[Federal Register Volume 67, Number 152 (Wednesday, August 7, 2002)]
[Rules and Regulations]
[Pages 51102-51105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19801]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0149; FRL-7192-5]


Dichlormid; Extension of Time-Limited Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation re-establishes time-limited tolerances for 
residues of the inert ingredient (herbicide safener) dichlormid (N,N-
diallyl dichloroacetamide) in or on corn commodities (forage, grain, 
stover) at 0.05 ppm. Dow AgroSciences requested this tolerance under 
the Federal Food, Drug, and Cosmetic Act, as amended by the Food 
Quality Protection Act of 1996. The tolerances expired on March 27, 
2002. This rule will re-establish these tolerances and extend them to 
December 31, 2005.

DATES: This regulation is effective August 7, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0149, 
must be received on or before October 7, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket ID number OPP-2002-0149 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Treva C. Alston, Registration 
Division 7505C, Office of Pesticide Programs, Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone 
number: (703) 308-8373; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

------------------------------------------------------------------------
                                                 Examples of Potentially
             Categories                 NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                    111  Crop production
                                            112  Animal production
                                            311  Food manufacturing
                                          32532  Pesticide manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently 
under development. To access the OPPTS Harmonized Guidelines referenced 
in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0149. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of September 16, 1998 (63 FR 49568) (FRL-
6025-8), EPA issued a notice pursuant to section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the 
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170), 
announcing the filing of a pesticide petition (PP 6F03344) by Zeneca Ag 
Products, 1800 Concord Pike, Wilmington, DE. This notice included a 
summary of the petition prepared by Zeneca Ag Products, the petitioner 
at that time. There were no comments received in response to the notice 
of filing. The Agency published a final rule in the Federal Register on 
March 27, 2000 (65 FR 16143)( FRL-6498-7) establishing time-limited 
tolerances, expiring on March 27, 2002. In correspondence to the 
Agency, Zeneca requested additional time past March 2002 for data 
generation. On November 9, 2000, Zeneca Ag Products sold certain parts 
of its business to Dow AgroSciences. In connection with the sale, 
Zeneca Ag Products transferred all rights, title, and interest in 
dichlormid to Dow AgroSciences. The new petitioner, Dow AgroSciences, 
has similarly requested additional time for data generation. In the 
Federal Register of May 22, 2002 (67 FR 35996) (FRL-6836-4), EPA issued 
a notice pursuant to section 408 of the FFDCA 21 U.S.C. 346a, as 
amended by the FQPA of 1996 (Public Law 104-170) announcing the filing 
of PP 6F03344 by Dow AgroSciences, 9330 Zionsville Road, Indianapolis, 
IN 46268. This notice included a summary of the petition prepared by 
Dow Agrosciences. There were no comments received in response to the 
notice of filing.
    The petition requested that 40 CFR 180.469 be amended by 
establishing tolerances for residues of the herbicide safener 
dichlormid, in or on field corn grain, field corn forage, and field 
corn fodder at 0.05 part per million (ppm).
    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) defines ``safe'' to

[[Page 51103]]

