1,2-ethanediamine, N, 41794-41798 [E9-19762]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 74, Number 159 (Wednesday, August 19, 2009)]
[Rules and Regulations]
[Pages 41794-41798]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19762]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2004-0285; FRL-8430-6]


1,2-ethanediamine, N,N,N ',N '-tetramethyl-, polymer with 1,1'-
oxybis[2-chloroethane]; 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 under 40 CFR 180.920 for residues of 1,2-ethanediamine, 
N,N,N ',N '-tetramethyl-, polymer with 1,1'-oxybis[2-chloroethane] (CAS 
Reg. No. 31075-24-8) when used as an inert ingredient in pesticide 
formulations applied to cotton or wheat crops only. Buckman 
Laboratories International, Inc 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 1,2-
ethanediamine, N,N,N ',N '-tetramethyl-, polymer with 1,1'-oxybis[2-
chloroethane].

DATES: This regulation is effective August 19, 2009. Objections and 
requests for hearings must be received on or before October 19, 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-2004-0285. All documents in the 
docket are listed in the docket index available at https://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 https://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.

[[Page 41795]]


FOR FURTHER INFORMATION CONTACT: Keri Grinstead, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8373; e-mail address: grinstead.keri@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 
https://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at https://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 https://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-2004-0285 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 October 19, 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-2004-0285, by one of the following methods:
     Federal eRulemaking Portal: https://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 September 17, 2004 (69 FR 56062) (FRL-
7675-9), EPA issued a notice pursuant to section 408 of FFDCA, 21 
U.S.C. 346a, as amended by Food Quality Protection Act (FQPA) (Public 
Law 104-170), announcing the filing of a pesticide petition (PP 4E6841) 
by Buckman Laboratories International, Inc., 1256 North McLean Blvd., 
Memphis, TN 38108. The petition requested that 40 CFR 180.920 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of 1,2-ethanediamine,N,N,N ',N '-tetramethyl-, 
polymer with 1,1'-oxybis[2-chloroethane] (CAS Reg. No. 31075-24-8) in 
or on raw agricultural commodities when used as an inert ingredient in 
pesticide formulations. That notice included a summary of the petition 
prepared by the petitioner. There were no substantive comments received 
in response to the notice of filing. The petitioner subsequently 
specified that the inert ingredient use of the chemical will be as an 
adjuvant or water conditioner in pesticide products applied only to 
cotton and to wheat prior to boot stage.
    For ease of reading in this document, 1,2-ethanediamine,N,N,N ',N 
'-tetramethyl-, polymer with 1,1'-oxybis[2-chloroethane] is herein 
referred to as BCETMD copolymer.
    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

[[Page 41796]]

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 1,2-
ethanediamine,N,N,N ',N '-tetramethyl-, polymer with 1,1'-oxybis[2-
chloroethane are discussed in this unit.
    The following provides a brief summary of the risk assessment and 
conclusions from the Agency's review of BCETMD copolymer. The Agency's 
full risk assessment for this action, ``Inert Ingredient Decision 
Document for Pesticide Petition 4E6841: 1,2-ethanediamine, N,N,N ',N '-
tetramethyl-, polymer with 1,1'-oxybis[2-chloroethane] (CAS Reg. No. 
31075-24-8)'', is available in the docket (EPA-HQ-OPP-2004-0285).
    Sufficient data were submitted to the Agency in support of this 
action. In acute toxicity studies, BCETMD copolymer exhibits low to 
moderate oral toxicity, slight irritation to the rabbit eye and skin, 
and is not a skin sensitizer in Guinea pigs. A subchronic study in rats 
had a no observed adverse effect level (NOAEL) of 221 milligrams/
kilogram/day (mk/kg/day) and a lowest observed adverse level (LOAEL) of 
752 mg/kg/day due to mineralization of the renal tubules. The following 
were observed at the two highest dosages: Decreases in body weights and 
possibly absolute organ weights (heart, liver, kidney and gonads); an 
equivocal decrease in red blood cell counts; elevated leukocyte counts; 
non-suppurative inflammation of the choroid plexus of the brain; and 
death. A chronic study in the dog showed: In males, a NOAEL of 250 mg/
kg/day and a LOAEL of 500 mg/kg/day based on testicular hypoplasia, 
atrophy/degeneration, aspermia, dysplasia and cellular debris of 
testicular origin in epididymis; and, in females, a NOAEL of 500 mg/kg/
day and a LOAEL of 1,000 mg/kg/day based on gastrointestinal 
disturbances, emaciation and neurological signs, bloody stools, weight 
loss and ataxia. Reproductive/developmental toxicity was only seen at 
dosage levels at or above those which also caused maternal effects. 
BCETMD copolymer was determined not to be mutagenic or carcinogenic. In 
metabolism studies, most (>86%) of the chemical was excreted in the 
feces.

