Document ID: EPA-HQ-OPP-2005-0327-0113
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-06-15T04:00Z

March 22, 2010

Mr. Steven Bradbury, Acting Director

Office of Pesticide Programs

Environmental Protection Agency

One Potomac Yard

2777 South Crystal Dr.

Arlington, VA  22202

Subject:	Request for Container Rule Extension 

Dear Mr. Bradbury,

We are requesting an extension to the Container Rule (73 FR 64215) at
this time as we feel the August 16, 2010 deadline is not attainable for
our Antimicrobial products. 

Mason Chemical Company is a leading quaternary manufacturer, whose
antimicrobial actives are used in public health and non-public health
products. We are dedicated to putting forth superior EPA registered
products that are consistently efficacious against a variety of public
health and non-public health organisms. We have over 180 master labels,
with over 1500 distributor labels registered across all 50 states.

Antimicrobials have an increasingly important presence in our society.
They are used to mitigate the growth of human pathogenic microorganisms
are regulated as public health pesticides. The public health
antimicrobial use sites shown on our labels include food processing
plants, dairies, breweries, poultry houses and other animal feeding
operations, hospitals and medical and dental clinics and offices,
drinking water treatment facilities, schools, day care centers, public
access facilities and homes.

Non-public health antimicrobial pesticide uses are essential to the
economic health of an industrialized society, including extending the
in-use life of manufactured goods and other products, protecting
equipment used in industrial processing and manufacturing systems and
preserving energy efficiency in numerous systems and operations. 
Finally, antimicrobials 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. Our labels contains both of these types of claims
as well.

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 regulation also sets 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.
However, at the time the amendment was publicized, the full extent of
the issues and effort at both the federal and state levels was unclear.
As the August 16, 2010 deadline quickly 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
products.

When the labeling language contained in 40 CFR Part 156 Subpart H was
developed, it was initially considered not to be inclusive of
antimicrobial pesticides. However, with the issuance of the final rule
(71 FR 47330, August 16, 2006), it was determined that antimicrobials
were to be included and so revised language was made available.
Unfortunately, the wording on container handling specified in the
regulations for antimicrobial pesticides was not well understood or
addressed. Nor, it appears, was the proposed language vetted by the
Antimicrobial Division of The Agency. The potential issues and concerns
regarding the original deadline of August 16, 2009 were identified in
letters from industry groups where a 3 year extension was requested (see
letters from the Biocides Panel, September 16, 2007 at
EPA-HQ-OPP-2005-0327-0087 and from combined industry trades, October 29,
2007 at EPA-HQ-OPP-2005-0327-0090). 

 

 

While Mason Chemical Company supported the request and agreement of the
one year extension given to the industry in 2008, we now believe this
timeline is unrealistic and feel we are not going to be able to meet
deadline as it appears insufficient for both federal and state
authorities to complete the necessary approval processes for our
antimicrobial pesticides.

The reasons provided in the industry’s October 2007 request for a 3
year extension remain valid because of the following reasons:

1)  The wording in 40 CFR 156 Subpart H is not usable in a large number
of cases.  Neither Agency guidance in the Label Review Manual (Chapter
13, October 2008 version) nor PR 2007-4 (issued October 29, 2007,
revised April 29, 2008) is consistent with the final regulations.  In
reviewing submissions for antimicrobial pesticides, the Agency has
identified many concerns that the language in the regulations and
guidance was inappropriate, including different container handling and
rinsate required statements.  These issues were discussed between the
antimicrobial industry and the Agency in summer 2009 (see attached
letters June 30, 2009, July 7, 2009, and Agency letter of July 15,
2009), including further discussion in an Agency-led conference call on
August 26, 2009.  At the present time, the issues of appropriate and
relevant wording for antimicrobial products remains under discussion
with the Agency and still has not been fully resolved.

2)  Due to the difference in required statements between the actual
Container Rule and the Antimicrobial Division at EPA, we must now rely
more on the amendment process rather than the notification process as
described in The Rule to effect the required changes.  Because of this
process difference, we have endured multiple cycles of submissions
needed to address the additional and changed language, thus spreading
the timeline to over 18 months for compliance. 

