Professional Documents
Culture Documents
Rule: Animal Drugs, Feeds, and Related Products: Selenium Yeast in Feed and Drinking Water
Rule: Animal Drugs, Feeds, and Related Products: Selenium Yeast in Feed and Drinking Water
In support of its assertion, Public previously, a hearing will not be granted DEPARTMENT OF HEALTH AND
Citizen references a report from the on the basis of general descriptions of HUMAN SERVICES
International Consultative Group on positions and contentions (see
Food Irradiation titled ‘‘The § 12.24(b)(1) and (b)(2)). Public Citizen’s Food and Drug Administration
Development of X-Ray Machines for third objection relied on information
Food Irradiation (Proceedings of a that, even if established at a hearing, 21 CFR Part 573
Consultants’ Meeting),’’ dated October would not be adequate to justify
1995 (ICGFI report), for its statement [Docket No. 1998F–0196] (Formerly 98F–
resolution of the factual issue in the way 0196)
that ‘‘neutron activity produced by 5 sought by the objector. A hearing will be
MeV x-rays is in the order of 60 times Food Additives Permitted in Feed and
denied if the information submitted are
greater than that produced by 10 MeV Drinking Water of Animals; Selenium
insufficient to justify the factual
electrons.’’ Yeast
However, contrary to Public Citizen’s determination urged, even if accurate
objection, the ICGFI report shows that (§ 12.24(b)(3)). The issues posed by AGENCY: Food and Drug Administration,
the difference in expected neutron Public Citizen in support of the HHS
activation in irradiated food from objections do not justify the granting of
ACTION: Final rule.
electron beams and x-rays has been a hearing.
calculated, thereby permitting use of V. Summary and Conclusions SUMMARY: The Food and Drug
electron beam studies to estimate Administration (FDA) is amending the
neutron activation expected from The safety of x-rays produced by a regulations for food additives permitted
irradiation with x-rays. Public Citizen machine source at energies of 10 MeV (FAP) in feed to provide for the safe use
has offered no evidence to support its or lower, to inspect food irradiated at of selenium yeast as a source of
assertion that electron beam studies are doses up to 0.5 Gy has been thoroughly supplemental selenium in feed
inappropriate to support conclusions tested, and the data have been reviewed supplements for limit feeding for beef
about x-ray irradiation. FDA is denying by the agency. As discussed previously, cattle and in salt mineral mixes for free-
the request for a hearing on this point choice feeding for beef cattle. This
FDA concluded that the available
because the evidence submitted by action is in response to an amendment
studies establish the safety of food for
Public Citizen in support of their of a food additive petition filed by
argument, even if established at a human consumption irradiated at doses
Alltech, Inc.
hearing, would not be adequate to up to 0.5 Gy as a result of being
subjected to x-rays produced by a DATES: This rule is effective July 19,
justify resolution of the factual issue in 2007. Submit written or electronic
the way sought by the objector machine source at energies of 10 MeV
or lower. The petitioner has the burden objections and requests for a hearing by
(§ 12.24(b)(3)). August 20, 2007. See section V of this
Moreover, it bears noting that the to demonstrate safety before FDA can
document for information on the filing
ICGFI report directly supports FDA’s approve the use of a food additive.
of objections.
conclusion of safety in the final rule, Nevertheless, once the agency makes a
when it cites 10 MeV x-rays at doses finding of safety in an approval ADDRESSES: You may submit written or
less than 0.5 Gy (the maximum energy document, the burden shifts to an electronic objections and requests for a
and dosage in the final rule) as an objector, who must come forward with hearing identified by Docket No. 1998F–
example of ‘‘extremely low’’ dosage that 0196, by any of the following methods:
evidence that calls into question FDA’s
‘‘would not produce any significant Electronic Submissions
conclusion (American Cyanamid Co. v.
radioactivity.’’ Public Citizen’s reference Submit electronic objections in the
FDA, 606 F. 2d 1307, 1314–1315 (D.C.
to the conclusion in the ICGFI report following ways:
Cir. 1979)). For the reasons set out • Federal eRulemaking Portal: http://
that ‘‘increasing the energy of x-rays previously, the objections do not raise
above 7.5 MeV would result in * * * www.regulations.gov. Follow the
genuine and substantial issues of fact instructions for submitting comments.
possible induction of radioactivity in
supported by specifically identified • Agency Web site: http://
the irradiated food’’ is unavailing
because that conclusion refers to the reliable evidence that, if established at www.fda.gov/dockets/ecomments.
uses permitted by the Codex a hearing would be adequate to justify Follow the instructions for submitting
Alimentarius Commission for treating resolution in the way sought by Public comments on the agency Web site.
food at dosages up to 10 kGy, which is Citizen. Therefore, Public Citizen’s Written Submissions
20,000 times higher than the 0.5 Gy objections are not sufficient to justify a Submit written objections in the
maximum dosage permitted by the final hearing under the requirements of following ways:
rule for inspecting food. § 12.24(b). Accordingly, FDA is • Fax: 301–827–6870.
