[Federal Register Volume 64, Number 112 (Friday, June 11, 1999)]
[Rules and Regulations]
[Pages 31505-31511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300878; FRL-6086-6]
RIN 2070-AB78
Sulfosate; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
sulfosate (the trimethylsulfonium salt of glyphosate, also known as
glyphosate-trimesium) in or on poultry meat by-products (mbyp) and in
cattle, goat, hog, sheep, and horse kidney and mbyp, except kidney.
This regulation increases the tolerances for residues of sulfosate in
cattle, goat, hog, sheep, and horse fat and meat; in milk; in eggs; in
or on soybean seed; in soybean hulls; and in aspirated grain fractions.
This regulation revokes the existing tolerances in poultry, cattle,
goat, hog, sheep, and horse liver and mbyp ( except liver). Zeneca Ag.
Products requested this tolerance under the Federal Food, Drug, and
Cosmetic Act, as amended by the Food Quality Protection Act of 1996.
DATES: This regulation is effective June 11, 1999. Objections and
requests for hearings must be received by EPA on or before August 10,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300878], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300878], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: opp-
[[Page 31506]]
docket@epa.gov. Copies of objections and hearing requests must be
submitted as an ASCII file avoiding the use of special characters and
any form of encryption. Copies of objections and hearing requests will
also be accepted on disks in WordPerfect 5.1/6.1 file format or ASCII
file format. All copies of objections and hearing requests in
electronic form must be identified by the docket control number [OPP-
300878]. No Confidential Business Information (CBI) should be submitted
through e-mail. Electronic copies of objections and hearing requests on
this rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Jim Tompkins, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail address: Rm. 239, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-305-5697,
tompkins.jim@epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of April 8, 1999 (64
FR 17171) (FRL-6071-2), EPA issued a notice pursuant to section 408 of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as
amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law
104-170) announcing the filing of a pesticide petition (PP) for
tolerance by Zeneca Ag Products, PO Box 751, Wilmington, DE 19897. This
notice included a summary of the petition prepared by Zeneca Ag
Products, the registrant. There were no comments received in response
to the notice of filing.
The petition requested that 40 CFR 180.489 be amended by
establishing tolerances for residues of the herbicide sulfosate, in or
on cattle, goat, hog, sheep, and horse kidney at 3.5 parts per million
(ppm); in cattle, goat, hog, sheep, and horse mbyp, except liver and
kidney, at 1.0 ppm (due to an error, this tolerance was listed as 2.5
ppm in the notice of filing, at 64 FR 17171); and to increase the
tolerance in cattle, goat, hog, sheep, and horse fat to 0.2 ppm; in
cattle, goat, hog, sheep, and horse meat to 0.6 ppm; in cattle, goat,
hog, sheep, and horse liver to 0.75 ppm; in milk to 1.1 ppm;; in or on
soybean seed to 21 ppm (of which no more than 13 ppm is TMS); in
soybean hulls to 45 ppm (of which no more than 25 ppm is TMS); and in
aspirated grain fractions to 1,300 ppm (of which no more than 720 ppm
is TMS).
Due to differences in methods for estimating residues in food
commodities and EPA policy in expressing tolerances for residues in
mbyp, liver, and kidney, EPA determined that modifications were needed
to the following proposed tolerances: kidney of cattle, hogs, sheep,
goats, and horses should be increased from 3.5 ppm to 6.0 ppm; meat by-
products should be expressed in terms of ``mbyp (except kidney)'' at
1.5 ppm (instead of the requested 1.0 ppm); meat of cattle, hogs,
sheep, goats, and horses should be increased from 0.6 ppm to 1.0 ppm;
fat of cattle, hogs, sheep, goats, and horses should be increased from
0.2 ppm to 0.5 ppm; and milk should be increased from 1.1 ppm to 1.5
ppm. An amended new tolerance was not requested for eggs; the existing
tolerance should be increased from 0.02 ppm to 0.05 ppm. In addition,
the current tolerances for liver and mbyp (except liver) of cattle,
hogs, sheep, goats, and horses should be deleted because they are
covered by ``mbyp (except kidney)''. The current tolerance for poultry
mbyp, now expressed as ``mbyp (except liver)'' should be expressed in
terms of ``mbyp'', and the tolerance for poultry liver should be
deleted because it is covered by the tolerance for ``mbyp''.
