March 23, 2010

Steven Bradbury, Ph.D. Acting Director, Office of Pesticide Programs Environmental Protection Agency 2777 South Crystal Drive Arlington, VA 22202

Dear Dr. Bradbury:

Re: Request to Extend the Date for Compliance with the New Container Labeling Requirement by Amending 40 § CFR 156.159

The American Chemistry Council Biocides Panel (Panel) requests EPA’s Office of Pesticide Programs (OPP) to amend 40 CFR 156.159 to extend the date for compliance with the new labeling requirements fr om August 16, 2010 to August 16, 2012. As explained below, without action to extend the deadline, there will be a substantial interruption in the availability of needed antim icrobial pesticides, resulting in detrimental impact on public health, industria l production and the U.S. economy.

The Panel is composed of more than 50 companies that manufacture or formulate antimicrobial pesticides for use in industri al processes, material preservation, marine antifouling, industrial water treatment, public health applications and numerous other uses. A list of Panel member companies is attached (Attachment A). Many locations, processes and products offer ideal conditions fo r microbial growth that can lead to major health threats to people a nd animals or enormous economic losses or unpleasant and inhospitable ambient surroundings. Antimicrobi al pesticides are essential tools in controlling microorganisms in the inanimate envi ronment and in processes, to the benefit of human and animal health, and to th e benefit of economic welfare, resource conservation, and public safety. The benefits derived from their uses are incalculable.

The regulations promulgated by EPA on August 16, 2006 (71 FR 47329) and amended on October 29, 2008 (73 FR 64215) estab lish requirements for pesticide product container labeling, as well as for containe r and containment design standards. The regulations also set dates by which complia nce with each section is required. The

October 2008 amendment extend ed the original deadline from August 16, 2009 to August 16, 2010 for compliance with labeling requirements at 40 CFR 156 Subpart H. However, at the time that amendment was promulgate d, the full extent of the issues and the necessary level of effort by government agenci es at both the federal and state levels and by the regulated community was not fully recognized. As the August 16, 2010 deadline approaches, it has become clear that a signifi cant amount of work re mains, and there is no possibility that it will be completed in tim e to allow uninterrupted supply of necessary products to maintain public health and the U.S. economy.ACC Biocides Panel Request to Extend the Date for Compliance with the New Container Labeling Requirement March 23, 2010 Page 2 of 6

The August 16, 2010 Deadline is Not Attainab le for Many Antimicrobial Pesticides

Uncertainty Has Led to Serious Delays

The labeling language contained in 40 CFR Part 156 Subpart H was developed with a principal focus on agri cultural pesticides. The fi nal rule (71 FR 47330, August 16, 2006) provided generally applicable language. However, the wording in the regulations is inappropriate for many antimicrobial pes ticides. Registrants identified many issues and concerns regarding the original dead line of August 16, 2009, a nd a number of trade associations requested an ex tension of the compliance dead line for 3 years. (See, e.g., letter from The Panel, September 16, 2007 at EPA-HQ-OPP-2005-0327-0087 and letter from combined industry trade associa tions, October 29, 2007 at EPA-HQ-OPP-2005- 0327-0090). The Agency decided to grant a one year extension, and, on October 29, 2008 amended the regulations to a compliance date of August 16, 2010. It now is clear that, for many Panel member companies, th e one-year extension is insufficient. Notwithstanding good faith efforts by registrants, OPP and state authorities, there simply is not sufficient time to complete work on all the necessary la bel changes by August 10,

2010.

Many factors contribute to the need for an extension of the compliance deadline. Most importantly, the wording in 40 CF R 156 Subpart H, which can be used to implement label changes by Notification, is not applicable to a large number of antimicrobial pesticides. This means many label changes must be handled by amendments, a highly time consuming proce ss at both federal and state levels. In reviewing submissions for antimicrobial pe sticides, the Agency has identified many concerns with the label language that the regu lations suggest registra nts adopt. As just one example, standard rinsing instructi ons in the regulations at 40 CFR 156.146 for dilutable pesticides in nonref illable containers require incl uding wording that the rinsate be added to the application equipment. Howe ver, for pesticides for which instructions require a specific dilution procedure in order to obta in efficacy, following those

instructions would result in overdilution and a resulting adverse effect on performance. This is particularly relevant to many disinf ectants, where the concen tration of the active ingredient in the use dilution is essen tial to the efficacy against public health microorganisms. These issues were discusse d between the antimicr obial industry and the Agency in summer 2009 (see attached letters of June 30, 2009 (Attachment B), July 7, 2009 (Attachment C), and Agency letter of July 15, 2009 (Attachment D)), including further discussion in an Agency-l ed conference call on August 26, 2009.

