[Federal Register Volume 69, Number 62 (Wednesday, March 31, 2004)]
[Rules and Regulations]
[Pages 16796-16800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6933]



[[Page 16796]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0281; FRL-7347-7]


Rhamnolipid Biosurfactant; 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, rhamnolipid 
biosurfactant, on all food commodities when applied/used as a 
fungicide. Jeneil Biosurfactant Company 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 
rhamnolipid biosurfactant.

DATES: This regulation is effective March 31, 2004. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0281, 
must be received on or before June 1, 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: Denise Greenway, Biopesticides and 
Pollution Prevention Division (7511C), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8263; 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. 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-2003-0281. 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 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 on E-CFR Beta Site 
Two at http://gpoaccess.gov/ecfr/.
    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 May 9, 2003 (68 FR 25026) (FRL-7306-3), 
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 1F6288) by Jeneil Biosurfactant 
Company, 400 N. Dekora Woods Boulevard, Saukville, Wisconsin 53080. 
This notice included a summary of the petition prepared by the 
petitioner Jeneil Biosurfactant Company. 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 rhamnolipid biosurfactant.

III. Risk Assessment

    New 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 exemption 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. In determining whether an exemption 
is safe, the Administrator is directed to take into account the same 
factors set forth in section 408(b)(2)(C) and (D) for determining 
whether a tolerance is safe. 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

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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.
    Rhamnolipid biosurfactant (pc code 110029, CAS number 147858-26-2) 
has the CAS name decanoic acid, 3-[[6-deoxy-2-O-(6-deoxy-[alpha]-L-
mannopyranosyl)-[alpha]-L-mannopyranosyl]oxy]-, 1-(carboxymethyl)octyl 
ester, mixture with 1-(carboxymethyl)octyl 3-[(6-deoxy-[alpha]-L-
mannopyranosyl)oxy]decanoate. The basic composition of the active 
ingredient consists of a well-known carbohydrate (rhamnose sugar) and 
fatty acid (hydroxydecanoic acid). The active ingredient is a mixture 
of two types of rhamnolipid molecules, R1 (RLL) and R2 (RRLL) at a 
ratio of R2:R1 = 0.7 - 2.0. Chemical name of the rhamnolipid molecules 
is as follows: Molecule 1 (defined as R1 or RLL): Decanoic acid, 3-[(6-
deoxy-[alpha]-L-mannopyranosyl) oxy]-, 1-(carboxymethyl) octyl ester; 
and molecule 2 (defined as R2 or RRLL): Decanoic acid, 3-[[6-deoxy-2-O-
(6-deoxy-[alpha]-L-mannopyranosyl)-[alpha]-L-mannopyranosyl] oxy]-, 1-
(carboxymethyl) octyl ester.
    Adequate mammalian toxicology data are available and support 
registration of the product containing the active ingredient 
rhamnolipid biosurfactant. Rhamnolipid molecules are simple glycolipids 
consisting of a carbohydrate (rhamnose) ring and a fatty acid 
(hydroxydecanoic acid) tail. Individually, these molecules are not 
toxic. Rhamnose is a comparatively rare sugar approved by FDA as a food 
additive, and fatty acids are ubiquitous in animals and plants and are 
a major energy source in the body. Consequently, the breakdown products 
of rhamnolipids are of little toxicological concern. The mode of action 
of rhamnolipid biosurfactants is a physical action on the plant 
pathogen, rather than a toxic action. Rhamnolipid biosurfactant 
products are currently in use as emulsifiers, dispersants, wetting 
agents, and agricultural adjuvants. There have been no reports of 
adverse effects from any uses of rhamnolipid biosurfactants to date. 
The information submitted indicates there is already widespread 
exposure to rhamnose sugar, fatty acids, and rhamolipid biosurfactants 
without any reported adverse effects to human health. The acute 
toxicity studies, in conjunction with data or other information 
obtained from the open literature and the expected low exposure to 
humans, demonstrate that no risks to human health are expected from the 
pesticidal use of rhamnolipid biosurfactant.

