,500="" metric="" tons="" of="" lead,="" zinc,="" and="" brass="" sinkers="" (over="" 98="" percent="" of="" the="" volume="" represented="" by="" lead),="" an="" estimated="" 480="" million="" sinkers,="" are="" manufactured="" each="" year="" in="" the="" united="" states="" (support="" document="" 2).="" split="" shot="" sinkers,="" a="" round="" sinker="" with="" a="" slice="" through="" a="" small="" portion="" of="" it,="" are="" estimated="" to="" account="" for="" almost="" half="" of="" the="" total="" lead="" sinker="" market="" in="" terms="" of="" numbers="" of="" sinkers.="" fishing="" line="" is="" placed="" into="" this="" sliced="" area="" and="" then="" the="" sinker="" is="" ``pinched''="" onto="" the="" line.="" the="" majority="" of="" lead="" sinkers="" produced="" are="" equal="" to="" or="" less="" than="" 1="" inch="" in="" any="" dimension.="" fewer="" than="" 10="" major="" manufacturing="" companies="" account="" for="" most="" of="" the="" domestic="" production="" of="" lead="" fishing="" sinkers.="" production="" by="" individuals="" at="" home="" (home="" manufacturers)="" is="" estimated="" to="" be="" substantial.="" home="" manufacturers="" buy="" lead="" ingots,="" which="" are="" available="" at="" retail="" stores="" or="" through="" catalogues,="" melt="" the="" lead,="" and="" then="" pour="" it="" into="" molds.="" home="" manufacturers="" either="" use="" these="" sinkers="" for="" their="" personal="" use,="" or="" they="" sell="" these="" lead="" sinkers="" within="" the="" local="" area="" to="" other="" persons,="" or="" retailers,="" such="" as="" fishing="" tackle="" stores="" (support="" document="" 2).="" home="" manufacture="" for="" sale="" is="" referred="" to="" as="" the="" ``cottage="" industry''="" in="" this="" proposed="" rule.="" the="" majority="" of="" home="" manufacturers="" produce="" non-split="" shot="" fishing="" sinkers.="" it="" is="" estimated="" that="" between="" .8="" and="" 1.6="" million="" anglers="" may="" produce="" their="" own="" lead="" sinkers.="" lead="" fishing="" sinkers="" are="" imported="" into="" the="" united="" states="" in="" small="" volumes.="" the="" amount="" of="" lead="" fishing="" sinkers="" exported="" each="" year="" is="" also="" minimal.="" lead="" fishing="" sinkers="" are="" distributed="" from="" manufacturing="" companies="" to="" large="" retail="" establishments="" directly,="" or="" are="" furnished="" to="" a="" distributor="" who="" then="" supplies="" sinkers="" to="" smaller="" retailers.="" distributors="" range="" from="" individuals="" to="" national="" distribution="" operations.="" a="" significant="" amount="" of="" lead="" fishing="" sinkers="" is="" also="" supplied="" directly="" to="" mail-order="" companies="" for="" purchase="" by="" individuals="" through="" a="" catalogue.="" it="" is="" estimated="" that="" there="" are="" currently="" 31="" million="" freshwater="" anglers="" nationwide.="" c.="" epa's="" concerns="" the="" studies="" cited="" by="" the="" petitioners="" are="" supported="" by="" other="" studies="" in="" showing="" that="" lead="" fishing="" sinkers="" have="" been="" ingested="" by="" a="" number="" of="" different="" species="" of="" waterbirds="" in="" various="" parts="" of="" the="" country,="" and="" have="" caused="" mortality="" of="" those="" birds.="" this="" is="" not="" a="" localized="" occurrence,="" nor="" has="" only="" one="" type="" of="" lead="" sinker="" been="" ingested.="" however,="" no="" matter="" the="" specific="" type="" of="" sinker,="" lead="" is="" toxic="" and="" produces="" adverse="" effects="" in="" avian="" species.="" epa="" recognizes="" that="" united="" states="" waterbird="" populations="" migrate="" to="" other="" countries="" and="" can="" potentially="" ingest="" fishing="" sinkers="" that="" are="" exported="" from="" the="" united="" states.="" although="" epa="" is="" concerned="" about="" adverse="" effects="" exported="" sinkers="" may="" have="" on="" migratory="" waterbirds,="" epa="" does="" not="" at="" this="" time="" have="" information="" indicating="" that="" use="" of="" exported="" fishing="" sinkers="" poses="" an="" unreasonable="" risk="" to="" waterbird="" populations="" in="" the="" united="" states.="" therefore,="" epa="" is="" not="" taking="" action="" at="" this="" time="" to="" prohibit="" the="" export="" of="" lead-="" or="" zinc-containing="" fishing="" sinkers.="" epa="" is="" required="" under="" tsca="" section="" 6="" to="" examine="" substitutes="" when="" exploring="" regulatory="" actions="" concerning="" chemical="" substances="" or="" mixtures.="" in="" the="" course="" of="" its="" analysis,="" the="" agency="" discovered="" that="" some="" substitute="" materials="" for="" lead="" fishing="" sinkers="" could="" also="" pose="" an="" unreasonable="" risk="" of="" injury="" to="" waterbirds.="" there="" is="" evidence="" that="" zinc,="" a="" material="" presently="" used="" in="" fishing="" sinkers,="" can="" cause="" waterbird="" mortality="" based="" on="" a="" study="" involving="" mallards="" (support="" document="" 1).="" brass="" contains="" a="" notable="" amount="" of="" lead="" and="" zinc="" (as="" much="" as="" 8="" and="" 20="" percent="" by="" weight="" respectively),="" as="" well="" as="" copper,="" aluminum,="" and="" antimony.="" due="" to="" the="" low="" concentrations="" at="" which="" lead="" and="" zinc="" produce="" toxic="" effects="" in="" waterbirds,="" epa="" believes="" that="" brass="" fishing="" sinkers="" could="" also="" present="" an="" unreasonable="" risk="" of="" injury="" to="" waterbirds.="" epa="" is="" concerned="" that="" unless="" the="" agency="" takes="" action="" to="" address="" these="" other="" fishing="" sinkers="" (e.g.,="" zinc="" and="" brass),="" the="" rule="" would="" not="" reduce="" risk="" sufficiently.="" therefore,="" the="" agency="" is="" proposing="" restrictions="" on="" all="" sinkers="" containing="" lead="" and="" zinc="" of="" a="" size="" that="" are="" ingestible="" by="" waterbirds,="" as="" a="" necessary="" measure="" to="" prevent="" future="" exposures="" and="" mortality="" to="" those="" species.="" epa="" is="" also="" concerned="" about="" potential="" human="" exposures="" resulting="" from="" the="" home="" manufacture="" of="" lead="" fishing="" sinkers.="" while="" the="" agency="" has="" not="" characterized="" or="" determined="" the="" extent="" of="" human="" exposure,="" epa="" is="" aware="" that="" individuals="" and="" their="" family="" members="" may="" be="" exposed="" to="" potentially="" harmful="" airborne="" lead="" particles="" or="" vapors="" while="" pouring="" lead="" into="" lead="" fishing="" sinker="" molds.="" as="" discussed="" previously="" in="" this="" unit,="" lead="" can="" cause="" learning="" disabilities,="" impaired="" hearing,="" and="" behavioral="" changes="" in="" children,="" and="" hypertension="" and="" miscarriages="" in="" adults.="" epa="" is="" concerned="" about="" exposures="" to="" lead,="" particularly="" lead="" poisoning="" in="" young="" children,="" and="" in="" conjunction="" with="" other="" federal="" agencies,="" has="" established="" a="" national="" lead="" information="" center.="" for="" more="" information,="" persons="" may="" call="" 1-800-leadfyi="" (532-3394).="" this="" proposed="" rule,="" if="" implemented,="" may="" also="" reduce="" potential="" human="" exposures.="" as="" proposed,="" epa's="" rule="" would="" prohibit="" the="" manufacture="" of="" lead="" fishing="" sinkers="" by="" persons="" at="" home="" (home="" manufacturers="" and="" the="" cottage="" industry).="" these="" parties="" are="" included="" in="" the="" provisions="" of="" the="" rule="" because="" of="" the="" potential="" for="" human="" exposure,="" and="" because="" epa="" believes="" that="" a="" lead="" sinker,="" whether="" manufactured="" at="" home="" or="" by="" a="" large="" manufacturer,="" presents="" unreasonable="" risks="" to="" waterbirds="" when="" discarded="" in="" the="" environment.="" the="" rule="" as="" proposed,="" would="" also="" prohibit="" the="" production="" of="" fishing="" sinkers="" by="" individuals="" who="" purchase="" lead="" shot="" (ammunition),="" and="" cut="" a="" groove="" in="" the="" shot="" creating="" a="" split="" shot="" fishing="" sinker.="" this="" activity="" would="" be="" considered="" processing="" for="" the="" purposes="" of="" the="" rule.="" d.="" hazard="" to="" waterbirds="" for="" more="" detailed="" discussion="" of="" the="" studies="" reviewed="" by="" epa="" and="" utilized="" in="" the="" discussion="" presented="" in="" units="" iii.d.="" and="" iii.e.="" of="" this="" preamble,="" see="" support="" document="" 1="" (``ecological="" hazard="" and="" exposure="" assessment="" of="" lead="" fishing="" weights="" to="" birds'').="" although="" zinc-="" containing="" and="" brass="" fishing="" sinkers="" are="" subject="" to="" the="" provisions="" of="" this="" proposed="" rule,="" they="" are="" presented="" here="" as="" substitutes="" for="" lead="" sinkers="" due="" to="" the="" manner="" in="" which="" epa="" conducted="" its="" analysis.="" epa's="" investigation="" examined="" the="" toxicity="" of="" substitutes="" and="" compared="" their="" toxicity="" to="" lead.="" those="" substitutes="" found="" to="" be="" toxic="" (i.e.,="" zinc="" and="" brass)="" are="" also="" subject="" to="" this="" proposed="" regulatory="" action.="" 1.="" summary.="" epa's="" evaluation="" primarily="" focused="" on="" routes="" of="" exposure="" involving="" direct="" ingestion="" of="" fishing="" sinkers="" by="" waterbirds,="" but="" also="" considered="" uptake="" (not="" ingestion)="" and="" toxicity="" of="" metals="" contained="" in="" fishing="" sinkers="" to="" birds="" and="" aquatic="" organisms="" in="" laboratory="" studies.="" epa="" also="" examined="" the="" toxicity="" of="" lead="" and="" other="" sinker="" materials="" to="" mammalian="" species="" (rats="" and="" mice)="" to="" determine="" if="" there="" were="" additional="" risks="" to="" other="" organisms="" in="" the="" environment.="" based="" on="" the="" conclusions="" of="" epa's="" analysis="" which="" examined="" existing="" studies="" and="" laboratory="" data,="" zinc,="" and="" brass="" (with="" and="" without="" lead)="" could="" potentially="" result="" in="" greater="" toxicity="" to="" aquatic="" organisms="" (fish,="" invertebrates="" and="" algae)="" than="" lead.="" copper="" is="" also="" toxic="" to="" aquatic="" organisms,="" however,="" copper="" metal="" may="" be="" less="" bioavailable="" in="" the="" environment="" because="" it="" can="" easily="" bind="" with="" materials="" such="" as="" sediment="" or="" organic="" particulate="" matter="" which="" would="" serve="" to="" mitigate="" copper's="" toxicity="" to="" aquatic="" organisms.="" the="" toxicity="" of="" lead="" and="" zinc="" to="" aquatic="" organisms="" in="" freshwater="" may="" also="" be="" mitigated="" to="" some="" degree,="" although="" to="" a="" lesser="" extent="" than="" copper.="" available="" studies="" indicate="" that="" other="" substances="" used="" in="" fishing="" sinkers="" (i.e.,="" bismuth,="" tin,="" tungsten,="" steel,="" and="" antimony)="" are="" less="" toxic="" to="" aquatic="" organisms="" than="" lead.="" in="" comparing="" toxicities="" to="" avian="" species="" (mainly="" mallard="" ducks),="" zinc,="" brass,="" tin,="" copper,="" bismuth,="" tungsten,="" steel,="" and="" antimony,="" would="" be="" less="" toxic="" than="" lead.="" however,="" zinc="" is="" toxic="" at="" very="" low="" levels,="" and="" has="" been="" shown="" to="" produce="" zinc="" intoxication,="" and="" mortality="" of="" waterbirds="" (mallards).="" with="" regard="" to="" toxicity="" to="" mammals="" (rats="" and="" mice),="" bismuth,="" tungsten,="" steel,="" and="" tin="" are="" less="" toxic="" than="" lead,="" while="" zinc,="" antimony,="" copper,="" and="" brass,="" are="" more="" toxic="" to="" mammals="" than="" lead.="" epa="" believes="" that="" polypropylene,="" terpene="" resin="" putty,="" and="" iron="" (also="" potential="" sinker="" substitutes)="" are="" less="" toxic="" than="" lead="" to="" aquatic,="" avian,="" and="" mammalian="" species.="" 2.="" toxicity="" of="" lead.="" lead="" causes="" adverse="" effects="" to="" birds="" through="" a="" variety="" of="" aquatic="" and="" terrestrial="" pathways.="" lead="" is="" neither="" beneficial="" nor="" essential="" to="" animals,="" and="" studies="" commonly="" show="" its="" metabolic="" effects="" on="" birds="" to="" be="" adverse.="" the="" metal="" may="" cause="" several="" sublethal="" effects="" such="" as="" adversely="" modifying="" the="" function="" and="" structure="" of="" kidney,="" bone,="" the="" central="" nervous="" system,="" and="" the="" production="" and="" development="" of="" blood="" cells.="" it="" produces="" adverse="" behavioral,="" biochemical,="" histopathological,="" neuropsychological,="" fetotoxic,="" teratogenic,="" and="" reproductive="" effects.="" ingested="" lead="" can="" impair="" antibody="" production="" and="" lower="" numbers="" of="" white="" blood="" cells="" and="" spleen="" plaque-forming="" cells="" in="" mallards.="" severe="" damage="" to="" the="" central="" nervous="" system="" results="" in="" stupor,="" convulsions,="" coma,="" and="" death.="" other="" signs="" of="" lead="" poisoning="" include="" loss="" of="" appetite="" (and="" resulting="" weight="" loss),="" lethargy,="" weakness,="" emaciation,="" drooped="" wings,="" green="" liquid="" feces,="" impaired="" locomotion="" and="" an="" inability="" to="" fly,="" and="" impaired="" balance="" and="" depth="" perception.="" fat="" deposits="" in="" the="" body="" are="" eventually="" exhausted,="" and="" there="" is="" a="" marked="" atrophy="" of="" the="" bird's="" pectoral="" muscles.="" there="" is="" a="" definite="" progression="" of="" symptoms="" after="" sinkers="" are="" ingested,="" ending="" in="" most="" cases="" in="" death.="" after="" ingestion,="" lead="" sinkers="" are="" reduced="" in="" size="" and="" shape="" by="" dissolution="" in="" the="" acidic="" environment="" of="" the="" digestive="" system="" such="" as="" the="" stomach,="" as="" well="" as="" the="" physical="" grinding="" in="" the="" gizzard.="" soluble="" toxic="" salts="" are="" formed="" that="" are="" absorbed="" into="" the="" circulatory="" system="" causing="" toxicosis,="" neurological,="" and="" behavioral="" changes,="" and="" eventual="" death.="" once="" lead="" passes="" through="" the="" gut="" it="" binds="" to="" red="" blood="" cells.="" it="" is="" stored="" in="" bones="" and="" soft="" tissues,="" and="" is="" excreted="" in="" the="" bile="" to="" the="" small="" intestine="" and="" feces.="" dietary="" deficiencies="" in="" calcium,="" iron,="" zinc,="" copper,="" vitamin="" e,="" thiamin,="" phosphorus,="" magnesium,="" fat,="" protein,="" minerals,="" and="" ascorbic="" acid="" or="" diets="" low="" in="" these="" components,="" may="" increase="" absorption="" of="" lead,="" and="" thus,="" its="" toxic="" effects.="" the="" level="" of="" lead="" in="" the="" blood="" of="" waterbirds="" considered="" toxic="" by="" most="" researchers="" is="" 0.5="" ppm,="" and="" toxic="" symptoms="" may="" begin="" to="" appear="" at="" 0.2="" ppm="" lead.="" the="" level="" of="" lead="" in="" the="" liver="" that="" is="" considered="" to="" be="" lethal="" to="" waterbirds="" is="" 5.0="" ppm="" or="" more="" (3="" to="" 4="" micrograms="" per="" gram="" (ug/g)="" expressed="" as="" wet="" weight,="" or="" 10="" to="" 14="" ug/g="" expressed="" as="" dry="" weight).