Document ID: EPA-HQ-OPP-2008-0105-0004
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: Morpholine 4-C Acyl Derivatives
Posted Date: 2009-05-06T04:00Z

[Federal Register: May 6, 2009 (Volume 74, Number 86)]
[Rules and Regulations]               
[Page 20883-20887]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06my09-13]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0105; FRL-8409-1]

 
Morpholine 4-C6-12 Acyl Derivatives; 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 Morpholine 4-C6-12 Acyl 
derivatives (CAS Reg. No. 887947-29-7), herein referred to in this 
document as morpholine amide when used as the inert ingredient in 
pesticide formulations applied in or on growing crops. Huntsman 
Corporation submitted a petition to EPA under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), requesting an exemption from the requirement 
of a tolerance. This regulation eliminates the need to establish a 
maximum permissible level for residues of morpholine amide.

DATES: This regulation is effective May 6, 2009. Objections and 
requests for hearings must be received on or before July 6, 2009, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0105. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Alganesh Debesai, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8353; e-mail address: 
debesai.alganesh@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2008-0105 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 6, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2008-0105, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of June 13, 2008 (73 FR 33814) (FRL-8367-
3), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Pub. L. 104-170), announcing the filing of a 
pesticide petition (PP 6E7093) by Huntsman Corporation, 8600 Gosling 
Road, The Woodlands, TX 77381. The petition requested that 40 CFR 
180.920 be amended by establishing an exemption from the requirement of 
a tolerance for residues of Morpholine 4-C6-12 Acyl 
derivatives (CAS Reg. No. 887947-29-7), herein referred to in this 
document as morpholine amide when used as inert ingredient in pesticide 
formulations applied in or on growing crops. That notice included a 
summary of the petition prepared by the petitioner.

[[Page 20884]]

There were no comments received in response to the notice of filing.
    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. 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. 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 
morpholine amide is discussed in this unit.
    The following provides a brief summary of the risk assessment and 
conclusions for the Agency's review of morpholine amide. The Agency's 
full decision document for this action is available in the Agency's 
electronic docket (regulations.gov) under the docket number EPA-HQ-OPP-
2008-0105. The toxicological database for morpholine amide (CAS Reg. 
No. 887947-29-7) is limited; however, adequate studies are available on 
the structurally related compound, lauric DEA. Like lauric DEA, 
morpholine amide is expected to be readily absorbed and metabolized to 
succinic and adipic morpholine amide. Free fatty acids, mainly capric 
and caprylic acid as well as morpholine are expected to be potential 
impurities (minute quantity). Adequate toxicological information is 
available on these metabolites and impurities. The toxicological 
database on morpholine amide consists of: An acute toxicity battery, a 
mutagenicity battery and a reproductive and developmental screening 
study in rats (including neurotoxicity screening). There are no long 
term or carcinogenicity studies available on morpholine amide. However, 
studies on the structurally similar compound lauric DEA included two 
oral subchronic studies in rats, one subchronic study in dogs, a 
mutagenicity battery, a metabolism study, and subchronic and 
carcinogenicity studies in rats and mice via the dermal route of 
exposure. In addition, many subchronic and chronic studies are 
available on morpholine (a manufacturing impurity). EPA has 
toxicological data on fatty acids and caprylic acid, a potential 
metabolite of morpholine amide. Taking all these studies into 
consideration, EPA concluded that these studies can be used to evaluate 
the toxicity of morpholine amide. Other than the chronic studies, all 
other data are adequate to characterize the potential toxicity of 
morpholine amide.
    Animal studies show that morpholine amide has low acute toxicity 
(oral LD50 in the rat > 2,000 milligram/kilograms (mg/kg) 
and inhalation LC50 in the rat > 2.0 mg/L). Although 
morpholine amide was a mild eye irritant in the rabbit, it was not a 
skin irritant (rabbit). It was positive for skin sensitization in the 
Guinea pig. Based upon the metabolism and low toxicity characteristics 
of lauric DEA, subchronic and chronic toxicity of morpholine amide is 
also expected to be low. Although no specific neurotoxicity studies 
were performed, in the combined repeated dosed reproductive and 
developmental toxicity screening test, potential indications of 
neurotoxicity such as lethargy and altered functional observation 
battery (FOB) parameters were observed at a high dose of 600 mg/kg/day. 
However, these clinical signs were judged to be to high dose toxicity 
rather than as a result of a neurotoxic reaction. Moreover, since the 
toxic effects were seen only at a high dose, the NOAEL (200 mg/kg/day) 
will be protective from these effects (three fold lower than the dose 
that produced clinical signs of neurotoxicity). Additionally, the 
slight decrease in relative brain weight (<= 6%) in the reproductive 
and developmental screening study was not considered as the 
toxicologically relevant effect because the absolute brain weight was 
not affected, there were no pathological findings and this slight 
change in relative brain weight is considered due to changes in body 
weight at 600 mg/kg/day.
    No fetal effects were seen in a combined repeat dose reproductive 
and developmental toxicity study in Wistar Hannover rats at doses that 
produced maternal toxicity (lethargy and alterations in functional 
observational parameters). No treatment-related effects were observed 
for any reproductive or litter parameters at any dose level. The NOAEL 
for systemic toxicity is 200 mg/kg/day. The NOAEL for both reproductive 
and developmental toxicity is 600 mg/kg/day (the highest dose tested 
(HDT)). Based on this information, there in no concern, at this time, 
for increased sensitivity to infants and children to morpholine amide 
when used as an inert ingredient in pesticide formulations applied to 
growing crops.
    Based on negative response of morpholine amide in mutagenicity, 
equivocal evidence of carcinogenic activity of lauric DEA (dermal 
route, only one species, one sex), lack of carcinogenicity of impurity 
(morpholine) and other metabolites, EPA concluded that morpholine amide 
is not likely to be carcinogenic.
    The free fatty acid impurities on the subject chemical are not 
likely to impart any significant toxicity. Fatty acid salts have been 
reported to have a low acute toxicity. A chronic inhalation exposure of 
rats to morpholine, a potential impurity of the subject chemical for 2 
years at concentration of 150 parts per