The differences in tolerances determined for these commodities are
due to the following. Zeneca used an average of residues measured at
the three dosing levels in animal feeding studies to estimate residues
for animal commodities. Because residues of the PMG ion (N-
(phosphonomethyl)glycine) measured in animal feeding studies were less
than the limit of quantitation (LOQ) at lower dosing levels, EPA used
residue levels measured at the highest dose rate (1,000 ppm) to
calculate residues, resulting in higher values for tolerances for some
animal commodities as described above. In addition, requested
tolerances for mbyp of cattle, hogs, sheep, goats, and horses were
expressed in terms of ''mbyp except kidney and liver``. However, the
tolerance levels are higher than those needed to cover residues in
liver and, therefore, liver is being deleted from the ``except''
clause. Similarly, existing tolerances for poultry mbyp must be revised
to express the tolerance in terms of ``poultry mbyp'' and to delete the
tolerance expressions for ``poultry mbyp (except liver)'' and ``poultry
liver''.
I. Background and Statutory Findings
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) 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)
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 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
II. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), 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 sulfosate
and to make a determination on aggregate exposure, consistent with
section 408(b)(2), for tolerances for residues of sulfosate in or on
soybean, seed at 21 ppm (of which no more than 13 ppm is TMS); soybean
hulls at 45 ppm (of which no more than 25 ppm is TMS); aspirated grain
fractions at 1,300 ppm (of which no more than 720 ppm is TMS); kidney
of cattle, hogs, sheep, goats, and horses at 6.0 ppm; mbyp (except
kidney) of cattle, hogs, sheep, goats, and horses at 1.5 ppm; meat of
cattle, hogs, sheep, goats, and horses at 1.0 ppm; fat of cattle, hogs,
sheep, goats, and horses at 0.5 ppm; milk at 1.5 ppm; poultry mbyp at
0.1 ppm; poultry meat at 0.05 ppm; poultry fat at 0.05 ppm; and eggs at
0.05 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has 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 risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by sulfosate are
[[Page 31507]]
discussed in Unit II. A. of the Federal Register document published on
September 11, 1998 (63 FR 48597)(FRL-6026-6). Please note that this
unit included a typographical error. In the discussion of the feeding
carcinogenicity study in mice, ``79'' should have been ``7.9'' in the
following phrase: ``In addition, there was increased incidence of white
matter degeneration in the lumbar region of the spinal cord (males
only) (2, 3, 4, 4, 79% response, controls to high dose)...''.
B. Toxicological Endpoints
The toxicological endpoints for sulfosate are discussed in Unit II.
B. of the Federal Register document published on September 11, 1998 (63
FR 48597).
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.489) for the residues of sulfosate in or on a variety of raw
agricultural commodities. Risk assessments were conducted by EPA to
assess dietary exposures from sulfosate as follows:
Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated for assessing chronic dietary risk only
if the Agency can make the following findings: That the data used are
reliable and provide a valid basis to show what percentage of the food
derived from such crop is likely to contain such pesticide residue;
that the exposure estimate does not underestimate exposure for any
significant subpopulation group; and if data are available on pesticide
use and food consumption in a particular area, the exposure estimate
does not understate exposure for the population in such area. In
addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of percent of crop treated (PCT) as required by the section
408(b)(2)(F), EPA may require registrants to submit data on PCT.
The Agency used PCT information as follows:
For the acute analysis, tolerance level residues and 100% crop
treated (CT) were used. For the chronic analysis, tolerance level
residues, anticipated residue levels for soybean commodities based on
field trial data, treatment of 20 percent of soybeans in the United
States with sulfosate, and PCT information obtained from public and
proprietary databases for other crops were used. To estimate percent of
crop treated, typically a range of estimates are supplied, and the
upper end of this range is assumed for the exposure assessment. By
using the upper end estimate of percent of crop treated, the Agency is
reasonably certain that exposure is not understated for any significant
subpopulation group. The registrant submitted a projected market share
percentage of 20% for soybeans. EPA scientists determined that this
value is a reasonable conservative usage estimate based on comparison
to the market share of other herbicides presently applied to herbicide-
tolerant crops. Therefore, 20% was used in the chronic analysis for
soybeans. For soybeans, the percent of the crop that can be treated
with sulfosate will be capped at 14,500,000 acres (20% of the 1998
soybean acreage) by the sulfosate registration.
