EPA 730-N-96-007
\ UNITED STATES ENVIRONMENTAL PROTECTJON AGENCY
I ' WASHINGTON, D.C. 20460
^ , ' . ' ' ' '. = '
October ^1
VJVLUUCI 0±, PREVENTION, PESTICIDES, AND
OFFICE OF
ION, PESTIC
, • • ' • TOXIC SUBSTANCES
.PESTICIDE REGULATION (PR) NOTICE 96-8
NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS
AND REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION: Persons Responsible for Registration of Pesticide Products
SUBJECT: , Toxicologically Significant Levels of Pesticide Active Ingredients
This notice sets out the Environmental Protection Agency's (EPA's) interpretation of
the term"toxicologically significant" as it applies to contaminants in pesticide products that are
also pesticide active ingredients (AIs). This notice provides risk-based concentration levels of
such contaminants that will generally be considered lexicologically- significant. These
concentrations are defined according to the type of pesticide that is contaminated and the
pesticide category of the contaminant. As provided by regulation, registrants must report to
EPA contamination exceeding lexicologically significant levels. This Notice sets out
procedures for reporting such conlarninaliono
The following contamination scenarios are excluded from this notice: (1) rodenticides
as a contaminant and/or as the contaminated product; (2) microbial and biochemical pesticides
that are manufactured in fermentors and that are contaminated by active microbial pesticide
ingredients; and (3) plant-pesticides that are contaminated with other active plant-pesticide
ingredients. ,EPA would like to clarify that the Agency's previous position on lexicologically
significant levels of impurities that are also AIs would apply to pesticides that are exempt from
this notice. In other Words, any level of a contaminant in these three exempted categories
would be considered potentially lexicologically significant and musl be reported -to
EPA.
I. BACKGROUND
EPA requires all impurities of lexicological significance lo be reported and accepted as
part of product registration (40 CFR 158,167). EPA also requires that registrants propose
upper certified limils for lexicologically significant impurities in technical grade active
ingredients or products produced by an integrated system (40 CFR 158.175), and may require
upper certified limils. for other impurities.
At Ihe lime EPA promulgated Ihese regulations il did nol sel quantitative criteria for
determining whether an impurity is lexicologically significant. Rather, EPA has taken the
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position that any level of an active ingredient that is an impurity or contaminant in another
product is potentially toxicologically significant and must be reported to the Agency. Failure
to report such an impurity is a violation of FIFRA section 12(a)(l)(C) (composition of the
product differs from that registered with the Agency).
The Agency did make clear at the tune it promulgated its current reporting regulations
that its interpretation of the term "toxicologically significant" could be subject to further
refinement to the extent new information on impurities was available to the Agency. Based on
the analysis conducted during the development of this notice, the Agency has now determined
that for certain pesticides (see section IV below) it can establish generally applicable
quantitative criteria for deterrnining the toxicological significance of contaminants that are also
active ingredients. For this reason, EPA is today further refining its interpretation of the term
"toxicologically significant."
In Section IV of this notice, EPA is setting risk-based levels at which active ingredients
that are contaminants will generally be considered "toxicologically significant." For the
purposes of this notice, a contaminant is defined as an active ingredient that is not accurately
listed on the product's confidential statement of formula or listed in the discussion of
impurities. This notice addresses only impurities that are also active ingredients; EPA's
position on other impurities has not changed.
Additionally, nothing in this notice changes the conditions outlined hi the Bulk
Pesticides Enforcement Policy (Bulk Policy) 'dated July 11, 1977 and amended on March 4,
1991. The Bulk Policy is an important part of applying the 40 CFR Part 158 standards to bulk
pesticides at repackagrng/refilling establishments (often retail dealers). Specifically, EPA's
position that both parties (the registrant and the repackager) are accountable for the integrity of
the product as set'out in the Bulk Policy remains the same.
