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 from 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 antimicrobial pesticides, resulting in detrimental 

impact on public health, industrial production and the U.S. economy. 

The Panel is composed of more than 50 companies that manufacture or formulate 

antimicrobial pesticides for use in industrial 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 for microbial growth that can lead to major 

health threats to people and animals or enormous economic losses or unpleasant and 

inhospitable ambient surroundings. Antimicrobial pesticides are essential tools in 

controlling microorganisms in the inanimate environment and in processes, to the benefit 

of human and animal health, and to the 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) establish requirements for pesticide product 

container labeling, as well as for container and containment design standards. The 

regulations also set dates by which compliance with each section is required. The 

October 2008 amendment extended 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 promulgated, the full extent of the issues and the 

necessary level of effort by government agencies 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 significant amount of work remains, and there is 

no possibility that it will be completed in time 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 Attainable 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 agricultural pesticides. The final rule (71 FR 47330, August 16, 

2006) provided generally applicable language. However, the wording in the regulations 

is inappropriate for many antimicrobial pesticides. Registrants identified many issues 

and concerns regarding the original deadline of August 16, 2009, and a number of trade 

associations requested an extension of the compliance deadline 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 associations, 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, the 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 label changes by August 10, 

2010. 

Many factors contribute to the need for an extension of the compliance deadline. 

Most importantly, the wording in 40 CFR 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 process at both federal and state levels. In 

reviewing submissions for antimicrobial pesticides, the Agency has identified many 

concerns with the label language that the regulations suggest registrants adopt. As just 

one example, standard rinsing instructions in the regulations at 40 CFR 156.146 for 

dilutable pesticides in nonrefillable containers require including wording that the rinsate 

be added to the application equipment. However, for pesticides for which instructions 

require a specific dilution procedure in order to obtain efficacy, following those 

instructions would result in overdilution and a resulting adverse effect on performance. 

This is particularly relevant to many disinfectants, where the concentration of the active 

ingredient in the use dilution is essential to the efficacy against public health 

microorganisms. These issues were discussed between the antimicrobial 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-led conference call on August 26, 2009. 

For products registered by the Antimicrobials Division, the amendment process 

and required statements have changed over time. Initially, labels submitted to EPA with 

the standard language were accepted. Then, in mid 2009, labels submitted with the 

standard language were required to adjust the container language. EPA’s view on what is 

considered appropriate language for antimicrobial products has evolved. At the present 
ACC 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 relevant wording for many antimicrobial product 

labels remain under discussion with the Agency. The lengthy period it is taking to 

resolve these issues has led to registrant uncertainty as to what language OPP will accept. 

Many antimicrobial registrants submitted a first set of label amendments which 

included only some of their products. These registrants expected to apply the approved 

language to other registrations. Due to the issues described above, registrants are 

experiencing multiple review cycles and consequent 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 2010. Twenty-six of the Panel’s 53 member 

companies have responded. This partial snapshot of the current status of completion 

indicates that, as of March 1, the responding companies have the following actions 

associated with container labeling revisions pending at EPA: 

Number as notification for container labeling: 93 

Number as amendment for container labeling only: 62 

Number as amendment for container labeling plus other: 118 

Total number: 273 

In addition, as a result of the issues related 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 District of Columbia and several 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 companies will require a total of over 5,200

individual labels with amended language still to be approved at the state level. 

While certain states can and do approve amendments relatively quickly, many 

require significant amounts of time. Because of the volume of approvals needed, the 

prevalence of state staff furlough days, and staffing reductions in state agencies, the Panel 

has been informed by key states that it is likely to take between 9 and 15 months to get all 

labels through at the state level1. 

These estimates assume states will accept labels with the language approved by 

OPP. However, at times, states demand changes 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 have “blackout” periods 

when they will not review any labels during their annual renewal period. For example, 

Massachusetts has a blackout period from April through June. 

Registrants cannot sensibly produce products 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 labels 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 printing new labels and/or directly printing on containers require 

some time. Registrants that do not have their state approvals now, or possibly in the very 

near future, will be in very difficult situations to have labels physically available to meet 

the August 16, 2010 deadline. 