="" for="" some="" sensitive="" species="" of="" birds,="" survival="" was="" reportedly="" reduced="" at="" lead="" doses="" of="" 75="" to="" 150="" ppm="" body="" weight;="" reproduction="" was="" affected="" at="" dietary="" levels="" of="" 50="" ppm.="" sublethal="" signs="" of="" lead="" poisoning="" were="" present="" at="" doses="" of="" 7.5="" ppm="" body="" weight.="" mortality="" in="" waterbirds="" is="" usually="" caused="" at="" dose="" concentrations="" of="" 20="" to="" 40="" ppm="" of="" lead="" in="" experimental="" studies,="" and="" lethal="" levels="" range="" from="" doses="" of="" 5="" to="" 80="" ppm="" of="" lead.="" in="" 1="" study,="" 16="" mallard="" ducks="" (11="" males="" and="" 5="" females)="" received="" 2="" number="" 4="" lead="" shot.="" this="" dose="" resulted="" in="" mean="" lead="" levels="" in="" the="" liver="" of="" 32.16="" ppm="" (wet="" weight)="" in="" the="" males,="" and="" 13.85="" ppm="" (wet="" weight)="" in="" the="" females,="" and="" blood="" lead="" levels="" of="" 3.47="" ppm="" in="" the="" males,="" and="" 4.15="" ppm="" in="" the="" females.="" thus,="" ingesting="" only="" two="" lead="" shot="" can="" result="" in="" blood="" and="" liver="" levels="" considerably="" higher="" than="" those="" reported="" to="" be="" lethal.="" epa="" examined="" lead="" shot="" in="" its="" analysis="" because="" there="" is="" a="" substantial="" body="" of="" information="" concerning="" this="" form="" of="" lead="" (fate,="" transport,="" and="" distribution="" in="" the="" environment),="" and="" its="" toxicity="" may="" be="" similar="" in="" some="" cases="" to="" those="" for="" lead="" fishing="" sinkers.="" younger="" birds="" and="" waterfowl="" are="" more="" susceptible="" to="" lead="" from="" shot="" or="" sinkers="" than="" older="" animals.="" a="" single="" shot="" or="" two="" swallowed="" with="" food="" or="" taken="" up="" as="" grit="" in="" the="" gizzard="" of="" birds="" may="" introduce="" enough="" lead="" into="" the="" bloodstream="" to="" be="" fatal.="" based="" on="" this="" information,="" epa="" scientists="" believe="" that="" a="" single="" fishing="" sinker="" which="" is="" usually="" larger="" and="" typically="" contains="" much="" more="" lead="" than="" a="" single="" shot,="" could="" be="" fatal="" to="" waterbirds.="" death="" of="" waterbirds="" follows="" exposure="" to="" lethal="" amounts="" of="" lead="" by="" an="" average="" of="" 2="" to="" 3="" weeks.="" during="" this="" time,="" affected="" birds="" become="" less="" mobile,="" are="" limited="" in="" their="" ability="" to="" forage="" for="" food="" and="" seek="" cover,="" tend="" to="" avoid="" other="" birds,="" and,="" as="" a="" result,="" become="" increasingly="" susceptible="" to="" predators,="" adverse="" climate="" changes,="" and="" other="" causes="" of="" mortality.="" it="" is="" very="" difficult="" to="" derive="" a="" dose-response="" relationship="" for="" lead="" fishing="" sinkers.="" no="" studies="" were="" found="" in="" which="" increasing="" doses="" of="" lead="" were="" given="" to="" laboratory="" bird="" species="" that="" would="" enable="" a="" concentration-response="" curve="" to="" be="" derived.="" epa="" believes="" that="" it="" is="" difficult="" to="" determine="" such="" a="" dose-response="" level="" due="" to="" a="" number="" of="" factors,="" such="" as="" species,="" age,="" size,="" sex="" of="" the="" bird,="" diet="" habits,="" and="" time="" of="" year.="" however,="" based="" on="" available="" studies,="" and="" the="" similarity="" between="" lead="" fishing="" sinkers="" and="" lead="" shot,="" epa="" believes="" that="" ingestion="" of="" the="" smallest="" lead="" fishing="" sinker="" (1/100th="" of="" an="" ounce)="" is="" sufficient="" to="" cause="" adverse,="" and="" even="" lethal="" effects="" in="" waterbirds.="" 3.="" toxicity="" of="" substitutes.="" to="" determine="" the="" effect="" of="" lead="" fishing="" sinker="" substitutes="" on="" the="" environment,="" epa="" evaluated="" their="" toxicity="" to="" terrestrial="" (rats,="" mice,="" and="" ducks)="" and="" aquatic="" organisms="" (fish,="" oysters,="" crustaceans,="" clams,="" worms,="" insects,="" and="" algae)="" using="" available="" studies.="" however,="" epa="" believes="" avian="" species="" are="" most="" likely="" to="" be="" directly="" exposed="" to="" fishing="" sinkers="" (by="" ingestion)="" and="" therefore="" become="" adversely="" affected.="" the="" possible="" substitute="" metals="" examined="" in="" available="" studies,="" as="" individual="" metals="" or="" in="" combination="" with="" other="" metals,="" which="" were="" compared="" to="" lead="" were="" steel,="" zinc,="" tungsten,="" tin="" (inorganic="" form),="" antimony,="" copper,="" bismuth,="" brass="" without="" lead="" (zinc/copper,="" assumed="" to="" be="" a="" 50/50="" alloy),="" and="" brass="" with="" lead="" (zinc/copper/lead="" in="" a="" 12="" percent/80="" percent/8="" percent="" alloy).="" no="" avian="" toxicity="" information="" was="" discovered="" for="" tungsten,="" information="" on="" the="" toxicity="" of="" bismuth="" to="" avian="" and="" aquatic="" species="" was="" not="" found,="" and="" no="" mammalian="" or="" aquatic="" toxicity="" information="" was="" found="" for="" steel.="" no="" aquatic,="" avian,="" or="" mammalian="" toxicity="" information="" was="" found="" for="" other="" substitutes="" such="" as="" polypropylene,="" and="" terpene="" resin="" putty,="" and="" no="" toxicity="" information="" for="" aquatic="" or="" avian="" species="" on="" iron="" was="" found.="" the="" hazards="" of="" these="" substitutes,="" based="" on="" available="" data,="" to="" aquatic="" invertebrates,="" fish,="" and="" algae,="" and="" to="" birds="" and="" mammals="" were="" compared="" with="" lead,="" to="" determine="" if="" they="" were="" any="" more="" or="" less="" toxic="" than="" lead.="" the="" agency="" did="" not="" evaluate="" the="" direct="" ingestion="" of="" sinkers="" by="" fish="" or="" other="" aquatic="" organisms,="" which="" is="" assumed="" to="" be="" low="" in="" frequency.="" measured="" endpoints="" in="" the="" aquatic="" toxicity="" analysis="" were="" lethality="" or="" death="" (acute="" exposure),="" reduction="" in="" cell="" numbers="" (algal="" tests),="" and="" changes="" in="" reproduction/growth="" (chronic="" exposure).="" measured="" endpoints="" in="" the="" terrestrial="" tests="" were="" lethality="">50), changes 
    in reproduction, the lowest published toxic dose, and the lowest 
    published lethal dose. These laboratory effects were extrapolated to 
    what could occur in the environment were these substitutes to be used 
    in place of lead.
        a. Substitutes subject to regulatory action.--i. Zinc. Zinc is more 
    toxic to aquatic organisms (fish and crustaceans) than lead, may be 
    bioconcentrated by invertebrates (insects and oysters) and algae, and 
    may be more bioavailable to aquatic organisms. EPA believes that 
    environmental conditions could mitigate the toxicity of zinc to a 
    certain extent in freshwaters to aquatic organisms because it is more 
    soluble than lead.
        Zinc is toxic to mammals (rats and mice) and avian species. In one 
    study, 15 mallard ducks were dosed with 8 number 6 zinc shot. Three of 
    the dosed ducks died within 30 days, with an average time to death of 
    20 days. Weight loss, also a symptom of lead poisoning, was associated 
    with zinc ingestion. Two of the 3 mallards that died, and 10 of the 12 
    surviving mallards developed evidence of zinc intoxication before the 
    end of 30 days. These signs began with stumbling while walking, and 
    progressed to an inability to run, a complete loss of muscular control 
    of the legs, loss of the ability to move wings normally, and spasmodic 
    movement of wings. Birds showing signs of zinc intoxication would, as 
    with lead intoxication, be more susceptible to predation.
        ii. Brass. It is problematic to determine the aquatic and 
    terrestrial toxicities of brass with and without lead, because of the 
    difficulty of apportioning the toxic contribution of each metal (zinc, 
    copper, and lead) to the overall ``total toxicity'' of each alloy. Each 
    metal may not contribute equally to the total toxicity of the alloy and 
    the total toxicity may not be an average of the individual metal 
    toxicities. Total toxicity of the alloy can be less than the sum of the 
    parts, or more than additive (i.e., synergistic). Mixtures of zinc and 
    copper are generally more-than-additive in aquatic toxicity to a number 
    of different freshwater and marine fish and invertebrates. There is 
    some evidence that zinc and lead mixtures may also be more-than-
    additive to some marine invertebrates. In addition, the alloys may vary 
    in the percentage of a particular metal present. Also, the individual 
    metals may leach into aquatic environments and at different rates.
        The aquatic toxicity and fate of a brass dust consisting of copper, 
    zinc, and lead (as an impurity) was studied. Daphnid crustaceans that 
    were tested died, and the growth of algae was adversely affected after 
    exposure to brass dust in a laboratory study. The brass mixes with and 
    without lead was more toxic to aquatic organisms than lead alone 
    assuming that each metal contributed to the total toxicity of the 
    alloy, based on the percentage of each metal in the alloy. Brass with 
    and without lead was calculated to be more toxic to mammals (rats and 
    mice) than lead alone.
        Even though the toxicity of brass to waterbirds has not been 
    tested, based on the toxicity of lead and zinc, brass with and without 
    lead would also be very toxic to waterbirds.
        b. Substitutes not subject to regulatory action.--i. Steel. No 
    adverse toxicological effects (mortality) from steel have been 
    indicated as a result of a research program conducted by the FWS to 
    replace lead shot with steel shot, which examined relative toxicity to 
    ducks of five proposed substitute shot metals. Fifteen mallards were 
    dosed with eight number 6 teflon-coated steel shot. No mortalities or 
    significant body weight losses were reported over the 30-day study 
    period. In contrast, all 15 mallards dosed with 8 number 6 lead shot 
    died within 15 days, and an average 22 percent of their body weight was 
    lost. No information was found regarding the toxicity of steel to 
    aquatic and mammalian organisms. However, EPA believes that steel would 
    have low potential toxicity to those species.
        ii. Tin. Tin, in the inorganic form, is generally much less toxic 
    to aquatic organisms (crustaceans and fish) than lead because of its 
    low solubility, poor absorption, low uptake rate, and rapid excretion. 
    Based only on limited information, it appears that tin is also much 
    less toxic to waterbirds (mallards) and mammals than lead. No mortality 
    was reported, over 30 days, in mallards exposed to 8 number 6 tin shot. 
    Body weight losses in treated birds were not significantly different 
    from control birds.
        iii. Antimony. Laboratory studies indicate that antimony is less 
    toxic to aquatic organisms such as fish, crustaceans, worms, and algae 
    than lead. Even though antimony is not considered to be persistent, it 
    bioaccumulates in invertebrates, but not in fish. Laboratory data 
    indicate that antimony is more toxic to mammals (rats and mice) than 
    lead. No information was found which indicates that antimony is toxic 
    to avian species.
        iv. Copper. Laboratory studies indicate that copper is more toxic 
    to aquatic organisms, such as fish, crustaceans, and algae than lead. 
    However, the Agency believes that copper may act differently in the 
    environment than in laboratory studies due to the physical and chemical 
    nature of the aquatic ecosystem. EPA believes that environmental 
    conditions in freshwaters where substitute fishing sinkers would likely 
    be used, would mitigate the toxicity of copper metal (as cupric ions) 
    to aquatic organisms. Copper chemistry, availability, and mobility in 
    surface waters is complex, but the cupric ion has been found to be 
    highly reactive to many inorganic and organic constituents of natural 
    waters, and the proportion of copper present as the free cupric ion is 
    generally low. For example, moderate to strong complexes and 
    precipitates of carbonates, phosphates, amino acids, and humates are 
    formed. Cupric ions are readily absorbed onto surfaces of suspended 
    solids. These inorganic and organic copper and precipitates are 
    generally less toxic than free cupric ions and tend to reduce the total 
    toxicity of copper.
        Toxicity of copper to avian species such as mallards is less than 
    lead. In 1 study where 24 mallards were dosed with 8 number 6 copper 
    shot, 1 death occurred after 41 days, but the authors concluded that 
    this death could not be attributed to the copper pellet. Metallic 
    copper was also viewed as non-toxic to mammals in this study. However, 
    studies indicate that many copper salts are highly toxic to mammals, 
    and copper is more toxic to mammals than lead.
        v. Bismuth. No aquatic toxicity or avian toxicity studies were 
    found regarding bismuth. EPA has no information to indicate that 
    bismuth is toxic to avian species. However, information on the toxicity 
    of bismuth to mammals (rats and mice) is available. The lethal dose of 
    bismuth (chloride oxide salt) to 50 percent of rats tested is much 
    higher than that for lead.
        vi. Tungsten. Tungsten was found to have low toxicity to aquatic 
    organisms (crustaceans and algae). EPA found no information which 
    indicates that tungsten is toxic to avian species. The toxicity of 
    tungsten to aquatic organisms (daphnids and algae), and mammals (rats) 
    is less than lead based on laboratory studies.
        vii. Iron. No aquatic, or avian toxicity information or studies 
    could be found for iron. EPA found no information which indicates that 
    tungsten is toxic to aquatic organisms or avian species. The toxicity 
    of iron chloride and iron sulfate to mammals (rat) was examined. Both 
    forms of iron exhibited low toxicity to rats based on lethal 
    (LD50) and lowest toxic dose data.
        viii. Terpene resin putty. No aquatic, avian, or mammalian toxicity 
    information or studies could be found for terpene. EPA found no 
    information which indicates that terpene resin putty is toxic to avian 
    species. However, terpene resin putty contains approximately 92 percent 
    tungsten. Based on the low toxicity of tungsten to aquatic and 
    mammalian, EPA believes that terpene resin putty may also present a low 
    potential toxicity to these species.
        ix. Polypropylene. No aquatic, avian or mammalian toxicity 
    information or studies could be found for polypropylene. Polypropylene 
    is a polymer and has a high molecular weight. EPA believes that this 
    property would mitigate the transport of polypropylene through 
    biological membranes, tissues, and cells of the gizzard or gut of avian 
    species. Therefore, the polypropylene would not be absorbed and 
    bioaccumulated by organisms such as waterbirds, but rather would be 
    excreted after passage through the digestive system. EPA believes that 
    polypropylene would present a low potential toxicity to avian, aquatic, 
    and mammalian species.
    
