[Federal Register Volume 68, Number 112 (Wednesday, June 11, 2003)]
[Notices]
[Pages 34955-34958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14200]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0177; FRL-7308-7]


Acetic Acid; Notice of Filing a Pesticide Petition to Establish 
an Exemption from the Requirements of a Tolerance for a Certain 
Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket ID number OPP-2003-0177, must be 
received on or before July 11, 2003.

ADDRESSES:  Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:  Driss Benmhend, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-9525; e-mail 
address:[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
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 Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0177. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket

[[Page 34956]]

facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in EPA's Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B. EPA intends to work towards 
providing electronic access to all of the publicly available docket 
materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2003-0177. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID number OPP-2003-0177. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2003-0177.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID Number OPP-2003-0177. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or

[[Page 34957]]

CD ROM the specific information that is 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 docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed 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 
ID 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 a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical 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 this petition contains data or information 
regarding the elements set forth in FFDCA 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: May 22, 2003.
 Sheryl K. Reilly,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the petitioner and represents the view of the petitioner. 
The petition summary announces the availability of a description of the 
analytical methods available to EPA for the detection and measurement 
of pesticide chemical residues or an explanation of why no such method 
is needed.

Eastman Chemical Company

PP 3F6516

    EPA has received a pesticide petition (3F6516) from Eastman 
Chemical Company, P.O. Box 511, Kingsport, TN 37662 proposing, pursuant 
to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 
180 to establish an exemption from the requirement of a tolerance for 
the biochemical pesticide acetic acid. Pursuant to section 
408(d)(2)(A)(i) of the FFDCA as amended, Eastman Chemical Company has 
submitted the following summary of information, data, and arguments in 
support of their pesticide petition. The summary of the petition was 
prepared by the petitioner and represent the view of the petitioner. 
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.
    It is the purpose of this petition to re-establish an exemption 
from the requirement of a tolerance for acetic acid when used as a 
grain and hay preservative on agricultural commodities such as alfalfa, 
barley grain, Bermuda grass, bluegrass, brome grass, clover, corn 
grain, cowpea hay, fescue, lespedeza, lupines, oat grain, orchard 
grass, peanut grass, Timothy, vetch, and wheat grain, or commodities 
described as grain or hay.
    Acetic acid is currently exempt from the requirement of a tolerance 
when used as a catalyst under 40 CFR 180.1001(c). Previously, acetic 
acid was exempt from the requirement of a tolerance (40 CFR 180.1029), 
when used as a preservative on the above-mentioned commodities. This 
exemption was canceled, but only because the registrants at that time, 
did not wish to maintain the registration. Subsequent to the 
cancellation of the registrations, the tolerance exemption was revoked.

A. Residue Chemistry

    There have been no analytical procedures conducted to ascertain 
residual acetic acid on treated commodities. The application rate for 
the preservation of grain and hay as per instructions, will result in 
concentrations of about 1% on hay and about 1.5% on grain. 
Additionally, acetic acid is generally recognized as safe (GRAS) under 
the Food and Drug Administration (FDA), 40 CFR 184.1005, for use in 
food when used in accordance with good manufacturing or feeding 
practice.
    Since this request is for an exemption from the requirement of a 
tolerance, residual acetic acid on hay and grain will not pose a 
problem of exposure to humans or the environment especially since 
acetic acid is in the food chain and is naturally occurring in nature. 
Residuals at this low level are less than is found in vinegar used on 
foods.

B. Toxicological Profile

    1. Acute toxicity. Acute oral at 4,960 milligrams/kilogram body 
weight (mg/kg) (bwt) (Category III). Acute dermal at 1,060 mg/kg bwt 
(Category II). Acute inhalation at 11.4 milligrams/Liter (mg/L) 
(Category III). Eye irritation, corrosive (Category I). Dermal 
irritation, corrosive (Category I). Mild irritant to guinea pigs at 20 
mg/24 hours. (Category IV). Contact with concentrated acetic acid 
solutions may cause local damage to skin, eye, or mucosa.
    2. Genotoxicity. Acetic acid and the sodium salt of acetic acid, 
provided negative results for mutagenicity assays in strains of 
Salmonella typhimurium.
    3. Reproductive and developmental toxicity. In a teratogenicity 
study by the Food and Drug Research Laboratories, 5% acetic acid (apple 
cider vinegar), the administration of up to 1,600 mg/kg bwt, to 
pregnant mice for 10 consecutive days had no clear discernible effect 
on nidation or on maternal or fetal survival.
    Additionally, similar acids to acetic acid, such as fumaric acid 
and citric acid, illicit no teratogenic or reproductive toxicity in 
rats or chick embryos. This is also true for propionic acid (or salts 
thereof) which is used in the same manner as proposed for acetic acid.

