procymidone (Sumilex) Pesticide Tolerance 4/91
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Pesticide Tolerance for Procymidone
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This document establishes a time-limited tolerance for residues of
the fungicide procymidone, N-(3,5- dichlorophenyl)-l,2- dimethylcyclopropane
l,2- dicarboximide, in or on the raw agricultural commodity (RAC) wine grapes
grown prior to January 1, 1990, at 7.0 parts per million (ppm). Sumitomo
Chemical Co., Ltd., petitioned EPA to establish a maximum permissible level
for residues of procymidone on grapes. EFFECTIVE DATE: This regulation
becomes effective April 26, 1991. ADDRESSES: Written objections, identified
by the document control number, [OPP-300225C], may be submitted to: Hearing
Clerk (A-110), Environmental Protection Agency, Room 3708, 401 M St.,SW.,
Washington, DC 20460.
FOR FURTHER INFORMATION CONTACT: By mail: Susan Lewis, Product Manager (PM)
21, (H7505C), Registration Division Environmental Protection Agency. 401 M
St., SW., Washington, DC 20460. Office location and telephone number: Rm. 27
CM#2, 1921 Jefferson Davis Hwy. Arlington, VA 22202, (703)- 557-1900.
SUPPLEMENTARY INFORMATION: In the Federal Register of September 25,1990 (55
FR 39171), EPA issued an advanced notice of proposed rulemaking (ANPR) to
solicit comment on its consideration of Sumitomo's petition to establish a
tolerance of 5 ppm for residues of the fungicide procymidone on grapes and to
establish immediately an interim tolerance of 7 ppm to last 1 year. The
Agency issued this ANPR to (l) give its preliminary assessment of the risk
posed by procymidone residues in imported wine, (2) set out its options for a
decision, and (3) request public comment on key scientific and policy
questions raised by this petition for tolerance.
After considering the comments received on the ANPR and after further review
of the data submitted by Sumitomo, EPA issued a proposed rule in the Federal
Register of February 8, 1991 (56 FR 4772), giving notice that Sumitomo
Chemical Co., Ltd., had submitted a pesticide petition, PP OE3859, under
section 408(e) of the Federal Food. Drug, and Cosmetic Act (FFDCA) (21 U.S.C.
301 et seq.). This document proposed to establish a time-limited tolerance
for procymidone in wine grapes grown prior to January 1, 1990 at 7 ppm. In
the Federal Register of February 20,1991 (56 FR 6821), EPA reissued the
proposed rule in its entirety to include certain statements in the proposed
rule document that were inadvertently omitted in the February 6, 1991
EPA in this document is establishing a time-limited tolerance for procymidone
in wine grapes at 7 ppm. This tolerance has two conditions placed on it: (l)
The tolerance will only be effective for four years, and (2) the tolerance
will only apply to wine grapes grown in 1989 or before.
1. Comments on the Proposed Rule
In response to the procymidone proposed rule, 17 comments have been received.
1. Fifteen comments supported establishing a time-limited tolerance. A
majority, including the Delegation of the Commission of the European
Communities, French Embassy, Italian Embassy, and wine exporters and
importers, also stated that permanent tolerances should be established as soon
as possible. The French Embassy indicated that European wine growers could
encounter serious difficulties and sustain major losses in grape production
without procymidone to control botrytis.
EPA's response: As EPA stated in its proposal, EPA is unwilling to establish
a tolerance for procymidone which is of any wider scope than necessary to
address the extraordinary circumstances which warranted expedited
consideration of the petition. Once the Agency receives all the data
required, the petitioner's request for a permanent tolerance will be
2. Food & Allied Service Trades (FAST) and Consumer Union/Natural Resources
Defense Council (CU/NRDC) filed overlapping comments. First, CU/NRDC contended
that EPA cannot really establish a tolerance under the FFDCA unless the
pesticide has been registered under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) or an application for registration under FIFRA has
been filed. CU/NRDC quotes EPA regulations in support of this argument.
