[Federal Register Volume 81, Number 184 (Thursday, September 22, 2016)]
[Pages 65354-65356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22881]



[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.


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

[[Page 65355]]

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 

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 
     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 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].


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 

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-
    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 
[FR Doc. 2016-22881 Filed 9-21-16; 8:45 am]