Some Mason examples of submitted language and timeline issues include:

When first submitted, we used the required language as a notification as
per The Rule. However, AD determined the rinsate statement was not
applicable to antimicrobials and thus, denied our products and returned
them. Because of this change, our products were no longer allowed to be
reviewed as notifications.

Next, we submitted our labels as amendments with the AD preferred
rinsate statements and included refillable language. However, The Agency
then determined our products were not used in refillable containers and
so denied and returned our products again.

We have worked with The Agency on the refillable container issue and
thus resubmitted our labels. Some of them are now being approved, but a
majority of these submissions are still in the review process, with our
hope that we receive them all by May 1st.

Though we started submitting our labels in October 2008 in order to
comply with The Rule, after 3 rounds of submissions, we still have a
number of product labels in the federal review process. In addition,
because of the first two rounds of submission denials, we had delayed
submitting the remainder of our labels until we received approvals with
the necessary language as we needed to confirm language approval by The
Agency before sending the in.

While trying to comply with the issues raised by AD and waiting for our
submissions to be reviewed and accepted have delayed our label
compliance, submission to the states for their approval remains our
biggest obstacle. Not only do we have our own master labels but we are
also responsible for our supplemental distributor labels as well. As
stated above, this count is well over 1500 distributor labels. Of
course, we cannot start the state process before we get EPA approval -
then we have to wait for the states to approve our master labels before
we can start our supplemental compliance process. While most states do
not have a full review process and, therefore, take a shorter amount of
time to review the EPA approved labels, some states, such as California
and New York, take an exceedingly longer review time due to their
practice of reviewing all claims and statements on each and every label
submitted for their approval. This can take anywhere from 3 to 18
months. 

 

 

In addition to the initial review time at the state level, quite often
the state will not agree with EPA approved claims and statements on our
labels and will require changes to be made in order for registration to
take place in their state. In order to comply with the states, we then
must resubmit these same labels to The Agency, thus prolonging the
timeline even further. The Biocides Panel contacted two states (NY and
CA) who indicated that because of the volume of total industry labels
and staffing cutbacks, it could take between 9 and 15 months for any one
review to get through their system. That is just for one label
submission and does not include the time required to go back and obtain
EPA approval for additional changes that states can and do require
before approval at their level. 

In addition, we and our supplemental registrants cannot produce product
until we have obtained approval in all states where we intend to sell.
Because the regulations state that no product can be produced or
released for shipment after August 16, 2010 without including the
required container labeling language, the only option currently open to
our supplemental distributors is to produce product using labeling
currently approved at the state level, release that product for shipment
and then hold it in warehouses.  However, the enormous scope of
production that would be required makes this an untenable option as well
as a logistical and economic nightmare with inconsistent labels and/or
having to segregate certain products depending on their individual state
registration status. Though we cannot fully estimate how many individual
containers this might affect, we do know it would be enormously
expensive to store those containers and it is unlikely we could find the
appropriate amount of space for storage.

Mason Chemical Company, along with the industry, continues to work with
the Agency to resolve these issues, but the fact remains that there is a
significant amount of work yet to be done.  Because of the issues
related to appropriate wording, we are just now submitting our final
products to comply with this rule and therefore, do not believe we will
receive these back until almost August – which will not leave us time
to submit and receive approvals from the states for our labels as well
as our supplemental labels.

Due to time constraints, inconsistencies in interpretations without
clear guidance, and continued requirements for language that is neither
relevant nor practical as well as attempts to use the standardized
language despite any explanation of why other language is necessary, we
are now unable to comply with the deadline of The Rule. We hope that you
will carefully consider our request after reading this letter and allow
us to have an extension to this rule so that we are able to fully comply
with all of our labels. 

Thank you taking time to consider this request. If you have any
questions or would like to discuss this further, please feel free to
contact me at 800-362-1855 or   HYPERLINK "mailto:liz@maquat.com" 
liz@maquat.com .

Sincerely,

MASON CHEMICAL COMPANY

Elizabeth Tannehill