

[Federal Register: August 8, 2007 (Volume 72, Number 152)]
[Notices]               
[Page 44510-44511]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08au07-60]                         


[[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 

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]

BILLING CODE 6560-50-S