Although Public Citizen alleged that overruling the objections and is denying • Mail/Hand delivery/Courier [For
the studies that FDA evaluated do not the requests for a hearing. paper, disk, or CD–ROM submissions]:
support the safety of x-rays of 10 MeV Dated: July 11, 2007.
Division of Dockets Management (HFA–
or lower used for inspection of cargo 305), Food and Drug Administration,
containers that may contain food, Public Jeffrey Shuren, 5630 Fishers Lane, rm. 1061, Rockville,
Citizen did not present any evidence Assistant Commissioner for Policy. MD 20852.
that would have led to a different [FR Doc. E7–13947 Filed 7–18–07; 8:45 am] To ensure more timely processing of
conclusion concerning the safety of the BILLING CODE 4160–01–S objections, FDA is no longer accepting
subject additive. Because Public objections submitted to the agency by e-
cprice-sewell on PROD1PC66 with RULES
Citizen’s first and second objections mail. FDA encourages you to continue
provided no information to support to submit electronic objections by using
their assertions regarding FDA’s safety the Federal eRulemaking Portal or the
review, they provide no basis for FDA agency Web site, as described in the
to reconsider its decision to issue the Electronic Submissions portion of this
cargo inspection final rule. As noted paragraph.
VerDate Aug<31>2005 13:36 Jul 18, 2007 Jkt 211001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\19JYR1.SGM 19JYR1
Federal Register / Vol. 72, No. 138 / Thursday, July 19, 2007 / Rules and Regulations 39561
Instructions: All submissions received selenium in feed supplements for limit are to be submitted and are to be
must include the agency name and feeding for beef cattle and in salt identified with the docket number
docket number for this rulemaking. All mineral mixes for free-choice feeding for found in brackets in the heading of this
objections received will be posted beef cattle. The notice of filing provided document. Any objections received in
without change to http://www.fda.gov/ for a 60-day comment period on the response to the regulation may be seen
ohrms/dockets/default.htm, including petitioner’s environmental assessment. in the Division of Dockets Management
any personal information provided. For No substantive comments have been between 9 a.m. and 4 p.m., Monday
detailed instructions on submitting received. through Friday.
objections, see the ‘‘Objections’’ heading
II. Conclusion List of Subjects in 21 CFR Part 573
of the SUPPLEMENTARY INFORMATION
section of this document. FDA concludes that the data establish Animal feeds, Food additives.
Docket: For access to the docket to the safety and utility of selenium yeast, ■ Therefore, under the Federal Food,
read background documents or for use as proposed and that the food Drug, and Cosmetic Act and under
objections received, go to http:// additive regulations should be amended authority delegated to the Commissioner
www.fda.gov/ohrms/dockets/ as set forth in this document. of Food and Drugs and redelegated to
default.htm and insert the docket III. Public Disclosure the Center for Veterinary Medicine, 21
number, found in brackets in the CFR part 573 is amended as follows:
heading of this document, into the In accordance with § 571.1(h) (21 CFR
‘‘Search’’ box and follow the prompts 571.1(h)), the petition and the PART 573—FOOD ADDITIVES
and/or go to the Division of Dockets documents that FDA considered and PERMITTED IN FEED AND DRINKING
Management, 5630 Fishers Lane, rm. relied upon in reaching its decision to WATER OF ANIMALS
1061, Rockville, MD 20852. approve the petition will be made
available for inspection at the Center for ■ 1. The authority citation for 21 CFR
FOR FURTHER INFORMATION CONTACT:
Veterinary Medicine by appointment part 573 continues to read as follows:
Isabel W. Pocurull, Center for Veterinary
with the information contact person (see
Medicine (HFV–226), 7519 Standish Pl., Authority: 21 U.S.C. 321, 342, 348.
FOR FURTHER INFORMATION CONTACT). As
Rockville, MD 20855, 240–453–6853. ■ 2. Section 573.920 is amended by
provided in § 571.1(h), the agency will
SUPPLEMENTARY INFORMATION: delete from the documents any revising paragraph (h) to read as
materials that are not available for follows:
I. Background
public disclosure before making the § 573.920 Selenium.
In a notice published in the Federal documents available for inspection.