Second, FAST and CU/NRDC both assert that EPA does not have the authority to
set interim tolerances other than interim or temporary tolerances for
pesticides used pursuant to an experimental use permit under FIFRA. Third,
FAST and CU/NRDC argue that EPA does not have sufficient toxicity and exposure
data to establish a tolerance. Finally, FAST and CU/NRDC assert that EPA
elevated economic concerns over safety concerns in proposing a tolerance for
EPA received supplemental comments from Sumitomo responding to the comments
filed by CU/NRDC. Sumitomo noted that the lack of a FIFRA registration was
not a bar to a tolerance because it had petitioned for a tolerance under
section 408(e) and that CU/NRDC cited no authority for the proposition that
EPA could not put a time limitation on a tolerance. Sumitomo also disputed
CU/NRDC's claim that EPA focused primary attention on economic considerations.
Sumitomo cited the 11,000 pages of toxicology studies - submitted to EPA and
EPA's extensive review process for that data as demonstrating EPA's adherence
to its statutory mandate.
EPA's response: CU/NRDC's first comment is incorrect. A tolerance may be
established for a pesticide not registered under FIFRA. The FFDCA provides
two separate petition procedures for obtaining a tolerance. Under section
408(d) of the FFDCA, any person who has registered, or submitted an
application for registration, under FIFRA may file a petition for tolerance.
Under section 408(e), "[t]he Administrator may at any time, upon his own
initiative or upon the request of any interested party, propose the issuance
of a regulation establishing a tolerance * * *." The regulations quoted by
CU/ NRDC which appear to support their contention apply only to section 408(d)
petitions. See 40 CFR 180.7(a). Regulations governing section 408(e)
petitions are contained in 40 CFR 180.29. Neither section 408(e) nor 40 CFR
180.29 in any way restricts section 408(e) petitions to pesticides registered,
or for which registration application has been submitted, under FIFRA.
NRDC argued in comments to the ANPR that EPA had the authority to put time
limitations on tolerances only for temporary tolerances issued in connection
with experimental use permits. In response, EPA explained in the procymidone
tolerance proposal that the authority to grant temporary tolerances in section
408(j) did not restrict the broad general authority to grant tolerances in
section 408(b) which was being exercised in this instance. FAST and CU/NRDC
add essentially nothing new in this round of comments. FAST states only that
NRDC's comments were not adequately responded to by EPA. CU/NRDC cite a case
(National Coalition Against the Misuse of Pesticides v. Thomas, 815 F.2d 1579
(D.C. Cir. 1987)) which even they acknowledge does not address the issue.
CU/NRDC also reference the regulations pertaining to temporary tolerances
established in connection with experimental use permits (40 CFR 180.31). In
response to FAST, EPA would reiterate that the creation of authority to
establish tolerances for special circumstances (experimental uses of
pesticides) does not restrict EPA's ability to place conditions on tolerances
issued under its general tolerance-setting authority. In response to CU/ NRDC,
EPA would note that the regulations pertaining to section 408(j) temporary
tolerances issued in connection with experimental use permits have no
relevance to tolerances established under section 408(b)'s general tolerance
FAST and CU/NRDC also argue that EPA has inadequate information on toxicity
and exposure to establish a tolerance. The basis for this conclusion is that
EPA is requiring that several studies be repeated and that EPA's independent
Scientific Advisory Panel concurred with EPA that several studies should be
repeated to reduce the level of uncertainty. FAST and CU/NRDC, however, make
no attempt to contest EPA's and the Scientific Advisory Panel's explanation of
why, despite any uncertainties due to deficiencies in the existing studies,
the data are sufficient (l) to make a risk assessment and (2) to conclude that
the risks from procymidone are low.
Finally, FAST and CU/NRDC contend that EPA has elevated economic issues over
public health concerns. FAST and CU/NRDC argue that the deciding factors in
EPA's proposal to establish the procymidone tolerance were the disruption of
foreign trade and the impact on exporting countries which resulted from the
absence of a procymidone tolerance. That is incorrect. In establishing
tolerances under section 408, EPA is required to focus principally on factors
related to the public health. As noted by CU/NRDC, it has been held that
"health factors * * * [must] be at the forefront of EPA's deliberations."
National Coalition Against the Misuse of Pesticides v. Thomas, 809 F.2d 875,
882 (D.C. Cir. 1987) ("NCAMP I"). A health factor of central importance to
any tolerance determination is the degree of risk posed by the pesticide.