H. OBJECTIVES
EPA determined that this interpretation on cross contamination should:
o Recognize that cross contamination is a reality, and that not all cross contamination is
problematical;
o Set a clear standard that can be readily applied by EPA/States and the regulated
industry alike; , ' . .
o Ensure that allowable cross contamination does not pose unreasonable adverse effects;
o Minimize the paperwork burden for EPA and registrants;
o Maintain accountability for the product from the registrant to the end user; and
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o Not preclude marketplace/private solutions to correct problems that do arise.
III. APPROACH
EPA decided that a risk-based approach would most likely meet these objectives.
EPA considered the risks for several endpoints, including human health, adulterated
foodj contamination of ground water, and ecological effects to determine which endpoints
would be most sensitive to cross contamination and what levels of cross contamination could
be tolerated and remain generally protective of human health and the environment. For each
endpoint, an analysis was done to evaluate a reasonable worst case scenario or a range of
potential scenarios to see if an overall, generally protective contaminant concentration could be
determined. EPA grouped contaminants and pesticides into different categories (see the table
in section IV) to yield a scheme of lexicologically significant concentrations.
The following end points were considered. In most cases phytotoxicity to the target
plants is the most sensitive endpoint and, therefore, the limiting factor in determining
toxicological significance. •
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Human health effects. Because cross contamination caused by a specific AI is most
likely an intermittent event, short-term exposure is most likely.. Therefore, EPA focused on
the potential risks to individuals who would be handling contaminated products. The analyses
of these human health risks show that acute risks to humans at the cross contamination levels
allowed by this interpretation are negligible. Although intermittent contamination is the most
likely scenario for cross contamination, it is possible that the same AI contaminant would be
present in a particular pesticide product over a long period of tune. EPA analyses indicate that
chronic exposure to cross contamination is unlikely to present an unreasonable risk to human
health. ~
EPA also considered contamination in pesticides applied to the human body (e.g.,
insect repellents) and concluded that the risks from cross contamination at the level set in this
notice for these pesticides are negligible. ,
Adulterated food. Theoretically, a contaminant could cause residues hi food or feed
for which no tolerance has been established or that are in excess of an established tolerance.
In this case, that food or feed would be adulterated under the^Federal Food, Drug, and
Cosmetic Act. EPA's analysis indicates that this is a highly unlikely occurrence. Moreover,
because cross contamination with a specific AI occurs intermittently and at low levels, EPA
believes that potential exposure to and dietary risk from residues of unreported contaminants
under this notice would be negligible.
Ground water. The possibility of the contamination of ground water was raised as a
potential concern in locations with sandy soils and shallow aquifers. The Florida Department
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of Agriculture and Consumer Services (DACS) conducted a preliminary ground water
modeling exercise using a number of conservative assumptions regarding teachability,
pesticide half-life, and product application rate. EPA accepts the Florida DACS conclusion
that while contamination of ground water is possible, it is of minimal concern because
pesticide AIs as contaminants at the levels allowed by this notice are unlikely to move to
ground water in concentrations that would pose significant risk to human health,
^£QlQgJ£aL^e^sJfb^s^^^. Based on a preliminary review of potential ecological
effects from cross contamination (e.g., risks to birds, aquatic organisms, and plants), EPA
believes that plant toxicity, or phytotoxicity, is the most sensitive endpoint given the relatively
low concentrations of contaminants being considered: EPA believes that phytotoxicity damage
poses the greatest potential for ecological harm, EPA's phytotoxicity analyses focus on the
direct application of the contaminated product to terrestrial plants because this scenario
represents a higher level of exposure than other exposure pathways, such as runoff and off-
target drift.
EPA conducted several risk analyses based upon phytotoxicity as the end point of
concern to determine the appropriate lexicologically significant levels. These analyses are
presented in a technical support document. (See section VII on how to obtain more
information.)
microbial
pesticides^ Many microbial and certain biochemical pesticides are manufactured in
fermentors. A likely source of contamination of these pesticide products arises when a
fermentor is used also for the production of a different microbial pesticide active ingredient.