[[Page 20885]]

million (approximately 533 mg/m3) or less revealed no 
carcinogenic potential or chronic systemic toxicity. Consistent with 
its known irritating properties, morpholine produced only local 
irritation, which was limited almost exclusively to high dose animals.
    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs.
    Morpholine amide's acute toxicity is so low that it is not expected 
to pose an acute risk and derivation of an aPAD is unnecessary. A cPAD 
of 0.67 mg/kg/day was derived from the NOAEL of 200 mg/kg/day for the 
systemic toxicity seen in the reproductive and developmental toxicity 
study. A safety factor of 300 (10x for interspecies and 10x for intra-
species variations and additional 3X FQPA safety factor for the lack of 
chronic study) was used.

V. 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 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.
    In the absence of actual residue data for morpholine amide, the 
Agency performed a dietary (food and drinking water) exposure 
assessment for morpholine amide for the proposed pre-harvest use using 
worst case assumptions. These assumptions included that:
    1. Morpholine amide would be used as an inert ingredient in all 
food use pesticide formulations applied to all crops,
    2. One hundred percent of all food crops would be treated with 
pesticides containing morpholine amide,
    3. Morpholine amide residues would be present in all crops at 
levels equal to or exceeding the highest established tolerance levels 
for any pesticide active ingredient for pre-harvest uses, and
    4. A conservative default value of 1,000 parts per billion for the 
concentration of an inert ingredient in all sources of drinking water 
was used.
This approach is highly conservative as it is extremely unlikely that 
morpholine amide would have such use as a pesticide product inert 
ingredient and be present in food commodities and drinking water at 
such high levels.

VI. Cumulative Effects

    Section 408(b)(2)(D)(v) of 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.''
    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 morpholine amide and any 
other substances, and these chemicals do not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that these chemicals 
have 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 of EPA's website at http://ww.epa.gov/pesticides/
cumulative/.

