[Federal Register: September 1, 2006 (Volume 71, Number 170)]
[Rules and Regulations]
[Page 52003-52012]
[DOCID:fr01se06-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0373; FRL-8081-9]

2, 6-Diisopropylnaphthalene; Time-Limited Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for
residues of 2, 6-Diisopropylnaphthalene, resulting from post-harvest
applications to potato, in or on fat (cattle, goat, hog, horse, and
sheep) at 0.8 part per million (ppm); liver (cattle, goat, hog, horse,
and sheep) at 0.3 ppm; meat (cattle, goat, hog, horse, and sheep) at
0.1 ppm; meat byproducts (cattle, goat, hog, horse, and sheep) at 0.1
ppm; milk at 0.1 ppm; potato at 2.0 ppm; and potato, wet peel at 6.0
ppm. Loveland Products, Inc. had requested permanent tolerances (in or
on whole potato and potato peels at 2 and 6 ppm, respectively) under
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the
Food Quality Protection Act of 1996 (FQPA). The time-limited tolerances
will expire on August 1, 2009.

DATES: This regulation is effective September 1, 2006. Objections and
requests for hearings must be received on or before October 31, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0373. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be

affected by this action. Other types of entities not listed in this
unit could also be affected. The North American Industrial
Classification System (NAICS) codes have been provided to assist you
and others in determining whether this action might apply to certain
entities. If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this ``Federal Register'' document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines

referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm/
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0373 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before October 31, 2006.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0373, by one of the following methods.
     Federal eRulemaking Portal. http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail. Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery. OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of December 9, 2005 (70 FR 73234) (FRL-
7748-5), EPA issued a notice pursuant to section 408(d)(3) of the
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 1F6338), originated by Platte Chemical Company, now
Loveland Products, Inc., 7251 W. 4th Street, Greely, CO
80634. The petition requested that 40 CFR 180.590 be amended by
establishing permanent tolerances for residues of the biochemical
pesticide 2, 6-diisopropylnaphthalene (2, 6-DIPN), resulting from post-
harvest applications to potato, in or on whole potato and potato peels
at 2 and 6 parts per million (ppm), respectively. The electronic docket
(EPA-HQ-OPP-2005-0318) for this notice included a summary of the
petition prepared by Loveland Products, Inc., the registrant. In
submitting this petition, Loveland Products, Inc. (formerly Platte
Chemical Company) is relying on new data summarized in the cited
summary, and also on information previously submitted by Platte
Chemical Company, which was summarized in a previous notice of filing
published in the Federal Register on September 21, 2001 (66 FR 48677)
(FRL-6798-3). New data submitted to the Agency by Loveland Products,
Inc. on February 8, 2005 and summarized by the company in the current
petition are a magnitude of the residue in livestock study, which was a
condition of registration for the subject active ingredient when the
end-use product, EPA Registration Number 34704-843, was registered on
July 31, 2003. Other new data summarized in the electronic docket for
the December 9, 2005 notice were analytical enforcement methods to
determine residues in potato, potato peels (submitted by Loveland
Products, Inc. on February 15, 2005), and livestock commodities
(submitted by Loveland Products, Inc. on February 8, 2005); and a
magnitude of the residue study which presented recalculations of
previously submitted data to support proposed label amendments
(submitted by Loveland Products, Inc. on July 20, 2005). As explained
in this final rule, the Agency is not granting the two permanent
tolerances sought in Loveland Products, Inc.'s current petition, but
rather is establishing several time-limited tolerances that will expire
on August 1, 2009.
    One comment was received from a private citizen opposing the
establishment of the permanent numeric tolerances sought by the
petitioner.
    1. Comment. One commenter objected to the use of 2, 6-DIPN on
potato in storage, citing information from 60 references on
naphthalene, which is a structurally related chemical. There were 24
citations containing information on human health hazards and 36
describing animal studies. The hazards of concern associated with
naphthalene exposure included hemolytic anemia, cataracts, and
respiratory tract toxicity. Reported no-observed-adverse-effect levels
(NOAEL) for naphthalene ranged from 50 milligrams/kilogram/day (mg/kg/
day) (an oral chronic toxicity study in the rat) to 200 mg/kg/day
(administered by gavage 5 days/week for 13 weeks in mice).
    EPA response. Toxicity data on 2, 6-DIPN indicate a NOAEL of
approximately 100 mg/kg/day based on decreased body weights in a 13-
week feeding study in rats with supporting evidence from a
developmental toxicity study in rats. This NOAEL is in the range of
NOAELs described by the commenter for general toxicity of naphthalene
(i.e., decreased body weight). However, one of the commenter's
references in particular indicated that 2, 6-DIPN may be less toxic
than naphthalene since the plant regulator was the least toxic of the
four compounds tested for respiratory tract toxicity by the
investigators (the other three were naphthalene, 2-methylnaphthalene,
and 2-isopropylnaphthalene; Honda, T., et al. Chem Pharm Bull 38
(11):3130-5 (1990)). This study suggests that alkyl substituted
naphthalenes such as 2, 6-DIPN are not as likely to form toxic epoxides
in epoxidase-rich lung tissues.
    The 12 citations describing studies of respiratory tract toxicity
indicated that most investigators chose injection (an unlikely route of
exposure for pesticides), or dose levels much higher than those used to
define dose-response

relationships (including NOAELS) for general toxicity, or both, to
characterize toxicity in the lung. Therefore, use of the NOAELs based
on decreased body weight are assumed to be an adequate basis for
determining a reference dose for 2, 6-DIPN's risk assessment since body
weight decreases occurred at lower doses than those causing respiratory
toxicity.
    The Agency's Integrated Risk Information System (IRIS) contains a
report entitled ``Toxicological Review of Naphthalene'' dated August,
1998 (available at http://www.epa.gov/iris/toxreviews/ as of May 4,

