Document ID: EPA-HQ-OPP-2007-0364-0001
Agency: epa
Document Type: Notice
Title: Glutaraldehyde Risk Assessment; Notice of Availability and Risk Reduction Options
Posted Date: 2007-07-06T04:00Z

[Federal Register: July 6, 2007 (Volume 72, Number 129)]
[Notices]               
[Page 37008-37010]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jy07-64]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0364; FRL-8138-3]

 
Glutaraldehyde Risk Assessment; Notice of Availability and Risk 
Reduction Options

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's risk 
assessment and related documents for the pesticide glutaraldehyde, and 
opens a public comment period on these documents. The public is 
encouraged to suggest risk management ideas or proposals to address the 
risks identified. EPA is developing a Reregistration Eligibility 
Decision (RED) for Glutaraldehyde through a modified, 4-Phase public 
participation process that the Agency uses to involve the public in 
developing pesticide reregistration decisions. Through this program, 
EPA is ensuring that all pesticides meet current health and safety 
standards.

DATES: Comments must be received on or before September 4, 2007.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2007-0364, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0364. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 

provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access'' 
system, which means EPA will not know your identity or contact 
information unless you provide it in the body of your comment. If you 
send an e-mail comment directly to EPA without going through 
regulations.gov, your e-mail address will be automatically captured and 
included as part of the comment that is placed in the docket and made 
available on the Internet. If you submit an electronic comment, EPA 
recommends that you include your name and other contact information in 
the body of your comment and with any disk or CD-ROM you submit. If EPA 
cannot read your comment due to technical difficulties and cannot 
contact you for clarification, EPA may not be able to consider your 
comment. Electronic files should avoid the use of special characters, 
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available in regulations.gov. To access the electronic docket, go to 
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 

Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov web 
site to view the docket index or access available documents. Although

[[Page 37009]]

listed in the index, some information is not publicly available, e.g., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
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 OPP Regulatory Public Docket in Rm. S-4400, One 
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 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 Docket 
Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Michelle Centra, Antimicrobials 
Division (7510P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-2476; fax number: (703) 305-5620; e-
mail address:centra.michelle@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. 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 e-mail. 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 Registerdate 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.
    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.

II. Background

A. What Action is the Agency Taking?

    EPA is releasing for public comment its human health and 
environmental fate and effects risk assessment and related documents 
for glutaraldehyde, an antimicrobial pesticide, and soliciting public 
comment on risk management ideas or proposals. Glutaraldehyde is 
registered for use in disinfectant, sanitizer, biocide, fungicide, 
microbiocide, tuberculocide, and virucide antimicrobial products. EPA 
developed the risk assessment and risk characterization for 
glutaraldehyde through a modified version of its public process for 
making pesticide reregistration eligibility and tolerance reassessment 
decisions. Through these programs, EPA is ensuring that pesticides meet 
current standards under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
    As an antimicrobial agent, glutaraldehyde is applied to various 
sites, including food handling and food storage establishments such as 
commercial egg hatcheries, poultry/livestock equipment and processing 
premises, animal feeding and watering equipment; commercial/industrial 
buildings and trucks, construction materials, and laundry equipment; 
oil recovery drilling muds and secondary oil recovery injection water; 
metalworking cutting fluids; commercial/industrial water cooling 
systems and evaporative condenser and heat exchanger water systems; 
hospital, veterinary and laboratory premises/ equipment in addition to 
critical hospital plastic and rubber items; industrial coatings; and in 
the manufacture of a variety of materials as a preservative: cleaners, 
adhesives, paper and paperboard, water based coatings, latex paints, 
inks and dyes. It is not registered for any direct food uses. 
Glutaraldehyde containing products are also approved for use in aquatic 
areas such as ponds, flood water and sewage water and cooling tower 
water.
    EPA is providing an opportunity, through this notice, for 
interested parties to provide comments and input on the Agency's risk 
assessment for glutaraldehyde. Such comments and input could address, 
for example, the availability of additional data to further refine the 
risk assessments, such as an aerobic soil metabolism study; nontarget 
plant phytotoxicity tests in four species; seedling emergence and 
vegetative vigor testing; monitoring data in soil; and water for once-
through cooling tower use, or could address the Agency's risk 
assessment methodologies and assumptions as applied to this specific 
pesticide.
    Through this notice, EPA also is providing an opportunity for 
interested parties to provide risk management proposals or otherwise 
comment on risk management for glutaraldehyde. Risks of concern 
associated with the use of glutaraldehyde are: Residential handler 
inhalation and dermal exposures to paint and laundry detergent; 
residential postapplication inhalation exposures to paints and cooling 
tower emissions; occupational handler inhalation exposures to hard 
surface disinfection in medical, dental, and veterinary offices and 
poultry houses; occupational postapplication inhalation exposures to 
professional painters; and occupational postapplication dermal 
exposures to machinists using metal working fluids, and toxicity to 
terrestrial and aquatic organisms. In targeting these risks of concern, 
the Agency solicits information on effective and practical risk 
reduction measures.
    EPA seeks to achieve environmental justice, the fair treatment and 
meaningful involvement of all people, regardless of race, color, 
national origin, or income, in the development,

[[Page 37010]]

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, unusually high exposure to glutaraldehyde, 
compared to the general population.
    EPA is applying the principles of public participation to all 
pesticides undergoing reregistration and tolerance reassessment. The 
Agency's Pesticide Tolerance Reassessment and Reregistration; Public 
Participation Process, published in the Federal Register on May 14, 
2004 (69 FR 26819) (FRL-7357-9), explains that in conducting these 
programs, the Agency is tailoring its public participation process to 
be commensurate with the level of risk, extent of use, complexity of 
the issues, and degree of public concern associated with each 
pesticide. For glutaraldehyde, a modified, 4-Phase process with 1 
comment period and ample opportunity for public consultation seems 
appropriate in view of its refined risk assessment. However, if as a 
result of comments received during this comment period EPA finds that 
additional issues warranting further discussion are raised, the Agency 
may lengthen the process and include a second comment period, as 
needed.
    All comments should be submitted using the methods in ADDRESSES, 
and must be received by EPA on or before the closing date. Comments 
will become part of the Agency Docket for glutaraldehyde. Comments 
received after the close of the comment period will be marked ``late.'' 
EPA is not required to consider these late comments.

B. What is the Agency's Authority for Taking this Action?

    Section 4(g)(2) of FIFRA as amended directs that, after submission 
of all data concerning a pesticide active ingredient, ``the 
Administrator shall determine whether pesticides containing such active 
ingredient are eligible for reregistration,'' before calling in 
product-specific data on individual end-use products and either 
reregistering products or taking other ``appropriate regulatory 
action.''
    Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to 
review tolerances and exemptions for pesticide residues in effect as of 
August 2, 1996, to determine whether the tolerance or exemption meets 
the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review 
was completed by August 3, 2006.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: June 27, 2007.
Betty Shackleford,
Acting Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. E7-12996 Filed 7-5-07; 8:45 am]

BILLING CODE 6560-50-S