For products registered by the Antimic robials Division, the amendment process and required statements have changed over time . Initially, labels submitted to EPA with the standard language were accepted. Th en, in mid 2009, labels submitted with the standard language were require d to adjust the container language. EPA’s view on what is considered appropriate language for antimicr obial products has evolved. At the presentACC Biocides Panel Request to Extend the Date for Compliance with the New Container Labeling Requirement March 23, 2010 Page 3 of 6

time, the issues of appropriate and releva nt wording for many antimicrobial product labels remain under discussion with the Ag ency. The lengthy period it is taking to resolve these issues has led to registrant unc ertainty as to what language OPP will accept.

Many antimicrobial registrants submitted a first set of label amendments which included only some of their products. Thes e registrants expected to apply the approved language to other registrations . Due to the issues desc ribed above, registrants are experiencing multiple review cycles and conseq uent delays in approvals. Thus, the label amendments for many registrations have been recently submitted or are yet to be submitted. Registrants and the Panel are working with the Agency to resolve these issues, but the fact remains that there is a significant amount of work yet to be done.

The Remaining OPP Workload Cannot be Completed Within a Timeframe That Will Allow Registrants to Meet the August 10, 2010 Deadline

To quantify the remaining task to be completed, the Biocides Panel surveyed its member companies in February and March 201 0. Twenty-six of the Panel’s 53 member companies have responded. This partial snap shot of the current status of completion indicates that, as of Marc h 1, the responding companies have the following actions

associated with container labe ling revisions pending at EPA:

Number as notification for container labeling: 93 Number as amendment for container labeling only: 62

Number as amendment for contai ner labeling plus other: 118

Total number: 273

In addition, as a result of the issues re lated to acceptable wording, the responding Panel members report that they have yet to submit an additional 234 registration actions to address container labeling. Of those 234, 99 are expected to be submitted as notifications, with 135 that must be submitted as amendments. Registrants expect these to be submitted by the end of March.

Therefore, EPA has yet to address a total of 507 registrations for container labeling just from the responding members. With all of these pending and soon-to-be submitted registrations, it is unlikely that EPA and states could complete these registrations, and production labels put into place in time to meet the August 16, 2010

deadline.ACC Biocides Panel Request to Extend the Date for Compliance with the New Container Labeling Requirement March 23, 2010 Page 4 of 6

The State Workload is Another Source of Delay

Once EPA has accepted the label revisions that still are pending or yet to be submitted, registrants must then obtain state approvals prior to sale. Submissions to the states cannot be made until EPA acceptance is received.

While EPA approves one master label for a pesticide product, states separately approve each marketing label and supplemental distributor label. The 273 labels from responding Panel members currently pending at EPA are marketed under 3,186 separate labels. Each of these separate labels must be individually registered in all states with registration programs, the Dist rict of Columbia and severa l territories. Panel members responding to the survey report that they currently have 2,068 labels with revised container language pending at the state level. When added to the labels yet to be approved by EPA, the 26 responding comp anies will require a total of over 5,200 individual labels with amended language st ill to be approved at the state level.

While certain states can and do approve amendments relati vely quickly, many require significant amounts of time. Becau se of the volume of approvals needed, the prevalence of state staff furlough days, and sta ffing reductions in state agencies, the Panel has been informed by key states that it is likely to take be tween 9 and 15 months to get all labels through at the state level 1

.

These estimates assume states will accep t labels with the language approved by OPP. However, at times, states demand ch anges in EPA-approved label language. Any such cycles to address state-requested amendments will extend the necessary time for final approval. An additional complication is that some states ha ve “blackout” periods when they will not review any labels during their annual renewal period. For example, Massachusetts has a blackout pe riod from April through June.

