[Federal Register Volume 65, Number 68 (Friday, April 7, 2000)]
[Notices]
[Pages 18324-18328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8406]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-932; FRL-6499-7]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for Certain Pesticide Chemicals in or on Food

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 regulations for residues of 
certain pesticide chemicals in or on various food commodities.

DATES: Comments, identified by docket control number PF-932, must be 
received on or before May 8, 2000.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION.'' To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-932 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Treva C. Alston, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania 
Ave., NW., Washington, DC 20460; telephone number: (703) 308-8373; e-
mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                    NAICS            potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------


[[Page 18325]]

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under ``FOR FURTHER INFORMATION 
CONTACT.''

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-932. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-932 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 
20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: ``[email protected],'' or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-932. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified under ``FOR FURTHER INFORMATION 
CONTACT.''

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    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 this petition contains 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 support granting of the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

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

    Dated: March 30, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by the petitioner and represents the view of the 
petitioners. EPA is publishing the petition summary verbatim without 
editing it in any way. The petition summary announces the availability 
of a description of the

[[Page 18326]]

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. Ecolab Inc.

PP 9E6028

    EPA has received a pesticide petition (PP 9E6028) from Ecolab Inc., 
370 N. Wabasha Street, St. Paul, MN 55102 proposing, pursuant to 
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from 
the requirement of a tolerance for urea in or on raw agricultural 
commodities, in processed commodities, and in or on meat and meat by 
products of cattle, sheep, hogs, goats, horses, and poultry, milk, and 
dairy products, eggs, seafood and shellfish, and fruits and vegetables 
when such residues result from the use of urea as a component of a food 
contact surface sanitizing solution for use in food handling 
establishments. The request is for an unlimited clearance. 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. Analytical method. Because Ecolab Inc. is petitioning for an 
exemption from the requirement of a tolerance, an enforcement method 
for urea is not needed.
    2. Magnitude of residues. The residues which transfer from the 
sanitized dish or utensil to food are not of toxicological 
significance.

B. Toxicological Profile

    1. Acute toxicity. Urea is a direct food additive. Urea in 
concentrated form is severely irritating to the eyes and slightly 
irritating to the skin. It is essentially non-toxic for acute oral and 
dermal effects. From published literature values the acute oral 
LD50 in rats was determined to be 14,300 milligrams/
kilograms (mg/kg). No value is assigned for dermal LD50 
since it is essentially non-toxic via the dermal route.
    2. Genotoxicity. Nothing in the available literature indicates that 
urea is a genotoxic material. There is no data that would indicate it 
has carcinogenic properties.
    3. Reproductive and developmental toxicity. Nothing in the 
available literature indicates that urea is a developmental or 
reproductive toxin. It is generally recognized as safe and is a normal 
constituent in the human diet.
    4. Subchronic toxicity. Nothing in the available literature 
indicates chronic exposure of urea products any adverse toxicological 
effects unless it is ingested at extremely high doses. Urea has been 
used as a feed supplement in cattle. Levels of 5% in their diet did not 
result in adverse effects. At dietary levels approaching 25%, symptoms 
of ammonia toxicity such as central nervous system (CNS) effects 
develop. At normal dietary intake levels in the human diet, no adverse 
effects result. Due to the rapid excretion of urea, prolonged low level 
exposure does not produce cumulative toxicity. Most of the urea in the 
body is generated endogenously since urea is the major pathway of 
nitrogen excretion in man. The typical concentration of urea excreted 
in the urine is approximately is 1,000 mg/deciliter (dl).
    5. Chronic toxicity. Chronic exposure would not produce any 
additional effect over what is noted in subchronic exposure; therefore, 
no additional concerns are warranted. Nothing in the literature 
indicates that urea may be carcinogenic.
    6. Animal metabolism.. Urea is a normal constituent of cellular 
metabolism in man.
    7. Endocrine disruption. A review of information from the Agency 
for Toxic Substances and Disease Registry indicates that potential 
endocrine effects from exposure to urea have not been studied. To the 
best of our knowledge, nothing in the available literature suggests 
that urea acts as an endocrine disrupter or that it possesses intrinsic 
hormonal activity.

