[Federal Register Volume 68, Number 8 (Monday, January 13, 2003)]
[Proposed Rules]
[Pages 1575-1580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-615]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0346; FRL-7285-5]


Propanoic Acid, and its Calcium and Sodium Salts; Exemption from 
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to establish an exemption from the 
requirement of a tolerance for residues of propanoic acid, and its 
calcium and sodium salts when used as either an inert or active 
ingredient in pesticide formulations that are applied to growing crops 
or raw agricultural commodites (RAC) before or after harvest, and for 
pesticide formulations that are applied to animals, under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA). This document also proposes to 
reorganize the existing tolerance exemptions for propanoic acid and its 
salts.

DATES: Comments, identified by docket ID number OPP-2002-0346, must be 
received on or before March 14, 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: Treva Alston, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8373 and 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 code 111)
    [sbull] Animal production (NAICS code 112)
    [sbull] Food manufacturing (NAICS code 311)
    [sbull] Pesticide manufacturing (NAICS code 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-2002-0346. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and

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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 
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/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title;--40/40cfr180--00.html, a 
beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    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. Once in the system, select ``search,'' 
then key in the appropriate docket ID number.
    Certain types of information will not be placed in the EPA 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-2002-0346. 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-2002-0346. 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), Office of Pesticide Programs (OPP), 
Environmental Protection Agency (7502C), 1200 Pennsylvania Ave., NW., 
Washington, DC, 20460-0001, Attention: Docket ID Number OPP-2002-0346.
    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.

[[Page 1577]]

119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, 
VA., Attention: Docket ID Number OPP-2002-0346. 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 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. Offer alternative ways to improve the proposed rule or 
collection activity.
    7. Make sure to submit your comments by the deadline in this 
document.
    8. 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. Background and Statutory Findings

    In the Federal Register of February 12, 1997 (62 FR 6228) (FRL-
5583-9), EPA issued a notice under section 408 of the FFDCA, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP 6F4770) by 
Nayfa Industries, Inc., c/o 1625 K St., N.W., Suite 501, Washington, 
D.C. 20006. The petition requested that 40 CFR 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of the fungicide propionic acid, also known as propanoic acid 
(CAS Reg. No. 79-09-4) in or on the raw agricultural commodities 
sugarbeets, potatoes, and sweet potatoes. This notice included a 
summary of the petition prepared by Nayfa Industries, Inc., the 
petitioner. There were no comments received in response to the notice 
of filing. The Agency has not yet issued a final rule for this 
petition, and has, in fact, determined to issue a proposed rule.
    The Agency is now issuing this rule as a proposal for two reasons: 
First, the calcium and sodium salt forms of propanoic acid are being 
added to the existing exemptions from the requirement of a tolerance of 
propanoic acid (40 CFR 180.1023). Second, based on a review and 
evaluation of the available data, the Agency believes that a broader 
use than what was requested by the petitioner is appropriate. The 
Agency is proposing to remove the existing tolerance exemptions for 
propionic acid and sodium propionate in 40 CFR 180.1001(c). These 
exemptions from the requirement of a tolerance will be covered by the 
proposed revisions to 40 CFR 180.1023. No uses would be lost as a 
result of these actions. Since the 1997 publication of the Notice of 
Filing, the Agency has completed the Tolerance Reassessment process for 
propanoic acid. Based on the results of that reassessment, EPA on its 
own initiative, under section 408(e) of the FFDCA, 21 U.S.C. 346a, is 
proposing to establish an unlimited exemption from the requirement of a 
tolerance for residues of propanoic acid (CAS Reg. No. 79-09-4); 
propanoic acid, calcium salt (CAS Reg. No. 4075-81-4); and propanoic 
acid, sodium salt (CAS Reg. No. 187-40-6), when used as either an 
active or inert ingredient in pesticide formulations that are applied 
to growing crops or raw agricultural commodities and in pesticide 
formulations that are applied to animals.
    The data used by the Agency to make the safety determination for 
propanoic acid included data that was generated using the sodium and 
calcium salts of propanoic acid. Often, when conducting animal tests 
using an acid, such as propanoic acid, as the test substance, the acid 
must be neutralized (converted to a salt - in this case the calcium and 
sodium salt) to conduct the tests. Therefore, the Agency is proposing 
that these two salts of propanoic acid also be included in the 
tolerance exemption expression.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemptionfrom the requirement of a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of the FFDCA 
defines ``safe'' to mean that ``there is a reasonable certainty that no 
harm will result from aggregate exposure to the pesticide chemical 
residue, including all anticipated dietary exposures and all other 
exposures for which there is reliable information.'' This includes 
exposure through drinking water and in residential settings, but does 
not include occupational exposure.
    Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing an exemption from the requirement of a 
tolerance and to ``ensure that there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure to the 
pesticide chemical residue. . . .''
    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for the establishment of an exemption from the 
requirement of a tolerance for residues of propanoic acid and its 
calcium and sodium salts. EPA's assessment of exposures and risks 
associated with establishing the exemption from the requirement of a 
tolerance follows.

III. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the

[[Page 1578]]

toxic effects caused by propanoic acid and its calcium and sodium salts 
are discussed in this unit.
    Propanoic acid is a three carbon acid with a molecular formula of 
CH3CH2COOH. It is considered to be a medium 
strong acid. It occurs naturally in animal and dairy products such as 
butter and cheese. Propanoic acid and the salts of propanoic acid are 
direct food additives. (discussed in unit III.7.) The toxicological 
database for propanoic acid was determined to be adequate for 
reregistration eligibility at the time that the Reregistration 
Eligibility Document (RED) was completed in September 1991. A 
comprehensive search of the open literature from 1991 forward and a 
search for in-house toxicological data failed to reveal any new 
information on propanoic acid which would change the toxicological 
findings in the RED. Therefore, the toxicological findings/data from 
the Propionic Acid RED (which also addresses the calcium and sodium 
salts) are applicable to this current evaluation.
    1. Acute toxicity. Technical propanoic acid is of moderate to low 
acute toxcity via the oral, dermal, and inhalation routes of exposure 
(toxicity category of III), and is not a skin sensitizer. However, 
propanoic acid is acutely toxic in eye and dermal irritation tests 
(toxicity category I).
    2. Subchronic toxicity. No subchronic toxicity data are available 
on propanoic acid itself; however, data on calcium and sodium 
propionate are used to assess subchronic toxicity. Rats fed calcium or 
sodium propionate at one percent of the diet (equivalent to 750 
milligrams/kilogram/ day (mg/kg/day) of propanoic acid) for four weeks 
followed by 3% (equivalent to 1,200 mg/kg/day of propanoic acid) for 
three weeks showed no changes in weight gain compared to the the 
controls. Rats fed 5% propanoic acid in the diet (approximately 5,000 
mg/kg body weight) for 110 days developed lesions of the forestomach.
    Propanoic acid was given in the feed to dogs at 220, 735, or 2,066 
mg/kg/day for 90 days. The high dose dogs showed reduced food 
consumption, increased incidence of epithelial hyperplasia in the 
esophagus, and increased nitrite in the urine. These effects were no 
longer present in dogs held for a six week recovery period. In a 
limited 90-day dog study with calcium propionate (2,523 mg/kg/day) the 
dogs showed vomiting and diarrhea.
    3. Chronic toxicity. Twenty male rats per group were fed four 
percent propanoic acid in the diet for 2 years. The highest dose 
animals had hyperplasia and hyperplastic ulcers in the forestomach. 
Rats fed bread containing sodium propionate (4,000 mg/kg/day) for a 
year showed no adverse effects, nor did rats fed a similar diet for 32 
weeks, other than an initial depression of growth.
    4 Developmental toxicity. No maternal or fetal effects were seen 
upon feeding calcium propionate to pregnant animals at rates up to 300 
mg/kg/day for hamsters and rabbits.
    5. Mutagenicity
    Propanoic acid gave negative results in mutagencity assays in five 
strains of S. Typhimurium, and one strain of S. Cerevisiae, with and 
without activation.
    Additional data on calcium and sodium propionate indicated that 
both tested negative for mutagenicity in S. Typhimurium, and S. 
Cerevisiae.
    6. Metabolism Propanoic acid is produced in large quantities in 
ruminants (dairy cows), thus accounting for its presence in butter and 
dairy products. In humans, propanoic acid is one of the metabolic 
products from the breakdown of several amino acids. Propanoic acid is 
formed as the body oxidizes longer chain odd-numbered fatty acids or 
the side chain of cholesterol. It is a normal intermediary metabolite 
in the body that is utilized by most organs and tissues, and can be 
metabolized to glucose, carbohydrates, amino acids, and lipids.
    If directly ingested, propanoic acid is rapidly absorbed from the 
mammalian gastrointestinal tract, and thus enters a known metabolic 
pathway.
    7. FDA uses. The Food and Drug Administration (FDA) has approved 
various uses of propanoic acid, and its calcium and sodium salts. Under 
21 CFR 178.1010, propanoic acid can be used in food contact surface 
sanitizing solutions when the ready-for-use end-use concentration does 
not exceed 297 ppm. The calcium salt of propanoic acid is affirmed 
Generally Recognized As Safe (GRAS) under 21 CFR 184.1221. It is used 
as a mold inibitor in bread. The sodium salt of propanoic acid is 
affirmed GRAS under 21 CFR 184.1784. It is used as a mold inhibitor in 
cakes and unleavened goods and as a chemical preservative in animal 
drugs and feeds. Propanoic acid is affirmed GRAS under 21 CFR 184.1081. 
It is an antimicrobial agent and a flavoring agent.
    8. Findings of the United Nations Food and Agriculture 
Organization/World Health Organization (FAO/WHO) Expert Committee on 
Food Additives. Propanoic acid has been examined at several meetings of 
the FAO/WHO Joint Expert Committee on Food Additives (JECFA). The 
Seventeenth Report contained the following information: ``In human 
plasma propionic acid represents 0% to 4% of the total fatty acid and 
is a by-product of normal intermediate metabolism. Absorbed propionate 
is removed by the liver, kidneys, heart, muscle and adipose tissue. The 
liver can deal with 4.5 g free acid or 5.8 g sodium propionate per 
hour.''
    In 1973, the Committee determined that ``propionate is a normal 
intermediary metabolite, and a normal constituent of foods.'' Based on 
an understanding of this metabolic information, the Committee also 
determined that it was not necessary to specify an estimate of 
acceptable daily intake (ADI) in man. It was specified as 
``unlimited.'' This finding was reviewed in 1997: The 1973 ADI was 
maintained.
    9. Conclusions on the Toxicity of Propanoic Acid and its Calcium 
and Sodium Salts. Propanoic acid demonstrates an acute toxicity profile 
that is consistent with that of an acid: it is highly acutely toxic for 
eye and dermal irritation, i.e., it is corrosive to the eyes and skin. 
These effects are most appropriately addressed through the use of 
protective equipment and labeling, not through establishment of 
tolerance exemptions.
    The JECFA monograph deemed propanoic to be of such low concern that 
the acceptable daily intake is ``not specified.'' A consideration in 
this decision was the understanding that ``propionate is a normal 
intermediary metabolite, and a normal constituent of foods.'' Propanoic 
acid and its calcium and sodium salts are FDA affirmed GRAS direct food 
additives.
    When considering the oral exposure pathway, the most relevant in 
establishing a tolerance exemption, propanoic acid and its calcium and 
sodium salts have low toxic potential. There are no concerns for 
mutagencity, carcinogenicity, or developmental or reproductive 
concerns. Propanoic acid is a normal component of metabolism in the 
human body. The human body has a known pathway to metabolize propanoic 
acid. No additional data are necessary to assess the toxicity of these 
chemicals.