Registrants cannot sensibly produce produc ts that comply with the new label requirements until they have obtained approval in all states where they intend to sell. While a company in theory could produce labe ls while state registrations are in-process, this can become a costly and time-consuming error if even one state requires a label change affecting the container language or any other label provision. If a state requires a label change, a registrant would then need to return to EPA and all other states. In addition, the logistics of printi ng new labels and/or directly printing on containers require some time. Registrants that do not have thei r state approvals now, or possibly in the very near future, will be in very di fficult situations to have labels physically available to meet the August 16, 2010 deadline.

1 Impacts at the state level were confir med with NY Department of Environmental Quality (Ms. P. McBath) on March 10, 2010 and with CA Department of Pesticide Regulation (Ms. A. Prichard) on March 15, 2010.ACC Biocides Panel Request to Extend the Date for Compliance with the New Container Labeling Requirement March 23, 2010 Page 5 of 6

An Amendment to Extend the Compliance Deadline is Needed to Avoid Loss of

Products Critical to Pub lic Health and the Economy

There is No Work Around Available

The regulations state that no product can be produced or released for shipment after August 16, 2010 without the required cont ainer labeling language. If there is no extension, registrants’ only potential solution is to manufact ure, package and “release for shipment,” prior to August 16, adequate produ ct to meet demand until product with new, compliant, labels are available. The Panel believ es this could take as much as 24 months. To manufacture, package and store sufficient pr oduct to cover such a period is simply infeasible. The Panel asked its survey respondents to quantify the volume of product necessary to meet demand for one year. Of the 19 Panel members who could make such estimates, the number of containers that would have to be produced, released for shipment, and then warehoused to allow for a year of inventory is nearly 212 million containers. It is not possible for the responding members to produce and store this volume of product due to the cost, insuffici ent production capacity, limited appropriate storage availability, and, for so me products that have expira tion dates, excessive holding times. This number represents a small fracti on of the total producti on and inventory that would be required. In addition, based upon th e volume of approvals remaining at EPA and the states, another full year of inve ntory may be necessary to avoid a supply disruption. Therefore, there is no way to avoi d product supply disruptio ns if an extension is not granted.

An Extension is Necessary to Avert Serious Public Health and Economic Consequences

Antimicrobial pesticides are essential to protect public health and maintain industrial production. A severe interruption in the availability of antimicrobial products is certain to occur unless the compliance deadline is extended. This will have a devastating impact on the availabi lity of products to protect public health, and to protect industrial processes and articles from microbial attack. Thes e impacts will have serious negative effect across th e nation’s economy.

Antimicrobial pesticides used to miti gate the growth of human pathogenic microorganisms are regulated as public health pe sticides. Public hea lth antimicrobial use sites include food processing pl ants, dairies, breweries, poul try houses and other animal feeding operations, hospitals a nd medical and dental clinic s and offices, human drinking water and drinking water treatment faciliti es, swimming pools and spas, schools, day care centers, public access fa cilities and homes.

Industrial, non-public healt h, antimicrobial pesticide us es are essential to the

economic health of an industrialized soci ety, including extending the in-use life ofACC Biocides Panel Request to Extend the Date for Compliance with the New Container Labeling Requirement March 23, 2010 Page 6 of 6

manufactured goods and other products, pr otecting equipment used in industrial processing and manufacturing systems and pr eserving energy efficiency in numerous systems and operations. Antimicrobials also are used to maintain quality of life by mitigating microorganism growth that causes o dors, visual contamination resulting from mold and mildew growth and other mi crobiologically induced contamination.

The Panel believes that the information received from its members is only one small part of the picture. There are ma ny registrants who are not Panel members who likely are in a similarly dire situation. The Panel recogni zes that OPP and registrants have been working diligently to resolve the issues raised by the requirement to revise labels, as have state agencies. Neverthele ss, an extension is necessary to ensure uninterrupted supply of these critical products. Without a prompt extension, registrants will need to take immediate steps toward s ramped up production and securing storage space. Therefore, the Panel urgently request s the Agency to amend the regulations to extend the deadline for compliance to August 16, 2012.

* * * * *

If you require additional informati on, please contact me at 703-741-5637 or hasmukh_shah@americanchemistry.com

.