The Agency believes that the three conditions, discussed in section
408 (b)(2)(F) in this unit concerning the Agency's responsibilities in
assessing chronic dietary risk findings, have been met. Based on the
above information, EPA finds that the PCT information is reliable and
has a valid basis. The regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the consumption of food bearing sulfosate in a
particular area.
i. Acute exposure and risk. Acute food 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. The %PADs (Populated adjusted dose, RfD
adjusted for 3x FQPA safety factor, %RfD/3) were below the Agency's
level of concern at the 95th percentile for the U.S. population and all
subgroups, with the highest exposure of 42% PAD in the subgroup all
infants (< 1="" year).="" the="" results="" of="" this="" analysis="" indicate="" that="" the="" acute="" risk="" from="" sulfosate="" residues="" on="" food="" is="" below="" the="" agency's="" level="" of="" concern.="" ii.="" chronic="" exposure="" and="" risk.="" the="" chronic="" food="" analysis="" for="" sulfosate="" was="" conducted="" using="" use="" anticipated="" residues="" for="" some="" commodities="" and="" pct="" information.="" tolerance="" level="" residue="" values="" were="" used="" for="" the="" majority="" of="" the="" commodities.="" the="" %pads="" were="" below="" hed's="" level="" of="" concern="" for="" the="" u.s.="" population="" and="" all="" subgroups,="" with="" the="" highest="" exposure="" of="" 26%="" pad="" in="" the="" subgroup="" children="" (1-6="" years="" old).="" the="" results="" of="" this="" analysis="" indicate="" that="" the="" chronic="" risk="" from="" sulfosate="" residues="" on="" food="" is="" below="" the="" agency's="" level="" of="" concern.="" 2.="" from="" drinking="" water.="" epa="" does="" not="" have="" monitoring="" data="" available="" to="" perform="" a="" quantitative="" drinking="" water="" risk="" assessment="" for="" sulfosate="" at="" this="" time.="" in="" a="" previous="" risk="" assessment="" for="" the="" use="" of="" sulfosate="" in/on="" corn,="" wheat,="" pome="" fruit,="" and="" soybeans,="" ground="" and="" surface="" water="" exposure="" estimates="" were="" calculated="" for="" sulfosate="" at="" a="" maximum="" annual="" application="" rate="" of="" 4.75="" lbs="" a.i./acre="" (see="" 63="" fr="" 48597).="" for="" this="" risk="" assessment="" for="" the="" use="" of="" sulfosate="" on="" soybeans,="" the="" agency="" estimated="" ground="" and="" surface="" water="" exposures="" using="" the="" values="" provided="" in="" the="" previous="" risk="" assessment="" and="" adjusting="" for="" the="" current="" maximum="" annual="" application="" rate="" of="" 8="" lbs="" a.i./acre.="" i.="" acute="" exposure="" and="" risk.="" estimated="" acute="" drinking="" water="" levels="" of="" concern="" (dwlocs)="" range="" from="" 2,000="" parts="" per="" billion="" (ppb)="" for="" infants="">< 1="" year="" old="" to="" 10,500="" ppb="" for="" the="" u.s.="" population.="" the="" estimated="" average="" concentration="" of="" sulfosate="" in="" surface="" water="" for="" acute="" exposure="" is="" 211="" ppb.="" the="" estimated="" average="" concentration="" of="" sulfosate="" in="" groundwater="" is="" 0.00377="" ppb.="" the="" estimated="" acute="" concentrations="" of="" sulfosate="" in="" surface="" water="" and="" groundwater="" are="" less="" than="" the="" acute="" dwlocs="" for="" sulfosate.="" therefore,="" taking="" into="" account="" the="" present="" uses="" and="" uses="" proposed="" in="" this="" action,="" opp="" concludes="" with="" reasonable="" certainty="" that="" residues="" of="" sulfosate="" in="" drinking="" water="" (when="" considered="" along="" with="" other="" sources="" of="" [[page="" 31508]]="" exposure="" for="" which="" opp="" has="" reliable="" data)="" would="" not="" result="" in="" unacceptable="" levels="" of="" acute="" aggregate="" human="" health="" risk="" at="" this="" time.="" ii.="" chronic="" exposure="" and="" risk.="" estimated="" chronic="" dwlocs="" range="" from="" 250="" ppb="" for="" children="" 1-6="" years="" old="" to="" 1,060="" ppb="" for="" the="" u.s.="" population.="" the="" estimated="" average="" concentration="" of="" sulfosate="" in="" surface="" water="" for="" chronic="" exposure="" is="" 20="" ppb.="" the="" estimated="" average="" concentration="" of="" sulfosate="" in="" groundwater="" is="" 0.00377="" ppb.="" the="" estimated="" chronic="" concentrations="" of="" sulfosate="" in="" surface="" water="" and="" groundwater="" are="" less="" than="" the="" chronic="" dwlocs="" for="" sulfosate.