[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]]

[email protected]. 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, 
[email protected].

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, [email protected]. 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:

     [email protected].

     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