C. Aggregate Exposure

    1. Dietary exposure-- i. Acute. Due to the low toxicity, there are 
no toxicological concerns for urea. An acute dietary risk assessment is 
not appropriated.
    ii.Chronic. Chronic exposure would not produce any additional 
effect beyond what is noted in acute exposure, therefore, no additional 
concerns are warranted.
    iii. Food-- Chronic direct. A typical adult ingests significant 
quantities of urea via the diet. An even larger amount is generated 
endogenously by the liver as a part of nitrogen excretion. Following 
ingestion, urea is absorbed by the gastrointestinal tract. The 
approximate concentration of urea in the plasma is 15 mg/dl. When urea 
is used as a component of a food contact surface sanitizer, the residue 
that would be introduced into food will be insignificant compared to 
the normal dietary intake and endogenous production. Based on this, 
there are no toxicological concerns resulting from exposures to 
residues of urea resulting from the use of sanitizing solutions.
    2. Drinking water-- i. Acute. Since there are no acute 
toxicological concerns for urea, an acute drinking water risk 
assessment is not required.
    ii. Chronic. There are no toxicological concerns about the exposure 
of low concentrations of urea in the drinking water. Although it is 
possible that trace amounts of urea resulting from its use as a 
sanitizer may ultimately get into drinking water, no adverse health 
effects would result.
    3. Non-dietary exposure. The potential for significant additional 
non-occupational exposure to the general population (including 
children) is unlikely.

D. Cumulative Effects

    Well over 99% of the exposure to urea is expected to be via natural 
sources in the diet and through endogenous generation. Potentially 
small amounts of urea exposure will be the result of non-food uses. The 
amount of urea exposure resulting from indirect exposure to sanitizing 
solutions will be miniscule. Since urea in the diet poses no 
toxicological risk, the cumulative toxicity resulting from this 
additional exposure is negligible.

E. Safety Determination

    1. U.S. population. Since there are no adverse toxicological 
effects resulting from normal dietary concentrations of urea, there is 
no need to determine aggregate risks, or to conduct a safety 
determination. Urea is generally recognized as safe and the incremental 
exposure due to its use as an inert in a food contact surface sanitizer 
is negligible.
    2. Infants and children. As in adults, infants and children produce 
urea as a basic process of cellular metabolism. Children are at no 
greater ``risk'' from exposure to urea. Therefore, as with adults, a 
safety determination is not appropriate.

F. International Tolerances

    No codex maximum residue levels have been established for urea.

2. Ecolab Inc.

PP 9E6029

    EPA has received a pesticide petition (9E6029) from Ecolab Inc., 
proposing, pursuant to section 408(d) of FFDCA, 21 U.S.C. 346a(d), to 
amend 40 CFR part 180 to establish an exemption from the

[[Page 18327]]

requirement of a tolerance for nitric acid in or on raw agricultural 
commodities, in processed commodities, and in or on meat and meat 
byproducts of cattle, sheep, hogs, goats, horses, and poultry, milk, 
and dairy products, eggs, seafood and shellfish, and fruits and 
vegetables when such residues result from the use of nitric acid as a 
component of a food contact surface sanitizing solution for use in food 
handling establishments at 1,000 parts per million (ppm). 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 Analytical method. Because Ecolab Inc. is petitioning for an 
exemption from the requirement of a tolerance, an enforcement method 
for nitric acid is not needed.
    2. Magnitude of residues. The residues which transfer from the 
sanitized dish or utensil to food are not of toxicological 
significance.