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

    Section 408 of the 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 database on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. EPA concluded that the FQPA safety factor for 
morpholine amide should be reduced to 3X for the following reasons.
    1. Although the toxicological database on morpholine amide is 
limited, studies on the structurally similar compound lauric DEA are 
available. These studies include two oral subchronic studies in rats, 
one subchronic study in dogs, mutagenicity battery, metabolism study, 
and subchronic and carcinogenicity studies in rats and mice via dermal 
route of exposure. In addition, many subchronic and chronic studies are 
available on morpholine (a manufacturing impurity). EPA does not have a 
chronic toxicity study for either morpholine amide or lauric DEA. This 
lack of a chronic study is largely offset by the results of the 
Organization for Economic Cooperation and Development (OECD) 
reproduction/developmental screening toxicity study - which showed no 
target organ toxicity at doses up to 600 mg/kg/day - and the existing 
subchronic data.
    2. EPA concluded that there is no evidence of increased 
susceptibility to infants and children. No fetal effects were seen in 
the combined repeated dosed reproductive and developmental toxicity 
study in Wistar Hannover rats at doses that produce maternal toxicity 
(lethargy and alterations in functional observational parameters). No 
treatment-related effects were observed for any reproductive or litter 
parameters at any dose level. The NOAEL for systemic toxicity is 200 
mg/kg/day. The NOAEL for both reproductive and

[[Page 20886]]

developmental toxicity is 600 mg/kg/day (the HDT). No developmental 
toxicity study in rabbit is available in the morpholine amide database. 
However, EPA concluded that the developmental toxicity study in rabbits 
is not likely to provide lower endpoint than the endpoint selected for 
the risk assessment since no developmental or reproductive toxicity was 
observed in rats at doses up to and including 600 mg/kg/day.
    3. There is low concern that morpholine amide is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity. As noted, the slight 
decrease in relative brain weight (<= 6%) in the OECD reproductive/
developmental screening toxicity study in rats was not considered as 
the toxicologically relevant effect and the clinical signs (lethargy 
and altered FOB parameters) in the OECD reproductive/developmental 
screening study in rats are considered to be due to high dose toxicity.
    4. In the absence of actual exposure data on morpholine amide, a 
highly conservative exposure estimate using default parameters is not 
likely to underestimate risk to infants and children.
    Although there is some uncertainty due to the absence of a chronic 
study and a rabbit developmental study, there is low concern that risks 
will be underestimated due the results of the OECD reproduction/
developmental screening toxicity study showing no organ toxicity at 
high doses, the lack of a finding of developmental toxicity in that 
study, and the very conservative exposure assessment that has been 
conducted for morpholine. Nonetheless, a FQPA safety factor of 3X is 
being retained, primarily due to the absence of a chronic toxicity 
study.

VIII. Determination of Safety for U.S. Population

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate uncertainty/safety factors. EPA calculates the 
aPAD and cPAD by dividing the POD by all applicable uncertainty/
safetys.
    As noted in this unit, morpholine amide is not expected to pose an 
acute risk. To evaluate chronic risk, EPA compared estimated chronic 
exposure to the cPAD of 0.67 mg/kg/day. Utilizing a highly conservative 
aggregate exposure assessment, the resulting chronic exposure estimates 
do not exceed the Agency's level of concern (<100% cPAD). Children 1-2 
years old were the most highly exposed population with the chronic 
exposure estimate occupying 67.6% of the cPAD. In addition, this highly 
conservative exposure assessment is protective of any possible non-
occupational exposures to morpholine amide as it results in exposure 
estimates orders of magnitude greater than the high-end exposure 
estimates for residential uses of pesticides routinely used by EPA.
    Taking into consideration all available information on morpholine 
amide, it has been determined that there is a reasonable certainty that 
no harm to any population subgroup, including infants and children, 
will result from aggregate exposure to this chemical. Therefore, the 
exemption from the requirement of a tolerance for residues of 
morpholine amide (CAS Reg. No. 887947-29-7), when used as inert 
ingredient in pre-harvest applications, under 40 CFR 180.920 can be 
considered safe under section 408(q) of the FFDCA.

IX. Other Considerations

A. Analytical Method

    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.

B. Existing Exemptions

    There are no existing exemptions for morpholine amide.

C. International Tolerances

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

X. Conclusions

    Therefore, a tolerance exemption is established for morpholine 
amide (CAS Reg. No. 887947-29-7) when used as inert ingredient in 
pesticide formulations applied to growing crops only.

XI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance 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
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not 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).
    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).

[[Page 20887]]

XII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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 17, 2009.
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), 346a and 371.

0
2. In Sec.  180.920, the table is amended by adding alphabetically the 
following inert ingredient to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
Morpholine 4-C6-12 Acyl                               As a solvent
 Derivatives (CAS Reg. No.
 887947-29-7)
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E9-10071 Filed 5-5-09; 8:45 am]

BILLING CODE 6560-50-S