Quantitative criteria are not appropriate for determining whether active microbial pesticide
ingredients are contaminants of 'toxicological significance1 . This is because microorganisms
can multiply hi the environment, and especially in association with target pest hosts. The
criteria of from 20 ppm to 1000 ppm as "lexicologically significant levels" (Section IV) when
applied to a microbial pesticide active ingredient could allow for the presence of thousands to
millions of contaminating microorganisms per gram or milliliter of pesticide product. It cannot
be assumed that such levels of contamination are of insignificant toxicity, especially to non-
target organisms. ,
EPA is in the process of developing policy for regulatory oversight of plant-pesticides,
including defining the scope of oversight. Therefore, any determination of whether the quanti-
tative criteria for toxicological significance apply to plant pesticides should be made once the
plant-pesticide rule is finalized. Where applicants/registrants voluntarily submit plant-
pesticides for EPA regulation, the reporting as discussed in Section V of this Notice will
remain applicable unless otherwise changed by regulation.
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IV. TOXTCOLOGTCALLY STGNTFTCANT T.KVFJ.S OF CONTAMINATION
The following table defines the levels of contaminants that EPA generally considers to
be toxicologically significant. Specifically, the presence of a contaminant at a concentration
greater than the concentration specified in the table will generally be considered toxicologically
significant. Each contaminant should be considered individually.
The toxicologically significant levels apply to all registered products that are sold or
distributed, regardless of whether the container is nonrefillable (i.e., "packaged product") or
refillable (i.e., "bulk product.") The toxicologically significant levels do not apply to products
that are not sold or distributed, such as tank mixtures in an end user's application equipment.
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Toxicologically Significant Levels of Contaminants1-2
Category
1
2
.3
,4
, . 5
6 ' ;
7
Type of Contaminant
Insecticide5, fungicide, '.
molluscide, or nematicide in. . .
Herbicide, plant growth
regulator, defoliant, or desiccant
in. . .
Any pesticide* other than a low
application rate herbicide7 in. . .
Normal rate herbicide8, plant
growth regulator, defoliant, or
desiccant in. ..
Any pesticide6 in. . .
Normal rate herbicide, plant
growth regulator, defoliant, or
desiccant in. . .
Low application rate herbicide
in...
Type of Pesticide that is
Contaminated
Any insecticide, fungicide, '
molluscide, nematicide, herbicide,
plant growth regulator, defoliant,
or desiccant
Any pesticide6 where the
contaminant is accepted for use on
all sites for which the product is
labeled '
An antimicrobial pesticide
Any herbicide, plant growth
regulator, defoliant, or desiccant
A pesticide6 applied to the human
body
Any insecticide, fungicide,
molluscide, or nematicide
A low application rate herbicide
Toxicol. '••
Significant Level3
(ppm)4
1000
1000
1000
.250
100
100
t
• Level of
quantification9 or
100 ppm, which ever
is, higher
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8
9
Low application rate herbicide
in...
Low application rate herbicide
in...
A normal rate herbicide, plant
growth regulator, defoliant, or ,
desiccant
A pesticide6 other than a
herbicide, plant growth regulator,
defoliant, or desiccant
Level of
quantification9 or 20
pprti, which ever is
higher
Level of
quantification9 or 1
' ppm, whichever is
higher
Notes:
(1) For the purposes of this notice, a contaminant is defined as an AI that is not on the product's confidential statement .
of formula or listed in the discussion of impurities.
(2) The following contamination scenarios are excluded from this notice: (1) rodenticides as a contaminant and/or as the
contaminated product; (2) microbial and biochemical pesticides that are manufactured in fermentors and that are
contaminated by active microbial pesticide ingredients; and (3) plant-pesticides that are contaminated with other active
plant-pesticide ingredients. EPA would like to clarify that the Agency's previous position on lexicologically significant
levels of impurities that are also AIs would apply to pesticides that are exempt from this'notice. In other words, any
level of a contaminant in these three exempted scenarios would be considered potentially toxicologically significant and
would have to be reported to EPA. i
(3) This column presents the toxicologically significant level, i.e., the concentration at or above which EPA* would
consider the contaminant to be toxicologically significant.
