[Federal Register Volume 63, Number 82 (Wednesday, April 29, 1998)]
[Notices]
[Pages 23438-23444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-10840]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-803; FRL-5783-4]


Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of pesticide 
petitions proposing the establishment of

[[Page 23439]]

regulations for residues of certain pesticide chemicals in or on 
various food commodities.
DATES: Comments, identified by the docket control number PF-803, must 
be received on or before May 29, 1998.
ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticides Programs, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments 
to: Rm. 1132, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by following 
the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential 
business information should be submitted through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). CBI should not be 
submitted through e-mail. Information marked as CBI will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2. A copy of the comment that does not contain CBI must be submitted 
for inclusion in the public record. Information not marked confidential 
may be disclosed publicly by EPA without prior notice. All written 
comments will be available for public inspection in Rm. 1132 at the 
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: The product manager listed in the 
table below:

------------------------------------------------------------------------
                                   Office location/                     
        Product Manager            telephone number          Address    
------------------------------------------------------------------------
Bipin Gandhi (PM-5)...........  Rm. 4W53, CS #1, 703-   1921 Jefferson  
                                 308-8380, e-            Davis Hwy,     
                                 mail:gandhi.bipin@epa   Arlington, VA  
                                 mail.epa.gov.                          
Indira Gairola................  Rm. 4W57, CS #1, 703-   Do.             
                                 308-8371, e-mail:                      
                                 gairola.indira@epamai
l.epa.gov.                             
------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as 
follows proposing the establishment and/or amendment of regulations for 
residues of certain pesticide chemicals in or on various food 
commodities under section 408 of the Federal Food, Drug, and Comestic 
Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions 
contain data or information regarding the elements set forth in section 
408(d)(2); however, EPA has not fully evaluated the sufficiency of the 
submitted data at this time or whether the data supports granting of 
the petition. Additional data may be needed before EPA rules on the 
petition.
    The official record for this notice of filing, as well as the 
public version, has been established for this notice of filing under 
docket control number [PF-803] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The official record is located at the address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on disks in Wordperfect 5.1 file format or ASCII 
file format. All comments and data in electronic form must be 
identified by the docket number (PF-803) and appropriate petition 
number. Electronic comments on notice may be filed online at many 
Federal Depository Libraries.

List of Subjects

    Environmental protection, Agricultural commodities, Food additives, 
Feed additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: April 13, 1998

Susan Lewis,

Acting Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below 
as required by section 408(d)(3) of the FFDCA. The summaries of the 
petitions were prepared by the petitioners and represent the views of 
the petitioners. EPA is publishing the petition summaries verbatim 
without editing them in any way. The petition summary announces the 
availability of a description of the analytical methods available to 
EPA for the detection and measurement of the pesticide chemical 
residues or an explanation of why no such method is needed.

1. BFGoodrich Specialty Chemicals

PP 8E4958, 8E4961, 8E4962

    EPA has received a pesticide petition (PP 8E4958,8E4961,8E4962) 
from BFGoodrich Specialty Chemicals, 9911 Brecksville Road, Cleveland, 
OH 44141, proposing pursuant to section 408(d) of the Federal Food, 
Drug and Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to 
establish an exemption from the requirement of a tolerance for acrylic 
acid terpolymer, partial sodium salt in or on raw agricultural 
commodities when used as inert ingredients in the pesticide 
formulations applied to growing crops, raw agricultural commodities 
after harvest or to animals, under 40 CFR 180.1001(c) and (e). EPA has 
determined that the petition contains data or information regarding the 
elements set forth in section 408(d)(2) of the FFDCA; however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data supports granting of the petition. Additional data 
may be needed before EPA rules on the petition.

A. Toxicological Profile

    The Acrylate Terpolymers Good-RiteK-781,K-797, and K-798 
conform to the definition of polymer given in 40 CFR 723.250(b) and 
meets the following criteria that are used to identify low risk 
polymers:
    1. The Acrylate Terpolymers are not cationic polymers, nor are they 
reasonably anticipated to become cationic polymers in a natural aquatic 
environment.
    2. The Acrylate Terpolymers contain as an integral part of their 
composition the atomic elements carbon, hydrogen, oxygen, sulfur and 
nitrogen. It also contains the monatomic counterion Na+.
    3. The Acrylate Terpolymers do not contain as an integral part of 
their composition, except as impurities, any elements other than those 
listed in 40 CFR 723.250(d)(2)(ii).
    4. The Acrylate Terpolymers are not designed, nor are they 
reasonably anticipated to substantially degrade, decompose, or 
depolymerize.