Register of May 12, 1998 (63 FR 26193), * * * * *
FDA announced that a food additive IV. Environmental Impact (h) Selenium yeast is a dried, non-
petition (animal use) (FAP 2238) had The agency has determined under 21 viable yeast (Saccharomyces cerevisiae)
been filed by Alltech Biotechnology CFR 25.32(r), that this action is of a type cultivated in a fed-batch fermentation
Center, 3031 Catnip Hill Pike, that does not individually or which provides incremental amounts of
Nicholasville, KY 40356. The petition cumulatively have a significant effect on cane molasses and selenium salts in a
proposed to amend the food additive the human environment. Therefore, manner which minimizes the
regulations in § 573.920 Selenium (21 neither an environmental assessment, detrimental effects of selenium salts on
CFR 573.920) to provide for the safe use nor an environmental impact statement the growth rate of the yeast and allows
of selenium yeast as a source of is required. for optimal incorporation of inorganic
selenium in feeds for poultry, swine, selenium into cellular organic material.
and cattle. Based on the information in V. Objections and Hearing Requests Residual inorganic selenium is
the petition, the selenium food additive Any person who will be adversely eliminated in a rigorous washing
regulation was amended to include the affected by this regulation may file with process and must not exceed 2 percent
use of selenium yeast in feed for the Division of Dockets Management of the total selenium content in the final
chickens on June 6, 2000 (65 FR 35823). (see ADDRESSES) written or electronic selenium yeast product.
FDA sought additional data from the objections. Each objection shall be (1) Selenium, as selenium yeast, is
sponsor before approving use in other separately numbered, and each added to feed as follows:
species. After these data were submitted numbered objection shall specify with (i) In complete feed for chickens,
for turkeys and swine, the selenium particularity the provisions of the turkeys, swine, beef cattle, and dairy
food additive regulation was amended regulation to which objection is made cattle at a level not to exceed 0.3 part
to extend the use of selenium yeast in and the grounds for the objection. Each per million.
the complete feeds of turkeys and swine numbered objection on which a hearing (ii) In feed supplements for limit
on July 17, 2002 (67 FR 46850). is requested shall specifically so state. feeding for beef cattle at a level not to
Additional data submitted by the Failure to request a hearing for any exceed an intake of 3 milligrams per
sponsor and further amendments to the particular objection shall constitute a head per day.
petition provided information to extend waiver of the right to a hearing on that (iii) In salt-mineral mixtures for free-
the use to beef and dairy cattle. Based objection. Each numbered objection for choice feeding for beef cattle up to 120
on the information in the petition, the which a hearing is requested shall parts per million in a mixture for free-
selenium food additive regulation was include a detailed description and choice feeding at a rate not to exceed an
again amended to include the use of analysis of the specific factual intake of 3 milligrams per head per day.
selenium yeast in the complete feed of information intended to be presented in (2) Guaranteed organic selenium
cprice-sewell on PROD1PC66 with RULES
beef and dairy cattle on September 3, support of the objection in the event content from selenium yeast must be
2003 (68 FR 52339). Additional data that a hearing is held. Failure to include declared on the selenium yeast product
submitted by the sponsor and further such a description and analysis for any label.
amendments to the petition provided particular objection shall constitute a (3) The additive, as selenium yeast,
information for safe use of selenium waiver of the right to a hearing on the shall be incorporated into feed as
yeast as a source of supplemental objection. Three copies of all documents follows:
VerDate Aug<31>2005 13:36 Jul 18, 2007 Jkt 211001 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 E:\FR\FM\19JYR1.SGM 19JYR1
39562 Federal Register / Vol. 72, No. 138 / Thursday, July 19, 2007 / Rules and Regulations
(i) It shall be incorporated into each apprenticeship or other on-the-job paying the 2005 and 2006 fiscal year
ton of complete feed by adding no less training is applied retroactively to increases effective October 1, 2004 and
than 1 pound of a premix containing no October 1, 2005, to conform to statutory October 1, 2005 respectively.
more than 272.4 milligrams of added requirements. The changes in the break-
II. Increase in the Percentage of Basic
selenium per pound. pay regulations contained in 38 CFR Educational Assistance Payable to
(ii) It shall be incorporated into each 21.7640 are effective July 19, 2007. Reservists Pursuing Apprenticeship or
ton of salt-mineral mixture for beef FOR FURTHER INFORMATION CONTACT: Other On-the-Job Training
cattle from a premix containing no more Brandye R. Kidd, Management and
than 4.5 grams of added selenium per Program Analyst, Education Service The Veterans Benefits Improvement
pound. (225C), Veterans Benefits Act of 2004, Public Law 108–454,
(4) Usage of this additive must Administration, Department of Veterans temporarily increased the percentages
conform to the requirements of Affairs, 810 Vermont Avenue, NW., payable for apprenticeship and other
paragraphs (e) and (f) of this section. Washington, DC 20420, telephone (202) on-the-job training from 75 percent, 55
Dated: July 6, 2007. 273–7420. (This is not a toll-free percent, and 35 percent, to 85 percent,
number.) 65 percent, and 45 percent of the full-
Stephen F. Sundlof,
time rate of basic educational assistance,
Director, Center for Veterinary Medicine. SUPPLEMENTARY INFORMATION: respectively, after September 30, 2005,
[FR Doc. E7–13954 Filed 7–18–07; 8:45 am] and before January 1, 2008.
