[Federal Register Volume 81, Number 184 (Thursday, September 22, 2016)]
[Notices]
[Pages 65354-65356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22881]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2009-0317; FRL-9952-53]
Registration Review; Draft Malathion Human Health Risk
Assessment; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's draft human
health risk assessment for the registration review of malathion (case
0248) for public review and comment. Registration review is EPA's
periodic review of pesticide registrations to ensure that each
pesticide continues to satisfy the statutory standard for registration,
that is, the pesticide can perform its intended function without
unreasonable adverse effects on human health or the environment. As
part of the registration review process, the Agency has completed a
comprehensive draft human health risk assessment for malathion. After
reviewing comments received during the public comment period, EPA may
issue a revised human health risk assessment, explain any changes to
the draft risk assessment, respond to comments, and may request public
input on risk mitigation before completing its proposed registration
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review decision for malathion. Through this program, EPA is ensuring
that each pesticide's registration is based on current scientific and
other knowledge, including its effects on human health and the
environment.
DATES: Comments must be received on or before November 21, 2016.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0317, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For pesticide specific information contact the Chemical Review
Manager: Steven Snyderman at telephone number: (703) 347-0249; email
address: [email protected].
For general questions on the registration review program, contact:
Richard Dumas, Pesticide Re-Evaluation Division (7508P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-8015;
email address: [email protected].
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, farm worker, 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 Chemical Review Manager identified in FOR FURTHER
INFORMATION CONTACT.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticide
discussed in this document, compared to the general population.
II. Authority
EPA is conducting its registration review of malathion pursuant to
section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) (7 U.S.C. 136a(g)) and the Procedural Regulations for
Registration Review at 40 CFR part 155, subpart C. FIFRA section 3(g)
provides, among other things, that the registrations of pesticides are
to be reviewed every 15 years. Under FIFRA, a pesticide product may be
registered or remain registered only if it meets the statutory standard
for registration given in FIFRA section 3(c)(5) (7 U.S.C. 136a(c)(5)).
When used in accordance with widespread and commonly recognized
practice, the pesticide product must perform its intended function
without unreasonable adverse effects on the environment; that is,
without any unreasonable risk to man or the environment, or a human
dietary risk from residues that result from the use of a pesticide in
or on food.
III. Registration Review
As directed by FIFRA section 3(g), EPA is reviewing the pesticide
registrations for malathion to ensure that they continue to satisfy the
FIFRA standard for registration--that is, that malathion can still be
used without unreasonable adverse effects on human health or the
environment. Information concerning the registration review of
malathion (case 0248) is in the docket, under Docket ID No. EPA-HQ-OPP-
2009-0317.
Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity,
through this notice of availability, for interested parties to provide
comments and input concerning the Agency's draft human health risk
assessment for malathion. Such comments and input could address, among
other things, the Agency's risk assessment methodologies and
assumptions, as applied to this draft human health risk assessment. The
Agency will consider all comments received during the public comment
period and make changes, as appropriate, to the draft human health risk
assessment. EPA will then issue a revised risk assessment, explain any
changes to the draft risk assessment, and respond to comments. In the
Federal Register notice announcing the availability of the revised risk
assessment, if the revised risk assessment indicates risks of concern,
the Agency may provide a comment period for the public to submit
suggestions for mitigating the risk identified in the revised risk
assessment before developing a proposed registration review decision
for malathion.
1. Other related information. Additional information on the
registration review status of malathion, as well as information on the
Agency's registration review program and on its implementing regulation
is available at https://www.epa.gov/pesticide-reevaluation.
2. Information submission requirements. Anyone may submit data or
information in response to this document. To be considered during a
pesticide's registration review, the submitted data or information must
meet the following requirements:
To ensure that EPA will consider data or information
submitted, interested persons must submit the data or information
during the comment
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period. The Agency may, at its discretion, consider data or information
submitted at a later date.
The data or information submitted must be presented in a
legible and useable form. For example, an English translation must
accompany any material that is not in English and a written transcript
must accompany any information submitted as an audiographic or
videographic record. Written material may be submitted in paper or
electronic form.
Submitters must clearly identify the source of any
submitted data or information.
Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency should reconsider
the data or information in the pesticide's registration review.
As provided in 40 CFR 155.58, the registration review docket for
each pesticide case will remain publicly accessible through the
duration of the registration review process; that is, until all actions
required in the final decision on the registration review case have
been completed.
Authority: 7 U.S.C. 136 et seq.
Dated: September 14, 2016.
Yu-Ting Guilaran,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2016-22881 Filed 9-21-16; 8:45 am]
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