[Federal Register Volume 69, Number 42 (Wednesday, March 3, 2004)]
[Rules and Regulations]
[Pages 9958-9963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4707]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0003; FRL-7344-1]


Gellan Gum; 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 gellan gum when used as an inert 
ingredient in a pesticide product. CP Kelco submitted a petition to EPA 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by 
the Food Quality Protection Act (FQPA) of 1996, requesting an exemption 
from the requirement of a tolerance. This regulation eliminates the 
need to establish a maximum permissible level for residues of gellan 
gum.

DATES: This regulation is effective March 3, 2004. Objections and 
requests for hearings, identified by docket ID number OPP-2004-0003, 
must be received on or before May 3, 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 X. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: James Parker, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-0371; 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

[[Page 9959]]

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-2004-0003. 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, 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 thisFederal 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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?sid =baa35b6058a65d5fafe66e 
7269d4d215&c=ecfr&tpl =/ecfrbrowse/Title40/40cfrv21--02.tpl, a beta 
site currently under development.
    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. 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.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of July 16, 2003 (68 FR 42026) (FRL-7317-
4), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
a pesticide tolerance petition (PP 3E6567) by CP Kelco, 8355 Aero Dr., 
San Diego, CA 92123-1718. This notice included a summary of the 
petition prepared by CP Kelco. 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 gellan gum (CAS No. 71010-52-1).
    Section 408(b)(2)(A)(i) of 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(b)(2)(A)(ii) of 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 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....''
    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.

III. Human Health Assessment

    Consistent with section 408(b)(2)(D) of 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. The nature of the toxic effects caused by gellan 
gum are discussed in this unit. The information submitted in support of 
this petition included the review and evaluation of 14 toxicity studies 
performed using gellan gum by the Joint Expert Committee on Food 
Additives (JECFA) which is an international expert scientific committee 
that is administered jointly by the Food and Agriculture Organization 
of the United Nations (FAO) and the World Health Organization (WHO). 
Gellan gum is also approved as a food additive in 21 CFR 172.665.
    Gellan gum is produced through the fermentation of Pseudomonas 
elodea (a non-pathogenic bacteria). Gellan gum is a water-soluble 
polysaccharide that is composed of repeating units, which are called 
monosaccharides. These four units are one molecule of rhamnose (a sugar 
found in various plants), one molecule of glucuronic acid (an oxidized 
glucose molecule), and two molecules of glucose (a component of 
sucrose, which is common sugar). Gellan gum has a molecular weight 
greater than 70,000 with 95% above 500,000.
    According to the CP Kelco website (http://www.cpkelco.com) gellan 
gum would typically be used in icings and frostings, jams and jellies, 
jellied candies such as gummy bears, and various fruit and bakery 
fillings. As the name indicates, when dissolved in water, gellan gum 
acts as a thickening or gelling agent, and can produce textures in the 
final product that vary from hard, non-elastic, brittle gels to fluid 
gels.

A. WHO/JECFA Evaluation

    In 1990, gellan gum was evaluated by the JECFA. As part of their 
evaluation, they reviewed studies related to the absorption, 
distribution, and excretion of gellan gum (in rats). They also reviewed 
the following types of toxicological studies: Acute toxicity (in rats), 
short-term studies (in rats and monkeys), long-term/carcinogenicity (in 
mice, rats, and dogs), reproductive (in rats), and teratology 
(developmental) studies (in pregnant rats). The results of these 
reviews were discussed in the petitioner's July 16, 2003, Notice of 
Filing. The petitioner accurately and adequately stated the reviews 
performed by JECFA; therefore, the Agency has not reprinted them in 
their entirety in this final rule.
    Selected summary information includes the following:
    [sbull] Gellan gum was shown to be poorly absorbed and did not 
cause any deaths in rats which received a single large

[[Page 9960]]

dose (5 gram (g) per kilogram (kg) of body weight) in the diet or by 
gavage.
    [sbull] Short-term (90-day) exposure of rats to gellan gum at 
levels up to 60 g/kg in the diet did not cause any adverse effects.
    [sbull] In a 28-day study in prepubertal monkeys, no overt signs of 
toxicity were observed at the highest-dose level of 3 g/kg of body 
weight per day.
    [sbull] In reproduction and teratogenicity studies in rats in which 
gellan gum was given at dose levels up to 50 g/kg in the diet, there 
was no evidence of interference with the reproductive process, and no 
embryotoxic or developmental effects were observed.
    [sbull] Gellan gum was also shown to be non-genotoxic in a battery 
of standard short-term tests.
    [sbull] In a study in dogs, which were treated for 1 year at dose 
levels up to 60 g/kg in the diet, there were no adverse effects that 
could be attributed to chronic exposure to gellan gum.
    [sbull] In long-term carcinogenicity studies, gellan gum did not 
induce any adverse effects in mice or rats at the highest-dose levels 
of 30 g/kg and 50 g/kg in the diet, respectively.
    The Agency notes that the dose levels used in these animal studies 
were in g/kg body weight not milligrams (mg)/kg as in most of the 
studies reviewed and evaluated by the Agency.
    There was also a limited study on tolerance to gellan gum in 
humans. Results indicated that oral doses of up to 200 mg/kg of body 
weight administered over a 23-day period did not elicit any adverse 
reactions, although faecal bulking effects were observed in most 
humans.
    In its conclusions, the JECFA Committee indicated that the 
potential laxative effect (at high intakes of gellan gum) should be 
taken into account when used as a food additive. The JECFA Committee 
also allocated an ADI (average daily intake) of ``not specified'' to 
gellan gum, which means that a specific limit on the average daily 
intake of gellan gum was not needed.

