dichlormid Extension of Time-Limited Pesticide Tolerance 7/02
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Dichlormid; Extension of Time-Limited Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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: firstname.lastname@example.org.
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
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/
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
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
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
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:
B. International Residue Limits
There is neither a Codex proposal, nor Canadian or Mexican limits
for residues of dichlormid in corn commodities.
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
Chronic Feeding Study in Dogs, Test Guidelines 870.4100.
2-Generation Reporductive Study in Rats, Test Guideline
General Metabolism Study, Test Guideline 870.6200.
Subchronic Neurotoxicity Study, Test Guideline 870.6200.
The following product and residue chemistry data were also
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
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
The toxicological product chemistry and residue chemistry data gaps
as identified must be addressed before a permanent tolerance can be
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.
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
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@example.com,
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: firstname.lastname@example.org. 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
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
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
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
Dated: July 31, 2002.
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as
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) * * *
Commodity Parts per Revocation
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
* * * * *
[FR Doc. 02-19801 Filed 8-6-02; 8:45am]