[Federal Register Volume 69, Number 57 (Wednesday, March 24, 2004)]
[Rules and Regulations]
[Pages 13740-13745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6431]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0001; FRL-7341-3]


Ammonium Bicarbonate; Exemption from the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the biochemical pesticide, ammonium 
bicarbonate on all food commodities when applied/used according to its 
label instructions as a feeding attractant. Certis USA, LLC submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
as amended by the Food Quality Protection Act of 1996 (FQPA), 
requesting an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of ammonium bicarbonate.

DATES: This regulation is effective March 24, 2004. Objections and 
requests for hearings, identified by docket ID number OPP-2004-0001, 
must be received on or before May 24, 2004.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit IX. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Andrew Bryceland, Biopesticides and 
Pollution Prevention Division (7511C), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6928; 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:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions. 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-2004-0001. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119,

[[Page 13741]]

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.
    The legacy docket for this case is OPP-2002-0214, which was set up 
in connection with the Notice of Filing of this pesticide petition, (PP 
2F6477). It contains the Federal Register Notice dated September 25, 
2002 (68 FR 60236) (FRL-7194-1), which was published to announce this 
petition.
    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.

II. Background and Statutory Findings

    In the Federal Register of September 25, 2002 (67 FR 60233), EPA 
issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a(e), as amended by FQPA (Public Law 104-170), announcing the filing 
of a pesticide tolerance petition (PP 2F6477) by Certis USA LLC, 9145 
Guild Road, Suite 175, Columbia, MD 21046. This notice included a 
summary of the petition prepared by the petitioner Certis USA LLC. 
There were no comments received in response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of ammonium bicarbonate.

III. Risk Assessment

    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for 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(c)(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 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 * * * .'' Additionally, section 408(b)(2)(D) of the 
FFDCA requires that the Agency consider``available information'' 
concerning the cumulative effects of a particular pesticide's residues 
and ``other substances that have a common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

IV. Toxicological Profile

    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 and considered its validity, completeness, and 
reliability and the relationship of this information 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.
    Ammonia is a substance naturally produced in the human body from 
the metabolism of protein, amino acids, and other nitrogen containing 
chemicals (Refs. 1 and 2). A fairly large amount of ammonia (>50 mk/kg) 
is produced in the body each day from the breakdown of dietary protein 
and amino acids (Refs. 1 and 2). Bicarbonates are part of several 
commonly consumed compounds such as sodium bicarbonate and potassium 
bicarbonate, both of which have tolerance exemptions from EPA under 40 
CFR 180.1176 and 40 CFR 180.1177, respectively. The Food and Drug 
Administration (FDA) allowed the use of ammonium bicarbonate as a 
direct food additive and EPA exempted ammonium bicarbonate from the 
requirement from a tolerance when used as an inert ingredient such as a 
surfactant or a suspending or dispersing agent in formulations applied 
to growing crops, and as a post-harvest treatment (Refs. 1 and 3). EPA 
has been petitioned to exempt from the requirement of a tolerance 
ammonium bicarbonate as an active ingredient. The toxicology of 
ammonium bicarbonate is no different for an active ingredient than it 
is from an inert ingredient.
    Exposure of ammonium bicarbonate to ambient sunlight and heat 
results in the slow release of small amounts of ammonia (Refs. 1, 2, 
and 3). Ammonium bicarbonate is a preexisting component of the diet and 
degrades into ammonia, carbon dioxide, and water (Refs. 1, 2, and 3); 
therefore, during decomposition, ammonia would be the only component of 
concern and based on the commonly understood toxicology of ammonia, 
oral toxicity is not anticipated because when used as an attractant, 
the concentration of ammonia is estimated to be 100 times less than 
worldwide ambient atmospheric concentration (Refs. 1 and 2). Thus, it 
is unlikely that exposure to ammonium bicarbonate, or to the 
component(s) of ammonium bicarbonate, from the use of this pesticide 
will significantly add to ambient exposures already documented and 
without adverse effects.
    The petitioner did not generate any toxicology and/or pathogenecity 
data in support of this tolerance exemption. Waivers for data 
requirements for toxicology and pathogenecity were requested and 
granted based on information/data submitted from the open scientific 
literature in support of the tolerance exemption for ammonium 
bicarbonate and are discussed below.
    The following discussion of the evaluation of the information from 
the open scientific literature indicates a lack of toxicity and 
exposure to the pesticide and its degradation products will not likely 
add significantly to levels already present in the environment. More 
detailed analyses of these literature citations can be found in the 
specific Agency review of such information (Ref. 1). In addition, a 
substantial body of information on ammonium bicarbonate is published 
and selected copies are included in this reference (Refs. 2 and 3).
    1. Hypersensitivity incidents (40 CFR 152.12). No hypersensitivity 
incidents have been reported by the registrant. However, to comply with 
the Agency's requirements under section 6(a)(2), any incident of 
hypersensitivity associated with the use of this pesticide must be 
reported to the Agency.