    E. Exposure
    
        1. Summary. Fishing sinkers are used throughout the United States, 
    easily lost or discarded into the environment and, therefore, are 
    available for exposure to waterbirds. Sinkers may be found in areas 
    fished, such as along shorelines, embankments, rock barriers, and 
    piers. Sinkers may be lost in aquatic habitats if the hook or line gets 
    tangled in weeds or other obstructions, and when the line breaks, 
    sinkers may still be attached or fall off the line. Sinkers may also be 
    lost or discarded in terrestrial habitats if dropped by anglers. Any 
    sinker discarded in these areas could easily be ingested by waterbirds 
    feeding on seeds or other vegetative matter.
        For example, a recent study involving a lake dredging project that 
    focused on lead shot in upstate New York, reported that for a period of 
    5 months in 1990, the average number of fishing weights extracted from 
    the lake's sediment during dredging was 4.2 per day. The lake is 
    approximately 60 acres in size and 125 cubic meters of sediment were 
    dredged each day.
        An area along the river Trent in England, where one of the studies 
    took place that examined lead fishing sinker ingestion by mute swans, 
    was heavily fished and contaminated with lead sinkers. Over a 100 meter 
    stretch near the river, 1,100 lead split shot sinkers were collected by 
    2 persons in 1 hour.
        Another study which examined deposition of lead split shot by 
    anglers in South Wales and in England reported that a range of 5 to 300 
    sinkers per square meter were found in the water along the shoreline, 
    and along the bank of several small ponds and lakes. The authors 
    calculated that each person fishing dropped 4 to 7 sinkers per visit to 
    the waterbody. While this area in Great Britain may experience heavy 
    fishing pressure, it further demonstrates that sinkers enter the 
    environment, and can be available for exposure to waterbirds.
        Sinkers may be accidentally dropped along the shoreline, or can be 
    caught on items in the water, such as waterside or submerged branches 
    and vegetation. Waterbirds may intentionally pick them up, mistaking 
    them for seeds, or to use them as grit (materials birds use to aid in 
    digestion such as small pebbles), or may inadvertently ingest them 
    along with food such as discarded bait fish with a line and sinker 
    attached. It is necessary for birds to pick up and use grit to grind up 
    food items because birds lack teeth.
        Fishing sinkers discarded in shallow areas of aquatic habitats are 
    readily available for ingestion by waterbirds for perhaps several 
    years. Lead sinkers persist in the environment and may not completely 
    degrade for a period of at least 100 to 300 years. Zinc and brass 
    sinkers would also remain in the environment for many years.
        Natural deposition and sedimentation processes operate to 
    eventually cover the discarded sinkers with detritus and sediments. 
    However, activities such as boating or dredging may disturb sediments 
    and uncover discarded sinkers. Also, receding water levels due to 
    drought, tidal effects, natural subsidence, or intentional drawdowns 
    would make sinkers readily available.
        The size of the waterbird, especially the size of the gizzard or 
    esophagus may determine the size of the fishing sinker that can 
    potentially be swallowed.
        EPA believes that larger birds such as sandhill cranes could 
    swallow sinkers which are 2 inches in diameter, however, smaller 
    sinkers (1 inch and under) would be more readily ingested by most 
    species. The Agency believes that sinkers 1 inch or less more closely 
    resemble food sources or pieces of grit.
        Limited data are available regarding the size of fishing sinkers 
    ingested by waterbirds. While sinkers approximately 1/4 inch (7 mm) in 
    diameter have been found in the gizzard of common loons, EPA believes 
    that these sinkers were probably larger when initially ingested. This 
    is because sinkers are eroded in the gizzard by the mechanical grinding 
    of the sinker with other materials such as grit, and chemically by 
    acidic substances present in the gizzard or digestive tract. As the 
    sinker is broken down and the metal materials are rubbed from the 
    sinker surface, lead, zinc, or other metals are released into the 
    bloodstream, tissues, and organs of the bird. Even if a fishing sinker 
    is excreted from a bird after it has been ground down to a small size, 
    the lead already absorbed into the tissue of the bird could still cause 
    adverse effects and death.
        A scientist who has studied lead poisoning in common loons has 
    found lead sinkers up to, and including 1 inch in length in the gizzard 
    of common loons which died from lead poisoning. These particular 
    sinkers ingested appear to be worm weights, egg sinkers, and bass 
    casting sinkers. Lead jigs were also found in these common loons.
        The frequency of ingestion of sinkers may differ between species, 
    geographic region, and time of year. Data are not currently available 
    to determine to what extent ingestion of lead or other fishing sinkers 
    is incidental, accidental, or selected.
        The number of lead- or zinc-containing sinkers that waterbirds are 
    likely to ingest cannot be quantified. There are differences among 
    species of waterbirds, variations in feeding, mating, and migration 
    behavior, as well as in other factors such as age and sex of the bird 
    that can affect ingestion. In addition, accurate estimates of this sort 
    would depend on a number of conditions such as the extent of fishing in 
    a certain area, number of sinkers and waterbirds present in the area, 
    and many factors relating to bird behavior.
        Due to all these factors, a model is not available to predict the 
    probability of ingestion of fishing sinkers by waterbirds or the extent 
    of the exposure to birds over a specific time period (number of 
    waterbirds at risk or number of fishing sinkers available for 
    ingestion). In addition, an accurate number of waterbirds that could 
    receive a lethal dose of lead or zinc from fishing sinkers, or the 
    probability of consuming a lethal dose, cannot be estimated.
        Areas subject to fishing each year will continue to pose a threat 
    of sinker ingestion to waterbirds occurring or returning to migrate in 
    that area. However, whether accidental or intentional, ingestion of 
    sinkers does occur and is assumed to be proportional to availability. 
    Therefore, as the number of lead- and zinc-containing fishing sinkers 
    entering the environment increases, so does the probability of 
    ingestion by waterbirds.
        2. Feeding habits. Numerous species of waterbirds may intentionally 
    or inadvertently ingest fishing sinkers during feeding. While it is not 
    certain why waterbirds ingest small sinkers, perhaps it is due to a 
    similarity in size and shape to grain, seeds or roots of some plants, 
    or invertebrates, or they appear like pebbles or grit which aid in 
    digestion. Waterbirds may also ingest sinkers when preying on fish 
    still hooked to a broken line with a sinker attached.
        Studies have documented ingestion of lead fishing sinkers by common 
    loons, trumpeter swans, and mute swans. However, based on their feeding 
    habits, and where they forage for food (locations where people fish), 
    many other species could easily ingest lead- or zinc-containing 
    sinkers, and could also be affected.
        Loons can dive to a fairly substantial depth (up to approximately 
    30 feet) to capture fish, and may inadvertently ingest sinkers when 
    eating fish with tackle still attached. Loons may also intentionally 
    pick up sinkers for use as grit.
        Cranes and herons wade in the shallow areas of inland and coastal 
    aquatic habitats searching for prey. Both species dig into the sediment 
    with their bills to extract food. They consume fish, crustaceans, and 
    other benthic invertebrates, amphibians, insects, and vegetation 
    (including grains), and may incidently ingest lead fishing sinkers.
        Bay diving ducks (e.g., canvasbacks) and grebes, feed on aquatic 
    insects, fish, crustaceans, other invertebrates, and aquatic plants 
    found on the bottoms of aquatic habitats.
        Geese, ducks, and swans eat aquatic vegetation, plant shoots or 
    roots, seeds, bulbs, insects, small mammals, roots, berries, and nuts. 
    Often they feed along shorelines and may be readily exposed to 
    discarded or lost fishing sinkers. Swans frequently pull vegetation off 
    the bottom sediments. These species can easily ingest fishing sinkers 
    during feeding as they forage or sift through sediment on lake, pond, 
    or river bottoms.
        Raptors and scavengers such as hawks, osprey, and vultures consume 
    fish, small mammals, birds, and crustaceans. Monofilament line and 
    attached sinker weights hooked to bait such as worms or fish could also 
    be easily ingested by other fish or fish-eating predators.
        3. Affected species. EPA believes that over 75 individual species 
    are potentially at risk from exposure to lead- and zinc-containing 
    fishing sinkers based on their feeding habits and sources of food. 
    These species fall into a number of groups such as surface feeding 
    ducks, bay diving ducks, loons and grebes, sea ducks, cranes and their 
    allies, geese and tree ducks, swans, herons and their allies, raptors 
    and scavengers.
        During the course of EPA's analysis, additional reports were found 
    which document the ingestion of lead fishing sinkers and lead poisoning 
    in sandhill cranes (not the endangered Mississippi sandhill crane), 
    common loons, mute swans, and tundra swans.
        Two wild sandhill cranes (Grus canadensis) found dying were 
    submitted to the National Wildlife Health Research Laboratory for 
    diagnosis (Ref. 26). One female sandhill crane, that died from lead 
    poisoning shortly after capture, was found in Nebraska and contained a 
    portion of a lead fishing sinker in its gizzard. The lead level (wet 
    weight) in the crane's liver and kidney were 23 ppm and 29.8 ppm, 
    respectively. Another female sandhill crane which was weakened and 
    unable to fly was found in the Aransas National Wildlife Refuge in 
    Texas. A portion of a lead fishing sinker was found in the gizzard, and 
    lead poisoning was determined to be the cause of the moribund condition 
    of the bird. The lead level (dry weight) in the kidney was 113.4 ppm 
    and 258.8 ppm in the liver.
        Tufts University Wildlife Clinic examined (necropsied) 21 adult 
    common loons found dead or moribund in New England States from 1991 - 
    1993 (Ref. 30). Fourteen common loons had ingested either a lead 
    fishing sinker, lead worm weight, or lead jig. Nine of these 14 loons 
    died from lead poisoning; 5 were suspected of dying from lead poisoning 
    (they showed necropsy and histopathologic lesions consistent with lead 
    poisoning). Toxicological analysis of the 9 birds confirmed with lead 
    poisoning had lead liver levels ranging from 6.05 ppm to 13 ppm. The 
    lead sinkers, lead jigs, and lead worm weight that the loons had 
    ingested were also examined (weighted and measured). These lead objects 
    ranged in length from 0.27 to 1 inch; from 0.21 to 0.49 inches in 
    width; and in weight from 1.5 grams to 16.5 grams.
        Necropsy data from the Rose Lake Wildlife Research Center in East 
    Lansing, Michigan report that from 1988 to 1993: (1) Out of 55 common 
    loons examined, 3 died from lead poisoning due to lead fishing sinkers, 
    (2) 5 out of 60 mute swans examined, ingested lead fishing sinkers and 
    died from lead poisoning, and (3), 1 tundra swan (Cygnus columbianus) 
    died from lead poisoning due to the ingestion of a lead fishing sinker 
    (Ref. 15). Lead concentrations in the liver and kidney of the common 
    loons ingesting fishing sinkers ranged from 6 to 13 ppm and 28 to 46 
    ppm respectively. The data also indicated that 12 common loons ingested 
    what appeared to be lead jigs, which are weighted hooks. The lead 
    levels in the liver of these loons ranged from 11.7 to 98.2 ppm in the 
    liver and 18.1 to 124 ppm in the kidney.
         Data from the New York State Wildlife Resources Center in Delmar, 
    New York reported that seven common loons, and one mute swan 
    necropsied, died from lead poisoning due to ingestion of lead fishing 
    sinkers (Ref. 29). The common loon mortalities were as follows: (1) one 
    common loon located along Lake Ontario in 1983, and later died, had a 
    lead level in the liver of 9.3 ppm; a worn lead fishing sinker weighing 
    approximately 2 grams was found in the stomach, (2) one debilitated 
    common loon that died shortly after it was found in 1986 at Long Lake, 
    had ingested a worn elongated split shot fishing sinker; the lead 
    concentration in the liver was 41.2 ppm wet weight, (3) two common 
    loons that died in 1989, each with a worn lead fishing sinker in their 
    gizzards, had lead liver levels of 26.4 ppm, and 30 ppm, (4) one common 
    loon with a lead liver level of 9.8 ppm also died in 1989, and had 
    ingested a lead fishing sinker, (5) a ``large'' split shot lead fishing 
    sinker was found in a common loon that died in 1982 (2 assays were 
    conducted indicating that lead liver levels were 21 and 23 ppm), and 
    (6) one loon found dead on Kueka Lake had ingested an egg-shaped sinker 
    approximately 8 mm in diameter; the lead liver level was 15.5 ppm. The 
    New York State Wildlife Resources Center also reported that a female 
    mute swan that had ingested a teardrop-shaped lead fishing sinker died 
    from lead poisoning in 1986.
        A male whistling swan (also referred to as the tundra swan, Cygnus 
    columbianus) was found sick and extremely emaciated along the banks of 
    a creek in Maryland (Ref. 11). It was brought to the Patuxent Wildlife 
    Center for autopsy where it was found that the bird was lead poisoned. 
    The swan had ingested a lead sinker contained in the gizzard. The level 
    of lead found (on a wet weight basis) in the blood, liver, and kidney 
    was 830 ppm, 40 ppm, and 2,440 ppm respectively. The study authors 
    surmised that the very high levels of lead reflected a high level of 
    lead absorbed from the ingested sinker.
        Any endangered or threatened waterbirds, such as the Mississippi 
    Sandhill Crane (See Unit II.C.4. of this preamble) that feed in areas 
    with discarded or lost fishing sinkers may potentially ingest lethal 
    quantities of lead or zinc. Each individual is important to the 
    continued survival of an endangered or threatened species, and 
    therefore, impacts on even single individuals are of special concern. 
    Other listed endangered species, such as the whooping crane (Grus 
    americana), wood stork (Mycteria american), Aleutian canada goose 
    (Branta canadensis leucopareia), peregrine falcon (Falco peregrinus 
    peregrinus), and possibly the bald eagle (Haliaeetus leucocephalus), 
    may directly or indirectly ingest fishing sinkers.
        4. Species ranges. Ranges of these potentially exposed waterbirds, 
    as well as avian predators and scavengers include areas throughout the 
    United States with suitable aquatic habitats for feeding and breeding 
    activities. In some cases, these ranges correspond to areas subject to 
    moderate to heavy use by fishermen (e.g., northwest, midwest, 
    southeast, upper north central, and northeast U.S.). The range of a 
    species often is complex and large and it can consist of a summer or 
    breeding range, a winter range, and geographic areas where the species 
    occurs throughout the year. Often portions of these three areas 
    geographically overlap. The breeding ranges of the species with 
    reported mortalities (common loon, trumpeter swan, mute swan, tundra 
    swan, and sandhill crane) due to ingestion of lead fishing sinkers, the 
    ranges of other potentially affected species discussed above, and the 
    areas fished essentially cover the entire United States.
        Bay diving ducks and mergansers are generally found throughout the 
    United States during the year. Loons and grebes occur across the upper 
    midwest, northeast, west coast, and Alaska. Surface feeding ducks, 
    depending on the species, occur throughout the United States. Cranes, 
    herons, and their allies, generally occur throughout the United States 
    and along coastal areas. Sea ducks are commonly found along the United 
    States coast. Geese and tree ducks are distributed along the west 
    coast, northeast and Gulf coast. Swans are found in many areas of the 
    United States including the northeast, upper midwest, west coast, Rocky 
    Mountains, and Alaska. The distribution of raptors and scavengers is 
    widespread throughout the United States.
        5. Population effects. EPA recognizes that population effects 
    cannot be measured accurately in this case, because of the many species 
    that may be adversely impacted, and other complex variables involved. 
    It is difficult to separate out the precise degree of the hazard posed 
    by fishing sinkers to waterbird populations as opposed to that from 
    natural or other man-made sources of population mortality and 
    variability, or that caused by normal environmental change (e.g., 
    drought, increased predation). Many waterbird populations have been 
    decreasing progressively over the past several years and decades 
    because of increased hunting and a decline in suitable nesting habitats 
    (e.g., the net loss of 2.6 million acres of wetlands in the United 
    States from the mid-1970's to the mid-1980's).
        It is difficult to see the full effect on populations, as there 
    have not been large reported die-offs due to ingestion of fishing 
    sinkers. While the available studies may appear to indicate that a 
    small number of common loons, trumpeter swans, mute swans, tundra 
    swans, and sandhill cranes have died due to ingestion of lead fishing 
    sinkers, EPA believes that the potential magnitude of the risk to 
    waterbirds is greater than the number of known deaths indicates. 
    Species with similar feeding habits in similar ecosystems such as those 
    previously discussed (Unit III.E.2 of this preamble), are likely to 
    also be at risk, although no deaths due to ingestion of fishing sinkers 
    have been reported.
        The potential risks to waterbird populations may not be fully 
    reflected in the available data due to a number of factors. Birds that 
    are seriously ill from ingesting lead- or zinc-containing sinkers may 
    seek the cover of vegetation and are difficult to locate when they die. 
    Common loons and trumpeter swans do not flock together and 
    consequently, when individual birds seek cover they are often 
    overlooked. Because they are susceptible to predation, most of the ill 
    or dead birds may quickly disappear as they become meals for predators 
    such as mink, weasels, raccoons, fox, coyotes, eagles, hawks, and owls. 
    This complicates the ability to determine the magnitude of adverse 
    effects to waterbirds due to sinker ingestion. Therefore, EPA believes 
    that the true number of waterbird deaths is considerably larger than 
    those that have been observed and reported. Even if a known number of 
    carcasses are deliberately ``planted'' in known locations, it is 
    difficult to locate all of them at a later time.
        For example, in a study conducted in northwestern Missouri, 62 
    percent of 90 planted carcasses disappeared after only 4 days. In Texas 
    coastal marshes, 89 percent of 47 carcasses had disappeared in 8 days. 
    In a refuge in Missouri, 25 percent of ``planted'' carcasses were not 
    located when the areas were searched. If the number of dead and lead- 
    or zinc-affected waterbirds do not exceed the ability of predators to 
    consume them, few carcasses will be present. Carcasses would become 
    more evident when birds die in greater numbers, or if the number of 
    predators decreased.
        EPA also recognizes that naturally occurring populations of 
    waterbirds do not exist in isolation. The health of one population is 
    often dependent upon other populations within a natural community. As 
    such, lead- and zinc-containing fishing sinkers may cause direct 
    adverse effects on one population, but may also produce indirect 
    effects, such as perturbations on food webs in ecosystems. For example, 
    these perturbations could include disruptions in the predatory/prey and 
    competition relationships between individuals in interacting 
    populations within a community.
        However, EPA did examine how fishing sinkers may affect individuals 
    within a population. The number of individuals within the trumpeter 
    swan, common loon, and Mississippi sandhill crane populations are as 
    follows. Trumpeter swan populations are estimated to be approximately 
    13,000 in Alaska, 1,700 in the Rocky Mountain area, and 300 in the 
    interior portion of the United States. Common loon populations are 
    estimated to be 34,000 in Alaska and 47,000 in the rest of the United 
    States. The population of the Mississippi sandhill crane, found on and 
    near the Mississippi Sandhill Crane National Wildlife Refuge in Jackson 
    County, Mississippi, is estimated to be 142 individuals.
        Although the total population of trumpeter swans or common loons 
    may appear large and geographically dispersed, it can consist of 
    relatively small local breeding populations. The loss of a few members 
    of these local populations may be of great consequence. For example, 
    the common loon population in 4 New England States (Maine, New 
    Hampshire, Vermont, and Connecticut) is estimated to be approximately 
    4,374 individuals; however, Vermont has only about 16 nesting pairs or 
    32 individuals. As mentioned previously (Unit II.C.1. of this 
    preamble), common loons are listed as an endangered or threatened 
    species in some New England States (Ref. 5).
        If only a few of these loons die from poisoning due to ingestion of 
    a lead- or zinc-containing fishing sinker, there will be fewer birds to 
    reproduce, and less future offspring. This is of particular concern 
    regarding endangered species where both the total and local populations 
    are low, and the loss of an individual is very significant. Therefore, 
    deaths of individual birds may in turn impact the total population of 
    avian species. However, direct effects may only be seen concerning 
    individuals, or local breeding populations. Regardless of the 
    difficulty in fully determining the impacts on waterbird populations, 
    lead- and zinc-containing fishing sinkers remain as one source of 
    unnecessary adverse pressure on already stressed populations. This is 
    especially true if local breeding populations, made up of individuals, 
    have to cope with other adversities such as loss of habitat. In 
    addition, fishing sinker ingestion may result in toxic effects, thereby 
    significantly reducing or eliminating the opportunity for reproductive 
    effects to occur.
        Although the effects of lead- and zinc-containing fishing sinkers 
    on waterbird populations are impacts of concern, EPA does not believe 
    it is necessary to demonstrate population effects before taking 
    regulatory action (Ref. 3). Since most endangered species have very low 
    population numbers, concern would be high if even one individual was 
    adversely affected or died as a result of lead or zinc ingestion. By 
    the time such effects were conclusively shown, it might be too late to 
    mitigate any adverse effects to these species. In fact, the Mississippi 
    sandhill crane, a Federally endangered species, is in danger of 
    extinction due to a number of factors such as loss of habitat, human 
    predation, and presence of other toxins in the environment.
        EPA has previously implemented regulatory programs that protect 
    birds without estimating population effects. The Agency took action to 
    phase out most uses of granular carbofuran, an agricultural insecticide 
    and nematicide (Ref. 27), and to cancel certain registrations of the 
    pesticide diazinon, based solely on concerns about acute risks posed to 
    birds (Ref. 28).
    
