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acetic acid Pesticide Petition Filing 8/99


[Federal Register: September 1, 1999 (Volume 64, Number 169)]
[Notices]               
[Page 47791-47795]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01se99-96]                         

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ENVIRONMENTAL PROTECTION AGENCY

[PF-881; FRL-6090-8]

 
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).

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 
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 
response.

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 
address: acierto.amelia@epa.gov.

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 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 
CONTACT'' section.

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

[[Page 47792]]

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: ``opp-docket@epa.gov,'' 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 
CONTACT'' section.

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 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 
requirements.

    Dated: August 23, 1999.

James Jones,
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 
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 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 
significance.

B. Toxicological Profile

    1. Acute toxicity. Acetic acid is a direct food additive. It is 
considered

[[Page 47794]]

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 
relevant.
    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 
(child).
    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 
acid.


[FR Doc. 99-22747 Filed 8-31-99; 8:45 am]
BILLING CODE 6560-50-F