2006), which includes the citations found in the comment in a
comprehensive review and assessment of the literature on naphthalene.
That report notes (at page 41), ``the limited subchronic oral animal
data identify decreased body weight in rats as the most appropriate
critical effect for deriving a chronic oral RfD (reference dose) for
naphthalene.''
    The IRIS report further indicates (page 41) that an RfD of 0.02 mg/
kg/day ``...was derived by dividing a duration-adjusted NOAEL, 71 mg/
kg/day, for mean terminal body weight decrease (> 10% of control) in
male rats... by an uncertainty factor of 3,000 (10 to extrapolate from
rats to humans; 10 to protect sensitive humans; 10 to extrapolate from
subchronic to chronic exposure; and 3 for database deficiencies,...).''
A similar derivation of RfDs for 2, 6-DIPN (described as acute or
chronic population adjusted doses; aPAD and cPAD, respectively) is
accomplished by dividing the 100 mg/kg/day NOAEL by a thousandfold
uncertainty factor (10 for intraspecies variability, 10 for
interspecies extrapolation, and an additional 10 to consider
sensitivity of infants and children as required by the Food Quality
Protection Act (FQPA)). Application of an additional threefold
uncertainty factor based on data deficiencies was not done for 2, 6-
DIPN, because the plant regulator is classified as ``biochemical-like''
based on its structural similarity to 1-isopropyl-4,6-
dimethylnaphthalene, 1-methyl-7-isopropylnaphthalene, and 4-isopropyl-
1,6-dimethylnaphthalene which are naturally occurring plant regulators.
Based on the functional and structural similarities between these
naturally occurring alkyl substituted naphthalene plant regulators,
their plant-specific modes of action, and the decreased toxicity
associated with these compounds, 2, 6-DIPN's classification as
``biochemical-like'' requires less data for registration (i.e., the
data set required by 40 CFR 158.690 to support registration of
biochemical or biochemical-like pesticides is reduced compared to that
required for conventional chemical pesticides). In addition, using the
3,000-fold uncertainty factor for the reasons described in the IRIS
assessment would triple the dietary risks described below, but those
risks still do not exceed the level of concern for 2, 6-DIPN (i.e.,
dietary exposure remains < 100% of the acute population adjusted dose/
chronic population adjusted dose (aPAD/cPAD)).
    A late, ten-point comment was received from 1,4Group, Inc. Each of
the ten points raised by this comment is summarized individually below,
followed by EPA's response.
    2. Comment 1. It is requested that the Agency address whether the
three (unregistered) chemicals (1-isopropyl-4, 6-dimethylnaphthalene;
1-methyl-7-isopropylnaphthalene; 4-isopropyl-1, 6-dimethylnaphthalene)
to which 2, 6-DIPN is functionally/structurally similar, share a common
mechanism of toxicity.
    EPA Response. A ``common mechanism of toxicity'' in the context of
cumulative effects relates to the safety evaluation undertaken by EPA
in connection with related pesticides (e.g., organophosphates with the
common mechanism of toxicity such as cholinesterase inhibition). In
this case, 2, 6-DIPN and the three functionally and structurally
similar substances all act as plant regulators by a ``mode of action''
that is specific to plants, and therefore, their common mode of action
is unlikely to be relevant to a mechanism of toxicity in animals or
humans. The comparison of the four chemicals is made to demonstrate
biological activity (plant regulation in this case), which the Agency
has characterized as a non-toxic mode of action with respect to
pesticidal activity.
    3. Comment 2. This comment identifies a statement from the Agency's
2, 6-Diisopropylnaphthalene Biopesticide Registration Action Document
(BRAD), where on page one 2, 6-DIPN was incorrectly said to be
``...functionally and structurally identical to the naturally occurring
plant regulator in potato.''
    EPA response. The Agency recognizes the error; potato naturally
contain more than one plant regulator, and the synthetic 2, 6-DIPN is
similar in function and structure to 1-isopropyl-4, 6-
dimethylnaphthalene; 1-methyl-7-isopropylnaphthalene; and 4-isopropyl-
1, 6-dimethylnaphthalene, which are naturally-occurring compounds in
plant tissues, including those of potato.
    4. Comment 3. This comment is a request that the Agency provide
documentation of the natural occurrence of the three substances (1-
isopropyl-4, 6-dimethylnaphthalene; 1-methyl-7-isopropylnaphthalene;
and 4-isopropyl-1, 6-dimethylnaphthalene) to which 2, 6-DIPN is
similar.
    EPA response. 2, 6-Diisopropylnaphthalene is functionally and
structurally similar to the three referenced compounds, which are
naturally-occurring in plants. 1-isopropyl-4, 6-dimethylnaphthalene
(CAS No. 4545-23-7) is also known as daucalene or isocadalene and is
found in roots and plant oils:
     Bicchi et al., 1983. Journal of High Resolution
Chromatography and Chromatographic Communications 6(4): 213-215.
     Van Dooren et al., 1981. Planta Medica 42(4): 385-389).
    1-methyl-7-isopropylnaphthalene (CAS No. 490-65-3) is also known as
eudalene and is present in plant oils:
     Abegaz and Yohannes, 1982. Phytochemistry 21(7): 1791-
1793).
    4-isopropyl-1, 6-dimethylnaphthalene (CAS No. 483-78-3) is also
known as cadalin or cadelene, and is found in the foliage and wood of
trees, flowers, seeds, berries, hops and ferns:
     Chalchat et al., 1994. Journal of Essential Oil Research
6(3): 323-325.
     Dodd et al., 1994. Biochemical Systematics and Ecology
22(4): 393-400.
     El-Seedi et al., 1994. Phytochemistry 35(6): 1495-1497.
     Omata et al., 1990. Agricultural and Biological Chemistry
54(4): 1029-1033.
     Ekundayo and Hammerschmidt, 1988. Fitoterapia 59(1): 52-
54.
     Lawerance, 1984. Perfume and Flavor 9(5): 65-69.
     Tressel et al., 1983. Journal of Agricultural and Food
Chemistry 31(4): 892-897.
     Konecny et al., 1982. Collect. Czech. Chemistry
Communications 47(11): 3164-3169).
    5. Comment 4. In the fourth comment, the correspondent points out
that a rat metabolism study discussed in the 2, 6-
Diisopropylnaphthalene BRAD did not explain the ``fate of the remaining
77% of the administered dose,'' and asks if the conditional livestock
feeding study could account for it.
    EPA response. Although the submitted magnitude of the residue study
in livestock was conducted in a reasonable manner, it was designed to
determine the magnitude of 2, 6-DIPN residues (not residues from 2, 6-
DIPN metabolites) in cattle fed at up to 5.64 times the normal
application rate, and only in milk and edible tissues. It did not,
therefore, account for the fate of the remaining 77% of the
administered dose from the earlier rat metabolism study. The rat
metabolism study was also

designed to identify residues/metabolites of toxicological concern, and
the absence of a complete accounting of the administered dose was a
factor in determining the need for the livestock feeding study.
Furthermore, the cattle feeding study cannot be expected to resolve
metabolism questions arising from the rat data because the two species
may metabolize 2, 6-DIPN differently. The Agency is therefore
requiring, as a condition of registration, submission of a nature of
the residue study to determine the fate of the dose (i.e., to determine
the distribution of 2, 6-DIPN metabolites in livestock commodities),
and a laboratory-validated multi-residue analytical method. However,
because worst case (conservative) estimates were used to support the
time-limited tolerances established in this rule, EPA has concluded
that there is a reasonable certainty of no harm from the use of 2, 6-
DIPN during the short period while these studies are conducted.
    6. Comment 5. In this comment the correspondent observes from the
notice of filing (December 9, 2005 (70 FR 73234) (FRL-7748-5)) that the
petitioner is seeking use rates/tolerance levels higher than those
actually tested in the submitted residue trials.
    EPA response. The cited notice includes a discussion of information
and magnitude of the residue data previously submitted by the
petitioner to support a related request to amend the label of the 2, 6-
DIPN end-use product, EPA Registration No. 34704-843. That data, on
whole potato and potato peel, have been reviewed by the Agency and
found to adequately demonstrate that 2, 6-DIPN residues in both
commodities declined over time. Recalculations based on these storage
stability data for analytical samples, the increased application rate,
and more refined residue chemistry data including information on
secondary residues in cattle fed 2, 6-DIPN treated potato waste
resulted in significantly reduced risk (see discussion below and the
previous notice of filing of December 9, 2005, cited above). The
Agency's assessment of the new information (to project the residue
levels expected to result from an increased application rate) supports
the amended maximum yearly application rate of 1.5 (increased from 1.0)
pounds of active ingredient per 600 hundred[fxsp0]weight of potato.
Although the petitioner in their summary of PP 1F6338 referred to the
proposed application rate as 1.5 pounds of product per 600
hundred[fxsp0]weight of potato, any future references in this document
to the application rate will be expressed as pounds of active
ingredient per 600 hundred[fxsp0]weight of potato because (a) the end-
use product is 99.7% pure active ingredient, and (b) the subject of
this rule is the active ingredient. Available residue data also provide
adequate support to reduce the required period for holding treated
stored potato from 30 to zero days because in its analysis the Agency
considered data from samples collected on the day of treatment. The
adequacy of all of this data will be re-evaluated upon review of a
nature of the residue study for potato, which the Agency is requiring
as another condition of registration.
    7. Comment 6. Comment six cites the 2, 6-Diisopropylnaphthalene
BRAD (page 10) as stating that a developmental toxicity study in a
second species and a reproduction toxicity study were not available to
``...fully determine age-related differences in response.'' The
correspondent requests we address this lack of data, and states in this
comment, ``Since 2, 6-DIPN does not occur in nature, requirement of a
reproduction study would be appropriate.''
    EPA response. As indicated in the response to comment 1 above, 2,
6-DIPN was classified as a biochemical-like pesticide based on
functional and structural similarity to certain plant regulators, thus
qualifying for a reduced data set for registration (i.e., the data set
required by 40 CFR 158.690 to support registration of biochemical or
biochemical-like pesticides is reduced compared to that required for
conventional chemical pesticides). In the absence of the full
complement of developmental (in two species) and reproduction toxicity
studies, an added 10x uncertainty factor was retained for the reference
doses selected for dietary risk characterization. In addition, the
developmental toxicity study of 2, 6-DIPN considered by the Agency did
not indicate differences in sensitivity of maternal animals and their
offspring. Given these circumstances, the Agency has adequately
assessed age-related differences in responses to 2, 6-DIPN exposure by
retaining the 10x uncertainty factor in lieu of the second
developmental and reproduction toxicity studies.
    8. Comment 7. In this comment, the correspondent states that 2, 6-
DIPN is a pesticide for which pork may be tested under the U.S.
Department of Agriculture's Pesticide Data Program, which was developed
in coordination with the Agency's Health Effects Division, and asks (a)
if 2, 6-DIPN residues in pork have been found, and (b) why the required
livestock feeding study was limited to cattle.
    EPA response. No 2, 6-DIPN residues were found in pork because a
study with swine was not requested by the Agency. The conditionally-
required livestock feeding study was limited to cattle in alignment
with OPPTS Harmonized Guideline 860.1480, which states that, ``...in
most cases the results of the cattle feeding study will be used to
establish tolerances on goat, hog, horse, and sheep....'' This is
because the overall percentage of the potato commodities in the diet of
cattle is much higher than in the diet of swine (Table 1 of OPPTS
Harmonized Guideline 860.1000). Furthermore, of those potato
commodities utilized as feedstuffs, processed potato waste (i.e.,
potato, wet peel), where the majority of 2, 6-DIPN residue is expected
to occur, can represent a high percentage of the diet for cattle, but
is either not used, or used at less than 10%, in the diet for swine.
Testing of cattle rather than swine, therefore, represents the more
conservative, ``worst-case,'' scenario. Nonetheless, dietary
contributions of residues from swine fed 2, 6-DIPN treated potato were
factored into the Agency's dietary assessment by conservatively
assuming the same levels in pork commodities as those found in cattle.
    9. Comment 8. In this comment the correspondent observes from the
notice of filing (December 9, 2005 (70 FR 73234) (FRL-7748-5)) that,
except at the highest dose level, the petitioner reported 2, 6-DIPN
residues were not located in cow liver, an organ that usually
concentrates exogenous chemicals as it metabolizes them. The Agency is
asked to address if 2, 6-DIPN was radio-labeled for use in the cited
livestock feeding study.
    EPA response. Unless their purpose is to determine the nature of
the residue, feeding trials are conducted with standard analytical
methods without radio-labeled test material for determining the
presence of pesticide residues in meat, meat byproducts, milk, etc., to
establish the need for tolerances in those commodities and to develop
appropriate enforcement analytical methods. Radio-labeled test material
is used to evaluate absorption, distribution, metabolism (nature of the
residue), and excretion of an administered dose. Based on physical and
chemical properties, 2, 6-DIPN is soluble in non-polar solvents (e.g.,
fat), making it unlikely that 2, 6-DIPN will accumulate in the liver of
cattle fed treated potato waste. Also, in the livestock magnitude of
the residue study, 2, 6-DIPN residues were found in higher levels in
ruminant fat than liver. Tolerance levels in livestock