I. Increase in MGIB–SR Monthly Rates
BILLING CODE 4160–01–S VA began paying the increased rates
Under the formula mandated by 10 for reservists pursuing apprenticeship or
U.S.C. 16131(b), the rates of basic other on-the-job training effective
DEPARTMENT OF DEFENSE educational assistance under the MGIB– October 1, 2005, in accordance with
SR payable to students pursuing a Public Law 108–454.
DEPARTMENT OF HOMELAND program of education full-time, three-
SECURITY quarter-time, and half-time must be III. Changes to Education Break-Pay
increased by the percentage by which Regulations Including the Removal of
Coast Guard the total monthly Consumer Price Obsolete Provisions
Index-W for the 12-month period ending We are amending 38 CFR 21.7640(b)
DEPARTMENT OF VETERANS on June 30 preceding the fiscal year to remove obsolete provisions and
AFFAIRS during which the increase is applicable provide greater clarity of regulations
exceeds the Consumer Price Index-W for regarding benefit payments for school
38 CFR Part 21 the 12-month period ending on June 30 break periods between terms. In 2003,
the previous fiscal year. Using this 38 CFR 21.4138(f), governing payment
RIN 2900–AM50
formula, VA calculated a 2 percent for breaks between terms, quarters or
Increase in Rates Payable Under the increase for fiscal year 2005 and a 3 semesters, was amended to conform to
Montgomery GI Bill—Selected Reserve percent increase for fiscal year 2006. statutory requirements. The final rule
and Other Miscellaneous Issues Section 16131(b) also requires that VA was published June 9, 2003, in the
pay reservists, who are pursuing a Federal Register (68 FR 34327–34332).
AGENCIES: Department of Defense, program of education at less than half- The preamble to that final rule states
Department of Homeland Security time, an appropriately reduced rate. that changes made to § 21.4138(f) are
(United States Coast Guard), and Since payment for less than half-time applicable to the Montgomery GI Bill—
Department of Veterans Affairs. educational programs became available Active Duty, Survivors’ and
ACTION: Final rule. under the MGIB–SR in fiscal year 1990, Dependents’ Educational Assistance
VA has paid less than half-time students Program, Veterans Educational
SUMMARY: This document amends at 25 percent of the full-time rate. In this Assistance Program, and MGIB–SR.
Department of Veterans Affairs (VA) rule, VA continues that practice and Although we amended the language in
regulations to increase the monthly rates will pay eligible reservists 25 percent of § 21.4138(f) in that final rule, we
of basic educational assistance payable the increased full-time rate described neglected to make a conforming
under the Montgomery GI Bill— above. amendment to § 21.7640(b) regarding
Selected Reserve (MGIB–SR) program Section 16131(d) requires that payment for breaks, including intervals
for fiscal years 2005 and 2006 in reservists pursuing a full-time program between terms. This document amends
accordance with statutory requirements, of apprenticeship or other on-the-job the language in the aforementioned
increase the percentage of basic training be paid a percentage of the section in accordance with statutory
educational assistance payable to basic educational monthly rate. Benefits requirements and the previously
reservists pursuing apprenticeship or for the first 6 months of training, the published rule.
other on-the-job training in accordance second 6 months of training, and the The changes to the break-pay
with the Veterans Benefits Act of 2004, remainder of the program, are payable at regulations, including the removal of
and remove obsolete education break- 75 percent, 55 percent, and 35 percent obsolete provisions, are effective from
pay provisions. respectively. Based on the section July 19, 2007.
DATES: Effective Date: This final rule is 16131(b) formula described above, there
effective July 19, 2007. is a 2 percent increase for the Administrative Procedure Act
Applicability Dates: The changes in apprenticeship and other on-the-job Changes to 38 CFR part 21 are being
the MGIB–SR rates for fiscal years 2005 training pursued during fiscal year 2005 published without regard to the notice-
cprice-sewell on PROD1PC66 with RULES
and 2006 are applied retroactively to and a 3 percent increase for training and-comment and delayed-effective-
October 1, 2004, and October 1, 2005, during fiscal year 2006. date provisions of 5 U.S.C. 553 since
respectively to conform to statutory The increase in the MGIB–SR rates are they merely conform VA’s existing rules
requirements. The change in the applied in accordance with the to the statutory requirements.
percentage of basic educational applicable statutory provisions Accordingly, these changes involve
assistance payable to reservists pursuing discussed above. Thus, VA began interpretive rules that are exempt from
VerDate Aug<31>2005 13:36 Jul 18, 2007 Jkt 211001 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 E:\FR\FM\19JYR1.SGM 19JYR1