[[Page 13742]]

    2. Data waivers. Data waivers were requested for the following 
studies:
    i. Acute oral toxicity (OPPTS Harmonized Guideline 870.1100). No 
MRID. Acute oral LD50 toxicity study in the rat. No study 
was submitted, however, the literature and submitted material safety 
data sheets, report an acute oral LD50 value of 1,576 
milligrams/kilogram (mg/kg) in the rat. This information is acceptable 
to allow placement of ammonium bicarbonate in Toxicity Category III for 
the oral route (Refs. 1 and 2).
    ii. Acute dermal toxicity (OPPTS Harmonized Guideline 870.1200). 
The pH of ammonium bicarbonate is 7.8 in a 0.1N solution, and it 
degrades into ammonia, carbon dioxide, and water (Refs. 1 and 3). 
Therefore, no toxicity or irritation to the skin is expected, and 
further, no incidents of toxicity to the skin are reported.
    iii. Acute inhalation toxicity (OPPTS Harmonized Guideline 
870.1300). Ammonium bicarbonate degrades into ammonia, carbon dioxide, 
and water, and the only component of concern would be ammonia during 
decomposition. Acute and chronic inhalation minimum risk levels (MRL) 
for ammonia have been set at 0.5 parts per million (ppm) and 0.3 ppm, 
respectively; which far exceeds any potential exposure from the 
pesticide use (Ref. 1).
    iv. 90-Day oral toxicity in rodents (OPPTS Harmonized Guideline 
870.3100). Ammonium bicarbonate is a preexisting component of the diet, 
and degrades only to ammonia, carbon dioxide, and water; therefore, 
oral toxicity is not anticipated (Refs. 1, 2, and 3).
    v. Reproduction/developmental toxicity screening test (OPPTS 
Harmonized Guideline 870.3550). Ammonium bicarbonate is a preexisting 
component of the diet, and degrades only to ammonia, carbon dioxide, 
and water; therefore, reproduction/developmental toxicity is not 
anticipated(Refs. 1, 2, and 3).
    vi. Bacterial reverse mutation test (OPPTS Harmonized Guideline 
(870.5100). Ammonium bicarbonate (with or without S9 mix activation) 
was not mutagenic in the Ames assay when S. typhimurium strains TA97 
and TA102 were exposed to 0.1 to 10 mg/assay plate (Refs. 1 and 2).
    vii. Immunotoxicity (OPPTS Harmonized Guideline 870.7800). Ammonium 
bicarbonate is a preexisting component of the diet, and degrades only 
to ammonia, carbon dioxide, and water; therefore, immunotoxicity is not 
anticipated (Refs. 1, 2, and 3).
    Data waivers of acute and subchronic oral studies, a dermal 
toxicity study, an acute inhalation study, mutagenicity studies, an 
immunotoxicity study, and a developmental toxicity study were requested 
and granted based on the submitted information from the public 
literature (Ref.1). Exposure to either ammonium bicarbonate, or to the 
ammonia component of ammonium bicarbonate, from the pesticidal use is 
not likely to add significantly to ambient exposures already documented 
and without reported adverse effects (Ref. 1). The amounts of ammonia 
released from the product over time result in calculated concentrations 
of 0.03 parts per billion (ppb)/day, well below the chronic human 
inhalation MRL of 0.3 ppm (Refs. 1 and 2). This exemption is supported 
by the fact that there are likely to be zero to minimal residues and 
any residues that might be found are within the safe limits identified 
by the data.
    3. Subchronic, chronic toxicity, and oncogenicity, and residue 
data. Based on the information submitted by the registrant in 
accordance with the Tier I data requirements set forth in 40 CFR 
158.690(c), the Tier II and III data requirements were not triggered 
and, therefore, not required in connection with this action. In 
addition, because the Tier II and Tier III data requirements were not 
required, the residue data requirements set forth in 40 CFR 158.690(b) 
also were not required.

V. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA 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).