commodities were set accordingly. Should the conditionally-required
metabolism (nature of the residue in livestock) study be submitted, if
residues of 2, 6-DIPN and its metabolite(s) are found at some higher
level in cow liver, the Agency will re-evaluate its tolerance decision
based upon a new risk assessment revised to incorporate data on such
increased residues in cow liver. However, the existing residue data do
not indicate that 2, 6-DIPN accumulates in livestock liver.
    10. Comment 9. In this comment, the Agency is requested to assess
risk and exposure to 2, 6-DIPN using both a ``local milkshed'' and a
national average scenario (to account for the feeding of potato waste
containing pesticide residues to local cattle, from which meat/milk is
locally distributed), as was done in the Reregistration Eligibility
Document (page 25) for the conventional chemical, chlorpropham.
    EPA response. The ``local milkshed'' scenario assumes that finite
residues may be expected in milk and liver consumed by individuals
living in a highly localized area where cattle may be fed processed
potato waste from nearby potato processing plants (i.e., higher
exposure may be expected in rural communities where cattle are fed
peelings from treated potato). In the case of 2, 6-DIPN, since the
national average scenario is already based on a very conservative,
``worst case,'' scenario (that all potato nationwide are treated),
there is no need to duplicatively use a ``local milkshed'' scenario,
which also represents the worst case.
    11. Comment 10. In this comment, the correspondent states that
diisopropylnaphthalenes have commercial uses (primarily paper
production) in the U.S., and asks the Agency to address whether
aggregate exposure is likely and if the non-pesticidal commercial uses
of 2, 6-DIPN are likely to contribute to consumer exposure.
    EPA response. Section 408 (b)(2)(A)(ii) explicitly requires the
Agency to find that ``there is a reasonable certainty that no harm will
result from aggregate exposures, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' As discussed below, EPA has considered all available
information on non-dietary and non-occupational exposures in
establishing these time-limited tolerances. There is no potential for
exposure to residues of 2, 6-DIPN in drinking and ground water as a
result of application to potato stored in warehouses, where the
pesticide remains until the storage area is ventilated and 2, 6-DIPN
has degraded somewhat or evaporated. The FQPA requires conduct of an
aggregate risk assessment, considering all non-occupational sources,
including exposure from water, food, and residential use. But since
there are no registered residential or water uses, an aggregate
assessment for 2, 6-DIPN is not required. Pesticidal uses only are
aggregated; non-pesticide uses (i.e., the commercial uses identified in
the comment) are not part of this analysis.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of, and
to make a determination on aggregate exposure, consistent with section
408(b)(2) of the FFDCA, for time-limited tolerances for residues of 2,
6-DIPN, resulting from post-harvest applications to potato, in or on
fat (cattle, goat, hog, horse, sheep) at 0.8 ppm; liver (cattle, goat,
hog, horse, sheep) at 0.3 ppm; meat (cattle, goat, hog, horse, sheep)
at 0.1 ppm; meat byproducts (cattle, goat, hog, horse, sheep) at 0.1
ppm; milk at 0.1 ppm; potato at 2.0 ppm; and potato, wet peel at 6.0
ppm. EPA's assessment of the dietary exposures and risks associated
with establishing the time-limited tolerances follows.

A. Toxicological Profile

    EPA has previously evaluated the available toxicity data and
considered its validity, completeness, and reliability as well as the
relationship of the results of the studies to human health risk. EPA
has also considered available information concerning the variability of
the sensitivities of major identifiable subgroups of consumers,
including infants and children.
    In the Federal Register of August 8, 2003 (68 FR 47246) (FRL-7321-
61), EPA established time-limited tolerances (which were throughout
that final rule erroneously referred to as temporary tolerances) for
residues of the plant regulator 2, 6-diisopropylnaphthalene (2, 6-DIPN)
in or on the food commodities meat, meat byproducts, milk, potato
(peel) and potato (whole) at 1.35, 1.35, 0.7, 3, and 0.5 ppm,
respectively. Although not explicitly noted in the tolerance expression
(40 CFR 180.590) that these time-limited tolerances were limited to 2,
6-DIPN residues resulting from post-harvest application to potato, that
fact was implicitly noted throughout the final rule itself.
Nonetheless, this oversight is explicitly corrected in the new
tolerance expression for 2, 6-DIPN set forth in this final rule.
    The August 8, 2003 final rule included a summary of the Agency's
assessment of the health effects data submitted by the applicant, who
was seeking an exemption from the requirement of a tolerance, as
opposed to the time-limited numeric tolerances that the Agency
ultimately granted. Although the toxicity data do not indicate extra
sensitivity of offspring when compared with that of adult animals, due
to the application of uncertainty factors the data base does represent
a conservative FQPA assessment of potential age-related sensitivity or
acute effects other than lethality, notwithstanding the absence of a
developmental toxicity study in a second species, a multi-generation
reproduction toxicity study, or a range of doses adequate to induce a
full range of toxic responses (especially, potential acute effects in
any of the available studies). However, because 2, 6-DIPN has been
classified by the Agency as a biochemical-like active ingredient, it is
subject to a reduced data set which does not include the cited
developmental and reproductive toxicity data. Instead, the FQPA
criteria concerning the potential extra sensitivity of infants and
children

may be met by the application of a safety factor. Therefore, the August
8, 2003 final rule also announced that, in considering the sensitivity
of infants and children, the thousandfold safety factor (10x for
interspecies extrapolation, 10x for intraspecies variability and the
10x default safety factor) includes the retention of the FQPA default
tenfold uncertainty factor, which (in lieu of the cited data)
adequately accounts for age-related sensitivity for the subpopulations
of infants and children. The expiration date of the time-limited
tolerances was May 31, 2006.
    Summaries of the toxicological profile and other relevant health
effects data, in compliance with the requirements of the FFDCA, as
amended by the FQPA of 1996, were reported in the August 8, 2003,
Federal Register publication of the final rule establishing the time-
limited tolerances. Although the petitioner has not submitted the
conditionally-required independent laboratory validation of the
enforcement analytical methods and there is a newly-identified data gap
(nature of the residue in plants and livestock), based on (1) the
previously submitted data outlined in the August 8, 2003 Federal
Register final rule, and the rationale included therein, and (2) the
Agency's assessment of results from the new magnitude of the residue in
livestock study; the analytical enforcement methods to determine
residue in potato, potato peels and livestock commodities; and the
magnitude of the residue submission which presented recalculations of
previously submitted data to support proposed label amendments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to the U.S. population, including infants and
children, to 2, 6-DIPN, during the time period for which these time-
limited tolerances are established. This includes all anticipated
dietary exposures and all other exposures for which there is reliable
information.
    The conditionally-required magnitude of the residue study in
livestock (MRID 464650-01) involved testing at three dose levels in
dairy cattle. The dose levels were multiples (1x, 3x, and 10x) of the 9
ppm maximum theoretical dietary burden (MTDB) for dairy cattle which
was based on the original time-limited tolerances of 0.5 and 3 ppm in/
on whole potato and potato peels, respectively. Since the proposed
tolerances are 2.0 ppm in or on potato and 6.0 ppm in or on potato, wet
peel, the multiples of the revised MTDB (16 ppm) are 0.56x, 1.59x, and
5.64x. The highest residue levels were found in fat (0.095 ppm at
0.56x, 0.2 ppm at 1.59x and 0.74 ppm at 5.64x). The second highest
residue levels were found in milk cream (0.17 ppm at 5.64x). Whole milk
residue levels plateaued at approximately 0.025 ppm after 4 days'
feeding of the 5.64x test diet. At the end of the 29-day feeding study,
the residue levels of 2, 6-DIPN were at 0.033, 0.035, and 0.23 ppm in
milk, kidney, and liver, respectively at the 5.64x feeding level.
Although the highest multiple of the MTDB tested was fivefold to
sixfold, rather than the tenfold recommended in OPPTS Harmonized
Guideline 860.1480, the trial itself was conducted in a reasonable
manner. In the end, residues were found at levels below the proposed
time-limited tolerance levels for those matrices at an application rate
similar to the proposed new rate of 1.5 pounds of active ingredient per
600 hundred[fxsp0]weight of potato. The assumption of 100% crop treated
and the use of the results from the 5.64x dietary level provides an
adequate basis for estimating dietary exposures in the assessment of
potential risks associated with the normal (i.e., in accordance with
good agricultural practices) post-harvest use of 2, 6-DIPN on stored
potato as directed on the product label.
    The analytical methods submitted to enforce the time-limited
tolerance levels established for 2, 6-DIPN residues in potato, potato
peels, and in livestock commodities (MRIDs 464749-01, 464749-02, and
464650-02, respectively) are adequate for the purpose of this extension
and amendment of the time-limited tolerances for 2, 6-DIPN. Validation
of these methods by an independent laboratory remains a condition of
registration and must be submitted to the Agency for review in advance
of the new time-limited tolerance expiration date of August 1, 2009.
Furthermore, should the newly-imposed conditional data (nature of the
residue in plants and livestock) be performed, an independently
validated multi-residue laboratory method must be submitted to the
Agency for review in advance of the expiration date of August 1, 2009
for the new time-limited tolerances.
    The study in which previously submitted magnitude of the residue
data were recalculated (MRID 466005-01) to project residue levels for
the proposed increased application rate (from 1.0 to 1.5 lbs of active
ingredient per 600 hundred[fxsp0]weight of potato) adequately supports
the new maximum yearly application rate (which may be applied via
multiple treatments). Also acceptable is a proposal to reduce from 30
to zero days the required period for holding treated stored potato. The
highest residues of 2, 6-DIPN are 1.59 ppm for potato and 5.06 ppm for
potato peel at the zero day sampling. Since the proposed tolerance
levels exceed the extrapolated maximum residue values for the increased
application rate, the estimated risk characterization does not exceed
our level of concern.

