Document ID: EPA-HQ-OPP-2006-0297-0003
Agency: epa
Document Type: Rule
Title: Desmedipham; Pesticide Tolerance
Posted Date: 2007-09-19T04:00Z

[Federal Register: September 19, 2007 (Volume 72, Number 181)]
[Rules and Regulations]               
[Page 53445-53449]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se07-13]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

EPA-HQ-OPP-2006-0297; FRL-8146-8]

 
Desmedipham; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
desmedipham in or on beet, garden, roots; beet, garden, tops and 
spinach. The Interregional Research Project No. 4 (IR-4) requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 19, 2007. Objections and 
requests for hearings must be received on or before November 19, 2007, 
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-2006-0297. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 

Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: jackson.sidney@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 those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to 
provide 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 an electronic copy of this Federal 
Register document through the electronic docket 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 EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, any person may file an objection 
to any aspect of this regulation and may also request a hearing on 
those objections. 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-2006-0297 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 as required by 40 CFR part 178 on or 
before November 19, 2007.
    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

[[Page 53446]]

without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2006-0297, 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'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. Petition for Tolerance

    In the Federal Register of April 21, 2006 (71 FR 20666) (FRL-8064-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
6E7027) by the Interregional Research Group (IR-4), 500 College Road 
East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 
CFR 180.353 be amended by establishing a tolerance for residues of the 
herbicide, desmedipham, (ethyl-m-hydroxycarbanilate carbanilate) in or 
on the raw agricultural commodities: Beet, garden, roots at 0.05 parts 
per million (ppm), beet, garden, tops at 1.0 ppm, and spinach at 6.0 
ppm. That notice referenced a summary of the petition prepared by Bayer 
CropScience, the registrant, which is available to the public in the 
docket, http://www.regulations.gov. There were no comments received in 

response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish 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 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. 
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....'' These provisions were added to the FFDCA by the Food 
Quality Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for the petitioned-for tolerance 
for residues of beet, garden, roots at 0.05 ppm, beet, garden, tops at 
1.0 ppm, and spinach at 6.0 ppm. EPA's assessment of exposures and 
risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies 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. Specific information on the studies received and the nature 
of the adverse effects caused by desmedipham as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found in the 
Reregistration Eligibility Decision (RED) for desmedipham and FQPA 
Tolerance Reassessment Progress Report (TRED) for desmedipham (http://www.epa.gov/pesticides/reregistration/desmedipham/
) and at 

http://www.regulations.gov in document ``Desmedipham: Human Health Risk 

Assessment for Petition 6E7027 dated February 1, 2007'' in Docket ID 
EPA-HQ-OPP-2006-0297.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from 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) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC 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 
risks by comparing aggregate 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 LOC by all 
applicable UFs. Short-term, intermediate-term, and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for desmedipham used for 
human risk assessment can be found at http://www.regulations.gov in 

document ``Desmedipham: Human Health Risk Assessment for Petition 
6E7027 dated February 1, 2007'' at page number 6 in docket ID number 
EPA-HQ-OPP-2007-0297.
    Subsequent to completion of the February 1, 2007 risk assessment, 
EPA reevaluated the cancer classification of desmedipham. Previously, 
desmedipham was ``tentatively'' classified as a Group E carcinogen 
(evidence of non-carcinogenicity for humans) under the classification 
scheme in effect at the time. The classification was ``tentative'' 
pending submission of historical control data on the incidence of 
mammary gland fibroadenomas and information to address the number of 
animals examined at the low and mid-doses for histopathology in the 
chronic/carcinogenicity study in Wistar rats. To date, historical 
control data for the Wistar rat cancer study have not been submitted to 
the Agency. However, the need for this historical control data is 
alleviated by the submission of a new chronic/carcinogenicity study in 
Sprague Dawley rats. The new Sprague

[[Page 53447]]

Dawley rat study examined doses comparable to those examined in the 
Wistar rat study. In this new cancer rat study, there was no treatment 
related increase in the incidence of mammary gland fibroadenomas and no 
increase in any other tumor type or in the total number of tumors. EPA 
has concluded that desmedipham should now be classified as ``Not likely 
to be Carcinogenic to Humans'' based on the lack of carcinogenic 
potential noted in the available studies. EPA's re-evaluation of the 
cancer classification can be found at http://www.regulations.gov in document 

``Desmedipham: Re-evaluation of Cancer Classification'' in Docket ID 
EPA-HQ-OPP-2006-0297.
    To assess acute dietary exposure, an endpoint and dose were 
selected from a developmental study in the rat. The maternal NOAEL was 
10 milligrams/kilogram (mg/kg)/day based on increased methemoglobin at 
100 mg/kg/day (LOAEL). An UF of 100 was applied to the acute toxicity 
endpoint resulting in an aPAD of 0.1 mg/kg bodyweight (bw)/day. The 
FQPA safety factor was reduced from 10x to 1x.
    To assess chronic dietary exposure, an endpoint and dose were 
selected from a two-generation reproduction study in rats. The NOAEL 
from this study was 4 mg/kg bw/day and the LOAEL was 20 mg/kg/day based 
on parental systemic toxicity of hemolytic anemia accompanied by 
significant increases in splenic weights and compensatory functioning 
of the thyroid. An UF of 100 (10x for interspecies extrapolation and 
10x for intraspecies variability) was applied to the chronic toxicity 
endpoint resulting in a cPAD of 0.04 mg/kg bw/day. The FQPA Safety 
Factor (SF) was reduced from 10x to 1x.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to desmedipham, EPA considered exposure under the petitioned-
for tolerances as well as all existing desmedipham tolerances in (40 
CFR 180.353). EPA assessed dietary exposures from desmedipham in food 
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. In estimating acute dietary 
exposure, EPA used food consumption information from the U.S. 
Department of Agriculture (USDA) 1994-1996, and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, EPA assumed all foods for which there are existing and 
proposed tolerances were treated and contain tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996, 
and 1998 Nationwide CSFII. As to residue levels in food, EPA assumed 
all foods for which there are tolerances existing and proposed were 
treated and contain tolerance-level residues.
    iii. Cancer. Desmedipham has been classified as ``Not Likely to be 
Carcinogenic to Humans''. Therefore, the Agency concluded that 
desmedipham is not expected to pose a carcinogenic risk and 
quantification of exposure for the purpose of assessing cancer risk is 
not necessary.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for desmedipham in drinking water. Because 
the Agency does not have comprehensive monitoring data, drinking water 
concentration estimates are made by reliance on simulation or modeling 
taking into account data on the environmental fate characteristics of 
desmedipham. Further information regarding EPA drinking water models 
used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm
.