EPA's focus throughout this rulemaking proceeding has been directed precisely
at that issue. Both the ANPR and the tolerance proposal discussed in detail
EPA's findings from analysis of the scientific data on procymidone. EPA also
took the unusual step of requesting the advice of the independent Scientific
Advisory Panel created under the authority of the Federal Insecticide,
Fungicide, and Rodenticide Act on potential health risks of procymidone
exposure. Both EPA scientists and the Scientific Advisory Panel agreed that
the risk posed by procymidone was low. EPA's conclusion in this final rule is
that the risk posed by procymidone is so slight that the proposed procymidone
tolerance would be protective of public health. The other statutory public
health factors which under section 408 must be considered in establishing a
tolerance also support this determination. First, in the absence of a
procymidone tolerance, the adequacy and affordability of the food supply would
be adversely affected. It is undisputed that significant amounts of wine
would be excluded from the U.S. if a tolerance is not established, with
resulting ramifications on both the supply and cost of wine. Second, since
this is the first tolerance for procymidone, consumers do not have other
exposures to procymidone which must be taken into account.
EPA has candidly acknowledged that the potential trade implications posed by
the procymidone situation were considered by EPA in evaluating Sumitomo's
petition. EPA took into account potential impacts on both foreign and U.S.
economies and the public health of U.S. consumers. The U.S. Court of Appeals
for the District of Columbia Circuit has held that to the extent international
trade factors implicate the public health of U.S.consumers those factors are
central to the required public health determination under section 408.
National Coalition Against the Misuse of Pesticides v. Thomas, 815 F.2d 1579,
1582 (D.C. Circuit 1987); NCAMPI, 809 F.2d at 882. Further, that court held
that impact on foreign economies even where that impact is unrelated to U.S.
public health may be treated by EPA as having "some relevance" to its public
health determination. NCAMPI, 809 F.2d at 882. With the procymidone petition,
however, EPA's consideration of trade implications was more narrow than either
of the two circumstances contemplated by the District of Columbia Circuit
Court. EPA's consideration of trade implications did not relate to its public
health determination but solely to the timing of EPA's action on the petition
and the scope of any tolerance. Under normal circumstances, a petition such
as Sumitomo's would have simply been held by EPA while the petitioner redid
the studies which did not meet EPA guidelines. As a matter of administrative
efficiency, EPA is unwilling to devote its resources to reviewing studies
which are not fully acceptable. In this case, EPA decided that because of the
overwhelming trade issues, it would deviate from its usual administrative
practice and review studies which did not meet all guideline requirements to
determine if nonetheless there was sufficient information to make the
statutory "public health" finding under section 408. The trade issues, to an
extent, also shaped the scope of the tolerance in that EPA wanted to ensure
that any deviation from normal administrative practice was narrowly limited to
the circumstances which justified taking the extraordinary step. Thus, trade
issues were relied upon to justify an expedited decision and they shaped the
scope of what was under consideration; however, they did not affect EPA's
ultimate decision on whether or not to establish the tolerance. EPA's
decision-making procedure for establishment of a procymidone tolerance fully
adhered to the requirement under section 408 that "health factors * * * be at
the forefront of EPA's deliberations." Id.
The data submitted in the petition and other relevant material have been
evaluated and discussed in the proposed rule.
II. Peer Review
When the proposed rule was published, the Health Effects Division (HED) Peer
Review Committee of the Office of Pesticide Programs was reviewing the
Scientific Advisory Panel's conclusion to classify procymidone as a Group C-
Possible Human Carcinogen. The Panel had cited only the testicular tumors
seen in the chronic rat study. The Peer Review Committee did not concur with
the Scientific Advisory Panel, but concludes that the evidence supports a
Group B2- Probable Human Carcinogen classification. In addition to the
testicular tumors, the Group B2 classification was based on pituitary adenomas
in female rats and liver adenomas and combined adenomas/ carcinomas in female
mice. Additionally, a variant af hepatocellular carcinoma, hepatoblastoma,
had a significant trend in male mice. The HED Peer Review Committee
recommendations noted that this trend may be indicative of a progression to a
more anaplastic state. While the tumor incidence in mice was not greatly
elevated, the effects were seen at doses well below an adequate top dose, and
the available evidence for a mechanism involving altered hormonal influences
was not conclusive.