B. Toxicological Endpoints

    1. Acute toxicity. EPA's discussion and analysis of acute toxicity
of 2, 6-DIPN can be found in the Federal Register of August 8, 2003 (68
FR 47246) (FRL-7321-61).
    2. Short- and intermediate-term toxicity. EPA's discussion and
analysis of short- and intermediate-term toxicity of 2, 6-DIPN can be
found in the Federal Register of August 8, 2003 (68 FR 47246) (FRL-
7321-61). Based on the information summarized in that final rule, the
104 mg/kg/day NOAEL is selected as the endpoint for this assessment.
    3. Chronic toxicity. EPA has established the Reference Dose (RfD)
for 2, 6-DIPN at 1 mg/kg/day. This RfD is based on results from the
subchronic and developmental toxicity studies described above.
    4. Carcinogenicity. No study results suggest that 2, 6-DIPN is
carcinogenic. See the EPA's discussion and analysis in the Federal
Register of August 8, 2003 (68 FR 47246) (FRL-7321-61).

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40
CFR 180.590) for the residues of 2, 6-DIPN, resulting from post-harvest
applications to potato, in or on a variety of food commodities: fat
(cattle, goat, hog, horse, and sheep) at 0.8 ppm; liver (cattle, goat,
hog, horse, and sheep) at 0.3 ppm; meat (cattle, goat, hog, horse, and
sheep) at 0.1 ppm; meat byproducts (cattle, goat, hog, horse, and
sheep) at 0.1 ppm; milk at 0.1 ppm; potato at 2.0 ppm; and potato, wet
peel at 6.0 ppm. Risk assessments were conducted by EPA to assess
dietary exposures from 2, 6-DIPN. These assessments were based on 100%
crop treated, maximum label application rate, and used the tolerance
levels (which exceeded reported residue levels).
    Acute dietary risk assessments are performed for a food-use
pesticide if a toxicological study has indicated the possibility of an
effect of concern occurring as a result of a 1-day or single exposure.
In the case of 2, 6-DIPN, the limited toxicity data base did not
indicate an acute endpoint, but the 100 mg/kg/day NOAEL from the
subchronic toxicity study (rounded from 104 mg/kg/day) was used to
evaluate potential

acute dietary exposure as a conservative basis for risk
characterization. Also, if the 50 mg/kg/day NOAEL from the
developmental toxicity study had been used to establish an acute RfD,
this choice would have been inconsistent with the use of the 100 mg/kg/
day NOAEL since it implies that exposure to repeated daily doses at 100
mg/kg/day is potentially less hazardous than a single dose at 50 mg/kg/
day. Given the minimal nature of the responses in the subchronic and
developmental toxicity studies and the fact that the NOAEL from the
developmental study is only appropriate to the subgroup of females 13-
49 years of age, using the 100 mg/kg/day RfD for the acute and chronic
dietary assessments is more appropriate for assessing risk for other
subgroups and the general population. Therefore, a conservative
interpretation of these endpoints indicated the need for an acute
dietary exposure assessment. The 100 mg/kg/day endpoint was also
interpreted as requiring a chronic dietary exposure assessment.
    Acute and chronic dietary exposure assessments for 2, 6-DIPN were
conducted using the Dietary Exposure Evaluation Model software
(DEEMTM version 1.30) which incorporates consumption data
from USDA's Continuing Surveys of Food Intakes by Individuals (CSFII,
1994-1996/1998).
    For acute exposure assessments, individual 1-day food consumption
data define an exposure distribution which is expressed as a percentage
of the acute population adjusted dose (for 2, 6-DIPN, aPAD = 0.1 mg/
kg). For chronic exposure and risk assessment, an estimate of the
residue level in each food or food-form (e.g., orange or orange juice)
on the commodity residue list is multiplied by the average daily
consumption estimate for the food or food-form. The resulting residue
consumption estimate for each food or food-form is summed with the
residue consumption estimate for all other food or food-forms on the
commodity residue list to arrive at the total estimated exposure.
Exposure estimates are expressed as mg/kg body weight/day and as a
percent of the 2, 6-DIPN cPAD (0.1 mg/kg/day). These procedures are
performed for each population subgroup.
    2. From drinking water. Because 2, 6-DIPN treatment of stored
(i.e., post-harvest) potato occurs inside (in warehouses, for example),
no concern from exposure through water is expected regarding acute and
chronic dietary risk assessment. For this reason, the dietary risk
assessment did not include drinking water values.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). 2, 6-DIPN is not
registered for use on any sites that would result in residential
exposure. Furthermore, because the registered use involves applications
via a closed system, no exposure of consequence is expected to mixers
or loaders.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to 2, 6-DIPN and any other
substances. In this case, 2, 6-DIPN and the three functionally and
structurally similar substances all act as plant regulators by a ``mode
of action'' that is specific to plants, and therefore, their common
mode of action is unlikely to be relevant to a mechanism of toxicity in
animals or humans. The comparison of 2, 6-DIPN with three naturally
occurring alkyl substituted naphthalenes is made to demonstrate
biological activity (plant regulation, in this case), which the Agency
has characterized as a non-toxic mode of action with respect to
pesticidal activity. For the purposes of this tolerance action,
therefore, EPA has not assumed that 2, 6-DIPN has a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the policy
statements released by EPA's Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA's Web site at
http://www.epa.gov/pesticides/cumulative.

D. Aggregate Risks and Determination of Safety for U.S. Population and
for Infants and Children

    1. Acute risk. Acute dietary exposure estimates were based on the
tolerances (supported by the residue trial results, i.e. the tolerance
levels as established in this final rule) and worst-case assumptions.
    As reported in the Federal Register of August 8, 2003 (68 FR 47246)
(FRL-7321-61), EPA established a RfD of 1 mg/kg/day, and the aPAD and
cPAD at 0.1 mg/kg/day.
    For the U.S. population, acute dietary exposure was estimated to be
0.009167 mg/kg/day. This value represented 9.17% of the aPAD (27.5% if
the aPAD is calculated using the same uncertainty factor of 3,000 as
that described above for the IRIS assessment of naphthalene; aPAD =
0.033 mg/kg). The subpopulation with the highest acute dietary exposure
estimate was children 1 to 2 years of age (0.022197 mg/kg/day, 22.20%
of the aPAD; 66.6% when using the IRIS adjustment). If the 50 mg/kg/day
NOAEL from the developmental toxicity study is used to derive an aPAD,
the exposure for the subgroup females 13 to 49 years of age (0.006701
mg/kg/day) represented 6.7% of the subgroup-specific aPAD (0.05 mg/kg);
this subgroup's exposure represented 13.4% of the 0.05 mg/kg aPAD.
Therefore, the acute dietary exposures to all the subpopulations in the
analysis did not exceed EPA's level of concern (>100% of the aPAD).
    These dietary exposure estimates based on the 0.1 mg/kg/day aPAD
are less than previously described by the Agency. For example, the
previous estimated dietary exposure for the general U.S. population was
0.023113 mg/kg/day which is slightly more than twice the current
estimate. Residue data have been refined and, accordingly, support
revised tolerances (meat, meat byproducts and milk tolerances decrease
and new livestock commodities liver and fat are added based upon the
low or undetected residues from the livestock feeding trial; potato and
potato, wet peel tolerances increase based upon the residue data and
increased application rate) as follows: the previous tolerance on
potato (0.5 ppm) increases to 2.0 ppm; the 3 ppm tolerance on potato,
wet peel, increases to 6.0 ppm; the 1.35 ppm tolerances for meat and
meat byproducts decrease to 0.1 ppm; the milk tolerance of 0.7 ppm
drops to 0.1 ppm; and tolerances for liver (0.3 ppm) and fat (0.8 ppm)
are added. Overall, these revised tolerances have significantly reduced
estimated dietary exposures and the associated potential risks when
calculations are based on the 0.1 mg/kg/day aPAD.
    2. Chronic risk. EPA has concluded that the chronic dietary
exposure estimates based on the 0.1 mg/kg/day cPAD are also less than
previously described. For example, the previous