mean that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide chemical residue, including 
all anticipated dietary exposures and all other exposures for which 
there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) requires EPA to give 
special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section 
408(b)(2), for tolerances for residues of dichlormid on field corn 
grain; field corn forage; and field corn fodder, (now corn, field, 
grain; corn, field, forage; and corn, field, stover) at 0.05 ppm. EPA's 
assessment of exposures and risks associated with establishing the 
tolerances follows.
    The Agency prepared a risk assessment which was used as the basis 
for establishing time-limited tolerances in residues of corn, field, 
grain; corn, field, forage; and corn, field, stover. A final rule for 
these tolerances was published in the Federal Register of March 27, 
2000. Based on the risk assessment, EPA concluded at that time that all 
of the risks are below the Agency's level of concern and there is a 
reasonable certainty that no harm will result to the general 
population, and to infants and children from aggregate exposure to 
residues of dichlormid on corn commodities.
    For a complete description of the toxicological profile and 
endpoints, the uncertainty factors, the exposure assessment which 
included dietary exposure for both food and drinking water, the safety 
factor for infants and children, and aggregate risk for dichlormid, see 
the final rule of March 27, 2000.
    The final rule of March 27, 2002, discussed data gaps which needed 
to be addressed before permanent tolerances could be established. Data 
generation is underway. According to a schedule provided by Dow 
AgroSciences, the following studies have been completed:
    1. Chronic Feeding Study-Dog
    2. 2-Generation Reproduction Study-Rat
    3. General Metabolism
    4. Acute Neurotoxicity
    5. Subchronic Neurotoxicity
    6. Plant Metabolism
    7. Animal Metabolism
    Studies remaining to be completed are: Crop Field Trials and 
Rotational Crop (Confined). Upon completion of all studies, Dow 
Agrosciences will submit them to the Agency. The last scheduled 
completion date is June 2003 for the Rotational Crop (Confined) Study. 
Upon receipt, the Agency will review and evaluate these studies, and 
prepare a new risk assessment. The Agency believes that this review and 
evaluation, as well as the preparation of a new risk assessment will be 
completed by December 31, 2005. Until that time, this final rule 
establishes the time-limited tolerances expiring December 31, 2005 in 
order to allow for the completion and then subsequent Agency review and 
evaluation of these studies.
    There are a large number of studies that remain outstanding. 
However, the data gaps are not as extensive as it would seem. The 
nature of the residue in corn was previously found to be understood 
based on the published metabolism studies for a structurally similar 
chemical. Since the Agency's understanding of the plant metabolism of 
dichlormid was derived from an extrapolation from surrogate data, a 
plant metabolism study in accordance with OPPTS guidelines 860.1300 
using dichlormid is required.
    For the crop field trials, both pre-and post-emergent data using 
dichlormid have been provided. More field trials are to be submitted in 
order to fulfill the guideline requirements.
    To account for the incomplete toxicological database, the Agency 
retained an additional 10X safety factor for infants and children as to 
acute risk and an additional 30X safety factor as to chronic risk. Once 
the data gaps have been fulfilled, retention of these safety factors 
will be evaluated.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromotography) is available 
to enforce the tolerance expression. The method may be requested from: 
Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

    There is neither a Codex proposal, nor Canadian or Mexican limits 
for residues of dichlormid in corn commodities.

V. Conclusion

    Therefore, the time-limited tolerances are re-established for 
residues of the inert ingredient herbicide safener, dichlormid, N,N-
diallyldichloracetamide in corn, field, forage; corn, field, grain; 
corn, field, stover; corn, pop, grain; and corn, pop, stover at a 
tolerance level of 0.05 ppm. These tolerances will expire and be 
revoked on December 31, 2005. These tolerances are being established on 
a time-limited basis due to an incomplete datebase. The following 
toxicological data gaps (OPPTS Harmonized Test Guideline) have been 
identified:
     Chronic Feeding Study in Dogs, Test Guidelines 870.4100.
     2-Generation Reporductive Study in Rats, Test Guideline 
870.3900.
     General Metabolism Study, Test Guideline 870.6200.
     Subchronic Neurotoxicity Study, Test Guideline 870.6200.
    The following product and residue chemistry data were also 
identified:
     Product Chemistry Data-color, Test Guideline 830.6302; 
physical state, Test Guideline 830.6303; odor, 830.6304; melting point, 
Test Guideline 830.7200; boiling point, Test Guideline 830.7220; water 
solubility, Test Guideline 830.7840; and stability, Test Gudieline 
830.6313.
     Plant Metabolism Study, Test Guideline 860.1300.
     Animal Metablism Studies, Test Guideline 860.1300.
     Crop Field Trials, 860.1500.
     Rotational Crop Study, Test Guideline 860.1850 (Confined 
Study.
    The toxicological product chemistry and residue chemistry data gaps 
as identified must be addressed before a permanent tolerance can be 
established.

VI. 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.

[[Page 51104]]

 Although the procedures in those regulations require some modification 
to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
provides essentially the same process for persons to ``object'' to a 
regulation for an exemption from the requirement of a tolerance issued 
by EPA under new section 408(d), as was provided in the old FFDCA 
sections 408 and 409. However, the period for filing objections is now 
60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2002-0149 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 
7, 2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket ID number OPP-2002-0149, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or 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).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). 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 FFDCA section 408(d), 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. 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

[[Page 51105]]

responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism(64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.''`` Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have`` substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801et 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: July 31, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

    2. Section 180.469 is amended by revising the table in paragraph 
(a) to read as follows:


Sec. 180.469  N,N-diallyl dichloroacetamide; tolerances for residues.

    (a) *  *  *

------------------------------------------------------------------------
                                                            Expiration/
                  Commodity                    Parts per    Revocation
                                                million        Date
------------------------------------------------------------------------
Corn, field, forage..........................       0.05        12/31/05
Corn, field, grain...........................       0.05        12/31/05
Corn, field, stover..........................       0.05        12/31/05
Corn, pop, grain.............................       0.05        12/31/05
Corn, pop, stover............................       0.05        12/31/05
------------------------------------------------------------------------

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[FR Doc. 02-19801 Filed 8-6-02; 8:45am]
BILLING CODE 6560-50-S