						

					

	

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF PREVENTION,

 PESTICIDES AND

TOXIC SUBSTANCES

MEMORANDUM

DATE:		June 18, 2008

SUBJECT:	Alkyl Amine Hydrochloride:  EPA Response to Public Comments on
Preliminary Work Plan (PWP).  PC Code 069152, Case No. 3051 

FROM:	Heather Garvie, Chemical Review Manager

		Regulatory Management Branch II

		Antimicrobials Division (7510P)

THRU:		Mark Hartman, Branch Chief

		Diane Isbell, Team Leader

		Regulatory Management Branch II

		Antimicrobials Division (7510P)

        

The Agency received one comment during the 90-day public comment period
for the Registration Review Preliminary Work Plan (PWP) for Alkyl Amine
Hydrochloride.  The full comment can be found on the alkyl amine
hydrochloride docket at:    HYPERLINK "http://www.regulations.gov" 
www.regulations.gov ; docket ID:  EPA-HQ-OPP-2007-1039.  The comment was
submitted by the American Chemistry Council (ACC) in a document dated
March 11, 2008.  In summary, the comment states that the Agency has used
a Registration Review Summary document to impose a new generic data
requirement (90-day subchronic inhalation study) which ACC feels is
inconsistent with current regulations.  An excerpt from page 3 of the
ACC comment reads as follows:

“The registration review process cannot be used as a vehicle for
rulemaking. Yet this document plainly asserts that the Agency is
changing the data needed to support registrations for all material
preservatives. The language above stands in contrast to the current
regulation – which is legally binding on EPA – which specifies that
an inhalation toxicology study is: 

Required if use may result in repeated inhalation exposure at a
concentration which is likely to be toxic. 40 CFR 161.340(6). 

A review of EPA’s updated toxicity data requirements for conventional
pesticides provides a concurring but somewhat more comprehensive
description of the conditions appropriate to this requirement. 

Required if there is the likelihood of significant repeated inhalation
exposure to the pesticide as a gas, vapor, or aerosol. 

40 CFR 158.500(e)(14). Further, the new requirement imposed in the
Registration Review summary document is inconsistent with the Agency’s
clear technical guidance as identified by EPA/OPP/HED SOP 2002.01 (Aug
15, 2002). That guidance, while designed to explain where waivers for
subchronic inhalation toxicity studies may be appropriate, identifies
that consideration first must be given to whether there is potential for
significant human inhalation hazard and then identifies circumstances in
which such potential is minimal or when testing otherwise would be
inappropriate. That guidance identifies, for example, that it would be
inappropriate to conduct subchronic inhalation toxicity studies on
products that are non-volatile or otherwise not made inhalable.” 

The Agency Response is as follows:

	The Agency anticipates that additional toxicity and exposure data will
be needed for the registration review of alkyl amine hydrochloride.  In
addition, the EPA anticipates that an occupational and residential
handler assessment will need to be conducted for the dermal and
inhalation routes of exposure, since no specific quantitative
occupational or residential risk assessments are currently available for
alkyl amine hydrochloride.  The Agency believes that it needs to conduct
risk assessments to ensure that the alkyl amine hydrochloride
registration review case meets the registration and safety standards
established by FIFRA, as amended by FQPA and the Federal Food, Drug and
Cosmetic Act (FFDCA).

	The Agency acknowledges that the registration review process is not a
vehicle for rulemaking and the Agency is not attempting to institute a
new data requirement generically for material preservatives.  The Agency
recognizes that the specific wording in the PWP to which ACC points (The
following language appears in the PWP under the Risk Assessment Status &
Anticipated Risk Assessment and Data Needs: “At this time the Agency
anticipates that short- and intermediate-term dermal occupational
assessments as well as an inhalation assessment will be needed to assess
exposure for open situations in manufacturing settings for all material
preservative uses.”) may have been confusing and the Agency has
changed that language in the Final Work Plan (FWP) under the Risk
Assessment and Data Needs section to clarify that the data needs
identified in the PWP are specific to the active ingredient, alkyl amine
hydrochloride.  Additionally, ACC stated its belief that the Agency
imposed the data requirement in the PWP.  That did not occur.  In the
PWP, the Agency stated what it knows about that particular antimicrobial
pesticide and what additional risk analyses and data or information it
believes are needed to make a registration review decision.  The Agency
will comply with both FIFRA and its Registration Review regulations in
imposing any data requirements for Registration Review.