chronic dietary exposure estimate for the general population was
0.006939 mg/kg/day, which is more than twice the current estimate of
0.002718 mg/kg/day (2.7% of the cPAD). The subpopulation with the
highest chronic dietary exposure estimate was children 1 to 2 years of
age, with estimated exposures of 0.008068 mg/kg/day, which constitutes
8.1% of the cPAD. The previous chronic exposure estimates were more
than twice the values determined in the current exposure assessment for
the same reasons (refinements due to the availability of additional
data, and increased application rate) as for the dietary exposure
estimates described above. The chronic dietary exposures to all the
subpopulations, as estimated in 2003, and the current, even lower,
values estimated herein, do not exceed the Agency's level of concern.
    3. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the U. S. population, including infants and children, from aggregate
exposure to residues of 2, 6-DIPN resulting from post-harvest
applications, undertaken in accordance with good agricultural practices
and label directions, to potato. This includes all anticipated dietary
exposures and all other exposures for which there is reliable
information. In arriving at this conclusion, and as stated earlier in
Unit III.A. of this preamble, it is important to re-emphasize that EPA,
pursuant to FFDCA section 408(b)(2)(C), has retained the tenfold margin
of exposure in order to adequately account for potential pre- and post-
natal toxicity and completeness of the data with respect to exposure
and toxicity to infants and children.

IV. Other Considerations

A. Metabolism in Plants and Animals

    The nature of the residue in stored potato is not adequately
understood for the purpose of establishing non-time-limited/permanent
tolerances. The regulation at 40 CFR 158.690(a) requires that nature of
the residue data be submitted for plants when the application rate of
the product exceeds a level determined to be comparable to 0.7 ounces
active ingredient per application (when the application rate is not
expressed in terms of ounces per acre per application). Calculations
based on Agriculture Statistics 2005 indicate that the new maximum
single application rate of 1.5 pounds active ingredient per 600
hundred[fxsp0]weight of potato is approximately equal to 14 ounces of
active ingredient per acre per application, thus triggering the data
requirement. A study conducted in accordance with OPPTS Harmonized
Guideline 860.1300 is conditionally required to determine the
residue(s) of concern in or on stored potato treated with 2, 6-DIPN,
and must be submitted so as to permit an Agency decision on its
adequacy in advance of the August 1, 2009 expiration date for the time-
limited tolerances.
    The nature of the residue in livestock is not adequately understood
for the purpose of establishing non-time-limited/permanent tolerances.
The submitted metabolism study showed the total urinary excretion of 2,
6-DIPN metabolites to be about 23% of the administered dose, while the
fate of the the remaining 60% or 77% of the administered dose was
unexplained. Submission of a nature of the residue study in livestock
is conditionally required based on the same application rate criteria
discussed above for the nature of the residue in plants requirement. A
study conducted in accordance with OPPTS Harmonized Guideline 860.1300
is conditionally required to determine the distributions of residue(s)
of 2, 6-DIPN and its metabolites in livestock commodities, and must be
submitted so as to permit an Agency decision on its adequacy in advance
of the August 1, 2009 expiration date for the time-limited tolerances.
    Any multi-residue methods developed in conjunction with these
conditionally required nature of the residue studies (in plants and
livestock) must be validated by an independent laboratory and also be
submitted so as to permit an Agency decision on adequacy in advance of
the August 1, 2009 expiration date for the time-limited tolerances.
    Notwithstanding these data gaps and conditions of registration, the
EPA has determined, based on the available toxicological data, the
thousandfold uncertainty factor, and the levels of exposure, that there
is a reasonable certainty that no harm will result to the U.S.
population, including infants and children, from aggregate exposure to
the pesticide (2, 6-DIPN) and its residues during the period of the
time-limited tolerances.

B. Analytical Enforcement Methodology

    High Performance Liquid Chromatography (HPLC)/Ultraviolet(UV) and
gas chromatography (GC)/Mass Spectroscopy (MS) methods were used to
measure the levels of 2, 6-DIPN in the residue studies. However, as a
condition of the registration granted for 2, 6-DIPN on July 31, 2003,
the petitioner was required to submit an independent laboratory
validation (ILV) of the analytical enforcement method(s) used to detect
residues of 2, 6-DIPN in potato and livestock food commodities. Because
these data have not been submitted, the ILV remains a condition of
registration for 2, 6-DIPN. Furthermore, a newly-imposed condition of
registration is the submission of nature of the residue data for plants
and livestock, and the Agency is placing a 3-year time-limitation on
the established numeric tolerances. Multi-residue method(s) associated
with those conditional data are required, and also must be validated by
an independent laboratory. During this 3-year time period the
petitioner must supply all the required ILV, allowing adequate time
from its submission to permit the Agency's review and decision in
advance of the August 1, 2009 expiration date for the time-limited
tolerances.

C. International Residue Limits

    There are no Codex Alimentarius Commission (Codex) Maximum Residue
Levels (MRLs) for residues of 2, 6-DIPN.

V. Conclusion

    A data gap currently exists for an independent laboratory
validation (ILV) of the analytical enforcement method(s) used to detect
residues of 2, 6-DIPN in potato and livestock food commodities, because
the petitioner failed to submit these data as was required by a
condition of the July 31, 2003 registration of 2, 6-DIPN. There is also
imposed a new condition of registration; nature of the residue in
plants and livestock must be submitted. Any multi-residue method(s)
developed in association with these conditionally required data must
also be validated by an independent laboratory. All tolerances are
time-limited because of these data gaps. The time limitation allows for
conduct, submission, and review of the data. Notwithstanding these data
gaps and conditions of registration, the EPA has determined, based on
the available toxicological data, the thousandfold uncertainty factor,
and the levels of exposure, that there is a reasonable certainty that
no harm will result to the U.S. population, including infants and
children, from aggregate exposure to the pesticide (2, 6-DIPN) and its
residues during the period of the time-limited tolerances.
    Based on the information and rationale cited in the final rule of
August 8, 2003, plus the results of the new magnitude of the residue in
livestock study; the analytical enforcement methods to determine

residue in potato, potato peel and livestock commodities; and the
magnitude of the residue submission which presented recalculations of
previously submitted data to support proposed label amendments, the
Agency has determined that the establishment of the time-limited
tolerances by amending 40 CFR 180.590 in the manner set forth in this
final rule will be safe.
    Therefore, the following time-limited tolerances are established
for residues of 2, 6-DIPN in or on the following commodities resulting
from post-harvest applications to potato: fat (cattle, goat, hog,
horse, and sheep) at 0.8 ppm; liver (cattle, goat, hog, horse, and
sheep) at 0.3 ppm; meat (cattle, goat, hog, horse, and sheep) at 0.1
ppm; meat byproducts (cattle, goat, hog, horse, and sheep) at 0.1 ppm;
milk at 0.1 ppm; potato at 2.0 ppm; and potato, wet peel at 6.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes time-limited tolerances under section
408(d) of the FFDCA in response to a petition submitted to the Agency.
The Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). Because this rule
has been exempted from review under Executive Order 12866 due to its
lack of significance, this rule is not subject to Executive Order
13211, Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final
rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a petition under section 408(d) of the
FFDCA, such as the time-limited tolerances in this final rule, do not
require the issuance of a proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
In addition, the Agency has determined that this action will not have a
substantial direct effect on States, on the relationship between the
national government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this rule does not have any ``tribal implications''
as described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 14, 2006.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.590 is revised to read as follows:

Sec.  180.590  2, 6-Diisopropylnaphthalene (2, 6-DIPN); tolerances for
residues.

    (a) General. Time-limited tolerances are established for residues
of 2, 6-DIPN in or on the following commodities resulting from post-
harvest applications to potato, when 2, 6-DIPN is used in accordance
with good agricultural practices:

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Cattle, fat...................................          0.8       8/1/09
Cattle, liver.................................          0.3       8/1/09
Cattle, meat..................................          0.1       8/1/09
Cattle, meat byproducts.......................          0.1       8/1/09
Goat, fat.....................................          0.8       8/1/09
Goat, liver...................................          0.3       8/1/09

Goat, meat....................................          0.1       8/1/09
Goat, meat byproducts.........................          0.1       8/1/09
Hog, fat......................................          0.8       8/1/09
Hog, liver....................................          0.3       8/1/09
Hog, meat.....................................          0.1       8/1/09
Hog, meat byproducts..........................          0.1       8/1/09
Horse, fat....................................          0.8       8/1/09
Horse, liver..................................          0.3       8/1/09
Horse, meat...................................          0.1       8/1/09
Horse, meat byproducts........................          0.1       8/1/09
Milk..........................................          0.1       8/1/09
Potato........................................          2.0       8/1/09
Potato, wet peel..............................          6.0       8/1/09
Sheep, fat....................................          0.8       8/1/09
Sheep, liver..................................          0.3       8/1/09
Sheep, meat...................................          0.1       8/1/09
Sheep, meat byproducts........................          0.1       8/1/09
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E6-14545 Filed 8-31-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 85, Number 14 (Wednesday, January 22, 2020)]
[Notices]
[Pages 3676-3677]
[FR Doc No: 2020-00959]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 8865-008]

Notice of Withdrawal of Existing Licensee's Notice of Intent To
File a Subsequent License Application, and Soliciting Pre-Application
Documents and Notices of Intent To File a License Application; N.
Stanley Standal, Jr.