 1

 Impacts at the state level were confirmed 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 Public 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 container labeling language. If there is no 

extension, registrants’ only potential solution is to manufacture, package and “release for 

shipment,” prior to August 16, adequate product to meet demand until product with new, 

compliant, labels are available. The Panel believes this could take as much as 24 months. 

To manufacture, package and store sufficient product 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, insufficient production capacity, limited appropriate 

storage availability, and, for some products that have expiration dates, excessive holding 

times. This number represents a small fraction of the total production and inventory that 

would be required. In addition, based upon the volume of approvals remaining at EPA 

and the states, another full year of inventory may be necessary to avoid a supply 

disruption. Therefore, there is no way to avoid product supply disruptions 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 availability of products to protect public health, and to protect 

industrial processes and articles from microbial attack. These impacts will have serious 

negative effect across the nation’s economy. 

Antimicrobial pesticides used to mitigate the growth of human pathogenic 

microorganisms are regulated as public health pesticides. Public health antimicrobial use 

sites include food processing plants, dairies, breweries, poultry houses and other animal 

feeding operations, hospitals and medical and dental clinics and offices, human drinking 

water and drinking water treatment facilities, swimming pools and spas, schools, day care 

centers, public access facilities and homes. 

Industrial, non-public health, antimicrobial pesticide uses are essential to the 

economic health of an industrialized society, including extending the in-use life of 
ACC 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, protecting equipment used in industrial 

processing and manufacturing systems and preserving energy efficiency in numerous 

systems and operations. Antimicrobials also are used to maintain quality of life by 

mitigating microorganism growth that causes odors, visual contamination resulting from 

mold and mildew growth and other microbiologically induced contamination. 

The Panel believes that the information received from its members is only one 

small part of the picture. There are many registrants who are not Panel members who 

likely are in a similarly dire situation. The Panel recognizes that OPP and registrants 

have been working diligently to resolve the issues raised by the requirement to revise 

labels, as have state agencies. Nevertheless, an extension is necessary to ensure 

uninterrupted supply of these critical products. Without a prompt extension, registrants 

will need to take immediate steps towards ramped up production and securing storage 

space. Therefore, the Panel urgently requests the Agency to amend the regulations to 

extend the deadline for compliance to August 16, 2012. 

* * * * * 

If you require additional information, 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 

Attachments 
ATTACHMENT 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, LLC 
ATTACHMENT 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 with 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 understanding EPA’s container regulations and their 

implementation over last several years. The Panel 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 clarifications 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 guidance in addressing the situation 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 for the rejection was not a deficiency in the notification. 

Instead, the letter received by the member required the registrant to insert language that differed 

from that in the regulation and in PRN 2007-4. There is no rationale in the 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. Panel 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 that spanned several years. The label language 

was reiterated in PR Notice 2007-4, which established the notification option. Container 

regulations are still in force and, of course, can only be altered 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 established 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 other 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 program. In that event, 

I would appreciate receiving a detailed explanation 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 any new EPA position, the Panel 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 process 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 Edwards 
ATTACHMENT 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 Antimicrobial 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 emphasize the practical implications of the new 

policy that apparently is being implemented by the Antimicrobials Division (AD), which, 

without any opportunity for input from outside the Agency, requires registrants to use ADdeveloped language in place of that specified in the regulations or wording developed by 

registrants specifically for their products. Whether or not the AD-developed language is an 

improvement over the language specified in EPA’s regulations, the 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 deadline 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 combined with the time for state approval, and with 

the logistics of printing container labels, will make compliance a challenge. This is a very 

serious issue, as many registrants 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 guidance 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 spanned over a decade and reiterated in 2007, with 

language it developed internally only recently. This presents a number of fairness issues. AD’s 

new policy would penalize registrants that have 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 antimicrobial 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 input. 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 fair, 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 web site and have not been included in a PR Notice. In light of 

the short time frame remaining for regulatory compliance, including getting state approvals, 

AD’s new policy may force registrants in to non-compliance. The Biocides Panel submits that 

these concerns should be discussed and addressed by EPA prior to the Agency imposing new 

wording on registrants who are working to comply with the requirements 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 registrants, 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 receiving your response to these issues by Friday, July 

17. I need to communicate the final Agency decision on container labeling 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 Edwards 
ATTACHMENT C