[[Page 23440]]

    5. The Acrylate Terpolymers are not manufactured or imported from 
monomers and/or other reactants that are not already included on the 
Toxic Substances Control Act (TSCA) Chemical Substance Inventory or 
manufactured under an applicable TSCA Section 5 exemption.
    6. The Acrylate Terpolymers are not water absorbing polymers.
    7. The only reactive functional groups the Acrylate Terpolymers 
contain is a carboxylic acid.
    8. The Acrylate Terpolymers have a number average molecular weight 
greater than 1,000 and less than 10,000 Daltons (and oligomer content 
less than 10 percent below MW 500 and less than 25 percent below MW 
1,000).

B. Aggregate Exposure

    In the past decade Acrylate copolymers and terpolymers have been 
used in a variety of applications, most notably water treatment 
including boiler and retort waters, cooling waters, membrane 
separations systems and are now de rigor in these applications. In 
these and similar applications, reasonable levels of incidental 
exposure to the neat polymer is expected and accepted without regard. 
ANSI/NSF Standard 60 Drinking Water Treatment Chemical Additives 
listing has been extended to similar acrylate co-and ter-polymers. The 
chemical characteristics of these polymers and the published health and 
safety data indicates that aggregate exposure to Acrylate terpolymers, 
as listed in the current petitions, as inert ingredients in the 
preparation and application of pesticide formulations for use on 
growing crops, raw agricultural commodities after harvest or to animals 
poses no harm.

C. Cumulative Effects

    At this time there is no information to indicate that any toxic 
effects produced by the Acrylate terpolymers would be cumulative with 
those of any other chemical. Given the terpolymers' categorization as 
``low risk polymers'' (40 CFR 723.250) and their proposed use an inert 
ingredients in pesticide formulations, there is no reasonable 
expectations of increased risk due to cumulative exposure to the 
Acrylate terpolymers.

D. International Tolerances

    BFGoodrich is petitioning that the Acrylate terpolymers be exempt 
from the requirement of a tolerance based upon their status as low risk 
polymers as per 40 CFR 723.250. Therefore, an analytical method to 
determine residues of the Acrylate terpolymers in raw agricultural 
commodities treated with pesticide forumlations containing the Acrylate 
terpolymers has not been proposed.
    There are no Codex maximum residue levels(MRLs) established for the 
Acrylate terpolymers. (Bipin Gandhi)

2. Platte Chemical Company

PP 6E4742

    EPA has received a pesticide petition (PP 6E4742) from Platte 
Chemical Company, 419 18th Street, P.O. Box 667, Greeley, CO 80632, 
proposing pursuant to section 408(d) of the Federal Food, Drug and 
Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part 80 to establish 
an exemption from the requirement of a tolerance for residues of the 
inert ingredient Modal Alder Bark (MAB) alder bark flour (ABF) when 
used in pesticide formulations applied to growing crops, or in or on 
raw agricultural commodities after harvest. EPA has determined that the 
petition contains data or information regarding the elements set forth 
in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated 
the sufficiency of the submitted data at this time or whether the data 
supports granting of the petition. Additional data may be needed before 
EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. MAB is not absorbed or metabolized by plants. 
The ABF remains on the treated surface, where it decomposes to its 
natural constituents including, cellulose, hemicelluloses, lignin and 
various compounds such as suberins and phenolic acids. These 
decomposition products are further degraded by various bacteria and 
fungi to simple sugars, carbohydrates, gases and other molecular 
compounds. Eventually ABF will be completely decomposed by natural 
processes to nutrients which can be utilized by other plants.
    2. Analytical method. No analytical method is available for 
determining MAB, per se. Although various methods are available to 
determine the various components of alder bark (e.g., content of 
cellulose, lignin, polysaccharides, etc.), these methods are not 
specific to MAB and can not distinguish whether the components are 
derived from ABF or from other plant or soil sources.
    3. Magnitude of residues. Since ABF is not absorbed or metabolized 
by plants, no residues of MAB are expected to result in or on raw 
agricultural commodities. For example, potato commodities grown from 
seed potato pieces treated with formulations containing MAB do not have 
residues of the inert ingredient. Furthermore, any residues would be 
associated with the potato seed pieces, which shrivel as the daughter 
plants withdraw nutrients during ``seedling''growth. Consequently, the 
spent seed pieces are not harvested and will not be eaten. Finally, any 
MAB adhering to the harvested potatoes would be removed by brushing and 
washing.

