firm through the collection of documentation that the 
manufacturer submitting the notification performed, or is 
performing, appropriate corrective action. The manufac-
turer shall make such documentation available to the Sec-
retary during an inspection and, upon request of the Sec-
retary, electronically or by other means.’’. 
SEC. 8. ENVIRONMENTAL MONITORING. 
Section 412 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 350a) is amended by adding at the end 
the following: 
‘‘(n) REQUIREMENTS FOR ENVIRONMENTAL MONI-
TORING FOR CRONOBACTER SPP AND SALMONELLA.— 
‘‘(1) IN
GENERAL.—A manufacturer of pow-
dered infant formula shall establish and implement 
an environmental monitoring program to verify the 
effectiveness of sanitation and hygiene controls 
where the food has the potential to be exposed to 
Cronobacter spp. or Salmonella. The environmental 
monitoring program shall be written and include 
procedures for determining sampling location, num-
ber of samples to be taken, and timing and fre-
quency of sample collection and testing. 
‘‘(2) SAMPLING
LOCATION
AND
NUMBER
OF 
SAMPLES.—A manufacturer of powdered infant for-
mula shall ensure that the sampling locations from 
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which samples will be taken, and the number of sites 
to be tested during routine environmental moni-
toring pursuant to an environmental monitoring pro-
gram under paragraph (1), are adequate to deter-
mine whether sanitation and hygiene controls are ef-
fective. 
‘‘(3) TIMING
AND
FREQUENCY.—A manufac-
turer of powdered infant formula shall ensure that 
the timing and frequency for collecting testing sam-
ples pursuant to an environmental monitoring pro-
gram under paragraph (1) are adequate to deter-
mine whether sanitation and hygiene controls are ef-
fective. 
‘‘(4) RECORDS.— 
‘‘(A) AVAILABILITY TO THE SECRETARY.— 
A manufacturer of powdered infant formula 
shall make all records required under this sub-
section available promptly to the Secretary, 
upon request, for inspection and copying. 
‘‘(B) MAINTENANCE.—Records of environ-
mental monitoring conducted pursuant to this 
subsection shall be maintained for not less than 
2 years or the shelf-life of the infant formula, 
whichever is longer. 
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‘‘(C) CONDITIONS
OF
INSPECTION.—Any 
records that the Secretary may inspect under 
this subsection shall, upon the request of the 
Secretary, be provided to the Secretary by the 
manufacturer of powdered infant formula, in 
advance of or in lieu of an inspection, within a 
reasonable timeframe, within reasonable limits, 
and in a reasonable manner, and in either elec-
tronic or physical form, at the expense of such 
manufacturer. The Secretary’s request shall in-
clude a sufficient description of the records re-
quested. 
‘‘(D) CONFIRMATION OF RECEIPT.—Upon 
receipt of records requested under subpara-
graph (C), the Secretary shall provide to the 
person confirmation of receipt. 
‘‘(5) AUTHORITY OF THE SECRETARY.—Noth-
ing in this subsection supplants the authority of the 
Secretary to conduct inspections otherwise permitted 
under this Act in order to ensure compliance with 
this Act. 
‘‘(6) DELAYED
APPLICABILITY.—The require-
ments of this subsection apply beginning on the date 
that is 180 days after the date of enactment of this 
subsection. 
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‘‘(7) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed to exempt an in-
fant formula manufacturer from the requirements of 
this Act, including the requirements of this section 
and section 418.’’. 
Æ 
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