B. FDA Evaluation

    Gellan gum is approved by the Food and Drug Administration (FDA) as 
a direct food additive when added to foods as a stabilizer or thickener 
according to good manufacturing practices when used according to the 
following conditions (21 CFR 172.665):
    [sbull] The additive is a high molecular weight polysaccharide gum 
produced from Pseudomonas elodea by a pure culture fermentation process 
and purified by recovery with isopropyl alcohol.
    [sbull] The strain of Pseudomonas elodea is non-pathogenic and non-
toxic in man and animals.
    [sbull] The additive is produced by a process that renders it free 
of viable cells of Pseudomonas elodea.

C. Conclusions

    The evaluations performed by WHO and FDA indicate a substance of 
lower toxicity. The only concern that has been indicated for gellan gum 
as indicated by the JECFA Committee was a possible laxative effect 
which occurs only at high intakes of gellan gum. This laxative effect 
likely occurs as a result the body's limited ability to absorb gellan 
gum.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of 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).
     EPA establishes exemptions from the requirement of a tolerance 
only in those cases where the risks from aggregate exposure to 
pesticide chemical residues under reasonably foreseeable circumstances 
will pose no appreciable risks to human health. In order to determine 
the risks from aggregate exposure to pesticide inert ingredients, the 
Agency considers the toxicity of the inert in conjunction with possible 
exposure to residues of the inert ingredient through food, drinking 
water, and through other exposures that occur as a result of pesticide 
use in residential settings. If EPA is able to determine that a finite 
tolerance is not necessary to ensure that there is a reasonable 
certainty that no harm will result from aggregate exposure to the inert 
ingredient, an exemption from the requirement of a tolerance may be 
established.

A. Dietary Exposure

    1. Food. Gellan gum has been safely used as a food additive for 
over 10 years in various food formulations. Foods which can commonly 
contain gellan gum include frostings, gelatins, puddings, fillings, 
jams, milk products, fruit juices, and soft candy. CP Kelco supplied to 
the Agency, the direct use levels (expressed as percent) of gellan gum 
in a variety of food formulations. The typical amount of gellan gum 
used as a food additive does not exceed 0.5% of the processed food.
    Given the use of gellan gum as a thickening or jelling agent, there 
is a ``built in'' limitation as to the amount needed. Too much gellan 
gum would over-thicken, making the pudding or jam too stiff for the 
intended use. According to information provided by CP Kelco, the 
maximum percent of gellan gum in a food formulation to achieve the 
desired thickening or jelling effect would be less than 2%.
    Gellan gum has a molecular weight which is greater than 70,000 with 
95% above 500,000. Such large substances are not easily absorbed, as 
demonstrated by the rat metabolism study which indicated poor 
absorption. The constituents of gellan gum are naturally occurring 
materials (sugar monosaccharides) that, in fact, are found in living 
organisms.
    Gellan gum is approved for use as a direct food additive by FDA. To 
the best of the Agency's knowledge gellan gum has been used for over 10 
years as a stabilizer and thickener--as a gelling agent in foods 
without any reported incidence. The Agency estimated an annual U.S. 
population exposure for gellan gum using the annual production 
information provided by CP Kelco (100,000 kg) and a U.S. population 
estimate of approximately 290,809,777 as of July 1, 2003, from the U.S. 
census website (http://eire.census.gov/popest/data/national/popbriefing.php). The Agency estimated annual exposure of gellan gum to 
the U.S. population is approximately 0.94 mg/person/day.

    Equation used to calculate exposure provided below:

100,000 (kg/year) / (290,809,777 (people) x 365 (days/year)) = 0.94
100,000,000,000 (mg/year) / 106,145,568,605 (people/day/year) = 0.94 
mg/person/day

    The amount of gellan gum that could occur in food as a result of 
its use as an inert ingredient in a pesticide product should not 
significantly increase the amount of gellan gum in the food supply 
above those amounts currently permitted by FDA. Furthermore, it is 
unlikely that the manner which gellan gum is used in pesticide 
formulations will differ significantly from it's use as a direct food 
additive due to ``built in'' limitations based on the desired 
thickening or gelling effect.
    2. Drinking water exposure. Gellan gum is composed of repeating 
monosaccharides. When mixed with water, gellan gum acts as a thickener, 
thus producing a viscous solution. Eventually, the material will 
degrade to the constituent monosaccharides: Two glucose molecules, one 
glucuronic molecule, and one rhamnose molecule. The rate at which this 
occurs will

[[Page 9961]]

depend on the size of the ``bead'' that forms when dissolved in water. 
While physical/chemical degradation processes (such as hydrolysis) 
would occur, it is more likely that gellan gum would be degraded via 
microbial degradation. Due to the lower toxicity of the degradates, the 
naturally occurring sugars, there are no concerns for exposure to 
gellan gum in drinking water.