A. Dietary Exposure

    The ammonium bicarbonate in the end-use product will be contained 
within a polymeric substance, and as such will not come into direct 
contact with olives, thus no residues are expected and exposure via the 
oral route is unlikely.
    1. Food. Ammonium bicarbonate at low levels is a preexisting 
component of the diet and is not known to be a toxic compound in the 
human diet. FDA has classified ammonium bicarbonate as Generally 
Regarded As Safe (GRAS) (21 CFR 582.1135), and allows its use as a 
direct food additive (21 CFR 184.1135). Because the product is 
contained within a polymeric substance, there will be minimal 
additional dietary exposure from this use (Ref. 1). There is however, 
some potential for the ammonia gas from the decomposed product to come 
into contact with growing olives. However, it is expected that levels 
of gaseous ammonia would be well below the normal background levels of 
atmospheric ammonia present in an area of crop production.
    2. Drinking water exposure. Exposure to residues of ammonium 
bicarbonate via drinking water is not likely to occur because ammonium 
bicarbonate is soluble in water and would break down into ammonia, 
carbon dioxide and water (Ref. 1). As gases, most of the ammonia and 
carbon dioxide will be released from the water.

B. Other Non-Occupational Exposure

    The exposure levels of ammonia established by the Office of Safety 
and Health Administration (OSHA) at 35 ppm for 15 minutes (Refs. 1 and 
2). In addition, the levels of exposure expected from use of this 
product are again less than the levels of ammonia in the workplace as 
recommended by the National Institute of Occupational Safety and Health 
(NIOSH) which are to be 50 ppm for 5 minutes of exposure (Refs. 1 and 
2). The use of ammonium bicarbonate as a pesticide active ingredient is 
for field use, rather than indoor use. The additional exposure to 
ammonia as a degradation product of ammonium bicarbonate when used as a 
pesticide under field conditions will be far less than limits 
established by OSHA or NIOSH for occupational uses. Non-occupational 
exposure should be minimal.
    1. Dermal exposure. The potential for non-occupational exposure to 
residues of ammonium bicarbonate is unlikely because the method of 
application in a polymeric substance limits any anticipated dermal 
exposure (Ref. 1).
    2. Inhalation exposure. The potential for non-occupational 
inhalation exposure to residues of ammonium bicarbonate will occur at 
levels far lass than those established by OSHA and NIOSH. The total 
amount of ammonium bicarbonate applied per orchard/acre is 168 grams. 
The ammonium bicarbonate will slowly decompose to ammonia, carbon 
dioxide and water vapor. The total yield of ammonia would be 34.5 grams 
per season. If 36 g of ammonia is distributed in a single point in time 
over an acre of olive orchard to a height of 15 feet, the calculated 
concentration of ammonia would be 3 ppb. Assuming a release of ammonia 
from the product occurs over a 4-5 month period, a theoretical daily 
concentration can be

[[Page 13743]]

estimated at about 0.03 ppb/day during this time. This 0.03 ppb value 
is about 100 times less than the worldwide ambient atmospheric 
estimates of 1-3 ppb, and about 10,000 fold lower than ammonia 
concentrations (i.e., 300 ppb) reported over an agricultural field 
after fertilizer application. Furthermore, the 0.03 ppb value is lower 
than: The acute inhalation LC50 values after 15 minutes of 
exposure to ammonia that were reported as 17,401 ppm in the rat, and 
after 30 minutes of exposure, 21,430 ppm in the mouse; the acute and 
chronic inhalation minimal risk levels (MRLs) of 0.5 ppm and 0.3 ppm, 
respectively, that have been derived from studies with humans; the OSHA 
short-term (15 minute) exposure level of 35 ppm for ammonia; and the 
NIOSH recommended limited ammonia levels in the workplace of 50 ppm for 
5 minutes of exposure (Ref. 1).

VI. Cumulative Effects

    The Agency has considered the cumulative effects of ammonium 
bicarbonate and other substances in relation to a common mechanism of 
toxicity. These considerations include the possible cumulative effects 
of such residues on infants and children. There is no indication of 
mammalian toxicity at the maximum doses tested, of this or other 
products containing ammonium bicarbonate. Ammonium bicarbonate degrades 
into ammonia, carbon dioxide and water and the only component of 
concern would be ammonia (Refs. 1, 2, and 3); therefore, reasonably 
foreseeable exposures do not approach any toxicological level of 
concern.

