[Federal Register Volume 66, Number 86 (Thursday, May 3, 2001)]
[Rules and Regulations]
[Pages 22128-22133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11093]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301119; FRL-6778-9]
RIN 2070-AB78


Sucroglycerides; 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 sucroglycerides when used as an inert 
ingredient in or on growing crops or when applied to raw agricultural 
commodities after harvest. Rhodia Inc., submitted a petition to EPA 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by 
the Food Quality Protection Act 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 sucroglycerides.

DATES:  This regulation is effective May 3, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301119, 
must be received by EPA on or before July 2, 2001.

ADDRESSES:  Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301119 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Kathryn Boyle, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: 703-305-6304; and e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                      affected  entities
------------------------------------------------------------------------
Industry                          111                 Crop production
  ..............................  112                 Animal production
                                  311                 Food manufacturing
  ..............................  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

     1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules, '' and then look up 
the entry for this document under the `` Federal Register --
Environmental Documents. '' You can also go directly to the Federal 
Register listings at http://www.epa.gov/fedrgstr/.
     2. In person. The Agency has established an official record for 
this action under docket control number OPP-301119. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

     In the Federal Register of July 7, 1998 (63 FR 36681) (FRL -5795-
6), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food 
Quality Protection Act (FQPA) (Public Law 104-170) announcing the 
filing of a pesticide petition (PP) 6E4714 by Rhodia Inc., CN 7500, 
Cranbury, NJ 08512-7500. This notice included a summary of the petition 
prepared by the petitioner. There were no comments received in response 
to the notice of filing.
     The petition requested that 40 CFR 180.1001(c), be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of sucroglycerides.
     Section 408(b)(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.''

[[Page 22129]]

 Section 408(b)(2)(A)(ii) 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) 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. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert '' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Sucroglycerides

     Sucroglycerides are a mixture of substances, primarily of mono-, 
di-, and tri-glycerides and mono- and di-sucrose esters of fatty acids. 
The product is produced through a process of transesterification of an 
edible fat or oil with sucrose. Thus, sucroglycerides are composed of 
and basically produced from sugar and oil.
     Sucroglycerides have self-affirmed GRAS (generally recognized as 
safe) status. A GRAS substance is one that is generally recognized, 
among experts qualified by scientific training and experience to 
evaluate its safety, as having been adequately shown through scientific 
procedures to be safe under the conditions of its intended use. Under 
the FFDCA, there is no requirement that GRAS status can be determined 
only by the Food and Drug Administration (FDA). The GRAS determination 
may also be made by a company providing that the quantity and quality 
of data would be the same as if the data were submitted to FDA for 
review and evaluation.
     The sucroglycerides Independent Safety Determination was affirmed 
by an expert panel in 1991 which examined only sucroglycerides 
manufactured from palm oil. The same expert panel re-convened in 1994 
to evaluate sucroglycerides manufactured from edible fats and oils. 
This addendum to the Independent Safety Determination differed only in 
that the starting materials could be any edible fat or oil as opposed 
to palm oil only as originally evaluated in 1991. The panel concluded 
that sucroglycerides are GRAS for use in the food applications 
considered when used in accordance with good manufacturing practices.
     The intended food applications evaluated as part of the 
Independent Safety Determination included use as a texturizer in 
biscuit mixes, and as an emulsifier in baked goods and baking mixes, 
dairy product analogs, frozen dairy desserts and mixes, and whipped 
milk products. The maximum estimated content of sucroglycerides in 
these anticipated food uses is 1.5%. Under 21 CFR 172.859, a related 
mixture, sucrose fatty acid esters, can be used as direct food 
additives as emulsifiers in various baked goods and baking mixes, dairy 
and dairy analog products, chewing gum, confections and frostings, and 
coffee and tea beverages with added dairy or dairy analog products, as 
texturizers in chewing gum, confections and frostings, and surimi-based 
fabricated seafood products, and as components of protective coatings 
applied to fresh fruit to retard ripening and spoiling. Under 21 CFR 
184.1505, mono- and di-glycerides prepared from fats or oils are GRAS.