A. Acute Toxicology

    1. Acute oral toxicity (OPPTS Harmonized Guidline 870.1100; 152-10; 
MRID 45376702). Male and female rats (5 per sex) were dosed once with 
5,000 milligrams/kilograms (mg/kg) and observed for 14 days. The acute 
oral lethal dose (LD)50 was >5,000 mg/kg. The study was 
acceptable and placed the test material in Toxicity Category IV.
    2. Acute dermal toxicity (OPPTS Harmonized Guidline 870.1200; 152-
11; MRID 45376703). Male and female rats (5 per sex) were dosed with 
5,000 mg/kg for 24 hours and observed for 14 days The acute dermal 
LD50 was >5,000 mg/kg. The study was acceptable and placed 
the test material in Toxicity Category IV.
    3. Acute inhalation toxicity (OPPTS Harmonized Guidline 870.1300; 
152-12, MRID 45376704). Male and female rats (5 per sex) were exposed 
whole-body to a gravimetric concentration of 2.05 mg/liter (L) 9.5% 
rhamnolipid biosurfactant in water for 4 hours, and observed for 14 
days. The lethal concentration (LC)50 was >2.05 mg product/L 
(0.20 mg active ingredient (a.i.)/L). The study was acceptable and 
placed the test material in Toxicity Category IV.
    Other acute toxicology data also reviewed in support of the 
rhamnolipd biosurfactant registration include the following.
    1. Primary eye irritation (OPPTS Harmonized Guidline 870.2400; 152-
13; MRID 45376705).
    2. Primary eye irritation (OPPTS Harmonized Guidline 870.2400; 152-
13; MRID 45376706).
    3. Primary eye irritation (OPPTS Harmonized Guidline 870.2400; 152-
13; MRID 45376707).
    4. Primary dermal irritation (OPPTS Harmonized Guidline 870.2500; 
152-14; MRID 45376708).
    A data waiver was requested for the following study, and granted by 
the Agency. Although no study was conducted by the registrant, 
acceptable information/data was submitted to support the data waiver 
request.
    Dermal sensitization (OPPTS Harmonized Guidline 870.2600; 152-15).

B. Mutagenicity and Developmental Toxicity

    The requested waiver was granted by the Agency based on the fact 
that rhamnolipid biosurfactant is not related to any known mutagens and 
does not belong to a chemical class of compounds containing known 
mutagens. Rhamnolipid biosurfactant consists of rhamnose sugar and 
hydroxydecanoic acid, both of which have food-related uses.

C. Subchronic Toxicity, Immunotoxicity

    Requested waivers for 90-day oral toxicity and immunotoxicity were 
granted by the Agency based on the physical mode of action of the 
active ingredient; the lack of acute oral, dermal, and inhalation 
toxicity; and the innocuous nature of the potential breakdown products 
of rhamnolipid biosurfactants.

D. Chronic Exposure and Oncogenicity Assessment

    Repeated-dose studies are conditionally required if the potential 
for adverse chronic effects are indicated based on: (1) The subchronic 
effect levels established in Tier I subchronic oral, inhalation, or 
dermal studies, (2) the pesticide use pattern, or (3) the frequency and 
the level of repeated human exposure that is expected. Oncogenicity 
studies are required only if the active ingredient or any of its 
metabolites, degradation products, or impurities produce in Tier I 
studies any morphologic effects in any organ that potentially could 
lead to neoplastic changes. None of the results of the submitted 
studies triggered the need for chronic exposure or oncogenicity 
testing.

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

    1. Food. There is a great likelihood of exposure in the normal 
human diet to rhamnolipid biosurfactant's components for most, if not 
all individuals, including infants and children. Rhamnolipid 
biosurfactant constituents, rhamnose sugar and fatty acid, are normal 
parts of the human diet. To date, there have been no known reports of 
any hypersensitivity incidents from users of the surfactant. Even if 
exposure increased due to pesticidal use of rhamnolipid biosurfactant, 
given the low toxicity of the components (or of the surfactant) and the 
widespread dietary exposure to the components, the

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Agency believes the risk associated with dietary exposure to the 
biosurfactant by the oral route would be low to non-existent.
    2. Drinking water exposure. Because rhamnolipid biosurfactant has 
low acute mammalian toxicity, the constituent rhamnose sugar is a food 
additive, and constituent fatty acids are ubiquitous in plant and 
animals, no risk is anticipated should exposure occur through drinking 
water.