="" therefore,="" taking="" into="" account="" the="" present="" uses="" and="" uses="" proposed="" in="" this="" action,="" opp="" concludes="" with="" reasonable="" certainty="" that="" residues="" of="" sulfosate="" in="" drinking="" water="" (when="" considered="" along="" with="" other="" sources="" of="" exposure="" for="" which="" opp="" has="" reliable="" data)="" would="" not="" result="" in="" unacceptable="" levels="" of="" chronic="" aggregate="" human="" health="" risk="" at="" this="" time.="" 3.="" from="" non-dietary="" exposure.="" sulfosate="" is="" currently="" not="" registered="" for="" use="" on="" any="" residential="" non-food="" sites:="" therefore,="" residential="" exposure="" to="" sulfosate="" residues="" will="" be="" through="" dietary="" exposure="" only.="" 4.="" cumulative="" exposure="" to="" substances="" with="" common="" mechanism="" of="" toxicity.="" section="" 408(b)(2)(d)(v)="" 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.''="" epa="" does="" not="" have,="" at="" this="" time,="" available="" data="" to="" determine="" whether="" sulfosate="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances="" or="" how="" to="" include="" this="" pesticide="" in="" a="" cumulative="" risk="" assessment.="" unlike="" other="" pesticides="" for="" which="" epa="" has="" followed="" a="" cumulative="" risk="" approach="" based="" on="" a="" common="" mechanism="" of="" toxicity,="" sulfosate="" does="" not="" appear="" to="" produce="" a="" toxic="" metabolite="" produced="" by="" other="" substances.="" for="" the="" purposes="" of="" this="" tolerance="" action,="" therefore,="" epa="" has="" not="" assumed="" that="" sulfosate="" 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="" final="" rule="" for="" bifenthrin="" pesticide="" tolerances="" (62="" fr="" 62961,="" november="" 26,="" 1997).="" d.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" acute="" risk="" estimates="" associated="" with="" aggregate="" exposure="" to="" sulfosate="" in="" food="" and="" water="" do="" not="" exceed="" the="" agency's="" level="" of="" concern.="" the="" acute="" dietary="" analysis="" for="" sulfosate="" is="" a="" highly="" conservative="" estimate="" of="" dietary="" exposure="" conducted="" using="" tolerance="" level="" residue="" values="" and="" 100%ct.="" for="" the="" u.s.="" population,="" 10%="" of="" the="" pad="" is="" occupied="" by="" food="" exposure.="" for="" the="" most="" highly="" exposed="" subgroup,="" all="" infants="">< 1="" year),="" 42%="" of="" the="" pad="" is="" occupied="" by="" food="" exposure.="" the="" maximum="" estimated="" concentrations="" of="" sulfosate="" in="" surface="" and="" ground="" water="" are="" less="" than="" opp's="" dwlocs="" for="" sulfosate="" as="" a="" contribution="" to="" acute="" aggregate="" exposure.="" therefore,="" opp="" concludes="" with="" reasonable="" certainty="" that="" residues="" of="" sulfosate="" in="" drinking="" water="" do="" not="" contribute="" significantly="" to="" the="" acute="" aggregate="" human="" health="" risk="" at="" the="" present="" time="" considering="" the="" present="" uses="" and="" the="" uses="" proposed="" in="" this="" action.="" 2.="" chronic="" risk.="" using="" anticipated="" residues="" for="" soybean="" commodities;="" tolerance="" level="" residue="" values="" were="" used="" for="" the="" remaining="" commodities;="" %crop="" treated="" information="" for="" soybeans,="" oranges,="" grapefruit,="" corn,="" peaches="" and="" wheat;="" and="" exposure="" assumptions="" described="" in="" this="" unit,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" sulfosate="" from="" food="" will="" utilize="" 9%="" of="" the="" pad="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" children="" (1-6="" years="" old),="" discussed="" below.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" pad="" because="" the="" pad="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" despite="" the="" potential="" for="" exposure="" to="" sulfosate="" in="" drinking="" water,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" pad.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" sulfosate="" residues.="" 3.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" since="" there="" are="" no="" residential="" uses="" or="" exposure="" senarios,="" short-="" and="" intermediate-term="" aggregate="" exposure="" is="" not="" expected.="" 4.="" aggregate="" cancer="" risk="" for="" u.s.="" population.