Sincerely,

Hasmukh Shah, Ph.D. Manager, Biocides Panel

Cc: Bill Diamond Kevin Keaney Nancy Fitz Joan Harrigan-Farrelly

AttachmentsATTACHMENT A

*Affiliate Member American Chemistry Council

Biocides Panel Member Companies

March 23, 2010

AEGIS Environments JohnsonDiversey Inc.

AkzoNobel Chemicals Inc. Kemira Chemicals, Inc.
Albemarle Corporation LANXESS Corporation
American Chemet Corporation Lonza Inc.
Arch Chemicals, Inc. Lubrizol Corporation
Arkema Inc. Mason Chemical Company
Ashland Chemical Merichem Chemicals and Refinery Services
Bardyke Chemicals Ltd Microban International, Ltd.
BASF Corporation Milliken Chemical
Buckeye International, Inc. Nalco Company

Buckman Laboratories Nordox AS

BWA Water Additives Osmose, Inc.
Champion Technologies, Inc. PPG Industries Inc.
Chemtura Peninsula Copper Industries
Clariant Corporation Procter and Gamble Company
Clorox Company Reckitt Benckiser Inc.
Dial Corporation Rhodia Inc.

Dow Chemical SC Johnson & Son, Inc.

DuPont SCM Metal Products, Inc.
Ecolab Inc. Scientific & Regulatory Consultants, Inc.*
Elementis Chromium LP Sostram Corporation
Enviro Tech Chemical Services, Inc. Stepan Company
FMC Corporation 3M
GE Betz, Inc. Technology Sciences Group Inc.*
International Specialty Products Thor Specialties, Inc.
ISK Biocides, Inc. Troy Chemical Corporation

ICL North America Verichem

Janssen PMP Viance, LLCATTACHMENT B

June 30, 2009

Nancy Fitz Environmental Protection Agency Ariel Rios Building 1200 Pennsylvania Avenue, N. W.

Mail Code: 7506P Washington, DC 20460

RE: Label Changes through Notification to Comply w ith Container Regulations

Dear Nancy:

I am writing to follow up to our conversation of June 9, 2009, regarding issues and concerns associated with labeling changes to meet the requirements of the container regulations. The Biocides Panel has actively pursued unders tanding EPA’s container regulations and their implementation over last several years. The Pane l has diligently worked with EPA to ensure all members are aware of their compliance obligations and provided a vehicle for our members to raise questions and seek clar ifications about regulations.

In our telephone conversation Elizabeth Brown and I advised you of a situation that has arisen for a member company and seek your guidan ce in addressing the situ ation in a transparent manner across the OPP. As I mentioned, one Panel member recently contacted me to explain

that a notification submitted in full accordance with container regulations and with PR Notice 2007-4 was rejected. The reason fo r the rejection was not a defi ciency in the notification. Instead, the letter received by th e member required the registrant to insert language that differed from that in the regulation and in PRN 2007-4. Th ere is no rationale in th e letter for this new requirement other than a general statement in the transmittal e-mail from the product manager that the language specified in the PR Notice is not appropriate for antimicrobial products.

I am writing to ask you to look into this situation and provide assurance that the regulations and PR Notice remain in effect. Pane l members must be able to rely on EPA-issued guidance to comply with container regulations . Regulations, including the specific language, were issued through a formal rulemaking process th at spanned several year s. The label language was reiterated in PR Notice 2007-4, which esta blished the notificati on option. Container regulations are still in force and, of course, can only be al tered through another notice and comment process. With the August 2010 deadline fast approaching, both EPA and registrants have a strong interest in the orderly compliance process establ ished by the regulations and PR Notice 2007-4. For these reasons, I hope you will be able to confirm that the Panel member that received the letter, and all othe r registrants, can continue to rely upon EPA’s regulations and published guidance.Nancy Fitz, USEPA Container Label Changes through Notification
June 30, 2009 Page 2 of 2

If EPA takes any position other than that the regulations and PR Notice remain in effect for all antimicrobials, there may well be very serious implications for the pr ogram. In that event, I would appreciate receiving a detailed explanatio n of the Agency’s position as promptly as possible, including the Agency’s view as to how it plans to provide guidance to all registrants. Once the Panel has an opportunity to review an y new EPA position, the Pane l will contact you to discuss the situation. It is likely that we will be compelled to raise any effort to change the substance of required language or the proce ss with OPP upper management, as our members have planned to rely on the current regulations and guidance, and simply may not be able to comply with new procedures at this late date.