B. Toxicological Profile

    1. Acute toxicity. The use of MAB (ABF) as an inert ingredient in 
pesticide formulations is not expected to result in adverse effects due 
to its non-hazardous character, minimal potential for exposure, and 
projected absence of dietary exposure. There is a wealth of available 
information about the absence of, or minor health effects from, 
exposure to various wood flours, dusts, shavings, and other wood/bark 
components. Ingestion of wood flour, sawdust or wood shavings is 
neither lethal, nor toxic, and is even considered to be a source of 
non-nutritive dietary fiber. Dermal contact with wood or bark flour is 
not associated with death or toxicity, although dermal allergies 
(contact dermatitis) have been reported in certain sensitive 
individuals. Acute inhalation exposure to wood dusts for a limited time 
is not considered to be an occupational hazard if dust levels are below 
established Permissible Exposure Levels (PEL) for non-toxic particulate 
matter (i.e., unspecified dust particles). MAB is not expected to 
produce any more eye irritation than any chemically inert particulate, 
such as clay or wheat flour. In persons who may have a specific alder 
wood allergy, eye irritation or conjunctivitis is possible even though 
there are no known reports of such incidences. Alder wood dust is not a 
sensitizer nor is ABF expected to be a sensitizer.
    2. Genotoxicity. Evidence from studies with wood-related compounds 
indicate that MAB is not genotoxic. ABF is composed mostly of 
cellulose, hemicelluloses and lignins, which are not mutagenic.
    3. Reproductive and developmental toxicity. MAB is not expected to 
be a developmental or reproductive toxin, based on extensive testing of 
the three principle components (cellulose, hemicelluloses and lignins) 
of ABF. Additionally, wood flours have been used for numerous years to 
increase dietary fiber in animal feeds and human diets with no known 
adverse reproductive or developmental toxicity.
    4. Subchronic toxicity. There is no subchronic exposure to MAB from 
its use as a pesticidally inert ingredient. However, chronic toxicity 
data adequately address possible

[[Page 23441]]

toxicological effects that may result from subchronic exposure to ABF.
    5. Chronic toxicity. There is minimal-to-no chronic toxicological 
risk from the use of MAB as an inert ingredient in pesticide 
formulations. There are no known adverse reactions to chronic 
consumption or ingestion of wood flour. Ingestion of wood flour, 
sawdust or wood shavings for extended periods of time is not hazardous. 
Instead, it is considered to be a non-nutritive dietary supplement. In 
fact, the Food and Drug Administration (FDA) has allowed the use of 
wood flours in various prepared foods, such as bread, to increase 
dietary fiber levels and reduce caloric intake.
    Adverse effects of exposure to wood dust are limited to allergic 
reactions, such as rhinitis and contact dermatitis, and from chronic 
(lifetime) occupational exposure (via inhalation) to high 
concentrations of wood dust. Based on the absence of chronic effects 
from ingestion, the limited irritant and allergic effects from dermal 
contact, limited exposure to ABF from seed potato treatment, and the 
absence of chronic exposure by any route, Platte Chemical Company 
concludes that there is minimal-to-no chronic toxicological risk from 
the use of MAB in pesticide products.
    6. Animal metabolism. There is no known human metabolism or 
metabolic products from human ingestion of non-nutritive dietary fiber 
from wood products. In humans, the polymers of plants such as cellulose 
from plant cell walls (linkages), some pectins, hemicellulose, gums, 
mucilages and lignin, are not easily digested and are passed through 
the gastrointestinal tract as non-nutritive dietary fiber. Wood flour 
and sawdust are commonly used in animal feeds. In ruminants, such wood 
products are reduced to cellulose, hemicelluloses and lignins by 
endogenous bacterial/microbial populations in the gut. These wood 
product degradates are further reduced to simple sugars, carbohydrates, 
carbon dioxide and indigestible biomass. The indigestible biomass is 
readily excreted.
    7. Metabolite toxicology. There is no known evidence of metabolite 
toxicity from the ingestion of wood or ABF by either livestock or 
humans. In humans, no metabolites are produced after ingestion of non-
nutritive dietary fiber such as ABF.
    8. Endocrine disruption. No endocrine or estrogenic effects are 
expected from the use of MAB for the following reasons:
    i. The production of MAB includes oven drying the bark, which 
removes moisture and volatile organic compounds.
    ii. ABF does not penetrate and will not be absorbed by skin.
    iii. Alder bark is primarily composed of naturally-occurring, non-
digestible cellulose, hemicelluloses and lignin; and most importantly.
    iv. There is no non-occupational exposure to MAB when used as a 
pesticidally inert ingredient.