="" sulfosate="" was="" classified="" as="" a="" ``group="" e''="" carcinogen="" (no="" evidence="" for="" carcinogenicity="" in="" humans,="" see="" unit="" ii.b.4="" of="" the="" federal="" register="" document="" published="" on="" september="" 11,="" 1998="" (63="" fr="" 48597).="" 5.="" determination="" of="" safety.="" based="" on="" these="" risk="" assessments,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" sulfosate="" residues.="" e.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" infants="" and="" children="" 1.="" safety="" factor="" for="" infants="" and="" children--="" i.="" in="" general.="" the="" determination="" of="" the="" 3x="" safety="" factor="" for="" infants="" and="" children="" is="" discussed="" in="" unit="" ii.e.1.i.="" of="" the="" federal="" register="" document="" published="" on="" september="" 11,="" 1998="" (63="" fr="" 48597).="" ii.="" developmental="" toxicity="" studies.="" developmental="" toxicity="" is="" discussed="" in="" unit="" ii.e.1.ii.="" of="" the="" federal="" register="" document="" published="" on="" september="" 11,="" 1998="" (63="" fr="" 48597).="" iii.="" reproductive="" toxicity="" study.="" reproductive="" toxicity="" is="" discussed="" in="" unit="" ii.e.1.iii.="" of="" the="" federal="" register="" document="" published="" on="" september="" 11,="" 1998="" (63="" fr="" 48597).="" iv.="" pre-="" and="" post-natal="" sensitivity.="" pre-="" and="" post-natal="" sensitivity="" is="" discussed="" in="" unit="" ii.e.1.iv.="" of="" the="" federal="" register="" document="" published="" on="" september="" 11,="" 1998="" (63="" fr="" 48597).="" v.="" conclusion.="" with="" the="" exception="" of="" the="" requested="" developmental="" neurotoxicity="" study,="" there="" is="" a="" complete="" toxicity="" database="" for="" sulfosate="" and="" exposure="" data="" is="" complete="" or="" is="" estimated="" based="" on="" data="" that="" reasonably="" accounts="" for="" potential="" exposures.="" 2.="" acute="" risk.="" acute="" risk="" estimates="" associated="" with="" aggregate="" exposure="" to="" sulfosate="" in="" food="" and="" water="" do="" not="" exceed="" the="" agency's="" level="" of="" concern.="" the="" acute="" food="" analysis="" for="" sulfosate="" is="" a="" highly="" conservative="" estimate="" of="" food="" exposure="" with="" the="" use="" of="" tolerance="" level="" residue="" values="" and="" 100%ct.="" for="" the="" most="" highly="" exposed="" subgroup,="" all="" infants="">< 1="" year),="" 42%="" of="" the="" pad="" is="" occupied="" by="" food="" exposure.="" the="" maximum="" estimated="" concentrations="" of="" sulfosate="" in="" surface="" and="" ground="" water="" are="" less="" than="" epa's="" dwlocs="" for="" sulfosate="" infants="" and="" children="" as="" a="" contribution="" to="" acute="" aggregate="" exposure.="" therefore,="" epa="" concludes="" with="" reasonable="" certainty="" that="" residues="" of="" sulfosate="" in="" drinking="" water="" do="" not="" contribute="" significantly="" to="" the="" acute="" aggregate="" human="" health="" risk="" at="" the="" present="" time="" considering="" the="" present="" uses="" and="" the="" uses="" proposed="" in="" this="" action.="" 3.="" chronic="" risk.="" using="" the="" exposure="" assumptions="" described="" in="" this="" unit,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" sulfosate="" from="" food="" will="" utilize="" 26="" percent="" of="" the="" rfd="" for="" infants="" and="" [[page="" 31509]]="" children.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" pad="" because="" the="" pad="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" despite="" the="" potential="" for="" exposure="" to="" sulfosate="" in="" drinking="" water,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" pad="" rfd.="" 4.="" determination="" of="" safety.="" based="" on="" these="" risk="" assessments,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" sulfosate="" residues.="" iii.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" nature="" of="" the="" residues="" in="" plants="" and="" animals="" is="" understood.="" epa="" has="" determined="" that="" the="" tolerance="" expression="" for="" sulfosate="" must="" include="" both="" of="" the="" parent="" ions.="" b.="" analytical="" enforcement="" methodology="" analytical="" enforcement="" methodology="" for="" sulfosate="" is="" discussed="" in="" unit="" iii.b.="" of="" the="" federal="" register="" document="" published="" on="" september="" 11,="" 1998="" (63="" fr="" 48597).="" adequate="" enforcement="" methodology="" (example="" -="" gas="" chromotography)="" is="" available="" to="" enforce="" the="" tolerance="" expression.