	Alkyl amine hydrochloride is an antimicrobial pesticide used for
material preservative use sites such as: resins, paints, adhesives,
printing inks and dispersed colors, caulks, spackling, joint cements,
sealants, grouts, and wallboard compounds.  In manufacturing situations,
occupational handlers are expected to be exposed via the dermal and
inhalation exposure route to alkyl amine hydrochloride.  In the 1992 RED
issued for alkyl amine hydrochloride, the Agency concluded that when the
pesticide was used with Personal Protective Equipment (PPE) as directed
by the label, the occupational risks to alkyl amine hydrochloride would
be minimal.  Since the 1992 RED, the Agency identified new exposure
databases (PHED and CMA) that have more adequately characterized
specific antimicrobial exposures (e.g. paint).  The Agency has found
that for certain antimicrobial chemical product exposures, such as
paint, that there may be risk concerns to both occupational and
residential handlers even when PPE label restrictions are imposed. 
Therefore, the Agency needs to quantitatively assess risk.  

	The inhalation exposure assessment can not be assessed at this time due
to a lack of 90-day inhalation toxicity data.  The 90-day inhalation
toxicity study for alkyl amine hydrochloride is needed based on the
observed toxicity of the chemical from the available data and the lack
of hazard characterization by the inhalation route.  When toxicity is
observed with a pesticide chemical but there are no data to assess risk
from a major route of exposure (in this case, inhalation exposure to
breathable particles from airless spraying), a study by that route of
exposure is generally needed.  Although the chemical has a low vapor
pressure, that alone does not mitigate the need for testing for exposure
to aerosols of the chemical unless it can be demonstrated (per the HED
SOP 2002.01) that the aerosol is essentially non-inhalable (i.e. that >
99% of the particles are > 100 microns in diameter). In addition,
because alkyl amine hydrochloride can be used in both residential and
occupational settings in airless spraying applications, there is the
likelihood of significant repeated inhalation exposure.  

	Under the authority of FIFRA Section 3(c)(2)(B), the Agency can require
data it deems necessary to support a pesticide registration.   FIFRA
Sections 3(g)(2)(A) and (B) direct the Agency to use FIFRA Section
3(c)(2)(B) Data Call-In (DCI) authority to require any data necessary
for a registration review.  The Agency’s Registration Review
regulations at 40 CFR Part 155.40 et seq. include provisions regarding
the use of FIFRA Section 3(c)(2)(B) to obtain data necessary for
registration review.  

40 CFR Parts 158 and 161 also specify the types and minimum amounts of
data and information that an applicant for registration, amended
registration or reregistration must submit or cite in support of such an
application.  A 90-day subchronic inhalation test is required if the use
may result in repeated inhalation exposure at a concentration likely to
be toxic (See 40 CFR 158.500 and 40 CFR 161.340).  In addition, 40 CFR
Part 158 and Part 161 state that the Agency has the authority to require
any additional data it deems necessary in order to sufficiently evaluate
the potential of the product to cause unreasonable adverse effects on
man or the environment (See 40 CFR 158.75 and 40 CFR 161.75(a)).  

The PWP for alkyl amine hydrochloride does not impose any additional
data on the registrants, rather it lays out the exposure scenarios for
this particular active ingredient and states why the Agency believes
that certain data are needed in order to assess the risks associated
with the use of this chemical as an active ingredient in antimicrobial
products.  The registration review program is intended to make sure
that, as the ability to assess and reduce risk evolves and as policies
and practices change, all registered pesticides continue to meet the
statutory standard of no unreasonable adverse effects.  

Finally, alkyl amine hydrochloride registrants will not be required to
generate or submit any new data for the alkyl amine hydrochloride
registration review until a DCI is issued for alkyl amine hydrochloride.
 The DCI will not be issued until the Final Work Plan (FWP) is complete
and the DCIs have been cleared for release by OMB. 

 HED Standard Operating Procedure. Guidance: Waiver Criteria for
Multiple-Exposure Inhalation Toxicity Studies, August 15, 2002.

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