C. Aggregate Exposure

    1. Dietary exposure. Ingestion of MAB or its residues would simply 
increase the level of non-nutritive fiber in the diet, which has been 
shown to have beneficial health effects by reducing the incidence of 
diverticulosis, cancer of the colon and coronary heart disease as well 
as facilitating weight loss. Also, health claims for fiber-containing 
foods have been made for more than a century and the effects of fiber 
in promoting bowel evacuation are widely recognized.
    2. Food. The use of MAB in potato seed piece pesticides does not 
result in any significant dietary exposure to ABF. Residues, if any, 
surround the potato seed pieces, which shrivel as the daughter plants 
withdraw nutrients during ``seedling'' growth. Consequentially, the 
spent seed pieces are not harvested and will not be eaten. Brushing and 
washing potatoes to remove particulates, such as soil, would 
simultaneously remove any residues of MAB. However, should ABF residues 
adhere to harvested potatoes, the only effect would be to increase the 
level of non-nutritive dietary fiber. Were this to be the case, 
ingestion of MAB residues would be beneficial and of no toxicological 
concern since MAB can be considered to be a non-nutritive source of 
dietary fiber, which has been shown to improve health and lessen the 
incidence of diverticulosis, colon cancer and coronary heart disease.
    3. Drinking water . The use of MAB as an inert ingredient in 
pesticide formulations does not lead to alder bark particles in the 
drinking water. Wood and bark particles do not leach into the 
groundwater. Any particles that may be transported into water bodies 
will absorb moisture and either sediment out of the water column or be 
removed with other particulate matter during drinking water treatment. 
Similarly, any natural water-extractable components (humic acids, 
fulvic acids, etc.) of MAB are natural products that will also be 
removed during drinking water treatment.
    4. Non-dietary exposure. The only anticipated human exposure to MAB 
from non-dietary sources would be through occupational exposure during 
product use.

D. Cumulative Effects

    The use of MAB as an inert ingredient in pesticide formulations 
does not result in any cumulative effects, since there is no non-
occupational exposure to MAB.

E. Safety Determination

    1. U.S. population. The use of MAB does not pose a safety concern 
for the US human population due to the non-toxic nature of ABF (oral, 
dermal and acute exposure) and the absence of non-occupational 
exposure.
    2. Infants and children. Infants and children are not exposed to 
MAB from its use in pesticide formulations or the treatment of potato 
seed pieces.

F. International Tolerances

    No international tolerances have been established for ABF, wood 
flour or wood cellulose.

3. Wheelabrator Water Technologies, Inc.

PP 6E4732

    EPA has received a pesticide petition (PP 6E4732) from Wheelabrator 
Water Technologies, Inc., 8201 Eastern Boulevard, Baltimore, Maryland 
21224. proposing pursuant to section 408(d) of the Federal Food, Drug 
and Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to 
establish an exemption from the requirement of a tolerance for 
biosolids in or on the raw agricultural commodity Granulite. EPA has 
determined that the petition contains data or information regarding the 
elements set forth in section 408(d)(2) of the FFDCA; however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data supports granting of the petition. Additional data 
may be needed before EPA rules on the petition.

