[Federal Register Volume 59, Number 46 (Wednesday, March 9, 1994)]
[Unknown Section]
[Page 0]
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





_______________________________________________________________________



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 (LD50), 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