[Federal Register Volume 66, Number 236 (Friday, December 7, 2001)]
[Notices]
[Pages 63534-63537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30369]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-970; FRL-6737-9]


Notice of Filing Pesticide Petitions to Establish a Tolerance for 
a 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-970, must be 
received on or before January 7, 2002.

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-970 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Adam Heyward, Antimicrobials 
Division (7510C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone numbers: (703) 308-6422; 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 codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111...............  Crop production
  ..............................  112...............  Animal production
                                  311                 Food manufacturing
  ..............................  32532.............  Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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,'' ``Regulations and Proposed Rules,'' 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-970. 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-970 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, 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-970. 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.

[[Page 63535]]

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 Cosmetic 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 petitions. Additional data 
may be needed before EPA rules on the petitions.

List of Subjects

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

    Dated: November 28, 2001.
Frank Sanders,
Director, Antimicrobials 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. . The petition summaries 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.

I. Ecolab Inc.

PP 0F6193

    EPA has received a pesticide petition (0F6193) 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 pelargonic acid nonanoic acid in or on 
the raw agricultural commodity, 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 results from the use of 
pelargonic acid as a component of a food contact surface sanitizing 
solution for use in food handling establishments. The request is for 
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 pelargonic 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. From published literature values the acute oral 
LD50 in rats was determined to be greater than 3.2 gram/
kilogram (g/kg); the acute oral LD50 in mice was 15 g/kg. 
The dermal LD50 is greater than 5 g/kg. It is considered to 
be essentially non-toxic via the oral and dermal routes.
    2. Genotoxicity. Nothing in the available literature indicates that 
the pelargonic acid is genotoxic.
    3. Reproductive and developmental toxicity. Nothing in the 
available literature indicates the pelargonic acid is a developmental 
or reproductive toxin. No evidence of maternal or developmental 
toxicity was seen in a rat oral developmental toxicity screen with 
pelargonic acid at a dose of 1,500 milligrams/kilograms/day (mg/kg/
day).
    4. Subchronic toxicity. Nothing in the available literature 
indicates chronic exposure of pelargonic acid products any adverse 
toxicological effects unless it is ingested at an extremely high 
concentration. A 14-day oral toxicity test with rats revealed no 
adverse effects from pelargonic acid at any dose level, including the 
highest dietary concentration of 20,000 ppm, (equivalent to 1,834 mg/
kg/day, a level exceeding the limit dose of 1,000 mg/kg/day). In 
another study, eight rats were exposed to a diet consisting of 4.19% 
pelargonic acid for 4 weeks equivalent to approximately 2,090 mg/kg/
day). There was no effect on survival. At normal dietary intake levels 
in the human diet, no adverse effects would result.
    5. Chronic toxicity. Chronic exposure would not produce any 
additional effect over what is noted in subchronic exposure, therefore, 
no additional concerns were warranted. Nothing in the literature 
indicates that pelargonic acid may be carcinogenic.
    6. Endocrine disruption. A review of information from the Agency of 
Toxic Substances and Disease Registry indicates that potential 
endocrine effects from exposure to pelargonic acid have not been 
studied. The best of our knowledge, nothing in the available literature 
suggests that nonanoic acids as an endocrine disrupter or that it 
possesses intrinsic hormonal activity.

C. Aggregate Exposure

    1. Dietary exposure--i. Acute. There are no acute toxicology 
concerns for pelargonic acid, an acute dietary risk assessment is not 
required.
    ii. Chronic indirect. Using a worst-case scenario, the exposure 
resulting from the use of this material in a sanitizer would be 0.005 
mg/kg/day for a 70 kg person (adult) and 0.007 mg/kg/day for a 28 kg 
person (child).
    2. Food--Chronic direct. A typical adult ingest significant 
quantities of pelargonic acid via diet. When pelargonic acid is used as 
a compound

[[Page 63536]]

of a food contact surface sanitizer, the residue that would be 
introduce into food will be insignificant. Based on this, there are no 
toxicological concerns resulting from exposures to residues of 
pelargonic acid from the use of sanitizing solutions.
    3. Drinking water--i. Acute. Since there are no acute toxicological 
concerns for pelargonic acid, an acute drinking water risk assessment 
is not required.
    ii. Chronic. There are no toxicological concerns about the exposure 
of low concentrations of pelargonic acid in the drinking water. 
Although it is possible that the trace amounts pelargonic acid 
resulting for its use as a sanitizer may ultimately get into drinking 
water, no adverse health effects would results.
    4. Non-dietary exposure. The potential for significant additional 
non-occupational exposure to the general population (including 
children) is unlikely.

D. Cumulative Effects

    Potentially small amounts of pelargonic acid exposure will be the 
result of non-food uses. The amount of pelargonic acid exposure 
resulting from direct exposure to sanitizing solutions will be 
minuscule. Since pelargonic acid in the diet poses no toxicological 
risk, the cumulative toxicity resulting form 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 pelagonic acid, 
there is no need to determine aggregate risks, or to conduct a safety 
determination. Pelargonic acid 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 ingest 
pelargonic acid in their diet. Children are at no greater ``risk'' from 
exposure to pelargonic acid. Therefore, as with adults, a safety 
determination is not appropriate.