    The current license for the Stevenson No. 1 Hydroelectric Project
No. 8865 (Stevenson No. 1 Project) was issued with an effective date of
July 1, 1984, for a term of 40 years, ending June 30, 2024.\1\ The 70
kilowatt (kW) project is located on an unnamed tributary to the Snake
River. On June 28, 2019, N. Stanley Standal, Jr. (Mr. Standal) filed an
incomplete Notice of Intent (NOI) to file an application for a
subsequent license for the Stevenson No. 1 Project, pursuant to section
16.6 of the Commission's regulations.\2\ Mr. Standal failed to file an
accompanying pre-application document (PAD), pursuant to section 16.7
of the Commission's regulations.\3\
---------------------------------------------------------------------------

    \1\ Lynn E. Stevenson, 34 FERC 62,531 (1986).
    \2\ 18 CFR 16.6(c) (2019). At least five years before the
expiration of a license for a major water power project, the
licensee must file with the Commission an NOI that contains an
unequivocal statement of the licensee's intention to file or not to
file an application for a new license. See also 18 CFR 5.5 (2019).
    \3\ 18 CFR 16.7(d)(1) (2019). A licensee must, at the time it
files an NOI pursuant to sections 5.5 and 16.6, provide a copy of
the PAD required by section 5.6 of the Commission's regulations to
the entities specified in that paragraph. See 18 CFR 5.6 (2019).
---------------------------------------------------------------------------

    On July 17, 2019, Commission staff waived the provision of section
5.6(a)(1) that requires the filing of a PAD at the same time that the
NOI is filed and extended the deadline for filing a complete NOI and
the PAD by 90 days. On October 12, 2019, Joy Heller contacted
Commission staff on behalf of Mr. Standal and stated that more
information would be filed before October 31, 2019. On October 30,
2019, Mr. Standal filed a revised NOI but failed to file a PAD. On
November 19, 2019, Commission staff informed Mr. Standal that if a PAD
was not filed within 30 days, Commission staff would consider the lack
of response as an indication that he is no longer interested in seeking
a subsequent license to continue operating the project and a withdrawal
of his NOI to seek a subsequent license. Despite repeated efforts to
contact Mr. Standal, he has not returned staff calls or filed the
requisite PAD. Commission staff therefore consider Mr. Standal's NOI as
withdrawn.
    Pursuant to section 16.23(b) of the Commission's regulations, when
an existing licensee fails to file a complete NOI and PAD within five
years of expiration of the current license, the Commission must solicit
applications from potential applicants other than the existing
licensee.\4\ Any party interested in filing a license application or
exemption (i.e., a potential applicant) for the project must file an
NOI and PAD within 90 days from the date of this notice.\5\ While the
integrated

licensing process is the default process for preparing an application
for a new license, a potential applicant may request to use alternative
licensing procedures when it files its NOI.\6\
---------------------------------------------------------------------------

    \4\ 18 CFR 16.23(b) (2019).
    \5\ Pursuant to section 16.24(b)(1) of the Commission's
regulations, the existing licensee is prohibited from filing an
application either individually or in combination with other
entities. 18 CFR 16.24(b)(1) (2019).
    \6\ 18 CFR 5.3(b) (2019).
---------------------------------------------------------------------------

    Applications for a subsequent license or exemption from potential
applicants for the Stevenson No. 1 Project must be filed within 24
months prior to the expiration of the existing license.\7\
---------------------------------------------------------------------------

    \7\ 18 CFR 16.20(c) (2019).
---------------------------------------------------------------------------

    Questions concerning the process for filing an NOI should be
directed to Julia Kolberg at<PHONE_NUMBER> or<EMAIL_ADDRESS>
    Dated: January 15, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-00959 Filed 1-21-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 125 (Thursday, June 30, 2022)]
[Proposed Rules]
[Pages 39039-39043]
[FR Doc No: 2022-13985]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket DOT-OST-2022-0037]

Department of Transportation Drug and Alcohol Testing Data

AGENCY: Office of the Secretary, Transportation (DOT).

ACTION: Request for information.

-----------------------------------------------------------------------

SUMMARY: In March 2021, the Government Accountability Office (GAO)
published a report titled ``DOT Has Taken Steps to Verify and Publicize
Drug and Alcohol Testing Data but Should Do More.'' The report examines
how the Department of Transportation (DOT) uses drug and alcohol
testing data, how DOT verifies that data are reliable, and whether DOT
follows key actions for transparently reporting drug and alcohol
testing data. The drug and alcohol testing data are primarily used by
the DOT modal administrations and the United States Coast Guard (USCG)
to determine the random testing rate(s) for safety-sensitive employees
in each industry each year. In response to a recommendation from the
GAO Report, DOT requests information from potential users in the public
to determine if there is a broader audience for the public data,
consistent with key actions for open government data.

DATES: Comments on this notice must be received on or before August 1,
2022.

ADDRESSES: You may submit comments identified by Docket Number DOT-OST-
2022-0037 using any of the following methods:
     Federal eRulemaking Portal: Go to https://
www.regulations.gov/docket/

DOT-OST-2022-0037/document. Follow the online instructions for
submitting comments.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m.
and 5 p.m. ET, Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these methods. See the
``Public Participation and Request for Comments'' portion of the
SUPPLEMENTARY INFORMATION section for instructions on submitting
comments, including collection of information comments for the Office
of Information and Regulatory Affairs, OMB.

FOR FURTHER INFORMATION CONTACT: Mike Huntley, Office of Drug and
Alcohol Policy and Compliance, 1200 New Jersey Avenue SE, Washington,
DC 20590; telephone number<PHONE_NUMBER>; [email protected]. If you
have questions on viewing or submitting material to the docket, contact
Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

DOT Drug and Alcohol Testing Program Overview

    Safety is the top priority of DOT. A cornerstone of our safety
policy is ensuring that transportation providers across all modes--on
roads, rails, water, or in the air, over land and underground--employ
operators who do not use illicit drugs or misuse alcohol. The
Department works towards deterring the use of illicit drugs and the
misuse of alcohol in the transportation industries, and creating
prevention and treatment opportunities for transportation employers and
employees.
    Since 1988, DOT has regulated the process by which employers in the
different transportation industries (aviation, trucking, rail, transit,
pipeline, and maritime) must test their employees for drug and alcohol
use. Nearly 6 million people performing safety sensitive transportation
jobs are covered by the DOT drug and alcohol regulations, including
pilots and flight attendants, truck drivers, subway operators, ship
captains, pipeline controllers, aircraft mechanics, locomotive
engineers, bus drivers, and others. The DOT regulations govern the drug
and alcohol testing process for pre-employment, random, post-accident,
reasonable suspicion/cause, and required testing after an employee
returns to work after failing or refusing a test. More than 6 million
drug and alcohol tests are conducted each year under the DOT program.

History of DOT Drug and Alcohol Testing Program

    DOT first published its drug testing procedures regulation, 49 CFR
part 40 (``part 40''), on November 21, 1988 (53 FR 47002) as an interim
final rule. The rule was based on the Department of Health and Human
Services (HHS) guidelines for Federal agency employee drug testing (53
FR 11790; April 11, 1988), with some changes to fit the transportation
workplace. DOT published a final rule responding to comments on the
interim rule a year later (54 FR 49854; December 1, 1989), that
included, among other things, a provision for a 5-panel drug test for
cocaine, marijuana, phencyclidine, amphetamines, and opiates.
    Under the Omnibus Transportation Employee Testing Act (OTETA) of
1991, codified at 49 U.S.C. 45102 and 45104 (aviation industry
testing), 49 U.S.C. 20140 (rail), 49 U.S.C. 31306 (motor carrier), and
49 U.S.C. 5331 (transit), DOT was required to implement alcohol testing
programs in various transportation industries.\1\ In response to OTETA,
DOT added alcohol testing procedures to part 40 in a final rule
published on February 15, 1994 (59 FR 7340).
---------------------------------------------------------------------------

    \1\ OTETA also directed other changes to DOT's substance abuse-
related programs for most transportation industries that the
Department regulates. With respect to drug testing procedures, the
Act added a requirement for using the ``split sample'' approach to
testing which Congress believed would provide an additional
safeguard for employees.
---------------------------------------------------------------------------