(4) The concentration is determined in ppm based on the ratio of the weight of the contaminant to the weight of the
formulated product.
(5) The FIFRA definition of insect includes mites and other arthropods that are not classified by scientific nomenclature
as "insects." See FIFRA section2(o).
(6) The phrases "any pesticide" and "a pesticide" do not include the pesticides that are specifically exempt from this
notice as described in note #2 above.
(7) For the purposes of this notice, a low application rate herbicide is defined as a herbicide with a maximum labeled
application rate of AI less than or equal to 0.5 pounds Al/acre. This definition is intended to include products with AIs
that are amino acid inhibitors or ALS inhibitors, including but not limited to the sulfonylureas, imidazolinones, and
triazolopyrimidines. (8) For the purposes of this notice, a normal rate herbicide is defined as a herbicide with a
maximum labeled application rate of AI greater than 0.5 pounds Al/acre.
(9) For purposes of this notice, the level of quantification is the level of quantification achievable by EPA or its
designated representative (State Lead Agency) using an analytical method suitable for enforcement purposes at the tune
the analysis is performed.
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For categories 7, 8 and 9, the level of quantification is included in the table because ,
EPA does not currently have analytical methods to detect and quantify these AIs in other ,
products at concentrations as low as 100 ppm for category 7 (or lower for categories 8 and 9).
EPA does not want to set a standard it cannot enforce. Conversely, EPA does not want to set
a standard that constantly changes over time as analytical methods are continuously refined.
Therefore, the standard of category 7 is the level of quantification until the point in time when
the quantification limit drops below 100 ppm. The standard would then be 100 ppm, which is
the limit based on toxicological significance. For purposes of this notice, the level of
quantification is the level of quantification achievable by EPA or its designated representative
(State Lead Agency) using an analytical method suitable for enforcement purposes at the tune
the analysis is performed.
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In selecting the levels in the table, EPA attempted to strike a reasonable balance
between greater protectiveness and cost/burden considerations. If future experience indicates
that these values are not sufficiently protective, the Agency may find it appropriate to modify
,these levels of toxicological significance.
EPA believes the values in the table are generally protective in most
contaminant/product combinations. Because it is impracticable to consider every potential
contaminant/product permutation, however, adverse effects could occur when contamination is
present below the concentrations in the table.
i
The Agency recognizes that these standards will not prevent all possible adverse effects
from occurring; this is not a zero risk standard. For example, EPA is aware of a situation
where a normal rate herbicide contaminated an insecticide at levels below 100 ppm (as set out
in Category 6) and plant damage occurred. The Agency will continue to deal with such
situations using other regulatory tools including section 6(a)(2) of FIFRA.
Accordingly, this notice does not excuse applicants or registrants from the requirement
to submit to EPA factual information regarding unreasonable adverse effects of a pesticide
under section 6(a)(2) of FIFRA and EPA regulations at 40 CFR 152.50(f)(3). If an applicant
or registrant possesses factual information not previously reported to EPA indicating that a
contaminant in a product may pose risk to human health or the environment in concentrations
lower than those specified in the above table, that information must be submitted to EPA.
Failure to submit such information on a timely basis is a violation of sections 12(a)(2)(B)(ii)
and 12(a)(2)(N) of FIFRA. In addition, the distribution or sale of any product containing an
unreported contaminant that exceeds the levels identified in this notice is a violation of section
12(a)(l)(C) (composition differs) of FIFRA.
V. WHAT REGISTRANTS MUST DO
A. CONTAMINANT LEVRT. ROTTAT. TO OR GREATER THAN THF.
TOXTCOLOGTCATJ:Y SIGNIFICANT T.KVF.T.