IV. Aggregate Assessment

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens. lawns, or buildings (residential and other 
indoor uses).

[[Page 1579]]

    For propanoic acid and its calcium and sodium salts a qualitative 
assessment for all pathways of human exposure (food, drinking water, 
and residential) is appropriate given their low toxic potential for the 
oral route of exposure, that humans of all ages are highly exposed to 
propanoic acid from natural sources, and the human body has a known 
pathway for metabolizing propanoic acid.

V.Cumulative Effects

    Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify or revoke a tolerance or tolerance 
exemption, the Agency considers ``available information'' concerning 
the cumulative effects of a particular chemical's residues and other 
substances that have a common mechanism of toxicity.'' Propanoic acid 
and its calcium and sodium salts are lower toxicity chemicals. EPA does 
not have, at this time, available data to determine whether propanoic 
acid and its calcium and sodium salts have a common mechanism of 
toxicity with other substances or how to include these pesticide 
chemicals in a cumulative risk assessment.

VI. Determination of Safety for U.S. Population, Infants and Children

    Based on the available data, the lower toxicity of propanoic acid 
and its calcium and sodium salts, and considering the FDA affirmed GRAS 
uses and the JEFCA finding of the unlimited ADI, EPA concludes that 
propanoic acid and its calcium and sodium salts do not pose a dietary 
risk under reasonably foreseeable circumstances. Accordingly, EPA finds 
that there is a reasonable certainty that no harm will result to the 
general population, and to infants and children from aggregate exposure 
to propanoic acid and its calcium and sodium salts. For propanoic acid 
and its calcium and sodium salts, due to the expected low oral 
toxicity, a safety factor analysis has not been used to assess the 
risk. For the same reasons and especially considering the available 
developmental toxicity information, the additional tenfold safety 
factor for the protection of infants and children is unnecessary.