III. Projected Procymidone Risks
No modifications of the projected risks posed by procymidone are required as a
result of the Peer Review Committee's review of the Scientific Advisory
Panel's report because EPA had in its earlier risk assessment classified
procymidone under Group B2.
The upper bound to the carcinogenic risk is estimated to be 5.0 x 10.6 for a
high consumer and 4.6 x 10 7 for an average consumer assuming a theoretical
maximum residue of 3 ppm in wine based on the 7 ppm level in wine grapes.
Actual residues in wine probably will be less. The Food and Drug
Administration (FDA) in monitoring approximately 1,100 imported ,wine samples
collected over the past year (since February 1990) found the highest level of
only 0.6 ppm in wine. The incidence of positive samples (i.e., at or greater
than 0.02 ppm) was 9 percent, and the average positive finding was 0.06 ppm.
Assuming that a wine consumer chooses vintages from before 1990 for the next
10 years and residue levels of procymidone in wine are at 0.6 ppm. the highest
level detected by FDA, the upper bound on dietary carcinogenic risk is
estimated for the high consumer to be 1.9 x 10 7 and for the average consumer
to be 1.8 x 10.8. The average and high consumers were derived for wine
drinkers only and do not include the 53 percent of the U.S. population who
claim not to have drunk any wine in approximately 1 year.
Procymidone appears to cause effects on reproduction and development of
reproductive organs. Since neither a lowest effect level (LEL) nor a no-
observed-effect level (NOEL ) has been established, a quantitative assessment
is not possible at this time. However, in view of the 4 orders of magnitude
difference between the dose that did not cause frank effects in rats and
exposure even for the 99th percentile of wine consumers, it does not appear
that reproductive effects would be expected.
Developmental toxicity is also not expected. The NOEL from the accepted study
is above 1,000 mg/kg/day; exposure to the 99th percentile of wine consumers is
expected to be approximately 7 orders of magnitude less.
Based on the data and information considered, the Agency concludes that the
time-limited tolerances will protect the public health because the risks posed
by exposure to procymidone in wine grapes grown prior to 1990 are low.
Therefore, the tolerance is established as set forth below.
Any person adversely affected by this regulation may, within 30 days after
publication of this document in the Federal Register, file written objections
with the Hearing Clerk, at the address given above. The objections submitted
must specify the provisions of the regulation deemed objectionable and the
grounds for the objection. If a hearing is requested, the objections must
include a statement of the factual issue(s) on which a hearing is requested
and the requestor's contentions on each such issue. A request for a hearing
will be granted if the Administrator determines that the material submitted
shows the following: There is a genuine and substantial issue of fact; there
is reasonable possibility that available evidence identified by the requestor
would, if established, resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims to the contrary; and
resolution of factual issue(s) in the manner sought by the requestor would be
adequate to justify the action requested.
The Office of Management and Budget has exempted this rule from the
requirements of section 3 of Executive Order 12291. Pursuant to the
requirements of Regulatory Flexibility Act (Pub. L. 96-354, 94 Stat. 1164, 5
U.S.C. 601-612), the Administrator has determined that regulations
establishing new tolerances or raising tolerance levels or establishing
exemptions from tolerance requirements do not have a significant economic
impact on a substantial number of small entities. A Certification statement
to this effect was published in the Federal Register of May 4, 1981 (46 FR
List of Subjects in 40 CFR Part 180
Administrative practice and procedure, Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping requirements.
Dated: April 23, 1991.
Douglas D. Campt,
Director, Office of Pesticide Program
Therefore, 40 CFR part 180 is amended as follows:
PART 180 [AMENDED]
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 346a and 371.
2. By adding new section 180.455, to read as follows:
Section 180.455 Procymidone; tolerances for residues
A tolerance is established for the residues of the fungicide procymidone, N-
(3,5-dichlorophenyl)-l,2- dimethylcyclopropane-1,2- dicarboximide, in or on
the following raw agricultural commodity:
Commodity Parts Per Million Expiration Date
Wine grapes grown prior to
January 1, 1990 7.0 April 26, 1995
There are no U.S. registrations as of February 20, 1991.