    F. Risk Characterization
    
        EPA believes that lead- and zinc-containing fishing sinkers pose an 
    unreasonable risk to waterbirds for the following reasons.
        Fishing sinkers are used and can be found in ponds, lakes, and 
    streams, and along the shores and banks of these aquatic habitats 
    throughout the United States. They are available for ingestion by 
    waterbirds. The actual number of sinkers located in the environment 
    cannot be quantified; however, approximately 477 million lead, zinc, 
    and brass sinkers are sold each year in the United States. As more 
    sinkers are discarded or lost in the environment each year, more will 
    be potentially available to waterbirds, and additional waterbird deaths 
    may occur. Based on the toxicity of lead and zinc, one fishing sinker 
    can be sufficient to cause mortality in waterbirds.
        As previously discussed, the actual number of waterbirds that will 
    likely ingest fishing sinkers, and the definite number of fishing 
    sinkers ingested by each waterbird, cannot be estimated. However, the 
    true number of deaths may be higher than the number of documented cases 
    due to: (1) The lack of a national incident reporting system (in 
    addition, the studies and research conducted specifically to assess the 
    ingestion of fishing sinkers are small in number), (2) the difficulty 
    of locating carcasses in the field, and (3) limited resources and staff 
    to conduct necropsies.
        Ingestion of lead fishing sinkers by waterbirds has been 
    documented. There is clear evidence that ingestion of lead fishing 
    sinkers has resulted in toxic and often fatal effects to avian species 
    such as common loons, trumpeter, mute, and tundra swans, and sandhill 
    cranes.
        The size of lead fishing sinkers which have been ingested by 
    waterbirds has been documented. Sinkers up to and including one inch in 
    size have been found in common loons.
        Research has also demonstrated that zinc is toxic, and zinc pellets 
    have produced mortality when ingested by waterbirds such as mallards. 
    Therefore, ingestion of zinc fishing sinkers may also pose risks to 
    waterbirds.
        Other avian species that have similar feeding habits and breed or 
    migrate in areas containing lead- or zinc-containing fishing sinkers 
    are at risk.
    
    IV. Provisions of the Proposed Rule and Rationale
    
        The rule would impose a ban on all manufacture, import, and 
    processing of fishing sinkers containing any lead or zinc and which are 
    1 inch or less in any dimension for use in the United States 1 year 
    after promulgation of the final rule. The distribution in commerce of 
    such fishing sinkers would be prohibited 2 years after promulgation of 
    the final rule. The rule would not prohibit the manufacture and 
    processing of lead and zinc-containing fishing sinkers 1 inch or less 
    in any dimension solely for export. Manufacturers and processors of 
    those sinkers for export would be required to maintain records 
    regarding the production, inventory, and shipment of those sinkers. 
    This would allow EPA to track the distribution of regulated sinkers, 
    and effectively enforce the rule.
        EPA is proposing to prohibit the manufacture, processing, and 
    distribution in commerce of any lead- or zinc-containing fishing sinker 
    because EPA believes they pose an unreasonable risk of injury to avian 
    species such as waterbirds. Extremely small amounts of lead and zinc 
    (at the ppm level) adversely affect waterbirds, and ingestion of even 
    one fishing sinker can result in their death. If fishing sinkers were 
    allowed to contain a small amount of lead or zinc, although a trace 
    amount may not produce toxic effects, the cumulative impacts due to 
    ingestion of more than one sinker could result in mortality. In 
    addition, lead- and zinc-containing fishing sinkers are very persistent 
    in the environment and can be accessible for ingestion by waterbirds 
    for a number of years. Therefore, EPA is proposing to regulate the 
    production and sale of fishing sinkers containing any amount of lead or 
    zinc.
        EPA's economic analysis indicates that there are several available 
    or commercially viable substitutes for lead- or zinc-containing fishing 
    sinkers. This analysis, discussed further in Unit V. of this preamble, 
    indicates that the average increase in annual costs to each individual 
    person who fishes from this proposal would be substantially less than 
    $4.00 per year. EPA believes the scientific evidence demonstrating the 
    severe adverse effects to waterbirds from the ingestion of lead- and 
    zinc-containing fishing sinkers, the economic, social, and 
    environmental value of these birds, and the low costs and availability 
    of substitutes for these sinkers, outweigh any costs that would result 
    from imposition of the proposed regulation. Therefore, EPA believes the 
    continued manufacturing, processing, and distribution in commerce of 
    small size lead- and zinc-containing fishing sinkers presents an 
    unreasonable risk of injury to the environment.
        EPA does not believe that the use of lead- and zinc-containing 
    fishing sinkers is essential. Substitutes which the Agency determined 
    were less toxic to waterbirds are available, albeit at a somewhat 
    higher cost. These substitutes include tin, copper, antimony, bismuth, 
    steel, tungsten, and terpene resin putty. EPA believes these 
    substitutes for lead- and zinc-containing fishing sinkers would perform 
    as well as lead or zinc.
        This ban, as proposed, would greatly eliminate future entry of 
    these fishing sinkers into the environment, and therefore limit the 
    number of lead- and zinc-containing fishing sinkers available for 
    exposure. EPA believes this would ensure that any unreasonable risk 
    posed to waterbirds would be adequately reduced.
        EPA is proposing to regulate all sinkers 1 inch or less in any 
    dimension because those size sinkers resemble pieces of grit or small 
    food items such as seeds which waterbirds may ingest. The majority of 
    sinkers most likely to be used for recreational fishing are also 1 inch 
    and less in size.
        The Agency evaluated banning different types of sinkers 1 inch or 
    less in size (split shot and non-split shot). While a ban on split shot 
    type sinkers is the most economical option in terms of cost per sinker, 
    it would only account for 68 percent of the sinkers 1 inch or less on 
    the market. Therefore, an additional 32 percent of sinkers 1 inch or 
    less, or approximately 152 million sinkers, would still be manufactured 
    per year and potentially available for exposure to waterbirds. EPA 
    believes that it is important to capture this significant market 
    segment because regardless of type, sinkers 1 inch or less pose a risk 
    to waterbirds. In addition, the majority of home manufacturers produce 
    non-split shot sinkers. Therefore, the prohibition on all sinkers 1 
    inch or less in any dimension would assist in reducing human health 
    risks as well.
        It is estimated that the proposed ban would prevent over 450 
    million lead- and zinc-containing fishing sinkers 1 inch or less from 
    being produced each year, and potentially from entering the 
    environment.
        The provisions of this proposed rule concerning the ban on 
    manufacturing and processing would become effective 1 year after 
    promulgation of the final rule. EPA chose a 1-year delay, rather than 
    an immediate ban which the Agency believed to be too burdensome on 
    industry, to enable manufacturers of lead- and zinc-containing fishing 
    sinkers time to retool their equipment to produce other types of 
    sinkers.
        The proposal, if implemented, would also prohibit the distribution 
    in commerce of lead- or zinc-containing fishing sinkers, and that have 
    any dimension less than or equal to 1 inch, by any person effective 2 
    years after promulgation of the final rule. The sale of these types and 
    sizes of fishing sinkers in the United States by any person, including 
    retail stores or catalogues, would not be allowed. The Agency believes 
    restrictions on the distribution in commerce are necessary to eliminate 
    the continued availability and usage of lead- and zinc-containing 
    fishing sinkers less then or equal to 1 inch in size.
        The prohibition on the distribution in commerce of lead and zinc-
    containing sinkers would become effective 2 years after promulgation of 
    the final rule, in order to allow an adequate interval for distributors 
    to sell their remaining inventory of those sinkers. Although EPA 
    evaluated options which would further delay the regulatory requirements 
    (ban the manufacture, processing, and distribution after 3 or 5 years), 
    the Agency does not believe that these options would be justified in 
    light of the continued and increasing risk to waterbirds. If EPA 
    further delayed the ban, a potentially large number of lead- and zinc-
    containing fishing sinkers could enter the environment.
        EPA evaluated a number of options before choosing to prohibit the 
    manufacture, processing, and distribution in commerce of lead- and 
    zinc-containing fishing sinkers 1 inch or less in any dimension. While 
    the other options, discussed further in Unit VI. of this preamble, 
    would restrict a segment of the fishing sinkers available for exposure 
    to waterbirds, the Agency does not believe that these other options 
    would adequately reduce the availability of sinkers for exposure or 
    adequately reduce the unreasonable risk to waterbirds. To adequately 
    reduce this risk, EPA believes a ban on the manufacture, processing, 
    and distribution of lead- and zinc-containing sinkers 1 inch or less in 
    any dimension is necessary. EPA also evaluated the option of a 
    comprehensive ban on all fishing sinkers. While a comprehensive ban on 
    all lead- and zinc-containing sinkers would accomplish the greatest 
    degree of risk reduction, EPA did not select that option because the 
    burden placed on society associated with that option would be too 
    severe. Therefore EPA chose a limited ban targeting those sinkers which 
    EPA believes pose the greatest harm to waterbirds.
        The rule, as proposed would not prevent individuals from engaging 
    in fishing or from using sinkers, but rather would prohibit the 
    manufacture, processing and distribution of fishing sinkers of a 
    certain type and size to prevent unreasonable risk of injury to 
    waterbirds.
        This rule would not prohibit the use of fishing sinkers containing 
    lead and zinc by any person. TSCA section 6 (a)(5) authorizes EPA to 
    prohibit or otherwise regulate any manner or method of commercial use 
    of a substance or mixture. Because the fishing sinkers at issue are 
    those used in recreational fishing, EPA's proposal would not extend to 
    the recreational use of these fishing sinkers.
        The total cost of the proposed regulation for consumers is $71.6 
    million over 10 years. The cost to persons who fish is minimal (average 
    2 cents per fishing day).
    
    V. Economic Impacts
    
        All references and background information reviewed in this Unit of 
    the preamble are found in the ``Regulatory Impact Analysis of Options 
    for Regulating Lead and Other Toxic Fishing Sinkers,'' referred to in 
    this proposal as Support Document 2. EPA concentrated its analysis on 
    lead fishing sinkers as they account for the majority of sinkers 
    presently on the market. There is a small volume of brass sinkers 
    currently produced domestically, and a very small volume of zinc 
    sinkers which are imported. EPA estimates that approximately 477 
    million split shot and non-split shot lead, zinc, and brass sinkers are 
    sold each year and used for freshwater fishing.
    