V. Toxicological Profile

     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 sucroglycerides are discussed in this unit.
     The submission to the Agency consisted of two studies (subchronic 
and chronic toxicity/carcinogenicity) that contained individual animal 
data. These two studies were reviewed as guideline studies, that is, 
studies that meet the Agency's criteria for a well-conducted study that 
supplies the necessary information. The other submissions consisted of 
toxicology study summaries. The summaries varied in the amount of 
information presented. Some were literature reports and partial 
translations of studies conducted in France. Thus, these summaries 
provided useful information to the Agency which was used during the 
weight-of-the-evidence evaluation.
     1. Acute. The summary reported an acute toxicity study in which no 
adverse effects were reported. The LD50 was estimated to be 
greater than 30 gram/kilogram body weight (g/kg bwt).
     2. Subchronic toxicity. In a 13-week dog feeding study 
sucroglycerides were administered to 5 pure bred Beagle dogs/sex/dose 
in the diet at dose levels of 0, 5, 10, or 20% (control, 1.19, 2.59, or 
5.61 gram/kilogram/day (g/kg/day) for males and control, 1.31, 2.57, or 
4.7 g/kg/day for females). Three animals/sex/dose were sacrificed after 
13 weeks, and the remaining two animals/sex/dose continued on for an 
additional 8 weeks of observation on control diets, and were then 
sacrificed.
     No animals died on study and there was no overt toxicity. The 
decreased cholesterol levels, increased SGPT (serum glutamic pyruvic 
transaminase) values, ad hepatic pathology are effects that are 
comparable to those seen as a result of a high fat dietary intake. The 
grossly high doses of this fatty compound were over the limit dose and 
effects seen cannot readily be distinguished from those observed with a 
high fat diet. The NOAEL (no observed adverse effect level) was at the 
10% level (2.6 g/kg/day for males and females). The LOAEL (lowest-
observed adverse effect level) was determined to be at the 20% level 
(5.6 g/kg/day for males and 4.7 g/kg/day for females). This study is 
classified as acceptable and satisfies the guideline requirement for a 
subchronic oral study in dogs.
     In a different study, the summary reported that administration of 
sucroglycerides to rats for 100 days at concentrations up to 10% in the 
diet resulted in increased body weight gain and increased hepatic, 
total lipids and

[[Page 22130]]

lipid fractions with normal plasma lipid levels.
     3. Combined chronic toxicity/carcinogenicity 2-year rat study. In 
this study sucroglycerides were administered via the diet to 50 rats/
sex/group at dose levels of 0, 5, 10, or 20% (control, 1.59, 3.37, or 
7.70 g/kg/day in males and control, 1.86, 4.01, or 9.25 g/kg/day in 
females for up to 108 weeks). No adverse effects were observed in 
mortality, hematology, blood chemistry, ophthalmoscopy, organ weights, 
or gross pathology parameters for either sex at any treatment level. 
The NOAEL for this combined chronic/carcinogenicity rat feeding study 
is 5% (3.37 g/kg/day for males and 4.01 g/kg/day for females). The 
LOAEL is 10% (7.70 g/kg/day for males and 9.25 g/kg/day for females) 
based on decreased food efficiency in males.
     Under the conditions of this study, dosing is considered adequate 
to assess the carcinogenic potential of sucroglycerides based on the 
fact that the compound was administered at doses above the limit dose, 
food efficiency was reduced at 10% in males, and body weight and body 
weight gain, along with food efficiency was increased at 20% in both 
sexes. The administration of sucroglycerides to rats up to 20% in the 
diet did not result in an overall treatment-related increase in 
incidence of tumor formation. This study is classified as acceptable 
and satisfies the guideline requirement for a chronic toxicity/
carcinogenicity oral study in rats.
     In a different study, the summary reported that in a 25 to 28-
month rat study, food efficiency was decreased at 10% lard 
sucroglyceride in the diet. No other effects were noted.
     Summaries of another two long-term rat studies with 5 g/kg bwt 
sucroglycerides in the diet were submitted. These also demonstrated no 
adverse effects and no evidence of carcinogenicity.
     4. Mutagenicity. No mutagenicity studies were submitted to the 
Agency. However, none of the components of sucroglycerides are known 
mutagens. Given this information and since the combined chronic 
toxicity/carcinogenicity study did not result in an overall treatment-
related increase in incidence of tumor formation, mutagenicity studies 
will not be required.
     5. Developmental/reproductive toxicity. No developmental or 
reproductive toxicity guideline studies were submitted to the Agency, 
although summaries of two chronic toxicity/2-generation reproductive 
studies were submitted. Both summaries were partial translations of 
French studies. Both summaries reported no adverse effects.
     In a 1987 article in open literature describing a 2-generation 
reproductive and developmental toxicity study of a related compound, 
sucrose polyester (a mixture of hexa-, hepta-, and octa-esters of 
edible grade fatty acids with sucrose), was fed to rats at up to 10% of 
the diet. There were no adverse effects on reproductive function, on 
the development of the fetus, or on the viability or growth of the 
offspring into adult life.
     Given the observed lack of developmental and reproductive effects, 
and the fact the mono- and di-glycerides are not know developmental 
toxicants, guideline developmental and reproductive studies will not be 
required.
     6. Dermal toxicity. No dermal studies were submitted to the 
Agency. Sucrose esters of fatty acids and mono-and di-glycerides are 
unlikely to be absorbed through the skin in sufficient amounts to cause 
toxicity.
     7. Neurotoxicity. No neurotoxicity studies were submitted to the 
Agency. However, no neurotoxicity was observed in the oral guideline 
studies.
     The submitted toxicity studies demonstrate the low toxicity of 
sucroglycerides. For sucroglycerides, in several studies minimal 
effects occurred at doses that were expressed as grams of 
sucroglycerides per kilogram of animal body weight per day. For many 
chemicals, the Agency has reviewed data that demonstrate significant 
effects at doses that are expressed in milligrams per kilogram of 
animal body weight per day. Thus, the minimal toxicity that occurred 
with consumption of sucroglycerides, occurred at higher dose levels 
than normally used in testing.