    While there have been periodic updates to part 40 over the years,
the DOT drug and alcohol testing requirements have remained
fundamentally the same since the time that they were first established
as noted above.
    Part 40 is a DOT-wide regulation that prescribes how drug and
alcohol testing is conducted, who is authorized to participate in the
drug and alcohol testing program, and what employees must do before
they may return to duty following a drug and/or alcohol violation. In
addition, the Federal Aviation Administration (FAA), the Federal Motor
Carrier Safety Administration (FMCSA), the Federal Railroad
Administration (FRA), the Federal Transit Administration (FTA), the
Pipeline and Hazardous Materials Administration (PHMSA), and the USCG
have each established specific regulations that spell out their
prohibitions on drug use and alcohol misuse, who is subject to the
regulations, what testing is authorized, when testing is authorized,
and the consequences for violating the drug and alcohol testing
regulations. The DOT modal administrations and the USCG incorporate
part 40 into their regulations and enforce compliance of their
respective regulations.
    At the present time, only urine specimens are authorized for use in
DOT drug testing.\2\ These urine specimens are collected by a qualified
collector and sent to a laboratory certified by the HHS National
Laboratory Certification Program for screening and confirmation. DOT
requires testing for (1) marijuana, (2) cocaine, (3) opioids (codeine,
morphine, heroin, hydrocodone, hydromorphone, oxycodone, oxymorphone),
(4) phencyclidine (PCP), and (5) amphetamines, methamphetamines, and
methylenedioxymethamphetamine (MDMA). Alcohol testing involves
analyzing breath or saliva specimens for initial (screening) tests, and
breath specimens for confirmation tests. The breath/saliva specimen is
collected by a qualified Breath Alcohol Technician or Screening Test
Technician (as appropriate) and analyzed by an alcohol testing device
approved by the National Highway Traffic Safety Administration.
---------------------------------------------------------------------------

    \2\ DOT published a notice of proposed rulemaking on February
28, 2022 [87 FR 11156] that proposes to add oral fluid specimens to
part 40 for use in the DOT drug testing program.
---------------------------------------------------------------------------

Drug and Alcohol Testing Management Information System (MIS) Data

    Employers subject to DOT or USCG drug and alcohol testing
regulations must submit annual drug and alcohol testing data as
required by their respective DOT modal administration or the USCG (see
49 CFR 40.26). When submitting drug and alcohol testing data, employers
are required to use the standardized, one-page ``Drug and Alcohol
Testing MIS Data Collection Form'' (MIS Form) provided in Appendix H to
part 40.\3\ FAA, FMCSA, FRA, FTA, and USCG now permit (and prefer)
employers to submit the required drug and alcohol testing data
electronically, while PHMSA requires the required data be submitted
electronically.
---------------------------------------------------------------------------

    \3\ A copy of the MIS Form has been placed in the docket for
this notice.
---------------------------------------------------------------------------

    An employer collects and compiles drug and alcohol testing data
generated throughout the year by their company's drug and alcohol
testing program, and

submits that data in its annual filing of the MIS Form. Specifically,
for each employee category, an employer is required to provide (1) drug
testing data (number of verified negative tests, verified positive
tests (for each drug), refusal to test results (adulterated,
substituted, shy bladder, others), and cancelled results), and (2)
alcohol testing data (number of screening tests above and below 0.02,
number of confirmation tests above and below 0.04, refusal to test
results (shy lung, others) and cancelled results) for each type of test
conducted (e.g., pre-employment, random, post-accident, reasonable
suspicion/cause, return-to-duty, or follow-up).
    The employer must complete the MIS Form and certify that the
information is accurate. The annual drug and alcohol testing data
submitted for a specific calendar year is to be submitted by March 15th
of the following calendar year. The completed MIS Form contains only
aggregate data, and does not contain any employee-specific information.

How the MIS Data Is Used

    The DOT modal administrations and the USCG use the drug and alcohol
MIS testing data primarily to determine the random testing rate(s) for
safety-sensitive employees in each industry for subsequent years.\4\
Specifically, each DOT modal administration and the USCG uses the
random drug testing positive/refusal rate and the random alcohol
testing violation rate, as applicable and respectively, from the prior
year to determine the random testing rate in the following calendar
year.
---------------------------------------------------------------------------

    \4\ In addition to using drug and alcohol testing data to
calculate the annual random testing rate, DOT has periodically used
that data to target educational outreach to the industry.
---------------------------------------------------------------------------

    All five of the modal administrations and USCG require their
regulated employers to conduct random drug tests. Their respective
regulations provide that the minimum annual percentage rate for random
drug testing for the industry will be either 25 or 50 percent,
depending on the industry-wide random drug testing positive/refusal
rate reported for the previous calendar year or years. For example, if
the random drug testing positive/refusal rate is at or above 1 percent,
then the modal administration or USCG will increase the minimum annual
percentage rate for random drug testing for the following year to 50
percent or make no adjustment if it is already at 50 percent. If the
minimum annual percentage rate for random drug testing is at 50 percent
and the positive/refusal rate is less than 1 percent for 2 consecutive
years, then the DOT modal administration or USCG has the discretion to
lower the minimum annual percentage rate for random drug testing to 25
percent for the following year. For 2022, the minimum annual percentage
rate for random drug testing is set at 50 percent for three DOT modal
administrations (FMCSA, FTA, and PHMSA) and the USCG, and at 25 percent
for FAA and FRA (both for FRA maintenance-of-way (MOW) employees and
FRA covered service employees).\5\
---------------------------------------------------------------------------

    \5\ See https://www.transportation.gov/odapc/random-testing-rates.
---------------------------------------------------------------------------

    Four of the five DOT modal administrations require random alcohol
testing (FRA, FAA, FMCSA, and FTA).\6\ Their respective regulations
provide that the minimum annual percentage rate for random alcohol
testing for the industry will be 10, 25, or 50 percent. These DOT modal
administrations adjust this alcohol testing rate for safety-sensitive
employees based on their respective industry-wide random alcohol
testing violation rate reported for the previous calendar year or
years. For example, regardless of whether the random testing rate is
50, 25, or 10 percent, if the violation rate is 1 percent or more for a
year, then the modal administration will increase the alcohol testing
rate for the next year to 50 percent, or make no adjustment if it is
already at 50 percent. The 2022 random alcohol testing rate is 10
percent for all four modal administrations.\7\
---------------------------------------------------------------------------

    \6\ PHMSA and the USCG do not require random alcohol testing.
    \7\ See https://www.transportation.gov/odapc/random-testing-rates.
---------------------------------------------------------------------------

    The DOT modal administrations and the USCG publish annual notices
in the Federal Register that outline the prior years' positive/refusal
rates or alcohol violation rates, as relevant, and state the minimum
annual percentage rate(s) for random testing for the next calendar
year.\8\ The minimum annual percentage rate for random testing is the
specified minimum percentage of safety-sensitive employees that
employers must randomly select and test throughout the calendar year.
Employers may select and test at a higher rate but must select and test
at the minimum mandatory rate to comply with the respective modal
regulations.
---------------------------------------------------------------------------

    \8\ FMCSA only publishes a Federal Register notice if its
testing rate changes.
---------------------------------------------------------------------------

Support for Patients and Communities Act

    Federal Bill H.R. 6., the ``Substance Use-Disorder Prevention that
Promotes Opioid Recovery and Treatment for Patients and Communities
Act'' (the ``SUPPORT Act'') was signed into law on October 24, 2018.

Drug and Alcohol Testing MIS Database

    Section 8103 of the SUPPORT Act, titled ``Department of
Transportation Public Drug and Alcohol Testing Database'' required DOT
to, not later than March 31, 2019, establish and make publicly
available on its website a database of the drug and alcohol testing
data reported by employers for each mode of transportation, and update
the database annually. Specifically, for each mode of transportation,
the database must include (1) the total number of drug and alcohol
tests by type of substance tested; (2) the drug and alcohol test
results by type of substance tested; (3) the reason for the drug or
alcohol test, such as preemployment, random, post-accident, reasonable
suspicion or cause, return-to-duty, or follow-up, by type of substance
tested; and (4) the number of individuals who refused testing.
    In response to the above, DOT published aggregated data from its
internal database on its website in March 2019 for each mode (i.e.,
FRA, FAA, FMCSA, FTA, and PHMSA) and the USCG by substances tested
(drugs or alcohol), by reason for testing, and by year (2003 through
2018). The database has since been updated annually to include the most
recent available data for 2019 and 2020. The database may be accessed
at https://www.transportation.gov/odapc/DOT_Agency_MIS_Data. The
database does not contain any personally identifiable information.