="" the="" method="" may="" be="" requested="" from:="" calvin="" furlow,="" prrib,="" irsd="" (7502c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" office="" location="" and="" telephone="" number:="" rm="" 101ff,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va,="" (703)="" 305-5229.="" c.="" magnitude="" of="" residues="" the="" crop="" field="" trial="" data="" are="" adequate="" to="" support="" these="" tolerances.="" d.="" international="" residue="" limits="" there="" are="" no="" codex,="" canadian="" or="" mexican="" tolerances="" or="" maximum="" residue="" limits="" for="" residues="" of="" sulfosate="" in="" the="" subject="" commodities.="" therefore,="" a="" compatibility="" issue="" is="" not="" relevant="" to="" the="" proposed="" tolerances.="" e.="" rotational="" crop="" restrictions="" epa="" has="" previously="" reviewed="" two="" confined="" rotational="" crop="" studies="" for="" sulfosate="" and="" concluded="" that="" rotational="" crop="" restrictions="" were="" not="" required.="" iv.="" conclusion="" therefore,="" the="" tolerances="" are="" established="" for="" residues="" of="" sulfosate="" in="" soybean="" seed="" at="" 21="" ppm="" (of="" which="" no="" more="" than="" 13="" ppm="" is="" tms);="" soybean="" hulls="" at="" 45="" ppm="" (of="" which="" no="" more="" than="" 25="" ppm="" is="" tms);="" aspirated="" grain="" fractions="" at="" 1,300="" ppm="" (of="" which="" no="" more="" than="" 720="" ppm="" is="" tms);="" kidney="" of="" cattle,="" hogs,="" sheep,="" goats,="" and="" horses="" at="" 6.0="" ppm;="" mbyp="" (except="" kidney)="" of="" cattle,="" hogs,="" sheep,="" goats,="" and="" horses="" at="" 1.5="" ppm;="" meat="" of="" cattle,="" hogs,="" sheep,="" goats,="" and="" horses="" at="" 1.0="" ppm;="" fat="" of="" cattle,="" hogs,="" sheep,="" goats,="" and="" horses="" at="" 0.5="" ppm;="" milk="" at="" 1.5="" ppm;="" poultry="" mbyp="" at="" 0.1="" ppm;="" and="" eggs="" at="" 0.05="" ppm.="" in="" addition,="" the="" current="" tolerances="" for="" liver="" and="" mbyp="" (except="" liver)="" of="" cattle,="" hogs,="" sheep,="" goats,="" horses,="" and="" poultry="" are="" revoked.="" v.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" august="" 10,="" 1999,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" under="" the="" ``addresses''="" section="" (40="" cfr="" 178.20).="" a="" copy="" of="" the="" objections="" and/or="" hearing="" requests="" filed="" with="" the="" hearing="" clerk="" should="" be="" submitted="" to="" the="" opp="" docket="" for="" this="" regulation.="" the="" objections="" submitted="" must="" specify="" the="" provisions="" of="" the="" regulation="" deemed="" objectionable="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" each="" objection="" must="" be="" accompanied="" by="" the="" fee="" prescribed="" by="" 40="" cfr="" 180.33(i).="" epa="" is="" authorized="" to="" waive="" any="" fee="" requirement="" ``when="" in="" the="" judgement="" of="" the="" administrator="" such="" a="" waiver="" or="" refund="" is="" equitable="" and="" not="" contrary="" to="" the="" purpose="" of="" this="" subsection.''="" for="" additional="" information="" regarding="" tolerance="" objection="" fee="" waivers,="" contact="" james="" tompkins,="" registration="" division="" (7505c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" office="" location,="" telephone="" number,="" and="" e-mail="" address:="" rm.="" 239,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va,="" (703)="" 305-5697,="">tompkins.jim@epa.gov. Requests for
waiver of tolerance objection fees should be sent to James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon
by the requestor (40 CFR 178.27). A request for a hearing will be
granted if the Administrator determines that the material submitted
shows the following: There is genuine and substantial issue of fact;
there is a reasonable possibility that available evidence identified by
the requestor would, if established, resolve one or more of such issues
in favor of the requestor, taking into account uncontested claims or
facts to the contrary; and resolution of the factual issues in the
manner sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). Information submitted in connection with an
objection or hearing request may be claimed confidential by marking any
part or all of that information as CBI. Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2. A copy of the information that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice.