B. Toxicological Profile

    1. Acute toxicity. Nitric acid (HNO3) in concentrated 
form is corrosive to the eyes and corrosive to the skin. In neutral 
solutions, nitric acid dissociates into nitrate ions (NO3-). 
Nitrate is a normal constituent of the diet. Nitrate (as sodium 
nitrate) is allowed under 40 CFR 180.1001(d) as an inert ingredient in 
pesticide formulations applied to growing crops without limit in the 
formula. No data are available on the acute oral LD50 of 
nitric acid. The rat oral LD50 of sodium nitrate is 
approximately 2,000 mg/kg. Acute or short-term exposure at relatively 
high doses of nitrate may result in the formation of methemoglobin. 
This is caused by the reduction of nitrate to nitrite by microorganisms 
in the oral cavity or gastrointestinal tract. Nitrite ion is capable of 
rapidly oxidizing the ferrous ion to ferric ion in hemoglobin, 
producing methemoglobin. The body possesses enzymes capable of 
reduction of the methemoglobin back to hemoglobin.
    2. Genotoxicity. Nothing in the available literature indicates that 
nitric acid or nitrate are considered to be genotoxic or mutagenic.
    3. Reproductive and developmental toxicity. Nothing in the 
available literature indicates that nitric acid or nitrate are 
developmental or reproductive toxins. Sodium nitrate has been 
repeatedly tested for adverse reproductive effects. A series of 
teratology studies were conducted under the direction of the Food and 
Drug Administration (FDA) using mice, rats, hamsters and rabbits. Mice 
(doses up to 400 mg/kg), rats (doses up to 250 mg/kg), hamsters (doses 
up to 400 mg/kg), and rabbits (doses up to 250 mg/kg) were treated 
through the organogenesis phase of gestation and sacrificed just prior 
to parturition. There were no effects on fetal survival, reproductive 
parameters or incidence of malformations. Many other studies have 
corroborated these results. Some studies have demonstrated fetal death 
and other adverse effects, but only at doses that caused significant 
methemoglobinemia and maternal toxicity.
    4. Subchronic toxicity. No studies are available on the long-term 
effects of nitric acid. In neutral solutions, nitric acid dissociates 
into nitrate ions. Data are available on long-term exposure to nitrate. 
Nitrate is a normal constituent of the diet. Studies on nitrate have 
focused on the effects on the blood, namely the induction of 
methemoglobin formation. Bacteria in the oral cavity and 
gastrointestinal tract reduce nitrate to nitrite (NO2-). 
Approximately 5-10% of a typical dose of nitrate is converted into 
nitrite. Nitrite is capable of oxidizing the hemoglobin iron from a +2 
valence to +3 valence resulting in the formation of methemoglobin. 
Methemoglobin is not capable of oxygen transport. Normal levels of 
methemoglobin in human blood range from 1-2% of the total hemoglobin 
content. Methemoglobin levels below 10% are asymptomatic. Animal 
studies have demonstrated that chronic, low level exposure to nitrate 
does not result in adverse health effects. Rats drinking water 
containing 2,000 mg/L sodium nitrate (NaNO3) (corresponding 
to doses of up to 150-300 mg nitrate/kg/day) did not demonstrate 
increased levels of methemoglobin. Other studies reported similar 
findings. Long-term exposure at very high levels can result in an 
increased red blood cell turnover and subsequent hemosiderosis and 
hepatic atrophy. Animals exposed to relatively low levels of nitrate do 
not demonstrate any hematological or histopathological effects. Nitrate 
does not accumulate in the body. It is excreted primarily in the urine 
or is converted to nitrite via bacteria in oral cavity and 
gastrointestinal tract. Nitrite in the blood quickly reacts with 
hemoglobin. The toxicological profile of nitrate clearly demonstrates 
that, except for the cases of large bolus doses, nitrate is not a 
chronic toxicant. Residue levels and exposure limits should be based on 
the acute toxic effects rather than on long-term exposures.
    5. Chronic toxicity. Chronic exposure would not produce any 
additional effect beyond what is noted in subchronic exposure, 
therefore, no additional concerns are warranted. Several studies have 
been conducted on nitrate. None have concluded nitrate is a carcinogen.
    6. Animal metabolism. Nitrate is a normal constituent of the diet.
    7. Endocrine disruption. A review of information from the Agency 
for Toxic Substances and Disease Registry indicates that potential 
endocrine effects from exposure to nitric acid or nitrate ion have not 
been studied. To the best of our knowledge, nothing in the available 
literature suggests that nitric acid acts as an endocrine disrupter or 
that it possesses intrinsic hormonal activity.