Thank you for looking into this situation, and I look forward to your response. Please feel free to call me at 703-741-5637, if you have any questions or need additional information.

Sincerely,

Hasmukh Shah Manager, Biocides Panel

Cc: Jeanne Kasai Joan Harrigan-Farrelly Betty Shackleford

Dennis EdwardsATTACHMENT C

July 7, 2009

Nancy Fitz Environmental Protection Agency 1200 Pennsylvania Avenue, N. W.

Mail Code: 7506P Washington, DC 20460

Re: Practical Implications of New Antim icrobial Container Labeling Wording being Considered by the Antimicrobials Division

Dear Nancy:

This is a follow up to our conversation of June 9, 2009 and my letter of June 30, 2009, regarding issues and concerns associated with labeling changes to meet the requirements of the container regulations. I am writing again to em phasize the practical imp lications of the new policy that apparently is being implemente d by the Antimicrobials Division (AD), which, without any opportunity for input from outside the Agency, re quires registrants to use ADdeveloped language in place of that specified in the regulations or wording developed by registrants specifically for their products. Wh ether or not the AD-deve loped language is an improvement over the language spec ified in EPA’s regulations, th e policy, if implemented, will create a number of practical problems and inequities.

Most importantly, as explained in my June 29, 2009 correspondence, by compelling registrants to submit amendments, AD will make it difficult and probably impossible for some registrants to meet the EPA established dead line for compliance, August 10, 2010. Although the deadline is about a year away, the additional time required for amendment review and possibility of addressing issues arising in that process co mbined with the time for state approval, and with the logistics of printing containe r labels, will make compliance a challenge. This is a very serious issue, as many registra nts relied upon the regulations and process publicly established by EPA and planned to proceed by notification. They now will be disadvantaged by relying upon EPA’s binding regulations and official guidan ce and forcing them in to regulatory noncompliance at no fault of their own.

It also is important to recognize that AD seems to be planning to replace language developed through a rule-making process that sp anned over a decade and reiterated in 2007, with language it developed internally only recently. Th is presents a number of fairness issues. AD’s new policy would penalize registrants that ha ve recently submitted or would newly submit notifications over past submitters. This does not treat all registrants equally. Similarly, the issues raised by AD are not specific to antimicrobi al pesticides but would be equally applicable to many products sold in small size containers regulated by other OPP Divisions. AD acting alone will create a non-unified approach across the OPP.Nancy Fitz, USEPA Container Label Changes through Notification July 7, 2009 Page 2 of 2

Finally, the label statements developed by EPA through the rulemaking process have the benefit of extensive public inpu t. While AD’s new statements may be viewed by some as an improvement, they have not been subject to any sort of review outside the Agency, and may have received only limited review outside of AD. This certainly is not the fa ir, transparent and open process EPA is committed to. Similarly, the new requirements are not broadly available. They are not in the CFR, not on EPA’s we b site and have not been included in a PR Notice. In light of the short time frame remaining for regulatory compliance, including ge tting state approvals, AD’s new policy may force registrants in to non- compliance. The Biocides Panel submits that

these concerns should be disc ussed and addressed by EPA prio r to the Agency imposing new wording on registrants who are working to comp ly with the requireme nts of the container regulations.

The Panel is willing to work with the Agency on a path forward for future improvements in the container labeling language without forcing registrants in to non-compliance at no fault of their own. The current regulations are the law for both EPA and regi strants, and time is of the essence for registrants to comply with them. I look forward to your response concerning how the Agency will proceed. I would appreciate receiv ing your response to these issues by Friday, July 17. I need to communicate the final Agency decision on container la beling language to my member companies as soon as possible.

Thank you for looking into this situation, and I look forward to your response. Please feel free to call me at 703-741-5637, if you have any questions or need additional information.

Sincerely,

Hasmukh Shah Manager, Biocides Panel

Cc: Jeanne Kasai Joan Harrigan-Farrelly Betty Shackleford

Dennis EdwardsATTACHMENT C