A. Residue Chemistry

    1. Residues in the raw agricultural commodity and processed food/
feed. A tolerance for substances potentially present in biosolids for 
raw or processed foods is not anticipated to be needed, based on the 
very low risk posed by residues in raw food/feed, as discussed 
throughout this application for a tolerance exemption for Granulite 
heat-dried biosolids.
    2. Background information and use profile. Granulite is a heat-
dried biosolids (sewage sludge) product. Biosolids are the solid, semi-
solid, or liquid residue generated from domestic wastewater treatment, 
and have been used for centuries as a soil conditioner and fertilizer. 
Regulations regarding the use and disposal of biosolids have been 
introduced over the years to protect

[[Page 23442]]

human health and the environment, culminating in the 40 CFR part 503 
rule promulgated in 1992, which regulates biosolids based on a 
comprehensive risk assessment consucted by EPA. This rule has since 
undergone relatively minor revisions, including the deletion of 
chromium from the regulation; changes to the limits for molybdenum and 
selenium; and a narrowing of a focus of future biosolids rulemaking to 
dioxins/furans and polychlorinated biphenyls (PCBs). Land application 
of biosolids enhances soil conditions and plant growth on agricultural, 
forest, reclaimed, and public use (e.g., recreational, highway) lands. 
Over 5 million dry metric tons of biosolids are generated annually in 
the U.S. at publicly owned treatment works. A minimum of 33% of the 
biosolids generated annually are land applied (this percentage has 
probably increased significantly in recent years), while the remaining 
are incinerated or disposed of using surface disposal. Of the biosolids 
that are land applied, an estimated 67% are applies to agricultural 
lands, 3% to forests, 9% to reclamation sites, and 9% to public use 
sites. Biosolids are land applied by either incorporating or injecting 
the biosolids into the soil or spreading the biosolids on the soil 
surface.