    In the environment, at neutral to alkaline pH, desmedipham is 
rapidly hydrolyzed to EHPC (ethyl-(3-hydroxyphenyl) carbamate). Given 
that EHPC has a sub-structure that has been associated with 
methemoglobin effects, the endpoint of concern for the parent 
desmedipham for acute and chronic exposures, EHPC has been included in 
the dietary risk assessment for drinking water.
    The Agency calculated Tier 1 (upper-bound) Drinking Water 
Concentrations (EDWCs) for the combined residues of parent desmedipham 
plus EHPC. EDWCs for desmedipham plus EHPC were calculated using the 
FQPA Index Reservoir Screening Tool (FIRST) (surface water) and 
Screening Concentration In - Ground Water (SCI-GROW) (ground water) 
drinking water models. Both models provide estimates suitable for 
screening purposes. Modeled EDWCs for peak and average concentrations 
of desmedipham plus EHPC in surface water are 130 parts per billion 
(ppb) and 71 ppb, respectively. The modeled peak and average EDWCs for 
ground water are 0.04 ppb.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 130 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 71 ppb was used to assess 
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Desmedipham is not registered for use in or on any sites that would 
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. 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.''
    EPA has determined that desmedipham does not have a common 
mechanism of toxicity with the other N-methyl carbamate pesticides. 
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 desmedipham and any other 
substances and desmedipham 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 desmedipham 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 EPA's website at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional (``10X'') 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 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. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not

[[Page 53448]]

support the choice of a different factor, or, if reliable data are 
available, EPA uses a different additional FQPA safety factor value 
based on the use of traditional UFs and/or special FQPA safety factors, 
as appropriate.
    2. Prenatal and postnatal sensitivity. Desmedipham is not 
considered a developmental toxicant or a mutagen. Developmental 
toxicity studies show no increased sensitivity in fetuses as compared 
to maternal animals following in utero exposures in rats and rabbits. A 
two-generation reproduction toxicity study in rats showed no increased 
susceptibility in pups when compared to adults, There was no evidence 
of abnormalities in the development of the fetal nervous system in the 
pre/post natal studies. Neither brain weight nor histopathology of the 
nervous system was affected in the subchronic and chronic toxicity 
studies.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    The toxicology database is complete and there are no data gaps. 
There are no residual concerns regarding pre- or post-natal toxicity. 
There is no evidence requiring a developmental neurotoxicity study, and
    i. The toxicology database is complete and there are no data gaps.
    ii. There are no residual concerns regarding pre- or post-natal 
toxicity.
    iii. There is no evidence requiring a developmental neurotoxicity 
study, and
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% crop treated (CT) and tolerance-level residues. Conservative 
ground and surfacewater modeling estimates were used. These assessments 
will not underestimate the exposure and risks posed by desmedipham.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC to ensure that the MOE called for by the product of all 
applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to desmedipham will occupy 26% of the aPAD for the population group 
(all infants less than 1 yr old) receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
desmedipham from food and water will utilize 13% of the cPAD for the 
population group all infants less than 1 yr old.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Desmedipham is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Desmedipham is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
    5. Aggregate cancer risk for U.S. population. Desmedipham is 
classified as ``Not Likely to be Carcinogenic to Humans'' and is not 
expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to desmedipham residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Liquid Chromatography/Mass 
Spectrometry/Mass Spectrometry (LC/MS/MS) method AL/01/02) is available 
to enforce the tolerance expression. The method may be requested from: 
Chief, Analytical Chemistry Branch, Environmental Science Center, 701 
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; 
e-mail address: residuemethods@epa.gov.

B. International Residue Limits

    There are no established or proposed Codex, Canadian or Mexican 
MRLs for desmedipham.

V. Conclusion

    Therefore, the tolerance is established for residues of the 
herbicide, desmedipham (ethyl-m-hydroxycarbanilate carbanilate) in or 
on the raw agricultural commodities: Beet, garden, roots at 0.05 ppm, 
beets, garden, tops at 1.0 ppm, and spinach at 6.0 ppm.

VI. 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 rule has been 
exempted from review under Executive Order 12866, 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) 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 the 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 the 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.

[[Page 53449]]

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 6, 2000) do not apply to this rule. In addition, 
This 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).

VII. 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: September 7, 2007.
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.  180.353, paragraph (a) is revised to read as follows:

Sec.  180.353  Desmedipham; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide desmedipham, (ethyl-m-hydroxycarbanilate carbanilate) in or 
on the following raw agricultural commodities in the table that 
follows:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Beet, garden, roots..................................               0.05
Beet, garden, tops...................................                1.0
Beet, sugar, roots...................................                0.2
Beet, sugar, tops....................................                0.2
Spinach..............................................                6.0
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-18373 Filed 9-18-07; 8:45 am]

BILLING CODE 6560-50-S