    A. Availability, Application, and Cost of Substitutes
    
        1. Summary. EPA has investigated a number of possible substitute 
    materials for lead fishing sinkers. The substitutes considered suitable 
    for lead fishing sinkers, are also appropriate for zinc and brass 
    fishing sinkers. Substitutes were evaluated on the basis of 
    availability, application, and cost, in addition to toxicity relative 
    to lead and zinc (as detailed in Unit III.D. of this preamble). 
    Availability refers to the current market for sinkers made of the 
    various types of materials, while application refers to the sinker 
    types that could be manufactured from a particular material. EPA is 
    aware that there may be other substitutes which are being developed, 
    but are not yet on the market, and others which may only be available 
    locally such as glass and ceramic. The Agency has not analyzed these 
    substitutes in detail, mainly because there is a lack of information 
    regarding them.
        As evaluated by the Agency, the costs of substitutes include raw 
    materials, energy, operations and maintenance, capital, and conversion 
    costs. These costs, along with toxicity considerations, were used to 
    estimate the market share of various substitutes which would result 
    following implementation of the proposed regulatory option.
        The identified substitutes for split shot sinkers are different 
    from those identified for non-split shot sinkers. Substitutes for lead 
    split shot need to be malleable and have a soft edge so that fishing 
    lines are not damaged when substitute weights are crimped or squeezed 
    onto the line. The same considerations are not important for larger 
    weights (i.e., non-split shot) that are tied onto the line. Hence, the 
    list of feasible substitutes is different for the split shot segment of 
    the market than it is for non-split shot sinkers.
        Substitutes for lead fishing sinkers, which are identified as being 
    currently commercially available and are subject to this proposed rule 
    are zinc, and brass. Other potential substitute materials which are not 
    subject to this proposal are: (1) Tin, (2) tin/antimony, (3) bismuth, 
    (4) terpene resin putty, (5) copper, (6) stainless steel, and (7) 
    polypropylene tungsten composite.
        Finally, the suitability of lead jigs as a substitute was examined. 
    While a jig basically accomplishes the same objective as a fishing 
    sinker, the Agency does not believe they are viable substitutes for 
    lead or zinc sinkers. Generally, jigs are used as artificial lures 
    which require the angler to manipulate it such that it appears life-
    like. Sinkers are generally used with live bait and do not require such 
    handling. Accordingly, it is estimated that lead jigs would substitute 
    for less than 1 percent of lead fishing sinkers currently in use. 
    Several of the substitutes are described below.
        2. Substitutes subject to regulatory action.--i. Zinc. Zinc fishing 
    sinkers under 1 inch are not currently manufactured in the United 
    States. Non-split shot sinkers such as worm weights are presently 
    imported for use. EPA does not believe that zinc sinkers are produced 
    at home. Zinc is more expensive than lead, and could replace lead for a 
    few product forms such as worm weights.
        Disadvantages of zinc relative to lead are that it is more 
    expensive, is more difficult to manufacture, can damage the 
    manufacturing equipment, and has a harder edge, and therefore may 
    damage the fishing line. Also, zinc has a lower density, and is not as 
    soft and easy to work with as lead.
        ii. Brass. Brass sinkers are currently available in the United 
    States for purchase, and are slightly more expensive than comparable 
    lead sinkers. Primarily non-split shot brass sinkers such as those used 
    for bass casting are produced in the United States. EPA does not 
    believe that brass sinkers are produced at home. Brass sinkers can be 
    plated with silver, zinc, or with zinc plus black chromate.
        One disadvantage of brass is that it cannot be crimped onto the 
    line as easily as lead shot because of the hardness of brass. It is 
    therefore considered too hard for use as split shot, and mechanical 
    crimping methods such as rubber appendages must be used. Also, brass 
    may contain 7 to 8 percent lead, and 5 to 20 percent zinc. Furthermore, 
    brass is less dense than lead and has a higher melting point than lead 
    and other substitutes, making processing more difficult.
        3. Substitutes not subject to regulatory action.--i. Tin. Tin, 
    although less dense than lead, is suitable for use as split shot due in 
    part to its softness. Tin split shot is currently available in the same 
    weights as lead split shot. It appears that tin sinkers are easier to 
    affix to the line than are lead sinkers. The tin shot is opened with 
    the thumbnail, but has no ears for release, as does removable lead 
    shot. Raw material costs for tin are approximately 10 times the cost of 
    lead. Because of this higher cost, tin is not considered practical for 
    use in sinkers other than split shot.
        The main disadvantage of tin sinkers is that they are less dense 
    than lead sinkers, resulting in roughly a 50 percent increase in 
    material to achieve the same effect as for typical split shot. Also, 
    although tin is soft, it requires greater precision methods to 
    manufacture so that it will not damage the fishing line. Tin sinkers 
    could be produced by home manufacturers; however, the relatively high 
    cost of tin would likely discourage this activity, and home-
    manufactured tin split shot could cause line damage due to the 
    relatively hard edge.
        ii. Bismuth. Sinkers that are 99.99 percent bismuth are 
    manufactured and distributed to retail stores. Five types of bismuth 
    sinkers have been identified including bell sinkers, bass casting 
    (swivel) sinkers, walking sinkers, egg sinkers, and worm weights.
        Bismuth sinkers generally costs approximately twice as much as 
    comparable lead sinkers. Bismuth sinkers could be manufactured at home, 
    using a lead sinker mold. However, if home-manufacturers were to use 
    bismuth, the resulting sinkers would be considerably more expensive 
    than lead sinkers and hence, probably would not be purchased by 
    retailers.
        The advantages of using bismuth rather than lead, zinc, or brass 
    include its slightly lower melting point, which means that it requires 
    slightly less energy to manufacture than lead. The melting point of 
    bismuth is also lower than the melting points of the possible 
    substitutes copper and steel. Furthermore, the density of bismuth is 
    high relative to other substitute materials like tin and copper.
        Bismuth can be used to replace all lead, zinc, and brass sinker 
    types except split shot. Bismuth cannot effectively replace lead for 
    split shot because of its brittleness, which results in breakage when 
    it is crimped onto the line. The small density difference compared to 
    lead is overcome by making the sinker slightly larger.
        iii. Terpene resin putties. A putty of terpene resins containing 92 
    percent tungsten by weight is currently manufactured. It has 
    approximately 80 percent of the density of lead. The product is sold 
    wholesale to retail outlets and distributors.
        Terpene resin putty is approximately three to four times as 
    expensive as lead split shot. Although the putty is more expensive than 
    lead shot, in the fly fishing market, the only market into which it 
    currently is marketed, this higher cost of the putty is insignificant 
    compared to the high costs of other fly fishing equipment (e.g., a 
    person fly fishing may purchase 100 flies at $1.20 each for one fishing 
    trip). The product is not, however, an economically viable choice for 
    most types of fishing that require weights larger than split shot.
        Terpene resin putty currently is marketed only for fly fishing, 
    although it can substitute for all sizes of split shot and most sinker 
    sizes. The putty is not suitable for use as a heavy weight since it 
    cannot be tied onto the line. However, like removable split shot, the 
    putty can be reused many times. The major disadvantage of putty 
    relative to lead is its higher cost.
        iv. Steel and copper. Steel and copper theoretically could also be 
    used as substitutes for lead, zinc, or brass fishing weights. However, 
    for various reasons these substitute materials are not considered as 
    practical alternatives at this time. Steel rusts unless expensive non-
    corrosive alloys are used. Steel generally costs more and is less dense 
    than lead. Furthermore, steel products usually have very high melting 
    points and are hard, making these materials impractical for manufacture 
    with traditional technologies. Steel could not be injection molded; it 
    could be stamped, but only with very heavy equipment. Typically, 
    forging and foundry operations are required for processing steel into 
    shapes. Copper has a density of approximately 79 percent of lead and a 
    melting point greater than lead, zinc and brass. These factors may make 
    copper unsuitable for use as a substitute for lead in fishing sinkers.
        v. Polypropylene, iron, and tungsten mixtures. One company is 
    currently developing an iron and tungsten impregnated polypropylene 
    mixture that can be molded into fishing sinkers of the same size, 
    shape, and dimensions as lead fishing sinkers. These weights have the 
    same ``look'' as lead fishing weights, although they have roughly 50 
    percent of the specific gravity of lead. Raw material costs are 
    estimated at $1.50 to $1.75 per pound or approximately five times 
    greater than lead.
    
    B. Cost of Proposed Rule
    
        The Agency developed estimates of the cost of the proposed 
    regulatory option. The analysis, presented in Support Document 2, 
    details the costs, methodology, and results for the proposed rule and 
    for several additional regulatory alternatives.
        In general, the approach of the cost analysis is to utilize a 
    stepped demand function to depict demand for fishing sinkers and to 
    estimate changes in consumer surplus resulting from various regulatory 
    options. This type of function is appropriate where many substitutes 
    are available and performance differences among the substitutes are not 
    significant. The estimation of these functions incorporates basic 
    information on the substitutes for lead- and zinc-containing sinkers 
    and estimated market shares of the substitutes.
        Stepped demand functions depict consumers as ceasing to demand 
    certain quantities of a product when the cost of the product exceeds 
    the cost of a comparable substitute. Therefore, there will be no 
    reduction in the quantity demanded in the event of a price rise, unless 
    the price rises sufficiently to be above the price of the next 
    substitute. The cost of each substitute provides the height of each 
    step, and the market share of substitutes provide the width. Demand is 
    assumed to be relatively constant over the 10-year period--1993 to 
    2002.
        While market shares are determined by a combination of toxicity and 
    cost concerns to sensitivity analyses are performed, in the first 
    market share is based predominately on cost concerns and, in the 
    second, market share is based predominately on toxicity concerns. The 
    base case market shares under the proposed regulatory option for non-
    split shot are estimated to be: Polypropylene-55 percent, bismuth-5 
    percent, tin-35 percent, steel-2 percent, and tin/antimony alloy-3 
    percent. The estimated base case market shares for split shot are: Tin-
    90 percent, tin/antimony alloy-2 percent, and terpene resin putty-8 
    percent. The supply of lead sinkers is assumed to be perfectly elastic 
    in the long run, therefore, no producer surplus exists in these 
    markets. Thus, most of the cost of the regulation will be borne in the 
    long run entirely by consumers of these goods.
        The present value social cost of the proposed regulatory option is 
    estimated to be $75.9 million discounted at 7 percent. The total costs 
    over the 10-year period apportioned to consumers is estimated to be 
    $71.6 million discounted at 7 percent. This implies a cost of about 
    $9.6 million per year for the 31 million freshwater anglers that 
    participate in freshwater fishing annually or only 2 cents per fishing 
    day (average fishing days per individual per year are equal to 14). 
    This does not mean to suggest however, that the increase in the 
    purchase price of sinkers is 2 cents. EPA has estimated that the cost 
    impact of the final rule per average angler would be approximately 31 
    cents per year. However, this figure does not include the markups 
    associated with retail process. The purchase price paid for sinkers by 
    the average angler could be $1.50 to $3.50 per year, or 10 to 25 cents 
    per day of fishing. In any case, the increased price in fishing sinkers 
    is relatively minimal in comparison to the total cost incurred by 
    anglers for other expenditures such as fishing rods, reels, and other 
    tackle, licenses, fishing trips, and boats.
    
    C. Benefits of Proposal
    
        Conducting a benefits analysis is complicated by a number of 
    factors. First, the large number of bird species potentially at risk, 
    the paucity of available data on local bird populations, deaths from 
    all causes, and on deaths from lead- or zinc-containing sinker 
    ingestion make it difficult to estimate current exposures and effects. 
    Second, it is difficult to estimate the probability that a lost lead- 
    or zinc-containing sinker will be picked up by an individual bird. 
    Last, the accumulation of lead in the environment based on historical 
    fishing, together with uncertainties about its continued availability 
    to migratory waterbirds, creates problems for estimating the potential 
    effectiveness of alternative regulatory options in reducing exposure 
    and observed effects. Because of these difficulties, the approach taken 
    in the benefits analysis is to illustrate the potential routes of 
    exposure and describe the circumstances that suggest that significant 
    numbers of waterbirds are potentially at risk.
        The benefits are presented in terms of number of sinkers removed 
    from the market. As indicated in Unit III.D. of this preamble, one 
    lead- or zinc-containing sinker can generally lead to mortality. 
    Following this assumption, this analysis provides estimates of the 
    number of these ``toxic'' sinkers removed from the marketplace as a 
    result of a regulatory option. This information provides an indication 
    of the potential for a regulatory option to reduce exposure and risk to 
    birds. While this approach cannot definitively describe absolute risk 
    reduction, it is an effective means of comparing regulatory options.
        For the regulatory options that EPA considered, the estimated 
    number of ``toxic'' sinkers entering the environment which would be 
    avoided over a 10-year period ranged from near zero to near 4.8 
    billion. The number of sinkers in the environment avoided over 10 years 
    resulting from the regulatory option proposed in this rule, a ban on 
    the manufacture, processing, and distribution in commerce, is 
    approximately 4.2 billion fishing sinkers or 470 million sinkers per 
    year. This estimate assumes that the regulation is effective in 
    reducing the home manufacture of lead fishing sinkers. Therefore, this 
    estimate represents a decrease in the number of lead sinkers alone of 
    89 percent. The remainder of lead, zinc, and brass sinkers left on the 
    market will consist of sinkers greater than 1 inch in size.
        EPA also reviewed relevant economic valuation literature for the 
    variety and range of values associated with the loss of birds. The 
    range of values which is developed in the analysis is used to produce 
    an estimate analogous to a break-even estimate of the number of birds 
    required to generate positive net benefits from the regulatory option. 
    This range is based solely on the relative costs of each of the options 
    and does not address the effectiveness or cost-effectiveness of any 
    given option in terms of risk reduction.
        Birds have value to society for a variety of reasons. Values 
    include those from: bird watching; as part of and essential to the 
    health of the ecosystem, its structure or function; biodiversity value; 
    aesthetic environment for hikers, campers, anglers, and nature walkers 
    in national and state parks and other natural environments; potential 
    future genetic or medical value; and game for hunting.
        For example, approximately 58 million persons engaged in non-
    consumptive, non-residential recreation involving various forms of 
    wildlife including birds. Recreational benefits or expenditure 
    associated with birds including birdwatching, photography, and feeding 
    is estimated to be $18.1 billion, or approximately $310 per spender. 
    Other non-consumptive recreational benefits have examined endangered 
    species such as the whooping crane. A valuation study found that 
    persons were willing to pay $21 to $149 per year for a refuge that 
    would help protect the crane which they could visit.
        Because environmental benefits are usually not traded as market 
    goods and services, estimating values for these benefits is difficult. 
    However, economists have developed approaches with which to estimate 
    these values.
        Previously conducted valuation studies on birds are used in this 
    analysis to produce an estimate of the number of non-endangered birds 
    for which the regulatory costs would equal the value of birds for 
    purposes of comparing regulatory options. This is similar in concept to 
    a break-even point. Valuation studies which have been used focus 
    primarily on use value and, thus, do not account for values which 
    society places on endangered species, such as the Mississippi Sandhill 
    Crane, which may be positively affected by the regulation. In addition, 
    the estimates do not account for the value of risk reduction to human 
    health which will occur as a result of the regulatory requirements. 
    Thus, any ranges calculated can help to indicate the potential number 
    of birds that would have to be saved to provide net benefits solely on 
    the basis of benefits to non-threatened or non-endangered birds. The 
    range offers useful guidance in comparing regulatory options, but does 
    not measure absolute benefits or risk reduction.
        To calculate the range, the costs of the selected regulatory option 
    were divided by the estimated range of values for non-threatened or 
    non-endangered birds. The results of EPA's analysis indicate that a 
    likely breakeven range is equal to 367,000 to 3.4 million non-
    threatened or non-endangered birds. While not trivial, the upper bound 
    of this estimate, 3.4 million birds, represents only 5 percent of the 
    estimated fall population of game birds, which embody only a portion of 
    the potentially affected species. Additionally, if as few as one 
    percent of the sinkers removed from the market each year caused 
    waterbird deaths, approximately 4.7 million birds could potentially be 
    saved as a result of the regulation, well in excess of the high end of 
    the estimated breakeven range.
        While reductions in risk to human health and endangered species 
    have not been quantified, they cannot be ignored. Because the proposed 
    regulation encompasses home manufacture, human health benefits are 
    expected because exposure to lead fumes and dust during the home 
    manufacturing process are expected to be eliminated. Finally, several 
    endangered species are potentially at risk from smaller lead- and zinc-
    containing sinkers. The values for these birds have not been accounted 
    for, yet evidence suggests that society does place a high value on 
    endangered species. For instance, in 1991, an estimated $1.37 million 
    was spent on preservation efforts for the Mississippi Sandhill Crane 
    alone. While not necessarily a measure of the social value of 
    individuals of this species, it does suggest that these values are 
    real.
    
    D. Cost-effectiveness
    
        The Agency also compared the costs of various regulatory options 
    relative to the benefits achieved by each option. For this analysis, 
    cost-effectiveness was evaluated as cost per 1,000 ``toxic'' or lead- 
    and zinc-containing sinkers removed from the market. This type of 
    analysis can be useful in two ways: (1) For regulatory options yielding 
    similar quantified benefits, it can assist EPA in identifying the most 
    cost-effective options, and (2) for regulatory options yielding 
    dissimilar or quantified and non-quantifiable benefits (as in this 
    analysis), it can assist EPA in identifying the incremental increase in 
    cost per unit increase in quantifiable benefits. This analysis shows 
    that a ban solely of split shot would have the lowest cost per 1,000 
    sinkers avoided. EPA is not proposing a ban on split shot alone because 
    such a ban, on an annual basis, would address only 68 percent of lead 
    sinkers 1 inch or less in size. EPA believes this option would be an 
    inadequate response to the risks posed to waterbirds. The proposed 
    option, however, increases benefits to include 100 percent of fishing 
    sinkers 1 inch or less on an annual basis, at a still reasonable cost. 
    In addition, the proposed option offers benefits to human health which 
    would not accrue under a ban solely on split shot. EPA is not proposing 
    a ban on fishing sinkers over 1 inch in any dimension, or an immediate 
    ban of sinkers, in part, because this analysis showed that the 
    incremental costs were high relative to the benefits achieved.
    
