acetic acid Pesticide Petition Filing 8/99
[Federal Register: September 1, 1999 (Volume 64, Number 169)]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
Ecolab Inc.; Notice of Filing a Pesticide Petition to Establish a
Tolerance for Certain Pesticide Chemicals in or on Food
AGENCY: Environmental Protection Agency (EPA).
SUMMARY: This notice announces the initial filing of a pesticide
petition 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-881, must be
received on or before October 1, 1999.
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'' section. To
ensure proper receipt by EPA, it is imperative that you identify docket
control number PF-881 in the subject line on the first page of your
FOR FURTHER INFORMATION CONTACT: By mail: Amelia M. Acierto,
Registration Support Branch, Registration Division (7505W), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460; telephone number: (703) 308-8375; and e-mail
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 potentially
Categories NAICS 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 in the ``FOR FURTHER INFORMATION
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-881. 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 (CM #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-881 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, 401 M St., SW., 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, CM #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: ``firstname.lastname@example.org,'' 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 5.1/
6.1 or ASCII file format. All comments in electronic form must be
identified by docket control number PF-881. 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 in the ``FOR FURTHER INFORMATION
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
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
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
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 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 supports 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
Dated: August 23, 1999.
Director, Registration Division, Office of Pesticide Programs.
Summaries of Petitions
2. PP 9E5086
Summary of Petition
EPA has received a pesticide petition (PP 9E5086) from Ecolab Inc.,
370 N. Wabasha Street, St. Paul, MM 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 acetic acid in or on the 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 fruit and
fruits and vegetables when such residues result from the use of acetic
acid 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
A. Residue Chemistry
1. Analytical method. Because Ecolab Inc. is petitioning for an
exemption from the requirement of a tolerance, an enforcement method
for acetic acid is not needed.
2. Magnitude of residues. The residues which transfer from the
sanitized dish or utensil to food are not of toxicological
B. Toxicological Profile
1. Acute toxicity. Acetic acid is a direct food additive. It is
generally recognized as safe by the Food and Drug Administration and is
a normal constituent in the human diet. Acetic acid is allowed under 40
CFR 180.1001(c) as an inert ingredient in pesticide formulation applied
to growing crops or to raw agricultural commodities after harvest
without limit in the formula. Acute oral lethel dose (LD<INF>50</INF>)
(rat): 3310 3530 milligrams/kilograms (mg/kg); Acute oral
LD<INF>50</INF> (mouse): 4960 mg/kg; Inhalation LC<INF>50</INF>
(mouse): 5620 parts per million (ppm)/l hour(s); Dermal LD<INF>50</INF>
(rabbit): 1060 mg/kg.
2. Genotoxicty. Nothing in the available literature indicates that
acetic acid is a genotoxic or mutagenic compound. It is generally
recognized as safe and is a normal constituent in the human diet.
3. Reproductive and developmental toxicity. Nothing in the
available literature indicates that acetic acid 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 long term exposure to acetic acid produces any adverse
toxicological effects unless it is ingested at a concentration where it
produces corrosive or other effects on the gastric mucosa. There are no
studies indicating that prolonged exposure to acetic acid produces
cumulative toxicity since acetic acid is a normal constituent of
cellular metabolism. Acetic acid is a catabolic breakdown product of
fatty endogenous acid metabolism and is also used in the synthesis of
lipids. Estimated daily intakes of acetic acid/acetate ion are in the
range of 2 grams per day for an adult. As a normal constituent of the
human diet, there are no toxicological concerns with acetic acid.
5. Chronic toxicity. Chronic exposure would not produce any
additional effect beyond what is noted in subchronic exposure,
therefore, no additional concerns are warranted. Nothing in the
literature indicates that acetic acid may be carcinogenic.
6. Animal metabolism. Acetic acid and its derivatives are used in
the metabolism fatty acids. It is a normal constituent of mammalian
metabolism, therefore, a discussion of acetic acid metabolites is not
7. Metabolite toxicology. ``Metabolites'' of acetic acid are used
in several processes of cellular metabolism. These metabolites are
normal constituents of the cell, therefore a discussion of metabolite
toxicity of acetic acid is not relevant.
8. Endocrine disruption. Acetic acid does not act like hormones or
inhibit hormonal activity. It is not strucurally related to any known
endocrine disruptor. Nothing in the literature suggests that it is an
endocrine disruptor or possesses intrinsic hormonal activity.
C. Aggregate Exposure
1. Dietary exposure. Acute: There are no acute toxicological
concerns for acetic acid, an acute dietary risk assessment is not
required. Chronic Indirect: Using a worst-case scenario, the additional
exposure from food contact surface sanitizers would be 0.03 mg/kg/day
for a 70 kg person (adult) and 0.04 mg/kg/day for a 28 kg person
i. Food. Chronic Direct: A typical adult ingests approximately 2
grams (2000 mg) of acetic acid/acetate per day via the diet. The
incremental increase in exposure as a result of the use in food contact
surface sanitizing solutions is negligible.
ii. Drinking water. Acute: Since there are no acute toxicological
concerns for acetic acid, an acute drinking water risk assessment
should not be required. Chronic: There is no concern about the
potential for transfer of acetic acid residues to human drinking water.
It is essentially impossible that residues from the proposed use will
transfer acetic acid residues to any sources of human drinking water.
2. 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 acetic acid will be via the diet.
Most of this exposure will be through ingestion of ``vinegar'' in the
diet. Small amounts of acetic acid exposure will be the result of non-
food uses. The amount of acetic acid exposure resulting from indirect
exposure to sanitizing solutions will be virtually zero. Since acetic
acid 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 not adverse toxicological
effects resulting from normal dietary concentrations of acetic acid,
there is no need to determine aggregate risks, or to conduct a safety
determination. Acetic acid is generally recognized as safe and the
incremental exposure due to its us as an inert in a food contact
surface sanitizer is negligible.
2. Infants and children. As in adults, infants and children use
acetic acid as a basic constituent of cellular metabolism. Children are
at no greater ``risk'' from exposure to acetic acid. Therefore, as with
adults, a safety determination is not appropriate.
F. International Tolerances
No Codex maximum residue levels have been established for acetic
[FR Doc. 99-22747 Filed 8-31-99; 8:45 am]
BILLING CODE 6560-50-F