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.
    The primary route of exposure to BCETMD copolymer from its use as 
an inert ingredient in pesticide products applied to cotton and wheat 
crops would most likely be through consumption of food to which 
pesticide products containing it as an inert ingredient have been 
applied, and possibly through drinking water (from runoff). The use of 
this chemical is limited to pesticide formulations applied to cotton 
and wheat crops only, therefore, there are no residential uses of this 
chemical, and thus no residential (dermal and inhalation) exposures are 
expected.
    No adverse effects attributable to a single exposure of BCETMD 
copolymer were seen in the toxicity database. Therefore, an acute 
dietary risk assessment is not required.
    There are no data provided regarding BCETMD copolymer residues in 
food or any other nonoccupational exposures to BCETMD copolymer. In the 
absence of actual residue data for BCETMD copolymer, the Agency 
performed a chronic dietary (food and drinking water) exposure 
assessment for BCETMD copolymer when used as an inert ingredient in 
pesticide formulations applied pre-harvest to cotton and wheat using a 
series of very conservative assumptions. This exposure assessment was 
calculated based on the following assumptions:
    1. BCETMD copolymer would be used as an inert ingredient in all 
food use pesticide formulations applied pre-harvest to cotton and wheat 
crops.
    2. A hundred percent of all cotton and wheat crops would be treated 
with pesticide products containing BCETMD copolymer.
    3. BCETMD copolymer residues would be present in all cotton and 
wheat crops at levels equal to or exceeding the highest established 
tolerance levels for any pesticide active ingredient.
    4. A conservative default value of 1,000 parts per billion (ppb) 
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 BCETMD copolymer would have such use as a pesticide 
product inert ingredient and be present in cotton and wheat 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 pesticide ingredients 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 BCETMD 
copolymer and any other substances and BCETMD copolymer 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 
BCETMD copolymer 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 https://www.epa.gov/pesticides/cumulative/.

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VII. Determination of Safety for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold (10X) 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 based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the FQPA safety factor (SF). In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    EPA has determined that reliable data show the safety of infants 
and children would be adequately protected if the FQPA SF were reduced 
to 1X. That decision is based on the following findings:
     1. The database is considered adequate for FQPA assessment. The 
studies included in the toxicological database are: 90-day toxicity 
study in rats via the oral route, 90-day dermal toxicity study in 
rabbits, chronic toxicity study in dogs, carcinogenicity study in mice, 
combined chronic/carcinogenicity study in rats, several mutagenicity 
studies (in vivo and in vitro), metabolism study in rats and dermal 
penetration study in rats. There are no acute and/or subchronic 
neurotoxicity studies available in the database. There was no evidence 
of clinical signs of neurotoxicity in the database except ataxia in the 
chronic toxicity study in dogs (1,000 mg/kg/day) and convulsions in a 
carcinogenicity study in mice (1,200 mg/kg/day). These effects are 
considered due to excessive toxicity and not of a neurologic origin. 
Therefore, there is no need for acute and subchronic neurotoxicity 
studies for this chemical. EPA also concluded that there is no need for 
a developmental neurotoxicity study for this chemical because there is 
no evidence in the database of neurotoxicity or increased 
susceptibility to infants and children.
    2. There is no evidence of increased qualitative or quantitative 
susceptibility in the developmental toxicity study in rats and rabbits 
and in the two-generation reproduction study in rats. No developmental 
effects were observed in the rat developmental toxicity study at doses 
up to 500 mg/kg/day highest dose tested (HDT) in the presence of 
maternal toxicity. In the rabbit developmental toxicity study, the 
maternal and developmental NOAELs were 45 mg/kg/day. In this study, 
skeletal variations (developmental effects) were observed in the 
presence of equally severe maternal toxicity (abortions). In the 2-
generation reproduction study in rats, pup weights were decreased at a 
dose level higher than the dose that produced maternal toxicity.
    3. The highly conservative dietary exposure assessment using 
default assumptions would not underestimate the risk to infants and 
children.

VIII. Determination of Safety for U.S. Population

    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. 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.
    Residues of concern are not anticipated for dietary exposure (food 
and drinking water) from the use of BCETMD copolymer as an inert 
ingredient in pesticide products applied pre-harvest to cotton and 
wheat and there are no residential uses/exposures from this use. The 
toxicology data indicate that BCETMD copolymer does not pose an acute 
risk and, therefore, derivation of an aPAD is unnecessary. Chronic risk 
was assessed by comparing aggregate exposure to BCETMD copolymer to a 
cPAD of .45 mg/kg/day (based on a NOAEL of 45 mg/kg/day in the 
developmental toxicity study in rabbits and a safety/uncertainty factor 
of 100X (10X for interspecies and 10X for intraspecies variations). 
Utilizing the highly conservative aggregate exposure assessment 
described above, the resulting chronic exposure estimates do not exceed 
the Agency's level of concern; the chronic dietary estimate for the 
U.S. population was 6.7% (non-nursing infants were the most highly 
exposed population with the chronic exposure estimates occupying 20.0% 
of the cPAD).
    Taking into consideration all available information on BCETMD 
copolymer and the limitations in the proposed tolerance exemption, EPA 
has determined that there is a reasonable certainty that no harm to any 
population subgroup will result from aggregate exposure to BCETMD 
copolymer under reasonable foreseeable circumstances. Therefore, the 
establishment of an exemption from tolerance under 40 CFR 180.920 for 
residues of BCETMD copolymer when used as an inert ingredient in 
pesticide formulations applied pre-harvest to cotton and wheat only, is 
safe under section 408 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 BCETMD copolymer.

C. International Tolerances

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

X. Conclusions

    Therefore, an exemption from the requirement of tolerance is 
established under 40 CFR 180.920 for BCETMD copolymer (CAS Reg. No. 
31075-24-8) when used as an inert ingredient (adjuvant or water 
conditioner) in pesticide formulations applied to cotton or wheat only.

XI. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of 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

[[Page 41798]]

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 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.
    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).

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: August 6, 2009.
G. Jeffrey Herndon,
Acting 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.


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

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
1,2-ethanediamine,N,N,N ', N '-   For use in          Adjuvant or water
 tetramethyl-, polymer with 1,1'-  pesticide           conditioner
 oxybis[2-chloroethane] (CAS       formulations
 Reg. No. 31075-24-8)              applied to cotton
                                   or wheat only
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E9-19762 Filed 8-18-09; 8:45 am]
BILLING CODE 6560-50-S