    VI. Other Options Considered
    
    A. Summary
    
        In granting the petition, EPA agreed to examine labeling as one 
    course of action. However, EPA also considered a number of other 
    regulatory options such as: (1) A comprehensive ban on all sizes and 
    types of lead- and zinc-containing fishing sinkers; (2) a geographic 
    ban on lead- and zinc-containing fishing sinkers; (3) a prohibition on 
    the manufacture, processing, and distribution in commerce of lead- and 
    zinc-containing fishing sinkers under 2 inches in size; (4) a 
    prohibition on the manufacture, processing, and distribution in 
    commerce of lead and zinc-containing split shot fishing sinkers; (5) a 
    prohibition or limitation on the amount of lead and zinc allowable in a 
    fishing sinker; and (6) the use of an economic incentive or fee on the 
    sale of lead- and zinc-containing fishing sinkers. These options are 
    not mutually exclusive, and could be proposed in conjunction with one 
    another. Although EPA did examine a combination of some options (e.g., 
    labeling and ban), the Agency evaluated each individual option's 
    ability to reduce the number of sinkers available for exposure to 
    waterbirds. After consideration of the options and the available 
    information, EPA believes that the proposal to prohibit the 
    manufacture, processing, and distribution in commerce of smaller 
    fishing sinkers that contain lead and zinc is the least burdensome 
    means to adequately address the unreasonable risk of injury posed by 
    fishing sinkers to waterbirds.
    
    B. Labeling
    
        The petitioners' section 21 petition requested that the Agency 
    require a label on lead fishing sinker packaging. However, the petition 
    also stated that depending upon the ``efficacy of the action requested 
    of EPA today, it may at some point in the future be necessary for EPA 
    to restrict further the manufacture, distribution, and sale of lead 
    fishing sinkers under TSCA'' (Ref. 5).
        A proposal to label could include the following: (1) Placing a 
    label or warning notice on lead- and zinc-containing fishing sinker 
    packaging stating that the product is toxic to waterbirds; (2) for 
    sinkers sold in bulk, requiring retailers to post a sign with similar 
    language; and (3) requiring catalogues selling fishing sinkers to 
    contain language regarding the toxicity of the sinkers. This label 
    could be placed on fishing sinkers manufactured and sold for use in the 
    United States, and well as those for export. The goal of such a label 
    would be to modify consumer behavior and cause anglers to purchase less 
    toxic sinkers.
        Labels generally provide consumers with information indicating how 
    to use a product safely. However, in this case, labeling would have 
    little effect on the quantity of toxic sinkers lost in the environment, 
    regardless of how careful anglers are. One ingested lead- or zinc-
    containing sinker can be enough to cause death to a waterbird.
        Additionally, labels provide consumers with information regarding 
    the risks associated with the product. The Agency has reviewed studies 
    regarding factors affecting labeling effectiveness and concludes that 
    consumers generally respond more readily to labels which state or 
    suggest that an immediate and significant personal risk is associated 
    with that product (Ref 31). In situations where the product would not 
    pose such a risk (as is the case with anglers purchasing and using 
    fishing sinkers), studies indicate that a label is often less effective 
    in changing consumer response (Ref 31). Therefore, it is questionable 
    whether a label would be effective in causing consumers to purchase 
    other types of fishing sinkers.
        EPA examined various rates of consumer response to a labeling 
    provision in order to assess the impacts of such an option. The 
    response rates evaluated include, 0, 5, and 10 percent, where a 0 
    percent response rate indicates that there would be no change in 
    consumer purchasing behavior. EPA estimates that at a 5 percent 
    response rate, approximately 22 million lead- and zinc-containing 
    sinkers annually would not be purchased, and approximately 45 million 
    sinkers annually would not be purchased at a response rate of 10 
    percent. In comparison, the proposed option, a ban on the manufacture, 
    processing, and distribution in commerce of lead- and zinc-containing 
    fishing sinkers, would result in removing over 450 million sinkers from 
    the market on an annual basis, preventing them from entering the 
    environment and becoming available for ingestion by waterbirds.
        The Agency believes that labeling would not significantly affect 
    the number of toxic sinkers lost in the environment and would only 
    minimally affect consumer purchasing behavior. Therefore, the Agency 
    believes that labeling would not adequately reduce any unreasonable 
    risks of injury to waterbirds.
    
    C. Comprehensive Ban, No Size Limit
    
        This option would prohibit the manufacture, processing, and 
    distribution in commerce of all types and sizes of lead- and zinc-
    containing fishing sinkers. This would guarantee the future elimination 
    of all sizes and types of these sinkers in the environment. EPA 
    believes this option would be unduly burdensome and would unnecessarily 
    place restrictions on the types of sinkers that are not readily 
    ingested by waterbirds, and, therefore do not pose a significant risk 
    to those species. The Agency believes that there are less costly 
    options which would effectively reduce the number of sinkers available 
    for exposure to waterbirds. Therefore, EPA rejected this option.
    
    D. Geographic Ban
    
        EPA also considered a geographic ban to restrict the sale of lead- 
    and zinc-containing fishing sinkers in certain areas such as those with 
    freshwater habitats (e.g., near lakes, ponds, or rivers), or in 
    habitats of affected species (see Unit III.E.3. of this preamble). The 
    Agency rejected this option because these areas would essentially 
    include the entire United States, and would be very difficult to 
    enforce. In addition, waterbirds are migratory and could easily ingest 
    sinkers in areas where the sale of these fishing sinkers was not 
    prohibited. Anglers are also mobile, and could buy the sinkers in one 
    location, and use them in another area where their sale is prohibited, 
    thus defeating the purpose of the prohibition. For these reasons, EPA 
    rejected this option.
    
    E. Ban on Sinkers 2 Inches or Less in Size
    
        EPA considered prohibiting the manufacture, processing, and 
    distribution in commerce of lead- and zinc-containing fishing sinkers 
    which were 2 inches and less in any dimension. EPA believes 2 inches is 
    a diameter to which larger species, such as sandhill cranes, can expand 
    their esophagus to swallow food or other items. However, after further 
    consideration, although larger birds are physically capable of 
    swallowing sinkers greater than 1 inch, EPA believes that most 
    waterbirds would not likely ingest sinkers of that size. Moreover, the 
    majority of sinkers over 1 inch in any dimension are used for fishing 
    in the ocean, and would not be readily available for exposure to 
    waterbirds. This option is less cost effective than the proposed option 
    in terms of removing lead- and zinc-containing fishing sinkers from the 
    market. This generally occurs because the number of total sinkers 
    between 1 and 2 inches is small compared with the cost of regulating 
    them. For these reasons, EPA rejected regulating sinkers over 1 inch 
    and less than 2 inches in any dimension.
    
    F. Ban on Split Shot Sinkers Only
    
        EPA examined placing restrictions on the type of lead- and zinc-
    containing fishing sinkers which could be produced or sold. 
    Specifically, EPA considered limiting split shot type sinkers because 
    they constitute a significant market segment of the types of lead- and 
    zinc-containing sinkers currently produced. However, while prohibiting 
    the manufacture, processing, and distribution in commerce of these type 
    sinkers would capture a large portion of sinkers available for 
    exposure, EPA believes that regardless of shape, sinkers 1 inch or less 
    in any dimension pose the same risk to waterbirds. As discussed earlier 
    in this preamble, both split shot and non-split shot sinkers have been 
    found in waterbirds that have died from lead poisoning. A ban solely on 
    split shot would not adequately reduce the number of sinkers deposited 
    in the environment.
        In addition, EPA believes that the majority of the home 
    manufacturers produce non-split shot fishing sinkers. An option to only 
    restrict split shot sinkers would not reduce any human health risks 
    associated with the home manufacture of non-split shot. For these 
    reasons, EPA rejected this option.
    
    G. Regulation of Lead and Zinc Content in Sinkers
    
        EPA also examined regulating lead and zinc content by weight, or by 
    percentage of lead and zinc present in each sinker. A specific weight 
    or percentage limit would not effectively address the low level of lead 
    or zinc which when ingested by waterbirds could result in a lethal dose 
    (parts per million range). It may not be feasible to measure accurately 
    such a small amount of lead or zinc, making it troublesome for industry 
    to comply with the option, and difficult for the government to enforce 
    adequately. EPA has therefore rejected this option.
    
    H. Economic Incentive
    
        The Agency considered placing a fee on the sale of lead- and zinc-
    containing fishing sinkers. While this option would encourage 
    manufacturers, the cottage industry, or consumers to switch to 
    substitutes, it is difficult to predict the risk reduction that would 
    result from a given fee. In addition, home manufacturers would not be 
    subject to a fee unless they sold the sinkers. As such, the quantity of 
    sinkers manufactured at home would not be expected to decrease as a 
    direct result of the fee (in fact it may increase as consumers attempt 
    to avoid the fee on purchased sinkers) possibly undermining the 
    intended change expected from the fee. For these reasons, EPA rejected 
    this option.
    
    VII. Other Federal Statutes
    
    A. Endangered Species Act
    
        The Endangered Species Act (16 U.S.C. 1531 to 1544) was enacted to 
    protect and preserve plants and animals that have been designated by 
    the Secretary of the Interior as endangered or threatened. The 
    Mississippi sandhill crane is listed as an endangered species under 50 
    CFR 17.11. EPA has an obligation to conserve the Mississippi sandhill 
    crane, and to consult with the Secretary of the Interior (through the 
    FWS) to insure the action specified in this proposal is not likely to 
    jeopardize the continued existence of the crane, or other endangered 
    species, or result in the destruction or adverse modification of their 
    habitats.
        While this proposal is intended to protect and preserve all 
    waterbirds, the Agency is especially concerned about the continued 
    existence of the endangered Mississippi sandhill crane, and potential 
    risk posed to other endangered and threatened species by lead- and 
    zinc-containing fishing sinkers. Other endangered species such as the 
    whooping crane, Aleutian canada goose, peregrine falcon, and possibly 
    the bald eagle could also benefit from this rule as proposed. A 
    prohibition on the manufacture and sale of lead- and zinc-containing 
    fishing sinkers would prevent future exposures and risks to these 
    cranes and other endangered or threatened species. Although there has 
    only been one reported death of a Mississippi sandhill crane due to 
    lead poisoning, possibly from a lead fishing sinker, the Agency is 
    concerned about each individual of an endangered species, and its 
    importance to the continued survival of the species.
        EPA has conferred with the FWS during the development of this 
    proposed rule, to receive their input regarding the scientific aspects 
    of this proposal, and to ensure that there is coordination between both 
    agencies.
    
    B. Migratory Bird Treaty Act
    
        In considering this action under TSCA, EPA is also mindful of other 
    statutes intended to protect birds such as the Migratory Bird Treaty 
    Act (MBTA) (16 U.S.C. 703). Under the MBTA, it is unlawful to ``take'' 
    migratory birds whether by killing, possessing, or trading except as 
    permitted by regulations. Section 703 of the MBTA prohibits ``by any 
    means or in any manner, to. . .take, capture, kill, attempt to take, 
    capture, or kill. . . migratory birds.'' The MBTA applies to ingestion 
    of lead by birds as seen by action taken by the FWS to ban the use of 
    lead shot to hunt certain waterfowl species. Numerous migratory 
    waterfowl have died from lead poisoning due to ingestion of spent lead 
    ammunition. Species such as sandhill cranes, and trumpeter, mute, and 
    tundra swans are migratory birds which would be protected under the 
    MBTA.
        EPA believes that the MBTA is complimentary to the TSCA in 
    potentially reducing risks to waterbirds. While this rule as proposed 
    would regulate the manufacture, processing, and distribution in 
    commerce of fishing sinkers in the United States, the Department of 
    Interior has the authority to regulate the manner or method of fishing 
    on lands under their control.
    
    C. Other EPA Activities
    
        EPA has been active in protecting migratory birds, and signed a 
    Memorandum of Agreement along with the FWS, U.S. Forest Service, Bureau 
    of Land Management, National Park Service, Department of the Navy, and 
    the Agency for International Development on May 14, 1991, establishing 
    the Neotropical Migratory Bird Conservation Program (``Partners in 
    Flight''). This program, now comprised of many other Federal and State 
    agencies, non-governmental organizations, and academia addresses noted 
    population declines of migratory bird species which nest and breed in 
    North America and winter in Mexico, Central and South America, and the 
    Caribbean. In concert with other ``Partners in Flight,'' EPA plays a 
    major role in maintaining the environmental quality of migratory bird 
    habitats.
    
    VIII. Coordination with Other Federal Agencies
    
        Concurrent with petitioning EPA under section 21 of TSCA, on 
    October 20, 1992, the EDF, North American Loon Fund, Trumpeter Swan 
    Society, and Federation of Fly Fishers also petitioned the Department 
    of Interior (DOI) to utilize its authorities under the Migratory Bird 
    Treaty Act, 16 U.S.C. sections 703-712, the National Wildlife Refuge 
    System Administrator Act, 16 U.S.C. sections 668dd and 668ee, and the 
    National Park Service Act, 16 U.S.C. sections 1-3, to prohibit, by 
    regulation, the use of lead weights for fishing on any National 
    Wildlife Refuge or National Park where the trumpeter swan or common 
    loon breeds or stops over during migration. On June 4, 1993, DOI 
    published a Federal Register notice requesting comment on the petition 
    (58 FR 31740). Comments were due by September 2, 1993. It is EPA's 
    understanding that DOI is still developing its response to the 
    petition.
        Under section 9 of TSCA, EPA is directed to consider whether the 
    risk to be addressed by regulatory action under TSCA may be prevented 
    or reduced to a sufficient extent by action taken under a Federal law 
    not administered by EPA. EPA recognizes that in the area of protection 
    of wildlife, and specifically of waterbirds and other avian species, 
    there are some areas of overlap between the statutory authorities 
    administered by EPA and DOI. However, some activities, the regulation 
    of which could protect wildlife (e.g., regulation of the manufacture, 
    processing, and distribution in commerce of chemical substances), are 
    clearly within the purview of EPA.
        At this point, EPA has preliminarily determined that the potential 
    unreasonable risks to waterbirds would not be sufficiently prevented or 
    reduced through future regulatory initiatives by DOI so as to make 
    regulatory action under TSCA unnecessary. As discussed above, EPA has 
    worked closely in the past with a number of federal agencies, including 
    DOI, to protect migratory birds. EPA has also conferred with the FWS of 
    the DOI to ensure that there is coordination between the two agencies. 
    EPA will continue to confer with and coordinate its activities with DOI 
    in the course of this rulemaking to ensure a unified approach that 
    adequately protects human health and the environment, and avoids 
    unnecessary or duplicative Federal regulation.
    
    IX. Unreasonable Risk
    
    A. Standard
    
        To promulgate a rule under TSCA section 6(a), EPA must find that 
    there is a ``reasonable basis to conclude'' that activities involving a 
    chemical substance or mixture present or will present ``an unreasonable 
    risk of injury to health or the environment.'' The finding of 
    unreasonable risk is a judgement under which the decision-maker 
    determines that the risk of health or environmental injury from the 
    chemical substance or mixture outweighs the burden to society of 
    potential regulations.
        It is important to note that section 6 of TSCA does not require a 
    factual certainty, but only a ``reasonable basis to conclude'' that a 
    risk is unreasonable. The legislative history of TSCA makes it quite 
    clear that EPA may take regulatory action to prevent harm even though 
    there are uncertainties as to the threshold levels of risk. Congress 
    recognized that in addition to basing its decision on known facts, EPA 
    must, of necessity, often base its action on scientific theories, 
    consideration of projections from available data, modelling using 
    reasonable assumptions, and extrapolations from limited data. (H.R. 
    Rep. No. 1341, 94th Cong., 2d Sess. 32 (1976))
        Although TSCA uses unreasonable risk as its basic standard for 
    deciding on appropriate action regarding the manufacture, processing, 
    distribution in commerce, use, or disposal of a chemical substance or 
    mixture, TSCA does not define the term ``unreasonable risk.'' The only 
    guidance in the statute is provided in section 6(c), which established 
    the requirements that to make an unreasonable risk determination under 
    section 6(a), EPA must consider the following: (1) The effects of the 
    chemical on health and the magnitude of its exposure to humans; (2) the 
    effects of the chemical on the environment and the magnitude of its 
    exposure to the environment; (3) the benefits of the chemical for 
    various uses and the availability of substitutes for such uses; and (4) 
    the reasonably ascertainable economic consequences of the rule, after 
    consideration of the effect on the national economy, small business, 
    technological innovation, the environment, and public health.
        Section 6(c) offers no further guidance to decisionmakers. In 
    particular, it does not discuss how each of these factors are to be 
    weighed in relationship to each other. Consequently, guidance on 
    implementation of the unreasonable risk standard in regulatory 
    decisionmaking requires consideration of the legislative history. The 
    House Report on TSCA (H.R. Rep. No. 1341, 94th Cong., 2d Sess. 13-15 
    (1976)) provides the most useful pertinent explanation. The House 
    Report describes the finding of unreasonable risk as involving a 
    balancing of the probability that harm will occur, and the magnitude 
    and severity of that harm, against the adverse effects (social and 
    economic) on society of the proposed Agency action to reduce the harm. 
    In other words, unreasonable risk involves a weighing of the risks to 
    be reduced by Agency action and the consequences of the action.
    
