Document ID: EPA-HQ-OPP-2014-0219-0001
Agency: epa
Document Type: Notice
Title: Draft Guidances: Pesticides; Consideration of Volatilization in Pesticide Risk Assessment
Posted Date: 2014-03-26T04:00Z

[Federal Register Volume 79, Number 58 (Wednesday, March 26, 2014)]
[Notices]
[Pages 16791-16793]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06545]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0219; FRL-9907-92]

Pesticides; Consideration of Volatilization in Pesticide Risk 
Assessment: Notice of Availability and Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing the availability of several draft guidance 
documents for public comment. These documents detail EPA's approach in 
developing a pesticide volatilization screening methodology for human 
health. Once final, these guidance documents will be posted on EPA's 
Web site, to promote consistent risk assessment practices and provide 
transparency for pesticide registrants and other interested 
stakeholders.

DATES: Comments must be received on or before May 27, 2014.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2014-0219, 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: Charles Smith, Health Effects Division 
(7507P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-0291; email address: smith.charles@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. What is the Agency's authority for taking this action?

    Pesticides are regulated under both the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et. seq., and 
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a.

B. Does this action apply to me?

    You may be potentially affected by this action if you are a 
producer of pesticide products (NAICS code 32532), importers of such 
products, or any person or company who seeks to obtain a tolerance for 
such a pesticide. The North American Industrial Classification System 
(NAICS) code is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Other types of entities not listed could also be affected.

C. 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 submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.

[[Page 16792]]

    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

D. What action is the Agency taking?

    Volatilization of a pesticide can be characterized as the physical 
movement of the vapor phase of a pesticide through the air after an 
application has occurred from the target site to any non- or off-target 
site. This does not include pesticide movements by spray drift, 
erosion, migration, or windblown soil particles after application. 
Volatilization is dependent on a number of physical and chemical 
properties, weather conditions, and other factors. Once off-target, 
pesticide volatilization can result in inhalation exposure to people, 
such as bystanders.
    EPA has developed a guidance document describing EPA's approach in 
developing a volatilization screening methodology for human health. The 
``Human Health Bystander Screening Level Analysis: Volatilization of 
Conventional Pesticides'' document (and its appendices) describes the 
development of the screening tool, the guiding principles behind the 
screening tool, the various inputs utilized in the screening tool, and 
the results of the screening analysis that EPA has recently completed 
using this methodology.
    These documents are available in the docket for this action using 
the docket ID number EPA-HQ-OPP-2014-0219 (Refs. 1, 2, 3, 4, and 5). 
These policies will promote consistency within EPA, as well as with 
other Federal agencies and international regulatory partners that 
consider volatilization for pesticides.

II. Consideration of Volatilization in Human Health Risk Assessment

    Over many years, EPA has been actively engaged in evaluating 
possible exposures associated with air borne, off-target movement of 
pesticides. EPA has worked to develop and refine its methodologies for 
assessing bystander inhalation exposures resulting from volatilization 
of fumigants as well as to spray drift from the application of 
conventional pesticides in agricultural settings. Recently, EPA 
published a notice for comment in the Federal Register of January 29, 
2014 (79 FR 4691) (FRL-9903-12) two draft guidance documents describing 
how EPA plans to evaluate off-site spray drift for ecological and human 
health risk assessments. These documents are available at 
regulations.gov using the docket ID number EPA-HQ-OPP-2013-0676.
    To account for volatilization from non-fumigant uses, EPA has been 
adapting the approaches developed for conducting risk assessments for 
the fumigants in assessing potential bystander inhalation risk. Notable 
milestones in this effort include the 2009 FIFRA Scientific Advisory 
Panel (SAP) review of issues related to volatilization of conventional 
pesticides (Ref. 6) and the 2013 chlorpyrifos preliminary volatility 
assessment (Ref. 7).
    These adaptations have resulted in a Volatilization Screening Tool 
that provides a consistent and health protective framework to assess 
the potential inhalation bystander risks resulting from volatilization 
of conventional pesticides. A Volatilization Screening Tool Guidance 
Document (Ref. 2) was produced to support the screening tool. To 
estimate potential bystander inhalation risks, the screening tool uses:
     A number of physical and chemical properties to predict 
flux (i.e., the rate at which a chemical volatilizes off of a treated 
field).
     The AERSCREEN model (Ref. 8) to estimate air 
concentrations at different distances from a treated field.
     Chemical-specific human health toxicological data.
    Four of the draft documents (Refs. 1, 2, 3, and 4) provide details 
on the volatilization screening methodology including the development 
of the screening tool, the guiding principles behind the screening 
tool, and the various inputs used in the screening tool. To demonstrate 
the application of this methodology, two documents (Refs. 1 and 5) 
present the results of the screening analysis that EPA completed using 
this methodology which examined all of the conventional pesticides 
being evaluated in the Registration Review process. It is important to 
note that ``failing'' the screening analysis does not necessarily mean 
that the pesticide poses a risk of concern due to volatilization. 
Rather, due to the purposely conservative nature of the screening 
analysis, failing the screen is merely a trigger for the Agency to 
further investigate the question of exposure from volatilization of the 
pesticide.

III. References

    As indicated under ADDRESSES, a docket has been established for 
this notice under docket ID number EPA-HQ-OPP-2014-0219. The following 
is a listing of the documents that are specifically referenced in this 
action. The docket includes these documents and other information 
considered by EPA, including documents that are referenced within the 
documents that are included in the docket, even if the referenced 
document is not physically located in the docket. For assistance in 
locating these other documents, please consult the person listed under 
FOR FURTHER INFORMATION CONTACT.
    1. EPA. Human Health Bystander Screening Level Analysis: 
Volatilization of Conventional Pesticides (Draft dated 3/1/2014).
    2. EPA. Appendix A: Volatilization Screening Tool Guidance Document 
(Draft dated 3/1/2014).
    3. EPA. Appendix B: Inhalation Equivalent Concentration 
Calculations for the Registration Review Chemical Analysis (Draft dated 
3/1/2014).
    4. EPA. Appendix C: Data Entry Sheets for the Registration Review 
Chemical Volatilization Screening Analysis (Draft dated 3/1/2014).
    5. EPA. Appendix D: Registration Review Chemical Volatilization 
Screening Analysis Results (Draft dated 3/1/2014).
    6. FIFRA SAP. December 1-4, 2009: Scientific Issues Associated with 
Field Volatilization of Conventional Pesticides. Available at http://www.epa.gov/scipoly/sap/meetings/2009/120109meeting.html (accessed 2/
24/2014), or in the docket at regulations.gov using the document ID 
number EPA-HQ-OPP-2009-0687).
    7. EPA. Chlorpyrifos Preliminary Evaluation of the Potential Risks 
from Volatilization: Available in the docket at regulations.gov using 
the document ID number EPA-HQ-OPP-2008-0850-0114).
    8. EPA. Technology Transfer Network Support Center for Regulatory 
Atmospheric Modeling: Preferred/recommended Models. Available at http://www.epa.gov/ttn/scram/dispersion_prefrec.htm (accessed 2/26/2014).

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests.

[[Page 16793]]

    Dated: March 18, 2014.
Marty Monell,
Acting, Director, Office of Pesticide Programs.
[FR Doc. 2014-06545 Filed 3-25-14; 8:45 am]
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