Document ID: EPA-HQ-OPP-2009-0121-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-03-25T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 		     WASHINGTON, D.C. 20460

 ADVANCE \d61 	OFF		ICE OF PREVENTION,

OFFICE OF PESTICIDES AND TOXIC SUBSTANCES        

MEMORANDUM

DATE:		February 13, 2009

SUBJECT:	Preliminary Human Health Assessment for the Registration Review
of Capsaicin

				Registration Review Case #: 4018

				PC Code: 070701

				CAS #: 404-86-4

				Chemical Class: Biochemicals

FROM:		Sadaf Shaukat, Biologist

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

THROUGH:	Angela Gonzales, Biologist

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

TO:			Chris Pfeifer, Regulatory Action Leader

				Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

ACTION REQUESTED

The following is a preliminary human health assessment for the
biopesticide Capsaicin in support of the development of the Registration
Review Work Plan.  

RECOMMENDATIONS AND CONCLUSIONS



Executive Summary

Based on the available data and information, the Agency, in general,
does not foresee the need for new data or for a new human health risk
assessment for capsaicin, with the exception that the Agency is aware of
information regarding the potential mutagenicity of the active
ingredient, of which it will investigate further.  It is important to
note that there is a reasonable certainty of no harm based on what is
known about capsaicin, and although this investigation is not likely to
entail a full risk assessment, the Agency intends on thoroughly
addressing this issue in the Final Report.  All data requirements per 40
CFR 158.2050 have been fulfilled for this active ingredient.  Hazard and
exposure data and information as well as Agency risk assessments on this
chemical were evaluated against current safety standards established by
the Agency’s scientific policies and regulations and it was determined
that there is no need to conduct an additional, full human health risk
assessment, again, with the exception of further research into
capsaicin’s potential for mutagenicity.  The active ingredient is a
naturally-occurring substance, has a non-toxic mode of action (it is a
repellent) and there is a significant history of exposure to humans and
the environment.  Excessive exposure may cause some slight eye and skin
irritation.  Personal protection equipment (PPE) requirements and
sufficient label warnings provide sufficient protection for these
exposures.  All registered end-use products have a low concentration of
capsaicin, ranging from 0.0001% to 4.94%. There is reasonable certainty
that no harm will result to the general population from the products
containing this active ingredient when they are used according to label
instructions.  

  

I. Background

Capsaicin is the active component of chili peppers, plants that belong
to the Capsicum genus.  It is obtained by grinding chili peppers into a
fine powder.  

According to some of the product labels containing capsaicin as the
active ingredient, it has the ability to repel certain insects
(including aphids, cabbage loopers, etc.) from plants such as citrus
fruits, and root, bulb, and leafy vegetables.  In addition, it can be
used to repel animals such as deer, elk, rabbits, dogs, cats, and
groundhogs.  

Currently, there are thirty-three end-use products that are registered
with BPPD containing this biochemical.  Eighteen products have capsaicin
as the only active ingredient.  The remaining fifteen products are
combination products and the other active ingredients found in them
include allyl isothiocyanate, oil of black pepper, piperidine,
butanethiol, putrescent whole egg solids, and garlic oil.  One of the
registered end-use products (Capsyn Reg No. 43889-1) may be considered
an MP as it is cited as a source of active ingredient in other products.
 However, the label solely indicates that it is an EP.

II. Toxicity Profile

Capsaicin is a commonly consumed food commodity and has a significant
history of exposure to humans.  It has been determined that due to the
nature of this compound, it is unlikely that products containing
capsaicin will have adverse effects on human health.  All toxicology
data requirements have been satisfied and it is unlikely that any
additional data will required, pending the investigation on potential
mutagenicity.  Toxicology data and or rationale to fulfill or waive
these requirements are available on the currently registered EPs; all of
which indicate that these products are of low toxicity.

Available acute toxicity data on the EP’s indicates that all
thirty-three products fall into Toxicity Category III or IV for all
routes of exposure.  According to one study, capsaicin was considered
weakly mutagenic at the highest dose tested.  However, based on the
weight of evidence that capsaicin has a long history of being widely
available in the food supply and there have previously been no accounts
of deleterious mutagenic effects, the Agency has reason to believe that
exposure to capsaicin is not likely to cause mutagenic effects when the
products are used according to label instructions.  Nevertheless, the
Agency will investigate this matter further.

No studies were provided to fill the data requirements for 90-Day Oral
Toxicity/OPPTS 870.3100, Prenatal Development/OPPTS 870.3700, or
Mutagenicity: In vitro Mammalian Cell Assay (mouse lymphoma)/OPPTS
870.5300.  According to the RED, these studies have been waived due to
the long history of use by humans as food additive without any
indication of deleterious health effects.  

Based on capsaicin’s physical and chemical properties, it is
considered to be non-persistent in the environment.  It degrades rapidly
in the environment and therefore, human exposure to pesticidal residues
is expected to be minimal.   

Based on the information presented above, the Agency does not foresee
the need for new data or for a new human health risk assessment.   There
is reasonable certainty that no harm will result to the general
population from exposure to capsaicin in the products containing this
active ingredient when they are used according to label instructions. 
The Agency will investigate the potential for mutagenicity from exposure
to the active ingredient, although there is a reasonable certainty of no
harm based on what the Agency knows about capsaicin.         

III. Tolerances

§ 180.1165   Capsaicin; exemption from the requirement of a
tolerance.

Capsaicin is exempt from the requirement of a tolerance in or on all
food commodities when used in accordance with approved label rates and
good agricultural practice.

[63 FR 39521, July 23, 1998]

IV. Incidents

According to the Incident Data System, there have been nine reports of
human-related incidents from use of capsaicin products. 

One incident was a human fatality due to the lack of efficacy of a
bear-deterrent product.  Four unspecified incidents were due to the lack
of efficacy of a dog repellent product.  One major incident occurred
with a red pepper spray, however no information was available to
determine the cause.  Two other incidents (one moderate and one minor)
were due to misuse/lack of following label directions.  The last
incident was considered minor and caused minor irritation to throat and
eyes.  Not enough information was provided to determine whether this was
due to misuse or not.  None of these incidents are attributable to
information unknown to the Agency regarding the nature of capsaicin. 
Label language on capsaicin products is appropriate and sufficient to
protect users/handlers of these products.

V. References

U.S. EPA RED Fact Sheet for Capsaicin (070701).  Issued June, 1992.

U.S. EPA RED-Capsaicin (070701). Issued June, 1992.

 cc:  S. Shaukat, C. Pfeiffer, BPPD Science Review File

	 S. Shaukat, FT, PY-S: 2/12/09

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