    B. Finding
    
        Utilizing this analysis, EPA has evaluated the following elements 
    to make its preliminary ``unreasonable risk'' finding: (1) Evidence of 
    the toxicity of lead and zinc, (2) effects of lead fishing sinkers on 
    waterbirds, (3) species exposed and adversely affected by lead-
    containing and potentially affected by zinc-containing fishing sinkers, 
    (4) potential magnitude of exposure to lead- and zinc-containing 
    fishing sinkers, (5) substitutes for lead- and zinc-containing fishing 
    sinkers, and (6) economic impacts of imposing the proposed rule. Each 
    individual element is discussed in detail in Units III. and V. of this 
    preamble.
        EPA has weighed the risks of injury to waterbirds from continued 
    use of smaller lead- and zinc-containing fishing sinkers against the 
    costs of eliminating the manufacture, processing, and distribution in 
    commerce of such sinkers. The Agency believes that the benefits of 
    eliminating the effects to waterbirds of ingesting these fishing 
    sinkers outweigh the costs to society of the rule as proposed based on 
    the following:
        1. The toxicity associated with lead exposure is well documented. A 
    review of extensive research on the toxicity of lead to waterbirds 
    leads to the conclusion that ingestion of lead fishing sinkers poses a 
    significant hazard to waterbirds. Specifically, common loons, trumpeter 
    swans, mute swans, sandhill cranes, and tundra swans have been 
    demonstrated to ingest lethal amounts of lead, either intentionally, 
    accidently, or incidentally, while feeding in aquatic habitats 
    containing discarded lead sinkers. Research has shown that one small 
    lead fishing sinker is enough to cause mortality in these and other 
    waterbirds. In addition, based on the toxicity of lead and zinc, other 
    lead-containing or zinc-containing fishing sinkers such as brass would 
    also pose a risk to waterbirds.
        2. Lead and zinc are persistent in the environment. As more lead- 
    and zinc-containing sinkers are produced and sold, more may enter 
    ecosystems where they can become available to waterbirds.
        3. The rule as proposed would create benefits by preventing 
    potential waterbird deaths. It is estimated that the proposed ban would 
    prevent over 450 million lead- and zinc-containing fishing sinkers that 
    have any dimension 1 inch or less from being produced each year, and 
    potentially from entering the environment.
        4. Waterbirds have many benefits to society for reasons such as 
    bird watching, photography, biodiversity, part of and essential to the 
    health of the ecosystem, potential future genetic or medical value, 
    contributing to the aesthetic environment for hikers, campers and 
    anglers, and game for hunting. It is clear that significant public and 
    private expenditures are made to protect and enjoy these birds.
        5. Although the magnitude of the effect lead fishing sinkers have 
    on waterbird populations is uncertain, it is reasonable to conclude 
    that as more lead fishing sinkers are discarded or lost in the 
    environment and are available for ingestion, further deaths will occur. 
    In the case of endangered species particularly, each individual is 
    valuable and vital to the continuation of the species.
        6. Scientific evidence has demonstrated that zinc is also very 
    toxic to waterbirds (exposure to mallards has resulted in their death), 
    aquatic organisms, and mammals. Based on EPA's comparative toxicity 
    analysis, ingestion of zinc-containing fishing sinkers could also cause 
    death in waterbirds.
        7. Substitutes for lead- and zinc-containing fishing sinkers are 
    available which perform as well as lead and zinc, albeit at a higher 
    cost. These sinkers can be manufactured using existing technologies.
        8. EPA's analysis indicates that the costs of this proposed 
    rulemaking will not result in serious economic consequences for small 
    businesses or the national economy, and would result in minimal 
    economic consequences for anglers. The annual cost of the rule as 
    proposed to the average angler is less than $4.00.
        9. A vast number of lead fishing sinkers are made by persons at 
    home. Exposure to lead may cause severe adverse health effects such as 
    brain damage in children, miscarriages, and hypertension. The rule as 
    proposed may assist in preventing exposures which may result from the 
    lead vapors or fumes created when making sinkers, and potential risks 
    to human health.
        After examination of these factors, EPA has preliminarily concluded 
    that the continued manufacture, processing, and distribution in 
    commerce of fishing sinkers that contain any lead or zinc, and that 
    have any dimension 1 inch or less, presents or will present an 
    unreasonable risk of injury to waterbirds.
    
    X. Issues for Comment
    
        While EPA solicits comment on all aspects of this proposal, the 
    Agency specifically requests comments on the following issues: (1) The 
    size of fishing sinkers prohibited from being manufactured, processed, 
    and distributed in commerce; (2) whether the prohibitions will create 
    difficulties for manufacturers of other types of fishing sinkers 
    containing small amounts or impurities of lead and zinc; (3) the level 
    at which lead or zinc impurities are present in other type of metals 
    used for fishing sinkers; (4) additional avian or aquatic toxicity 
    information for antimony, brass, tin, copper, bismuth, tungsten, 
    terpene resin, polypropylene, and iron; (5) whether other types of 
    sinkers should be included under the proposed ban; (6) whether the 
    manufacture and sale of lead jigs should be prohibited or limited, and 
    if so, how could the Agency distinguish jigs from other types of lures; 
    (7) whether lead jigs are a likely or suitable substitute for lead 
    fishing sinkers; (8) whether other suitable less toxic substitutes are 
    available; (9) the effective date, or timing of the manufacture, 
    processing, and distribution ban on lead- and zinc-containing fishing 
    sinkers; (10) any further information which indicates that either lead- 
    and zinc-containing fishing sinkers, jigs, lures, or other uses of lead 
    in fishing equipment may be toxic to waterbirds, or other wildlife; 
    (11) studies or any other information regarding the valuation or 
    benefits of waterbirds, other birds, or endangered species (particular 
    avian), or methods to estimate those benefits; (12) comments on the 
    estimates of the cost associated with the proposed rule; (13) whether 
    the proposal would inadvertently lead to greater human exposure due to 
    increased illegal home production of lead fishing sinkers; (14) 
    potential impacts of the proposed rule on small manufactuers and the 
    cottage industry; (15) EPA's definition of fishing sinker; (16) 
    information, studies, or comments on whether consumers' response to 
    labels that do not warn of immediate and significant personal risk is 
    likely to be small or uncertain compared to the response to labels that 
    warn of personal risk; (17) whether warning labels on lead- or zinc-
    containing fishing sinkers are likely to reduce purchases of such 
    sinkers by 0 to 10 percent; and (18) whether it is desirable or 
    feasible to pursue any of the rejected options versus the one EPA has 
    proposed.
    
    XI. Exports
    
        Section 12(b) of TSCA requires that any person who exports or 
    intends to export a chemical substance or mixture for which a rule has 
    been proposed or promulgated under section 6 of TSCA must notify EPA of 
    such exportation or intent to export. In this proposed rule, EPA is 
    addressing lead- and zinc-containing fishing sinkers. Since such 
    sinkers may consist of lead and zinc in combination with any other 
    material, EPA has concluded that it is proposing to regulate 
    ``mixtures'' in the rule for purposes of applying section 12(b) export 
    notification requirements. Thus, as a result of this proposed rule, any 
    person who exports or who intends to export any lead- or zinc-
    containing fishing sinker described in this proposed rule, to a foreign 
    country, would be required under section 12(b) of TSCA to notify EPA of 
    such exportation or intent to export. The export notification 
    requirements are described in 40 CFR part 707.
        EPA anticipates that the burden of the export notification 
    requirements will be minimal. Exporters are required only to provide 
    notification the first time they export or intend to export to each 
    country in a calendar year. The notification requirements are set forth 
    in 40 CFR part 707 and consist of the company's name and address, 
    chemical name, TSCA section that triggered the notification (in this 
    case section 6), countries that are the receivers, and the export date 
    or intended export date. As described in Unit V. of this preamble, 
    there is very little export of sinkers.
    
    XII. Recordkeeping
    
        As discussed in Unit XI. of this preamble, TSCA section 12(a) 
    authorizes EPA to impose recordkeeping requirements under TSCA section 
    8 on a chemical substance, mixture, or article containing a chemical 
    substance or mixture even when it is manufactured, processed, or 
    distributed in commerce and properly marked or labeled as being 
    intended solely for export. Section 12(b) of TSCA permits EPA to 
    require export notification for any substance or mixture regulated or 
    proposed to be regulated under TSCA section 6.
        EPA has the authority under section 8(a) of TSCA to require persons 
    to engage in recordkeeping and reporting activities. Section 8(a)(1) of 
    TSCA gives EPA authority to require persons who manufacture or process 
    chemical substances and mixtures to maintain records for manufacturing 
    purposes, including records necessary for effective enforcement of TSCA 
    requirements. Small manufacturers and processors are generally exempt 
    from recordkeeping under section 8(a). However, section 
    8(a)(3)(A)(ii)(I) provides that, when, as here, the chemical substance 
    or mixture involved is subject of a rule proposed or promulgated under 
    TSCA section 6, small manufacturers and processors also can be required 
    to report and keep records.
        Pursuant to these authorities and to ensure compliance with this 
    proposed rule and TSCA section 12(b) export notification requirements, 
    as applicable, and to assist in enforcement efforts, each person who 
    manufactures or processes fishing sinkers that would be subject to the 
    rule, after the effective date of the final rule, would be required to 
    maintain manufacturing and shipment/distribution records for a period 
    of 3 years from the date of manufacture or shipment, such as: (1) The 
    product or brand name; (2) quantity and date of sinkers manufactured, 
    processed, or shipped; (3) name, address, and telephone number of the 
    person who shipped, and who received the sinker shipment; and (4) 
    inventory records of sinkers manufactured or produced.
        EPA believes that the recordkeeping requirements will be necessary 
    for effective enforcement of the rule. This would enable EPA to ensure 
    compliance with the rule and conduct inspections effectively. 
    Examination of records would enable EPA to track distribution patterns 
    and would aid in identifying sites where a potential violation of the 
    final rule may exist.
    
    XIII. Enforcement
    
        Section 15 of TSCA makes it unlawful to fail or refuse to comply 
    with any provision of a rule promulgated under section 6 of TSCA. In 
    addition, section 15 of TSCA makes it unlawful for any person to: (1) 
    Use for commercial purposes a chemical substance which such person knew 
    or had reason to know was distributed in commerce in violation of a 
    rule under section 6; (2) fail or refuse to establish and maintain 
    records, submit reports or notices, or permit access to or copying of 
    records, as required by TSCA; or (3) fail or refuse to permit entry or 
    inspection as required by section 11 of TSCA.
        Violators may be subject to both civil and criminal liability. 
    Under the penalty provision of section 16 of TSCA, any person who 
    violates section 15 could be subject to a civil penalty of up to 
    $25,000 per day for each violation. Each day of operation in violation 
    of the rule would constitute a separate violation. Knowing or willful 
    violations of the rule could lead to the imposition of criminal 
    penalties of up to $25,000 for each day of violation or imprisonment 
    for up to 1 year, or both. In addition, other remedies are available to 
    EPA under sections 7 and 17 of TSCA, such as seeking an injunction to 
    restrain violators of the rule and seizing any chemical substance or 
    mixture manufactured or imported in violation of the rule.
        Individuals, as well as corporations, could be subject to 
    enforcement actions. Sections 15 and 16 of TSCA apply to ``any person'' 
    who violates various provisions of TSCA. EPA may, at its discretion, 
    proceed against individuals as well as companies. In particular, EPA 
    may proceed against individuals who report false or misleading 
    information or cause it to be reported.
    
    XIV. Business Confidentiality
    
        A person may assert a claim of business confidentiality for any 
    public comments submitted to EPA in connection with the proposed rule. 
    Any person who submits a public comment that contains information 
    claimed as confidential, must also submit a nonconfidential version. 
    Any claim of confidentiality must accompany the information when it is 
    submitted to EPA. Persons may claim information confidential by 
    circling, bracketing, or underlining it, and marking it with 
    ``CONFIDENTIAL'' or some other appropriate designation. EPA will 
    disclose information subject to a claim of business confidentiality 
    only to the extent permitted by section 14 of TSCA and 40 CFR part 2, 
    subpart B. If a person does not assert a claim of confidentiality for 
    information in public comments at the time it is submitted to EPA, the 
    Agency will put the comments in the public docket without further 
    notice to that person.
    
    XV. Hearing Procedures
    
        If persons request time for oral comment, EPA will hold informal 
    hearings in Washington, DC. Any informal hearing will be conducted in 
    accordance with EPA's ``Procedures for Conducting Rulemaking under 
    Section 6 of the Toxic Substances Control Act'' (40 CFR part 750). 
    Persons or organizations desiring to participate in the informal 
    hearing must file a written request to participate. The written request 
    to participate must be sent to the Environmental Assistance Division at 
    the address listed under FOR FURTHER INFORMATION CONTACT by [insert 
    date 60 days after date of publication in the Federal Register]. The 
    written request to participate must include: (1) A brief statement of 
    the interest of the person or organization in the proceeding; (2) a 
    brief outline of the points to be addressed; (3) an estimate of the 
    time required; and (4) if the request comes from an organization, a 
    non-binding list of the persons to take part in the presentation. 
    Organizations are requested to bring with them, to the extent possible, 
    employees with individual expertise in and responsibility for each of 
    the areas to be addressed. Organizations which do not file main 
    comments in the rulemaking will not be allowed to participate at the 
    hearing, unless the Record and Hearing Clerk grants a waiver of this 
    requirement in writing.
    
    XVI. Rulemaking Record
    
        In accordance with the requirements of section 19(a)(3) of TSCA, 
    EPA has established a record for this rulemaking [docket number OPPTS-
    62134]. This record includes information considered by the Agency in 
    developing the proposed rule, and will include comments on the proposed 
    rule. A public version of the record which does not include information 
    claimed as confidential business information is available to the public 
    in the Nonconfidential Information Center (NCIC). The NCIC is located 
    in Rm. E-G102, 401 M St., SW., Washington, DC 20460, and is open from 
    noon to 4 p.m., Monday through Friday except legal holidays.
    
    XVII. Support Documents
    
        1. Smrchek, Jerry, U.S. EPA Environmental Effects Branch, Office of 
    Pollution Prevention and Toxics. Ecological Hazard and Exposure 
    Assessment of Lead Fishing Weights to Birds, With A Discussion of 
    Possible Substitutes, and Their Effects on Birds and Aquatic Organisms. 
    February 3, 1994.
        2. ICF Incorporated. Economic Analysis of Options for Regulating 
    Lead and Other Toxic Fishing Sinkers. Prepared for the Office of 
    Pollution Prevention and Toxics, Economics, Exposure, and Technology 
    Division, Regulatory Impacts Branch. February 6, 1994.
    
