[Federal Register: January 13, 2003 (Volume 68, Number 8)]
[Proposed Rules]
[Page 1575-1580]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ja03-24]
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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: alston.treva@epa.gov.
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
[[Page 1576]]
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 opp-docket@epa.gov,
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.
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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
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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).
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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