F. International Tolerances

    No codex maximum residue levels have been established for 
pelargonic acid.

II. Ecolab Inc.

PP 0F6194

    EPA has received a pesticide petition (0F6194) from Ecolab Inc., 
370 N. Wabasha St., 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 decanoic acid in or on the raw 
agricultural commodity, 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 results from the use of decanoic acid as 
a component of a food contact surface sanitizing solution for use in 
food handling establishments. The request is for 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 decanoic 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. From published literature values the acute oral 
LD50 in rats ranged from 3.2 g/kg to greater than 10 g/kg. 
The dermal LD50 in rats greater than 5 g/kg.
    2. Genotoxicity. Nothing in the available literature indicates that 
the decanoic acid is genotoxic.
    3. Reproductive and developmental toxicity. Nothing in the 
available literature indicates the decanoic acid is a developmental or 
reproductive toxin. It is generally recognized as safe and is normal 
constituent in the human diet.
    4. Subchronic toxicity. Long term studies with decanoic acid have 
shown that this material is a relatively non-toxic. In on study, rats 
were fed decanoic acid in their diet at the level of 10% for 150 days. 
No adverse effects were observed at the conclusion of the study. In 
another study rats were administered decanoic acid at dietary levels 8% 
(corresponding to approximately 4 g/kg/day for 6 weeks. These animals 
exhibited reduced body weight gain and increased plasma triglyceride 
levels. Dogs fed approximately 4.4 g/kg/day of decanoic acid for 102 
days showed no adverse effects.In another study, rats were fed 2.5 g/
kg/day of decanoic acid (as the triglyceride) for 47 weeks. These 
animals showed no abnormalities in the cellular structure of the liver 
or intestine. Other animals ingesting 5 g/kg/day for 150 days did not 
develop abnormal tissues in the gastrointestinal tract. No other 
tissues were examined.
    5. Chronic toxicity. Chronic exposure would not produce any 
additional effect over what is noted in subchronic exposure, therefore, 
no additional concerns were warranted. Nothing in the literature 
indicates that decanoic acid may be carcinogenic.
    6. Endocrine disruption. A review of information from the Agency 
for Toxic Substances and Disease Registry indicates that potential 
endocrine effects from exposure to decanoic acid have not been studied. 
The best of our knowledge, nothing in the available literature suggests 
that decanoic acid acts as an endocrine disrupter or that is possesses 
intrinsic hormonal activity.

C. Aggregate Exposure

    1. Dietary exposure-- i. Acute. There are no acute toxicology 
concerns for decanoic acid, an acute dietary risk assessment is not 
required.
    ii. Chronic indirect. Using a worst-case scenario, the exposure 
resulting from the use of this material in a sanitizer would be 0.0008 
mg/kg/day for a 70 kg person (adult) and 0.0010 mg/kg/day for a 28 kg 
person (child).
    2. Food--Chronic direct. A typical adult ingest significant 
quantities of decanoic acid via diet. When decanoic acid is used as a 
compound of a food contact surface sanitizer, the residue that would be 
introduce into food will be insignificant compared to the normal 
dietary intake. Based on this, there are no toxicological concerns 
resulting from exposures to residues of decanoic acid from the use of 
sanitizing solutions.
    3. Drinking water-- i. Acute. Since there are no acute 
toxicological concerns for decanoic acid, an acute drinking water risk 
assessment is not required.
    ii. Chronic. There are no toxicological concerns about the exposure 
of low concentrations of decanoic acid in the drinking water. Although 
it is possible that the trace amounts decanoic acid resulting for its 
use as a sanitizer may ultimately get into drinking water, no adverse 
health effects would results.
    4. Non-dietary exposure. The potential for significant additional 
non-occupational exposure to the general population (including 
children) is unlikely.

D. Cumulative Effects

    Over 99% of the exposure to decanoic acid is expected to be via the 
diet.

[[Page 63537]]

 Potentially small amounts of decanoic acid exposure will be the result 
of non-food uses. The amount of decanoic acid exposure resulting from 
indirect exposure to sanitizing solutions will be minuscule. Since 
decanoic acid in the diet pose no toxicological risk, the cumulative 
toxicity resulting from the additional exposure is negligible.

E. Safety Determination

    1. U.S. population. Since there are no adverse toxicological 
effects resulting from normal dietary concentrations of decanoic acid, 
there is no need to determine aggregate risks, or to conduct a safety 
determination. Decanoic acid 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 ingest 
decanoic acid in their diet. Children are at no greater ``risk'' from 
exposure to decanoic acid. Therefore, as with adults, a safety 
determination is not appropriate.

F. International Tolerances

    No codex maximum residue levels have been established for decanoic 
acid.

[FR Doc. 01-30369 Filed 12-6-01; 8:45 a.m.]
BILLING CODE 6560-50-S