    XVIII. References
    
        1. Birkhead, M. 1982. Causes of Mortality in the Mute Swan Cygnus 
    olor On the River Thames. Journal of Zoology. London. 198:15-25.
        2. Blus, L.J., R.K. Stroud, B. Reiswig, and T. McEneaney. 1989. 
    Lead Poisoning and Other Mortality Factors in Trumpeter Swans. 
    Environmental Toxicology and Chemistry. 8:263-271.
        3. Ciba-Geigy Corporation v. United States Environmental Protection 
    Agency. 874 F.2d 277 (5th Cir. 1989).
        4. Ensor, K.L., D.D. Helwig, and L.C. Wemmer. 1992. Mercury and 
    Lead in Minnesota Common Loons (Gavia immer). Water Quality Division, 
    Minnesota Pollution Control Agency, St. Paul, Minnesota.
        5. Environmental Defense Fund, Federation of Fly Fishers, The 
    Trumpeter Swan Society, and the North American Loon Fund October 20, 
    1992. Petition to EPA Administrator William K. Reilly pursuant to the 
    Toxic Substances Control Act, and the Administrative Procedure Act.
        6. Environmental Defense Fund, Mr. Bruce Manheim. December 10, 
    1992. Letter to EPA Administrator William K. Reilly.
        7. Environmental Defense Fund, Mr. Bruce Manheim and Mr. Michael 
    Bean. January 26, 1993. Letter to EPA Administrator Carol Browner.
        8. Environmental Defense Fund, Inc. v. Carol Browner and the 
    Environmental Protection Agency. Amended Complaint for Declaratory and 
    Injunctive Relief filed in United States District Court for the 
    District of Columbia. Civil Action Number 93-0532. May 18, 1993.
        9. Environmental Defense Fund, Inc. v. Carol Browner and the 
    Environmental Protection Agency. Joint Motion for Continuance filed in 
    United States District Court for the District of Columbia. Civil Action 
    Number 93-0532. June 22, 1993.
        10. Franson, J.C., 1992. Causes of Mortality in Common Loons. 
    Abstract of Presentation at the ``Symposium on the Loon and Its 
    Ecosystem: Status, Management, and Environmental Concerns,'' College of 
    the Atlantic, Maine.
        11. Locke, L.N. and L.T. Young. 1973. An Unusual Case of Lead 
    Poisoning in a Whistling Swan. Maryland Birdlife. 29(3):106-107.
        12. Locke, L.N., S.M. Kerr, and D. Zoromski. 1981. Lead Poisoning 
    in Common Loons (Gavia immer). Avian Diseases. 26(2):392-396.
        13. Pokras, M.A., and R., Chafel. 1992. Lead Toxicosis From 
    Ingested Fishing Sinkers in Adult Common Loons (Gavia immer) in New 
    England. Journal of Zoo and Wildlife Medicine. 23(1):92-97.
        14. Pokras, M.A., Tufts University School of Veterinary Medicine. 
    Personal communication to N. Laurson, EPA, Office of Pollution 
    Prevention and Toxics. Photocopy of Lead Fishing Sinkers Found in 
    Common Loons Which Died of Lead Poisoning. September 2, 1993.
        15. Rose Lake Wildlife Research Center. Wildlife Disease 
    Laboratory. Mortality Summary Tables and Necropsy Records for Common 
    Loon and Mute Swan Mortalities in Michigan 1988-1993.
        16. Simpson, V. R., A.E. Hunt, and M.C. French. 1979. Chronic Lead 
    Poisoning in a Herd of Mute Swans. Environmental Pollution. 18:187-202.
        17. U.S. Department of the Interior, Fish and Wildlife Service, 
    National Wildlife Health Research Center. Summary of Necropsy Records 
    for Common Loons and Trumpeter Swans. April 13, 1993.
        18. U.S. Department of the Interior, Fish and Wildlife Service, 
    National Wildlife Health Research Center. Diagnostic Services Case 
    Report Number 10625. April 20, 1992.
        19. U.S. Department of the Interior, Fish and Wildlife Service. 
    Endangered Species Technical Bulletin, Vol. 27 Nos. 3-8 1992. p. 16.
        20. United States District Court for the District of Columbia. 
    Order Granting Joint Motion for Continuance filed in United States 
    District Court for the District of Columbia. Environmental Defense 
    Fund, Inc. v. Carol Browner and the Environmental Protection Agency. 
    Civil Action Number 93-0532. July 2, 1993.
        21. U.S. Environmental Protection Agency. Office of Prevention, 
    Pesticides and Toxic Substances. Letter to Mr. Bruce Manheim and Mr. 
    Michael Bean, Environmental Defense Fund from Deputy Office Director, 
    Office of Pollution Prevention and Toxics. Receipt of Section 21 
    Petition Regarding Lead Fishing Sinkers. November 23, 1992.
        22. U.S. Environmental Protection Agency. Office of Prevention, 
    Pesticides and Toxic Substances. Letter to Mr. Bruce Manheim and Mr. 
    Michael Bean, Environmental Defense Fund from Assistant Administrator 
    for Prevention, Pesticides and Toxic Substances. Response to Section 21 
    Petition Regarding Lead Fishing Sinkers. January 14, 1993.
        23. U.S. Environmental Protection Agency. Office of Prevention, 
    Pesticides and Toxic Substances. Letter to Mr. Bruce Manheim and Mr. 
    Michael Bean, Environmental Defense Fund from Assistant Administrator 
    for Prevention, Pesticides and Toxic Substances. Response to January 
    26, 1993 Letter Regarding Lead Fishing Sinkers. March 11, 1993.
        24. U.S. Environmental Protection Agency. Office of Prevention, 
    Pesticides and Toxic Substances. Letter to Mr. Bruce Manheim and Mr. 
    Michael Bean, Environmental Defense Fund from Assistant Administrator 
    for Prevention, Pesticides and Toxic Substances. Update on Progress in 
    Developing Proposed Rule. May 21, 1993.
        25. U.S. Environmental Protection Agency. Office of Prevention, 
    Pesticides and Toxic Substances. Letter to Mr. Bruce Manheim and Mr. 
    Michael Bean, Environmental Defense Fund from Assistant Administrator 
    for Prevention, Pesticides and Toxic Substances. Clarification of May 
    21, 1993 Letter. June 22, 1993.
        26. Windingstad, R.M., S.M. Kerr, L.N. Locke, and J.J. Hurt. 1984. 
    Lead Poisoning of Sandhill Cranes (Grus canadensis). Prairie 
    Naturalist. 16(1):21-24.
        27. U.S. Environmental Protection Agency. Office of Pesticide 
    Programs. Preliminary Determination to Cancel Registrations of 
    Carbofuran Products, Availability of Technical Support Document and 
    Draft Notice of Intent to Cancel. 54 FR 3744. January 25, 1989.
        28. U.S. Environmental Protection Agency. Office of Pesticide 
    Programs. In the Matter of: Ciba-Geigy Corporation, et al., 
    Petitioners; Remand Decision. 55 FR 31138. July 31, 1990.
        29. New York State Department of Environmental Conservation. 
    Wildlife Resources Center. Autopsy Reports. Case Numbers: 31-19, 82-70-
    8, 86-35-19, 86-26-24, 89-8-16, 89-66-29, 90-09-32, and 90-25-23.
        30. Pokras, M.A., and H. Stern. Tufts University School of 
    Veterinary Medicine. Personal communication to N. Laurson, EPA, Office 
    of Pollution Prevention and Toxics. Common Loons found in New England 
    between 1991 and 1993. February 1, 1994.
        31. U.S. Consumer Product Safety Commission. Carol Pollack-Nelson. 
    March 1991. Estimated Effectiveness of Warning Labels.
    
    XIX. Regulatory Assessment Requirements
    
    A. Executive Order 12866
    
        Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
    Agency must determine whether the regulatory action is ``significant'' 
    and therefore subject to review by the Office of Management and Budget 
    (OMB) and the requirements of the Executive Order. Under section 3(f), 
    the order defines a ``significant regulatory action'' as an action that 
    is likely to result in a rule: (1) Having an annual effect on the 
    economy of $100 million or more, or adversely and materially affecting 
    a sector of the economy, productivity, competition, jobs, the 
    environment, public health or safety, or State, local or tribal 
    governments or communities (also referred to as ``economically 
    significant''); (2) creating serious inconsistency or otherwise 
    interfering with an action taken or planned by another agency; (3) 
    materially altering the budgetary impacts of entitlement, grants, user 
    fees, or loan programs or the rights and obligations of recipients 
    thereof; or (4) raising novel legal or policy issues arising out of 
    legal mandates, the President's priorities, or the principles set forth 
    in this Executive Order.
        This proposed rule was submitted to OMB for review, and any 
    comments or changes made in response to OMB suggestions or 
    recommendations have been documented in the public record.
    
    B. Regulatory Flexibility Act
    
        Pursuant to the provisions of 5 U.S.C. 605(b), EPA is required to 
    make a statement concerning the economic impact of this proposed rule 
    on small businesses. This proposed rule, if promulgated, will have a 
    significant economic impact on a number of small entities. A 
    substantial number of small business entities will be affected by the 
    proposed action such as the cottage industry.
        The analysis indicates that the manufacturers of lead, zinc, and 
    brass sinkers all fall under the Small Business Administration's 
    definition of a small business. However, the analysis identified three 
    distinct subgroups of these manufacturers, ``large'' manufacturers with 
    significant capital, ``small'' manufactures which are often one or two 
    person operations, and home manufacturers. The impacts on these 
    segments were examined separately.
        Large manufacturers are able to respond to the regulatory 
    requirements and switch to alternative processes and/or materials and 
    remain viable. While home manufacturers are unable to easily switch to 
    alternatives, they would not be adversely impacted because retail sale 
    of sinkers is not considered to be a primary source of income for these 
    individuals. While small manufacturers may be adversely impacted, 
    regulatory alternatives which may reduce the burden to these 
    manufacturers could create unfair market advantages for them and their 
    actions could continue to pose an unreasonable risk to the environment. 
    An exemption for certain non-split shot sinkers would serve to reduce 
    the burden on only some of the disproportionately impacted small 
    businesses but not others. To conclude, it is difficult to devise a 
    regulatory alternative which reduces the burden to this segment of the 
    industry without compromising the intent of the regulation.
        The selected regulatory option would impose recordkeeping 
    requirements on industry; however, the overall impact of these 
    requirements is expected to be minimal. The estimated maximum cost to 
    industry is $16,450 annually, or approximately .2 percent of the annual 
    cost of the regulation overall.
    
    C. Paperwork Reduction Act
    
        Pursuant to the Paperwork Reduction Act (44 U.S.C. 3501, et seq.), 
    the information collection requirements in this proposed rule have been 
    submitted to the OMB for approval. An Information Collection Request 
    (ICR) has been prepared by EPA (identified as ICR Number 1671.01), and 
    a copy may be obtained from Sandy Farmer (2136), Information Policy 
    Branch, EPA, 401 M St., SW., Washington, DC 20460, or by calling (202) 
    260-2740.
        This collection of information has an estimated annual 
    recordkeeping burden of 54 hours per respondent. This estimate includes 
    time for gathering and maintaining information needed.
        EPA believes that the proposed rule provisions regarding 
    maintenance of information poses a minimal burden. Manufacturers and 
    processors of lead- and zinc-containing fishing sinkers for export 
    would be required to keep records which establish the sale and/or 
    transfer of fishing sinkers that would be banned for domestic 
    consumption under this proposal. The type of information required 
    should already be maintained as normal business records, and readily 
    available. Therefore the information collection provision of this 
    proposed rule would not impose a significant burden on the regulated 
    entities.
        Send comments regarding the burden estimate or any other aspect of 
    this collection of information, including suggestions for reducing this 
    burden to Chief, Information Policy Branch (2136), EPA, 401 M St., SW., 
    Washington, DC 20460, and to the Office of Information and Regulatory 
    Affairs, OMB, Washington, DC 20503, marked ``Attention: Desk Officer 
    for EPA.'' The final rule will respond to any OMB or public comments on 
    the information collection requirements contained in this proposal.
    
    List of Subjects in 40 CFR Part 745
    
        Environmental protection, Hazardous substances, Lead, Recordkeeping 
    and notification requirements.
    
        Dated: February 28, 1994.
    Carol M. Browner,
    Administrator.
        Therefore, it is proposed that 40 CFR part 745 be amended to read 
    as follows:
        1. The authority citation for part 745 would be revised to read as 
    follows:
    
        Authority: 15 U.S.C. 2605, 2607, and 2681-2692.
    
        2. Subparts F-Q are reserved and subpart R is added consisting of 
    Sec. 745.475 to read as follows:
    
    Subparts F-Q--[Reserved]
    
    Subpart R--Requirements for Specific Products Containing Lead
    
    
    Sec. 745.475   Lead- and zinc-containing products.
    
        (a) Scope, purpose, and applicability. (1) Scope. This subpart 
    contains restrictions on the manufacture (including import), 
    processing, and distribution in commerce of certain types of lead- and 
    zinc-containing fishing sinkers. This subpart imposes requirements on 
    persons who manufacture, process, or distribute fishing sinkers in 
    commerce for use in the United States that contain any lead or zinc in 
    combination with any other chemical substance, and are less than or 
    equal to 1 inch in any dimension.
        (2) Purpose. The purpose of this subpart is to protect waterbirds 
    from unreasonable risk from ingestion of lead- and zinc-containing 
    fishing sinkers.
        (3) Applicability. This subpart applies to any person engaged in 
    the manufacture, processing, or distribution in commerce of lead- and 
    zinc-containing fishing sinkers, as defined in this subpart. Any person 
    who manufactures or processes any such lead- or zinc-containing fishing 
    sinker for export or intends to export any such fishing sinker to a 
    foreign country will be subject to the export notification requirements 
    of section 12(b) of TSCA. The notification requirements are set forth 
    in 40 CFR part 707.
        (b) Definitions. In addition to the terms defined in section 3 of 
    TSCA, the following definition also applies for the purposes of this 
    subpart:
        (1) Fishing sinker means a weight which can be attached to a 
    fishing line, not permanently affixed to a hook. This includes, but is 
    not limited to split shot, worm weights, egg sinkers, bass casting, 
    pyramid sinkers, rubber core sinkers, pinch grip sinkers, and slip shot 
    sinkers.
        (2) [Reserved]
        (c) Manufacturing and processing limitations. Effective [insert 
    date 1 year after promulgation of the final rule], all persons are 
    prohibited from manufacturing or processing any fishing sinker for use 
    in the United States which contains any lead or zinc, and is less than 
    or equal to 1 inch in any dimension.
        (d) Distribution in commerce limitations. Effective [insert date 2 
    years after promulgation of the final rule], all persons are prohibited 
    from distributing in commerce any fishing sinker for use in the United 
    States which contains any lead or zinc, and is less than or equal to 1 
    inch in any dimension.
        (e) Recordkeeping. (1) Each person who manufactures or processes 
    lead- and zinc-containing fishing sinkers less than or equal to 1 inch 
    in any dimension for export shall maintain the following records: (i) 
    Product name and/or brand name of such fishing sinkers manufactured or 
    processed; (ii) location of where such fishing sinkers were 
    manufactured or processed; (iii) quantity and date of such fishing 
    sinkers manufactured or processed; (iv) product name and/or brand name 
    of such fishing sinkers distributed (shipped); (v) quantities of such 
    fishing sinkers shipped or delivered for shipment; (vi) date such 
    fishing sinkers shipped or delivered for shipment; (vii) name, address, 
    and telephone number of consignee; (viii) name, address, and telephone 
    number of originating shipment carrier; and (ix) inventory records of 
    the product and/or brand names, and quantity of such fishing sinkers 
    manufactured or processed (these records may be disposed of when a more 
    current inventory record is prepared by the manufacturer or processor). 
    This information must be retained for a period of 3 years from the date 
    of manufacture, processing or distribution in commerce. Shipping and 
    receiving documents such as invoices, freight bills, and receiving 
    tickets which provide the required information will be considered 
    satisfactory for purposes of this section.
        (2) [Reserved]
        (f) Enforcement. (1) Failure or refusal to comply with any 
    provision of this section is a violation of section 15 of TSCA (15 
    U.S.C. 2614).
        (2) Failure or refusal to permit entry or inspection as required by 
    section 11 of TSCA (15 U.S.C. 2610) is a violation of section 15 of 
    TSCA (15 U.S.C. 2614).
        (3) Violators are subject to the civil and criminal penalties 
    specified in section 16 of TSCA (15 U.S.C. 2615), or specific 
    enforcement and seizure as specified in section 17 of TSCA (15 U.S.C. 
    2616).
        (g) Inspections. EPA will conduct inspections under section 11 of 
    TSCA (15 U.S.C. 2610) to ensure compliance with this section.
    
    [FR Doc. 94-5298 Filed 3-8-94; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Published:
03/09/1994
Entry Type:
Uncategorized Document
Action:
Proposed rule.
Document Number:
94-5298
Dates:
Written comments in response to this proposed rule must be received by May 9, 1994. If persons request time for oral comment, EPA will hold an informal hearing in Washington, DC. The exact date, time, and location of the hearing, if held, will be announced in the Federal Register. For further information regarding the hearing, see Unit XV. of this preamble.
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: March 9, 1994
CFR: (1)
40 CFR 745.475