GAO Report on DOT's Collection and Use of Drug and Alcohol Testing Data

    Section 8104 of the SUPPORT Act, titled ``GAO Report on Department
of Transportation's Collection and Use of Drug and Alcohol Testing
Data,'' required GAO, not later than 2 years after the date the DOT
public drug and alcohol testing database was established under Section
8103 of the Act, to (1) review the DOT drug and alcohol testing MIS,
and (2) submit to the Committee on Commerce, Science, and
Transportation of the Senate and the Committee on Transportation and
Infrastructure of the House of Representatives a report on the review.
The GAO Report was required to include (1) a description of the process
DOT uses to collect and record drug and alcohol testing data submitted
by employers for each mode of transportation, (2) an assessment of
whether and if so, how DOT uses the data in carrying out its
responsibilities,

and (3) an assessment of the DOT public drug and alcohol testing
database required under the Act. The Report was to include
recommendations regarding how DOT can best use the drug and alcohol
testing data, any improvements that could be made to the process by
which the data is collected from employers, and whether and, if so, how
the DOT drug and alcohol testing database could be made more effective.
    Pursuant to the above, GAO conducted a performance audit on the DOT
drug and alcohol testing data from October 2019 to March 2021. In
conducting the audit, GAO reviewed relevant laws and regulations, among
other things. To determine how DOT verifies that data are reliable, GAO
reviewed documents, analyzed data in the DOT internal database from
calendar years 2003 through 2018, and interviewed DOT officials. GAO
also reviewed the DOT public website and compared it to key actions for
open government data.
    In March 2021, GAO published a report titled ``DOT Has Taken Steps
to Verify and Publicize Drug and Alcohol Testing Data but Should Do
More.'' \9\ The report examines (1) how DOT uses drug and alcohol
testing data, (2) how DOT verifies that data are reliable, and (3)
whether DOT follows key actions for transparently reporting drug and
alcohol testing data.
---------------------------------------------------------------------------

    \9\ A copy of the GAO Report (Report GAO-21-296) has been placed
in the Docket for this notice.
---------------------------------------------------------------------------

    GAO made three recommendations to DOT \10\ as follows:
---------------------------------------------------------------------------

    \10\ GAO's Recommendation 2 applies to the USCG only, and not to
DOT.
---------------------------------------------------------------------------

    (1) ``The Secretary of Transportation should direct the
Administrators of FAA, FMCSA, FRA, FTA, and PHMSA to: (1) evaluate the
different processes used by each modal administration to verify drug
and alcohol testing data--including comparing data to records during
inspections, checking data for errors manually or with software, and
contacting employers that do not submit a report or submit an
incomplete report--and (2) determine what, if any, additional steps
should be taken to improve the reliability of the information.
(Recommendation 1)''
    (2) ``The Director of ODAPC should disclose known limitations of
drug and alcohol testing data on DOT's website, consistent with key
actions for open government data. (Recommendation 3)''
    (3) ``The Director of ODAPC should reach out to potential users in
the public to determine if there is a broader audience for the public
data, consistent with key actions for open government data, and if a
broader audience is identified, engage with users to evaluate the
benefits and costs of adopting additional key actions for open
government data and any other possible improvements to the website.
(Recommendation 4)''
    Regarding Recommendation 3 and Recommendation 4, GAO found that
DOT's drug and alcohol testing website, which DOT published in March
2019 as required by the SUPPORT for Patients and Communities Act,
follows eight of 16 key actions that GAO has previously identified for
transparently reporting government data. However, GAO found that DOT
does not fully follow eight other key actions for transparently
reporting data on the drug and alcohol testing website, including: (1)
disclosing known data limitations (Recommendation 3) and (2) reaching
out to potential users in the public to encourage data use
(Recommendation 4). In addition, GAO stated that ``DOT currently does
not follow or partially follows six other key actions that may improve
the website. However, the immediate benefits and costs of following
these six actions are unclear because DOT has not reached out to users
to determine if the value of making changes to the website outweigh the
time and resources necessary to implement them.''
    Specifically with respect to Recommendation 4, GAO found that while
DOT's Office of Drug and Alcohol Policy and Compliance (ODAPC) ``does
discuss the modal administrations' drug and alcohol testing programs at
industry conferences, it does not discuss the public drug and alcohol
testing data.'' In addition to being a key action identified by GAO,
the OPEN Government Data Act \11\ requires agencies to develop a plan
to allow for collaboration with non-government entities, including
businesses, researchers, and the public, for the purpose of
understanding how data users value and use government data.
---------------------------------------------------------------------------

    \11\ The Open, Public, Electronic and Necessary Government Data
Act of 2018 (OPEN Government Data Act) is Title II of the
Foundations for Evidence-Based Policymaking Act of 2018 (Evidence
Act).
---------------------------------------------------------------------------

    GAO stated that `` potential users in the public may not be aware
of the website or potential uses of the data. For example, if aware
that the information is now publicly available, a motor carrier
employer could use the public drug and alcohol testing data to
understand how that individual employer's drug and alcohol testing
results compare to industry-wide results. However, because ODAPC has
not identified or reached out to potential users in the public,
officials cannot be certain the public is not interested in the data.
As a result, DOT does not know whether the website meets the
requirements for transparently providing data, or if additional
improvements could make this a more valuable resource for users.''

DOT Actions in Response to the GAO Report

    DOT concurred with each of the recommendations above.

Recommendations 1 and 3

    In response to Recommendation 1, DOT has committed to take action
to implement the steps recommended by GAO. Each operating
administration plans to conduct a review of its drug and alcohol data
collection process to identify additional process improvements, if any,
that should be taken to improve the reliability of the information it
collects. DOT expects to complete this action by June 30, 2022.
    In response to Recommendation 3, ODAPC posted the known data
limitations for FRA and FMCSA on the drug and alcohol testing website
in February 2022, beginning with the 2020 data.

Recommendation 4

    In response to Recommendation 4, ODAPC has discussed the
availability of the public drug and alcohol testing data on the DOT
website at numerous industry and government conferences and training
sessions, including at meetings of (1) the American Association of
Medical Review Officers, (2) the Drug and Alcohol Testing Industry
Association, (3) the Substance Abuse Program Administrators
Association, (4) HHS's Substance Abuse and Mental Health Services
Administration's Drug Testing Advisory Board, and (5) the FTA's annual
drug and alcohol conference.\12\
---------------------------------------------------------------------------

    \12\ In addition to the actions taken by ODAPC, as required by
GAO Recommendation 4, individual DOT modes have also discussed the
availability of the public drug and alcohol testing data during
presentations to industry groups.
---------------------------------------------------------------------------

    In addition, and consistent with the requirements of the OPEN
Government Data Act, DOT is publishing this Request for Information to
(1) increase awareness regarding the availability of the drug and
alcohol testing data on the DOT website, and (2) collaborate with, and
solicit input from, non-governmental entities such as stakeholders,
researchers, and the public to better understand how those users may
value and use the drug and alcohol testing data that is publicly
available on the website.

    Importantly, open government data only create value to the extent
that they are used. GAO--in a separate report \13\--has identified
three key actions for engaging with users:
---------------------------------------------------------------------------

    \13\ GAO Report GAO-19-72, titled ``Treasury Could Better Align
USAspending.gov with Key Practices and Search Requirements.''
---------------------------------------------------------------------------

    (1) Identify data users and their needs. By identifying who is
using the data and what content or features are important to them, data
providers can better prioritize their efforts to present information to
data consumers. From this:
    a. DOT requests information regarding what entities use the drug
and alcohol testing data on the DOT website.
    b. DOT requests information regarding how those entities use the
drug and alcohol testing data on the DOT website.
    (2) Solicit and be responsive to user feedback. Soliciting and
being responsive to user feedback--both when a website is being
developed and on an ongoing basis--can help ensure that the website
meets users' needs. Feedback can also surface issues with the
functionality of the website, thus enabling the data provider to make
corrections when needed. From this:
    a. DOT requests information regarding the functionality of the DOT
drug and alcohol testing data website, and whether users have specific
recommendations regarding possible improvements to the website that
would enhance the user's ability to use the available data.
    (3) Reach out to potential users to encourage data use. Actively
engaging potential users can provide an opportunity to educate them on
how the data can be appropriately used and encourage innovation. From
this:
    a. DOT primarily uses the drug and alcohol testing data to
determine the random testing rate for safety-sensitive employees in
each industry for the following year, and also sometimes to target
educational outreach to the industry. DOT requests information
regarding whether users envision other appropriate uses for the drug
and alcohol testing data on the DOT website.

Conclusion

    GAO noted that DOT's drug and alcohol testing website follows eight
of 16 key actions that GAO has previously identified for transparently
reporting government data. Two others--disclosing known data
limitations and reaching out to the public--are addressed through the
specific GAO recommendations discussed above. While GAO noted that DOT
does not fully follow six other key actions that could improve its drug
and alcohol testing website, GAO noted that the potential benefits and
costs of following those six actions are unclear because DOT has not
reached out to potential users. GAO stated that ``With a better
understanding of potential needs and uses of the data, DOT would be
able to determine whether implementing these actions would provide
benefits consistent with any implementation costs.''
    DOT will review and evaluate the comments received from potential
users that are submitted in response to this notice. If a broader
audience for the drug and alcohol testing data is identified, DOT will
engage with users to evaluate the benefits and costs of adopting
additional key actions for open government data and any other possible
improvements to the website.
    DOT seeks input on the questions set forth above and welcomes
comments from all interested parties.

Bohdan S. Baczara,
Deputy Director, Office of Drug and Alcohol Policy and Compliance.
[FR Doc. 2022-13985 Filed 6-29-22; 8:45 am]
BILLING CODE P