[[Page 34958]]

    4. Subchronic toxicity. Waivers have been requested for the 90-day 
feeding, dermal and inhalation studies. The conditions of potential 
exposure requiring these studies are not triggered. Acetic acid is a 
food acid and is naturally occurring. Acetic acid is absorbed from the 
gastrointestinal tract and through the lungs and is readily, although 
not completely, oxidized in the organism. Acetic acid is proposed to be 
used as a hay and grain preservative at low concentrations, and for 
animal food only, and these low concentrations are lower than is found 
in commercially available vinegar (5% to 7%). Therefore, there would be 
no expected subchronic effects from the limited exposure expected to 
acetic acid, and the waivers should be granted.
    5. Chronic toxicity. Waivers have been requested for chronic 
toxicity requirements for acetic acid. However, the results of two 
Russian studies reported the induction of hyperplasia in rats at 60 mg/
kg bwt. This result is similar to induction of hyperplasia in rats by 
propionic acid in a 2-year study.
    6. Animal metabolism. Acetic acid is a food acid and is naturally 
occurring. Acetic acid is utilized as an energy source in the body by 
combining first with Co-enzyme A to form Acetyl-CoA which then enters 
the Kreb's citric acid cycle by combining with oxaloacetate to yield 
citrate. This process is active in all animals and higher plants and is 
carried out in the mitochondria. Acetic acid is proposed to be used as 
a hay and grain preservative at low concentrations, and for animal food 
only. There are no expected adverse effects.
    7. Metabolite toxicity. Acetic acid is a food acid and is naturally 
occurring in the environment as well as in plants and animals. Acetic 
acid is utilized as an energy source in the body by combining first 
with Co-enzyme A to form Acetyl-CoA which then enters the Kreb's citric 
acid cycle by combining with oxaloacetate to yield citrate. This 
process is active in all animals and higher plants and is carried out 
in the mitochondria.

C. Aggregate Exposure

    1. Dietary exposure. Acetic acid is a food acid and is naturally 
occurring in plants and animals. Acetic acid is utilized as an energy 
source in the body by combining first with Co-enzyme A to form Acetyl-
CoA which then enters the Kreb's citric acid cycle by combining with 
oxaloacetate to yield citrate. This process is active in all animals 
and higher plants and is carried out in the mitochondria.
    Acetic acid is most commonly encountered by the human population in 
the form of vinegar, varying in concentration of acetic acid, from 4-
7%. Acetic acid is considered generally recognized as safe (GRAS) by 
FDA when directly added to foods (20 CFR 184.1005). There are no 
reports in the literature of contact sensitization to vinegar.
    Used in accord with instructions for the preservation of grain and 
hay, the concentration of acetic acid on the commodities used for 
animal food, will be less than 2%. Dietary exposure to acetic acid used 
in this application will therefore pose no threat to humans or the 
environment.
    2. Non-dietary exposure. The only non-dietary exposure to acetic 
acid is the occupational exposure. Acetic acid end-use products are 
sprayed on grains and hay at application rates in ranges of less than 
3% on the commodity, depending on the moisture content of the treated 
crop. Based on the use patterns, the potential for exposure of 
applicators and workers in the field being treated with acetic acid 
could be significant. However, applicators are generally confined in 
the cab of the tractor pulling the collecting systems to which the 
applicating sprays are attached. The hay or grain collected would 
contain less than 3% of the acetic acid and therefore subsequent 
exposure to the crop would cause no significant exposure to the acetic 
acid.
    Certain protective clothing is recommended for acetic acid users 
due to eye and skin hazards associated with the handling of 
concentrated acetic acid and the use of such clothing and protective 
equipment is presented on the label.

D. Cumulative Effects

    Acetic acid is used similarly as propionic acid, for the 
preservation of hay and grains. Under an aerobic conditions propionic 
acid acts as a carbon source for various microbes and is metabolized to 
acetic acid, methane, carbon dioxide, and water. For propionic acid, 
the metabolite of acetic acid poses no problems because acetic acid is 
also found in the food chain, is naturally occurring, and is applied in 
the same manner as propionic acid as a pesticide. For propionic acid 
all environmental fate data requirements are waived for the uses this 
petition requests for acetic acid. There should be no concern for 
cumulative effects for acetic acid as well.

E. Safety Determination

    Human health assessment--i. U.S. population. Acetic acid is a 
normal component of metabolism in the human body and humans ordinarily 
consume acetic acid as vinegar, as a natural component of common foods, 
and as an added ingredient. Dietary exposure from pesticidal use would 
be very low.
    ii. Infants and children. As noted above acetic acid is produced by 
the human body. Humans include infants and children as well as adults. 
For the same reasons as above, dietary exposure from pesticidal use 
would be of minimal concern.

F. Tolerance Exemptions for the Proposed Uses

    The petitioner proposes that the use of acetic acid as a grain and 
hay preservative be granted an exemption from the requirement of a 
tolerance, as proposed below:
    1. Post-harvest application of acetic acid, when used as a 
fungicide or preservative is exempted from the requirement of a 
tolerance for residues in or on the following raw agricultural 
commodities: Alfalfa, barley grain, Bermuda grass, bluegrass, brome 
grass, clover, corn grain, cowpea hay, fescue, lespedeza, lupines, oat 
grain, orchard grass, peanut hay, peavine hay, rye grass, sorghum 
grain, soybean hay, sudan grass, Timothy, vetch, and wheat grain, or 
commodities described as grain or hay.
    2. Acetic acid is exempt from the requirement of a tolerance for 
residues in or on meat, and meat by-products: Cattle, sheep, hogs, 
goats, horses, and poultry, milk, and eggs when applied as a 
bactericide/fungicide to livestock drinking water, poultry litter, and 
storage areas for silage and grain.
    3. Post-harvest application of acetic acid when used as a 
fungicide/preservative is exempted from the requirement of a tolerance 
for residues in or on the following raw agricultural commodities: 
Cottonseed, peanuts, rice grain, and soybeans.
    Noticeably, this tolerance exemption request re-establishes the 
same exemption criteria as was previously granted for acetic acid for 
this use.

G. International Tolerances

    There are no known international tolerances for residues of acetic 
acid in food or animal feed.
[FR Doc. 03-14200 Filed 6-10-03; 8:45 am]
BILLING CODE 6560-50-S