VII. Other Considerations

    1. Endocrine disruptors. FQPA requires EPA to develop a screening 
program to determine whether certain substances, including all 
pesticide chemicals (both inert and active ingredients), may have an 
effect in humans that is similar to an effect produced by a naturally 
occurring estrogen, or such other endocrine effect. EPA has been 
working with interested stakeholders to develop a screening and testing 
program as well as a priority setting scheme. As the Agency proceeds 
with implementation of this program, further testing of products 
containing propanoic acid and its calcium and sodium salts for 
endocrine effects may be required.
    2. Analytical enforcement methodology An analytical method is not 
required for enforcement purposes since the Agency is establishing an 
exemption from the requirement of a tolerance without any numerical 
limitation.
    3. Existing exemptions Several tolerance exemptions for the 
residues of propionic acid, have been established in 40 CFR 180.1023. 
Under 40 CFR 180.1023(a) propionic acid or a mixture of methylene 
bispropionate and oxy(bismethylene) bisproprionate is exempted from the 
requirement of a tolerance when used as a fungicide on 22 commodities. 
In addition exemptions from the requirement of tolerances from residues 
of propionic acid (see 40 CFR 180.1023(b)) have been established in or 
on meat and meat byproducts of 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. The two above exemptions are only being modified for the 
nomenclature change from propionic to propanoic acid.
    The current exemption under 40 CFR 180.1023(c) will be replaced by 
a new tolerance exemption which covers the existing exemptions under 
(c), but is broader and will also include the calcium and sodium salts 
of propanoic acid.
    Exemptions from the requirement of a tolerance have been 
established in 40 CFR 180.1001(c) for sodium propionate with a use as a 
preservative and for propionic acid with a use as a catalyst in the 
pesticide formulation. These exemptions are now duplicative and will be 
removed.

D. International Residue Limits

    The Agency is not aware of any country requiring a tolerance for 
propanoic acid and its calcium and sodium salts nor have any CODEX 
Maximum Residue Levels (MRLS) been established for any food crops at 
this time.

VIII. Conclusion

    Based on the information in the record, summarized in this 
preamble, EPA concludes that there is a reasonable certainty of no harm 
from aggregate exposure to residues of propanoic acid, calcium 
propionate, and sodium propionate. Accordingly, EPA finds that 
exempting propanoic acid; propanoic acid, calcium salt; and propanoic 
acid, sodium salt from the requirement of a tolerance will be safe. 
With the establishment of this tolerance exemption in 40 
CFR180.1023(c), the existing tolerance exemptions for inert ingredients 
in 40 CFR 180.1001(c) are duplicative and can be removed.

IX. Regulatory Assessment Requirements

    This proposed rule establishes a consolidated and expanded 
exemption from the requirement for a tolerance under section 408(d) of 
the FFDCA. The Office of Management and Budget (OMB) has exempted these 
types of actions from review under Executive Order 12866, entitled 
Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because 
this proposed rule has been exempted from review under Executive Order 
12866 due to its lack of significance, this proposed rule is not 
subject to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This proposed rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). The Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) generally requires an 
agency to prepare a regulatory flexibility analysis of any rule subject 
to notice and comment rulemaking requirements under the Administrative 
Procedure Act or any other statute unless the agency certifies that the 
rule will not have a significant impact on a substantial

[[Page 1580]]

number of small entities. Small entities include small businesses, 
small organizations, and small governmental organizations. After 
considering the economic impacts of today's proposed rule on small 
entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. Establishing 
an exemption from the requirement of a pesticide tolerance (or, 
expanding and consolidating a tolerance exemption, as is proposed 
today), is in effect, the removal of a regulatory restriction on 
pesticide residues in food and thus such an action will not have any 
negative economic impact on any entities, including small entities. In 
addition, the Agency has determined that this action will not have a 
substantial direct effect on States, on the relationship between the 
national government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism(64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.''``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This proposed rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this proposed rule does not have any ``tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000). Executive Order 13175, requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive Order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This proposed rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this proposed rule.

X. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: January 2, 2003.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 180-- [AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

PART 180.1001 [Amended]

    2. Section 180.1001 is amended in paragraph (c) by removing from 
the table, the entries for ``propionic acid'' and ``sodium 
propionate.''

    3. Section 180.1023 is amended in paragraph (a) and (b) by revising 
the term ``propionic acid'' to read ``propanoic acid;'' and by revising 
paragraph (c) to read as follows:


Sec.  180.1023  Propanoic acid and its sodium and calcium salts; 
exemptions from the requirement of a tolerance.

* * * * *
    (c) Residues of propanoic acid (CAS Reg. No. 79-09-4), propanoic 
acid, calcium salt (CAS. Reg. No. 4075-81-4), and propanoic acid, 
sodium salt (CAS Reg. No. 137-40-6) are exempted from the requirement 
of a tolerance when used as either an active or inert ingredient in 
accordance with good agricultural practice in pesticide formulations 
applied to growing crops, to raw agricultural commodities after 
harvest, and to animals.
[FR Doc. 03-615 Filed 1-10-03; 8:45 am]
BILLING CODE 6560-50-S