B. Toxicological Profile

    EPA has determined that the limits for inorganic pollutants 
(metals) calculated in the EPA biosolids risk assessment protect humans 
(including children), animals, and plants from reasonably anticipated 
adverse effects via the 14 different exposure pathways evaluated. The 
40 CFR part 503 rule regulates metals based on these risk assessment 
limits, and regulates pathogens based on an operational standard 
requiring certain pathogen and vector controls that reduce pathogens to 
low levels (as described in ``Safety Determination: U.S. General 
Population'' below). For biosolids that meet the most stringent 
pollutant limits and pathogen controls of part 503, as Granulite does, 
only minimal additional part 503 requirements need to be met because of 
the low risk associated with these biosolids, which therefore are 
allowed to be used as freely as any other soil conditioner. Research 
indicates that risks associated with the bioavailability of metals in 
biosolids are low when biosolids are land applied at rates commonly 
used in agriculture and when good management practices commonly 
implemented (e.g., soil pH above 5.0) are followed.
    1. Acute toxicity. EPA initially submitted a list of 200 pollutants 
potentially found in biosolids for review by a panel of experts; this 
panel recommended that 50 of these pollutants be studies further, based 
on avaliable toxicity and exposure data. EPA then developed hazard for 
each of these 50 pollutants, derived by dividing a pollutant's 
estimated concentration in soil, plant or animal tissue, or air by the 
lowest concertration of the pollutants found in the scientific 
literature to be toxic to the organism being evaluated via the most 
sensetive route of exposure and dassuming maximum toxic effect. A 
hazard index of less than 1 indicated that the pollutant was not toxic 
to the organism (via that particular exposure pathway), and thus was 
not analyzed further. EPA further evaluated pollutants with a hazard 
index value of 1 or greater in the biosolids risk assestment (except 
for pollutants deferred of deleted due to insufficient or limited 
data). EPA also evaluated several additional pollutants based in the 
addition of four exposure pathways. This process resulted in EPA 
evaluating 23 pollutants in its biosolids risk assestment for land 
application (see Table 1).
    2. Reproductive and developmental toxicity. The ingestion of lead 
by children, which is associated with developmental effects (e.g., 
learning disabilities), was addressed by the EPA biosolids risk 
assessment in a conservative manner. EPA evaluated the risk to pica 
children (children who regularly eat soil) because it is possible that 
children might ingest soil to which biosolids has been land applied. 
However, only a small number of children are likely to ingest biosolids 
in gardens or lawns, especially on a regular basis, and thus this 
evaluation is more conservative than dietary or drinking water 
exposures. In addition to lead, limits for arsenic, cadmium, mercury, 
and selenium are also included in the part 503 rule, based on a child 
ingesting biosolids that potentially contain these pollutants. 
Granulite meets all of these limits. For more details, see ``Safety 
Determination: Infants and Children'' below.
    3. Chronic toxicity. EPA's risk assessment for the land application 
of biosolids included the evaluation of chronic effects based on RfDs 
or RfCs for metals and organic substances potentially found in 
biosolids. RDAs were used when RfDs were unavailable, or analogous no 
adverse effect levels were used. Acceptable doses of a substance were 
estimated for animals, using the most sensitive or most exposed 
species. The RfDs, RfCs, or analogous levels were combined with other 
variables to calculate the concentrations of pollutants in biosolids 
that are reasonably protective against adverse impacts. For the 
ingestion (dietary) pathways, RfDs were combined with a relative 
effectiveness RE variable. The RE of exposure accounts for differences 
in bioavailability depending on the route of exposure (e.g., ingestion 
or inhalation); because of limited available data, the RE was 
conservatively set at 1, which assumes 100% bioavailability intake, and 
thus underestimates the allowable dose of biosolids pollutants and 
reflects conservative pollutant limits. The pollutant concentrations 
calculated in the risk assessment were used to develop the most 
stringent limits in the 40 CFR part 503 rule, which Granulite meets.
    4. Carcinogenicity. EPA's risk assessment for the land application 
of biosolids included evaluation of carcinogenicity based on q1*s for 
metals and organic substances potentially found in biosolids. The q1*s 
were used with other variables to calculate the concentrations of 
pollutants in biosolids that are reasonably protective against adverse 
impacts; these calculated concentrations were used to develop the most 
stringent pollutant limits in 40 CFR part 503 rule, which Granulite 
meets. EPA also conducted a population-based risk assessment which 
indicated that prior to the part 503 rule, biosolids use and disposal 
practices (including land application, incineration, and surface 
disposal) could have contributed 0.9 to 5 cancer cases annually; the 
part 503 rule reduced cancer cases by 0.09 to 0.7 annually. This 
analysis included exposure to pollutants potentially found in biosolids 
from all sources, including food, drinking water, residential, and 
other non-occupational sources.
    5. Endocrine disruption. The EPA biosolids risk assessment 
considered all adverse effects identified in the scientific literature, 
including endocrine effects, if any, and used these to identify no 
observed adverse effect levels (NOAEL) for the pollutants evaluated. 
Future research may include additional impacts on wildlife due to 
limited available field data. Although not specific to endocrine 
effects, interactive (synergistic) effects observed with biosolids 
reduce (rather than increase) adverse risks to potential receptors. 
Interactions between certain elements typically found in biosolids 
hinder the uptake of metals by plants and the bioavailability of metals 
to animals and humans. See ``Cumulative Risk'' below for more 
information on these interactive effects.

[[Page 23443]]

