[Federal Register Volume 72, Number 152 (Wednesday, August 8, 2007)]
[Notices]
[Pages 44510-44511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15109]
[[Page 44510]]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0434; FRL-8133-9]
2,4-D, 2,4-DP, and 2,4-DB; Decision Not to Initiate Special
Review
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces EPA's Decision Not to Initiate a Special
Review for 2,4-D, 2,4-DB and 2,4-DP. Based on extensive scientific
review of many epidemiology and animal studies, the Agency finds that
the weight of the evidence does not support a conclusion that 2,4-D,
2,4-DB and 2,4-DP are likely human carcinogens. The Agency has
determined that the existing data do not support a conclusion that
links human cancer to 2,4-D exposure. This conclusion applies to 2,4-DB
and 2,4-DP because they were considered for Special Review based solely
on their similarity to 2,4-D. In addition, because they are used
significantly less than 2,4-D, their contribution to exposure is
minimal relative to 2,4-D. Because the Agency has determined that the
existing data do not support a conclusion that links human cancer to
2,4-D exposure, the Agency is not initiating a Special Review of 2,4-D,
2,4-DB and 2,4-DP. This decision was first proposed on March 23, 1988
(53 FR 9590).
FOR FURTHER INFORMATION CONTACT: Richard P. Dumas, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8015; fax
number: (703) 308-8005; e-mail address: dumas.richard @epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. 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 Get Copies of this Document and Other Related Information?
1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2007-0434. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Drive Arlington, VA. The hours of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Facility Docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
II. Background
A. What Action is the Agency Taking?
On September 22, 1986, the Agency issued a preliminary notification
of Special Review of 2,4-D. Because of their similarity to 2,4-D, on
December 3, 1986, EPA issued preliminary notifications of Special
Review of 2,4-DB and 2,4-DP. These notices were issued because of
concerns for epidemiological links of 2,4-D, 2,4-DB and 2,4-DP to non-
Hodgkin's lymphoma from both occupational and residential exposure. A
proposed decision Not to Initiate Special Review was published on March
23, 1988 ((53 FR 9590; FRL-3353-3)) based on findings that such a link
is not supported by the existing data. Two sets of comments were
received in response to the proposal, both on behalf of the 2,4-D Task
Force. Both sets supported the proposed decision, but questioned the
need for a new cancer study. The latter point is moot because the
registrant ultimately conducted and submitted an acceptable cancer
study. The final decision was deferred until a more comprehensive
review of 2,4-D was completed. This review was completed with the
signature of the Reregistration Eligibility Decision for 2,4-D in June
of 2005.
To address the potential link of non-Hodgkin's lymphoma to 2,4-D
exposure, a joint Science Advisory Board/Scientific Advisory Panel
Special Joint Committee was convened to review available
epidemiological and other data on 2,4-D. In 1992, the Committee
concluded that ``the data are not sufficient to conclude that there is
a cause and effect relationship between exposure to 2,4-D and non-
Hodgkin's lymphoma.'' 2,4-D was classified as a Group D, ``not
classifiable as to human carcinogenicity.'' To help better inform the
Agency, EPA requested further histopathological examinations of mouse
and rat tissue from previously conducted studies. These exams were
submitted and reviewed, and on March 16, 1999, the Agency notified the
2,4-D Task Force that the EPA would continue to classify 2,4-D as a
Group D carcinogen.
The Agency has twice recently reviewed epidemiological studies
linking cancer to 2,4-D exposure. In the first review, completed
January 14, 2004, EPA concluded there is no additional evidence that
would implicate 2,4-D as a cause of cancer (EPA, 2004). The second
review of available epidemiological studies occurred in response to
comments received during Phase 3 of the Public Participation Process
for the 2,4-D RED. EPA's report, dated December 8, 2004, found that
none of the more recent epidemiological and animal studies support a
conclusion that 2,4-D, 2,4-DB and 2,4-DP are likely human carcinogens.
Because the Agency has determined that the existing data do not support
a conclusion that links human cancer to 2,4-D exposure, it has decided
not to initiate a Special Review of 2,4-D, 2,4-DB and 2,4-DP.
B. What is the Agency's Authority for Taking this Action?
A pesticide product may be sold or distributed in the United States
only if it is registered or exempt from registration under the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) as amended (7 U.S.C.
136 et seq.). Before a product can be registered it must be shown that
it can be used without causing ``unreasonable adverse effects on the
environment,'' FIFRA section 3(c)(5). The term ``unreasonable adverse
effects on the environment'' is defined in FIFRA section 2(bb) as ``any
unreasonable risk to man or the environment, taking into account the
economic, social, and environmental costs and benefits of the use of
any pesticide.'' The burden of proving that a pesticide meets this
standard for registration is, at all times, on the proponent of initial
or continued registration. If at any time the Agency determines that a
pesticide no longer meets this standard, the Administrator may cancel
this registration under section 6 of FIFRA.
The Special Review process provides a mechanism to permit public
participation in EPA's deliberations prior to issuance of any Notice of
Final
[[Page 44511]]
Determination describing the regulatory action which the Administrator
has selected. The Special Review process, which was previously called
the Rebuttable Presumption Against Registration (RPAR) process, is
described in 40 CFR part 154, published in the Federal Register of
November 27, 1985 (50 FR 49003, 49015; FRL-2914-6). The purpose of this
process is to determine whether some or all registrations of a
particular active ingredient or ingredients meet the FIFRA standard for
registration, or whether amendment of the terms and conditions of
registration or cancellation of portions or all of the registrations is
appropriate.
Prior to formal initiation of a Special Review, a preliminary
notification is sent to registrants and applicants for registration
pursuant to 40 CFR 154.21 announcing that the Agency is considering
commencing a Special Review. Registrants and applicants for
registration are allowed 30 days from receipt of the notification to
comment on the Agency's proposal to commence a Special Review.
If the Agency determines, after issuance of a notification pursuant
to 40 CFR 154.21, that it will not conduct a Special Review, it is
required under 40 CFR 154.23 to issue a proposed decision to be
published in the Federal Register. That regulation requires that a
period of not less than 30 days be provided for public comment on the
Proposed Decision Not to Initiate a Special Review. Subsequent to
receipt and evaluation of comments on the Proposed Decision Not to
Initiate a Special Review, pursuant to 40 CFR 154.25 the Administrator
must publish in the Federal Register his final decision regarding
whether or not to initiate a Special Review. As discussed above, the
Agency previously published a notice pursuant to 40 CFR 154.23 for
these compounds, considered public comments and has decided not to
initiate the Special Review under 40 CFR 154.25(b).
List of Subjects
Environmental protection, Pesticides and pest.
Dated: July 30, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E7-15109 Filed 8-7-07; 8:45 am]
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