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

    1. U.S. population. There is reasonable certainty that no harm will 
result from aggregate exposure to residues of ammonium bicarbonate to 
the U.S. population, infants and children. This includes all 
anticipated dietary exposures and all other exposures for which there 
is reliable information. The Agency has arrived at this conclusion 
based on the classification by FDA that ammonium bicarbonate is GRAS 
(21 CFR 582.1135), and allows its use as a direct food additive (21 CFR 
184.1135). EPA exempts ammonium bicarbonate from the requirement of a 
tolerance when used as a surfactant, or a suspending or dispensing 
agent in formulations applied to growing crops or to food commodities 
after harvest, 40 CFR 180.1001(c) (Refs. 1, 2, and 3). Further, the 
active ingredient will be contained in a polymeric substance, in a 
retrievable device and while contained in this device, the product will 
slowly decompose to ammonia, carbon dioxide, and water at a rate which 
exceeds that which the human body produces each day from the breakdown 
of proteins and amino acids. Moreover, the levels of ammonia produced 
by the human body far exceed those levels of ammonia anticipated to be 
released from the use of this product and the estimated worldwide 
atmospheric levels of ammonia.
    2. Infants and children. FFDCA section 408 provides that EPA shall 
apply an additional tenfold margin of exposure (safety) for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the data base unless EPA 
determines that a different margin of exposure (safety) will be safe 
for infants and children. Margins of exposure (safety) are often 
referred to as uncertainty (safety) factors. In this instance, based on 
all available information, the Agency concludes that ammonium 
bicarbonate is practically non-toxic to mammals including infants and 
children. Because there are no threshold effects of concern to infants, 
children and adults when ammonium bicarbonate is used as labeled, the 
provision requiring an additional margin of safety does not apply. 
Further, the provisions of consumption patterns, special 
susceptibility, and cumulative effects do not apply. As a result, EPA 
has not used a margin of exposure (safety) approach to assess the 
safety of ammonium bicarbonate.

VIII. Other Considerations

A. Endocrine Disruptors

    Based on available data, no endocrine system-related effects have 
been identified with consumption of ammonium bicarbonate. It is 
produced in the human body, exempt for tolerance requirement by EPA as 
an inert ingredient, and allowed by the U.S. Department of Agriculture 
as a direct food additive. To date, there is no evidence to suggest 
that ammonium bicarbonate affects the immune system, function in a 
manner similar to any known hormone, or that it acts as an endocrine 
disruptor.

B. Analytical Method(s)

    The Agency proposes to establish an exemption from the requirement 
of a tolerance for residues of ammonium bicarbonate, without any 
numerical limitation. Reasonably forseeable exposures to residues of 
ammonium bicarbonate will not significantly add to the levels already 
in the environment because the proposed use involves containing the 
active ingredient within a polymeric substance and because ammonium 
bicarbonate rapidly degrades to ammonia. Exposure to residues from 
ammonium bicarbonate will not significantly add to the levels already 
present in the environment because the active ingredient will be 
contained within a polymeric substance and it rapidly degrades into 
ammonia, water and carbon dioxide, at levels much below any reported 
levels of toxicological concern. Ammonium bicarbonate is a preexisting 
component of the human diet and is allowed as a direct food additive by 
the FDA (Refs. 1, 2, and 3).
    The Agency concludes that an analytical method is not required for 
enforcement purposes for ammonium bicarbonate. However, an enforcement 
analytical method (OPPTS Harmonized Guideline 830.1800) was provided by 
the petitioner.

C. Codex Maximum Residue Level

    There is no CODEX maximum residue levels for residues of ammonia or 
ammonium bicarbonate.

IX. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. However, the period for filing objections is now 60 days, rather 
than 30 days.

A. What Do I Need To Do To File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2004-0001 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be

[[Page 13744]]

mailed or delivered to the Hearing Clerk on or before May 24, 2004.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential 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. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit IX.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2004-0001, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to:[email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

X. References

    1. Sjoblad, R.S. Memorandum. Review of Data/Information Submitted 
by Certis USA to Support a Tolerance Exemption (Petition No. 2F6477) 
for Residues of Ammonium Bicarbonate in Olives (D288947; Case 295326; 
S631096). March 26, 2003.
    2. Syracuse Research Corporation. Volume 3: Toxicological Profile 
for Ammonia, MRID No. 457120-02. December 1990.
    3. Wagner, J.M. Volume 2: Public Literature Submitted to Support 
the Petition for the Exemption of Ammonium Bicarbonate from the 
Requirement of a Tolerance for Residues in or on Olives, MRID No. 
457120-01. April 2002.

XI. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement under section 408(d) of the FFDCA in response to a petition 
submitted to the Agency. 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 rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this 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 final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501et 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). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the exemption in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. 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,

[[Page 13745]]

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 final 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 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 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 rule.

XII. Congressional Review Act

    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: March 5, 2004.
James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.1244 is added to subpart D to read as follows:


Sec.  180.1244  Ammonium bicarbonate; exemption from the requirement of 
a tolerance.

    An exemption from the requirement of tolerance is established for 
residues of ammonium bicarbonate used in or on all food commodities 
when used in accordance with good agricultural practices.

[FR Doc. 04-6431 Filed 3-23-04; 8:45 am]
BILLING CODE 6560-50-S