C. Aggregate Exposure

    The 14 exposure pathways that EPA evaluated in its biosolids risk 
assessment included: children ingesting biosolids/soil directly (the 
pica child); adults ingesting plants grown in soils amended with 
biosolids or drinking ground-water or surface-water containing 
substances present in biosolids; adults ingesting fish from surface-
water containing substances in biosolids; adults ingesting animal 
products derived from animals that ingested biosolids; animals 
ingesting biosolids or plants grown in biosolids-amended soils; and 
plants grown in biosolids-amended soils. Thus, the EPA risk assessment 
for the land application of biosolids addressed exposures from dietary, 
drinking water, and non-occupational sources. The most conservative 
estimate from the 14 exposure pathways was then selected as the limit 
for each of the pollutants potentially found in biosolids, thus 
representing protection based on aggregate exposure. Granulite meets 
these limits.
    In addition, the EPA risk assessment calculations for all 14 
pathways initially included pollutant exposure from sources other than 
biosolids (food, air, and water). Exposures from sources other than 
biosolids were then subtracted from the total allowable dose, yielding 
a result that represented the allowable dose of a pollutant from 
biosolids only. This value was then combined with other variables to 
derive a pollutant limit.
    1. Dietary exposure. Parameters for human, animal, or plant health 
(e.g., based on RfDs, q1*s, etc., as described above in ``Chronic 
Effects'' and (``Carcinogenicity'') were combined with pollutant intake 
information (e.g., the amount of a particular food type consumed) to 
derive pollutant limits in the EPA biosolids risk assessment. Several 
pollutant limits were based on a dietary exposure pathway (for the 
inorganic chemical molybdenum and for several organic chemicals). 
However, the limits for molybdenum were re-evaluated and new limits are 
expected to be less stringent, and limits for organics were not 
included in the part 503 rule, as discussed in ``Other Considerations'' 
below. For other pollutants, exposure pathways other than dietary 
exposure posed more risks, and pollutant limits were based on these 
higher-risk pathways.
    2. Drinking water. The part 503 rule requires that biosolids be 
land applied at the agronomic rate (the rate that provides the amount 
of nitrogen needed by a crop or vegetation to attain a desired yield 
while minimizing the amount of nitrogen that will pass below the root 
zone of the crop or vegetation to ground-water), thus protecting 
ground-water from biosolids with nitrogen levels in excess of estimated 
crop needs. In addition, for ground-water, the EPA risk assessment 
analyzed the pathway involving: the land application of biosolids; the 
leaching (mobility) of pollutants from soil into ground-water; and the 
subsequent drinking of well water containing these pollutants by 
humans. The ground-water pathway evaluation included: a mass balance 
(between erosion, leaching, volatilization, and degradation 
persistence); a reference water concentration (based on the q1* or 
MCL); and use of the VADOFT (from RUSTIC) and the AT123D models. For 
surface-water exposure, EPA analyzed the pathway involving: the land 
application of biosolids; the erosion (mobility) of soil containing 
pollutants in biosolids; the transfer of the pollutants contained in 
the eroded soil to surface-water; and the ingestion of the surface-
water and fish living in the surface-water by humans. The surface-water 
pathway evaluation included: a mass balance (as described above for 
ground-water); a reference intake (based on the q1* or RfD); acute or 
chronic freshwater criteria for aquatic life; a bioconcentration 
factor; a food chain multiplier; and a dilution factor, among other 
parameters. No pollutant limit was based on the ground-water pathway 
because other exposure pathways resulted in more restrictive limits. 
Only one pollutant limit, for DDT/DDD/DDE, was based on the surface-
water pathway; however, organics, including DDT, were deleted from part 
503 regulation because they met at least one of three criteria set by 
EPA (see ``Other Considerations'' below).
    While metals potentially present in biosolids may be persistent, 
they are bound in the biosolids-soil matrix for long periods of time, 
as discussed in ``Environmental Fate Data Summary'' below. Also, the 
dry characteristics of Granulite, which is heat-dried, minimize water 
content and leachability of metals.
    3. Non-dietary exposure. EPA's biosolids risk assessment evaluated 
exposure to pollutants potentially found in biosolids that are land 
applied to gardens, lawns, and other residential and non-occupational 
settings in non-dietary pathways.

D. Cumulative Effects

    Extensive field data used in EPA's risk assessment for biosolids 
show no adverse effects of low levels of metals in land-applied 
biosolids. Some metals are not transferred into edible plant parts 
(even when their concentrations are greatly increased in the biosolids/
soil mixture) because these metals (e.g., chromium) are insoluble or 
strongly bound to the biosolids-soil matrix (by iron or certain other 
oxides, organic matter, or phosphates in biosolids) or to plant roots 
(e.g., lead). Or, if other substances commonly found in biosolids, such 
as zinc, calcium, and iron, are present, these substances will inhibit 
absorption of some metals (e.g., selenium, molybdenum, and cadmium) 
from the ingested food into the organism's intestines and blood stream. 
Also, the EPA biosolids risk assessment included bioavailability and 
bioaccumulation factors to account for uptake of pollutants by animals 
(e.g., fish) and subsequently by humans.