If an applicant or registrant knows or has reason to believe that a contaminant that EPA
would consider lexicologically significant (i.e.,"an AI at a concentration equal to or greater
than the appropriate level in the table) may be present, s/he must then include an expanded
discussion-of the possible formation of the impurity and the amounts at which it might be-
present in accordance with 40 CFR 158.167(c). EPA would.then make a regulatory decision
on whether to approve the registration or amendment to allow the sale and distribution of the
product under FIFRA. Sale or distribution of a pesticide which equals or exceeds the
lexicologically significant level prior to EPA approval of the registration amendment would be
a violation. Reporting would be required regardless of where the contamination would be
expected to occur in the production and distribution processes. As noted in the preamble to
the regulations at 40 CFR 158.167, formulators utilizing registered materials are not required
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to seek information on the identify or level of impurities in the registered technical products
they purchase. The Agency realizes that such information may not be made known to the
formulator.
To submit an expanded discussion in accordance with 40 CFR § 158.167(c), an
applicant or registrant must provide EPA with (1) the identity of the contaminant and (2) the
concentration at which it might be present. The information should be sent to EPA as follows.
For US Postal Service submissions: >
Document Processing Desk (PM Team #_)
Office of Pesticide Programs (7504C)
U.S. Environmental Protection Agency
401M Street, S.W. , '
Washington, D.C. 20460-0001.
For courier deliveries: •
Document Processing Desk (PM Team #_)
Office of Pesticide Programs (7504C)
U.S. Environmental Protection Agency ,
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202-4501.
B. COJ^AMMANTJJEYEIJLESSJHAN THE TOXTCOLOGTCALLY
SIQNIFJCAHTJLEYEL
If an applicant or registrant knows or has reason to believe that a contaminant may be
present at a concentration that is less than the lexicologically significant level, s/he is not
required to report this information to EPA. Please note that if a product is distributed or sold
with levels of contamination that are equal to or exceed the lexicologically significant level,
the product is in violation of FIFRA, irrespective of the registrant1 s knowledge.
However, adverse effects could still occur below the "lexicologically significant"
concentrations set out in this notice. Registrants are reminded that they are responsible for
reporting any adverse effects under FIFRA section 6(a)(2). Specifically, if an applicant or
registrant possesses factual information not previously reported to EPA indicating that a
contaminant hi a product may pose risk to human health or the environment in concentrations
lower than those specified hi the above table, that information must be submitted to EPA.
Failure to submit such information on a timely basis is a violation of sections 12(a)(2)(B)(ii)
and 12(a)(2)(N) of FIFRA. ' . , .
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This notice is not intended to relieve registrants from liability that may exist under
State law resulting from damage caused by contaminants.
As noted above, this notice is intended to inform registrants of the interpretation of the
term "lexicologically significant" that the Agency intends to apply in implementing the
provisions of 40 CFR Part 158. It is not intended, nor can it be relied upon, to create any
rights enforceable by any party on litigation with the United States. EPA officials may act at
variance with the guidance when circumstances indicate that a contaminant is of toxicological
significance at levels different from those set forth in this notice.
EPA will take any regulatory action necessary to ensure that the levels of
contamination in a product do not cause unreasonable adverse effects to human health or the
environment. ,"•;.,
VI. EFFECTIVE DATF
, This notice is effective immediately.,
VII. FURTHER INFORMATION
The public comments received on the proposed interpretation, the comment summary
and response document, and the technical support document for this notice are available in the
public docket under document number "OPP-00424." The public docket is located at: Public
Docket and Freedom of Information Section, Field Operations Division, Office of Pesticide
Programs, U.S. Environmental Protection Agency (7506C), Room 1132, Crystal Mall #2,
1921 Jefferson Davis Highway, Arlington, Virginia, 22202.
If you have questions about the implementation of this notice, please contact Jim Jones
at (703) 308-8358. . . ..
Daniel M. Barolo, Director
Office of Pesticide Programs
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