VI. Aggregate Exposures

     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).
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that 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

     For the purposes of assessing potential exposure under this 
exemption, EPA considered that sucroglycerides could be present in all 
raw and processed agricultural commodities and drinking water, and that 
non-occupational non-dietary exposure was possible.
     1. Food. As previously stated, sucroglycerides have self-affirmed 
GRAS status. EPA will regulate only the use of sucroglycerides as an 
inert ingredient in pesticide formulations. Thus, the amount of 
sucroglycerides that can be applied to food as a result of their use in 
a pesticide product as an inert ingredient would not significantly 
increase the amount of sucroglycerides in the food supply above those 
amounts permitted by FDA.
     2. Drinking water exposure. The solubility of sucroglycerides in 
water is very low, less than 1 part per billion. Given this low 
solubility in water and the low toxicity, both of which were 
demonstrated in testing, the Agency has determined that exposure for 
all human population groups through drinking water would be extremely 
low.

B. Other Non-Occupational Exposure

     Currently, there are no residential uses of sucroglycerides. Given 
that sucroglycerides are unlikely to be absorbed through the skin in 
sufficient amounts to cause toxicity, even if residential uses of 
sucroglycerides were to occur, toxicity would not occur.

VII. 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.'' Sucroglycerides 
have a demonstrated lack of toxicity, and thus are unlikely to share a 
common mechanism of toxicity with any other substances.

[[Page 22131]]

VIII. Determination of Safety for U.S. Population

     Given the available toxicity information indicating minimal 
effects, there should be no concerns for human health, whether the 
exposure is acute, subchronic, or chronic. Thus, based on the low 
toxicity of sucroglycerides and the low potential for exposure from the 
EPA regulated uses of sucroglycerides, the Agency has determined that 
there is a reasonable certainty of no harm to the U.S. population from 
aggregate exposure to residues of sucroglycerides and that a tolerance 
is not necessary.

IX. Determination of Safety for Infants and Children

     FFDCA section 408 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 safety will be safe for infants and children. Due to the 
expected low toxicity of sucroglycerides, EPA has not used a safety 
factor analysis to assess the risk. For the same reasons the additional 
tenfold safety factor is unnecessary. The Agency has determined that 
there is a reasonable certainty of no harm to infants and children from 
aggregate exposure to residues of sucroglycerides and that a tolerance 
is not necessary.

X. Other Considerations

A. Endocrine Disruptors

     There is no available evidence that sucroglycerides are an 
endocrine disruptor.

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 Exemptions

     There are no existing exemptions for sucroglycerides.

D. International Tolerances

     The Agency is not aware of any country requiring a tolerance for 
sucroglycerides nor have any CODEX Maximum Residue Levels (MRLs) been 
established for any food crops at this time.

XI. Conclusions

    Based on the information in this preamble, EPA concludes that there 
is a reasonable certainty of no harm from aggregate exposure to 
residues of sucroglycerides. Accordingly, EPA finds that exempting 
sucroglycerides from the requirement of a tolerance will be safe.

XII. 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 of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
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 control number OPP-301119 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 July 2, 
2001.
     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 (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. 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 (202) 260-4865.
     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.
     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.
     3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.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.2. Mail 
your copies, identified by docket control number OPP-301119, 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. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. 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

[[Page 22132]]

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).

XIII. Regulatory Assessment Requirements

     This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) 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). 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 FFDCA section 408(d), 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 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 FFDCA section 408(n)(4).
     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.

XIV. 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: April 13, 2001.

James Jones,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is 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.

    2. In Sec. 180.1001, the table in paragraph (c) is amended by 
adding alphabetically the following inert ingredient to read as 
follows:


Sec. 180.1001  Exemptions from the requirement of a tolerance.

* * * * *
    (c) * * *

[[Page 22133]]



 
------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
         *        *        *        *        *        *        *
Glycerides, edible fats and oils                      emulsifier,
 derived from plants and                               dispersing agent.
 animals, reaction products with
 sucrose (CAS Reg. Nos. 100403-
 38-1, 100403-41-6, 100403-39-2,
 100403-40-5)
         *        *        *        *        *        *        *
------------------------------------------------------------------------


[FR Doc. 01-11093 Filed 5-2-01; 8:45 am]
BILLING CODE 6560-50-S