E. Safety Determination

    1. U.S. population. The EPA biosolids risk assessment as well as 
field data show that certain biosolids that meet low pollutant limits 
for metals can be considered NOAEL biosolids that have no observed 
adverse effects on public health and the environment. Granulite meets 
these limits. Human and animal health protection from pathogens are 
addressed in the part 503 regulation through technology-based 
requirements that minimize pathogen densities and reduce vector 
attraction. Granulite meets the most stringent ``Class A'' part 503 
requirements that pathogen densities be reduced to low levels.
    2. Infants and children. For several of the metals evaluated in 
EPA's biosolids risk assessment, the pollutant limit identified was 
based on the exposure pathway for a pica child ingesting biosolids/
soil. These limits are conservative because they go beyond expected 
dietary and drinking water exposures (i.e., a very small percentage of 
children are expected to consume biosolids in gardens or on lawns). 
Also, the limit for lead in biosolids in the part 503 regulation is 300 
ppm, based on animal data. This number provides an additional margin of 
safety for growing children because it is lower than the 500 ppm limit 
for lead derived using EPA's Integrated Exposure Uptake Biokinetic 
(IEUBK) model. In addition, animal (rat) studies show that the 
bioavailability of lead in biosolids is 12-fold lower than that assumed 
in the IEUBK model calculations used; thus the 300 ppm lead limit 
provides even more of a margin of safety. The limits identified for the 
other metals (arsenic, cadmium, mercury, and selenium) based on a child 
ingesting biosolids/soil were calculated in algorithms developed

[[Page 23444]]

specifically for the EPA biosolids risk assessment. The most stringent 
part 503 pollutant limits for metals in biosolids that are land applied 
are based on these figures; Granulite meets these limits.

F. Other Considerations

    Organic chemicals were evaluated in the EPA biosolids risk 
assessment. However, the part 503 rule did not set limits for organic 
chemicals because all the organic chemicals analyzed met one or more of 
the following criteria:
    i. The pollutant has been banned or restricted for use in the U.S. 
or is no longer manufactured in the U.S.
    ii. The pollutant is infrequently found in biosolids (e.g., 
detected less than 5% of the time).
    iii. The limit for the pollutant identified in the EPA biosolids 
risk assessment is not expected to be exceeded in biosolids that are 
used or disposed.
    iv. Nearly all of the organic chemicals evaluated met two or more 
of these criteria.

G. Practical Analytical Method

    Numerous analytical methods were used in the hundreds of research 
studies on which the EPA risk assessment for the land application of 
biosolids was based. Examples of analytical methods used for analyzing 
metals concentrations in plant and animal tissue include atomic 
absorption, X-ray fluorescence spectroscopy, and autoradiography.

H. List of All Pending Tolerances and Exemptions

    The only known exemption from tolerance being proposed for 
biosolids as an inert ingredient is this application, which is based on 
the health and environmental protection identified in EPA's part 503 
risk assessment for the land application of biosolids, as discussed 
throughout this application.

I. Environmental Fate Data Summary

    Studies have shown that metals are bound in the biosolids-soil 
matrix over the long-term and that the binding properties of biosolids 
are environmentally stable. The binding of metals by biosolids renders 
the metals less bioavailable to plants, animals, and humans, and 
studies have shown no adverse effects when biosolids containing metals 
meeting the part 503 pollutant limits, which includes Granulite, are 
land applied.
    The EPA risk assessment for the land application of biosolids 
included analysis of ecological risks through ground-water, surface-
water, plants, livestock, and wildlife (as well as to humans, including 
children). Low risks were found to be associated with the ground-water 
pathway and to wildlife, and thus pollutant limits for chemicals of 
concern for these pathways or endpoints were based on other, more 
restrictive risk assessment limits for other pathways/endpoints. 
Granulite meets all of these limits. The one organic pollutant of 
concern identified for the surface-water pathway was deleted from 
regulation, as discussed in ``Other Considerations'' above.

J. International Tolerances

    None known. Compatibility with any existing MRLs should be 
possible, based on the low risk of adverse effects identified in EPA's 
risk assessment for the land application of biosolids. (Bipin Gandhi)
[FR Doc. 98-10840 Filed 4-28-98; 8:45 am]
BILLING CODE 6560-50-F