C. Aggregate Exposure

    1. Dietary exposure-- i. Acute. Nitric acid is converted into 
nitrate in aqueous solutions. Nitrate is a common constituent of the 
human diet. Nitrate is found mostly in green leafy vegetables such as 
beets (2,400 ppm), celery (2,300 ppm) and turnip greens (6,600 ppm). It 
is the acute toxicity, not chronic exposure that is a concern, 
especially in infants (0-3 months). Based on the acute toxicological 
effects of nitrate, an EPA IRIS oral reference dose (RfD) of 7.0 mg 
nitrate/kg/day was established. This number assumes that the infant is 
the most susceptible sub-population and an uncertainty factor of 1, 
since the results are based on actual human data.
    ii. Chronic. Chronic exposure would not produce any additional 
effect beyond what is noted in acute exposure, therefore, no additional 
concerns are warranted.
    iii. Food. A typical adult ingests significant quantities of 
nitrate in the diet. A typical adult's daily intake of nitrate is about 
1.3 mg nitrate/kg/day. The dietary intake of nitrate accounts for the 
vast majority of all nitrate exposure. Using a worst case scenario, 
exposure to nitrate resulting from the use of nitric acid as a 
component of a hard surface sanitizer at 1,000 ppm would be 0.057 mg/
kg/day for adults. This value is calculated by using standard FDA 
calculations for exposures to hard surface sanitizers.
    2. Drinking water-- i. Acute. Nitrate is commonly found in drinking 
water, most typically in well water. Although there have been several 
instances of chronic methemoglobinemia reported from people consuming 
water containing high nitrate levels, typically the concentration of 
nitrate is quite low.

[[Page 18328]]

The EPA has set the drinking water equivalent level (DWEL) for nitrate 
at 10 mg nitrate-nitrogen/L (44 mg nitrate/L).
    ii. Chronic. There are no chronic toxicological concerns about the 
exposure of low concentrations (below 44 mg/L) of nitrate in the 
drinking water. Although it is possible that trace amounts of nitrate 
from a sanitizer may ultimately get into drinking water, no adverse 
health effects would result. The amount of ``naturally occurring 
nitrate'' in drinking water (especially well water) will greatly exceed 
the amount derived from sanitizing solutions. Since only a small 
fraction of the population drinks well water with elevated 
concentrations of nitrate, this is not a concern for the general 
population.
    3. Non-dietary exposure. The potential for significant additional 
non-occupational exposure under the use proposed to the general 
population (including children) is unlikely.

D. Cumulative Effects

    Well over 99% of the exposure to nitric acid/nitrate is expected to 
be via natural sources in the diet and drinking water. Trace amounts of 
nitric acid/nitrate exposure may result from non-food uses. The amount 
of nitric acid/nitrate exposure resulting from indirect exposure to 
sanitizing solutions will be virtually zero. Since nitric acid/nitrate 
in the diet poses little toxicological risk, the cumulative toxicity 
resulting from this additional exposure to hard surface sanitizers is 
negligible.

E. Safety Determination

    1. U.S. population. Since there are no adverse toxicological 
effects resulting from normal dietary concentrations of nitric acid/
nitrate ion, and the additional exposure from sanitizers is miniscule, 
there is no need to determine aggregate risks, or to conduct a safety 
determination.
    2. Infants and children. Infants under 3 months of age are the most 
susceptible population; however, their diet is unlikely to be in 
contact with food contact surface sanitizers.

F. International Tolerances

    No Codex maximum levels have been established for nitric acid.
[FR Doc. 00-8406 Filed 4-6-00; 8:45 am]
BILLING CODE 6560-50-F