B. Other Non-Occupational Exposure

    The potential for non-dietary exposure to rhamnolipid biosurfactnt 
residues for the general population, including infants and children, is 
unlikely because potential use sites are horticultural and agricultural 
crops. Rhamnolipid biosurfactant's constituent carbohydrate (rhamnose 
sugar) and fatty acid (hydroxydecanoic acid) are not considered toxic; 
rhamnose sugar is a food additive and fatty acids, ubiquitous in plants 
and animals, are a major energy source in the body. Rhamnolipid 
biosurfactant's toxicity has been determined to be very low through the 
oral, dermal and inhalation routes. Therefore, while there exists a 
great likelihood of prior exposure to rhamnolipid biosurfactant's 
components, any risk from increased exposure due to the proposed 
product would be negligible.

VI. Cumulative Effects from Substances with a Common Mechanism of 
Toxicity

    Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, 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 does not have, at this time, available data to determine 
whether rhamnolipid biosurfactant has a common mechanism of toxicity 
with other substances. 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 
rhamnolipid biosurfactant and any other substances and rhamnolipid 
biosurfactant 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 rhamnolipid biosurfactant 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/.

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

    1. U.S. population. The Agency has determined that there is 
reasonable certainty that no harm will result from aggregate exposure 
to residues of rhamnolipid biosurfactant to the U.S. population. This 
includes all anticipated dietary exposures and other non-occupational 
exposures for which there is reliable information. The Agency arrived 
at this conclusion based on the anticipated low exposure estimates from 
its pesticidal use; the low mammalian toxicity of rhamnolipid 
biosurfactant; and the already widespread human exposure to rhamolipid 
biosurfactant constituents, rhamnose sugar and hexadecanoic acid, 
without any reported adverse effects to human health.
    2. Infants and children. FFDCA section 408 provides that EPA shall 
apply an additional tenfold margin of exposure for infants and children 
in the case of threshold effects unless the Agency determines, based on 
reliable data, that a different margin is safe. Margins of exposure are 
referred to as uncertainty or safety factors, and are used to account 
for potential prenatal and postnatal toxicity and any lack of 
completeness of the data base. Based on all the reliable available 
information the Agency reviewed on rhamnolipid biosurfactant, including 
that showing a lack of threshold effects, the Agency concluded that the 
additional margin of safety is not necessary to protect infants and 
children and that not adding any additional margin of safety will be 
safe for infants and children.

VIII. Other Considerations

A. Analytical Method(s)

    The Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation for the reasons stated 
above, including low toxicity and low exposure from the pesticidal use 
of rhamnolipid biosurfactant. For the same reasons, the Agency 
concludes that an analytical method is not required for enforcement 
purposes for rhamnolipid biosurfactant.

B. Codex Maximum Residue Level

    There are no CODEX maximum residue levels for rhamnolipid 
biosurfactant.

IX. Conclusions

    Based on the toxicology information/data submitted and other 
information available to the Agency, there is a reasonable certainty 
that no harm will result from aggregate exposure of residues of 
rhamnolipid biosurfactant to the U.S. population, including infants and 
children, under reasonably foreseeable circumstances, when the 
biochemical pesticide is used in accordance with good agricultural 
practices. This includes all anticipated dietary exposures and all 
other non-occupational exposures for which there is reliable 
information. The Agency has arrived at this conclusion based on the 
information/data submitted (and publically available) demonstrating no 
toxicity. As a result, EPA is establishing an exemption from the 
tolerance requirements pursuant to FFDCA 408(c) and (d) for residues of 
rhamnolipid biosurfactant in or on all food commodities.

X. 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-2003-0281 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be

[[Page 16799]]

mailed or delivered to the Hearing Clerk on or before June 1, 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-2003-0281, 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 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. 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 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, 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

[[Page 16800]]

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 22, 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 180.1245 is added to subpart D to read as follows:


Sec.  180.1245  Rhamnolipid biosurfactant; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of rhamnolipid biosurfactant when used in accordance with good 
agricultural practices as a fungicide in or on all food commodities.
[FR Doc. 04-6933 Filed 3-30-04; 8:45 am]
BILLING CODE 6560-50-S