VI. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300878] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
opp-docket@epa.gov.
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit will be kept in
[[Page 31510]]
paper form. Accordingly, EPA will transfer any copies of objections and
hearing requests received electronically into printed, paper form as
they are received and will place the paper copies in the official
record which will also include all comments submitted directly in
writing. The official record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance 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). 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 prior consultation as specficed by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(d), such as the
tolerance 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. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a generic matter, that there is no
adverse economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
VIII. Submission to Congress and the Comptroller General
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 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 the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
[[Page 31511]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 8, 1999.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), (346a), and 371.
2. In Sec. 180.489 the table to paragraph (a) is amended as
follows:
i. By removing the complete entries for cattle, liver; cattle, mbyp
except liver; goats, liver; goats, mbyp, except liver; hogs, liver;
hogs, mbyp except liver; horses, liver; horses, mbyp except liver;
poultry, liver; poultry, mbyp except liver; sheep, liver; and sheep,
mbyp except liver.
ii. By revising the entries for aspirated grain fractions; cattle,
fat; cattle, meat; eggs; goats, fat; goats, meat; hogs, fat; hogs,
meat; horses, fat; horses, meat; milk; sheep, fat; sheep, meat;
soybean, hulls; and soybean, seed.
iii. By adding entries for cattle, kidney; cattle, mbyp (except
kidney); goats, kidney; goats, mbyp (except kidney); hogs, kidney;
hogs, mbyp (except kidney); horses, kidney; horses, mbyp (except
kidney); poultry, mbyp; sheep, kidney; and sheep, mbyp (except kidney).
The additions and revisions read as follows:
Sec. 180.489 Sulfosate (Sulfonium, trimethyl-salt with N-
(phosphonomethyl)glycine (1:1)); tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Aspirated grain fractions (of which no more than 720 ppm is 1,300
TMS)......................................................
* * * * *
Cattle, fat................................................ 0.5
Cattle, kidney............................................. 6.0
Cattle, mbyp (except kidney)............................... 1.5
Cattle, meat............................................... 1.0
* * * * *
Eggs....................................................... 0.05
Goats, fat................................................. 0.5
Goats, kidney.............................................. 6.0
Goats, mbyp (except kidney)................................ 1.5
Goats, meat................................................ 1.0
* * * * *
Hogs, fat.................................................. 0.5
Hogs, kidney............................................... 6.0
Hogs, mbyp (except kidney)................................. 1.5
Hogs, meat................................................. 1.0
Horses, fat................................................ 0.5
Horses, kidney............................................. 6.0
Horses, mbyp (except kidney)............................... 1.5
Horses, meat............................................... 1.0
Milk....................................................... 1.5
* * * * *
Poultry, mbyp.............................................. 0.1
* * * * *
Sheep, fat................................................. 0.5
Sheep, kidney.............................................. 6.0
Sheep, mbyp (except kidney)................................ 1.5
Sheep, meat................................................ 1.0
* * * * *
Soybean, hulls (of which no more than 25 ppm is TMS)....... 45
Soybean, seed (of which no more than 13 ppm is TMS)........ 21
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-14994 Filed 6-10-99; 8:45 am]
BILLING CODE 6560-50-F