B. Other Non-occupational Exposure

    The Agency believes that the potential for the use of gellan gum in 
and around the home exists.
    1. Dermal exposure. Based on the high molecular weight of gellan 
gum, it is not likely to be absorbed through the skin.
    2. Inhalation exposure. Based on the fact that gellan gum is a 
polysaccharide which would degrade into naturally occurring sugars, it 
is not likely to cause any adverse effects when inhaled. The resulting 
molecules are normally found in living organisms (including humans) and 
would be metabolized normally.

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 consider ``available information'' concerning the 
cumulative effects of a particular chemical's residues and ``other 
substances that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to gellan gum and any other 
substances, and gellan gum does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that gellan gum has a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408 of FFDCA provides that EPA shall apply an additional 
tenfold margin of 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 concludes that a different 
margin of safety will be safe for infants and children. The JEFCA 
committee has evaluated reproductive and teratogenicity (developmental) 
toxicity studies in rats in which gellan gum was given at dose levels 
up to 50 g/kg in the diet and found no indication of increased 
susceptibility. Based on the WHO/JECFA evaluation of gellan gum, EPA 
has not used a safety factor analysis to assess the risk of gellan gum. 
For the same reasons the additional tenfold safety factor is 
unnecessary.

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

    The JECFA Committee reviewed and evaluated 14 toxicity studies and 
as a result of their review and evaluation, JECFA determined an ADI 
(Acceptable Daily Intake) of ``not specified.'' The only concern was 
for the potential laxative effect at high intakes. FDA has also 
approved the use of gellan gum as a direct food additive when used as a 
stabilizer and thickening agent (21 CFR 172.665).
    Based on the available information which includes an Agency 
estimated-daily exposure of 0.94 mg/kg/day, toxicity studies conducted 
in g/kg body weight rather than mg/kg body weight (with few to no 
effects), evaluations by both FDA and WHO/JEFCA, and the high molecular 
weight of gellan gum, the EPA finds that exempting gellan gum (CAS No. 
71010-52-1) from the requirement of a tolerance will be safe.

VIII. Other Considerations

A. 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 gellan gum for 
endocrine effects may be required.

B. Analytical Method(s)

    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.

C. Existing Tolerances

    There are no existing tolerances or tolerance exemptions for gellan 
gum.

D. International Tolerances

    Gellan gum is used as a food additive in many countries. The Agency 
is not aware of any country requiring a tolerance for gellan gum nor 
have any CODEX Maximum Residue Levels (MRL's) been established for any 
food crops at this time.

E. List 4A (Minimal Risk) Classification

    The Agency established 40 CFR 180.950 (see the rationale in the 
proposed rule published January 15, 2002 (67 FR 1925) (FRL-6807-8)) to 
collect the tolerance exemptions for those substances classified as 
List 4A, i.e., minimal risk substances. As part of evaluating an inert 
ingredient and establishing the tolerance exemption, the Agency 
determines the chemical's list classification. The results of the 
review and evaluation performed by WHO/JECFA as well as FDA's approval 
of gellan gum as a direct food additive, indicate a substance of lower 
toxicity. Therefore, gellan gum (CAS No. 71010-52-1) is to be 
classified as a List 4A inert ingredient.

IX. Conclusion

    Based on the information in the official public docket, summarized 
in this preamble, EPA concludes that there is a reasonable certainty of 
no harm from aggregate exposure to residues of gellan gum (CAS No. 
71010-52-1). Accordingly, EPA finds that exempting gellan gum from the 
requirement of a tolerance will be safe.

X. Objections and Hearing Requests

     Under section 408(g) of 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 of 1996, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of 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 
FFDCA, as was

[[Page 9962]]

provided in the old sections 408 and 409 of 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-2004-0003 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before May 4, 
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 X.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-2004-0003, 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).

XI. Statutory and Executive Order Reviews

     This final rule establishes an exemption from the tolerance 
requirement under section 408(d) of 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, entitledRegulatory 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. 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). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of 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, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the

[[Page 9963]]

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 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: February 17, 2004.
Lois Rossi,
Director, Registration Division, 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. In Sec.  180.950, the table in paragraph (e) is amended by adding 
alphabetically the following entry to read as follows:


Sec.  180.950  Tolerance exemptions for minimal risk active and inert 
ingredients.

* * * * *
    (e) * * *

------------------------------------------------------------------------
                          Chemical                             CAS No.
------------------------------------------------------------------------
                                * * * * *
Gellan gum.................................................   71010-52-1
                                * * * * *
------------------------------------------------------------------------


[FR Doc. 04-4707 Filed 3-2-04; 8:45 am]
BILLING CODE 6560-50-S